Hearings to examine proposed budget estimates for fiscal year 2026 for the Department of Agriculture.

1[Senate Hearing 119-061]2[From the U.S. Government Publishing Office]34                                                        S. Hrg. 119-06156   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND7          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 202689=======================================================================1011                                HEARINGS1213                                before a1415                          SUBCOMMITTEE OF THE1617            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE1819                    ONE HUNDRED NINETEENTH CONGRESS2021                             FIRST SESSION2223                                   on2425                           H.R. 4121/S. 22562627 AN ACT MAKING APPROPRIATIONS FOR AGRICULTURE, RURAL DEVELOPMENT, FOOD28   AND DRUG ADMINISTRATION, AND RELATED AGENCIES FOR THE FISCAL YEAR29           ENDING SEPTEMBER 30, 2026, AND FOR OTHER PURPOSES3031                               __________3233                       Department of Agriculture34 Department of Health and Human Services: Food and Drug Administration3536                               __________3738         Printed for the use of the Committee on Appropriations3940                 [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]4142       Available via the World Wide Web: https://www.govinfo.gov4344                               __________4546                 U.S. GOVERNMENT PUBLISHING OFFICE474860-249 PDF                WASHINGTON : 20264950                      COMMITTEE ON APPROPRIATIONS5152                     SUSAN M. COLLINS, Maine, Chair5354MITCH McCONNELL, Kentucky            PATTY MURRAY, Washington,  Vice55LISA MURKOWSKI, Alaska                   Chair56LINDSEY GRAHAM, South Carolina       RICHARD J. DURBIN, Illinois57JERRY MORAN, Kansas                  JACK REED, Rhode Island58JOHN HOEVEN, North Dakota            JEANNE SHAHEEN, New Hampshire59JOHN BOOZMAN, Arkansas               JEFF MERKLEY, Oregon60SHELLEY MOORE CAPITO, West Virginia  CHRISTOPHER A. COONS, Delaware61JOHN KENNEDY, Louisiana              BRIAN SCHATZ, Hawaii62CINDY HYDE-SMITH, Mississippi        TAMMY BALDWIN, Wisconsin63BILL HAGERTY, Tennessee              CHRISTOPHER MURPHY, Connecticut64KATIE BOYD BRITT, Alabama            CHRIS VAN HOLLEN, Maryland65MARKWAYNE MULLIN, Oklahoma           MARTIN HEINRICH, New Mexico66DEB FISCHER, Nebraska                GARY C. PETERS, Michigan67MIKE ROUNDS, South Dakota            KIRSTEN E. GILLIBRAND, New York68                                     JON OSSOFF, Georgia6970                  Elizabeth McDonnell, Staff Director71                  Evan Schatz, Minority Staff Director7273                                 ------7475     Subcommittee on Agriculture, Rural Development, Food and Drug76                  Administration, and Related Agencies7778                  JOHN HOEVEN, North Dakota, Chairman7980MITCH McCONNELL, Kentucky            JEANNE SHAHEEN, New Hampshire,81SUSAN M. COLLINS, Maine (ex              Ranking82    officio)                         JEFF MERKLEY, Oregon83JERRY MORAN, Kansas                  TAMMY BALDWIN, Wisconsin84CINDY HYDE-SMITH, Mississippi        MARTIN HEINRICH, New Mexico85DEB FISCHER, Nebraska                GARY PETERS, Michigan86MARKWAYNE MULLIN, Oklahoma           KIRSTEN E. GILLIBRAND, New York87MIKE ROUNDS, South Dakota            JON OSSOFF, Georgia8889                           Professional Staff9091                              Morgan Ulmer92                              Macie Kelly93                             Lindsay Morris9495                        Hart Clements (Minority)96                      Rachel Erlebacher (Minority)97                       Claire Wengrod (Minority)9899                            C O N T E N T S100101                              ----------102103                                hearings104105                          Tuesday, May 6, 2025106107                                                                   Page108109Department of Agriculture........................................     1110111                         Thursday, May 22, 2025112113Department of Health and Human Services: Food and Drug114  Administration.................................................    49115116                              back matter117118List of Witnesses, Communications, and Prepared Statements.......   117119120Subject Index:121122    Department of Agriculture....................................   119123124    Department of Health and Human Services: Food and Drug125      Administration.............................................   119126127   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND128          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2026129130                              ----------131132                          TUESDAY, MAY 6, 2025133134                                       U.S. Senate,135           Subcommittee of the Committee on Appropriations,136                                                    Washington, DC.137    The subcommittee met at 10:35 a.m. in Room SD-124, Dirksen138Senate Office Building, Hon. John Hoeven (chairman) presiding.139    Present: Senators Hoeven, Collins, Moran, Hyde-Smith,140Fischer, Shaheen, Murray, Merkley, Baldwin, Heinrich, Peters,141and Ossoff.142143                       DEPARTMENT OF AGRICULTURE144145STATEMENT OF HON. BROOKE L. ROLLINS, SECRETARY146147                opening statement of senator john hoeven148149    Senator Hoeven. We will call this meeting of the Ag150Appropriations Subcommittee to order.151    And I want to begin by thanking Secretary of Agriculture,152Brooke Rollins, for being here today. We appreciate you being153here. We also appreciate you getting out and about around the154country, as you have, and getting a chance to meet with our155great farmers and ranchers in our respective states. So thanks156so much for that as well.157    I am very pleased to be joined by Senator Jeanne Shaheen.158As you can tell, she is very young, but she and I were actually159governors together.160    Senator Shaheen. We were both very young. Yes.161    Senator Hoeven. Starting about 25 years ago, when she was a162teenager and I was not as old as I am now. And so we have had163an opportunity to work together as governors, and we work164together on various appropriations committees, like Homeland165Security, and others. And I just want to welcome her in this166new role as the Ranking Member on the Ag Appropriations167Committee, and just express how much I appreciate her and168working with her; so welcome, and really good to have you on169the committee.170    Also, we are joined by our Chairman of the Full171Appropriations Committee, who also, we have worked together a172long time, and she is providing a strong leadership for the173Appropriations Committee and doing everything in her power to174see that we get back to regular order.175    And so I would pause here for just a minute and ask if our176Chairman would like to make a few comments. Chairman Collins.177178                   statement of senator susan collins179180    Senator Collins. I just want to say that I am absolutely181delighted that Senator Hoeven is chair of this committee and182that Senator Shaheen is the vice chair. That means this183subcommittee is in very good hands.184    And we welcome the Secretary.185    Senator Hoeven. Thank you, Chairman.186    Again, Secretary, thanks for being here today. We187appreciate you, and appreciate you being here right away to188talk about this Ag Appropriations Budget. You had a great189chance out in North Dakota, and I know you have been to other190states as well, to see what our farmers and ranchers are doing191out there, firsthand. But I know you really don't--that is not192new to you, having grown up on a ranch, which is incredibly193important that you have that background, and then having gone194to Texas A&M, an Ag school.195    Secretary Rollins. Well said. Thank you.196    Senator Hoeven. And a very good one at that.197    Secretary Rollins. Thanks.198    Senator Hoeven. And they play reasonably good football,199too, last I checked.200    Secretary Rollins. Until November, but yes.201    Senator Hoeven. Yes. Well, again, we are pleased that you202are getting out and about like you are, and that you are with203us here today.204    Secretary Rollins. Thank you.205    Senator Hoeven. Obviously, our farmers and ranchers across206the country are dealing with a lot of challenges right now.207They always deal with challenges, whether it is markets,208whether it is prices, and certainly always the weather, none of209which they control. So it is vitally important that we do a210good job for them in our farm program, but also in the things211that we do here in the Ag Appropriations Committee, as well as212the countercyclical safety net, and the other things that we213think of, crop insurance, that our farmers and ranchers need214every day to stay in business.215    And we can't, as you and I talked about before, we have in216agriculture about 16 million people that work either directly217or indirectly in agriculture. We have a system of small218businesses out there in farming and ranching, family-based219small businesses that produce the highest quality, lowest cost220food supply in the world that benefits every single American221every single day.222    And we, as Americans, spend less on our food and have the223best food, and the best choice, and we spend less as a percent224of our budget than pretty much any developed country in the225world, brought to us by our family farms and ranches. And that226we can't take that for granted.227    Secretary Rollins. Yes.228    Senator Hoeven. There is so much concentration in so many229industries, and we have to recognize that it is not by accident230that we have this great system. And so good farm policy is so231important to keeping that, and it benefits every single232American. Well, you were out in our state. You saw North Dakota233State University and the incredible work that our land grant234universities do, like A&M, and many others.235    But you also got to see the amazing new technology that is236coming with Precision Ag, Grand Farm, example that we showed237you out there of really leading the world with precision238agriculture, as well as the research, and so forth, that is239being done in tandem with land-grant universities through240National Institute of Food and Agriculture (NIFA), Agricultural241Research Service (ARS), your research function, and our farmers242and ranchers, which has revolutionized agriculture.243    When I grew up in western North Dakota, we could grow a244couple row crops. Now our state grows 40 different crops, and245we lead the country in about 15 of them, which we try to rub246into South Dakota as often as we can, because they do great247stuff too, and we appreciate all of our ag states very much.248    So again, that is what we are talking about here today. And249so the funding for these programs, and we talked to you about,250Farm Service Agency (FSA) and all these things, out on the251ground, we have got to make sure we are getting it done for our252farmers and our ranchers every single day. So we want to find253savings, we want to work with you to find savings, but we have254got to know that we are still going to deliver that service255that keeps those family businesses, those farms and ranchers256going every single day to the benefit of every single American.257    So again, thanks for being here so much.258    And I will turn to our ranking member, Senator Shaheen.259    Secretary Rollins. Thank you, Senator.260261                  statement of senator jeanne shaheen262263    Senator Shaheen. Thank you, Mr. Chairman. And I would just264echo your comments about how nice it is to work together again.265Thank you for those very nice remarks.266    Secretary Rollins, thank you for coming before the267committee.268    I think it is helpful as we think about questions today to269take stock of where we are and how we got here more than 100270days into this administration, because we all know that our271farmers, producers, and rural communities are no strangers to272uncertainty, the pressure from outside of their control, from273fluctuating commodity prices, to rising output costs, to a274rapidly changing climate and more extreme weather events.275    But what I have heard from farmers in New Hampshire is that276the Federal Government has always been a critical partner that277our farmers could rely on. That is until now, sadly, because278what I have heard from farmers over the past 100 days of this279administration is that they are not sure they can trust the280Federal Government anymore. I have heard from farmers across281our state who no longer know if they can rely on the Federal282Government honoring a basic signed contract, and I have heard283in great detail from all kinds of farms in New Hampshire about284the hardship that this uncertainty, this delayed reimbursement285causes for their ability to run their businesses.286    And as they say, in New England where the weather is very287problematic, anything that contributes to that uncertainty and288disruption is challenging. Rural communities can't be certain289if their small businesses and operations will survive the added290costs of tariffs on top of the other uncertainties, farmers291risk losing hard-fought market access due to President Trump's292trade war.293    And I am sorry that we had not yet received the fiscal year2942026 Budget when we were preparing for this hearing, because295the limited information that I have seen to date has been296extremely disappointing. The proposed budget top lines released297last Friday fall well short of the President's purported298commitments to farmers and rural communities.299    I don't believe that we support farmers by gutting research300that will boost yields and improve crop quality. And I don't301believe we put rural America on a path to thrive by slashing302core rural development programs, from housing, to water and303waste infrastructure, to energy assistance. And when grocery304prices are too high, we don't help families put food on the305table by undercutting vital nutrition programs. Yet, that is306exactly what this skinny budget would do.307    I hope that we will have a chance to move forward with308bipartisan appropriations, with a serious nondefense309discretionary number that reflects the urgent needs that are310facing families and communities in New Hampshire and across311this country, because there are plenty of places where we can312work together to ensure that these programs deliver for313producers in rural America, from investing in our rural314communities and boosting the rural housing supply, to315supporting programs that help local food systems thrive, to316investing in cutting-edge research that will allow our farmers317and ranchers to feed our nation and the world.318    So again, I appreciate your being here today, Secretary319Rollins, and I look forward to the discussion.320    Thank you, Chair Hoeven.321    Secretary Rollins. Thank you.322    Senator Hoeven. Thank you, Senator Sheehan. At this point,323we would turn to you, Secretary Rollins, for your opening324comments.325326                summary statement of hon. brooke rollins327328    Secretary Rollins. Great. Thank you, Chairman Collins,329Chairman Hoeven, Vice Chair Murray, Ranking Member Sheehan, and330distinguished members of this subcommittee. I am so grateful331for the opportunity to appear before you to share what we have332accomplished at USDA in the last 100 days, but also to answer333your questions on the President's budget request and the334priorities moving forward.335    When farmers prosper, rural America prospers, and I want to336thank you all for your shared bipartisan commitment to that337effort in ensuring that our farmers, and our ranchers, and our338rural communities thrive.339    During my confirmation hearing, which some of you attended,340not all, I quoted Thomas Jefferson's 1787 letter to George341Washington in which he wrote, ``Agriculture is our wisest342pursuit because it will, in the end, contribute most to real343wealth, to good morals, and to happiness.'' I have had the344distinct privilege of serving American farmers and ranchers for345the past 82 days, and I can tell you our farmers continue to346embody every single day the ideals that Thomas Jefferson347described over two centuries ago, and serving as their champion348continues to be my greatest honor.349    We at the Department of Agriculture have wasted no time in350implementing President Trump's bold policy agenda. The351President's fiscal year 2026 discretionary budget that we are352talking about today identifies the priorities of our353administration with the same degree of prudence and frugality354our family farmers practice when they draft their annual355budgets. Let me touch on a few highlights of the last 82 days356and then turn it back to you, Mr. Chairman.357    Upon taking office, I was tasked by President Trump to358lower the cost of eggs in the short term, and also to provide359farmers with resources that are needed to combat the avian360influenza in the long term.361    In February, at the direction of President Trump, we362announced a five-point plan to meet this challenge head on, and363I am proud to report that since that plan was introduced, the364wholesale price of eggs has decreased 56 percent, with the365retail price following. In taking this position, I fully366understood that American agriculture was facing one of the most367economically challenging times in our country's history.368    For generations, American producers and consumers enjoyed369the fruits of an agricultural trade surplus, but under the last3704 years, that surplus went from zero--or that trade deficit371went from zero to a nearly $50 billion trade deficit, and the372newest numbers coming in are actually significantly more than373that.374    President Trump and I know this problem will not solve375itself. That is why he is taking action, bold action, which I376am sure we are going to talk about today, to address our377imbalanced trade commitments, and I am working tirelessly to378promote American agricultural products on the world stage.379    In April, USDA launched our agricultural trade promotion380programs for fiscal year 2026 and is currently accepting381applications for four export market development programs. As382part of this effort, I will be traveling to seven countries in383the next few months. The first trip begins Sunday when I head384to the UK, where I will be making sure our trading partners385know that American agriculture is the crown jewel of American386production.387    And in fact, Chairman Hoeven, I have to leave here at noon388because the Secretary of Agriculture from Mexico has just389landed here in Washington, and I am going to meet and talk with390him momentarily as soon as we finish.391    We are also streamlining unnecessary regulations and392cutting red tape for agricultural producers and industries so393that they can continue to do what they do best, and that is to394every day feed, fuel, and clothe America and our world.395    To that end, my team and I have sought to eliminate waste,396fraud, and abuse in all USDA programs, including the SNAP397improper payments, fraud, and programs that fail to fulfill the398USDA mission of putting farmers first. Our team is meeting399daily with our partners at the Department of Government400Efficiency, with DOGE, which again I am sure we will get into,401to ensure that we are doing right by the American taxpayer402while also protecting critical USDA programs.403    What is also of paramount importance at the United States404Department of Agriculture is our mission to make America405healthy again. We have been taking major steps to fulfill this406mandate by accepting SNAP waivers and working alongside our407country's great governors, both Republican and Democrat, as we408move that project forward.409    The Make America Healthy Again (MAHA) movement at USDA has410also supported major, major voluntary changes to make food411healthier, including just last week the International Dairy412Foods Association's most recent announcement related to dyes in413school lunch dairy products. We are also working around the414clock to address major threats to our farmers and our ranchers,415including the new world screw worm, which would devastate our416cattle industry in this country.417    Alongside Secretary of State, Marco Rubio, and Deputy418Secretary of State Christopher Landau, we were pleased to share419just last week that we have negotiated a deal with the420Government of Mexico to allow the best preventative tools we421have to land our response aircraft in Mexico without further422hindrance, additionally working to ensure that Mexico abides by423the 1944 Water Treaty, providing the water it owes to our ag424producers in America.425    Finally, and again, just a quick summary of the last 82426days: Just last week, alongside Senator Rounds and some other427great Americans, we stood with Charles and Heather Maude, a428South Dakota cattle family, fifth-generation cattle ranching429family who operates small cattle and hogs, who endured a430senseless, politically motivated prosecution over 25 acres of431forest land that had had a fence line on it for almost 100432years.433    The criminal charges against the family were dropped last434week, and to prevent further injustices against our farmers and435our ranchers, we launched a portal for farmers and ranchers to436tell us their stories, if they, too, are being treated in a437similar situation as to the Maudes.438    And since we launched that a week ago, Thursday, so I guess439just four or five days ago now, we have had over 100 farmers440and ranchers reply and move their stories into our portal. So441we are already following up on that.442    Again, during my first 82 days, as the Secretary of443Agriculture, we have visited 15 states. If we have not visited444yours yet, we are coming very, very soon. I have attended over445100 events, given dozens and dozens of keynote speeches, and446met with nearly 1,000 farmers and ranchers across this great447country, both here in Washington and out in the states.448    We will continue to build based on their feedback, based on449their hard work, and based on reconstituting, rebuilding, and450revivifying the United States Department of Agriculture to451better serve our customers.452    American ag does not rest, and I can assure you that under453my tenure, neither will the U.S. Department of Ag. I am proud454to be at the helm of the People's Department, as President455Lincoln so aptly launched and said in the 1860s, I am proud to456be at the Department, I am proud to be at the table with457President Trump, and I am so proud to be fighting for the most458American of all Americans, and that is our farmers, and our459ranchers, and our agriculture communities.460    Thank you so much.461    [The statement follows:]462               Prepared Statement of Hon. Brooke Rollins463    Chairman Hoeven, Ranking Member Shaheen, and distinguished members464of this subcommittee, I appreciate the opportunity to appear before you465to present on the U.S. Department of Agriculture (USDA) and what we've466accomplished since President Trump took office. President Dwight D.467Eisenhower said, ``Farming looks mighty easy when your plow is a468pencil, and you're a thousand miles from the corn field.'' I can assure469you, being a part of agriculture and visiting with the people who tend470the land and our Nation's livestock every day, farming isn't easy. I am471proud of the work we are doing at USDA. Making Agriculture Great Again472means promoting efficiencies, cutting regulatory red tape, and473refocusing the mission to expand market opportunities for farmers474rather than promoting programs that only satisfy the special interests475of Washington D.C., bureaucrats who have never set foot in a field or476pasture.477    For far too long, the hardworking Americans who feed, fuel, and478clothe the world were left on the sidelines. Farmers and Ranchers now479have a seat at the table. We have had an action- packed first one480hundred days of the Trump Administration, affirming the bold leadership481of President Donald J. Trump. I've visited 15 States, attended or held482over one hundred events, and have visited with hundreds of different483agricultural stakeholders. In the first one hundred days we have484reprioritized American Agriculture.485    Since my first day, we have been intensely focused on tackling the486avian influenza crisis. It was my very first briefing at USDA and I487fully understand the importance of animal health issues and the effects488they have not just on ranchers and producers, but on everyday489consumers. In February, at the direction of President Trump, we490announced a five-pronged plan to curb avian influenza to protect491producers and lower egg prices for all Americans. A plan which has been492applauded by agriculture and government leaders across the country.493Today, a dozen eggs at wholesale cost less than half of what they did494at the end of February. The expansion of biosecurity assessments495available to commercial poultry producers has also been successful. I496am happy to report that, since I've taken office, we have completed497over four hundred wildlife biosecurity assessments and biosecurity498incentive-focused assessments combined. As this program expands, we499expect these results to continue to impress. We also know that America500thrives when it innovates. That's why we have such hope for the up to501one hundred million dollars announced as a funding opportunity to502explore prevention, therapeutics, research, and potential vaccine503candidates to protect poultry from avian influenza. These projects504should give us new and innovative tools to use to keep the virus away,505protect producers, and keep prices low for consumers.506    While much of the public attention has been on avian influenza, we507are also working around the clock to address the other threats to our508farmers and ranchers, including New World screwworm. This pest feeds on509livestock and could seriously jeopardize our food supply and create an510economic impact of well over a billion dollars if it enters through our511southern border. This devastating pest started spreading north through512Central America under Joe Biden's failed leadership. Under President513Trump, we are working to drive this pest south, out of Mexico by using514proven sterile insect technology. This approach has been successful in515previous eradication efforts, and it remains the most effective516strategy to protect our domestic industry from this devastating pest.517To address the ongoing spread of New World screwworm I recently sent a518letter to my counterpart in Mexico demanding Mexico eliminate519impediments to aircraft operations and landings that were impairing the520U.S. response, which was successful, and we are now landing the planes521we need to.522    On the eve of a nearly fifty-billion-dollar agricultural trade523deficit, USDA is not sitting idle, but taking action to move our524industry back to becoming a net exporter. USDA's Trade and Foreign525Agricultural Affairs is well positioned to help producers gain new526market access opportunities. Since President Trump took office, USDA's527Foreign Agricultural Service has expanded access to foreign markets for528U.S. agricultural products. Panama partially opened its pork import529quota mechanism, which will allow an estimated additional thirty530million dollars in U.S. pork product exports. South Africa also531restored market access for U.S. microwave popcorn shipments, valued at532two to three million dollars. USDA conducted two trade missions to533Thailand and Guatemala and hosted USA Pavilions at six global trade534shows with a combined total of two hundred and eighty-two million535dollars in projected exports. In the last 2 months, FAS has worked with536India to reduce India's tariff on U.S. bourbon imports by fifty537percent, resulting in a likely two million dollar increase in distilled538spirits exports to India in 2025. We worked with Japan to lift the539mandatory aflatoxin testing requirements on U.S. almonds, resulting in540a likely eight to 10 percent increase of U.S. almond exports to Japan541annually.542    Looking ahead, USDA will continue its efforts to improve foreign543market access for U.S. producers and address the agricultural trade544deficit. In April, USDA launched agricultural trade promotion programs545for fiscal year 2026 and is accepting applications for four export546market development programs totaling over two hundred and fifty million547dollars. I will also visit seven countries in the next 6 months:548Vietnam, Japan, India, Peru, Brazil, Italy, and the United Kingdom.549Together with the U.S. Trade Representative, we will build new markets,550expand current markets, and hold existing trading partners accountable551to ensure trade is fair and reciprocal and that the competitive552position of U.S. agriculture reaches new heights. USDA is committed to553leveling the playing field by identifying unfair imports, breaking down554export barriers, tackling non-tariff sanitary and phytosanitary555obstacles, advocating for lower foreign tariffs on U.S. agricultural556exports, and diversifying foreign markets for U.S. exports. USDA is557dedicated to an America First policy, ensuring that every action USDA558takes overseas makes America safer, stronger, and more prosperous.559    On March 19, ahead of its statutory deadline, we issued 10 billion560dollars in economic assistance for farmers and ranchers through the561FSA-administered Emergency Commodity Assistance Program which was562passed by congress in December of 2025. The program has been extremely563efficient, paying farmers within three business days of an application564submission. A note of thanks to all of you for your unwavering support565for producers in times of economic crisis by passing that legislation.566USDA is working to soon roll out its Congressionally authorized567Supplemental Disaster Relief, over 20 billion dollars. On April 22,568USDA dispersed three hundred and forty million Congressionally mandated569disaster dollars across thirty-one States to deliver relief to farmers,570ranchers and rural communities impacted by natural disasters such as571hurricanes and wildfires that have caused devastation across the572country. We are also making sure these programs are offering the most573effective assistance where needed and not duplicating and wasting574taxpayer money.575    There is a very public, yet very important endeavor to make America576healthy again through the President's Executive Order No. 14212. It is577no secret diet-related, chronic disease is plaguing American families,578including a substantial portion of children and adolescents from low-579income households. At the direction of President Trump, I, along with580relevant stakeholders, will continue to explore ways to encourage581better health through the Make America Healthy Again Commission. In582talking to Governors, many States are interested in testing innovative583solutions to our Nation's many health crises. I have made it clear, and584I will do so here, that I am open to these requests and look forward to585providing technical assistance and dialogue. There have been586significant developments on this around the country during State587legislative sessions, and we look forward to receiving State requests588to operate pilot programs to make the program more nutritious.589    On February 13, upon my swearing in, I sent a letter to States and590Tribal, territory, and local government partners. I reminded them that591the mission of the Department's 16 nutrition programs is critical, but592that the American taxpayer expects their generosity to be valued and593for programs to be executed with integrity and accountability. The594letter noted a suite of guiding principles, each of which can serve as595catalysts for change, allowing the Department-and the American596taxpayer-to better serve vulnerable families and communities. It is597important to note, USDA spends four hundred and five million dollars a598day on nutrition programs. Furthermore, USDA issued guidance to all599State agencies directing them to enhance identity and immigration600verification practices when determining eligibility for the601Supplemental Nutrition Assistance Program (SNAP). This is to make602certain that SNAP benefits exclude any ineligible alien who entered the603United States illegally, or is otherwise unlawfully present in the U.S.604A recent Government Accountability Office (GAO) report indicated a605staggering 10 and a half billion dollars in improper SNAP payments were606made in fiscal year 2023 alone. This was about 12 percent of total SNAP607payments that year. The inadequate verification of an applicant's608identity and citizenship by States is specifically highlighted as609contributing to the improper payments of SNAP funds.610    Under President Trump's leadership, we are streamlining unnecessary611regulations and cutting red tape for agricultural producers, and other612industries under the USDA purview, to allow them to feed, fuel, and613clothe the world. This includes making sweeping reforms to protect614national forests and boost domestic timber production, ending615regulations that have stifled energy and mineral development on Federal616lands so we may reaffirm America's role as a global energy powerhouse,617and reducing wildfire risk through public-private partnerships and many618other actions. I have been fortunate to spend time with our wildland619firefighters to thank them for their heroic service. I value their620perspectives and feedback, and I am proud of the work they do to save621lives and protect our beautiful homeland. We will continue to execute622President Trump's agenda to make America's forests healthy and623productive again.624    In March, I announced new action to reduce burdens on the U.S. pork625and poultry industries, allowing for greater efficiency while626maintaining food safety standards. We are extending waivers allowing627existing establishments to maintain higher line speeds and are moving628towards rulemaking to make these standards permanent for more pork and629poultry plants. We have also withdrawn overly burdensome proposals630related to Salmonella in poultry as we reconsider more effective ways631to achieve public health objectives. These reforms will strengthen U.S.632food production, reduce costs for producers, and support a more633resilient supply chain-all without compromising food safety. It is also634important for farmers and ranchers to have access to timely, accurate,635and useful statistics to help make important decisions about their636operations; however, the Biden Administration ignored this directive637and cancelled the July Cattle Report and the County Estimates for Crops638and Livestock last year. I am so pleased to share that the National639Agricultural Statistics Service has reinstated these critical reports,640and they will be published later this year.641    American agriculture began four centuries ago, when neighbors born642across an ocean came together in a New World to clear fields, build643homes, and plant crops on the edge of wilderness. That same spirit644animates us now. Our farmers who tend the fields do not rest from their645labor-neither do our ranchers and livestock producers who steward their646lands, herds, and flocks-and neither do the American mothers and647fathers who rely upon American agriculture to feed their families.648American agriculture does not rest-and neither will we at USDA. I'm649proud to be at the helm of the People's Department, at the table with650President Trump, and fighting for the most American of industries--651agriculture.652653    Senator Hoeven. Thank you, Secretary Rollins.654    We will now start rounds of five-minute questions.655    And I am going to defer to our Full Committee Chairman,656Senator Collins, to start that process.657    Senator Collins. Thank you very much, Mr. Chairman.658Welcome, Secretary Rollins.659    Secretary Rollins. Thank you.660    Senator Collins. It is great to see you here today. When we661first met, we discussed Per-and Polyfluoroalkyl Substances662PFAS.663    Secretary Rollins. Yes.664    Senator Collins. Those are the toxic class of forever665chemicals that are being found in our soils, water, animal666feed, crops, and livestock. In Maine, the presence of PFAS and667wastewater sludge that was spread decades ago as a fertilizer668is preventing some of our family farmers from being able to669sell their products, causing them significant financial harm.670    To support these affected farmers and to come up with671solutions, the University of Maine is undertaking research on672the presence of PFAS in agricultural land. To build upon this673work, I secured $17 million in fiscal year 2024 for the ARS and674the University of Maine to establish a new center of Excellence675for PFAS solutions, and the whole purpose is to help address676these very serious PFAS contamination in agriculture.677    Madam Secretary, will you continue to support the678partnership between ARS and the University of Maine in679establishing this research center to help our farmers? And I680would note that the research that is being done there won't681just help the farmers in Maine, but across the nation.682    Secretary Rollins. Across the country. Well, Madam683Chairman, as we discussed, this is an issue that is very close684to my family's heart. My mom, Helen Kerwin, is almost 78. She685is the youngest elected freshman to the Texas House of686Representatives in Texas history, and her number one issue is687PFAS. And she decided to run for a lot of reasons, but one of688those was, I believe it was the New York Times did an expose or689a big story, if you will, on a farm in Johnson County, Texas,690which is close to where we grew up and where my mom still691lives, rural Texas.692    And she was so stunned by what had happened to these693farmers, and specifically through the PFAS contamination, it694had destroyed their lives. And so she became very, very695passionate about this particular issue. She is crushing it in696her first session in the Texas Legislature right now. And, in697fact, her very first bill that she will get a hearing on is her698PFAS Bill, and it will be tomorrow in Austin.699    So I have been hearing a lot about this at the family700dinner table for quite some time now. But yes, we remain701committed to this research, very proud of that $7 million grant702to the Center for Excellence. And I think that, at least703according to my mom, who is amazing, raised my sisters and me,704by herself, she was a single mom, but at least according to my705mom, Maine leads the way in many respects on this important706issue for all of our farmers and our ranchers.707    And I am excited to learn more. Perhaps even come visit the708center in Maine, see the work that they are doing firsthand,709and to continue to support it. So thank you for your leadership710on that.711    Senator Collins. Thank you so much. And, in this case,712listening to your mother makes all the sense in the world.713    Secretary Rollins. All the sense in the world. I need to714tell my four teenagers that.715    Senator Collins. Yes. In late March, I wrote you a letter716detailing my concerns about USDA's delay in releasing some717program funds.718    Secretary Rollins. Yes.719    Senator Collins. I have heard from constituents who have720received grant award letters from USDA in the previous721administration, only to later receive letters from USDA722informing them that their grant funding is frozen. Now, this is723obviously very troubling to them. It creates a lot of724uncertainty. And we are a state that has lost 600 farms in the725past decade. And that is very troubling to me. I grew up in726Northern Maine. One of my first jobs was picking potatoes for a727farmer. And I am aware of how important that heritage is to our728state and to our food supply.729    So we have seen a situation where farmers, landowners,730loggers, natural resource businesses that have applied for USDA731loans, still have no clarity on what decisions will be made.732And the timing of this funding is absolutely critical, because733as you know well, agricultural producers are making purchases734now for this year's crops, and processing facilities need to735order equipment for the summer and the fall harvest.736    Local farm economies are fragile. And timing is really737important. So I know and appreciate that you have made some738significant strides in releasing program funding over the past739few weeks. Could you provide the subcommittee with an update on740Federal funding at USDA that remains frozen, and a time line741for when you plan to finish your reviews?742    Secretary Rollins. I will, and I take to heart so sincerely743everything you have said. And I know many of you have reached744out during this process of frozen funds from both sides of the745aisle. And my goal is to respond immediately. Sometimes it is746at midnight. Sometimes it is at 5 a.m. But my goal is always to747respond and to be available. I have an amazing team. Kailee748Buller, is our chief of staff, she is here, Jen Tiller and a749few others that you all probably know well. And we are working750around the clock, going line, by line, by line. We are down to751the final 5 billion out of, I believe, almost 20 billion of752frozen funds. But $5 billion is a lot of money. And when you753think about that in terms of, you know, grant or contract and754moving that out quickly, we are very hopeful to keep moving755through that very, very quickly and have that done very soon.756    But what I will say, and you all know this that have worked757with me, I am always available. So if there is one or a group758in particular that you want us to make sure we are getting to,759please just let me know. I know almost everybody here has my760cell phone number, maybe not a few of you, but I am always761available. Several of these guys have it too. So just call me762and just know we are doing our very, very, very best.763    Some of the funding that we have pulled back and then764reopened, we have asked for reapplications to realign around765this President's priorities, which, of course, not766surprisingly, is not diversity, equity, and inclusion, or some767climate programs, but instead to reapply where the farmer would768receive, farmer or rancher would receive 65 percent of the769funding or more, that is another piece of this as well.770    So we, again, are going line by line. We are working around771the clock. And believe me, we are on it. But please know to772always reach out if there is something specific. And I hear773you.774    Senator Collins. Thank you very much.775    Secretary Rollins. Thank you, Madam Chairman.776    Senator Hoeven. Appreciate it.777    Senator Sheehan.778    Senator Shaheen. Thank you, Mr. Chairman. And just to779follow up on that. I referenced this in my opening statement,780but in New Hampshire USDA has frozen an $11 million RCPP award781for the Connecticut River Conservancy. It is a project that has782leveraged public-private partnerships for critical ecosystem783restoration across the watershed. And unfortunately, the784months'-long delay has slowed seasonal work, and it has driven785up the costs of the project.786    Given that it is been more than 3 months since the787administration froze this program, when will USDA release the788funding?789    Secretary Rollins. What is the name of it again?790    Senator Shaheen. It is a Regional Conservation Partnership791Program (RCPP) award for the Connecticut River Conservancy, and792we are happy to follow up with whoever the appropriate person793is. And just to follow up on that, one of the things, as we794know, that Congress did at the end of last year was to pass795disaster funding, that included $220 million as a set-aside for796small farms in the six New England States, plus Hawaii and797Alaska. And we have got apple growers in New Hampshire who, in7982023, lost about 90 percent of their crop. Virtually all stone799crops were wiped out in that season. They have been waiting800desperately for the funding to be released from that emergency801supplemental.802    Senator Tillis and I sent you a letter back in March803emphasizing the need to get this assistance out. So again,804along the lines of Senator Collins' question, can you provide805an update for when the remaining funds will be released, and806how we will ensure that the funding goes particularly to the807small farms in states like New Hampshire, where they are808desperately in need of some assistance?809    Secretary Rollins. Yes, ma'am. I appreciate that. The810Emergency Commodity Assistance Program (ECAP) funding, the811economic assistance, of course, we were given a statutory812deadline of March 21st, I believe, when you all passed that, or813when it was passed in late last year. I think March 16th or814March 17th the portal opened, and it is a three-day turnaround815in most cases. I think we have already moved out, I don't have816the number in front of me, but of the $10 billion, almost $8817billion. You all correct me if I am wrong.818    So we have actually moved almost all of that money out in,819I would argue, record speed, but maybe there have been a few820that we haven't. So please let us follow up on that.821    I have got right in front of me, Madam Chairman, that in822your state we have moved out $395 million just into New823Hampshire to 17,476 of your producers in New Hampshire. So I824think we have done pretty well on that. But again, if there are825instances where you are not hearing those stories and that it826hasn't moved as quickly as we believe it has, please let us827know, and we will run that down.828    On the disaster relief part of it, which is the additional829$20 billion, in the coming weeks, by the end of May, that830portal will open also. Obviously as part of that $20 billion831there was specific funding for the Mexican water issue in832Texas, and then of course up in the northeast where you are,833and I believe Alaska was the third specific instance. But we834are working with governors across the country. That was a835little more complicated than the ECAP, the disaster--or the836emergency relief payments; but we are really close, within a837matter of days, where we certainly by the end of this month,838that money will begin moving as well.839    Senator Shaheen. Well, thank you. I appreciate that. As you840know, farming is very different in New England than it is in841the Midwest, and many states in the west, and anything that we842can do to be helpful in terms of getting information from out843farmers to make sure that they qualify for those programs,844please work with us.845    Secretary Rollins. Absolutely. Yes.846    Senator Shaheen. I also served on the Foreign Relations847Committee, and of the things the fiscal year 2026 Budget848Request eliminates, is the Food for Peace Program, and the849McGovern-Dole Food for Education Program. In 2023, those850programs provided over 1.1 million metric tons of U.S.-grown851commodities to people abroad.852    For weeks earlier this year, more than 550 metric tons of853U.S.-grown rice, peas, wheat, beans, super cereal, and ready-854to-use therapeutic food sat at risk of spoilage in ports, on855ships, and in warehouses across the world, because of the856dismantling of USAID. We are tracking that more than 350 metric857tons of mixed commodities from American farmers are either858pending purchase or will not be purchased this year due to the859administration's terminations and delays.860    So can you talk about what you are saying to farmers to861address this and how we are replacing that food that is so862desperately needed by people around the world?863    Secretary Rollins. Yes. I will talk briefly about the864McGovern-Dole Program first. And I think it is important to865realize that that is a $240 million program, but our numbers866show only about $37 million of that is directly tied to867agriculture, which of course is what I am focused on. So as we868are looking to realign the government, to reorganize, to make869it more efficient for the American taxpayer, looking at870programs like McGovern-Dole, which obviously all these871government programs have a very worthy mission statement with872very wonderful intentions, but at the end of the day, are they873serving the American taxpayer who is funding them? And are we874providing and meeting the metrics of what the original intent875was?876    And without knowing all the details of the McGovern-Dole877Program, for example, the fact that of a $240 million program,878only $37 million is being used regarding commodities, our879American farmer commodities. And I don't say $37 million isn't880a big number, and especially for our farmers and our ranchers,881but I think in the context of what the effort is to ensure that882everything we are doing is aligned with the best and highest883use of taxpayer dollars, and understanding that the layers of884bureaucracy, and the administration, and all of the money going885to lots of other places other than our ag community, that we886need a wholesale reapproach to all of it.887    And that is what I realize, Senator, I will agree to888disagree on this, but that is what President Trump's vision is.889And while we are going through, it is never easy to change the890status quo. The easiest thing for us to do is just say: Oh. It891is great, and we don't want to make anyone mad, and let us just892keep moving forward and keep adding money to the programs. This893is what I believe the voters asked for and we will continue to894have these discussions.895    So I hear you. It is something we are looking at every day,896and the Food for Peace Program as well. But programs like897McGovern-Dole, it is time to really take a deep look and see898what we are spending the money on, and if it is being899effective.900    Senator Shaheen. I am out of time. And I appreciate what901you are saying. And I think most of us would agree that902examining the programs and being more efficient and effective903is something that we all support.904    Secretary Rollins. Sure.905    Senator Shaheen. But when we do it in a way that allows906millions of tons of food and medicine to rot because we have907cut off funding to ensure that that goes where it is supposed908to go, that is not efficient and effective.909    Thank you, Mr. Chairman.910    Senator Hoeven. Thank you, Ranking Member Sheehan.911    Secretary, so at the end of the year we ended up with a 1912year extension of the Farm Bill because we did not have913agreement to update the countercyclical safety net like we need914to, which as you know we are working on very hard. But with915that 1 year extension we put in place $33.5 million (sic) in916emergency assistance, for the $10 million excuse me, $33.5917billion--for the $10 billion that is market conditions based we918put a number of conditions on it. One that you would provide919it--start providing it within 90 days, and you would follow a920format called WHIP+, which we put in statute back in 2017. You921did both.922    Secretary Rollins. Yes.923    Senator Hoeven. And you started dispersing, or started the924process of dispersing March 19th. I think of that 10- you are925probably closing on $7 billion. You have already dispersed926states, my state it is about $0.5 billion, I think. You already927referenced the Ranking Member and other states as well. That is928how we want to work with you. So I want to put right out front,929that is how we want to work between this subcommittee, and I930think Senator Boozman will tell you our Ag Committee, Full Ag931Committee and USDA.932    So then I just want to step over now to the weather-based933$20 billion. What is your plan on that for getting it going,934and kind of the format so we know? We are getting questions on935that now from our producers.936    Secretary Rollins. That is right. So we are within days of937announcing the application process. Of course, that is a little938more complicated because we don't have the specifics and it939isn't--yeah, as you mentioned in North Dakota, 15,794 of your940farmers and ranchers have received money through that first941tranche, through the first $10 billion, the emergency aid. On942the weather-related programs, that application opens in the943next week or two and we will be moving very, very quickly.944    We realize that this is a long time coming and it is945related to disasters that happened a while ago, and so ensuring946that we get that out as quickly as we possibly can with the947team that we have in place. I am really proud of, I believe,948how efficiently and how quickly the team moved out that first949tranche. And I believe that you will see the same sort of950efficiency and effectiveness with the second tranche. So it is951within the coming weeks.952    Senator Hoeven. And I know you have to wait until you get953the data from the different locations that had the weather954disasters. Like in our case, it was fires and ranchers, we lost955lives.956    Secretary Rollins. Right.957    Senator Hoeven. Not only cattle, but lives of people.958    Secretary Rollins. Yeah.959    Senator Hoeven. And so I know you have to wait to get that960data, but you are thinking within weeks, timeframe?961    Secretary Rollins. Um-hum.962    Senator Hoeven. Okay.963    Secretary Rollins. By the end of the month, the964applications will be open, and we will be moving out. Now, we965have already moved out the $280 million to the Texas Department966of Agriculture for the water issue in South Texas with the967Mexicans, and so the ones that were specifically named in the968legislation that you all worked on so hard.969    Senator Hoeven. Right.970    Secretary Rollins. Those have already moved, those have971been moving for a little while. But this next round, the big972round, will be within the next few weeks.973    Senator Hoeven. Yes. And that is what I was referring to.974    Secretary Rollins. Yes.975    Senator Hoeven. And that is, again, in line with what we976passed, and so I appreciate that very much. Restructuring USDA,977we all want to find waste, fraud, and abuse. We want to find978savings, efficiencies, reductions, clearly, here in D.C., I979think there is plenty of room for that in terms of reducing the980size and scope of the bureaucracy. One of the keys for us,981though, out on the ground, you and I have talked about it, and982I know you know this, is FSA.983    Talk to me about how we make sure that we have those984frontline FSA officers or employees out there working directly985with our farmers and ranchers; that is, you know, key. So talk986about that. So again, yeah, we definitely--and we are seeing987the reductions in the bureaucracy. Again, we want to find988those, but we want the frontline folks out there, the hands-on989folks.990    Secretary Rollins. I don't know, at least at USDA, if there991is any role more important than those frontline FSA offices,992and those remain a priority. Of course, right next to that is993our wildland firefighters as we are moving into wildfire994season, that is extremely important in being operationally995ready, which we are. Also, our Animal and Plant Health996Inspection Service (APHIS), our veterinarians, et cetera, those997are as important.998    But the FSA operators that are managing and working with999our farmers and our ranchers every single day, it is not in our1000plan to close any of those offices. There are 4,500, I think,1001total across the country, which is a big number, but we are1002also working to be, again, more efficient with online, et1003cetera, technical assistance, et cetera, that in the future may1004not rely so much on an on-the-ground presence.1005    But today we can't rip that rug out from underneath our1006farmers and producers, and that remains a priority. I signed a1007memorandum; I don't know, maybe last week, all the days are1008running together, that put as a priority ensuring that those1009offices are fully staffed. As I know we all in this room know,1010often hiring in rural America is a little bit more difficult1011because you just don't have the numbers of people.1012    But what I have told the team, and as we continue to focus1013on rural prosperity moving forward, is that finding the men and1014women out there, the patriotic Americans that are willing to1015work around the clock. We already have a lot of that in the1016FSA, but I think we can do better and more, so we will be1017spending some good time on that moving forward.1018    Senator Hoeven. Thank you, Secretary.1019    Secretary Rollins. Thank you.1020    Senator Hoeven. Excuse me. Thank you.1021    And I am going to turn to our ranking member on the Full1022Committee, Senator Murray.1023    Secretary Rollins. Good morning.1024    Senator Murray. Good morning. And thank you very much,1025Chair Hoeven. I look forward to working with you and with our1026new ranking member, Senator Shaheen, in her new role as the two1027of you lead this committee. It is a really critical one.1028    Secretary Rollins, thank you for being here. Let me be1029really frank with you. The very mission of USDA is under1030incredible threat from this administration. We are seeing1031dedicated researchers and experts who are being pushed out the1032door. Research, safety efforts have been put on hold, funds1033that Congress passed have been frozen and canceled by this1034administration, and nearly $17 billion in investments are now1035being held up at USDA.1036    That to me is really unacceptable and needs to change. We1037are seeing our food banks with less, increased prices at the1038grocery store. We are seeing Forest Service personnel who have1039been fired. They respond to our wildfires, we need them.1040Experts working on avian flu gone, and my farmers are extremely1041concerned about these illegal funding freezes and the illegal1042tariffs that are impacting them.1043    We also know that 15,000 employees have been pushed out,1044that is more than 15 percent of your Department. We know USDA1045cannot help farmers or communities without the people and the1046resources that it needs, which is really to me why this1047arbitrary workforce cuts combined with the sweeping cuts that1048President Trump proposed in the new budget that we just got is1049really alarming.1050    Secretary Rollins, let me just say to you, this committee1051needs a lot more information about how your Department is1052spending this funding that Congress provided earlier this year,1053and the fiscal year 2025 spend plan that you submitted last1054year, required by law, part of the Continuing Resolution, just1055isn't satisfactory. We need to have that information in order1056to write our appropriations bills.1057    And I just want you to know I expect you to work with1058members on both sides of this aisle to provide the details so1059we understand how you are spending money, and what is actually1060needed in the coming year. That is what I really want you to1061know and why I especially wanted to be here today.1062    But I do have some questions for you, because in Washington1063State, my home state and across the country, these abrupt1064terminations and resignations of ARS scientists and support1065staff have really gutted some of our vital agricultural1066research programs overnight. This is really undermining years1067of progress, research on plant diseases, making crops more1068resilient, extreme weather, that work is really fundamental to1069our farmers, and they are deeply worried about that being gone.1070    I know that many of the ARS scientists have been1071reinstated. Essential support staff has not. So will you commit1072to taking steps to reinstate the ARS support staff and1073stabilize these research units across the country?1074    Secretary Rollins. Well, there was a lot in that, Senator.1075So I will try to talk really quickly and answer as much as I1076can. And then please, reach out to me directly, and we can1077always have this conversation anytime. I don't think you were1078in here, but I have had long conversations with members on both1079sides of the aisle about all of this in the last couple of1080months, so I welcome that conversation anytime.1081    The first thing I want to say is the 15,000 number it is1082less than 15 percent of our total workforce. I realize that is1083still a very, very big number, but I think it is important to1084realize in the context that every year, USDA, through1085attrition, loses between 8,000 and 10,000 employees, so as a1086massive government agency.1087    Senator Murray. But they are refilled.1088    Secretary Rollins. Well, and that is what we are looking to1089refill, the frontliners that is what I was talking about right1090now. So whether it is FSA, APHIS, the wildland firefighters,1091those are, through a memorandum I just signed, we are actively1092looking and recruiting to fill those positions that are1093integral to the efforts and the key frontlines.1094    Senator Murray. So you let people go and you are looking1095for new people to fill the positions that they had experience1096in?1097    Secretary Rollins. We are having those discussions right1098now. We are working with all of you around the country in your1099states. We believe our firefighters are operationally ready for1100wildfire season. Our FSA offices, we are looking, you know, we1101are making things more efficient, but bringing on new people1102that could potentially bring and be a game changer in those1103offices.1104    But by the way, the people that you are talking about, the110515,000, those are all deferred resignations. None of those1106people were fired. So if they want to come back and if they1107were in a key position, then we would love to have that1108conversation.1109    The other thing in the second round of Deferred Resignation1110Program (DRPs), which just happened about, I don't know, a1111couple of weeks ago, we did not accept the DRPs of employees1112that were in those key positions that I outlined, that a few of1113them, I think we had several hundred that said, all right, we1114are going to take it. And we said, no, those are, your role is1115too important right now. We are not going to accept it.1116    So we are very intentionally approaching this. Have we done1117it perfectly? No. Any type of whole scale change and big effort1118to basically realign an entire government agency is difficult.1119And we know that. And we know that it hasn't been perfect. But1120we are working every day to solve for a lot of this. And I1121think we are making a lot of really good progress.1122    Senator Murray. Okay. You didn't answer my question1123specifically on ARS scientists, research, the support staff.1124    Secretary Rollins. Well, what I would love if you or your1125team could get us exactly what you are talking about, who you1126are talking about, and where you are talking about it. Because1127we have been, like I say, line by line, keeping the staff in1128place where we believe it is of utmost importance and aligns1129with the Agency's mission in areas where we don't believe we1130haven't been as focused on that. But again, that is a1131conversation I would so welcome to understand exactly where and1132what that looks like.1133    Senator Murray. That is important. But this is on record.1134And so one of my concerns is that you let people go however you1135want to characterize it, who knew these jobs, and now you are1136looking for people to fill these jobs because now we know how1137essential they are, that doesn't seem to me to be very1138efficient.1139    But I need to ask you about nutrition programs in my last1140minute here.1141    Secretary Rollins. Sure.1142    Senator Murray. Because we have about 134,000 people in1143Washington State, 7 million people nationwide who rely on1144Women, Infants, and Children (WIC) Program. It provides, as you1145know, essential nutrition support to moms and kids during the1146earliest, most vulnerable stages of life. It is one of the most1147effective programs that we have. It has always received1148bipartisan support on this committee, it is glaringly absent1149from the President's budget request.1150    WIC, Supplemental. Nutrition Assistance Program (SNAP),1151Commodity Supplemental Food Program (CSFP), these are really1152key, important programs for seniors. They are not optional.1153They are essential programs that feed moms and babies and the1154elderly. So I wanted to ask you, do you fully support funding1155WIC; yes or no?1156    Secretary Rollins. Well, okay, so are you talking about the1157Local Food for Schools Cooperative Agreement Program (LFS) and1158Local Food Purchase Assistance (LFPA) contracts that were1159canceled, or SNAP?1160    Senator Murray. I am talking about the budget that came1161over to us on Friday.1162    Secretary Rollins. WIC is fully funded. SNAP is, so that is1163why I am confused by your question. I am sorry, Senator.1164    Senator Murray. Well, in our looking at this, it is absent.1165I am happy to get the information to you. But this, for this1166committee, I know it is something we have always supported on a1167bipartisan basis. It is something we need to continue.1168    Secretary Rollins. Yeah. WIC is fully funded. I am happy to1169talk SNAP or some of the other cuts, but.1170    Senator Murray. Yeah, WIC, it is eliminated in the budget1171that the President sent on Friday.1172    Senator Shaheen. We also thought that, so.1173    Secretary Rollins. We will clarify that and get that right1174back to you. I know there had been some realigning in SNAP and1175in some of the food banks, et cetera, that is kind of where we1176have been talking and focusing on.1177    Senator Murray. The President--for the committee members,1178the President sent over his budget on Friday. It does eliminate1179WIC in it. So we obviously need to have better information from1180the administration.1181    Senator Hoeven. Our understanding is that--I mean, number1182one, we fully funded WIC in the last go around in the CR, as1183you know, Senator. And our understanding is just in the skinny1184budget, it just wasn't included. It is funded for this year.1185    Secretary Rollins. Yeah, it is funded.1186    Senator Hoeven. This is the skinny budget. There are things1187we don't have yet. So that, at least, was our understanding.1188    Secretary Rollins. It is fully funded.1189    Senator Murray. That would be interesting to see in1190writing.1191    Secretary Rollins. You are welcome.1192    Senator Hoeven. Thank you, Senator Murray.1193    Secretary Rollins. Thank you, Senator Murray.1194    Senator Hoeven. Let me turn to Senator Moran.1195    Senator Moran. Chairman, thank you. Thank you to you and1196Senator Shaheen.1197    Secretary, welcome. Thank you for coming to Kansas,1198although you came when I had the flu.1199    Secretary Rollins. We missed you.1200    Senator Moran. Please come back.1201    Secretary Rollins. Yes. I know.1202    Senator Moran. On a day that is not 16 below zero, and we1203will show you a different side of our state. I want to talk a1204bit before I get to a couple other topics, about Food for1205Peace. Senator Hoeven and I, when we saw what was happening1206with Food for Peace at USAID and the State Department, we1207introduced legislation to transfer the authority to manage and1208operate Food for Peace to the Department of Agriculture.1209    It was my understanding that both OMB and the Department of1210Agriculture, your Department, responded to that idea favorably.1211And I am anxious to have you tell me what it is that I and my1212colleagues ought to be doing to keep providing the commodities1213that we grow in the United States to people who are starving1214around the globe, and is this something you are still1215interested in acquiring?1216    Secretary Rollins. Yes. And it is my understanding this1217program was started in Kansas; is that right?1218    Senator Moran. That is true.1219    Secretary Rollins. Yes. The Great State of Kansas, with1220about 150 farmers who came together and came up with the1221program. So not surprisingly, I don't want to get ahead of my1222boss, and certainly Secretary Rubio and I have had very initial1223conversations about it.1224    Senator Moran. And I would add. I also understood that1225Secretary Rubio was willing or capable of sharing that1226responsibility or giving you that responsibility.1227    Secretary Rollins. Yeah. We have had really great1228conversations about it. Obviously, we will follow your lead,1229and if in fact this is the will of Congress, I think we would1230be very willing to take that on if that was your direction and1231would be excited to partner on that.1232    Senator Moran. And to the elimination of McGovern-Dole,1233which we call in Kansas Dole-McGovern, the elimination of that1234program is not an indication of the lack of interest in the1235Department of Agriculture making available American-grown1236commodities to people who are hungry around the globe; is that1237true?1238    Secretary Rollins. That is true. Thank you for that1239clarification. That is really important.1240    Senator Moran. In the conversation that you have had about1241employees at USDA and the efforts to right-size, downsize,1242whatever the right words are, the Department, let me highlight1243for you the importance of FSA and NRCS employees in county1244offices across the state of Kansas and around the country, I1245assume. And it was particularly troublesome when those on1246probation were those who were eliminated. We love the1247circumstance when a young man or woman out of college, returns1248home, goes to work for USDA in a county office. We do not have1249sufficient personnel in those county offices today.1250    Secretary Rollins. Right.1251    Senator Moran. But we particularly love when they are1252somebody who is in their 20s, they come home, and they raise a1253family in a small county of Kansas. And so would you pay1254particular attention to trying to make certain that county1255offices where farmers sit across the table from USDA employees1256and have a conversation about--certainly about the farm1257programs and conservation programs takes place, that is1258different than ever trying to do that on a computer.1259    Secretary Rollins. That is right.1260    Senator Moran. So what would you tell me about your1261commitment to that?1262    Secretary Rollins. Well, I think it is of paramount1263importance. And you think about what USDA who we are called to1264serve, the initial intention of the Agency, of course, in the1265founding of our country, we had the original four agencies,1266Treasury, Defense, the Attorney General, and Justice and then1267just a few years later, a couple decades later, Interior was1268added, and right after that was Agriculture.1269    So this goes back to almost the founding of our country,1270and certainly we take that very, very, very seriously. In1271President Lincoln's best vision and his intention in founding1272this agency, it was to have that on-the-ground support for our1273farmers and our ranchers.1274    So as President Trump is working to make America great1275again and restore prosperity across our country, my role in1276that is to ensure that rural America sees a level of prosperity1277that perhaps they haven't seen in our lifetimes. And there is a1278lot that goes into that formula, right, there is a lot we have1279got to do. We have got to get government off the back of our1280people. We have got to cut taxes.1281    Senator Moran. Let me ask you one more question.1282    Secretary Rollins. We have got to deregulate but, yes, the1283FSA remains at the very top of that list.1284    Senator Moran. Thank you. And I do appreciate having1285employees return to the office to work, it is as important as1286well.1287    Secretary Rollins. Yes. That is an important part, too,1288yes.1289    Senator Moran. I had mentioned to you when we visited about1290the National Bio Ag Facility that is in Kansas, it is the1291replacement for Plum Island, we had this conversation when you1292were in my office before the confirmation.1293    Secretary Rollins. Yes.1294    Senator Moran. I want to just highlight, because I have one1295second left, but I want to highlight that facility, that1296institution, and ask you to either tell me or get me a report1297on National Bio and Agro-Defense Facility (NBAF) operational1298status as of today?1299    Secretary Rollins. I think it is a huge asset, and it is an1300important asset to the greater good of the country. And as we1301talked about in your office that day, a couple of months ago1302now, my commitment in fulfilling Congress' intent has not1303changed. And so I think, Senator, you and I can just make sure1304you need to send me reports if you are hearing anything1305different. But we are committed to ensuring that that facility1306moves forward in a way that best serves all of America and,1307frankly, the world. It is a really important asset.1308    Senator Moran. Thank you, Secretary.1309    Secretary Rollins. Thank you, Senator.1310    Senator Hoeven. Senator Baldwin.1311    Senator Baldwin. Thank you, Mr. Chairman.1312    Secretary Rollins. Good morning.1313    Senator Baldwin. Secretary Rollins, thank you for joining1314us today.1315    Secretary Rollins. Thank you.1316    Senator Baldwin. The Dairy Business Innovation Initiative1317has delivered critical and high-impact support to small dairy1318farms and businesses in Wisconsin and across the country. Since1319its inclusion in the 2018 Farm Bill, the program has helped1320producers expand their product lines, access new markets, and1321modernize their operations. In Wisconsin, these small-dollar1322grants have made a real difference in helping expand a globally1323respected dairy industry.1324    As we consider additional funding for USDA in 2026, I am1325really deeply concerned about the treatment of the Dairy1326Business Innovation Initiative under this administration.1327Congress has secured funds annually in statute in the1328bipartisan annual appropriation bills, and they were promised1329to farmers by the USDA. Yet over 400 dairy businesses had1330nearly $30 million on the chopping block due to a Diversity,1331Equity, and Inclusion Executive Order issued by President Trump1332this February. I hope we don't confuse diversity and1333biodiversity, as important issues.1334    But I appreciated the opportunity to discuss this with you1335personally, and you know, the need to issue these funds to1336Wisconsin and other farmers expeditiously, especially when1337their margins are already incredibly slim. But I still have1338concerns. How are you planning to restore Congress' confidence1339in USDA's ability to implement and fund programs required by1340statute, like the Dairy Business Innovation Initiative? And how1341will you ensure the Agency's communication to farmers and small1342businesses can be relied upon when they make real-time1343investment decisions in their operations based on awards?1344    Secretary Rollins. Well, I appreciate that question. And on1345my second trip, it wasn't to your beautiful state, but it was1346to Kansas, as we talked about. I think Senator Moran stepped1347out. But we talked about--we actually visited a major dairy1348operation and have since visited half a dozen more in1349Pennsylvania and several other states. So I look forward to1350coming to Wisconsin and seeing the operation there.1351    The program you are talking about is not frozen. I think1352after we spoke, we looked into that. But I want to make sure1353that is clear from your understanding as well.1354    Senator Baldwin. It is.1355    Secretary Rollins. So that is moving forward.1356    Senator Baldwin. After my intervention and our1357conversation, the funds were released. But that was still, you1358know, people make expenditures in reliance of an award that1359they have gotten.1360    Secretary Rollins. I understand. It was maybe a 30-day1361delay, and I apologize for that. Any delay, I think, on a1362worthy program, especially with our dairy farmers is, one day1363is one day too many. I know you understand.1364    Senator Baldwin. There was uncertainty of whether they were1365ever going to get the funds.1366    Secretary Rollins. That is fair.1367    Senator Baldwin. Let me move on to another one that you1368have already referenced briefly. I was really deeply concerned1369when the USDA abruptly cut funding to critical food assistance1370programs in March, including the Local Food Purchase Assistance1371Program and the Emergency Food Assistance Program (TEFAP).1372    In 2024, through the TEFAP program, Wisconsin distributed1373over 21 million pounds of food, serving over 618,0001374households. Hunger Task Force in Milwaukee had about $615,0001375worth of food they expected to help feed people during this1376summer, halted by the Trump administration.1377    And Wisconsin farmers and producers worked tirelessly to1378grow food that feeds hungry children and stocks our local food1379pantries. And the decision to cancel these vital programs only1380hurts families trying to put food on the table and the1381Wisconsin farmers who produce it.1382    So Secretary Rollins, will you reinstate these critical1383food assistance programs in fiscal year 2026?1384    Secretary Rollins. So let us talk about that for a second.1385First of all, those were COVID-era programs. They were never1386meant to go forever and ever. This is part of the problem1387with--and again, not Democrat or Republican, but any1388government, in general, you put an era program in, and then it1389literally never goes away, which, by the way, is not fair to1390taxpayers. But let me answer your question directly.1391    Senator Baldwin. Well, I would also argue that the1392situation of hunger for----1393    Secretary Rollins. Well, that is what I was going to--may I1394respond to that part of it? So specifically to Wisconsin, your1395program in Wisconsin, aside from what was pulled back, still1396has $1.2 million left sitting in a bank account, out of $8.11397million in your Local Food Purchase Assistance Program. You1398also had your state, not you, Senator, but your state asked for1399a contract extension because they couldn't spend the money fast1400enough. Your tribes have 500,000 left out of 700,000.1401    Senator Baldwin. I think you are confusing the programs,1402because the local food assistance purchased that creates1403opportunities for local farms to produce fresh produce.1404Secretary Rollins: I am not.1405    Secretary Rollins. That is the LFPA.1406    Senator Baldwin. Some of these others, you know, get canned1407commodities, et cetera. I visited several food banks in1408Wisconsin.1409    Secretary Rollins. I am talking about the LFPA, Senator.1410    Senator Baldwin. Right now and we have 200 to 300 farms1411that were engaged in this, and this was an expected customer1412that they no longer have.1413    Secretary Rollins. But, Senator, it was an era--it was1414COVID-era program that, by the way, you still have millions of1415dollars left, right, that you can use to pay those farmers.1416    Senator Baldwin. The need is still there.1417    Secretary Rollins. That is the point. Most of that--a lot1418of that money was never spent, you couldn't spend it fast1419enough, that is not fair to the taxpayers. Do you know USDA1420spends $400 million a day on nutrition and food programs, just1421USDA? That is aside from this food bank. There is plenty of1422money in the system. We just have to be better about how we are1423spending it.1424    So I hear you. But I think that it is important to look at1425where this money is sitting, how it is being spent, and making1426sure that we are using the taxpayer dollars effectively. But1427thank you.1428    Senator Hoeven. Senator Fischer.1429    Senator Fischer. Thank you, Mr. Chairman.1430    Secretary Rollins, it is so good to see you here today.1431Thank you.1432    Secretary Rollins. Thank you.1433    Senator Fischer. I share your desire to realign and1434reprioritize resources across USDA to put our ranchers and our1435farmers first. This is especially important for USDA's1436Agricultural Research Service to ensure that we are funding1437innovative and high-impact research that benefits our farmers1438and ranchers. I have been working to secure funding for an ARS1439facility that is focused on innovative, precision agriculture1440research that is co-located at the University of Nebraska-1441Lincoln.1442    And I look forward to continuing to work with you on that1443facility to ensure we can have high-impact, high-priority1444research taking place there. You have also talked about having1445more USDA's workforce located closer to the people that they1446serve.1447    Secretary Rollins. Yes.1448    Senator Fischer. And while no official announcements have1449been made, I think this would be a great step, and I know1450Nebraska would be a great location to relocate parts of USDA,1451like the Ag Research Service, giving our proximity to a number1452of strong land-grant institutions, lower cost of living, and1453strong existing relationship with the Agency at the facilities1454I mentioned beforehand.1455    Can you talk about your plans for relocating parts of USDA1456to the heartland, and how do you anticipate relocation efforts1457could save taxpayer dollars and create greater efficiencies for1458the Agency itself?1459    Secretary Rollins. We are very close, I will say, in the1460coming weeks you will hear a lot more about these plans, and I1461have really--I am so grateful because I have gotten a lot of1462feedback from you and from others about potential locations1463around the country. What I am most excited about in this1464realignment, though, is exactly how you outlined it, Senator,1465that we have to move--this is a customer-service-oriented1466agency; and why do we have so many people in Washington, D.C.?1467    And then you bring the force part into that, and then the1468nutrition into that, and it just doesn't make as much sense. It1469will also be cheaper for the taxpayer, and the customer service1470agent will be closer to the people that they serve. So we are1471very in the weeds on that today, and an announcement is1472forthcoming.1473    Senator Fischer. I appreciated your comments to Senator1474Moran about the FSA and keeping those local offices open. I am1475very well aware in rural communities across my state how1476important it is that farmers have that in-person access. And1477while we may be using technology in many areas, there still, I1478think, at this point in time, needs to be that face-to-face1479contact.1480    Secretary Rollins. I agree.1481    Senator Fischer. So thank you for that as well. In1482Nebraska, we are also so proud of the work that is being done1483at USDA's Meat Animal Research Center at Clay Center. That is a1484strong relationship that the Center has with our livestock1485producers in the state.1486    Last month, both Nebraska cattlemen and Nebraska pork1487producers talked to me about how they valued the research that1488is being done there. The President's budget does call for cuts1489to ARS funding, but I think it is also important for us to make1490sure that the dollars that we do spend on research and1491facilities gets stretched as far as it can. Due to1492overregulation, you have touched on that in some of your1493answers, a lot of burdensome contracting requirements out1494there, simple maintenance and upkeep costs end up costing1495sometimes three to four times more than they should.1496    And this is especially true for unique research centers1497like U.S. Meat Animal Research Center (USMARC) at Clay Center,1498who operate--they are working farms, they are working ranches,1499they handle livestock on a daily basis.1500    So would you agree that research done in collaboration with1501the livestock industry at USMARC's Working Farm and Ranch is1502important? And would your team work with mine to ensure that1503the improvements that we make to ARS facilities don't end up1504dramatically costing more than it would for the private sector1505to operate those?1506    Secretary Rollins. I will, Senator. And I appreciate that1507and the great research that happens in Nebraska. A quick note1508on ARS, while we are decreasing the budget, it is $2.1 billion1509currently under the President's budget from Friday. It goes1510down to $1.9 billion. that is about a 7.5 percent decrease, and1511that is really focused on just some facilities that are way1512behind on repair and just out of date, and not meeting the1513mark, obviously not yours in Nebraska. So that is a very1514targeted decrease in funding that shouldn't affect, we remain1515highly, highly focused on the priorities of ARS and ensuring1516those are funded.1517    Senator Fischer. You know, I hope you can also look at that1518overregulation that we have with contracting that I mentioned,1519because a lot of times just those really simple maintenance, it1520does end up costing more, and more, and more, where if we can,1521you always hear about government regulation and how burdensome1522it is, and there is some good examples that we need to get rid1523of those good examples and make sure that we are dealing with1524common sense and in the real world to meet those lower costs1525that should be available.1526    Secretary Rollins. And the most important thing you can do1527is send us, have your team send us those examples, and we will1528get on it right away.1529    Senator Fischer. Great.1530    Secretary Rollins. Thank you, Senator.1531    Senator Fischer. Thank you, Madam Secretary.1532    Senator Hoeven. Senator Heinrich.1533    Senator Heinrich. Thank you, Chairman.1534    Secretary, the Iron Fire is currently burning in the Gila1535National Forest, and you and I have talked about the Silver1536City Dispatch Center, which is in charge of coordinating the1537response between air assets and frontline firefighters in the1538Southwest. It is still among the dispatch centers that DOGE is1539seeking to close. And in our conversations, you assured me that1540you would seek to keep this dispatch center open, that you1541would designate it mission critical. Talk to me about what you1542are doing to make good on that promise?1543    Secretary Rollins. Yeah, we have been in conversations with1544GSA on that, Senator, and certainly as we have many hands1545working across the Trump administration to deliver on our1546promise for a more effective and efficient government, we agree1547that this is important, and especially as wildfire season is1548heating up, ensuring that we are operationally ready at every1549turn in your state and in other states that are highly affected1550by that. So we remain focused on that. And if you hear1551something different, please call me.1552    Senator Heinrich. Let us return to something that you1553discussed with my colleague from Wisconsin. The local Food1554Purchasing Assistance and Local Food for Schools programs, in1555my view, are two of the best, and they may be COVID programs,1556but they are two of the best examples of using American-grown1557produce to produce healthier outcomes in our students. To me,1558that is making America healthy again.1559    You have canceled both of those contracts, even though1560those contracts were signed and farmers had bought supplies for1561planting based on those contracts. So what would you say to1562both the producers and the schools who made financial decisions1563based on those commitments?1564    Secretary Rollins. Well, I would love, Senator--the first1565thing I will say is could you send me specific information on1566that, because that would be really helpful. We have talked a1567lot in broad strokes, but if I could see the details. In New1568Mexico, you still have $1.5 million of the last tranche left1569out of 6 million.1570    Senator Heinrich. I can't speak to what the state is doing,1571and we will be happy to run that to ground. But the people I am1572hearing from are, literally, the schools and the producers who1573were impacted, the growers.1574    Secretary Rollins. Yeah. I would love to get more details1575on that and what that looks like. Again, it is a COVID-era1576program. The other side of this, and I want to make sure you1577have got plenty of time to ask your other questions, but the1578other side of this as far as the local nutritious farms, et1579cetera, I mean, I think that is a massive push.1580    I think it is important we remain prioritized on that. But1581again, the $400 million a day we spend at USDA on nutrition,1582just on nutrition, I believe sincerely that we will be able to1583check a lot of those boxes without continuing a program that1584was supposed to end at the end of COVID and that, in fact, most1585states still have a lot of money left in the bank. They haven't1586been able to spend it.1587    Senator Heinrich. My colleague from Kansas mentioned Food1588for Peace and McGovern-Dole. These programs have provided life-1589saving, American-grown food to people around the world. I have1590literally met with mothers and children who relied on American1591food aid for their survival. So I appreciate that you have had1592initial discussions with Secretary Rubio about these programs,1593but what I saw two weeks ago with several of my Republican1594colleagues on the ground at a refugee camp, was kids who were1595on fractional rations, who didn't have enough calories per day1596to thrive.1597    So what are we doing to fill the gap between the historic1598commitment of those programs and whatever that replaces them,1599in the meantime, when the impact is kids who are not getting1600enough to eat?1601    Secretary Rollins. And you are talking specifically on the1602international programs. Yes, that is a great conversation. We1603continue to talk about it. The President has been very clear1604that we have to ensure that our kids here in America that are1605hungry, that we are serving, obviously they are the priority.1606It doesn't mean that we don't care about or want to move out1607our American farmers' produce, and we should, and commodities1608across the world, but really focusing here in America first.1609    But secondly, understanding what those programs are, which1610I talked a little bit about with the back and forth with1611Senator Baldwin, I think--it may have been Senator Murray. But1612how important and effective those are, where we are spending1613the money, how it is being spent, and what that looks like.1614    Senator Heinrich. I think you will get a lot of support1615from this committee to go after overhead, excess overhead.1616    Secretary Rollins. Yes.1617    Senator Heinrich. I think we have to check too many boxes,1618and there are a lot of entities that have gotten good at1619running those contracts because they can check those boxes. But1620what we saw on the ground was kids who had malaria and other1621diseases because they simply didn't have enough food to eat,1622because commitments we made were not being made good on.1623    Secretary Rollins. Well, I would love more details on that.1624That would help me understand, in fact, where it was you all1625went, and then my commitment to you is to study that. And you1626know, my heart is with what you are saying, but again we,1627putting America first, understanding how we are feeding our1628children, and we haven't had a MAHA discussion yet, but if we1629do, we can talk a little bit more about that, is important.1630    But also understanding that, again, the mission and that1631the intention of these programs are always good, it is how we1632are effectuating them and putting them into play and really1633looking at that closely.1634    Senator Hoeven. Thanks. Senator Hyde-Smith.1635    Senator Hyde-Smith. Thank you, Mr. Chairman, and thank you,1636Ranking Member. And thank you, Madam Secretary, for being here.1637    Secretary Rollins. Thank you, Senator.1638    Senator Hyde-Smith. I am thrilled to have you there. I1639think you have already proven to be a great Secretary of1640Agriculture, my hat is off to you, the challenges that you are1641facing in reorganization and a new administration is a tall1642drink of water.1643    Secretary Rollins. Yes.1644    Senator Hyde-Smith. And I certainly want to be helpful any1645way I can, and I can attest to those 5 a.m. texts, that I don't1646know when you sleep. But there is so many challenges out there.1647    Secretary Rollins. There are.1648    Senator Hyde-Smith. And of course, as the former Head of1649the Mississippi Department of Agriculture, I know all the1650players. And getting the calls I am getting now on the concerns1651that you are desperately trying to address is very much1652appreciated.1653    Secretary Rollins. Thank you.1654    Senator Hyde-Smith. Because there is a lot of glaring1655concerns that we have to take a look at. And I just admire the1656speed that you are tackling this and the tasks that you have in1657front of you. And before I go to the questions, and I know that1658this is about the 2026 Budget Request, but before I go into1659these questions. I just want to say this to everybody in the1660room. Congress needs to address the outdated and inadequate1661safety nets that is in the Farm Bill during the budget1662reconciliation process.1663    Secretary Rollins. Right.1664    Senator Hyde-Smith. There is a lot of farmers in1665Mississippi and across this country that are not going to be1666able to continue unless we do address this. It is so concerning1667for me. And addressing one aspect of the Farm Bill, SNAP, in1668reconciliation without making improvements to the farm safety1669net, it will make it extremely difficult to pass a Farm Bill,1670but it is so critical.1671    So American farmers, as you well know, desperately want a1672new and improved Farm Bill. And I think it is our job to1673improve the Farm Bill. So let us give that to them by1674addressing the safety net and reconciliation. I can't scream1675that enough. Like I said, I know this is about the budget, but1676that is so critically important that we do this now.1677    I want to just commend you on how efficiently and fast the1678Department got out the 10 billion in disaster aid Congress1679passed in December to help commodity producers cope with the1680unbelievable input and cost and the depressed commodity prices.1681You were excellent at doing that. And I have had my farmers1682call and thank me for that. But through the USDA's Emergency1683Commodity Assistance Program (ECAP) that you have referenced,1684you know, many farmers are able to farm this crop this year1685that, literally, they would not be able to otherwise.1686    Secretary Rollins. Yes.1687    Senator Hyde-Smith. When I have bankers come to me and say,1688we are not going to finance your farmers next year without1689something, it was that critical. And it was not sounding the1690alarm; it was just pure fact is what we were dealing with.1691    Secretary Rollins. Yes.1692    Senator Hyde-Smith. So thank you for that. But when can we1693expect USDA to distribute the remaining disaster funds for 20231694and 2024 for the weather-related losses? That is the questions1695that we are being asked right now; if you could address that?1696    Secretary Rollins. Yes, ma'am. And I appreciate all the1697good words. And just quickly, it is the team sitting over my1698right shoulder and the people back at USDA that literally1699worked seven days a week, 18- 20-hour days to get that first1700tranche of funding out. And I am so grateful to them and the1701unbelievable amount of time and effort they put into it. They1702are putting that same amount of time and effort into this now1703second tranche on the disaster relief.1704    The portal should open within a matter of weeks, before the1705end of the month, to allow those grant applications to begin1706being processed, our goal is timely, efficient, and turn it1707around quickly. With the first tranche, that first $10 billion,1708the ECAP, we were turning it in two to three days, which I1709believe is unprecedented for any government program, but1710certainly for USDA.1711    Senator Hyde-Smith. We had four.1712    Secretary Rollins. And our goal is to have the same sort of1713speed, timeliness, and hopefully effectiveness on the second1714tranche as well.1715    Senator Hyde-Smith. And thank you for that. And there is no1716doubt that you are not going to accomplish that because you1717have done so well so far. And we have talked about the FSA1718county levels, and the staffing, and the decisions that have1719been made, but again, as I hear from all of my producers and so1720many throughout the country, we know that some of this is so1721necessary and it is going to benefit us in the long run. It is1722kind of like cleaning out a closet. You dread doing it, and you1723get everything out, and it is just stuff everywhere until you1724get it sorted and organized and put back.1725    Secretary Rollins. That is an amazing metaphor, but I can1726completely understand and appreciate.1727    Senator Hyde-Smith. Yes, we have four children. We can1728clean out closets.1729    Secretary Rollins. Yes, we can.1730    Senator Hyde-Smith. Because that is where we are.1731    Secretary Rollins. Yes, ma'am.1732    Senator Hyde-Smith. And to get it organized, put in the1733proper place.1734    Secretary Rollins. Right.1735    Senator Hyde-Smith. But to get to the end of, you know, the1736conclusions, is it being spent properly? And are we doing the1737most that we can to make it efficient? So my question is just,1738it is so critically important that support continues to reach1739these producers. And can we just ask that you work with the1740subcommittee on doing that?1741    Secretary Rollins. Absolutely. And it brings up a bigger1742question, I think, Senator, that the average age of the farmer1743is 58. That is a whole other hearing for another time, how we1744reverse that trend. But I think it goes to not to cast any of1745us, you know, around that age or older, aspersions at any of1746us, but that, you know, moving to online is important at some1747point.1748    But that is my point. It isn't today. And especially with1749all the challenges and the headwinds against our producers, we1750have to keep those front liners in place as we are moving these1751projects out.1752    Senator Hyde-Smith. Well, you have an unbelievable task1753with a huge agency. But I just want you to know you have got my1754support. I have been on the frontlines. I have been there. And1755I am very, very pleased with what you are doing and the1756direction you are headed.1757    Secretary Rollins. Thank you.1758    Senator Hyde-Smith. And thank you for being willing to do1759it.1760    Secretary Rollins. Thank you, Senator. Thank you.1761    Senator Hoeven. Senator Peters.1762    Senator Peters. Thank you, Mr. Chairman.1763    Secretary Rollins. Good morning.1764    Senator Peters. Secretary Rollins, good to see you again.1765    Secretary Rollins. You, too.1766    Senator Peters. And welcome to the committee.1767    Secretary Rollins. Thanks.1768    Senator Peters. Secretary, as part of the 2018 Farm Bill,1769Congress passed the PAWS Act legislation, which I authored to1770establish a grant program to provide shelter options for1771domestic violence survivors with companion animals. Research1772had found that up to 84 percent of women entering domestic1773violence shelters reported that their partners had threatened,1774abused, or had killed the family pet, used that as a source of1775intimidation for these survivors.1776    In fact, nearly half the survivors report that they have1777stayed with their abuser longer, sometimes months, sometimes1778years, because of fear of what would happen to that beloved1779part of their family. PAWS funding is a priority that I pushed1780throughout my time on this committee and in the Senate. And it1781is a line item that I hope to see in the President's budget1782once we receive the details.1783    So my question for you, Secretary Rollins, is would you be1784willing to support this important issue, and certainly I would1785hope to count on you to get that continuing support that1786survivors have been able to get these last few years.1787    Secretary Rollins. Senator, if we could follow up and have1788a longer conversation, I would welcome that opportunity. This1789is the first I have heard of it, so I don't want to commit1790without knowing more. But I really appreciate your leadership1791and your quiet, steady hand in all of this, and I would love to1792have a longer conversation about that.1793    Senator Peters. Great. We will follow up with you and your1794team.1795    Secretary Rollins. Yeah, it would be great.1796    Senator Peters. I will be happy to do that. In my home1797state of Michigan, food and agriculture is the second largest1798contributor to our state's economy. Everybody thinks about1799manufacturing and making cars. We do that really well, but ag1800is incredibly important. And specialty crop industries are the1801biggest part of that equation. That is why I have long fought1802for strong, consistent funding for the APHIS Specialty Crop1803Pest Program. And that is also why I am so alarmed by some of1804the recent reports that more than 1,300 APHIS employees have1805accepted the deferred resignation option.1806    So my question for you, Madam Secretary, is how will your1807Agency continue to meet its responsibilities after such a major1808reduction in staffing?1809    Secretary Rollins. Well, it is a really important question,1810and one that I have been talking about quite a bit in media. I1811think that while we are moving through the reduction in force,1812one point that I made, Senator, I don't know if you were in the1813room, that while 15,000 of our employees of 106,000 staffed1814agencies, a little less than 15 percent have accepted the1815deferred resignation program, our typical attrition is between18168,000 and 10,000. Now, obviously, this is a significant jump1817from that, but it is one that I believe is manageable.1818    I signed a memorandum a few weeks ago at USDA putting our1819key areas, such as APHIS, such as wildland firefighting, such1820as FSA offices, at the very top of the list. So as we have lost1821important employees as part of this process, we are out1822recruiting and ensuring that they become and are prioritized as1823we rehire, realign, and reorganize the Agency.1824    Senator Peters. Okay. Well, I look forward to working with1825you on that as well.1826    Secretary Rollins. Yes, sir.1827    Senator Peters. It is a major concern for us. As you know,1828public investment in agricultural research has decreased since18292002. While we have seen competitors such as China surge in1830their research efforts, they have now far surpassed U.S.1831investment in agricultural research as well as development. And1832given the critical importance of food security, to national1833security, China competitiveness in this context I think is of1834utmost importance for us to keep an eye on. That is why I am1835frustrated to see that the President's budget calls for hefty1836cuts in ag research funding.1837    So my question for you, Madam Secretary is, is ag research1838a priority for this administration? And if so, how do you1839square that with this year's budget request?1840    Secretary Rollins. Obviously, the research is a key1841component of this, of the work at USDA. In this budget1842discussion, we are just talking about the discretionary1843funding, which is about 30 billion of our total $200-plus1844billion annual budget, so at about 20 percent total is what we1845are discussing today. In total of that, the research part of it1846in the budget that came out Friday went from $2.1 billion down1847to $1.9 billion. So while it is a cut, it is not a massive cut.1848It is a 7 percent cut, and it is very much focused on outdated1849facilities.1850    So as we continue the high priority and the focus on the1851important research, I believe that none of that will be1852compromised, Senator. If you see something different on the1853ground in Michigan or across the country, would you please flag1854it for us, because it shouldn't affect the key, most important1855parts of the research.1856    Senator Peters. Great. Well, thank you for that.1857    Thank you, Mr. Chairman.1858    Secretary Rollins. Thank you, Senator. Good to see you.1859    Senator Hoeven. Senator Ossoff.1860    Secretary Rollins. Good morning.1861    Senator Ossoff. Thank you, Mr. Chairman.1862    Good morning, Madam Secretary.1863    Secretary Rollins. Good morning.1864    Senator Ossoff. Thank you for joining us. I want to follow1865up on hurricane disaster assistance, key, key priority for1866farmers in Georgia, Madam Secretary. It is worth noting that1867after Hurricane Michael in 2018, it took the Congress the1868better part of a year to pass disaster assistance. We worked1869together across the aisle here to get it done after Hurricane1870Helene in less than 90 days.1871    Here is a quote from Arren Moses, owner of Moses Pecan in1872Uvalda, Georgia, ``We lost almost our entire 2024 pecan crop1873when Hurricane Helene hit our orchards. We lost the majority of1874our mature pecan trees, which will set our farms' production1875back for years. We were thankful that Congress approved1876disaster assistance funding at the end of last year, but it is1877critical that these funds get to those that need help.''1878    Here is a quote from Chris Hopkins, a cotton producer in1879Toombs County, he said that ``The storm has created a void due1880to loss of yield and quality as well as cost of cleanup that1881has become untenable to a first-generation operation like1882mine.''1883    When can farmers in Georgia expect that hurricane relief,1884which we passed timely in Congress, to be out the door?1885    Secretary Rollins. Yeah. And first of all, thank you for1886that. That relief was passed very quickly and very impressively1887at the end of last year, and so we have been tracking it very,1888very closely. I have visited Georgia. Hopefully next time I1889will see you. I have visited some of those peanut farmers1890especially. I have seen the devastation firsthand. It is1891heartbreaking to witness it. I had mentioned earlier, but it is1892good to keep repeating it, that within a matter of weeks, the1893portal will open on those grant applications. Under ECAP which1894was the first tranche, that first 10 billion that went out for1895emergency assistance.1896    Senator Ossoff. That is the economic assistance.1897    Secretary Rollins. That is right.1898    Senator Ossoff. I am referring to the disaster assistance.1899    Secretary Rollins. I understand, but I just want to use1900that as an explanation of how we are going to be also doing the1901second tranche, which is the disaster. We, on March 17th,1902announced it. On March 20th, funds were moving out and into1903farmers' bank accounts.1904    Senator Ossoff. When will the portal be open for disaster1905assistance?1906    Secretary Rollins. By the end of the month, hopefully in1907the next week.1908    Senator Ossoff. And how will that impact states that are1909using a block grant arrangement with USDA?1910    Secretary Rollins. Well, that is a state-by-state question,1911so I will be happy to follow up with Tyler Harper, your Ag1912Commissioner, who I know is tracking this very, very closely,1913and I ensure that we both understand----1914    Senator Ossoff. When do you expect those discussions with1915the state to be resolved?1916    Secretary Rollins. Well, again, there are 50 states. We are1917talking to all of them. When we open that portal, hopefully it1918moves almost immediately. We have already moved the 280 million1919that was outlined in that disaster relief into Texas. Because1920it was outlined, it was obviously easier than, the open book on1921the rest of the states. But it will move very, very quickly.1922    Senator Ossoff. Because time is of the essence.1923    Secretary Rollins. Then would you please let me know?1924    Senator Ossoff. Yes, I will.1925    Secretary Rollins. And we will do everything we can.1926    Senator Ossoff. Madam Secretary, are you familiar with the1927Local Foods for Schools Program?1928    Secretary Rollins. Yes, sir.1929    Senator Ossoff. So here is a few quotes from my1930constituents, this is from Scott Richardson of the Dawson1931County School District: ``Local Foods for Schools Program has1932transformed our ability to bring healthy, fresh, and locally1933grown fruits and vegetables to our students. Prior to the LFS,1934purchasing from local farmers was often cost prohibitive.''1935    Here is a quote from Parrish Akins, he owns a family farm1936in Nashville, Georgia. Mr. Akins said, this program, quote,1937``Has allowed our farming operation to capture some of the1938profits, which in the past would have gone to another member of1939the supply chain, and has allowed us to increase our1940revenues.''1941    Here is Colquitt County School Nutrition Office,1942``Purchasing local foods has significantly enriched our school1943community by providing fresher, healthier meal options for1944students.''1945    Here is Atlanta Neighborhood Charter School Nutrition, ``We1946bought some Georgia shrimp from a guy who has been in the1947shrimp industry since he was a teenager.''1948    In Brunswick, Crisp County School Nutrition, ``Through the1949Local Food for Schools Program, we were able to establish1950reliable and stable local food sources.'' This is a program, of1951course, that helps Georgia farmers sell food to Georgia1952schools. Why did you cancel the program?1953    Secretary Rollins. Well, let us talk about Georgia for a1954second.1955    Senator Ossoff. I have 50 seconds left, so I just want to1956know about the----1957    Secretary Rollins. Well, that is a big question. You have1958got to give me a little bit more time.1959    Senator Ossoff. You can take your time, but I want to know1960why you canceled the program.1961    Secretary Rollins. Well, we canceled the program. It was a1962COVID-era program, first of all. Second of all, the money was1963not being spent. In the current tranche, your state has $21964million of $7 million left in the account. You are asking for1965contract extensions because you cannot spend the money quickly1966enough. The food for the FPA and the LFPA, we have got $101967million of $20 million left, so you have got money in the bank.1968    Senator Ossoff. Why rather than tailor the program did you1969cancel it?1970    Secretary Rollins. It is not a good use of taxpayer funds1971when you have got taxpayer dollars.1972    Senator Ossoff. Well, my constituents believe that it1973Constituents, the farmers----1974    Secretary Rollins. Well, I would love to talk to your1975constituents, I wonder if they know that the State of Georgia1976has not moved that money out, we just can't continue that.1977    Senator Ossoff. Constituents, the farmers--Will you please1978provide to the committee an economic justification for the1979outright cancellation of that program?1980    Secretary Rollins. An economic justification for the1981outright cancellation of the COVID-era program that was due to1982end, yes, we will do that.1983    Senator Ossoff. Of the Local Food for Schools program that1984the constituents enjoy and rely on?1985    Secretary Rollins. Yes, we will be happy to do that, sir.1986    Senator Ossoff. Thank you, Madam Secretary.1987    Secretary Rollins. Thank you.1988    Senator Hoeven. Senator Merkley.1989    Secretary Rollins. Good morning.1990    Senator Merkley. Thank you, Mr. Chairman.1991    And welcome.1992    Secretary Rollins. Thank you.1993    Senator Merkley. So agricultural research is very important1994in the State of Oregon. We have such varied types of1995agricultural activity. Just to give you an example, in1996Corvallis the work is done on sudden oak death, which has a1997huge threat to our nursery stock industry but also a huge1998threat, potentially, to our timber. In Pendleton, the research1999being done on drought-resistant dry land wheat varieties is2000essential. In Burns, the research on how to reseed grasses that2001are beneficial to cattle after a fire, rather than having cheap2002grass take over, is essential.2003    Secretary Rollins. Sure.2004    Senator Merkley. So we were shocked when all these2005scientists were fired. We lobbied like hell to get them back.2006We got them back, thank you very much. But I am very concerned2007about the proposed cut of 160 million to research in the2008proposed budget.2009    Can you ensure, or can you assure the farmers and all the2010ranchers in all these different places in Oregon that the2011research will go on in a vibrant and significant way? Not only2012for these reasons, that is just a short list, I mean, we have2013invasive flies affecting the berries.2014    Secretary Rollins. Right.2015    Senator Merkley. You know, we have warmer conditions in the2016ocean affecting our shellfish. Can you assure us that we are2017not going to end up without this essential research being done?2018    Secretary Rollins. Yes, sir. And I really appreciate this2019question, Senator. So the ARS portion of USDA has a $2.12020billion budget. The President's budget suggests, as you2021mentioned, the $160 million decrease. That takes us down to20221.9. That is about a 7 percent decrease, so it is not, you2023know, as big as maybe it is being made out to be in the press.2024And that specifically is focused on closing outdated facilities2025around the country that have nothing to do with the different2026issues that are being researched that are outlined.2027    So yes, we can commit to ensure that the robust body of2028research that is so important to our agriculture producers2029continues. And I look forward to working with you. And if you2030hear anything differently, please call me direct.2031    Senator Merkley. Are there any outdated facilities that you2032think are outdated in Oregon?2033    Secretary Rollins. I do not believe so, but we will follow2034up on that.2035    Senator Merkley. Okay. Thank you.2036    Secretary Rollins. Thank you.2037    Senator Merkley. Because I don't know of it, I have2038visited, I think, all of them, and they are incredibly2039important.2040    Secretary Rollins. We will follow up on that today, sir.2041    Senator Merkley. Okay. I want to turn to the question about2042the funding to decrease, essentially, the challenge of food2043insecurity. And we have one in six kids in Oregon who are2044facing that insecurity, which basically means they are going2045hungry. And so the suspension of the Commodity Credit2046Corporation payments to food assistance programs, including2047TEFAP, have really been shocking. I don't think President Trump2048campaigned on: I am going to help increase the number of hungry2049kids. So what is going on there with that?2050    Secretary Rollins. Well, and let me pull up the Oregon2051numbers just so you are aware. So again, USDA spends about,2052$400 million a day on nutrition programs. That is a stunning2053number. The specific program you are talking about, sir, to2054answer your question, was a COVID-era program that, at the2055time, probably made a tremendous amount of sense but never was2056meant to continue indefinitely.2057    And specifically to Oregon, of the $2 million under the LFS2058program and the $7 million under the LFPA, Oregon has $330,0002059left in the first and $5 million left in the second. Almost2060every state was asking for contract extensions because they2061couldn't spend the money quickly enough. So I think it just2062goes to the balance we have to strike every single day on2063ensuring that every taxpayer dollar is spent to the best and2064highest use.2065    And it was the decision of our President and this2066administration that perhaps that COVID-era program had2067fulfilled its purpose. But we can still continue to make sure2068that we are supporting our farmers and getting nutritious foods2069into the schools and into the food banks, but through different2070and other programs.2071    Senator Merkley. You know, I guess I would like to have you2072look at this from the perspective: Is there a current need that2073needs to be addressed, whether or not it was originated under2074COVID or not? I have visited those food banks. I have seen the2075high increase in demand, which, it is kind of scary to see how2076that need has grown. I have the estimate from the Oregon Food2077Bank that the changes that are currently happening under the2078credit corporation, the suspension, will reduce their ability2079to provide about three million meals, 2.88 they said, three2080million meals.2081    It seems like a pretty significant impact to an ongoing2082problem, regardless of whether the program was created under2083COVID. So could you just take a look at that in more detail?2084    Secretary Rollins. I will.2085    Senator Merkley. All of those numbers you provided, I did2086not catch if one of those was a TEFAP number?2087    Secretary Rollins. Yes, sir.2088    Senator Merkley. Okay. Because I know that has been the top2089priority of the Oregon Food Bank, is being able to move produce2090around the state, which had been very helpful to our farmers in2091one place that have a surplus, or grocery stores that have a2092surplus, they are donating it, but it has to be moved to where2093it is needed, and it has to move in a timely fashion so it2094doesn't rot.2095    Secretary Rollins. Right.2096    Senator Merkley. And all the vegetables and so forth. So I2097see that five minutes have vanished, and my stack of another2098ten questions are ongoing.2099    Secretary Rollins. Well, I am always available. So I2100welcome a phone call. Just, you know, call me anytime, and we2101will be so happy to walk through any of this with you.2102    Senator Merkley. Thank you. Thank you very much.2103    Secretary Rollins. Yeah, thank you, Senator. Nice to meet2104you.2105    Senator Hoeven. Secretary, we know you have a time line. We2106certainly want you visiting with the Mexican Ambassador. We2107will go to close up.2108    Let me turn to Ranking Member Shaheen for her final2109comment.2110    Secretary Rollins. Yeah. And Senator Shaheen, if you have2111any other questions, we can, we can go a few more minutes.2112    Senator Shaheen. Well, I just wanted to clarify what2113Senator Murray and I think we were asking you about with2114respect to the WIC Program which, as you pointed out, is not2115mentioned at all in the skinny budget. And what also is not2116mentioned is the cash value benefit for fruits and vegetables.2117So what we wanted to know from you is whether you would support2118fully funding WIC, including that cash benefit?2119    Secretary Rollins. If you do not mind, I would like to take2120a good look at it, since it wasn't in this particular round. I2121haven't spent the time on it, but obviously this administration2122believes that WIC is very important.2123    Secretary Kennedy and I have had conversations about it2124pretty extensively already. So the more that I can learn and be2125in contact with you all, I would welcome that.2126    Senator Shaheen. We would appreciate your getting back to2127us on whether you support both aspects of the WIC Program. The2128other thing I just wanted to clarify is, I was not quite clear2129where you got the numbers of money that has gone out to New2130Hampshire and the number of recipients, because when we check2131the online dashboard, New Hampshire has received 24,000 only,2132of the $10 billion in economic disaster assistance that was2133provided in the December supplemental, and the dashboard states2134that 51 applications have been approved. So I am not sure where2135those numbers came from, but they are a lot higher than any2136numbers I have ever heard related to the agricultural sector in2137New Hampshire.2138    Secretary Rollins. So you know what, Senator, my apologies,2139it looks like there was a typo on yours--you and South Dakota2140are exactly the same on this sheet. And we know that those are2141two very different states, so my sincere, sincere apologies.2142This is unacceptable. It will not happen again. And we will2143make sure and get it right, and today we will follow up. Now, I2144do not know we will get this up today.2145    Senator Shaheen. Thank you. And actually, the numbers are2146not as big a concern for me as making sure that the funding2147goes to the people who need it in New Hampshire.2148    Secretary Rollins. Yes, ma'am.2149    Senator Shaheen. That is the concern.2150    Secretary Rollins. We will follow up with your team today2151on that and make sure you have the up-to-date numbers.2152    Senator Hoeven. Yeah. And I can add there. Again, I think2153that is weather-related, which you will have coming out. We put2154a number of different components in there.2155    Secretary Rollins. Right.2156    Senator Hoeven. So I think, Senator Shaheen, correct me if2157I am wrong. You just want to make sure in that weather2158component they are cognizant of the language you talked about2159with the allocation specifically regarding small farms; is that2160right?2161    Senator Shaheen. Well, the $220 million set aside for the2162eight states for New England is a concern.2163    Senator Hoeven. Yes.2164    Secretary Rollins. Yes.2165    Senator Shaheen. But the other concern is the halt on2166funding and the applications that have been submitted for all2167of the assistance programs. Thank you.2168    Secretary Rollins. Yeah. We will get direct information on2169that.2170    Senator Shaheen. Mr. Chairman, yes.2171    Senator Hoeven. Right. There were like five different2172pieces to that, and so I think she is referring to a piece that2173was weather-related, separate from the market conditions base--2174the 10 billion-base that we talked about.2175    Secretary Rollins. That is right.2176    Senator Hoeven. I think that is the confusion.2177    Secretary Rollins. We will fix that. Yes, ma'am.2178    Senator Hoeven. So I will follow up with her on that. And2179again, from what I have seen, you are following very well what2180we laid out in that emergency assistance, and we appreciate it2181in getting this squared away.2182    Secretary Rollins. Thank you.2183    Senator Hoeven. Just final couple comments or questions.2184Any update on tariff agreement timelines?2185    Secretary Rollins. Yes. I don't want to speak for Secretary2186Lutnick, Secretary Bessent, or our U.S. Trade Rep, Jamieson2187Greer, or the President, but we are exceedingly close to having2188significant announcements that of anyone that will be impacted,2189no one will be impacted positively more than our agriculture2190industry, as these announcements begin to roll out very2191quickly.2192    Senator Hoeven. And we think weeks, not months?2193    Secretary Rollins. Oh yes. That is right.2194    Senator Hoeven. Yes.2195    Secretary Rollins. That is exactly right, within week/2196weeks.2197    Senator Hoeven. Yeah. Okay. And then there was some2198discussion regarding ARS restructuring, those kind of things.2199Obviously, the policy centers, you have got one at A&M, FAPRI,2200NDSU, Nebraska, Omaha, we are going to want to be involved in2201that very closely with you, very important, as well as the NIFA2202funding. So those are things that we are going to want to talk2203to you about closely more.2204    Secretary Rollins. We would welcome that.2205    Senator Hoeven. Critically important.2206    Secretary Rollins. Yes. Thank you.2207    Senator Hoeven. Yeah. And then, just anything else that you2208want to add for the record, Secretary, before we adjourn?2209    Secretary Rollins. I would just say that I really, really2210appreciate the opportunity. This is my first hearing, other2211than the confirmation hearing. And I have been--you know,2212obviously there are some differences of opinion, and we can2213agree to disagree, but the agriculture side of this effort, we2214are all in this together. And I think even on the other side of2215the aisle, you know, understanding that every one of our2216elected officials on both sides really want what is best for2217our ag producers, and our farmers, and our ranchers.2218    And I know you know this, Senator Hoeven; and Senator2219Shaheen, you may not yet, but I am always available. And I just2220want this to be a productive conversation and productive 42221years where we can hopefully get these farmers and ranchers2222back to a place of prosperity, and where they are not worrying2223about losing their farm every single year. So that is my goal,2224and I look forward to working across party lines to do that.2225    Senator Hoeven. Well again, Secretary, thank you for being2226here.2227    Secretary Rollins. Well, easy. Thank you. And I should not2228say that before the questions come in, but we will do that. And2229one other thing for you all to know too, we are working really2230hard on the letters to make sure we are timely on responding to2231letters. We have gotten about 140 since I took office about 802232days ago, and we have responded to more than half of those to2233date. And we have responded to everyone on this committee. So I2234feel really good, and we are way understaffed. So I think that2235we will be able to be much more timely, moving forward. And2236that is really important to me as well.22372238                     ADDITIONAL COMMITTEE QUESTIONS22392240    Senator Hoeven. Questions for the record are due by next2241Tuesday, May 13th. And we would appreciate responses back from2242USDA within 30 days.2243               Questions Submitted to Hon. Brooke Rollins2244               Questions Submitted by Senator John Hoeven2245    Question. On May 16, I was informed of a round of terminations of2246the McGovern-Dole Food for Education grants; some of which were mid-way2247through a multi-year program. The FY2025 bill provided $240 million to2248this program, which is the largest global donor to school feeding2249efforts. The program provides U.S. agricultural commodities, funding,2250and technical assistance to reduce hunger, support nutrition, and2251improve literacy, primary education and training around the world. The2252McGovern-Dole Program supports domestic agricultural producers,2253advances U.S. diplomatic interests, and has received bipartisan support2254since 2002. Can you provide details such as which programs were2255terminated and the justification for termination?2256    Answer.In line with President Trump's January 20, 2025, Executive2257Order: Reevaluating and Realigning United States Foreign Aid, USDA2258terminated the below 17 McGovern-Dole projects that do not align with2259the foreign assistance objectives of the Department. USDA continues to2260maintain 30 active McGovern-Dole projects in 22 countries, and the FY252261Notice of Funding Opportunity for the program was posted on May 9.22622263------------------------------------------------------------------------2264               FY                       Country          Organization2265------------------------------------------------------------------------2266FY19............................          Uzbekistan         Mercy Corps2267FY19............................                Togo                 CRS2268FY20............................           Guatemala                 CRS2269FY20............................            Honduras                 CRS2270FY20............................                Mali                 CRS2271FY21............................               Benin                 CRS2272FY21............................        Burkina Faso                 CRS2273FY21............................          Kyrgyzstan         Mercy Corps2274FY21............................                Laos                 CRS2275FY21............................        Sierra Leone                 CRS2276FY22............................             Burundi                 CRS2277FY22............................             Lesotho                 CRS2278FY22............................          Madagascar                 CRS2279FY22............................         Timor-Leste                CARE2280FY23............................               Nepal                 WFP2281FY23............................           Nicaragua     Project Concern2282                                                                   Int'l2283FY24............................       Guinea-Bissau                 CRS2284------------------------------------------------------------------------22852286                                 ______22872288            Questions Submitted by Senator Cindy Hyde-Smith2289    Question. USDA Watershed and Flood Prevention Operations2290administered by the Natural Resources Conservation Service (NRCS) are2291vital to rural Mississippi. Local sponsoring organizations throughout2292Mississippi are working constantly to prevent flood, erosion, and2293sedimentation damage in various watersheds--all of which affect2294conservation, water disposal, and land utilization. Should Congress2295provide funding for NRCS watershed operations above the FY2026 budget2296request, are you confident that the Department could effectively put2297those additional funds to good use?2298    Answer. NRCS is committed to supporting the technical and financial2299assistance needs of local sponsoring organizations who have watershed2300flooding, erosion and sedimentation concerns using funds provided to2301the Watershed and Flood Prevention Operations program.2302    Question. I was pleased to see that the FY26 USDA budget request2303calls for increased funding for the Food Safety and Inspection Service2304(FSIS). Since USDA assumed responsibility over catfish inspection,2305along with meat, poultry and egg products, the import of products2306containing substances that could be harmful to human health has2307declined. But USDA can do more to stop foreign countries, like Vietnam,2308from sending us catfish grown in unsanitary conditions and treated with2309chemicals not approved for U.S. aquaculture. With any additional2310funding provided for FSIS in FY26, will you work to make sure USDA2311catfish inspections are strengthened to the maximum--especially for2312imports from known violators?2313    Answer. FSIS is committed to ensuring foreign suppliers meet the2314same rigorous food safety standards as domestic catfish producers. USDA2315will also continue working with the Department of Commerce and across2316the Trump administration to ensure our producers have a level playing2317field with our trading partners, including for our catfish producers.2318    Question. USDA administers the National Veterinary Stockpile (NVS),2319a repository of materiel that can support State-based outbreaks of2320livestock infectious disease. The unabated threat from H5N1 avian2321influenza necessitates that those responding to these outbreaks have2322access to effective personal protective equipment (PPE). It also2323necessitates even more robust preparedness for any mutation of the2324virus that could be especially virulent and transmissible to people.2325This latter scenario would require significant levels of PPE to ensure2326the safety of all animal agriculture workers and outbreak response2327personnel. Can you please report back on the following: What specific2328PPE supplies have the USDA stockpiled in the NVS? What planning2329scenarios are these assets tied to? How many critical personnel could2330be supported by this PPE in these scenarios? Have you coordinated with2331the Department of Health and Human Services to plan for leveraging PPE2332assets in the Strategic National Stockpile in the event of an emergency2333that exceeds the assets in the NVS?2334    Answer. The PPE in the NVS includes goggles, disposable coveralls,2335respirators, gloves, boot covers, and bouffant caps. The NVS is2336designed to maintain sufficient amounts of countermeasures capable of2337deployment against the most damaging animal diseases within 24 hours.2338USDA is committed to working with our partners across the Federal2339Government and routinely communicates with other agencies to ensure the2340best outcomes in the event of large-scale emergencies.23412342                                 ______23432344               Questions Submitted by Senator Mike Rounds2345    Question. As you know, Highly Pathogenic Avian Influenza (HPAI)2346continues to devastate producers in South Dakota. While farmers in my2347state are taking proactive steps to protect poultry and dairy2348populations, the presence of migratory birds continues to exacerbate2349the spread of HPAI. These circumstances have led many producers to2350support the development of an HPAI vaccine.2351    Secretary Rollins, it was encouraging to see USDA support the2352conditional approval of an avian flu vaccine for poultry. Do you2353believe the USDA Agricultural Research Service (ARS) has the necessary2354resources to support the development of additional HPAI vaccine2355candidates?2356    Answer. ARS is fully committed to providing the necessary resources2357to combat HPAI through detection, biosecurity, and vaccine development2358and testing. Several vaccines against the currently circulating viruses2359for chickens have been tested by ARS and licensed by the USDA Center2360for Veterinary Biologics. ARS is currently receiving congressionally2361appropriated funding for poultry vaccine development and approaches,2362such as mass vaccination of birds and vaccines that enable2363differentiating infected from vaccinated animals (DIVA vaccines).2364    For other species (cattle, small ruminants, and swine), ARS2365received additional Commodity Credit Corporation funding through an2366interagency agreement with APHIS. These additional resources support2367foundational research on species-specific animal models and vaccine2368testing, thereby enhancing our knowledge and understanding of a disease2369previously unknown in these species.2370    Question. Secretary Rollins, South Dakota ranch families work2371tirelessly to produce the safest, highest quality and most affordable2372beef in the world. Yet as you know, foreign animal disease threats have2373the ability to halt the U.S. beef trade. Unfortunately, the previous2374administration lifted a long-standing ban on Paraguayan beef imports.2375    Secretary Rollins, does USDA's Animal and Plant Health Inspection2376Service (APHIS) currently have the necessary resources to effectively2377combat foreign animal diseases such as Foot and Mouth Disease (FMD) or2378New World Screwworm?2379    Answer. Yes, APHIS currently has the resources needed to combat2380foreign animal diseases and will continue to reassess needs as2381warranted.2382    Question. For too long, American producers have been forced to2383compete with lower quality foreign beef that falsely bears the 'Product2384of USA' label. I previously introduced the USA Beef Act to make certain2385the ``Product of USA'' label is only applied to beef derived from2386livestock raised and slaughtered in the United States. Since this time,2387USDA has implemented this change through rulemaking.2388    Secretary Rollins, with USDA set to implement this rule next year,2389can you confirm whether the Food Safety and Inspection Service (FSIS)2390will be fully prepared to administer the voluntary ``Product of USA''2391labeling program?2392    Answer. USDA is thoroughly reviewing significant rules put in place2393by the previous administration, such as the voluntary ``Product of the2394USA'' labeling program. FSIS will continue to review stakeholder and2395Congressional input as this review is ongoing.2396    Question. USDA's Rural Utilities Service (RUS) provides critical2397financing to electric cooperatives across rural America, enabling many2398small South Dakota communities to upgrade their rural electric2399infrastructure. While the agency has traditionally worked well with2400rural leaders, cooperatives in my state have recently encountered2401lengthy delays due to RUS environmental reviews-a problem that2402originated during the previous administration.2403    Secretary Rollins, will you work to help resolve these bureaucratic2404delays and make sure that appropriated RUS funding is disbursed2405promptly to rural electric cooperatives?2406    Answer. RUS has been working to identify process improvements to2407streamline reviews to ensure compliance with the National Environmental2408Policy Act. We have already implemented emergency procedures to comply2409with Executive Order EO 14156, Declaring a National Emergency. USDA is2410actively participating with other Federal agencies to comply with EO241114154, Unleashing American Energy, by identifying and adopting agency2412level implementing regulations to expedite permitting approvals and2413meet deadlines established in the Fiscal Responsibility Act of 20232414(Public Law 118-5).24152416                                 ______24172418             Questions Submitted by Senator Jeanne Shaheen2419    Question. There are several Regional Conservation Partnership2420Program awards in New Hampshire that have been disrupted by this2421administration's funding freezes. The pauses and failure to provide2422clear communication to grantees about the review have injected2423unnecessary uncertainty in the process and delayed key seasonal work.2424Given that it has been more than 3 months since the administration2425froze this program and many others, when will USDA release the funding2426and allow RCPP projects to proceed?2427    Answer. On June 11, USDA notified all RCPP partners of the status2428of their project.2429    Question. More than 12,000 women, infants and children in New2430Hampshire rely on the WIC program for healthy food, breastfeeding2431support and nutrition education. An important part of this program is2432the WIC Cash Value Benefit, which helps participants afford the level2433of fresh fruits and vegetables each month recommended by the National2434Academies of Sciences, Engineering and Medicine. Do you agree that2435failing to fully fund the fruit and vegetable cash value voucher2436undermines the nutritional quality of the WIC program?2437    Answer. I appreciate the value of the Special Supplemental2438Nutrition Program for Women, Infants, and Children (WIC) to pregnant2439and postpartum mothers and their children. WIC has a proven track2440record of improving children's health by providing access to2441supplemental foods, nutrition education, and health referrals. It2442allows health- conscious food purchases that are adjusted according to2443participants' life stage nutritional needs. The President's Budget2444would continue to ensure WIC participants receive nutritious2445supplemental foods--including support for purchasing fresh fruits and2446vegetables--to promote healthy eating habits and improved health2447outcomes.2448    Question. The Snow Telemetry Network (SNOTEL) has been providing2449western States with vital measurements of snow accumulation and snow2450melt prediction data for decades. In recent years, this Committee2451provided additional funding to expand the SNOTEL program to the2452Northeast-this data will be key for the region to better understand2453flood potential, water supplies and the effects on seasonal businesses.2454Do you commit to continuing the SNOTEL expansion to the Northeast? What2455resources are needed in Fiscal Year 2026 to keep the expansion on track2456and what benchmarks does NRCS hope to reach over the course of the next2457year?2458    Answer. As our new Administration continues to evaluate all USDA2459agency programs to identify opportunities to reduce inefficiencies, and2460enhance customer service, especially to agricultural producers, NRCS is2461currently focused on protecting our historical investments in the Snow2462Survey and Water Supply Forecasting Program. We will continue to2463collaborate with other federal, State and local agencies to develop and2464encourage use of new techniques, improving data collection and2465processing. Additionally, NRCS is evaluating a request for a no cost2466extension of the existing Cooperative Agreement with the Northeast Snow2467Survey Feasibility Study partners to accomplish the following2468benchmarks though Fiscal Year 2026:24692470  --Summary report on interest holder engagement process and outcomes2471        to share with interest holders.24722473  --Summary report of snow monitoring in northern New England and New2474        York to share with NRCS colleagues and interest holders.24752476  --Systems Engineering plan linking network objectives to data2477        products, processing workflow, measurement specifications, and2478        spatial design.24792480    Question. New England experiences significant weather variability,2481including historically dry and historically wet years over the last2482decade. For many small and diversified operations in New Hampshire,2483protected agriculture systems are critical to reducing weather2484exposure, limiting damage from pests and diseases and helping farmers2485extend their growing seasons. There is an opportunity for ARS to do2486further research into optimal uses of these systems, and there are2487ready partners like the University of New Hampshire who have done2488related extension work.2489    Will you work with me on expanding investments in research relating2490to protected agriculture?2491    Answer. If ARS is provided with funding from Congress to support2492research relating to protected agriculture, I look forward to working2493with you and ARS leadership to find ways to work with ready partners to2494conduct this research.2495    Question. In Fiscal Year 2024, this Committee created a pilot2496program to add an additional tool to preserve the rural affordable2497housing portfolio. Do you commit to continuing to pursue and providing2498the committee with regular updates regarding the Multifamily Housing2499decoupling pilot? How many staff will be dedicated to affordable2500housing preservation, and how many properties does RD plan to offer2501decoupled rental assistance agreements to in Fiscal Year 2026?2502    Answer. We will ensure sufficient staff are dedicated to affordable2503housing preservation to meet the statutory requirements. In Fiscal Year25042026 there are 52 units initially eligible for the pilot, with 1,2092505units eligible for preservation through the pilot program.2506    Question. In October 2023, the Government Accountability Office2507released a report titled ``Sugar Program: Alternative Methods for2508Implementing Import Restrictions Could Increase Effectiveness''. GAO2509made recommendations on improving the trade aspects of the program, and2510USDA and USTR stated that they concurred with the recommendations.2511Career officials at USDA communicated to stakeholders that policy2512announcements to implement the GAO recommendations would be initiated2513within 18 months of the report's release. When will USDA announce2514policies to initiate implementation of the GAO recommendations?2515    Answer. USDA remains in close coordination with the Office of the2516United States Trade Representative as it implements its GAO2517recommendation. In 2024, USDA concurred with GAO's recommendation for2518USDA to evaluate the effectiveness of the WTO raw sugar tariff rate2519quota allocation methods. USDA committed to providing USTR an2520evaluation report within 2 years and expects to share this evaluation2521in 2025; USDA will inform GAO once the report has been shared to close2522out its recommendation.25232524                                 ______25252526              Questions Submitted by Senator Jeff Merkley2527    Question. According to the Oregon Food Bank, 1 in 8 people and 1 in25286 kids in Oregon and Southwest Washington are going hungry. However,2529earlier this year, the USDA announced that it would suspend Commodity2530Credit Corporation payments to food assistance programs, including the2531Emergency Food Assistance Program (TEFAP). As a result, this year,2532Oregon food banks will be unable to provide 2.88 million meals. How2533many fewer meals will be delivered as a result of the decision to spend2534Commodity Credit Corporation payments?2535    Do you agree that suspending CCC payments to food assistance2536programs has resulted in more individuals going hungry?2537    Answer. USDA spends roughly $400 million per day across its 162538nutrition programs. Currently, one in four Americans will participate2539in a USDA Food and Nutrition Service Program at some point over the2540course of the year. Taxpayers generously fund these programs to help2541ensure that no children, in Oregon or any other state, go hungry. We2542owe it to taxpayers to ensure these programs are effective and2543accountable. And with these nutrition programs and the Section 322544market support program in place, USDA remains focused on its core2545mission: supporting agricultural markets and ensuring access to2546nutritious food. The Department will continue to use its procurement2547authority to support producers and consumers where appropriate, and2548ensure families continue to have access to affordable and abundant2549food.2550    Question. When will Commodity Credit Corporation (CCC) payments to2551food assistance programs resume?2552    Answer. USDA continues to purchase food for TEFAP, with more than2553$669 million spent in Fiscal Year 2025, as of May 14, 2025, to connect2554families to food. Additionally, since March 27, 2025, USDA has2555announced $328 million in available fruits, vegetables, tree nuts,2556Atlantic groundfish, canned pears, dried sweet cherries, great northern2557beans, and Pacific pink shrimp made possible through Section 322558purchases. These foods go directly to food banks and other charitable2559organizations.2560    Question. At the hearing, you stated that the proposed $159 million2561decrease for the Agricultural Research Service is ``specifically2562focused on closing outdated facilities around the country that have2563nothing to do with the different issues that are being researched...2564yes, we can commit to ensure that the robust body of research that is2565so important to our agriculture producers continues.'' You also2566committed to following up with me to assure that no facilities in2567Oregon were targeted for closure. Are any ARS units in Oregon proposed2568for closure or consolidation?2569    Answer. The President's Budget does not propose the closure or2570consolidation of any ARS units in Oregon.2571    Question. What facilities or ARS units are proposed for closure or2572consolidation? Why?2573    Answer. The President's Budget proposes the closure of three2574locations to support the Administration's priority of reducing the2575Federal footprint. These include Newark, Delaware; Riverside,2576California; and Urbana, Illinois. The research programs and resources2577will be consolidated with other existing ARS laboratories and2578locations.2579    Question. You stated clearly that the proposed funding cut to the2580Agricultural Research Service would only be used to close outdated2581facilities. This statement contradicts the President's so-called2582``skinny budget,'' which States, ``The Budget reduces funding for2583research sites across the Nation that have exceeded their ideal2584lifespan and reduces funding for research projects that are not of the2585highest national priority.'' Please clarify whether the U.S. Department2586of Agriculture intends to cut funding for research projects. If so,2587which projects does the Department intend to cut?2588    Answer. The President's Budget proposal for ARS terminates $1452589million for Climate Science research and the Climate Hubs. These2590activities are not aligned with the Administration's priorities.2591    Question. I am concerned with this administration's attempt to2592withhold funds that were directly allocated for specific purposes by2593Congress. For example, this administration initially froze the2594Partnerships for Climate-Smart Commodities (PCSC) program which had2595awarded grants to more than 130 agriculture projects across the2596country, including in some of Oregon's most rural communities. Now, the2597program has been rebranded by the Department of Agriculture and2598possesses a different set of criteria for applicants to reapply for2599funding. I have heard from ranchers in Oregon who received a PCSC grant2600that has been terminated. They do not intend to reapply for the2601rebranded program because they do not trust that the USDA will uphold2602its commitments for funding and because they do not believe that the2603USDA understands the time and resources it takes for small farms to2604apply to Federal grants. How does USDA intend to maintain trust with2605our farmers and ranchers while creating an environment of uncertainty2606and pulling funding from critical projects in agricultural communities2607across the country?2608    Answer. The Partnerships for Climate-Smart Commodities (PCSP)2609program was established by the previous administration utilizing2610discretionary authorities under the Commodity Credit Corporation2611without funding direction or input from Congress. In creating the2612Advancing Markets for Producers initiative, USDA will continue to2613support farmers and encourage partners to ensure their projects are2614farmer focused or re-apply to continue work that is aligned with the2615priorities of this Administration.2616    Question. On May 5th I sent a letter to the U.S. Department of2617Agriculture requesting that the Agricultural Marketing Service (AMS)2618approve the Westcoast Seafood Processors request for a Section 322619purchase of Pacific pink shrimp. If approved, the Section 32 purchase2620of Pacific pink shrimp would provide economic certainty to Oregon2621fisheries and coastal communities in addition to providing much needed2622relief in response to the impacts of this administration's tariff war.2623Although the U.S. and EU have paused tariffs and retaliatory tariffs,2624European customers cancelled their orders of American seafood products,2625including up to 50% of the Oregonian pacific pink shrimp in response to2626the President's announcement of tariffs. The pacific pink shrimp season2627opened on April 2, 2025--leaving no time for the industry to find2628alternative markets to offset the loss of consumers from the European2629market. Will the Agricultural Marketing Service approve of the2630Westcoast Seafood Processors request for a Section 32 purchase?2631    Answer. On May 23, AMS announced a Section 32 purchase of up to $162632million of Pacific Pink Shrimp.2633    Question. The Watershed and Flood Prevention Operations (WFPO)2634Program--also known as PL-566--has been integral to agricultural2635producers in the west to modernize their irrigation systems through2636piping to respond to increased drought conditions. This program is ran2637through USDA's Natural Resources Conservation Service (NRCS). During2638the President's first term, a group of NRCS State Conservationists2639developed a white paper proposing improvements to the PL-566 program to2640streamline the approval of watershed plans and break ground on more2641projects in a timely manner. In the years that followed, the2642recommendations in this white paper were never fully adopted/2643implemented by the agency. The President's ``Skinny'' Budget released2644last week would provide $0 for WFPO, which specifically supported2645multi-benefit projects in the West. Given the President's Budget2646request calls for eliminating funds specifically for projects that2647support Western farmers combat drought and implement multi-benefit2648projects, how do you plan to maintain these activities at the agency?2649    Answer. There is permanent funding of $50 million provided annually2650through the Farm Bill to support watershed projects. In addition, this2651program received an enormous influx of funding through IIJA, which NRCS2652is still working to obligate.2653    Question. Does the agency have plans to modernize the WFPO program2654to facilitate multi- benefit projects? What steps will you be taking to2655accomplish this modernization?2656    Answer. The NRCS WFPO program utilizes a continuous process2657improvement strategy to prioritize changes related to Congressional2658directions and local project sponsor feedback. Specifically, NRCS plans2659to streamline:26602661  --the Preliminary Investigation and Findings Report (PIFR)2662        development process,26632664  --the Watershed Project Plan development, review and implementation2665        authorization process,26662667  --and the development of Environmental Assessments or Environmental2668        Impact Statements for WFPO projects.26692670                                 ______26712672              Questions Submitted by Senator Tammy Baldwin2673                                biofuels2674    Question. What actions is USDA taking to ensure that EPA2675understands the importance to US agriculture of quickly getting the2676upcoming Renewable Volume Obligation rulemaking out the door that2677includes biomass-based diesel volumes at 5.25 billion gallons and2678implied ethanol volumes at no less than 15 billion gallons? When do you2679expect the EPA proposal to be released?2680    Answer. USDA staff have been and will continue to be in2681communication with EPA about rules that impact U.S. farmers and rural2682communities. On June 13, the Environmental Protection Agency released2683the Proposed Renewable Fuel Standards for 2026 and 2027 including a2684proposed 15 billion gallons of conventional renewable fuels.2685    Question. Once volumes are set, they must not be undermined by2686small refinery exemptions. What steps is USDA taking to ensure that EPA2687and the White House understand the need for a careful and judicious2688approach to any justified small refinery exemptions that ensures that2689blending requirements are not reduced?2690    Answer. USDA staff have been and will continue to be in2691communication with EPA about rules that impact U.S. farmers and rural2692communities.2693                       climate smart commodities2694    Question. On April 14, 2025, USDA announced cancellation of the2695Partnership for Climate Smart Commodities program. The program had2696funded 28 projects that had touch points and conservation enrollment2697opportunities for Wisconsin producers as well as sizeable projects2698focused on our State's vital dairy community. At the same time the2699cancellation notice was provided USDA also announced the new2700``Advancing Markets for Producers'' initiative. Could USDA please share2701with the Committee:27022703  --A breakdown (including funding allocations) of both terminated2704        projects as well as projects selected to continue;27052706  --What if any modifications were required for projects selected to2707        continue;27082709  --Specific details on Advancing Markets for Producers (AMP)2710        initiative, including but not limited to:27112712    --Eligible applicants.27132714    --AMP objectives and timelines.27152716    --Size, scope and duration of projects sought through AMP.27172718    --Application materials and deadlines.27192720    --Expected Federal funding committed to AMP.27212722    --Application review and grant awarding process.''27232724    Answer. The Partnerships for Climate-Smart Commodities (PCSP)2725program was established by the previous administration utilizing funds2726under the Commodity Credit Corporation without funding direction or2727input from congress. In creating the Advancing Markets for Producers2728initiative, USDA will continue to support farmers and encourage2729partners to ensure their projects are farmer focused or re-apply to2730continue work that is aligned with the priorities of this2731Administration.2732                            organic concerns2733    Question. The Organic Agriculture Research and Extension Initiative2734(OREI) and the Organic Transition Program (ORG) run under the National2735Institute of Food and Agriculture (NIFA) are the only competitive grant2736programs dedicated to organic agriculture research topics. We are2737hearing from organic researchers across the country that OREI and ORG's2738request for applications (RFA's) have been pulled from the NIFA2739website. This is very concerning because under normal timelines, the2740review process for both of these programs would be almost done at this2741point. For OREI, which is Congressionally authorized and has permanent2742and mandatory funding through the Farm Bill, we have also heard that2743the Scientific Review Board has been disbanded. No Scientific Review2744Board means no awards given out.2745    Can you confirm if the RFA's for the only two grant programs2746dedicated to organic agriculture topics will be released soon? Lastly,2747can you confirm if the Scientific Review Board for OREI has truly been2748disbanded?2749    Answer. The RFAs for both programs (OREI and ORG) are currently2750being reviewed and will be released in the near future.2751    Additionally, no scientific peer review panel for any NIFA program2752has disbanded. To make the scientific peer review panel more efficient,2753NIFA recently transitioned to using a ``panel chair'' selected from the2754members of the scientific peer review panel to manage the review2755process. This is a change from the previous ``panel managers'' who were2756recruited to serve as temporary Federal employees, and this recruitment2757slowed down the review process.2758    Question. Federal funding freezes and Federal employee deferments2759have crippled NIFA research projects as well as the in-house research2760efforts at ARS. ARS and NIFA research projects require steady2761monitoring and evaluation since they often revolve around organic2762materials such as animals, crops, soil, and so on. Shuttering2763agriculture research before their intended end date can risk spoiling2764research results and the tax payer dollars spent to find agricultural2765innovations.2766    What efforts is the USDA taking to protect ongoing research from2767being sullied by the deferments and funding freeze?2768    Answer. USDA continues to work with stakeholders to ensure that2769priority research continues by prioritizing their review and release.2770    Question. The Economic Research Service (ERS) States, ``it is2771widely agreed that increased productivity, arising from innovation and2772changes in technology, is the main contributor to economic growth in2773U.S. agriculture.'' Increased agriculture productivity not only spurs2774growth but makes our products more competitive domestically and abroad.2775According to ERS, organic agriculture has grown by over 600% in the2776last 20 years to become a more than $64 billion industry. However, less2777than one percent of the Agriculture Research Service's (ARS) budget and2778less than two percent of NIFA's budget goes towards organic farming2779research. Meanwhile, ERS shows us having a more than 400% trade deficit2780in organics.2781    If you believe ERS' original statement about productivity deriving2782from innovation is true, what ways does the President's budget address2783our organic farming research funding problem so our organic producers2784can have the best innovation to better compete at home and abroad?2785    Answer. In addition to the two NIFA grants programs specific to2786organic agriculture (OREI and ORG), NIFA will continue to accept2787submission of proposals focusing on organic agriculture to other2788relevant programs like Agriculture and Food Research Initiative (AFRI).2789                             aphis staffing2790    Question. Recent reports indicate that USDA, and specifically2791APHIS, is experiencing significant staffing changes, including2792reductions in force (RIF) and delayed replacement practices (DRP).2793These workforce losses raise serious concerns about APHIS's ability to2794carry out its core functions, including disease detection and response,2795permitting, and safeguarding animal and plant health. Specifically,2796USDA does not have the personnel and resources to effectively manage2797multiple threats simultaneously with the four active threats to animal2798agriculture including the Highly Pathogenic Influenza (ongoing outbreak2799in the USA and globally); New World Screwworm (active in Mexico); Foot2800and Mouth Disease (active in many parts of the world, including recent2801outbreaks in Germany, Hungary, and Slovakia); and African Swine Fever2802(active on the island of Hispaniola).2803    What is the number of APHIS employees lost due to RIF, DRP, or2804other budgetary cuts?2805    Answer. APHIS has not initiated any layoffs in recent months. All2806APHIS employees were offered the opportunity to participate in DRP 1.02807and DRP 2.0. To date, 1,386, or approximately 17% of all APHIS2808employees participated in the DRP and the program has closed. USDA has2809not initiated a reduction in force (RIF).2810    Question. What part(s) of APHIS did they work for, and what were2811their job titles and roles?2812    Answer. APHIS employees taking the DRP were from all APHIS programs2813and support units and represent a wide range of positions.2814    Question. What are the impacts of employee losses on functionality?2815    Answer. APHIS has the resources needed to maintain mission critical2816activities.2817    Question. Given the severe understaffing in USDA APHIS's travel2818approval office-resulting in delayed approvals, reduced outreach2819capacity, missed deadlines, and increased costs- what is the2820Department's plan to address this issue, and what is the timeline for2821implementation?2822    Answer. APHIS has the resources needed to maintain mission critical2823activities, including mission critical travel.2824                     national milk testing strategy2825    Question. Many States have agreed to participate but have yet to2826begin testing as part of the NMTS.2827    Will all States be required to actively participate in the NMTS?2828    Answer. Though States are not required to actively participate in2829the NMTS, 45 of the 48 continental States have enrolled in the program.2830USDA's goal is to enroll the remaining States by 2026.2831    Question. How will USDA sustainably fund NMTS to protect food2832security, trade, and animal agriculture over the next 2 years?2833    Answer. USDA will continue to use the CCC funding authorized by2834Congress and dedicated to NMTS and reassess any additional needs as2835warranted.2836                   highly pathogenic avian influenza2837    Question. We understand the current CCC funds available to support2838HPAI-related activities to be $490 million.2839    What will happen if the current funds are expended in the next wave2840of HPAI outbreaks? Will the Secretary be requesting additional funds?2841    Answer. I will examine budgetary issues related to HPAI and report2842to Congress as appropriate.2843 local food for schools (lfs) & local food purchase assistance program2844    Question. The abrupt end to LFS and LFPA, after agreements had been2845signed for the second round, devastated farmers like Stacey and Tenzin2846Botsford of Red Door Family Farm in Marathon County, Wisconsin. How2847will you ensure farmers can trust this Administration and trust that a2848signed contract with USDA is honored? Will you re-obligate FY25 funds?2849Will you allow States to utilize FY26 funds?2850    Answer. Over $340 million is still available under existing2851agreements for LFPA and LFS, and these programs will continue to be in2852effect for the remainder of the period of performance. The period of2853performance varies by agreement, but entities with agreements may2854request extensions. Upon request, LFPA agreements may be extended2855through December 2026 and LFS agreements may be extended through June28562026.2857    Question. It's imperative that USDA support local food market2858channels through programs other than LFS, some of which the Secretary2859pointed to during her testimony. How will the agency ensure that these2860programs are strengthened, including fully funded and staffed? How will2861the agency ensure that they are accessible to small- and medium-sized2862operations, as well as beginning farmers?2863    Answer. I will continue to assess staffing needs to ensure mission2864critical activities are carried out and will use the funding provided2865by Congress to implement programs across the Department. I will also2866continue to work with agencies to understand where opportunities and2867challenges are for small and medium-sized operations and beginning2868farmers.28692870                                 ______28712872             Questions Submitted by Senator Martin Heinrich2873    Question. The New World Screwworm (NWS) is a serious threat to2874cattle and wildlife in New Mexico and throughout the west.2875    What do you need from this committee to ensure that we not only2876prevent the further spread of NWS but push it back south of the Darien2877gap in Panama?2878    Answer. Sterile insect technology is one key tool of several we2879have for fighting New World screwworm. Should the screwworm continue2880moving north, having access to many more flies than the existing2881production facility in Panama can produce will be important to protect2882U.S. agriculture. We are exploring possible options for increasing our2883capacity to produce these sterile insects, which could include a2884domestic facility here in the United States.2885    Question. The President's budget decreases USDA's Rural Development2886by $721 million, including the complete elimination of Community2887Facilities Grants. These grants are in incredibly high demand and have2888been critical to improving rural health and public safety. Many of2889these grants are also specifically directed by Members of Congress, who2890know their districts better than any bureaucrat in Washington DC. Is it2891this Administration's position that rural communities don't need or2892deserve these funds or that they should just be forced to fend for2893themselves?2894    Answer. The Administration is fully supportive of the Community2895Facilities program; the Budget proposes $1.2 billion in Community2896Facilities Direct Loans level and $650 million in loan guarantees,2897which will provide sufficient investment in rural infrastructure and is2898expected to have a measurable impact by fostering competition based on2899the program's point system and program design. Reducing Community2900Facilities Grants accounts for $18 million of the $721 million in2901decreases included for USDA Rural Development as part of the2902President's FY26 Budget, and will have little impact. Funds that are2903provided for these grants are 100 percent earmarked by Congress. This2904has resulted in carryover funding of $569M in unspent funds at the2905beginning of FY25, which could be seen as a waste of tax payer dollars.2906    Question. Some of this country's best wildlife and habitat2907conservation work has been done through voluntary partnerships with2908private landowners and has relied on NRCS Conservation Technical2909Assistance. The Working Lands for Wildlife program and the Migratory2910Big Game Initiative have been particularly successful. How do you plan2911to support these programs and other critical conservation efforts with2912a budget that completely eliminates Conservation Technical Assistance2913funding?2914    Answer. The Budget eliminates discretionary funding for2915conservation technical assistance because it has historically received2916over a billion dollars in mandatory funding, in addition to funding at2917the State and local levels. While funding has helped producers deploy2918conservation practices on their lands, many have been forced to2919participate in the program in order to comply with State environmental2920regulations such as California's Irrigated Lands Regulatory Program,2921which regulates agricultural runoff. These cost drivers should be2922connected to the resource demands they impose.2923    Question. Chronic Wasting Disease is an untreatable disease found2924in deer, elk, and moose that is always fatal. It has been detected in292534 States, including New Mexico. For years, the Animal and Plant Health2926Inspection Service has partnered with state fish and wildlife agencies2927to monitor and prevent the spread of Chronic Wasting Disease. Given the2928impact of chronic wasting disease, why does your budget request2929eliminate resources that would allow the USDA to continue its work to2930reduce the impact of this disease?2931    Answer. Since 2021, APHIS has invested over $41 million for2932projects to research, manage, and respond to CWD in conjunction with2933State and Tribal partners. USDA will continue to make decisions to2934accommodate the most pressing needs of the Department.2935    Question. There are approximately 321,370 people facing hunger due2936to food insecurity in New Mexico, including at least 37,500 seniors.2937For these seniors, the Commodity Supplemental Food Program funds local2938food banks to access their next meal. You intend to completely2939eliminate the $425 million Commodity Supplemental Food Program and2940replace it with ``MAHA food boxes.'' How can these boxes be distributed2941without utilizing the already well-established food bank networks2942across the country?2943    Answer. All nutrition programs, old or new, should be oriented to2944promote healthy choices and healthy outcomes for the families that2945receive them. CSFP is a relatively small program, and it is crucial to2946focus limited resources on nutrition programs that are universally2947available to serve low-income populations, like SNAP. To promote2948healthier foods and support American farmers, the Administration2949envisions converting a portion of SNAP benefits into MAHA boxes. These2950boxes will be filled with commodities sourced from domestic farmers and2951distributed to American households. Current CSFP participants will be2952eligible for MAHA boxes. I look forward to discussing this legislative2953proposal in more detail in the future.2954    Question. As of March 2025, egg prices have continued to rise to a2955whopping cost of $6.23 for a dozen eggs, according to the U.S. Bureau2956of Labor Statistics. On February 7th, I asked what your plans were to2957combat Highly Pathogenic Avian Influenza and lower egg and poultry2958prices. You said you would use every tool at your disposal to eradicate2959this disease--including vaccine research at the Agricultural Research2960Service. But now, the President is proposing a $159 million cut to the2961Agriculture Research Services. How can USDA carry out critical vaccine2962research and fulfill its commitments to food affordability and animal2963health while slashing funding to one of the very agencies tasked with2964delivering on those goals?2965    Answer. The President's Budget does not reduce any research funding2966for animal vaccine development and testing. Instead, it proposes an2967increase of $51,221,000 to enhance efforts in protecting U.S.2968agriculture and food from invasive pests and diseases, as well as to2969develop advanced technologies that will improve animal and plant health2970and production.2971    Specific to HPAI, ARS is currently receiving congressionally2972appropriated funding for research in poultry and there are no proposed2973funding reductions to these programs in the President's Budget. For2974other species (cattle, small ruminants, and swine), ARS received2975additional Commodity Credit Corporation funding through an interagency2976agreement with APHIS. These additional resources support foundational2977research on species-specific animal models and vaccine testing, thereby2978enhancing our knowledge and understanding of a disease previously2979unknown in these species.2980    Question. With the ongoing threat of Highly Pathogenic Avian2981Influenza, USDA's mission to monitor and mitigate this disease is more2982critical than ever and yet, the Administration has sewn chaos2983throughout the workforce, pushing more than 2,632 employees from the2984Animal and Plant Health Inspection Service and the Agriculture Research2985Services. What is your plan for replacing this institutional knowledge2986and expertise essential to effectively dealing with and preventing2987future avian flu outbreaks?2988    Answer. APHIS has not pushed employees out or initiated any2989layoffs. APHIS and ARS employees were offered the opportunity to2990participate in the Deferred Resignation Programs, DRP 1.0 and DRP 2.0.2991Some APHIS job series were included in the Department's exemption from2992the hiring freeze for public safety mission delivery. ARS has also been2993able to use the exemption memo for filling key public safety positions.2994I will continue to work to optimize delivery of the Agency's critical2995mission to safeguard U.S. agriculture.2996    Question. On May 6, the Food and Nutrition Service (FNS) issued2997guidance to States requiring them to share with the Federal Government2998detailed records about more than 42 million past and current2999Supplemental Nutrition Assistance Program (SNAP) participants,3000including sensitive information such as names, dates of birth,3001addresses, Social Security numbers, and the amount of food benefits3002received. This information is protected by 7 U.S.C. 2020(e)(8)(A),3003which allows States to share information only with ``persons directly3004connected with the administration or enforcement'' of the Food and3005Nutrition Act, regulations issued pursuant to the Food and Nutrition3006Act, Federal assistance programs, or federally-assisted State programs.3007The law also limits the subsequent use of the information disclosed to3008such individuals ``only for such administration or enforcement.''3009    Please describe the individuals ``directly connected'' with3010administration or enforcement who will have access to these records.3011    How will FNS ensure this information is disclosed only to the3012individuals authorized under 7 U.S.C. 2020(e)(8)(A) and is not3013disclosed to unauthorized individuals?3014    How will FNS ensure this information is used only for the purposes3015allowable under 7 U.S.C. 2020(e)(8)(A) and is not used for unallowable3016purposes?3017    How long will FNS store these sensitive records?3018    What is the total cost associated with implementing this guidance,3019including collecting, protecting, storing, and analyzing these records?3020What funding will FNS use for this purpose?3021    Answer. Due to pending litigation, USDA does not have any comment.30223023                                 ______30243025           Questions Submitted by Senator Kirsten Gillibrand3026    Question. Since 1981, Puerto Rico has been excluded from the3027Supplemental Nutrition Assistance Program (SNAP), resulting in the loss3028of billions of dollars in aid and reduced nutrition benefits. Yet,3029Puerto Ricans pay billions in Federal taxes every year, including $53030billion in 2023. Additionally, in 2022, the Food and Nutrition Service3031of the USDA published a feasibility study in which it concluded that3032Puerto Rico is ready to transition from the current Nutrition3033Assistance Program (NAP) to the Supplemental Nutrition Assistance3034Program (SNAP). I have legislation, the Puerto Rico Nutrition3035Assistance Fairness Act, which would authorize the transition from NAP3036to SNAP for Puerto Rico. Can you commit to working with my office to3037provide technical assistance and necessary budget information that3038would support development of this legislation and Puerto Rico's ability3039to transition?3040    Answer. USDA is available to provide technical assistance as you3041and your office draft legislation.3042    Question. The Community Eligibility Provision (CEP) for the3043National School Lunch Program is widely utilized in New York State as3044it reduces administrative burdens and helps to feed all students3045breakfast and lunch. In 2023, USDA changed the minimum Identified3046Student Percentage, or ISP, from 40 percent to 25 percent. This change3047has helped many schools and students in New York and throughout the3048country. Can you commit to maintaining the ISP at 25 percent, or if you3049are planning to change the ISP, what level do you believe it should be?3050    Answer. States have a significant role in administering the3051National School Lunch Program (NSLP) and are granted various3052flexibilities to tailor its implementation to local needs and3053circumstances. As I mentioned at my confirmation hearing, children are3054suffering from diet-related chronic disease at unheard of rates. School3055lunch is an important part of that conversation, because we should all3056want it to be the best meal eaten, not just the best meal served. Like3057the rest of the Administration, USDA is conducting a comprehensive3058review of all rules from the previous administration to ensure they3059follow the law, align with current Administration priorities, and find3060opportunities to provide regulatory relief.3061    Question. During your confirmation hearing, you testified that3062USDA's Special Supplemental Nutrition Program for Women, Infants, and3063Children (WIC) is an important part of the safety net, and that you3064hoped to learn more about the program in the weeks and days to come.3065The President's Budget Request for Fiscal Year 2026 discussed at the3066May 6 Agriculture subcommittee hearing is void of any mention of WIC.3067Accordingly, can you give this subcommittee your support for fully3068funding WIC in Fiscal Year 2026 so that no eligible mother or child3069will be turned away from receiving nutritional support and having their3070basic needs met?3071    Answer. The President's Budget would support all eligible women,3072infants, and children who seek WIC benefits in 2026, and adjusts the3073vegetables and fruits benefit allowing more women, infants, and3074children access to the program and driving them towards better health3075outcomes.3076    Question. More than 15,000 USDA staff have accepted the3077administration's offer of deferred resignation, and we are expecting3078Reductions in Force (RIFs) to eliminate more staff. The Plum Island3079Animal Disease Center, a mile off the North Fork of Long Island in New3080York, is transitioning its research mission to the National Bio and3081Agro-Defense Facility (NBAF) in Manhattan, Kansas. Right now, the3082Department of Homeland Security has an ongoing closure program that3083also relies on NBAF coming online and mission transfer to occur. Will3084the resignations and reductions-in-force affect this timeline, and can3085you provide an update on the status, timeline, and next steps of3086mission transfer from Plum Island to NBAF?3087    Answer. There have not been any reductions in force at USDA. The3088standup of NBAF continues to be a priority, and voluntary resignations3089at USDA will not negatively impact the mission transfer timeline.3090    Question. The President's Budget Request proposes to reduce funding3091for formula grants. This formula funding in the form of capacity3092grants, such as Smith-Lever capacity grants, goes to every single state3093and their land-grant university and cooperative extension. Capacity3094grants give each State flexibility to work on their State's3095agricultural and rural priorities. How do you propose to maintain youth3096and K-12 programs when a significant portion of that funding comes from3097formula grants?3098    Answer. The President's Budget reduces funding for formula grants3099because they generally do not achieve the same results as competitive3100programs. The President's Budget protects funding to youth and K-123101programs such as 4-H clubs, Tribal colleges, and universities.3102Additionally, NIFA will continue to accept submissions of education-3103related proposals for competitive funding opportunities.31043105                          SUBCOMMITTEE RECESS31063107    Senator Hoeven. With that, we are adjourned.3108    [Whereupon, at 12:14 p.m., Tuesday, May 6, the subcommittee3109was recessed, to reconvene subject to the call of the Chair.]31103111   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND3112          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 202631133114                              ----------31153116                         THURSDAY, MAY 22, 202531173118                                        U.S. Senate3119            Subcommittee of the Committee on Appropriations3120                                                    Washington, DC.3121    The subcommittee met at 10:40 a.m. in Room 124, Dirksen3122Senate Office Building, Hon. John Hoeven (chairman) presiding.3123    Present: Senators Hoeven, Collins, Hyde-Smith, Shaheen,3124Murray, Peters, and Ossoff.31253126                DEPARTMENT OF HEALTH AND HUMAN SERVICES31273128                      Food and Drug Administration31293130STATEMENT OF HON. DR. MARTIN A. MAKARY, M.D., M.P.H.,3131            COMMISSIONER31323133                OPENING STATEMENT OF SENATOR JOHN HOEVEN31343135    Senator Hoeven. Good morning. We'll call this hearing to3136order. Dr. Makary, thanks for being here. We appreciate it very3137much.3138    Dr. Makary. Thank you.3139    Senator Hoeven. I know it's a busy day for you, and so3140appreciate you being here. And, of course, Ranking Member3141Shaheen. Thank you. Look forward to working with you on this3142Approap' Subcommittee. You and I have worked before on Approap'3143Subcommittee, and so I'm pleased now we're--I have that3144opportunity here with Ag.3145    Agriculture is incredibly important. My state, and I know3146the ranking member's state, well, our great farmers and3147ranchers do every single day affects every American every3148single day with the highest quality, lowest cost food supply in3149the world. And of all the developed countries, Americans spend3150less their budget on food, and they have better choice and3151better quality than any other country in the world. And we3152can't take that for granted. And so, you'll, you'll find that3153we're pretty strong advocates for our farmers and ranchers.3154    Dr. Makary. Great.3155    Senator Hoeven. We understand that your job at FDA is to3156keep people safe whether it's primarily the drugs they eat, but3157many food products obviously as well. I've appreciated the3158conversations that we've had. And I must say, as I've told you3159in our conversations, I think you've got an incredible record3160in healthcare.3161    I certainly believe that John Hopkins is one of the finest3162hospitals, medical centers in the country. I have direct3163personal experience where I've taken family members to John3164Hopkins, and I've been impressed not only with the quality of3165healthcare, but with the culture of the people there and the3166caring. And then not only your tenure there, but all that3167you've accomplished is remarkable. And so, we appreciate your3168willing to take on this public service, this incredibly,3169incredibly important job.3170    In it, you're going to have to, of course, primarily make3171sure that our food and drugs are safe, that the organization is3172working as absolutely well as it can, which is why I appreciate3173your background, not only in medicine, but in business.3174Obviously, we're all trying to find savings across government3175to address the debt and the deficit. I know you've been charged3176with that task as well, but paramount, your job is safety. I3177understand, of course, they'll be releasing the Make America3178Healthy Again (MAHA) report today. You're looking at new ways3179to do things. That's important. We need to do those kinds of3180things.3181    At the same time, there are practical realities, which you3182and I have talked about, that our farmers and ranchers face3183every day producing that highest quality, low cost food supply3184that I just referenced, that benefits every Americans every3185single day.3186    So, whether it's the fertilizers, the pesticides, the3187equipment, all the things that go into them producing that food3188supply, they have to face the practical realities of operating3189in a market that every day they don't control. They don't3190control the weather, they don't control the prices, they don't3191control trade agreements, and on and on it goes.3192    And when you look across our economy, so many industries3193are a few big companies. A few big companies that run the whole3194thing. I personally am not a fan of that. But when you look at3195agriculture, 16 million people directly or indirectly involved3196in agriculture, small family farms and businesses across this3197country that have become quite sophisticated with precision Ag3198and everything else. And we do it better than anybody in the3199world and have higher standards. But that is what we have. And3200I firmly believe that that's what Americans want to make sure3201we have for long into the future.3202    So, I spent a little time on that in this opening3203statement, because we have to be aware, you have to be aware of3204how that works. And as we make changes, again, making sure we3205do all we can for a healthy America, that we understand those3206realities and the challenges that those people have, and that3207we can't just take it for granted, and that we have to3208understand and make sure that all of this works for everybody3209on both sides of the equation.3210    So, with that, I'll turn to our Ranking Member, and I'm3211going to have to ask to excuse myself to vote. I may miss some3212of your opening statement, but I'll see if I can't get anything3213that I miss via the written remarks, and then be back. Ranking3214Member.32153216                  STATEMENT OF SENATOR JEANNE SHAHEEN32173218    Senator Shaheen. Well, thanks very much, Chair Hoeven. And3219let me just welcome, as you did, Commissioner Makary. Very nice3220to have you here this morning. And I would echo the chair's3221commitment to agriculture, and how important it is our farmers3222are to our food supply and to the economy of this country.3223    It's a very different enterprise in New Hampshire with our3224farms, because they are small family farms, but very important3225to the state nevertheless. But of course, this morning, we're3226here to talk about the role of the Food and Drug3227Administration. Federal investment and stability in biomedical3228innovation are vital not just for our competitiveness and3229national security, but also for local economies, in New3230Hampshire and across the country.3231    Right now, we have the earliest access to new cures and3232treatments, and we attract the best talent from across the3233globe because of the good paying jobs that are in emerging3234research. Those jobs fuel our small towns and cities, including3235in New Hampshire, where we have a growing industry in3236biomedical companies.3237    It's very exciting to see the growth that's occurring in3238our state. As we speak, they're developing cutting-edge cell3239and gene therapies to cure terrible diseases like diabetes and3240cancer. And I think when we met, we talked about some of the3241work that's being done in New Hampshire, particularly at the3242Advanced Regenerative Manufacturing Institute (ARMI).3243    But of course, to keep pioneering breakthroughs in curative3244treatments, they need stability and predictability, something3245this administration, sadly, has failed to provide so far. It's3246more than just a lack of stability. I fear the very mission of3247the FDA is at risk because of the actions of this3248administration. More than 4,000 people have been pushed out of3249FDA since January. The majority of those targeted by3250probationary terminations and reductions in force that don't3251seem to have any real analysis of who's important to keep and3252who is not critical to the mission.3253    To date, this committee has not received key information on3254where specifically these workforce cuts are happening across3255centers and offices at the FDA, and that's information that we3256need as we're going to write this budget. What I want to3257emphasize is that it didn't really have to be that way. I think3258there is bipartisan support to see how we make our government3259agencies and departments more effective and efficient. But to3260do that, we need to have a process that people understand or3261are engaged in. And I fear that the process that's been done so3262far is going to prove to be very wasteful to patients and3263families in New Hampshire and across the country.3264    Scientists at the FDA have been fired along with support3265staff who make their work possible, from those who assist with3266product reviewers to those who quite literally keep the lights3267on. Patients across this country are depending on the FDA, as3268you know, to review medical products to ensure that new and3269novel treatments are approved. And yet, reports now suggest3270that medical product reviews have slowed, that essential3271meetings have been postponed or canceled, and that deadlines3272for user fee agreements have been missed.3273    And as Congress has provided the FDA with new authorities3274and directives from the Tobacco Control Act, to the Food Safety3275Modernization Act, to the Modernizing of Cosmetics Regulation3276Act, the FDA has hired talented people who have gotten the work3277done to keep the American people safe.3278    Going backwards, I think, is unacceptable. I'm seriously3279concerned that the workforce cuts across the agency will harm3280the progress that this committee has supported on a bipartisan3281basis to ensure a strong FDA that supports innovative3282treatments and gives families peace of mind that the drugs we3283take, the food we eat, and the cosmetics we use are safe.3284    Now, moving on to the fiscal year 2026 budget, which is the3285topic of this hearing. I wish we'd received and had a chance to3286review the full President's budget request prior to this3287hearing, though I would point out that that's not unique to3288FDA. We haven't gotten the details of the budget in any other3289Appropriations hearings that I've been part of. The FDA was not3290mentioned in the preliminary budget materials we received three3291weeks ago. So, we are sitting here today talking about a budget3292that this committee has not received.3293    I'm disappointed to see the vast and drastic proposed cuts3294to the Department of Health and Human Services, and my priority3295is that the FDA has the resources that you need to carry out3296the core missions of the agency. But without a budget, it's3297hard for us to assume that the President's proposal will meet3298those goals.3299    Now, in closing, the FDA at its core has an incredibly3300hopeful mission. The agency has the power to bring hope and3301comfort to millions of people by approving groundbreaking cures3302and treatments developed here in America by the best scientific3303minds in the world. So, I think, we, on this committee, stand3304ready to be partners in this effort.3305    And I with that, Commissioner Makary, I appreciate your3306being here today, again, and I look forward to hearing your3307statement, and to the discussion that we will have with members3308of the committee about your budget proposals. Thank you.33093310             SUMMARY STATEMENT OF HON. DR. MARTIN A. MAKARY33113312    Dr. Makary. Thank you, Chair Hoeven, and thank you Ranking3313Member Shaheen, and members of the subcommittee. Thank you for3314having me here to testify on the FDA budget for 2026.3315    The Trump Administration is proposing a $6.8 billion budget3316for the FDA, including $3.2 billion in budget authority and 3.63317billion in user fees for fiscal year 2026. This allows us to3318take the necessary steps to support the Make America Healthy3319Again agenda, as we have already been busy implementing.3320    Now, I've been at the FDA for about seven weeks, and I'm3321proud of the early progress we've made working to remove all3322nine petroleum-based food diets from the U.S. food supply,3323eliminating unnecessary animal testing requirements for drugs.3324We approved a new blood test for Alzheimer's, which could help3325enable more early treatment. For the pharmaceutical3326manufacturing facilities overseas that the FDA inspects, there3327has been a routine of using scheduled inspections, which in my3328opinion, are no inspections at all. They're a joke, and we are3329moving towards surprise inspections.3330    We don't allow FDA inspectors anymore to accept limo rides3331from the pharmaceutical manufacturing companies that they are3332there to inspect. I'm amazed at some of the stuff that I'm3333learning when I look under the hood. We've begun taking action3334against new challenges such as gas station heroin, and3335childhood vaping with illegal Chinese vaping products.3336    Our borders have been far too porous. Working with the3337Trump Administration's reenergized Customs and Border3338Protection, we're not wasting any time. Today, we are3339announcing the seizure of nearly 2 million illegal vaping3340products from China. Last week, we announced plans to withdraw3341from the market, chewable, ingestible fluoride tablets,3342currently prescribed to six-month-old babies.3343    And this week we published in the New England Journal of3344Medicine, our framework for Covid vaccine booster regulation,3345so that developers and companies can see what we're thinking3346and have predictability. And we are planning to bring back gold3347standard science and common sense.3348    We also have to modernize. On Day 1 of me being on the job,3349I actively began an effort to organize to use AI for our3350scientific reviewers to make their jobs easier. Well, two weeks3351ago, we just announced our first AI-assisted review with the3352latest generation AI technology. One reviewer said that what3353normally took him two to three days, the AI did in six minutes.3354    I've set an aggressive goal of June 30th to have AI-3355assisted scientific reviews help our reviewers agency-wide, and3356we're going to be ahead of schedule and under budget on meeting3357that aggressive goal. The goal is to reduce the paperwork3358burden of reviewers, which is tremendous, so that we can3359deliver more cures and meaningful treatments to the American3360people faster.3361    That's been the first seven weeks of my job at the FDA.3362Here are other important goals I have for the FDA, and we're3363already hard at work on them. Healthier food for children, a3364universal flu shot, meaningful treatments for ALS, Parkinson's3365and other neurodegenerative disorders, treatments for rare3366diseases, cancer therapies that are so powerful a tumor is3367eliminated without the need for surgery or chemo. That's not a3368theoretical, that something we've already seen.3369    And one of my highest priorities is to ensure that we are3370not wasting any time in evaluating novel treatments for PTSD.3371Many of our brave veterans served in unnecessary wars, and we3372owe it to them. I've not yet hit the two-month mark, so I'm3373doing a lot of listening. I appreciate all of your input, but3374one question we must ask is why does it take over 10 years for3375a new drug to come to market?3376    My team and I are working very actively to examine the3377approval process in all of its details so we can try to figure3378out how to deliver more cures, and meaningful treatments, and3379devices faster and in a more user-friendly way for developers3380without cutting any corners on the scientific review and3381independence.3382    We're also committed to President Trump's promise to lower3383drug prices at the FDA. We can help by bringing more low-cost3384generics and biosimilars to market among many other strategies3385we're exploring.3386    In conclusion, the FDA is filled with an enormously3387talented and committed group of employees representing, in my3388opinion, one of the greatest brands in the world. It's my duty3389to make sure that everybody central to the core mission has all3390the resources they need to do their job well.3391    So, I look forward to answering your questions. Thank you.3392    [The statement follows:]3393         Prepared Statement of Hon. Dr. Martin A. Makary, M.D.3394    Chairman Hoeven, Ranking Member Shaheen, and Members of the3395subcommittee, thank you for the opportunity to appear before you today3396to discuss the President's Fiscal Year 2026 Budget request for the Food3397and Drug Administration (FDA or the Agency). I would like to start by3398thanking the subcommittee for your continued support of FDA. The Agency3399greatly appreciates the Committee's sustained commitment to our mission3400and providing vital resources which have been critical for FDA's3401protection of the public health, and we look forward to continuing to3402work with you to further address critical issues impacting the health3403and wellbeing of Americans.3404    Looking ahead to FY 2026, we will embrace President Trump and3405Secretary Robert F. Kennedy's Make America Healthy Again (MAHA) agenda3406by restoring trust in our food system, prioritizing public health, and3407strengthening national nutrition and food safety. America is facing an3408unprecedented chronic disease crisis, with heart disease, diabetes, and3409obesity affecting millions of lives. Meanwhile, food safety failures,3410contamination events, and formula shortages have exposed systemic3411weaknesses in our food and nutrition infrastructure. The FY 2026 budget3412directly supports the MAHA agenda by ensuring safety of the United3413States food supply, investing in nutrition, preventing food safety3414failures and infant formula contamination and shortages, and ensuring3415appropriations needed to meet certain spending triggers for user fee3416programs.3417    In my first 6 weeks or so at FDA, I have worked to make sure the3418reviewers and inspectors have what they need to help protect the public3419health of the American people. FDA will not go through a significant3420reorganization, we will be centralizing and streamlining shared3421functions that were previously duplicated throughout the centers and3422offices, such as IT, communications, and operations. In addition, we3423are exploring and moving to quickly implement where AI and novel3424technology can help reduce workload as a tool for the expert scientists3425and inspectors at the FDA. The initial response from the review staff3426has been very positive, and I look forward to building on this3427experience and expanding it throughout the centers at FDA.3428    The funding requested in the President's FY 2026 Budget includes3429critical elements to safeguard public health and the food supply for3430the American people. Our FY 2026 budget requests $6.8 billion,3431including $3.2 billion in budget authority and $3.6 billion in user3432fees. This includes an 11.5% reduction in budget authority compared to3433the current fiscal year, improving efficiency while still increasing3434investments in areas that are critical for the American people.3435                       make america healthy again3436    FDA serves a critical role in supporting the Administration's3437extensive efforts to protect the food supply, protect against chronic3438disease, remove any dangerous chemicals and additives from foods, and3439address any shortages of critical foods such as infant formula.3440    FDA is committed to radical transparency to give Americans the3441latest information about the food ingredients they are eating and their3442effects--in alignment with both MAHA and FDA's mission. The Agency is3443leading efforts to protect the U.S. food supply to combat the growing3444risks associated with some chemical additives used in food, expand3445Closer to Zero efforts to reduce toxic elements, such as arsenic, from3446foods consumed by infants and young children, reduce sodium and added3447sugars, and provide new forms of nutrition labeling to better inform3448consumers about the foods they consume.3449    FDA will also expand a new pilot grant program to help schools3450transition to safer and healthier foods, as well as address failures in3451inspecting high-risk facilities, strengthen import oversight, reduce3452foodborne disease outbreak response times, and decrease the number of3453associated illnesses. This includes supporting advancements in3454technology to rapidly identify and combat food borne pathogens, such as3455Salmonella, E. coli, and Listeria. FDA will also continue its3456commitment to supporting the safety, nutritional quality, and3457availability of infant formula; maintaining and expanding laboratory3458capabilities; and supporting cooperative agreements, grants, and3459contracts in support of federal-state initiatives. FDA and its3460regulatory partners have a shared mission to ensure the food Americans3461eat is safe. This mission can only be achieved by fully leveraging3462resources, expertise, and capabilities as part of an integrated food3463safety system.3464           continuity of user fee funding for medical devices3465    FDA's user fee agreements are negotiated with regulated industry3466and implemented when Congress authorizes the user fees. Under the3467Medical Device User Fee Amendments (MDUFA), for FDA to collect and use3468the medical product user fees, a certain amount of non-user fee3469appropriations must be appropriated by Congress and spent by FDA on the3470application review process (known as the ``non-user fee spending3471trigger''). The FY 2026 President's Budget intends to meet non-user fee3472spending triggers, including an $8.2 million increase for FDA's medical3473device program non-user fee spending trigger and to meet the goals and3474commitments under MDUFA V.3475                               conclusion3476    FDA believes the funding in the FY 2026 President's Budget will3477enable the Agency to operate more efficiently, while addressing3478critical public health and safety priorities, in particular restoring3479trust in our food system and prioritizing public health. FDA looks3480forward to working with the subcommittee to address these critical3481issues and improve the health and wellbeing of Americans. Once again, I3482thank the subcommittee for your continued support, and I look forward3483to our continued collaboration. I am happy to answer your questions.34843485    Senator Shaheen [presiding]. Thank you very much, Dr.3486Makary. We're honored to have the chair of the Appropriations3487Committee, Senator Collins, with us. And Senator Collins,3488Senator Hoeven went to vote, so he turned the gavel over to me.3489So, I will turn it over to you.3490    Senator Collins. Thank you very much, Temporary Chair.3491    [Laughter.]3492    Senator Collins. But it's been an honor to work with you on3493so many issues that we care about in this space, including Type34941 diabetes in particular. Doctor, I appreciated hearing your3495comments this morning. Americans have relied on the FDA for3496more than a century to ensure that their medicines are both3497safe and effective. Recognizing that America biotech leads the3498world in innovation, we in Congress have taken a number of3499actions to ensure that FDA's rigorous regulatory review keeps3500pace with the speed of science and solves problems in areas3501where we don't have cures, or effective treatments, or a means3502of prevention.3503    Recent staffing changes at the FDA appear to have affected3504the balance between innovation and regulatory review. From what3505I'm hearing, I'm particularly concerned about the downstream3506impact of delays on patients suffering from debilitating rare3507diseases like ataxia and birth syndrome, as well as more common3508terrible diseases like ALS, which you mentioned Alzheimer's and3509other neurodegenerative diseases.3510    As I mentioned, Senator Shaheen and I'm sorry, I am out of3511it today, apparently.3512    Senator Shaheen. It was a late night and early morning.3513    Senator Collins. We have worked together on Type 1 diabetes3514for many years. We're encouraged by what's going on in STEM3515therapy and immunotherapy in that area. And today, you,3516yourself, talked about the need for more efficient regulatory3517pathways and innovative treatments for rare life-threatening3518diseases, particularly when there are no major safety issues3519and existing treatments, or either don't exist, or they're3520limited.3521    So, what I'm hearing is there's a real slow down in FDA,3522and that's not what you were committing to today, but that's3523what I'm hearing. The reality is, there are a number of rare3524disease new drug applications that have been pending at FDA for3525some time.3526    What specifically is FDA doing under your leadership to3527accelerate getting new treatments for rare diseases to patients3528safely and as soon as possible, particularly since we have3529developed these accelerated pathways, particularly for those3530patients, for which there are no treatment options now.3531    Dr. Makary. Good to see you, Senator Collins. I share in3532your interest in this topic because I have cared for people3533with rare diseases and rare cancers, and it is the worst3534feeling in the world to have to break bad news. And when people3535say, is there anything out there to be--to not have anything to3536respond with is a very difficult position.3537    So, we need to customize the regulatory process to the3538condition being treated. And so, if it is a rare condition, we3539have to drop our randomized control trial requirements in some3540instances. I will say, however, that the trains are running on3541time at the FDA. There have been no staffing changes that have3542changed any approval schedules. We are on track to meet all of3543our Prescription Drug User Fee Act (PDUFA) targets.3544    There are on occasion, every year, essentially every year,3545a couple drugs that are very complex, where the career3546scientists ask for more time, either to convene an advisory3547committee to weigh in or to design a very unique specific3548randomized trial.3549    So, in reference to one of the products that you had3550mentioned, I had gotten briefed and was assured that there was3551no delays related to staffing. These were additional time3552because of the complexity of the early data. And the staff3553truly believe career scientists truly believed they needed a3554few more weeks. And I thought, we're on track to meet our PDUFA3555targets. They believe we're completely on track to meet our3556PDUFA targets if they took a few more weeks. And I thought that3557was reasonable.3558    The trains are running on time. The food inspectors are3559doing their job. We have 12 food labs. There's no backlog at3560the food labs. The cuts that you referenced and Senator Shaheen3561referenced were to things like this 2,600: This is at the FDA35622,600 HR staff, Contract staff, and budget staff. Now, I think3563that's too much. And we, they, they were part of the reduction3564in force. In total, about 1,800, almost 1,900 people were3565involved in the reduction in force. And I think a lot of that3566is consolidation.3567    Just to be clear; there were no reductions in scientific3568reviewers as a part of the reduction in force, and we're3569actually hiring scientists because there's normally turnover3570with our scientific staff. And I hope the AI and the other3571tools will help make their jobs more efficient.3572    Senator Collins. Well, I am hearing something entirely3573different. So, I will convey directly to you the concerns that3574I'm hearing since Dr. Peter Marks was removed from his3575position. And it is disheartening for patients with serious3576diseases, as you know very, very well from your clinical3577practice for which I know you are a dedicated physician, but it3578is disheartening when it appears that a new treatment or drug3579is on the horizon and then FDA says, no, we need three more3580months. We need three more months. We need three more months3581over and over again, despite the years that have gone into3582developing a particular treatment for an illness that has no3583treatment.3584    And, again, that's why we work so hard to establish these3585accelerated pathways. So, I'll be in further touch with you. I3586don't disagree with the need to look at the staffing of FDA and3587to make sure that as much of it as possible is going into the3588process that speeds food inspection, new drugs to the American3589people, sensible regulation and guidance on diet, lifestyle3590factors. All of that is extremely important. So, it's not that3591I object to looking at that, but I don't want it to come at the3592expense of drugs that are desperately needed. Thank you.3593    Dr. Makary. Thank you, Senator. I will just say that the3594person, the scientist replacing Peter Marks is outstanding. And3595I would say, take a close look at his credentials. He has3596published over 540 peer-reviewed scientific articles. He's a3597professor from UCSF, trained at the National Cancer Institute.3598He's a scientific genius.3599    So, I've rejected the idea that there's only one scientist3600in the world that can run Center for Biologics Evaluation and3601Research [CBER] well, and I think we need fresh new ideas. The3602new scientist replaced Peter Marks, 42-year-old. He brings a3603fresh new perspective, and it will not change our approach to3604rare diseases, or the predictability that people need in the3605market and development investment space to know that they need3606to continue to invest in those technologies.3607    Senator Collins. I look forward to meeting him. Thank you.3608    Dr. Makary. Thank you.3609    Senator Hoeven [presiding]. Thank you, Madam Chair.3610Appreciate you being here. Doctor, you came into roughly a361119,000-person agency. Your budget top line is about 3 percent3612less. But there's been estimates as high as potentially 4,0003613reduction in force, voluntary or actual rifs.3614    Where are you on that, and how's it going? You and I've3615again talked about this before. I was--you know, at that time,3616you know, we talked about how once you got in there and had3617more time, you were going to obviously have a better analysis3618of what your needs are and where you're at with the personnel3619situation. So, go through that for us, will you?3620    Dr. Makary. Sure. So, there have been about nearly 1,9003621people involved in the reduction in force. Roughly, another36221,200-plus involved in the early retirement package. We are3623hiring scientists to replace scientists that may have left for3624an early retirement, but no scientific reviewer or inspector3625was cut as a part of the reduction in force.3626    Now, any discussion of the reduction in force, I believe,3627deserves one important fact of context which is always omitted3628in the media coverage. And that is in 2007, the FDA had not a3629little over 9,000 employees, and a few months ago was 19,000.3630So, there was a 100 percent increase in the number of employees3631at the FDA over the last 15, 16 years. And that is how we get36322,600 HR people, contracts and budget people, at the agency.3633380 communications positions, we're now down to about 160.3634    They're doing a good job, 160 people. That covers a lot of3635the communication work. Did we need 125 travel coordinators and3636travel offices in each center, or 13 strategy offices at the3637FDA? A lot of this reorganization is smart, and it's being3638smart with taxpayer dollars because I personally believe when3639this institution here, U.S. Congress is spending $2 trillion3640more than we have as a country, it is driving inflation, which3641is a backhanded tax on the poor.3642    And that is the harsh reality. It doesn't affect people of3643wealth like myself. It affects the 50 percent of Americans that3644have less than $500 of cash on hand. And they are forgotten3645when we spend too much money and we drive inflation. And that's3646why I support many of these reductions in force, where it makes3647sense.3648    Senator Hoeven. Okay. But you also get fee agreements from,3649you know, drug companies that want to get new drugs to the3650market. And so, you have to be able to staff that so that you3651bring in that fee revenue, which of course is not a cost to the3652taxpayer. So, I agree with you. Yeah, we need to find better3653ways to do things. We need to find savings, and that's good.3654But talk to us how you're making sure that you manage things. I3655mean, again, paramount to your mission of safety, as we talked3656about on the front end. I know you understand that. You're a3657doctor, took the Hippocratic Oath.3658    But those fee agreements make it more complicated, but they3659bring in revenue. Talk about that, as well as making sure we3660get these new drugs to the market as safely and efficiently as3661possible, because that ultimately saves lives.3662    Dr. Makary. Yes, Senator. So, thank you for that question.3663And, again, I want to reassure the public to see through the3664headlines, and to know that the trains are running on time at3665the FDA, and we're on track to meet all of our user fee targets3666as an agency. And we need the staff to help with the user fee3667management. And that's why I've made sure that we have the3668appropriate staff to make sure that we can report on our user3669fees and sort of service conductors in managing the user fee3670targets.3671    Now, look, I'm a surgeon, and so the reductions in force3672are never perfect. So, I've done everything humanly possible3673since I've gotten there to try to make sure we heal and3674reorganize appropriately. We have brought back some people, and3675my job is to make sure that the scientists, and inspectors,3676that the law enforcement officials at FDA have all the3677resources they need to do their job well.3678    Senator Hoeven. Okay. I think I'm going to give you a short3679question to save my long. Well, now I'm going to go with the3680longer one. I'm going to probably run over my time a little3681bit, ranking member, so I'll beg your indulgence and certainly3682return the favor. The MAHA Commissions coming out with their3683report, I think pretty much right after this hearing.3684    Dr. Makary. Yeah, noon.3685    Senator Hoeven. Yeah. So, if you want to kind of give us3686all the details right now, that's great, and just get a jump on3687things.3688    [Laughter.]3689    Senator Hoeven. But guessing that you might not, you do3690need to talk to us about it in that, as I laid out my opening3691statement, this committee has jurisdiction both in regard to3692all of your funding at FDA, but also USDA for our farmers and3693ranchers. And we have to address both.3694    So, I know you're coming out, you know, the Department of3695Health and Human Services (HHS) writ large, is coming out with3696this MAHA study plan today. But as I said in my opening, we're3697very concerned not only how that's going to affect the American3698consumers, but also how that's going to affect agriculture. And3699as you know, agriculture goes--I mean, they're regulated like3700everybody else. In fact, in my opinion, they're overregulated3701like everybody else.3702    And so, you know, with this report coming out, I get y'all3703are going to be working very hard to make sure it's3704scientifically-based and all that. But a lot of what our3705farmers and ranchers in producing that food supply have had to3706do, that's all scientifically-based, too, heavily regulated.3707And there's been years, and years, and years of that analysis3708and regulation done, and a heck of a lot of expertise.3709    So, how do you approach that in this plan of action, and3710the analysis that you're doing, and so forth, and the studies3711you're doing to make sure that that's adequately included in3712terms of your evaluation, and the results and the3713recommendations that you make?3714    Dr. Makary. Well, Senator, you shouldn't be concerned about3715the MAHA report. It is simply information. And it's important3716information about health written by people who have excellent3717citations, and are representing the many scientists that have3718been waving a flag in the air for many years saying, ``Hey,3719look at root causes.''3720    We have the sickest, most disabled, most medicated, most3721obese population in the history of the world. Half our nation's3722kids are sick. And why are they sick? Because when the immune3723system, or some inflammatory response is reacting to the many3724different chemicals that go down their GI tract, the immune--3725they feel, blah, they don't feel well. And so, we have got to3726look at root causes.3727    Now, there's no single chemical in the food supply that is3728accounting for a root cause for the driving our chronic disease3729epidemic, but I think everything has to be on the table. We,3730for example, at the FDA, just convened, two days ago, a round3731table on talc. Now, talc has been identified as a cancer-3732causing agent. It's been removed from baby powder.3733    There have been 30 studies saying that talc may cause3734ovarian cancer in women with a high odds ratio in statistical3735significance. International cancer bodies have warned about the3736cancer-causing effect and the mechanism of talc. And so, it's3737been removed from baby powder. But do you know kids are eating3738talc every day? It's in candy. You take chewing gum and the3739white powder on there, people think it's sugar. Sometimes, it's3740talc. Talc is in our food supply. Kids are eating talc.3741    And it's not just in food, it's in medicines. The number 1,37423, 9 and 10 most common medications in the United States have3743talc on it. Why? Because it's a lubricant. It's just the way3744we've been doing business. It's a lubricant in the machines3745when it's mass produced. Well, there's a low-cost alternative3746that is generally considered to be safe.3747    This is the--we're not fighting anybody here. We're trying3748to bring the latest scientific information to inform good3749decisions. And I think you're going to be pleased with the MAHA3750Commission report. It puts at the forefront of our discussions3751of health many issues that sciences have been talking about for3752years.3753    Never in my oncology meetings do we talk about the root3754causes of cancer. Cancer's going up in kids, young people under3755age 50. It's everyone's scratching their heads. You get a3756diagnosis, they come to Johns Hopkins, we would look at them3757and parents would say, ``What could possibly cause this?''3758Well, guess what? We don't talk about any of this in our3759national conferences. That is what the MAHA Commission report's3760going to talk about.3761    What have we been talking about? Insulin, chemotherapy,3762CAR-T therapy, radiation, sophisticated operations. We have got3763to talk about food and chemicals, not just chemo and insulin.3764And so, this MAHA Commission is going to put front and center3765as a setting our research priorities, setting a national3766conversation, setting our own internal goals so that we're3767going to deliver in another 100 days from today some of what3768we're going to do.3769    The MAHA Commission report is a diagnosis. And I think we3770have to do something differently. We have a healthcare system3771that's breaking the budget, that's resulting in inflation,3772that's burdening businesses. That's the number one cause of3773household bankruptcy in the United States; is medical bills.3774And no one is talking about the root cause. And that is the3775health of the population that is actively deteriorating right3776in front of our eyes.3777    And so, we've got to move from a reactionary healthcare3778system where we're playing whack-a-mole with all these3779treatments in the hospital and late stages, and be proactive3780and actually talk about the root causes, and why we don't see3781some of these problems in other countries. I think this report3782is going to be the cornerstone of a broader discussion, and3783there's no one single ingredient that's going to be vilified.3784    Senator Hoeven. So, after the report comes out, after we do3785some work on your budget, we're going to want you to come back3786and talk to us. Are you going to be willing to do that?3787    Dr. Makary. Of course. I'd love to talk.3788    Senator Hoeven. Good. Thank you very much. Ranking Member3789Shaheen.3790    Senator Shaheen. Well, thank you, Chair Hoeven. And I3791certainly agree with you that we ought to focus on the root3792causes of what's causing diseases. And I've been trying for3793years to get to change the sugar subsidy system that we have3794that encourages sugar to be added to our food supply in so many3795ways. But so far there hasn't been the political will to do3796that.3797    So, one of the things that I would urge you to do, Chair3798Hoeven suggested that we would like to have you come back and3799talk about this. I hope that there will be more of an effort to3800engage Congress in the changes that you're talking about making3801than there was in the cuts that were made.3802    Because again, I think there's a lot of appetite to try and3803look at how we do things better. But boy, there's not an3804appetite to have one person and a DOGE Commission go around and3805make all these decisions without engaging Congress, because so3806much of that has not only been not well received, it's been3807outright illegal.3808    That's not your problem. But I hope as you think about3809looking at the changes that we need to make to get at root3810causes, that you will come back and engage with us on what3811you're proposing because there's a lot of expertise on this3812committee, and I'm sure a lot of ideas for what we ought do3813better, too.3814    But I want to go back to diabetes, one of the most3815expensive chronic illnesses we have. It's one that you and I3816talked about. Senator Collins and I have done a lot of work as3817co-chairs of the Diabetes Caucus on this. As I explained to3818you, for me, it's not just a policy issue, it's a personal3819issue. I have a granddaughter with Type 1, so I know the3820struggles that the community has had, and many of those with3821the FDA before you got here.3822    But they have been real. And one of the issues right now3823that I'm hearing from the diabetes community is about C-3824peptide, which is a marker of the body's own insulin3825production. It's emerging as a potentially more accurate tool3826for measuring how well a person cells are functioning. However,3827the FDA does not currently recognize C-peptide as a validated3828surrogate endpoint. Meaning, that the community has to use3829other endpoints that are less--many people believe less3830accurate. So, will you commit to reviewing C-peptide as a3831validated surrogate endpoint?3832    Dr. Makary. I'm happy to, Senator. I love C-peptide. I'm a3833pancreatic specialist. And so, I don't understand why it would3834not be recognized. It is a naturally occurring hormone that is3835an indicator of the physiologic health of the pancreas. So,3836I'll take a look at that for you. Happy to.3837    Senator Shaheen. Good, thank you. I hope we can stay in3838touch on that. In the last couple of days, there have been a3839lot of news reports about the COVID-19 vaccine. I would think3840that one of the real accomplishments of the first Trump3841Administration was the development of the COVID-19 vaccine. I3842would think people would be very proud of that effort.3843    And so, I was surprised to hear about the FDA's3844announcement earlier this week that would limit access to3845COVID-19 boosters. And it seems like the announcement would3846take away people's ability to make that choice on their own by3847limiting it to only people 65 or at high risk.3848    So, can you help us understand why that decision was made,3849and why people who may think that that booster would be helpful3850to them will no longer be available?3851    Dr. Makary. Happy to. It's been four to 5 years since we've3852had a randomized controlled trial. And so, we don't know the3853right number of boosters that a healthy American should take.3854What is that number? Is it two, like the MMR vaccine? Is it two3855or three, like HPV or hepatitis B? Or is it 80? Do we believe3856in giving 80 mRNA shots to a healthy girl born today in her3857average lifespan of 80 years? Is that the right answer?3858    That has been a theory that the repeat booster strategy in3859healthy individuals is the correct evidence-based strategy, but3860there's been no data to support it. So, we are doing our job to3861say that if we are going to approve a Covid vaccine for3862younger, healthy Americans, we'd like to see some clinical3863trial data, given that it's a much different population from 53864years ago.3865    There's broad ubiquitous population-based immunity, and3866there's also a different virus circulating. And this is a new3867vaccine formulation that creates a new protein in the body.3868Should we blindly rubber stamp a vaccine that creates a new3869protein in the body every year for the rest of our lives, for3870the next 100 years? I don't think so.3871    And so, that's why we published in the New England Journal3872of Medicine this week, a framework for sensible Covid vaccine3873booster regulation in the United States that uses an age-3874stratified approach. And really, honestly, we are catching up3875with the rest of the world. Some of the rest of the world has3876been laughing at us using this blind strategy.3877    We're now switching to a scientific strategy. The UK only3878recommends Covid boosters and people 75 years of age and high-3879risk. France, 80 years of age and high risk. I don't think we3880should be pushing this on healthy 6-year-old girls without any3881evidence every year for the rest of their lives. And so, that's3882why we've outlined this framework. And by the way, the vaccine3883manufacturers put out positive statements about the framework3884because I believe they like predictability.3885    Senator Shaheen. Well, so I understand that rationale. Do3886you have a timetable for when you expect to have the trials3887done and a decision made about the future?3888    Dr. Makary. When the companies present trials to us, and in3889the case of high risk, our New England Journal paper outlines3890how they can seek clinical trial data after approval in high-3891risk populations. But it's up to the companies to present data3892to us. It's always been that way where the FDA reviews clinical3893trial data that companies present, and we make a decision about3894safe and effective.3895    We have been suspending that role for the last 4 years with3896Covid boosters. And so, we're saying this is a reasonable time3897to check in and look at clinical trial data given how different3898it is. By the way, America doesn't want Covid boosters----3899    Senator Shaheen. But I assume--I'm sorry to interrupt, but3900I'm out of time. Actually, I assume that you're talking to some3901of those companies so you have some idea of their level of3902interest in coming back to do those clinical trials and what3903they may be thinking about in terms of a timeframe.3904    Dr. Makary. Look, some of these companies made $100 billion3905in the Covid booster. They can afford to run a clinical trial3906and they have time to run a clinical trial. The VRBPAC meeting3907meets later today to pick a strain. So, there's time and3908there's money. We're setting a well common-sense framework.3909    Senator Shaheen. Yes, but I get.3910    Dr. Makary. Eighty-five percent of healthcare workers----3911    Senator Shaheen. Are you talking about--are we talking3912about 6 months, 1 year, 5 years, 10 years? I'm just trying to3913get some ideas so that when people call our office and ask,3914when I run into people and say, well, ``How come I can't get3915the Covid booster?'' That we can give them some kind of an3916answer for what they can expect.3917    Dr. Makary. Eighty-five percent of healthcare workers said3918no to the last Covid boosters. You're not suggesting that we3919blindly approve Covid boosters each year without clinical trial3920data?3921    Senator Shaheen. You're not listening to me, Dr. Makary.3922    Dr. Makary. Is that what you're----3923    Senator Shaheen. I'm not asking for a blind approval. I'm3924saying that I understand the argument you're making. What I'm3925asking you is, do you have any timeframe for when you think3926this might happen? And I'm sure you're talking to3927pharmaceutical companies so that they might have some idea so3928that we can just answer questions from the public. Part of what3929I'm objecting to here is that all of these decisions are being3930made without engaging the public, and I think that's a problem.3931    Dr. Makary. The public has said no to Covid boosters.3932Seventy percent of the public has not gotten a Covid booster,3933and they don't trust us because there's no----3934    Senator Shaheen. You're still not answering my question,3935though. Do you not have any idea?3936    Dr. Makary. The timeframe is reasonable, and it is amicable3937to what the industry thinks is they can do. And so, we've had3938these conversations and we do with industry. I can't share3939individual product conversations with manufacturer, but they3940think that the timeframes that we've outlined are reasonable3941and we think they're reasonable.3942    Senator Shaheen. But you still haven't said what they might3943be.3944    Dr. Makary. Well, there's plenty of time between now and3945the fall, and so there's plenty.3946    Senator Shaheen. So, you're looking--you think it's going3947to be more of a short-term timeline.3948    Dr. Makary. In the high-risk group.3949    Senator Shaheen. This is not a trick question. I'm not3950trying to trick you here. I'm just trying to get some answers.3951    Dr. Makary. And I'm not trying to not answer your question.3952It's just different for each age group. For young, healthy3953individuals, we have a different timeframe from the high-risk3954community where we are approving the Covid--well, I shouldn't3955say we are because we haven't reviewed all the data, and all3956the applications are not in.3957    But for high-risk individuals, we do have a framework now3958by which they can run the trials after the approval in high-3959risk individuals throughout the Covid season. And then3960Americans will know it either works or doesn't work. So, it's3961roughly a year. It's roughly a year. In Operation Warp Speed,3962they ran that Phase 3 clinical trial over the summer. And if3963they want to do the same thing, there's plenty of time, in my3964opinion.3965    Senator Shaheen. Thank you.3966    Dr. Makary. Thanks.3967    Senator Shaheen [presiding]. Senator Hyde-Smith.3968    Senator Hyde-Smith. Thank you very much. And thank you, Dr.3969Makary, for being here and joining us on the Hill today. We've3970discussed the issue of chemical abortion before. However, I'd3971like to revisit the topic in light of new data published last3972month by the Ethics and Public Policy Center. This data reveals3973a much higher risk from the abortion drug, mifepristone, than3974previously acknowledged.3975    And this raises the questions whether it's time to3976reconsider the broadly unrestricted access to the drug. It3977makes me question if the FDA should reinstate the original3978safeguards in order to protect vulnerable women and minors from3979experiencing the horrible adverse and life-threatening3980complications that could follow the chemical abortion regimen.3981    First, let me summarize the new data. In April, 2025,3982researchers from Ethics and Public Policy Center and the3983Foundation of the Restoration of America reviewed the outcomes3984of 865,000-plus drug induced abortions from 2017 to 2023. These3985abortions occurred after the FDA in 2016 removed the3986requirement for doctors to report non-fatal but adverse3987complications. The data shows 94,605 serious adverse events3988proving conclusively that more than 1 out of 10 women are put3989at risk by the mifepristone.3990    This real-world rate is 20 times greater than the rate the3991FDA used when it originally approved the drug. Specifically,3992this status shows that, their words, ``10.93 percent of women3993experience sepsis, infection, hemorrhaging, or other serious3994adverse events within 45 days following the chemical3995abortion.''3996    If serious complications have increased as safety rules3997have been loosened over the last 25 years, then logically, it3998makes sense to bring those safety protections back. At the very3999least, the FDA should restore the original safety requirements4000from 2000 under its risk evaluation and mitigation strategies.4001    How do you view this new data, and will the FDA be taking4002this new data into consideration and commit to restoring4003common-sense protections, like requiring an in-person doctor4004visit before women can actually access mifepristone?4005    Dr. Makary. Thank you, Senator Hyde-Smith, and good to see4006you again. I think a lot of people are asking those questions.4007And so, I did see those top line results that you referenced,4008and we are going to take a look at those data as they become4009available. There is no peer-reviewed publication, and the4010underlying data set is not available. But when it does become4011available, we're going to take a hard look at it. Thank you.4012    Senator Hyde-Smith. Thank you. I would appreciate that4013very, very much.4014    Dr. Makary. Thank you.4015    Senator Hoeven. Senator Ossoff.4016    Senator Ossoff. Thank you, Mr. Chairman. And Dr. Makary,4017good to see you.4018    Dr. Makary. Good to see you.4019    Senator Ossoff. Thank you for joining us. I was pleased to4020see that the secretary has made the safety of infant formula a4021priority for the Department. Is that correct?4022    Dr. Makary. That's right. And the FDA will be convening the4023world experts on infant formula on June 4th, and we're going to4024be having a robust discussion because parents want infant4025formula options with a better supply chain, without added sugar4026and seed oils.4027    Senator Ossoff. Did you see a recent consumer report study4028which found that of 41 tested infant formulas more than 30 were4029found to have potentially dangerous levels of lead?4030    Dr. Makary. Yeah. Heavy metals in infant formula is4031something that's getting a lot of attention, as it should. And4032so that is part of Operation Stork Speed to take a hard look at4033that. And it is one of the priorities of our infant formula4034roundtable at the FDA on June 4th.4035    Senator Ossoff. And it's the Human Foods Division of your4036agency responsible for infant formula safety, at least in large4037part. Yes?4038    Dr. Makary. Yes.4039    Senator Ossoff. I'm trying to make sure I understand some4040of the relevant personnel decisions given the concern that4041families in Georgia have about the safety of infant formula,4042the safety of the food supply. James Jones, the Deputy4043Commissioner for Human Foods, submitted a resignation letter4044February 17th, included the quote, ``The indiscriminate firing4045of 89 staff in the Human Foods Program is beyond shortsighted.4046The foods program staff at FDA is the envy of the world in its4047technical, professional, and ethical standards.''4048    It goes on, ``The employees fired this past weekend are the4049most recent hires, and generally come to Federal service with4050the most recent education and represent the future of the4051agency. They included staff with highly technical expertise in4052nutrition, infant formula, food safety response, and even 104053chemical safety staff hired to review potentially unsafe4054ingredients in our food supply.''4055    That was February 17th. You were asked on April 17th4056whether any of the personnel reductions had included personnel4057responsible for food safety or infant formula safety. You said,4058``There were no cuts to scientists, or reviewers, or4059inspectors. Absolutely none.''4060    You were asked on April 23rd on CNN and said again, ``There4061were no cuts to scientists, or inspectors. But then just two4062days later, an HHS spokesperson confirmed that, in fact,4063scientists had been fired and that you were scrambling to4064rehire them. Is that--did you in fact say on April 23rd,4065``There were no cuts to scientists or inspectors?'' Just before4066we get into the details, is that an accurate quote?4067    Dr. Makary. No scientific reviewer was cut as a part of the4068reduction in force.4069    Senator Ossoff. But you said there were no cuts to4070scientists or inspectors. Didn't you say that?4071    Dr. Makary. My understanding whether there was--that there4072were no cuts to the scientific staff, but specifically, the4073scientific reviewers is what I was referring to.4074    Senator Ossoff. But you said there were--it's a very4075straightforward question. You said there were no cuts to4076scientists or inspectors. Correct?4077    Dr. Makary. Scientific reviewers is what I was referring4078to, that's the vast majority of scientists there.4079    Senator Ossoff. But you said----4080    Dr. Makary. Jim Jones is an economist.4081    Senator Ossoff. Five days before you had said there were no4082cuts to scientists. You said that right?4083    Dr. Makary. I was referring to scientific reviewers. There4084are a couple----4085    Senator Ossoff. But scientists had been fired. Correct?4086    Dr. Makary. There have been a couple. There have been4087research scientists in some labs that have been doing some4088research. Some of that research is good, some of it is not4089good. And so there have been no cuts to scientific reviewers.4090    Senator Ossoff. And, in fact, scientists who study the4091safety of infant formula had been fired. Correct?4092    Dr. Makary. I'm not aware of any scientists studying infant4093formula that----4094    Senator Ossoff. Well, here's the reporting in the New York4095Times, which says the HHS spokesman said those employees called4096back had been inadvertently fired, and the decision to rehire4097specialists on outbreaks of food-related illnesses and those4098who study the safety of products like infant formula.4099    So, is this reporting accurate? Had, in fact, scientists4100who study outbreaks of food-related illnesses and the safety of4101infant formula been fired?4102    Dr. Makary. The reason it's not accurate, it's Senator, is4103that people were not fired. They were scheduled for the4104reduction in force. And when I--this was before I got there.4105When I got there, we did an assessment. And so, some of those4106individuals out of the 19,000 were restored. Jim Jones was an4107economist, and he was upset about the DOGE cuts. So, he self-4108doged. I didn't--he was not fired. I wish he would've stayed.4109    Senator Ossoff. Have all scientists responsible for food4110safety and infant formula safety been rehired or reinstated?4111    Dr. Makary. Look, we have not reduced in force the4112scientific review staff. I know where you're going with this.4113We're not allowed to----4114    Senator Ossoff. I'm trying to clarity on statements. You4115said there were no cuts to scientists, and then the HHS4116spokesperson said, actually there were cuts to scientists and4117now we're trying to rehire them. I mean, so it gives the4118impression you're not sure about the personnel actions ongoing4119in your own agency.4120    Dr. Makary. Again, No one was cut in the reduction of4121force.4122    Senator Ossoff. And that's information from your testimony4123here today.4124    Dr. Makary. They were scheduled for the reduction in the4125future, down the road. It has not happened yet. So, the people4126scheduled to be cut. We did a review and found some research4127scientists--when I made those statements, it was very specific.4128I was very clear. We're talking about scientific reviewers4129because the trains have to run on time. And if you're concerned4130about backlog.4131    Senator Ossoff. My time is up. You were very specific. You4132said there were no cuts to scientists. And then five days4133later, ``There were no cuts to scientists.'' Those are your4134direct quotes. ``There were no cuts to scientists,'' but there4135were cuts to scientists. Right?4136    Dr. Makary. No, there were no cuts to scientists because4137people were scheduled for the reduction in force down in the4138future. And the people scheduled were reevaluated and we4139restored a couple research scientists, and I was referring not4140only to them, but to to the scientific reviewers.4141    Senator Ossoff. How many scientists responsible for4142preventing outbreaks of food-related illnesses and the safety4143of infant formula have been restored or reinstated?4144    Dr. Makary. There were no scientists that were in charge of4145preventing outbreaks that were part of reduction.4146    Senator Ossoff. I didn't say in charge.4147    Dr. Makary. But, I mean, this is the problem in government.4148Somebody has a fancy sounding name like infant formula safety,4149and no one can ever touch them even if they're not doing their4150job.4151    Senator Ossoff. Okay. Say, how about this? I'll send you so4152that you can get accurate information to the committee. I'll4153send you some very detailed questions about this and you'll4154respond in full. Yes?4155    Dr. Makary. Yes. Just keep in mind, the agency was half its4156size in 2007.4157    Senator Ossoff. But you'll respond in full----4158    Dr. Makary. We didn't have outbreaks and rampages, and food4159outbreaks----4160    Senator Ossoff. But we had a huge infant formula safety4161crisis in this country just a few years ago. Do you recall4162that?4163    Dr. Makary. That was because of several problems4164including----4165    Senator Ossoff. So, you will respond in full to the4166questions that I send you.4167    Dr. Makary. I'm always happy to respond in full to you,4168Senator.4169    Senator Ossoff. Thank you so much, Dr. Makary. Thank you.4170    Senator Hoeven. Doctor, I know that that you're working on4171Operation Stork speed, speaking of baby formula, that Secretary4172Kennedy's already talked about Operation Stork Speed, which4173goes right to this issue. Yes. And you're already working on4174it, made it a priority. Would you like to address that?4175    Dr. Makary. We're working hard on it, and that's why we're4176convening the world's experts. And the part of the problem with4177infant formula that the Senator is alluding to, which is a real4178problem, is that the FDA has been so rigid in the way it4179evaluates infant formula.4180    Basically, we have for decades said you have to follow this4181recipe because we as the government know exactly what infants4182need and you can't deviate from this recipe. And guess what?4183They got added sugar on there and seed oils. And there's been4184no innovation in infant formula practically since 1998 when we4185saw the last change in infant formula on the monograph recipe,4186with the exception of selenium that was added. Basically, no4187innovation in, in infant formula since 1998.4188    And so that's what we're working to fix. That is one of the4189underlying problems. The more innovation, the more competitors4190that can come to market, the more predictability with the4191regulatory process, the better products. We're going to see4192more options for moms that want infant formula that's safe, low4193on heavy metals without seed oil, without added sugar. And that4194is, I think, going to help also lower prices and increase the4195supply chain.4196    Senator Hoeven. And, of course, moms know, but there needs4197to be a choice in that baby formula so that you've got the4198product you need for your child.4199    Dr. Makary. Absolutely. We're all about choice.4200    Senator Hoeven. And so, there's a lot to it, and again, I4201commend you for--and the secretary for making that a priority.4202And I do like the name Operation Stork Speed. That's a great4203name. I don't know if you came up with it or the secretary, but4204it's a good one.4205    Dr. Makary. I did not, but I'll pass all along to the4206person that did that.4207    Senator Hoeven. You liked it. And the other thing is this4208seems like a timely thing to say because the senior Senator4209from the State of Michigan just showed up, and he and I4210actually have legislation on baby formula, bipartisan4211legislation.4212    I don't know if you had a chance to look at it yet, but I4213would ask that you work with us on it because it goes to some4214of these very same things. And I think we worked very hard to4215make it very practical, actually reflecting some of the things4216you just talked about; how do we make sure safe, but we4217innovate and have choice.4218    Dr. Makary. It's great legislation, Senator. Thank you for4219working on it.4220    Senator Hoeven. That was the right answer. I've got another4221question, but I'm going to turn to Senator Murray before I ask4222my final question, and then of course, Senator Peters. Senator4223Murray.4224    Senator Murray. Thank you very much, Chair Hoeven. Look4225forward to working with you on this really important committee.4226    You know, Commissioner Makary, the FDA has a really4227important job to do. Lives literally are at stake. And that4228work requires the utmost diligence, and care, and commitment to4229following the science and upholding FDA's gold standard. We all4230expect to walk into the drugstore and know that what we are4231buying has passed a safety and efficacy standard. And we have4232to be assured of that, and we have to be assured that the4233work's been done, that we don't have to question that.4234    So, I don't think it's careful leadership when you do mass4235fire 1 in 5 people across FDA only to, frantically, then bring4236some back because you didn't stop and think two seconds about4237whether those jobs were actually important. We really, Mr.4238Chairman, cannot cheap out on the FDA and expect to maintain4239that gold standard. That means that people know that drugs are4240safe.4241    We can't just cut, and cut, and hope nobody gets sick when4242you're slow to issue a recall, or hope no one needs that4243medicine that had its approval delayed, or hope there isn't4244another infant formula issue while your staff are getting4245fired, or getting rehired, or wherever they are.4246    This work really takes investments. This committee knows4247that, and it expects expert staff, like the people that have4248been shoved out the door. Drug approvals are already getting4249delayed. Food and drug safety inspections are lagging behind.4250We are going in the wrong direction fast.4251    We still have yet to see from you a full budget request.4252That is unacceptable. You are now testifying that the budget4253proposes to slash FDA by more than 11 percent. That's actually4254news to all of us. And I'll tell you right now, it is not going4255to fly. It's reckless and it's not going to happen as long as I4256have anything to say about it.4257    Now, Commissioner Makary, when it comes to your mass firing4258of FDA employees in April, you said, ``I can tell you there4259were no cuts to scientists or inspectors.'' Well, that is not4260true. I think Senator Ossoff covered that. And I think the4261point here is that all of this firing and rehiring, I don't see4262how that's efficient. Frankly, it kind of shows that you don't4263know what you're doing and you're breaking things in the4264process here.4265    And so let me ask you a question, and hopefully it is an4266easy one for you. Does it save taxpayer dollars to fire staff4267who work in centers that are fully funded by user fees, not4268taxpayer dollars, yes or no?4269    Dr. Makary. Nice to see you again, Senator Murray. You4270asked me to do an assessment of the staff when I came here for4271my confirmation hearing and, and I hear that you're criticizing4272me for bringing back some individuals after the cuts that I was4273not a part of.4274    Senator Murray. No, I'm saying that's good. I'm just saying4275in the long run, this has been very inefficient. But my4276question to you is not about that. And I know you've covered it4277with several other members. So, does it save taxpayer dollars4278to fire staff who work in centers that are fully funded by user4279fees, not taxpayer dollars. Is that efficient? Does it save4280much?4281    Dr. Makary. The cuts were to HR, IT, communications. There4282were 2,600 HR staff----4283    Senator Murray. But they're funded by user fees.4284    Dr. Makary. In part.4285    Senator Murray. It's not saving anymore.4286    Dr. Makary. In part.4287    Senator Murray. Well, the many of the staff you fired were4288in centers that are actually fully funded by user fees. You4289know that. Correct?4290    Dr. Makary. So, if we have 2,600 HR people, do you want me4291to not make any cuts to that number?4292    Senator Murray. No. I'm asking you a specific question4293about the centers that are fully funded by user fees.4294    Dr. Makary. That's one center. It's the tobacco center.4295    Senator Murray. Okay, well, let me just say----4296    Dr. Makary. You said we can't just keep cut and cut. We4297can't keep hiring and hiring. The agency doubled since 2007.4298So, let me ask you, what is the right number of employees?4299    Senator Murray. No. You're here to answer my questions and4300I'm going to ask some more. Without critical support staff you4301fired, inspectors cannot plan their trips. They cannot do their4302jobs. I want to ask you; what percent of planned inspections4303has FDA missed since those April 1st firings?4304    Dr. Makary. In the 12 labs that we have that evaluate food4305products in the food inspection realm, there are no--as of last4306week, I just did a check. There are no backlogs. They're4307running at 100 percent efficiency. There are no drug approval4308delays despite the--you know, what people want to attribute.4309    Senator Murray. Well, that is not what I have been told. I4310have been told, and I would like you to go back and check and4311report back to us because we know that some of the planned4312inspections at these--that supposed to take place have been4313missed. And to me, why that's so important, if there is not4314inspections, the public doesn't have the information that they4315need. I am going to run out of time, so I want to move on.4316    Dr. Makary. There are no cuts to inspectors, Senator.4317    Senator Murray. Will you go back and check for me, please?4318    Dr. Makary. Absolutely.4319    Senator Murray. I understand. And, by the way, inspectors4320are one thing, but if you don't have this support staff to make4321sure that they know where the4322    Dr. Makary. But 2,600 HR staff and procurement staff?4323    Senator Murray. Okay. I understand that the Freedom of4324Information Act [FOIA] staff producing documents related to4325ongoing litigation by the Children's Health Defense, Secretary4326Kennedy's organization, were shielded from the rif, while other4327FOIA staff who are responsible for FOIA responses and other FDA4328centers were targeted for termination. Is that true?4329    Dr. Makary. That's not true, Senator. We are have our FOIA4330staff. They continue to work at the FDA. I've made sure that4331all the FOIA staff at the FDA are doing their job. We are also4332using AI to reduce the burden on that staff.4333    Senator Murray. Well, for the record, my understanding is4334that the Children's Health Defense FOIA staff were not fired4335when other ones were, all the FOIA staff were there. And that4336seems like a real conflict of interest to me, considering that4337the secretary's extensive history with that organization,4338Children's Health Defense, and his goal to remove4339authorizations for vaccines. So, I just want that on record.4340    Dr. Makary. It's not true.4341    Senator Murray. Well----4342    Dr. Makary. All FOIA staff are in place.4343    Senator Murray. Okay. So, if a study came out saying that4344people who took a certain medication experience a certain rate4345of ``serious adverse effects'', but the study's authors refuse4346to say what they were counting as an adverse event, would that4347raise serious questions for you about the study's validity?4348    Dr. Makary. Yes, Senator. So, I have the natural4349inquisition of a scientist that's done a lot of research. So, I4350would want to see the underlying data. Yes.4351    Senator Murray. Okay. Well, I am of course talking about4352the sham study from the Ethics and Public Policy Center. It's4353an anti-abortion group. It's bankrolled by extremists. They4354fought to overturn Roe v. Wade. And this study, if you can call4355it that, is unsound and has been widely panned by medical4356experts.4357    But days after its release, you and Secretary Kennedy are4358now suggesting that we need a complete review on the safety of4359mifepristone. Now, to be clear, mifepristone has been proven4360safe and effective in more than 100 studies over three decades.4361And the people that are now pushing that bogus study and saying4362that mifepristone is dangerous for women, are the exact same4363people who think that abortion is never necessary to save a4364woman's life, and that 10-year-olds should somehow be forced4365into childbirth.4366    I believe that this administration is laying the groundwork4367to rip away access to medication abortion across the country.4368This has not gotten enough attention. And I know you'd prefer4369to keep it that way, but I want you to know I'm not going to4370let that happen.4371    Dr. Makary. I have not seen that study, Senator, and you4372have not seen that study. So, how can you call it a sham, bogus4373study? Neither of us have seen the study, the underlying data,4374or the methodology.4375    Senator Murray. Actually, that's not true. But I will say4376this, Mr. Chairman, we have a lot of differences here. I know4377you came before this committee to present your side of the4378story, but I am very clear that laying off people, cutting4379budgets is not going to improve the safety and efficacy that we4380count on when we go to the drugstore to get our drugs. And I4381know that sham studies that try to prove a point that came from4382a political group, is not going to tell the public that they4383can count on the medications they count on.4384    Thank you, Mr. Chairman. I yield back.4385    Senator Hoeven. Senator Peters.4386    Senator Peters. Thank you, Chairman Hoeven. And thank you4387for talking about infant formula and talking about our bill4388specifically. And thank you for eliciting a response from our4389witness that we both really appreciate. So, thank you for doing4390that.4391    Dr. Makary, as when I was chair of Homeland Security and4392Governmental Affairs, we did a study looking at persistent drug4393shortages throughout the country and found that a lot of us,4394because we're overreliant on foreign sources for those4395supplies, and many of the precursors are, as you know, all4396overseas.4397    And in fact, in that study when I put it out, I said it's4398pretty clear based on these challenges with the supply chain,4399that when there is a pandemic, we're going to find ourselves in4400a very difficult position. Six months later, that academic4401study became reality as we dealt with the pandemic and4402certainly saw that we had highly efficient supply chains, but4403they were not resilient.4404    And I remain concerned that the FDA does not have the4405visibility it needs into essential medicine supply chains from4406the key ingredients needed for manufacturing our drug products,4407to the distribution to the patients, and hospitals, and4408pharmacies. And these blind spots clearly limit our ability to4409accurately assess national security risk, including our over4410dependence on China, in particular, for many critical inputs.4411    So, last week, I reintroduced the MAPS Act with several of4412my bipartisan colleagues, which would address this critical gap4413by requiring HHS through public-private partnerships to4414essentially map out the medical supply chains using data4415analysis, and to assess all the threats and vulnerability.4416    So, my question for you is, do you agree that this is a4417significant concern? And if so, will you commit to work when we4418pass this legislation to make this a reality?4419    Dr. Makary. Senator Peters, I love this topic. It's so4420important. I'm glad you're raising it. I've written about it in4421a book in 2019. I've written about it in the Journal of the4422American Medical Association. I felt like no one has been4423paying attention. I warned about exactly what happened at the4424beginning of Covid, and it happened.4425    So, I am totally aligned with you that this is an important4426issue. I think there are root causes that we've not been4427talking about that we need to talk about. I mean, we can get4428out a ruler and map out, you know, the supply chains, and I'm4429not opposed to that exercise, but the underlying problem is4430that manufacturing has moved overseas.4431    And it's not just one or two things. It is most of what we4432use in anesthesia to perform surgery. It is most antibiotics.4433It is most of these cutting-edge therapies is the vast majority4434of generic drugs. And so, I totally am in support of President4435Trump's agenda here to bring manufacturing back to the United4436States.4437    And we've already had a tremendous amount of success. There4438are companies announcing moving manufacturing in the United4439States. We're creating incentives, we're removing regulation.4440And this is a national security issue. So, I am 100 percent4441with you on this.4442    Senator Peters. Very good. In April, FDA reported4443suspending programs to improve testing for potential bird flu4444virus contamination of milk, cheese, and pet food because of4445the mass layoffs that occurred. We know that the bird flu virus4446can kill pets who eat contaminated raw pet food, and it can4447pose a real danger to humans who also consume unpasteurized4448dairy products.4449    As you know, the more people and animals who get infected4450with bird flu the more opportunities there are for the virus to4451mutate. And I'm really worried that we only may be a couple,4452and it's not just me, others are worried that there may be a4453couple of mutations away from having another--potentially a4454pandemic.4455    So, my question for you, sir, is with the continued spread4456of bird flu in the country and the significant personnel4457disruptions at FDA food safety programs, could you tell me on4458the committee specifically what the FDA is currently doing to4459ensure our food is free from bird flu contamination?4460    Dr. Makary. Well, first of all, that story was debunked by4461The Washington Post. It was the normal procurement pause to4462recalibrate the equipment. And so, when that happened, people4463who were trying to make us look bad, sometimes internally,4464sometimes externally, said, aha, there were layoffs, and4465there's a pause in some of the milk inspection, and therefore4466the cuts may have been related to this, or were related to4467this, and that's going to affect food safety.4468    No. It was a normally scheduled pause to recalibrate4469equipment. It went through its normal schedule, and it is back4470up and running, and it's normally done to recalibrate the4471equipment. The cuts were to 380 communications people. What's4472the right number of communications people for the FDA? Not 380.4473125 travel coordinators, 13 strategy offices, 2,600 HR people,4474and budget and procurement people. So, I mean, are we not4475supposed to address some of this redundancy?4476    Senator Peters. My question is, what exactly are you doing4477to safeguard our food supply and to safeguard to people from4478bird flu? So, that was the question. I think you're prepared4479for a different question and you gave the answer to the4480different question. But the question is suggested specifically4481what you're doing, please.4482    Dr. Makary. You suggested the cuts increased our risk of4483bird flu, and I firmly reject that that's not true. And the4484inspection trains are running on time.4485    Senator Peters. I think I said personnel disruptions, so.4486    Dr. Makary. There's no personnel disruptions involved.4487    Senator Peters. There are no personnel disruption----4488    Dr. Makary. No calibration facility that was written about.4489    Senator Peters. So, there are no personnel disruptions4490related to your work on bird flu. Is that what you're telling4491this committee?4492    Dr. Makary. What I'm saying is the story that you4493referenced was saying that our milk calibration facility paused4494because of disruptions.4495    Senator Peters. I don't remember--I don't think I cited a4496particular article. I don't know where you--obviously, you're4497prepared. You may not--you're prepared for a question that I4498didn't ask. That's fine.4499    Dr. Makary. No, I mean, you referenced it.4500    Senator Peters. You probably gave a good answer to a4501question that I didn't ask. And so, it shows you were prepped4502for it. I'm asking you, what are you doing about bird flu? Just4503answer that. Please don't give a runaround about other stuff.4504    Dr. Makary. Doing a lot on bird flu.4505    Senator Peters. Don't use your prepared talking points.4506Tell me, what are you doing to help us and protect the American4507people from bird flu? Please tell me that?4508    Dr. Makary. We're doing a lot on bird flu.4509    Senator Peters. Please tell me that. That's why we're here.4510    Dr. Makary. We got--so look, when there is an antigenic4511shift that represents an epidemic threat, when there is human-4512to-human transmission, that strain that is involved in that4513human-to-human transition is the strain that we should be using4514to base any potential future vaccines.4515    And in the interim, as I said in my opening comments,4516delivering on a universal flu shot is one of our top goals. And4517there are two universal flu shots that are in development. And4518we are not in a receive-only mode with those developers. We are4519actively trying to partner with those individuals because it4520may be that you could come in for a single birch, a single4521influenza vaccine, or a two-dose strategy, or something like4522that and be immune for life against multiple different variants4523of influenza, including bird flu.4524    And so, early preclinical data in animal studies has shown4525some promise that a universal flu shot using a traditional4526vaccine platform can actually create antibodies to the current4527strain of bird flu. The question, of course is, and I think4528this is really what you're getting at, is if we have a bird flu4529epidemic or even an outbreak in a human-to-human fashion, what4530strain is that going to be? Because one thing we know for sure4531is it's not going to be the strain that's circulating right now4532in millions of birds. So, it is a huge priority for us,4533Senator.4534    Senator Peters. Good. Thank you.4535    Dr. Makary. Thank you.4536    Senator Peters. Thank you, Mr. Chairman.4537    Senator Hoeven. Doctor, and in just one follow-up on the4538avian flu. I've spent quite a bit of time visiting with4539Secretary Brooke Rollins on that issue as well. And she put out4540a comprehensive plan to address it and a very thoughtful plan4541because, for example, the issue of inoculation is really4542complicated because if you inoculate chickens, and then you got4543broilers, and then you have trouble with export to Europe and4544all these kinds of things.4545    Dr. Makary. Yes.4546    Senator Hoeven. So, I think she put out a comprehensive4547plan, but she did it very judiciously because some of these4548things we still got to figure out. Right? So, any comments you4549have in terms of working with her and understanding that this4550it's very complicated, and as doctors say, we want to first do4551no harm but address it in a comprehensive way? Would that be a,4552a fair evaluation, and what are your thoughts?4553    Dr. Makary. 100 percent. Secretary Rollins has been on top4554of this, she has been in communication with the emergency4555preparedness scientists at HHS and our FDA team, as well as4556people in the Office of Science Technology Policy to evaluate4557whether or not we should be mandating preemptive bird flu4558vaccines to chickens in the United States.4559    Some countries have done it, and I think they made the4560right decision in saying that does not make sense at this time.4561Sometimes, it represents messing with mother nature in ways4562that we may not foresee. It may drive mutant strains of the4563virus. So, I think we need to be alert and ready. But at the4564same time, we need to wait until we see human-to-human4565transmission, and see what that strain is before we develop a4566strain specific vaccine.4567    And in the meantime, we can advance the universal flu shots4568that encompass those bird flu strains currently in circulation,4569provided that they are safe and effective. And, you know, not4570100 percent of vaccines are wonderful. I love vaccines. I4571believe in vaccines. Vaccines save lives. Any death from a4572vaccine-preventable illness is a tragedy.4573    But the anthrax vaccine was a disaster. The swine flu4574vaccine was a disaster. The rotavirus vaccine was removed from4575the market. We had a vaccine that we had to remove from the4576market a few weeks ago for a rare infectious disease in the4577United States. And when the data clearly shows that there's not4578broad safety as we're commissioned by Congress to do, then we4579have to do our job.4580    Senator Hoeven. And there is concern by producers in terms4581of, if you start inoculating some of the flock, then you4582actually have the disease in the flock. But then if you're4583still, you know, keeping that flock, then does the disease4584spread also, as I say, depending on whether they're layers or4585they're broilers. That makes--so there's a lot that that goes4586into this, and it's a really complicated. Very important we4587address it, but a really complicated issue.4588    And that's why I'm pleased that you and Brooke are working4589together in the way that you are on it.4590    Dr. Makary. Thank you, Senator.4591    Senator Hoeven. Yeah. I want to ask about AI, and I don't4592mean AI as we talked about on the ranch. This I mean artificial4593intelligence. And, you know, talk to me--I hear so much about4594what AI's going to do in every field, but certainly in4595medicine. Just give me, you know, some of your thoughts on not4596only how we should be using it and what it will do for us, but4597how we make sure that we don't get ourselves into a problem4598with it.4599    Dr. Makary. Well, we spend a lot of time thinking about4600cybersecurity and proprietary information. We don't want a4601situation where AI is stealing proprietary information. And we4602don't want to expose ourselves to any cyber risks, which is why4603we have ensured that the AI that we're using to summarize4604clinical data and background information for our scientific4605reviewers lives in a very secure space. And the reviewers love4606it.4607    And it's not just AI to assist in the scientific reviews.4608We're using AI to identify where we should be concentrating our4609food inspections. And it turns out the AI can sometimes figure4610out pattern recognition faster than, you know, we can as human4611beings. And we'd like to use this also to address the issue of4612illegal vapes coming into our border.4613    Senator Hoeven. Okay. And how do we make sure it doesn't4614get off and running on us and we have problems?4615    Dr. Makary. We have to keep an eye on it always. I mean, we4616cannot have blind trust in anything, which is why all the areas4617where we are using AI currently at the FDA, we also have a4618human being reviewing the information and having full access to4619the underlying data.4620    Senator Hoeven. Okay. Thank you, Doctor. Ranking Member4621Shaheen.4622    Senator Shaheen. Yes. I just have a couple more questions.4623One is, again, apropos the need to address Type 1 diabetes. One4624of the things that Senator Collins and I have worked on is a4625more efficient pathway for biosimilar drug approvals that are4626currently lacking competition.4627    So, can you give us an update on what you think is4628happening in that arena and whether there's any reason to hope4629that that's going to get expedited, and if there are any other4630approvals or anything that you need at the FDA to ensure that4631that is being addressed in a way that allows those biosimilars4632to come to market?4633    Dr. Makary. Well, thank you, Senator. This is a very4634important topic that directly relates to drug prices for4635everyday Americans. And there's a reason why when you watch the4636news now, you're basically watching, you know, people dancing4637in the fields and singing with these drug ads nonstop in the4638commercial breaks because they're so expensive.4639    And so, the companies have figured out that if they can get4640a few people to, you know, shake their doctor down to prescribe4641one of these drugs to them, or I guess somehow let their doctor4642know that they're a candidate--it might be a little insulting4643to the doctor that they don't already know it, in my opinion.4644But that's why these ads are running nonstop.4645    And so, there are low cost biosimilars that can be made4646available by the FDA, approved by the FDA, and that process is4647too slow, in my opinion. We have to look at whether or not we4648really need to require confirmatory trials for each biosimilar.4649I mean, we don't do that for generics with regular branded4650pills. We don't say, ``Well, you make a generic with the same4651molecular structure, go out and do a confirmatory trial.'' I4652think we need to look at that.4653    There's a bill, I believe, that Senator Rand Paul is4654putting forward to take a look at that. And then finally, we4655can look at whether or not we can sort of approve a class of4656interchangeable drugs that they're very similar in the class.4657And so, an interchangeability provision could help create more4658incentives because we want to incentivize companies to make4659safe biosimilars.4660    Senator Shaheen. I agree. You mentioned in your opening4661statement the seizure of vaping products from China. One of the4662things that I've been concerned about for a very long time is4663the increased use of vaping by young people. And the numbers4664have gone up dramatically in the last 10 years, and also the4665health impacts of that we're not even, I think, fully aware of4666at this point.4667    So, can you talk about what more you're doing at the FDA,4668and how you did that interdiction, who you're working with,4669again what more can be done to get those products off the4670market?4671    Dr. Makary. Well, Senator, thank you for your interest in4672this topic. We can do a lot more. And I've realized that what's4673happening now is these illegal Chinese vaping products designed4674to attract children, they are video game vaping products with4675an inhalation port designed to addict young children so they4676can vape as they play these games. These fruit video game4677products that are so small, they have an inhalation port.4678    What happens is these products that are banned in China,4679and made in China, show up in U.S. ports. And what's been4680happening, I learned, is that they are set aside, the FDA looks4681at them, and then we say, ``Well, you know what? These are4682shouldn't be coming in our country. We'll put them back on the4683ship they came on, and then the ship goes to another U.S. port4684and will come in through. Basically, we're 100 percent porous.4685    It's been a joke, and they've been laughing at us, and so4686we are going to stop that. And we have incredible interest at4687DOJ, at Department of Homeland Security, and we are creating an4688endeavor that is going to basically say we're not going to send4689them back anymore. We're going to confiscate and seize these4690products because we've got to get serious about them.4691    These are designed to get kids addicted, and there are kids4692in America today who are addicted. They know they're addicted.4693They come from good families, they're good kids, and they can't4694stop. And that is something that we have to address. There are4695high schools in America now where kids are saying half of the4696kids in high school are addicted to these vaping products.4697    So, we cannot get burned, again, like we did on opioids,4698and Vioxx, and other things where the problem is so far down4699the road it's hard to undo some of the tragedy. And so, this is4700a top priority for this administration, for this President, for4701this secretary, and for me.4702    Senator Shaheen. Well, I agree. I think we ought to right4703out ban vaping products for anybody under a certain age,4704certainly. And one of the other things we need to do, as you4705know, is to get a treatment for people who are trying to get4706off vaping products. Because one of the other selling points4707that they use is that, well, it's a way to get cigarette users4708to stop smoking. They can vape and the harmful impacts are not4709as serious.4710    But I'm pleased to hear that you're doing everything4711possible. And I don't know if you, again, if this is an area4712where you need additional authorization or support, but I think4713there are a number of us in the Senate who are all in to try4714and address this because it is having a huge impact.4715    I've been to those schools in New Hampshire where I've4716talked to students who have gotten hooked on vaping, who can't4717get off, and who don't have any aids to help them do that. So,4718it's something that we've really got to address.4719    Dr. Makary. Thank you so much, Senator. And as you know, we4720confiscated today $34 million worth of illegal vaping products4721and e-cigarettes. And so that announcement is coming out today.4722    Senator Shaheen. Thank you.4723    Dr. Makary. Thank you.4724    Senator Hoeven. Doctor, thanks for being here. Did you have4725anything else that you wanted to express for the record before4726we wrap?4727    Dr. Makary. I appreciate the input and the feedback. And,4728look, I'm on a listening tour. We're going to be traveling4729around the country, myself and some of the other FDA leaders,4730meeting with industry leaders, developers, inventors,4731scientists, academics, and we want to hear how we can perform4732better.4733    We don't claim to have all the answers. We don't claim to4734have the truth on health, but we do have a lot of intellectual4735curiosity, and we plan when we see something that needs action4736to take action. So, I want to thank you and this committee for4737the input that you've provided and made available to me.47384739                     ADDITIONAL COMMITTEE QUESTIONS47404741    Senator Hoeven. We appreciate you being here today. We look4742forward to having you back as well. Questions for the record4743are due by next Thursday, May 29th. And then, we'd appreciate4744responses from FDA within 30 days, so.4745    Dr. Makary. I can't wait.4746            Questions Submitted to Hon. Dr. Martin A. Makary4747               Questions Submitted by Senator John Hoeven4748                         maha commission report4749    Question. The Make American Healthy Again (MAHA) Commission report4750was made public the day of our hearing. This subcommittee has a special4751interest in the recommendations in the report as we are at the4752intersection of food and health with jurisdiction over both the FDA and4753the USDA. I am curious about the next stage in the process for the MAHA4754Commission, which will entail the publication of a strategy to build4755upon the report which is due by August of this year.4756    Can you speak to the MAHA report and how you believe it will impact4757your work at the FDA? Will you work closely with the USDA on the next4758phase of the MAHA Commission Strategy development to ensure our farmers4759will continue to enjoy support for their work providing the fresh4760fruit, vegetables and other dietary staples that are important to4761ensuring the health and nourishment of all Americans?4762    Answer. On April 22, the U.S. Department of Health and Human4763Services and U.S. Food and Drug Administration (FDA) announced new4764measures to work with industry to phase out all petroleum-based4765synthetic dyes from the Nation's food supply-a significant milestone in4766the administration's initiative to Make America Healthy Again. The FDA4767is taking a number of actions, including:47684769  --Initiating the process to revoke authorization for two petroleum-4770        based food colorings-Citrus Red No. 2 and Orange B.47714772  --Working with industry to phase out the use of six remaining4773        petroleum-based dyes-FD&C Green No. 3, FD&C Red No. 40, FD&C4774        Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue4775        No. 2-from the food supply by the end of next year.47764777  --Partnering with the National Institutes of Health (NIH) to conduct4778        comprehensive research on how food additives impact children's4779        health and development. In partnership with the NIH Nutrition4780        Regulatory Science and Research Program, the FDA will enhance4781        nutrition and food-related research to better inform regulatory4782        decisions.47834784  --The FDA fast-tracked the review of calcium phosphate, Galdieria4785        extract blue, gardenia blue, butterfly pea flower extract,4786        which are color additives derived from natural sources. The4787        agency is also taking steps to issue guidance and provide4788        regulatory flexibilities to industries.47894790    Lastly, FDA has and will continue to collaborate with USDA on a4791variety of cross-cutting work related to the MAHA Commission Report.4792                          human foods program4793    Question. As I mentioned in my opening statement, the FDA regulates479480 percent of our Nation's food supply. We know that there have been4795staffing changes and reductions at the Human Food Program this year. We4796have also heard of the possibility of changes in FDA's food inspections4797that would lead to a decrease in FDA's direct involvement. I assume4798this would lead to more support of state inspectors, which are more4799cost effective.4800    Can you speak to your vision for FDA's food regulation and4801inspections for the next year?4802    Answer. The President's proposed budget for Fiscal Year 20264803includes a plan to shift responsibility for many routine food facility4804inspections from FDA to State agencies. This shift is part of a larger4805proposal to enhance FDA's efficiency. As part of the plan, FDA and4806state co-regulators would work in a coordinated framework, sharing data4807and responsibilities to ensure coverage of regulatory responsibilities4808in a jurisdiction. It is anticipated that each State would have a4809unique distribution of work based on its capacity and capability, while4810FDA would focus on areas where its national scope and specialized4811expertise would be most impactful. This proposed framework will reduce4812duplication and streamline work planning between FDA and state co-4813regulators, as well as provide more complete food safety coverage and4814optimize resource utilization at both the State and Federal levels.4815    From a training perspective, FDA's Partnership for Regulatory4816Education and Training (PRET) program helps enable States to have more4817qualified personnel to conduct inspections. PRET is designed to assist4818State, local, Tribal, territorial and military (SLTTM) partners by4819equipping them to independently deliver training courses. By enhancing4820training capabilities and strengthening regulatory capacity across all4821levels, FDA is reinforcing our collective commitment to safeguarding4822public health. PRET offers an opportunity to empower jurisdictions to4823meet their own training needs while using FDA-designed course materials4824and utilizing FDA-trained qualified instructors from the SLTTM's own4825staff.4826                           ai product reviews4827    Question. I noted your recent announcements around the use of AI at4828the FDA; including the hiring of the FDA's first Chief AI Officer and4829the completion of the first AI assisted product review, with the goal4830of scaling widespread use of AI in reviews at the agency by July. I am4831curious if you can discuss parameters of the rollout.4832    Specifically, can you touch on the safeguards you have in place4833that will protect proprietary information and ensure accuracy?4834    Answer. In June 2025, FDA deployed the generative AI Tool, Elsa,4835across the entire Agency. Elsa's development team was comprised of4836experts from every Center. Currently, we have approximately 11,4004837users of Elsa, with 6,000-7,000 weekly active users, making it one of4838our most utilized applications. Elsa is an FDA-wide solution that can4839be employed to help with tasks in every Center/Office. The system4840supports diverse functions, from administrative tasks to Freedom of4841Information Act requests and human resources needs. We also expanded4842accessibility by developing mobile capabilities specifically for field4843investigators. In addition to Elsa, FDA is currently compiling the 20254844annual HHS AI use case inventory in accordance with Executive Order484513960, ``Promoting the Use of Trustworthy Artificial Intelligence in4846the Federal Government.'' FDA's 2024 use case list may be found here:4847AI Use Cases Inventory HHS.gov.4848    Regarding cybersecurity and information security measures, Elsa4849operates within the most robust security framework available to Federal4850agencies. The system is deployed in a FedRAMP/FISMA High environment,4851which represents the highest level of Federal cybersecurity standards.4852Our key security measures include comprehensive data protection4853protocols. The system is also not connected to the internet and4854operates securely behind the FDA firewall, allowing our staff to input4855FDA confidential information safely while maintaining the highest4856security standards. We maintain strict access controls, including user4857profile restrictions and the ability to create locked-down, user-4858specific document libraries. Staff can upload documents and data during4859individual chat sessions, and this information remains within that4860specific session and user context, preventing unauthorized access or4861data sharing. Additionally, we maintain rigorous vendor management4862protocols with our cloud solution providers and AI vendors, ensuring4863they meet all Federal security requirements while providing us with4864access to the latest modeling capabilities within our secure4865environment.4866    Question. Can you discuss how FDA reviewers are being trained, and4867any cost or savings this may bring to the agency?4868    Answer. Since Elsa's launch on June 2, 2025, over 6,290 FDA staff4869have completed initial training, and currently, we maintain 6-7,0004870weekly active users out of approximately 11,400 total users Agency-4871wide. This makes Elsa one of our most utilized applications outside of4872standard Microsoft Office products.4873    Our training approach is deliberately structured and progressive.4874We have conducted extensive trainings paired with multiple office hours4875and video recordings, and to date, over 6,290 staff have attended4876training sessions. Our approach focuses heavily on prompt engineering--4877teaching users to craft specific, effective queries rather than relying4878on generic interactions. As new features and models are released, staff4879will be required to attend trainings to unlock such additional AI4880models and features. This ensures we have a process to continually4881train and reinforce the proper use of these tools as they advance.4882    Some administrative tasks that previously required days to weeks of4883work can now be completed in fractions of the time, representing4884significant labor cost savings across our large user base. For example,4885analyzing public docket comments for high-level themes could normally4886require days of efforts from several staff members, however, through4887Elsa such themes can now be identified more efficiently.4888    The system development and deployment occurred in 2-3 weeks using4889existing FDA staff with minimal contractor support, demonstrating4890relatively low implementation costs. Our training investment is4891generating returns through accelerated adoption and more effective4892utilization of AI capabilities across diverse Agency functions,4893including assisting staff in drafting warning letters, processing4894meeting transcripts, and supporting various aspects of our review4895processes.4896    FDA maintains rigorous mechanisms to ensure regulatory compliance4897and protection of sensitive information. All users are trained that4898Elsa is a supportive tool, not a decision-maker, and that they must4899verify all outputs through our established multiple levels of review.4900We maintain structured processes with extensive oversight, ensuring4901that AI-assisted work still meets our rigorous scientific and4902regulatory standards. Users learn to utilize feedback mechanisms,4903including rating systems that help our development team understand4904usage patterns and improve the system.4905    Finally, we have implemented features in our system such that when4906users are interacting with Document Libraries, Elsa is forced to read4907prompts in the context of those documents and cite relevant documents,4908significantly limiting the likelihood that Elsa hallucinates4909information or references. Regardless, FDA staff are required to4910validate sources and information in every instance.4911    We also plan to provide Center leadership with information about4912usage patterns, enabling them to understand how their teams are4913utilizing the tools and ensure appropriate application within their4914specific regulatory contexts. Finally, we maintain currency with the4915latest AI capabilities, while ensuring all updates meet our security4916and functionality requirements. We recently upgraded from Claude 3.5 to4917Claude 4.0 within our secure environment, demonstrating our commitment4918to providing staff with cutting-edge tools while maintaining the4919highest security standards.4920    Question. Will the use of AI have effects on staffing levels?4921    Answer. Our current focus is on Human-in-the-loop capabilities to4922support our workforce and not on replacing staff functions with AI.4923                              inspections4924    Question. Inspections are important to promote domestic4925manufacturing. In addition to modernizing the foreign inspection4926process, there are steps that could be taken to address avoidable4927inefficiencies that impact the time and expense of product reviews.4928    Inspections are a critical step in the safety assessment and the4929approval process. They need to be thorough and complete while at the4930same time being accurate and rationale, particularly given the reliance4931on contract manufacturing sites, which can be spread across multiple4932buildings and with distinct products.4933    Can you share with the committee your plan to modernize4934inspections, and commit to working with Congress to identify and4935address improvements to current practices?4936    Answer. FDA has focused on more efficient and timely inspections4937and comprehensive but succinct inspection reports, as well as4938additional technological tools to assist in modernization. Together4939these approaches should allow for an increase in the number of4940inspections performed and allow broader coverage of industry.4941    The Agency is also utilizing remote assessment tools and other4942alternative inspectional tools to gather information and records in4943advance of or in lieu of inspections. This allows FDA to leverage such4944information and records to focus subsequent inspections or to forgo the4945need for inspection in certain cases, as appropriate, e.g., if the4946information in the reviewed records is sufficient for the agency's4947purposes. FDA is also using our authority under section 704(a)(4) of4948the FD&C Act, as recently amended by Congress, to require provision of4949records or other information in advance of or in lieu of an inspection.4950    Question. Will you commit to reporting back to the committee on how4951many inspection issues have led to delayed approvals in the form of4952Complete Response Letters (CRLs), particularly noting those cases in4953which the inspection issue that resulted in the delay is ultimately4954determined to be a non-issue or is unrelated to the product that was4955delayed?4956    Answer. The focus of current good manufacturing practice (CGMP)4957inspections is on system-wide controls that ensure manufacturing4958processes consistently produce quality drugs. FDA will use information4959gathered from inspections to assess an establishment's compliance with4960CGMP requirements, including, among other things, evaluating the4961effectiveness of the establishment's quality system.4962    FDA provides information on inspections, including the median time4963to start a pre-approval inspection (PAI) and the number of facilities4964that failed to address inspection issues leading to application4965Complete Response Letters (CRLs) for new drug applications (NDAs) and4966abbreviated new drug applications (ANDAs), in the publicly available4967FDARA 902 report. The number and type (e.g. PAI, surveillance, for-4968cause) of inspections resulting in Official Action Indicated (OAI)4969classifications is documented, but a categorical breakdown of the type4970requested pertaining to CRL reasons is not available with current4971systems.4972                         fda it infrastructure4973    Question. Please provide details on FDA's IT modernization roadmap,4974including timelines, risk mitigation strategies, and how the agency4975plans to maintain continuity of operations during any system4976transitions.4977    Answer. The FDA has developed a roadmap to consolidate the agency's4978mission critical applications across all centers. The consolidation4979focuses on data intake systems, regulatory workflow management4980platforms, publishing platforms, and the aggregated data platforms. The4981implementation follows a three-phase timeline approach spanning4982calendar years 2025-2028, with the agency currently in the first phase4983which began in May 2025.4984    The first phase, spanning May 2025 through October 2025 (6 months),4985focuses on foundational setup beginning with the launch of frequent4986adverse event data publishing to provide more timely post-market data4987to the public, followed by the initiation of historical data4988digitization to enhance knowledge sources and cross-center system4989consolidation planning, including the deployment of the AI platform4990Elsa 2.0 and Adverse Event Monitoring (AEM) capabilities alongside five4991additional foundational initiatives.4992    The second phase, covering November 2025 through October 26 (124993months), concentrates on core transformation activities, including the4994completion of adverse event system consolidation from seven (7)4995separate databases into one (1) unified system that supports downstream4996regulatory reviews, analytics, reporting, and data mining functions4997without operational interruption. This phase also includes the4998deployment of more real-time sentinel capabilities, the launch of4999parallel real-time review processes for early-phase clinical trials,5000and the implementation of comprehensive real-time surveillance5001capabilities.5002    The third and final phase, planned for November 2026 through April50032028 (18 months), achieves full integration by completing historical5004data digitization, establishing full cross-center system integration,5005and scaling real-time review capabilities from early-phase trials to5006include late-phase trials, thereby creating a comprehensive and timely5007regulatory framework.5008    The consolidation effort employs an approach that minimizes the5009risk by maintaining all existing applications, systems, platforms, and5010resources in their current operational state until successful5011implementation, testing, and migration to the consolidated platform is5012completed. Each initiative involves representatives from every center,5013including both business subject matter experts and technical personnel,5014to ensure ownership of business and IT operations and to provide input5015on proposed changes before any code base modifications occur. Business5016continuity is ensured through embedded change management teams within5017each center that provide hands-on training and various training5018modalities to ensure smooth transitions without major disruptions.5019    Additionally, comprehensive backup plans maintain systems in their5020current operational state as contingency measures, ensuring that5021critical regulatory functions continue uninterrupted throughout the5022transformation process.5023    Question. Please provide the committee with an update on the5024current review process for reviewing contracts at FDA, including:5025    How long is it currently taking FDA to process procurement5026contracts?5027    Answer. The time to process procurement actions, receipt to5028contract award generally takes 2-3 months.5029    Question. How is HHS ensuring that FDA contract governance adheres5030to best practices in procurement, risk management, and operational5031resilience?5032    Answer. HHS is ensuring FDA contract governance adheres to best5033practices in procurement, risk management, and operational resilience5034through implementation of the Administration's priorities. Through HHS,5035the FDA is implementing changes to the Federal Acquisition Regulation5036(FAR) as part of the President's Executive Order (EO), ``Restoring5037Common Sense to Federal Procurement'' (EO 14275), through the5038Revolutionary FAR Overhaul \1\ (RFO). HHS' oversight of FDA's5039acquisition activities helps ensure the FDA realizes the goals of the5040RFO: faster acquisitions, greater competition, and better results.5041---------------------------------------------------------------------------5042    \1\ https://www.acquisition.gov/far-overhaul5043---------------------------------------------------------------------------5044    Additionally, HHS has enabled the FDA to be flexible and innovative5045in adopting best practices, risk management, and operational resilience5046through promotion of the HHS ``Acquisition Innovation Program,'' which5047is transforming ``the department's acquisition process through5048fostering a culture of innovation, streamlining procedures, and5049piloting new approaches to deliver best value to the taxpayer.'' In5050particular, HHS has provided ``streamlined acquisition efficiencies to5051assist the HHS contracting workforce with year-end actions . . . [and]5052low-risk efficiencies that are easy to implement to ensure successful5053execution of FY25 year-end requirements,'' such as streamlined5054acquisition planning, small business-related reviews, and strategic5055sourcing opportunities (HHS Acquisition Alert 2025-07). The FDA is5056implementing many of these approaches to effectively support the FDA,5057including the Department of Homeland Security's Procurement Innovation5058Lab's (PIL) source selection techniques.5059    Question. What internal controls are in place to prevent potential5060bottlenecks during the contract approval process?5061    Answer. Controls include standardized review timelines, designated5062approval authorities at each organizational level, and systematic5063tracking mechanisms that monitor contract progress through each stage5064of the approval workflow. Additionally, the Agency maintains escalation5065procedures and regular communication protocols between contracting5066officers, program officials, and FDA leadership to identify and resolve5067any delays that may arise during the contract approval process.5068    Question. Building off the progress in genomic medicine/rare5069disease--Congress has spent decades providing regulatory tools and5070encouraging their use, from innovative trial designs to expedited5071programs, surrogate endpoints, and real-world evidence. In your efforts5072to build a more efficient FDA that upholds the world's ``gold5073standard,'' it is imperative that FDA makes full use of the tools that5074Congress has provided in applying that standard. This is especially5075important for patients with serious rare diseases where randomized5076controlled trials may not be possible.5077    What does the Administration intend to do to ensure we are able to5078advance the field of cell and gene therapy, and will this5079Administration continue to support the full use of regulatory tools5080Congress has provided, including accelerated approval and single arm5081trials when placebo controls are not possible, in order to speed the5082delivery of these life-changing treatments to patients?5083    Answer. The FDA is committed to advancing cell and gene therapy5084development and making full use of the regulatory tools Congress has5085provided, particularly for rare diseases where traditional trial5086designs may not be feasible.5087    The FDA is actively implementing several key initiatives to support5088cell and gene therapy advancement. The Agency has established the5089Support for Clinical Trials Advancing Rare Disease Therapeutics (START)5090Pilot Program for CBER and CDER, which provides enhanced communication5091between sponsors and FDA staff to address product-specific development5092issues more efficiently. This program specifically targets gene and5093cellular therapies for serious rare diseases, offering frequent advice5094and regular informal communication to help move development programs5095forward more quickly. Additionally, FDA has launched the Rare Disease5096Innovation Hub that will leverage expertise across the Agency to5097advance regulatory science on critical issues including novel5098endpoints, biomarker development, and innovative trial designs.5099    Regarding the use of regulatory flexibilities that Congress has5100provided, FDA explicitly confirms its commitment to applying these5101tools appropriately. These flexibilities include accelerated approval5102based on surrogate endpoints that are reasonably likely to predict5103clinical benefit, reliance on a single adequate and well-controlled5104trial with confirmatory evidence instead of requiring two trials, use5105of natural history study data as external control data, use of novel5106trial designs, and use of novel statistical methodologies.5107    The FDA also continues to support the Rare Disease Endpoint5108Advancement (RDEA) Pilot Program, a joint CBER and CDER initiative5109designed to support novel endpoint efficacy development for drugs that5110treat rare diseases by providing a mechanism for sponsors to5111collaborate with FDA throughout the efficacy endpoint development5112process. The Agency emphasizes that it considers all relevant statutory5113authorities and available flexibilities when making decisions5114appropriate to each particular rare disease and therapeutic product,5115and ensuring that the tools Congress has provided are being utilized5116effectively to benefit patients with serious rare diseases who have5117limited treatment options.5118  rare diseases require innovative approaches to drug development and5119                               regulation5120    Question. Dr. Makary, you have previously articulated the5121challenges in rare disease drug development, stating that for5122debilitating, life-threatening rare conditions, ``you can't expect5123companies to do a randomized controlled trial'' because it would ``kill5124investment in those innovative ideas.'' You also spoke about the need5125to ``customize the approval process to the condition'' and uphold5126``gold standard science.'' I was encouraged by your statements because5127Congress has provided FDA with a wide array of regulatory tools to do5128just that, and these tools are especially important for rare diseases5129that are complex and challenge traditional approaches to drug5130development.5131    As you work towards building a more modern, efficient FDA, how will5132you ensure that your vision for customized approaches to regulation and5133gold standard science is implemented at the review level? Can we count5134on FDA under your leadership to fully leverage all the tools Congress5135has provided to apply innovative regulatory approaches beyond just5136focusing on randomized controlled trials--especially in rare diseases5137where such traditional approaches may not be possible?5138    Answer. FDA currently has numerous programs (e.g., accelerated5139approval, breakthrough therapy designation, fast track designation, and5140priority review) to help speed the availability of drugs intended to5141treat patients with serious and life-threatening diseases, while at the5142same time meeting appropriate safety and effectiveness standards and5143facilitating the collection of scientific data that is relevant and5144reliable.5145    FDA also focuses significant resources on rare disease drug5146development and initiatives to help bring safe and effective treatments5147to rare disease patients. These initiatives include:51485149  --Rare Disease Innovation Hub \2\: In July 2024, FDA announced the5150        creation of the Hub to serve as a point of collaboration and5151        connectivity between CBER and CDER with the goal of ultimately5152        improving outcomes for patients with rare diseases.5153---------------------------------------------------------------------------5154    \2\ https://www.fda.gov/industry/medical-products-rare-diseases-5155and-conditions/fda-rare-disease-innovation-hub5156---------------------------------------------------------------------------5157  --CDER's Accelerating Rare disease Cures (ARC) Program \3\: In May5158        2022, CDER launched the ARC Program with a vision to speed and5159        increase the development of safe and effective treatment5160        options to address the unmet needs of patients with rare5161        diseases.5162---------------------------------------------------------------------------5163    \3\ https://www.fda.gov/about-fda/center-drug-evaluation-and-5164research-cder/accelerating-rare-disease-cures-arc-program5165---------------------------------------------------------------------------5166  --CBER/CDER START Pilot Program \4\: FDA's CBER and CDER initiated5167        the Support for clinical Trials Advancing Rare disease5168        Therapeutics (START) Pilot Program to help further accelerate5169        the development of novel drug and biological products for rare5170        diseases.5171---------------------------------------------------------------------------5172    \4\ https://www.fda.gov/science-research/clinical-trials-and-human-5173subject-protection/support-clinical-trials-advancing-rare-disease-5174therapeutics-start-pilot-program5175---------------------------------------------------------------------------5176  --Rare Disease Endpoint Advancement (RDEA) Pilot Program \5\: This5177        pilot is a PDUFA VII commitment designed to support novel5178        efficacy endpoint development for drugs that treat rare5179        diseases.5180---------------------------------------------------------------------------5181    \5\ https://www.fda.gov/drugs/development-resources/rare-disease-5182endpoint-advancement-pilot-program5183---------------------------------------------------------------------------5184  --The Oncology Center of Excellence (OCE) Rare Cancers Program \6\:5185        This program is intended to promote the development of safe and5186        effective new drugs and biologics totreat patients with rare5187        cancers by engaging with multiple internal and external groups5188        involved in rare cancer drug development, including patient5189        groups, academia, industry, etc., and holding various workshops5190        for pediatric cancers, rare cancers and ultra-rare cancer tumor5191        indications. Importantly, the OCE has applied regulatory5192        flexibility in many rare cancer drug approvals, including5193        acceptance of the use of single arm trials where appropriate,5194        one adequate and well controlled trial under accelerated5195        approval, use of master protocols and seamless trial designs,5196        etc.5197---------------------------------------------------------------------------5198    \6\ https://www.fda.gov/about-fda/oncology-center-excellence/oce-5199rare-cancers-program5200---------------------------------------------------------------------------5201  threats to us biotech's future investment and global competitiveness5202    Question. The National Security Commission on Emerging5203Biotechnology recently issued a report on the impact of emerging5204biotechnology on national security. The Commission's conclusion was a5205clear warning--the U.S. risks permanently forfeiting its position as5206the global leader in biotechnology if supportive action is not taken in5207the next few years. I am concerned that the US can fall behind5208competitors like China, which has been investing in biotech for the5209last two decades in an attempt to overtake the U.S. in this area.5210    What actions can the Administration take to restore the confidence5211and predictability needed in the regulatory process to ensure the5212viability of U.S. biotech, and what is this Administration's broader5213plan to preserve and defend our standing as the global leader in5214biotech and ensure that Americans have access to innovative, lifesaving5215treatments?5216    Answer. To preserve America's competitive edge in biotechnology,5217FDA is taking action across our product areas, including some notable5218examples below, to increase regulatory predictability, accelerate5219review timelines, and foster greater industry collaboration.5220    The FDA recognizes that drug developers and capital markets alike5221want predictability. To that end, FDA published more than 200 complete5222response letters (CRLs) to provide significantly greater insight into5223the FDA's decision-making and the most common deficiencies cited that5224sponsors must address before their application is approved. The Agency5225plans to publish additional CRLs from our archives.5226    The Agency also recently announced its Commissioner's National5227Priority Voucher (CNPV) program. The new voucher may be redeemed by5228drug developers to participate in a novel priority program by the FDA5229that shortens its review time from approximately 10-12 months to 1-25230months following a sponsor's final drug application submission.5231    Additionally, the Commissioner recently launched a six-city5232listening tour to gather direct input from biotechnology and5233pharmaceutical leaders on how FDA can modernize its regulatory5234framework to better support innovation and patient access to safe and5235effective therapies.5236    Lastly, FDA has streamlined its procedures for oversight of foods5237and animals developed using biotechnology and recently implemented a5238Voluntary Premarket Meeting process to help certain foods from genome5239edited plants reach the market much more quickly. This approach5240continues to protect public health and promote transparency while5241reducing FDA's regulatory timeline from months to weeks for these kinds5242of products.5243    Taken together, the US system generally, and FDA procedures in5244particular, have enabled the marketing of more biotechnology-derived5245food and animal products in the US than anywhere else in the world.5246                            staffing at fda5247    Question. Can you confirm the number of current FDA staff and how5248that compares to 2024?5249  --Have these staff losses affected certain offices, centers, or5250        divisions more than others? If so, which?5251  --How many of these staff reductions were funded by user fees versus5252        annual appropriations?5253  --Is the agency currently meeting its PDUFA-mandated review5254        timelines, including for applications granted priority review5255        or for those targeting rare diseases?5256  --What steps are you taking to ensure that the FDA has the staff it5257        needs to review applications within the statutorily mandated5258        timeline?5259    Answer. The table below shows the staff on board as of December 31,52602024, and May 22, 2025. The May 22, 2025, numbers exclude individuals5261that remain on administrative leave with anticipated departures due to5262DRP and pending RIF actions.52635264--------------------------------------------------------------------------------------------------------------------------------------------------------5265                                                                                                                                                 Grand5266                        As Of                             CBER       CDER       CDRH       CTP        CVM        HFP         OC        OII       Total5267--------------------------------------------------------------------------------------------------------------------------------------------------------526812/31/2024...........................................       1373       5655       2192       1183        698       1966       3148       2983      1919852695/22/2025............................................       1304       5388       2017       1078        634       1801       2769       2825      178165270Change (%)...........................................      5.03%     -4.72%     -8.12%     -8.88%     -9.17%     -8.39%    -12.04%     -5.30%     -7.20%5271--------------------------------------------------------------------------------------------------------------------------------------------------------52725273    As demonstrated in the table above, the reductions range from5274approximately 18% to 23% by Center. The Office of the Commissioner is5275an outlier at 27.54%, reflective of the focus of the RIF actions on5276administrative, non-scientific positions without direct roles in the5277reviews, inspections, and investigations.5278    52% of FTEs who left the FDA during the time frame above were5279funded by user fees.5280    FDA continues to meet all of its user fee-related timelines, and5281therapeutics for rare diseases is a significant priority for the5282Agency. As in the past, FDA is monitoring and assessing organizational5283hiring needs to respond according to hiring authority guidelines, so5284that the Agency can continue to review applications within the5285statutorily mandated timelines.5286                      vaccine regulatory framework5287    Question. The Advisory Committee on Immunization Practices (ACIP)5288is an independent body of clinical experts that provides guidance with5289regard to vaccines Last month, the ACIP met and made several5290recommendations that are still pending review by HHS. Can you provide5291any timeline or update as to when HHS will consider the ACIP5292recommendations?5293    Answer. The Advisory Committee on Immunization Practices is an5294advisory committee of the Centers for Disease Control and Prevention5295(CDC). FDA recommends reaching out to CDC for further information.5296                            benzodiazepines5297    Question. Commissioner Makary, recent media investigations have5298underscored the severe risks of the benzo (benzodiazepines) class of5299drugs-including dependency, cognitive decline, and fatal withdrawal5300complications-prompting many patients and providers to seek safer5301alternatives. In the last 2 years the Committee has asked FDA to report5302back on this topic.5303    Given that the FDA and DEA are currently collaborating on an5304analysis to determine whether to deschedule or reschedule newer DORA5305class insomnia medications, will you prioritize this analysis?5306    Answer. Under the Controlled Substances Act (CSA), drug scheduling5307is an effort coordinated between the Drug Enforcement Administration5308(DEA) and the Department of Health and Human Services (HHS), where a5309final scheduling action is taken by DEA. Generally, FDA, on behalf of5310the Secretary of HHS, performs the medical and scientific evaluation of5311substances for control under the CSA, pursuant to provisions under 215312U.S.C. 811(a-c). According to an April 11, 2024, opinion from the5313Department of Justice Office of Legal Counsel, such scientific and5314medical determinations from HHS ``must be binding [on DEA] until5315issuance of a notice of proposed rulemaking"; once formal rulemaking5316has commenced, DEA must continue to accord ``significant deference'' to5317those determinations. As such, we acknowledge our significant and5318important role in evaluating the science to support the scheduling5319process. However, the Agency notes that DEA is the Federal agency that5320takes final scheduling actions under the CSA, including any potential5321descheduling or rescheduling of DORA class substances (suvorexant,5322lemborexant, and daridorexant).5323                    alternative methods for testing5324    Question. As you know, the FDA issued a Roadmap to reduce animal5325testing.5326    Please provide an update on the agency's plans and timeline5327regarding this initiative?5328    Answer. Our Roadmap, released before the hearing on April 10, 2025,5329outlines an approach for FDA to reduce toxicity testing in animals in5330the next 3 years:53315332    1. Explore Pre-existing International Data.53335334    2. Encourage sponsors to submit new approach methodologies (NAM)5335data in parallel with animal data to build a repository of experience.53365337    3. Develop an open-access repository with a comprehensive5338collection of international drug toxicity data from animals and humans.53395340    4. Reduce the routine 6-month primate toxicology testing for5341monoclonal antibodies (mAbs) that show no concerning signals in 1-month5342studies plus NAM tests to 3 months.53435344    5. Reduction in animal toxicity testing timeframes for other drug5345categories.53465347    6. Changes in toxicity testing will be tracked and quantified on a5348bi-annual basis.53495350    Following the release of the roadmap, FDA and NIH held workshop on5351July 7 titled, ``FDA & NIH Workshop on Reducing Animal Testing''. The5352workshop discussed how the FDA and NIH can collaborate to reduce the5353animal testing currently performed for new drugs and other products.5354    In addition, over the coming year, the FDA aims to launch a pilot5355program allowing select monoclonal antibody developers to use a5356primarily non-animal-based testing strategy, under close FDA5357consultation. Findings from an accompanying pilot study will inform5358broader policy changes and guidance updates expected to roll out in5359phases.5360                          foreign inspections5361    Question. Commissioner Makary, as you know many generic drugs used5362in the U.S. are manufactured overseas, particularly in India and China.5363I'm hopeful we can onshore more of this activity. In the interim, we5364still have to ensure those who depend on these medications can trust5365that they are safe and effective when they are imported.5366    How will the FDA ensure that it will be able to sustain its foreign5367inspection schedule?5368    Answer. FDA has resumed the recruitment and hiring of new5369investigators. Training our new and existing workforce of Investigators5370who conduct inspections remains a priority. FDA is committed to the5371continuous assessment and implementation of various training5372improvements, standardization efforts, and evaluations in efforts to5373support the development of the inspectorate and contribute to the5374completion of planned foreign inspections. Emerging training focusing5375on unique aspects of foreign inspections will help ensure that the time5376to prepare for foreign inspection work is minimized, thereby5377facilitating an aggressive foreign inspection schedule.5378                      regulatory review timelines5379    Question. Commissioner Makary, many small biotech firms have5380stressed that the predictability and speed of FDA regulatory engagement5381is critical to their investment decisions. Can you give us your5382assurance that regulatory review times and processes will not be5383significantly impacted by any staffing changes at the agency?5384    Answer. One of my highest priorities is to ensure that the U.S.5385continues to be at the leader in biotechnology innovation and to get5386these cutting-edge therapies to the American public quickly. For this5387reason, we made sure that there were no RIFs of reviewers of medical5388products and others serving in critical roles to support FDA's mission5389and operations. The Agency continues to meet its review goals under the5390user fee agreements and we anticipate continuing to do so. In fact, we5391have recently undertaken a number of new initiatives to make reviews5392more efficient in an effort to further reduce current review times,5393including for products targeting rare diseases.5394    Dr. Makary, you have previously stated, ``our number one goal is5395delivering cures and meaningful treatment and healthier foods for5396Americans.'' Smoking cessation therapies have been approved for decades5397but it has been almost 20 years since a new smoking cessation therapy5398has been approved.5399    Question. Under your leadership, how can the Center for Drug5400Evaluation and Research (CDER) help Americans be more effective in5401their efforts to quit smoking with new, safe and more effective smoking5402cessation therapies?5403    Answer. FDA recognizes there is an unmet need for novel therapies5404particularly for individuals who have not been able to quit smoking5405despite available therapies.5406    We are encouraging development of novel smoking cessation drug5407therapies that show benefit over existing products by providing5408recommendations on how to qualify expedited development pathways such5409as fast track, breakthrough, and priority review.5410    In May 2023, CDER finalized the draft guidance Smoking Cessation5411and Related Indications: Developing Nicotine Replacement Therapy [NRT]5412Drug Products. The NRT Guidance provides recommendations for applicants5413to make NRT development easier, efficient, and streamlined:54145415  --Clarifying recommendations for companies that seek approval for a5416        product that alters the route of administration compared to5417        approved NRT drug products, e.g., products with pulmonary route5418        of administration rather than an oral route of administration.5419  --Explaining when simplified efficacy study requirements may be used5420        (e.g., recommending a 4-week study as the minimum period of5421        efficacy ascertainment)5422  --Clearly outlining the abbreviated review pathways available for NRT5423        products, including how to use FDA's previous findings of5424        safety and how already approved NRT products and published5425        literature can be leveraged.5426  --Encouraging sponsors to consider expedited development and review5427        pathways, as well as providing details on how to qualify.5428    In addition, because the data are so strong in demonstrating that5429quitting smoking can lower a person's chance of having lung disease,5430heart disease, and certain types of cancer, drug products that have5431been demonstrated to be effective for cessation can be approved with5432labeling claims regarding these benefits without additional data5433supporting benefit of the particular product on these outcomes.5434    To support the majority of smokers who wish to quit and to increase5435utilization of cessation products and interventions, FDA and the5436National Institutes of Health (NIH) are collaborating to identify5437opportunities for the development of novel therapies, support5438innovative trial designs, and facilitate product development for5439smoking cessation therapies. Opportunities for innovation exist in many5440areas including collaboration with researchers to help identify novel5441targets, use of innovative clinical trial design and conduct, inclusion5442of individuals underrepresented in research, developing a better5443understanding of quit failures and relapse, and utilizing FDA's5444expedited programs for medical product development.5445    To this end, FDA held a joint public meeting with NIH to discuss5446innovations in development of smoking cessation products. The overall5447goal of the meeting was to stimulate novel product development to5448reduce rates of smoking and related chronic illnesses. Input gathered5449from that meeting will help inform future guidance for industry on5450development of non-nicotine containing drug products for smoking5451cessation.5452    Question. A recent study published in JAMA Oncology looked at the5453impact of smoking after a cancer diagnosis and concluded that evidence-5454based smoking cessation treatment within 6 months following a cancer5455diagnosis maximizes survival benefit, supporting smoking cessation as5456an important early clinical intervention for patients after being5457diagnosed with cancer, yet, the current smoking cessation toolkit5458hasn't changed in nearly two decades. Under your leadership, how will5459you ensure that all patients, including cancer patients, have the best5460chance for the most optimal treatment outcomes, including for patients5461for whom it is critical they are more effective in their attempts to5462quit smoking?5463    Answer. Nicotine is a highly addictive substance, making nicotine5464dependence a very challenging condition to treat. The reasons for low5465success quit rates include multiple factors unrelated to availability5466of safe and effective smoking cessation products, such as weight gain,5467lack of access to effective therapies due to financial hardship,5468exposure to other smokers and secondhand smoke, loss of an ability to5469manage stress, and comorbid alcohol and other substance use disorders.5470    Unfortunately, less than one-third of smokers who try to quit use5471counseling and FDA-approved smoking cessation drug products, which is5472one potential area for intervention. Although many national oncology5473organizations have emphasized the importance of smoking cessation5474treatment in comprehensive cancer care, use of FDA-approved smoking5475cessation products remains low in cancer patients as well. Among cancer5476patients, lack of access to smoking cessation therapies has been5477identified as a barrier to use. That is why we have worked to improve5478access by making so many of these products available in the5479nonprescription setting via the prescription to nonprescription switch5480pathway, making these products accessible to consumers without the need5481to see a healthcare provider.5482    Specifically, FDA has issued a final guidance intended to assist5483sponsors in the clinical development of nicotine replacement therapy5484(NRT) drug products intended to help cigarette smokers stop smoking.5485That guidance, Smoking Cessation and Related Indications: Developing5486Nicotine Replacement Therapy Drug Products, provides recommendations to5487assist sponsors in getting novel therapies directly in the hands of5488consumers, in the nonprescription setting, without going through5489development as a prescription product first. This pathway could be5490especially meaningful for cancer patients who seek timely access to5491supportive care treatments and who wish to reduce the burden of5492additional physician visits. In the guidance, we provide5493recommendations for developing over-the-counter (OTC) NRT products,5494which can reduce potential hurdles for access, and recommendations for5495sponsors to help get novel products over the goal line for approval. It5496also describes potential abbreviated pathways available for NRT5497products, including how to use FDA's previous findings of safety and5498how already approved NRT products and published literature can be5499leveraged. Finally, the NRT Guidance encourages sponsors to consider5500expedited development and review pathways and provides recommendations5501on how to qualify for this review.5502    Question. What opportunities do you see for innovation in smoking5503cessation therapies to be part of the administration's work to Make5504America Healthy Again?5505    Answer. As part of broader national efforts to reduce the burden of5506chronic conditions, such as Chronic Obstructive Pulmonary Disease5507(COPD), heart disease, and cancer, there is growing interest in5508advancing innovative approaches to smoking cessation. FDA's 2023 NRT5509guidance, discussed in the response to Question 16A encourages5510development of novel nicotine replacement therapies by providing5511recommendations for applicants to make NRT development easier,5512efficient, and streamlined.5513    Question. In October 2024, the Food and Drug Administration and the5514National Institutes of Health held a joint public meeting on smoking5515cessation, at which several patient and public health organizations5516underscored the detrimental impact smoking continues to have on the5517health of Americans and the importance of prioritizing innovations in5518smoking cessation therapies. What opportunities do you see to ensure5519FDA does not accept the status quo and the Center for Drug Evaluation5520and Research (CDER) approaches the risk-benefit considerations for5521nicotine replacement therapies in a manner that reflects the realities5522of how hard it is to quit and the unmet need for patients who continue5523to fail in their quit attempts?5524    Answer. Please see FDA's response to previously question.5525    Question. Cigarette smoking and secondhand smoke exposure account5526for nearly half a million deaths in the United States each year.5527Smoking-related death and disease cost the United States $600 billion5528each year and contribute to significant health challenges. Reducing5529smoking is not only an urgent public health challenge for Americans,5530but also an economic challenge for the health care system and American5531taxpayers. What is the administration doing to advance innovation in5532smoking cessation in order to offer Americans access to new therapies5533that can help them succeed in their quit attempts and limit the toll5534smoking-related health conditions take on the Medicare and Medicaid5535programs, and most importantly, the patients served by these health5536programs?5537    Answer. It is important to note that FDA does not develop drugs.5538Historically, FDA has seen limited interest from sponsors in developing5539nicotine replacement therapy products and we have not seen a recent5540change. Please see FDA's response to Question 16A for information about5541how FDA is attempting to encourage development novel smoking cessation5542drug therapies.5543                           compounding drugs5544    Question. In the Drug Quality and Security Act, Congress authorized5545the FDA to identify drug formulations that are ``demonstrably difficult5546to compound (DDC),'' to protect patients when the scientific evidence5547demonstrates that the risks of compounding a particular drug outweigh5548the benefits. Once added to the DDC list, it becomes unlawful to5549compound.5550    Commissioner Makary, as you know, the FDA is authorized to limit5551503A compounding of specific drug products and 503B compounding of5552drugs and categories of drugs. In a March 2024 proposed rule, the FDA5553described six criteria for evaluating whether a drug should be added to5554the DDC list. I have heard concerns from constituents that the agency5555may seek to use those criteria to ban entire categories of drugs from5556503A compounding. This could negatively impact patients who rely on5557compounded medications for a wide range of conditions, including when5558drugs are on shortage.5559    Will you commit that you will not finalize any rule that exceeds5560the agency's statutory authority under section 503A, including that5561only individual drug products may be added to the 503A DDC list?5562    Answer. As you note, FDA issued a proposed rule, ``Drug Products or5563Categories of Drug Products That Present Demonstrable Difficulties for5564Compounding Under Sections 503A or 503B of the FD&C Act,'' in March55652024.5566    The Agency is currently reviewing public comments on the proposed5567rule, including comments regarding the scope of the Agency's5568authorities regarding the development of the DDC lists.5569    FDA plans to finalize the rule consistent with our authorities5570under the FD&C Act.5571                      regulatory review timelines5572    Question. Many individuals are accessing health information through5573the use of digital tools, in addition to health care providers who are5574using such tools to make treatment decisions. Prescription Drug-Use-5575Related Software continues to play an increasing role in patient care5576and it is important to have a consistent framework in place that takes5577a modern approach to digital regulation. During the first Trump5578Administration, FDA issued guidance to advance such a framework.5579    Dr. Makary, do you plan to advance and/or update the guidance5580released during the first Trump Administration regarding the regulation5581of Prescription Drug-Use-Related Software?5582    Answer. FDA is considering whether to prepare a final version or5583issue another draft of the Regulatory Considerations for Prescription5584Drug Use-Related Software (PDURS) draft guidance document. FDA will5585continue to engage with stakeholders who are exploring PDURS and will5586consider whether to issue or revise guidance based on stakeholder5587feedback as appropriate and evolving regulatory considerations.5588    Phenobarbital--Phenobarbital, a schedule IV controlled substance,5589is a barbiturate that can slow the activity of a user's brain and5590nervous system. It is my understanding that phenobarbital in tablet5591form is primarily for veterinary use, and the only use approved by FDA5592is for the control of seizures associated with idiopathic epilepsy in5593dogs. Despite FDA's approval in 2023, many animals are being treated5594with unapproved phenobarbital drugs intended for human use.5595    I understand the FDA is aware of this issue and announced earlier5596this year that in November, 2024 warning letters were issued to six5597firms that were selling unapproved drugs that do not contain5598phenobarbital and that claim to treat and control seizures in dogs.5599    Question. In addition, has the FDA considered sending letters to5600companies prescribing or dispensing unapproved phenobarbital human5601drugs in lieu of an approved veterinarian phenobarbital drug?5602    Answer. CVM published a CVM Update following the conditional5603approval of Fidoquel-CA1 (phenobarbital tablets) for dogs on September56046, 2023, that included the statement, ``Unapproved phenobarbital5605tablets from the human drug marketplace have historically been used in5606veterinary medicine to help control seizures in dogs. Fidoquel-CA1 are5607the only phenobarbital tablets that have received the agency's5608conditional approval for safety, quality manufacturing and reasonable5609expectation of effectiveness.'' CVM Updates are posted on our website5610and are also sent to various stakeholders.5611    Question. Given that ``Dear Veterinarian Letters'' and ``Dear5612Pharmacy Professional Letters,'' are issued by the FDA, has the agency5613considered appropriately notifying veterinarians and pharmacists of the5614availability of the FDA-approved phenobarbital drug for treatment of5615their animal patients in lieu of unapproved phenobarbital preparations5616intended for human use?5617    Answer.When CVM conditionally approved Fidoquel-CA1 (phenobarbital5618tablets), a CVM Update was issued (FDA Conditionally Approves5619Phenobarbital Tablets to Control Seizures in Dogs with Idiopathic5620Epilepsy FDA). This CVM Update explains that Fidoquel-CA1 tablets are5621the only phenobarbital tablets that have received the agency's5622conditional approval for safety, quality manufacturing, and reasonable5623expectation of effectiveness. The CVM Update further explains that5624conditional approval allows an animal drug sponsor to legally market5625its product after demonstrating that the drug is safe and manufactured5626in accordance with full approval standards, and that there is a5627reasonable expectation of effectiveness for use. At this time, CVM does5628not intend to issue a ``Dear Veterinarian Letter'' or ``Dear Pharmacy5629Professional Letter'' about Fidoquel-CA1, as this information is5630already captured in the CVM Update. The sponsor of Fidoquel-CA1 was5631encouraged to share the CVM update with veterinarians and pharmacy5632professionals.56335634                                 ______56355636               Questions Submitted by Senator Jerry Moran5637    Question. The Prescription Drug User Fee Act (PDUFA) was5638established in 1992 to address concerns regarding delays in the FDA's5639regulatory review of new medications for patients. Congress enacted5640PDUFA as a bipartisan approach to ensure that the American public5641receives the high-standard regulatory authority it deserves. PDUFA5642performance goals are designed to enhance the efficiency and5643effectiveness of the first cycle review process and minimize the number5644of review cycles required for approval. Compared to its inception in56451992, significant progress has been made. However, despite the shared5646commitment between the U.S. FDA and the regulated industry, recent5647performance signals have raised concerns: 1) inconsistent first cycle5648approval rates, 2) fewer priority reviews granted in 2024 compared to5649the past 5 years, and 3) delayed responsiveness to meeting requests5650from companies developing medications for patients. What specific5651measures will be implemented to improve FDA performance?5652    Answer. FDA has worked and will continue to work diligently to meet5653its PDUFA performance goals. The FDA responds to each of the5654performance signals identified in this question:5655    The rate of first cycle approval is not a PDUFA performance goal;5656however, PDUFA commitments negotiated between FDA and regulated5657industry can contribute to greater first cycle approvals of marketing5658applications. As published in CDER's New Drugs Approval Reports,5659approvals of novel therapies in the first review cycle have5660consistently been well above 50% for the past 4 years: 86% in 2021 (435661out of 50); 76% in 2022 (28 out of 37); 84% in 2023 (46 out of 55); and566274% in 2024 (37 out of 50). For 2025, CDER has approved 19 novel5663therapies as of July 3, 2025, and 15 (79%) of these are first cycle5664approvals. CBER's first cycle approvals were 89% in 2021 (8 out of 9);5665100% in 2022 (12 total); 82% in 2023 (9 out of 11); and 90% in 2024 (95666out of 10).5667    The number of priority reviews granted is also not a PDUFA5668commitment and instead reflects the type of marketing applications5669submitted to the FDA. Priority review is granted only if the marketing5670application meets the criteria for this expedited review program.5671Similar to the data for first cycle reviews, this information is5672provided in CDER's New Drugs Approval Reports, and the percentage of5673novel drugs approved that were designated priority review has5674consistently been above 50% for the past 4 years: 68% in 2021; 57% in56752022; 56% in 2023; and 56% in 2024. Of the 19 novel therapies approved5676in 2025 thus far, 10 (53%) were priority reviews. Of CBER approved5677products, there were high percentages of priority designated products:567878% in 2021; 75% in 2022; 73% in 2023; 70% in 2024.5679    Although neither of these above metrics is a PDUFA performance5680goal, FDA's ability to consistently deliver in both of these areas is a5681reflection of the extensive engagement between FDA and regulated5682industry throughout drug development.5683    In regard to your third concern, providing a timely response to5684meeting requests by either granting or denying the request is a PDUFA5685performance goal. FDA has historically met or exceeded this goal for5686most meeting types. To continue to maintain our PDUFA performance, FDA5687is committed to hiring, training, and retaining quality scientific5688staff across multiple disciplines.5689    Question. Complete Response Letters (CRLs) from the FDA for all5690approved products have remained relatively constant since 2018, but the5691proportion of those CRLs that can be attributed to manufacturing and5692quality-related issues has increased substantially. CRLs can arise for5693a wide range of issues, but with good, prompt communication between the5694FDA and sponsors there can be opportunities to avoid CRL and achieve a5695First Cycle Approval.5696    Given the increasing proportion of CRLs for manufacturing and5697quality-related issues, what steps will FDA take to improve5698communication with sponsors during the review and adjust the timing of5699manufacturing inspections to reduce unnecessary CRLs and accelerate5700patient access to innovative medicines?5701    Answer. Timely interactive communication with sponsors during drug5702development is a core Agency activity and helps achieve the Agency's5703mission to facilitate efficient and effective drug development5704programs.5705    FDA publishes policy documents such as guidance documents,5706compliance programs, and manuals of policies and procedures to5707facilitate an applicant or manufacturer's understanding of requirements5708and recommendations, and FDA business processes. This information5709enables applicants and manufacturers to proactively understand and meet5710pharmaceutical quality standards before submitting an application for5711review.5712    After FDA receives an application, FDA's obligation is to manage5713the review process and determine whether a submitted application meets5714the legal and scientific requirements for approval of the product. To5715increase the likelihood of first cycle approval, however, the5716applicant's continued active involvement is important, especially in5717responding to requests for additional information that may be prompted5718by the ongoing reviews.5719    In addition, we have initiated a new program for Post-Warning5720Letter Meetings (PWLM) regarding a facility's ongoing efforts to5721remediate current good manufacturing practice (CGMP) deficiencies.5722    Beyond the User Fee Commitments on facility inspections/5723evaluations, FDA has enhanced existing practices to provide earlier5724communication to a sponsor or applicant when any facility inspection,5725not just preapproval, may impact approvability to promote interaction5726between sponsor/applicant and their manufacturing facility to attempt5727to remediate the inspection observations prior to the application goal5728dates.5729    To avoid first-cycle CRLs due to manufacturing and quality issues,5730FDA continues to recommend that applicants/sponsors conduct due5731diligence to audit their manufacturing facilities, ensure they are5732meeting CGMP requirements that help protect patients and to provide5733access to high quality, safe, and effective medicines. Leveraging pre-5734submission meetings with the FDA and applying current FDA guidance and5735advice to their submissions, can help alleviate challenges that occur5736when a submission is of poor quality or does not incorporate5737recommendations found in publicly available guidance.5738    FDA works with all sponsors to resolve issues and help speed5739development of new products, while maintaining high, scientifically5740based safety and efficacy standards.5741    Question. Considering the decrease in the percentage of novel drugs5742approved first in the US from 86% in 2016 to 64% in 2023, what actions5743will be taken to ensure the FDA has adequate resources to uphold its5744high standards for regulatory review and enhance transparency in the5745review process to accelerate American access to innovative, safe and5746effective treatments?5747    Answer. The decrease in novel drugs approved first in the US is5748likely attributable to multiple factors. Pharmaceutical companies'5749decisions of where to first bring a novel drug to the market is likely5750based on a variety of business considerations, most of which would be5751beyond FDA's expertise and ability to opine on. It's also worth noting5752that the proportion of first-in-class drugs has increased from 20235753(36%) to 2024 (48%), indicating that drugs with novel mechanisms of5754action may be starting to represent a larger proportion of novel drug5755approvals in the US.5756    FDA cannot comment publicly on specific drug development programs5757or existing or potential applications of unapproved products. However,5758FDA recognizes that drug developers and capital markets alike want5759predictability. To that end, FDA published more than 200 letters, known5760as complete response letters (CRLs). Many were issued in response to5761applications submitted to the FDA for approval of novel drug or5762biological products between 2020 and 2025. By making the CRLs5763available, the public now has significantly greater insight into the5764FDA's decision-making and the most common deficiencies cited that5765sponsors must address before their application is approved. The Agency5766is in the process of publishing additional CRLs from its archives and5767is continuously exploring ways of providing the public with greater5768transparency into its decision-making process.5769    Commissioner Makary, you should know that Kansas is home to part of5770the Animal Health Corridor, which has more than 300 animal health5771companies--the largest concentration in the world. The animal health5772industry works with farmers and ranchers, government agencies, and5773veterinarians to ensure the health and safety of animals, humans, and5774the food supply. The Center for Veterinary Medicine (CVM) at FDA has5775long been an agency operating independently with the unique mission to5776review food, food additives, and drugs for animals to ensure they are5777safe and effective for the market.5778    Question. How will FDA ensure the animal product review functions5779at CVM can not only continue, but be improved?5780    Answer. CVM will continue to recruit scientific reviewers to5781maintain essential staffing levels and specialized expertise to ensure5782compliance with statutory and user fee goals. Integration of artificial5783intelligence tools will help streamline current review processes,5784furthering efficient review determinations for new animal drugs.5785    Question. What changes are needed at CVM to improve the review5786process and allow more innovation to come to the market?5787    Answer. FDA believes that facilitating increased innovation is5788critical to supporting the agriculture industry and others working to5789support both human and animal health. The Agency has begun modernizing5790its approaches, including through the use of artificial intelligence,5791and it welcomes the opportunity to work with Congress on any approaches5792that may be useful in improving these efforts.5793    Question. In March, HHS Secretary Kennedy directed the FDA to5794explore rulemaking to revise the Substances Generally Recognized as5795SAFE (GRAS) Final Rule to eliminate the self-affirmed GRAS pathway.5796    What is the current status of this directive?5797    Answer. We are pursuing the Secretary's directive and exploring5798potential rulemaking to eliminate the self-affirmed GRAS pathway.5799    In the Spring 2025 Unified Agenda, FDA announced intent to publish5800a proposed rule, that if finalized would amend the Generally Recognized5801as Safe (GRAS) regulations in 21 CFR parts 170 and 570 to require the5802mandatory submission of GRAS notices for the use of human and animal5803food substances that are purported to be GRAS.5804    Question. If FDA were to eliminate this pathway, in part or whole,5805what does the FDA view as an adequate replacement or alternative that5806will not force food companies into a pipeline process that could be5807subject to excessive delays?5808    Answer. To give a sense of the current baseline of FDA GRAS5809reviews, the program currently completes review of an average of 855810human and animal foods GRAS notices per year. FDA's FY26 President's5811Budget request proposes investing additional resources to support FDA's5812capacity to assess the safety of exposure to chemicals in the food5813supply, including meaningfully exploring closing the Generally5814Recognized as Safe (GRAS) loophole and more quickly implementing a5815framework for proactive, systematic, and risk-based reassessment of5816chemicals used in food.5817    Further, the accessibility of certain information made available to5818the public on FDA's website through the GRAS Notice Inventory as well5819as publishing the Agency's determinations when a substance is deemed5820not GRAS will continue to provide transparency to the industry to help5821support GRAS submissions to the agency.5822    Question. How will FDA engage food producers, especially small5823manufacturers, as they look for regulatory certainty?5824    Answer. FDA values transparency and public engagement and will5825continue to engage with industry as we consider regulatory options for5826improving the GRAS program. FDA is initiating rulemaking regarding the5827voluntary GRAS notification program, and will issue a notice of5828proposed rulemaking and invite public comment as part of that process.5829    Industry members looking to consult with FDA on pre-market5830submissions can contact FDA's Office of Premarket and Additive Safety,5831which operates the Voluntary GRAS Notification Program, at5832premarkt@fda.hhs.gov for human foods and animalfood-5833premarket@fda.hhs.gov. for animal foods.58345835                                 ______58365837            Questions Submitted by Senator Cindy Hyde-Smith5838    Question. Dr. Makary, you have discussed the importance of medical5839innovation to improving the health of our Nation and made the comment5840that drug development takes too long for many patients who are5841suffering from diseases that have no current treatment.5842    During a recent media interview, you advocated for new regulatory5843pathways for rare disease drugs, allowing for their conditional5844approval based on a ``scientifically plausible mechanism.'' You stated5845that in some instances, ``You can't expect the companies to do a5846randomized, controlled trial; you'll kill innovation. You'll kill5847investment in those innovative ideas,'' Makary said.5848    Can you give us examples of what you are doing to ensure that the5849FDA under your leadership is moving quickly to advance new pathways for5850rare disease?5851    Answer. FDA exercises appropriate regulatory discretion for rare5852diseases to help safe and effective products come to market as quickly5853as possible in accordance with the approval standards established by5854law. We leverage numerous programs, tools, and resources, that serve to5855speed the availability of products intended to treat patients with5856serious and life-threatening diseases, while at the same time meeting5857appropriate safety and effectiveness standards and facilitating the5858collection of scientific data that is relevant and reliable. An example5859of a new initiative we've launched that is intended in part to address5860unmet medical needs, including drugs to treat or prevent rare diseases5861is the Commissioner's National Priority Voucher (CNPV) Pilot Program.5862    Additional details can be found at the following website: https://5863www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-5864pilot-program5865    We know that there are pending applications for rare diseases that5866have either missed their PDUFA dates or have recently extended their5867PDUFA dates.5868    Question. What are you doing to ensure your staff applies maximum5869regulatory flexibility as required by the law and works urgently to5870complete their reviews of rare disease applications on time, or even5871early, to meet the urgent medical needs of patients who are waiting for5872life-altering treatments).5873    Answer. See response to previously question.5874    Question. It's my understanding that FDA has an ongoing Unapproved5875Drugs Initiative to remove and replace drugs that do not have the5876required regulatory approval from the market. The Agency's website5877States, ``FDA has taken hundreds of unapproved prescription drugs off5878the market since 2006 and has executed multiple class actions announced5879through Federal Register Notices''. FDA's guidance to industry5880encourages manufacturers to seek FDA approval of these drugs and in5881return, the Agency uses a risk-based approach to remove unapproved5882drugs from the market that pose a risk to public health.5883    I am aware of a company who received approval for a phenobarbital5884sodium product in November 2022, which marked the first, and only,5885approval of phenobarbital for human use, yet thirty months later, the5886Agency has not utilized its enforcement authority to remove the5887unapproved drugs from the market. As explained to me, phenobarbital is5888a controlled substance and many of the unapproved drugs contain5889preservatives that the Agency has prohibited from use in products5890administered to neonates because of known toxicity.5891    I am concerned the Agency's lack of action threatens the integrity5892of the Agency's regulatory mission, discourages manufacturers from5893making the significant investment to seek FDA approval, and poses5894health risks to these patients. I am hopeful that under your leadership5895the Agency will prioritize this important initiative.5896    Will you commit to reviewing this issue in a timely manner to5897ensure patients are receiving the safest, and most effective drugs?5898    Answer. FDA approved Sezaby (phenobarbital sodium) in November 20225899solely for the treatment of neonatal seizures in term and pre-term5900infants. Sezaby is the first FDA-approved phenobarbital sodium5901injection product, and it is preservative-free. It is not approved for5902use in adolescents or adults, and its labeling includes a boxed warning5903that the product is only for short-term use.5904    There are a number of unapproved phenobarbital sodium injection5905products currently on the market. These products generally are5906indicated for use in the adult population as a sedative, hypnotic,5907preanesthetic, or long-term anticonvulsant and for use in pediatric5908patients as an anticonvulsant and sedative.5909    FDA exercises a risk-based approach to prioritizing enforcement5910action regarding unapproved drugs. This involves considering all the5911facts of a given circumstance and focusing on enforcement priorities5912for drugs that pose the highest risk to public health without imposing5913undue burden on patients or unnecessarily disrupting the availability5914of medically necessary drugs on the market.5915    The Agency is currently reviewing a Citizen Petition regarding5916unapproved phenobarbital sodium injection drugs, and will respond to5917the Petition as soon as possible and post the response to the public5918petition docket.5919    Question. A new study presented on Capitol Hill yesterday5920highlights a critical gap: most healthcare professionals misunderstand5921the risks of nicotine and remain unaware of the FDA's role in5922authorizing smoke-free alternatives. They continue to equate nicotine5923with cancer, despite evidence that it's the smoke- not nicotine-causing5924disease. These misperceptions are preventing pivotal informed patient5925counseling. This same study showed the overwhelming majority of5926healthcare providers want clear, accurate guidance from FDA on5927authorized smoke-free products so they can share this information with5928their patients.5929    Will you commit to immediately prioritize educating the medical5930community on the continuum of risk and the public health potential of5931authorized smoke-free products?5932    Answer. FDA agrees that the medical community has a unique and5933important role to play in the education of adults who use tobacco5934products. FDA's CTP currently disseminates educational content5935explaining that tobacco products exist on a continuum of risk, with5936combustible products such as cigarettes being the most harmful. CTP's5937``The Relative Risks of Tobacco Products'' webpage \7\ informs5938consumers and stakeholders about tobacco product relative risk. CTP has5939also published commentaries \8\ discussing evidence-based opportunities5940for addressing misperceptions about tobacco product relative risks,5941including the role of medical providers as trusted messengers of5942relative risk messaging for adults.5943---------------------------------------------------------------------------5944    \7\ https://www.fda.gov/tobacco-products/health-effects-tobacco-5945use/relative-risks-tobacco-products5946    \8\ https://www.fda.gov/tobacco-products/ctp-newsroom/ctp-director-5947co-authors-new-journal-commentary-relative-risks-tobacco-products5948---------------------------------------------------------------------------5949    Question. Commissioner Makary, FDA places all tobacco and nicotine5950products on a continuum of risk, with smoking being the most harmful.5951Recent data shows that most medical professionals do not understand the5952continuum of risk across nicotine products and often misperceive5953nicotine- not smoke- as the main cause of tobacco related diseases.5954    Will you commit to educating the medical community on the relative5955risks of tobacco and nicotine products, including FDA-authorized smoke5956free alternatives?5957    Answer. See response to previously question.5958    Question. Skin cancer is the most common cancer in the United5959States, affecting over five million Americans annually and resulting in5960significant healthcare costs. Despite its prevalence, four out of five5961cases of skin cancer can be prevented through sun-safe practices,5962including the use of effective sunscreens. The United States has not5963approved a new sunscreen active ingredient since the 1990s while our5964peer countries have moved several generations ahead of the U.S. in5965terms of sunscreen technologies.5966    Considering the preventable nature of skin cancer and the5967importance of effective sunscreens, do you commit to utilizing your5968budget to improve the approval process for new sunscreen active5969ingredients to ensure that Americans have access to the most advanced5970and effective sun protection products?5971    Answer. FDA is strongly committed to timely evaluation of any5972industry submission requesting that FDA determine conditions under5973which a new active ingredient is generally recognized as safe and5974effective (GRASE) for use in sunscreens to enable that ingredient's use5975in OTC monograph sunscreen products marketed in the U.S. Once an active5976ingredient is included in the OTC sunscreen monograph (subject to an5977exclusivity period afforded by section 505G of the FD&C Act, if5978applicable), each sunscreen product that uses that ingredient can be5979marketed without first being reviewed by FDA, so long as that product5980conforms to the sunscreen monograph conditions and other general5981requirements. This can make it easier for firms to introduce individual5982sunscreen products to the market. The Agency has taken significant5983steps to help advance the development of submissions that could support5984a positive GRASE determination for use of new sunscreen active5985ingredients. We will continue to dedicate resources to this goal as5986well as to evaluation of any submissions industry makes.59875988                                 ______59895990             Questions Submitted by Senator Jeanne Shaheen5991    Question. I am concerned about the workforce reductions at the FDA5992and the impact they will have on the FDA's ability to complete5993statutorily mandated functions of the Agency. Please provide responses5994to the following questions:59955996  --How many people are employed by the FDA as of May 29, 2025?59975998  --How many people were employed by the FDA on January 19, 2025?5999    Answer.60006001------------------------------------------------------------------------6002                                           As of Jan 19,   As of May 29,6003              Position Type                    2025            20256004------------------------------------------------------------------------6005Advisory Committee......................            1785            16676006Civilian................................           19166           178216007Commissioned Corps......................             954             9456008      Total.............................           21905           204336009------------------------------------------------------------------------60106011                          probationary firings6012    Question. How many probationary staff were let go from the FDA6013since January 20th, 2025? Please provide a total and breakdown by6014Center.6015  --Of the probationary staff fired, how many were brought back?6016  --What were the factors used to determine which staff to bring back?6017    Answer. On 2/15/2025, the following probationary employees were6018placed on administrative leave:60196020------------------------------------------------------------------------6021                  Center/Office/Program                      Employees6022------------------------------------------------------------------------6023CDER....................................................              136024CDRH....................................................             2296025CTP.....................................................             1086026CVM.....................................................              416027HFP.....................................................              896028OC......................................................             2026029OII.....................................................              126030      Total.............................................             6946031------------------------------------------------------------------------60326033    On 5/8/2025, the following probationary employees were terminated:60346035------------------------------------------------------------------------6036                  Center/Office/Program                      Employees6037------------------------------------------------------------------------6038CDER....................................................               16039CDRH....................................................              286040CTP.....................................................              746041CVM.....................................................              186042HFP.....................................................              206043OC......................................................              936044OII.....................................................               16045      Total.............................................             2356046------------------------------------------------------------------------60476048    The following probationary employees were not terminated at the6049time for the following reasons:60506051--------------------------------------------------------------------------------------------------------------------------------------------------------6052                      Reason Not Terminated                          CDER       CDRH       CTP        CVM        HFP         OC        OII       Total6053--------------------------------------------------------------------------------------------------------------------------------------------------------6054Probationary Period Completed...................................          0         71          7         12         18         14          0        1226055Data Correction--Not Probationary...............................          0          2         13          0          2         18          0         356056Leadership Determination........................................          0        108          4         36         22         11        1816057Resigned........................................................          0          3          2          1          4          5          0         156058Remained on Admin Leave Pending RIF.............................         12         17         12          6          9         50          0        1066059      Total.....................................................         12        201         34         23         69        109         11        4596060--------------------------------------------------------------------------------------------------------------------------------------------------------60616062    Probationary employees restored due to leadership determination6063were based upon mission requirements and the needs of the agency.6064                       reductions in force (rif)6065    Question. How many people were let go because of the RIFs that6066occurred on April 1, 2025? Please provide a total and breakdown the6067RIFs by Center.6068  --Of the employees who were a part of the RIF, how many have been6069        brought back? Please breakdown by Center.6070  --What were the factors used to determine which staff to bring back?6071    Answer.60726073----------------------------------------------------------------------------------------------------------------6074              Data                 CBER     CDER     CDRH     CTP      CVM      HFP       OC      OII     Total6075----------------------------------------------------------------------------------------------------------------6076Positions impacted by RIF as of      193      825      233      220      148      256      415      170     24606077 4/1/2025......................6078Positions impacted by RIF             55      214       73      109       89       94      103       24      7616079 Rescissions as of 7/14/2025...6080Positions impacted by RIF as of      133      593      167      165      113       65      333      144     17136081 7/14/2025.....................6082----------------------------------------------------------------------------------------------------------------60836084    Rescission decisions were based upon impact analysis and impact to6085mission.6086                      deferred resignation program6087    Question. How many people at the FDA took the offer for the6088Deferred Resignation Program? Please provide a total and breakdown by6089Center.6090  --Were there staff at the FDA who sought to participate in the6091        Deferred Resignation Program but were not allowed to? If so,6092        what factors were used to determine which staff at the FDA6093        could participate in the Deferred Resignation Program?6094    Answer. Please see the below table. No eligible staff were6095disallowed from participating in the deferred resignation program if6096they indicated their interest to participate by the program deadline.60976098------------------------------------------------------------------------6099                                                                DRP6100                           COP                             Participants6101------------------------------------------------------------------------6102CBER....................................................              246103CDER....................................................              856104CDRH....................................................              556105CTP.....................................................              216106CVM.....................................................              186107HFP.....................................................              516108OC......................................................             1026109OII.....................................................             1006110      Total.............................................             4566111------------------------------------------------------------------------61126113                           early retirements6114    Question. How many people at the FDA have opted into the Voluntary6115Early Retirement Authority or Voluntary Separation Incentive Program6116since January 20, 2025? Please provide a total and a breakdown by6117Center.6118  --How many people at the FDA combined early retirement authorities6119        with the Deferred Resignation Program?6120    Answer. See the below table for the number of individuals signed up6121for the VERA and/or VSIP program after the DRP program was closed. As6122part of the DRP program, 91 people indicated they were participating6123under the VERA retirement authority.61246125------------------------------------------------------------------------6126                                                                DRP6127                           COP                             Participants6128------------------------------------------------------------------------6129CBER....................................................              476130CDER....................................................             1126131CDRH....................................................              726132CTP.....................................................              306133CVM.....................................................              346134HFP.....................................................             1076135OC......................................................             2096136OII.....................................................             1106137      Total.............................................             7216138------------------------------------------------------------------------61396140                                 hiring6141    Question. You stated in your testimony that you are currently6142hiring scientists and other staff. How many people and which positions6143are you actively hiring for across the agency? Please provide a total6144and breakdown by center or office as well as a complete list of6145positions for which the agency has sought and received an exemption6146from the Office of Personnel Management to the ongoing hiring freeze.6147Please also share the links to positions the FDA is hiring for on USA6148Jobs.6149    Answer. FDA has sought and received an exemption from OPM for 1,0006150positions for reviewers, inspectors, and criminal investigators. FDA6151plans to move forward with this hiring throughout the course of the6152summer and fall. FDA will continue to provide updates to the Committee,6153requested.6154    Question. What are you doing to ensure that all inspections move6155ahead as planned and to improve the rate of attrition among inspectors?6156How will that be reflected in the Fiscal Year 2026 budget request?6157    Answer. FDA continues to identify the highest priority inspectional6158work and is taking steps to improve efficiencies in conducting6159inspections. This includes using feedback mechanisms and working to6160centralize and enhance key operational functions across the Agency,6161empowering the Office of Inspections and Investigations (OII) to focus6162more directly on its core mission-related work.6163    FDA has also resumed the recruitment and hiring of new6164investigators. FDA is addressing attrition through various means,6165including the use of hiring authorities and through improved training6166processes.6167    OII and the Centers have ongoing collaborations to improve the6168efficiency and effectiveness of investigator training, with the goal of6169lessening the time for new investigators to begin conducting6170independent inspections, while ensuring the FDA maintains its gold6171standard for the quality of our inspection programs to protect public6172health and safety. Through this training modernization effort, which6173includes experiential learning and on the job training, early6174engagement and meeting staff training needs will also lessen the risk6175of attrition.6176    The FY 2026 President's Budget proposes funding levels for OII to6177support all of these efforts.6178    Question. One known way to cure type 1 diabetes (T1D) is through6179cell therapies, which replace destroyed beta cells with external cells6180that make insulin and protect them so that they maintain function long-6181term. The advancement of cell therapies holds immense promise for6182transforming the lives of those with T1D and other diseases. However,6183challenges and uncertainty in the therapy pipeline, including review6184timeliness and insufficient patient and expert input, are causing6185delays. What steps will you take to ensure cell therapies can reach the6186T1D populations that need them without unnecessary delay?6187    Answer. FDA works with all sponsors to resolve issues and speed6188development of new products, while maintaining high standards for6189safety and efficacy that are based on science. Clinical holds for6190Investigational New Drug applications (INDs) investigating Cell and6191Gene Therapy (CGT) products for treating various diseases, including6192Type 1 diabetes, have markedly decreased in the past few years. The6193decline results from many factors, including outreach efforts to better6194inform sponsors of IND content necessary to assess risks and address6195safety issues, and internal Agency efforts to ensure timely review of6196potential clinical hold issues, which enables sponsors to provide6197missing/additional information when feasible.6198    FDA also works with patients and their advocates to ensure that the6199patient voice is included in the regulatory process, and that reviewers6200have access to the latest science. For example, to advance Type 16201diabetes products, CBER works with Breakthrough T1D (formerly the6202Juvenile Diabetes Research Foundation) on an annual Cell Therapies6203Educational Seminar series, where outside experts provide science-based6204lectures on emerging technologies for the treatment of diabetes. Prior6205to the 2023 approval of LANTIDRA (donislecel-jujn), a cellular therapy6206product composed of purified allogeneic deceased donor pancreas derived6207islets of Langerhans for the treatment of certain adults with Type I6208diabetes, an FDA advisory committee meeting was held where the6209committee and FDA reviewers considered testimony from patients who6210participated in clinical studies for the product.6211    FDA remains committed to advancing the development of safe and6212effective CGT products to treat serious or life-threatening conditions,6213including various rare diseases, forms of cancer, and Type 1 diabetes.6214When combined, FDA's scientific and patient-focused efforts increase6215predictability in the regulatory process to support a robust CGT6216product development pipeline.6217    Question. FDA participation in external scientific efforts that6218advance development and review of new therapies is critical. Such pre-6219competitive engagement guides the research to align with FDA6220expectations in real time, keeps the FDA informed on the current state6221of science, and makes future reviews more efficient. We've heard recent6222reports that FDA staff have declined invitations to participate in such6223external scientific efforts, citing bandwidth and the need to focus on6224PDUFA activities. We've also heard that previously planned and6225recurring events between the FDA and non-governmental organizations6226have been cancelled by the agency. When will external engagement at6227these types of events resume? What is the agency's policy on external6228engagement?6229    Answer. For more than 100 years, the FDA has been working to carry6230out our mission of promoting and protecting public health, and engaging6231with the public and the scientific community is a key part of that6232work. While there was a brief pause for certain types of engagements6233and communications at the agency at the beginning of the new6234administration, external engagements have resumed and remain a6235priority. The commissioner also recently began a series of Expert6236Panels to engage the public, media, and the scientific community on6237important public health topics, which have been open to the public and6238livestreamed. This initiative is part of the FDA's broader efforts to6239apply rigorous, evidence-based standards to ingredient safety and6240modernize regulatory oversight, thoroughly considering evolving science6241and consumer health.62426243                                 ______62446245              Questions Submitted by Senator Patty Murray6246    Question. In 2022, Congress passed the bipartisan Modernization of6247Cosmetics Regulation Act (Moca) which finally empowered the FDA with6248the tools it needs to better ensure cosmetic products are safe. MoCRA6249passed over 2 years ago, and the FDA has not put out any Good6250Manufacturing Practices for any cosmetic products. When does FDA expect6251those to be finalized?6252    Answer. FDA has listed a proposed rule, ``Good Manufacturing6253Practice for Cosmetic Product Facilities,'' on the Unified Agenda as a6254long-term action.6255    Question. Do you have a timeline for finalization?6256    Answer. MoCRA established timeframes requiring the Secretary to6257publish a proposed rule not later than 2 years after December 29, 2022,6258which was on December 29, 2024, and to publish a final rule not later6259than 3 years after December 29, 2022, which is on December 29, 2025.6260Although the statutory date for publishing the proposed rule has6261passed, FDA is prioritizing this rulemaking.6262    The Long-Term National Strategy to Increase the Resiliency of the6263Infant Formula Market outlines several actions the FDA should be taking6264to protect the integrity of the infant formula supply chain, including6265taking measures to prevent contamination, and incentivizing new infant6266formula manufacturers to enter the U.S. market.6267    Question. What are you doing to implement the recommendations6268within the National Strategy to improve the integrity of infant formula6269supply chain in the U.S.?6270    Answer. FDA has taken numerous steps to implement recommendations6271in the Long-Term National Strategy to Increase the Resiliency of the6272U.S. Infant Formula Market:62736274  --In October 2024, FDA established the Office of Critical Foods to6275        oversee the regulation of critical foods (i.e., infant formula6276        and medical foods) and continues prioritizing staff hiring,6277        including having dedicated investigators to conduct infant6278        formula inspections. The FY 2026 President's Budget proposes6279        increased funding for infant formula work.62806281  --FDA has worked to enhance infant formula supply diversity by6282        providing a pathway for domestic and foreign infant formula6283        manufacturers that were provided enforcement discretion to6284        continue marketing their products while they worked to meet all6285        FDA requirements. All the manufacturers participating in the6286        enforcement discretion transition pathway submitted their new6287        infant formula submissions, for a total of 12 new infant6288        formula products, consistent with FDA's timing expectations.62896290  --FDA is enhancing post-market surveillance by taking the following6291        steps:62926293    --Released draft guidance in December 2024 for infant formula6294            manufacturers on notifying the FDA of permanent6295            discontinuances or interruptions that are likely to lead to6296            a meaningful disruption in the U.S. supply.62976298    --Engaging with infant formula manufacturers to monitor and assess6299            production levels, ingredient supply chains, and final6300            product distribution. FDA also monitors in-stock rates to6301            track product volume and variety, as well as sales data to6302            identify early signals of potential disruption.63036304    --Working with industry to establish a system for voluntary6305            reporting of product samples that test positive for6306            Cronobacter or Salmonella.63076308    --FDA collaborates with USDA's Special Supplemental Nutrition6309            Program for Woman, Infants, and Children (WIC) to help6310            ensure infant formula manufacturers meet evidence-based6311            standards while exploring enhanced contract flexibilities6312            during supply disruptions.63136314    Question. How are you ensuring this work remains ongoing in light6315of agency reorganization efforts, probationary firings, deferred6316resignations, and RIFs?6317    Answer. FDA's Human Food Program is dedicated to and continues to6318prioritize the work contained in the Long-Term National Strategy and6319Operation Stork Speed. Overall, the functions outlined in the strategy6320are all related to critical foods work and, therefore, were not6321substantively affected by staff reductions. Additionally, despite the6322Federal hiring freeze, we have been able to post some high-priority job6323vacancies, one of which is the Director of the Office of Critical6324Foods, who will be directly responsible for the oversight of infant6325formula.6326    I am concerned that there was not a public search for the Director6327of the Center for Biologics and that Title 21 hiring authority may have6328been used. Title 21 was part of the landmark 21st Century Cures Act6329that I championed, was intended to help the FDA bring experts on board6330quickly and at relatively competitive salaries. Title 21 hiring6331authorities were drafted as such to prevent the hiring of political6332appointees.6333    Question. Can you confirm whether Dr. Prasad was hired under Title633421 and, if so, explain why a public search was not conducted, as has6335been done for all of the other recent senior leadership positions at6336the centers?6337    Answer. Following a nationwide search, Dr. Prasad was hired under6338the Title 21 hiring authority as the best candidate available. Dr.6339Prasad's extensive background as a medical practitioner, an author, and6340in academia made him uniquely qualified for the critical position as6341Director of the Center for Biologics Evaluation and Research. Given the6342importance of this position, it was not in the public interest to leave6343it vacant for many months. Title 21 allowed FDA to expedite the6344recruitment process and more efficiently onboard Dr. Prasad, as the6345Agency has done with other highly qualified experts in the past.6346    This approach aligns with the legislative intent of the 21st6347Century Cures Act to help the FDA attract top talent quickly with6348competitive salaries.6349    Question. If not hired under Title 21, what authority was used to6350hire Dr. Prasad?6351    Answer. Dr. Prasad was hired under Title 21 hiring authority.6352    Question. Do you commit to doing public searches for the Center for6353Drug Evaluation and Research and the Human Foods Program, who currently6354have acting directors?6355    Answer. As of December 3, 2025, Dr. Tracey Beth Hoeg is the acting6356Director of the Center for Drug Evaluation and Research. FDA has made a6357permanent hire of Kyle Diamantes as the Deputy Commissioner for Human6358Foods. Both are extremely qualified and have already provided great6359contributions in support of public health.6360    Question. The FDA is now requiring Pfizer and Moderna to expand6361warning labels of their COVID-19 vaccines to include risk of heart6362inflammation in adolescents and young men ages 18 to 24. This was6363determined after FDA's own analysis of insurance claims indicated an6364increased incidence from the 2023-2024 formulations. Will FDA be6365releasing this report and the data you used to determine this new6366practice?6367    Answer. In a post-approval U.S. study \9\ funded and co-authored by6368FDA, study authors noted that myocarditis and pericarditis is a known6369complication of mRNA 9 vaccines, most frequently seen in adolescent and6370young adult males 1 to 7 days following vaccination.6371---------------------------------------------------------------------------6372    \9\ https://www.sciencedirect.com/science/article/pii/6373S2589537024003882?via%3Dihub6374---------------------------------------------------------------------------6375    Using data in a separate analysis, the estimated incidence rate of6376myocarditis and pericarditis during the 1-7 days following6377administration of the 2023-2024 formula of mRNA COVID-19 vaccines was6378approximately 8 cases per million doses in individuals 6 months through637964 years of age, with the highest rate among males aged 12-24 years at6380approximately 27 cases per million doses. These estimates do not6381provide an analysis of or evidence of an increased risk over time in6382any age group, but a standalone estimates of risk in the 1 to 7 days6383following the 2023-2024 Formula of mRNA COVID-19 vaccines.6384    The BEST initiative conducts continuous monitoring and assessment6385of the safety of vaccines, including the mRNA COVID-19 vaccines. These6386safety studies include prespecified analyses that assess whether the6387risk of an outcome is elevated and associated with vaccination, and6388results can be found on the BEST. Results of the 2023-2024 formula mRNA6389COVID-19 vaccine safety studies have been submitted for peer-reviewed6390publication and are currently under review.6391    Question. As FDA Commissioner, you have talked about increasing the6392transparency of the agency. Did you share the data mentioned in6393Question 4 with outside experts to help the FDA make a decision about6394including this risk on vaccine labels?6395    Answer. Information about myocarditis (inflammation of the heart6396muscle) and pericarditis (inflammation of the lining outside the heart)6397following vaccination with these mRNA COVID-19 vaccines has been6398included in the labeling since 2021. FDA has considered presenting the6399updated myocarditis/pericarditis data at a future Advisory Committee on6400Immunization Practices meeting if the opportunity arises. FDA is also6401evaluating the best way to disseminate these results.6402    Question. The FDA is essentially limiting COVID-19 vaccine6403approvals to people 65 and older and those with underlying conditions,6404because pharmaceutical companies are unlikely to conduct randomized6405control trials of updated vaccine formulations each year, as your new6406policy States they need to do. In alignment with your goal of6407transparency, will you please share which outside experts reviewed FDA6408recommendations on this policy change?6409    Answer. FDA notes that vaccine manufacturers have agreed to conduct6410additional randomized controlled studies in individuals 50 to 65 years6411of age without high-risk conditions and the Agency plans to review and6412take appropriate action on applications for vaccines with 2025-266413COVID-19 vaccine formulations. Further, it has not been established6414that updated vaccine formulations will be necessary each year in6415perpetuity. Please refer to ``An Evidence-Based Approach to Covid-196416Vaccination'' in New England Journal of Medicine which was published6417after discussion with the expert editorial staff of NEJM.6418    Question. Did any of the outside experts feel that this policy6419change was unwarranted?6420    Answer. Please reference previously question.6421    Question. What ethical concerns about this policy change were6422expressed?6423    Answer. Please reference previously question.6424    Question. What data did you present to outside experts to determine6425that this policy was evidence-based?6426    Answer. Please reference previously question.6427    Question. The Make American Healthy Again Commission is6428recommending that pesticides be reduced, as they are a driver of6429chronic health conditions in American children. What process will you6430create to start broad conversations with experts outside of the FDA to6431determine next steps regarding pesticide use?6432    Answer. FDA will take the following steps regarding appropriate6433pesticide use, including by engaging experts outside of the FDA as6434appropriate: 1) monitor pesticide residues in the American diet through6435compliance surveys and the FDA Total Diet Study while also providing6436transparent reporting of that data to all applicable stakeholders,6437including those in the US government; 2) coordinate with USDA and6438States to inform data-driven policies; 3) as appropriate, provide6439technical support to EPA in their role to reduce unnecessary or harmful6440pesticide use; and 4) as appropriate, engage in any reforms to Federal6441programs that favor traditional field crops over organic foods when and6442if FDA is the appropriate agency to be engaged.6443    Question. How will you identify best practices for improving6444childhood nutrition as a driver of childhood chronic disease?6445    Answer. Improving nutrition is one of the most effective public6446health interventions for reducing diet-related chronic illnesses and6447premature death. The vast majority of Americans, including children, do6448not eat enough fruits, vegetables, dairy, seafood, whole grains, and6449healthy oils. Researchers have estimated that more than half of6450calories consumed by adults and children in the U.S. are from foods6451considered to be ultra-processed, which are linked to increased risk of6452negative health outcomes. There are many best practices that can and6453are being implemented across the Federal Government to support6454Americans in meeting recommendations for a healthy eating pattern. For6455example, FDA is encouraging industry to make healthier foods and6456helping provide nutrition information so that consumers can make6457informed choices. Further, FDA recently updated the definition of the6458``healthy'' content claim to help consumers identify foods that are6459particularly useful as the foundation of a diet that is consistent with6460dietary recommendations. We will continue to work with Federal partners6461to research and identify best practices, including through FDA and the6462National Institutes of Health's recently announced Nutrition Regulatory6463Science Program.6464    Question. Will you work with USDA to ensure that the SNAP, WIC, and6465the National School Lunch Program is fully funded so that children and6466families have access to healthy food?6467    Answer. Reducing childhood chronic diseases is a priority for this6468Administration and FDA. The U.S. Department of Agriculture (USDA) is6469responsible for administering these programs and FDA regularly6470collaborates with USDA and other Federal agencies on a variety of6471nutrition programs and issues.6472    Question. What do you see as the biggest barrier to improving6473childhood nutrition in the U.S. and what steps will you take to address6474this?6475    Answer. While there are numerous factors that impact children's6476health, improving nutrition is one of the most effective public health6477interventions for reducing diet-related chronic illnesses. FDA is6478committed to addressing the root causes of chronic disease through its6479authorities, including by helping provide people with information and6480tools to help support healthy food choices while improving the6481nutritional quality of the food supply.6482    FDA is already moving forward with helping provide Americans with6483'at-a-glance' information they can use to make better informed6484nutritional decisions, including with its front-of-package nutrition6485labeling work. FDA is also working with USDA and other Federal partners6486to develop a definition for ultra-processed foods to support uniform6487research and policies and provide increased transparency to consumers6488about the food they eat. The FY 2026 President's Budget includes a6489request to increase funding for FDA's nutrition work, including6490expanding a new pilot program to help schools research nutrition and6491transition to healthier foods to help ensure children in our Nation are6492served nutritious, wholesome food that will set them up for a healthy6493future.6494    Question. You recently held a virtual FDA Expert Panel on Talc.6495Could you please share the takeaways from that panel, and what FDA's6496next steps are related to address talc exposure?6497    Answer. As part of the Trump Administration's commitment to6498transforming the future of American health care and restoring trust in6499public health, the U.S. Food and Drug Administration held an6500independent panel of scientific experts for a roundtable discussion in6501a public forum on Tuesday, May 20, 2025. Using gold-standard science6502and a transparent process, this historic roundtable set the public6503standard for future roundtables, evaluating the safety and necessity of6504talc as an additive in food, drug, and cosmetic products. The expert6505panel, comprised of leaders in their respective fields, reviewed the6506latest scientific evidence, evaluated potential health risks, explored6507alternatives, and offered their recommendations for action. The Agency6508will take a close look at the literature shared by the panel and re-6509engage with stakeholders as questions emerge. Regarding additional6510steps, FDA continues to prioritize this issue and is working toward6511rulemaking.6512    Question. What process did the FDA use to determine who should be6513on the Expert Panel?6514    Answer. The panel was designed to bring together experts with a6515broad representation of perspectives to discuss the issue.6516    Question. You have indicated that you will soon hold an FDA6517roundtable on menopause hormone replacement therapy. Could you please6518share more details about these plans?6519    Answer. FDA will host the ``FDA Expert Panel on Menopause and6520Hormone Replacement Therapy for Women'' on July 17, 2025, from 1:00--65213:00 ET. Panelists include Marty A. Makary, M.D., M.P.H., FDA6522Commissioner and Sara Brenner M.D., M.P.H., FDA Principal Deputy6523Commissioner. Additional panelists include those with expertise in6524various aspects of menopausal health, including gynecological,6525urological, cognitive, bone, and cardiovascular care. The purpose of6526the meeting is to discuss the latest understanding of the benefits and6527safety of menopause hormone therapy. The event will be live streamed6528and can be viewed over the FDA's YouTube channel.\10\6529---------------------------------------------------------------------------6530    \10\ https://www.youtube.com/user/USFoodandDrugAdmin6531---------------------------------------------------------------------------6532    Question. Is the FDA going to be reviewing only hormonal treatments6533for menopause, or will you also consider non-hormonal treatments?6534    Answer. The FDA Expert Panel discussion will focus on hormonal6535treatments for conditions related to menopause. Regarding drugs to6536treat menopausal symptoms more broadly, FDA considers development6537programs and applications for hormonal and non-hormonal medications.6538    Question. What is the FDA currently doing to ensure that the6539accelerated approval pathway is available for rare disease treatments?6540    Answer. FDA supports drug development through the accelerated6541approval pathway in many ways. Sponsors are encouraged to communicate6542with the Agency early in the drug development process concerning (1)6543the potential eligibility of a drug for accelerated approval, (2)6544proposed surrogate endpoints or intermediate clinical endpoints, (3)6545clinical trial designs, and (4) the planning and conduct of6546confirmatory trials. In addition, the Rare Disease Endpoint Advancement6547Pilot Program is a PDUFA VII commitment designed to support novel6548efficacy endpoint development for drugs that treat rare diseases.6549    FDA's recent initiatives also help facilitate the use of the6550accelerated approval pathway for rare disease therapies. For example,6551the Rare Disease Innovation Hub launched in 2024 serves as a point of6552collaboration and connectivity between CBER and CDER with the goal of6553ultimately improving outcomes for patients with rare diseases. The Hub6554program is intended to support both internal alignment and6555communication with the rare disease community on a variety of topics,6556including guidance on surrogate endpoints and accelerated approval.6557Communication with rare disease stakeholders is an important aspect of6558facilitating rare disease product development.6559    Approximately 60-70% of drugs approved under the accelerated6560approval pathway are oncology drugs, including drugs to treat rare6561cancers. Quite often the appropriate regulatory pathway (e.g.,6562traditional approval or accelerated approval) for drugs intended to6563treat rare cancers is discussed early on in pivotal trial design.65646565                                 ______65666567              Questions Submitted by Senator Jeff Merkley6568    Question. When Congress gave FDA the authority to oversee tobacco6569products, it established an appropriately high bar for a new tobacco6570product to enter the market. Under the standard established in the6571Family Smoking Prevention and Tobacco Control Act, manufacturers must6572provide strong evidence that the benefits of introducing a new tobacco6573product to the market will outweigh the risks.6574    In reviewing applications for e-cigarettes in recent years, FDA has6575determined that flavors pose an additional level of risk because they6576are much more appealing to youth than tobacco-flavored products.6577Because of this higher level of risk, FDA has required e-cigarette6578manufacturers to show that a flavored e-cigarette will be more6579effective at helping a smoker to stop smoking cigarettes than a6580tobacco-flavored e-cigarette. A unanimous Supreme Court recently upheld6581this requirement. The vast majority of e-cigarette applications for6582flavored products have not been able to provide the evidence of a6583benefit to smokers that outweighs the risk to kids.6584    Under your leadership, will FDA continue to require robust evidence6585that the benefit of a flavored product in helping smokers quit is6586sufficient to outweigh the demonstrated risk of the flavor to youth?6587    Answer. The Federal Food, Drug and Cosmetic Act (FD&C Act) requires6588that FDA deny a premarket tobacco application (PMTA) where it finds6589``there is a lack of a showing that permitting such tobacco product to6590be marketed would be appropriate for the protection of the public6591health.'' FDA is committed to its responsibility to protect public6592health, follow the law, and carefully review the science presented in6593each premarket application when determining if a product meets the6594standard for marketing.6595    Flavors are an important consideration in the review of a PMTA6596because of their impact on potential toxicity, consumer perceptions,6597and health risks-especially to youth. The burden is on the applicant to6598provide evidence to meet the public health standard provided by6599Congress. FDA will continue to consider whether PMTAs for flavored e-6600cigarette products contain evidence of an added benefit to adult6601smokers, as compared to tobacco-flavored e-cigarette products, that6602could outweigh the known and substantial risk of flavored e-cigarette6603products to youth.6604    Question. Do you think the premarket review process is an important6605way to keep e-cigarettes that are particularly appealing to young6606people off the market?6607    Answer. Ensuring new tobacco products undergo premarket evaluation6608by FDA is a critical part of the Agency's mission to protect the public6609health, particularly for the youth, and to reduce tobacco-related6610disease and death. As part of the evaluation of e-cigarettes, FDA6611determines whether to authorize the marketing of a new product under6612the ``appropriate for the protection of the public health'' standard6613and will not authorize marketing if the applicant does not demonstrate6614that the public health benefit outweighs the risk to non-users,6615including youth.6616    Question. Earlier this year, dozens of staffers at the FDA's Center6617for Tobacco Products (CTP) were placed on administrative leave,6618including the Center's director. How many total FDA CTP employees have6619lost their jobs? How many have lost their jobs as a result of:66206621  --The recent reductions in force announced by the Department on March6622        27, 2025 (including transfers to other Federal agencies)?6623  --The termination of probationary employees?6624  --Other Administration efforts to reduce the Federal workforce (e.g.,6625        early retirement and Fork in the Road)?6626    Answer. Thus far, no CTP employees have been removed as a result of6627the reduction in force, as they remain pending. 73 CTP probationary6628employees were terminated. A total of 51 employees voluntarily left6629their positions and made use of one of the incentive programs.6630    Question. For each office within FDA CTP (e.g., Office of the6631Director, Office of Management, Office of Regulations, Office of6632Science, Office of Health Communications and Education, and Office of6633Compliance and Enforcement), how many people have been removed from6634their positions and how many remain?6635    Answer.66366637----------------------------------------------------------------------------------------------------------------6638                                                                    Terminated         Other6639                           Row Labels                             (Probationary)    Termination       Retain6640----------------------------------------------------------------------------------------------------------------6641CTP.............................................................              73               3             9246642OFFICE OF THE CENTER DIRECTOR...................................                                              276643OFFICE OF MANAGEMENT............................................                               2              196644OFFICE OF REGULATIONS...........................................                                              256645OFFICE OF SCIENCE...............................................              67               1             5586646OFFICE OF HEALTH COMM & EDUCATION...............................               3                              556647OFFICE OF COMPLIANCE & ENFORCEMEN...............................               4                             2406648----------------------------------------------------------------------------------------------------------------66496650    Question. Which directors of offices within FDA CTP have been6651removed from their positions, placed on administrative leave, or6652transferred to other Federal agencies?6653    Answer. As of 7/26/2025, the Director for the Office of Science6654within FDA CTP is on administrative leave pending reassignment to IHS.6655In addition, the Director of the Center for Tobacco Products was6656initially placed on administrative leave pending reassignment to IHS6657but has since resigned.6658    Question. Does FDA CTP intend to spend the $712 million in tobacco6659user fees authorized under the Family Smoking Prevention and Tobacco6660Control Act and included in the FY 2025 Full-Year Continuing6661Appropriations and Extensions Act (Public Law 119-4)? Please indicate6662how CTP intends to spend its tobacco user fees for FY 2025, including,6663but not limited to, dollars spent on premarket review, enforcement of6664marketing and sales of illegal products, and Tobacco Centers of6665Regulatory Science.6666    Answer. In FY 2025, CTP plans to spend $680M in the following6667program areas:66686669------------------------------------------------------------------------6670                                                          FY Planned6671                    Program Area                           Spending6672------------------------------------------------------------------------6673Product Review, Scientific Research, and Research                  $277M6674 Infrastructure.....................................6675Compliance and Enforcement..........................               $164M6676Public Education Campaigns and Communications.......                $80M6677Leadership, Management Oversigt, and Administrative                 $37M6678 Services...........................................6679Related Overheard Activities........................               $122M6680      Total Obligations:............................               $680M6681------------------------------------------------------------------------66826683    Please note that because most of CTP's tobacco regulatory6684activities cut across product classes and programs, we do not track6685spending by tobacco product class or for specific programs such as6686premarket review or enforcement against illegally marketed products.6687However, both PMTA review and Tobacco Centers of Regulatory Science6688spending is captured in the Product Review, Scientific Research, and6689Research and Research Infrastructure program area.6690    The Center's FY 2025 planned spending level is lower than its6691annual user fee collection amount for the following reasons.6692  --As a result of litigation, CTP no longer has the statutory6693        authority to collect user fees from manufacturers and importers6694        of premium cigars. For FY25, this means that about $16M in user6695        fees will not be collected. When the litigation concludes, FDA6696        intends to consider what options are feasible and statutorily6697        authorized for reallocating the fees.66986699  --Additionally, through the HHS cost efficiency initiative, CTP has6700        reduced planned acquisitions spending in FY 2025 by the6701        required $78.5 million. However, any unspent user fees in FY6702        2025 will be carried over and available to spend in FY 2026.6703    Question. What functions of CTP have been transferred to other6704offices at FDA or to other agencies? To which offices or agencies were6705they transferred?6706    Answer. None of CTP's functions have been transferred.6707    Question. What functions of CTP have been eliminated?6708    Answer. None of CTP's mission areas have been eliminated. The6709Center continues to perform all of its programmatic functions.67106711                                 ______67126713               Questions Submitted by Senator Gary Peters6714    Question. In response to questioning about FDA's suspension of6715programs to improve testing for potential H5N1 contamination in6716consumer products, including testing of milk, cheese and pet food, due6717to mass layoffs, you testified that a Washington Post article6718``debunked'' these concerns.6719    Please provide a copy of the Washington Post article you referenced6720in your testimony.6721    Answer. As requested, the Washington Post article, titled ``FDA's6722milk testing program pause is not cause for alarm, experts say'', can6723be found at the following: https://www.washingtonpost.com/food/2025/04/672423/fda-milk-testing-program-paused/6725    Question. Has FDA suspended, scaled back, or changed any of its6726programs to monitor and test for H5N1 since January 20, 2025? If so,6727please explain FDA's actions and its reasoning for suspending, scaling6728back, or changing any of these programs.6729    Answer. FDA programs to test for H5N1 in animal and human food have6730not changed since January 20, 2025. A combination of FDA internal6731laboratories, USDA's National Veterinary Services Laboratory, and FDA's6732Veterinary Laboratory Investigation and Response Network are supporting6733testing of animal and human food products for H5N1 virus.6734    You also testified that FDA suspending milk testing was due to a6735``normally scheduled pause'' to ``recalibrate the equipment'' and that6736it is ``back up and running.''6737    Question. Please provide the full schedule for the Interlaboratory6738Comparison Exercise as it stood on April 1, 2025.6739    Answer. As of April 1, 2025, the HPAI Interlaboratory Comparison6740Exercise (ICE) schedule was as follows:6741Completed work:67426743    Planning began in November 2024. Sample testing, including6744stability, was completed in March 2025.6745Scheduled work from April 1:67466747        April 2025: Finalize instruction documents and training6748        materials for participating laboratories6749        April 28th 2025: Ship sample sets to laboratories6750        May 12th 2025: Laboratory results due6751        June 2nd 2025: Send preliminary report to laboratories6752        August 2025: Complete final report6753    Question. Please list all the entities that have or were scheduled6754to participate in the Interlaboratory Comparison Exercise as of January675520, 2025, or later, including those from FDA's Veterinary Laboratory6756Investigation and Response Network and food laboratories, the USDA's6757National Animal Health Laboratory Network, and private industry.6758    Answer.43 laboratories have participated in the HPAI6759Interlaboratory Comparison Exercise, as of January 20, 2025:67606761  --21 state laboratories67626763  --13 university laboratories67646765  --2 private industry laboratories67666767  --2 other government laboratories67686769  --5 FDA Laboratories:67706771    --FDA Arkansas Human and Animal Food Laboratory67726773    --FDA San Francisco Human and Animal Food Laboratory67746775    --FDA Denver Laboratory67766777    --FDA New York Human and Animal Foods Laboratory67786779    --FDA Atlanta Human and Animal Food Laboratory6780    Question. Please describe all quality assurance programs FDA is6781currently carrying out with regards to identifying potential H5N1 virus6782contamination in human or pet food.6783    Answer. FDA testing is performed in accordance with the ``FDA6784Regulatory Testing Laboratory Manual of Quality Policies,'' which was6785prepared to meet the requirements for the laboratories' accreditation6786to the International Organization for Standardization/International6787Electrotechnical Commission (ISO/IEC 17025:2017). FDA HPAI RT-qPCR6788detection methodology incorporates internal amplification controls in6789the qPCR reactions in addition to surrogate virus extraction controls6790to establish confidence in laboratory results.6791    Question. Please list all staff positions within FDA's Human Food6792Program as of January 20, 2025 and a corresponding description of each6793position, including:67946795  --The job or function the position relates to.67966797  --Whether the position was filled on January 20, 2025.67986799  --Whether there have been any changes to the staffing of the position6800        since January 20, 2025, and if so, describe the specific6801        change(s).68026803  --Whether FDA has any plans to reduce or eliminate the position6804        within the next 24 months, and if so, what it may or will be6805        replaced with.6806    Answer. Below is a table noting each job function within HFP and6807the number of positions within that function. Because staffing is fluid6808and employees are hired, leave FDA, or move to other parts of the6809Agency, staffing levels may change on a day-to-day basis. FDA currently6810does not have plans to reduce or eliminate such positions within the6811next 24 months.6812    As of January 20, 2025, HFP had the following 1,965 employees:68136814------------------------------------------------------------------------6815                     Position Title                          Positions6816------------------------------------------------------------------------6817Acquisition Program Specialist..........................               56818Acquisition Program Specialist Assistant Commissioner                  16819 For Par................................................6820Acquisition Program Specialist Audiovisual Production                  26821 Special................................................6822Acquisition Program Specialist Bio (Sensory-                           16823 Organoleptic)..........................................6824Acquisition Program Specialist Biological Science Lab                  16825 Technic................................................6826Acquisition Program Specialist Biological Science                      26827 Technician.............................................6828Acquisition Program Specialist Biologist................             1766829Acquisition Program Specialist Biologist (Molecular)....               16830Acquisition Program Specialist Biologist (Senior Science               16831 Advisor)...............................................6832Acquisition Program Specialist Biologist (Reg Prog                     16833 Expert)................................................6834Acquisition Program Specialist Branch Chief.............               76835Acquisition Program Specialist Branch Chief For Budget                 16836 Formulation............................................6837Acquisition Program Specialist Branch Chief, Chemical                  16838 Contami................................................6839Acquisition Program Specialist Branch Chief, Exposure                  16840 Assessm................................................6841Acquisition Program Specialist Branch Chief, Supervisory               16842 Phar...................................................6843Acquisition Program Specialist Budget Analyst...........              106844Acquisition Program Specialist Business Analyst.........               16845Acquisition Program Specialist Business Information                    16846 Management.............................................6847Acquisition Program Specialist Certification Control                   16848 Assistant..............................................6849Acquisition Program Specialist Chemist..................             2406850Chemist (Industrial)....................................               16851Chemist (Investigative Analyst).........................               16852Chemist (Quality Assurance Man).........................               16853Chemist (Color Spec)....................................               16854Chemist (QA Manager)....................................               16855Chemist (Residue Testing)...............................               16856Chemist (Technology)....................................               16857Chemistry...............................................               16858Chief Critical Foods Officer............................               16859Computer Scientist......................................               26860Consumer Complaint Coordinator..........................               76861Consumer Complaints Coordinator.........................               26862Consumer Safety Officer.................................             2386863Consumer Safety Officer (Compl).........................               16864Consumer Safety Officer (Milk)..........................               16865Consumer Safety Officer (Nation)........................               16866Consumer Safety Officer (Program).......................               16867Consumer Safety Officer (Retail.........................              216868Consumer Safety Officer (Shell).........................              156869Consumer Safety Officer Product.........................               16870Consumer Safety Technician..............................               16871CSO (National Standardization)..........................               16872Data Scientist..........................................               26873Dep Dir For Animal Der Foods............................               16874Dep Dir For Scientific Operation........................               16875Deputy Commissioner For Human...........................               16876Deputy Director.........................................               16877Deputy Director For Plant Deri..........................               16878Deputy Director ODSP....................................               16879Deputy Director, Office Of Par..........................               16880Deputy Director, Office Of Reg..........................               16881Deputy Office Director..................................               26882Deputy Office Director, Office..........................               16883Dietitian/Nutritionist..................................               16884Dir, Ne Regional Lab....................................               16885Director Of The Office Of Diet..........................               16886Director, DBP...........................................               16887Director, OARSA.........................................               16888Director, Office Of Core................................               16889Director, Office Of Executive...........................               16890Director, Office Of Management..........................               16891Director, Office Of Nutrition...........................               16892Director, Office Of Regulatory..........................               16893Director, Southeast Food And F..........................               16894Division Director, Analytical...........................               16895Division Director, DITM.................................               16896Division Director, DWM..................................               16897Electronic Engineer.....................................               16898Electronics Technician..................................               16899Emergency Response Specialist...........................               16900Entomologist............................................              146901Epidemiologist..........................................              166902Ethics Management Specialist............................               16903Executive Assistant.....................................               26904FDA Liaison To CDC......................................               16905Food Defense Science Program C..........................               16906Food Technologist.......................................               96907Food Technologist.......................................               16908General Health Scientist................................               46909Geneticist..............................................               26910Geneticist (Research)...................................               16911Government Information Special..........................               46912Health Communication Specialist.........................               36913Health Communications Spec..............................               56914Health Communications Specialist........................               26915Health Communications Specialist........................              156916Health Informaticist....................................               26917Health Science Policy Advisor...........................               16918Health Scientist........................................               66919Health Scientist (Quality)..............................               16920Horticulturist..........................................               36921Hydrologist.............................................               16922Industrial Hygienist....................................               16923Industrial Property Management..........................               16924Information Technology Special..........................               26925Instructional Systems Specialist........................               46926Interdisciplinary Scientist.............................               16927Interdisciplinary Scientist (B..........................               16928International Policy Analyst............................               66929Laboratory Support Assistant............................               96930Laboratory Technician (Oa)..............................               16931Laboratory Worker.......................................               26932Lead Biologist..........................................              136933Lead Chemist............................................              196934Lead Consumer Safety Officer............................               86935Lead Government Information Sp..........................               26936Lead Management Analyst.................................               16937Lead Management And Program An..........................               26938Lead Microbiologist.....................................              166939Lead Toxicologist.......................................               16940Legal Instruments Exam (Oa).............................               26941Legal Instruments Examiner..............................               16942Legal Technician (Oa)...................................               16943Management And Program Analyst..........................               16944Management & Program Analyst............................               16945Management Analyst......................................              456946Management And Program Analysi..........................               36947Management And Program Analyst..........................              306948Management/Program Analyst..............................               16949Management And Program Analyst..........................               26950Mathematical Statistician...............................              106951Mathematician Statistician..............................               26952Medical Officer.........................................               26953Mgt And Prog Analysis Officer...........................               16954Microbiologist..........................................               16955Microbiologist..........................................             1566956Microbiologist (QSS)....................................               16957Microbiologist (Spec Asst To Lb.........................               16958Microbiologist..........................................               26959Miscellaneous Administration A..........................               16960Ntnl Food Sfty Edc Advisor..............................               16961Nutritionist............................................               86962Office Director.........................................               16963Office Director, Office Of Pri..........................               16964Office Support Assistant................................               16965Operations Research Analyst.............................               26966Pharmacologist..........................................               16967Physical Science Technician.............................               36968Physical Scientist......................................               16969Physician...............................................               36970Policy Advisor..........................................               16971Policy Analyst..........................................              296972Policy Analyst (International)..........................               36973Program Analyst.........................................              796974Program Analyst (International).........................               26975Program Manager (Communication).........................               16976Program Manager (Diversity, Eq).........................               16977Program Specialist......................................               96978Program Support Specialist..............................              136979Project Coordinator.....................................               16980Project Manager.........................................              316981Project Officer.........................................               26982Project Specialist......................................               86983Public Affairs Specialist...............................               96984Public Health Advisor...................................               46985Public Health Analyst...................................               26986Public Health Educator..................................               56987Public Information Specialist...........................               16988Quality Assurance Manager...............................               16989Quality Assurance Specialist............................               36990Quality Systems Specialist..............................               26991Records & Info Management Spec..........................               26992Regulations Analyst.....................................               16993Regulatory Counsel......................................              146994Regulatory Health Information...........................               16995Regulatory Information Special..........................               26996Regulatory Policy Analyst...............................               36997Research Biologist......................................              286998Research Biologist (Bioinformatic)......................               16999Research Chemical Engineer..............................               27000Research Chemist........................................              227001Research Entomologist...................................               17002Research Food Technologist..............................               27003Research Microbiologist.................................              317004Research Microbiology...................................               17005Research Pharmacologist.................................               27006Safety And Occupational Health..........................               17007Sample Evidence Specialist..............................              137008SBRBPAS Expert..........................................               57009SBRBPAS Expert (Parasitologist).........................               17010SBRBPAS Expert (Microbiologist).........................               17011Science Policy Analyst..................................               17012Senior Advisor..........................................               27013Senior Advisor For Compliance...........................               17014Senior Advisor For Intentional..........................               17015Senior Advisor For Policy...............................               17016Senior Consumer Safety Officer..........................               17017Senior Dietician........................................               17018Senior Health Communication Sp..........................               17019Senior Physician........................................               37020Senior Policy Advisor...................................               87021Senior Policy Analyst...................................               57022Senior Project Manager..................................               37023Senior Project Officer..................................               17024Senior Regulatory Advisor...............................               17025Senior Regulatory Counsel...............................               37026Senior Regulatory Counsel For...........................               17027Senior Science Advisor..................................               27028Senior Science Advisor For Bio..........................               17029Senior Science Advisor For Eco..........................               17030Senior Science Advisor For Foo..........................               37031Senior Science Advisor For Glo..........................               17032Senior Science Advisor For Int..........................               17033Senior Science Advisor For Mil..........................               17034Senior Science Advisor For Nut..........................               27035Senior Science Advisor For Pro..........................               17036Senior Science Advisor For Ris..........................               17037Senior Science Advisor For Tox..........................               27038Senior Staff Fellow.....................................               17039Senior Staff Fellow (Biologist).........................               17040Sensory Expert Organoleptic.............................               17041Social Science Analyst..................................               57042Social Scientist........................................               27043Special Assistant.......................................               47044Staff Assistant.........................................               57045Staff Director..........................................               47046Staff Fellow............................................              247047Staff Fellow (Biologist)................................               37048Staff Fellow (Consumer Safety...........................               17049Staff Fellow-Pharmacologist.............................               17050Statistician............................................               17051Statistician............................................               17052Strategic Communications Specialist.....................               17053Student Trainee.........................................               17054Supervisory Government Info Special.....................               17055Supervisory Consumer Safety O...........................               37056Supervisory Program Analyst.............................               17057Supervisory Project Specialist..........................               27058Supervisory Biologist...................................              117059Supervisory Biologist (Integra).........................               17060Supervisory Budget Analyst..............................               37061Supervisory Chemist.....................................              437062Supervisory Consumer Safety Of..........................              547063Supervisory Consumer Safety Off.........................               17064Supervisory Data Scientist..............................               27065Supervisory Entomologist................................               17066Supervisory Food Technologist...........................               27067Supervisory General Health Sci..........................               27068Supervisory Geneticist..................................               17069Supervisory Health Communication........................               17070Supervisory Health Scientist............................               17071Supervisory Information Commun..........................               17072Supervisory Information Techno..........................               27073Supervisory Management Analyst..........................               67074Supervisory Management And Pro..........................               77075Supervisory Management Liaison..........................               17076Supervisory Management Officer..........................               17077Supervisory Microbiologist..............................              297078Supervisory Physician...................................               17079Supervisory Policy Advisor..............................               17080Supervisory Project Specialist..........................               17081Supervisory Public Health Educ..........................               27082Supervisory Quality Assurance...........................               17083Supervisory Regulatory Counsel..........................               37084Supervisory Regulatory Special..........................               17085Supervisory Safety And Occupational.....................               17086Supervisory SBRBPAS Expert..............................               17087Supervisory SBRBPAS Expert (Ch).........................               17088Supervisory Science/Regulatory..........................               17089Supervisory Toxicologist................................               47090Supply Management Specialist............................               17091Support Services Specialist.............................               47092Supervisory Facilities Res Specialist...................               17093Supervisory Consumer Safety Officer.....................               37094Supervisory Health Communications Spe...................               17095Supervisory Mathematical Statistician...................               17096Supervisory Mgmt And Prog Analyst.......................               27097Supervisory Microbiologist..............................               27098Supervisory Program Manager.............................               17099Supervisory SBRBPAS Expert (Chemist)....................               37100Supervisory SBRBPAS Expert (Nutrition)..................               17101Supervisory Social Scientist............................               17102Supervisory Training Specialist.........................               17103Supervisory Public Affairs Specialist...................               17104Survey Statistician.....................................               17105Technical Information Specialist........................               67106Toxicologist............................................              217107Training Administrator..................................               17108Training Specialist.....................................               77109Vet Medical Officer (Pathology).........................               17110Visiting Associate (Biologist)..........................               17111Visiting Scientist......................................               17112Visual Information Specialist...........................               37113Writer-Editor...........................................               17114      Total.............................................            19657115------------------------------------------------------------------------71167117    Question. You testified that staffing cuts at FDA have not7118increased the risks related to bird flu. Has FDA cut any staffing7119positions or responsibilities related to bird flu since January 20,71202025?7121  --As of January 20, 2025, please list every position at FDA that has7122        responsibilities regarding H5N1/bird flu and, for each,7123        describe:71247125  --The specific responsibilities related to H5N1/bird flu carried out7126        by the person in the position.71277128  --Whether the position was filled on January 20, 2025.71297130  --Whether there have been any changes to the staffing of the position7131        since January 20, 2025, and if so, describe the specific7132        change(s).71337134  --Whether FDA has any plans to reduce or eliminate the position7135        within the next 24 months, and if so, what it may or will be7136        replaced with.71377138    Answer. The reduction in force (RIF) has not had an impact on FDA's7139activities related to H5N1. Upon my arrival at FDA, the Agency7140undertook an evaluation of all positions to ensure that any jobs7141critical to FDA's mission or operations were either not part of the RIF7142or had the RIF rescinded. FDA currently does not have plans to reduce7143or eliminate such within the next 24 months.7144    You testified that a potential future H5N1/bird flu vaccine should7145be based on a strain showing an ``antigenic shift that represents a[n]7146epidemic threat, when there is human-to-human transmission.''7147    Question. What evidence has FDA collected, obtained, or received to7148date demonstrating that such an antigenic shift has occurred for H5N1?7149    Answer. In the United States, the Centers for Disease Control and7150Prevention (CDC) is the lead for monitoring H5 avian influenza (bird7151flu) activity in people. As of July 7, 2025, the CDC reported publicly7152that there is no known person-to-person spread at this time in the7153United States and the risk is low for the general public.7154    Question. Is FDA at any stage of evaluation for potential H5N17155vaccine candidates for humans? If so, please describe what vaccines are7156being evaluated and which H5N1 strain(s) are being targeted.7157    Answer. FDA has approved three H5N1 vaccines for use in the U.S.7158[Sanofi Pasteur Inc (2007), ID Biomedical Corporation of Quebec (2013),7159and Seqirus, Inc. (2020). The vaccines manufactured by ID Biomedical7160and Seqirus are approved for use in individuals 6 months of age and7161older.7162    The vaccine manufactured by Sanofi is approved for use in7163individuals 18 through 64 years of age.7164    As discussed during FDA's October 2024 Vaccines and Related7165Biological Products Advisory Committee meeting,\11\ licensed vaccine7166manufacturers have prepared candidate H5 influenza vaccines for A/7167Astrakhan/3212/2020, which has a hemagglutinin that is closely related7168antigenically to the HA of currently circulating H5 clade 2.3.4.4b7169viruses. Clinical trials to evaluate immunogenicity and safety have7170been initiated and FDA is working closely with these manufacturers to7171evaluate the results. Information about these vaccines is available on7172clinicaltrials.gov at https://clinicaltrials.gov/study/7173NCT05975840?id=NCT05975840&rank=1 and https://clinicaltrials.gov/study/7174NCT05874713?id=NCT05874713&rank=1.7175---------------------------------------------------------------------------7176    \11\ https://www.fda.gov/media/182543/download7177---------------------------------------------------------------------------7178    Question. Please provide any evidence FDA has that demonstrates a7179``universal flu shot'' would be effective against H5N1 infection or7180transmission in or among mammals. For the ``current strain of bird7181flu'' you cited that such a universal vaccine may protect against,7182please provide the specific H5N1 strain information.7183    Answer. The goal of developing a ``universal'' influenza vaccine7184would be to provide protection against many or most clades and strains7185of influenza and several experimental approaches are being actively7186pursued by researchers and vaccine manufacturers. Some vaccine7187candidates have demonstrated their potential for broad immunity in7188animal models, but all are still in development.7189    In May, doctors at the Children's Hospital of Philadelphia7190announced an incredible medical breakthrough--a baby born with a rare7191genetic disorder appears to be largely cured thanks to personalized7192gene therapy that uses CRISPR gene-editing technology. It took just 67193months from the time the baby was born to the doctors giving him the7194first treatments--a speed only made possible by rapid FDA approval of7195the novel therapy and knowledge learned from decades of robust Federal7196funding for science. Please describe what FDA is currently or planning7197on doing to ensure it has enough skilled personnel to help Americans7198benefit from remarkable advancements in personalized medicine.7199    Question. How many FDA personnel (irrespective of hiring mechanism)7200were assigned to reviewing, or consulting with outside stakeholders7201(such as academia and industry) on, applications for novel gene/7202personalized medicine therapies on January 20, 2025, and how many7203personnel are so assigned as of May 22, 2025?7204    Answer. The Office of Therapeutic Products (OTP) within FDA's7205Center for Biologics Evaluation and Research leads and oversees the7206development of CGT products and other products. It should be noted that7207many staff split their time between reviewing novel cell and gene7208therapy (CGT) products and other products regulated by CBER. As such,7209it is difficult to give a precise answer to the personnel assigned to7210reviewing or consulting on such applications. However, as an7211approximation, 366 employees were assigned to OTP on January 20, 2025,7212and 349 employees were assigned to the office on May 22, 2025.7213    Question. Please list all FDA positions responsible for reviewing,7214or consulting with outside stakeholders on, applications for novel7215gene/personalized medicine therapies that are or will be impacted as7216part of a reduction in force, deferred resignation, or early retirement7217program.7218    Answer. As noted in Question 6A it is difficult to give a precise7219answer to the personnel assigned to reviewing or consulting on such7220applications. As of September 16, 2025, 4 OTP employees were part of7221the deferred resignation program and 10 OTP employees took part in7222early retirement programs. No OTP staff members involved in review of7223CGT applications were subject to reduction in force.7224    Question. Please list all FDA positions responsible for reviewing,7225or consulting with outside stakeholders on, applications for novel7226gene/personalized medicine therapies that are or will be considered for7227elimination. For each position, please describe whether the position7228will be replaced by something else (for example, an AI tool) or7229combined with another position(s).7230    Answer. FDA is working to retain and recruit reviewers for CGT7231products and is not considering these positions for elimination or7232replacement.7233    Question. Please describe the specific artificial intelligence (AI)7234tools FDA is or will deploy as part of its regulatory and research7235processes, including the entity or entities that developed or have some7236level of ownership of the tool. For each AI tool:72377238  --Please list which specific FDA components, programs, or offices7239        will be deploying it.72407241  --Please describe what cybersecurity and information security7242        measures are or will be in place to safeguard intellectual7243        property and other proprietary information, confidential or7244        other privacy-related data, and any other sensitive information7245        or data.72467247  --Please describe the training that FDA personnel have or will7248        receive before and while using the tool.72497250  --Please describe what oversight FDA personnel will perform over the7251        output produced by the tool, to include ensuring quality7252        control, regulatory compliance, protection of privacy,7253        protection of intellectual property, etc.72547255    Answer. In June 2025, FDA deployed the generative AI Tool, Elsa,7256across the entire Agency. Elsa's development team was comprised of7257experts from every Center. Currently, we have approximately 11,4007258users of Elsa, with 6,000-7,000 weekly active users, making it one of7259our most utilized applications. Elsa is an FDA-wide solution that can7260be employed to help with tasks in every Center/Office. The system7261supports diverse functions, from administrative tasks to Freedom of7262Information Act requests and human resources needs. We also expanded7263accessibility by developing mobile capabilities specifically for field7264investigators. In addition to Elsa, FDA is currently compiling the 20257265annual HHS AI use case inventory in accordance with Executive Order726613960, ``Promoting the Use of Trustworthy Artificial Intelligence in7267the Federal Government.'' FDA's 2024 use case list may be found here:7268AI Use Cases Inventory HHS.gov.7269    Regarding cybersecurity and information security measures, Elsa7270operates within the most robust security framework available to Federal7271agencies. The system is deployed in a FedRAMP/FISMA High environment,7272which represents the highest level of Federal cybersecurity standards.7273Our key security measures include comprehensive data protection7274protocols. The system is also not connected to the internet and7275operates securely behind the FDA firewall, allowing our staff to input7276FDA confidential information safely while maintaining the highest7277security standards. We maintain strict access controls, including user7278profile restrictions and the ability to create locked-down, user-7279specific document libraries. Staff can upload documents and data during7280individual chat sessions, and this information remains within that7281specific session and user context, preventing unauthorized access or7282data sharing. Additionally, we maintain rigorous vendor management7283protocols with our cloud solution providers and AI vendors, ensuring7284they meet all Federal security requirements while providing us with7285access to the latest modeling capabilities within our secure7286environment.7287    Our training approach is deliberately structured and progressive.7288We have conducted extensive trainings, paired with multiple office7289hours and video recordings. Our approach focuses heavily on prompt7290engineering--teaching users to craft specific, effective queries rather7291than relying on generic interactions. As new features and models are7292released, staff will be required to attend trainings to unlock such7293additional AI models and features. This ensures we have a process to7294continually train and reinforce the proper use of these tools as they7295advance.7296    FDA maintains rigorous mechanisms to ensure regulatory compliance7297and protection of sensitive information. All users are trained that7298Elsa is a supportive tool, not a decision-maker, and that they must7299verify all outputs through our established multiple levels of review.7300We maintain structured processes with extensive oversight, ensuring7301that AI-assisted work still meets our rigorous scientific and7302regulatory standards. Users learn to utilize feedback mechanisms,7303including rating systems that help our development team understand7304usage patterns and improve the system. Finally, we have implemented7305features in our system such that when users are interacting with7306Document Libraries, Elsa is forced to read prompts in the context of7307those documents and cite relevant documents, significantly limiting the7308likelihood that Elsa hallucinates information or references.7309Regardless, FDA staff are required to validate sources and information7310in every instance.7311    We also plan to provide Center leadership with information about7312usage patterns, enabling them to understand how their teams are7313utilizing the tools and ensure appropriate application within their7314specific regulatory contexts. Finally, we maintain currency with the7315latest AI capabilities, while ensuring all updates meet our security7316and functionality requirements. We recently upgraded from Claude 3.5 to7317Claude 4.0 within our secure environment, demonstrating our commitment7318to providing staff with cutting-edge tools while maintaining the7319highest security standards.7320    Question. Were algorithms used to make decisions about FDA's7321staffing cuts? If so:73227323  --Who created the algorithms FDA used to execute these staffing cuts?7324        Please identify the name, title, and affiliation of each7325        individual involved.73267327  --Who at FDA reviewed the algorithm decisions about staffing cuts7328        prior to their execution?73297330  --Who executed the staffing cuts and rehiring decisions at FDA?73317332    Answer. FDA is not aware of algorithms used to make staffing7333decisions. Decisions were made by the Principal Deputy Commissioner and7334executed by the Chief Operating Officer.7335    An April 21, 2025, Brookings report raised concerns regarding the7336lack of quality standards for active ingredient manufacturers of7337semaglutide used in bulk compounding. The report found that a ``large7338share'' of these manufacturers were based ``almost exclusively'' in7339China, most had never been inspected by FDA, and many of those who had7340been inspected ``had drug quality assurance violations.'' Reports also7341raised concerns that FDA's staffing cuts may impact its ability to7342conduct foreign drug inspections.7343    Question. What is FDA doing to ensure quality standards for bulk7344semiglutide and that all drug products entering the U.S. are safe and7345effective?7346    Answer. FDA reviews shipments of drugs offered for import to7347determine whether they appear to comply with applicable standards and7348are admissible into the U.S. FDA may detain and refuse products that7349appear to be compliant products. The Agency's risk-based oversight has7350enabled us to effectively identify potential violations and take7351action, ultimately contributing to a more secure supply chain.7352Surveillance inspections for registered active pharmaceutical7353ingredient (API) and finished dosage form drug manufacturers are7354prioritized by the CDER risk-based Site Selection Model (SSM). The SSM7355uses risk factors, based on statutory requirements and emerging risks7356to prioritize inspectional assignments from CDER-regulated sites.7357    On September 5, 2025, FDA established a ``green list'' import alert7358to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) API,7359including semaglutide, from unverified foreign sources from entering7360the U.S. market. This is part of the agency's steps to safeguard7361consumers from GLP-1 active ingredients imported from overseas that7362fail to meet applicable quality standards or are otherwise unlawful to7363help ensure patient safety and a secure drug supply chain. The green7364list includes GLP-1 API from suppliers the agency has evaluated (e.g.,7365through establishment inspections or review of records requests) that7366appear to be in compliance with the FDA's rigorous standards--standards7367applicable to all API manufactured within or outside the U.S. The7368agency will continue to work with state regulators, monitor the market,7369and take enforcement actions as necessary to prevent unsafe or7370fraudulent GLP-1 drugs from reaching U.S. consumers.7371    FDA actively monitors the internet to identify unsafe online7372pharmacies and websites offering misbranded and/or illegally marketed7373unapproved drugs for sale to U.S. consumers and has issued warning7374letters seeking to stop and prevent the distribution of illegally7375marketed GLP-1 drugs. For instance, FDA has issued warning letters to7376companies, including compounding pharmacies and suppliers of active7377pharmaceutical ingredients used in compounding, that have illegally7378sold semaglutide, tirzepatide, or retatrutide drugs. FDA has urged7379consumers not to purchase these products, which are of unknown quality7380and may be harmful to their health. FDA's Office of Criminal7381Investigations has also worked with the Department of Justice to bring7382actions against parties for introducing unapproved and misbranded drugs7383into interstate commerce, including GLP-1 drugs.7384    In the President's FY 2026 proposed Budget, FDA proposed that7385Congress amend the FD&C Act to clearly require that the label and any7386accompanying certificate of analysis for an API for use in drug7387manufacturing, including human drug compounding, identify the name,7388address, and unique facility identifier of the API's original7389manufacturer. The original manufacturers of API are not always readily7390identified in labeling, such as when the label only indicates the7391repackager or distributor. This supply chain information is critical to7392investigate quality and safety problems.7393    Question. Has FDA made any staffing cuts that would impact its7394ability to carry out domestic and foreign drug manufacturing7395inspections?7396    Answer. FDA's investigator positions were not included in the RIF7397and the Agency continues to carry out inspections of both domestic and7398foreign drug facilities. Notably, FDA has recently embarked on an7399effort to increase the number of unannounced foreign facility7400inspections.7401    Question. In addition to FDA's announcement that it will be7402conducting unannounced foreign drug inspections, what specifically is7403FDA doing to ensure its inspection workforce is sufficiently staffed7404with experienced investigators to carry out quality inspections of both7405active pharmaceutical ingredient (API) and finished dosage form (FDF)7406manufacturing facilities to ensure products entering the U.S. meet7407FDA's quality standards and Current Good Manufacturing Practices7408(CGMPs)?7409    Answer. FDA notes that it has been conducting unannounced and7410short-notice inspections of foreign drug manufacturing facilities for7411several years and that we are now building on and significantly7412expanding those efforts. In terms of staffing, the Agency has resumed7413the recruitment and hiring of new investigators, including having7414announced multiple vacancies for investigator positions in efforts to7415hire additional inspectional staff.7416    Training our new and existing investigator workforce remains a7417priority. In support of the Agency's mission to have the workforce7418trained and operationally ready more quickly, the Office of Inspections7419and Investigations (OII) Office of Training, Education, and Development7420recently updated new Investigator training (aka Operational7421Foundations) to support basic inspection training across all7422commodities, and is exploring options for more effectively leveraging7423technology (e.g., AI) and immersive learning to improve efficiency and7424reduce the time to achieve the Independent Work qualification.7425    OII and the Center for Drug Evaluation and Research are7426collaborating to continually enhance and improve the training content7427and delivery to ensure that any staff conducting inspections on behalf7428of the Agency are consistently trained and prepared to conduct high7429quality inspections of both API and FDF drug manufacturing facilities.74307431                                 ______74327433           Questions Submitted by Senator Kirsten Gillibrand7434    Question. In February, FDA announced the recall of Lyons ReadyCare7435and Sysco Imperial frozen supplemental shakes. The recall is connected7436with an outbreak of Listeria that has infected 42 people from 217437States, including New York, and has led to 41 hospitalizations and 147438deaths. As Ranking Member of the Special Committee on Aging, I am7439concerned about this outbreak because the shakes were sold to7440congregate care settings, such as nursing homes.7441    Although FDA closed its investigation into the Listeria outbreak, I7442am concerned about how HHS cutbacks and efforts by the so-called7443``Department of Government Efficiency'' may have impacted the7444investigation. My Aging Committee staff reached out to FDA with a7445series of questions on March 17, 2025. On March 27, HHS Secretary7446Kennedy announced his ``reorganization'' of the Department of Health7447and Human Services. On April 1, FDA informed my staff that the7448individuals working on a response to my staff's questions ``are no7449longer at FDA as of this morning'' and suggested that I reach out to7450HHS directly for a response. Given this turn of events, I ask that you7451answer the following questions:7452    How did staffing on the FDA team responding to the Listeria7453outbreak change between January 20, 2025 and the conclusion of FDA's7454investigation into the outbreak? Please provide information detailing:7455    Answer. HFP's Coordinated Outbreak Response and Evaluation team did7456not experience any staffing changes during this time-period.7457    Question. The number of staff on the FDA team on January 20, 2025.7458    Answer. The response team is a multidisciplinary group composed of7459six members.7460    Question. The number of staff on the FDA team when the Listeria7461investigation was closed.7462    Answer. The response team consisted of six members when this7463investigation was closed.7464    Question. The number of staff on the FDA team who accepted the7465``deferred resignation'' scheme e-mailed by OPM to Federal employees on7466January 28, 2025, or who accepted any subsequent buyout or deferred7467resignation offers.7468    Answer. No members of the response team accepted the deferred7469resignation program.7470    Question. The number of staff on the FDA team who were laid off or7471fired between January 20, 2025 and the date when the Listeria7472investigation was closed.7473    Answer. No members of the outbreak response team were laid off or7474fired during the course of the investigation.7475    Question. What were the specific roles and duties of the staff on7476the FDA team that responded to the Listeria outbreak who accepted the7477January 28, 2025 deferred resignation scheme, or any subsequent buyout7478or deferred resignation offers? Please also detail:7479    Answer. As stated above, no members of the response team left the7480Agency during that time period.7481    Question. How those staff were involved in supporting the7482investigation into the Listeria outbreak connected to frozen shakes.7483    Answer. As stated above, no members of the response team left the7484Agency during that time period.7485    Question. What were the specific roles and duties of the staff on7486the FDA team who responded to the Listeria outbreak who were laid off7487or fired between January 20, 2025 and the date that FDA closed the7488investigation into the Listeria outbreak? Please also detail:7489    Answer. As stated above, no members of the response team left the7490Agency during that time period.7491    Question. How those staff were involved in supporting the7492investigation into the Listeria outbreak connected to frozen shakes.7493    Answer. As stated above, no members of the response team left the7494Agency during that time period.7495    Question. Please describe the role and duties of the FDA team that7496responded to the Listeria outbreak in responding to other outbreaks of7497foodborne illnesses.7498    Answer. FDA's Office of Coordinated Outbreak Response, Prevention,7499& Emergency Preparedness (CORE+EP) has several specialized teams to7500support outbreak detection and response. Once it is determined that a7501multi-State outbreak of foodborne illnesses or series of adverse events7502is likely due to an FDA-regulated human food, CORE+EP's Response Teams7503lead the coordination of stopping the outbreak and preventing7504additional illnesses.7505    Response Teams work directly with FDA field offices, FDA subject-7506matter experts, CDC, and state partners on a response strategy. The7507team coordinates investigations, inspections, sampling, and traces7508product distribution. Close coordination among FDA, CDC, and State and7509local regulatory, public health and agriculture departments is crucial7510to stopping an outbreak.7511    Investigations coordinated by CORE+EP also inform follow-up7512activities carried out by other offices and divisions of FDA. These7513include, but are not limited to, follow-up inspections, continued risk7514assessments, and development of prevention strategies.\12\7515---------------------------------------------------------------------------7516    \12\ https://www.fda.gov/food/outbreaks-foodborne-illness/post-7517outbreak-response-and-prevention-strategies-enhance-food-safety-7518updated-january-17-20257519---------------------------------------------------------------------------7520    Question. How many staff on the FDA team does FDA anticipate laying7521off or firing over the next year?7522    Answer. FDA does not anticipate any additional reductions in force.7523    During a March 14, 2025, call between my Aging Committee staff and7524subject matter experts at FDA and CDC, it was noted that the Federal7525Government supports State and local public health infrastructure that7526plays a critical role in responding to outbreaks of foodborne7527illnesses. That infrastructure includes State and local health7528departments and laboratories that the Federal Government assists with7529training and equipment. Please:7530    Question. Describe this State and local network in greater detail,7531including how the network assists CDC and FDA as they investigate and7532respond to outbreaks of foodborne illnesses.7533    Answer. FDA staff work in conjunction with CDC, State, and local7534partners during foodborne illness investigations to leverage regulatory7535authorities to effectuate the best public health outcome. This enables7536all parties to rely on, coordinate with, and leverage one another's7537work, data, and actions to meet the public health goal of a safe7538national food supply.7539    State and local epidemiologists help track illnesses, interview7540patients, identify outbreak sources and collect samples. State and7541local health laboratories help analyze food, environmental, and7542clinical samples. State and local partner agencies also help conduct7543retail food inspections, produce inspections, manufactured food7544inspections, and surveil the food supply for a variety of hazards. They7545assist in finding the food that caused illnesses (traceback) and help7546conduct root cause assessments to find the cause of food contamination;7547or if they discover a hazard before an outbreak is detected or occurs,7548they work with FDA to help prevent illnesses.7549    Question. Describe in specific detail how the Federal Government7550supported this State and local network prior to January 20, 2025,7551including through Federal funding and grants, technical assistance, and7552training.7553    Answer. Prior to January 20, 2025, FDA provided support to State,7554local, Tribal, and territorial (SLTT) agencies, universities, and7555nonprofit organizations by routinely working directly with these7556partners and funding cooperative agreement programs--federal awards7557with substantial FDA involvement--that support personnel, supplies,7558training, technical assistance, and equipment to support these7559integrated response efforts. Further, FDA's Program Standards and Rapid7560Response Team Technical Experts also support state partners with7561technical assistance and training by participating in state-hosted7562meetings, capturing and sharing best practices amongst program7563participants, and facilitating national level training courses.7564    Question. Describe how Federal support for this network has changed7565between January 20, 2025, and present, including:75667567  --Any grants to State or local governments, public health agencies,7568        or laboratories that have been reduced or cancelled.7569  --Any Federal technical assistance or training for State or local7570        governments, public health agencies, or laboratories that have7571        been reduced in frequency or cancelled.7572  --Any other assistance, including with technology or equipment, to7573        State and local governments, public health agencies, or7574        laboratories that has been reduced or cancelled.7575    Answer. Since 2022, FDA allocated unspent dollars to increase7576annual state partnerships funding from the $83 million appropriated by7577Congress to $116 million. Given increasing inflationary costs and7578changes implemented as part of the FDA's 2024 Agency-wide7579reorganization, the Agency was no longer able to allocate this level of7580additional funding beginning in FY 2025. FDA is in the process of7581finalizing awards for FY 2025 and ensuring that resources are7582prioritized to the highest public health priorities using the7583Integrated Food Safety System (IFSS) Prioritization Model.7584    The FY 2026 President's Budget includes $33 million to restore the7585previous level of enhanced state funding to $116 million. If7586appropriated, this funding will support the expansion of current state7587agreements for routine inspections of domestic food facilities to cover7588all applicable domestic facilities, to the extent feasible. This7589paradigm shift streamlines routine inspections through a transformative7590oversight model that fosters enhanced collaboration between Federal and7591State agencies and reduces redundancy.75927593                                 ______75947595               Questions Submitted by Senator Jon Ossoff7596    Question. What is the total number of probationary and non-7597probationary employees terminated from FDA's Human Foods Program since7598Thursday, February 13, 2025? Please include the following information:75997600  --The job titles of employees who have had their termination7601        finalized,76027603  --The job titles of employees who have been scheduled to be7604        terminated and their pending termination date, and76057606  --The number of probationary and non-probationary terminated workers,7607        from each office and center within the division, in raw7608        numbers, and as a percentage of each office's, center's, and7609        the division's total workforce.7610    Answer. All anticipated terminations within HFP have been finalized7611as of 7/26/2025. There are no pending or scheduled terminations within7612Human Foods Program (HFP).76137614                         Probationary and Non-Probationary Employee Terminations by COP76157616----------------------------------------------------------------------------------------------------------------7617                     HFP Office                          Terminations          % of HFP            % of FDA7618----------------------------------------------------------------------------------------------------------------7619Human Foods Program.................................                   0               0.00%               0.00%7620Nutrition Center of Excellence......................                   0               0.00%               0.00%7621Office of Communications, Education, and Engagement.                  38              56.72%               0.18%7622Office of Compliance and Enforcement................                   5               3.29%               0.02%7623Office of Coordinated Outbreak Response, Evaluation,                   1               1.61%               0.00%7624 and Emergency Preparedness.........................7625Office of Executive Programs........................                  16              43.24%               0.08%7626Office of Food Chemical Safety, Dietary Supplements,                   7               3.74%               0.03%7627 and Innovation.....................................7628Office of Integrated Food Safety System Partnerships                   3               2.63%               0.01%7629Office of Laboratory Operations and Applied Science.                  15               1.93%               0.07%7630Office of Microbiological Food Safety...............                  14               8.97%               0.07%7631Office of Policy and International Engagement.......                   0               0.00%               0.00%7632Office of Quality Assessment and Management.........                   1               4.55%               0.00%7633Office of Resource Management.......................                  64              46.04%               0.31%7634Office of Strategic Programs........................                  12              85.71%               0.06%7635Office of Surveillance Strategy and Risk                               8               8.42%               0.04%7636 Prioritization.....................................7637Office of the Deputy Commissioner for Human Foods...                   6              35.29%               0.03%7638      Total.........................................                 190  ..................               0.91%7639----------------------------------------------------------------------------------------------------------------76407641    Question. On April 17th, you told Megyn Kelly ``there were no cuts7642to scientists, reviewers or inspectors or law enforcement'' at FDA. On7643April 23rd, you told Dana Bash ``there were no cuts to scientists or7644inspectors.''7645  --Did you make those statements?7646  --Were those statements accurate?7647    Answer. There were no reductions in force (RIFs) for any reviewers,7648investigators, or law enforcement personnel. In addition, following the7649initial RIF decisions-which were made prior to my arrival at FDA-we7650took a close look at mission impacts and rescinded RIF notices for any7651employees who were in critical positions to the Agency's mission or7652operations.7653    Question. A fact sheet circulated by HHS States that the7654elimination of roles at FDA ``will not affect drug, medical device, or7655food reviewers, nor will it impact inspectors.'' Please specify what is7656meant by the elimination of 3,500 roles at FDA not ``affect[ing]7657reviewers'' or ``impact[ing] reviewers.''7658    Answer. Please see the response to the above question.7659    Question. According to AgencyIQ reporting, over 200 employees7660supporting the critical work of the Human Foods Program no longer have7661active files in the U.S. Health and Human Services' (HHS) employee7662database. Many of them had job titles listing occupations such as7663Chemist, Biologist, and Microbiologist. On April 25, 2025, the New York7664Times reported an HHS spokesperson reinstated employee who had been7665``inadvertently fired because of inaccurate job classification codes.''7666  --Will you conduct a full evaluation of these positions to ensure7667        employees critical to safeguarding our Nation's food and7668        preventing food-related illness and death were not7669        ``inadvertently'' fired or scheduled for termination? Will you7670        include each employee's duties, expertise, and past performance7671        in such analysis?7672  --If after such analysis, you determine certain employees should not7673        be reinstated or de-scheduled for termination, please provide7674        your rationale.7675  --If after such analysis, you determine certain employees were7676        critical for ensuring food safety, will you reinstate them?7677    Answer. After the HHS RIF, FDA reviewed impacts to FDA's mission7678and rescinded RIF notices of positions critical to the Agency's7679operations and mission areas.7680    Question. The FDA coordinates food surveillance activities with the7681Centers for Disease Control and Prevention. How has this coordination7682been impacted by the Reduction in Force and layoffs that have occurred7683within both agencies since February 13, 2025?7684    Answer. FDA's Human Food Program is dedicated to-and continues to7685prioritize-our foodborne illness surveillance work with CDC. These7686functions were not significantly affected by the reduction in force.7687For example, foodborne outbreak communications and the Outbreak7688Investigation Table continue to be published to provide relevant,7689timely, and actionable information to consumers and stakeholders.7690    Question. How has FDA evaluated the impact of the closure of the7691food safety labs?7692    Answer. No food safety labs have been subjected to closure.76937694                          SUBCOMMITTEE RECESS76957696    Senator Hoeven. Again, thank you. Appreciate it. Have a7697great day.7698    Dr. Makary. Thank you, Senator.7699    Senator Hoeven. We are adjourned.7700    [Whereupon, at 12:06 p.m., Thursday, May 22, the7701subcommittee was recessed, to reconvene subject to the call of7702the Chair.]77037704       LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS77057706                              ----------7707                                                                   Page77087709Baldwin, Senator Tammy, U.S. Senator from Wisconsin, Questions7710  Submitted by...................................................7711  43.............................................................77127713Collins, Senator Susan, U.S. Senator from Maine, Statement of....7714  2..............................................................77157716Gillibrand, Senator Kirsten, U.S. Senator from New York,7717  Questions Submitted by77187719Heinrich, Senator Martin, U.S. Senator from Questions Submitted7720  by.............................................................7721  45.............................................................7722Hoeven, Senator John, U.S. Senator from North Dakota:7723    Opening Statement of77247725    Questions Submitted by77267727Hyde-Smith, Senator Cindy, U.S. Senator from Mississippi,7728  Questions Submitted by77297730Makary, Hon. Dr. Martin A., M.D., M.P.H., Commissioner,7731  Department of Health and Human Services, Food and Drug7732  Administration:7733    Prepared Statement of........................................7734      54.........................................................7735    Questions Submitted to.......................................7736      77.........................................................7737    Statement of.................................................7738      49.........................................................7739    Summary Statement of.........................................7740      52.........................................................7741Merkley, Senator Jeff, U.S. Senator from Oregon, Questions7742  Submitted by77437744Moran, Senator Jerry, U.S. Senator from Kansas, Questions7745  Submitted by...................................................7746  89.............................................................7747Murray, Senator Patty, U.S. Senator from Washington, Questions7748  Submitted by...................................................7749  97.............................................................77507751Ossoff, Senator Jon, U.S. Senator from Georgia, Questions7752  Submitted by...................................................7753  115............................................................77547755Peters, Senator Gary, U.S. Senator from Michigan, Questions7756  Submitted by...................................................7757  103............................................................77587759Rollins, Hon. Brooke L., Secretary, Department of Agriculture:7760    Prepared Statement of........................................7761      7..........................................................7762    Questions Submitted to.......................................7763      37.........................................................7764    Statement of.................................................7765      1..........................................................7766    Summary Statement of.........................................7767      4..........................................................7768Rounds, Senator Mike, U.S. Senator from South Dakota, Questions7769  Submitted by...................................................7770  39.............................................................77717772Shaheen, Senator Jeanne, U.S. Senator from New Hampshire:7773    Questions Submitted by77747775    Statement of77767777                             SUBJECT INDEX77787779                              ----------77807781                       DEPARTMENT OF AGRICULTURE77827783                                                                   Page77847785Additional Committee Questions...................................7786  37.............................................................7787APHIS Staffing...................................................7788  44.............................................................7789Biofuels.........................................................7790  43.............................................................7791Climate Smart Commodities........................................7792  43.............................................................7793Highly Pathogenic Avian Influenza................................7794  45.............................................................7795Local Food for Schools (LFS) & Local Food Purchase Assistance7796  Program........................................................7797  45.............................................................7798National Milk Testing Strategy...................................7799  45.............................................................7800Organic Concerns.................................................7801  43.............................................................78027803                               __________78047805                 DEPARTMENT OF HEALTH & HUMAN SERVICES78067807                      Food and Drug Administration78087809Additional Committee Questions...................................7810  77.............................................................7811AI Product Reviews...............................................7812  78.............................................................7813Alternative Methods for Testing..................................7814  85.............................................................7815Benzodiazepines..................................................7816  84.............................................................7817Compounding Drugs................................................7818  87.............................................................7819Continuity of User Fee Funding for Medical Devices...............7820  55.............................................................7821Deferred Resignation Program.....................................7822  95.............................................................7823Early Retirements................................................7824  95.............................................................7825FDA IT Infrastructure............................................7826  80.............................................................7827Foreign Inspections..............................................7828  85.............................................................7829Hiring...........................................................7830  96.............................................................7831Human Foods Program..............................................7832  78.............................................................7833Inspections......................................................7834  79.............................................................7835MAHA Commission Report...........................................7836  77.............................................................7837Make America Healthy Again.......................................7838  54.............................................................7839Probationary Firings.............................................7840  94.............................................................7841Rare Diseases Require Innovative Approaches to Drug Development7842  and Regulation.................................................7843  82.............................................................7844Reductions In Force (RIF)........................................7845  94.............................................................7846Regulatory Review timelines78477848Staffing at FDA..................................................7849  84.............................................................7850Threats to US Biotech's Future Investment and Global7851  Competitiveness................................................7852  83.............................................................7853Vaccine Regulatory Framework.....................................7854  84.............................................................78557856                              [all]