    [House Hearing, 117 Congress]
    [From the U.S. Government Publishing Office]

       AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
                    RELATED AGENCIES APPROPRIATIONS FOR 2023

                                  ----------

                                               Tuesday, March 29, 2022.

    OVERSIGHT HEARING: OFFICE OF THE INSPECTOR GENERAL, U.S. DEPARTMENT OF
                                  AGRICULTURE

                                   WITNESSES

    HON. PHYLLIS K. FONG, INSPECTOR GENERAL, U.S. DEPARTMENT OF AGRICULTURE
    KEVIN TYRELL, ASSISTANT INSPECTOR GENERAL FOR INVESTIGATIONS
    GIL HARDEN, ASSISTANT INSPECTOR GENERAL FOR AUDIT
    ANN COFFEY, DEPUTY INSPECTOR GENERAL
    JENNY BANNER RONE, ASSISTANT INSPECTOR GENERAL, ANALYTICS AND
        INNOVATION
        Mr. Bishop. Good morning. This hearing will now come to
    order.
        As this hearing is fully virtual, we must address a few
    housekeeping matters. For today's hearing, the chair or staff
    designated by the chair may mute participants' microphones when
    they are not under recognition for purposes of eliminating
    inadvertent background noise.
        Members are responsible for muting and unmuting themselves.
    If I notice that you have not unmuted yourself, I will ask if
    you would like the staff to unmute you. If you indicate
    approval by nodding, staff will unmute your microphone.
        I remind all members and witnesses that the five-minute
    clock still applies. If there is a technology issue, we will
    move to the next member until the issue has been resolved and
    you will retain the balance of your time.
        You will notice a clock on your screen that will show how
    much time is remaining. At the one-minute remaining mark, the
    clock will turn yellow. At 30 seconds remaining, I will gently
    tap the gavel to remind members that their time is almost
    expired.
        When your time has expired, the clock will turn red, and I
    will begin to recognize the next member.
        In terms of speaking order, we will begin with the chair
    and ranking member. Then members present at the time of the
    hearing's call to order will be recognized in order of
    seniority.
        Finally, members who are not present at the time that the
    hearing is called to order will be recognized in the order of
    arrival.
        Finally, House rules require me to remind you that we have
    set up an email address to which members can send anything that
    they wish to submit in writing at any of our hearings or
    markups. That email address has been provided in advance to
    your staff.
        That being said, I would like to welcome everyone to
    today's hearing, our first of this year.
        Before we get underway, I would like to welcome Dr. Harris,
    as the subcommittee's acting ranking member, as well as to
    welcome the other members of the subcommittee.
        Also, on a somber note, I would like to take a moment to
    acknowledge and remember our colleague, Representative Don
    Young, who passed away last week.
        Representative Young was the longest serving member of the
    House, with 49 years of service. He was a strong advocate for
    the people of Alaska, a great public servant, a gentleman, and
    a friend.
        We will miss him, and we extend our deepest condolences to
    his family.
        I would ask at this time that we observe a moment of
    silence in honor of Representative Young.
        [Pause.]
        Mr. Bishop. Thank you.
        I would also like to welcome our witnesses this morning:
    Ms. Fong, Ms. Coffey, Mr. Harden, Ms. Rone and Ms. Rone--excuse
    me--Mr. Tyrell from USDA's Office of Inspector. Thank you for
    appearing before us this morning.
        I especially want to express my appreciation of Inspector
    Fong for your dedicated service over the past eight months
    managing responsibilities for both USDA and the Federal Housing
    Finance Agency.
        Since the budget was just transmitted yesterday, this
    hearing will focus more on the OIG's oversight of a wide-
    ranging department that touches the lives of every single
    American.
        I am pleased to note that the fiscal year 2022 bill fully
    funded the President's request for the Office of Inspector
    General, which provided a very generous increase for your
    office. As I have stated in previous years, I have always been
    a big supporter of your office. Day in and day out, the OIG
    staff are truly the unsung heroes in the battle against waste,
    fraud, and abuse.
        Your work through audits, investigations, and reviews helps
    protect the taxpayers' interest while improving the
    department's effectiveness and efficiency.
        So like previous years, I would like to hear more about
    your plans to develop adequate oversight of USDA programs and
    the challenges you face in ensuring agreed upon recommendations
    are, in fact, implemented and complaints are appropriately
    addressed.
        [The information follows:]
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        Mr. Bishop. Now, let me invite our distinguished acting
    ranking member, Dr. Harris, if he has any opening remarks, and
    I would like to recognize him at this time.
        Dr. Harris, the floor is yours.
        Mr. Harris. Thank you, Chairman Bishop, and I appreciate
    your flexibility and everyone's willingness to begin today's
    hearing earlier so that members can attend the memorial service
    for Representative Don Young.
        Ms. Fong, it is good to see you again, and I want to thank
    you and your staff for being with us today and for your being
    flexible with scheduling this morning as well.
        We appreciate the critical work your agency is performing.
    Conducting audits, investigations, and other activities is
    challenging work even under normal circumstances.
        However, over the past two years, programs have been set up
    or expanded in response to the pandemic, which has only made
    your work more important. According to the OIG's COVID Funding
    Dashboard, nearly $172 billion has been provided to USDA just
    for pandemic activities, with 78 percent of the funds going
    toward nutrition programs.
        I look forward to hearing more today about how your office
    monitors the programs and funding, especially when there are
    headlines like, quote, ``FBI Sees Massive Fraud in Group's Food
    Programs for Needy Children,'' which was in the New York Times
    this month on March 9th.
        With billions and billions of Federal dollars going out the
    door, it is very enticing for those who might want to defraud
    taxpayers. Your office, working with other Federal, State, and
    local partners, is critical to ensuring program integrity
    through your audit and investigative functions.
        Your testimony also mentions the oversight your office will
    need to conduct, with respect to the nearly $3 billion being
    provided for broadband loans and grants, and watershed and
    flood prevention operations in the Infrastructure Investment
    and Jobs Act.
        I look forward to hearing what your budgetary needs might
    be in order to conduct that work.
        As we continue to review the fiscal year 2023 budget
    materials, I remain concerned about the uncontrolled spending
    though that continues to drive up inflation. The administration
    continues to show a lack of regard for hard-earned taxpayer
    dollars in this regard, and we cannot keep adding to our nearly
    $30 trillion national debt.
        At USDA, we depend upon your agency to provide us with
    information as to whether the department is effectively
    implementing the various programs and appropriately using
    taxpayer dollars.
        Again, I appreciate you being with us and look forward to
    today's hearing.
        Mr. Chairman, I yield back.
        Mr. Bishop. Thank you, Dr. Harris.
        I am not sure if the full committee chairwoman, Ms.
    DeLauro, is present. If she is, I would invite her to offer any
    opening statement she would like.
        I know that she is quite busy and has another commitment
    immediately, and if Ms. DeLauro is not present, I would
    certainly invite the full committee ranking member if she is
    present to have any opening remarks.
        [No response.]
        Mr. Bishop. Not hearing from either of them, I would at
    this point like to recognize Ms. Fong.
        Ms. Fong, I should let you know that without objection,
    your entire written testimony will be included in the record,
    and I will now recognize you for your statement.
        And following that, we will proceed with questions.
        Ms. Fong, the floor is yours.
        Ms. Fong. Thank you, Mr. Chairman, and thank you, Acting
    Ranking Member Harris, and the distinguished members of the
    subcommittee.
        We truly appreciate your very warm welcoming remarks today
    and your support of our mission. And we appreciate the
    invitation to appear to talk about our oversight activities.
        And as, Mr. Chairman, you remarked earlier, we especially
    appreciate the expanded funding for us for fiscal year 2022 and
    the constructive dialogue that we have with members of the
    subcommittee all the time on ongoing issues.
        As you know, you know our mission. We are here to help the
    department deliver its programs as effectively as possible, and
    ultimately you also know that we do not have the authority to
    implement our own recommendations. We depend on USDA officials
    to take necessary corrective actions.
        For much of the past two years, we have been working in a
    maximum telework setting, and I have to say I am extremely
    proud of our dedicated staff. They have demonstrated
    flexibility and innovation. They have produced outstanding
    oversight work.
        As you all know, we have issued 33 audit products this past
    year. We obtained 228 convictions in criminal matters, and we
    reported over 686 million in dollar results for fiscal year
    2021, all of which demonstrate the dedication of our staff.
        As we move forward in fiscal year 2022, we have a number of
    challenges in our oversight portfolio. We will continue to
    finish our work and start other work with respect to several
    major funding streams that some of you have alluded to. We are
    finishing our work on all of the disaster assistance programs
    that were funded in the wake of the hurricanes in 2017.
        We have much ongoing work with respect to pandemic funds.
    Billions and billions of dollars went to the department for
    pandemic relief, and we have to provide appropriate oversight
    of that.
        And as you also allude to, the infrastructure investment
    that Congress passed this past November, we do have oversight
    responsibilities for all of those programs as well. This is in
    addition to our normal portfolio of statutory mandates, of
    financial statement audits, improper payments, IT security, and
    other requirements, as well as our ongoing responsibilities to
    provide a level of oversight to all of USDA's programs and
    agencies.
        So we believe that our hands are full, and to handle this
    increased workload we will need all the resources that you have
    appropriated for us in fiscal year 2022, as well as the
    increase that has been proposed in the President's fiscal year
    2023 request.
        We will also have to work smarter. On our own part, we are
    going to need to develop additional tools and approaches, and
    to that end we are looking to our data analytics staff as we
    hone our ability to understand data, develop new approaches and
    products, and identify potential areas for our audit and
    investigative work.
        This is all in addition to our traditional tools of audit
    products, criminal investigations, and partnerships with other
    IG office as we identify and address trends and cross-cutting
    issues.
        As you mentioned, my full statement is in the record. It
    describes many of the reports we issued last year. So I will
    just close, again, by thanking all of you and asking for your
    continued support as we move through the process, the
    appropriation process, for fiscal year 2023.
        The President's request would provide $112 million for OIG
    in 2023, which is an increase of about $5.7 million, which
    would allow us, in particular, to provide more oversight of the
    infrastructure investment in NRCS, RUS, and NIFA, among other
    priorities.
        So with that, we would be very happy to address any
    questions that you might have.
        Thank you.
        [The information follows:]
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        Mr. Bishop. Thank you very much, Ms. Fong.
        We will now proceed with questions. As I mentioned earlier,
    we will begin with the chair and ranking member, then
    alternating majority and minority with members present at the
    time of the hearing start in the order of seniority. After
    that, I will recognize members not present at the time that the
    hearing was called to order in order of their arrival.
        Each member will have five minutes in each round. So please
    be mindful of your time.
        Ms. Fong, I have two questions for your opening related to
    civil rights. First, you and I discussed that a recent
    agriculture authorizing committee hearing, the $6 million
    increase for the Office of Civil Rights in the House fiscal
    year 2022 bill.
        I am extremely happy to report to you that we retained the
    full House level for OCR in conference, and the conference
    report specifically says that the increase is for addressing
    program deficiencies identified by the Office of Inspector
    General.
        For my colleagues on this subcommittee, would you discuss
    what you see is the benefit of these funds?
        And, second, at that same hearing with the Agriculture
    Committee, you and Chairwoman Hayes discussed the impact of the
    2018 reorganization of civil rights functions at USDA. You
    indicated that their strategic plan was no longer effective, as
    stated in a recent report on USDA's oversight of the civil
    rights complaints process.
        I want to cut to the chase. Did the reorganization under
    the previous administration do more harm than good?
        If so, how can we fix it?
        Ms. Fong. Thank you for your questions.
        And I remember our dialog at that hearing. It was very
    productive, and I appreciate knowing that the funds have been
    appropriated for the Office of Civil Rights. That is great
    information.
        As members of this committee may know, we did an audit
    report last year that looked at the Assistant Secretary for
    Civil Rights Office's ability to handle program complaints of
    inequitable treatment, and we have some very significant
    findings that the handling of complaints was much longer than
    set forth in all the timelines that would apply.
        And while we did our work, the staff of that office made it
    very clear to us that they felt they needed additional
    resources both for staffing as well as for information
    technology systems to track their work and the progress and
    their outcomes.
        And I think it is in relation to that that this committee
    was able and recognized the need to provide additional
    resources.
        My sense is that it will be very important to see how that
    office takes those funds, how they use it. Are they able to get
    the resources to where they need to get them so that they can
    make progress in terms of addressing those delays and
    implementing an effective IT system?
        In terms of your question, Mr. Chairman, on whether the
    reorganization was effective or not, I think our report
    indicates that the approach to processing complaints which had
    been to decentralize it and put more responsibility in the
    agencies with less oversight centrally, that that approach was
    not effective as borne out by our recommendations.
        And so we will watch with great interest to see how that
    office moves forward in the future, and at some future
    appropriate time, we will undoubtedly do additional work.
        Mr. Bishop. Thank you very much, Ms. Fong, for that.
        I think I have about a minute left. So let me go to another
    question.
        I want two questions related to animal fighting. Your
    testimony discussed the recent dog fighting case in Michigan
    that OIG and other law enforcement agencies brought to
    conclusion.
        Do you wait for evidence that non-USDA criminal activities
    are involved before taking action on cases of dog or animal
    fighting?
        If you proceed alone, how many cases have you sued alone
    and how many with law enforcement?
        Second, the fiscal year 2021 bill included an increase of
    $500,000 earmarked for animal fighting, and that funding is in
    the base for fiscal year 2022.
        How have you used those funds? And are your resources
    constrained in terms of your work for animal fighting?
        And you have got about 34 seconds from my time.
        Ms. Fong. We will be happy to provide additional detail in
    a QFR, but very briefly, we get involved in these cases. We
    have about 67 open investigations currently. We definitely
    spent all of the $500,000 last year and more.
        And we get involved in many different ways, through hotline
    allegations, through referrals from the FBI, referrals from
    APHIS and the program officials, referrals from State and local
    law enforcement. Any number of ways that you can think of, we
    do initiate cases based on that, and we work very closely with
    our State and local law enforcement partners on these cases.
        Mr. Bishop. Thank you very much, Ms. Fong. My time has
    expired.
        And at this time I am happy to yield to our acting ranking
    member, Dr. Andy Harris.
        Dr. Harris, you are recognized for five minutes.
        Mr. Harris. I thank you very much.
        Let me first just ask broadly. With the increase in funding
    for COVID and, again, you know, just tens of billions of
    dollars have increased, as well as the increase, the ongoing
    increase, I think, in the SNAP Program through the updated
    Thrifty Food Plan, I mean, the enticement for fraud appears to
    be greater.
        So you dealt with the SNAP Program in your testimony and
    with COVID funding to some extent, but where do you think the
    largest fraud potentially could have occurred with the COVID
    funding to USDA?
        And what are you doing to try to search that out?
        Ms. Fong. With respect to the COVID response funds, and
    thank you for your question on that, we have been looking at
    potential fraud in all the programs because we know that there
    is always a potential whenever there is a large amount of
    money.
        We also, as you know, have a hotline, and so we receive any
    number of allegations pertaining to all of USDA programs.
        We have been working very closely with the Farm Service
    Administration on the CFAP Program in a proactive way to try
    and identify potential indicators of fraud, and we did that
    with FSA very early on.
        We issued a number of bulletins to their staff to say take
    a look at this. If you have got situations coming up where you
    might see this indicator, please contact us because it is
    really important to get involved at the front end on these
    kinds of issues.
        We have also received allegations in the Food Box Program.
    We have had a number of cases that have looked at those
    allegations, and as well, you know, in the SNAP Program, the
    feeding programs we receive allegations and run those down as
    well.
        Mr. Harris. Thank you.
        Yes, with regard to the infrastructure oversight, and I
    know I have asked you about this last year. A grave concern to
    me is that, you know, we are spending billions of dollars for
    broadband extension, for instance, but is your office
    conducting oversight into whether or not those funds are used
    appropriately and grants given to providers who actually can
    deliver on their promise?
        I mean, it is one thing to send the money to them. Another
    one whether or not they can actually deliver. And you do not
    mention that in your testimony.
        Ms. Fong. Yes. We actually have been following the
    broadband programs over a number of years. It's a matter that
    we regularly audit on a periodic basis.
        We do have an ongoing audit right now of the Reconnect
    Program which looks precisely at the issues you are talking
    about, eligibility of recipients, making sure that recipients
    are appropriately selected.
        And through that audit we hope to also evaluate whether RUS
    has addressed concerns that we have raised in prior audits over
    the years.
        And, of course, as you mentioned, under the Infrastructure
    Act, we do have oversight responsibility of those funds, and we
    are at this time evaluating how best to move forward with that.
        Mr. Harris. Well, thank you very much.
        You know, I will tell you one of the fascinating parts of
    this job is that I learn a lot of new things, and in reading
    your testimony, I came across the term ``data story.'' I am
    sorry. I am just not familiar with what a data story is.
        So I did what everyone else would do and Googled it, and I
    am curious if what I understand is true. Why would the OIG's
    Office be doing data stories about programs?
        Why would, for instance, the Farm Service Agency not do the
    data story about CFAP payments?
        I mean, why would it fall to the OIG's Office?
        Ms. Fong. And that is a really interesting question. We
    view it as part of our role to bring transparency to government
    spending and how funds are being used, and we also view it as
    an opportunity for us when we do these data stories to generate
    our own thinking about potential audits, inspection, and
    investigative work.
        So we do it for, you know, a range of reasons.
        In terms of explaining it, I would be happy to ask Jenny
    Rone to offer some comments if you would like more detail on
    that.
        We have a data story coming out soon, which I think is very
    exciting.
        Mr. Harris. Yes, Ms. Fong, maybe just send me a copy of the
    data story.
        Thank you very much.
        I yield back.
        Mr. Bishop. Thank you very much, Dr. Harris.
        At this time I am delighted to yield to the gentleman from
    Wisconsin, Mr. Pocan.
        Mr. Pocan, you are now recognized for five minutes.
        Mr. Pocan. Thank you very much, Mr. Chairman. I appreciate
    it.
        And thanks for our guests being with us.
        I would like to try to get to two different areas if
    possible, one being animal welfare and the other being meat
    packing plants.
        So first on animal welfare, I just want to thank you for
    honoring my request for an audit around the enforcement of the
    Animal Welfare Act with respect for dog breeders. I know it got
    abbreviated because of COVID, but I am looking forward to
    seeing it, and also the fact that you are going to continue
    that audit in fiscal year 2023.
        I was just curious if you could share a little more
    detailed timeline on what I can expect and what will be
    considered in that.
        The second part of the animal welfare question is, as you
    know, the inadequate Animal Welfare Act enforcement has been a
    longstanding issue for APHIS. Your office found in a 2010 audit
    that the agency chose to take little or no enforcement action
    against serious or repeat violators, which weakened the
    agency's ability to protect animals.
        A decade later we are still seeing puppy mills with
    hundreds of violations of Federal law and they get to keep
    their licenses while the animals in the cages are the ones who
    are suffering.
        I appreciate that your office had conducted repeated audits
    of the agency and made many recommendations for how they can
    improve, but I am disappointed that more progress has not been
    made. I worry that we are still going to be asking the same
    question ten years from now if something does not change.
        So what plans do you have to ensure that APHIS actually
    fulfills its statutory obligation to enforce the Animal Welfare
    Act going forward?
        Ms. Fong. Yes, and thank you for your interest in all of
    that work that we do and have done and will be doing.
        I am going to offer the mike to Gil Harden who has probably
    more detail on the audit that we are going to do in 2023.
        Mr. Harden. Yes, thank you.
        And, Congressman, we do plan to do that work in 2023. As
    you know and as Phyllis has said, we are starting our movement
    back into the offices and thinking about doing work onsite. So
    that is why it was pushed to next year.
        But it will get into looking more deeply at the
    recommendations we made in the past in terms of enforcement,
    which we need to do the work on the ground at the site to know
    how well that is being enforced or overseen.
        We did continue to see, you know, problems with oversight
    and what we could look at this time around, and so we will just
    continue that look in the future.
        Mr. Pocan. And to the second part of the question about
    ensuring APHIS actually fulfills its statutory obligation
    enforcing the Animal Welfare Act?
        Mr. Harden. I think it will be part of looking at how they
    dealt with those recommendations as to whether we can ask
    questions about how well or how they can better enforce the
    Act.
        Mr. Pocan. Okay. Thank you.
        And then as a second area, and I noticed Madam Chairman has
    joined us, and I know this is important to her, too, is the
    COVID outbreak and the meat packing plants.
        You know, last year we talked about your investigation into
    food safety and inspection services' response to outbreaks of
    COVID at meat packing plants. I see that your fiscal year 2022
    annual plan includes continuing to evaluate this COVID response
    at meat slaughter/processing establishments.
        I was wondering, again, what the scope is on here and when
    we can expect to see that report, especially with concern on
    when your office's pulse survey found that 48 percent of front-
    line inspectors agreed that FSIS was responsive to safety
    concerns during the pandemic.
        Ms. Fong. Yes. That audit is very close to completion. I
    think it is safe to say--Gil, correct me if I am wrong--that it
    should be out in the next few months.
        Mr. Harden. Yes.
        Ms. Fong. And the scope of it is as you explained or
    discussed just now. It is what FSIS did with its COVID funds,
    how it ensured that inspections continued, the steps it took to
    ensure the safety of its inspectors, and whether it had
    sufficient resources for PPE and other kinds of equipment.
        So I think you will see that very shortly.
        Mr. Pocan. Great. Also, in poultry I think in your fiscal
    year 2022 annual plan, they are looking at an audit on the new
    poultry inspection system. Can you tell us a little bit about
    that timeline and that report?
        Ms. Fong. Gil, I turn it to you.
        Mr. Harden. Thank you.
        That is one that we did include in the plan that we
    published in October. Because of delays in terms of getting
    back in the office and actually doing work in the field, we
    have not started that work as of yet. We will be looking to see
    if we can start that later this fiscal year or early in 2023.
        Mr. Pocan. Okay. Thank you very much, Mr. Chairman. I have
    got 16 seconds. So I yield.
        Mr. Bishop. Thank you very much, Mr. Pocan.
        At this time I would like to recognize the gentleman from
    Washington, Mr. Newhouse, who will be followed by the chair of
    the full committee, Ms. DeLauro, who has joined us, and at that
    time she can give an opening statement, and she can also ask
    her questions.
        But I now recognize Mr. Newhouse. The floor is yours.
        Mr. Newhouse. Well, thank you, Mr. Chairman.
        I am going to write this date down, one of the few times
    that I get to go before Madam Chair.
        So thank you very much, Mr. Chairman and Dr. Harris, as
    well.
        I just want to thank Ms. Fong and your team for being with
    us today. Thank you for all of the things that you do at USDA
    to ensure that those precious Federal taxpayer dollars are
    being used, spent properly and everything that you do in
    support of the USDA mission.
        You know, combatting waste and abuse is a huge job, and
    something that we have to be ever vigilant on. I think some of
    the numbers in your statement, I think, bear repeating.
        In fiscal year 2021, oversight work resulted in monetary
    results totaling over $686 million. I appreciate that.
        That led to 228 convictions. Your investigative work is
    just a tremendous record there, and I appreciate your diligence
    in these results.
        Unfortunately, you know, people are taking advantage of
    some of these things that are meant to assist American
    citizens. That one example of a Georgia man who was sentenced
    to 30 months in prison, had to pay in restitution almost
    $250,000.
        These things happen, and we need to have a strong
    oversight. So I appreciate the work that you and your team do.
        Mr. Chairman, I will submit questions for the record in
    anticipation of attending the memorial service for the Dean of
    the House, Mr. Young. I will be leaving shortly, and so I
    wanted to recognize that that is going on today.
        But I do fully appreciate the work that USDA and the OIG
    Office do on behalf of the American taxpayer, and I appreciate
    you being with us this morning.
        Mr. Bishop. Okay. Thank you, Mr. Newhouse.
        And at this time, I recognize the chair of the full
    Appropriations Committee, Representative DeLauro, the
    gentlelady from Connecticut.
        The Chairman. Thank you so much, Mr. Chairman. I am
    delighted to be with you, and thank you for recognizing me. And
    thank you to Dr. Harris as well.
        It is great to see you, Inspector Fong, and welcome back to
    the Appropriations Committee. We are always so grateful for
    your testimony.
        I want to ask about an issue that you and I have discussed
    before. That is the hundreds of millions of dollars that have
    flowed to what I view as corrupt Brazilian meat packer, JBS,
    the procurement contract awarded by the Department's
    Agricultural Marketing Service.
        As I have said to you before, I am concerned by that
    because, as you know, the Federal Acquisition Regulations and
    the related USDA policies require that government contractors
    have, quote, ``present responsibility,'' and accordingly,
    present responsibility can be impacted by fraud, bribery, and
    other violations of Federal laws.
        You also know that in recent years, I have repeatedly urged
    the department to open its suspension and debarment
    investigation into JBS to determine whether the company meets
    its legal requirement of, quote, ``present responsibility.''
        They have refused.
        In the past, I have also urged you to conduct an
    investigation using your independent authority and
    responsibility under the Inspector General Act of 1978, to
    ensure that taxpayers' dollars do not continue to flow to a
    company engaged in criminal activity.
        At the time, you suggested to me and similarly your staff
    suggested to my staff that you would not investigate because
    the Department of Justice had an ongoing investigation.
        Well, Inspector General, the DOJ has concluded their
    investigation. It ended with the Batista brothers pleading
    guilty, guilty, conspiring to violate the Foreign Corrupt
    Practices Act.
        So, Chairman, I would like to submit the guilty plea into
    the record.
        Stunning charges by the DOJ, showing more than a decade of
    criminal activity, a massive bribery scheme by the Batista
    brothers to obtain illicit loans from Brazil's National Bank.
        These ill-begotten loans were then used by JBS to illegally
    enter and consolidated the meat packing industry in the United
    States to the detriment, to the detriment of America's farmers
    and ranchers, as well as consumers and their families.
        I could go on about JBS' illegal activity. They have a
    history of manipulating cattle markets, price fixing in beef
    and poultry. Recently President Biden's National Economic
    Council released data showing that they are price gouging
    consumers at the grocery store. They have an abhorrent track
    record of exploiting their workers and failing to ensure a safe
    workplace.
        And since 2019, JBS--and this does not count the preceding
    years--JBS has received $171.5 million, and they are receiving
    subsidies today from the Federal Government.
        My question is simple. How with the guilty plea, why have
    you not opened an investigation?
        Why is the Federal Government subsidizing what is likely
    the most corrupt corporation on the face of the earth?
        Ms. Fong.
        Ms. Fong. Yes, thank you very much for your concerns.
        I know we have had dialogue over the years on this issue,
    but I appreciate the information you provided for the record on
    the guilty plea, and I think you have raised an interesting
    question about whether or not suspension and debarment is an
    appropriate remedy at this time, given that there has been a
    guilty plea and a conviction.
        I think our staff will go back and see if there is anything
    additional that we can do now that the Justice Department is
    completed with its process.
        The Chairman. You can open up an investigation. Will you
    open up an investigation now that the guilty plea is there?
        That is the question. Now that we have a guilty plea, why
    is there not immediately an investigation into all of this.
        And--anyway, why can we not move that? What is the timing?
    Are you going to proceed to do that?
        And we are continuing to subsidize JBS. Today we subsidize
    JBS, and to the detriment of our farmers and ranchers in this
    country.
        Ms. Fong. I will say to you that we will go back and
    evaluate the situation to see if there is anything appropriate
    for us to investigate or whether there are other remedies, and
    we will get back to you on that.
        The Chairman. I would hope you would.
        They have been found guilty. They have been found guilty.
    We know what happens when someone is found guilty, and that we
    cannot even have an investigation to deal with suspension and
    disbarment seems to be an abdication of responsibility and the
    abdication of the independent authority that you have to move
    forward on this.
        There would appear to be no going back and looking at what
    is there. You have got a fait accompli. They are guilty of
    violating the Foreign Corrupt Practices Act. There is so much
    documentation about they are manipulating the market, about
    price gouging, about a workplace where we had six people who
    died who they did not take care of their workers.
        And yet it just seems that we cannot move. I need to know
    why, and I want to know how soon we will have an investigation.
        Thank you, Mr. Chairman.
        Mr. Bishop. Thank you very, Madam Chairman.
        And the documents are submitted and received and made a
    part of the record of this hearing.
        The Chairman. Thank you. Thank you very much.
        [The information follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Bishop. At this time I would like to recognize the
    gentlelady from Illinois, Ms. Underwood.
        You have five minutes for questions.
        Ms. Underwood. Thank you, Mr. Chairman.
        And thank you to our witnesses for being here and for the
    important work that you do.
        Cybersecurity needs to be front of mind for every industry
    in America right now, including agriculture. The cyber threat
    proposed by Putin's unprovoked war in Ukraine and the solar
    wind attack last year underscores just how vulnerable our
    Federal agencies and critical infrastructure can be.
        Weak cybersecurity at our Federal agencies exposes
    Americans to privacy and security threats while putting our
    national security at risk, and at USDA, attacks or disruption
    to agency operations threatens our food supply, our economy,
    and our scientific achievement.
        So today I would like to learn more about your assessment
    of the cybersecurity vulnerabilities at USDA and your plans in
    the space moving forward.
        Your office's fiscal year 2021 Information Security
    Modernization Act audit reported that USDA's IT security
    program for fiscal year 2021 was, quote, ``not effective.''
    This clearly is cause for some concerns.
        Ms. Fong, without going into sensitive detail on this
    public setting, can you tell us broadly what areas of USDA's IT
    security program warrant the greatest or most urgent attention
    for fiscal year 2022?
        Ms. Fong. I will be happy to comment on that and then, Gil,
    I think you may have some additional details to offer.
        The department's IT security posture has been a significant
    issue for any number of years. We have not yet at the
    department made it to an adequate level of IT security, and
    that is something that just continually needs attention.
        What we see, generally speaking, is that at the department
    level there are good policies that are put into place, but then
    each individual USDA agency has to implement that with regard
    to all of its IT systems, and that is where we see a number of
    challenges over the years.
        So there needs to be concerted effort throughout the
    department to bring every agency into a secure environment.
    That being said, we do that FISMA review every year to provide
    an overall picture.
        We also have a number of ongoing and planned audits focused
    on specific aspects of cybersecurity that are especially
    vulnerable.
        And I will turn the mike over to Gil to offer some
    additional comments on that.
        Mr. Harden. Thank you, Phyllis.
        With respect to some of the key areas for them to focus on
    this year in response to the FISMA review we did, they need to
    focus on areas of risk management, data protection, and
    privacy, some security training, and configuration management
    type issues.
        We also do looks just for awareness on IT security as part
    of our financial statement of work. So it is covered in other
    areas annually as part of those reviews.
        Other work that we have ongoing, two to highlight, one
    deals with some penetration testing that we are doing around
    security at this point in time.
        Another area is configuration of USDA virtualization
    platforms.
        We can be happy to schedule time with you and your staff to
    discuss all that and maybe some detail as well as some other
    work that we are doing in this IT security arena.
        But it is one that we do have as a matter of focus because
    of the sensitivities that you mentioned, as well as it being a
    longstanding security weakness for the department.
        Ms. Underwood. Good. I am looking forward to that
    conversation.
        The audit noted that USDA has at least 22 open
    recommendations for actions to improve IT security. Only four
    were completed last year, while 16 new ones were added. Can you
    tell us more about why it is important that the agency
    implement these recommendations in a timely manner?
        Mr. Harden. Implementing those in a timely manner will help
    put the policies in place so that they can be assessed, which
    is one of the areas that the department needs to take the next
    steps to be at a higher security posture.
        They do have policies and procedures in place that are
    consistently implemented. They need to implement some other
    ones, but they need to take the next step of assessing how well
    they were implemented and revising where appropriate.
        Ms. Underwood. And only about a third of USDA systems were
    reviewed by your office in the fiscal year 2021 audit. What
    budget would your agency need to complete a full IT security
    review that included all systems each year?
        Mr. Harden. I would have to get back to you on that, but I
    would offer that we do a sampling of systems in any IT work or
    any audit or inspection work that we do. So the systems that
    are sampled each year are different.
        And so like three agencies in OCIO were part of the review
    last year. There will be different agencies and systems that
    are reviewed this year. And other systems are also covered in
    other reviews.
        Ms. Underwood. Well, given the heightened threat
    environment, I think this is an area that we would like to
    continue to explore and work with you to ensure the protection,
    again, of not just the critical Federal system, but the data
    and information so that we can continue to have a robust and
    reliable food supply chain in this country.
        Thank you.
        And I yield back.
        Mr. Bishop. Thank you, Ms. Underwood.
        And at this time I am delighted to yield to the chair of
    the Military Construction, Veterans Affairs, and Related
    Agencies Subcommittee of the full Appropriations Committee, Ms.
    Debbie Wasserman Schultz, the gentlelady from Florida.
        You are now recognized.
        Ms. Wasserman Schultz. Thank you so much, Mr. Chairman, and
    I appreciate the opportunity to talk with the IG and her team.
        I want to return to the issue of animal fighting. I know a
    couple members have asked about this and animal welfare in
    general, but the USDA does play a major role in animal welfare
    because you are in charge of enforcing the Animal Welfare Act.
        And animal fighting is not only cruel and unethical. It can
    also spread disease, and your role is, in particular, critical
    to bringing to justice those engaged in this horrendous act.
        My question is of Mr. Tyrell.
        Mr. Tyrell, my fellow animal lovers on this committee--as
    you can see there are many--joined me in working hard to
    increase your budget so that you have the resources needed to
    successfully locate and identify perpetrators.
        Can you provide this committee with any details on what
    your office is doing with the increased funding Congress
    provided in recent fiscal years?
        And what are you doing to coordinate efforts with State and
    local officials to leverage those resources provided to combat
    animal fighting?
        Mr. Tyrell. Thank you, Congresswoman Schultz.
        So we work very closely with both APHIS and our Federal,
    State, and local counterparts in looking at the Animal Welfare
    Act and conducting these investigations.
        You know, every allegation we receive we have to assess
    carefully to look at the overall impact that each of these
    allegations may have on a criminal investigation or whether we
    should open a criminal investigation.
        You know, these are very complex investigations, obviously,
    and we consider a number of factors before we open them, but
    any allegations of health and safety are really one of our
    highest priorities.
        The monies that we received last year went a long way in
    helping us tackle this problem and put more resources into it.
    So any additional resources will obviously help us put more
    focus on this issue and try to, you know, bring it under
    control as best we can.
        Ms. Wasserman Schultz. And coordinating with State and
    local officials so you can leverage those resources?
        Mr. Tyrell. We actively coordinate with State and local
    officials already. So you know, a lot of the allegations that
    we get concerning animal fighting actually come from our State
    and local counterparts.
        And when they reach out to us, you know, we partner up with
    them and work very closely on trying to combat this problem.
        Ms. Wasserman Schultz. Have you been able to step up
    enforcement and increase investigations as a result of the
    funding?
        Do you have more reach specifically?
        Mr. Tyrell. We have. So last year, as an example, you know,
    we nearly saw probably about a 50 percent increase in the
    number of investigations that we are able to conduct from the
    previous year, and you know, a lot of that can be attributed to
    the additional funding that we received.
        Ms. Wasserman Schultz. Great. I want to turn to issues
    surrounding Florida citrus. In 2018, Congress provided more
    than $2 billion for disaster assistance to help offset
    agricultural producers' losses related to hurricanes and
    wildfires.
        Within that funding, we allocated $340 million specifically
    to the Florida Citrus Block Grant Program, which is a joint
    venture between USDA and the Florida Department of Agriculture.
        These were funds that were a lifeline for many citrus
    producers in Florida that have been on the frontlines of
    experiencing the damaging effects of climate change.
        Mr. Harden, last June your office finalized a report
    evaluating this program. Can you provide us with a summary of
    your findings?
        Mr. Harden. Yes, ma'am. A problem with the microphone.
        Yes, we did take a look at that program, and one of the key
    things that we found was that a significant number of those
    participants, 31 of the participants we looked at, had not also
    applied for the Wildlife and Hurricanes Indemnity Program,
    which was a prerequisite for the block grant.
        We did not make any additional recommendations regarding
    that matter in the report just because we had mentioned or we
    had already made recommendations in another report related to
    the hurricane funding.
        Ms. Wasserman Schultz. So I am sorry. If they made a
    mistake, does that means that there needs to be and better
    guidance from the department so that they include enough
    information to be eligible to receive the assistance?
        Mr. Tyrell. Yes, I think that would be part of the answer.
    I mean, by the time----
        Ms. Wasserman Schultz. I am not sure why you would not have
    made any recommendations if that was an issue.
        Mr. Tyrell. To explain that a little clearer, I am sorry.
    We had made recommendations to clarify that in another separate
    report. So we did not need to make the recommendations again.
        Ms. Wasserman Schultz. Okay. I would like a little bit more
    information from you on this than my time is allowing. So if
    you would follow up with me I would appreciate it.
        Mr. Tyrell. I would be happy to follow up.
        Ms. Wasserman Schultz. Thank you, Mr. Chairman. I yield
    back.
        Mr. Bishop. Thank you, Chair Wasserman Schultz.
        At this time I am delighted to yield to the gentlelady from
    New York, Ms. Meng, for five minutes for your questions.
        Ms. Meng, you have the floor.
        Ms. Meng. Thank you, Mr. Chairman.
        And thank you to Inspector Fong and your team for being
    here today.
        I wanted to ask about a report that your office had
    released last August regarding the SNAP online purchasing
    pilot. As you know, this 2014 initiative was dramatically
    expanded from five to 47 States, including Washington, D.C.,
    last year due to the coronavirus pandemic.
        I have strongly advocated for expanding this pilot,
    including working in a letter with 94 New York elected
    officials from all levels of government to the previous
    administration.
        But as we consider expanding, I want to make sure that this
    program is functioning with the utmost integrity to reach as
    many recipients as possible. And that integrity has to include
    protecting participants' personal identifiable information.
        The report noted that FNS had not updated its risk
    assessment since 2014, and we know it is problematic because
    many people have to submit really sensitive information like a
    Social Security number or their date of birth.
        The report also stated that FNS can do a better job of
    monitoring, evaluating, and documenting retailers' compliance
    with safeguarding this personal information of SNAP
    participants, to which FNS agreed to.
        I wanted to ask how frequently should FNS be updating its
    risk assessment to protect privacy and data.
        And also, given that the total value of online SNAP
    purchase transactions increased from 18.9 million to more than
    1.5 billion from March to December of 2020, are there any
    recommendations for FNS to ensure the program's integrity?
        Ms. Fong. I will just offer a few comments and Gil may have
    more specifics.
        And thank you for raising that audit. I think it really
    highlighted significant issues that you mentioned about
    protecting privacy information. That was really one of our
    significant findings there.
        And the point that we were making on the risk assessment
    was that with the tremendous increase in the number of States
    and the dollars, the volume, that it clearly called out for a
    new risk assessment because the risk had theoretically just
    been magnified.
        I think in terms of moving forward, we would recommend that
    FNS update risk assessments as appropriate when there is a
    change in the risk environment, if some other factor comes into
    being that would, you know, militate towards updating the risk
    assessment. That would be the time to do it.
        Gil, I am going to turn it to you for some comment.
        Mr. Harden. Yes, thanks, Phyllis.
        And I will just echo kind of what you were saying in
    response to your question, Congresswoman, in terms of how often
    to update it.
        IT is really driven by what is going on in the program and
    no way what the changes are. Clearly, with the increase in
    volume in the program, they needed to update that risk
    assessment.
        Now that they know that there is the potential weakness
    with personal and private information, they need to make sure
    that risk is addressed as well.
        Most all of the work that we have done at FNS with regard
    to COVID, as well as other agencies as well, has asked the
    question about risk. How do you access that risk? What risk are
    you willing to accept? And why are you willing to accept those?
        And for the ones that you are not willing to accept, what
    measures are you putting in place to address those risks?
        So that is a very standard question that we are asking as
    part of that in most of the work.
        Ms. Meng. Thank you.
        I am sorry just to switch really quickly. I wanted to ask
    about another report that OIG had released about the Emergency
    Food Assistance Program, which was really helpful to us here in
    New York and around the country when our local pantries
    experienced a dramatic increase in requests for their services.
        But we know that there are many challenges that FNS faced
    in implementing TEFAP during the pandemic: cancelled food
    orders, inability to conduct oversight of State agencies
    because of travel restrictions.
        From OIG's perspective, what lessons should FNS learn from
    the pandemic to ensure that they are better prepared to combat
    ongoing supply chain and food distribution issues?
        Mr. Harden. In response to that, we are actually in the
    process of completing our work on TEFAP. We have issued two
    interim reports.
        So there again, the one area that we saw that they needed
    to take better action on was looking at a risk assessment for
    TEFAP and the changes that were happening traditionally versus
    going on with COVID.
        But the team is also working on the final questions that we
    were looking at now and we may have some additional insights
    into your questions with that report that will be forthcoming.
        Ms. Meng. Great. I would love to see that.
        Thank you, Mr. Chairman, and I yield back.
        Mr. Bishop. Thank you, Ms. Meng.
        At this time, I am delighted to recognize the gentleman
    from Texas, Mr. Cuellar. You have five minutes, and you are now
    recognized.
        Mr. Cuellar. Thank you, Mr. Chairman.
        And, again, to the witnesses, thank you so much.
        The committee is a big supporter of the USDA's Reconnect
    Program to help the rural and the underserved communities to
    make sure they can access the digital tools so they can improve
    their health, educational, economic outcomes.
        As you know, the committee added an additional $450
    million, and I want to thank the chairman for his leadership on
    this Reconnect Program in the fiscal year 2022 appropriations,
    and that is on top of the $2 billion that got provided in the
    Infrastructure Investment and Jobs Act.
        My question, and I think we all have got different
    communities that have high poverty. Along the U.S.-Mexico
    border we have what we call the Border Colonias, basically no
    water, no sewage, and I think a lot of us members have similar
    types of communities.
        My question is: do you all have any metrics or performance
    measures that have been established to ensure that the
    Reconnect Program is effectively serving those communities that
    are impacted by high and persistent poverty?
        It is a great program, but I keep hearing from constituents
    in my area, and I do not know about other members, about not
    having enough funding for this program so we can connect them.
        I would appreciate any ideas on performance measures and
    how you measure the impact of the Reconnect Program.
        Ms. Fong. That is a really interesting question. As you
    know, we have talked earlier in the hearing about the fact that
    we have got an ongoing audit or inspection of the Reconnect
    Program focused on eligibility, which is, you know, an
    important question to ask.
        But your question goes even further, which is to assess the
    impact of the program and are the funds getting to the
    communities that have a great need for them.
        And as I am sitting here thinking about it, the data
    stories that we talked about earlier in the hearing, which is a
    product that we will be issuing shortly for the Food Box
    Program, which takes data that shows where the program monies
    went, who touched it, who received the benefit of it; it could
    be that this could be an interesting project for us to think
    about from a data analysis standpoint, to see is their data
    shows; does RUS keep the data that shows the communities it is
    going to?
        What does that look like with an overlay of, say, census
    data?
        And what can we learn from that?
        So I think that is a really interesting question, and we
    will go back and give some thought to that.
        Gil and Jenny might have comments as well.
        Mr. Harden. Yes. I was just going to add from the rollout
    of the infrastructure money and starting to listen at how the
    department is dealing with all four buckets of money, one of
    the things that they talk about is the equity action plans, and
    which is getting to those underserved or less served.
        And so we will be monitoring and following how they are
    going to measure that, and if they are not measuring that,
    asking questions as to how or why that is not being addressed.
        Mr. Cuellar. Well, thank you.
        My time is up but I appreciate any way the committee can
    work with you. Thank you so much.
        Thank you, Mr. Chairman.
        Mr. Bishop. Thank you, Mr. Cuellar.
        I think we have completed the first round, and we will move
    on to a second round, but during the second round, given the
    fact that we have got some other activities, particularly the
    memorial for Mr. Young, we are going to reduce the time for the
    second round to two minutes.
        At this time I yield to myself to continue to question Ms.
    Fong.
        The OIG's latest semiannual report to Congress was issued
    in November of 2021, and it shows significant decreases in the
    number of open audit recommendations, OIG recommendations of
    which agencies have not completed corrective actions.
        Since OIG started reporting these open recommendations in
    2014, the average numbers about 420 at the end of a fiscal
    year. As of September 30th, 2021, the number of open
    recommendations was down to 260.
        Can you explain what that means? Is it because you are
    issuing fewer recommendations or the agency is putting more
    effort into implementing your recommendations or is it
    something else?
        Or is this cause for celebration?
        Ms. Fong. Thank you for the question.
        We issue recommendations where we think recommendations are
    warranted. So it is not that we are trying to issue fewer
    recommendations.
        I think the change that we are seeing comes from the tone
    at the top at USDA where the Secretary has made it very clear
    to all of us that he wants to see these recommendations
    addressed where appropriate; take action if circumstances have
    changed. We get into dialogue with that.
        We have, our office has worked very closely in partnership
    with the Office of the Chief Financial Officer and the program
    agencies to really identify the issues that need to be
    addressed and to pursue them.
        And I think what we are seeing here is the result of that
    concerted effort on the part of the whole department to address
    these issues.
        Mr. Bishop. Thank you, Ms. Fong.
        Dr. Harris, you are recognized.
        Mr. Harris. Thank you very much.
        Just a brief question. You know, I have seen some memos
    from March 23rd from the U.S. Department of Agriculture
    instructing the WIC Program, the SNAP Program, and the School
    Lunch Program to help conduct voter registration.
        And what is of concern to me in the memos, and I read it
    verbatim, the first memo says, ``The NVRA requires SNAP State
    agencies to offer voter registration opportunities to any
    person who applies or renews for an application.''
        But it does not say that an instruction has to be provided
    as to whether or not someone is actually eligible to vote.
        So, for instance, we know that under WIC and under School
    Lunch Program, people are in the country illegally, can get the
    program, but obviously are not eligible to vote. They do not
    even have a green card much less eligible to vote citizenship.
        Why is that instruction? I mean, would that not be an
    important thing to emphasize that part of the education of the
    people who are giving these voter registration forms should be
    to inform them of who actually can vote and who cannot?
        Ms. Fong. That is a very interesting issue. I personally am
    not aware and have not seen the memos. I think I do understand
    your question and will have to go back and take a look at that
    and perhaps reach out to your staff, you and your staff, to see
    if there is anything that is appropriate for us to do at this
    point.
        Mr. Harris. All right. And if I can, Mr. Chairman, I will
    be more than happy to enter the three memos into the record and
    provide them to the OIG.
        I just, you know, wonder whether this is the best use of
    nutrition program money because my understanding is
    administration money can be used for this.
        And if we are going to do it, whether or not we should also
    be providing a clear guidance on who can and cannot register to
    vote or who can or is not eligible to vote.
        Anyway, thank you very much, Mr. Chairman. I yield back.
        Mr. Bishop. Thank you, Dr. Harris.
        Ms. Underwood, you are now recognized.
        Ms. Underwood. Thank you.
        Last year constituents reached out to my office regarding a
    USDA licensed tiger exhibitor with a facility in my district.
    These constituents were horrified to find publicly available
    inspection reports from the Animal and Plant Health Inspection
    Service, APHIS, showing repeated violations of the Animal
    Welfare Act.
        Some of these violations affected the welfare of the
    animals, like a lack of veterinary care. Others endangered the
    community, like insufficient fencing for tigers at another
    facility in Kansas.
        The idea of a local Tiger King was scary enough, but APHIS'
    response added to our angst. We tried for months to get answers
    from the agency, and we were eventually able to get a staff
    level briefing, but at that briefing, we were informed that the
    exhibitor's license had just been canceled.
        But then we learned last week that APHIS has reversed
    course and issued a new license to a repeated offender for a
    facility in Kansas.
        In a March 2021 report, your office assessed that, quote,
    ``APHIS cannot fully ensure the safety of the animals exhibited
    or the safety of the public who view those animals.''
        In light of this disturbing example, I am concerned that
    this is still the case. Ms. Fong, does your office plan to
    conduct any kind of follow-up to the March 2021 report to
    evaluate whether APHIS is now able to ensure the safety of
    animals and the public?
        Ms. Fong. Just thank you for bringing that to our
    attention. I had not heard of that situation.
        As you mentioned, we issued that report about a year ago.
    We do not normally do a follow-up audit a year later. We try to
    give the agency time to, you know, address our recommendations.
        That being said, we can go back and take a look to see what
    the status of our recommendations are, where the agency is with
    it, and see if there is anything appropriate for us to do at
    this point.
        Ms. Underwood. Yes, ma'am. I think that that would be an
    appropriate course of action. It is clear to me that APHIS has
    a lot of room for improvement, and OIG's review and
    recommendations are welcome first steps, but these wild animals
    in our communities is upsetting.
        I yield back.
        Mr. Bishop. Thank you, Ms. Underwood.
        Ms. Fong, we talked about major management challenges last
    year and how some require persistent efforts year after year
    just to even make progress. I am particularly concerned about
    improper payments.
        It appears that USDA has not been compliant with various
    improper payment statutes for each of the last ten years.
    Earlier this month, your office reported that the previous
    administration may have overpaid over $57 million to over
    150,000 producers through the Market Facilitation Program.
        Would you tell us what went wrong and what corrective
    actions has USDA taken?
        And are they able or can they recoup the money?
        Ms. Fong. Thank you.
        You are referring to a report that we recently issued on
    the Market Facilitation Program, which was based on a
    statistical sample, a review of a number of producers and the
    payments that were made to them.
        And we found, you know, as you mentioned, that a number of
    payments were improperly made.
        The recommendations that we issued to the department were
    that FSA needs to strengthen its controls to make sure that
    they have the right documents to support the payments that they
    are making.
        And we also recommended that FSA go back with respect to
    the 2021 payments that we thought were not supported and talk
    to the producers and take any appropriate action to get
    repayment of the overpayment, if appropriate.
        So I think moving forward, you know, we have made those
    recommendations to improve the program and to try and recoup
    some of the funds.
        Mr. Bishop. Thank you.
        Mr. Harris.
        Mr. Harris. I have no other questions, Mr. Chairman.
        Mr. Bishop. Okay. Well, I have one other question.
        Your annual plan for fiscal year 2022 indicates that you
    expect to use about a third of your resources dedicated to the
    investigation side of OIG on the Farm Production and
    Conservation Programs. This is almost 50 percent higher than
    anticipated for last year.
        Can you tell us the reason you are expecting to need more
    investigative resources for the Farm Production and
    Conservation Program this year?
        And are there trends of specific issues or concerns that
    you are expecting or that you are seeing?
        Ms. Fong. Thank you for that question.
        I think either Kevin or Ann would offer some thoughts on
    that.
        Ms. Coffey. Okay. Just in terms of the program, each year
    we assess where we are in terms of what percentage of resources
    that we use and that is based on sort of what our current work
    is.
        So for fiscal year 2021, we are looking at the number of
    cases we had with respect to the farm servicing and
    conservation services, and so from that perspective, that sort
    of serves as a basis for us to determine what our next year's
    work is going to do, especially in light of the fact that we
    have cases that go multiple years. We do not necessarily
    conclude a case in one year.
        And obviously with COVID there has been a number of
    programs that are out there which are responsive and fall under
    the farm service agency, where we have seen an uptick in
    investigative work.
        And so that really would account for the increase that we
    have seen or that we anticipate seeing for fiscal year 2022.
        Mr. Bishop. Thank you, Ms. Coffey.
        Ms. Fong, Ms. Coffey, Mr. Harden, Ms. Rone, and Mr. Tyrell,
    thank you for your testimony and for spending time with us
    today.
        Along with what we have discussed, we will also forward
    additional questions for the record, and we appreciate your
    diligence in getting responses to us in a timely manner.
        Dr. Harris, do you have any closing remarks?
        Mr. Harris. No, I do not. I just want to thank the Office
    of the Inspector General for the wonderful work the Inspector
    Generals do across the government agencies and look forward to
    working with you and working on your budget request.
        Thank you. I yield back.
        Mr. Bishop. Thank you, Dr. Harris and all of the members of
    the committee for attending.
        Thank you also to our staff who put this hearing together.
        And, again, thank you, Ms. Fong and your staff for your
    participation and the excellent work that you do year after
    year.
        With that, I believe that this subcommittee has completed
    its work for the day, and the subcommittee is now adjourned.
        [Questions submitted for the record follow:]
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                                              Thursday, April 28, 2022.

                         U.S. DEPARTMENT OF AGRICULTURE

                                   WITNESSES

    HON. TOM VILSACK, SECRETARY OF AGRICULTURE, U.S. DEPARTMENT OF
        AGRICULTURE
    JOHN RAPP, DIRECTOR, OFFICE OF BUDGET AND PROGRAM ANALYSIS
        Mr. Bishop. Good morning. This hearing will now come to
    order.
        As this hearing is fully virtual, we must address a few
    housekeeping matters.
        For today's hearing, the chair or staff designated by the
    chair may mute participants' microphones when they are not
    under recognition for the purposes of eliminating inadvertent
    background noise.
        Members are responsible for muting and unmuting themselves.
    If I notice that you have not unmuted yourself, I will ask if
    you would like staff to unmute you. If you indicate approval by
    nodding, staff will unmute your microphone.
        I remind all members and witnesses that the five-minute
    clock still applies.
        If there is a technology issue, we will move to the next
    member until the issue is resolved and you will retain the
    balance of your time.
        You'll notice a clock on your screen that will show how
    much time is remaining. At one minute remaining, the clock will
    turn yellow. At 30 seconds remaining I will gently tap the
    gavel to remind members that their time is almost expired.
        When your time has expired, the clock will turn red, and I
    will begin to recognize the next member.
        In terms of speaking order, we will begin with the chair
    and the ranking member. Then members present at the time the
    hearing is called to order will be recognized in order of
    seniority and, finally, members not present at the time the
    hearing is called to order, in the order of their arrival.
        Finally, House rules require me to remind you that we have
    set up an email address to which members may send anything they
    wish to submit in writing at any of our hearings or markups.
    That email address has been provided in advance to your staff.
        Well, good morning, and welcome to today's budget hearing.
    Today we are examining the Department of Agriculture's fiscal
    year 2023 budget request.
        I am pleased to introduce our distinguished witness today,
    Secretary Tom Vilsack.
        Thank you for being here, sir. It was good having you in
    Albany, Georgia last week to announce USDA's investment in
    radium screens and to highlight the impact of Infrastructure
    Investment and Jobs Act and what it will have and how it will
    impact rural communities across our country.
        Now, this budget comes to Congress at a very important
    moment in time. For the past two years, USDA has played a major
    part in the government's response to COVID-19. Through six
    coronavirus relief bills, including the American Rescue Plan
    Act, Congress entrusted USDA with tens of billions of dollars
    and additional flexibilities.
        For those funds and authorities, USDA is helping to put
    food on the table both at home and at school by expanding
    access to food programs.
        USDA is strengthening the food supply chain by investing in
    infrastructure and support for food processors and local food
    systems to build resiliency in the food supply.
        And USDA is doubling down on its efforts in rural America,
    including investments to support rural hospitals, local
    communities, rental assistance for low-income and borrowers,
    and further investments in broadband expansion.
        But even as some aspects of the pandemic response wind
    down, there are issues such as addressing climate change,
    securing the food supply chain, ensuring more of our rural
    communities have access to the same high-speed Internet as our
    suburban and urban communities. That will keep USDA at the
    forefront of American policy priorities for the foreseeable
    future.
        With all that as the backdrop, USDA's fiscal year 2023
    request for this subcommittee is $23.6 billion, an increase of
    2.2 billion, or 10 percent, over fiscal year 2022.
        Overall, I am pleased that this budget continues to build
    on agency-wide priorities that were funded in fiscal year 2022,
    including investments to ensure equitable participation in USDA
    programs, address the impacts of climate change, and support
    staff and leadership officers at USDA.
        Notable investments include a $200 million increase for the
    ReConnect Program; a $119 million increase for the Agriculture
    and Food Research Initiative; $50 million to expand
    Conservation Assistance for beginning, historically
    underserved, or veteran farmers; fully funding the SNAP, Child
    Nutrition, and WIC Programs to meet expected participation in
    fiscal year 2023.
        So today I will be interested to hear about how USDA can
    improve the quality of life in our communities, how its work
    affects the lives of every American on a daily basis.
        Secretary Vilsack, thank you, again, for being here. I
    appreciate all of the work that you have done in a little over
    a year, and I look forward to working with you as the fiscal
    year 2023 process moves forward.
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        Mr. Bishop. Now, let me ask our distinguished ranking
    member, Dr. Harris, if he has any opening remarks, and if so, I
    would like to recognize him at this time.
        Dr. Harris.
        Mr. Harris. Thank you, Chairman Bishop.
        Thank you, Secretary Vilsack. I also want to welcome you to
    today's hearing. I look forward to discussing the U.S.
    Department of Agriculture's fiscal year 2023 budget request and
    some other topics of importance.
        Now, the USDA's budget request for the Agriculture
    Subcommittee, as the chair has just indicated, is an increase
    of ten percent over last year's level, which is a large
    increase.
        Yet this request does not address the immediate concerns on
    the minds of consumers, farmers, and ranchers, such as
    inflation, which is at a 40-year high at 8.5 percent and began
    skyrocketing well before the war in Ukraine.
        Supply chain issues continue to affect the agriculture
    industry, from bottlenecks at shipping terminals, labor
    shortages in the trucking and rail industries, and farm
    equipment and parts in short supplies.
        It is unfortunate the President's budget includes
    provisions threatening the stepped-up basis and imposing
    capital gains taxes on hardworking farm families to pay for his
    climate agenda and other big government spending.
        These ideas have been rejected by Congress before when the
    administration tried to sell the American people on the Build
    Back Better plan which included those provisions, and I expect
    these proposals will meet the same fate again.
        Now, with the war in Ukraine, we are on the brink of a
    global food crisis. America's producers are the most
    innovative, efficient, and capable in the world and are ready
    to step in to fill the needs.
        But when fertilizer costs are up more than 300 percent in
    some areas, there are significant concerns among producers
    about the future. Rising energy and input costs in agriculture
    are taking away from the momentum of higher commodity prices
    that might help producers break even or be just above the
    bottom line.
        USDA needs to be communicating the department's plan to
    address this global food crisis and support producers in
    meeting the increased global demand.
        While this subcommittee is responsible for discretionary
    funding, I think it is important that we maintain close
    oversight of the mandatory spending as well. USDA has proven
    itself quite capable of single-handedly increasing mandatory
    spending without a blink from the Office of Management and
    Budget or approval from Congress.
        Last year, USDA unilaterally increased spending $20 billion
    a year on the SNAP Program by reevaluating the Thrifty Food
    Plan, which is a market basket of foods a household should
    purchase for a healthy diet and is used to establish SNAP
    benefit levels.
        As stewards of taxpayer dollars, we have an obligation to
    scrutinize mandatory funding when it goes beyond what Congress
    has authorized or intended, and that was one example. My
    Republican colleagues at the House and Senate Agriculture
    Committee have asked the GAO to review USDA's methodology for
    reevaluating the Thrift Food Plan, and I look forward to
    results of that review.
        Mr. Secretary, we had a chance to visit a few months ago.
    So you know that I have a large poultry district, and I am
    closely watching the highly pathogenic avian influlenza
    outbreak.
        I appreciate the recent meeting I had with the Animal and
    Plant Health Inspection Service Administrator, Kevin Shea, and
    want to continue working with USDA on addressing this very
    destructive disease.
        I am also monitoring the Packers and Stockyards Act
    rulemaking process with great concern to my constituents.
    Greater transparency and competition in the livestock and
    poultry markets is well intentioned, but there could be
    unintended consequence.
        So I will be closely watching as the department moves
    forward with an analysis of the economic effect of any changes.
        Again, Mr. Secretary, I appreciate you being with us and
    look forward to today's hearing.
        I yield back, Mr. Chairman.
        Mr. Bishop. Thank you, Dr. Harris.
        I am not sure if the chair of the full committee, Ms.
    DeLauro, is on the line. Is she?
        If so, I would recognize her.
        [No response.]
        Mr. Bishop. If not, I would also recognize the ranking
    member of the full committee, Ms. Granger, if she is on the
    line, if she is available.
        [No response.]
        Mr. Bishop. Hearing from neither at this time, I would like
    to recognize Secretary Vilsack, and without objection, sir,
    your entire written testimony will be included in the record,
    and I will recognize you now for your opening statement, and
    then we will proceed with questions.
        Secretary Vilsack. Mr. Chairman and Ranking Member and
    members of the committee, thank you very much for the
    opportunity to be with you this morning.
        You know, I do not think this committee needs to be
    reminded. Perhaps those who are watching this hearing need to
    remember the importance and significance of the food and
    agriculture industry in our country. It is a critical part of
    our infrastructure.
        Our food independence is critical to our national security.
    It contributes nearly 20 percent for our Nation's economic
    activity; plays an important role in ten critical
    infrastructure sectors, everything from food and health and
    water to manufacturing and finance and transportation; and is
    responsible for employing nearly 29 million Americans.
        Our national security interests are intimately tied to the
    strategic investment in the Department of Agriculture in this
    sector and to rural American. This sector's assets and supply
    chain systems and networks provide vital services to our Nation
    and are essential to our security, our economic vitality, and
    our way of life.
        I want to spend the remaining minutes of my time this
    morning talking about three specific areas that often do not
    get the kind of attention that I think they deserve.
        Let me begin with the fact that as of today, the Department
    of Agriculture has 5,300 fewer people working at it than it did
    when I left office in January of 2017. This is despite the fact
    that both the discretionary and mandatory budgets have
    increased. The discretionary budget has been increased by 18
    percent, and the programmatic spending has increased by several
    billion dollars.
        The reality is that effective management of the resources
    that you all provide does, in fact, require staffing. We have
    critical shortages in rural development and food and nutrition
    in the consumer service area, and in our NRCS area or
    conservation.
        As you look at this budget, you are going to see requests
    for additional staffing, and it is a response to the fact that
    we are down by 5,300 folks. Now, what is that?
        I think there are two fundamental reasons, and I appreciate
    the fact that this committee last year for the first time in
    quite a while not only approved pay increases for workers, but
    also provided the resources for those pay increases.
        In the past that has not been the case, and the result is
    that oftentimes we would have to reduce staff in order to cover
    the cost pay increases.
        At the same time, while non-discretionary spending grew
    from 2014 to 2021 by 27.4 percent, USDA's discretionary budget
    grew by only 14 percent, roughly one-half of other agencies.
        During the course of the last four or five years, we have
    seen non-defense spending by Congress increase by 21 percent,
    while USDA's increase was less than six percent.
        I would suggest to you that as you look at this budget,
    please bear in mind the relative position that USDA bears to
    other non-defense administrations and the important work that
    we do at USDA.
        The second area I would like to talk about briefly is
    research. You know, it is interesting. Over the last 24 years,
    health care research has increased by over 400 percent. R&D
    research at the USDA, however, over the last ten years, if you
    take inflation into consideration, has essentially been
    flatlined.
        I would suggest to you that it's important and necessary
    for us to pay attention to agricultural research, as I'm often
    reminded while health care research can cure diseases, USDA
    research can prevent disease, both in terms of people and in
    terms of animals.
        Our agricultural share of the total Federal investment in
    non-defense R&D over the last 20 years or so has declined from
    4.3 percent of the overall non-defense R&D to now 2.3 percent.
        So I would encourage this committee to take a look at the
    important role that research can play and the necessity of
    having adequate resources. We are falling behind in agriculture
    research to our friends in China, and that is an area that I do
    not think we want to essentially be second place in.
        And I think it ultimately has negative implications for
    agricultural productivity and our ability to deal with the
    pests and diseases that we that we are currently dealing with
    and those that may occur as a result of climate change.
        The last item I want to visit with in the remaining time
    that I have is just to remind the committee of the importance
    of our rental housing portfolio at USDA. We have over 403,000
    units that we essentially provide resources to that enable to
    have families have access to affordable rental housing.
        Unfortunately, many of the mortgages on those properties
    are going to be paid off in the very near future, and as they
    are, those units are going to come out of the Rental Assistance
    Program, which is going to create some challenges for families.
        In addition, we have not over a period of time invested in
    revitalizing and rehabbing many of those units. In fact, we are
    going to begin to see a loss of thousands of units as a result.
        So we are requesting additional resources to allow us to
    upgrade the rental housing stock in rural America so that we
    can continue to provide decent housing for those who want to
    live, work, and raise their families in rural communities.
        Mr. Chairman, I know there are a variety of issues that you
    all want to discuss, and so I will stop there and look forward
    to the questions of the committee.
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        Mr. Bishop. Thank you, Mr. Secretary.
        We will now proceed with questions.
        As I mentioned earlier, we will begin with the chair and
    ranking member, then alternating majority and minority, those
    members present at the time the hearing started in order of
    seniority.
        After that I will recognize members not present at the time
    the hearing was called to order in their order of arrival.
        Each member will have five minutes in each round. So please
    be mindful of your time.
        I will now recognize myself for questions.
        Mr. Secretary, I was interested in your comment because in
    February during the Agriculture Committee hearing on foreign
    policy, I asked Under Secretary Bonnie about staffing concerns
    in the Farm Production and Conservation Mission area, and I
    recognized the increased workload over the past few years,
    especially at FSA, due to ad hoc programs like the Market
    Limitation Program, the Coronavirus School Assistance Program,
    the Wildfire and Hurricane Indemnity Program.
        We are all glad that USDA has the flexibility of creating
    and administering these programs in support of our producers,
    but ensuring FSA is fully staffed is key to their effective and
    timely delivery, and I am happy that you have recognized that
    and brought that to the forefront in your budget request.
        You request an additional 64 employees for FSA, an
    additional 535 for Conservation Technical Assistants at NRCS,
    noting expanded staffing capacities needed to keep pace with
    increased mandatory financial assistance authorities that will
    exceed $3 billion in 2023.
        And I am happy that you are asking for additional resources
    for staffing.
        My question is will these requests meet the needs to do the
    core work, especially at FSA, and I am concerned that those 64
    employees may not be able to keep pace with retirements and
    attrition.
        And while we are discussing FSA staffing levels and
    workload, can you provide the committee an update of the timing
    for the WHIP disaster limitation and sign-up for the 2020 and
    2021 property process.
        Secretary Vilsack. Mr. Chairman, I am confident that our
    request will allow us to continue to do the good work at FSA
    offices across the United States.
        NRCS is a different story. The reality is we have to have
    people working individually with producers, particularly for
    those who have been historically underserved so that they fully
    understand and appreciate the programs that are available to
    them.
        We also have, as you know, an expanded urban agricultural
    presence which is going to require as well additional resources
    for NRCS.
        So between the two I think we have made a request that will
    allow us to continue to do the work that is incredibly
    important. And I will tell you that this is an organization
    that last year, last fiscal year, basically provided over
    53,000 farm loans to farmers in need and also provided nearly
    43,000 NRCS contract conservation contracts which were
    approved, in addition to all of the pandemic assistance and all
    of the additional expenses that were forthcoming as a result of
    a variety of programs that you all have funded recently.
        Mr. Bishop. The administration has rightfully made ensuring
    equitable participation in USDA program a top priority. And two
    weeks ago you released the USDA's Equity Action Plan.
        And two findings stood out to me in particular. First, that
    USDA farm programs are tailored to the needs of larger
    agriculture producers and, second, that FSA and RMA have had
    very few programs and avenues providing technical assistance
    and support to organizations that help underserved farmers and
    ranchers.
        So I have been concerned the majority of financial and
    technical assistance goes to larger farmers, and I am glad that
    this is being recognized.
        As we discuss the unique challenges that our small farmers
    face, is there anything that we need to do in our fiscal year
    2023 bill to address these identified gaps in service?
        Secretary Vilsack. Well, fortunately, Mr. Chairman, you
    passed the American Rescue Plan, which provided us the
    resources to begin a process of creating relationships between
    USDA and a series of community building organizations that can
    provide technical assistance, trusted organizations in
    communities to reach out to historically underserved producers,
    and to provide the one-on-one information and contact that is
    necessary for those producers to understand (a) what is
    available and (b) how to basically qualify for it.
        In addition, you also provided resources for us to
    adequately fund the Heirs' Property Relending Program, which is
    going to allow us to enable those fractionated interests and
    the owners of that land to be able to consolidate land
    ownership so that they are able to participate fully in
    programs.
        Our risk management folks have found $2 million to provide
    additional outreach, and they have begun to craft a series of
    programs and risk management tools that are directly connected
    to and speak to this issue of small and midsize producers.
        They recently announced a micro crop insurance program that
    is providing crop insurance protection for facilities that have
    less than $100,000 in sales.
        So there is a tremendous opportunity here and a tremendous
    outreach effort that is undertaken in order to ensure they will
    be able to get the access to programs they need.
        Mr. Bishop. Thank you, Mr. Secretary.
        My time is up, and we will now go to Dr. Harris.
        And, Dr. Harris, you are now recognized for your questions
    for five minutes.
        Mr. Harris. Thank you very much, Mr. Chairman.
        Again, thank you, Mr. Secretary.
        Now, I have read your written remarks to the committee, and
    the second paragraph talks about economic indicators that are
    overwhelmingly positive. So I am not sure when this was
    written, but I am sure you are aware that the GDP actually
    contracted 1.4 percent last quarter. That is not economically
    positive.
        We have inflation at historic highs. That is not
    economically positive.
        We have interest rate increases that are being planned that
    will likely result, and most economists feel most likely
    result, in recession. That is not economically positive.
        And a majority of Americans simply disagree that they think
    the economy is in good shape.
        So I am not sure. You know, if we start from an unrealistic
    predicate, then we are going to make bad decisions.
        So, for instance, you talked about 5,000 fewer employees,
    but in an organization that has nearly 100,000 employees, that
    is just doing a little more with a little less, and I think
    that is what Americans expect from us, as our trillion-dollar
    deficits fuel inflation. And the American people have figured
    it out.
        I think we have to look at ways of doing more with less in
    the government, not doing the same with more, which I think is
    what you suggest when we have to add employees, for instance,
    in then FNS program which should be winding down because of,
    again, the wind down in some of the COVID funds. We should
    actually require fewer employees than we have now as these
    funds wind down.
        So that leads into my question about the SNAP Program. If
    the administration is doing so well with the economy, why do
    you estimate SNAP participation will actually increase 1.2
    million people next year because the SNAP Program is usually a
    reverse indicator of the economy?
        The economy gets better, SNAP participation goes down
    because fewer people qualify. But you project an increase. So
    do you believe the economy is getting better or not?
        Secretary Vilsack. Well, I think the response is a balanced
    view here. You have mentioned some of the challenges that we
    have with inflation, and that is true.
        But you did not mention the fact that we have had
    significant job growth recently, and while that is good news,
    we still have a challenge in many areas of the country in terms
    of unemployment rates that continue to be high, particularly in
    persistently poor areas.
        I was recently in Mississippi and communities where the
    poverty rate has been in excess of 20 percent for over 20
    years.
        So there are still challenges, number one.
        Number two, I think it is important to recognize that we
    need to continue to look for ways in which those who are
    eligible for programs actually participate in the programs.
        One of the areas in SNAP that we want to continue to focus
    on are senior citizens, folks who have retired, who are on
    fixed incomes, perhaps it is a Social Security check, who
    actually qualify for SNAP but currently are not receiving the
    benefit of SNAP.
        Obviously, it is in our best interest to make sure folks
    have access to these programs.
        The same thing is true with our WIC Program. Fifty percent
    of those who are eligible for that program do not participate
    in that program, Congressman, and so therefore, it is important
    for us to continue to look for ways in which we can make sure
    that the programs that you all have created are available and
    utilized by the people that they are designed for.
        Mr. Harris. Well, thank you. I appreciate the answer, but I
    hope that is weighed, again, in a time when you paint this
    incredibly rosy picture of the economy with millions of people
    getting more jobs.
        That should actually take millions of people off of being
    eligible for SNAP benefits.
        Now, you know that GIPSA is a concern of mine. My
    Republican counterparts in the House and Senate Ag. Committee
    sent you a letter about the importance of doing an updated
    comprehensive economic analysis.
        You know, your reply was a little vague. Again, I look
    forward to seeing that economic analysis. Will you still commit
    to ensuring that a proper updated economic analysis is going to
    be performed on that?
        Secretary Vilsack. Yes.
        Mr. Harris. Okay. Great.
        The ReConnect Broadband Program, you know, again, the rural
    areas do need broadband. That was so clearly exemplified during
    the COVID crisis, and I am glad that we have more resources.
        But is the USDA coordinated? Because now we have several
    agencies involved, are you coordinating with the National
    Telecommunications and Information Administration to ensure
    that we are not duplicating?
        We are sending all of this money out there, that we are
    actually spending efficiently, wisely and not duplicating
    government effort.
        Secretary Vilsack. We are sharing data through an MOU that
    was recently signed. We have weekly meetings. We are basically
    coordinating our mapping, as well.
        So, yes, that coordination is taking place, and the goal,
    obviously, is to avoid duplicating and providing double
    coverage and not being able to provide coverage throughout the
    entire country.
        That is the goal here, is to get everyone access to high-
    speed Internet.
        Mr. Harris. Well, thank you so much because, again, we have
    the resources now. Let's go and get it done.
        Thank you very much. I yield back, Mr. Chairman.
        Mr. Bishop. Thank you, Dr. Harris.
        At this time I am delighted to recognize the gentleman from
    Wisconsin, Mr. Pocan.
        Mr. Pocan. Thank you very much, Mr. Chairman, and thank
    you, Mr. Secretary, for being with us.
        One of the things I wanted to lead with is to thank you for
    that additional money for SNAP and the outreach defined, making
    sure that everyone who needs that program has access to that
    program.
        Perhaps in a body made up of half millionaires, we do not
    quite understand the need for SNAP like people in my district
    do, and even though we are coming out of COVID, there are some
    industries that have not and some populations that have not.
        So thank you for that increase in the budget.
        I would like to get to three subject areas, and I think the
    first two you can probably answer fairly quickly and maybe
    leave a little bit more time for the third.
        Just kind of giving you a little up-front.
        ARS buildings and facilities, you know, those Agricultural
    Research buildings are so important. We recently in the omnibus
    got money to replace a World War II era building that we had in
    Wisconsin in my district. I appreciate that.
        So we also know that with increased cost, some of those
    building costs are going to be more than people anticipated.
    These buildings across the country, I am hearing estimates of
    price increases that are approaching $200 million.
        So my question is are we able to support meeting these
    needs in the fiscal year 2023 appropriations bill?
        And how can we make sure that, you know, with these
    increases when people have budgeted for something that there
    may be additional support for these buildings to still be able
    to get off the ground?
        Secretary Vilsack. It is a great question, and I will be
    honest with you. It is a challenge. We have got 23 or so
    projects that we were adequately and fully funded by Congress
    in previous budgets. We now are very concerned about the
    increased cost and the impact on those 23.
        We have several that are partially funded, which obviously
    will impact. We are going to continue to look for ways in which
    we can stretch those dollars.
        These facilities are incredibly important to our research
    priorities, and so we are going to continue to look for ways to
    make sure we do as much as we can with the resources that we
    have.
        Mr. Pocan. I appreciate that. Thank you.
        Community facility loans, you know, we have had a couple of
    communities in my district last year that, through some of your
    department's critical functions, you are providing financing
    for infrastructure in rural communities. We are grateful that
    they approved these community facility loans for projects in
    Baraboo and Lafayette in my district.
        However, both of these communities ran into the same issue
    in dealing with real development and ultimately had to have
    their loan underwritten twice, once by the State office and
    then once by the Federal office. That put both projects in
    jeopardy because of the length of time it took, and honestly, I
    ran out of excuses in talking to them along the way.
        Can you speak to why there is this process that is now
    taking twice to have some of these loans underwritten and what
    we could do to maybe streamline that timeline?
        Secretary Vilsack. You know, Congressman, that is a
    question that I do not have a very good answer to, but it is a
    concerning question that you ask, and what I will do is I will
    go back to our team and ask the question why we have made it
    more difficult.
        The goal here should be to making it easier instead of more
    difficult.
        Mr. Pocan. Yes, and I know that is your goal. So that
    right, but maybe this is more raising awareness, but in two
    communities we had this problem, and one, it was a little
    embarrassing. Every time I went up there I did not have an
    answer for them.
        At least, you know, everything is taken care of now, but it
    is an issue.
        Finally, I want to thank you for the additional money that
    you have in antitrust enforcement you asked for, specifically
    what I would call the meatpacking cartel in this country.
        As we know, we have very few companies that are doing this,
    and yet at a hearing this week, you know, again, they deny any
    price fixing and everything else, but we are hearing from the
    actual cattle ranchers that they get some of the lowest prices
    and they are barely getting by.
        As you look at this money, how can some of this go to
    trying to address the cost increases that people right now are
    experiencing?
        Because I truly believe this is one where price gouging is
    at the center of why we have some of these increases around me.
        Secretary Vilsack. I think there are three things. First of
    all, it is important and necessary for us to have continued
    competition and expanded competition, which is why we have
    announced a series of programs to help existing processing
    facilities that are small and midsize stay in business and be
    able to expand, while we have also addressed and will be
    addressing this summer the expansion of new facilities to
    provide competition.
        Secondly, I think it is about transparency. We are, in
    fact, looking at the packers and stockyard rules and making
    sure that they are strong enough to be able to send a clear
    message that it is not appropriate to take advantage of
    producer.
        And then finally, it is, in fact, once you have
    strengthened packers and stockyards' capacity basically having
    the resources to be able to call people and hold people
    accountable.
        And that is the intent of what we expect to be able to do
    at USDA.
        Mr. Pocan. Well, with my time left I am going to make sure
    I am respectful of the chairman's request, but thank you very
    much on this front, and I really look forward to what we are
    able to do.
        So thanks so much. I appreciate it.
        I yield back, Mr. Chairman.
        Mr. Bishop. Thank you, Mr. Pocan.
        At this time I am delighted to recognize the gentleman from
    California, Mr. Valadao.
        Mr. Valadao, you are recognized.
        Mr. Valadao. I appreciate that. Thank you very much,
    Chairman.
        Secretary Vilsack, thank you for coming today to testify in
    front of the subcommittee.
        The jurisdiction of your department includes one of the
    most important issues of agriculture producers in rural
    communities, members throughout my district and in the Central
    Valley of California.
        And personally, I would like to thank you for taking some
    time to personally come out and visit the district a few months
    back. I really appreciate that.
        Since you last testified the water conditions have
    unfortunately not improved throughout the West, particularly in
    Central Valley. Despite the adoption of more modern and
    efficient technologies, including drift, farmland in my
    district continues to be fallow. Wells are going dry.
        And your testimony highlights the importance of all
    Americans to, as you say, have access to healthy, affordable
    food. And I could not agree more.
        But it is the situations like the one we are currently
    facing in the West, along with supply chain issue and workforce
    shortages, that are proving to make this task a much more
    difficult task than it should be.
        Last spring President Biden established the Drought Relief
    Working Group, of which you are a part. Please update us on
    what you and the other task force members are doing to assist
    agriculture producers and rural communities as it relates to
    the horrible effects of the ongoing drought.
        Secretary Vilsack. Well, there are several things,
    Congressman. First of all, we are in the process of providing
    the resources that you all provided with the WHIP-Plus program.
    We just recently put out about $550 million to livestock
    producers that were impacted by a series of weather-related
    issues.
        We have basically simplified that process. We anticipated
    and expect that we will begin to get the payments to crop
    producers out in May and early June, and that process is going
    to result in resources getting to farmers relatively quickly.
        We also are obviously making sure that folks take full
    advantage of the Livestock Indemnity Program. Crop insurance
    and the NAP Program are available.
        We recently made sure that folks were aware of the
    Emergency Assistance for Livestock, Honeybee and Farm-Raised
    Fish, and expanded that opportunity not only to cover
    indemnity, but also to cover transportation expenses.
        So we have looked for ways in which we can make it a little
    bit easier. We continue to work on our modeling. We continue to
    work on providing information to producers so they can make the
    most informed decisions concerning what they can do and where
    they can do it.
        We continue to focus on our climate hubs to provide
    additional ways of mitigating and adaptation strategies. So
    there is, I think, a series of things that we have done, and we
    will continue to look for ways in which we can provide
    assistance and help.
        Mr. Valadao. I appreciate that, and hopefully we can work
    together on that because that situation is going to get more
    dire as the weather warms up.
        So, Secretary Vilsack, the next issue for me is farmers in
    my district have had nearly four years of market turmoil
    overseas and here at home. At this very moment, the industry
    faces millions in losses every day simply because they cannot
    get their goods onto ships out of port.
        We have seen government purchasing sprees for feeding
    programs' support payment, but these actions miss the mark in
    significantly connecting our farmers' and ranchers' abundance
    of food with our growing population.
        Simply put, USDA must do more and must be more aggressive
    to promote our homegrown agriculture goods and encourage U.S.
    consumers to support our local farmers.
        How does the USDA plan to address the ongoing challenge,
    especially with the port situation, and take action to ramp up
    domestic consumption and promotion of U.S. products?
        Secretary Vilsack. Well, we have had an opportunity to work
    with the Port of Oakland and the Port of Seattle to create
    essentially a pop-up location, which hopefully will increase
    the utilization of empty containers that have been leaving our
    ports without agricultural products to be essentially with
    agricultural products.
        We had a record year in exports last year. We anticipate
    and expect a record year as well this year, but there is
    obviously continued work.
        We continue to reach out to shippers, have had
    communications and contact with the shippers to encourage them
    to do a better job.
        We are obviously taking a look at what you all and Congress
    can do in terms of the legislation that is being proposed to
    essentially provide some additional tools.
        We continue to work with the Maritime Commission to
    encourage them to use the tools that are available.
        We recently talked to the National Surface Transportation
    Board to deal with the rail issues that have been problematic.
        We continue to work with our sister agencies to encourage
    an acceleration of CDLs so we get folks behind the wheels of
    trucks to be able to move product in the market both
    domestically and internationally.
        We are going to continue to look for creative ways. We are
    open to ideas and thoughts, and, Congressman, if you have ideas
    and thoughts about what we need to be doing that we are not
    doing, I am more than happy to hear from you and to be able to
    direct some of the resources that we have available for that
    purpose.
        Mr. Valadao. I appreciate that.
        With the five-minute time limit, it is hard to get into
    those types of details here, but I do look forward to that
    opportunity to have a continued dialogue because a lot of the
    ideas that you mentioned are helpful.
        The Ocean Shipping Reform Act, if we can get that out of
    Congress over to the President's desk, I think that would be
    helpful.
        But the reality is farmers are seeing lower prices. I mean,
    almonds are low. Pistachios, still not very well. I met with my
    walnut guys, and these guys are all truly struggling because
    they cannot get product on the ships.
        So I appreciate the efforts, and I yield back.
        Mr. Bishop. Thank you, Mr. Valadao.
        I now recognize the gentlelady from Illinois, Ms.
    Underwood. You are now recognized for five minutes for your
    questions.
        Ms. Underwood. Well, thank you, Mr. Chairman.
        And thank you, Secretary Vilsack and Mr. Rapp, for joining
    us for this hearing today.
        I have been hearing from farmers in my district who are
    facing increased input cost, including the cost of fertilizer,
    and I am hearing that it is cutting into their bottom line.
        Pandemic-related supply chain disruptions and Putin's
    unprovoked war against Ukraine have undoubtedly contributed to
    this problem.
        But we also know that a longstanding, significant factor
    has been the trends of market consolidation and anticompetitive
    practices in the agriculture industry.
        We also understand that the vast majority of our fertilizer
    supply is controlled by a small number of large corporations,
    which is similar to what is happening with our meat processing
    system.
        And so, you know, farmers and producers are absorbing high
    cost and accepting unfair contracts because huge corporations
    know that they do not have a choice.
        It is also threatening the sustainability of smaller farms.
    It is destabilizing our food supply and harming consumers.
        We know that the Biden administration and USDA are taking
    action, including a recent announcement that USDA is setting up
    a $250 million grant program to support independent and
    sustainable American fertilizer production.
        Can you give us an update on the status of this grant
    program, including when this funding will become available and
    whether it will continue for fiscal year 2023?
        Secretary Vilsack. Well, I appreciate the question.
        Our intent and goal are to try to solicit information which
    we are doing at this point in time on ideas about how best to
    use those resources.
        I would expect and anticipate that we will close that
    information gathering process sometime this summer and begin to
    make decisions in terms of how best to allocate those resources
    and perhaps even add to those resources.
        I would also say that we have taken additional action. We
    are working with State Attorney Generals who are currently
    doing a market study of the very issue that we talked about in
    terms of consolidation and whether or not these price increases
    that the farmers have seen are justified.
        We continue to do research on ways in which we potentially
    could use less fertilizer. We continue to look for ways in
    which we can encourage farmers to use conservation practices
    and crop decisions that may result in the need for less
    fertilizer.
        And we have recently provided a new risk management tool to
    encourage farmers, particularly in the Midwest, to consider
    only a single application of nitrogen fertilizer, and then if
    they suffer product loss as a result or productivity loss, we
    would have an opportunity to provide some additional resource
    to sort of offset that loss.
        So there is a variety of ways in which we are currently
    trying to address this issue in a very aggressive way.
        Ms. Underwood. I appreciate that, but for the grant do you
    have any estimation for fiscal year 2023?
        Secretary Vilsack. Well, our goal is to obviously make
    decisions before the end of this fiscal year. We have utilized
    these resources from CCC. So it is an opportunity for us to
    basically figure out what is it that farmers and what is it
    that the market believes needs to be done.
        It is not an easy issue. It is a relatively complicated
    issue, and we may find that need to put more resources behind
    this initiative, and that is one of the reasons why we are
    collecting information.
        Ms. Underwood. I am also very pleased that USDA and the
    Department of Justice are working together to increase
    enforcement of Federal antitrust laws in the Packers and
    Stockyards Act, including setting up a joint online portal for
    producers to report potential violations.
        Can you provide an update on the progress of this joint
    USDA-DOJ effort so far?
        And does this scope extend beyond the meat processing
    sector, for example, into fertilizers, seed, and other
    industries?
        Secretary Vilsack. We continue to monitor the portal for
    information that would allow the Department of Justice to make
    decisions about whether or not cases should be pursued.
        In the meantime, what we are doing at USDA is the process
    of strengthening the Packers and Stockyards Act to make sure
    that we have an Act that, in fact, provides a balanced and
    level playing field for producers.
        You will probably see in the very near future our efforts
    in terms of the poultry tournament system, providing greater
    transparency and fairness in that system. That will be followed
    by a focus on discrimination and retaliation to basically
    provide some relief in circumstances where folks are being
    discriminated against or retaliated against.
        And then we will have a rule at some point in time this
    year on our preferences. So there is an effort to try to
    strengthen our capacity to take action.
        Ms. Underwood. In addition to unfair and anticompetitive
    forces in agricultural input industries in the markets for
    agricultural goods, our small and midsized farmers are up
    against farm un-consolidation. For decades Federal policy has
    consistently favored large farm operations, and start-up farms
    and small farms have struggled to access USDA resources.
        What efforts are you all taking to reverse those trends?
        Secretary Vilsack. Well, the first thing we did is to
    establish the rule that was in the 2018 farm bill for heirs'
    property, to basically allow the consolidated or fractionated
    interest into a single owner so that individuals could qualify
    for programs that would allow them potentially to purchase
    land.
        Secondly, as you may know, under the American Rescue Plan,
    Section 1006, there are resources for us to figure out ways in
    which we can provide access to land.
        You know, this is a complicated issue. We are looking at
    ways in which, for example, Federal lands could potentially be
    made more readily available to historically underserved
    producers.
        We are working with our outreach partners. We have recently
    provided $75 million in resources at 20 different organizations
    and groups to help us understand how we can best provide not
    only land access, but also market access. You can have land,
    but if you don't have markets, you need both, and we are in the
    process of trying to figure out ways in which we can expand
    both land access and market access.
        Ms. Underwood. I yield back.
        Mr. Bishop. Thank you, Mr. Secretary and thank you Ms.
    Underwood, for your very insightful questions.
        And at this time I would like to recognize the gentleman
    from Washington, Mr. Newhouse.
        Mr. Newhouse. Thank you, Mr. Bishop. Mr. Chairman, I
    appreciate that.
        It is good to see you, Secretary Vilsack. Thanks for being
    with us today.
        Let me associate myself with some of the remarks you have
    already heard. As one of the farmers that is serving in
    Congress, as you well know, there is a lot of anxiety in ag.
    country these days. There are a lot of challenges that we face,
    and we certainly appreciate your efforts in recognizing those
    facts and all of the hard work the agency is doing to assist
    the industry.
        First of all, something that is very important to me, I
    want to thank you for your support of the Farm Workforce
    Modernization Act, particularly your testimony. I think it was
    last fall, last year anyway, in front of the Senate Judiciary
    Committee.
        I am sure in your travels around the country you are
    hearing just like I am that labor is one of the biggest issues
    facing our farmers and our ranchers, and it goes without saying
    that our immigration laws are broken. We need to fix them. We
    need meaningful immigration reform.
        We have got to have a legal workforce and an available
    workforce, and I appreciate your efforts on that.
        I am hopeful still and I would appreciate if you could
    continue to put some urgency in the Senate as much as you can
    with your strong voice that we can get something done this year
    to pass that legislation into law.
        Kind of an unrelated topic though, I wanted to touch on the
    dietary guidelines for Americans just issued. As you are well
    aware, the last few rewrites of the DGA have been criticized,
    gosh, from several different sectors.
        Congress has repeatedly urged the USDA and HHS I should say
    to improve the transparency, the process, the objectivity, and
    to rely on the preponderance of scientific evidence to make any
    changes.
        You are well aware that Congress at least twice over the
    last several years has mandated that NASEM, or the National
    Academies of Sciences, Engineering, and Medicine, review the DJ
    process and report back to us, as well as other relevant
    agencies with recommendations.
        We have also weighed in as part of the fiscal year 2022
    Appropriations Act, directing NASEM to further review the 2020
    process and advise the agencies on how the next rewrite could
    be improved.
        So, Mr. Secretary, it is my understanding these
    recommendations from NASEM are still not out. Admittedly, there
    have been some starts and stops, but to complicate things, your
    agency as well as HHS issued in April a Federal Register notice
    that the process to write the new 2025 to 2030 dietary
    guidelines has begun, including the release of the proposed
    research questions to be considered by the next committee.
        So a couple of things, and maybe I will ask several
    questions here and in your response, you can touch on some of
    them.
        Can you help us feel assured that the work of NASEM is not
    being ignored?
        And how will the department plan to incorporate the
    findings and recommendations of NASEM's review?
        And could you inform me why the committee's work at the
    NASEM was put on hold for two months earlier this year?
    Essentially why the start and stop that we are seeing?
        And will you assure that the department will incorporate
    the findings and recommendations of any NASEM review into the
    development of the new guidelines?
        And then particularly, was a decision not to have the next
    DGA Committee focus on any alcohol research questions a result
    of recommendations from the NASEM or was that a recommendation
    from another Federal agency?
        I know there is a lot there, but if you could respond, I
    would appreciate that.
        Secretary Vilsack. Well, I think the key take-away to your
    question, Congressman, about the DGA is the amount of time it
    takes to actually get this done in an orderly and proper
    fashion. So it is important for us to have started this process
    now by basically putting together a set of questions which we
    are asking people to respond to and react to.
        It may very well be that the set of questions that we
    propose are not, in fact, the set of questions that we actually
    present to the researchers for consideration because we may get
    push-back. We may get, ``Hey, you left out this or you should
    not have included that.''
        That is the whole purpose here. The whole purpose is to
    give people an opportunity to weigh in on whether we are
    hitting the mark or missing the mark, and I would expect and
    anticipate to the extent that the research and review of the
    DGAs comes up with proposals to strengthen the effort to make
    sure that we are, in fact, following the science, there would
    be no reason why we would not be interested in adopting those.
        Obviously, we have got a partner in this in HHS, and they
    have a say in it as well. In fact, they are the lead agency for
    this go-round.
        But we will continue to work hard to try to make sure these
    dietary guidelines are appropriate and supported by the
    science.
        Mr. Bishop. Thank you very much, Mr. Newhouse and Secretary
    Vilsack.
        Mr. Newhouse. Thank you.
        Mr. Bishop. At this time, we have been joined by the
    distinguished chair of the full committee, the gentlelady from
    Connecticut, Ms. DeLauro.
        At this time recognizing her busy schedule and conflicting
    hearings today, I would like to recognize her for five minutes
    for whatever purpose she may deem appropriate.
        The Chair. Thank you so much. Thank you very, very much. I
    want to thank my colleagues on the committee as well for
    allowing me to move forward.
        And it is wonderful to see you, Mr. Secretary, again and
    thank you for your testimony, but thank you for your many years
    of dedication and hard work always in this area.
        I have questions that I will submit for the record, but I
    wanted to speak about an extremely disturbing report that I
    recently acquired from a whistleblower who worked at the Abbott
    facility, which produces instant formula recalled by the FDA in
    February.
        Chairman Bishop, I really appreciate you giving me the
    opportunity to share this during this hearing.
        Mr. Secretary, to my knowledge you have not seen this
    report, and I bring it to your attention because I know of your
    deep commitment to child nutrition and the WIC Program is
    important to maternal and child health outcomes.
        Abbott Nutrition is the exclusive supplier for the majority
    of State WIC agencies, and this has a serious impact on
    families served by WIC. Over 1.2 million infants serviced by
    WIC are limited to specific grants of contract formula, like
    Similac.
        I believe you will be as outraged as I am by what this
    report means for the health of those infants.
        In September 2021, FDA learned of a potential link between
    a rare and deadly food-borne pathogen in powered infant formula
    manufactured by Abbott Laboratories in a facility in Sturgis,
    Michigan.
        This week, I received a 34-page report from a
    whistleblower, a former employee at the plant which produced
    the contaminated formula, which led to at least four
    hospitalizations and the deaths of at least two babies.
        The whistleblower report lays out a damning list of
    allegations of wrongdoing at this factory, including
    falsification of records relating to testing of seals, signing
    verifications without adequate knowledge, failure to maintain
    accurate maintenance records, shipping packages with fill rates
    lower than what was on the label, and more; releasing untested
    infant formula; hiding information during the 2019 FDA audit;
    lax practices associated with clean, in-place procedures; lack
    of traceability of the product; failure to take corrective
    measures once the company knew their testing procedures were
    deficient; an atmosphere of retaliation against any employee
    who raised concerns about company practices.
        And these are just a few of the allegations laid out in the
    report.
        I want to remind everyone we are talking about infant
    formula. Parents trust that formula will be safe and healthy
    for their newborn babies. It should be the most regulated of
    any product.
        I am deeply concerned about the practices at this Abbott
    facility and their apparent failure to implement and enforce
    internal controls at this facility. We need to know exactly who
    in the company was aware of this failure and the alleged
    attempts to hide this information from the FDA.
        I am equally concerned that the FDA reacted far too slowly
    to this report. The report was submitted to the FDA on October
    19, 2021. The FDA did not interview the whistleblower until
    late December 2021.
        According to news reports FDA did not inspect the plant in
    person until January 31st, 2022, and the recall was not issued
    until February 17th, 2022.
        Why did the FDA not spring into action? Why did it take
    four months to pull this formula off store shelves?
        How many infants received contaminated formula during this
    time by parents who trusted that formula they were buying was
    safe?
        How many additional illnesses and deaths were there due to
    the FDA's slow response?
        I have already requested the HHS Inspector General to look
    into this. I can assure that this committee will also carry out
    its oversight role to find answers into how this happened and
    how we can prevent it from ever happening again.
        I want to say thank you to the brave whistleblower for
    coming forward with this critical information. Mr. Secretary,
    we look to you and the USDA for leadership on issues of child
    nutrition. I strongly encourage you to investigate USDA's
    contracts with Abbott Nutrition. If Abbott cannot guarantee the
    safety of infant formula purchased through the WIC Program, the
    federal government should not be in business with them. I look
    forward to working with you on this.
        And Mr. Chairman, I ask unanimous consent to submit this
    report to the committee record for this hearing.
        Mr. Bishop. Without objection, it is so ordered.
        The Chair. And I want to once again thank you, Mr.
    Chairman. I know of your interest in the issues of child
    nutrition and of children being safe with the food that their
    parents believe that they are eating and, in this particular
    case, what infants are being fed, so, again, thank you very,
    very much. And I want to thank, again, my colleagues on the
    committee for allowing me to move forward.
        Mr. Bishop. Thank you, Madam Chair. Thank you very much. At
    this time, I am delighted to recognize the gentleman from
    Michigan, Mr. Moolenaar. Is Mr. Moolenaar--I'd like to
    recognize you for five minutes for your questions. You are now
    recognized, sir.
        Mr. Moolenaar. Thank you, Mr. Chairman. And Mr. Secretary,
    thank you for appearing today. And just a few things I wanted
    to touch base with you on. First of all, just want to
    reemphasize the importance of rural broadband. And I know that
    is something very high on your radar screen. And just want to
    continue encouraging movement forward in that.
        Also, I wanted to talk with you about the avian influenza
    and just get your thoughts on that going forward and how we are
    addressing it and what we need to do going forward. And, you
    know, obviously the African swine fever also is a concern as
    well. But wanted to talk with you briefly about the influenza.
        Secretary Vilsack. Congressman, as of today, there are
    roughly 29 states that have dealt with and are dealing with AI,
    the roughly 200--almost 240 blocks have been impacted and
    affected. In 21 states, it's both commercial and backyard
    blocks. In eight states, it's just simply backyard. We have 585
    folks between the federal and state efforts here focused on
    this on a daily basis.
        We are concerned, obviously, about rapid spread, and that
    is why we have encouraged producers to be very cautious and
    very careful about biosecurity. I would say that we, I think,
    have seen improvements in that respect. We more rapidly
    identify AI. We more rapidly respond and more rapidly
    quarantine. We more rapidly depopulate and dispose. And
    that's--and compared to where things were in 2014 and 2015,
    we've sequenced about 1100 genomes of this virus so that we
    have a sense of where its headed. About $146 million, which has
    been paid in indemnities to this point, we just recently
    received approval for another 263 million.
        To put this in proper perspective, that is about half of
    where we were in 2014/2015 with the last outbreak. We are going
    to continue to focus on rapid detection, quick quarantine and
    disposal--depopulation and disposal. And hopefully with the
    warming temperatures, we will see an abatement of this--of this
    virus. Not much you can do in terms of wild fox. So that is why
    it is important for producers to be very careful in
    biosecurity.
        On African swine fever, obviously the goal here is to make
    sure it doesn't hit the mainland. We have created a protective
    zone in Puerto Rico. We are working with the Dominican Republic
    and Haitian officials to begin the process of trying to get it
    under control in those countries. We are working with other
    partners, Mexico, to basically encourage a real focus in the
    Dominican Republic and Haiti on this issue. We provided
    resources. We provided staff. We provided lab operations, and
    we have also bulked up our own security, working with Customs
    folks. We are making sure that the right questions are being
    asked. And the last thing I would say is we have got a very
    aggressive advertising and marketing program in airports
    basically encouraging folks not to bring into the United States
    anything that could potentially compromise our pork industry.
        Mr. Moolenaar. Okay. Thank you very much, Mr. Secretary.
    I'm kind of between two hearings this morning, so I appreciate
    your response and look forward to working with you in the year
    ahead.
        Thank you, Mr. Chairman. I yield back.
        Mr. Bishop. Thank you, Mr. Moolenaar.
        And at this time, I am pleased to recognize the gentlelady
    from New York, Ms. Meng. You are now recognized for five
    minutes.
        Ms. Meng. Thank you, Mr. Chairman, and Secretary Vilsack.
    It is good to see you again. Thank you so much for being with
    us today. I wanted to ask about the availability of foods that
    are certified kosher and halal in the Emergency Food Assistance
    Program. As you know, there has been a tremendous increase in
    demand for food assistance nationwide. But unfortunately, there
    are still very few items that are certified kosher on the TEFAP
    available foods list that is critical for helping pantries and
    banks meet this increased demand.
        Last year, I secured language in the House report urging
    your department to work with both Jewish and Muslim community
    leaders on expanding this list to ensure TEFAP was accessible
    for those with culturally or religiously sensitive diets. In
    September, we then sent a letter signed by 47 of my colleagues
    requesting an update on USDA's plan.
        I am aware that USDA is gathering information. But while I
    appreciate that a comprehensive strategy will take time, I
    would like to know what can be done now to address so many of
    the unmet needs of individuals with religious or cultural
    dietary needs and TEFAP food boxes. And also, are there
    particular challenges that USDA is facing in expanding the
    number of processed or shelf-stabled foods that are certified
    kosher or halal that are listed on the TEFAP available foods
    list? And does USDA need additional funding to expand kosher
    and halal options on the list?
        Secretary Vilsack. Well, one of the things we have done,
    Congresswoman, is we have begun to try to develop a more robust
    local and regional connection to the TEFAP program. So we have
    provided resources that will go through states to be able to
    establish and provide hundreds of millions of dollars of
    purchasing at the local and regional level. And this is one way
    of addressing the issue as we are formulating a much more
    longer-term and more comprehensive strategy.
        It gives the ability to use those resources at the local
    level to purchase those culturally appropriate foods. We are
    also doing this, I might add, not only for TEFAP, but we are
    also doing it in relationship to School Nutrition Program as
    well, providing additional resources to schools and encouraging
    them to utilize this for the purchases at the local level.
        We also have been working and provided a program called the
    Region Resiliency Program with food banks where we are offering
    resources to be able to allow them to deal with culturally
    sensitive foods. And this is also remote and rural areas as
    well as the infrastructure. The first wave of those grants
    should be forthcoming in the very near future. So there is an
    effort here to provide the resources while we are putting
    together the plan.
        I think we have sufficient personnel to put the plan
    together. Obviously, it somewhat depends on the input that we
    get in terms of whether or not we have sufficient resources.
    And once we have a sense of that, we will certainly let you
    know.
        Mr. Bishop. Congresswoman, I think you are on mute.
        Ms. Meng. Sorry. Thank you for that. And then I wanted to
    also ask quickly about hot foods exemption and SNAP. We
    discussed this last year when you came before this committee. I
    am grateful to see your review of the Thrifty Food Plan include
    an increase to the SNAP benefit to reflect current food prices
    beneficiaries are facing but also want to know of any
    additional efforts to modernize the SNAP program, specifically
    a permanent repeal of the hot foods provision.
        Secretary Vilsack. Our focus--to be candid, our focus
    initially on SNAP was to take a look at the Thrifty Food Plan,
    not only to take a look at what families are, in fact,
    purchasing from the grocery store but looking at food costs,
    looking at the dietary guidelines and looking at what the
    nutrition science tells us. You know, I will tell you that we--
    you know, we continue to look for ways in which we can create
    greater convenience with reference to SNAP. And we are also
    doing this as well on the WIC Program, basically providing
    online opportunities, online capacity. I think there is still
    some--some policy issues that we have to work through in terms
    of online access, but we are continuing to focus on trying to
    make it as convenient as possible.
        Ms. Meng. Thank you. And we are working on SNAP PLUS Act
    legislation, bipartisan effort with Congress members Bobby Rush
    and Brian Fitzpatrick, which would permanently repeal this
    exemption in SNAP. And in light of the upcoming Farm Bill
    reauthorization, would love to work with you and your team to
    ensure that we are making key nutrition programs accessible to
    the needs of our current world. Thank you, and I yield back.
        Mr. Bishop. Thank you, Ms. Meng. At this time, I am
    delighted to recognize my friend, the gentleman from Alabama
    and the former chair of the subcommittee, Mr. Aderholt. Mr.
    Aderholt, you are now recognized for five minutes.
        Mr. Aderholt. Thank you, Mr. Chair. It is great to be on
    the virtual call today with the Secretary and Mr. Rapp. Thank
    you both for being available today. Of course, it is--as we all
    know, agriculture is a core pillar of American history since
    the foundation of this country. And it is critical that we
    ensure that your department is well-supported to continue that
    legacy. And certainly we want to do what we can to make sure
    that we--from a congressional standpoint and appropriations
    standpoint do what we can. Of course, I want to just mention
    the broadband issue that is something that resonates with so
    many of us on this subcommittee and all through Congress and
    across the United States, whether it be rural districts whether
    it be urban districts, whether it be conservative districts,
    whether it be liberal districts. It is something that really
    is--everybody can agree on it.
        So it is good. Occasionally, they have those issues that
    everyone can agree on and we feel like is important to--for the
    benefit of the entire nation, especially what we have seen
    after the situation with COVID over the last several--or
    actually the last couple of years. But I want to pivot a little
    bit to more on international side of agriculture.
        Of course, Russia's unprovoked war on Ukraine has had a
    ripple effect across the global markets, including the trade of
    key items like wheat and fertilizers. My question, Mr.
    Secretary, would be does the USDA's budget for fiscal year 2023
    address any of the concerns that are emanating from the war in
    Ukraine and its impact on the global food supply chain.
        Secretary Vilsack. I'm kind of used to calling you Mr.
    Chairman. Congressman----
        Mr. Aderholt. I get--chairman.
        Secretary Vilsack. Appreciate the question. Our budget
    basically provides the resources to do what we think is
    necessary. I would say that we just recently today announced
    the ability of us to tap in the Bill Emerson Trust to fully
    utilize all of the resources in that trust to provide food
    assistance. And we are also utilizing some resources from CCC
    to reduce the transportation costs associated with getting
    those products to folks in need. There may very well need to be
    the need to rebill, if you will, the Emerson Trust. And I think
    there is a provision in perhaps a supplemental bill that would
    potentially address that issue.
        So that is a new development and obviously could not take
    into consideration at the time the budget was put together,
    which was pre-invasion. But I would say we want to keep an eye
    on that issue in terms of our ability to provide additional
    assistance in the future.
        Mr. Aderholt. Okay. Good to know that that is on your radar
    screen and will be addressed. And then one last thing. If we
    look beyond the crisis in Ukraine and towards an additional
    efforts to reassure our supply chain, especially in regards to
    China, how does USDA's fiscal year 2023 budget request address
    our reliance on Chinese exports?
        Secretary Vilsack. Well, I would say that the concern we
    have about Chinese exports, Congressman, is the need for us to
    continue to look for ways in which we can diversify so that we
    are not as overly reliant on a single market. We know what
    happened when that market was disrupted during the trade war.
    We saw the devastation to producers. So we are continually--
    look for ways in which we can expand new market opportunities.
    The Indo-Pacific framework that was announced by the USTR is
    one way of focusing on ways in which we can knock down
    barriers. Recently, additional beef sales in Japan, additional
    corn sales, frozen pork sales in Vietnam, potatoes in Mexico.
    We are breaking down barriers, so that we can expand access to
    additional markets.
        I think there are opportunities in Southeast Asia. I think
    there are opportunities in Africa. So the budget basically
    provides us the opportunity to continue to look for ways in
    which we can expand presence.
        At the end of the day, expanding market opportunity is
    about presence. It is about having people in place, which we
    have. It is about the resources that MAPP and FMD provide to
    basically have promotions and the opportunity for us to do
    additional trade missions. So you are going to see a very
    aggressive effort in trade missions this year.
        We had one in the Middle East. We have got one scheduled in
    Spain. We have got one scheduled in Kenya. We have got one
    scheduled in the Philippines. So there is going to be a
    continued focused effort on increasing and expanding our
    presence in these foreign markets, so that we diversify and we
    are not as reliant on China as we have been in the past.
        Mr. Bishop. Thank you, Mr. Aderholt, and thank you, Mr.
    Secretary.
        At this time, I am happy to recognize my friend from Texas,
    Mr. Cuellar. Mr. Cuellar, you are now recognized for 5 minutes.
        Mr. Cuellar. Thank you, Mr. Chairman, and, Mr. Secretary,
    it is a pleasure seeing you again. I want to first of all say--
    I want to thank you for the work that you all are doing in the
    Rural Partners Network. I think it is a great idea getting the
    whole of government together, getting all of the I believe
    about 16 agencies working together. So I certainly want to say
    thank you so much.
        I do understand you have a first cohort that went out, and
    I think there is a second one. But I am still looking for the
    State of Texas where we have got more colonias than any other
    place in the rural areas that we have.
        Just want to see if there is anything we can help you in
    building capacity, because I know that could be an issue. But
    we certainly want to work with you on that issue. That is one
    question on when you think the U.S.-Mexico border can come in.
    I think New Mexico has been covered, but we have the largest
    amount of colonias.
        And then you and I had talked about the colonias
    coordinators and about appointed--you didn't want to have an
    office, but you said we will look at a coordinator. So I want
    to see if there is an update on that.
        And, finally, I want to ask you about the cattle fever
    ticks effort. Since 2008 when we had that farm bill, we have
    been adding monies and appropriations. Through the help of
    Chairman Bishop and other folks, the Farm Bureau, we have been
    adding monies. But in the areas of South Texas along the
    border, we have the Rio Grande Valley, and that causes issues
    because we might do our work on the U.S. side, but then you
    have wildlife that will cross the river. So we are trying to
    set up a buffer state with the governors of Mexico that border
    Texas.
        So I want to see how we can work with you on fever ticks
    because even though we have added millions of dollars, the
    containment has not shrunk. It actually has grown, and that
    affects our cattle industry.
        So those are the questions that I have. And, Mr. Secretary,
    I really want to thank you for the great work that you are all
    doing. We want to be helpful to you in this Appropriations
    Committee.
        Secretary Vilsack. Congressman, we established the Rural
    Partners Network with the $5 million that was appropriated, and
    we have asked in this budget for an increase to $39 million.
    And so our ability to expand this program to other states and
    to other areas of the country is obviously dependent on the
    ability to provide the resources for the staff.
        What this is is basically putting people in specific
    communities, so they are there 365 days a year working with
    folks at the local level to identify programs, and then working
    with the rural desk officers in the 13 federal agencies and 3
    commissions to basically remove whatever barriers may exist to
    developing successful projects.
        We are hopeful that this pilot basically gives us a very
    clear idea of how we need to do business in the future in terms
    of whole of government approach. So, obviously, the additional
    resources would be helpful.
        We haven't forgotten about Texas and the colonias. I can
    tell you that we have our rural development folks very much
    focused on making sure that resources are getting into and
    providing the technical assistance and support for projects in
    that area.
        And I am certainly happy to work with you to encourage
    Secretary Villalobos and others in the Mexican government to
    work collaboratively with you to make sure that we are
    containing the cattle fever tick issue in a way that is more
    satisfactory than we have in the past. Obviously, what we want
    to do is constrain this. We don't want to see it expanded.
        Mr. Cuellar. And, again, before my time is over, I want to
    say thank you. And I want to say thank you on the avocado
    issue. People talk about border crisis, but I think our crisis
    would have been if we would have not got those avocadoes from
    down there to cross the border.
        But I do want to say thank you because of your good
    relationship with the Mexican government that can help us
    diffuse some of those difficult issues that sometimes arise.
        So, Mr. Secretary, just for the record--and it will depend
    on the generosity of this chairman--but we did--we are making a
    request to increase the funding for the rural network program
    that you talked about. So we will work with the chairman and
    the generosity of the full committee. Hopefully, we can expand
    that to other states also because it is a good approach.
        With that, thank you so much, Mr. Secretary.
        Thank you, Mr. Chairman.
        Mr. Bishop. Thank you, Mr. Cuellar and Mr. Secretary.
        At this time, I am pleased to recognize the gentlelady from
    Minnesota, the chair of the Defense Subcommittee. Ms. McCollum,
    you are now recognized for 5 minutes for your questions.
        Ms. McCollum. Thank you, Mr. Chair. Mr. Vilsack, good to
    see you. As you know, we are struggling with Avian Flu in
    Minnesota, and we in the metropolitan area are even trying to
    do our fair share in ceasing the spread of this by asking
    people to remove their bird feeders. It might sound like a
    small thing to do, but we are trying to do everything we can to
    help you and help the Minnesota folks with Avian Flu.
        I was pleased to see that there was an increase of more
    than $350 million to USDA's research programs. They have been
    dealing with COVID-19, climate change, conflict, economic
    downturns. They have all contributed to the rise in hunger, and
    then Russia's unlawful invasion into Ukraine and the effects
    that that has had on global food supply.
        So we are all aware that costs are up, yields are going to
    be down, and I believe, from what I have read, we are at the
    greatest risk with our global food supply since World War II.
        These impacts are being felt at home. They are also being
    felt around the world. Africa imports a huge percentage of its
    food from Russia and Ukraine, and it is being hit especially
    hard. Wheat prices are up by 20--excuse me, 60 percent.
    Fertilizer shortages could cut food production by almost 20
    percent.
        So, and that continent which already is facing severe food
    and malnutrition, security concerns before the conflict, they
    could lose up to $11 billion worth of food, and then, as I have
    said, we have got the conflict--the war in Ukraine.
        This feeds into a national security crisis for the United
    States when there is so much civil strife going on, especially
    for access to food. So I am going to acknowledge the work--I
    have been reading while the hearing has been going on the
    supplemental request.
        Thank you for all the work the Department of Agriculture is
    doing in that to address this. But I want to take just a few
    minutes to ask you about research. U.S. producers and
    consumers, you know, they need help with improving resistance
    to pest, disease, and droughts, and scaling up climate
    resilience.
        So what can you tell us about the role that you hope these
    new investments in agriculture research will play in helping to
    meet not only our food here in the United States and prices
    families can afford, but also the global challenges and demands
    that you are seeing happen?
        Secretary Vilsack. If population projections are accurate,
    we would need as a global community to increase food production
    by 50 percent by the year 2050 in order to feed all of the
    people in the world.
        That is a tremendous increase in productivity, and it is
    not going to happen unless we have the research that allows us
    not only to be more productive but to be more productive in the
    context of a changing climate where we may have less available
    water resources in some parts of the world to be able to
    continue productivity as we know it today.
        So it is incredibly important, from gene editing to
    adaptation and mitigation strategies for climate, that we have
    a robust effort on the research side.
        I am part of the President's Cancer Moonshot. And when I
    say ``I,'' I mean the Department of Agriculture is. I am on the
    Moonshot cabinet. And the reason I am on that cabinet is
    because we have the capacity through research potentially to
    prevent cancer, not to cure it but to prevent it, through
    proper nutrition.
        Specifically, precision nutrition, the ability to really
    focus on specific dietary needs of individuals based on their
    health condition in which food and the food that they consume
    may very well be helpful in either preventing or mitigating the
    consequences of a disease that they may be prone to have. So
    that research is incredibly important.
        We are dealing with an obesity issue in this country. That,
    obviously, speaks to the need for research.
        We have talked about Avian Influenza. We have talked about
    African Swine Fever. We need vaccines. The good news is, on
    African Swine Fever, that we seem to be making some progress,
    fairly accelerated progress, in terms of the development of a
    vaccine that would absolutely cause a sigh of relief on the
    part of pork producers, not just in this country but around the
    world.
        You know, I could go--I mean, there are unlimited
    opportunities. We have aviation biofuel. There is a necessity
    of understanding precisely how to produce a low carbon fuel for
    our transportation system. The airlines are begging for this
    fuel. They need it. We need to do more research on precisely
    what feedstock actually works and how we develop logistically
    the supply chain for that feedstock. There are issues relative
    to the health of our forests that we can talk about. I could go
    on and on and on.
        The point of this is that we haven't funded research. We
    haven't funded it anywhere near the level of importance and
    significance that it has, and that was the reason why I opened
    today with focusing in part on research. If we don't get
    serious about this and continue to nickel and dime it, we are
    just not going to be able to make good progress, and others are
    researching. Our Chinese friends are definitely researching.
        We don't want to be second rate or second class when it
    comes to agriculture research. We need to continue to be a
    leader in this world--in this area.
        Ms. McCollum. Thank you, Mr. Chair, and thank you, Mr.
    Secretary. Mr. Chair, you are muted. You are muted, Mr. Chair.
        Mr. Bishop. I am so sorry. Thank you, Ms. McCollum, and
    thank you, Mr. Secretary.
        And at this time, I would like to recognize the gentlelady
    from Maine, the chair of our subcommittee of interior. Ms.
    Pingree, you are now recognized for 5 minutes for your
    questions.
        Ms. Pingree. Well, thank you so much, Mr. Chair. Thank you
    for holding this hearing today. And, Secretary Vilsack, it is
    always wonderful to see you, and I appreciate your spending
    time with our committee and talking to us about the budget for
    the next year.
        I have a couple of questions I will submit for the record.
    I have some things I often talk to you about about the organic
    rules and about climate change. But I really want to just spend
    my time talking about one thing that is a relatively new issue
    in my State, but really a devastating issue, and that is the
    challenge that our farmers are finding in having their land
    contaminated by PFAS.
        I know I have communicated with the Department about this a
    little bit, and it may be an issue that some of my colleagues
    haven't thought about much, but treat this as a cautionary tale
    because I think that Maine has done a lot of investigation into
    this, our farmers are very actively engaged in trying to
    understand the impact this has on their farms.
        But because much of the contaminated land is due to the
    spreading of sewage sludge on the land, much of it back in the
    1970s and 1980s, it is likely to be appearing in states all
    over the country. And as I say, it is just devastating. I have
    participated in some roundtables with farmers in our State who
    already know they have contaminated land.
        I have met extensively with our commissioner of agriculture
    and our head of the environment, and I am really proud of my
    State for investing in the funds to help farmers test their
    land and to do everything they can to support these farmers.
    But when you listen to a young family--and I know we are all
    anxious to have more young farmers and we have been really
    proud in our State at how many young people have gotten engaged
    in farming--many of them are certified organic, so they are
    particularly cautious about that land.
        But once they find out that they have gotten that diagnosis
    of PFAS contamination, it is just--it is a dead stop. You know,
    all of a sudden, the products that you have been cultivating in
    the greenhouse, the things you are about to plant in the land
    this spring, you just have nowhere to turn.
        Your land is contaminated, and very likely you have produce
    that will be unsaleable. Perhaps you have a dairy herd which
    has been eating contaminated feed. Perhaps you don't have
    contaminated land, but you brought hay from somebody else who
    had contaminated land and didn't know about it. And we have
    just really seen the tip of the iceberg.
        But like I said, it is heartbreaking to talk to the
    farmers. Many of them are concerned about their own health.
    Because we have a lot of young farmers, a lot of them have
    young children who have been, you know, outside playing in the
    yard or drinking the water that is also contaminated.
        Our State is doing a wonderful job investing in testing,
    but it takes a long time. It takes a long time to discover
    which lands had sewage sludge spread on them, and there is a
    lot because it was a conventional practice and probably for
    many years we assumed it was a good idea, and adding fertility
    to the land. We didn't know that there were these permanent
    chemicals--PFAS--in some of that sewage sludge, and we are
    finding it all over our State.
        Some of the farmers, because they don't have time to wait
    for the State, are paying for their own testing. They are
    testing themselves and finding extremely high level of
    contamination in their own bodies, in their children's bodies.
        So I just can't say enough about how hard it is to witness
    this going on and to realize we just don't have the resources.
    We don't have the science. We can't tell a farmer right now
    what to do to mitigate the problem, to remediate the problem,
    and we are still trying to figure out what are safe levels in
    produce, in other products. And our own CDC in the State of
    Maine is doing that kind of research.
        So I know I am kind of going on here, but I just can't say
    enough about it and the importance of the USDA stepping in to
    help. Funds are being set up in our State to support those
    farmers who may be devastated economically, to do more
    research, to do more testing, to support the testing, but I
    guess--and I have contacted the USDA, and I know that you are
    working cooperatively with us, but what else do you need to be
    able to take a bigger leadership role? What kind of funding do
    you think you need to face this problem going into the future?
        And, as always, I certainly invite you to come to the State
    of Maine, because I would love nothing more than having you sit
    down with some of the farmers and hearing their story firsthand
    and hearing, with our own Department of Agriculture, about how
    they are dealing with this.
        Secretary Vilsack. Well, you have correctly identified the
    need for more information. I think we need a national standard,
    so that there is a better understanding of precisely what is
    acceptable. I think we also need to get away from the ad hoc
    commodity-by-commodity assistance program that we currently
    have to create more of an overall program that basically covers
    all of the commodities.
        We have something for the dairy industry, but we don't
    necessarily have something today for produce. And so this is a
    significant funding issue and one that I suspect you are going
    to take up in the farm bill.
        And I would use this opportunity that you have raised just
    simply to make this pitch. We always go into the farm bill
    discussions with the notion that we have to do it within the
    existing budget. I think that is a mistake, and I think there
    needs to be some real thought about this, and we need to maybe
    suggest that on at least this occasion there may be a need for
    additional resources in that farm bill to address these kinds
    of emerging issues that you have just identified.
        Ms. Pingree. Well, thank you for that, and I wholeheartedly
    support you in that endeavor and will look forward to working
    with the Department about all of the things that you needed--
    the criteria, the support, and, really, the change in the way
    that we look at supporting farmers because, as you said, we may
    have some ideas about how to go about it in the dairy industry,
    but beyond that, we haven't given it enough thought, and we
    certainly don't have the program.
        So thank you for your consideration. Thank you very much,
    Mr. Chair. I look forward to working with you on this
    challenging issue.
        Mr. Bishop. Thank you, Ms. Pingree, and thank you, Mr.
    Secretary.
        We have completed the first round of questions, and we will
    now begin the second round. And in that light, I recognize
    myself for 5 minutes.
        Mr. Secretary, I was pleased to see a strong focus on
    minority serving institutions in your fiscal year 2023 budget
    request. And, in particular, I was pleased to see that it
    included requested increases for the Cooperative Extension
    Service and the programs focused on 1890 and 1994 land grant
    institutions.
        Extension programs are notable in their ability to rapidly
    get new agricultural knowledge to end users. 1890 and 1994 land
    grant partners are critical to ensuring that those research
    gains are felt equitably for all of our stakeholders across the
    country.
        As a federal partner of the Nation's extension system, NIFA
    plays a key role in funding, organizing, and strategizing
    extension initiatives. What is your goal for increasing
    extension efforts and building up our minority serving
    institutions?
        Secretary Vilsack. Mr. Chairman, when states began to
    undercut and underfund extension services at the state level,
    extension at the 1862 land grant universities began to
    transition away from providing individual farmer assistance to
    a method of basically working with consultants who in turn are
    working with individual farmers.
        The problem is that many farmers, particularly those who
    have been historically underserved, don't necessarily have
    those crop consultants. They may not be large enough to have
    the crop consultants to be able to provide the assistance and
    technical advice. So it is essential and necessary for us to
    understand the necessity of providing that level of technical--
    individual technical assistance to those producers.
        And one way to do that, obviously, is through minority
    serving institutions. It isn't the only way, but it is an
    important way, because they are a trusted source in those
    communities for information. And so that's why we have
    encouraged an increase--proposed an increase in the budget, to
    basically provide those resources to be able to do more of
    that.
        In addition, we have also, as I mentioned earlier,
    utilizing the Section 1006 money from the American Rescue Plan,
    to also create multiyear commitments to provide additional
    technical assistance and access.
        This is really, really important. You can have a program,
    but if people don't know about it and don't know how to go
    through the process for applying for it, you essentially don't
    have a program. So this is incredibly important, and we hope
    that you find the wisdom in providing additional resources in
    this area.
        Mr. Bishop. Thank you, Mr. Secretary. At last month's
    hearing with the inspector general, we talked about the impact
    of the previous Administration's reorganization of civil rights
    functions at USDA. The OIG recently issued a report that
    indicated that the departmental civil rights strategic plan was
    no longer effective, especially in terms of handling
    complaints. During the hearing, the inspector general stated
    that this was due to the decentralized nature of the approach
    that put more responsibility on the agencies with less
    oversight centrally.
        What is your opinion of the OIG's assessments? And do you
    have plans to undo that reorganization and how you are
    addressing the issues identified in the IG's report?
        Secretary Vilsack. I have a great amount of respect for the
    OIG and its function, and I have a good relationship with
    Phyllis Fong and her team. We meet on a monthly basis to
    basically go over investigations and audits, and so forth, and
    so we are very serious about following the recommendations that
    are made in OIG reports. And that is also true of GAO reports
    as well.
        I will say that our civil rights effort has improved. We
    were at 69 percent EEO rating, and we are now at 79 percent,
    and our hope is that by the end of this fiscal year we are
    closer to 100 percent. We have clearly focused on providing
    information concerning the level of complaints and the handling
    in a timely way of those complaints.
        I get a monthly report on that as well, and I have seen
    progress to the point where now 90--more than 90 percent of all
    EEOC complaints are being handled in a timely way through all
    aspects--acceptance, denial, review, investigation, and so
    forth. So I think we are seeing progress. We have got more to
    do, and we are committed as part of our effort, at creating a
    great place to work and our equity commitment at USDA. We are
    committed to making sure we do everything we can to follow the
    recommendations of the OIG.
        Mr. Bishop. Thank you, Mr. Secretary.
        And, at this time, I will yield and recognize our ranking
    member, Mr. Harris, for additional questions.
        Mr. Harris. Thank you very much, Mr. Chairman. And, again,
    thanks, Mr. Secretary, for being here. Obviously, very
    important Department you run for my district.
        Just to follow up a little bit on the reconnect broadband,
    just to, you know, express a little concern that the
    infrastructure law changed the threshold for underserved area,
    you know, from 90 percent to only 50 percent. You know, if you
    could just keep an eye on it, make sure that doesn't cut out
    some of our rural areas or delay the buildout into our rural
    areas, you know, I would greatly appreciate that.
        Let me talk--just ask one question about the SNAP program.
    You know, the SNAP employment and training programs are great
    ideas. Obviously, you know, a hand up is just as important as a
    handout. In Maryland, we have a couple of great providers, one
    in Annapolis that takes homeless individuals on the program and
    teaches them culinary skills, so they can get employed in the
    food industry.
        How many new SNAP employment and training programs have you
    brought into the program while you have been secretary?
        Secretary Vilsack. Well, we don't bring the--it is not the
    Department's responsibility to bring those programs in. It is
    essentially we provide resources to the state, and then states
    basically provide employment and training.
        When I was secretary before, we basically did a pilot
    project to identify best practices. For example, I can tell you
    the State of Washington has got a very, very good employment
    and training program.
        The one benefit that I have seen between this time and last
    time, we did see historically states not spending, not
    investing all of the employment and training money. That is no
    longer--I am told that is no longer the case, that states are
    in fact utilizing those resources. They are taking resources in
    an innovative way.
        You mentioned Maryland's two programs. I think you would
    find that that is true in many states across the country.
        Mr. Harris. Well, that is great. If you can get back to me
    just with the total numbers that are being funded, I realize
    you are not responsible for getting them in, but, you know,
    what is happening down----
        Secretary Vilsack. Oh, okay.
        Mr. Harris [continuing]. At the state----
        Secretary Vilsack. Yeah.
        Mr. Bishop [continuing]. That would be great. You know,
    just going back to the global food crisis, you know, I
    understand the announcement made today, over $600 billion, I
    guess $670 billion, going to be spent with some--with the
    drawdown on the Bill Emerson Humanitarian Trust for the
    commodity purchase, which is only $282 million of that. That is
    the amount that is going to go to American farmers.
        $388 million from the Commodity Credit Corporation is for
    necessary costs and transportation expenses. Now, I have a
    little heartburn over that because, you know, that seems like
    the tail is wagging the dog. I mean, we have way more costs of
    delivering the item than actually the food product itself,
    which obviously benefits our American farmers.
        And, you know, I understand that, for instance, we could
    save $20 million by not having the requirement for a U.S.
    shipper to deliver these products. Now, again, the Food for
    Peace program, we have that requirement. The shippers have to
    be U.S. shippers.
        But this is an emergency situation, and our choice is
    between spending that 20 million in an already congested market
    for shipping or buying more product from our farmers. So if you
    can address that. You know, is the goal of the USDA to get as
    much product as possible there, realizing that of course these
    administrative costs look very, very high?
        Secretary Vilsack. I had the same reaction you had. In
    fact, the first time I saw the number it was actually higher
    than the 300 million number that you mentioned. We were able to
    essentially ask questions about that high number, got it down
    to the number where it is today.
        There are two components to this. You have mentioned one
    component--well, actually two components. You have mentioned
    one component. There is a cargo preference component, which is
    roughly about $89 million of that number. The balance of that
    number is basically the cost of transportation in the countries
    that we are sending the food to.
        So this is an issue of how difficult it is to get product,
    once you make the decision to provide product to Ethiopia, for
    example, how much does it cost to actually get it to people in
    Ethiopia? That is a pretty expensive proposition, apparently.
        So we ought--we raise these issues. I don't think I--I am
    not sure that I have the authority, as secretary, to waive
    those provisions. I think there are others in the
    Administration that have that authority and would raise that
    issue, and that is a decision that will be made, obviously, by
    those who have the authority to do so. But we have at least put
    it on the table and basically made sure people were aware of
    the fact that we could save those resources.
        Mr. Harris. Thank you.
        Secretary Vilsack. We are obviously looking for ways in
    which we can provide help and assistance. And I might add that
    we are also looking for ways in which we can increase
    productivity here at home, which is why you will see in this
    proposal additional resources to increase the marketing
    assistance loan program and also to incent double cropping in
    the areas where that may make sense for producers, providing
    them incentives and----
        Mr. Harris. Thank you very much. Our time is out. I would
    just ask you to--you know, if we could get that strategic plan
    for Ag ARDA that would be great, you know, get that off the
    ground. But I understand we don't have the plan yet.
        Anyway, I yield back, Mr. Chairman.
        Mr. Bishop. Thank you, Mr. Harris, Dr. Harris, and
    Secretary Vilsack.
        At this time, I am happy to yield for a second round to the
    gentlelady from Illinois. Ms. Underwood, you are now----
        Ms. Underwood. Thank you, Mr. Chairman. Farmers on the
    front lines of climate change both bury the brunt of its
    impacts but also central to delivering climate solutions on the
    path to net zero by 2050, but they cannot do it alone. Advances
    in research, technical assistance, and investments in climate
    smart agricultural practices through USDA will be vital to this
    mission.
        USDA's fiscal year 2023 budget request increased funding
    for the conservation technical assistance to address the
    Administration's priority of addressing climate change.
        Secretary Vilsack, can you explain on how the agency plans
    to use this funding to improve assistance to producers to
    implement climate smart practices?
        Secretary Vilsack. Yes. Basically, what we want to be able
    to do is to continue to provide resources to contract with
    trusted community-building organizations and entities that have
    access to and are connected, if you will, to producers,
    particularly historically underserved producers, to basically
    make sure that they are receiving information about
    conservation programs and receiving information about how to
    apply for and qualify for those conservation programs, helping
    guide them through the process to make sure that they actually
    get the assistance and help.
        Chief Cosby is very interested in and very committed to
    this. We established an appropriation or a set of resources
    this year. We obviously want to make sure that that continues,
    that technical assistance continues. I would also point out
    that we are also providing a billion-dollar initiative on
    climate-smart commodity in forest products. We look forward to
    receiving applications. The deadline for applications is about
    ready to expire. We anticipate and expect a very good interest
    in that program that will also provide support. And we have
    structured that program in a way that ensures that historically
    underserved producers can participate in. We will certainly
    make sure that happens.
        Ms. Underwood. Great. I am encouraged by the
    Administration's request to extend, enhance WIC of cash value
    benefits for fruits and vegetables which reach over 4.75
    million moms and kids across the country, including many in my
    district. These enhanced benefits align with science-based
    recommendations to build on WIC's demonstrated record of
    improving maternal and child health. Improved maternal
    nutrition, in particular, is a key step in preemptively
    addressing risk factors for pregnancy as we seek to reduce
    instances of maternal mortality and morbidity.
        In your view, Mr. Secretary, how do enhanced WIC benefits
    strengthen WIC's public health impact?
        Secretary Vilsack. Well, by providing greater access to
    fruits and vegetables, the belief is that that is obviously
    going to make a difference in terms of the health and well-
    being of pregnant women as well as their children.
        It is one of the reasons why yesterday, I had the
    opportunity to speak to the Black Mayors Association conference
    that is being held in Washington, D.C., and I used that
    opportunity to encourage the mayors who were in attendance at
    that reception to expand access to WIC and to take full
    advantage of the WIC program.
        I am concerned, and I know you are personally, about the
    fact that 50 percent of those who qualify for the program are
    currently not engaged and involved in the program. And
    unfortunately many of those who are qualified that are involved
    are people of color, women of color. And so it is important and
    necessary for us to continue to do a better job of outreach.
        It is one of the reasons why we are allocating some of the
    resources from the American Rescue Plan to basically look at
    ways in which we can improve outreach to get more participation
    in that program. So it is not only increasing the bonus, it is
    also making sure that people are actually available for the
    regular benefits of the program.
        Ms. Underwood. Well, we would certainly be interested in
    hearing more details about that kind of ARP-funded outreach
    effort, if you can have your team follow up with my office.
        Additionally, when we can expect USDA to comprehensively
    evaluate the WIC food package to better align it with scienced-
    based nutrition recommendations, which would strengthen WIC's
    positive impact on maternal and child health?
        Secretary Vilsack. That is forthcoming in the very, very
    near future. I think we are very close to getting that done.
        Ms. Underwood. Okay, but you are committed to doing it?
        Secretary Vilsack. Yes, well, yes, absolutely.
        Ms. Underwood. Okay, great. Thank you so much.
        I yield back.
        Mr. Bishop. Thank you, Ms. Underwood.
        At this time I recognize for a second round of questions.
    Mr. Valadao from California, you are now recognized. Mr.
    Valadao.
        Mr. Valadao. Thank you, Mr. Chairman.
        Mr. Secretary, again, thank you for this opportunity.
    Secretary, the Administrator had a nominee at the USTR for the
    position of Chief Agricultural Negotiator, but that nomination
    was recently pulled and this position remains vacant. Although
    this position is not within your department--I know you
    understand just how important this role is to the people your
    department serves--this role needs to be filled as soon as
    possible, and I am concerned the Administration is not taking
    this position, and to be honest with you, trade as a whole as
    seriously as it should be.
        How do you plan to work with the President, with President
    Biden and USTR Representative, or Ambassador Tai, to support
    filling this role with the most appropriate candidate?
        Secretary Vilsack. I am aware of the fact that the Trade
    Representative just recently concluded three interviews for
    that position. I know two of the three people that she
    interviewed, and I can assure you that both of those
    individuals are highly qualified for that job and they are
    taking that position extremely seriously. And we are in the
    process of hopefully in the final stages of getting a nominee
    to the Undersecretary position here on Trade.
        I would, with all due respect Congressman, I would take a
    little bit of exception to the notion that we are not taking
    trade seriously. I can tell you that I have had more
    conversations on trade, more conversations with ag ministers
    across the--in fact yesterday it was Ireland and the U.K.--we
    are doing more trade missions, we are seeing more barriers
    being broken and taken down in terms of additional product and
    we have a record amount of exports now.
        I understand that there are some commodities that you are
    interested in where we have work to do, but on balance we are
    seeing a significant increase in trade activity. So I think in
    fairness, I wanted to make those points.
        Mr. Valadao. I appreciate that and, obviously, my district
    represents, I want to say somewhere around three, four hundred
    different commodities, and so yes, there have been some where
    exports have increased, but there are some that are truly
    struggling and it is a tough time for a lot of farmers across
    the country. But I just have such a wide variety that I hear,
    especially the ones who are having the toughest time, we hear
    from the most, and so this is something that we are watching
    closely, and I appreciate the efforts that are being made and
    hopefully we get to a conclusion soon and have someone in that
    position.
        The second one comes up a lot as well, the sign-up for the
    second round of the Coronavirus Food Assistance Program, or
    CFAP, closed last October. A lot of my constituents have since
    reached out to my office asking if additional CFAP rounds will
    become available in the future. Our agriculture producers
    across the U.S., especially in my district in Central Valley,
    are still hurting as a result of the pandemic and other issues.
        Do you plan on opening up CFAP again for another round?
        Secretary Vilsack. Well, I think it is dependent on whether
    or not there are resources. There are other steps that we
    intend to take to improve the safety net, which we expect and
    anticipate to be able to roll out during the spring and summer.
    I do not know if it is ``CFAP'' but I think there are
    additional programs that will be made available to producers.
        Mr. Valadao. All right. Mr. Secretary, I appreciate you
    taking some time for us. That is really all the other questions
    I had. Anything else, if I have more, I will submit for the
    record. So thank you for your time today and the opportunity.
        I yield back.
        Mr. Bishop. Thank you very much, Mr. Valadao, and Secretary
    Vilsack.
        At this time for a second round, I am delighted to
    recognize Mr. Newhouse from Washington. You are now recognized
    for five minutes for additional questions.
        Mr. Newhouse. Thank you very much, Mr. Chairman. I
    appreciate that.
        Mr. Secretary, I know you are aware that the Federal
    Columbia River System in the Pacific Northwest comprises 31
    hydroelectric projects in the Columbia River Basin. In fact, I
    would say it is crucial to the ag industry, not only in my
    state but the entire nation, literally 50 percent of our
    domestic exported wheat of the United States goes through this
    system. And that is just one example of really how important
    this is to the agricultural industry.
        I sent you, along with several of my colleagues, a letter,
    I think it was dated March 15th, citing several questions about
    the CEQ's engagement process, the stakeholder engagement
    process, and the focus that breaching the Lower Snake River
    dams would have on our agricultural sector, and if I could, I
    would like to follow up on that letter.
        My questions are this: Has the CEQ included USDA in the
    current stakeholder engagement process examining the species
    recovery in the Columbia River Basin; and if so, what is the
    USDA's role in that process?
        And then has the USDA been consulted on the impact removing
    the Lower Snake River dams would have on wheat producers, and
    specifically and how removing the producer's method of
    transportation to the West Coast would affect U.S. wheat and
    other domestic markets?
        Secretary Vilsack. Congressman, I would say that our
    responsibility both with CEQ and also I would say also with EPA
    is to make sure that we are engaging with them to make sure
    they have all the information necessary on the impact that a
    particular course of action being considered would have on
    producers. That is the first thing.
        The second thing is to make sure that we advocate,
    obviously, on behalf of producers, and depending upon what the
    decisions are made, that we then take a look at how we at USDA
    can utilize the resources we have to mitigate the consequences
    or impact of any decision. I mean I don't want to tell CEQ
    necessarily or EPA exactly what to do because I don't frankly
    want them telling me exactly what to do, but we have an
    advisorary role. And then based on what they decide to do
    within their jurisdiction, we can figure out ways in which we
    can potentially help farmers implement, help farmers mitigate
    the consequences of actions.
        Mr. Newhouse. So can I take from that, then, that USDA has
    been engaged with CEQ through this process? Or----
        Secretary Vilsack. I believe it has, Congressman. I could
    be mistaken about this, and if I am we will let you know, but I
    believe we have been engaged because that is our job and it is
    our responsibility.
        Mr. Newhouse. Okay. Okay, well, just to underscore the
    importance of that entire system, too, like I said, the
    nation's agricultural industry, but in particularly the Pacific
    Northwest and the seven neighboring states, it is a critical
    piece of infrastructure would--the breaching dams would
    significantly, negatively, and adversely impact the industry,
    and I appreciate your input and your communication with the CEQ
    as they consider options here.
        Thank you very much, Mr. Secretary. It is always a pleasure
    to see you in front of our committee.
        With that, Mr. Bishop, I will yield back.
        Mr. Bishop. Thank you very much. And Secretary Vilsack,
    thank you so very much for your testimony here today. Mr. Rapp,
    thank you for your attendance and support of Secretary Vilsack.
    We all understand how incredibly busy you are these days, so
    thank you, thank you, thank you for your time. Thank you also
    for the hard work that you and the department are doing to help
    lift up rural America. I look forward to working with you as we
    continue the fiscal year 2023 appropriations process.
        Along with what we have discussed, we will also forward
    additional questions for the record and we will appreciate your
    diligence in getting your responses to us in a timely manner.
        I would recognize Dr. Harris, but I believe he had to
    excuse himself for another hearing, and so he will not be
    giving a closing statement.
        So let me just say in his absence, thank you to Dr. Harris
    and to all of the members in attendance, and thank you for the
    staff who work so hard to pull this hearing together. With
    that, this subcommittee is now adjourned.
        [Questions and answers submitted for the record follow:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

                                                Thursday, May 19, 2022.

                       U.S. FOOD AND DRUG ADMINISTRATION

                                    WITNESS

    DR. ROBERT M. CALIFF, MACC COMMISSIONER OF FOOD AND DRUGS, U.S. FOOD
        AND DRUG ADMINISTRATION
        Mr. Bishop. This meeting of the Agriculture Subcommittee of
    the Appropriations Committee will now come to order.
        At this hearing, it is fully virtual. We must address a few
    housekeeping matters.
        At today's hearing, the chair or staff designated by the
    chair may mute participants' microphones when they are not
    under recognition for purposes of eliminating inadvertent
    background noise.
        Members are responsible for muting and unmuting themselves.
    If I notice that you have not unmuted yourself, I will ask if
    you would like the staff to unmute you. If you indicate
    approval by nodding, staff will unmute your microphone.
        I remind all members and witnesses that the five-minute
    clock still applies. If there is a technology issue, we will
    move to the next member until the issue is resolved. You will
    retain the balance of your time.
        You will notice a clock on your screen that will show how
    much time is remaining. At one minute remaining, the clock will
    turn yellow. At 30 seconds remaining I will gently tap the
    gavel to remind members that their time is almost expired.
        When your time has expired, the clock will turn red and I
    will begin to recognize the next member.
        In terms of speaking order, we will begin with the chair
    and ranking member. Then members present at the time the
    hearing is called to order will be recognized in the order of
    seniority, and finally, members not present at the time the
    hearing is called to order are in the order of their arrival.
        Finally, House rules require me to remind you that we have
    set up an email address which members can send anything they
    with to submit in writing at any of our hearings or markups.
    That email address has been provided in advance to your staff.
        That being said, we will begin.
        And let me just say good morning. I want to welcome all of
    you to today's hearing. The hearing this morning is review the
    Food and Drug Administration's fiscal year 2023 budget request.
        Our witness is the Commissioner of the Federal Drug
    Administration, Dr. Robert Califf.
        Before we begin with hearing proceedings, I would like to
    welcome a new member to our subcommittee. Ms. Julie Letlow
    representing the Fifth District of Louisiana was recently
    selected to join us.
        Welcome, Ms. Letlow, to the wonderful world of Agriculture
    Appropriations.
        Dr. Califf, we would first like to congratulate you on your
    recent confirmation as Commissioner. It has been over a year
    since the FDA had a permanent leader during a time when the
    agency continues to have vast and ever-growing
    responsibilities.
        FDA continues to play a vital role in ensuring the safety
    and efficacy of vaccines and drugs designed to address the
    coronavirus. However, there are countless other ways that your
    work matters to all Americans, and we need to ensure those
    critical responses get the attention that they need.
        I expect much of our conversation today to discuss the
    overall safety and effectiveness of the products under FDA's
    purview, and improvements can be made on both the food and
    medical sides.
        Aside from COVID-19, a myriad of other public health
    challenges, including combatting the opioid crisis, youth
    tobacco use, and new tobacco product standards on flavors. All
    have real world impact on Americans and their health.
        At the forefront of many minds right now is the critically
    low supply of infant formula affecting so many American
    families. The American people rely on FDA to protect infant
    health by ensuring they have access to safe formula.
        I would like to later discuss what FDA is doing to mitigate
    shortages and what changes can be made to improve the
    inspection process of manufacturers. This includes harmful
    delays and inaction on warnings at the Sturgis, Michigan
    facility. The agency received reports as early as September of
    2021, but did not inspect the associated facility until January
    of 2022, which is, indeed, unconscionable.
        I would also like to hear plans to address the backlog of
    foreign inspections and plans to conduct foreign inspections
    moving forward, admitting that all too well that over 75
    percent of active drug ingredients are provided by foreign
    countries, including some with very poor safety profiles.
        Given concerns about drug manufacturing in foreign
    countries, these facilities must be held accountable and
    treated equitably with U.S. manufacturers.
        Unfortunately, food-related illness stemming from outbreaks
    of E. coli and salmonella or toxic levels of heavy metals in
    baby foods and food-related health concerns continue to be of
    monumental concern.
        Citizens put their trust in FDA's regulation and oversight
    every time they sit down for a meal or take a pill, and they
    deserve an FDA that is at the top of its game.
        We want to work with you to help modernize FDA so that you
    can carry out your mission of protecting the health and safety
    of all Americans.
        I want to thank you for being with us today, and I look
    forward to our discussion.
        Lastly, I wish to commend the commitment and talent at the
    agency. While certain issues may exist, we recognize the
    commitment of those that work so hard at the agency to keep our
    food, our medical devices, and our prescription drugs safe.
        In that vein, a special shout-out to the leadership and
    staff at the Center for Biologics and the Center for Devices
    for their monumental effort to get us vaccines and tests for
    COVID-19.
        [The information follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Bishop. Now, let me ask our distinguished Acting
    Ranking Member, Dr. Harris, to give any opening remarks that he
    might have, and I certainly would like to recognize him at this
    time for that purpose.
        Dr. Harris, you are now recognized.
        Mr. Harris. Thank you, Chairman Bishop.
        And I also want to welcome Ms. Letlow to the committee and
    congratulate her on being our new subcommittee member.
        We all look forward to working with you this year.
        Dr. Califf, I want to welcome you to today's hearing. I
    look forward to the discussion on FDA's budget request and
    other topics of importance.
        I will say that FDA's total request of $8.4 billion, which
    is a 25 percent increase above the fiscal year 2022 enacted
    level, is quite steep. I recognize that $1.6 billion in
    mandatory funding is requested to support FDA's part of the
    administration's pandemic preparedness plan.
        But setting that aside, FDA is still seeking an overall
    increase of $509 million, more than half a billion dollars
    above fiscal year 2022, with $153 million coming from new user
    fees.
        Now, without a doubt FDA does critical work that touches
    the lives of all Americans. However, this budget request does
    not acknowledge the economic reality that our Nation faces. In
    times like these, as stewards of taxpayer dollars, we must make
    tough decisions in the greater interest of the American people.
        Growing the size of government programs and the Federal
    workforce is generally not in the best interest of our Nation's
    economy and future.
        Further, I believe that many of the problems facing your
    agency can be solved through strong leadership rather than more
    money.
        For example, as I am sure you are aware, last month
    Politico ran an article titled ``The FDA's Food Failure.''
    There were some repeated concerns that stood out, such as the
    lack of leadership at FDA, the slow decision-making processes,
    and the lack of transparency and accountability to Congress.
        Too often we as appropriators hear how problems will be
    solved if there was only more money or only more staff, but I
    disagree. Leadership is needed to be good stewards of the
    resources at your disposal and to make sure FDA is fulfilling
    its core critical mission.
        Nothing makes that point clearer than the recall and
    shortage of infant formula that is causing almost unimaginable
    stress and anxiety for countless parents and caretakers across
    the country. Nationwide there are reports that 40 percent of
    formula is out of stock. Yet one of the largest formula
    manufacturers in the U.S. has had one-third of its production
    halted since February.
        We need to make sure this plant is re-safe to open, but it
    is hard to see any evidence that FDA has made it a priority to
    get this plant clean and cleared and back online.
        In light of this issue and many other highlights in the
    political water, FDA's budget request for an additional $11.6
    million increase for the Center for Food Safety and Applied
    Nutrition, CFSAN, for health equity through nutrition gives me
    great concern.
        Do not get me wrong. I want all populations to have access
    to healthy foods and the nutritional information they need to
    make healthy decisions. But other agencies within the
    Department of Health and Human Services, along with the U.S.
    Department of Agriculture and their collaboration on the
    dietary guidelines are already doing this type of work.
        Rather than engage in duplicative efforts, I would urge the
    FDA to focus on its core responsibilities.
        It is clear upon the infant formula recall and examples in
    the Politico article that CFSAN does not need to take on new
    initiatives. It needs to focus on its mission-critical
    functions first, such as ensuring a safe and abundant food
    supply for babies and all Americans, and let the other agencies
    tasked with promoting nutrition information do their job.
        Dr. Califf, after you were confirmed, we had the chance to
    talk, and I mentioned my concerns about FDA's EUA standard,
    health care supply chain vulnerabilities, and some other topics
    that I look forward to discussing today.
        Specifically, I would like to see the FDA do more to
    utilize its emergency authorities to more quickly and
    effectively respond in times of crises. I am sure all of us are
    eager to hear how you will bring leadership, accountability,
    and transparency to FDA in light of the recent challenges the
    agency has faced.
        I look forward to working with you, and I appreciate you
    being with us for today's hearing.
        Thank you, Mr. Chairman, and I yield back.
        Mr. Bishop. Thank you very much.
        And at this time I see that we are fortunate to have the
    full committee chair with us, and I would like to now yield to
    Chairwoman Rose DeLauro, the gentlelady from Connecticut, for
    any opening remarks that she may have.
        Ms. DeLauro, you are now recognized. The floor is yours.
        The Chair. Thank you so much, and thank you very, very
    much, Mr. Chairman, and thank you to Acting Ranking Member
    Harris, for holding what is a very important hearing.
        And I want to say a thank you to you, Commissioner Califf,
    for testifying this morning.
        We are dealing with an infant formula emergency in this
    Nation, a crisis of both safety and supply. I sounded the alarm
    on this crisis and have been working on this issue since news
    of the recall growth in February.
        I am glad that you are testifying before us today because
    we need to get to the bottom of the disgraceful lack of
    oversight and a terrible safety issue from an Abbott Nutrition
    manufacturing plant that led to at least two babies dying and
    several others being hospitalized after consuming Abbott's
    infant formula.
        We need also to get to the bottom of FDA's full response
    which contributed to product staying on the shelves and in the
    homes of families the country over, potentially putting babies
    at risk and forcing parents to play a game of Russian roulette
    that they did not know they were playing.
        I want to say thank you to Chairman Bishop for holding this
    hearing and for your long-time leadership on this subcommittee.
        In September 2021, FDA inspectors conducted a routine
    inspection of the Abbott laboratory's facility in Sturgis,
    Michigan, where suspicions of wrongdoing were already present,
    as noted in a Bloomberg article published May 12th from a
    reporter who obtained the FDA report through a Freedom of
    Information Act request.
        On October 20th, 2021, a whistleblower, who worked at that
    Abbott facility, submitted a report to the FDA unveiling a
    damning list of allegations of wrongdoing at the hands of
    Abbott.
        Recalls happened, but if the allegations are true, the
    company has lied, cut corners, falsified records to cover up
    their misdoings at the risk of infant health, and retaliated
    against employees who tried to correct the problems they were
    seeing.
        They knowingly put a contaminated product on the market.
    That is plain wrong.
        The FDA knew about what Abbott was doing in October, but it
    was not until late December that the FDA interviewed the
    whistleblower and then not until a month after that in late
    January was the plant inspected in person.
        Abbott then issued the recall in February, some four months
    later.
        In March, I requested an HHS Office of the Inspector
    General to start looking into the tragedy, and then I got hold
    and submitted for the record the whistleblower report, with a
    truly awful allegation against Abbott.
        Their wrongdoing includes the falsification of records, the
    testing seals on empty cans, releasing untested infant formula,
    just to name a few.
        It all begs the question: why did the FDA not spring into
    action? Why did it take four months to pull this formula off
    the stores' shelves? How many more illnesses and deaths were
    caused due to the FDA's slow response?
        Who received the report at the FDA? What did they do with
    the report? Who in the leadership had access to that report?
    Who did not have access to that report? And why was there no
    reaction?
        It makes me question which side the FDA is on. Are they on
    the side of Abbott and industry or on the side of the American
    consumers, in this case babies and their moms and dads?
        We must get to the bottom of this whole safety issue, but
    today we are dealing with a serious infant formula shortage in
    this country, where parents, many of whom are struggling, are
    now scrambling to find a formula to feed their babies.
        The shortage was caused in large part by the lack of action
    by the FDA and by corporate greed and consolidation, in this
    case, Abbott putting profits and production over people.
        This should not happen in the wealthiest Nation in the
    world, and there are two parts of this shortage: safety and
    supply. And we cannot and should not have to choose between the
    two, and I reject there is danger in this false dichotomy.
        President Biden just announced that he will be invoking the
    Defense Protection Act to increase domestic production of
    infancy formula and launching Operation Fly Formula to use
    Federal planes to fly formula in from abroad.
        I have been calling for the swift importation of safe
    infant formula from FDA approved facilities overseas. That is
    the direction we need to go in. That is what I hope is being
    planned.
        These steps can help us to achieve the goals, and I applaud
    the first steps this week, and we passed last evening a bill to
    deal with a portion of this effort, and last night we voted on
    a bill to provide $28 million in new funding for the FDA to
    address the shortage, to prevent fraudulent products from
    entering the marketplace, and to help acquire better data on
    the situation in the marketplace.
        To prevent shortages from happening again, we will work to
    strengthen the workforce focused on formula issues and increase
    FDA's inspection staff.
        But as the ranking member has pointed out, funding is not
    the only answer. This issue goes beyond funding, and that has
    to do with a structural problem.
        For another time I would want to discuss the need for a
    Deputy Commissioner for Food, with accountability to the
    Commissioner and have direct line authority over the Center for
    Food Safety and Applied Nutrition, the Center for Veterinary
    Medicine, and food related components and operations of the
    Office of Regulatory Affairs.
        This should happen immediately, and the person who is
    appointed needs to have relevant and appropriate food
    credentials, someone with that background who understands this
    issue.
        I understand the FDA has begun to take action to address
    the shortage, which is encouraging. I remain concerned about
    the safety of the formulas that end up on our shelves, and as I
    have said, we cannot be forced to make a false choice between
    safety and supply.
        I am disappointed that the FDA's recently released guidance
    does not go far enough to ensure formula is safe for our babies
    because the food we feed our babies must be the safest product
    on the market, which is why I want to focus on FDA-approved
    facilities, because we have a standard that may not have been
    applied to Abbott, but we have a standard when people grab a
    container of infant formula from the shelf. I want them to know
    that they do not have to play a guessing game. I want them to
    know that they can have confidence that it is safe.
        Commissioner Califf, I hope that you have been able to
    reflect on what went wrong, and with that, come with answers
    because we are all waiting for them. We need to get to the
    bottom of this terrible tragedy to prevent anything like this
    from ever happening again.
        And I thank you so much, Chairman Bishop and Acting Ranking
    Member Harris.
        And I yield back.
        Mr. Bishop. Thank you, Ms. DeLauro, and thank you for your
    passion and compassion on this issue.
        It appears that Ranking Member Granger has not yet entered
    the meeting, and so with that, Dr. Califf, without objection,
    we will recognize you for your testimony.
        Your entire written testimony will be included in the
    record, but I hope that you will give a somewhat abbreviated
    statement so that we can proceed with questions.
        I am sure that members have a number of questions for you
    and we would like to expedite the hearing as much as possible.
        So at this time, Dr. Califf, you are recognized for your
    opening remarks.
        Dr. Califf. Thank you, Mr. Chairman.
        And I will go quickly here because I certainly understand
    your request.
        Chairman Bishop, Ranking Member Harris, and members of the
    subcommittee, thank you for the opportunity to appear before
    you today.
        First, let me thank the subcommittee for your continued
    support of FDA, particularly over the last two years, as the
    agency has worked tirelessly to respond to the COVID-19
    pandemic and other challenges facing the agency, including the
    recent stress on the infant formula supply chain.
        Before discussing FDA's fiscal year 2023 budget request, I
    want to discuss the current events around infant formula and
    reiterate FDA's firm commitment to ensuring the parents and
    caregivers have access to safe and nutritious infant formula.
        As a parent and grandparent, I recognize that many parents
    and caregivers have been unable to access the infant formula
    and critical medical foods that they need, and they are
    understandably frustrated and anxious.
        My daughter spent a month in an intensive care unit as an
    infant, and the memories are certainly still with me.
        The United States was facing infant formula supply chain
    stress even before the Abbott nutrition recall that began in
    February. The pandemic, the war in Ukraine, and labor supply
    issues have all had an impact, and I can assure you FDA has
    been working tirelessly to address this issue.
        This week we have set up a mechanism that streamlines the
    ability for companies that do not normally sell infant formula
    in this country to do so and provides other flexibilities to
    domestic distributors who can help increase availability.
        I want to be clear. Under this process, an infant formula
    would only be imported after the agency reviews the product and
    determines the product is safe and provides adequate nutrition.
    Safety is paramount.
        In addition, a consent decree, a permanent injunction was
    entered between the FDA and Abbott Nutrition. Under the consent
    decree, Abbott has agreed to take actions overseen by FDA and
    independent experts that will result in an increase of infant
    formula products and ensure safe powdered infant formula is
    produced at the facility.
        As you also know, yesterday the President invoked the
    Defense Production Act to ensure that manufacturers have the
    necessary ingredients to make safe, healthy infant formula here
    at home and announced Operation Fly Formula to speed up the
    import of infant formula to stores as soon as possible.
        Again, we know many parents and caregivers are feeling
    frustrated. With these three recent actions, we anticipate that
    additional products can quickly hit U.S. stores.
        We have a critical opportunity here to invest in FDA's
    ability to work with partners to ensure a safe and adequate
    supply of infant formula and metabolic formulas for the
    millions of infants who rely on them for their sole source of
    nutrition.
        Approximately three and a half million infants are born
    annually in the United States, and yet CFSAN has funding for
    only 13 staff members to ensure the safety and adequate
    nutrition of these products.
        We also have no authority or dedicated resources to monitor
    and respond to supply chain disruption. This crisis has shown
    us the impact of having a single manufacturer cease production
    for a brief period, and unless we strengthen the resilience of
    our supply chain, we could be one natural disaster, quality
    mishap, or cyberattack from being here again.
        I hope I can with this committee ensure we have the tools
    and resources we need moving forward. While expressions of
    empathy are important, I know that parents want formula on the
    shelves for healthy infants and in the hands of pediatricians
    for infants with special metabolic problems.
        Since the American public is our customer, I urge when
    considering the budget to give our public funding for
    technology and experts at least as good as businesses we
    regulate. No modern company or health system would make such
    major decisions without a robust data and analytical system and
    dedicated expert analysts to do the work.
        Our budget request will help build a foundation for FDA to
    ultimately enable the agency to meet the growing needs and
    mandates upon which the public depends.
        While there are many critical priorities in our budget
    proposal, I would like to mention three specific funding needs
    that do not get enough public attention: data and technology
    modernization; people; and infrastructure.
        The technology and data systems that we have are not of the
    quality we need for us to fully facilitate innovation in the
    rapidly moving industry which we regulate in order to protect
    the public from well-meaning or intentionally harmful products.
        A final thought here. When we review the infant formula
    situation, we will certainly find specific issues where we
    could have done better, and we will, of course, take
    accountability for any shortcomings. But unless we make the
    right investments in our infrastructure, including technology
    data, people, and a modernized supply chain system, we will
    continue to see shortages and problems across the industries we
    regulate.
        Thank you for inviting me, and I look forward to answering
    your questions.
        [The information follows:]
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        Mr. Bishop. Thank you very much, Commissioner.
        At this time we will begin our questions, and I will begin.
        Commissioner, there will be a lot of questions about the
    infant formula crisis today, but I wanted to lead with the most
    basic questions, and the subcommittee wants a real answer.
        It is unconscionable that it took four months from the time
    the first infant illness was reported before FDA sent an
    inspector to the plant. Why was that?
        Can you walk us through the process going forward on how
    you get the Abbott plant in Sturgis, Michigan back online?
        The President has invoked the Defense Production Act to
    address the formula shortage, and we will purchase formula
    under that from other countries and have them flown into the
    U.S. to restock our shelves, and that we expect to be done
    quickly.
        But this is temporary action. What is the FDA going to be
    doing to assure that this product is safe? As the chairlady has
    pointed out, not only do we need supply, but we need safety.
        Would you address that?
        Dr. Califf. Chairman, first of all, the question of what
    happened. I think Chairman DeLauro, I think, correctly stated
    the time frames. The dates are well known. The information is
    in the public.
        We have an ongoing investigation about the details of
    exactly what happened, you know, from Point A to Point B along
    the way, and since it is ongoing, I cannot give extensively
    more details on that part of it.
        I will comment directly on the issue of bringing the
    Sturgis plant back up, and I think the issues that you all have
    raised in your opening comments really exemplify the problem
    that we face when we have a concentrated industry where taking
    down one plant had such an enormous impact.
        This creates a situation where we have a delicate balance.
    If conditions are unsafe, how do we get the plant back up and
    operating without interrupting the supply, remembering that
    this plant not only makes general infant formula but is the
    largest supplier of the special metabolic formula for about
    3,000 infants in our country who are totally dependent on very
    specialized formula that no one else makes?
        And so we had to really wrestle this to the ground with
    Abbott, ending up in a consent decree with the Justice
    Department, to make sure that as we bring the plant up, both
    the FDA Inspectorate and external experts are watching every
    step of the way.
        I am pleased to say today we have already made significant
    progress, and I think we are on track to get open within the
    next week to two weeks, most likely at the out bounds, two
    weeks, but we are monitoring it every----
        Mr. Bishop. Thank you, Commissioner.
        I hate to interrupt you, but I wanted to get to another
    question quickly, and my time is going to expire. We have moved
    to four minutes.
        Of course, you have heard reference to Politico's story
    indicating a quote that current and former officials used the
    term ``ridiculous,'' ``impossible,'' ``broken,'' ``Byzantine,''
    and ``a joke'' to describe the state of food regulation at FDA,
    and there are questions about the leadership problem.
        What can we expect to see?
        You announced last night that you plan to leverage the
    Principal Deputy Commissioner expertise to provide strategic
    counsel, including the Center for Food Safety and Applied
    Nutrition and Office of Regulatory Affairs.
        What can we expect from this action to improve the
    operations?
        And what is your reaction to Chair DeLauro's suggestion for
    restructuring the center?
        Dr. Califf. Thank you for raising those questions.
        I learned in 2016 that the food side of the FDA was under
    resourced consistently, very much so compared to the medical
    product side of the FDA. You know, we will make sure you are
    supplied with the comparative information.
        It is very important that we have the proper hiring
    authority and are able to pay the salaries of scientists, but
    you are also raising the question of leadership.
        You know, I will mention that many of the most critical
    people were in position of leadership in the past, and so they
    are certainly in a place to know. This is not a surprise.
        As I was considering coming back to the FDA, many of them
    called me. So I was very well aware coming in that we need to
    do major improvements on the food side of the FDA, not because
    the people are bad, but there is a need for consistent
    leadership and the right resources for people to get their work
    done.
        What Dr. Woodcock brings----
        Mr. Bishop. Mr. Commissioner, you will have an opportunity,
    I think, to elaborate on that.
        Dr. Califf. I understand.
        Mr. Bishop. My time has expired, and I want to give the
    opportunity to the other committee members to engage in
    questions because we are pushed for time this morning.
        So I would like to yield to Dr. Harris as the distinguished
    ranking member for his questions.
        And we have reduced the question time to four minutes
    because of the exigencies of our time this morning.
        You are now recognized, Dr. Harris, for your questions.
        Mr. Harris. Thank you very much, Mr. Chairman.
        Dr. Califf, on Monday the FDA issued enforcement discretion
    guidance to help increase the supply of formula, including
    formula that is being imported. Under that guidance, could we
    be importing infant formula from China?
        Dr. Califf. It is not our primary intent to be bringing in
    formula from China, and it is not our first call. That is not
    excluded under the guidance, but we know a number of the
    facilities around the world that we can use where we have
    experience already, as Chairman DeLauro already pointed out.
        Mr. Harris. Okay. Thank you.
        No, my concern is just that, you know, during COVID we have
    not done as many inspections overseas, and now we are going to
    be bringing in things from overseas where perhaps the
    inspections over the past few years have not been as rigorous.
        Now, a lot has been said, you know, that the Cronobacter
    cases came from the Abbott plant, but am I correct that the CDC
    concluded its investigation with no findings of a definitive
    link between the Abbott formulas and the four cases based on
    their genetic analysis of the Cronobacter?
        Dr. Califf. I do appreciate your question, and this is very
    complicated. So we will have to get back to you about the
    details, but the short side of it is using genotyping we could
    not connect the cases directly to the Abbott plant. That is
    correct.
        But the investigation is not over because Cronobacter is a
    very difficult organism to culture, and we do have five
    cultures that are positive for different types of Cronobacter
    from the Abbott plant. They just do not match up.
        And so the plant definitely needed to be dealt with. Saying
    that cases came directly from that plant is something that we
    cannot say until the investigation is entirely completed.
        Mr. Harris. Well, thank you.
        That was my concern because I think Ms. Psaki and the White
    House actually said that infants died from that plant, and just
    to correct the science, that link has not been definitively
    made.
        And we should stick with the science on that. I mean, it
    may well have happened, but not scientifically proven.
        Finally, you and I have discussed emergency use
    authorization, and the administration has said we could have
    100 million cases of COVID this fall. It could be a new
    variant.
        I am still concerned that there is no end stage treatment.
    Those are for individuals who have gone to the ICU, have been
    put on a ventilator, have pneumonia. We know that there is not
    a good treatment available for that under emergency use
    authorization.
        And I would just urge and ask, you know, is this of concern
    to the FDA because I know, as we have talked about this, the
    regulation is pretty clear and the statute is clear. ``May be
    effective'' should be the guideline for when the EUA can be
    issued when nothing else is available.
        And as you know, there are studies being done, Phase 3
    trials on late-stage therapies. Obviously, they may be
    effective. They are in phase three trials, and there is no
    other treatment.
        So could you briefly address what the FDA is doing to make
    sure that this fall, if we get a resurgence of COVID, we
    actually have an emergency use authorized or approved drug for
    treatment?
        Dr. Califf. Two quick comments on that. Number one, we do
    have treatments that are effective. They are not curative for
    that stage, that have a benefit. Steroids now, being two in
    particular, but we will get you more details on those.
        We are always looking for more effective treatments and
    welcome anyone who can bring data indicating they have an
    effective treatment, and we will act on it as quickly as we
    possibly can, which I think has been very quickly in the past
    and will continue to do that.
        Mr. Harris. Thank you very much.
        Mr. Chair, I yield back.
        Mr. Bishop. Thank you, Dr. Harris.
        At this time, I am delighted to yield to the chairlady of
    the full committee, the gentlelady from Connecticut who has
    been so vigilant in monitoring this issue and bringing it to
    public attention.
        So at this time I yield to Chairwoman Rosa DeLauro for your
    questions.
        The Chair. Thank you very, very much, Mr. Chairman.
        Just a couple of very quick facts. The fact is at the FDA
    food safety is not a priority. That is a fact. It just is not.
    There needs to be a restructuring of the food safety with
    people who know food safety.
        I also might add that Dr. Woodcock was the Acting
    Commissioner when this October whistleblower report reached the
    agency.
        A fact about bacteria. It changes. I am not a doctor. It
    mutates over time. It thrives in the kind of dry powder that
    formula is made up of, and it could have changed over time.
        My question is the following. Dr. Califf, have you read the
    whistleblower report?
        Dr. Califf. I have, yes. I have looked at it, yes.
        The Chair. Okay. Let me just say what was the allegation
    that concerns you the most?
        Dr. Califf. I would say the most concerning--let me just
    point out that in my career, I have frequently been in the
    position of being the person in charge when whistleblower
    complaints are raised in an organization.
        The most concerning charge is that the integrity of the
    organization was compromised. So once that integrity is
    compromised, then the question is how can you trust any of the
    systems that are in place.
        The Chair. Well, in fact, yes. Whoever looked at that
    report felt that there was no need to respond at all from
    October to February, until there was a recall. That is a
    dereliction of duty, in my view.
        And in addition to which you have a person who, as an
    Acting Commissioner, should have done that. Now it would appear
    that that person is going to oversee this effort. That is the
    fox in the henhouse.
        If I can, let me ask you this issue. In the guidance that
    you put forward, you list recommended, recommended but not
    required information for the manufacturers, and the
    manufacturers are most likely not FDA approved.
        You have seven FDA approved facilities which you could go
    to immediately, but what you are talking about in the guidance
    is that you list recommendations, recommendations that are not
    required to be followed, and so, in fact, they do not even have
    to include your recommendations in their application for
    certification and for review.
        Will you commit to not exercising enforcement discretion
    with respect to critical statutory and regulatory safety
    requirements?
        Dr. Califf. Yes, with an emphasis on those critical
    requirements. We will not let infant formula into the U.S. that
    is not safe.
        The Chair. Well, but these folks do not have to abide by
    your recommendations. It is a guidance. Nothing is required of
    these potential manufacturers, nothing.
        Dr. Califf. With due respect, Madam Chairwoman, you are
    correct in what you say, except that we have the authority to
    either let the product in or not. So we have control over
    there.
        The Chair. Well, if you have got somebody who certifies and
    you also talk in your guidance that people and efforts can
    self-certify or have a third party certify so that you, in
    fact, do not have the tangible evidence from these facilities
    that, in fact, their product is safe to be imported, that baby
    formula is safe.
        I just want you to commit to the safety portion of this
    effort, and you do not have in place a mechanism that would
    guarantee the safety right now. You just do not. That guidance
    does not allow you to determine and to define the safety of the
    products that may be coming from facilities that are not FDA
    approved.
        And why are we not going to facilities that are FDA
    approved and not allowing all of these other potential
    manufacturers to enter into our system with the potential of
    creating another crisis?
        Guidance is not standardized. You have no guidance
    standardized across applications. You pick and you choose. If
    you do not have standards and they go across the board, you do
    not have a standard application process and which you can judge
    upon.
        I apologize to you, Mr. Chairman, for going over.
        Mr. Bishop. Thank you, Ms. DeLauro. Hopefully we will be
    able to come back and follow up.
        At this time I would like to recognize the gentleman from
    California, Mr. Valadao, for your questions.
        Mr. Valadao. Thank you, Mr. Chairman.
        Commissioner Califf, thank you for coming to testify in
    front of the subcommittee today.
        This hearing is obviously very timely at this shortage that
    is an emergency and has been for way too long.
        I believe all of us here on the committee are hearing from
    our constituents about the dire infant formula situation.
    Between the infant formula recall, subsequent plant shutdown,
    ongoing supply chain disruption, and people panic buying out of
    fear that they will not be able to feed their babies, this has
    become a dangerous and unacceptable situation.
        Low income and disadvantaged communities like many in my
    district are suffering from consequences of the recall that
    started three months ago or closer to four months ago. These
    families have been suffering through the COVID-19 pandemic,
    ongoing supply chain issues, inflation, and more, and they need
    a break.
        This administration appears interested in alleviating the
    issue, but it has taken too long to get to this point. We must
    ensure the shortage is fixed immediately.
        As you well know, especially on this committee, recalls of
    products in our country is not a new thing, and when it comes
    to something as vital as the children's food supply, it seems
    the FDA just did not take this one as seriously as they should.
        This is not about purchasing a popular, trendy type of
    infant formula. This is about a critical access to specific
    formulas parents and caregivers need for their babies.
        Even one of my own children was relying on a very specific
    type of formula. So as a father who has had the opportunity or
    been in a situation where I had to drive all over town to chase
    specific formulas, and this was far before any shortage, I can
    only imagine the stress these parents are experiencing.
        Did the FDA treat this just like every other or any other
    recall that they have had to deal with or did they understand
    the gravity of the situation from the beginning?
        More importantly, do they now fully grasp how devastating
    this entire situation has been and continues to be?
        Dr. Califf. Well, first of all, I thank you for raising the
    specific issues of concern.
        From day one when we saw the problems with the Abbott
    plant, we knew that this was a critical plant for the supply
    chain, and the team was meeting on a very regular basis, trying
    to figure out how to manage the situation, hoping to keep the
    plant open with better quality measures, and then it became
    clear that was not going to work, and we had a period of time
    of having to reach a consent decree, which is a complicated
    legal proceeding.
        But as I have indicated, we are all very aware. Many of us
    are parents or grandparents. Many of us have relatives that are
    in the same situation. We are hearing from everyone. So we are
    very focused.
        Mr. Valadao. All right. I appreciate that, and so I am
    limited on time obviously. So I hope you understand this is
    something that is having a huge effect, and obviously people
    all over the country are struggling with this.
        We are hearing two weeks, and I know that the chairwoman
    had mentioned that we want to see this open. I would like to
    know what the FDA is doing on the ground at the Abbott plant in
    Michigan to help the situation as much as they possibly can.
        Are they working with them? Are folks on the ground as we
    speak right now making sure that we can get this facility up
    and running?
        Dr. Califf. We are working with Abbott every day, and I am
    getting a report twice a day, in the morning and the evening,
    about the progress that is being made.
        I mean, recognize we are just on day three now, but it
    looks like it is going well; that Abbott has remediated a
    number of the issues; and we are going to make sure it gets
    done as quickly as it possibly can.
        Mr. Valadao. All right. I understand that you have
    announced a Principal Deputy Commissioner. I think you had
    mentioned it earlier in one of the statements. Dr. Woodcock
    will have a greater role in the strategic counsel over the food
    side of the FDA. I know she has tremendous expertise on the
    drug side, but I am hearing some concern about whether this
    decision will lead to a change that is needed on the food side,
    especially when she has been in the FDA for decades.
        Can you help me understand the rationale of this decision?
        Dr. Califf. Sure. I would say this is just a start of a
    change. As I mentioned earlier, I knew coming in that we are
    going to need to make major fortification of the food side of
    the FDA with a focus on the things that you all have all
    brought up.
        Dr. Woodcock knows every nook and cranny of the FDA. She
    knows how the operations work. She already had information
    technology redesign underway, which is critically needed.
        If you think about our inspectors out there, comparing the
    technology they have compared to what I saw in my previous job
    at Alphabet, it is night and day, and we have to fix that so
    that they can be efficient.
        This is just the start of a change. She is not going to be
    permanently in the job. It still reports to me, and we will
    make further changes that you will hear about over the next
    period of time.
        Mr. Valadao. All right. I appreciate.
        My time is up. I yield back.
        Mr. Bishop. Thank you, Mr. Valadao.
        At this time I am delighted to recognize the gentlelady
    from Maine, Ms. Pingree. You are now recognized for your
    questions.
        Ms. Pingree. Thank you so much, Mr. Chair, and thank you so
    much for having this critical hearing at this moment in time.
        And thank you, Mr. Commissioner, for being with us today
    and answering our questions.
        I just want to associate myself with questions that have
    already been asked by Chair Bishop, Chair DeLauro, Mr. Valadao,
    really on both sides of the aisle. Obviously, this is a very
    troubling, troubling situation.
        And I am not going to repeat all of the same questions. I
    just want to say that I am concerned, Mr. Commissioner, that
    you are not providing us with more detailed information. I
    think we have to dig deeper into this troubling pattern of
    leadership challenges and structural issues on food safety at
    the FDA.
        This is not new, and we have to work on this. And this is a
    huge crisis for America, and I am very, very concerned about
    where we are.
        I am just going to pivot because, like I said, I feel
    really grateful that my colleagues have been asking good
    questions, and I know others will be asking more as well.
        I just want to talk a little bit about vaccine access for
    children. You know, I really appreciate that the FDA has done
    some challenging, essential work over the last two years on
    COVID, particularly in the vaccine space. One key group with no
    authorized COVID vaccines are children five and under.
        I totally understand and appreciate how important it is to
    evaluate safety and efficacy. That is a huge concern in
    America, but I am hearing all the time from parents and
    caregivers in Maine and also around the country who are just
    really frustrated and feel left behind.
        Any further delays that continue, these children will enter
    yet another school year unvaccinated. Can you commit to us that
    reviewing any potential authorization for a vaccine covering
    children under five will happen as quickly as possible?
        And what timeline can we reasonably expect and tell people
    you will follow once an application is received?
        Dr. Califf. I will answer quickly. You know, I have been
    involved in children's therapeutics my whole career, and one of
    the major lessons is that children are not just small adults.
    And so you have to do specific studies for the biology and the
    size and mechanics of how children dispose of therapeutic
    interventions.
        Having said that, we now have the Moderna application in
    hand, as you know. As soon as we are ready, which is imminent,
    we have a number of dates reserved for the Advisory Committee
    meetings. So as soon as we are ready, we will have that meeting
    and have the Advisory Committee weigh in on whether the safety
    and efficacy are adequate.
        And there are others. The Pfizer application should be
    coming in sometime soon also.
        So I am definitely committed as quickly as possible. I have
    two grandchildren under age five. So I am very much in the same
    boat that is being described.
        Ms. Pingree. So there was some talk for a while that the
    FDA would wait until the Pfizer application was in, which seems
    really unthinkable not to move forward as quickly as possible,
    but just for some level of efficiency or I do not know what the
    rationale was.
        Can you commit that that is not going to happen?
        Dr. Califf. There is no delay in the Moderna application
    because of another application. Each one will be considered on
    its own.
        And I do not need to tell you that sometimes discussions
    that are held as you are developing a strategy get touted as if
    that is a decision that has actually been made. That was never
    the case, and I want to refute that from the beginning.
        Ms. Pingree. Well, thank you for setting that straight and
    for moving with all appropriate speed.
        Obviously, that is a critical age group, and you know, they
    have different bodies and, you know, needs. So I do want to be
    as safe as possible, but you know, congratulations to you on
    having two grandchildren under five. I have four grandchildren
    under five and, you know, again, we hear this from mothers and
    caregivers all the time.
        So thank you for the work that you have been doing, and
    really please continue this conversation about food safety and
    the huge difficulties that people are having today. That is
    really very important to the oversight of this committee.
        Mr. Chair, I yield back.
        Mr. Bishop. Thank you, Ms. Pingree.
        I now recognize Mr. Moolenaar of Michigan. You are now
    recognized for your questions, Mr. Moolenaar.
        [No response.]
        Mr. Bishop. Please unmute, Mr. Moolenaar.
        [No response.]
        Mr. Bishop. Mr. Moolenaar, I believe that you are still
    muted. We will move to Mr. Newhouse and see if we cannot get
    you some technology and come back to you.
        At this time I recognize Mr. Newhouse, and we will come
    back to Mr. Moolenaar at the earliest convenience.
        Mr. Newhouse. Thank you, Mr. Chairman. Hopefully the clock
    will reset.
        I appreciate the opportunity. Dr. Califf, thank you for
    being here with us.
        I will not repeat what others have said but just associate
    myself with much of the concern that has been expressed.
        I would like to ask you about the money that was just
    appropriated. I would like to know how in your estimation an
    additional $28 million assures parents that imported formula
    will be safe for their children, how it is going to help
    replenish the inventory in grocery stores in a timely manner.
        Did you request this additional funding, especially in
    light of the fact that just a couple of months ago we increased
    the FDA budget by over $100 million, $11 million of that
    specifically for maternal and infant health and nutrition
    activities?
        So could you shed some light on some of the money situation
    for us?
        Dr. Califf. Sure. I appreciate the question.
        I think Chairwoman DeLauro made the case very strongly that
    safety has to be paramount. So the bulk of that money would go
    for inspectors to make sure that material is not being put on
    the shelves which is unsafe, which is a very laborious effort
    right now, particularly given our information technology
    deficits that I have mentioned.
        We also need the in-house expertise to evaluate these
    applications as we try to diversify the supply chain, and
    overseeing the Abbott plant takes up a whole number of people
    to make sure every single aspect of that is being done
    correctly.
        And then as I have already mentioned, the underlying
    information technology is critical here. American business or
    health care systems would not depend on the kind of information
    technology we have to make these kinds of decisions, and we
    need to do something about it, in my opinion.
        And let me just also mention. You mentioned the other
    maternal-fetal issues. This it not the only one. We have toxins
    in infant and baby food. We just had a guidance on apple juice,
    for example. This takes very high-quality scientists to do the
    analyses, collect the data to figure out how quickly we can
    bring these levels closer to zero, just as one example.
        And then many members have been concerned about
    recommendations on seafood. I could go on and on. These things
    are all critical to our most vulnerable people, our children
    and their mothers. So they all need to be a priority.
        Mr. Newhouse. No doubt. I totally agree.
        Did you request the additional funding?
        Dr. Califf. Yes.
        Mr. Newhouse. Well, like I said, I associate myself with a
    lot of the comments made.
        I would like to shift gears, if I could, to another topic.
    Since the legalization of hemp and hemp products was made
    several years ago, I believe we are still waiting on FDA for
    some action to be taken, and currently the industry is in a
    state of uncertainty because of no direction.
        Could you provide an update on FDA's comprehensive sampling
    of CBD products that was discussed in July of 2020, a report on
    this labeling, and specifically the long-term plan that you may
    have and what you have found to date?
        Dr. Califf. I really appreciate that question, and the
    amazing plethora of derivatives of the cannabis plant is really
    quite profound and astounding and already in widespread use for
    a variety of means, as you know.
        Most of the FDA efforts so far have been spent on research
    to figure out what the risks, if any, are of various uses of
    this material in its different forms.
        We are committed. I just want to tell you 2016 I worked on
    this. Coming back in 2022, it looks pretty much the same in
    terms of where we are. We just know more now because we have
    done more research.
        I am very committed to taking a path on this and just to
    put a marker down, I do not think the current authorities we
    have on the food side and the drug side necessarily give us
    what we need to have to get the right pathways forward. We are
    going to have to come up with something new, and I am very
    committed to do that.
        Mr. Newhouse. Well, I appreciate hearing that.
        Mr. Bishop. Thank you, Commissioner.
        I am afraid the gentleman's time has expired.
        Let me recognize Mr. Pocan, and following Mr. Pocan we will
    go back to Mr. Moolenaar.
        Mr. Pocan. Okay. Thank you, Mr. Chair.
        And thank you, Commissioner Califf. I really have
    appreciated the previous conversations we have had.
        Please take this in the proper vein, but I think, you know,
    there was frustration when you were asked what happened and the
    answer you gave back is we are investigating and I cannot talk
    about it.
        You can talk about it. Honestly, you should talk about it.
        One problem that I have seen over and over with the FDA in
    my ten years here is you guys are not good at communicating,
    and you know, this is something that parents are asking us
    about. They want to know what happened. You all have got to get
    that down to explaining in a way that real people can
    understand.
        I understand there is science behind it. But it is not
    acceptable to say that you cannot comment on it.
        I am just putting that out there. The public wants to know
    more. We have got to do that.
        I also share in all of the questions that people have asked
    in this area, as well as Representative Pingree's questions
    around the vaccine. We are getting that for children under
    five. When is that going to be available?
        Let me go to a couple of different subjects. CBD, while CBD
    is widely used in a number of products, as you just had the
    conversation with Mr. Newhouse, technically CBDs fail in the
    eyes of the FDA as illegal.
        What is FDA's plan to clarify that CBD could not possibly
    be regulated as a food or food additive, and is there any
    timeline?
        Dr. Califf. The research so far has shown that there are
    some risks with CBD, and so we are going to need a different
    pathway than just the standard food pathway.
        I have told you and I really mean it. I am committed to do
    something about this, and it is going to take some work. I hope
    that you will work with me on that because It is going to take
    some creativity.
        You know, when you come back six years later to the job you
    had before and nothing has really changed, that is telling you
    that you cannot just keep trying to do the same thing over and
    over.
        Mr. Pocan. Yes, this is the frustration. I will be honest.
    I have had it with FDA also on Kratom. You and I have had that
    conversation where, you know, as you may know, Senator Lee and
    I sent a letter to actually Secretary Becerra in March of this
    year, bipartisan letter. The Secretary acknowledged that there
    is emerging science that contradicts the previous positions of
    the FDA on Kratom's safety profile.
        And yet you have recently put more alerts, import alerts,
    on companies that are going a legal, proper way of handling
    Kratom coming into the country versus the companies that are
    not.
        And the real question is is there a way to try to lift that
    import restriction on those companies that followed all the
    rules. I believe the technical language is a structure function
    claim versus the others because right now it is kind of hitting
    everyone with one FDA order, which I think is an extremely
    antiquated position that the FDA has on Kratom.
        As you know, you and I have talked about it. NIDA is in a
    very different place than you are on Kratom.
        Dr. Califf. Well, I do look forward to coming back to you
    hopefully in a couple of months with very specific suggestions
    on what to do. There are millions of people using Kratom. We do
    have real adverse events though, I mean, real negative things
    that had happened to people, and it does interact with multiple
    neurotransmitters.
        NIDA is doing a lot of research. I am very good friends
    with Nora Volkow, the head of NIDA. We will continue to work
    with NIDA, and we will go where the science tells us to go.
        But like I said with regard to cannabis products, we need
    something different for these kinds of products that are not
    traditional foods, not traditional drugs.
        Mr. Pocan. If I can just reclaim just because I have 28
    seconds, also you recently updated the fact sheet on Kratom on
    April 27th with only minor modifications, and honestly, there
    is not only arguable conclusions, but you are linking to
    outdated, incomplete, and inaccurate information.
        Again, in this letter, Secretary Becerra seems to have a
    bit of a different position. If you could just look at that,
    that update was not much of an update, and I think it is being
    very unfair to the consumers who are legally using Kratom in
    this country.
        And I will yield back.
        Dr. Califf. I will definitely look at it. Thank you.
        Mr. Pocan. Thank you.
        Mr. Bishop. Can you hear me?
        Okay. Mr. Moolenaar, you are now recognized. I hope your
    technical difficulties have been resolved.
        [No response.]
        Mr. Bishop. I am afraid we cannot hear you, Mr. Moolenaar.
    Okay. With that, we will try to come back to you, Mr.
    Moolenaar.
        Ms. Letlow, you are now recognized. Welcome to the
    committee. And the floor is yours.
        Ms. Letlow. Thank you, Chairman Bishop, Dr. Harris, and
    members of the subcommittee.
        I am honored to join this distinguished and to have the
    opportunity to represent the priorities of the Fifth
    Congressional District of Louisiana and the communities
    throughout the Delta region.
        As the newest member of this subcommittee, I am
    particularly eager to work with my colleagues in advocating on
    behalf of our farmers, ranchers, and forest landowners.
        Agriculture is the backbone of my district, and it is one
    of the largest economic forces in the area.
        Dr. Califf, as a mother of a four and a two-year-old, it
    was not long ago that I was completely dependent on infant
    formula to fulfill my children's nutritional needs. I can only
    imagine the terror of parents across this country are feeling
    as they desperately search for formula to keep their children
    alive, quite literally, with some parents forced to admit their
    children to the hospital when no formula can be found.
        This shortage impacts parents and health care providers
    nationwide. It is at the forefront of everyone's mind today,
    but for my district it is incredibly important that we work in
    an expeditious fashion to increase access to safe formula
    options because I represent a heavily rural district and makes
    up close to 20 percent of the Louisiana population and covers
    the largest geographic area with a diverse economic base.
        I say all of this to paint a picture of what families face
    in urban areas is likely exasperated in rural America where
    proximity to retailers and availability of certain goods could
    be a 30-minute drive to the nearest retailer.
        Dr. Califf, as I am sure you are aware, there are specialty
    metabolic formulas that only Abbott produces, which are
    necessary formulas for many families. With the forced closure
    of the Abbott facilities, did FDA consider there was no one
    else that could step in to provide those specialty formulas?
        And at any point did FDA become concerned about a lack of
    supply in the days prior or following the closure of this
    plant?
        Dr. Califf. Let me just say for everyone concerned, I do
    think it is useful to divide the formula into the general
    formula, as you all have astutely done in your questions, and
    the specialty metabolic formula which deals with a much smaller
    but really critical group of infants who are totally dependent
    not just on formula, but on the very exact makeup of the
    formula.
        So from the first day, we had a team of people, and we were
    in connection with the American Academy of Pediatrics to try
    and do everything we could to keep the formula coming from that
    Abbott plant, from their stores and releasing it on a lot-by-
    lot basis as needed, carefully weighing the safety and the
    critical needs that these infants have.
        This system is not perfect, but the network of
    communication is still very much in play with the pediatric
    community, the hospital community, and our team at the FDA
    working together.
        It will not get better until we can rev up that plant again
    and also diversify, but I hope you also appreciate that because
    this special metabolic formula is very complicated, you cannot
    just start up a plant and do it. It takes a lot of work to get
    a plant able to do it.
        So we have gone to work with Abbott to make this work while
    we are also diversifying this line.
        Ms. Letlow. Thank you, Dr. Califf. I want to get one more
    question in.
        Given the FDA's recent announcement on the new enforcement
    discussion guidance, how much formula do you expect will be
    imported?
        And what is the real timeline of seeing those products on
    our store shelves?
        Dr. Califf. Well, the way we are thinking about it is we
    are pulling a bunch of levers at the same time. The other
    formula manufacturers in the U.S. have revved up their supply
    to 24-by-seven. It has increased considerably.
        We are going to start up the Sturgis plant. We have the
    importation that you are referring to, and I think with a
    combination of all three, we should begin to see improvement
    within days.
        And I do want to point out that right now in the last week,
    we have had more infant formula bought, by between 11 and 19
    percent, than what was bought in the month before the closure
    of the plant.
        So we are actually have----
        Ms. Letlow. So I can tell my constituents that within a
    matter of days they will be able to find formula on the
    shelves?
        Dr. Califf. It will gradually get better. You know, the big
    problem we have right now is distribution, and I think your
    question very important, what you called attention to. The
    worst problems are in the rural areas because they are not the
    major areas that are purchasing these goods, and we are going
    to have to pay very special attention to that.
        So within days it will get better, but it will be a few
    weeks before we are back to normal.
        Ms. Letlow. Thank you so much for your time.
        Mr. Chairman, I yield back.
        Mr. Bishop. Thank you, Ms. Letlow.
        At this time I recognize the gentlelady from Illinois, Ms.
    Underwood. You are now recognized for four minutes.
        Ms. Underwood. Well, thank you, Mr. Chairman.
        Hi, Dr. Califf.
        FDA has recently announced several steps to get more
    formula onto shelves, including permitting Abbott Nutrition to
    release products from the Sturgis facility to people needing
    urgent supplies for certain specialty and metabolic formulas on
    a case-by-case basis.
        Dr. Califf, can you describe how your agency is
    communicating with health care professionals and with families
    about the risks and benefits of using specialty and metabolic
    formula products from the Sturgis facility so that parents can
    make informed decisions about safely accessing the products
    their infants need?
        Dr. Califf. Thank you.
        And I know that you have a nursing background. So you have
    a very special feel for what is at stake here.
        As I just described, the specialty formula--general formula
    is hard enough, 30 constituents have to be there in just the
    right amount or we have a history in this country of disasters
    that have occurred when that does not happen. And so it does
    take very much hands-on evaluation step by step.
        There is a committee of the American Academy of Pediatrics,
    and in fact, a physician that was featured in the New York
    Times yesterday, I talked with him on the phone. He is the
    chair of the committee on this subject at the American Academy
    of Pediatrics.
        So we are working through the professional society on this,
    and case by case, if families are having problems, we need to
    hear from them.
        Ms. Underwood. Okay. As we take action to immediately
    address infant formula shortages, we also need to
    comprehensively assess the causes of the current shortages so
    that this never happens again.
        A whistleblower report included numerous disturbing
    allegations about wrongdoing at the Sturgis plant, and it was
    especially troubling to learn that the report was submitted to
    FDA on October 20th of 2021, but FDA did not inspect the plant
    in person for more than three months.
        But in this time frame, on December 29th, 2021, FDA
    temporarily postponed some inspections due to the Omicron
    surge, but continued to conduct, quote, mission critical work.
        According to your agency's resiliency roadmap for FDA
    inspectional oversight, there are four factors for determining
    if a product meets a threshold for mission critical
    inspections: if it receives breakthrough designation; if it is
    used to treat a serious medical condition; if it is related to
    the agency's COVID-19 response; or if there is evidence of
    serious adverse events.
        So based on these criteria, would powdered infant formula
    at the Sturgis facility be considered a product that meets the
    threshold for mission critical inspections?
        Dr. Califf. As I said in my opening statement, we will find
    specific issues where we could have done better. You have just
    done a very good job of enumerating several of those, including
    this one.
        So I cannot disagree with your statement.
        Ms. Underwood. Yes, it is not optional for families. This
    is essential. So what steps will FDA take to ensure that
    inspections of infant formula manufacturing facilities continue
    to be carried out on a safe and timely basis during public
    health emergencies or any other period where the inspections
    are postponed?
        Dr. Califf. Well, I have already assured you all that no
    matter what, we will be on top of this issue until we are back
    to normal, you know, working around the clock day and night.
        It would surely help if we had a larger number of people
    because, as we diversify the facilities and we bring in we
    sources, as the chairwoman has already made the point quite
    succinctly, we are going to need people who can actually
    evaluate whether the formula is safe; not only that, whether it
    is effective, especially in these metabolic formulas.
        There are only a handful of people that even understand the
    illnesses that these children have.
        Ms. Underwood. Right. Okay. Thank you.
        I yield back.
        Mr. Bishop. Thank you, Ms. Underwood.
        We will try Mr. Moolenaar again. You are now recognized,
    and hopefully we have got the technical difficulties resolved.
        You are now recognized, Mr. Moolenaar.
        Mr. Moolenaar. Mr. Chairman, thank you for continuing to
    call on me. I am hoping I am coming through.
        Mr. Bishop. You are.
        Mr. Moolenaar. All right. Dr. Califf, thank you for your
    testimony today. I know you have been getting a lot of
    questions on baby formula shortage. I just wanted to share with
    you.
        I have been hearing from hundreds of Michigan families
    about how this formula shortage is affecting them or someone
    they know, and I just wanted to share a couple of stories with
    you and ask how you as an agency can respond to them.
        A father in Manton, Michigan wrote, ``My child has an
    allergy to milk. So she has to have a very specific formula.
    Now that that formula is short, other babies that do not need
    this type of formula that is necessary for my daughter are
    allowed to purchase it through the WIC program, making her
    formula even more scarce. I have had to resort to getting
    formula from out of state and Canada at times. The shipping
    costs are a huge burden on my family and it requires hours of
    research that I could be spending with my family.''
        And a mother in Macomb County wrote, ``I have had issues
    finding my son's formula since October of 2021. So I bought in
    bulk. Then everything I had on hand was recalled. I could get
    it at Target for a few weeks. Then they stopped having it. Even
    Amazon stopped getting it. Back in March of this year I had to
    switch to a different kind of formula. I am fortunate enough to
    be able to afford and buy multiple cans at a time. So when I
    found it at Costco, my mom, me, and my sister bought what I
    needed to get through six weeks. Now the kind my son is on is
    not even in stock at Costco. I pray I have enough to get him to
    his first birthday. My friends have to search multiple stores
    to find the kind the baby is on. Another ends up changing
    formula each time she runs out because it is all she can find.
    We just cannot breastfeed. Our babies rely on formula. It is
    scary being a mother right now.''
        I will also add a local grocery store owner also wrote me
    saying, ``It is heart wrenching to have to tell our customers
    that we have no baby formulas to offer them. We are concerned
    that our local babies are not getting the nutrition they need.
    Nutrition in general is a very challenging problem in our rural
    area.''
        Dr. Califf, what would you like to tell these parents who
    are concerned about just simply finding food for their babies?
        Dr. Califf. I will tell them that we are very concerned and
    feel badly that they are going through this, and we are doing
    everything we can to fix it.
        And if I could make a couple of quick points about things
    that you brought up, you know, as I mentioned, the sales are
    actually higher than they were. People are buying more formula
    now than before the recall, and so we have a problem of
    distribution.
        The FDA has no access right now into the supply chain data
    from the companies that manufacture and sell the formula. So a
    good bit of my week this week is getting on the phone with CEOs
    using an old-fashioned method called the telephone to try to
    get the right product to the right place in an organized way.
        We are requesting, again, that we have more authority to
    look at the supply chains, much like the banks did years ago,
    so that we can task and preempt these kinds of problems rather
    than having to react to them.
        Mr. Moolenaar. Well, thank you, Dr. Califf.
        Just a quick question, also changing gears a bit on
    standards of identity. The lack of enforcement of dairy
    standards is something I have raised with you and several of
    your predecessors. I am hoping that the forthcoming guidance
    will move beyond the current practice of nonenforcement and
    require everyone to simply follow the law.
        A related issue I wanted to raise with you is the standard
    of identity for yogurt, and it is my understanding that the FDA
    recently updated this in June of 2021, but the industry
    actually does not support that.
        Mr. Bishop. Mr. Moolenaar, I am so sorry, but your time has
    expired.
        Mr. Moolenaar. Okay.
        Mr. Bishop. And I want to get to Ms. Wasserman Schultz of
    Florida, and following Ms. Wasserman Schultz, I will declare
    the subcommittee in recess subject to the call of the chair,
    immediately following votes.
        But Ms. Wasserman Schultz will not be able to return. So
    you are now recognized, Ms. Wasserman Schultz, for your
    questions.
        Ms. Wasserman Schultz. Thank you, Mr. Chairman. I
    appreciate your indulgence.
        And I really want to say that everyone knows that the
    world's best oranges are grown in the great State of Florida.
    My good friends on this committee from California might
    disagree, but the truth is that Florida's climate has a
    distinct impact on how oranges are grown, making them
    comparatively sweeter and juicier than growers from other
    states.
        Unfortunately though pests, diseases, and more violent
    hurricanes are having a devastating impact on Florida's citrus
    growers and processors. These circumstances have resulted in a
    natural decline in the Brix level for Florida's mature oranges.
        In fact, for most of the last citrus season, Florida's
    oranges did not meet the Federal minimum standard of 10.5
    degrees Brix.
        The Brix standard was adopted nearly 60 years ago in 1963
    at a time when our understanding of climate change was minimal.
    And despite these natural changes to Brix levels, there are no
    known adverse health consequences for consumers.
        We need FDA to work directly with Florida citrus growers
    and processors to find a solution, which should include
    providing additional flexibility by modernizing requirements to
    account for the naturally occurring Brix variation.
        Failure to do so will result in the industry losing out on
    imports from Brazil and Mexico and worsening our trade deficit.
        Commissioner, what is FDA's current engagement on this
    issue?
        And are you committed to finding a solution to this problem
    in the immediate future?
        Dr. Califf. I am definitely committed to finding a
    solution, and your point, I think, exemplifies something we
    have been talking about, changes in the climate, changes in the
    crops, human health. This is high science, and we need the
    people who can actually do the work to make the best judgments
    based on the data.
        It is not something you just make up. You actually need the
    data, and you need analysis. So very much appreciate your
    interest in this.
        Ms. Wasserman Schultz. Thank you. I appreciate you as well.
        And the other thing I wanted to focus on is something that
    I know you and I have talked about several times before. In
    Florida, for example, more than 25 percent of high school
    students use e-cigarettes, and more than 29,000 kids under 18
    try cigarettes for the time each year.
        Tobacco kills 32,300 people in my State every year, costing
    Florida about $8.64 billion in annual health care expenses, and
    the proportion of cancer deaths in Florida attributable to
    smoking is 29 percent.
        These are not just numbers. These are our friends and
    family and devastatingly our children. I lost my own mother to
    lung cancer just a year ago.
        The FDA has the authority to address this serious public
    health problem, and I have been advocating for several years
    for FDA to consider rulemaking to prohibit menthol cigarettes
    and flavored cigars, and I am thrilled that FDA initiated this
    process just a few weeks ago with proposed product standards.
        Can you provide the committee with an update on these
    proposed standards and the impact this would have on preventing
    children from falling victim to big tobacco?
        Dr. Califf. Sure. And I am a cardiologist. I have spent
    many years, three and a half decades caring for people who are
    critically ill, many of them in the State of North Carolina due
    to tobacco-related illness. So I am very sensitive to this
    topic.
        These standards are now out for public comment, and we are
    going to have several public meetings, and then we will answer
    the comments, and then they will be put into effect, with
    modifications based on the comments that we do get.
        So we are encouraging people to come to the table,
    particularly the sensitive issue of, as the standards come into
    play, what do we do about local enforcement if there is illicit
    trade, where this might be applied differentially.
        So I am very sensitive to that issue. The FDA is not
    involved in local enforcement, but we want to make sure through
    community engagement that people understand that we are going
    after the people manufacturing these products, not local
    citizens, but also make sure that local law enforcement in
    communities understand that.
        Ms. Wasserman Schultz. Thank you so much.
        I only have a little bit of time left, not enough to ask
    another question. So I appreciate your indulgence, Mr.
    Chairman, and I yield back.
        Mr. Bishop. Thank you, Ms. Wasserman Schultz.
        The committee will now stand in recess, subject to the call
    of the chair, immediately following the vote and we will
    reconvene.
        [Recess.]
        Mr. Bishop. All right. The subcommittee is now called to
    order. We will resume, and I believe when we went into recess I
    was about to recognize the gentlelady from New York, Ms. Meng.
        So at this time, I'm delighted to recognize for questions
    Ms. Meng. You now have the floor.
        Ms. Meng. Thank you, Mr. Chairman, and thank you, Ranking
    Member Harris. It is good to be with all of you and thank you
    for this opportunity.
        Dr. Califf, as you know, there are concerning reports about
    the presence of hazardous chemicals that are known by the EPA
    to be likely cancer-causing substances as well as undisclosed
    fragrance chemicals that contain potential allergens in
    menstrual products. And given that these products are
    frequently used in highly absorptive parts of the body, the
    risk that fragrance ingredients could pose to health is grave.
    And just because an ingredient is not on the list of fragrance
    allergens does not mean that it will not have an impact on a
    woman's health.
        I wanted to ask what the FDA process looks like for
    fragrance ingredients to be listed as an allergen, and are
    there additional resources necessary for your scientists to
    continue advancing this research?
        Dr. Califf. Thank you for your interest in this topic,
    which is complex. And I would say the first principle is we--I
    think all of us at FDA believe that whatever is in something
    that's sold to the public, it should be listed so that people
    know it's there, which, as you know, has been--just that in
    itself has been a big challenge to get the authority to require
    that that is the case.
        Beyond that, in order to deal with this scientifically, we
    need to do an evaluation of the level of the constituent, what
    its effects are on the health of individuals and others who may
    come in contact with it. And we are therefore supportive of
    working towards having the correct labeling and understanding
    the risks with all the factors involved.
        I think we have already heard quite a bit this morning
    about the resource issues that we have on this side of the FDA,
    and I just want to emphasize this is not a simple matter of
    someone sort of guessing about what the levels are and what the
    risks are. This is a huge scientific issue requiring big data
    and computational skills to get the answer, and federal
    agencies working together.
        So, appreciate your interest. We look forward to working
    with you on it.
        Ms. Meng. Thank you. Definitely. And I also wanted to ask
    about your Closer to Zero Action Plan to reduce exposure to
    metals in foods for babies and young children. I know that FDA
    missed its first deadline. It wasn't until mid-April that the
    FDA submitted its proposal to OMB for review.
        I wanted to ask what the FDA's revised schedule for the
    Closer to Zero Action Plan is and what are plans for
    coordination with OMB?
        Dr. Califf. Yes. First, just to acknowledge that we'd all
    like these levels to be zero, so that is why it is Closer to
    Zero. We have to bring these levels down at a rate which will
    enable the industry to adapt and get there. I think you are
    aware that the apple juice levels just came out, and for the
    kids who drink a lot of apple juice this will be, like, over a
    40 percent reduction in exposure for those kids.
        We do have several others that are in OMB. I met with the
    head of OMB last week to urge that we move as quickly as
    possible, and we are going to stay in touch and shepherd these
    through as quickly as we possibly can.
        Again, just like what I said about the fragrance issue,
    exactly where the level should be over time as we bring it down
    is a matter of scientific discussion and measurement about
    which there are several opinions, and we need to get that
    resolved.
        Ms. Meng. Thank you very much. And I will yield back, but I
    just wanted to also associate myself with the comments of our
    chairman and many of our colleagues today about the infant
    formula shortage. I had one of my babies had to use EleCare,
    one of the special formulas only produced by Abbott, and that
    was hard to find even during good times. So I really want to
    associate myself with the comments of my colleagues and ask
    that you please communicate with us and our families across
    America so that we can be responsive with our efforts.
        Dr. Califf. Okay, if I may, Mr. Chairman, just quickly
    mention EleCare is our main focus right now in the plant in
    Michigan, and I hope we--I think we are going to be moving very
    quickly on that. It is the number one priority because it is
    essential. It is the largest population of--it is essential
    infant formula.
        Mr. Bishop. Thank you, Ms. Meng, and thank you, Mr.
    Commissioner. We have completed our first round of questions
    and we will now begin the second round.
        But I continue to be disturbed by the length of time that
    it took for FDA to really start to address this problem, and
    secondly, of the nonspecific and the vague way that the
    implementation of a plan to solve it with the supply chain,
    with the inspections, with the safety. That is really a
    concern, and I hope that before we close that you can be a
    little bit more specific in terms of how that is going to
    happen.
        Let me go to the question of the foreign drug inspections.
    Over the last two years we provided funding specifically for
    FDA to increase unannounced foreign drug inspections in certain
    countries to ensure the safety of the drug supply, and the
    FDA's practice of announcing foreign inspections weeks in
    advance brings up the issue of parity with how we treat our
    domestic manufacturers and what kinds of issues could be
    covered up during a waiting period.
        Unfortunately, FDA used our 2021 funding to set up a test
    of announced versus unannounced inspections and not to restart
    the unannounced inspections, which was our intent.
        You know well the perils of drug manufacturing in certain
    countries. Can you give us your commitment that you will direct
    FDA to restart unannounced inspections as directed by Congress?
        Dr. Califf. Yes, sir. Let me assure you that I have been
    the subject of inspection in universities and companies I
    worked for for clinical trials, biologics and technology
    development, and I am very well aware of the importance of
    having a certain amount of unannounced inspections. We
    appreciate the money that was allocated the first time around,
    I think about 8.5 million, and today I can say that we have
    started the unannounced inspection program in India. China will
    follow behind, but as you know, because of the COVID outbreak,
    it is difficult to get started in China.
        So the plan is to have hundreds of unannounced or short-
    notice inspections that we will be able to report back to you
    about.
        Mr. Bishop. All right. The infant formula crisis has
    focused attention on the fact that the infant formula office
    has a staff of only nine people. The budget acknowledges that
    funding in our fiscal year 2022 bill will add four people to
    the office, which is great, but I worry about how many other
    drastically understaffed offices there are at FDA that we don't
    know about.
        It seems we only learn about those staffing shortages when
    there is a crisis. This has been a concern for many years and
    over a number of administrations. So speaking for the
    subcommittee, we want to help ensure that all of FDA's
    operational units are properly staffed. What are the other
    understaffed parts of FDA that we should be concerned about
    that are not addressed in your budget request?
        Dr. Califf. I would just say the entire food side of the
    FDA is understaffed in every category. That is why in the
    budget we have asked for money to staff up, and also to improve
    the authority for hiring and salaries just like we have on the
    medical products side. This is absolutely essential.
        I certainly want to notice that I don't disagree with your
    statement that money alone won't fix it. But basically, I think
    you can see with infant formula, I mean, nine people for
    something this important is just not enough. And we got money
    for four more, but in the current federal hiring authority it
    takes months to bring someone on board. And we don't see that
    with the authority that we got with 21st Century Cures on the
    drug and device side.
        So I really want to implore you to help us get staffed up,
    and I take seriously your other part of it that the money and
    people alone will not solve the problem; we also have to have
    leadership and structure.
        Mr. Bishop. My time has expired. Hopefully the Senate will
    pass the supplemental quickly.
        Let me yield to Dr. Harris for a second round of questions.
    My ranking member, you are now recognized.
        Mr. Harris. Thank you very much, Mr. Chairman.
        Dr. Califf, I know that last fall the FDA released its
    final guidance on short-term sodium--voluntary short-term
    sodium reduction. Look, I understand that for some people
    sodium is not a good thing and reducing dietary intake is
    probably warranted. For others it may not make a difference. We
    don't know how to differentiate between those two right now. So
    I worry about a one-size-fits-all plan.
        But will the FDA conduct a study on the impact of the
    short-term targets to understand consumer acceptability and
    what impacts those reductions might have on public health?
        Dr. Califf. Dr. Harris, I know you are an anesthesiologist
    and know a good bit about the topic of autoregulation, and so
    for sure one size fits all is not the solution to the problem.
    But I also know you are aware that in the voluntary levels, we
    are talking about super-high levels that are built into food,
    just bringing it down to a level that would be more like what
    the average intake is for most people. And I think the data are
    very clear that super-high levels are not good for anyone
    unless you have one of the strange diseases--by the way, post-
    COVID is part of dysautonomia where you don't have enough
    constriction of your blood vessels to keep a blood pressure
    when you stand up.
        And so we will be evaluating the impact and the progress
    towards reduction, and I am very excited a focus of the
    administration across NIH and FDA and Department of Agriculture
    is going to be diet, what we eat. There is a big summit coming
    up at the White House, and I am sure sodium will be a key part
    of it.
        Many people will weigh in on where we are and where other
    societies are with regard to sodium. So we need to keep an open
    mind about the right policy.
        Mr. Harris. Okay. Thank you very much. It has been touched
    on with regards to the infant formula, this--the problem of
    domestic manufacturing versus overseas manufacturing. But writ
    large, I think COVID has made us aware that we don't have
    enough domestic manufacturing of both pharmaceuticals and
    active pharmaceutical ingredients.
        How is your agency and specifically this budget request
    supporting more domestic manufacturing of pharmaceuticals and
    medical products so that we don't have this issue of do we have
    to depend upon foreign nations, sometimes unfriendly?
        Dr. Califf. Well, I would like to spend an hour talking
    with you about this, but in brief, because this is a big focus
    of ours and I am going to write a lot about it, you are going
    to see more about it. The two cases we have in front of us now
    are examples of why the two extremes are wrong. The infant
    formula crisis is happening in the face of complete domestic
    production. And you know about contrast media, if one of you
    were to--we have had some prominent politicians have strokes
    recently--one of the major suppliers of contrast media only had
    one factory in Shanghai that was making contrast media, and
    when that shut down because of COVID, now when people roll in
    with a stroke or heart attack they may not be able to get an
    angiogram because you need contrast media.
        So we have got these two extremes. What we need is a
    versatile supply chain built on a digital backbone so that we
    can keep track of where the products are and to stress test
    that supply chain.
        Now, in the budget is manufacturing in place, which I think
    is the most exciting technology part of it, and also platform
    manufacturing. It is in the budget. I know we have limited
    time, but I could talk a long time about this, as you can tell.
    We have to do something about this. The answer is not just
    onshoring. The answer is having a diversified system where we
    can prevent shortages occurring preemptively instead of waiting
    for them to happen.
        Mr. Harris. Okay, thank you very much. Mr. Chair, I yield
    back.
        Mr. Bishop. Thank you, Dr. Harris. At this time I yield for
    a second round to the chair of the Committee, the gentlelady
    from Connecticut, Ms. DeLauro.
        The Chair. Thank you very, very much, Mr. Bishop. And just
    a quick follow-on to I think what Dr. Harris was speaking
    about. And also, Dr. Califf, our biggest problem here is the
    consolidation of the industry. We only have four sources in the
    United States that are manufacturing this product, and quite
    frankly, Abbott has cornered the market, 43 percent of it. So
    when they go out of sync--so underlying all of this, and not
    for today's conversation because it is a lengthy one, is just
    we have to get out of the sole-source contracting business and
    we need to do this not only here but in the meatpacking
    industry as well.
        It has been said by Chairman Bishop, and I associate myself
    with his comments and also with the Ranking Member's comments.
    I understand you need resources, and I have worked to increase
    resources to the FDA, but your problems are structural. You
    have serious structural leadership issues. Someone in this
    agency needs to have serious, relevant and food credentials,
    who understands it, because otherwise food safety will be a
    second-class citizen--continue to be a second-class citizen at
    the FDA.
        I want to just mention to you a colleague earlier on--you
    can't hide behind an investigation. We need answers and we need
    them now. Who received this report? What did they do with it?
    Who was heading the FDA at that time? My understanding is that
    the acting commissioner was Janet Woodcock. What did she know
    about this?
        So who was handling all of this and when this report went
    through the FDA and investigating all of this?
        Dr. Califf. Well, as I have said, you have got the timeline
    down and you have got the key issues. I know we have an
    oversight hearing next week, and we will be prepared to go into
    much more detail at that point. And as I have said, we could do
    better than we did and----
        The Chair. You have an Oversight Committee next week. You
    are before the Committee that funds what you do.
        Dr. Califf. Yes.
        The Chair. So this information is relevant to this
    subcommittee of Appropriations.
        Dr. Califf. Well, I appreciate what you are saying, but it
    is the investigation is not completed yet and so I am not in a
    position to answer specifics like that.
        The Chair. So you have no idea who received the documents
    at the agency?
        Dr. Califf. Well, we do know--well----
        The Chair. So who physically received the document? Where
    did it go? Who read it? What was the chain of command? You
    apparently don't have any answers to that question. That is
    indicative of, again, not responding to the seriousness of this
    issue. That says it all, Dr. Califf. It says it all.
        One last point I want to make. I only learned this in the
    last 48 hours. 2014, Abbott deliberately and successfully tried
    to weaken bacteria-testing safety standards. And I will credit
    FDA here. FDA issued a proposed rule that would have increased
    regular safety inspections of infant formula manufacturing
    facilities and in the effort to prevent the contamination of
    infant formula.
        I believe it was Abbott, I think it might have been Gerber,
    and there may have been others who led--they led the charge to
    weaken the inspection regime. Now, this is a company and a
    manufacturing entity that has a sole-source contract. And that
    is what----
        Dr. Califf. Well, but----
        The Chair. But I want--my question to you, I want you to
    address that, but do you have a plan to increase inspections
    and testing at these facilities, and what is that plan?
        Dr. Califf. As we--first of all, thank you again for the
    additional funding, but the plan is to increase the inspections
    with the workforce that we have in a very orderly way,
    particularly in the Sturgis facility. Essentially it's like a
    daily inspection. We are there with the Abbott people
    overseeing what they are doing, so we are in the plant.
        And as for the other U.S. facilities, we'll have to get
    back to you on the specific number of times we will inspect,
    but we will have a very orderly specific inspection system.
        I would like to add the supply chain issues that we have
    all been talking about, we need to have access to the supply
    chain data, which we don't have. In other words, each company
    has its own supply chain. They handle it very carefully for
    their own needs. But if you ask the question, how do they all
    fit together? We don't have that information. And they can give
    it to us if they want, but we need to have the authority to get
    that.
        And let me just also----
        The Chair. I have to ask----
        Dr. Califf [continuing]. Acknowledge, I think you said it
    says it all: I am committed to get back to you with specifics
    about what happened. I am just not prepared today to do it. I
    apologize for that.
        The Chair. Well, we have to change underlying--and I will
    end here because my colleagues have been indulgent with me here
    this morning. The fact that you are the regulatory agency and
    you do not--first of all, you do not have mandatory recall, and
    you do not have, you just said, access to data. Well, you ought
    to be up here demanding that we provide you with that kind of
    authority to get the information that you need in order to be
    able to do your job as a regulatory agency.
        Thank you, Mr. Chairman; thank you to the Ranking Member
    and to my colleagues.
        Mr. Bishop. Thank you, Ms. DeLauro.
        And at this time I'd like to recognize Mr. Valadao for a
    second round.
        Mr. Valadao. Thank you, Mr. Chairman.
        Mr. Califf, I'd like to discuss the issue of feed additive
    approvals. As you know, new animal feed additives can offer
    meaningful environmental benefits in dairy and other ag
    production. Reducing intrinsic methane emissions by as much as
    30 percent, but FDA's current approval process treats these
    items as drugs even though they move entirely through the
    animal's digestive tract.
        We included language in the fiscal year 2022 report to
    direct FDA to look at reviewing ingredient claims on
    environmental and other issues as foods, as we provided 1
    million in new funding approvals in the final bill. Can you
    provide us an update with the work your agency is doing on
    this?
        Dr. Califf. Yes, we are moving along well with that, and I
    am fully aware that. This is a big issue for the farming
    community both on the animal side and also on the agriculture
    side. So we want to come to a resolution.
        So we are getting a good bit of research done about the
    safety and benefits of addition to food, and in not too long a
    period of time we will get back to you with specifics about
    that. It is something that we are working on.
        Mr. Valadao. No, it is something that honestly is important
    to a lot of folks and it has come up quite a bit in especially
    my district. I have got one of the largest dairy districts in
    the country, and it is important. So I look forward to hearing
    from you and talking to you more about this.
        And Mr. Chairman, I have asked all the questions I have got
    for the record right now. I think I will submit anything else
    we have got through the--for the record on the side. So,
    appreciate the time. Thank you very much. Thank you,
    Commissioner.
        Mr. Bishop. Thank you, Mr. Valadao.
        Ms. Underwood, you are now recognized for a second round.
        Ms. Underwood. Thank you, Mr. Chairman.
        As a registered nurse, another priority that I am focused
    on is protecting our nation's young people from the health
    risks of e-cigarette products. According to a 2021 survey data
    from CDC and FDA, more than one in three high school students
    and more than one in 10 middle school students reported that
    they have used tobacco products, and e-cigarettes were the most
    commonly used product.
        CDC and FDA researchers concluded that factors that might
    continue to promote tobacco product use among U.S. youth, such
    as the availability of flavors and access to tobacco products,
    remained prevalent in 2021.
        Let's be clear. The reason why flavored e-cigarettes have
    been and continue to be so accessible for young people is
    because of the FDA's unacceptable delays in reviewing pre-
    market tobacco product applications and the failure by your
    predecessor to meet the court-ordered review deadline of
    September 9th, 2021.
        While I have been pleased to see the marketing denial
    orders that you have announced since being confirmed, some of
    the most popular products among young people remain on the
    market and just last week FDA filed a status report in the U.S.
    District Court for the District of Maryland in which the agency
    provided an estimation that application reviews will not be
    completed until June 30th, 2023.
        Dr. Califf, with more kids getting addicted to nicotine
    every day, can you provide an explanation of why FDA is
    projecting that reviews will not be completed until next June,
    nearly two years after the court-ordered review deadline?
        Dr. Califf. Thanks for bringing attention to this issue.
    And as a cardiologist and someone very involved in medicine, et
    cetera, the addiction to nicotine is a very difficult problem
    and there is no question that there is an industry that
    develops specifically to get teenagers addicted to nicotine, in
    which case the old statement that was uncovered in the tobacco
    industry, customers for life. Because stopping vaping is
    extremely difficult to do.
        There is nothing I would like more than to move these
    things along more quickly, but what we gave the court was an
    honest assessment giving the number of people we have and the
    legal requirements we have to consider these applications. And
    I also want to emphasize this is an industry that has amazing
    capabilities on the legal front. If we make one single error in
    process, we could be set back for years in these applications.
        Ms. Underwood. Yes, sir.
        Dr. Califf. And then finally, I just want to add we have
    consistently for the last I don't know how many years asked for
    user fees from the vaping industry. Right now, all of this work
    is entirely unfunded. We are doing it borrowing people from
    other parts of the FDA, and we have a request in for what I
    think is, for such a prosperous industry, a very reasonable
    user fee arrangement and I hope Congress will act on this.
        Ms. Underwood. Thank you. We know that tobacco products
    must have an FDA marketing order before coming to market,
    meaning that e-cigarette products without marketing orders are
    currently on the market illegally and FDA has the authority to
    initiate enforcement actions to remove these products from the
    market. Will you commit to using this authority while FDA
    completes its review of the remaining pre-market tobacco
    product applications?
        Dr. Califf. Well, I appreciate the sentiment, which I share
    to a great degree. But I know you are also aware that if we
    take action like that, we will end up with a lot of our legal
    force tied up in court. And so we are going to have to be very
    judicious the way we use that authority, because we want to
    reserve our abilities on the legal front to take care of the
    problems that we know will be lasting.
        So I want to come back to you and discuss that specifically
    to make sure that we at least have an understanding of what our
    capabilities are in that regard.
        Ms. Underwood. Right, but Dr. Califf, I mean, to say that
    we are going to wait another several months, over a year, to be
    able to take enforcement action is something that is just
    unconscionable given what we know is happening in the
    communities that we serve across this country.
        Thank you, I yield back.
        Mr. Bishop. Thank you very much, Ms. Underwood. Thank you,
    Commissioner. I believe that we have exhausted the questions
    from the members, and I appreciate very much your availability,
    Commissioner Califf.
        We all understand how incredibly busy you are these days,
    and we appreciate your time. These issues are very, very, very
    important, though. And as I mentioned at the outset, FDA's work
    is vitally important to every American in order to keep them
    safe and healthy. And the challenges that we discussed today
    show just how crucial it is for the agency to be at peak
    performance with all hands on deck every single day.
        We want to help you in any way that we can to surmount
    these challenges, and with respect to the infant formula issue
    that we have been dealing with today, I want to just make sure
    that people know that we are not finished with this. We are
    going to dig down deep and on May 25th, next week, we are going
    to be dealing with the infant formula stakeholders that we will
    hear from to get their perspective on what this crisis means
    and how we need to deal with it.
        But along with all that we have discussed, we will also
    forward additional questions to you for the record and we look
    forward to your diligent and timely responses.
        Dr. Harris, do you have any closing remarks? If so, I will
    yield to you for that purpose.
        Mr. Harris. Thank you. Thank you, Mr. Chair. Dr. Califf,
    again, thanks for coming before the subcommittee. As we talked
    about I think when we first met, you have got a tough job. I
    mean, the FDA is an agency with very broad regulatory authority
    in areas that are, because of COVID and now because of the
    infant formula, quite controversial.
        So good luck in doing it. Let us know in any ways we can
    help. And again, I just want to thank you for being willing to
    step up, being willing to head the agency, and good luck in the
    future.
        I yield back, Mr. Chairman.
        Mr. Bishop. Thank you, Dr. Harris, and thank you to all of
    the members of the subcommittee in attendance, and thank you to
    our staff who put this hearing together.
        With that, this subcommittee hearing is adjourned.
        [Questions and answers submitted for the record follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

                                               Wednesday, May 25, 2022.

                           THE INFANT FORMULA CRISIS

                                   WITNESSES

    GINGER CARNEY, DIRECTOR OF CLINICAL NUTRITION, ST. JUDE'S CHILDREN'S
        RESEARCH HOSPITAL
    SARAH CHAMBERLIN, EXECUTIVE DIRECTOR, NATIONAL PKU NEWS
    MICHAEL GAY, OWNER AND MANAGER, FOOD FRESH
    BRIAN RONHOLM, DIRECTOR OF FOOD POLICY, CONSUMER REPORTS
        Mr. Bishop. Three, two, one. Good morning for those in
    western time zones. Good afternoon for those of us in central
    and eastern time zones. This hearing will now come to order.
        As this hearing is fully virtual, we must address a few
    housekeeping matters. For today's hearing, the chair or staff
    designated by the chair may mute participants' microphones when
    they are not under recognition for purposes of eliminating
    inadvertent background noise. Members are responsible for
    muting and unmuting themselves. If I notice that you've not
    unmuted yourself, I would ask you if you would like for staff
    to unmute you. If you indicate approval by nodding, staff will
    unmute your microphone. I remind all members and witnesses that
    the five minute clock still applies. If there is a technology
    issue, we will move to the next member until the issue is
    resolved, and you will retain the balance of your time.
        You will notice a clock on your screen that will show how
    much time is remaining. At one minute remaining, the clock will
    turn yellow. At 30 seconds remaining, I will gently tap the
    gavel to remind members that their time has almost expired.
        When your time has expired, the clock will turn red, and I
    will begin to recognize the next member. In terms of the
    speaking order, we will begin with the chair and ranking
    member, then members present at the time the hearing was called
    to order will be recognized in the order of seniority, and
    finally, members not present at the time the hearing was called
    to order in their order of arrival.
        Finally, House rules require me to remind you that we have
    set up an email address to which members can send anything they
    wish to submit in writing at any time during our hearings and
    mark ups. That email address has been provided in advance to
    your staff.
        Good afternoon, and welcome to today's hearing. Following
    last week's hearing with FDA Commissioner Dr. Robert Califf, we
    are again looking at the infant formula recall, the nationwide
    formula shortage, and the impact it is having on infants, kids,
    and families.
        In the past week, both Congress and the administration have
    moved swiftly to address the formula shortage crisis. Last
    week, Congress passed two bills which would expedite the return
    of safe formula to store shelves and expand the options that
    our most vulnerable families have when purchasing formula
    through the supplemental nutrition program for women, infants,
    and children.
        We must continue to press forward with oversight of the
    FDA, as well as get the FDA the much-needed resources to meet
    the needs of the crisis, and allow them to increase the
    capacity to inspect and ensure the safety of the formula
    supply, both in the U.S. and as we bring in emergency supplies
    from abroad. We need the funds to get this done.
        The Administration also moved quickly by invoking the
    Defense Production Act to streamline the supply lines for
    existing, safe formula to get to American shelves, even from
    overseas supplies. The administration is also using the Defense
    Production Act to make sure that our domestic manufacturers
    have access to the ingredients they need to ramp up production
    of the formula.
        Today's hearing is important, because we need to fully
    understand the impact of a shortage of formula supply on our
    country. As we will hear from today's witnesses, formula supply
    does not just impact infants. It strains our grocery chains,
    and families in different communities face different
    challenges. Without information, worry takes over and leads to
    counterproductive behavior, like hoarding, and it creates
    fertile ground for bad actors creating fake formulas, and
    sellers, and price gougers.
        With that, I am pleased to introduce and welcome our panel
    of witnesses, Sarah Chamberlin, executive director of the
    National PKU News. Michael Gay, owner and manager of FoodFresh
    in Paxton, Georgia, representing the National Grocer's
    Association. Ginger Carney, director of clinical nutrition at
    St. Jude's Children's Research Hospital, and Brian Ronholm,
    director of food policy at Consumer Reports. Thank you all so
    much for being here.
        Our first witness is Sarah Chamberlin, a mother whose
    eight-year-old daughter relies on special formula for about 70
    percent of her nutrition. It is a reminder that formula is not
    just for infants, and that specialty formula is life
    sustaining, and can be needed for lifelong nutrition as a
    medical treatment for certain conditions. Simply put, there are
    no alternatives.
        And also glad we will hear from Michael Gay, representing
    the National Grocer's Association. Grocers are very much on the
    frontlines. They are on the ground, and can see a community's
    needs in real time. I'm very concerned about our rural
    communities that often have only one grocery store, leaving
    people with little choice but to travel significant distances
    for formula.
        I'm also looking forward to hearing from our other
    witnesses, Ginger Carney, who is the director of clinical
    nutrition at St. Jude's Children's Research Hospital. Carney
    and Brian Ronholm, director of food policy at Consumer
    Reporters, to gain insight from their expert knowledge and
    their decades of experience.
        Both Abbott and FDA share in the blame for the situation we
    are in right now. Whereas Abbott failed the public by not
    maintaining a safe manufacturing site to produce this vital
    nutritional resource, the FDA did not live up to expectations,
    inspecting and responding to concerns about the manufacturing
    process and safety.
        Because of these circumstances, we find ourselves climbing
    out of a crisis, which has harmed children and understandably
    worried families. I'm glad this committee will give voice to
    those stories today.
        I again want to thank our witnesses for being here. We know
    how busy you are, and on behalf of the committee, we are
    grateful that you've taken the time to speak with us today.
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        Mr. Bishop. Now, I'd like to ask our distinguished ranking
    member, Dr. Harris, if he has any opening remarks, and if so, I
    would like to recognize him at this time for those remarks. Mr.
    Harris, you are now recognized.
        Mr. Harris. Thank you, Chairman Bishop, and I'd like to
    welcome our witnesses to the hearing today. I appreciate you
    all sharing your experiences with us as our country remains in
    the middle of an infant formula supply crisis.
        Like parents across America, I'm frustrated by the Biden
    Administration's lack of urgency prior to last week to address
    this issue. Supply challenges started last fall. On November
    12th, 2021, WSOC in Concord, North Carolina reported that Dr.
    Margaret Quinlan, a UNC Charlotte professor, said, ``Our
    Country is failing us if they are not seeing this as something
    that needs to be a priority.''
        CNN also had a headline a few days later, ``baby formula is
    getting harder to find,'' but rather than tackle this looming
    crisis, the Biden Administration chose to work on the holiday
    gift supply chain instead.
        The formula shortages cited in national and state media
    outlets last fall have been exacerbated with the Abbott recall
    of infant formula, and the facility closing in February.
        Again, CNN had a headline in February, baby formula
    shortage has some families scrambling, and when did the
    administration finally decide to take action? Last week. The
    administration should have made it a priority to address supply
    chain shortages long before now. Instead, parents and
    caregivers are facing unimaginable stress and anxiety as they
    search for formula to feed their babies.
        After one of the largest formula manufacturing facilities
    in the U.S. closed, the administration should have been working
    around the clock to get this plant safely back online as
    quickly as possible. Three months have passed, the facility
    remains idle. I believe this crisis could have been averted if
    the administration had acted on supply chain issues last fall.
        Existing funding and authorities were at their disposal,
    and could have been utilized to address this predictable
    situation much more quickly, just as Republicans suggested, and
    just as the administration did this past weekend by having
    formula flown in from overseas. None of these actions needed
    more money or more authority from Congress. It would have just
    taken leadership and initiative from the administration. It's
    disappointing we find ourselves in this situation when the
    alarms were sounding months ago.
        But again, I want to thank our witnesses for joining us
    today to share their experience and the impacts they have seen
    from this crisis. I look forward to today's discussion. Thank
    you, Mr. Chairman, and I yield back.
        Mr. Bishop. Thank you, Dr. Harris. We are fortunate to have
    the full committee chair with us, and I would now yield to
    Chairwoman DeLauro for any opening remarks that she may have.
    Chairwoman DeLauro, who has been very, very passionate on this
    issue, and we certainly look forward to hearing your remarks.
        The Chair. Thank you very, very much, Mr. Chairman, and let
    me just congratulate you on yesterday's election. It's great to
    see you, and as we try to move forward, I want to say thank you
    both to you and to the acting ranking member, Mr. Harris, for
    holding what is an important hearing.
        And I would particularly thank our witnesses this afternoon
    for testifying on the infant formula crisis in our country. We
    are all absolutely shocked by the crisis that's facing
    America's babies, and for moms and dads, a crisis about safety
    and supply.
        At least two babies died and several others were
    hospitalized after consuming Abbott's infant formula, and for
    the past several months, parents all over the country have been
    struggling to find safe formula to feed their babies. On
    Monday, I held a roundtable in my district and heard
    heartbreaking stories of already vulnerable parents scrambling
    to feed their babies. They reiterated a formula that has been
    historically difficult to find is now nearly non-existent on
    shelves. Moms and their advocates fear that babies may become
    undernourished and develop enduring health problems.
        One 19-year-old mother told me that that despite relying on
    formula to feed her three-month-old baby, she was denied WIC,
    and was told she should just breastfeed. Like far too many
    others, she is unable to produce nourishing breastmilk and
    relies on community support to feed her baby, and now she is
    struggling to find any baby formula at all.
        Also heard from grandmothers who were taking care of their
    grandchildren and having to take them to the emergency room
    with vomiting and with diarrhea, and linked directly to the
    formula that they were taking, Abbott's formula.
        Another was a mom of a baby who after eating Abbott's
    contaminated formula, which was later on the recall list, was
    sick for eight days in and out of the hospital, and told--and
    told that her son merely had a virus.
        This formula stayed on shelves much longer than it should
    have. The stories I have heard were absolutely unacceptable,
    and these same stories are happening in big cities, small
    towns, rural communities all over our nation. Parents need more
    help.
        As you know, in September 2021, FDA inspectors conducted a
    routine inspection of an Abbott nutrition facility, where
    suspicions of wrongdoing were already present. On October 20th,
    someone working at the facility submitted a whistleblower
    report to the FDA unveiling a damning list of allegations,
    asserting that the company lied, cut corners, falsified records
    to cover up their misdoings.
        Not until late December did the FDA interview the
    whistleblower, and then not until late January was the plant
    inspected in person. Abbott then issued the recall in February
    some four months later.
        In March, I requested an HHS Office of Inspector General
    report to look into the tragedy, and then I got ahold of a
    whistleblower report and submitted it for the record to make it
    public. Last week, I introduced and the House passed a $28
    million supplemental appropriations bill to give the FDA the
    resources it needs to address the coming shortage. It is mostly
    personnel to be able to deal with inspecting facilities, and
    also to review the infant formula applications that are coming
    in. They do not have the personnel.
        I have no problem faulting the FDA for what they have done,
    but we cannot compound the problem by not providing resources
    at this moment for much needed inspection personnel and infant
    application submission reviewers in order that we know that the
    products that are coming in are safe, and are--not wanting to
    move forward on that $28 million really says a lot about people
    and their care about what is going on in this--in this space.
        At a hearing last week, the subcommittee questioned the FDA
    Commissioner Califf on FDA's incredibly slow response, which
    led to Abbott products staying on the shelves longer than they
    should have and potentially putting even more babies at risk.
        In the long term, the FDA must address its longstanding
    structural issues. I believe we must establish a deputy
    commissioner for food safety within the FDA. Someone with
    extensive knowledge, background, and credentials in food
    safety.
        This week I will introduce the Keep Infant Formulate Safe
    and on the Shelves Act, which addresses the root cause of the
    crisis, including product safety and supply infrastructure, and
    I'm moving to deal with the issue of consolidation in the
    industry, which only allows for four major suppliers, thereby
    if one is gone, we have this shortage that's been created--
    that's been created.
        Because unfortunately then none of this is new. We recently
    learned that in 2014, the formula industry deliberately and
    successfully tried to weaken bacteria testing safety standards.
    The FDA had proposed rules, a protocol that year to increase
    the regular safety inspections of infant formula manufacturing
    facilities to prevent the contamination--the specific
    contamination that we are discussing today. This very crisis is
    now facing our nation's babies.
        And while the FDA was slow to respond, and I'm going to
    make a distinction between the FDA and the Biden
    Administration, because the Biden Administration moved quickly,
    as did USDA when dealing with waivers for WIC recipients to be
    able to purchase another product other than the Abbott product.
        But the administration put Operation Fly Formula, and the
    invocation of the Defense Production Act has secured infant
    formula from FDA regulated facilities to be flown in and
    imported quickly to meet this urgent need. I will follow up to
    make sure that they are FDA related--approved facilities.
        I am concerned about FDA guidelines, which say that we can
    entertain other facilities that do not meet the FDA standards.
    The first batch of that formula arrived quickly. It arrived
    this week in Indianapolis. More is coming. There's a shipment
    that arrives at Dulles today. We are--the administration is
    addressing the critical supply issue while ensuring that the
    product being manufactured is safe and healthy for our babies.
        In the wealthiest nation in the world, babies should not be
    at risk of going hungry. Parents should not have to play a
    guessing game and wonder if they are feeding their babies
    something that is safe. Unfortunately, that is where corporate
    greed, consolidation of formula production into just four major
    companies, and a lack of proper oversight have led us.
        I hope that our witnesses can help us further understand
    the impact that this shortage has had on babies and their
    parents, and what else we can do to prevent this from happening
    again. I want to say a thank you to the chairman, who really
    has moved--speaking about moving quickly, moved very quickly on
    addressing this issue and calling hearings in order to address
    it, and also thank the acting ranking member. I yield back.
        Mr. Bishop. Thank you very much, Ms. DeLauro. I don't
    believe the full committee ranking member is present with us,
    or I would ordinarily recognize her at this time, but in her
    absence, I will now recognize our distinguished guest for five
    minutes for brief oral statements, and then we will proceed
    with questions.
        Without objection, each of your entire written testimonies
    will be included in the record. So, if you could summarize your
    testimony within the five minutes, we would most appreciate
    that. Ms. Chamberlin, welcome, and you are now recognized.
    Please proceed.
        Ms. Chamberlin. Good afternoon, Madam Chairwoman, Chairman
    Bishop, ranking members Granger and Harris, and members of the
    subcommittee. Thank you for inviting me to testify.
        My name is Sarah Chamberlin, and my younger daughter has
    the genetic metabolic disorder phenylketonuria, better known as
    PKU. I am here to share the profound effects of the formula
    crisis on our family and those like us.
        There are very few exactly like us. Of the three and a half
    million babies born in the U.S. each year, only about 275 are
    diagnosed with PKU, but let me be clear: this crisis is not
    limited to infants. There are many others who rely on formula
    as their lifeline from infancy to adulthood, including
    thousands with inborn errors of metabolism, GI and allergic
    disorders. I hope my testimony will amplify their voices.
        People with PKU can't metabolize one of the amino acids in
    protein, which then builds up and acts as a neurotoxin. Babies
    with PKU are born healthy, and within months if untreated
    become irreversibly brain damaged. Newborn screening now allows
    us to detect and begin to treat PKU almost immediately after
    birth, ensuring normal or near normal health outcomes for these
    individuals, provided they have lifelong access to medical
    formula.
        My daughter Izzy was diagnosed at six days old, and she'll
    be nine in August. She is limited to a diet of five grams of
    protein from food per day, which is the equivalent of about one
    slice of American cheese. The rest of her nutrition is provided
    by an Abbott amino acid formula, so it was not part of the
    recall.
        To Izzy, her milk, as she calls it, is her life. It has
    sustained her since she was an infant, and she knows it. Her
    health all comes down to the formula. It's essential. It's
    expensive. It's inconvenient. It tastes awful, but it's what
    allows her to live a full life, playing softball, learning
    fractions, and taking jazz dance every Friday. She's relied on
    it her entire life, and suddenly she can't rely on it.
        That's why I'm here today. When the Abbott plant was closed
    in February, we knew we couldn't risk running out of formula,
    and that we'd have to transition her to a new brand slowly.
    Every formula has very distinct tastes. To me, Izzy's tastes
    like nickels dissolved in sugar, with a fair dash of salt, and
    the only reason they are tolerable, is because they are
    necessary, and because patients get used to them over years.
        By earlier April, we were at half-new, half-old formula,
    which was right about when we heard that the new formula we
    were transitioning her to was on back order. So, what are we
    supposed to do now?
        We are not alone in our distress. A friend in Louisiana had
    to ration the formula her daughter gets for a similar disorder.
    The video she sent me of her usually vibrant, active 12-year-
    old curled in the fetal position, crying, is heartbreaking.
        Last week, two children with short bowel syndrome were
    hospitalized because without the specialty formula, the only
    way to keep them alive is IV nutrition. A friend in her 40s
    with PKU who was without formula wrote, I am a wife and mother.
        I am exhausted and having constant migraine headaches and
    memory issues. I am overwhelmed and emotionally fragile. I am
    malnourished. The message from our community in short is this,
    ``we are not okay''. Chairwoman DeLauro has said that,
    ``parents should not have to choose between the supply of
    products and food safety. That is unconscionable.''
        I could not agree more, but in mid-March, the FDA said that
    patients considering using Abbott metabolic products
    manufactured at Sturgis between January and March should
    consult with their healthcare provider in considering whether
    the benefit of consuming such products outweighs the potential
    risks of bacterial infection.
        The consequences of inadequate medical nutrition are so
    grave that we really have no choice. My daughter Izzy does not
    have a choice. Going without her formula would mean temporary
    disability. It would mean missing the end of her softball
    season, not mastering fractions, and never perfecting her jazz
    dance routine for her performance next month. Long term, it
    would mean permanent brain damage. For people with other
    similar disorders, it could mean coma and death.
        I deeply appreciate the work of the committee to increase
    immediate supply, and demand accountability from the FDA to
    avoid a future crisis. As the immediate shortage recedes thanks
    to this work and the work of your Congressional colleagues in
    the administration, we must remember that supply is not the
    same thing as access. In the US today, thousands face huge
    bills for medical nutrition, the very formula we're discussing
    today, but their insurance refuses to cover, and this has
    disastrous consequences for their health.
        The Medical Nutrition Equity Act, HR-3783, and S-2013
    provides for insurance coverage for these formulas as essential
    medical treatment. It is critical that you pass the MNEA this
    year to ensure that everyone has access to the formulas that
    you are all working so hard to resupply. We need your help. We
    are not okay. Thank you for your time and consideration today.
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        Mr. Bishop. Thank you, Ms. Chamberlin. Mr. Gay, you are now
    recognized for five minutes.
        Mr. Gay. Thank you.
        Mr. Bishop. You may begin.
        Mr. Gay. Good afternoon, Chairman Bishop, ranking member
    Harris, and members of the Agricultural Appropriations
    Subcommittee. My name is Michael Gay, and I currently manage
    Food Fresh, and independent, locally owned grocery store in
    Claxton, Georgia.
        It's an honor and privilege to speak with you today. I am
    testifying on behalf of the National Grocer's Association, the
    trade association representing the independent grocery stores.
    My store, Food Fresh, is the only grocery store in Evans
    County. We work very hard every day to make our community
    better and our store conditions wonderful.
        The formula shortage has hit our community hard. Moms and
    families are worried about where their child's next meal will
    come from. I've had to put limits on formula that customers can
    purchase in my store. This is heartbreaking to do, and so many
    families are in such great need. My managers have had to
    personally manage formula stock in my stores because demand has
    been so great. I had seven phone calls just yesterday asking if
    we had a specific type of formula in the store.
        When I told most of the moms that the formula they were
    asking for was not available, but I did have it in a different
    brand, they were very scared to switch, because they didn't
    understand that the formulas are very, very similar.
        These are examples of what I've seen happening in my store.
    I would like to share a little bit about what the members of
    NGA are experiencing. In a survey of its members, NGA found
    that most stores are dealing with significant formula
    shortages. The vast majority are unable to access specialty
    formula. They are receiving inconsistent information from state
    WIC agencies, and customers are panic buying.
        These stories are all very important context for what I
    believe is critical to recognize, the role that WIC is playing
    in this shortage. WIC purchases account for more than half of
    the formula sold in the United States. Therefore, WIC is ever
    present in the infant formula discussions for retailers.
        WIC is an essential program for families in my community.
    It provides supplemental nutrition to moms, babies, kids, and
    we are honored to be able to provide this program. WIC is not a
    money maker for retailers. In fact, it's the opposite. Many
    stores actually lose money as WIC vendors, but it is an
    important community service that we participate in to ensure
    that our families get the resources that they need to raise
    healthy kids and future leaders.
        Independent community grocers play an essential role as the
    private partners in the public/private partnership of WIC. But
    as it exists today, WIC is very burdensome for retailers to
    offer this program. I'm going to share a few opportunities for
    improvement to consider avoiding future disruptions of WIC
    products like infant formula.
        First, WIC's rigid rules have made it difficult for the
    program to be responsive to critical shortages throughout the
    pandemic and now during the formula crisis. Substitutions may
    be easily available when situations like this arise. The
    emergency waivers instituted by the USDA during the pandemic
    have provided flexibility in some states, but those waivers
    were only available because of the pandemic.
        To prevent this issue from happening in the--happening in
    the future, Congress should allow WIC vendors operating during
    severe supply shortages, disasters, or public health
    emergencies, areas to automatically substitute limited WIC
    approved products impacted by supply chain disruptions.
        The USDA should direct states to include product
    substitutions for WIC in their emergency preparedness plans.
    These changes would have allowed families to immediately switch
    to another formula in states with shortages, allowing for a
    smoother continuation of feeding infants.
        Secondly, there is a significant need for USDA to examine
    the long-term effects of cost containment, competitiveness, and
    peer grouping formula for WIC vendors. States operate a peer
    group system to monitor vendor prices and determine
    reimbursements are cost competitive. These cost containment
    measures have led to reduced retail imbursement, and reduced
    retailer participation in a program leading to fewer locations
    for families to access formula.
        Additionally, the WIC infant formula cost containment
    measures have led to extreme consolidation in the formula
    marketplace, leaving it highly vulnerable to supply disruptions
    like we are experiencing now.
        These contracting policies must be reviewed to ensure
    future food security of the nation's babies and families.
    Finally, the FTC announced they are launching an inquiry into
    the ongoing shortage of infant formula. NGA supports getting to
    the bottom of this issue to ensure that it never happens again.
        In conclusion, we want to work to maintain our strong
    existing public/private partnership with the WIC program, and
    continue to serve our rural and urban families. We all know
    that infant formula is a necessity for babies to grow and
    thrive. Let's all work together to get these babies fed and
    ensure that this never happens again. Thank you all for the
    opportunity to discuss this important issue today, and I look
    forward to any questions you might have.
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        Mr. Bishop. Thank you very much, Mr. Gay. Ms. Carney, you
    are now recognized.
        Ms. Carney. Thank you, good afternoon Chairs DeLauro and
    Bishop, and ranking member Harris. Committee members, and my
    fellow distinguished panelists, I am honored to have the
    opportunity to speak before you today.
        My name is Ginger Carney. I am a registered dietician
    nutritionist, and international board certified lactation
    consultant, and director of clinical nutrition and lactation
    services for St. Jude's Children's Research Hospital in
    Memphis, Tennessee.
        I'm here today on behalf of the Academy of Nutrition and
    Dietetics, which represents more than 112,000 nutritional
    professionals. As the immediate past president of the Tennessee
    Academy of Nutrition and Dietetics, I'm prepared to give you a
    sense of how this crisis is impacting families across the
    country.
        No child should face hunger because of safety and supply
    shortages. Since February 2022, dieticians have been working
    around the clock to determine appropriate and safe formula
    alternatives for patients impacted by the current shortage. I
    have experienced the devastation the formula supply chain
    disruptions has placed on so many families, even in my own home
    town.
        In my role in a pediatric research hospital, we have
    experienced shortages in our interval feeding formulas, or
    formulas provided through a tube for those children who cannot
    or will not eat enough to sustain them.
        Many of our patients are children with cancer, who cannot
    tolerate certain foods because their digestive systems have
    been compromised by chemotherapy and radiation, causing them to
    rely on specialized formula for their nutrition needs.
        The clinical dieticians on my staff have had to draw on
    their extensive expertise to recommend the appropriate tube
    feeding formulas to provide optimal nutrition support while
    monitoring tolerance in these children that we serve here at
    St. Jude.
        Dieticians around the country can spend hours on the phone
    every day speaking with vendors to try to find formula for
    their patients. One colleague of mine in Miami, Florida,
    reported that parents will file prescriptions to pharmacies,
    but it may take up to one month before a shipment is received,
    and then there is no guarantee that an ongoing supply of
    formula will be there.
        Recently in Memphis, two children were admitted to our
    local pediatric hospital with dehydration caused by intolerance
    to a formula which had been substituted for their regular,
    specialized formula. Caregivers are at their wit's end, and
    feel that they must find something to feed their children.
        When an infant is hungry, or a child is dependent on a
    specialized feeding, it can be life threatening when these
    needed formulas are not available. In February of 2022, a
    colleague in Florida met with first time parents of a set of
    premature 10-month-old twins in her clinic. At the time of this
    visit, she observed that the babies were behind
    developmentally, and not yet able to eat solid foods. So, it
    was recommended that they continue their hypoallergenic formula
    to meet a hundred percent of their nutritional needs.
        When the formula became unavailable, the parents began
    giving the babies almond milk, thinking this was an appropriate
    substitution. The switch to almond milk caused a reduction in
    the babies' calorie intake by nearly 60 percent. The babies
    eventually became lethargic and malnourished, leading to an
    emergency hospital admission.
        Imagine having to worry that you might not be able to keep
    your baby fed as your last can of formula is almost empty.
    Parents are driving for hours to nearby towns to find formula,
    and many families are not even able to do this given financial
    or geographic limitations.
        So this crisis is disproportionately impacting low income
    and rural families. My WIC colleagues in Louisiana and
    Tennessee have similar experiences fielding phone calls from
    panicked caregivers. Some WIC dieticians are even riding around
    their cities to take pictures of store shelves to advise their
    clients which store has the formula that they need in stock.
        One mother remarked that she was petrified that any formula
    she found could be contaminated. We appreciate that members of
    Congress are taking action, but more needs to be done. Our
    Government needs to do more to help new moms establish and
    maintain breastfeeding, even if they return to work or school.
    But when that is not possible, there has to be systems set up
    so that we never experience this kind of formula crisis ever
    again.
        Our recommendations include first, we know the importance
    of the first 1,000 days of life for long term health outcomes.
    We must track the cohort of children experiencing this crisis
    and determine the short and long term impact on their medical
    outcomes and nutrition security. To date, we are not aware of
    any efforts to formally document this.
        Second, other developed countries seem to have managed any
    shortages without significant issues. We must learn from others
    and revisit the laws and regulations to ensure a stable supply
    in our country in the future. This includes a thorough
    examination from production and oversight to access and
    affordability.
        And third, insurance companies must reduce the burden
    required for treatment authorization for non-formulary infant
    formulas. I want to thank everyone for your time and
    consideration today, and I'm happy to answer any follow up
    questions. Thank you so much.
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        Mr. Bishop. Thank you very much, Ms. Carney. Mr. Ronholm,
    you are now recognized for five minutes. You may proceed.
        Mr. Ronholm. Thank you, Chairman Bishop, and Chairwoman
    DeLauro, Dr. Harris, subcommittee members. Thank you for the
    opportunity to testify today. When a root cause analysis of
    this crisis is conducted, there will be several issues that
    will be examined to determine the contributing factors.
        First and foremost, the actions of Abbott will need to be
    thoroughly reviewed, especially given the allegations contained
    in the whistleblower report. Another factor is what impact did
    market concentration have in causing this problem?
        However, I would like to focus my testimony on how the
    structure, governance, and performance of the FDA approved
    program impacted the infant formula problem. A timeline of
    FDA's actions throughout the infant formula situation is
    attached as part of my testimony. As you will see, there are
    numerous questions that many of you in Congress have, and many
    consumers have about whether FDA performed its regulatory role
    effectively.
        The evidence suggests that the agency was too slow to act,
    failed to take this issue seriously, and was not forthcoming
    with information to parents and caregivers. The infant formula
    crisis exposed a greater structure and culture problem that has
    long existed at FDA.
        This was merely one symptom of the overall problem, and it
    is clear that confidence in the food program at FDA is eroding.
    A big reason for this is the food program has second class
    status within FDA, and it's resulted in serious problems.
        The FDA also lacks a single, full time, fully empowered
    expert leader of all aspects of the food program. As you know
    in recent decades, most FDA commissioners have been medical
    specialists who naturally focus on the programs impacting
    medical products. This is certainly warranted considering the
    impact these programs have on public health, and the pandemic
    as a perfect example of this.
        However, this usually results in intense competition for
    the commissioner's time and support, and focus on the food
    program is typically what has suffered under this dynamic. It
    has become impossible for an FDA commissioner to possess the
    bandwidth to provide leadership and accountability to a set of
    offices that regulate 80 percent of our food supply.
        It is this fragmented structure that led an unprecedented
    coalition of consumer groups, industry trade associations, and
    state and local regulators to join together recently to call on
    FDA to unify the food program under a deputy commission for
    food.
        This position would have accountability to the
    commissioner, and direct line authority over CFSAN, VCM, and
    the food related operations of ORA. This will bring focused
    leadership and accountability to the food program.
        The current fragmented structure of the food program
    results in delays in making compliance decisions, including
    recalls. Congress and the HHS Inspector General should
    investigate how this fragmented structure in leadership
    affected its response to the Abbott infant formula problem.
        Perhaps sensing this frustration, Dr. Califf recently
    announced the appointment of Dr. Janet Woodcock, FDA's
    principal deputy commissioner, to oversee several parts of the
    FDA, including the major food program offices. This is another
    issue where consumer groups and industry agree, this move is
    disappointing and needs reconsideration.
        Dr. Woodcock's extensive FDA career has focused on policies
    impacting medical products, but she has no notable food policy
    credentials. Plus, this new arrangement provides no integration
    or accountability, and no expert leader. It virtually ensures
    that the food program will continue to have second class
    status.
        Another area where there are serious questions is how
    funding is allocated within the FDA food program. This is an
    issue that Chairwoman DeLauro and Chairman Bishop have led in
    seeking these answers. ORA, which is responsible for
    inspections and compliance, receives approximately 70 percent
    of all FDA food program funding, and despite the funding
    increases Congress has provided, ORA's domestic food
    inspections have declined in the years following the enactment
    of the Food Safety Modernization Act, and before the pandemic
    shutdown.
        So the question this subcommittee needs to be asking about
    ORA, or, how does ORA allocate food program funding, and is ORA
    making the best use of these resources? We are fortunate to
    have a person with immense expertise and abilities like Dr.
    Califf serving as FDA commissioner. His recent testimony about
    investing in technology to leverage oversight activities
    certainly makes sense. However, investing in technologies and
    implementing structural changes for better governance are not
    mutually exclusive opportunities. We are not going to algorithm
    our way out of the existing problems in the FDA approved
    program, and we also need structural changes and stronger
    leadership that places a great emphasis on food policy. Thank
    you for the opportunity to testify today, and I look forward to
    your questions.
        [The information follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Bishop. Thank you, Mr. Ronholm. We will now proceed
    with questions. As I mentioned earlier, we will begin with the
    Chair and Ranking Member then alternating Majority and Minority
    with members present at the time the hearing started in order
    of seniority. Following that I will recognize members not
    present at the time the hearing was called to order in their
    order of arrival. Each member will have five minutes in each
    round, so please be mindful of your time. I will now recognize
    myself for questions.
        Let me start with you, Mr. Ronholm. In your testimony, you
    indicated a successful foods program at FDA requires
    transparency and engagement from the agency, and you mentioned
    the recent announcement that Dr. Woodcock would be providing
    strategic counsel that seeks to improve coordination and
    transparency of food operations at FDA. However, this move does
    not reinstate the position--reinstitute the position of Deputy
    Commissioner of Foods which provided a direct line of authority
    over the food and regulatory activities at FDA. You suggest
    that part of the solution to improve the foods inside of FDA is
    to reinstate the position of Deputy Commissioner of Foods, and
    we will certainly look into doing that.
        In the interim, given your expertise and familiarity with
    FDA are there other changes that could be made to improve
    transparency and accountability to help rebuild confidence
    following the recent criticism of FDA?
        Mr. Ronholm. Thank you, Mr. Chairman. Reinstating--I would
    just note that reinstating the Deputy Commissioner for Foods
    position would not require congressional action. Dr. Califf
    could certainly make that announcement at any time of making
    this move. But setting that point aside, I would just say that
    because ORA's human food inspection operations reports directly
    to the commissioner instead of a food policy leader that means
    there's no single FDA official whose job it is to lead the Food
    Mission area and provide effective oversight to the program as
    a whole.
        So if this fragmented structure is meant to succeed,
    information on budget, planning and program information must be
    widely shared to managers across the program, and decision
    roles must be clear. Also, accountability for how resources are
    used must be in place. So this means CFSAN and the Office of
    Food Policy and Response should have full access to all ORA
    budget planning and budget implementation data related to the
    Human Food Program. It also means that CFSAN and the Office of
    Food Policy and Response should have full access to all ORA
    operational data related to inspection, lab analysis and state
    partnerships.
        So again as a result of this fragmented structure there
    needs to be that increased coordination and accountability to
    make it more effective.
        Mr. Bishop. Thank you. Ms. Chamberlin, thank you so much
    for your testimony. It was very moving. I am glad we were able
    to highlight your family story. Of those with rare medical
    conditions, formula is life sustaining. I know you have been an
    advocate for many years, and I imagine it felt difficult to say
    everything in just five minutes. So is there anything
    additional that you would like to add?
        Mr. Ronholm. Thank you, Chairman Bishop, and thank you for
    your co-sponsorship of MNEA. I have two quick things. Since the
    onset there has been sort of an in joke in people who advocate
    for rare disease that COVID taught the rest of the world what
    it was like to have a rare disease. So many people were sick.
    We had no idea what was going on for a while. We had no
    diagnosis. We had no treatments. We still have no cure, and we
    were confined to our homes and isolated, but that crisis
    spurred good things.
        There was remarkable support from our government and
    innovation in our scientific community, and I feel much the
    same about the formula crisis. So many people now understand
    how vital the white powder in these cans is to so many, and I'm
    hopeful that those of us who rely on this lifelong will have
    the attention and the support of both the public and our
    government in supporting the MNEA. Now that people understand
    us we need them to take action.
        Mr. Bishop. Thank you very much. Mr. Carney, I thank you
    for your testimony. Can you talk about some of the possible
    short-term concerns? You mentioned hospitalizations and that
    there are perhaps a number of short- and long-term impacts with
    medical outcomes and nutrition security. Can you talk about
    some of the short-term concerns and long-term and the risk of
    making formula--diluting formula to try to make it last longer?
    My time is almost expired.
        Ms. Carney. Okay. I will be quick. Yes, we need to make
    sure that parents know that this--as we have said today this
    crisis will be going on for several more weeks, so we need to
    be prepared. I would want to warn parents not to make homemade
    formulas--the American Academy of Pediatrics warns against
    that--as well as they should not dilute the formula as both of
    these situations can lead to disastrous results and lead
    possibly to hospital admissions. They should check with their
    pediatricians or even a registered dietitian that specializes
    in pediatric for guidance on proper substitutions.
        Mr. Bishop. Thank you. My time has expired, and at this
    time I will yield to the distinguished Ranking Member, Dr.
    Harris, for your questions. Dr. Harris, you are recognized for
    five minutes.
        Mr. Harris. Thank you very much, Mr. Chairman. I want to
    thank all the experts here today. Ms. Carney, let me ask I am
    hearing that some hospitals are having admissions through the
    emergency rooms. Parents can't find formula or, I don't know,
    maybe even some infants are getting ill because they don't have
    the formula they need. Is this happening nationwide? Or how
    would we know if that is happening and the extent to which that
    is happening?
        Ms. Carney. Certainly we have heard of infants and older
    children, too, being admitted to the hospital when they try to
    substitute formulas or they make their own formula. As I
    referred to in my testimony here in Memphis we had two
    children, I believe they were older children, with Short Bowel
    Syndrome that were admitted to the hospital because of
    intolerance to the formula. They needed an elemental formula,
    and they went to something that they could--just anything they
    could find. And since they were not able to absorb it they had
    severe diarrhea and got severely dehydrated.
        Mr. Harris. So there is obviously some risk from this
    formula shortage that doesn't have to do with contamination. It
    has to do with the result of not having formula.
        Mr. Ronholm, let me ask you specifically because in your
    timeline you don't mention the CDC and state agencies looking
    at the Cronobacter cases--because Cronobacter is ubiquitous. I
    mean, it is all over--that CDC could not find a link between
    the Cronobacter that was found in the Abbott plant and the
    Cronobacter that infected children. In fact, one of the cases
    it was found in the distilled water that was used to mix the--
    Cronobacter found in distilled water used to mix the formula.
        So given that, is there some concern that this should have
    been resolved a lot earlier? I mean, they could have
    investigated this a lot earlier and started reopening the plant
    earlier when there was no direct linkage between the
    Cronobacter at the Abbott plant, again something that is
    ubiquitous, and the Cronobacter that caused these tragic
    infections two of which of course led to death but none of them
    genetically the Cronobacter that was in the Abbott plant.
        Mr. Ronholm. Thank you, Dr. Harris. So the timeline that we
    put together was focused exclusively on FDA action, so we
    didn't incorporate the CDC and state actions. Just in terms of
    making that link with the Abbott plant I think we probably need
    to be a little careful just in terms of the small sample size I
    think that was taken during that testing process and trying to
    make that link with the Abbott facility.
        You are absolutely correct that at this point there is no
    direct link, but I would just say that if you are taking a
    small sample size I think it makes it more difficult to make
    that link. So if you were to imagine a barrel full of Lego
    pieces and you grab one handful, but it doesn't include a red
    piece. So you conclude that the tub must not contain a red one.
    I mean, it is highly unlikely that would be the case, but that
    is just an example that we have to be careful about making that
    definitive conclusion that there is no link because I think a
    lot of it has to do with what happened with the testing at the
    Sturgis facility.
        Mr. Harris. Sure. So let me just follow up. One thing you
    mentioned in your testimony and goes a little beyond your
    testimony actually, look, when the FDA was set up we were in a
    much different world. The drug industry and the need to have a
    high level of expertise in drugs kind of distracts the FDA I
    think from the food aspect of it. Is it time to split the two
    apart and not to split the two within the FDA but to split them
    into two separate agencies one of which deals with
    pharmaceuticals and one of which deals with food safety?
        Mr. Ronholm. I think that idea, Dr. Harris, deserves a lot
    of attention and merit. I know it is something that Chairwoman
    DeLauro has been focused on for years and that splitting out
    the food safety functions of the agency as it exists now and
    creating a separate agency while still remaining under the HHS
    umbrella that certainly would be I think an effective approach
    that would get to the issues that I think everyone has become
    aware of during this crisis. Absolutely.
        Mr. Harris. Yeah. Of course that will take statutory
    action. I mean, we have to do that. In the meanwhile, what
    qualifications should the person at the FDA who will now be put
    in charge of food, what qualifications should they have?
        Mr. Ronholm. Yeah. So right now I think as an interim step
    before we can get to that point where you are taking food
    safety out of FDA I think what we need is an empowered deputy
    commissioner position that holds food programs accountable, has
    oversight authority, and I think that person needs to have
    strong, deep food policy credentials, decades of experience in
    food policy whether it is industry consumer groups, et cetera.
    There needs to be somebody who is steeped in food policy that
    can understand the intricacies, the nuance to be able to
    develop policies to react, to focus on illness prevention and
    react to a crisis like this.
        I mean, I think today what happened at the other committee
    hearing they couldn't decide whether three or four people
    should testify on this crisis. If you have one person leading
    the whole program, all Congress has to worry about is inviting
    one person to testify and hold that person accountable.
        Mr. Harris. Thank you very much. I yield back, Mr.
    Chairman.
        The Chair. Mr. Chairman, you are on mute.
        Mr. Bishop. I am sorry. Thank you. Dr. Harris, thank you
    for your questions. At this time, I would like to yield to the
    Chairwoman, Ms. DeLauro, who has been very tenacious,
    aggressive and unyielding in getting to the bottom of this
    crisis.
        Chairwoman DeLauro, you are now recognized for your
    questions for 5 minutes.
        The Chair. Thank you so much, Mr. Chairman. I was just very
    interested in the exchange between Dr. Harris and Mr. Ronholm
    because, in fact, I recommended and Senator Durbin has as well
    for many years an independent food safety agency because when
    we get into these crises not unlike what happened today at the
    prior committee meeting no one is in charge. No one individual
    is in charge of food safety where the responsibility lies.
        In the interim, I think that Mr. Ronholm has laid out a
    structure because we know that it takes a while to get to where
    we want to go, but eventually single food safety agency. We now
    have 15 agencies at the federal level who deal with some form
    of food safety. The principal ones are USDA and FDA. It should
    be one single agency.
        Mr. Ronholm, the FDA received a report from a worker from
    the Abbott manufacturing facility in Michigan unveiling a
    damning list of allegations--falsification of records, testing
    scales on empty cans, releasing untested infant formula to name
    a few. Have you read the whistleblower report? And then as a
    food safety----
        Mr. Ronholm. Yes, I have.
        The Chair. Thank you. As a food safety expert what was the
    allegation that you found alarming?
        Mr. Ronholm. The most alarming allegation in the report
    that I found would be the falsification of records. Now,
    falsifying records doesn't necessarily represent an immediate
    food safety threat in and of itself, but what it does reflect
    is the lack of a strong food safety culture at the facility,
    and that points to a much deeper problem that exists both at
    the facility and within the corporation. So when you have that
    level of a food safety culture problem, it results in things
    like gloating about hiding information from the FDA and other
    more immediate food safety threats like releasing the untested
    products, the unsanitary conditions at the plant and failure to
    take corrective actions.
        And you think of the other things that falsifying
    information can lead to such as making it difficult to recall
    bad products. It would be difficult to trace where and what
    communities were affected by a particular recall if the records
    have been falsified or not available. There would be no way to
    look back at fixing problems that have been identified in the
    past. So you have all of this--you have all of these
    activities, all of these important actions that plants take
    tied to falsifying records, so that to me is the major red flag
    of how a bad food safety culture can permeate an organization.
        The Chair. Quite frankly, I wish Dr. Taylor when I asked
    him that question had a similar answer or at least had an
    answer to that issue.
        Dr. Carney, my opening remarks on Monday I did a roundtable
    event with community organizations, Mothers on Infant Formula.
    I mentioned a grandmother brought two of her grandchildren to
    the emergency room experiencing vomiting and diarrhea. Later
    the grandmother realized that the formula she was giving her
    grandchildren were part of the recall. A couple of quick
    questions. Currently, Cronobacter is not a reportable disease.
    Does that contribute to the issue of tracking?
        Ms. Carney. Thank you so much, Ms. DeLauro. I don't know if
    that is an issue of tracking. I think it is--yeah, because it
    is not a diagnosed disease, and the only way we would know is
    if somebody was admitted for those different symptoms that you
    have just described is to look at their condition, look at what
    they had consumed and knowing what formula or feeding had been
    recommended for them.
        So we have to know if formula is contaminated before it
    gets to the children. We cannot let that happen and then try to
    diagnose that in the emergency room or in the hospital
    somewhere so that it can be--so we don't ever give it to them
    and make sure that they are getting clean, safe formulaic
    feeding.
        The Chair. Okay. I am going to run out of time, Dr. Carney.
    Should it be a reportable disease? Let me just ask you for a
    yes or no. Should it be a reportable disease?
        Ms. Carney. I think we have to report it so that we can
    track it and we can----
        The Chair. I have legislation, by the way, that I talked
    about which would make it a reportable disease. The other thing
    is because of this trying to track the cases which you
    mentioned before we had two infants that died, four
    hospitalized, do you think there is any underreporting of this
    because we don't have a tracking system? And you have got to be
    brief because I have ten seconds.
        Mr. Ronholm. I'm sorry, Rosa. Was that directed at me?
        The Chair. It was going to go to Dr. Carney, but let me--
    Mr. Ronholm. Somebody.
        Ms. Carney. I am sorry. I missed the question.
        Mr. Bishop. All right. We will perhaps come back to it, Ms.
    DeLauro. Your time has expired.
        I will now recognize the gentleman from California, Mr.
    Valadao, for five minutes.
        You are now recognized, Mr. Valadao.
        Mr. Valadao. Thank you, Mr. Chairman.
        Thank you to all of our witnesses for your willingness to
    testify in front of the subcommittee today and share your
    perspectives of the ongoing infant crisis.
        Less than one week ago, the Food and Drug Administration
    Commissioner testified in front of this committee as well.
    There is still much that is unknown.
        It was more than discouraging to see that he was unable to
    answer questions related to timing, causes, accountability, and
    more. It is unacceptable. We need formula on our shelves
    yesterday, and we need real answers from our officials so that
    we can ensure this never happens again.
        Just yesterday I was in a grocery store in my district and
    noticed the lack of formula on the shelves. Instead there were
    pieces of paper with a picture of the formula and a note
    instructing the customer to take the paper to the cashier to
    purchase.
        I am not sure what their exact inventory is, but it did not
    look promising, unfortunately.
        It is almost June now. The recall was in February, and how
    are families in rural communities supposed to provide food for
    their babies that rely on this product, especially those who
    participate in the WIC Program or do not have the means to
    drive all over the region looking for a specific type of
    formula.
        Thank you all again for your participation and continuing
    the conversation as we wait for the FDA and Abbott Nutrition to
    get the Sturgis facility back up in production.
        The FDA provided a response yesterday to a letter I sent
    earlier this month along with my colleagues related to the
    infant formula shortage. In this letter, they claim that the
    FDA began alerting Federal partners and stakeholders about the
    potential supply disruption even before Abbott voluntarily
    recalled the product.
        It seems an advanced alert like this could have better
    prepared stakeholders for the formula shortage disruption. Mr.
    Gay, were you notified about the forthcoming formula shortage
    by the FDA, USDA, a manufacturer?
        If so, when?
        Mr. Gay. Thanks for the great question.
        We were, but it was very late, probably just a few weeks
    before it really hit the news. Our warehouse tried to procure,
    obviously, different things, but the bigger issue for our store
    particularly is that in a rural area such as ours, probably 85,
    90 percent of my formula is WIC formula, which is just down to
    one type of formula.
        So even like today, for example, on my truck Monday, I got
    about 20 cases of Gerber formula in different varieties, but
    that is not approved on WIC, and the Georgia WIC Office just
    approved some substitutions for formulas that were, you know,
    subscribed by the doctor with the contract formula.
        So therein lies the problem, is there is no easy way to
    substitute that for the customer, and so even if you had
    advanced knowledge of it, there is no way to go around whatever
    your customers, particularly in our area, would have been able
    to buy.
        Mr. Valadao. So you were given about a two-week heads-up,
    it sounds like. And then in your testimony, you provide
    recommendation for the WIC Program that you feel would improve
    the process for both WIC retailers and participants.
        Have you expressed these concerns to the WIC Program
    officials?
        And if so, how have those concerns and recommendations been
    received and what kind of feedback have you heard?
        Mr. Gay. Unfortunately for us, Georgia will be probably the
    last remaining State to not be eWIC approved. So we are still
    actually taking paper vouchers, which has made the process
    doubly hard because it is not a matter of just substituting
    UPC. You have to physically go back to the WIC office and have
    your WIC exchanged.
        We have, you know, obviously addressed those before even in
    our area. Hurricanes are things with similar things, and we
    very rarely get any real guidance or any help, so to speak,
    from the WIC Offices here. It falls basically to us to handle
    it the best we can with our customers.
        Mr. Valadao. The paper prescription one in your testimony
    is the one that blew my mind. I was totally surprised by that
    one, but I appreciate you expressing that one. That is
    something we do need to look into more.
        And then, Ms. Carney, as of last week's FDA hearing, I
    expressed concerns with the Commissioner about Dr. Janet
    Woodcock becoming Principal Deputy Commissioner due to her lack
    of expertise in food policy. I was not reassured with the
    response I received and still have those concerns.
        In his testimony, Mr. Ronholm expressed a similar concern
    with this action and potential consequences this decision will
    have on food policy under her leadership.
        Ms. Carney, given your expertise and line of work, I am
    curious about your opinion on this decision. Do you agree with
    the concerns that Dr. Woodcock is not the best suited for this
    position and that the FDA should have someone with adequate
    expertise on food policy in this role?
        Ms. Carney. I do not know if I can speak directly to that.
    I am not really familiar with the person in charge, but I will
    say that we do have to have somebody that is competent and
    understands the repercussions of getting babies and children
    unsafe formula and food.
        Mr. Valadao. All right. Thank you.
        And my time has expired. So I yield back.
        Mr. Bishop. Thank you, Mr. Valadao.
        And at this time I am delighted to recognize the gentlelady
    from Maine, Ms. Pingree.
        Ms. Pingree, you are now recognized for five minutes for
    your questions.
        Ms. Pingree. Thank you so much, Mr. Chair, and thank you
    for holding this hearing and to my colleagues for their
    questions and the panel for all that you are talking to us
    about.
        Mr. Ronholm, you have already provided us with such great
    information, and I appreciate the work you have done on this
    and the role Consumer Reports plays in making sure consumers
    have this important information.
        You have already talked a lot about how changing the
    agency, maybe a single agency could make all the difference and
    a different leadership structure.
        Is there anything else you want to add on information
    sharing, leadership structure that we should consider as we
    think about how restructuring would work?
        Mr. Ronholm. Yeah, I mean, I think the leadership component
    of this is the key. I mean, I think we really need to have that
    one single person in charge of the Food Program to be able to
    have that expertise, to have that oversight authority of the
    Food Programs to be able to respond to these types of
    situations.
        I think one thing that I also mentioned was that if this
    fragmented structure is going to go forward, you must have
    information sharing between ORA, the Office of Regulatory
    Affairs, which is in charge of the inspection compliance piece
    for FDA, and allow them to share that information and work
    plans with CFSAN, CVM, and the Office of Group Policy and
    Response.
        Without this type of information sharing, without this type
    of collaboration, you know, I think we are going to continue to
    see what we are seeing now, just this kind of fragmented
    structure and how it leads to these types of crises.
        You know, there is a running joke. If the Group Policy
    would alter the F is silent in FDA and the F only roars when
    there's a crisis like this, and I think you need that type of
    collaboration.
        Ms. Pingree. Yes, I totally agree. And thank you for that.
    I think it is something we have all been talking about for a
    long time, and I think there could be bipartisan agreement on
    how to go about doing that.
        I want to take up a slightly different topic other than
    just how the agency worked, and, Ms. Chamberlin, you actually
    mentioned this, about how the pandemic really got us thinking
    about a whole variety of different things, and now this has
    really helped people to understand formula, particularly those
    formulas that are medically necessary.
        I am always interested in nutrition, diet, and health, and
    this fits right into that, and I have been a cosponsor of the
    Medical Nutrition Equity Act, which would ensure a baseline of
    insurance coverage.
        So between you and Ms. Carney, could you talk a little bit
    about it? I think people really do not understand the insurance
    challenges, the cost, and the lack of availability to those
    people who need this.
        Ms. Chamberlin. Yes, thank you.
        And thank you for your co-sponsorship. It is very important
    to so many.
        So my daughter is just over four feet tall, and she weighs
    about 62 pounds, and her formula is billed out at almost $1,600
    a month to her insurance, and that is an amount that will
    increase, you know, with weight and age, and she will be on
    that her entire life.
        The way that insurance reimbursement for medical nutrition
    is structured is State-based, and so one State may cover a
    child up to age one. One State may cover up to age five.
        You may only get coverage for PKU but not tyrosinemia just
    because that wasn't written into the law. You know, it is age,
    disorder, gender, type of insurance, income, and then anyone
    who is on a self-insured plan will not be bound by any State
    law. So that plan will not be bound by any requirements to
    cover medical foods. They can do it, but they do not have to,
    and so you will be----
        Ms. Pingree. Thank you.
        Go ahead, yes.
        Ms. Chamberlin. I was just going to say you have a huge
    number of people who slipped through all of those loopholes,
    and what the MNEA does is for those people we will provide that
    Federal floor. This is their medical treatment for life, and it
    guarantees that they can continue to thrive.
        Ms. Pingree. Yes, and thank you.
        And thank you for using your personal knowledge of your
    daughter's challenges and informing us of all of that.
        And, Ms. Carney, I do not have a lot of time left, but you
    know, we can see how important it is to have a Federal standard
    here, but you must experience this all the time when families
    are challenged by insurance rules.
        You are muted, I think.
        Ms. Carney. Thank you so much.
        Yes, absolutely, and registered dieticians are so important
    in working with families like Ms. Chamberlin is describing all
    kinds of children that need different formulas, different
    diets.
        Another Medical Nutrition Therapy Act is up for discussion
    that would allow dieticians to provide specialized nutrition to
    the families and patients that are in need of these special
    formulas.
        Ms. Pingree. Thank you.
        Thank you, Mr. Chairman. I yield back.
        Mr. Bishop. Thank you.
        At this time I am delighted to yield to the gentlelady from
    Louisiana, Ms. Letlow.
        Ms. Letlow, you are now recognized for five minutes for
    your questions.
        Ms. Letlow. Thank you, Chairman Bishop and Dr. Harris.
        I join my colleagues on the subcommittee in expressing my
    sincere gratitude to all our witnesses with us today.
        Just last week, the Food and Drug Administration
    Commissioner, Dr. Califf, testified before this subcommittee as
    one of his first official visits to Congress since the start of
    this crisis, and while it was past time for answers and a
    solution, we were still left with grave uncertainty, with no
    clear end to this shortage in sight.
        As a mother of a four-year-old and two-year-old, I cannot
    imagine the sheer terror families must be experiencing as they
    desperately search to find the most basic, life sustaining
    nourishment for their children. I stated in my remarks to Dr.
    Califf it was not too long ago that I myself was completely
    dependent on formula to fulfill my children's nutritional
    needs.
        In many cases not all formulas are the same. Families know
    the specific brands and types of formula that work best for
    their children, and access to these essential goods simply
    should never be compromised.
        In part of my questioning, I asked Dr. Califf how much
    formula FDA expects will be imported under the new enforcement
    discussion guidance, and what is the real timeline of seeing
    those products on our store shelves.
        His answer was it will gradually get better. Unfortunately,
    many of our constituents have encountered empty shelves for
    three weeks now, and it is time we seek solutions to address
    this shortage expeditiously and establish safeguards should our
    domestic supply ever be threatened again.
        Ms. Carney, as heartbreaking as it is to hear the personal
    stories you have shared, thank you for shedding some light on
    the true crisis families are facing and for your dedicated work
    as a nutritionist to provider care to your most critical
    patients during this time.
        As you and Ms. Chamberlin both mentioned in your testimony,
    families and health care providers took it upon themselves soon
    after the closure of the Abbott facility to introduce new
    formula mixes to sustain their children's daily nutritional
    needs. Maybe at the time it was for precautionary reasons, but
    it is now a reality.
        Through this committee's work in funding our Federal
    agencies, the FDA just received a $102 million budget increase,
    including an $11 million increase specifically for maternal and
    infant health and nutrition for fiscal year 2022.
        Having provided the necessary resources, how could the FDA
    work more collaboratively with manufacturers and health care
    providers to address disruption in the supply chain and avoid
    this unprecedented shortage?
        Ms. Carney. Sure. Thank you so much for that question.
        I think that we have to stay on top of the supply chain. I
    am in a hospital. When our supplies get low, we scramble to
    find the right substitute or not even substitute, but a good
    alternative to feed our patients and keep them nutritionally
    sound.
        We need communication. We need accountability, and we need
    to know what is available that we can give to our patients so
    that they do not suffer some of these things that I described
    in my testimony.
        Ms. Letlow. Sure. Thank you.
        And to follow up to that, given that Abbott is the only
    producer of some specialty metabolic formulas, from a health
    care perspective, do you believe there is a role providers
    could play in working with the industry and FDA to ensure
    additional options for therapeutic formulas remain available
    when the main source is at risk?
        Ms. Carney. For sure we need alternative sources, and we
    need to look to other places that might produce this formula,
    manufacture some formulas. I do not think there needs to be a
    monopoly by one company in these specialty formulas because, as
    Ms. Chamberlin has described her daughter, when they are out of
    that formula, that is the only thing she can take.
        So with the help of dieticians, we can help figure out some
    other dietary things that she can do to keep her daughter
    thriving and growing, but it causes a lot of distress, of
    course, and so we need other options and other sources besides
    one company. It just should not be that way.
        Ms. Letlow. Sure. Mr. Gay, I represent a heavily rural
    district where the proximity and availability of retailers for
    certain goods as limited, and given your background as a rural
    retailer, I am sure you understand how important these stores
    are to our local communities.
        Can you share with the subcommittee how the shortages not
    only affected your store, but most importantly, your customers?
        And secondly, I believe retailers can play a vital role in
    the distribution of essential products. What additional steps
    have you taken to overcome these supply challenges to make sure
    infant formula is restocked, especially in our rural
    communities?
        Mr. Gay. Thanks for the question.
        Yes, the nearest big box retailer, so to speak, from any
    direction of my store is probably 25 to 30 minutes, and like I
    said, a lot of our formula, you know, 90 percent of it is
    probably sold just on WIC.
        So it becomes a big problem that people cannot leave to go
    get anything else.
        And as far as this specific formula thing, it has been much
    different than any of the other pandemic stuff. There were
    times when some of the bigger box retailers were getting items
    that I could not get or were not getting my fair allocation of.
        I have talked to some warehouses, and this is not one of
    those situations. Everyone is getting their fair share of
    formula now.
        So I say that to say this. If there were times when my
    customers needed something and I could get it from somewhere
    else, I go get it whether we sell it at what we paid for it or
    are not making any money on it just so they do not have to
    leave the community.
        This is one of those times where I do not have the ability
    to go get it from anywhere else. This solely falls back to a
    shortage with the oversight is not getting the plant back open
    fast enough.
        Ms. Letlow. All right. Thank you so much.
        Mr. Bishop. Thank you, Mr. Gay.
        Thank you, Ms. Letlow. I believe your time has expired.
        And at this time I am pleased to recognize the gentleman
    from Wisconsin, Mr. Pocan.
        Mr. Pocan, you are now recognized for five minutes for your
    questions.
        Mr. Pocan. Thank you very much, Mr. Chairman.
        And thanks for having in many ways the second hearing on
    this subject in two weeks, which is showing again, I think,
    Congress responding quickly like we did in the House, passed a
    bill to the President, the Defense Production Act.
        Clearly, there were problems at the FDA, and we have had a
    great conversation about that this morning, but I think there
    may be some other concerns we should also talk about a little
    bit.
        I just want to start with Ms. Chamberlin. I just want to
    let you know your advocacy, today you have just got a new
    sponsor on that bill. I was texting my office, and we called up
    Jim McGovern's office, and we are on it.
        So I just want to let you know your time has been well
    spent, and thank you for informing me, and as other members may
    ask the question, I will also refer them to that bill. So thank
    you for your time today.
        I do want to ask a question of Mr. Ronholm. What you
    started to say and I will not start with the monopoly problems.
    I will talk about the FDA, and I think we have talked a lot
    about the FDA.
        I think though we do have to fix the FDA situation on this,
    and I think we can do it in a bipartisan way. There is still a
    problem when four companies are producing 90 percent of the
    product, right? And we know what that means.
        Often consumers are going to get a raw deal, perhaps on
    paying out for it from things like right now when someone goes
    down who has got these exclusivity contracts through WIC.
        So I guess my questions are: one, how has sole-sourced WIC
    contracts impacted parents during the infant formula shortage,
    trying to get to this monopoly issue?
        Second, should we be considering any changes in Congress
    either in the appropriations process or the next farm bill to
    adjust this?
        And then third, should we be allowing this monopoly
    structure that States are using our WIC Federal dollars to then
    have these monopoly relationships?
        Because to me that may be part of the problem.
        Mr. Ronholm. Yes, those are all very critical questions,
    Mr. Pocan, and I think your point is certainly well taken in
    terms of, you know, four companies that control 90 percent of
    the market, and only three of them actually bid with rebate
    contracts, and Abbott is by far the largest one, and I believe
    they have contracts in 30 or 31 States, I think was the latest
    figure.
        So, you know, when those contracts come up, these companies
    submit based on their ability to meet the demand in a
    particular State, and Abbott is usually the only one that is
    big enough to do that.
        And I think, you know, we mentioned that they have a large
    part of the market. I think when it comes to the WIC market,
    they have approximately 55 to 60 percent of the WIC market. So
    that is a significant size of the market that really needs to
    be examined so when situations like this hit, how does it
    impact that particular market.
        And it is obviously going to have a bigger impact because,
    you know, these companies use the WIC market to get into the
    overall non-WIC market, to even increase the share of their
    market. So that creates further shortage problems.
        You know, in terms of your question about what Congress can
    do in terms of fixing FDA, I mean, I think this is going to be
    a several-step process. The first step that the FDA can take is
    to appoint that empowered Deputy Commissioner expert leader
    that could provide the leadership and accountability in the
    Foods Program, be that single person in charge to hold the
    agency accountable.
        You know, the next step is to maybe consider legislation
    that Chairwoman DeLauro and Dr. Harris had discussed about the
    splitting the food part of the FDA and creating a separate
    agency while still under the HHS umbrella.
        And the third ultimate step long term is ultimately
    creating this independent food safety agency, much like the
    EPA.
        Mr. Pocan. So let me just ask. None of those actually
    address the monopoly issues, right?
        Mr. Ronholm. Right.
        Mr. Pocan. So I understand that is being decided. I think
    that has been well talked about, but how about this monopoly
    side?
        Are we actually creating a bigger problem by allowing WIC
    dollars to be used in the way they currently are because we
    have really now made it not just a monopoly of the three
    companies bidding, but like you said, it is really one company
    that is left out there?
        Mr. Ronholm. Yes, it is absolutely a problem when that one
    company can control that much of the market. You know, I am not
    the market concentration expert, FTC expert, but certainly
    anyone can identify this as an issue that needs to be
    addressed, for certain.
        Mr. Pocan. Great. Thank you.
        And very quickly, Mr. Gay, if you can do it in like 20
    seconds or less, I have got 28 seconds. How is your store
    making purchase decisions about formula impacted by WIC?
        Mr. Gay. Like I said, with it being 90 percent of the
    thing, we basically only carry WIC formula, and so you know,
    whatever they use we carry that almost exclusively.
        Mr. Pocan. Got you.
        I yield back, Mr. Chairman. Thank you very much.
        Mr. Bishop. Thank you very much, Mr. Pocan.
        And at this time I am pleased to yield to the gentlelady
    from Illinois, Ms. Underwood. You are now recognized for five
    minutes.
        Ms. Underwood.
        Ms. Underwood. Well, thank you, Mr. Chairman.
        I want to begin today by acknowledging just how terrifying
    our Nation's infant formula shortage is for parents and how
    urgent our response must be from the administration, from
    formula manufacturers, retailers, and all other stakeholders.
    We need an all hands on deck response until every family has
    access to the same formula they need.
        We also need to be thinking more broadly about what this
    crisis says about our Nation's support system for growing
    families. While the current infant formula shortage is unique,
    it is a symptom of long-term policy failures to prioritize the
    nutrition needs of infants.
        This is happening in a country with a glaring lack of
    sufficient support for breastfeeding, in a country with a
    higher maternal mortality rate than any other high income
    nation, and in a country where even before the current
    shortage, low-income families struggled to access the nutrition
    their children need due to the highly concentrated infant
    formula market in which four companies make up approximately 90
    percent of formula available, and the Special Supplemental
    Nutrition Program for Women, Infants, and Children, known as
    WIC, offers limited formula option for participating parents.
        Today's infant formula shortages are a symptom of both
    market failures and policy failures, and both issues must be
    addressed to not only get more formula onto shelves now, but
    also to prevent something like this from ever happening again,
    and to ensure that America is the most supportive place in the
    world to grow a family.
        Ms. Carney, how would a more robust support system for
    growing families in the United States, including support for
    breastfeeding, help parents access the nutrition their infants
    need and address maternal and infant disparities?
        Ms. Carney. Thank you, Ms. Underwood, for that question. I
    would love to address that.
        First of all, just a word about WIC and--excuse me--and our
    supply of formula here at St. Jude, and we are so blessed here
    at St. Jude from our donors that we are able to get any formula
    not based on WIC bids or anything that the WIC Program has put
    the babies or children on before they arrived at St. Jude.
        So we do provide whatever formula our dieticians think is
    best for these children.
        To address your question, I do think in my work in public
    health in graduate school, we always looked at working upstream
    rather than downstream, so to find something that would promote
    public health before we go dealing with the problem.
        So instead of curing things, let's do prevention, and I
    always think that breastfeeding or, well, we know that
    breastfeeding is optimal feeding for infants. So if we can
    think about upstream for a few minutes, to answer your
    question, and have more effort to support moms and babies to
    successfully breastfeed, we are not looking at so much formula
    usage, and the infants and children that do need formula, more
    would be available for them.
        I know that----
        Ms. Underwood. We also know--oh, go ahead.
        Ms. Carney. I know that women, mothers face challenges, and
    they have to return to work and to school, and they do not get
    the support they need. So I think, you know, us looking at ways
    to provide possibly more paid maternity leave after delivery of
    a baby and more support from lactation consultants like I am so
    that they can successfully breastfeed would really help address
    this problem and increase breastfeeding rates in this country.
        Ms. Underwood. Yes, ma'am. Increasing access to lactation
    consultants and making sure that, you know, we are avoiding
    moms and babies going hungry so that they can achieve their
    milestones and grow into healthy, thriving children is very
    important.
        Ms. Carney, Federal agencies have released guidance on the
    current infant formula shortage, which includes a
    recommendation that parents contact their child's pediatrician
    if they have questions about safely providing the nutrition
    their infant needs.
        What about the parents of children who do not have a
    consistent pediatric health provider? Where can they turn to
    for guidance?
        Ms. Carney. So if a child does not have a primary care
    provider, I would suggest they would check with their local WIC
    Office, who could guide them, and also the Health Department
    Clinic in their community, and there you will find pediatric
    registered dieticians to help them decide or to consult what is
    the best formula for them.
        Ms. Underwood. Thank you so much for providing that
    information.
        As a registered nurse, I know how important it is to share
    clear, accurate, and evidence-based information with patients
    to address their concerns and answer questions. Many of us do
    have these WIC Offices in our communities. We all have Health
    Departments that are great resources for all of us to consult.
        And I would encourage the American people to be in touch.
        Thank you so much to our witnesses, and I yield back.
        Mr. Bishop. Thank you, Ms. Underwood.
        At this time I yield to the gentlelady from California, the
    chair of the Foreign OPS Subcommittee of Appropriations, Ms.
    Lee. You are now recognized for five minutes.
        Ms. Lee. Thank you very much, Mr. Chairman.
        And thank you, Ranking Member and members and witnesses,
    for this very important hearing.
        You know, for the life of me, initially when I heard about
    this baby formula shortage, I asked myself how could this
    happen in the wealthiest and most powerful country in the
    world. Baby formula shortage, unbelievable.
        Then I realized this is an example of what we call monopoly
    capitalism where only four companies own actually 90 percent of
    the market. So this has got to change just in terms of the
    structural issues because if you do not have competition in a
    capitalist society, this is what happens.
        And so I am just wondering if any of you could tell us how
    you see this in terms of agencies, Federal agencies, working to
    address these unfair practices because like stock buybacks,
    price gouging, you know, all of the issues that led to this.
        I do not know if you are looking at how this happened
    structurally, but if you are, I would like your take on that.
        And then secondly, and I guess, Mr. Ronholm, this would be
    a question for you or Mr. Gay. In terms of WIC and low-income
    and disadvantaged communities, of course, they are suffering
    tremendously from the consequences of this infant formula
    recall having already disproportionately suffered from COVID-19
    and the resulting economic pressures.
        And now with the new strategies to try to immediately bring
    formulas to our children, our babies, what kind of hesitancy do
    you see or do you see any hesitancy, given the long history of
    medical racism in this country?
        Are WIC recipients, especially recipients of color, are
    they reluctant or resistant or questioning the efficacy and the
    safety of the formulas that now will be available?
        Mr. Gay. I guess I will jump in on that one. This is
    Michael Gay.
        A great question. The biggest issue, I think, here as far
    as hesitancy is just like yesterday. Not only has Georgia WIC
    been slow to make a substitution, but especially younger
    mothers in general are very hesitant to even change formula for
    their baby, even though nutritionally it may be the same
    quality and a fair swap. They are very hesitant and skittish to
    take their baby off of whatever they have talked about with
    their doctor about feeding their child.
        So even though there may be, like we did get a different
    national brand available, they walked out of the store and did
    not buy anything because, you know, you could tell they were a
    little hesitant just to buy it because it was not what was on
    their WIC, even after telling them to go back to the WIC office
    and check with them.
        So there is definitely an issue there with WIC and the way
    they handle formula.
        Ms. Lee. Well, are we looking at outreach strategies?
        And I asked the other day in our prior hearing about this.
    So it was actually a meeting with the White House. Are there
    strategies, and we used some during COVID, to have trusted
    messengers, people that the communities can relate to provide
    the information about the safety of the formulas that are
    coming in?
        Has anyone looked at that as being important at this point
    given the medical racism and hesitancy we have in many of our
    communities?
        Mr. Gay. Honestly, ma'am, the first email I received about
    using different formulas was Monday of this week from WIC.
    Other than that, we have heard zero from our WIC Offices as to
    how to proceed, more as we just kind of do the best we can at
    the store level to provide, but we are not really given any
    direction from the WIC Office at all.
        Ms. Lee. Okay, Mr. Chairman. I think that is something we
    need to follow up with because I know in many communities this
    is an issue, as it was with regard to the vaccines and the
    COVID treatments and the outreach efforts, and the real
    reluctance because of the history of what we know in terms of
    systemic racism in this country in low-income and minority
    communities.
        The other question, maybe, Mr. Ronholm, can you just--is it
    Ronholm?--tell me what you think?
        Have any of your reports looked at how this monopoly can be
    broken up?
        Mr. Ronholm. Yes, I mean, it certainly has an impact, as
    Mr. Pocan alluded to as well.
        I think another big piece of this, too, that we can look at
    is how can we work with the States in terms of fixing that
    system and changing that contract structure.
        Because you know, at FNS, at USDA, they do not approve
    these, you know, WIC contracts. It is the States that do them,
    and so, you know, it is how can we work with State partners in
    order to change that system. Can they break up those contracts
    where they are splitting them up by region to give other
    companies an opportunity to bid on them?
        Because, you know, when one company has the contract of 30-
    plus States, that is a pretty significant share, and that can
    have a big impact on supply when we face the situation.
        So if there is a way we can work with States to kind of
    figure out how to break up contracts by region to give more
    companies an opportunity to make those bids, to get into those
    markets, I think that might be an important step to consider.
        Ms. Lee. A good idea.
        Mr. Bishop. I thank you, Ms. Lee. Your time has expired.
        Ms. Lee. Thank you.
        Mr. Bishop. And at this time I am delighted to yield to the
    gentlelady from Minnesota, the chair of the Defense
    Subcommittee, Ms. McCollum.
        Ms. McCollum, you are now recognized for five minutes.
        Ms. McCollum. Thank you, Mr. Chair, and I am glad you had a
    good night last night.
        Ms. Carney, I want to start with you. Thank you for your
    testimony.
        A member of the Academy of Nutrition and Dietetics in
    Minnesota recently shared her experience dealing with the
    infant formula crisis. She found parents getting conflicting
    information, awful from some unqualified people on social media
    who were showing misinformation, how to do home formula
    ingredients using goat milk. And I saw some of that even before
    I had spoken with the dietician myself.
        And then as many of my rural colleagues have pointed out,
    you know, they do not often have registered dieticians on local
    staff at clinics and doctors. They are not necessarily familiar
    with formula option brands that they do not get.
        So my point is as the administration is working on its
    plans to address this immediate formula shortage, as Ms. Lee
    said, a horrible environment of mistrust has also been created.
        Maybe can you speak a little bit about this environment of
    mistrust and what you think needs to be done in the future and
    better ways to help WIC with participants so that they are not,
    you know, so disproportionately impacted by this?
        Now, a lot of this, as has been pointed out, is Federal and
    it is State. This is an opportunity for me, and I am going to
    be doing it at our sessions ending here in Minnesota for the
    State legislators, to reach out to my State legislators and
    talk about how we can be better partners on this and how we can
    streamline it and what may need to happen federally to do it.
        Can you just share some of your thoughts and experiences on
    this?
        And are the online media sites, is Twitter, is anybody
    helping? Is anybody recommending this is a safe site to go if
    you are looking for something to help your child?
        Ms. Carney. Thank you for that question so much.
        Yes, I have seen the social media, too. It is rampant with
    homemade formula recipes and suggestions, and they will get
    goat's milk or almond milk, like I mentioned in my testimony,
    and I also mentioned the dietician said that one of her clients
    told her, ``I do not think I want to get any formula that is on
    the shelf because it could all be contaminated. When is the
    next time I am going to go reach for a formula and they are
    going to recall it and say do not give it to your baby?''
        So there is a huge mistrust feeling out there among all of
    our mothers and fathers and parents in the country, and we have
    got to address this.
        And I want to go back a minute. We were talking about what
    are we doing with the companies out here that have so much of
    the market share of our whole entire country for infant
    formula.
        And one thing that we really have not talked about is the
    WHO code for marketing breastmilk substitutes, and that is what
    these formulas are, you know. They are breastmilk substitutes.
        Ms. McCollum. Right.
        Ms. Carney. So if we look at the WHO code, in other
    countries, other developed countries are abiding by the WHO
    Code, and this gives guidelines for how companies can market
    their infant formulas in a safe way.
        So maybe we should go back to that and think about what is
    it about the WHO Code that would benefit all of our families in
    the country so that they are assured when they do have to reach
    for infant formula, when breastfeeding cannot be an option or
    will not be an option, what are the things that are marketed
    directly to our families that tell them about the formula.
        There is a lot of confusion about that. So I did want to
    mention that, too.
        Ms. McCollum. Thank you.
        Mr. Ronholm, anything you want to add on that?
        You are out there in the heartbeat of Consumer Reports, and
    you are watching consumers just get misled with bad
    information.
        Mr. Ronholm. Yes, absolutely, Congresswoman. You know, the
    stories that we have been getting are very heartbreaking. You
    hear the desperation, and you know, they are just at a loss of
    what they can do, and of course, low-income WIC recipients have
    it especially tough when you consider that they do not have the
    resources to drive all around to try to find product.
        So, yes, I mean, I do not think I can add anything more
    than what Ms. Carney had stated.
        Again, it is just heartbreaking to hear the stories come in
    that we are compiling. I actually did some of them as part of
    my testimony, and certainly it has compelled all of us to act.
        Ms. McCollum. So, Mr. Chair, I think I see an opportunity
    to communicate better with my State legislators, but I also see
    a failed opportunity for, quite frankly, our public media
    organizations to get the facts out, to get them right, whether
    it is news, radio, or whatever, or social media.
        We have been trying to do it the best we can on our
    Website. These are our public airways. This is a public crisis,
    just as COVID was, and rather than just slice a news story here
    and there without any follow-up, I just think it was a huge
    failure also for some of these companies that manufacture it
    not to put out public announcements.
        Thank you, Mr. Chair, for having this hearing, and let's
    hope we never have to have a hearing like this again.
        Mr. Bishop. Thank you, Ms. McCollum.
        At this time I will recognize the gentlelady from Florida,
    the chair of the Military Construction, Veterans Affairs
    Subcommittee, Ms. Wasserman Schultz. You are now recognized for
    five minutes.
        Ms. Wasserman Schultz. Thank you, Mr. Chairman.
        You know, the brutal truth is that four companies control
    nearly 90 percent of America's baby formula market, and that is
    the very definition of an oligopoly.
        This corporate consolidation hurts all of our families, but
    especially lower income workers. It is the same with greedy oil
    CEOs who keep energy supplies low and pump prices high, hurting
    those who do the real work.
        At the end of the day, we need to make sure that we have
    adequate supply, and that we can keep children safe. And the
    Biden administration is doing all it can to fix this, from
    boosting supplies to importing massive shipments from Europe
    with Operation Fly Formula, but the long-term problem will not
    go away until we address corporate consolidation, improve WIC,
    and adopt sensible FDA safety standards.
        Now, the WIC Program provides information on healthy eating
    and helps millions of families buy nutritious foods, including
    baby formula. Half of all U.S. formula consumption goes through
    the WIC Program, which provides free infant formula, as we have
    been talking about today, where States negotiate bulk discounts
    in exchange for market exclusivity.
        I will take you back to 1989 when Republican President
    George Bush enacted legislation requiring all State WIC
    Programs to use competitive bidding for the purchase of infant
    formulas. In practice, this means that the State of Florida,
    for example, is required to use a single supplier for the
    entire State supply of WIC baby formula.
        The competitive bidding process has yielded 1.3 billion to
    $2 billion a year in savings and allowing WIC to serve about
    two million more participants annually because of the discount.
        However, when there is a supply shock caused by one of the
    four market participants, like what happened with Abbott in
    this case, it creates a serious risk to infant health across
    the country.
        And that problem is further exacerbated when the interests
    of private monopolists are put ahead of American families.
        And you may remember when the Trump administration actually
    threatened countries with trade sanctions and withdrawal of
    military aid if they supported an international resolution in
    support of breastfeeding as a healthy option for infants. I
    mean, that is completely outrageous.
        So my first question is to Mr. Ronholm. We need to find a
    long-term solution for this problem that is caused by a
    monopolized industry. Can you explain for us really how the
    single source contracting for WIC baby formula might have
    contributed to consolidation in the industry?
        Mr. Ronholm. Thank you, Congresswoman.
        Yes, absolutely. I think as you rightly pointed out, when
    you have only these folks' WIC contracts, what ends up
    happening is these companies assess their ability to meet the
    demand for these particular contracts and place those bids.
        And right now, you know, as we have discussed, there are
    only three companies that do that right now, and Abbott being
    the largest one because they have that ability and they have
    the infrastructure to meet the demand in a particular State,
    especially larger population ones. And as a result, you only
    see them in 30-plus States.
        And to your point about supply shock, so when we are faced
    with these types of situations, it makes it more difficult for
    these other companies to rebuild the market share for the
    supply that is lost with these supply shocks because they may
    not be as big as Abbott and so they may have not had
    infrastructure to ramp up production quickly enough to get to
    that point where we can rebuild that supply.
        So, yeah, I mean, this certainly is an issue that deserves
    careful examination. How do those contracts get broken up where
    you allow for multiple bidders to minimize any supply shocks
    that happen?
        Ms. Wasserman Schultz. And why does the U.S. market not
    support more competition in the baby formula industry outside
    of WIC sales? It certainly seems like there is a tremendous
    amount of desire and need out there.
        Mr. Ronholm. It could be for any number of reasons: you
    know, cost of entry to the market, the availability of limited
    supply ingredients, you know, the cost of those supplies.
        So, again, when you are faced with those market dynamics,
    it is only the kind of larger players that are able to afford
    the ingredients that go into these products, and to be able to
    produce them in the mass scale.
        That is not to say that that applied in this particular
    situation specifically, but typically with markets, that is
    what ends up happening.
        Ms. Wasserman Schultz. And I want to just ask you really
    quickly because we know that in Europe, they consistently
    produce a baby formula surplus. But there are rigid labeling
    and nutritional requirements for formula containers here in the
    U.S. that the FDA requires, and they prohibit the sale of many
    European-made products even though the formulas themselves meet
    FDA nutritional and purity standards.
        So what sort of policy changes would you like to see
    undertaken to ease restrictions on baby formula imports while
    still ensuring that the product meets our safety standards?
        Mr. Ronholm. Yes. I think it is critical that we maintain
    those safety standards that FDA has set on infant formula. That
    is absolutely critical.
        So there is a comfort level with consumers when they are
    able to purchase something that they knew is an FDA inspected
    facility overseas.
        But to your point, you know, sometimes these regulations,
    these really strict regulations are thinly disguised trade
    protection measures, and so you know, that is certainly an
    issue that we would have to examine carefully to make sure that
    we can have that access.
        Mr. Bishop. Well, thank you, Ms. Wasserman Schultz. I
    believe your time has expired.
        Ms. Wasserman Schultz. Thank you.
        Mr. Bishop. At this time I would like to yield to the
    gentlelady from New York, Ms. Meng.
        Ms. Meng, you are now recognized for five minutes.
        Ms. Meng. Thank you. Mr. Chairman.
        My question is for Mr. Ronholm. Consumer Reports published
    an article in March where your organization described FOIA
    requests for FDA inspection reports in 2019, 2021, and 2022.
        These reports show that FDA had documented serious and
    ongoing safety concerns at Abbott's plants just as the outbreak
    emerged in March.
        These reports also review that Abbott received 17 consumer
    complaints between 2019 to 2021, including 15 complaints of
    infants having tested positive for another pathogen,
    salmonella, and one complaint related to Cronobacter.
        I wanted to find out, relatively speaking, is the number of
    complaints about this product, for example, lower or higher
    compared to another product.
        And how many complaints, let's say, would raise the level
    to cause alarm or how can we ensure that the public is aware of
    these consumer complaints much earlier on in the process to
    allow consumers to make the most informed choices?
        FDA obviously reacted too slowly, and the company obviously
    did not reveal to the public the number of complaints that they
    had received.
        Mr. Ronholm. Yes, Ms. Meng. I do not have a specific frame
    of reference of what threshold for complaints, you know, would
    trigger concern. I would say that I think overall 17 is a
    notable number, and I think it would certainly gain some
    attention at a Federal agency, just based on my experience at
    USDA.
        And when you combined that with the inspection reports that
    FDA had of the Sturgis facility in the years that you
    mentioned, combine that with the consumer complaints, clearly,
    there were some red flags there that needed to be addressed.
        And so the concern from the consumer standpoint is these
    complaints are being filed. You have these inspection reports
    that encounter, you know, the Salmonella test sample, the
    Cronobacter, et cetera. That is cause for concern. That should
    be a sign to FDA that there is a problem at this particular
    facility. They need to set up shop there to figure out what the
    problem is.
        Ms. Meng. So, no, thank you. That is very helpful.
        And you know, I know we have talked a lot about needed
    reform at the FDA, but on top of that, do you think there are
    things that we can require, let's say, of private companies
    when complaints are being made?
        I know there is not necessarily a framework of a minimum
    threshold or trigger level, but are there things that companies
    should be doing when they are receiving complaints over
    complaints of relatively serious illnesses resulting from their
    product?
        Mr. Ronholm. Yes. I think certainly companies when they get
    these complaints, they should share them immediately with the
    FDA.
        I think what they also should be doing is sharing their
    test results, microbial test results that they take at their
    particular facilities. So when they take those samples and if
    there is an issue, they need to share them with the FDA so
    there can be some sort of record so in the event there is a
    problem, they have the ability to go back, see that this
    facility experienced the problem in the past, and they need to
    fix it.
        So I think as much information sharing as there can be
    between the company and the FDA certainly would be beneficial.
        Would it prevent the situation altogether? I think that
    remains to be seen, but it certainly helps everyone get
    educated on precisely what the issues are at a particular
    facility, absolutely.
        Ms. Meng. Right. So if the FDA does not react
    appropriately, let's say there were 100 complaints to a
    business like Abbott. If FDA had not done its due diligence and
    a company like Abbott does not reveal anything to the public,
    if there are 100, 200 complaints, that means they would keep
    selling this product and no one in the public would even know
    that complaints were being made, right?
        Mr. Ronholm. That is right. And I think it also speaks to
    the question of the fragmented leadership at FDA. You know, you
    have the major whistleblower report come in, and you know, they
    did not bother to share it with everybody within the agency,
    let alone react to it. So that is certainly an issue as well.
        Ms. Meng. Thank you. I yield back.
        Mr. Bishop. Thank you very much, Ms. Meng.
        I believe we have completed the round of questions. I
    understand that there are no more questions, except for the
    chairlady, Ms. DeLauro, who I believe has one additional
    question.
        So I will at this time yield to Chairwoman DeLauro for your
    final question.
        I yield to Ms. DeLauro.
        The Chair. Thank you.
        Very, very quick, first of all I just said to my colleague,
    Congresswoman Meng, what the FDA needs to do is to understand
    that they are a regulatory agency and what that entails.
        We do not produce infant formula at the Federal level. That
    is not our job. Our job is, through the FDA, is to be able to
    make sure that those who do produce it are held to a standard
    and to make sure that standard is adhered to, and if it is not
    adhered to, they need to be accountable for that.
        The product should come off the market until we have a
    solution to it.
        Very, very quickly because I just wanted to get the answers
    from you, Dr. Carney. If you could unmute, because of the
    inability to track the cases, as you have mentioned, we know
    two infants have died, four others were hospitalized. Do you
    think that there is underreporting because we do not have a
    tracking system so there could be more cases out there?
        Ms. Carney. Thank you, Chair DeLauro.
        I am not a doctor. So I appreciate that honor, but I am a
    dietician.
        I definitely agree with you that there is a problem if we
    cannot track that. We need to, and I know that we were just
    talking about informing the parents and out there in the
    public, but there are so many sick children already in
    hospitals, if we give them contaminated formula on top of their
    current illness, it would be devastating.
        So we have got to have some tracking and reporting on
    consistent basis.
        The Chair. So many of the women that I spoke to yesterday
    at the round table had a child. They took them to the emergency
    room. Then they came out of the emergency room, but then they
    looked at the product that they had, and it was a recalled
    product. So there is every likelihood that it could be
    connected to it.
        Thank you very much, and thank you so much, Mr. Chairman.
    Thank you for doing the hearing today. It really is a critical
    issue.
        Thanks.
        Mr. Bishop. Thank you, Ms. DeLauro.
        And let me say thank you again to our witnesses, Ms.
    Chamberlin, Mr. Gay, Ms. Carney, and Mr. Ronholm. We very much
    appreciate this discussion. Your testimony was powerful and
    informative.
        As we continue to look for answers and solutions to this
    crisis, it is important that you all have a voice. You are on
    the ground, and you experience the consequences of something
    like this firsthand.
        Thank you also for the hard work that you do, from
    advocating for important policies to supporting your local
    communities.
        Dr. Harris, do you have any closing remarks?
        Mr. Harris. Thank you, Mr. Chair.
        Just to say thank you to the witnesses today. Ms.
    Chamberlin, thank you very much for testifying. I know how
    incredibly difficult it must be for you and people who you know
    who have children with PKU to have this happen, and rest
    assured that we will do our best to make sure it does not
    happen again because we know that for some children the
    specialty infant formulas are very, very essential.
        Again, thanks to all of the witnesses today.
        Thank you, Mr. Chairman. I yield back.
        Mr. Bishop. Thank you, Dr. Harris.
        And thanks to all of the members who were in attendance,
    and let me say a thank you to our staff who worked so hard to
    put this hearing together quickly.
        So thank you so much, and with that, this subcommittee is
    adjourned.

                                               Wednesday, May 25, 2022.

                                  MEMBERS' DAY

                                   WITNESSES

    HON. JAMES R. BAIRD, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF
        INDIANA
    HON. SHONTEL M. BROWN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF
        OHIO
    HON. KIM SCHRIER, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF
        WASHINGTON
        Mr. Bishop. This hearing will now come to order.
        As this hearing is fully virtual, I must address a few
    housekeeping matters. For today's meeting, the chair or staff
    designated by the chair may mute participants' microphones when
    they are not under recognition for the purposes of eliminating
    inadvertent background noise.
        Members are responsible for muting and unmuting themselves.
    If I notice that you have not unmuted yourself, I will ask you
    if you would like the staff to unmute you. If you indicate
    approval by nodding, staff will unmute your microphone.
        I remind all members that the 5-minute clock still applies.
    If there is a technology issue, we will move to the next member
    until the issue is resolved, and you will retain the balance of
    your time.
        You will notice a clock on your screen that will show how
    much time is remaining. At 1 minute remaining, the clock will
    turn yellow. At 30 seconds remaining, I will gently tap the
    gavel to remind members that your time is almost expired. When
    your time has expired, the clock will turn red, and I will
    begin to recognize the next member.
        In terms of the speaking order, we will follow the
    predetermined order that has been provided to your offices,
    beginning with the chair's and acting ranking member's brief
    opening remarks. We will then begin with the first member on
    the schedule and move forward from there.
        Finally, House rules require me to remind you that we have
    set up an email address to which members may send anything they
    wish to submit in writing at any of our hearings or markups.
    That email address has been provided in advance to your staff.
        Last reminder, please ensure that your video is turned on
    at this time.
        Good afternoon. Today we will hear testimony from our
    colleagues on both sides of the aisle on the agencies under our
    subcommittee's jurisdiction. As I have often noted, these
    agencies conduct vital work that touches the lives of all
    Americans, and today's hearing represents a great opportunity
    to listen to a diverse group of members from across the country
    share their views on a wide range of issues related to our
    bill.
        We look forward to hearing your thoughts on the
    appropriations process and learning more about the programs and
    issues that affect your district and your constituents. Your
    input is invaluable as we draft funding legislation for the
    upcoming fiscal year for the U.S. Department of Agriculture,
    the Food and Drug Administration, the Commodities Futures
    Trading Commission, and the Farm Credit Administration.
        Before we begin, I would like to express my sincere
    appreciation for the ranking member and all of the members
    testifying for accommodating our busy schedule. Given the
    lateness of the day, I would like to adhere to the 5-minute
    rule, so that we can remain on schedule.
        I want to thank every member who has taken the time to
    participate. We appreciate your interest in the work of this
    subcommittee.
        Now I would like to recognize our distinguished acting
    ranking member, Dr. Harris, if he has any opening remarks, and,
    if so, Dr. Harris, the floor is yours. You are now recognized.
        Mr. Harris. Thank you, Mr. Chairman, for holding today's
    hearing to receive testimony from our colleagues. I look
    forward to hearing more about the projects and programs in the
    ag appropriations bill that are important to each of your
    districts and to communities across the country. Your input
    will be crucial as we work to fund the agencies under this
    subcommittee's jurisdiction.
        I look forward to working with Chairman Bishop to
    accommodate these priorities as best we can as the fiscal year
    2023 appropriations process moves forward. Thank you again to
    each of our colleagues who have taken time out of your busy
    schedules this afternoon to speak with us and bring these ideas
    to our attention.
        Thank you, Mr. Chairman, and I yield back.
        Mr. Bishop. Thank you, Dr. Harris.
        We will now proceed with member testimony. Each member will
    have 5 minutes to give your oral statement.
        I will now recognize our first witness, the gentleman from
    Indiana, Mr. Jim Baird, for 5 minutes.
        Mr. Baird, you are now recognized.
                                  ----------

                                               Wednesday, May 25, 2022.

                                    WITNESS

    HON. JAMES R. BAIRD, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF
        INDIANA
        Mr. Baird. Thank you, Chairman Bishop and Ranking Member
    Harris, for the opportunity to join you today and share the
    issues that I feel are priorities for the agricultural
    industry.
        For those of you who do not know me well, I represent
    Indiana's 4th Congressional District, the largest ag district
    in an already-ag-heavy state. I am a Ph.D. animal scientist and
    a farmer myself. So needless to say, I have a great passion for
    serving our Nation's farmers and ranchers and providing the
    tools needed to keep America's food system healthy, affordable,
    and stable.
        The first initiative that I would like to call your
    attention to is increasing the funding and the direction for
    FDA's Center for Veterinary Medicine for evaluation and
    approval of animal food ingredients. Animal food manufacturers
    are researching and bringing to market innovative feed
    ingredients that can improve animal nutrition, health, and
    production, and also make food safer and reduce the industry's
    environmental footprint.
        They are able to do this because regulatory schemes
    elsewhere in the world have kept pace with the evolving science
    of animal nutrition. Unfortunately, our farmers and ranchers in
    the United States are missing out on using these same
    ingredients due to the Food and Drug Administration's outdated
    way of regulating these products and the restrictions on how
    they are marketed. By hiring more staff, improving the
    infrastructure and regulatory processes, and providing IT
    assistance, the FDA's Center for Veterinary Medicine would be
    able to alleviate long-existing backlogs and delays for animal
    feed ingredient reviews, as well as providing the center with
    the capacity needed to focus on these emerging needs in
    regulation of important products.
        With this in mind, I request the committee provide $5
    million in funding for the CBM for needed improvements in
    timeliness and from process.
        The next important issue I would like to discuss is the
    regulation of animal biotechnology products, which falls
    squarely into the subcommittee's jurisdiction as it remains
    mired between the USDA and FDA. Animal biotechnology products
    have the potential----
        Mr. Bishop. Excuse me. Mr. Baird, can I ask you to turn on
    your camera?
        Mr. Baird. Sure.
        Mr. Bishop. Thank you.
        Mr. Baird. Is that better?
        Mr. Bishop. Your camera just went off.
        Mr. Baird. Mr. Chairman, I am using----
        Mr. Bishop. Thank you.
        Mr. Baird. Mr. Chairman?
        Mr. Bishop. Yes.
        Mr. Baird. I am using the same iPad for both the video as
    well as my testimony. So if I----
        Mr. Bishop. We can hear you fine, and we can see you also.
        Mr. Baird. Yeah. But as soon as I go back to my testimony,
    it will----
        Mr. Bishop. Oh, I see.
        Mr. Baird [continuing]. The camera will go off. So----
        Mr. Bishop. All right.
        Mr. Baird. So if you can tolerate my camera being off, I
    think you can still hear me.
        Mr. Bishop. Very good, sir. Go ahead.
        Mr. Baird. Thank you.
        Mr. Bishop. You may proceed.
        Mr. Baird. Thank you. I am getting there.
        Mr. Bishop. We will give you additional time, sir.
        Mr. Baird. Okay. Can you still hear me okay?
        Mr. Bishop. Yes, I can. And I will ask the staff if they
    would restart your clock to I think it was somewhere around 4
    minutes, if I am not mistaken.
        Mr. Baird. Thank you, sir.
        Mr. Bishop. And of course you don't have to use all of the
    time. We will receive your full testimony for the record.
        Mr. Baird. So how much time do I have left, Mr. Chairman?
        Mr. Bishop. We are giving you 4 minutes.
        Mr. Baird. Okay. We were talking about animal biotechnology
    products, and they have the potential to bring tremendous
    benefits to the world of animal agriculture. These remarkably
    innovative new tools have the capacities and the ability to
    address some of the zoonotic disease infection, markedly
    improve the sustainability of livestock production, help
    mitigate climate change, enhance animal welfare, and provide
    for the additional production efficiency to meet the growing
    global demand for animal protein.
        Unfortunately, the existing regulatory system is not
    conducive to timely adoption of these innovations. In the past
    25 years, only two animals intended for agricultural purposes
    have been approved for use domestically by the FDA. A
    continuation of this costly, protracted regulatory system will
    only serve to further stifle important new agricultural
    innovations.
        And as we look to new solutions to address the myriad of
    challenges facing American agriculture, I strongly encourage
    the committee to direct the Department of Agriculture to
    advance their rulemaking for establishing regulations governing
    agricultural applications of these technologies and to direct
    the FDA to finally sign and implement the Memorandum of
    Understanding developed with the Department of Agriculture
    regarding animal biologies and develop a more appropriate
    regulatory approach.
        Related to the important new possibilities that animal
    biotechnology can yield for our Nation's food system are two
    new priority issues I would like to emphasize before the
    committee with the February--for fiscal year 2023--excuse me.
        Your continued support of plant biotechnologies by
    providing FDA with the necessary resources to support the
    issuance of guidance for the industry on food derived from
    plants produced from using genome editing and to modernize and
    improve the timeliness and productivity of the Plant
    Biotechnology Consultation Program, the other being include
    language to direct USDA's APHIS to take measurable steps to
    establish predictable and science-based regulatory pathways for
    innovation in genetically engineered microbes.
        As we have seen through the year following Russia's
    invasion of Ukraine, we must adjust to meet the challenges of
    global food insecurity caused by geopolitical tensions, now and
    in the future, and continue innovating--just one moment--to
    overcome other numerous production challenges faced by American
    farmers and ranchers.
        I strongly encourage your support of these important
    provisions in fiscal year 2023. The relative stability and
    self-sufficiency in the American food supply would not be
    possible without the numerous research activities conducted by
    USDA on countless commodity crops and farming practices.
        Amongst all of the tremendously important projects, I would
    like to call your attention to a few that I feel are of
    particular value. ARS research activities not only increase
    commodity yields and disease resistance but also ensure that
    American consumers continue to have abundant and affordable
    access to milled grain products to meet nutritional needs.
        I urge the committee to increase ARS genetic oak research
    funding by $1.5 million in fiscal year 2023 and continue to
    fund the U.S. wheat and barley scab initiative at the fully
    authorized amount of $15 million.
        [The information follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Bishop. Thank you, Mr. Baird.
        Mr. Baird. Yes.
        Mr. Bishop. We appreciate your testimony and your expert
    knowledge on animal science. With both of our being members of
    the agriculture committee, I look forward to working with you
    to continue support for our farmers and our ranchers.
        Dr. Harris, do you have any questions or comments?
        Mr. Harris. No. I just want to thank the gentleman from
    Indiana.
        Mr. Baird. And I thank you for the opportunity. Have a
    great day.
        Mr. Bishop. Thank you for speaking with us today. And
    without objection, your entire written testimony will be
    included for the record. Thank you.
        Mr. Baird. Thank you, Mr. Chairman.
        Mr. Bishop. The chair now recognizes the gentlelady from
    Ohio, Ms. Shontel Brown. Ms. Brown, you are now recognized for
    5 minutes, and we look forward to your testimony.
                                  ----------

                                               Wednesday, May 25, 2022.

                                    WITNESS

    HON. SHONTEL M. BROWN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF
        OHIO
        Ms. Brown. Thank you, Chairman Bishop, Ranking Member
    Harris, and members of the committee. Thank you for the
    opportunity to testify. I am especially grateful for the
    opportunity to work with Representative Meng to craft report
    language that addresses key child nutrition issues.
    Congresswoman Meng has been a proven leader in fighting hunger
    and strengthening food security, and I am honored to join her
    in this effort to ensure no child goes hungry.
        Due to the public health emergency and subsequent economic
    fallout, child hunger has spiked dramatically. Data shows that
    student participation in the school breakfast and lunch program
    has dropped significantly.
        The waiver authorities that Congress gave USDA through the
    Families First Coronavirus Response Act have made it possible
    for school nutrition programs and community organizations to
    continue to feed students in wake of school closures, virtual
    learning, and social distancing, as well as the challenges
    faced by ongoing supply chain disruptions and staffing
    shortages.
        Unfortunately, these critical waivers are set to expire at
    the end of June. This creates uncertainty as schools prepare
    for the next school year. It is important that Congress fully
    recognize how useful and critical these waivers have been and
    continue to be. For these reasons, I urge the committee to
    include language accompanying the final agriculture
    appropriations bill that expresses the committee's support for
    the child nutrition waivers authorized in the Families First
    Coronavirus Response Act and directs the Secretary of
    Agriculture to submit a report to Congress on the effectiveness
    and use of these waivers.
        Additionally, we must ensure that children are being fed
    year-round including in the summers. For millions of children,
    summer is the hungriest time of year. With school buses not
    running and feeding sites often at different locations for
    multiple children in one household, few children can get to
    meal sites twice or even once a day in the summer. This is a
    serious issue that children living in both rural and urban
    areas face.
        Therefore, I am urging the committee to include language
    that--including language accompanying the final agriculture
    appropriations bill that highlights the support for the USDA
    Food and Nutrition Service and allows state agencies to enable
    the Summer Food Service Program service institution that
    operate in areas where children and youth have barriers to
    access to a congregate feeding site to use their reimbursement
    payments to develop creative ways to make food available to
    children through non-congregate means.
        Thank you again, Chairman Bishop, Ranking Member Harris,
    and members of the committee for the opportunity to submit the
    testimony. I stand ready to work with you all to help fight
    child hunger and food insecurity. And with that, I yield the
    balance of my time to my good friend, Ms. Grace Meng.
        Mr. Bishop. Ms. Meng, you are recognized.
        Ms. Meng. Thank you, Mr. Chairman and Ranking Member
    Harris. And thank you to my colleague, Representative Brown. I
    want to associate myself with the remarks of Representative
    Brown and thank her for her important and compassionate
    leadership.
        If there is one thing the pandemic has taught us all it is
    that the world can and sometimes must pivot on a dime. We must
    ensure our nutrition and food policies provide the flexibility
    necessary to adjust in an ever-changing world.
        The child nutrition waivers authorized in the Families
    First Coronavirus Response Act are critical in this
    flexibility, and I thank Representative Brown for her remarks
    and her partnership on this issue, as well as the issue of non-
    congregate settings for the Summer Food Service Program.
        Thank you, and I yield back.
        [The information follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Bishop. Thank you, Ms. Meng and Ms. Brown.
        Dr. Harris, do you have any questions?
        Mr. Harris. No. Just thank you for your interest in
    childhood nutrition.
        Mr. Bishop. And I join Dr. Harris. We appreciate your
    strong interest and support for the nutrition programs,
    especially for our children, and we look forward to working
    with you to continue the conversation and to ensure that these
    programs have the resources that they need to succeed.
        Thanks for speaking with us today. And without objection,
    Ms. Brown, your entire written testimony will be included for
    the record.
        And thank you, Ms. Meng, for your comments.
        At this time, I am delighted to recognize the gentlelady
    from Washington, Ms. Kim Schrier. Ms. Schrier, you are now
    recognized for 5 minutes.
                                  ----------

                                               Wednesday, May 25, 2022.

                                    WITNESS

    HON. KIM SCHRIER, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF
        WASHINGTON
        Ms. Schrier. Well, thank you, Chairman Bishop, and thank
    you, Ranking Member Harris. And, first, I want to associate
    myself with Representatives Brown and Meng on their attention
    to child nutrition.
        Today I appreciate the opportunity to share my priorities
    and concerns as a representative of Washington State's 8th
    Congressional District, including agricultural research
    infrastructure and the community project funding request.
        I submitted my full testimony for the record, which
    includes a few requests I won't have time to touch on today,
    including funding for specialty crop research, nutrition
    programs, and the school kitchen equipment grants.
        So, first, I want to ask for your support to fund
    agricultural research infrastructure. Along with my colleague
    from Kansas, Representative Tracey Mann, and a strong group of
    bipartisan members, I sent a letter to the committee urging
    $365 million in investment for agricultural research
    infrastructure as authorized through the Research Facilities
    Act, which was included in the 2018 Farm Bill.
        Within NEFA, funding for the Research Facilities Act will
    support competitive grants to land grant universities and non-
    land grant colleges of agriculture for facility construction,
    acquisition, modernization, renovation, or remodeling. And
    these facilities need it. Without specific investment in the
    facilities, many from the 1950s and 1960s, the U.S. really
    risks its competitiveness and its ability to properly recruit
    and train the next generation of world-class researchers.
        Modern ag research and education facilities serve as the
    backbone of our Nation's cutting edge ag and food research
    enterprise, but 69 percent of research facilities are U.S.
    colleges are really at the end of their useful life. Some don't
    even have indoor plumbing. That is why we need to address our
    deferred research maintenance backlog and increase investments
    in the next generation of ag research work.
        This investment will reposition the United States for long-
    term success, competitiveness, and leadership in global ag and
    food research.
        Second, I want to highlight a community project funding
    request for my district. This one is a request for $3 million
    for the development of a new food distribution center for the
    Chelan-Douglas Community Action Council, or CDCAC. This
    organization provides support for individuals experiencing food
    insecurity.
        They currently support 22 area food pantries, meal sites,
    and low-income senior housing facilities with over 2 million
    pounds of food annually, providing good nutrition to those who
    are facing food insecurity. And the quantity of food that CDCAC
    receives and distributes has doubled in the past 3 years. In
    fact, their current food distribution facility is really
    inadequate to meet this kind of demand, avoid food waste, and
    to ensure the safe storage of food products and the safety of
    employees and volunteers.
        And a new facility will reduce travel times, will expand
    programs focusing on the local purchasing of farm goods--and
    this is an agricultural area--through the expansion of
    commercial processing equipment, improved safety measures, and
    provisions for dedicated volunteer and employee training space.
    It is a really worthwhile investment for rural America and
    rural Washington State.
        I want to thank you for your attention. Again, I will refer
    to my written testimony for details on my other priorities. And
    I just want to thank you, Mr. Chairman and Mr. Ranking Member,
    for your leadership during this process, for consideration of
    needs in my district, and for your attention to child
    nutrition.
        I yield back.
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        Mr. Bishop. Thank you, Dr. Schrier. We appreciate your
    dedication and your passion for the programs that are in our
    bill, and we look forward to working with you to address the
    issues that you have raised on the community project funding
    requests. Our staff is still working to vet the requests, and
    it is our hope that we can fund as many of these projects as
    possible.
        Dr. Harris, do you have any questions or comments?
        Mr. Harris. I just want to thank Dr. Schrier and agree that
    research is very, very important in agriculture and is going to
    keep us the leading country in the world in our agricultural
    sector.
        Thank you for taking the time this afternoon.
        Mr. Bishop. Okay. I see Representative Newhouse is on the
    call. Do you have any comments or questions, Mr. Newhouse?
        Mr. Newhouse. Thank you, Mr. Chairman, Mr. Ranking Member.
    Not really. Just I do appreciate the engagement of all of the
    witnesses that we have had today. Like you said, many of the
    things that we touched on are very important, and it is good to
    know that they are priorities for other members outside the
    committee.
        I am particularly interested in Dr. Schrier's emphasis on
    helping the food safety net that we have in central Washington
    State. That bleeds over into my district as well--the
    investment that she is talking about--so I particularly
    appreciate that and look forward to working with all of our
    witnesses in furthering the development of our agricultural
    industry and meeting the needs of our growing population.
        Thank you.
        Mr. Bishop. Well, thank you very much, Dr. Schrier, for
    speaking with us today. And without objection, your entire
    written testimony will be included in the record.
        I want to thank all of the members again for testifying
    before our subcommittee today. We appreciate your coming out
    and taking the time to talk with us about the projects and the
    programs that are important to your constituents. Your input
    will be vital as we move forward with the 2023 appropriations
    process.
        At this time, I would like to recognize Dr. Harris for any
    comments that he would like to make before we close. Do you
    have any closing remarks, Dr. Harris?
        Mr. Harris. No, Mr. Chairman. I just want to associate
    myself with your closing remarks. I want to thank our members
    for their interest and, you know, keeping our agricultural
    economy moving forward in the important work we do in our
    subcommittee. And, again, thank the members for taking time
    this afternoon.
        Mr. Bishop. Thank you, Dr. Harris. And thanks to all of the
    members who were in attendance. Thanks to our wonderful staff
    who put this hearing together.
        For members who were not able to attend this hearing to
    testify in person, if you wish to submit written testimony,
    please do so by the end of the day. Your entire testimony will
    be included in the record.
        With that, the subcommittee is now adjourned.
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