[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.
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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.
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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:]
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    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 
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    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:]
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                                            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:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    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:]
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                                           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.
    [The information follows:]
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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.
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    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.
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    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.
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                                           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.
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    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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