[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]




    AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
                RELATED AGENCIES APPROPRIATIONS FOR 2016

_______________________________________________________________________

                                 HEARINGS

                                 BEFORE A

                           SUBCOMMITTEE OF THE

                       COMMITTEE ON APPROPRIATIONS

                         HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FOURTEENTH CONGRESS

                              FIRST SESSION
                                 ________

      SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG 
                  ADMINISTRATION, AND RELATED AGENCIES

                  ROBERT B. ADERHOLT, Alabama, Chairman

  KEVIN YODER, Kansas               SAM FARR, California
  THOMAS J. ROONEY, Florida         ROSA L. DeLAURO, Connecticut
  DAVID G. VALADAO, California      SANFORD D. BISHOP, Jr., Georgia
  ANDY HARRIS, Maryland             CHELLIE PINGREE, Maine
  DAVID YOUNG, Iowa
  STEVEN M. PALAZZO, Mississippi

  NOTE: Under Committee Rules, Mr. Rogers, as Chairman of the Full 
Committee, and Mrs. Lowey, as Ranking Minority Member of the Full 
Committee, are authorized to sit as Members of all Subcommittees.

                 Tom O'Brien, Pam Miller, Andrew Cooper,
                           and Elizabeth King,
                             Staff Assistants
                             ________


                                  PART 4

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  Natural Resources Conservation Service
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  Food and Drug Administration..........
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                                ________

          Printed for the use of the Committee on Appropriations

                    U.S. GOVERNMENT PUBLISHING OFFICE

  96-947                       WASHINGTON : 2015









                      COMMITTEE ON APPROPRIATIONS

                                ----------                              
                   HAROLD ROGERS, Kentucky, Chairman


  RODNEY P. FRELINGHUYSEN, New Jersey    NITA M. LOWEY, New York   
  ROBERT B. ADERHOLT, Alabama            MARCY KAPTUR, Ohio
  KAY GRANGER, Texas                     PETER J. VISCLOSKY, Indiana
  MICHAEL K. SIMPSON, Idaho              JOSE E. SERRANO, New York
  JOHN ABNEY CULBERSON, Texas            ROSA L. DeLAURO, Connecticut
  ANDER CRENSHAW, Florida                DAVID E. PRICE, North Carolina
  JOHN R. CARTER, Texas                  LUCILLE ROYBAL-ALLARD, California
  KEN CALVERT, California                SAM FARR, California
  TOM COLE, Oklahoma                     CHAKA FATTAH, Pennsylvania
  MARIO DIAZ-BALART, Florida             SANFORD D. BISHOP, Jr., Georgia
  CHARLES W. DENT, Pennsylvania          BARBARA LEE, California
  TOM GRAVES, Georgia                    MICHAEL M. HONDA, California
  KEVIN YODER, Kansas                    BETTY McCOLLUM, Minnesota
  STEVE WOMACK, Arkansas                 STEVE ISRAEL, New York
  JEFF FORTENBERRY, Nebraska             TIM RYAN, Ohio
  THOMAS J. ROONEY, Florida              C. A. DUTCH RUPPERSBERGER, Maryland
  CHARLES J. FLEISCHMANN, Tennessee      DEBBIE WASSERMAN SCHULTZ, Florida
  JAIME HERRERA BEUTLER, Washington      HENRY CUELLAR, Texas
  DAVID P. JOYCE, Ohio                   CHELLIE PINGREE, Maine
  DAVID G. VALADAO, California           MIKE QUIGLEY, Illinois
  ANDY HARRIS, Maryland                  DEREK KILMER, Washington
  MARTHA ROBY, Alabama
  MARK E. AMODEI, Nevada
  CHRIS STEWART, Utah
  E. SCOTT RIGELL, Virginia
  DAVID W. JOLLY, Florida
  DAVID YOUNG, Iowa
  EVAN H. JENKINS, West Virginia
  STEVEN M. PALAZZO, Mississippi

                William E. Smith, Clerk and Staff Director

                                   (ii)

 
   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
                RELATED AGENCIES APPROPRIATIONS FOR 2016
                               ________
                               
                               
                                      Wednesday, February 25, 2015.

           DEPARTMENT OF AGRICULTURE--OFFICE OF THE SECRETARY

                               WITNESSES

HON. THOMAS VILSACK, SECRETARY, DEPARTMENT OF AGRICULTURE
DR. ROBERT JOHANSSON, CHIEF ECONOMIST, DEPARTMENT OF AGRICULTURE
MICHAEL YOUNG, BUDGET OFFICER, DEPARTMENT OF AGRICULTURE

                       Introduction of Witnesses

    Mr. Aderholt. Good morning. It is good to welcome everybody 
to the subcommittee hearing this morning. I think we have 
several subcommittee hearings that are going on at the same 
time. So there may be members that will be going back and forth 
from different subcommittees.
    I know we have the Secretary of Health and Human Services 
just next door. That is going on so if you see people leaving, 
it is probably not something you said, but rather just because 
of schedules.
    I want to welcome all of you to today's hearing. Our 
primary goal this morning is to examine the Department of 
Agriculture's fiscal year 2016 budget, while also reviewing the 
funds used past and present.
    Our witnesses for this morning is the Secretary of 
Agriculture, the Honorable Tom Vilsack. He is joined by Acting 
Chief Economist, Robert Johansson, and USDA's Budget Director, 
Mr. Mike Young. Welcome to each of you.

                    Opening Statement--Mr. Aderholt

    Before I begin, Mr. Secretary , I do want to commend you 
and your team for your timely implementation of the 2014 Farm 
Bill programs to date. You had quite a few programs to 
implement, and you seem to have stayed on schedule, and again, 
I congratulate you on that.
    As I have mentioned in previous hearings, we have three 
goals in this Subcommittee as we move through the fiscal year 
2016 appropriations process. The first goal is improving the 
management of the agencies and programs within our purview. 
Continue to build upon oversight efforts in previous years. The 
goal is enhanced accountability in spending of taxpayer dollars 
to improve agency governance, processes and internal controls; 
and ensuring transparent decision making.
    Specific to USDA, the agency has authorized and has 
regulations in place to properly oversee various efforts under 
its jurisdiction, from nutrition to farm programs, to 
conservation operations.
    USDA needs to utilize their oversight capabilities in all 
areas to better ensure resources are spent wisely. USDA must 
also tighten controls for areas subject to large expenditures 
with unclear results and where performance tasks or milestones 
are not met, such as information technology investments.
    Inspector General Fong testified before this Subcommittee 
about two weeks ago. In her testimony, she says that USDA has 
challenges with overseeing information technology security and 
performance and agrees that the agency needs to strengthen its 
internal control.
    Moreover, between fiscal year 2009 and fiscal year 2013, 
the Inspector General made 55 recommendations for improving the 
overall security of USDA systems, but the agreed upon 
corrective action has been implemented for only 21 of these 
recommendations.
    The second goal before us is to target funds to the most 
important programs and functions. There is a wide range of 
programs in our bill, and I want to be sure that we make wise 
decisions in allocating the funding. We should continue to 
invest in programs that prove effective and have broad support, 
such as WIC, Research and Rural Development Programs.
    We should also support programs that have a clear and 
distinct reason for funding, for using Federal funding, such as 
addressing emerging agricultural pests and disease threats that 
are across the Nation.
    In addition to funding these programs, we must reduce or 
eliminate funding for lower priorities and those programs that 
are less effective or may be duplicative.
    The third goal is to promote U.S. agricultural free and 
fair markets. The safe food and medicines is a good example. 
The United States has one of the most highly productive food 
agricultural sectors in the world, and the U.S. Government 
plays a unique role in ensuring the sector's vitality.
    For instance, we support a vibrant rural economy by 
investing in infrastructure, such as water and waste and 
housing programs. We set the ground rules to ensure efficient 
trading of agricultural commodities, and we promote a free and 
fair international trade regime that allows U.S. commodities 
and products to be sold around the world.
    USDA has proposed substantial changes to the programs that 
support these efforts, and we will need to carefully evaluate 
them to ensure that we continue programs and not undermine 
these areas.
    Agricultural exports play a crucial role in the U.S. 
economy, supporting more than one million jobs and record 
levels of exports for our farmers and our ranchers valued at 
$152 billion in fiscal year 2014 alone. We need to be mindful 
of the intricate trade system if we are to remain a reputable 
trading partner, acting quickly to resolve issues on the rail 
lines and at ports of entry.
    USDA's budget request includes increases for discretionary 
and mandatory programs that appear to disregard the debt crisis 
facing our Nation. The agency is again proposing to establish 
new programs in offices using scarce discretionary resources.
    The justification of these actions is lacking robust data 
to support the request, hindering this Subcommittee's ability 
to adequately evaluate their merit. Data such as a clearly 
identified need for these additional programs or offices, the 
total estimated cost for the efforts, and the anticipated 
results for intended outcomes are not provided.
    The issue becomes more complex as these increases are 
offset by questionable decrease, such as large reductions 
attributed to operating efficiencies.
    The savings are justified by a few nebulous sentences that 
cite decreased travel, fuel and printing costs that will yield 
large savings. However, these savings have been claimed by the 
agency in previous years and have been claimed by the agency, 
but they are not likely to produce amounts suggested that they 
would save in the budget request. These are programs within 
USDA's request that remain a priority.
    USDA is requesting increased resources to assist with 
implementation of the Food Safety Modernization Act. The Food 
and Drug Administration is also requesting additional funding 
for this purpose. Nevertheless, the subcommittee and the 
American public need assurance that the agencies are 
coordinating efforts and pursuing effective means for the 
implementation.
    I want to ensure proper implementation of the Act and hope 
that we can discuss this in more detail during our question 
period.
    In looking at the mandatory programs USDA is proposing to 
reinvest savings into new and improved efforts. While these 
efforts are well intended, evidence is not provided that 
demonstrates current efforts are effective in assisting the 
beneficiaries that the resources for new efforts will result in 
better services for the customers.
    Therefore, I am still a little hesitant to reinvest the 
savings into these efforts. I am especially concerned about the 
major changes proposed to the Crop Insurance Program. Farmers 
have endured an estimated 43 percent decline in net farm income 
over the last two years. They are experiencing tough economic 
times with sharply lower crop prices and a number of natural 
disasters. There are a number of uncertain economic factors in 
the future.
    Yet USDA is proposing to reduce crop insurance by $16 
billion, which is a reduction of over 17 percent, and make it 
increasingly difficult for them to secure funding.
    I join with my fellow colleague, the chairman of the 
authorizing Committee on Agriculture, Mike Conaway, in the 
question that we not adversely change the rules of the Farm 
Bill, and I certainly do not want to do so through the 
appropriations process.
    The Ryan-Murray budget deal signed into law back in 2013 
caps overall spending as well as defense and non-defense 
spending. I anticipate that the subcommittee's funding levels 
will remain relatively flat at best. USDA's budget request 
largely exceeds the 2015 enacted funding levels.
    Today and in the months ahead as we proceed on, we must 
analyze the request and focus on allocating the funding using 
the goals that I have outlined to the most effective, highest 
priority programs that are available.
    Ms. Pingree, the Ranking Member is not here. Would you like 
to make any opening comments?

                     Opening Statement--Ms. Pingree

    Ms. Pingree. Thank you, Mr. Chair.
    I do not have any comments prepared, but I will just 
welcome the Secretary. Thank you for the work that you do. I, 
too, am looking forward to the hearing and looking forward to 
figuring out how the President's budget and what are likely to 
be the budget numbers from this Committee come together and 
where your priorities will be.
    And I will just make a short personal note. At this hearing 
last year, which was my first term on this particular 
committee, I asked you about the Senior Farmers' Market 
Nutrition Program, which in my State is called the Maine 
FarmShare Program, and whether that would be funded for the 
2014 growing season, and I just want to thank you because that 
afternoon you gave us an answer, and that was wonderful work on 
your part, and that was an important program for the seniors in 
our State in dealing with some of the hunger challenges they 
have in making sure they get fresh food. So I will just start 
with a little thank you for that and your quick work last year, 
and I look forward to everything being solved this afternoon 
from today's hearing as well.
    So thank you very much.
    Mr. Aderholt. Thank you, Ms. Pingree.
    Secretary Vilsack, without objection your entire written 
testimony will be included in the record, and I will now 
recognize you for your statement and then we will proceed with 
the questions.
    So, again, welcome. Secretary Vilsack.

                  Opening Statement--Secretary Vilsack

    Secretary Vilsack. Thank you very much, Mr. Chairman. I 
certainly appreciate the opportunity to be here today.
    I would be remiss if I did not acknowledge the absence of 
one of the members of this Committee for quite some time, 
Congressman Nunnelee. Our thoughts and prayers continue to go 
with him and his family and this Committee for his loss.
    Mr. Chairman, a budget is an expression of values. It is 
also a roadmap for a better future. The budget presented to you 
today is a budget that is based on middle class economics in 
which we believe we are expanding a family's ability to meet 
basic needs, while at the same time creating opportunity 
through investment and infrastructure innovation. The 
President's budget overall reflects the damage that has been 
done in the past by a policy of sequester that has been 
damaging both to defense and non-defense investment and 
interests.
    This budget is also based on a reality in rural America 
which is that, indeed, agriculture is critically important to 
the future of the rural economy and of America. It has a $775 
billion impact on the American economy. One out of every 12 
jobs is connected in some way, shape or form to agriculture, 
but we have an aging producer population that needs to be 
addressed.
    It also reflects the reality of persistent poverty, 
especially impacting children. Ninety-five percent of the 
counties with highest poverty rates in this country are located 
in rural America. So let me take a few minutes to reflect on 
the importance of American agriculture, the need for expanding 
a family's ability to meet basic needs, and the investments in 
innovation and infrastructure.
    This budget contains enough resources to fund 42,964 
operating and ownership loans to farmers, 23,000 of which will 
be extended to beginning farmers. It provides access to credit. 
It will promote financial literacy and business planning among 
new and beginning farmers, and it will provide further 
awareness and greater awareness of USDA programs and resources 
for our farm families.
    It provides for $8.2 billion in crop insurance, which will 
help assist us in protecting the value of a $110 billion crop. 
It promotes trade as the Chairman rightly indicates, something 
that is extraordinarily important to American agriculture, 
helping us to knock down barriers that exist to the record 
exports that we have experienced over the last five years.
    It will provide additional resources in adequate resources 
for the Animal and Plant Health Inspection Service (APHIS) to, 
indeed, protect the livestock industry, which is a $191 billion 
industry, and it will also provide funding for 20 million 
additional acres to our record enrolled Conservation Programs. 
It will also provide $200 million in watershed protection and 
flood prevention.
    So it does reflect the importance of American agriculture 
to the economy. It also provides assistance and help for 
beginning farmers.
    On expanding a family's ability to meet basic needs, this 
budget provides additional support for the Supplemental 
Nutrition Assistance Program (SNAP), focused on our efforts to 
improve employment and training efforts to put able bodied 
people to work. At the same time, the fact that senior citizens 
are not accessing this program as effectively as they should, 
we want to pay a little attention to our senior citizens in 
terms of access to the SNAP Program.
    Six, point, six billion dollars for the Special 
Supplemental Nutrition Program for Women, Infants and Children 
(WIC) funding will serve 8.5 million women, infants, and 
children. I note that 53 percent of all newborns in this 
country currently participate in WIC.
    Over $26 billion in loans and other assistance which will 
provide rental assistance for over a quarter of a million low 
income families whose income is roughly somewhere between 
$10,000 and $11,000 a year annually. It will also provide 
financing for 171,000 single family homes. It will expand 
summer feeding, will continue to focus on the 23.5 million 
Americans who live more than a mile from a grocery store by 
providing money for the Healthy Food Financing effort, and 
obviously continued support for our School Nutrition Programs 
with a focus on expanding school breakfast and ensuring that 
community eligibility is available.
    In terms of investment in innovation, we will continue to 
focus on job growth. This budget provides assistance for 32,000 
jobs. Community infrastructure is supported. Twenty-four 
broadband projects, 1,300 waste water sewage projects, roughly 
400 electric projects, and over 2,500 community facilities can 
be financed through this budget.
    On the research side let me just point out that we are 
proud of the 758 patent applications that have occurred as a 
result of USDA research since 2009, and the 398 new plant 
varieties that have been identified by our scientists. This 
budget provided additional resources and adequate resources for 
the 800 research projects that are ongoing at Agricultural 
Research Service (ARS) facilities, as well as adequate 
resources for our National Institute of Food and Agriculture 
(NIFA), with an emphasis on new opportunities for antimicrobial 
resistance and pollinators.
    I shared with you, Mr. Chairman, the importance of our two 
institutes that we are proposing in nanotechnology and 
biomanufacturing and hope that the questions allow us to 
amplify on that a bit today.
    On poverty, and I will just quickly finish with this, one 
in four American children live in poverty in rural areas. In 
the Deep South it could be as high as one in three. It is the 
highest rate of child poverty since 1986, and that is why we 
have included resources in this budget to develop new 
approaches and better coordinated efforts within the Federal 
Government focused on child poverty.
    This budget does contain reforms, and I would simply point 
out in conclusion that this budget is still below the fiscal 
year 2010 budget that was approved by a previous committee. So 
we are in the process of going on six years with no additional 
resources, but we have found ways within the existing resources 
to save through our administrative services process and our 
Blueprint for Stronger Services that has identified $1.4 
billion in savings, and I am happy to go into greater detail. 
It is far more extensive than travel and the items that you 
listed.
    So with that, Mr. Chairman, I am happy to try to answer and 
respond to questions.
    [The statement of Secretary Vilsack follows:]
    
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                    DIETARY GUIDELINES FOR AMERICANS

    Mr. Aderholt. Okay. Let me begin by just talking about 
something recently that has come up with the dietary guidelines 
for Americans. I appreciate your recent comments that you have 
spent time reviewing the law establishing the dietary 
guidelines for Americans, and you have concluded that you and 
Secretary Burwell have a narrow mandate in issuing the 
following guidelines.
    You did acknowledge that the Advisory Committee had a 
greater latitude to opine about a variety of issues, but your 
function at USDA is to adhere to the statutory directive.
    I guess my question that I would pose to you is: do 
American farmers and ranchers have assurance from you that the 
final report will include nutrient and dietary recommendations 
and not include environmental factors and other extraneous 
material?
    Secretary Vilsack. Mr. Chairman, I fully expect and 
anticipate that I will work with my colleague in the Health and 
Human Services (HHS) to make sure that we follow the 
appropriate approach within the statutory guidelines and 
directions that we have received.
    I understand we need to color inside the lines and do not 
have the luxury of coloring outside the lines.
    Mr. Aderholt. I find it interesting that the Advisory 
Committee has found that cholesterol is not a nutrient of 
concern for over consumption even though previous dietary 
guidelines have recommended limiting cholesterol intake to more 
than 300 milligrams per day.
    There are other such examples in recent past where the 
Advisory Committee completely changed its focus despite claims 
of sound science. The Advisory Committee also recommended a 
diet higher in plant base foods and lower in animal base foods 
as more health promoting, even though lean meat has been 
included as part of a healthy, balanced diet in previous 
dietary guidelines.
    How are consumers supposed to feel confident about 
following dietary guidelines when the recommendations that are 
put forward contradict what was just put out there five years 
ago?
    Secretary Vilsack. Mr. Chairman, I think it points out the 
fact that in many areas science is evolving, and science 
changes. The committee that formulated these recommendations is 
supposed to take a look at the most recent science and 
determine from a review of scientific literature and studies.
    You know, part of the issue, I think, here is that we need 
to be focused on a broader range of research projects because 
if you have a narrow band of research projects that are 
conducted over a five-year period, most of what you are going 
to find out through this review is what basically has been 
written and published in the last five years. It is one of the 
reasons why, frankly, in the beef industry I am encouraging the 
beef industry to take a look at their check-off program and 
expand it because I think there is additional research that is 
required, and with additional research it may very well be that 
the science will continue to evolve.
    It is also the reason why it is important for folks to 
understand that they do have a comment opportunity here. These 
recommendations are just that. They are not the guidelines, and 
it is important for folks who feel differently, and I know that 
there are scientists who do feel differently about all of this, 
to weigh in with their comments so that we can take into 
consideration the breadth of opinions.
    Mr. Aderholt. Back last November, Mr. Kingston and I wrote 
to you and Secretary Burwell concerning the scientific evidence 
used by the two departments to establish sodium 
recommendations.
    You responded on January 23rd, and thank you for your 
response. I would move the original letter and response to be 
made part of the record.
    [The information follows:]
  
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    Mr. Aderholt. As you know, fiscal year 2015 Omnibus 
includes section 752, which states that the sodium levels in 
the school milk programs cannot be further reduced until the 
latest scientific research establishes the reduction is 
beneficial for children.
    With regards to the action of the Dietary Guidelines 
Advisory Committee, it appears they only reviewed literature 
that fit the objective of lowering sodium consumption in 
Americans. The point of including the bill language was to make 
sure all relevant and recent science was considered so that we 
do not harm the health of Americans, including school children, 
by forcing a sodium level that the most recent research shows 
is harmful.
    Would you think is important that USDA and the Health and 
Human Services consider this data as well, as they protect the 
health of school children?
    Secretary Vilsack. Well, certainly, Mr. Chairman, any 
information that is relevant and specifically focused on the 
welfare of children we ought to consider. I hope that during 
the comment period that we would solicit additional information 
by virtue of your comments and questions today, and that our 
teams would be understanding their statutory responsibility and 
the budget law to comply with that.
    Mr. Aderholt. And, again, of course, if I understood you 
correctly, you are giving your assurance that the final report 
will include the nutrient and dietary recommendations that are 
included without environmental factors and other extraneous 
material?
    Secretary Vilsack. Mr. Chairman, I do not want to be cute 
about this. I do not want to make a representation to you that 
binds Secretary Burwell. What I will commit to you is I 
understand my responsibility is color inside the lines, that we 
have a responsibility to focus on guidelines that are dietary 
and nutritional in impact and effect, and that they will, 
indeed, be used to educate the public as well as Federal 
nutrition policy.
    That is my responsibility, and I intend to live up to that 
responsibility. I do not want to speak for Secretary Burwell. 
She can certainly do a good enough job by herself on that.
    Mr. Aderholt. Thank you.
    Mr. Farr.

                          2016 BUDGET REQUEST

    Mr. Farr. Thank you very much, Mr. Chairman.
    Sorry I have been in and out. Right next door is the 
Milcon/veterans hearing, and I have a lot of military bases in 
my district. So I am running back and forth.
    Thank you very much for your testimony, and I really admire 
your ability to sort of seize the capability you have as 
Secretary to look at consolidation and prioritization within 
the Department. I think it is long overdue.
    You know, these moments of our first hearings are all ones 
of nice-and-nice because nobody talks about what happens if we 
do not give you the money you are asking for, and I think 
hopefully these hearings can talk about that because what will 
happen is we will do everything in the public like we are doing 
right now, and then the Budget Committee meets, gives us our 
numbers, and we do all of the cut, squeeze and trim without 
public comment.
    I hope, Mr. Chairman, if that happens that you will invite 
the Secretary back so he can talk about what might be the 
implications of anything we give him less than what he is 
asking for. And perhaps you just want to suggest how essential 
these monies are.
    You know what? I find in Congress that everybody wants to 
solve problems, but nobody wants to pay for solving the 
problem. There is not anything in our family situation where a 
problem does not require some funding or a business where we do 
not do it. We throw money at it, and in Congress we have a very 
hard time. We might agree that there is a problem there, but we 
have a very hard time deciding we want to give you more money 
or additional money to solve that problem.
    So if there is sequestration, which is rumored in the 
Budget Committee that these cuts may go back to 2008 level, 
what would be the consequences?
    Secretary Vilsack. Well, it is a loss of opportunity. You 
know, just take Rural Development programs. For example, it 
means fewer projects, fewer job opportunities, fewer job 
creating projects, fewer infrastructure needs that are met.
    It is one of the reasons why given the fact that we have a 
budget that is less than it was in fiscal year 2010, we are 
proposing a budget today that is less than it was in fiscal 
year 2010, and we are currently in a budget that was less than 
fiscal year 2010, that we have sought to figure out ways in 
which we can leverage our resources more effectively, and there 
is a limitation to that but we are trying every possible way we 
can think of to try to meet the need that is out there.
    Congressman, we have one in four kids in rural America that 
are in poverty. So if you are impacting and affecting jobs, if 
you are impacting and affecting the ability to obtain housing, 
if you are impacting and affecting the ability to get a decent 
education, you are basically making sure that those kids have a 
much steeper hill to climb.
    And one of the concerns that I have is that all of us 
collectively have not spent enough time and attention on rural 
poverty, especially as it relates to children, and this budget 
begins that process.

                             RURAL POVERTY

    Mr. Farr. How do you prioritize those poverty projects 
around the country?
    Secretary Vilsack. Well, we had a meeting with the Rural 
Council yesterday that I chair in which we are going to try to 
create an opportunity to better coordinate the Federal programs 
that exist.
    You know, we know programs that work, but we have a 
tendency to operate them in our silos and in isolation. So we 
operate our USDA poverty reduction----
    Mr. Farr. You mean silos outside of just USDA.
    Secretary Vilsack. Correct.
    Mr. Farr. Transportation?
    Secretary Vilsack. Our nutrition programs may be operating 
differently in a different place than HHS' programs, and HHS' 
programs may be operating differently than Transportation's 
programs.
    We believe that it is important and necessary, and I have 
got this map that basically shows the counties and areas of the 
country where the poverty rate for kids is higher than 30 
percent, and so obviously geographically focuses our attention, 
but we also have to make sure that we coordinate and target all 
of our resources and coordinate those resources. We have not 
done as good a job of that probably ever, not just this 
Administration, any Administration, for quite some time.
    So yesterday we began a process of trying to figure out how 
to do that better.
    Mr. Farr. You know, outside of just being Secretary of 
Agriculture, I mean, you have been a mayor. You have been a 
councilmember. You have been a Governor, Secretary , and a 
legislator. I mean, you have seen it all. Many of us have been 
through local government as well.
    I have never seen a willingness of the Federal Government 
to really assess these capabilities and re-prioritize them. I 
think it is one of the finest things that the Administration 
and you are really doing that, and I really applaud you for 
that because everybody in Congress wants to get the best bang 
for the buck, and we are not going to get that best bang unless 
we use this sort of collaborative effort.
    And somebody has to pull it all together. So I hope in 
those kind of new starts that we in Congress do not then turn 
around and cut you flat because it is a new idea. It is a new 
idea that in the long term it is going to be much more cost 
effective than essentially our kind of welfare spending that we 
all criticize.
    So I applaud that, and, Mr. Chairman, if we do cut his 
budget significantly, I would really request that we have 
another hearing to hear from the Secretary about what the 
consequences of those cuts will be.
    Mr. Aderholt. Mr. Yoder.

                          AGRICULTURAL EXPORTS

    Mr. Yoder. Thank you, Mr. Chairman.
    Mr. Secretary , welcome to the Committee, and I want to 
thank you for your time recently that you spent in Kansas and 
in my district.
    Mr. Chairman, the Secretary came out and met with 
agriculture producers and others who create and promote 
transportation of goods in our country to discuss the 
importance of transportation of those goods and trade.
    And I wanted to thank you for your time. I thought it was a 
very good use of our time to visit about the opportunity to 
sell more goods from Kansas, agricultural products in 
particular and other States around the globe.
    I thought maybe you could just briefly highlight what 
Congress could do or what we should be doing as a country to 
promote the export of goods from Kansas and Alabama and 
California and Florida and, you know, the other States 
certainly that are here and that are in Congress that have a 
lot of agriculture basis.
    How important is it to them and what can we do? What would 
be your position on what Congress could do and how we could 
work together, both parties, to create more jobs at home?
    And, frankly, the best way to lift some of these young kids 
out of poverty is to bring more dollars into the United States 
through exporting goods from their communities.
    Secretary Vilsack. It is an excellent question, 
Congressman. I would say three things. One, recognizing the 
fact that 30 percent of all agricultural sales are export 
related, which is roughly equivalent to a net cash income for 
farming. So theoretically if you were to do away with exports, 
you would essentially do away with any real significant profit 
margin in farming.
    So obviously you need to continue that. So we have to 
continue to fund and promote our programs that allow us to go 
out and advocate on behalf of and market agricultural exports. 
That is why we have asked for an increase in the budget in our 
trade promotion efforts, $35 to one return on investment of 
those monies.
    Two, we need the Congress to give the President the same 
authority that every President has had since Franklin Delano 
Roosevelt, which is trade promotion authority, so that as we 
finalize important negotiations on free trade agreements, 
Congress has the ability to review them, but ultimately to vote 
up or down.
    And then finally, to the extent that we conclude a strong, 
fair, and appropriate access, and reducing barrier trans-
Pacific partnership, understanding the significance of that, we 
have got to control the rulemaking in Asia and the market 
development in Asia.
    I'll just finish with this. Today there are 525 million 
middle class consumers in Asia. Within 15 years, that is going 
to be 3.2 billion. There is a tremendous opportunity here. We 
do not want China writing those rules. We want to write those 
rules.

                        FARM BILL SAVINGS--SNAP

    Mr. Yoder. I appreciate your leadership on those issues, 
and it is important to Kansas. I know it is important to a lot 
of farmers in our districts who depend on selling their goods 
around the globe, and so it is an important economic 
development tool I think we could work together on, and we look 
forward tomoving on some of those items that you suggested.
    I noted last year during the Farm Bill debate that there 
were some expected reductions in savings that the two parties 
worked together to sort of iron out in a compromise bill. One 
of those areas of savings was related to agriculture, farming, 
and the other area was related to the Food Stamp Program, SNAP 
Program. We know that about 80 percent of the Farm Bill is for 
food stamps, yet the area in savings on the Food Stamp Bill was 
only eight billion out of 23 billion in total savings. So it is 
a disproportionately small savings.
    But it was, I think, an ability for the sides to show they 
can sort of iron out some differences, but to get to that 
solution, the compromise was savings through the Low Income 
Energy Assistance Program (LIHEAP). I guess I would like an 
update on your implementation of those savings and where we 
think that is going to end up.
    I think the estimate was about eight and a half billion in 
savings, and I note that an article in Politico stated at the 
time the single biggest savings comes from cracking down on 
what many see as an abusive scheme employed by about 16 States 
that distribute token amounts of low income free assistance to 
households to help them gain higher benefits.
    Have we corrected that abusive scheme? And what will the 
savings be?
    Secretary Vilsack. Congressman, I think we will have 
savings in the program. It may not come from exactly the area 
that Congress has directed. Seventeen States were impacted by 
what you all did in the Farm Bill. Twelve States have 
essentially increased their commitment in LIHEAP, which they 
are capable of doing and able to do. But we are seeing 
declining numbers in SNAP, and I have always said that the most 
effective way of reducing SNAP is an improved economy and 
focusing time and attention and resources on getting able 
bodied people to work who are currently receiving SNAP.
    We are currently doing that, and I think we will see from 
the pilots and from an improved economy significant reductions 
in the same way under the farm programs the expectation was 
that we were going to receive savings from our safety net 
programs. The reality is we are probably going to have to 
trigger those a little bit quicker than anticipated.
    So, you know, at the end of the day, I think you are going 
to have the cumulative savings, but you may have it in a 
slightly different mix and a slightly different calculation.

                        WIC PROGRAM ELIGIBILITY

    Mr. Yoder. I also note, Mr. Secretary , your statement 
which I think many people would be surprised to hear that 53 
percent of newborns in our country start out on the WIC 
program. I think that is clearly an example of the economy not 
working well enough for enough people that we have these young 
mothers and families reliant upon this program.
    But it's also by some reports an example of a poorly 
administered program. I am sure you are familiar with the 
General Accountability Office (GAO) report in 2013 that stated 
that the Food and Nutrition Service (FNS) regularly monitored 
State and local WIC administration through the management 
evaluations conducted by its regional offices, and in one-third 
of the States reviewed since 2010, FNS found problems with 
income eligibility determination, policy and procedures.
    Furthermore, the GAO found that FNS has not reviewed 
findings on income eligibility determination and as a result, 
they have not focused their technical assistance in this area.
    So that report was pretty damning in that it stated some of 
the explosion in WIC eligibility is related to an improper 
implementation of the program.
    Mr. Aderholt. Let me just interject here.
    Mr. Yoder. And I apologize, Mr. Chairman.
    Mr. Aderholt. You did run a little bit over, but if you 
could give some of your answer quickly so we can move on to the 
next.
    Mr. Yoder. How would you fix this and what is your response 
to that?
    Secretary Vilsack. Additional training, and additional 
focus on this. I would say this is actually an answer to 
Congressman Farr's question on the impact of inadequate 
resources. We have seen a reduction in workforce, and if you 
have got fewer people, it is very difficult to do all of the 
work that you all want us to do, and we see this not just in 
WIC, but we also see this in some of the other programs.
    So we are doing our level best to try to improve training 
and make sure the States understand their responsibilities.
    We are also focusing on fraud and improper use of the 
program, which I know is also an interest and a priority of 
this Committee.
    Mr. Yoder. Thank you, Mr. Chairman.
    Mr. Aderholt. Ms. Pingree.

                      FOOD SAFETY OUTREACH PROGRAM

    Ms. Pingree. Thank you, Mr. Chair.
    Mr. Secretary , thank you for your testimony and your 
answer to the previous questions.
    I want to talk about an issue that is of concern to the 
farmers in our State and I think in places like mine around the 
country. As you know, the Food and Drug Administration (FDA) is 
getting close to finalizing new food safety regulations later 
this year, and I am very interested to see if we can have a 
discussion on the USDA's plans for the Food Safety Training 
Competitive Grants Program, which will be operated by the USDA 
under the NIFA agency.
    Now, in Maine I have heard from farmers for the last couple 
of years who are very concerned that the Food Safety 
Modernization Act (FSMA) rules are going to be applied in a way 
that unfairly targets small and medium sized farms, when we 
know the intent of the law was to prevent food safety outbreaks 
like those from massive farms and farm operations like Foster 
Farms where salmonella affected eggs and people in 18 States.
    Like a lot of New England and other States, small farmers 
in my State who sell locally and direct to the consumer are by 
definition better protected from a food safety outbreak. They 
have a limited market, can more easily trace their sales, and 
as you can imagine, farmers in our State have turned out to 
public hearings on this, so we have had a lot of discussions 
with the FDA on what the final rules will look like.
    We do not know the funding levels yet, but if it is 
adequately funded, the Food Safety Outreach Program could play 
a crucial role in preparing the farmers for FSMA by conducting 
outreach to help train them for the complex web of the new 
rules and easing some of the burdens of compliance for these 
farmers.
    I think without the training, FSMA will fall short of its 
goal of improving on-farm safety. I am very pleased that we 
were able to provide the Food Safety Outreach Program, for the 
first time, with funding in fiscal year 2015, and I am very 
supportive of the USDA's request to double those funds in 
fiscal year 2016.
    I would like to hear you talk about the $5 million that has 
been requested, how it would be spent, and if you have enough 
funding for what really needs to be done.
    This will be a massive change for farms of that size.
    Secretary Vilsack. Well, we obviously will do this in 
conjunction with the Department of Health and Human Services. 
First and foremost, it is going to be important for producers 
to know who is in and who is out of the program because there 
are exemptions for the program, particularly aimed at small 
size producers.
    You know, using technology through Webinars and using the 
Extension Service, the expectation would be that we would try 
to reach as many farmers who were interested in this and in 
need of assistance. We are really focused on trying to build a 
local and regional food system in rural America as a complement 
to production agriculture, and so this becomes critically 
important because oftentimes those small producers are 
specialty crop producers and the people who will fall within 
FSMA's reach.
    So I would say we will extensively use Extension, 
extensively use Webinars, and utilize our land-grant university 
system to try to get the word out.
    Ms. Pingree. Just a little bit of a follow-up, and I agree 
with you, and I appreciate in your testimony that in both the 
organic market and in the local foods market you recognize that 
this is a fast growing market, and there is a lot of interest 
in it and great opportunities for many of our rural farmers to 
grow or establish new opportunities, and I am lucky enough to 
come from one of the States where the average age of our farmer 
is not going up and we have more farms coming into production 
and returning to some of the ways farming used to look like in 
the 1800s. So we are happy about that, maybe except for the 
excessive snowfall this winter, but other than that, we are 
happy for some of that return.
    My understanding is that the USDA is partnering with the 
FDA on this initial round of grants to establish a National 
Coordination Center and several regional centers for food 
safety training. I just have some concerns about the plan, 
namely, that grant funding may be limited to large regional 
centers rather than to organizations that work directly with 
small and mid-sized farmers and food businesses.
    I think some of them are best suited to provide the 
outreach in education and training. Can you talk a little bit 
more about the vision for the Competitive Grants Program and 
beyond, particularly how you will make sure that this funding 
has real impacts?
    Secretary Vilsack. Well, a component of any competitive 
grant will be the ability to establish your capacity to reach 
the people in the field and out in the countryside, and to the 
extent that I can say one thing with certainty about this USDA 
is that we are all about collaboration. We are all trying to 
figure out how we leverage scarce resources and use all of the 
support entities that we can.
    So I would expect and hope that NIFA would continue to do 
what it has done on many other initiatives similar to this, 
which is as a component of the grant basically say: how are you 
going to ensure us that the word is actually going to get 
beyond the university campus? How is it going to get actually 
to that farmer or that producer who may be concerned about 
whether they are exempt or not, how they comply, what they have 
to do, what paperwork they have to fill out and so forth?
    So I can assure you that that will be part of the 
competitive process and part of the decision making process.
    Ms. Pingree. Well, I look forward to working with you on 
that. Thank you for your answer.
    Thank you, Mr. Chairman.
    Mr. Aderholt. Mr. Valadao.

       UNDER SECRETARY FOR TRADE AND FOREIGN AGRICULTURAL AFFAIRS

    Mr. Valadao. Thank you, Mr. Secretary.
    First I wanted to say that your department, especially Dana 
Coale and others there, are helping out quite a bit working 
with our California dairy producers on this process to go with 
the Federal marketing order. So it has been going well, and she 
has been very well received in the district and very 
informative.
    The recently enacted Farm Bill included a mandate that USDA 
create a new Under Secretary for Trade and Foreign Agricultural 
Affairs. As part of the fiscal year 2015 Agricultural 
Appropriation Act, this Subcommittee also commissioned an 
independent study similar to the one USDA was supposed to 
complete by July of last year. The new Under Secretary would 
become USDA's tip of the spear for agriculture trade, export 
and import efforts. This is in addition to the higher level 
efforts led by the U.S. Trade Representative.
    Currently trade and foreign affairs functions are spread 
across the Department. Streamlining trade priorities through 
the new Under Secretary , I believe, will result in much more 
efficient and effective process.
    In your testimony you even highlighted the exponential 
growth in agriculture exports as one of the few bright spots in 
our economy. A large portion of these are coming from my 
district, and we want and need to see this to continue.
    We have seen two recent examples of the manufacture crisis 
that cost our farmers, ranchers and producers dearly: the West 
Coast port shutdown and the backlog of Midwest railway 
shipments.
    Mr. Secretary , how can a newly organized function provide 
direction to the Department and U.S. agriculture in general by 
strategically focusing on trade related issues and avoid these 
types of situations in the future?
    Will you make the creation of this new function a priority 
in complying with the mandate?
    Secretary Vilsack. Congressman, I would be happy to have 
our Acting Chief Economist talk to you about the contracting 
process that we are currently undergoing to comply with the 
budget directive to have this studied, if that would be 
helpful.
    But I would say, first and foremost, that this is a 
complicated issue because it does require a review of all the 
mission areas that are impacted within USDA by trade, and 
certainly we have taken a role both in the port resolution and 
in the rail issue. The port deal, as you know, was resolved in 
large part because of Secretary Perez's intervention, and he 
will tell you that the most powerful message that he carried 
out to the West Coast was from farmers because he was given 
that information from us.
    On the rail side, it is good to note that we continue to 
see investment by our rail companies, and we are now beginning 
to see a much more competitive secondary market for cars. So 
that has abated a bit, and hopefully with additional 
investments from the rail industry that we have advocated for 
and pushed for that will be less of a concern in the future.
    But would you like the Chief Economist to sort of----
    Dr. Johansson. Thank you, Congressman, for the question.
    As you know, my office, the Office of the Chief Economist, 
was given extra funding to pursue this study, and we are moving 
ahead as quickly as possible with getting the contract vehicle 
fleshed out and put in place. Of course, as the Secretary 
mentioned, it is a very complicated issue, and we expect to be 
working with the group that is going to be working on that 
report over the next couple of months, next six months or so to 
get that report.
    And we will have several places during that process by 
which we can come up here and brief folks about the progress we 
have made and to solicit any input that you might have on that, 
but we will be working forward on this and hopefully we will 
get that contract in place within the next few weeks.

                 DIETARY GUIDELINES ADVISORY COMMITTEE

    Mr. Valadao. Perfect. And then back to the Secretary.
    Since 1985, HHS and USDA have appointed Dietary Guidelines 
Advisory Committee consisting of nationally recognized experts 
in the field of nutrition and health. The charge of the 
Committee is to review the scientific and medical knowledge 
current at the time and to provide recommendations for the next 
edition of Dietary Guidelines based on their current review of 
the literature.
    To date the committee has consisted entirely of human 
nutrition and health experts. However, during the review 
process, agriculture questions often arise, especially 
regarding common practices and processing methods associated 
with food production.
    In order to appropriately address the needs of the 
committee, do you feel that it is beneficial to have an 
agriculture expert included in this Committee?
    Secretary Vilsack. Congressman, I am not sure that it is 
absolutely essential or necessary that it be involved in the 
committee, but obviously it is very important that those 
considerations be taken into consideration when the guidelines 
are established.
    I mean, at the end of the day what we have here is a 600 
page report that ultimately will be substantially whittled down 
to probably less than 100 pages by our teams at HHS and USDA. 
So I think it is important for that viewpoint to be in the 
process, but I do not necessarily think it has to be. It might 
be helpful, but it does not have to be included in the 
recommendations.
    Mr. Valadao. All right. Thank you.
    Mr. Aderholt. Mr. Rooney.

                 DIETARY GUIDELINES ADVISORY COMMITTEE

    Mr. Rooney. Thank you, Mr. Chairman.
    Mr. Secretary , it is good to see you again.
    As you know, my district is largely citrus based, and I 
have a comment with regard to that, but then I have a question 
with regard to another big part of my district, which is beef 
cattle.
    I was happy to finally see that the Specialty Crop Research 
Initiative (SCRI) funds were released to the projects chosen by 
the Citrus Subcommittee. This has been an incredibly 
challenging time in Florida's history, and while the industry 
is resilient, the delay in getting these projects out the door 
is concerning to the growers in my district.
    I know that a majority of the Multi-Agency Coordination 
(MAC) funding is going to shorter term projects, and the SCRI 
funds tend to be more focused on the longer term solutions, but 
the overwhelming anxiety over any solution to the problem makes 
me concerned about the level of funding requested in your 
budget for the programs directed to solve the problem.
    I am hopeful that in the future this Citrus Subcommittee 
will improve their communications not only among their members, 
but also the stakeholders on the ground. That is something that 
I have been hearing in my district time and time again.
    I do not know if you have a comment on that, but I just 
wanted to make sure that you knew where our growers stood.
    Now, with regard to this issue of lean meat, I am concerned 
with the recent Dietary Guideline Advisory Committee's report 
that removes lean meat from the definition of a healthy dietary 
pattern, but does mention healthy benefits associated with lean 
meat in a footnote and a handful of other times in the 571-page 
report.
    The final recommendation from the advisory committee I find 
confusing since they spend significant portions of their 
meetings talking about healthy diets like the Mediterranean 
style diet, which is higher in red meats than the U.S. diet.
    So on one hand the Committee is touting diets with more red 
meat, but on the other, removes lean meats from what they 
consider a healthy diet. Now, I assume that you believe that 
red meats and processed meats have a role in a healthy and 
nutritious diet, but what I want to ask you specifically deals 
with genetically modified organisms (GMOs).
    The 2015 report states that access to sufficient nutritious 
and safe food is an essential element of food security for the 
U.S. population. A sustainable diet helps to ensure this access 
for both the current population and future generations. 
However, the report fails to mention the strong scientific 
consensus behind the safety of GMOs or their apparent net 
positive impact on both food sustainability like increased 
yields per acre and the environment, like the reduced use of 
pesticides overall.
    So given that the recommendation to decrease meat 
consumption was included based on moderate scientific evidence 
and there is arguably strong scientific evidence demonstrating 
the environmental benefits of GMOs in a sustainable 
agricultural production, how will this be addressed in the 
final 2015 dietary guidelines?
    Secretary Vilsack. Well, may I comment on the citrus issue 
first? I want to point out that $40 million has been invested 
to date in citrus greening, and it has been focused on trying 
to find a wide variety of better surveillance, better 
detection, better treatment, and better prevention initiatives.
    We were directed to set up a process that involved asking 
our advisory council to essentially operate this and to 
essentially make recommendations about where the priorities 
ought to be, and they came up with 20 priorities, which 
obviously is 20. That is a lot.
    They have since looked at this and narrowed it down to 
four. So I fully expect in the future that decisions will be 
much quicker because that process has been completed, and I 
would also expect and anticipate that we wouldn't necessarily 
only focus on short-term review, but we would also be looking 
at long-term solutions as well.
    So you can be reassured we are focused on this and we are 
investing in it.
    Okay. As it relates to GMOs, you know, there is no question 
in my mind that GMOs are safe. There is no question in my mind 
that we have a conversation that needs to take place in this 
country about the science behind GMOs, and there is no question 
in my mind that we have to figure out ways in which organic 
producers and our genetically modified producers can coexist in 
the agricultural world that we live in. In my view we need both 
for potentially different reasons.
    And I would say that a good deal of attention is being 
placed on recommendations. Again, I want to emphasize my 
understanding of my role here, which is nutrition and dietary 
only. That's my function, and I intend to be very vigilant in 
looking at the statutory direction to me in terms of the 
development of these guidelines, and I am going to be 
personally involved in this.
    I have on my desk a very large book that advocates a 
slightly different approach to all of this, and so my hope is 
that through the comment period we will expand the knowledge 
and the reach and the information, and that all of that can be 
taken into consideration so that we can provide the United 
States citizens and health care policy makers clear direction 
in terms of nutrition and dietary guidelines, and that is what 
I intend to do.
    Thank you.
    Mr. Aderholt. Mr. Young.

                        WATERS OF THE U.S. RULE

    Mr. Young. Mr. Secretary , fellow Iowan, good to see you 
today. Thanks for being here.
    Thank you, Mr. Chairman, for this hearing.
    I want to ask you about the Environmental Protection Agency 
(EPA's) Waters of the U.S. rule. I know it is not under the 
USDA, but I hear a lot from farmers, and I know that many folks 
here in the room do as well. I see this as a massive land grab 
that will hurt Iowa agriculture by regulating farmland instead 
of the navigable waters as Congress intended.
    Unfortunately, Iowa farmers think this rule will hamper, 
disincentivize, and possibly prohibit voluntary conservation 
practices that are actually working.
    What has the USDA done in response to the Waters of the 
U.S. rule and will you, Mr. Secretary , stand with the farmers 
and publicly oppose this rule?
    Secretary Vilsack. Congressman, we were engaged in a 
process with sister agencies in providing education and 
information in terms of real life responses or reactions to 
anything that is being proposed or considered. We will do that, 
have done that, will continue to do that.
    I think the most effective way for me to be effective on 
behalf of American agriculture is to continue to make sure 
sister agencies as they are making decisions that may impact 
agriculture in rural America, that they are aware of the real 
life implications.
    Secondly, I have encouraged the Administrator of EPA to 
open up dialogue and conversation with producers so that she 
can hear directly from producers what you are hearing when you 
travel back to our home State, and she has traveled to rural 
America. She has gone to farms. She has visited with farm 
groups, and we have set up a regular communication system and 
process with community groups, livestock groups so that the EPA 
Administrator can hear directly from them.
    Third, we are very heavily invested in supporting and 
advocating for voluntary conservation. We believe it works, and 
we believe we have assessed the impact of voluntary 
conservation. It is now at record levels, over 400 million 
acres, over 600,000 producers. We know from our assessment 
programs that nutrients are being reduced, that erosion is 
being reduced. We believe it works, and we believe the reaction 
to the Farm Bill Regional Conservation Partnership Program, 
which was more than we expected in terms of interest, sort of 
supports the notion that voluntary conservation has an 
important role to play.
    And finally, we have stressed to our sister agencies the 
importance of predictability, stability and the ability of 
certainty, the opportunity for folks to know precisely what the 
rules are so that they can comply with them, so that there is 
no question or confusion about that. We have done that with the 
Endangered Species Act. We have also done it in the context of 
EPA regulations.

                     FEDERAL CROP INSURANCE PROGRAM

    Mr. Young. I appreciate those comments, and you know, 
farmers really are terrified of this rule. I believe it hurts 
Iowa agriculture. I ask you to continue to be that voice to the 
sister agencies on behalf of the Iowa farmer and ask that you 
oppose this rule during the interagency process.
    I want to talk a little bit about the Federal crop 
insurance program. Farmers anticipated this new Farm Bill would 
provide some certainty, and now they are concerned less than a 
year after its passage. The Administration is cutting programs 
that farmers rely on. I believe it is a cut of $16 billion over 
ten years.
    As you know, those crop insurance premium supports are the 
most vital and important risk management tool for Iowa farmers 
and farmers across the country.
    Can you explain the Administration's proposal to cut the 
crop insurance premium supports?
    Secretary Vilsack. Sure. The GAO and Inspector General have 
been concerned about the preventive planning aspects of crop 
insurance suggesting that it has a disincentive for the 
planting of a second crop, and part of what we have proposed 
and suggested is to remove that disincentive so that farmers 
are encouraged to plant a second crop.
    Secondly, there is the issue of the harvest price loss 
option. In some cases the reimbursement in subsidy rate is 
anywhere from 60 to 80 percent taxpayer supported. We believe 
this is a partnership between taxpayers, producers and 
insurance companies and a partnership in our view is a little 
bit closer to 50-50 than 80-20, and we think that our 
responsibility with crop insurance is to ensure that we are 
insuring against Mother Nature. The harvest price loss insures 
not just against Mother Nature, but also against market 
decisions that producers are making. It is one of the reasons 
why we have an Agriculture Risk Coverage (ARC) and Price Loss 
Coverage (PLC) program.
    So the combination of those things suggest to us the need 
for proposed modifications and changes, and particularly since 
it looks as if the harvest price loss option might result in 
nearly 50 percent of the cost of the crop insurance program. I 
would say $8.2 billion being invested in this program is an 
indication that we understand the importance of it and the 
significance of it, but there are some issues that have to be 
dealt with.
    Mr. Young. I appreciate that, and I also appreciate your 
comments on the reliance of sound science when it comes to 
GMOs. I appreciate that.
    I yield back my time, Mr. Chairman.
    Mr. Aderholt. Dr. Harris.

                  FARM SERVICE AGENCY (FSA)--STAFFING

    Dr. Harris. Thank you very much, and thank you, Mr. 
Secretary , for appearing before us.
    You know, I represent Maryland's First Congressional 
District, a rural area, 12 counties most of which are rural. 
Farmers in my district have been contacting my office about 
concerns about their local FSA office specifically as it 
relates to their operating hours and staffing.
    You know, the language agreed upon in the fiscal year 2015 
omnibus included a moratorium on closing FSA offices until a 
comprehensive assessment of its workload is conducted. Given 
this language could you provide an update on the status of the 
workload assessment?
    Secretary Vilsack. We are in the process of doing that. We 
actually were in the process of doing that before the budget 
bill was proposed. The budget bill approves us to spend an 
additional $400,000 to do what we have already done, which we 
will do.
    The reality is, as I told the Chairman yesterday, 
Congressman, we have 31 offices around the United States that 
have no employees in them, and one of the reasons we were 
asking for permission to right-size these offices is to focus 
on 31 offices that have no physical person in them. No business 
would operate that way.
    We have some issues with our office structure. I know that 
there is an issue in your district involving a held over lease 
situation, which we are going to rectify and take care of, but 
it is a small indication of a larger problem that we are 
currently dealing with.
    Dr. Harris. Is there a hiring freeze in place right now 
that would prevent FSA from hiring additional staff?
    Secretary Vilsack. It is a budget issue.
    Dr. Harris. But internally is there a hiring freeze?
    Secretary Vilsack. No.
    Dr. Harris. I mean, has the decision been made not to hire 
additional----
    Secretary Vilsack. No. In fact, we have added additional 
staff as a result of the passage of the Farm Bill.
    Dr. Harris. Okay, and I will ask you----
    Secretary Vilsack. But, Congressman, we are actually 
significantly below where we were when I first started this 
job. It is roughly 15 percent, I think, or so of workforce 
reduction.

             APHIS--AGRICULTURAL QUARANTINE INSPECTION FEES

    Dr. Harris. Okay. And I will ask you to provide for the 
record an update on the staffing situation in my district, 
including both permanent and temporary employees, as well as 
any available vacancies.
    [The information from USDA follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    One other issue that has come to my attention is that the 
APHIS has proposed a new rule that would revise the 
Agricultural Quarantine Inspection fees on aircraft, ships, 
trucks and railroad cars to, quote, more accurately rely on the 
fees for the costs of the services.
    But when you look through the proposed fees, the 
international passenger flights pay between $225 and $1,600, 
but if you are an all-cargo flight no matter how big an 
airplane, it is a flat $225 fee. So obviously airline 
passengers will be paying more than if it were just cargo, and 
private flights pay nothing at all.
    How do you justify this kind of inequitable treatment of 
private airline passengers? I mean, they are going to pay a 
disproportionate amount which could be as much as $150 million 
a year.
    Secretary Vilsack. Actually, Congressman, if you look at 
the overall proposal, it is designed to address part of that 
inequity. We did, in fact, see that passenger air travel was 
disproportionately bearing the cost. We had a consulting group 
come in and basically take a look at the entire fee structure, 
which has not been changed in over a decade. We have obviously 
seen significant import increases and challenges with imports.
    So we asked them to take a look at that. How would you 
basically provide the balance? We created this proposal. We 
have also been working with the industries that are impacted 
and affected and have made certain modifications. But I think 
if you look at the overall program, it is designed to better 
balance between passenger service and commercial service.
    Dr. Harris. So when all is said and done will there be a 
disproportionate fee paid? I mean, will, in fact, the passenger 
airlines be paying more than their share even under the new 
program's proposed fees?
    Secretary Vilsack. I am hesitant to say it is totally 
equitable, you know, but I would say that it will be better 
than it was.

                   BIOTECHNOLOGY REGULATORY SERVICES

    Dr. Harris. Okay. Well, thank you very much for that.
    I am going to just echo my concerns, my colleague from Iowa 
here, with the proposed Waters of the U.S. rule. I would hope, 
first of all, that your department was consulted extensively 
prior to proposing the rule because of the disproportionate 
impact on agriculture. This is the number one issue in my 
district. People are just afraid that the irrigation ditches 
are going to be declared navigable waters of some kind.
    And I would hope that through the interagency process, 
again, as my colleague from Iowa has suggested, that you 
aggressively protect American farmers from this intrusion by 
the EPA and Corps of Engineers on their water.
    Finally, in fiscal year 2015, the agency was appropriated 
an additional $740,000 to help ensure the agency will continue 
to make strides toward improving regulatory predictability. And 
with regards to that, at what point in the future does the 
agency anticipate it will start meeting those goals of the 
regulatory predictability with regard especially to 
biotechnology regulation?
    Secretary Vilsack. Actually we have done a good job of 
reducing the backlog that I inherited when I was Secretary. We 
had 23 pending applications when I became Secretary. We are now 
down to three.
    We have had since that time ten additional applications, 
and I believe we have taken action on seven. So we have 
actually improved, and we have actually reduced the amount of 
time it takes for regulatory approvals from roughly 900 days to 
somewhere around 18 months, and our goal is to get to 13 to 15 
months, which will be very consistent with international 
approvals.
    Dr. Harris. Well, thank you very much, Mr. Secretary.
    I yield back.

                             FSA--STAFFING

    Mr. Aderholt. Before I recognize Mr. Rogers, I want to 
clarify. You mentioned about the FSA offices. The issue last 
year when you were dealing with this, how did that come about? 
Was it a budget freeze or hiring freeze rather, or was it 
because of trying to free up money regarding MIDAS?
    Secretary Vilsack. No, no, no. Congressman, the reason we 
focused on the proposal was first to address the fact that we 
have offices today, and we have had these offices for some time 
that have had no full-time physical person in them.
    Secondly was, based on where we knew the work was--now you 
are asking us to review this again, which we will be happy to 
do--based on where we knew the work was, retrofit it, right-
sizing the staffing levels of offices so that they can 
effectively address the needs and demands, and that was the 
purpose and reason.
    Mr. Aderholt. Yes, but I think last year there was some 
money that was used to free up, not this year but last year, to 
free up because of the MIDAS issue, as I recall.
    Secretary Vilsack. Well, there is no question that, given 
the reductions in the Salaries and Expenses (S&E) accounts that 
have occurred over a period of time, there were resources that 
were used to ensure that we had and continue to have better 
technology for our producers.
    But their driving purpose of the consolidation was to make 
sure that we had adequate numbers of people in offices to be 
able to do the workload that we knew individual offices had, 
and in some places where there was very little, we were 
overstaffed.
    Mr. Aderholt. I understand. I think the MIDAS thing was a 
factor last year.
    Secretary Vilsack. It may very well be, but from my 
perspective the key here is to continue looking at ways in 
which we can become more efficient, and that is part of it.
    Mr. Aderholt. Mr. Rogers.

                   ECONOMIC AND COMMUNITY DEVELOPMENT

    Mr. Rogers. Thank you, Mr. Chairman.
    Mr. Secretary , good to see you. Welcome to you and your 
aides.
    I apologize for my tardiness here, but we have another 
hearing going in another room next door, and I missed the 
opening statements, but I want to briefly welcome you and thank 
you for visiting my district back in January of 2014.
    As you know, in Eastern Kentucky we are working on a 
regional community development initiative known as SOAR, 
Shaping Our Appalachian Region. Your attendance at one of those 
early SOAR meetings meant a lot to the region and the 
communities involved.That program, by the way, is moving along 
wonderfully. We are starting to see some early success stories 
in the region, and I want to thank you for designating that 
area as a Strike Force region of the country, which means a 
lot.
    To continue on that path, I want to learn more about 
section 6025 of the Farm Bill, which allows USDA Rural 
Development the ability to prioritize projects that are part of 
multi-jurisdictional strategic economic development or 
community development plans, multi-county organizations, such 
as SOAR.So at your convenience, would you give us an update on 
USDA's progress in implementing that provision of the Farm 
Bill?
    Secretary Vilsack. Mr. Chairman, we have over 50 regions of 
the country that we have invested resources in to enable those 
multi-county and in some cases multi-State areas to take a look 
at how they might create a compelling economic vision for the 
region, and then to be able to identify resources that can be 
directed to make that vision a reality.
    Earlier today I showed this map, Mr. Chairman, which you 
are probably very familiar with. This is a map, and I apologize 
for the smallness of it, that reflects the counties in this 
country where the child poverty rate is in excess of 30 
percent. And it tells us and shows us, and the SOAR Program in 
particular created a greater awareness of our having a more 
comprehensive approach; that it was not enough just to simply 
make one investment over here and one investment over here; 
that there needed to be coordination within USDA.
    That is why we have Strike Force. I can tell you Strike 
Force has resulted in over 100,000 investments being made in 
Strike Force areas pursuant to an overall strategic plan. I can 
tell you that we have invested over $11 million in those Strike 
Force areas, and I think we are seeing some signs of progress.
    We are now working with our Federal sister agencies to try 
to figure out a way in which we can better coordinate each 
other's programs. I visited earlier about the Rural Councils 
Initiative in this respect. So we are very much engaged in 
this. We understand it is the best way to use resources.
    The last thing I would say is we are also indicating and 
educating people in the private sector about investment 
opportunities that exist.
    The problem we have is that we have an enormous number of 
water projects that we could fund. We will have resources to 
fund 1,300, but we might have 2,300 applications. We cannot get 
the investment community interested in a single water project 
even if it is a $5 million project, but if we could figure out 
a way to bundle 50 of those projects, we could actually create 
an investment asset class that the private sector would be 
willing to invest in.
    So we are now in the process of having folks come in, take 
a look at our portfolio, figuring out how we can adequately 
bundle sufficient numbers of projects, and we are now beginning 
to identify capital markets that might be willing to invest in 
those bundled assets. That is why CoBank announced the $10 
billion initiative. It is why Citibank yesterday just announced 
a $100 billion effort, part of which is going to go in rural 
areas.
    So it is a combination of strategic visioning, coordinating 
our resources, coordinating sister agency resources, and 
engaging the private sector.
    Mr. Rogers. Well, good luck. That is very, very important.
    Secretary Vilsack. Well, you are making it. The leadership 
that you and Governor Beshear have provided in Kentucky are, I 
think, a terrific example of how this ought to be done in other 
parts of the country.
    Mr. Rogers. Thank you.
    Secretary Vilsack. Of course, it helps to have the Chairman 
of the Appropriations Committee engaged in the process, I might 
add, and a Governor who is pretty dog gone progressive.

                        WATERS OF THE U.S. RULE

    Mr. Rogers. Thank you, and it is great to have the 
Secretary of Agriculture as a part of that team.
    Having said that, let me ask you about the Waters of the 
U.S. Rule. We had our Farm Bureau from Kentucky here yesterday, 
several hundred of them, and that was a big topic of 
conversation with farmers. They are worried; they are 
frightened at this notion that the Federal Government would 
assert jurisdiction over farm ponds, irrigation canals, 
culverts on farms, drainage ditches, and the like and require 
them to come to Washington and get a permit to put a culvert on 
their farm or to restock a pond or what have you.
    Can you give us any alleviation of those concerns?
    Secretary Vilsack. Well, Mr. Chairman, I have indicated to 
Administrator McCarthy concerns that I expected would be 
expressed, as you have expressed them, particularly as it 
relates to ephemeral streams, the notion of a bed, the bank, 
and water in there at some point in time creating potential 
opportunities. And we have expressed that to EPA.
    I respect my sister agency and the determination and 
responsibility they have, both statutory and from a judicial 
direction, and we have done our best to make sure that they are 
educated about the impacts of this. We have encouraged the farm 
community to comment, as they have.
    Our focus is to create the most strong and robust voluntary 
conservation possible so that we are in a position to provide 
assistance and help to farmers regardless of what ultimately is 
determined or decided by EPA, and ultimately decided by the 
courts, so that they are in the best position to comply.
    And I am proud of the fact that we have a record number of 
acres enrolled in conservation, and I am very, very pleased 
with the reaction to our regional conservation program, which 
has shown great interest and collaboration.

                    DEPARTMENTAL OFFICE STAFF LEVELS

    Mr. Rogers. And finally, Mr. Secretary , let me ask you 
briefly about some increases you have requested. You are asking 
for $908.5 million above the 2015 level, and included in that 
is a huge increase in staff.
    According to data, USDA has increased staff to support 
Department activities at the Federal headquarters from 3900 in 
2009 to 4900 for 2016, a 25 percent increase. During that same 
time period, many agencies at USDA have seen a reduction in 
staff to support critical activities.
    What do you think? Are you asking too much?
    Secretary Vilsack. Mr. Chairman, first of all let me say, 
as a practical matter, the budget that was submitted by the 
President is attempting to convey a very strong message about, 
in our view, respectfully, the inappropriate policy of 
sequester and the impact it has not just on non-defense 
spending but also on defense spending. So it is reflective of 
that.
    It is also reflective of the fact that we have had 
reductions in workforce. I am happy to check on those numbers. 
I do not believe that those are accurate, but I could be wrong. 
I know that we have had overall reductions in workforce. In 
many areas some of the questions that have been asked today are 
why we are not doing more of this or that, and part of the 
reason is that there are a limited number of people working.
    But we are at record levels of participation, and this 
budget that we are proposing, despite the increases, is still 
below the budget that I had in fiscal year 2010, which was the 
first full budget the President submitted. And we have been 
able to identify almost $1.4 billion of additional savings 
through our administrative services process. But I am happy to 
check those numbers, and if you are right about those numbers, 
I will be asking serious questions because I do not believe 
that is accurate.
    Mr. Rogers. Well, in your budget request, you will have 
increased staff to support Department activities by 25 percent 
in just six years, including your 2016 request. Those numbers 
are, I think, pretty accurate.
    Secretary Vilsack. Well, I know that we have had an 18 
percent reduction prior to this year, an 18 percent reduction 
in FSA employees. And I know that we are very conscious of 
making sure that we do not disproportionately impact outside of 
the D.C. area.
    And in fact, we are in the process now of consolidating our 
offices to be able to save rent space on folks who are located 
in the Capital District that are not physically in our 
building, the Whitten Building, or the South Building.
    Mr. Rogers. Would you for the record furnish----
    Secretary Vilsack. Sure. Sure.
    Mr. Rogers [continuing]. On staff numbers, and increases or 
decreases and what have you, so that we have got a picture of 
where you are?
    Secretary Vilsack. That is a fair request. Absolutely.
    [The information follows:]
   
   [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
   
    
    Mr. Rogers. Because the request that you have for 
additional staff in headquarters is rather shocking.
    Thank you, Mr. Chairman.
    Mr. Aderholt. Thank you.
    Along with the chairman, we are also happy to have the 
ranking member with us, Mrs. Lowey. So you are recognized.

                      SNAP--ELDERLY PARTICIPATION

    Mrs. Lowey. Thank you very much, Mr. Chairman.
    And Secretary Vilsack, welcome. I want to thank you for 
coming before the Agriculture Subcommittee today. And as I am 
sure others did, I apologize for not coming on time, but we 
have four Secretaries appearing before the Committee. So I want 
to thank Chairman Aderholt and Ranking Member Farr for having 
this hearing to discuss the fiscal year 2016 budget request.
    There are many areas, but what I want to do is limit my 
questions to two. One is SNAP for the elderly. I was really 
shocked by this report. According to the National Council on 
Aging, over 4 million low income seniors rely on SNAP to put 
food on the table. The amount of seniors facing food insecurity 
has more than doubled--this is the United States of America--
since 2001. And yet three out of five seniors who qualify for 
SNAP benefits do not apply.
    Your budget requests $9 million to work with States to 
improve access to SNAP for low income seniors, and I thank you. 
How do you plan to target eligible seniors, to prevent senior 
hunger? What obstacles does the Department face in getting the 
message out about SNAP for the elderly?
    Secretary Vilsack. Congresswoman, thank you very much for 
the question. If I can just take five seconds of your time.
    Mr. Chairman, part of those numbers are the National 
Finance Center, which is located in New Orleans. And perhaps 
the increase of that number is a result of the fact that we are 
taking on more responsibility for processing applications and 
paperwork and payroll for a variety of other sister agencies, 
which actually saves money over time. But we will get you more 
detailed information about that.
    I appreciate the question about SNAP and the elderly. I too 
am concerned about the fact that only 42 percent of eligible 
folks are receiving the benefits. And what we have found out 
from our initial study is that the process is cumbersome. The 
process requires annual recertification, which is difficult and 
problematic for seniors, who may not have adequate 
transportation.
    And so what we are looking at is a way in which we might be 
able to streamline the application process, make it a little 
bit easier for folks to understand the application process, and 
take a look at perhaps not having the need for annual 
recertification, given the fact that these seniors are most 
likely not going to be employed or their financial 
circumstances are not going to change significantly. They are 
probably living on a very, very small Social Security check.
    And also getting over the hurdle that many have, where they 
see this as something that they do not have the right to 
receive, and that is a generational issue that we are going to 
have to address and deal with.
    Mrs. Lowey. This has been going on for a long time. And I 
understand attitudes take time to change, but in terms of the 
process, how big a hurdle is that?
    Secretary Vilsack. Well, I think it is a significant 
hurdle. But I think perhaps what has happened is that we have 
paid a lot of attention to children. We have paid a lot of 
attention to families. But we have forgotten about this 
component, which is equally important, which are seniors.
    And now, because of these numbers, we are going to put a 
little more attention and focus on it. My hope is that that 
will make a difference in the numbers. And I will tell you that 
when we have put a focus on certain States and certain groups 
of people, we have seen increases. We are now at 83 percent of 
eligibles participating, which I suspect is probably close to a 
record if not a record level of participation.

                            CHILD NUTRITION

    Mrs. Lowey. Thank you. Now, you said we have paid attention 
to children. I guess so. But when I was looking at those 
statistics, according to the Centers for Disease Control and 
Prevention (CDC), more than one in five children between the 
ages of 12 and 19 are obese. This has long-term consequences to 
the health of our Nation as well as our economy.
    We know that children and adolescents who are obese early 
in life are more likely to suffer significant health problems, 
type 2 diabetes, strokes, and cancer, among others. The USDA 
has been tasked with improving school lunches, child nutrition, 
and increasing standards under WIC.
    I have worked on this issue a long, long time. In fact, I 
can remember--oh, gosh, I was working at the State before I got 
to Congress--and we were hiring the unemployed, helping them 
work in school lunch programs, having them use commodities, 
teaching them how to prepare healthy foods.
    Can you tell me about any new programs you have, or what 
does the Department do to improve childhood nutrition in the 
coming year? Or you can talk about an old program if that maybe 
has not been working as successfully and we would like to make 
it more successful.
    Secretary Vilsack. Well, this is an issue that has evolved 
over time. It is an issue that is not necessarily going to be 
resolved in a short period of time. It is going to take time. 
We have reformulated the WIC package. We have instituted many 
of the Healthy, Hunger-Free Kids proposals. We are helping 
school districts; 93 percent of school districts have adopted 
those guidelines and proposals.
    We are helping those who were having difficulty with a 
variety of programs--Smarter Lunchroom grants; school equipment 
grants; additional recipes from a recipe contest that makes it 
easier for people to do nutritious meals; expanding the school 
breakfast program--that is a focus of this year's efforts; 
also, expanding the summer feeding program, and using 
innovative and creative ways to get more kids covered. And we 
have seen 23 million additional meals served since 2010, when 
we began this effort.
    And so we are focused on a holistic effort. Within SNAP, we 
are engaged in educating SNAP recipients on healthy choices, 
and we are providing opportunities through the Food Insecurity 
Nutrition Initiative to provide point-of-sale incentives for 
more fruits and vegetables and healthier foods.
    We are also expanding the opportunity for locally and 
regionally produced foods, and particularly fruits and 
vegetables, through a series of pilots that were authorized in 
the Farm Bill. So there is an awful lot of activity in this 
area, but I think it is going to be over a long period of time 
that it will take for attitudes to change, for the food 
processing industry to make adjustments--which they are 
making--reducing sugar, reducing sodium, reducing the fat 
content of certain items.
    And I will tell you, the 70 percent of elementary school 
kids surveyed in a recent survey I saw are embracing these 
changes. Even 63 percent of high school kids are embracing 
these changes. I know when I was governor, if I had a 70 
percent approval rating or 63 percent approval rating, I was 
doing okay. Probably folks here would be okay with those; maybe 
your numbers are higher. I do not know.
    But it is going to take time, and it is going to take 
effort. And it also has to take understanding. This chart--I 
have shown it three times now--this explains to me a lot of the 
challenges that are faced because some of these areas and some 
of these school districts that are doing it are poor. They are 
poor. And they are pinching pennies, and they are finding it 
difficult. And we are trying to provide help.
    We created a program called Team Up for Success, where we 
are taking schools that are having a hard time adjusting to 
these new standards and pairing them up with similarly situated 
schools who have embraced them so they have a mentor. And we 
are providing assistance from the University of Mississippi and 
their nutrition center, and from Cornell and its nutrition 
work, for strategies to make it a little bit easier for these 
school districts. But you have to have some understanding of 
the challenges that some school districts face with poverty.
    Mrs. Lowey. I just want to say, in conclusion, I really 
appreciate the work you are doing. Some of us, especially my 
colleague Congresswoman Pingree, have been working on these 
issues for a very long time, and I would love you to keep us 
posted.
    It seems to me we have been talking about these issues a 
long time, and there are some successes. And maybe we have to 
publicize them more and help those who are having the success 
visit school districts who are having problem. But even in poor 
school districts, and I think of one in particular, using 
government commodities you can be creative; and using some of 
the fresh food around, maybe they can be even be more creative.
    But I appreciate the work you are doing, and I look forward 
to getting regular updates, as I know Ms. Pingree and other 
members of the committee would appreciate as well. So I thank 
you. Thank you, Mr. Chairman.
    Mr. Aderholt. Mr. Bishop.

                      ARC AND PLC PROGRAM COVERAGE

    Mr. Bishop. Thank you very much. Welcome, Mr. Secretary , 
and I apologize for my delinquency. I had three Subcommittees 
scheduled at the same time, one of which I am ranking member 
on. I really wanted to get here, though, because I did have 
some questions. But first I have two thank yous for you.
    I was very pleased to see that the President's budget for 
fiscal year 2016 included a significant investment of almost 
$114 million for a new Research Service Agricultural poultry 
laboratory. As you may or may not know, I am co-chair of the 
Congressional Chicken Caucus, and Georgia, of course, is the 
number one producer and exporter of poultry in the country. At 
another time--I am not going to ask you now--I would like for 
you to give us an update on the progress of that.
    The second thank you has to do with the broadband wireless 
technology project. You recall that you visited in 2010 in 
rural Southwest Georgia. We experienced significant delays and 
a number of problems and challenges. But I just learned last 
week that Rural Utilities Service (RUS) 2 has signed off on the 
final contracts. There has been a readjustment there.
    The City of Albany has assumed responsibility for that 
project, and it looks like it will enable thousands of rural 
residents in our Southwest Georgia area to get high-speed 
internet for the first time. So I just want to thank you for 
that, and thank the RUS staff for continuously working with us 
on that.
    I want to get to a more substantive generic question with 
regard to cotton. The 2014 Farm Bill transitions existing 
cotton base to generic base. And allowing the traditional 
cotton base to be protected as generic base has given farmers 
in my State a tremendous amount of flexibility in planning 
while still providing an adequate safety net.
    If a producer has generic base, the quantity of payment 
acres determined may not include any crops that are 
subsequently planted during the same crop year on the same land 
for which the first crop is eligible for price loss coverage or 
agriculture risk coverage payments.
    For example, the provision would penalize a farmer who 
plants a cover commodity such as oats or wheat for grazing and 
then follows behind on the same land with corn that was planted 
and harvested. That producer has to take the base on the first 
crop despite the fact that crops used for grazing are often or 
not ever harvested.
    Is there anything that USDA can do to exempt cover 
commodities that are used for grazing and not taken to harvest 
from the generic base allocation?
    Secretary Vilsack. Congressman, the Farm Bill does provide 
for some flexibility relative to cover crops with the ARC and 
PLC program, but it is very, very specific. If it is used for 
haying and grazing, wheats, oats, other crops that are used for 
haying and grazing, that is okay. The law does not allow us to 
use it if it is for cover only.
    So there is sort of a glitch potentially or a modification 
that may be required in terms of our statutory authority. We 
will work with the flexibilities we are given, but we cannot 
work outside of the flexibilities you all have given us.

                BIOBASED MARKETS PROGRAM-FOREST PRODUCTS

    Mr. Bishop. Thank you for that. It is a problem, and 
hopefully we can work together to try to alleviate that glitch.
    Let me also thank you for your leadership in promoting wood 
products in building construction through both your symposium 
last March, ``Building With Wood and Jobs in the Environment,'' 
and the launch of your Tall Wood Building competition. Of 
course, for Georgia, wood products are incredibly important and 
where processing and manufacturing of forest products employs 
almost 150,000 people in the State and supports 504,000 family 
woodland owners who supply most of the industry with raw 
material.
    The recent Farm Bill made some changes to the Biobased 
Markets program which will provide opportunities to strengthen 
markets for forest products, which is again a key economic 
driver. With the strong markets for forest products, we have 
got healthier forests and stronger rural economies.
    Can you provide an update now that USDA has begun to 
implement the changes to the Biobased Markets program to 
include forest products, and how is that program working for 
forest products, and what are the next plans for 
implementation?
    Secretary Vilsack. Well, we are getting the word out about 
it, and I think it is going to take a little while in terms of 
BioPreferred programs for the word to get out. But we are in 
the process of advertising that.
    We are excited about the response on the Biomass Crop 
Assistance Program (BCAP) to the utilization of woody biomass. 
I think it is something in the neighborhood of 300,000 tons of 
woody biomass was created and supported through the recent BCAP 
announcement.
    And we are also really excited about this tall building 
competition. I think it is going to be amazing to see 20-, 30-
story buildings made solely from wood in some of our major 
cities. We were very pleased with the reaction, and in fact, 
the Softwood Lumber Council was so impressed with the 
applications we received that they added another million 
dollars to the contest. So it is now basically a $3 million 
pot, which is going to enable us, I think, to fund more than 
one project, which I think is really going to get people's 
attention.

               COUNTRY OF ORIGIN LABELING (COOL) PROGRAM

    Mr. Bishop. Okay. Finally, and before my time runs out, the 
COOL program, a couple of years ago the World Trade 
Organization (WTO) issued a decision favoring Mexico and Canada 
with respect to the Country of Origin Labeling, and 
specifically the treatment of Canadian and Mexican cattle 
imports to the USA resulting from our COOL law and procedures.
    Under the law, cattle either processed in Canada or Mexico 
or imported to the U.S. from Mexico or Canada must be labeled, 
and of course the WTO found that it prejudiced U.S. consumers 
against Mexican and Canadian beef. Can you give us a status of 
USDA's activities in that regard?
    Secretary Vilsack. Congressman, the process is under appeal 
with WTO. We are expecting a decision some time this spring. 
There are two options here. We either win the appeal or 
Congress has to change the law because we cannot navigate a 
requirement that we label with U.S. product without segregating 
U.S. product. And once we segregate, WTO comes into play.
    So either there has to be a generic label established by 
Congress or you have to essentially repeal what is in the 
current law if we lose the WTO appeal. Those are the two 
options.
    Mr. Bishop. Thank you very much. My time is expired, but 
thank you very much.
    Mr. Aderholt. Ms. Lowey. I am sorry, Ms. DeLauro.

                       SINGLE FOOD SAFETY AGENCY

    Ms. DeLauro. Thank you very much, Mr. Chairman.
    Good morning, Mr. Secretary. Sorry to be late in coming, 
but a lot of secretaries today on Capitol Hill testifying. 
Hello to you, but also if I might just say hello to Melinda 
Cep. USDA has got a number of former DeLauro employees on their 
staff, so I am pleased to see that they are there. And it is 
good to see you, Melinda.
    I want to say thank you to you, Mr. Secretary, for your 
work in preserving and strengthening child nutrition, WIC, 
SNAP, commodity supplemental feeding programs. They are 
important programs. They lift people out of poverty. They 
assure our next generation is ready for the future.
    To that end, while I was not here, I do understand that 
there were comments made about the SNAP program and the WIC 
program. I really believe it is unconscionable that folks would 
want to further cut SNAP benefits when we know the program has 
been successful in helping families. Low wage recovery, 
sluggish job growth, this was a lifeline.
    Actually, the House Agriculture Committee views an 
estimates letter shows bipartisan agreement that SNAP costs are 
coming down. The SNAP error rate is very low. It declined from 
2.77 in 2012 to 2.6 in fiscal year 2013.
    With regard to WIC, it is highly effective. It reduces the 
probability of high-risk births, especially in very premature 
and low birth weight babies. And for every dollar we spend on a 
pregnant woman in WIC, it is up to $4.21 is saved in Medicaid 
for her and her baby. So I think we should take a hard look at 
the value of these programs before we comment about their 
inefficiencies, maybe link to some other programs that are 
inefficient.
    I am going to try to tick off two or three quick questions 
because I have to go back.
    A proposed consolidation of the Food Safety and Inspection 
Service (FSIS) and food safety activities, you and I have had 
this conversation many times. You know I am a supporter of an 
independent agency. I know you have expressed support for this 
proposal. I agree it is a good first step.
    Can you talk about your thinking on the issue and why you 
think an independent food safety agency within HHS is the way 
to go? You also know that I have felt that FSIS and the food 
safety functions of FDA were back burner issues and that this 
kind of an approach for a single effort would be more 
beneficial for food safety.
    Secretary Vilsack. Fifteen different agencies have some 
jurisdiction or some responsibility for food safety, and it 
creates 15 opportunities for the right hand not to know what 
the left hand knows and not to be able to react and respond 
accurately and quickly. And this proposal is a way of 
underscoring the fact that the President ought to have the 
ability to reorganize and restructure the Executive Branch of 
government for greater efficiency.
    To me, it is about food safety. It is about making sure 
that everyone knows what they need to know when they need to 
know it so that we can prevent food safety issues or be able to 
respond to them as quickly as possible so that we can prevent 
more foodborne illness.
    We still have work to do. If you put this in the context of 
the number of meals that are served every day in this country 
and the number of items in each meal, we are talking about over 
a trillion opportunities for foodborne illness. So when we look 
at the numbers in that context, I think we can say that we have 
a relatively safe food supply.
    But when 45 million people have a foodborne illness, when 
130,000 of them are hospitalized and several thousand 
unfortunately and tragically die, there is still obviously work 
to do. And one way to do it is to create a more efficient 
system, and that suggests a single food safety agency. And I 
really take issue with the notion that by doing that, that 
somehow you are going to put all of this on the back burner.
    I can tell you the people that work in my shop and the 
people that are in my office, we take this issue very 
seriously, which is why we have proposed a number of changes in 
terms of E. coli, a number of changes in terms of Salmonella 
and Campylobacter, that I think do suggest that we take this 
seriously, and it is not a back burner issue and it should not 
be. It should never be. And a single food safety agency is not 
going to make it a back burner issue, regardless of what other 
jurisdictional issues----

                          BEEF LABELING RULES

    Ms. DeLauro. I do not expect it will be a back burner 
issue. We have often seen the opportunity because you have dual 
missions in both you and the FDA with regard to promotion of 
product. And FDA has so much on its plate--excuse the pun--that 
it has been difficult to really address the food safety issues. 
I am of the view that this is a good first step in moving 
forward, and my hope is that you all will be sending 
legislation here so that we can look at it.
    Let me move to mechanically tenderized beef. I have been 
for nearly a decade been urging the Department to finalize the 
mechanically tenderized beef labeling rule. A comment period 
closed on December 24th.
    My questions are, why did it take USDA until November 21, 
2014--December 24, 2013 is when it closed--2014 to transmit the 
final rule to the Office of Management and Budget? What is the 
holdup with getting the rule finalized? Will the USDA take 
action to suspend the provisions of the uniform labeling 
regulation in order to implement the rule in 2016 and 2018?
    Let me just at the same time talk about the beef grinding 
rule. I will not go through the background on that; I do know 
my colleague, Ms. Pingree, is interested in this. But what is 
the status of this proposed rule? Do you intend to move forward 
with the rule soon? Will there be further delays? And will you 
move forward with the rule even if there is industry 
opposition?
    Secretary Vilsack. I am not quite sure where to start yet. 
I will try to answer all those questions. I hope I do not 
forget them.
    Ms. DeLauro. Well, no. Will USDA take action to suspend----
    Secretary Vilsack. Yes.
    Ms. DeLauro. What took us so long and what held up the role 
on mechanically tenderized beef? Will we suspend provisions of 
uniform labeling in order to move in 2016 versus 2018?
    Secretary Vilsack. We obviously have to take the comments 
that are provided seriously, and we have to review them, and we 
take our time to make sure that we comply with the 
administrative process.
    Having said that, I think you have a legitimate concern 
about the fact that because we were delayed, that under the 
Uniform Labeling Act, that this will not become effective in 
2018. You find that unacceptable, and frankly, I do, too. So we 
are going to suspend that and we are going to move the timeline 
up.
    Ms. DeLauro. Thank you. Thank you very much.
    Secretary Vilsack. On the----
    Ms. DeLauro. Grinding.
    Secretary Vilsack [continuing]. Grinding laws, we are 
proceeding with that, and I can assure you that we understand 
the importance of getting that done. We have had a recent issue 
in Massachusetts that suggests the need for this, and we are 
going to proceed forward with it.

                      TRADE AGREEMENT NEGOTIATIONS

    Ms. DeLauro. Thank you. Thank you very much. I am going to 
get an extra two minutes, and then I will depart.
    TPP trade questions, Mr. Secretary. There was a report from 
the Administration saying that completing the Trans-Pacific 
Partnership (TPP) provides the opportunity to open markets, 
lower tariffs, and help support an additional 650,000 jobs. 
Washington Post Fact Checker found this claim to be patently 
false. In the Post analysis, it was discovered that the net 
effect of the TPP on jobs was zero.
    In October 2014, a report issued by USDA calculated that if 
the TPP in fact slashed all tariffs and the tariff rate is to 
zero, it would not alter U.S. gross domestic product at all. In 
the first two years of the Korea free trade agreement, U.S. 
exports to Korea declined, growing trade deficits with the 
country that resulted in nearly 60,000 lost jobs.
    Given the findings as reported by the USDA and the threat 
that the 11-nation TPP poses to jobs and wages for the average 
American worker, how does the Administration justify the 
pursuit of fast track authority for this trade deal?
    If I can, I would like to ask a couple of other questions, 
and if you do not get to them, we can get back for the record.
    The Transpacific Trade and Investment Partnership (TTIP) 
negotiations, the European Union would like for FSIS to grant 
equivalency status to the entire E.U. as a whole for its 
inspection systems for meat, poultry, and engaging products 
rather than conducting equivalency determinations for each 
individual country in the E.U. What is the USDA position on 
this approach?
    And for APHIS, reports of the current trade negotiations 
indicate that there might be a new sanitary or phytosanitary 
dispute mechanism to speed up resolution of possible 
disagreements. Is it true? If so, how will this mechanism 
impact both APHIS and FSIS rulemaking processes for imported 
processes? How will that impact imported inspection systems 
that are currently in place?
    Secretary Vilsack. The sanitary-phytosanitary (SPS) 
decision-making process ought not to alter the inspection 
process that is required for imports to ensure producers and 
consumers of the safety of whatever is being imported.
    On TTIP and recently with beef, we have indicated a strong 
desire that each individual country meet its responsibilities. 
That is the way we are approaching this today, and I do not 
know of any reason why that would change because we have to be 
assuring our consumers of the equivalency in terms of safety.
    In terms of TPP, I will tell you that obviously we are 
going to have a disagreement on whether or not this is going to 
create opportunity for agriculture and whether or not that 
opportunity in expanded exports will create jobs. It is 
certainly true that free trade agreements have increased 
agricultural exports by 130 percent, and our determination is 
for every billion dollars of agriculture trade, roughly 6500 
jobs are supported. And so if you are going to expand trade 
opportunities to a middle class that is expanding 
exponentially, you are going to create jobs. You are going to 
create additional market opportunities for farmers.
    The last thing I would say is one of the most important 
reasons for TPP is to make sure that China does not write the 
rules. And I can assure you that Ambassador Froman is working 
extremely hard to make sure that the labor and environment 
standards that are in this TPP are historic in nature and 
cement significant gains in terms of labor and environment. And 
I frankly do not want China to be writing those rules. I would 
prefer the United States write those.
    Ms. DeLauro. Well, Mr. Secretary , with respect to China, 
et cetera, the way that we can really deal with China is to 
deal with currency, and currency is not going to be part of the 
TPP.
    Secretary Vilsack. That is a whole 'nother issue.
    Ms. DeLauro. It is a whole other issue. But that 
geopolitical issue is not one that has really to do with middle 
class families and their ability to have a job, to maintain a 
job, and to maintain good wages. Thank you very much.

                        SCHOOL MEALS REGULATIONS

    Mr. Aderholt. Sure. Thank you. And I think we have gotten 
through everyone once. What we will do is we will do another 
round, and we will conclude with this round. Instead of staying 
hard and fast to the five-minute rule, we will be a little bit 
lenient on that so we can go ahead and conclude.
    I know, from our meeting yesterday, you said this is your 
second day of testifying on the Hill, so I know that you have 
had a rigorous couple of days. I know there are other meetings 
after the noon hour. So we will try to do this one round. But 
again, if you want to go a little bit over five minutes, we 
will accommodate that just so we can go ahead and make sure 
that we can get everybody in the next round.
    We have talked a little bit about school meals, and I think 
every Member of Congress--and I cannot imagine any Member of 
Congress that would not want a healthy, balanced meal for our 
schoolchildren. I mean, I think that is a given. There is 
nobody that I know that is advocating of trying to give 
unhealthy meals or anything that would be harmful to students 
in any way.
    My efforts on the school meal issue that I have worked on 
really stem back from what I have heard back in my district. 
Some people have indicated that it is some kind of industry or 
something comments. I have not really even talked to industry 
about it. It stems back, actually, from conversations that I 
have had with the nutritionists at the schools.
    One in particular, Ms. Evelyn Hicks, she works in one of 
the schools in my home county of Winston County, serves 
students every day, and she is the one that told me about the 
struggles that she was facing with the new regulations. I am 
pleased that we were able to gain some flexibility on the whole 
grain requirements and the sodium standards in the fiscal year 
2015 omnibus. I appreciate the Department promptly issuing the 
guidance memos to States so that they can begin implementing 
the whole grain flexibilities.
    I realize that child nutrition programs are up for 
reauthorization this year in the authorizing Committee. But as 
the process moves forward, I would hope we could work together 
to find solutions to the specific challenges facing our 
schools, such as flexibility with Smart Snack regulations, a 
longer-term solution to whole grain and sodium requirements, 
and any other areas where we can bring practical and strategic 
fixes to the program.
    And I would just like to ask you if you would commit to 
working with us to provide school flexibility on these 
particular areas that will help provide and serve healthy meals 
without continued financial strain.
    Secretary Vilsack. Mr. Chairman, I think the USDA has been 
always willing to provide flexibility where it is warranted and 
needed, and we will certainly work with everybody and anybody. 
What we are concerned about, and I take reassurance from your 
comments, that we do not get into a situation where flexibility 
is a vehicle through which we take a significant step backward 
from the forward steps we have taken on child nutrition.
    So we are happy to work with folks, and I think we have 
reflected that. And our willingness to work with our Team Up 
for Success program, our willing to do the Smarter Lunchroom 
grant program, our school equipment grant proposals, are all 
designed to provide and equip school districts with the tools 
that they need to comply. We want this to work.

                       SINGLE FOOD SAFETY AGENCY

    Mr. Aderholt. Thank you. Let me switch issues here, the 
single food safety agency. The President's budget proposes 
transitioning to a single food safety agency by combining the 
Food Safety and Inspection Service and the food activities 
within the Food and Drug Administration to one agency under the 
Department of Health and Human Services. Support for the 
President's single food safety agency among consumer advocacy 
groups, and certainly the regulated industry, appear to be slim 
to nonexistent.
    Could you explain to the Committee how rearranging boxes on 
the organizational chart would produce a favorable public 
health outcome? And why do you think that the Health and Human 
Services can provide better leadership over food safety issues 
than the USDA?
    Secretary Vilsack. Well, Mr. Chairman, the President's 
budget uses this as an example for making the case for the 
ability of the Executive Branch to have the capacity to 
reorganize. And I think the President, as the chief executive 
officer of the Executive Branch, ought to have that authority.
    Let me say that we have had circumstances in the time that 
I have been secretary where there has been information that HHS 
and FDA may have had that would have impacted and affected some 
decision-making that we would make relative to school meals, 
for example, or circumstances where we had information where 
HHS might have been better off understanding immediately.
    There is this risk in any system that has multiple parts 
and multiple jurisdictional operations of the right hand not 
knowing what the left hand knows and not knowing it as quickly 
as they need to know it. So a single food safety agency, 
regardless of where it is located, would essentially eliminate 
that risk.
    And I think it is a significant risk and one that we are 
always conscious of in an effort to try to communicate with our 
sister agencies. But there are a number of agencies that are 
involved in this, and reorganizing would, I think, provide less 
risky circumstances.
    The location of it, I think it is just simply we do 20 
percent of food inspection. They do 80 percent. It is just, 
where is the bulk of the work currently being done? And with 
respect to consumer groups and the industry, I think they are 
assuming that if this were to happen, that somehow all of this 
would get lost in a large organization, and nobody would care 
about it, and it would not be adequately funded.
    I just do not think that is the case. That is certainly not 
how I would approach it, and I cannot imagine that Secretary 
Burwell or future secretaries of this department or her 
department would think that food safety was a back burner 
issue. It just is not.
    Mr. Aderholt. Is there any scientific evidence that 
consolidation would reduce the number of foodborne illnesses 
and provide a safer system?
    Secretary Vilsack. Well, I would be happy to research that 
question, and it is a legitimate question. But I will tell you 
from my own experience recently in having spoken to the mother 
and father of a young fellow who died as a result of consuming 
tainted meat, that when you look at the timeline, when you look 
at the relationship between the State health department and FDA 
and USDA, I do not know if the time would have made a 
difference.
    But there were gaps in when people knew information. And it 
led me believe that if those gaps did not exist, then that 
would be one less question we would have to ask about our 
system. But because they did exist, it is a question I asked: 
What can we do to make sure that those gaps do not exist in the 
current system? And the one way for sure that those gaps would 
not exist would be if you had just one agency.
    And you would also have better accountability because you 
would be able to point the finger at the agency that is 
responsible for food safety and say, why did you not do your 
job? Today it is very difficult. If you look at individual 
cases, it is very difficult to determine exactly where the 
fault might lie if there is a problem and a delay.

                    DIETARY GUIDELINES FOR AMERICANS

    Mr. Aderholt. Well, let me just say there is a lot of 
skepticism about this. And over the years, we have seen these 
type of proposals that would make some giant food safety 
agency, and there has been outbreaks and increases of foodborne 
illnesses that we have seen. So I just want to add that there 
is some skepticism, and unless we can see some scientific 
proof, there is going to be continued reluctance.
    As my time concludes and I go on to Mr. Farr, let me just 
follow up with--we were talking earlier about the Dietary 
Guidelines. And a couple other members have mentioned that in 
addition to my question. And understanding the tremendous 
amount of information and the literature from constituencies 
that have to be reviewed as you move forward in your taking 
public comment, would there be any harm in extending the 
comment period for an additional 60 days so that all the 
relevant data can be received?
    Secretary Vilsack. Given your request, Mr. Chairman, I 
would be happy to visit with Secretary Burwell. As you know, 
the Department of Health and Human Services is the lead agency 
in the formulation of these guidelines. We were the lead agency 
five years ago. And in deference to her and her department, I 
would want to make sure that I had a chance to visit with her. 
But I would be happy to do that if that would be all right with 
you.
    Mr. Aderholt. Thank you. That would be great. Thank you.
    Mr. Farr.

                        ORGANIC AQUACULTURE RULE

    Mr. Farr. Thank you very much for asking those questions. I 
hope that as you requested of the secretary to extend the 
comment period, I hope that our Committee will also extend the 
comment period for the impact of the Budget Committee's 
decision on what our expenditure level is in this Committee so 
that if it is less than what the Administration is asking for, 
we can have an extended comment period on how we feel about 
those impacts and really get the facts on what the consequences 
are going to be.
    I also wonder--Mr. Secretary , I think you are in a 
position in an agency--and I think you are the longest-serving 
Secretary now. You certainly have an incredible, distinguished 
background as a national leader, even being a candidate for 
President of the United States. I would hope that you realize 
that you can do a lot of message-making in this country that is 
beyond perhaps other agencies, and a couple of them that I 
would like to address on.
    One is this school meals, and I think that the chairman has 
got a legitimate concern. He is hearing from his constituencies 
that they do not like the way this program is being 
implemented. The kids are rejecting the food. Is there a way 
you can be a matchmaker and find school districts that are like 
the school districts that are rejecting it who have been 
successful?
    There are a lot of school districts out there. We have got 
1200 in California. I represent a K-12 school that only has 33 
students, a public school district in a really rural area. So 
it is all types. And I am sure that there are schools that are 
saying this is too hard, too difficult. The kids do not like 
it.
    The same size school somewhere else is saying, this is a 
great challenge and we have done some marvelous teaching 
opportunities with it. And if perhaps you could be the 
matchmaker to match up these successful and unsuccessful 
schools so that there will not be such a fight here in Congress 
to delay or opt out of the program.
    Second comment: I think that the biggest street battle, 
other than your issues on trade, are the discussions of GMOs, a 
totally confusing subject matter that the media and internet 
has taken it over. I think if we do not speak out quickly on 
the science side of it, we are going to lose the debate.
    California is going to go to a statewide initiative; I 
think it will pass. In the food area you are going to begin 
seeing what has happened in this chaos with--I hate to use the 
analogy, but it is the medical marijuana, where you have 33 
States that have 33 different opinions that are totally 
opposite of what the Federal law is.
    And there is just really mass confusion out there, and what 
you do in the end is lose respect for government. People who 
want to disobey the law have all kinds of reasons. And I think 
the Federal Government is hurting in its respect, and that is 
why voter turnout is so low.
    So a couple of these issues I think we have to get in front 
of. I think you are trying to do with that with the trade 
issue. But I do not think we have done a very good job between 
USDA and Food and Drug Administration to really get to the 
bottom of the GMO issue. And I hope that you will find a way 
that we could ratchet up that, get a discussion on the facts.
    And lastly I want to ask you, and this is one I want an 
answer to, why are you delaying or why is the Department 
delaying the rulemaking on organic aquaculture? It seems that 
suggestions for that rule have been in the books for a long 
time. In fact, some of my people have invested heavily in 
organic aquaculture, and they are waiting for that rule in 
order to stimulate the business.
    Secretary Vilsack. Congressman, your question was longer 
than my presidential campaign, so I appreciate your mentioning 
that. [Laughter.]
    The issue with aquaculture is just simply a matter of 
prioritization. You have limited people, lots of work to do, 
and the question is, how can you do the most amount of work 
that is going to implement the most amount of people 
effectively? This is an issue that we do take seriously, but 
there were competing rules. And you are bringing it up, so I 
will----
    Mr. Farr. A lot of work that gets to rulemaking by very 
wise people who have gone in, volunteering their time for years 
to make the suggestions.

                     GENETICALLY MODIFIED ORGANISMS

    Secretary Vilsack. That is true of many of the rules that 
we are engaged in, and that is the issue. But I take your 
concern.
    With the Chairman's permission and your permission, 
Congressman Farr, I have got to respond to the concerns that 
you expressed about stepping up the advocacy on some of these 
issues. On the GMO issue, we in USDA sponsored an AC-21 group, 
which brought organic and GMO and conventional producers 
together in a room and said, look, help us identify the steps 
that we need to take to make sure that everyone can basically 
get along here.
    And they essentially focused on the need for seed 
integrity. They focused on the need for better stewardship, 
focused on the need for risk management tools, focused on the 
need for a communication process. And I will tell you that we 
have made progress on every single one of those 
recommendations.
    Now, we are now scheduling a second followup conference 
that is going to take place in a couple of weeks at North 
Carolina State where we are going to bring folks back and we 
are going to have an additional conversation, say, well, now we 
have done all of this; what is the next thing we need to do?
    So we have been heavily engaged in this issue. And I have 
been addressing this issue of labeling in a way that I think 
makes sense, and would hope that Congress, at the end of the 
day, understands this. You have got these referendums. You are 
right, you cannot have 50 different sets of rules. That is 
crazy. It is not going to work. The courts are not going to 
allow it. And you cannot necessarily label something that 
suggests that there is something unsafe about the product when 
that is not the case.
    What you can do is you can use this bar code, and you can 
extend the bar code, so that people who are genuinely 
interested and wanting to know what is in this particular 
product can, with a smartphone or a scanner at a grocery store, 
get all the information they want about a product in a way that 
conveys, you have the right to know but you do not have the 
right to know in a way that conveys a misperception about the 
product.
    If you had an extended bar code and we were engaged in it 
or FDA engaged in it, somebody is engaged in basically creating 
the template for what information would be in that extended bar 
code, industry could solve that issue in a heartbeat. You would 
not need 50 different regulations. You would not need 
referendums. Consumers would have the right to know. They could 
make a choice.
    If they are informed, or if they do not care, as many 
consumers are more concerned about price or quality or 
whatever, then you are not creating a misperception about the 
product. That seems to me to be a way of furthering the process 
and addressing this issue.
    And then finally, on the issue of schools, we are in fact 
doing exactly what you are suggesting. We created this Team Up 
process. We had a pilot where we brought I think it is about a 
half a dozen schools to Mississippi, the University of 
Mississippi. They were down there for a day and a half. We 
brought a companion number of school districts that were 
successfully implementing these efforts and said, what can you 
learn from each other? And then we had a day and a half of 
training and additional information.
    We are following up, and we are proposing in this budget to 
extend this program in other parts of the country because 
legitimately, there are some school districts that struggle. 
And I do not have any doubt about that. And I have no doubt 
that the Chairman is right. These people are good folks and 
they care deeply about their kids and they want to do right by 
their kids. They just need help. And we are trying to provide 
help in a variety of different ways. And we will continue to do 
as much as we can to elevate this.
    The last thing I will say is the challenge with this 
department is its portfolio is so broad that it is very hard--I 
mean, I do an hour of press a day on a variety of issues, and 
so I can get you the clippings and show you how much we have 
talked about this if you are interested. But trust me, we are 
working on these issues.
    Mr. Farr. I am done.
    Mr. Aderholt. Okay. Mr. Young.

                     FARM BILL PROGRAM ELIGIBILITY

    Mr. Young. Thank you, Mr. Chairman.
    Mr. Secretary , we all want to be guardians of the taxpayer 
and stop abuse. In the 2014 Farm Bill, there is a requirement 
that USDA define those persons who are ``actively engaged in 
farming'' in order to receive federal farm payments. This 
provision will help end abuse of farm subsidies by limiting the 
number of individuals eligible for them.
    When does the USDA expect to have a final rule on the 
definition of ``actively engaged in farming'' for payment 
restrictions? Can you provide any comment on that whole issue 
in general?
    Secretary Vilsack. Congressman, I am a little hesitant to 
say when a final rule is available. But I can tell you that the 
proposal that we are going to put forward will be coming very 
soon for comment so that people will have the ability to weigh 
in on whatever it is we propose.
    And let me also say that this is an issue which I hope the 
expectations meet the statutory reality, which is to say that 
when Congress fashioned the Farm Bill, it basically created a 
fairly narrow lane for the USDA to navigate on this issue. It 
is suggested that whatever we come up with is not going to 
necessarily impact family farming operations. It is not going 
to impact corporations because you only have a single payment 
limit anyway.
    So what we are really focused on are limited and general 
partnerships, a couple percentage points, if you will, of the 
overall farming activity in the country. So it is a relatively 
small group of folks who are going to be impacted and affected 
by what we do.
    The second thing I would say is that as we look at this, we 
have to make sure that there is an appreciation and 
understanding for the complexity and size, and the differing 
complexities and sizes, of operations around the country. What 
you and I are used to is fundamentally, I suspect, a little bit 
different than what the Chairman is used to, which is 
absolutely different than what Representative Farr is used to. 
And you have to understand that, and you have to appreciate 
that in formulating any kind of rule.
    Last but certainly not least, we are all about trying to 
maintain confidence in this program. So it is important to 
close these loopholes so that people cannot unfairly criticize 
the safety net totally, which is ultimately what happens when 
there is an egregious circumstance. It taints the entire safety 
net, and the safety net is extremely important to maintain for 
producers.
    Mr. Young. I appreciate those comments and appreciate you 
being here today. Thanks for your service and your leadership. 
Many members here have thanked you for coming to their 
districts. I want to thank you for coming to my district every 
weekend or every other weekend since you live there and I see 
you at the airport.
    Secretary Vilsack. We will see you at the Booneville Tap 
for breakfast.
    Mr. Young. I will take you up on that.
    Mr. Aderholt. Ms. Pingree.

                     GENETICALLY MODIFIED ORGANISMS

    Ms. Pingree. Thank you, Mr. Chair.
    Well, thank you. I know the topic of GMOs has come up 
several times in this hearing, and I appreciate your last 
overview on all the things you are workingon. I will be looking 
forward to hearing what comes up in the next couple of weeks 
and maybe get a little more sophisticated understanding of how 
the bar code works. You brought that up last year, and if that 
is going to move forward at some point, it will be good for 
people to know more about it.
    I just want to add in one other part of the conversation, a 
little bit about the brand integrity. You made the point in 
your testimony that organics has become a $35 billion industry. 
I raise organic crops, have been involved in this topic since 
the 1970s, and I have really seen enormous change from this 
being a fringe sideline to now really a mainstream industry 
that certainly in New England has saved a lot of farms, brought 
people back to new markets, given people better pricing. There 
is a lot to be said about it.
    I am always interested in how much young people are engaged 
in this topic, whether it is GMOs or organics. And you know, 
and I will not get too carried away here, but you know there 
are a lot of things about what goes into an organic label, 
including that the ingredients are non-GMO.
    So last September I was a little distressed to read about 
the USDA's announcement that unapproved GMO wheat was 
discovered in the U.S. for the second time in as many years. 
And I know you know a lot about this, so I do not have to go 
through every detail here. But GMO wheat has not been approved 
for commercial usage. My understanding is that this wheat 
discovery was part of a drift left over from a Monsanto GMO 
field tried in the early 2000s.
    In that same announcement, you said that you were closing 
the investigation into a May 2013 GMO wheat contamination 
episode in Oregon without really any explanation. I could go 
through all the details with you, but you know this question. 
It certainly threatens the integrity of the market for people 
who market here and abroad.
    And with the growth in this market and questions coming up, 
about some of the issues that will come in around trade as 
well, I want to know, what are you doing to amend the field 
trials for GMO crops to ensure that these types of 
contamination episodes are prevented in the future? Are you 
actually conducting future tests to determine the extent of the 
Monsanto contamination? Is there funding for this kind of 
testing?
    I know I have heard the Department say before that some of 
the contamination issue could be solved by better neighbor-to-
neighbor relations, and I understand that is an important part 
of it. I live in a small town. I know how important it is when 
people can communicate with their neighbor. There has been 
suggestion that there be some kind of insurance to protect 
people against this.
    But I am worried that insurance and relationships do not 
take care of potential brand integrity. And as this market 
grows--and I know there are a lot of people who will debate 
forever about whether you should have a label, whether you 
should know if it is a GMO crop, or whatever--but the fact is 
the standards include and more, and more companies are saying, 
no GMO product can go into this brand. And as consumer demand 
grows, I do not want the USDA to be less vigilant about how we 
protect that.
    Secretary Vilsack. Well, there are no doubt research 
projects underway, and no doubt we are holding those who are 
conducting the research to rigorous standards relative to 
safety. We are also expanding research on the issue of drift so 
that we have a better understanding of precisely what it is.
    And I think there is going to be an executive board, if 
there is not already engaged, a discussion both domestically 
and internationally on precisely what it means to say that you 
are GMO-free. As testing mechanisms become extraordinarily 
precise, what is it, so many parts per what? And I do not know 
that anybody has the answer to that, but I would suggest that 
we collectively need to be asking that question and answering 
it so that the brand integrity is protected because it is a 
high-value proposition.
    And the discussions of stewardship and risk management 
tools are designed to create an understanding or a perception 
that we understand the importance of maintaining that brand. 
And that is why we continue to look at ways to strengthen the 
organic program. It is why we are excited about the organic 
research initiative that we have launched through the Farm 
Bill. It is why we are excited about the marketing assistance 
that we are providing.
    So it is a holistic effort because this is a growing aspect 
of agriculture, and you are correct that there is a lot of 
passion and enthusiasm, a lot of entrepreneurship, and it is a 
way for new and beginning farmers to enter without necessarily 
having to buy a very, very large operation.
    Ms. Pingree. Great. Well, I will end with that. And thank 
you again for your testimony and your presence here today.
    Mr. Aderholt. Mr. Bishop.

                         RURAL HOUSING PROGRAMS

    Mr. Bishop. Thank you very much. I have got a couple of 
questions.
    The first one is regarding rural housing. Despite proposing 
an overall 7 percent increase in domestic discretionary 
funding, the Administration again proposed to cut the budget 
authority for USDA housing programs by more than 27 million. If 
enacted, the President's budget would cut rural housing 
programs by $235 million, or 61 percent since 2010.
    Likewise, USDA proposed to reduce the Section 523 Mutual 
Self-Help Housing program by 60 percent, or $17.5 million to 
just $10 million. This is a program where families work on 
nights and weekends to build their own home.
    While these are relatively small programs, if utilized, 
they cumulatively represent enormous opportunities for 
constituents in my district and others on this Committee in 
rural areas. And given that the traditional public housing and 
Section 8 voucher programs are nearly nonexistent in rural 
communities, what can we do to make sure that there is an 
adequate supply of housing, particularly rental housing, for 
our rural and poor communities?
    Secretary Vilsack. Congressman, your question, I think, 
requires me to point out that over one-half of the 
discretionary budget that I have control over and that you all 
make decisions on is allocated to food safety, rental 
assistance, WIC, and fire suppression and forest management. 
Just those four items.
    All of those items are important. And in the rental 
assistance area in particular, because Congress over a period 
of years has gone from fully funding a unit for the life of the 
unit to doing it on a year-to-year basis, every single year for 
the next 10 years we are going to continue to see increases in 
rental assistance required unless we do a better job of 
adopting some of the reforms we have suggested because the 
programs that were funded for 20 years or 15 years or 10 years 
are going off that program, and they now have to be funded 
every single year. So it places a great deal of stress on 
housing generally because you have to continue to bump up 
rental assistance.
    You have also a significant problem on the horizon, and 
this is something, Mr. Chairman, that we have not had a chance 
to talk to you about but we need to talk to you about, and that 
is that as the mortgages on these rental assistance properties 
are paid off, they fall out of the program and there is not a 
voucher associated with that. So you are looking at units 
coming out of the program, but you still are going to have 
families in need of the program.
    And so I have asked my team to take a look at how we might 
be able to extend some of those mortgages, reduce payments for 
the property owner, and have the property owner commit to 
taking the additional income that they have and creating 
improvements to the property so that you get a continuation of 
the program, you get better units, but folks are not kicked 
out.
    Mr. Bishop. You do agree, though, that there is a need, and 
particularly as you look at StrikeForce and look at the 
persistent poverty counties across the country, that housing is 
as much a vital need as food and other economic activities.
    Secretary Vilsack. No question about it. And this budget 
basically supports nearly a quarter of a million families in 
subsidized rental assistance and 171,000 home loans. But the 
reality is that when 50 percent of your budget is consumed by a 
small number of items, it puts a lot----
    Mr. Bishop. There is a lot of stress. I understand that.
    Secretary Vilsack. There is a lot of pressure. And you have 
got to make decisions.

                        FARM SAFETY NET PROGRAMS

    Mr. Bishop. And the other thing, farm income and the farm 
safety net. A couple of weeks ago, the Economic Research 
Service (ERS) released its 2015 farm sector income forecast, 
which stated, ``Net farm income is forecast to be $73.6 billion 
in 2015, down nearly 32 percent from 2014's forecast of $108 
billion. The 2015 will be the lowest since 2009.'' They also 
pointed out that the annual value of U.S. crop production is 
expected to decline in 2015 from the 2013 record high value, 
reflecting net inventory loss and the third straight year of 
declining cash receipts for crops.
    And then finally, the ERS reported that the net cash farm 
income is $79,200 for all farm businesses in 2015, which is a 
decline of 22.7 percent from 2014, which represents the average 
amount of cash available to individual farmers to pay and 
service their debt, pay family living expenses, and make 
investments.
    I know that agriculture is very cyclical. In one year you 
can record crops and income across commodity lines, and in 
another year farms can lose their shirts. And it is exactly 
that kind of volatility which led Congress to create farm 
support programs in the first place.
    Let me ask you, should farm income continue to decline over 
the next few years, do you expect that the demand on our farm 
and our agriculture support programs will rise as well? And how 
is that going to be impacted by the worldwide agriculture 
competition?
    And what do we have to look forward to, and how are we 
going to anticipate and deal with perhaps this trending for a 
decline in farm income if we are going to produce the highest 
quality, the safest, the most abundant, and economical food and 
fiber anywhere in the industrialized world, which is our claim 
to fame now?
    Secretary Vilsack. You know, I get a little bit troubled by 
the headlines on farm income. Since pitchers and catchers 
reported recently to spring training, I have got kind of a 
baseball mentality here. You know, if I hit .370 as a ball 
player one year and I hit .320 the next year, I suppose you 
could say that my performance had declined. But my guess is 
that you would still be paid millions of dollars to hit .320.
    And the reality is the farm income is coming off of record 
highs because commodity prices were exceedingly high. And that, 
frankly, created some stress on some aspects of agriculture, 
the livestock industry in particular. So we are going to see 
the livestock industry do a little bit better.
    The answer to your question is a combination of producers 
making informed decisions about the market and understanding 
what they need to do in terms of planting. When you plant a 
record number of acres and you have decent weather, you are 
going to have a heck of a crop. And when the rest of the world 
also at the same time has a heck of a crop, then you have got 
abundance, and that obviously is going to drive prices down.
    So I would expect and anticipate that people will start 
making some market decisions about what they farm and what they 
grow, and the market will adjust, and that will affect. The 
second thing is----
    Mr. Bishop. Does that mean that you are going to have to 
get involved in more closely advising and educating the 
agriculture community perhaps better than has been done in the 
last two or three years?
    Secretary Vilsack. Not necessarily. I think it is----
    Mr. Bishop. Because obviously, somebody has not been 
planning consistently with what the expected----
    Secretary Vilsack. Well, no. Farmers, Congressman, have 
done this forever. This is not a new phenomenon. It is very 
cyclical, and the reality is that is why you have got safety 
net programs. That is why we expect the safety net programs are 
probably going to get triggered sooner than it was anticipated 
when the Farm Bill was signed.
    And it is why we are going to continue to focus on 
marketing opportunities. It is why you need trade. It is why 
you need trade promotion authority. It is why you need trade 
agreements that allow us to move more product to market, and 
why you need to focus on the efficiencies.
    It is why you have to find additional uses for these 
products, which is why this Administration supports the biofuel 
industry and the bioeconomy, the ability to take agricultural 
waste product and convert it into a variety of other materials, 
which the Farm Bill is now going to allow us to do.
    So it is a combination of all those things. The key here is 
making sure right now that producers, as they make a very 
important decision that they have to make--we have had over 
nearly 5,000 interactions with the producers about ARC and PLC, 
what their options are. We have created computer models that 
they can put their numbers into; over 176,000 folks have 
utilized that.
    And hopefully by the end of March they are in a position to 
determine for us, for the next four or five years, ARC is 
better or PLC is better, and that they make the most informed 
decision. That is the focus right now, making the most informed 
decision about the safety net.
    Mr. Bishop. Thank you.

                      MEAT ANIMAL RESEARCH CENTER

    Mr. Aderholt. Thank you, Mr. Bishop.
    Before we adjourn the hearing, I want to just mention a 
couple of key areas that are important to the subcommittee. As 
States begin issuing exemptions to schools that are seeking 
flexibility from the school meal whole grain requirements, I 
would ask that you would keep the subcommittee informed of the 
process.
    Second, I also appreciate the Department issuing the 
guidance to WIC State agencies, allowing participants to 
purchase white potatoes with their cash value vouchers. As the 
Institute of Medicine continues its review of the WIC food 
package, I would ask that you would also keep the subcommittee 
apprised.
    As you know, the fiscal year 2015 omnibus contains report 
language directing you to submit a report with language of 
legislative changes needed to implement the Country of Origin 
Labeling, otherwise known as COOL, that complies with 
international trade obligations. The report is due no later 
than May 1st, and we look forward to receiving that report at 
that time.
    Lastly, Mr. Farr and I have asked the Inspector General to 
conduct an audit of the Meat Animal Research Center (MARC), and 
we have heard about the review that you have ordered. And on 
behalf of the Subcommittee, we would like to request that you 
share the results with us on that as soon as you are able to do 
that.
    Secretary Vilsack. Can I comment on that issue?
    Mr. Aderholt. Yes, please.
    Secretary Vilsack. As you know, we did order a review. I 
want to make sure that everyone understands the three primary 
reasons for ordering that review.
    First is to make sure that we identify current practices 
versus prior practices because the Times article that generated 
this really had--it was difficult to determine whether they 
were talking about things that occurred 20 years ago or 30 
years ago or things that were occurring in the very recent 
past.
    Secondly, to make sure that we identify the responsible 
party, we have a standard that is not statutorily required but 
that we do wish to live up to, which is the animal welfare 
standard. Research that is done at these facilities oftentimes 
involves multiple different parties other than ARS personnel, 
and so we want to make sure whatever concerns there might be, 
that we have identified who is responsible for that research.
    And then finally, to the extent that there have been 
concerns that are legitimate, we want to make sure we get a set 
of recommendations that we can institute relatively quickly. We 
also have an ombudsman that we have appointed, and that 
ombudsman is going to be the recipient of any additional 
concerns. And that person is also going to conduct additional 
training.
    And then once we receive the 60-day report, and we are 
happy to share it with you, we will also begin a process of 
reviewing other locations where there are research projects 
that we are involved in.
    Mr. Aderholt. Thank you. And like I said, as you move 
forward, keep us posted on that. We would very much appreciate 
that.
    And with that, the Subcommittee is adjourned.
    
    
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                                         Friday, February 27, 2015.

                 NATURAL RESOURCES CONSERVATION SERVICE

                               WITNESSES

JASON WELLER, CHIEF, NATURAL RESOURCES CONSERVATION SERVICE
MICHAEL YOUNG, BUDGET OFFICER, U.S. DEPARTMENT OF AGRICULTURE

                       Introduction of Witnesses

    Mr. Aderholt. The Subcommittee will come to order. I would 
like to welcome Mr. Jason Weller, Chief of the Natural 
Resources Conservation Service, and also Mr. Mike Young, USDA's 
Budget Director, to the Agriculture Appropriations Subcommittee 
this morning. Welcome to both of you for being and thank you 
for being here.

                    Opening Statement--Mr. Aderholt

    We convene today, of course, to review the Natural 
Resources Conservation Service's Fiscal Year 2016 budget 
request. NRCS requests a total of $1.03 billion in 
discretionary funds, and it is for salaries, expenses, 
programs, and activities. In addition, about $3.2 billion will 
be available through the Farm Bill's mandatory conservation 
programs to farmers, ranchers, private forests, land owners, to 
help them preserve, protect, and enhance their land.
    For several years the NRCS has been working to bring its 
financial and accounting systems into line with today's 
transparency and accountability standards. This work is 
enormously important to ensuring the integrity of NRCS's 
operation, and also their programs.
    The cooperation work between the NRCS and the farm, ranch, 
and forest land families to conserve and to maintain their 
productive lands is often unrecognized. The science-based, 
locally-led and volunteer approach to conservation on these 
lands is an incredible legacy that arose out of the dustbowl 
years. This legacy is worth defending. But we must have an 
appropriate so-called ``back-office systems'' and controls in 
place to ensure that it can be passed on to future generations.
    NRCS is about to embark on a significant restructuring that 
will strengthen integrity of its programs and its systems to 
ensure the legacy of the science-based and locally-implemented 
and voluntary conservation continues. The plan appears to be 
thoughtful and to be thoroughly vetted.
    Chief Weller, I would like to congratulate you and also 
your staff on the time, the effort that you put in. Also, the--
I am sure--blood, sweat, and tears that were invested in 
putting this plan together over the past several months. And I 
look forward to hearing more about it as we go through the 
hearing today.
    So, at that, I would like to recognize the Ranking Member, 
Mr. Farr, if he has any comments he would like to make at this 
time.

                      Opening Statement--Mr. Farr

    Mr. Farr. Thank you very much, Mr. Chairman. I have no 
prepared comments, I just have some observations.
    I have the privilege of flying across this country every 
week, and back to California. And it hit me, looking out the 
window of the plane often, how much of this land is an open 
space in America. And almost all that land is in private 
ownership. And it really strikes you that--what a delicate 
balance there is, because you have people who own that land, 
and much of it is in productivity, with agriculture and/or 
grazing. There is no way in the world that you could make all 
that land public, or lock it all up, but it is really important 
that--best management practices and smart use of land.
    I think that is where your agency really comes in with 
technical assistance, kind of an advisor, almost as people have 
financial advisors, you know. You do land conservation--not 
even sure the word ``conservation'' ought to be in--best 
management practices of what we have learned in applying that, 
and giving them assistance with that.
    I would be very interested to know how we can leverage that 
more with private-public partnerships--so you work with a lot 
of different agencies. There are a lot of silos back here in 
Washington. But I think we are at a time as the Chairman 
pointed out--that, with limited resources, we are going to have 
to get better collaboration, get a better bang for our buck.
    And I am wondering if you can, in your remarks, talk about 
how we could leverage state and non-profit organizations so 
that they were all kind of going in the same direction, and 
putting our money, matching money and things like that, carrot 
stick-type thing--I think that is what you are trying to do 
with reorganization, and I look forward to hearing about it. 
Thank you very much.
    Mr. Aderholt. Thank you, Mr. Farr. Chief Weller, the floor 
is yours.

                     Opening Statement--Mr. Weller

    Mr. Weller. All right. Well, thank you very much. Good 
morning, Chairman Aderholt, Ranking Member Farr, members of the 
Committee. I am very honored to serve as chief of the Natural 
Resources Conservation Service, and work for the 10,500 men and 
women that work in this agency across the United States. And 
hopefully, I am able to well represent what they deserve, in 
terms of good representation today before the Committee.
    I am particularly proud of where I work, because it is an 
example of what I view government at its best, in that we 
actually empower people. We empower families, we empower 
businesses, we empower communities to take charge of their 
operations, their businesses, to make investments on their 
lands and their operations to be economically successful, but 
also better manage those resources for the long term. 
Ultimately, to grow the feed and fiber and food we need, as a 
nation, but also maintain the quality of life that we deserve 
and expect in this country.
    Mr. Farr, with respect to your observation about the United 
States, you are absolutely right. If you look continentally, 70 
percent of the land in the lower 48 is in private ownership. 
And, particularly in the Southeast and the East Coast, it is 
upwards of 80 or 90 percent of the land is in private 
ownership. So if you talk about the long-term environmental 
quality or economic vibrancy or ability to feed ourselves, but 
also still have water and wildlife and other amenities we 
demand, it is ultimately the decisions those millions of 
private landowners make.
    And, in my view, another way I think about NRCS is as one 
of the world's largest management consulting firms. We are 
actually out there every day, working one on one, voluntarily, 
at the invitation of those land owners, to help them make wise 
business decisions, which ultimately help their bottom lines, 
but also help them better manage their soils and the water and 
the habitat more effectively.
    So, I have sort of four core priorities for this agency. I 
just want to briefly touch upon that, hopefully, you will see 
reflected in this budget.
    Number one is that I want NRCS to be known as and to 
continue delivering excellent and innovative service across the 
United States. I think that is emblematic on how this agency 
took what Congress provided us last year in the new Farm Bill, 
and we are ready. In a matter of weeks we caught it, we 
pivoted, and delivered on the promise of that Farm Bill. So we 
got all the programs out last year. That resulted into tens of 
thousands of contracts, billions of dollars of financial and 
technical assistance, and we got all our rules out on time. And 
so it is no muss, no fuss, no drama, we got that Farm Bill 
implemented.
    Second priority is that we need to be able to modernize and 
strengthen NRCS's Conservation Delivery System. Chairman 
Aderholt, to your point, one of the examples, that is our 
administrative transformation, where we are looking at how to 
transform NRCS as the business of conservation so we can become 
a leading-edge example of how government can manage itself more 
effectively, more efficiently, and ultimately provide better 
customer service.
    But another example is the Conservation Delivery 
Streamlining Initiative. Hopefully I can also expand upon that. 
This Committee has entrusted us resources the last several 
years to invest in this modernized IT infrastructure, and we 
have delivered on that. The first major component, first of its 
kind, cutting edge technology which is then empowering land 
owners to manage their business and interact with us without 
having to come into a field office.
    Third priority is to enhance and expand NRCS's technical 
and scientific capabilities. Again, that is exampled from our 
soil health campaign, where we are helping farmers and ranchers 
not just manage the physical and chemical properties of the 
soils, but also the biological properties of the soils, 
treating the soil as a living ecosystem, so the livestock below 
the surface of the soil can support the livestock and the food 
production above the surface.
    But also, then, part of our budget request is increased 
support for the Conservation Effects Assessment Project, CEAP, 
as it is known by its acronym: world-class, cutting-edge, only 
one of its kind, in my view, in the world, that is looking, on 
a continental basis, what is the return on investment when we 
invest in conservation. What does that mean for the land owner 
and, ultimately, for the resources in that area?
    And the fourth priority is to expand the scope, the reach, 
and customers and partners of NRCS. Again, that is--I would 
like to, hopefully today, expand upon this. An example of this 
is our Strike Force Initiative. We are investing serious money 
in the poorest communities in this country, working with land 
owners for a variety of reasons have been left behind. We are 
making a difference. We are offering economic opportunity and 
hope to these families. But, in return, also helping better 
manage the resources.
    And also, the Regional Conservation Partnership Program. 
Again, to your point, Mr. Farr, about how to leverage from the 
private sector, from foundations, state and local governments, 
other federal agencies, philanthropic investors. We have an 
example of how we are trying to do this a little bit 
differently, outside the box, and I would like to talk a little 
bit more later on today about that new approach.
    I really appreciate this Committee's support for this 
agency, for conservation in general, but for our agency, 
specifically. And I really look forward to today's 
conversation. Thank you, sir.
    [The information follows:]
    
    
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                     ADMINISTRATIVE TRANSFORMATION

    Mr. Aderholt. Thank you. Let me just begin by mentioning 
back in 2013 the Committee approved the NRCS's reorganization 
plan to separate the management of its business operations from 
the management of its policy and programs. This was an early 
step toward the changes mentioned in your testimony regarding 
the streamlining and improvement to NRCS's administrative 
functions.
    What is the status of the plan to transform the 
administrative services?
    Mr. Weller. So just to real quickly--for other Members, for 
their awareness, what NRCS--we have invested in--the last 
couple years, taken a really hard look at how we do the 
business of NRCS. So, principally looking at our human 
resources, our financial management, and our contracting 
property management. Big picture, what are--the vestige of how 
we manage that business is we are very decentralized. So think 
about us being a franchise. We have 53 independent franchises, 
each with their own HR operation, their own budgeting 
operation, their own contracting operation.
    That worked well, historically. But now that we have to be 
more efficient and more cost-effective with the money, the 
irony is, corporately, we are probably spending too much, in 
terms of the management. But if you look at each state, where 
you have an independent state office, probably too thin. We 
don't have enough support in each state.
    So, for example, you're one person deep in your budget 
office. You are one person deep in your HR office. That means 
you are one retirement, one sick day away from that business 
operation shutting down. So what we are trying to look at is 
how do we become more cost effective and a better-managed 
business of NRCS, be more accountable, be more streamlined, but 
also ultimately provide better service, more timely, internally 
and externally.
    And so, yes, we have invested the last two years, taken a 
look at how to harness the latent power and capacity of all of 
these professionals. We have close to 600 professionals across 
the United States in all these different disciplines. How do we 
use their expertise, but really then, instead of having them 
wear multiple hats, expect them to be jacks of all trades, 
instead allow them to be the experts they are, and focus on 
what they are trained in, they have their educational 
attainment in, they have their tools and capabilities to be 
focused on. So you allow accountants to be accountants, you 
allow contracting officers to be contracting officers, and HR 
specialists to be HR experts.
    And so, we are creating national teams that will be 
providing service from the field office to my office, and 
everywhere in between. And we are looking forward--we have 
already stood up several of these national teams for managing 
our fleets, managing our reimbursable payments, managing our 
budget processes, managing our hiring staffing, and it is 
showing--it works. You can get higher quality service delivered 
faster and cheaper.
    And so, we are looking forward to--we are going to be--we 
briefed the Committee staff earlier last week--finalizing final 
approvals within the Department, and we look forward to them 
coming before the Committee officially, and seeking your review 
and concurrence with this approach. The goal is to have this 
completely stood up this calendar year. And we are really 
excited about what this will ultimately mean for the long-term 
resiliency and cost-effectiveness of our agency.
    Mr. Aderholt. You mentioned the employees. What does it 
mean for the current employees?
    Mr. Weller. So we have--I have core commitments to those 
employees. Number one, everyone gets to keep their jobs. This 
is not a large RIF. They will all remain NRCS employees. 
Importantly too, they all get to keep their grade and pay. 
Three, they can stay where they are. We are not creating a Taj 
Mahal of administration somewhere, where everyone has to move 
to. They can stay in their current locations, because we have 
the technology and tools to manage this, virtually.
    And so, we really, then, are looking to then get these 
folks realigned into teams where you have experts delivering 
what they are trained to do. They are being supervised, 
importantly, by experts, then, who know this discipline. 
Because HR policy is incredibly complex. Contracting policy, 
grants and agreements policy, very complex. You want to have 
experts doing this day in and day out. You got economies of 
scale. But then you want to have good training, the 
supervision, the collaboration that occurs in these teams that 
then, ultimately, we will expect.
    So I think this is, ultimately, for our employees, going to 
be a better morale-booster. Employees who have been on these 
interim teams serving on detail assignments, the feedback we 
get is that they are really excited. They actually see this as 
a big improvement in their quality of life. It is less stress. 
But then also, we all save some time and money, as well, at the 
end of the day.

                            FINANCIAL AUDITS

    Mr. Aderholt. As you are aware, the Inspector General has 
issued numerous reports under financial management system. And, 
as you know, this Subcommittee has been concerned about the 
audits for several years. NRCS has made great progress, but 
there continues to be a great number of deficiencies.
    I understand that the planned administrative transformation 
also addresses these deficiencies and concerns. What is the 
relationship between audits and your work to transform the 
NRCS's administrative functions?
    Mr. Weller. So there is no one more concerned about the 
financial audit and our financial management capabilities than 
me. And part of--this is very personal for me, because in a 
past life I actually was the OMB budget examiner for this 
agency. And my parting gift, when I was at OMB, to NRCS was to 
require them to go into a stand-alone audit, some parts.
    So, fast forward to today. I am now bearing the joy of 
that--what I inflicted upon myself. So kind of back to the 
future. [Laughter.]
    This agency has come a long way. If you go back to where we 
were three years ago, we had seven material weaknesses. 
Completely unacceptable. In just the last three years we are 
down now to three material weaknesses, just three weaknesses. 
And now we are on the cusp of getting this done. We know what 
we need to do, and this administrative transformation is going 
to get us over the line. So, instead of having 53 different 
business centers writing into our general ledger, we will have 
one team writing into our general ledger. While instead of 
having 53 different reimbursement payment teams issuing 
payments, we will now have one team issuing payments to this 
agency, using standard operating procedures, standard policies, 
same technology, the same training. So this is absolutely the 
way we will nail it, and stick our audit.
    Mr. Aderholt. Okay. Just in closing, when do you expect to 
achieve a clean audit?
    Mr. Weller. So, our goal this year, it is very complex. I 
don't want to equivocate here. Our goal is this fiscal year to 
end with clean balances. This is the goal, so that our auditors 
can tie to our balances, which then sets us up for clean 
balances for 2016. And then you need to maintain your internal 
controls for a whole fiscal year. So the goal is, by end of 
2016, they will be able to get an opinion on our books. That is 
what we are aiming for.
    Mr. Aderholt. End of the year.
    Mr. Weller. Yes.
    Mr. Aderholt. Mr. Farr.

                          LEVERAGING RESOURCES

    Mr. Farr. Well, thank you, Mr. Chairman. I am so impressed 
with--I guess we call you Chief Weller. Sounds like law 
enforcement. But I am really impressed with your ability to get 
in and do that reorganization, because there is so much of that 
that is essential in government these days. In all levels, not 
just the federal government. California is into a term now 
called ``realignment,'' where we are going to--reorganizing.
    Is that because you were a member of this staff, and you 
got really good training. Perhaps, Mr. Chairman, we ought to 
require that all the agencies have to hire former 
Appropriations staff members.
    I would like to pursue just that, what you are trying to do 
to leverage your resources. I mean I represent a really 
beautifully environmental area. We had dozens of non-profits, 
you know: Save the Redwoods, the Big Sur Land Trust, Santa Cruz 
Land Trust, three or four farm land trusts. I will bet, if we 
add it up, we probably have 25 land trusts working in my area. 
All of them have a different client, different agenda, 
different staffing, but they all have one thing in common, they 
all want to come and have the land that they buy transferred to 
the federal government.
    But they are doing a lot of work with getting agricultural 
easements on lands by big land owners, and there is a lot of 
interest in that, just because they want to preserve their land 
and agriculture forever and ever, and they don't want their 
children to have to sell it off or dump it to some big 
developer. So there is a lot of private-sector interest in 
this. It is just I am interested in how we can better leverage, 
because, as you know, they are all in their own silos.
    I have got a lot of big Forest Service in my area. Forest 
Service is in your Department. Are you working with them also, 
so that there is kind of a one-stop--you talk about being 
that--what, strike team? Is that--could you explain more about 
that?
    Mr. Weller. Yes, absolutely. So there are two direct 
examples I will give you, sir. And one I mentioned in my 
opening remarks is the Regional Conservation Partnership 
Program (RCPP), which is a new authority in the 2014 Farm Bill. 
The basic idea here is you actually invite local partners to 
devise their own projects. You ask them what do they want to 
do.
    So, what we are finding is that, more often now, you go 
into places like the Salinas Valley or the Pajaro Valley in 
your district, for example, and there is a lot of people doing 
a lot of really good things. But, more often than not, we are 
not coordinated. We are putting a lot of money on the ground, 
but in a way we are like ships passing in the night.
    So what we did with the Regional Conservation Partnership 
Program is sort of like pulling a sock inside out. Instead of 
the federal government saying, ``This is what we are going to 
do in your community,'' instead we ask, ``Community, what do 
you want to do? And we are here to support you.''
    So, we opened it up to competition, and we got 
applications, 600 applications, from every state in the 
country, from all over the country. And folks were really 
excited about this. And what it does is it catalyzes that 
locally-led approach, where you get, like, the Santa Cruz 
Resource Conservation District (RCD). They then talk to 
Driscoll's Berries. They talk to the Pajaro Valley Water 
Management Agency. They talk to Santa Cruz extension. They talk 
to the marine sanctuary. And they leverage the resources up 
front, and then they come to us and say, ``NRCS, this is what 
we would like to do with the program in the Pajaro Valley to 
save water, but also to increase groundwater recharge.''
    And so, one of the projects we funded, then, in the Pajaro 
Valley this year through RCPP first round was $800,000 of NRCS 
money matched by $900,000 of the partners. So, total project, 
over $1.5 million that they estimate is going to save over 400 
acre-feet of withdrawal from the aquifer, but also add 
additional recharge to the aquifer of 600 acre-feet. That is a 
lot of water savings in a water-scarce area, but you are 
getting industry involved-- Driscoll's Berries. You are getting 
extension to provide really good outreach and education. You 
are engaging RCD, so it is a locally-led approach. And the 
federal government, then, is just a co-investor. We are a true 
partner in this. So this is one example.
    Nationally, we have 115 of these projects that-- they are 
just showing this is an approach we really absolutely have to 
pursue.
    Mr. Farr. Well, my time is up, but I really appreciate 
that. The ag industry is really excited about what Driscoll is 
doing, and Driscoll is, I think, taking a national lead in 
talking about how agriculture can do a lot to improve water 
conservation and water quality. Thank you.
    Mr. Aderholt. Yes, thank you. We are getting a call for 
votes, and we anticipated we were going to have a little bit 
more time. And so we are trying to make sure everybody gets 
their questions in. But we are going to go on as long as we 
can.
    So, Mr. Valadao.

                     CALIFORNIA DROUGHT INITIATIVE

    Mr. Valadao. Thank you, Chairman.
    Thank you again for coming and spending some time with us 
today. My question is about a drought initiative that started 
in February of 2014. About $25 million was spent. Can you give 
me an idea of what type of technologies and what type of 
response, and even some of the improvements, or maybe how much 
efficiency we have seen? Do we have any numbers that we can 
see?
    Mr. Weller. Yes, sir. Absolutely. I know in California--the 
whole state, but particularly in the San Joaquin--this is a 
huge issue. So, last year, just using our financial assistance 
program alone, we added an additional $25 million into 
California to go into the drought-stressed areas. Sort of three 
core things we are looking at.
    First, for fallow fields that we--there is no water to 
plant, we are looking at putting in some kind of cover. So 
whether that is keeping residue on the land, or actually 
planting a water crop that doesn't--or a cover crop that 
doesn't require a lot of water resources, lock those soils 
down.
    For folks that still have access to water, we are secondly 
trying to help upgrade their irrigation efficiency, so their 
microdrip irrigation--you know, remove flood irrigation, move 
to a different improved water management. And then, for grazing 
lands, again, helping them put in the infrastructure to support 
cows, getting cattle out of the riparian areas to reduce 
pressure on water there, developing water, you know, upstream, 
putting the proper fencing that works in receding pastures and 
range land areas to maintain the vitality of those areas.
    The big picture, though, we have been very focused on 
drought, long-term, in California. So we have actually 
partnered with Reclamation, joint partnership. Reclamation is 
making investments in their delivery mechanisms, their canal 
systems. And then we meet them at the farm gate, and we do the 
on farm savings. So this partnership, we have invested over $20 
million over the last several years in Central Valley. We 
estimate these projects, when complete, will save 167,000 acre-
feet per year, which is a lot of water. That actually equates 
to over 550 billion gallons of water, which sounds like a lot 
of water. Well, that is actually enough water to supply 3.7 
million homes with drinking water, annually. That is the amount 
of water we are saving. So we are very focused on drought and 
water scarcity in California.
    Mr. Valadao. All right. Well, I appreciate that. Thank you 
again, and I yield back.
    Mr. Aderholt. Mr. Bishop.
    Mr. Bishop. Thank you very much. And welcome, again, Chief 
Weller.
    Mr. Weller. Thank you.

              SOCIALLY-DISADVANTAGED FARMERS AND RANCHERS

    Mr. Bishop. Sounds good to address you as chief. Your 
budget justification indicated that you have successfully 
provided $99 million through 3,764 contacts with socially-
disadvantaged farmers and ranchers to treat approximately 2.3 
million acres. Is this on an annual basis, or is it the 
cumulative total over several years? And do you have any plans 
to expand the activities?
    Many of us at some point would like to see persistent 
poverty counties in the nation have a targeted plan of action 
from USDA and all federal agencies, really, whose mission it is 
to assist our lowest income communities, and particularly our 
rural areas. I congratulate you on what you are doing, but can 
you kind of expound on that.
    And I also want to congratulate you on your partnerships 
with the North Carolina A&T and Florida A&M, with regard to the 
biological, agriculture, and system engineering academic 
programs, which is a great partnership. But I would like to 
also remind you that there are 14 historically black land grant 
universities, not the least of which is Fort Valley State 
University in the Second District of Georgia. And all of them, 
I think, are in need of assistance. And if there is any way, 
any plans that you have for expanding those partnerships, I 
think it would help you help the nation. And, of course, it 
would help those universities.
    Mr. Weller. Yes, sir. So yes to both. First, starting with 
StrikeForce, very quickly. So we started--actually, Georgia was 
one of the original pilot states. And NRCS--I am really proud 
of how NRCS stood up here, and complete hats off to those field 
folks. They worked mightily to start working with community-
based organizations in Georgia and Mississippi and Arkansas. We 
went into every county in the state to improve outreach, to 
hold community sessions, town hall meetings. We had people at 
those meetings with contracts in hand, ready to sign people up 
as they leave the room, ``Let's get you in programs.''
    So, if you look at just last year alone, yes, it was over 
$90 million just annually, just to socially-disadvantaged 
producers. But, in total, NRCS invested over $286 million into 
the highest poverty counties in the Strike Force. Over the last 
four years, $992 million in financial assistance went to those 
poor communities. And so these are absolutely job-creating 
investments. It is helping those families put modest 
investments on their operation to help their bottom line. But 
it is also then a complete job creator, in really offering 
economic opportunities in those communities.
    Regarding interest in working with historically black 
colleges and universities, 1890s, absolutely. Actually, I just 
had a meeting last week with the new president of the Student 
Conservation Association. We have a shared interest in the Gulf 
State region, in particular, improving their association's 
engagement with the historically black colleges, and also 
Hispanic Institutions. We do, as well, because we have to start 
employing a 21st century workforce that is representative of 
this country, and ensuring we are having diversity in every 
sense of the word in the agency. So I am very much focused on 
this, and would be happy to visit with you or your staff about 
how we could work with you on----

                                 DRONES

    Mr. Bishop. Thank you. We will follow up on that. I 
appreciate that very much.
    Under the Natural Resource Inventory Program, you acquire, 
analyze, interpret, and deliver data through the NRI program 
and Conservation Effects Assessment Project. Can you tell us if 
you have any plans to utilize drones to assist in the 
collection of information? Because you do a lot of photography, 
put a lot of contracts out to take pictures, and there is a 
tremendous amount of interest in the use of drones and 
agriculture, particularly in assisting the optimal design of 
and layout of soil and water assessments, and other related 
issues.
    Have you looked at this issue? Are there any current inter-
agency discussions with FAA or other agencies concerning the 
growth and the use of drones? Obviously, there are some 
security issues involved, but there is also a great deal of 
interest for commercializing that practice, and using it in 
agriculture.
    Mr. Weller. Absolutely. It is a new technology, but we also 
have to be careful, because folks do have privacy concerns. FAA 
also had safety concerns. So, in part, NRCS, we were sort of at 
full-stop, let's wait for FAA to actually come out with a rule. 
Now that the rule has been issued, we are trying to figure out 
how NRCS can work within that to do remote sensing, but in a 
way that protects privacy, assures land owners who are not--
there is a regulatory component, because I know folks have some 
concerns when the federal government starts flying drones over 
their property.
    So we just need to make sure NRCS is doing this technology 
in a way that is appropriate, that is sensitive to land owners' 
concerns, but also then helps us do a better job of managing 
resources.
    Mr. Bishop. Thank you.
    Mr. Weller. Thank you.
    Mr. Bishop. Thank you very much. I yield back.
    Mr. Aderholt. Mr. Rooney.

               AGRICULTURAL CONSERVATON EASEMENT PROGRAM

    Mr. Rooney. Thank you, Mr. Chairman. I have a very brief 
question. A lot of my larger land owners, farmers, ranchers in 
Central Florida, which I represent, a lot of citrus, beef 
cattle--a lot of them are getting interested in this 
conservation easement program that--you have consolidated a lot 
of the easement programs into one new overarching program. I 
just wanted you to give us an update about how that is going, 
and how you have been working with the enrollees, or potential 
enrollees, that want to participate.
    Mr. Weller. So--yes, sir. The 2014 Farm Bill consolidated 
all these programs we had into one new program called the Ag 
Conservation Easement Program. ACEP is the acronym. Two 
components to this. There is the ag land easement component, 
which is like a working lands, grazing lands, row crop 
protection, which is we basically provide financial assistance 
to a state agency or to a land trust, and they go acquire the 
easement. And then there is a wetland component, where NRCS 
actually acquires the easement and does the wetland 
restoration, but it is still privately-owned land.
    It was well oversubscribed last year, so we invested $328 
million. We got 144,000 acres of easements across the United 
States. And so we are trying to do everything we can. We 
actually just--I think today--issued the interim final rule for 
the new program. So we have been working very hard with land 
trust and state agencies across the U.S. to understand how the 
program is working, how it is not, how we can fix it and make 
it better, an easier experience for state agency or land trust 
to work with us. But then also how to streamline this so, for a 
land owner, they have a better experience, they get their 
easements closed quicker, they understand kind of the rules of 
the road, so it is much more transparent and they know kind of 
what their responsibilities are, what they are getting involved 
in, but also, hopefully, what they see the benefits are of 
easements.
    At NRCS, over the last several years, we put a lot of very 
significant easement resources voluntarily into Central 
Florida, working particularly with the grazing community, the 
ranching community in Florida. A very strong interest in that 
community, and we are very proud of that partnership with them. 
Because what is great with this program, you can also have--you 
can still have working lands. So as long as we have an 
agreement on, you know, stocking rates and the management, you 
can still run cattle on those wetlands, and so you still have 
working ranch lands, but then you are also providing water 
quality, flood protection, wildlife habitat on the same working 
lands.
    So, we are real excited about our partnership with 
producers in Florida. Thank you.
    Mr. Rooney. Yield back.
    Mr. Aderholt. Mr. Young.
    Mr. Young. Thank you, Mr. Chairman. Chief, how are you 
today?
    Mr. Weller. Very well, thank you.

                           NUTRIENT DISCHARGE

    Mr. Young. Nice to see you again, Mr. Michael Young. I want 
to reflect back on one of my colleague's comments regarding 
drones. I appreciate your comments on privacy and respect for 
land owners. Also please be cognizant of what is being done in 
state legislatures and with state law regarding this, because 
there are some things going on in the states that you will have 
to reflect on as well. So thank you for your comments regarding 
privacy and the need for and the attention to that.
    In Iowa, we are working hard on a pragmatic approach to 
reduce the amount of nutrients discharged from point sources 
and non-point sources, wastewater treatment plants, as well as 
our farm fields. We have got state, federal, and farmer dollars 
that have been invested in this. It is a voluntary approach. 
You have flexibility to target those programs, I understand, to 
the needs of the region, county, and state. How much is the 
NRCS contributing to this effort, and does it plan on 
contributing more or less?
    Mr. Weller. If anything, more. But it is--again, it is at 
the invitation of those land owners in Iowa. But also, 
crucially, to Congressman Farr's--again, his request, or hope, 
that we are coordinating with government, with state agencies, 
and also with non-profits and other private organizations in 
Iowa.
    And, again, coming back to the Regional Conservation 
Partnership Program, there is two examples of this, two great 
projects in Iowa. One, we partnered up with the State of Iowa. 
The Department of Agriculture invested $3.5 million to then 
complement the state's resources to help implement their 
nutrient reduction strategy, which is part of this pragmatic 
approach you are talking about in Iowa.
    We also invested $2.5 million with the City of Cedar 
Rapids, again, to do source water protection for that city. We 
are working collaboratively with land owners up the river to do 
land treatment, good investments on their operations to help 
their bottom line, but also then to help protect drinking water 
quality coming in to the City of Cedar Rapids. These are two 
examples of that pragmatic approach we are trying to take in 
Iowa, working voluntarily with land owners to protect, help 
their bottom line be more efficient with their nutrients, and 
better manage their soils, be more productive, then also 
protect water quality for all Iowans.
    So we are very much proud of our partnership with the State 
of Iowa, but also with other associations like soybean, corn 
associations in Iowa, as well as non-profit organizations, like 
Nature Conservancy and other groups in Iowa. We are all 
collectively partnering on this.

                         WETLANDS DETERMINATION

    Mr. Young. Well, I appreciate that collective approach to 
what we are trying to do on a voluntary level. I believe that 
we will get it right. It is a matter of time. Some people want 
it sooner, rather than later. But to get it right, it may take 
a little more time. But we will see.
    Last year the NRCS proposed updating the way it conducts 
wetlands determination in the prairie pothole states--you know: 
Minnesota, Iowa, North Dakota, South Dakota. How will the 
wetland determination proposal affect producers? When there is 
a review, will there be an ability for folks to have a second 
request for review, and a second opinion, if they disagree with 
a determination you make?
    Mr. Weller. Yes. So, first, starting with what a producer 
hopefully will experience with this, what we are proposing is 
bringing a modern, up-to-date, scientifically-driven approach 
to doing what we are calling offsite determinations. This is a 
practice we have had at NRCS for decades. But what we didn't 
have in the prairie pothole region is a consistent approach 
across all four states. So, depending on where your property 
was, you had a different approach that we needed to update.
    So what this means, though, is actually, at the end of the 
day, when we implement this--because we were just seeking 
comments on this approach, so far--is better service for a 
producer. So, right now, as you know, there has been a backlog, 
particularly in North and South Dakota, but Iowa, as well. And 
a lot of cases it is because it is on-site determinations. It 
takes staff time. When you do an off-site determination, you 
are using remote sensing technology, photography, LIDAR 
coverage, other techniques to really do equivalent, if not more 
accurate, determination approach.
    Bottom line is time savings. So, the average number of time 
it takes to do an off-site determination is six hours. The 
average number of hours it takes to do on-site is at least 14 
hours. Many of them are 40 hours. And that doesn't count all 
the driving time. When you break that down into dollars and 
cents, if you just take the assumed $30 an hour for, like, a 
field technician to go out and do it, that equates to about 
$170 to do an off-site determination. When you do on-site it is 
like over $400 a determination, on average.
    But when you multiply it out over, like, South Dakota, 
where they have 2,500 determinations in the backlog, that is 
the difference between $300,000 over $1 million. And when it 
comes down to that kind of expenditure, when you add that up 
across four states, you are talking real money. And that is 
money I would rather employ back in the field to provide, you 
know, technical assistance to producers, as opposed to 
investing in a way that we could be more efficient.
    So, to your question about what happens for the producer, 
the first approach would be the off-site determinations, which 
would be much more efficient. They will get determinations made 
quickly. It is a preliminary determination. They don't like the 
determination, they can then appeal it and they can then 
request an on-site determination. They don't like the on-site 
determination from the field staff, they can then appeal that 
to the state office. They don't like the state office 
determination, they can then appeal that to the National 
Appeals Division. So there is absolutely all these protections 
for a producer. We are not changing any of that, how that 
works. We are actually just trying to streamline it and get the 
determinations made faster and cheaper.
    Mr. Young. So, with the off-site, it saves time. But you 
make that up with the technology you are talking about to get a 
more accurate read, you believe. If there is some disagreement, 
there is a review for on-site.
    Mr. Weller. Exactly.
    Mr. Young. Okay. About how many acres of wetlands are left 
in the pothole prairie region for review, do you know?
    Mr. Weller. So--I don't know the acreage, but in terms of 
the backlog, across all four states is a backlog, currently, as 
of January this year, 4,600 determinations backlog. But to put 
that in perspective, we have done over 50,000 determinations in 
the last 4 years. So there is a lot of folks coming in, and we 
have been keeping up with that, plus getting rid of the 
backlog. So we have a plan now to get rid of that backlog 
within the next two years.
    Mr. Young. Thank you, gentlemen. Mr. Chairman.
    Mr. Aderholt. Okay. We have been summoned for a vote, and I 
am not sure how long we will be over there. So what I would 
like to do is just open it up. Does any Member have another 
question they would like to ask Chief Weller before we adjourn? 
[No response.]
    Mr. Aderholt. So--okay, good. Well, thank you for being 
here, and we appreciate your assistance and work that you do. 
And we look forward to following up with you.
    We may have some questions that we will submit for the 
record. But, anyway, we appreciate your presence here. Thanks 
very much.
    Mr. Weller. Thank you, sir.
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
   
                                            Tuesday, March 3, 2015.

      DEPARTMENT OF AGRICULTURE MARKETING AND REGULATORY PROGRAMS

                               WITNESSES

ED AVALOS, UNDER SECRETARY, MARKETING AND REGULATORY PROGRAMS, 
    DEPARTMENT OF AGRICULTURE
KEVIN SHEA, ADMINISTRATOR, ANIMAL AND PLANT HEALTH INSPECTION SERVICE, 
    DEPARTMENT OF AGRICULTURE
ANNE ALONZO, ADMINISTRATOR, AGRICULTURAL MARKETING SERVICE, DEPARTMENT 
    OF AGRICULTURE
LARRY MITCHELL, ADMINISTRATOR, GRAIN INSPECTION, PACKERS AND STOCKYARDS 
    ADMINISTRATION, DEPARTMENT OF AGRICULTURE
MICHAEL YOUNG, BUDGET OFFICER, U.S. DEPARTMENT OF AGRICULTURE

                       Introduction of Witnesses

    Mr. Aderholt. The Subcommittee will come to order. Good 
afternoon. I want to welcome everybody here. I was mentioning 
to somebody earlier, you all bear with me. I have got a little 
bit of a sore throat, so you all have to be patient with me 
this afternoon with that.
    But I am pleased to begin our review of fiscal year 2016 
budget requests for the agencies of USDA's Marketing and 
Regulatory Program mission area. I would like to welcome to the 
Subcommittee Mr. Ed Avalos, USDA's Under Secretary for 
Marketing and Regulatory Programs. Good to have you.
    We also are joined today by Mr. Kevin Shea, Administrator 
of the Animal and Plant Health Inspection Service. Good to have 
you here. Ms. Anne Alonzo, Administrator of the Agricultural 
Marketing Service; Mr. Larry Mitchell, Administrator of the 
Grain Inspection, Packers and Stockyards Administration; and 
also welcome back Mr. Mike Young, USDA's Budget Director. So 
all of you, we welcome you here and glad to have you here this 
afternoon.

                    Opening Statement--Mr. Aderholt

    I have been emphasizing in previous hearings three goals of 
this Subcommittee as we move forward. First is improving the 
management of the agencies and programs under our purview, we 
will be enhancing accountability and spending of taxpayer 
dollars through improved agency governance process and internal 
controls, and ensuring transparent decisionmaking.
    Inspector General Fong testified a few weeks ago before 
this Subcommittee. She cited a lack of sufficient management 
controls to ensure that APHIS' pre-clearance offshore program 
was operating effectively. This program helps protect U.S. 
agriculture from foreign pests and disease, and it is 
imperative that you address the report recommendations.
    The second goal is to target funds to the most important 
programs and their functions. Likewise, we must continue to 
reduce or eliminate funding for lower priorities and those 
programs that are less effective or duplicative. This mission 
area has a broad spectrum of responsibilities that directly 
impact our domestic and international agricultural products and 
markets, and we will continue to support them.
    However, you are requesting additional funds for several 
initiatives that may be to the detriment of critical and 
successful programs. For example, in your mission area I think 
there is a missing component, such as a long-term strategic 
infrastructure plan, that is crucial to moving products 
domestically in order to expand trade and marketing 
opportunities. USDA has been reacting to market disruptions 
like those at the ports and railways instead of having a 
proactive plan in place.
    And the third goal is to promote U.S. agriculture, free and 
fair markets, and safe food. Your mission area facilitates the 
marketing of agricultural products domestically and around the 
world, it works to remove non-tariff barriers in trade, and to 
open, retain, and expand export markets, and also addresses 
agricultural threats to safeguard animal and plant health. We 
provided additional funding to APHIS in recent years to address 
significant agricultural threats. We are appreciative of your 
work with the private sector to address citrus greening and 
emerging swine health issues.
    I am also pleased the Department acted quickly to follow 
the Congressional direction rescinding the provisions regarding 
certain GIPSA regulations, as outlined in Section 731 of the 
fiscal year 2015 Omnibus, and halting activities to establish a 
duplicative and second beef checkoff program, as directed in 
the Omnibus explanatory statement.
    USDA is requesting a total of $987 million in discretionary 
resources in fiscal year 2016 for the mission area, and that is 
a decrease of $12.5 million from the 2015 enacted level. 
However, all these agencies are requesting increases for 
enhancing current activities or supporting new initiatives.
    I will be looking for evidence that current efforts are 
effective, and I would like to know what industry and public 
support exists for these expanded efforts. I am particularly 
concerned that USDA has requested scarce discretionary 
resources for lower priority programs.
    For example, APHIS has requested an increase to enhance 
implementation of Lacey Act provisions. I have trouble 
supporting such an increase at the expense of higher priority 
and more effective animal and plant health programs, many of 
which the agency has proposed to decrease.
    With the overall spending caps still in effect, I 
anticipate that this Subcommittee's funding levels will remain 
relatively flat at best. We have tough allocation decisions 
that are before us, and I want to be sure that we maintain 
funding for the most critical and the most successful programs.
    Today and in the coming months, we expect to have an 
ongoing dialogue with your agencies as we develop a fair and 
responsible budget for the next fiscal year.
    So again, thank you each for being here. I would now like 
to ask our distinguished Ranking Member, Mr. Farr, for any 
opening statements that he may have.
    Mr. Farr. Mr. Chairman, I have no opening statement. I am 
so excited listening to this distinguished, intelligent panel 
that let's just get on with the hearing.
    Mr. Aderholt. Very good. Thank you, Mr. Farr.
    Also, before I get started, let me just take time to 
recognize Karen Ratzow. She has been on detail with our office, 
with the Subcommittee office, from the APHIS budget office, and 
she has been a very valuable member to the Subcommittee over 
the past year.
    She is very diligent. She has a tremendous work ethic, is 
very knowledgeable in the budget process, always eager to 
volunteer and always to lend a hand wherever she can. She 
quickly became a part of this team from very early on when she 
came here, and while her detail is slowly coming to an end, we 
do want to thank her for her service and look forward to 
working with her as she returns to APHIS. So I just wanted to 
mention that. Thank you.
    At this time, Mr. Under Secretary , I will give you the 
floor and let you speak as you would like as your prepared 
remarks.

                     Opening Statement--Mr. Avalos

    Mr. Avalos. Thank you, Mr. Chairman.
    Distinguished members of the Subcommittee, before we get 
into the budget request, I would like to offer my condolences 
on the passing of Congressman Nunnelee. I vividly remember one 
exchange that the honorable Congressman and I had. We were 
discussing the Specialty Crops Grant Program and the different 
State marketing slogans we used to identify specific products 
and specific States.
    I mentioned using New Mexico: Taste the Tradition, when I 
was in charge of marketing at New Mexico Department of 
Agriculture--I told him his State slogan was unique and one of 
my favorites. He admitted that he did not know what it was, but 
when I told him that it was, ``Make Mine Mississippi,'' I saw a 
smile and look of pride in his face. He will be missed.
    Mr. Aderholt. Thank you.
    Mr. Avalos. I appear before you to discuss the activities 
of the Marketing and Regulatory Programs mission area at USDA 
and to present the fiscal year 2016 budget proposals for AMS, 
APHIS, and GIPSA. With me today are Ms. Anne Alonzo, Mr. Kevin 
Shea, and Mr. Larry Mitchell. They have statements for the 
record, and they will answer questions regarding specific 
budget proposals in their agencies. Also with me is Mr. Michael 
Young, USDA budget officer.
    The MRP agencies have achieved significant accomplishments 
recently. I will talk about a few today, and I have additional 
accomplishments in my written statement.
    In fiscal year 2014 APHIS, in cooperation with other 
agencies, successfully negotiated and resolved 170 sanitary and 
vital sanitary trade issues with an estimated value of $2.5 
billion. This includes opening new markets as well as retaining 
and expanding existing market access for U.S. agricultural 
products.
    To illustrate the impact of APHIS' efforts to open markets, 
I will highlight the agreement recently reached with China to 
allow U.S.-grown apples into the Chinese market. With this new 
agreement, the apple industry estimates exports will reach 
nearly $100 million.
    AMS also has a role in promoting trade and opening new 
markets. In July 2014, the U.S. and Korea announced an organic 
equivalency agreement that should create market access for a 
market that is valued at over $35 million a year.
    In fiscal year 2014, GIPSA provided over 3.3 million 
inspections on grain, with a value of over $45 billion. GIPSA 
has succeeded in making these inspections affordable. Export 
services' fees are about a penny per bushel. Further, the sheer 
volume of grain that GIPSA inspectors evaluate on a daily basis 
is absolutely astounding. GIPSA inspects, on the average, the 
equivalent of more than 380,000 acres of wheat. That is every 
day.
    Next I will present a select number of requests for 
increases in our 2016 APHIS budget. As part of the government-
wide initiative to address antimicrobial resistance, we are 
requesting $10 million to increase our surveillance efforts to 
antimicrobial-resistant bacteria.
    The budget also includes an increase to address the threat 
of citrus greening. This work continues the efforts that were 
initiated by this Subcommittee's direction to establish a 
multi-agency response.
    The budget also includes an increase to combat illegal 
logging. This increase is consistent with our goal today to 
balance the need to enforce the 2008 amendments to the Lacey 
Act with the need to facilitate legitimate trade.
    For AMS programs, additional funding is requested to work 
with Federal, State, and local stakeholders to access regional 
food systems and determine key characteristics that will help 
food system developers, investors, and State and local 
governments better understand the challenges and opportunities 
for growth in their local food systems.
    For GIPSA, the budget includes a modest increase in 
existing restrictions on user fee expenditures to a maximum of 
$55 million for grain inspection and weighing. This adjustment 
to the obligation cap will allow GIPSA to keep pace for overall 
increases in volume of trade as well as to be present in new 
export facilities as they come online.
    Mr. Chairman, this concludes my statement. I look forward 
to working with the Subcommittee on our fiscal year 2016 
budget. And we are happy to answer any questions.
    [The information follows:]
    
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        AGRICULTURAL QUARANTINE INSPECTION PRECLEARANCE PROGRAM

    Mr. Aderholt. Thank you for your testimony. As I had 
mentioned in my opening statement, the Inspector General 
testified before this Subcommittee a couple weeks ago, and she 
testified and included a summary of findings from a recent 
report on APHIS' pre-clearance offshore program.
    She mentioned that the agency did not have sufficient 
management controls in place to effectively protect the United 
States from the introduction of devastating foreign 
agricultural pests and disease. The findings included several 
management issues such as lack of oversight from top-level 
officials, inspection reports that were being generated but not 
read, and there were no consequences for repeated 
noncompliance.
    These are, of course, as you would agree, serious 
allegations when you consider that the program is designed to 
protect the health of United States citizens from harmful 
agriculture pests and disease. As you know, some of the pests 
in the country now are costing us billions of dollars to 
control and as we attempt to eradicate them.
    It is my understanding that 14 out of the 16 
recommendations have been resolved. Can you talk about and 
summarize APHIS' actions that they have taken to address these 
findings and these recommendations?
    Mr. Avalos. Mr. Chairman, first I just want to state that 
we take our mandate to protect animal and plant health in this 
country very seriously. I am going to ask our administrator at 
APHIS, Mr. Kevin Shea, to answer your question.
    Mr. Shea. Thank you, Mr. Avalos.
    Mr. Chairman, we certainly take that very, very seriously, 
and I think we did take some solace in that there was no 
indication that any pest or disease occurrence happened because 
of any deficiency in our systems. The main things that we 
learned from the Office of Inspector General (OIG), and we very 
much appreciate their recommendations, is that we lacked really 
systemic methods of overseeing the program.
    Those are all in place now. You mentioned, for example, 
lack of oversight of reports by high-level officials. We have a 
complete system in place now to ensure that does not happen 
again. We will complete not only the 14 you mentioned, but the 
other two as well by the time this fiscal year is over, and we 
are certainly dedicated to making sure that happens.
    Mr. Aderholt. Talk about some of the controls that you have 
in place to assure that these type of deficiencies will not 
occur in the future.
    Mr. Shea. Some of the things we have done: We have put in 
place a system of processes, a checklist, if you will, that 
will tell the inspectors what forms to fill out, what reports 
to file. That same system will apply to their supervisors so 
they can review things at a particular time.
    I think that was what we lacked. I think some of the things 
took place. I think some of the reviews took place, but it was 
not systematic. And that is what we now have, standard 
operating procedures that will apply to all aspects of the pre-
clearance program.

          BIOTECHNOLOGY REGULATORY SERVICES--PETITION REVIEWS

    Mr. Aderholt. APHIS has been improving the biotechnology 
petition review process for a couple of years. Last year you 
reported that you were only able to reduce the backlog of 22 
petitions by six. Your testimony this year states that you are 
nearly through the list of backlogged petitions. Can you 
provide us more details on the status of the backlog and what 
progress you have been able to achieve?
    Mr. Avalos. Mr. Chairman, under the direction of Mr. Shea, 
APHIS has done a fantastic job in reducing the backlog. They 
have really cut down on the time frame it takes to deregulate a 
specific product. So I am going to ask Mr. Shea to go ahead and 
expand on the answer.
    Mr. Shea. Mr. Chairman, I recall a year ago I pledged to 
you we would cut the backlog of 16 by at least half, and I am 
proud to say that the fantastic men and women who work in our 
biotechnology review program have indeed exceeded that goal and 
there are now only six of those 16 remaining. So that means we 
reduced it by more than half.
    I would say this also. When we began our business process 
improvement just a few years ago in 2012, there were 23 
deregulation requests in the backlog. Since then, 11 more 
requests have come in, so there were a total of 34 regulation 
requests. There are only six left. We got 28 out of 34 done. 
There are only six remaining. We are going to get those done, 
we think, by the end of this fiscal year.
    And so now we have the system in equilibrium. We can handle 
the amount that comes in. And not only can we handle them, we 
can handle them quicker. It was taking us three to five years 
to do these things. We are now down to 15 to 18 months. Our 
goal is no more than 15 months, and I think we are going to 
achieve that as well. So I am very proud of our progress there.
    Mr. Aderholt. So when do you think you will be caught up 
with no longer having a backlog?
    Mr. Shea. I do not think we will have any in a backlog, so 
to speak, at the end of this fiscal year. We would hope to have 
all of the 34 that were either in place in 2012 or have come 
into the system since then--we would expect to have most of 
them done and then be in an equilibrium where we can move out 
the same number that comes in over the course of 15 to 18 
months.
    Mr. Aderholt. Mr. Farr.

                  PLANT PESTS AND DISEASE SURVEILLANCE

    Mr. Farr. Thank you very much, Mr. Chairman.
    First of all, I would just like to introduce to the 
audience--California is our leading agriculture State--it is 
our number one industry in California. And I forget how many 
billions of dollars it is, but in my county alone, in one of my 
counties, Monterey County, which is the second in the nation, 
ag production is at $4.8 billion.
    And the head of that, the ag commissioner, Eric Lauritzen, 
he is here today. I just want to thank him for coming to our 
hearing because he is bringing a lot of ag commissioners. 
California has an ag commissioner in every county, 58 counties, 
and those commissioners have all the responsibility for 
enforcing the pesticide laws, the weights and measure laws, the 
consumer laws, also doing all the economic data--just about 
everything you have to do with agriculture.
    And what I am worried about--we are hearing about all 
this--we just had the Prime Minister of Israel talking to us 
about the fears of the Middle East. What we are worried about 
is the attack that is going on in California with invasive 
species.
    We have spent all our money on cyber-security and things 
like that, very little on invasive species, and yet California 
has the largest ports in the United States in Long Beach and 
L.A. It has a border with more people living on the other side 
in Mexico than any other State. It has dozens of international 
airports, and 36 million people who move around a lot. So 
invasive species is huge, and pest detection activities are 
critical if they are targeted.
    I really want to ask Kevin Shea, in the recent past you 
have only committed $27 million for the entire United States, 
for 50 States--that is less than a half a million dollars per 
State--for your pest detection line item. Is that enough?
    Mr. Shea. Mr. Congressman, I would say that we have $27 
million dedicated to general plant pest and disease 
surveillance. But we have a lot more money in individual pest 
disease programs that have surveillance. For example, we spend 
millions of dollars simply on fruit fly surveillance every 
year. That is just one example.
    Mr. Farr. But do we have enough money to bolster our system 
to protect agriculture and to therefore have to minimize 
eradication, like the fruit fly that you are talking about? 
That is a huge eradication program that has been going on for 
25 years or longer.
    Why is there a reduction in the specialty crop line item, 
knowing that the continued pressure for invasive species is 
going to hamper agriculture and impact our trade? The fresh 
fruits and vegetables out of California are wanted all over the 
world, and vice versa.
    Mr. Shea. We think that the level of spending on those 
programs is appropriate. What we think may not be appropriate 
is the share of costs between the Federal Government and the 
State governments. And that is what we are proposing here, is 
to shift some of those costs from the Federal Government and 
our declining appropriation to State governments.

                         LIGHT BROWN APPLE MOTH

    Mr. Farr. Well, I am all for that. But I think you cannot 
abandon your leadership role, particularly on the light brown 
apple moth. As you know, we have failed in the eradication, but 
we are moving to control and contain through the protocols. We 
do not want that dropped and left to the States, where 
everybody then starts a crazy war in this country of State 
against State.
    So I think it is important that you maintain your attention 
and bring resources to that. Can you commit that that is what 
you do to continue your effort in that regard?
    Mr. Shea. We are certainly committed to carrying out the 
light brown apple moth regulatory program, which has enabled 
tens of millions if not hundreds of millions of dollars' worth 
of product to move out of California, and particularly into 
Canada and Mexico and other parts of the United States. We are 
certainly committed to the----
    Mr. Farr. Well, there is a program where the industry puts 
up a lot of dough because they have got to go through all the 
protocols to make sure that they get the clearances. We just 
want you to make sure that you are involved in holding us to 
those protocols, and having money to do it.
    The other thing I would hope that you will do with these 
States is that I think we do this poorly throughout government. 
Some States just do not want to tax. They do not want to spend 
any money. Well, we ought not to give them money. If you are 
going to come in and get grants around here, the first thing 
that is asked is, how much money have you got in the game?
    We ought to be asking States, how much money have you got 
in the game to help solve this problem? And if they are not 
putting any money in it, we ought to put them at the end of 
this list. Help those who help themselves. That is a good 
Republican motto.
    I want to ask a question of Anne Alonzo, because you went 
to my district, and I loved your visit and I think you loved 
our district. It was really a love fest. [Laughter.]

                          ORGANIC AQUACULTURE

    Because you saw all the organic that we are doing and the 
ability to expand that market. So I am asking, when can we 
expect to see the rule clear USDA and OMB, and what are the 
timelines for the organic aquaculture rule?
    Ms. Alonzo. Thank you, Congressman.
    Mr. Farr. People want to grow fish and shellfish 
organically as well.
    Ms. Alonzo. We know the proposed rule is important to you. 
It is important to us. It is in departmental clearance, and we 
are expediting it. We hope to have the rule out of the 
Department in the next few months. From the Department it will 
go to OMB because it is economically significant. We figure it 
will be about there 90 days. And it took time. Some of the--
sorry.
    Mr. Farr. What is the bottom line about the rule. When do 
you think it is going to be out there?
    Ms. Alonzo. This year.
    Mr. Farr. This year?
    Ms. Alonzo. Yes. This year.
    Mr. Farr. Summer? Fall? Winter?
    Ms. Alonzo. We would hope that it would be out by May or 
June from the Department.
    Mr. Farr. Thank you.
    Mr. Aderholt. Mr. Rooney.

                            CITRUS GREENING

    Mr. Rooney. Thank you, Mr. Chairman.
    I wanted to talk about--I come from one of the largest 
citrus-producing districts, I think, in the Congress, if not 
the largest. And obviously, citrus funding is of utmost 
importance to my growers. So I wanted to talk first, if I 
could, about the citrus funding in the Multi-Agency 
Coordination (MAC) for the fiscal year 2016 budget. As you 
know, it provides an additional $7.5 million increase for the 
Huang-longbing (HLB) MAC.
    If you could for the Committee, could you go into more 
specifics about the USDA's plan for these additional resources? 
Like will this be for new research or existing programs or 
both? And if it is just existing, are you able to target that 
existing funding in a way that still gets at the critical 
needs?
    Mr. Avalos. Congressman, I am going to ask Mr. Shea to 
answer the question. But before I do that, I just wanted to 
emphasize that we understand how devastating this disease--
citrus greening--has been to the industry. And I want to assure 
you that we are doing everything we can to put tools in the 
hands of the growers so they can continue to be productive. We 
get it, and we are on board to support.
    I want to thank the Committee for the $20 million that was 
put in for a MAC group. I think that money is put to good use. 
We look for practical solutions, practical tools, that we can 
use today to help our growers.
    So anyway, I just wanted to----
    Mr. Rooney. Well, just if I could before you give the 
answer, I echo that and I thank you for saying that because it 
is a critical time. Driving around my district in the counties 
that I have and talking to the growers there, they do feel like 
we are at that moment of truth where they are either going to 
encourage their kids to get involved in this business or they 
are not.
    And I hear that more and more. And it is pretty depressing. 
But they are encouraged by what we are both doing, and so I 
think that that is why it is important that we reiterate and 
answer this question and encourage those growers that there is 
hope.
    Mr. Avalos. Absolutely, Congressman. And I did spend some 
time in your State and I did meet with quite a few of your 
growers. And we are committed to support the industry.
    Mr. Rooney. Thank you. Thank you, sir.
    Mr. Avalos. I am going to pass it on over to Mr. Shea.
    Mr. Shea. As the Under Secretary said, we are trying to 
focus the $20 million you generously provided to us last year 
and the $7.5 million we are proposing for 2016 on quick-hitting 
things that can help citrus growers in Florida, California, and 
Texas right away.
    We need to be able to have quick detection, we have to have 
citrus groves stay sustainable once they do incur some 
infection, we need to have therapies, and we need to have more 
vector control. So there are some things we are doing for that, 
really interesting things. And we are providing money to 
universities, private companies, all who come up with good 
ideas to try.
    For example, detection: We are learning that dogs can 
detect the disease, and so we can identify the disease faster 
than with visual survey. So that is one thing we are doing.
    Sustainability, several things we are trying to do there. 
One is, as I am sure you are well aware, there are abandoned 
citrus groves in Florida and they become reservoirs of 
infection and of the vector. And so we are providing money, in 
connection with Commissioner Putnam in Florida, helping to 
clear those fields or those groves and to have those not become 
reservoirs. So managing those groves is important.
    We are trying therapies that can help trees maintain their 
useful life. One that seems to be really promising is thermo-
therapy. Indeed, using the good Florida sun, heating the trees 
to a certain degree, can reduce the infection load. And one of 
the allocations currently that we have is for a company to 
figure out how to cover 150 trees at a time because, obviously, 
one tree at a time will not help. So that is something we are 
funding this year. There is half a million dollars' worth of 
work on that.
    And we are funding more work on antimicrobials, and more 
funding to release more parasitoids and other enemies of the 
Asian citrus psyllid that carries the disease. So we are doing 
lots of these things that we hope will buy time while some of 
the longer-term research, funded through the Farm Bill, will 
come through.
    Mr. Rooney. Thank you. And I will come back if--are we 
going to do another round or should I try to ask another 
question real quick?
    Mr. Aderholt. Since your time has expired----
    Mr. Rooney. Yes. Okay. I yield back. Thank you very much.
    Mr. Aderholt. We will try to do another round. We are 
uncertain about the floor schedule, but we will proceed on as 
best we can.
    Ms. Pingree.

                            ORGANIC CHECKOFF

    Ms. Pingree. Thank you, Mr. Chair. Thank you all for being 
here today and for your work on behalf of the farmers across 
the country and the consumers as well.
    I am going to ask a question of Administrator Alonzo about 
the organic checkoff and some of the organic things. I know you 
are very focused on the growth of the organic sector, and 
certainly understand that for a State like Maine, as part of 
the ability for agriculture to come back as an important part 
of our economic growth, the organic sector has provided a 
really important market.
    But I want to talk to you a little bit about the checkoff 
program. The Farm Bill included language that would exempt 
organic producers from paying into commodity checkoff programs, 
so that was a positive way to move forward.
    But the next proposal being considered is the creation of 
the checkoff program for the organic industry. Farmers and 
processors with a certain level of income would pay into the 
program, which USDA oversees but does not fund, and then that 
money, as you know, goes on to fund research, marketing, 
promotion campaigns, a lot of very good things to help people 
understand the organic sector better and for this to strengthen 
the sector.
    I just want to weigh in on the importance of making sure 
that this checkoff represents all farmers, from those farmers 
with a few acres, which are a very important part of this 
growing industry, to the giants that are out there really doing 
great work in feeding people organic food.
    So I think my question is, if the proposal exempts the 
smaller farmers from an assessment and from voting in the 
program, how do we make sure that those voices are included in 
the decisions that are going to be made, given the fact that 
there are more certified organic farmers in the small to 
medium-sized group, but some of them will not be included in 
this? And just in the discussion of this, what is the timeline 
for moving forward on this? You get my questions?
    Ms. Alonzo. Thank you, Congresswoman. First of all, all 
organic producers are important to us, small and large. And 
over the past year we have met with multiple groups about the 
Farm Bill authorization for the checkoff. No single group has 
control of this process.
    In terms of how the process works, the organic industry 
initiates it by filing a proposal with AMS, and the proposal 
must also indicate industry support for the proposal. We do not 
have a proposal yet so it is kind of difficult to talk about 
particulars.
    But in fact, any group is able to submit a separate order 
or submit a partial order or comment on the proposal that we do 
receive throughout the process. So there are many opportunities 
for everybody's to input. But before any of this becomes final, 
there will be a referendum vote and eligible voters will be 
able to vote.
    And so I just wanted to assure you that we are hearing all 
voices large and small, and there is ample opportunity for 
public input in this process.
    Ms. Pingree. Great. Well, thank you for your reassurance. 
It is certainly critically important.
    And I yield back.
    Mr. Aderholt. Dr. Harris.

                   HIGHLY PATHOGENIC AVIAN INFLUENZA

    Dr. Harris. Thank you very much.
    Let me start just by asking a couple of questions about the 
Avian Influenza virus because I have poultry in my district and 
am worried about that. Are there other actions that could have 
been taken by your agency or need to be taken with regards to 
the Avian Influenza at this point? And do you have the proper 
funding in this year's budget to do those actions?
    Mr. Avalos. Congressman, first I want to emphasize that at 
USDA at APHIS, we are committed to protecting the U.S. poultry 
industry from high-path avian influenza. We have a very good 
working relationship with our State partners, a very good 
relationship with the stakeholders, with the industry, and we 
have the best surveillance program in the world.
    Now, what has happened, when we had our two detections in 
California, several countries, they did not follow 
international guidelines. The World Organization for Animal 
Health (OIE) established these criteria as to how you restrict 
should an outbreak come out, and they encourage that you only 
restrict an area or a region or a State.
    Several of our trading partners did not do that. And so I 
just want to assure you, Congressman, that from Secretary 
Vilsack on down, we are communicating with our trading partners 
and working to get them in line with OIE guidelines.

                         AQI USER FEE INCREASES

    Dr. Harris. Well, thank you. Now, with regards to the 
agricultural quarantine and inspection user fees, my 
understanding is that USDA has proposed significant changes 
both to user fees and the overtime reimbursement rates. But we 
had language in the 2015 Omnibus, I think, that required you to 
take into account stakeholders' opinions before issuing the 
rule.
    Apparently the webinar was held on January 13 with the 
stakeholders, the final rule submitted to OMB on January 16. 
Now, you either did some pretty quick drafting in those three 
days or it appears that it was just a check-off-the-box 
action--yes, we have to talk to the stakeholders, so we will 
wait three days and publish the rule or submit the rule.
    Were there significant changes made taking stakeholders' 
opinions into account?
    Mr. Avalos. Congressman, I am going to ask Kevin Shea to 
answer your question. But before I do that, I just wanted to 
emphasize that Mr. Shea and his team at APHIS have put a lot of 
effort into this user fee. For the longest time, it has been on 
their agenda. So I know that it has not been something that 
they just did quickly. They have spent a lot of effort on 
developing an AQI user fee rule.
    So anyway, I will ask Mr. Shea to answer your question.
    Mr. Shea. Prior to the webinar you mentioned, we had had 
five or six public meetings or webinars before that. We had an 
open comment period, which was extended, as well. So many of 
the things we heard on January 13 were the same things we had 
heard in many of those other webinars.
    We were already prepared to make some adjustments in the 
initial proposal based on that feedback. And I think whenever 
we do publish a final rule, you will see that that feedback was 
addressed. But what we heard that day was the same thing 
generally that we have been hearing pretty much at all the 
other times.
    Mr. Harris. And when you took into account--because not 
only the service fees went up but the overtime reimbursement 
rates. And when you analyzed the impact on your stakeholders, 
was it just for each one individually or the fact that they 
could get hit with increases in both of them?
    Mr. Shea. We looked at those both in tandem. For example, 
there is one fee that has been very controversial--about a fee 
to oversee treatment, for example cold treatment or fumigation. 
And we were able to take that in tandem with the overtime rule 
as well to make some adjustments. So we definitely took them 
both into consideration in tandem.

                     FOOT AND MOUTH DISEASE VACCINE

    Dr. Harris. And just the last thing I am going to ask about 
is the foot-and-mouth disease vaccine. I know some of the 
livestock producers are concerned that although it is not a 
problem in the country now, that it could be at some point. And 
the way we do it is I understand we have the antigen here, but 
we send it to Europe to produce a vaccine. It seems a little 
cumbersome.
    Do we have the ability, given that system, to address an 
outbreak of foot-and-mouth disease in the United States? Do we 
have adequate resources? Do we have an adequate amount of the 
vaccine?
    Mr. Shea. Our first response to any foot-and-mouth disease 
occurrence in this country would be to try to stamp it out 
without vaccination. We have good surveillance systems in 
place. I think we would find the disease very quickly. And of 
course, we are lucky enough--we have not had it here in over 85 
years; we hope we will never have it here--but we have good 
surveillance that we think can find the disease quickly so that 
stamping it out could work.
    In the long run, vaccination is probably the way we should 
go. That is the way the rest of the world operates now with 
foot-and-mouth disease. To have an adequate amount of vaccine 
would be enormously expensive, and the amount of vaccine we 
have now certainly would not allow us to enter into a 
vaccination-only approach to a foot-and-mouth disease 
incursion.
    So I think it is really vital that we work with our 
industry stakeholders and others in trying to find a financial 
system to support a larger vaccine bank.
    Dr. Harris. Thank you very much. I yield back.
    Mr. Aderholt. Mr. Bishop.

                     SHELL EGG SURVEILLANCE PROGRAM

    Mr. Bishop. Thank you very much. I apologize for my 
delinquency. I had a conflict with another Subcommittee. But 
let me go to reductions in the shell egg surveillance program.
    According to your budget justification, the shell egg 
surveillance program inspects registered shell egg facilities 
and monitors the disposition of restricted eggs to limit the 
number of restricted eggs that get into consumer channels. 
Stoppages in the program could disrupt markets for the product 
and it could endanger customer health.
    So I find it a little bit curious that the Administration's 
budget proposal is to cut the program's budget by 17 percent 
and, more importantly, reduce the staff of the program by half. 
Packing plants in the past have gone through inspections at 
least four times annually and hatcheries once a year. Will you 
continue to be able to conduct these inspections at the 
frequency that they have occurred in the past, and in fact, are 
four annual inspections actually frequent enough?
    Inedible eggs are a small proportion of all shell eggs and 
they are typically destroyed, but a significant number is used 
for animal feed. Can you tell me how you are going to be able 
to do that? In other words, you have got to do more with less.
    Mr. Avalos. Congressman, Administrator Alonzo is going to 
answer the question for you. Administrator Alonzo will answer 
the question.
    Ms. Alonzo. Thank you, Congressman. Yes, we are requesting 
a decrease of $444,000 for two reasons. One is industry 
consolidation, which has reduced the number of facilities that 
need inspection. There has been a 28 percent decrease from 2000 
to 2013, so we have fewer facilities to inspect.
    Number two, we have better compliance. The number of 
compliance actions resulting from inspection has decreased by 
almost 70 percent in this same time frame. So less facilities, 
better compliance, and our service is not going to suffer.
    We have scheduled visits to these shell egg handlers. It is 
going to remain the same, four times per year, and annual 
visits to hatcheries. So we feel good about this decrease.
    Mr. Bishop. Thank you. Thank you for clarifying that.
    I think all of us have been concerned with the ongoing 
situation in Ukraine, and in particular, Russia's annexation of 
Crimea. As you know, APHIS began a new initiative to open and 
expand markets to Belarus, Kazakhstan, and Russia for U.S. day-
old chicks and hatching eggs, which was a very significant 
development for our poultry exporters here in the U.S.
    Can you give us an update on the status of our export 
activity in the region and whether or not the conflict in the 
region has had an impact on our agreements with the nations 
involved?
    Mr. Avalos. Congressman, we are going to have to get back 
to you on that question.
    [The information follows:]

   Day-Old Chicks and Hatching Eggs Exports to Russia, Belarus, and 
                               Kazakhstan

    APHIS has agreed to conditions for the export of day-old chicks and 
hatching eggs to the Russian Federation, Belarus, and Kazakhstan. The 
recent outbreaks of highly pathogenic avian influenza (HPAI) in the 
United States have impacted the existing conditions, with these 
countries now prohibiting the import of day-old chicks and hatching 
eggs from regions where HPAI outbreaks have been identified.

                     GENETICALLY MODIFIED ORGANISMS

    Mr. Bishop. All right. I still have some time. Let me ask 
you about the genetically modified organisms (GMOs). The APHIS 
enforcement program is designed to promote the integrity of the 
APHIS program for providing effective investigative and 
enforcement services. This funds biotechnology and regulatory 
services activities, which support the Department's strategic 
goal of helping to promote ag production and biotechnology 
experts by deregulating biotechnology products that are found 
safe for agriculture.
    In addition to the COOL debate, there continues to be 
considerable attention given to the issue of genetically 
modified organisms, GMOs. In both instances this has become a 
major concern for many of my producers, not only on the animal 
side but the fruit and vegetable side.
    Can you give us an update of your activities related to 
GMOs and whether the Department should be playing a greater 
role if not the leadership role in making sure that the public 
is made aware of all sides of the GMO issue, and in particular, 
the extensive current use of modified seeds, such as Roundup-
ready seeds for cotton and peanuts, for a variety of 
commodities, and the current research which is underway at our 
major land grant universities, and the real plans to expand the 
use of such research and technologies in other areas of the 
food chain.
    Mr. Avalos. Congressman, I am going to ask Administrator 
Shea to answer part of that question, anyway.
    Mr. Shea. Our role in regulating biotechnology or 
genetically engineered products is simply to determine whether 
or not a proposed product would be a plant pest or not. The 
Environmental Protection Agency (EPA) has a role. The Food and 
Drug Administration (FDA) has a role as well. We believe, as 
Secretary Vilsack has emphasized since he took office, that 
coexistence is so important; that there is room for genetically 
engineered, conventional, and organic growers throughout the 
country.
    Just next week we are having a major conference in Raleigh, 
North Carolina, bringing together all of those sectors to get 
input about genetically engineered products and how they can 
coexist. And all sectors will be there. And we think that is 
part of our effort to do as you suggested, to communicate with 
and help educate all aspects of American agriculture about what 
we are doing.
    Mr. Bishop. As you know, it is pretty controversial and it 
is beginning to fuel a lot of debates across the consumer 
market as well as the production markets. And of course, it 
impacts us when we consider exporting also because some of the 
European countries and other countries are very, very 
particular about not having GMOs come into their food chain.
    So are you the lead agency on it? Would you say that the 
other agencies, EPA and FDA, are further ahead of you, or are 
you working equally? Who is the lead agency?
    Mr. Shea. We work equally. Since 1986, in fact, there has 
been a consolidated framework for regulating genetically 
engineered agriculture, and FDA, EPA, and USDA have worked 
together equally over the entire almost 30 years now.
    Mr. Bishop. I think my time has expired.
    Mr. Aderholt. Mr. Young.

                MARKET NEWS REPORT--NATIONAL HOG REPORT

    Mr. Young of Iowa. Thank you, Mr. Chairman. And guests, 
thank you for coming before us today. We have a vote here soon 
so I am going to try to do this quickly.
    Ms. Alonzo, independent pork producers in my district have 
raised an issue regarding the national hog reports that are 
prepared by the AMS. Smaller independent producers sell on the 
prices based in your reports, and this has led to a very small 
proportion of overall sales nationally dictating prices for 
smaller producers, they believe.
    There is some concern that the current reporting 
methodology may not be offering the most fair price to farmers 
and that there could be price manipulation taking place in the 
market. Can you address those accusations and those fears that 
are out there? They are real. I see you raising your eyebrows, 
but I hear that in my district. Can you tell a little bit about 
your methodology?
    Ms. Alonzo. Well, you are referring to our Market News 
reports. These are the reports that are unbiased, and they are 
timely, and they are free for the public. And we issue hundreds 
of them every day, a quarter of a million a year. A lot of use.
    I am not familiar with what you are mentioning in terms of 
the distortion, and we would be happy to go back and look at 
that--unless, Under Secretary Avalos, do you want to speak to 
that issue?
    Mr. Avalos. Congressman, one thing I do want to mention is 
we do have livestock mandatory reporting. And I think this is 
very, very important to talk about because livestock mandatory 
reporting, it does encourage competition in the marketplace. It 
does create transparency. It does give us more quality price 
and supply data. And I think this is very important to the 
small producer.
    I do want to mention that this authority expires this year, 
and we do need support for reauthorization so we can maintain 
this quality supply and price data.
    [The information follows:]

                    Market News--National Hog Report

    AMS Market News is aware of the concern that the daily hog market 
can appear to be volatile because it is thinly traded with a limited 
number of buyers and sellers participating in the negotiated hog 
market. In an effort to normalize the reported market information, AMS 
is developing a five-day rolling average of the daily negotiated hog 
prices to be published in the current swine reports.

    Mr. Young of Iowa. Thank you. When we have more time, maybe 
we can have a meeting and follow up on this. But I appreciate 
that.
    Mr. Avalos. Absolutely, Congressman.

          BIOTECHNOLOGY REGULATORY SERVICES--PETITION REVIEWS

    Mr. Young of Iowa. Mr. Shea, in your testimony, you discuss 
how USDA is making the approval process for biotechnology 
products more efficient. Would you comment on the new process 
specifics, how they are streamlining the biotech approval 
process?
    Mr. Shea. There are several things that we are doing, Mr. 
Congressman. One is, it seems remarkably simple, but when we 
reviewed the business process that we used for deregulation, we 
saw how many different approval steps there were. And we simply 
were able to reduce some of those, and also give people a 
little less time to complete their part of the work. So that 
was one piece of it.
    A second piece is that we now publish an initial risk 
assessment so the public can see, so we can get input from the 
public very quickly and not drag out the process quite as long. 
We get a lot of input right up front with our initial risk 
assessment on any deregulation. So that is another thing we 
have done.
    Also, I would be remiss if I did not say the Committee has 
provided more funding for that item over the last several 
years. And that has allowed us to have more scientists on board 
to review the petitions, do the analysis. As Congressman Bishop 
pointed out, these are highly controversial things. We need to 
make sure we get it right because we do end up in the courts on 
many of these cases.
    Mr. Young of Iowa. Well, thank you. And I do have some 
questions for the record I will submit--we are short on time--
if that is okay, Mr. Chairman.
    Mr. Aderholt. That is fine.
    Mr. Young of Iowa. Thank you folks for your time.

                       COUNTRY OF ORIGIN LABELING

    Mr. Aderholt. Let me turn back to talk a little bit more 
about COOL. The fiscal year 2015 Omnibus directs the Secretary 
to work with the U.S. Trade Representative and to submit to 
this Committee a report with legislative language that would 
establish the country of origin labeling program for beef, 
pork, and poultry, which you know. And the report is due May 1.
    I asked the Secretary when he was here a week or so ago 
about this. My question to you is can we have your assurance, 
Mr. Under Secretary , that we will receive that report by May 
1?
    Mr. Avalos. Mr. Chairman, at USDA we stand ready to work 
with Congress on the next steps of addressing COOL.
    Mr. Aderholt. But do you all think that you all will have 
something to come back to Congress by May 1?
    Mr. Avalos. Mr. Chairman, I guess my answer to you would be 
that the request we take serious. And right now we do not have 
a regulatory fix, as the Secretary mentioned, and Congress 
really needs to amend the statute in order to move forward 
should we lose that appeal. So I can just tell you that we have 
taken the request seriously and that we stand ready to work 
with you to move forward.
    Mr. Aderholt. Well, if the U.S. does not win an appeal at 
the WTO, meaning, of course, industries will face retaliation, 
what commodities and industries are being targeted by Canada 
and Mexico for retaliation, and how much do you estimate that 
these various sectors will have to pay in tariffs?
    Mr. Avalos. Mr. Chairman, I do not have that information. 
That would probably be a question for USTR.
    Mr. Aderholt. Anybody have any more comment on that at all? 
[No response.]
    [The information from USDA follows:]

                       Country of Origin Labeling

    AMS is not aware of any official list of industries or commodities 
that would be subject to retaliation by Canada or Mexico, provided we 
lose the appeal. Should the WTO Appellate Body rule against the United 
States in the appeal of the COOL case, Canada and Mexico would have the 
right to request authorization from the WTO's Dispute Settlement Body 
(DSB) to suspend trade concessions. At that time, Canada and Mexico 
would inform the DSB and the United States of both the total level of 
retaliation proposed and the commodities for which Canada or Mexico 
seek to suspend concessions. The United States would have the 
opportunity at that time to object to the level of suspension proposed, 
in which case the matter would be referred to binding arbitration 
before a WTO Panel.

    -Mr. Aderholt. Okay. Excuse me just a second. [Pause]

                     TRANSPORTATION INFRASTRUCTURE

    We have got a vote going on, so we are just trying to 
monitor to make sure we can keep this going forward while we 
are voting at the same time.
    The United States has seen record levels of agricultural 
exports for the past few years. Your mission area has a large 
focus on trade and marketing opportunities for all agricultural 
products and plays a key role in that outcome. However, it 
seems that the focus on increased trade opportunities without 
consideration for infrastructure to adequately support it can 
be a little bit short-sighted. The rail situation and the 
disruptions at our ports are recent examples that USDA is 
reacting to the domestic international commerce circumstances 
instead of providing a proactive plan to move forward.
    With the latest budget request, there is a continued 
emphasis on expanded trade and marketing opportunities. 
However, the concern is that we do not have the infrastructure 
fully in place to support them. Having the goods available but 
not being able to deliver them just do not really seem to make 
a lot of sense, and it is a little disconcerting to see the 
Department's lack of a comprehensive vision in long-term 
planning to ensure the infrastructure is solid and to make sure 
that you are expanding these efforts.
    Can you provide us some particular examples of how the 
Department is looking at all aspects of transportation 
infrastructure to see how a comprehensive solution will benefit 
America's producers?
    Mr. Avalos. Mr. Chairman, I can comment just briefly on 
rail transportation. In my mission area at USDA, we do not have 
jurisdiction over transportation per se. However, we do have a 
component of AMS that looks at rail transportation from the 
perspective of agriculture. And we do testify in front of the 
Surface Transportation Board and we make recommendations on 
behalf of agriculture.
    Mr. Aderholt. I realize the Department has focused heavily 
on local and regional markets. But I would ask you commit today 
to providing the Committee with a long-term infrastructure plan 
that benefits all producers and not just those that market 
their products locally, and you give us that assurance that you 
will do that.
    Mr. Avalos. Oh, absolutely. At USDA our focus is on all 
components of agriculture, and local and regional just happens 
to be one component.
    [The information follows:]
    
  [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]  
    
    Mr. Aderholt. We are going to have to go into recess for 
just a minute for us to go cast our vote. And so we will 
reconvene probably in about 15 minutes. So we will just adjourn 
for 15 minutes.
    [Recess.]
    We will try to get back on track. Thank you all for your 
patience on the vote.
    I would like to now go to Mr. Farr.

                         RETAIL PET STORE RULE

    Mr. Farr. Well, thank you very much, Mr. Chairman. I am 
sorry Mr. Rooney is not here. He mentioned about kids not 
wanting to take over their parents' farms because they think it 
is a losing proposition.
    What I love about this Committee and the U.S. Department of 
Agriculture essentially is it is the rural America department 
that really handles the infrastructure of rural America. I hope 
that we will realize that if indeed rural America, as the 
Secretary indicated not this year but last year in his opening 
remarks, has not been in a recession; it has been in a 
depression.
    But when you think about the infrastructure, of trying to 
WiFi it and bring broadband in, that is under the jurisdiction 
of this Committee. When you think about the fact that what we 
are talking about here today is to sustain the health and 
safety of plants and animals, and I would say to Mr. Rooney, 
one of the things we need to do is we also need to realize that 
you cannot start a business in agriculture without millions of 
dollars in agricultural areas like my district.
    But the exception to that is these really small growers, 
starting off just going to farmers markets and doing organic 
where they do not have the cost of inputs. The bigger growers 
are having a big problem because it costs about $35,000 an acre 
to plant an acre of strawberries. Now, the pickers will get $19 
an hour. That is higher than Costco's wages. And you cannot 
find the farmworkers.
    So we have a huge labor shortage, which is, I think, why we 
need the Ags jobs bill. But anyway, that is just one of my 
lectures, that I think that this Committee is so able to really 
infuse energy into rural America. And I think that the growth 
industry for small businesses can be there as long as we 
support them at this level.
    One of the things, speaking of small businesses, that I 
tried to eliminate was puppy mills. I started in California 
when I was in the legislature, and I have been very interested 
since I have been in Congress because I do not think you ought 
to be making money in an inhumane way.
    And USDA finally got started in addressing the puppy mill 
problem by implementing the retail store rule and the puppy 
import rule. And so I want to know what has happened with the 
progress you have made on licensing the internet sellers and 
ensuring that puppies are not entering this country from 
foreign puppy mills for resale.
    Mr. Avalos. Congressman, this was a major concern. The 
loophole was there. And of course, Kevin Shea and his APHIS 
team did address it, so I am going to ask Mr. Shea to respond 
to your question.
    Mr. Shea. Mr. Farr, with the retail pet store rule, we have 
had 133 entities come under license since we put that into 
place, and our best knowledge so far is that about 30 to 35 of 
those were entities that had had a license many years ago and 
dropped it, and we believe possibly taking advantage of the 
internet loophole.
    So we think we are headed in the right direction by having 
that many more entities come under license, and seeing that we 
are getting back some of the ones who dropped their license 
when they said they were no longer breeders. They were retail 
pet sellers. So I think we have made some really good progress 
on that, and we will continue to work on it.

                           MARKET DIRECTORIES

    Mr. Farr. Well, would you let us know? I want to follow 
through. I just think we ought to put the puppy mill breeders 
out of business anywhere in the world, particularly if they are 
trying to get access to the American market.
    One of the things that I also wanted to compliment you on, 
and maybe you can comment on it, is the work you are doing on 
creating the national on-farm market directory. It seems to me, 
in this light of trying to give people opportunity--what I have 
seen in agriculture, and Mr. Valadao is certainly in it for a 
living and I am just in it on the sidelines, but the 
consolidation has just allowed no market competition.
    You are a beef operator, and boy, the prices are stable. 
And now you grow your beef cows on grasslands, and you can go 
to a local slaughter, hopefully; we are going to try to build 
that. And there you can keep it organic, and you can go and 
sell it in a farmers market and all that. These really are 
nifty new markets that are opening up, and restaurants who want 
to buy directly from growers.
    And now you are putting together this national on-the-farm 
market directory, and I wanted to know how that is coming. I 
guess you are doing town hall meetings to show rural America 
how they can get better educated, and for the assistance that 
you can give them, technical assistance for how you can do 
local food promotion program grants, how you can work with the 
regional rural development centers to conduct grant-writing 
workshops. All these things sound really cool to me.
    And I want to know, is it effective? Are people excited 
about this opportunity to see a light at the end of the tunnel, 
that maybe their dreams of being in agriculture might have some 
play out? I know you have converted some--I read that you 
converted an historic flour mill in Pennsylvania to a farmers 
market, a train depot in Tennessee, a ferry building in 
California, and shipping containers in New York. Is that still 
going on, and what is the response?
    Mr. Avalos. Congressman, first I want to say that we are so 
lucky in this country that our agriculture is so large and so 
diverse, and there are so many different types of growers, so 
many different products. And I just want to emphasize this, 
like I mentioned to the Chairman earlier.
    At USDA, we are focused on all types of agriculture. It is 
true that the bulk of the agriculture in this country is what 
we call your mainstream agriculture. But some of the local and 
regional--when I was in New Mexico, as you know, Congressman, I 
worked a lot to develop local and regional markets for small 
farmers. And this was an area that has been ignored for a long, 
long time.
    And as I mentioned to the Congresswoman earlier, back home 
a lot of agricultural land that had irrigation water rights was 
not being farmed. And it was not being farmed because the small 
grower did not have a place to go with his product. He could 
not pay the bills if he grew a crop on that farmland. But when 
you did not grow on that farmland, you lost your water rights. 
Three years in a row, your water rights were gone. So that is 
another component of this local and regional that is so, so 
important.
    But to get into your question on the directory, I am going 
to ask Ms. Alonzo to expand on it. Thank you.
    Ms. Alonzo. Thank you, Mr. Under Secretary.
    Yes, Congressman Farr. There is a lot of consumer interest 
and demand for local/regional information. In fact, last year 
we had about 2,000 requests for support. And as you mentioned 
in terms of supporting the rural economy, Secretary Vilsack has 
made support of local/regional as one of the four pillars in 
terms of how we are going to support the rural economy and 
economic development and jobs.
    And so we are very proud of that. Something called the 
``Know Your Farmer, Know Your Food'' Initiative across the 
Department, where we are looking at how we can support this 
growing industry, and we have had about 3,000 projects that we 
have been advancing throughout the United States because of our 
work collectively.
    There is a lot of demand. We just had an estimate of about 
$6.1 billion in sales in this area and growing. And in terms of 
my agency's role, we have a multifaceted role--technical 
assistance, research and information-gathering, procurement and 
grant-giving.
    But to your point, we recently put together four helpful 
directories. There is such a need for information. Folks are 
looking for where is the farmers market? Where is the food hub? 
And so we have directories on farmers markets, food hubs, 
community-supported agriculture, and on-site farm store 
directories. They were just launched. They are voluntary, and 
people are starting to put their information in so people can 
become aware of where these----
    Mr. Farr. Can you shift that into--do not answer this 
question except for yes--can you turn that into agritourism, 
all that information? Yes, you can.
    Ms. Alonzo. I am sure we can, and we will say yes.
    Mr. Aderholt. Mr. Valadao.

                    CALIFORNIA MILK MARKETING ORDER

    Mr. Valadao. Thank you, Mr. Chairman. Thank you, Under 
Secretary , for taking the time out for us today.
    My first question is actually directed towards Ms. Anne 
Alonzo. Obviously, the California dairy industry is something 
close to my heart, as I am the only dairy farmer in Congress.
    On February 5, 2015, USDA received a formal hearing request 
from California Dairies, Incorporated, Land O'Lakes, 
Incorporated, and Dairy Farmers of America, Incorporated, all 
coops representing the majority of California milk, which is 
owned by, as coops are all owned, by U.S. dairy farmers, to 
establish a Federal milk marketing order for the State of 
California.
    Ms. Alonzo, can you provide us an update on the status of 
California's application to establish a Federal order?
    Ms. Alonzo. Yes, Congressman Valadao, and thank you for 
your leadership in this area. Yes. My agency received the 
proposal on February 5, and we are now requesting additional 
proposals. We posted the proposal online, and we again 
requested the additional proposals.
    We have also sent out by mail to 2,000 folks this 
information. We wanted to make sure that this is very open and 
folks can understand what we are doing.
    Mr. Valadao. The 2,000 are dairy farmers?
    Ms. Alonzo. We believe so, yes. In terms of next steps, 
there are next steps. In May 2015 we are going to host three 
public outreach sessions throughout the State, and folks will 
have the ability to explain the intent of their proposals and 
we can explain the rulemaking process.
    Then we are going to follow a formal rulemaking hearing 
process to investigate the merits of this request. And in terms 
of when we can expect the hearing if that were to happen, it is 
going to be in September 2015, most likely in the Central 
Valley of California, and we expect it to last several weeks. 
And if initiated, rulemaking is expected to take over two 
years.

                         TRADE-RISK ASSESSMENTS

    Mr. Valadao. All right. Thank you.
    And then Under Secretary Avalos, USDA is proposing to amend 
regulations governing the importation of fruits and vegetables 
by broadening the existing performance standard and using 
notice-based process.
    Under Secretary Avalos, would this expedited process allow 
for access to the U.S. market without OMB and the Secretary 's 
review? And would potentially impacted parties have the 
opportunity to thoroughly review the risk assessment or to have 
OMB consider economic impacts to the U.S. economy, as in such 
cases as the lemon imports from Argentina?
    Mr. Avalos. I guess the general answer is no. We are 
looking at more efficiency, to do the job better, to meet the 
needs of the stakeholders.
    Mr. Valadao. What stakeholders are you referring to?
    Mr. Avalos. It would be importers and exporters. But I am 
going to ask Mr. Shea to answer your question because I know 
that he has worked quite a bit on this issue.
    Mr. Valadao. All right. Thank you.
    Mr. Avalos. Now, before I do that, I did want to mention--
you mentioned lemons from Argentina. I know that is a concern 
in California. I have had California folks come in to see me 
several times on this issue, and I just want to assure you and 
assure your citrus industry in California that before we start 
talking about a proposed rule for lemons from Argentina, that 
APHIS is going to do a very, very thorough site visit into 
Argentina.
    We are going to make sure that mitigations are in place, 
that mitigations would not be removed over time, to prevent the 
entry of any pest or disease from Argentina. But again, this is 
in the very, very early stages, and I just want to make you 
aware, Congressman----
    Mr. Valadao. Appreciate that.
    Mr. Avalos [continuing]. That it is on our radar and we are 
talking to your industry.
    Mr. Valadao. Thanks.
    Mr. Shea. To get to some of your specific questions, the 
Secretary would always have to approve anything that we did 
along these lines.
    Second, while OMB would not have formal approval 
involvement, they certainly would have informal involvement, 
and we are working with them so that they would always have the 
opportunity to look at one of these things before we do it.
    And I think the ironic thing here is we really are 
proposing this to try to help stakeholders. You asked the 
question, who are the stakeholders. We really think we need to 
streamline our import regulation process because when we go to 
other countries to try to gain new markets, often the question 
back to us is, well, we would like your market as well. And our 
process takes much longer than most of their processes do.
    So what we were really trying to do here was to get 
leverage in our trade negotiations with other countries by 
being able to more quickly respond to their requests, but with 
the full risk assessment done. And again, to get back to one of 
your very specific questions, even under this process, the risk 
assessment would be published with an ample comment period for 
everyone to look at it.
    Mr. Valadao. Thank you. I yield back.
    Mr. Aderholt. Ms. Pingree.

                        ANTIMICROBIAL RESISTANCE

    Ms. Pingree. Thank you, Mr. Chair, and thank you again to 
the panel for being here. And I do appreciate, Mr. Under 
Secretary , your remarks about the opportunity for all markets 
here and how important that is at the USDA because certainly, 
opening up more local and regional things and some of the 
opportunities for organic growth have really been helpful in a 
lot of the New England States and other places in the country.
    I think my question is for APHIS about antibiotic 
resistance. I do not think I have to make the case to you that 
this is a very serious health concern. The CDC has told us that 
at least 20 million illnesses and 23,000 deaths are caused by 
antibiotic-resistant bacteria each year in the U.S. alone.
    So I was very happy to see that the President's budget 
acknowledges the seriousness of that threat and allocates $1.2 
billion across the Government to tackle antibiotic resistance. 
Of that, $77 million goes to the USDA for research alternatives 
to antibiotic use, which is, as I understand it, quadrupling of 
current funding. So that is great.
    I just want to know more about how APHIS is going to work 
with USDA's research agencies to combat the issue. Is it 
working with the FDA? CDC? NIH? Just interested in a little 
more about what you think is likely to happen. Or whoever wants 
to answer the question; I did not mean to point at you.
    Mr. Avalos. Congresswoman, let me just make a comment, and 
then I will turn it over to Mr. Shea.
    I just wanted to say that at USDA, we know that the use of 
antibiotics is really important to the livestock industry. And 
it is a priority for us to make sure that, today and going into 
the future, antibiotics will still be a tool for the livestock 
industry. And that is one of the reasons that we asked for this 
additional funding.
    Now, we are going to use this money--well, you know what? I 
will let Mr. Shea expand because I know that he will have a 
better answer than me.
    Ms. Pingree. Well, thank you. Thank you both.
    Mr. Shea. I am sure he would have had a fine answer. But 
let me say that our role in APHIS is to use our on-farm 
relationships to be able to gather data. I think there is an 
assumption by some that farm practices constitute the biggest 
problem with antimicrobial resistance. And we are not sure that 
that is exactly true.
    What we want to do is gather information. So we are going 
to be doing surveys with farmers and ranchers. We are going to 
be collecting samples and testing them at our Veterinary 
Services laboratories to see what the bacteria level is on 
farms.
    So that is the kind of thing we are going to be doing. So 
we are gathering real basic data about on-farm use of 
antimicrobials to see just how they are used, and to be able to 
analyze that data and provide that to the larger national 
discussion with FDA and the research agencies.
    Ms. Pingree. Thank you. Thank you, Mr. Chair.

                          FERAL SWINE PROGRAM

    Mr. Aderholt. The committee provided $20 million to support 
a new effort that addresses feral swine in the United States. 
Animals have caused an estimated $1.5 billion annually in 
damage to the United States, and frequently have interactions 
with livestock and humans posing a real health risk.
    Can you tell us a little bit about the actions that APHIS 
has taken and what its partners have taken up to this time?
    Mr. Avalos. Mr. Chairman, first of all, again, we really 
appreciate your support to our feral swine program. As you 
mentioned, feral swine do a lot of damage, not only to cropland 
but to private property and to natural resources. And also 
another thing that a lot of people forget is these feral swine, 
they carry diseases like pseudorabies and brucellosis that 
USDA, with the support from this Committee over the years, 
eradicated in our livestock. And now these wild pigs are 
carrying these diseases.
    So we appreciate your support, and our folks at Wildlife 
Services have really done a good job to address the issue of 
feral swine. They have done a very good job to remove some of 
these pigs. They have done a good job to manage the spread of 
feral swine in several States. To date with the funding, we 
have established 41 management programs in 41 different States.
    And the good news is that in two States this year we will 
eradicate feral swine, in Idaho and in Maryland. And this is 
three years ahead of schedule. So I just want to applaud the 
work of Mr. Shea, APHIS, and Wildlife Services in this arena.

                        GRAIN EXPORT INSPECTIONS

    Mr. Aderholt. Let me switch to GIPSA just for a minute. 
Last summer there was a great deal of upheaval at the Port of 
Vancouver when the Washington State grain inspectors did not 
conduct inspection of grain shipments citing safety concerns 
due to an ongoing labor dispute at the port.
    There was an expectation and statutory requirement that 
Federal inspectors would carry out the activities in the 
absence of State inspectors. To my knowledge, Federal 
inspectors did not conduct inspections, also in citing safety 
concerns. After a great deal of delay, the situation was 
finally resolved and the Washington State inspectors resumed 
their duties.
    In order to expand trade opportunities, it is vital that 
our trading partners know we are a reliable source of goods. 
This is a situation where USDA can directly assist with export 
opportunities. I know worker safety is important, but I think 
the delay on behalf of USDA was unnecessarily long in this 
instance.
    My question is: Given what happened in Washington last 
year, should all export inspection be conducted by Federal 
inspectors?
    Mr. Avalos. Mr. Chairman, I am going to ask Larry Mitchell, 
our GIPSA administrator, to answer your question because I 
agree fully that having dependable access to the ports is 
critical to agricultural trade, and it is very, very important 
to how our trading partners think and how they feel about us.
    But this issue was very, very complicated and very, very 
complex. So I am going to ask Mr. Mitchell to answer your 
question.
    Mr. Mitchell. Thank you, Mr. Avalos.
    I believe your question was, should all the inspections be 
done by Federal inspectors.
    Mr. Aderholt. Given what happened in Washington.
    Mr. Mitchell. Given what happened in Washington. I am not 
sure that I concur with that. This was an isolated incident at 
one elevator, one elevator out of over 10 export facilities in 
the Pacific Northwest. There were some unique issues there.
    The Washington State Department of Agriculture inspectors 
found it to be a hostile and very dangerous environment to get 
in and out for work. When they had to stand down, we went in to 
do a safety assessment. That safety assessment showed that we 
needed a full safety mitigation plan to ensure the safety of 
our inspectors going in and out.
    It took longer than I wanted, and longer than everyone else 
that I know wanted, to get that plan established. We had the 
plan established, were ready to go into the facility with 
Federal inspectors, about the time that the labor-management 
dispute was resolved. In fact, we were planning to go in that 
morning, and the night before was when the agreement was made.
    But to answer your question, I do not know that we would 
have gotten in there any quicker than Washington State. It was 
a very hazardous environment. I can say that we do have that 
safety mitigation plan in place. It is on the shelf. Should 
this occur again, the time frame for dusting it off, 
reassessing it, and moving inspectors in to ensure the export 
of our grain would be much shorter.
    Mr. Aderholt. Well, in the future, I hope and I think we 
certainly expect that GIPSA will respond in a more expedited, 
swift manner if another incident like that should occur.
    Mr. Farr.

                           MARKET DIRECTORIES

    Mr. Farr. Thank you very much, Mr. Chairman. I am sorry 
about your cold. I hope you get over it.
    I want to again follow up on this directory because I see 
these opportunities opening up. We have a farmworker training 
center, not necessarily farmworkers, ag workers, who want to 
learn how to be other than just pickers. They want to be able 
to operate machinery. They want to actually go into farming. 
And it is very successful. And they have got incubator plots 
where they can start.
    What they have found is that they then go out and make 
contacts with restaurants and with the Community Supported 
Agriculture (CSAs) and develop their own marketing. I would 
love to see them get into your market directories. What are you 
doing to really outreach? Do you give incentives? You said you 
get a whole bunch of hits, but it seems to me these directories 
really ought to be--every county in America ought to have this 
directory full because I think then you can develop markets for 
the tourists and, for example, the on-the-farm markets.
    If you think about it, wineries have been on-the-farm 
markets forever. You go to the farm and you sample what they 
have and you walk away with some samples. I hope we can do that 
some with meat and poultry someday with our craziness in that 
area.
    But is there an opportunity? What are you doing to really 
go out and tell people, look, we can help you match up what you 
are making, getting people here to buy it on farm, or get 
people to buy a basketful of food that we will deliver to your 
door under the CSAs, and to list all those things? Because 
people are hungry to know about that.
    When I got here in Washington--I do not think it is legal 
any more--there used to be a guy that came in here with his 
vegetables in our building and sold them to our offices. And 
everybody raved about it because it was always fresh and it was 
right from the farm.
    But where there are opportunities for that, I hope you will 
seize it. So what are you doing to do an outreach, and 
aggressive outreach?
    Mr. Avalos. Congressman, before I turn it over to Ms. 
Alonzo, I just want to follow up a little bit on your 
agritourism comment. It caught my attention because years ago, 
when I was out in the countryside in New Mexico, we did just 
that. And it was in cooperation with USDA, AMS, because at one 
time they had a very strong agritourism program. And we used to 
have directories, partially funded by USDA, to advertise on-
farm agritourism.
    And to this day, all over the country, agritourism is a 
very important component of a farm. It generates income other 
than just regular crop production. Agritourism is another 
source of income.
    Mr. Farr. Well, wineries have done it really well. What 
about the rest of it? I have got people who can pick apples and 
strawberries and loganberries and raspberries. All the families 
go out and do it, and if you do not want to take it home and 
make your own pies, they also have a bakery there and they make 
the pie so you can take the pie home. But it is just really all 
this value-added.
    Mr. Avalos. Oh, absolutely. And it is really another option 
for a smaller producer. Instead of producing, say, their grapes 
and selling them to the wholesale market to mainstream, they 
can generate more money for that small acreage by selling 
direct and by being creative and creating some agritourism, or 
just a simple thing like a bakery, tying it with education with 
the schools.
    There are so many components. So when you mentioned 
agritourism, it reminded me of the stuff that we used to do 
years ago.
    Mr. Farr. What are we doing on a national level to make 
sure that you have all that information and can put it into a 
standardized national directory so people can look it up county 
by county, city by city?
    Mr. Avalos. I think Ms. Alonzo probably can answer that 
question for you.
    Ms. Alonzo. Well, Congressman Farr, a top priority of ours 
is communicating what we are doing. It is really not helpful to 
put all these tools in place for these stakeholders unless they 
know that they are available. So we keep our public affairs 
office very busy with blogs, with webinars, with press 
releases. We have proactively tried to communicate all these 
value-added tools.
    In fact, in terms of some of the grants that we have 
available, we are putting in place 109 workshops this year to 
go out to the different States. And I believe Congresswoman 
Pingree may even be participating with us in some of these 
grant workshops where we are going to be educating stakeholders 
about some of our grants.
    So I guess I would just summarize that we have had a very 
big communications focus on these tools. And you have probably 
read about some of what we are doing in some of the blogs and 
the webinars and the press releases. But we recognize the 
importance of communicating these programs.
    Mr. Farr. Have you included flower growers in that?
    Ms. Alonzo. Flower growers are very important to us. We 
have funded some projects with our Specialty Crop Block Grants. 
We also do grading of flowers. And I know in the past there was 
an effort underway to create a committee, a checkoff, if you 
will. But yes, this is all part of the stakeholders that we 
serve and we communicate to.
    Mr. Farr. For on-farm markets, including flowers in that 
category, too?
    Ms. Alonzo. I believe so.
    Mr. Aderholt. Ms. DeLauro.

                       COUNTRY OF ORIGIN LABELING

    Ms. DeLauro. Thank you, Mr. Chairman. And my apologies to 
you and to our guests. Crazy day. But thank you. And I have got 
a couple of questions for AMS and then for APHIS.
    In AMS, Ms. Alonzo, have you been following the recent 
foodborne illness outbreaks in Australia, which are the 
imported berries from the Peoples Republic of China that were 
contaminated with hepatitis A? We have had about, I think, 21 
Australians sickened. The majority of the victims are kids. 
Because of the outbreak, Australia is now considering 
tightening its Country of Origin Labeling requirements.
    Has AMS been consulted on what the Australian Government 
intends to propose? Could those new requirements be challenged 
at the WTO? And how will this labeling requirement affect U.S. 
agricultural products exported to Australia?
    Mr. Avalos. Congresswoman, I am not aware of the situation 
and we have not been consulted. So thank you for bringing it to 
our attention.
    Ms. DeLauro. Terrific. Well, if you would just get back to 
us, that would be great.
    Mr. Avalos. Yes, we can. Absolutely.
    [The information follows:]
    
   [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] 
    
                            POULTRY IMPORTS

    Ms. DeLauro. Yes, please. Again with regard to AMS, and 
this is the Chinese chicken ban, what has AMS done to implement 
Section 736 of the Omnibus Bill, which would prohibit USDA from 
purchasing poultry products from the Peoples Republic of China 
for the various nutrition programs that the USDA administers?
    Have there been communications sent to State nutrition 
programs and school districts about this provision of the law? 
If so, may we receive those documents?
    Ms. Alonzo. Congresswoman, we only purchase 100 percent 
domestically produced food under our commodity procurement 
program.
    Ms. DeLauro. So for the State nutrition programs and the 
school district programs, you are only purchasing domestic 
product?
    Ms. Alonzo. That is correct.
    Mr. Avalos. And also, Congresswoman, on chicken coming in 
from China, right now no chicken, whether it be fresh, frozen, 
or cooked, is allowed to come into this country.

                         FOOT AND MOUTH DISEASE

    Ms. DeLauro. The language that was in the Omnibus would 
prohibit because we do not know what the future will bring us 
in this area. So we certainly do not want it to be part of the 
nutrition programs.
    Brazilian/Argentinian beef imports, the status of the two 
proposed rules that would permit 14 Brazilian States and 
Argentina to export fresh and chilled beef to the U.S. domestic 
livestock producers have been upset about this because of foot-
and-mouth disease in their animal herds. We have not had a case 
like this since 1929 because of the strict ban that we have had 
on the importation of live animals or meat from these 
countries. Why are we now relaxing that ban?
    Mr. Avalos. Congresswoman, I want to assure you that at 
USDA, it is our priority to protect the livestock industry from 
any animal disease such as FMD. It is a priority that is not 
going to change.
    Now, I also want to state that when we get a request from 
different countries, our decisions have to be science-based. 
Our decisions have to follow international guidelines. And the 
reason that I am saying this, Congresswoman, is because when we 
seek access into other countries, we have to follow certain 
criteria and that country has to follow certain criteria. So if 
we are not doing what they do, we will not get market access, 
either.
    Ms. DeLauro. Just for one second, both Brazil and Argentina 
have checkered food safety pasts. Both of these countries have 
been accorded food safety equivalency by FSIS, and then we have 
discovered that there are deficiencies in these systems. And 
the issue is the coordination with FSIS on this, and we have 
two proposed rules that would allow for the export efforts 
here.
    So if you could get back to me on where we stand on those 
rules. And again, to answer the question, can we wait until the 
GAO study--there is a GAO study going to be published before we 
move to finalize the rules about allowing this or relaxing this 
ban.
    Mr. Avalos. Congresswoman, absolutely. We will get back to 
you on where we are. I can tell you now we have had comment 
periods. We have received comments. We are still reviewing 
them. And we have not determined which way we are going at this 
time.
    [The information follows:]

                 Brazilian and Argentinian Beef Imports

    We have not implemented any final rules regarding this issue and 
are still considering how to move forward. In regard to GAO, they have 
not contacted APHIS to begin an audit on beef imports from Brazil and 
Argentina. When GAO contacts us to begin the audit, APHIS will be happy 
to provide all of the information they request.

    Ms. DeLauro. A quick question for APHIS. How engaged has 
APHIS been in the two trade negotiations that are currently 
taking place? Would you supply us with a list of the dates that 
APHIS staff has physically participated in these negotiations 
and the subject matter discussed?
    Mr. Shea. We would certainly have to provide those for the 
record, the exact dates. But we have been involved and we are 
certainly doing everything we can to make sure that animal and 
plant health considerations remain important.
    Ms. DeLauro. But you will provide us with the information 
and the dates and the subject matter?
    Mr. Shea. We will provide any information we may have.
    [The information follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    
    Ms. DeLauro. Thank you. Thank you very, very much. I am out 
of time. Thank you, Mr. Chairman.
    Ms. Pingree. Mr. Chair, I have one long question on 
superweeds, and I will submit it for the record and yield back 
the rest of my time to Congresswoman DeLauro.

                        FOOD SAFETY COOPERATION

    Ms. DeLauro. Thank you very much, Ms. Pingree. Thank you, 
Mr. Chairman.
    Would you describe again how AMS has been working with U.S. 
Food and Drug Administration in the development of regulations 
for the Food Safety Modernization Act? Does AMS anticipate 
playing any role in the enforcement of the regulations? How 
will those regulations impact any existing marketing orders 
that contain food safety components to them?
    Mr. Avalos. Congresswoman, I am going to ask Ms. Alonzo to 
answer your question.
    Ms. DeLauro. Thank you.
    Ms. Alonzo. Congresswoman, as you know, FDA and FSIS are 
the primary agencies with responsibility for food safety. It is 
not part of our core mission.
    That said, in terms of the Food Safety Modernization Act 
(FSMA), I guess we like to look at ourselves as bridging the 
gap, if you will, between stakeholders and the FDA to address a 
lot of the concerns that might be in the marketplace about 
produce safety, for example.
    And so, for example, we have a full-time position that acts 
as a liaison to FDA relative to all FSMA, if you will, related 
activities and FDA funds the position, which is great. And we 
have a jointly funded Produce Safety Alliance, which is an 
effort with Cornell University. And we are trying to help the 
produce industry with educational opportunities to understand 
best practices, if you will, and future regulatory 
requirements, especially since a lot of this is coming down the 
pike.
    And we also have several projects related to good 
agricultural practices in the marketplace to make sure that 
what we are doing aligns with FDA produce safety regulations. 
And so many, many more. We have a group Good Agricultural 
Practices (GAP) project with small producers to make sure that 
they work together. They get audited and they get sampled, and 
this pilot, if you will, is in six States and we want to expand 
it.
    All this to say that we have a very close relationship with 
FDA, and we are working very closely on the expected FSMA 
eventuality and making sure that our stakeholders feel 
comfortable and educated about what is going to be required.

                       BEEF AND POULTRY PURCHASES

    Ms. DeLauro. I have a question about the testing of beef 
and poultry. What is the testing regime for beef and poultry 
products that are purchased by AMS for the nutrition programs 
that USDA administers? Do we have performance standards used by 
the agency for the various pathogens for which it tests? If so, 
what are they?
    And you may not be able to answer all these now, but you 
may want to--how are vendors held accountable for those 
standards? What is the policy for AMS to drop a vendor from its 
approved list based on the microbiological testing program that 
it conducts?
    Mr. Avalos. Congresswoman, these are really good questions 
and very good concerns. And I do not have an answer at this 
time, but if you would allow us, we would like to get back to 
you and answer those questions for you.
    Ms. DeLauro. Sure. I absolutely will, and I appreciate 
that. Sometimes you just do not know the answer to all the 
questions. I get that. But if you can get back to us on all 
these issues, that would certainly be helpful.
    And I want to say thank you, Mr. Chairman, and yield back 
the balance of Ms. Pingree's time.
    And thank you all very much.
    [The information from USDA follows:]

            Beef and Poultry Testing for Commodity Purchases

    All beef and poultry procured by AMS must be produced at an FSIS-
inspected establishment. In addition, AMS purchase specifications 
require approximately every 2,000 pounds of boneless beef trim and 
every 10,000 pounds of ground beef to be tested for the presence of 
microorganisms. All beef is tested for standard plate count organisms, 
generic Escherichia coil, and coliforms as indicators of process 
control. Any beef found to contain these microorganisms at levels 
exceeding AMS-defined critical limits is rejected for purchase. In 
addition, the testing results are used to monitor a vendor's process 
control, based on which a vendor may be declared ineligible to produce 
for AMS. Beef that is intended to be delivered raw is also tested for 
Salmonella and for E. coil 026, 045, 0103, 0111, 0121, 0145, and 0157. 
Any beef testing positive is rejected for purchase by AMS. Cooked diced 
chicken is sampled and tested for the pathogens Salmonella and Listeria 
monocytogenes, and for the following indicator microorganisms: standard 
plate count organisms, total coliforms, generic E. coil, and 
Staphylococcus aureus. Any lot of product found to contain pathogens or 
found to exceed any indicator microorganism critical limit is rejected 
for purchase by AMS. A detailed description of the AMS microbiological 
purchase specification program, including sampling methodology and 
sampling results, is available  at  http://www.ams.usda.gov/AMSv1.0/
ams.fetchTemplateData.do?temp 
plate=TemplateA&navID=MicrobialTestingofCommodities&rightNav1=Microbial 
TestingofCommodities&topNav=&leftNav=&page=FPPMicroDataReports&result 
Type=&acct=ls std.

    Mr. Aderholt. Okay. Well, thank you all for being here this 
afternoon, and that concludes our hearing. And we look forward 
to hearing your answers on some of these issues.

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                                          Wednesday, March 4, 2015.

                      FOOD AND DRUG ADMINISTRATION

                               WITNESSES

DR. MARGARET HAMBURG, COMMISSIONER, FOOD AND DRUG ADMINISTRATION
JAY TYLER, CHIEF FINANCIAL OFFICER, FOOD AND DRUG ADMINISTRATION
NORRIS COCHRAN, DIRECTOR, OFFICE OF BUDGET, ASSISTANT SECRETARY FOR 
    FINANCIAL RESOURCES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Mr. Aderholt. The Committee will come to order, and good 
morning, everybody. It is good to have everyone here and 
welcome everyone to the hearing. Of course, the intent of the 
hearing this morning to look at the Food and Drug 
Administration's fiscal year 2016 budget request.
    And of course, in addition to that, as we move forward 
through the hearing, I know a lot of the members will want to 
seek information on the Agency's use of current and past 
resources, including the activities, policies, and practices 
that are supported with appropriated funds from Congress.
    Our witness today is Commissioner of the Food and Drug 
Administration, Dr. Margaret Hamburg. Thank you for being here. 
It is good to have you here. She is joined by Norris Cochran, 
who is the Deputy Assistant Secretary for Budget at the 
Department of Health and Human Services--good to have you 
here--and Jay Tyler, the Chief Financial Officer of FDA. So 
welcome to all of you.
    As you note in your statement that you have submitted, you 
will be stepping down at the end of the month. And of course, 
we talked about that as you were in my office earlier this 
week. You have not only served six years in your current post, 
and it is one of the most challenging, I think, and demanding 
jobs in the Federal Government, but you have served with great 
success on behalf of your dedicated staff and also on behalf of 
the American people.
    Of course, we have differing opinions on some things; we 
all do regarding policies and regarding regulations, and 
regarding funding. But there is bicameral and bipartisan 
respect for the way you have provided leadership in your role 
and in your very important job in the public health agency.
    As I have mentioned in previous hearings, we have 
established three primary goals for this Subcommittee as we 
progress through the fiscal year 2016 Appropriations process.
    The first goal is to improve the management of the agencies 
and programs within our purview. Continuing to build upon the 
efforts of previous years, our goal is enhancing accountability 
in spending the taxpayer's dollars through improved Agency 
governance processes and internal controls and also ensuring 
transparent decision-making.
    FDA has vast authority and regulations to properly oversee 
various efforts under its jurisdiction--from the safety of food 
and medical products, to the effectiveness of drugs and 
devices, to the safety of vaccines and the blood supply. With 
these responsibilities, FDA needs to utilize their oversight 
capabilities in all areas to better ensure that our limited 
resources are spent wisely.
    The Food and Drug Administration must also tighten controls 
for areas subject to large expenditures with unclear results 
and where performance tasks or milestones are not met, such as 
information technology. To assist Congress in monitoring the 
use of scarce resources, we have authorized the transfer of 
$1.5 million in fiscal year 2015 to the Department of Health 
and Human Services' Office of the Inspector General.
    The second goal is to target funds to the most important 
programs and functions. This bill contains vast and diverse 
responsibilities and a limited amount of resources. It would be 
impossible to meet the full demands of any one agency, so there 
are tough decisions that have to be made by this Subcommittee. 
I want to continue to be sure that we make wise decisions in 
allocating the funding as we move forward.
    We will continue to invest in programs that prove effective 
and that have broad support, such as the FDA's Medical 
Countermeasures Initiative, WIC, and Rural Development 
programs. We should also support programs that have a clear and 
distinct reason for using Federal funding, such as addressing 
emerging agricultural pest and disease threats across the 
Nation or the monitoring of safety issues with food or medical 
products. In order to fund these programs we must reduce or 
eliminate funding for lower-priority and those that are maybe 
duplicative or less effective.
    And then the third goal is to promote U.S. agriculture, 
free and fair markets, and safe food and medicines. The United 
States has one of the safest medical product markets and the 
safest, most highly productive food and agriculture sectors in 
the world, and the U.S. Government plays a unique role in 
ensuring that all of these sectors remain in their current 
vitality.
    For instance, we support a vibrant rural economy by 
investing in infrastructure such as water and waste and housing 
programs. We fund FDA's efforts to oversee a growing number of 
drugs and drug ingredients produced outside of our borders. We 
also promote a free and fair international trade regime that 
allows U.S. commodities and products to be sold around the 
world.
    As you remind us in your testimony that you have submitted, 
FDA regulates over 20 percent of every consumer dollar spent on 
products in the United States. This Subcommittee must 
continually remind FDA and the Administration that they need to 
be very aware of the comprehensive economic impact of their 
regulatory decisionmaking so that the path to greater safety 
and effectiveness of products under their jurisdiction is not 
littered with lost jobs and struggling small businesses.
    The Agency's approval of 51 new molecular entities and 
biological products as well as a record number of orphan drugs 
in a single year are commendable, but we just remind you that 
regulations have the potential to limit both scientific 
discovery and also ingenuity.
    The size of the FDA's fiscal year 2016 budget request 
includes increases for budget authority that disregard the debt 
crisis facing our Nation. The Agency is proposing large 
increases using scarce discretionary resources. Since FDA is 
informing Congress that food safety, medical product safety, 
and rental and infrastructure needs are their highest 
priorities this year, it will be incumbent upon FDA to prove to 
Congress that such priorities cannot be funded out of base 
resources first. In addition, the Agency must demonstrate that 
all efforts have been made to review current operations for 
potential savings and efficiencies.
    Lastly, the Subcommittee and the American public need 
assurance that the Agency is coordinating and not duplicating 
other efforts across the Department of Health and Human 
Services, the United States Department of Agriculture, and 
elsewhere to ensure the most efficient means of accomplishing 
its mission. We hope to touch upon each of these issues in more 
detail as we move forward in the questioning process.
    In looking to the proposed user fees, FDA is again 
proposing to collect and spend $198.6 million in new and 
unauthorized programs. While there is a time and place for user 
fees, as demonstrated by the success of most of FDA's user fee 
programs, FDA provides no evidence that demonstrates current 
efforts are effective in assisting the beneficiaries and that 
the resources for new efforts will result in better services 
for the customers.
    The Ryan-Murray budget deal signed into law back in 2013 
capped overall spending not only on defense but also non-
defense as well. I anticipate that this Subcommittee's funding 
levels will remain relatively flat at best. FDA's request for 
budget authority exceeds the 2015 enacted level by 6 percent. 
Today and in the months ahead, we must analyze the request and 
focus on allocating the funding using the goals that I have 
outlined above to the most effective and to the highest-
priority programs.
    At this time I would like to recognize Ms. Pingree, who is 
standing in for the distinguished Ranking Member, Mr. Farr, and 
see if she has any opening remarks.
    Ms. Pingree. Thank you, Mr. Chair, and I will just speak 
briefly.
    Thank you very much, Commissioner Hamburg, for being here 
today. I am filling in the very large shoes of my colleagues 
here, who are all unfortunately at many of the hearings that 
are going on today. But they will be joining us soon, and I am 
happy to fill in for our Ranking Member.
    I will also just add my thoughts to the Chair's comments. 
Thank you so much for being here today, but also for your six 
years of very distinguished service at the FDA. We really 
appreciate your commitment to public service and the work that 
you have done here.
    I know you have a lot of challenges ahead, and certainly 
there will be a lot of challenges in this budget. But I think 
we also do have to balance it with the growing responsibilities 
of the FDA, with the tremendous number of new drugs that are 
coming on line, and the very fast-changing world that you are 
dealing with.
    I personally have been very grateful to you for the work 
you have done to help us improve the Food Safety Modernization 
Act rules and working with your agency on that. I think many of 
my colleagues will remain committed to providing the FDA with 
the resources it needs to fully carry out its responsibility to 
our public health and safety.
    So I look forward to hearing your testimony today and 
hearing you answer the questions of my colleagues, and thank 
you very much for being here with us.
    Mr. Aderholt. Thank you, Ms. Pingree.
    We are also very happy to have the Chairman of the full 
Appropriations Committee, Mr. Rogers, here with us, and I would 
like to recognize him for any opening statement that he would 
like to make.
    Mr. Rogers. Thank you, Mr. Chairman. And welcome, 
Commissioner and staff, to the hearing. I first want to pay 
tribute to the Commissioner for six years of service at this 
chore, which I think is a modern-day record if not an all-time 
record tenure; but also, not just the time you have served, but 
the quality of service that you have given to the country.
    This is a really tough job you have. People do not 
appreciate that. It is fairly obscure in the pantheon of 
alphabet in the city, but the remarkable regulatory entity and 
breadth of your responsibilities is astonishing. You have 
brought a public health perspective to an Agency charged with 
ensuring the safety of our country's drugs, biological devices, 
our human and animal food chain, cosmetics, anything that emits 
radiation.
    Dr. Hamburg. Dietary supplements. Tobacco. [Laughter.]
    Mr. Rogers. We support you in this important mission. And 
while we certainly understand the breadth of your 
responsibilities, I am concerned by the size of the budget 
request before us. At $4.9 billion, this is the largest FDA 
request in recent history. And while you have indeed taken cues 
from Congress to utilize budget authority rather than saddling 
industry with the costs associated with finalizing a number of 
FSMA regulations this year, a $150 million increase will be 
tough to swallow. We look forward to hearing from you today 
about your plans for adhering to the terms of the FSMA court 
order.
    While I know many of the members of this Subcommittee have 
a number of areas of concern, there are three that I would like 
to briefly touch on with you--first, prescription drug abuse, 
which I am sure you would have guessed I would put first.
    As your time as Commissioner comes to a close, it gives us 
all an opportunity to reflect on your legacy regarding this 
issue, which is near and dear to my heart. My district in 
Kentucky was ground zero for prescription drug abuse with 
OxyContin a dozen years ago, which started me on my tear on 
this subject.
    The first time I approached FDA about the abuse of 
prescription medications was in 2000, and for over a decade, my 
pleas for FDA to take action on this life-or-death issue fell 
on deaf ears. And in the meantime, kids and teenagers and 
people from all over my district were dying, overdosing in 
emergency rooms almost every night.
    And when this problem reached epidemic proportions, I found 
in you a willing partner, Madame Commissioner, and I am 
grateful for all of your efforts to address this very complex 
public health challenge. I hope you can provide an update on 
the guidance for abuse-deterrent formulations that hopefully 
will be finalized before your tenure comes to a close.
    You have been a real champion for helping to solve this 
problem with helping make prescription medicines, opioids, 
abuse-deterrent. In the case of OxyContin, for example, a 12-
hour-release pain reliever for terminally ill patients, mainly 
for severe pain, first you changed the definition so that it 
could be used only for severe pain and not just for moderate to 
severe pain. You helped educate the medical community, 
particularly prescribing doctors, about the danger of this drug 
if abused and the difficulty in breaking its habit. You 
upscaled for tighter controls the hydrocodones. And you have, 
in the case of OxyContin, for example, changed that formulation 
so now it is abuse-deterrent.
    You cannot shoot it up. You cannot crush it. You cannot 
snort it. You can only take it for what it is supposed to be. 
That is an amazing change that has taken place thanks to your 
tenure and so many others in that second vein.
    Second, your proposed tobacco deeming regulation is of 
interest to a lot of people, as evidenced by the 135,000 
comments that were submitted in response to its publication. 
You and I have discussed the regulation of premium cigars in 
the past. The decision FDA makes regarding e-cigarettes has the 
potential to be transformative for this emerging market. I know 
many are eager for your thoughts about how and whether these 
products will be regulated and whether FDA has the adequate 
resources and infrastructure in place to tackle a really 
herculean chore.
    Finally, like many, I am concerned about obstacles created 
by the Chinese Government to our inspection of foreign food and 
drug products. While the safety of American consumers is our 
paramount concern, there is also a fundamental question about 
fair trade practices. Domestic manufacturers and producers are 
subjected to extensive regulation to ensure the safety of their 
products, and they should have an equal playing field with 
their foreign competitors. The fiscal year 2015 Omnibus 
included $2 million to speed up drug facility reviews in China, 
and we are looking forward to an update on that effort and 
where you see it going.
    With that, I am going to close my remarks here, Mr. 
Chairman. And in doing so, I want to close with a very high 
tribute to this public servant who has given her entire 
adulthood to public service, both in New York City and, of 
course, here, among others.
    So Madame Commissioner, we are indebted to you. Your 
service has been stellar, and we hate to see you go. You bring 
a fresh, optimistic approach to things, and I hope that your 
successor can be half as good as you. Thank you.
    Dr. Hamburg. Thank you so much.
    Mr. Aderholt. Thank you.
    Commissioner Hamburg, without objection, your entire 
written testimony will be included in the record. But now I 
would like to recognize you for comments that you would like to 
make, and then we will proceed with the questions from the 
members. So the floor is yours.
    Dr. Hamburg. Thank you very much. Thank you, Chairman 
Rogers, Chairman Aderholt, and all the members of the 
Subcommittee. And I certainly appreciate the chance to be here 
before you today to discuss the President's fiscal year 2016 
budget request for FDA.
    This, as you know, will be my final appearance before the 
Subcommittee. I am stepping down at the end of this month. So I 
really do want to thank you, as I begin, for the investments 
that you have made in FDA and the confidence and support that 
you have placed in my leadership.
    Your support has helped us address many of the demands of 
our broad and increasingly complex mission, and I really have 
felt that we have had the opportunity for many constructive 
dialogues over the years as we have shaped our budgets and 
prioritized our budget needs.
    And I also want to, as I reflect on the work of this 
Subcommittee, express my condolences to the family, friends, 
and colleagues of Representative Alan Nunnelee. His legacy of 
service I know will not be forgotten.
    During my tenure at FDA, Congress has recognized the vital, 
unique, and dynamic role that FDA plays in promoting and 
protecting the health of the public in our increasingly complex 
and global environment. You have provided the Agency with 
resources, and tasked us with a multitude of new 
responsibilities.
    In response, our accomplishments demonstrate our ability to 
respond to evolving public health needs and opportunities 
across the spectrum of the products that we regulate. But even 
as FDA has risen to meet these challenges, successful 
implementation of our authority and existing responsibilities 
really does require additional resources.
    To help meet this need for fiscal year 2016, FDA is 
requesting, as you noted, $4.9 billion, $2.7 billion in budget 
authority and $2.2 billion in user fees. The increase above 
fiscal year 2015 is $425 million, of which $148 million is new 
budget authority.
    Recognizing the larger pressures on the Federal budget, we 
focused the budget request on essential functions and urgent 
needs of our Agency, as Chairman Aderholt has indicated is a 
priority for the Committee.
    I would like to begin by discussing FDA's efforts to 
improve and protect America's food supply. The fiscal year 2016 
budget request includes a total of $1.5 billion for food 
safety, including $109.5 million budget authority increase over 
fiscal year 2015. And that increase will largely be dedicated 
to implementing the Food Safety Modernization Act, or FSMA.
    And since FSMA was passed in 2011, FDA has made 
extraordinary progress in implementing the new law. We have 
issued seven major proposed rules, and we have also been 
developing innovative new technologies to identify the source 
of foodborne outbreaks more quickly so that needed actions can 
be taken to prevent additional illness.
    But past achievement is no guarantee of future success, 
particularly when significant funding gaps loom. We will issue 
final FSMA regulations this year. Implementing these 
regulations will require us to modernize inspections and 
retrain staff to apply the new rules effectively and 
consistently, provide guidance and technical assistance to 
industry to support their compliance efforts, and invest in the 
capacity of our State partners to leverage their local 
knowledge and resources.
    We also must address the concerns about the safety of the 
large and growing volume of food imported from other countries. 
FSMA empowers the Agency to hold foreign food producers to the 
same standards we expect of food producers in the United 
States. We must do so, as you note, to assure level playing 
fields for American firms, but also to protect American 
consumers.
    I cannot overstate the importance of our request to fund 
continued successful implementation of FSMA. A shortfall in our 
funding will undermine Congress' intent to transform our 
Nation's food safety program and will harm all stakeholders. If 
we invest now, I am confident that we can fulfill FSMA's vision 
of a modern, prevention-oriented food safety system that works 
collaboratively across our global food system to reduce 
foodborne illness, bolstering public confidence in the food 
supply and maintaining U.S. leadership on food safety 
domestically and internationally.
    Now, in the vital area of medical product safety and 
innovation, the fiscal year 2016 budget request provides a 
program level of $2.7 billion, including a budget authority 
increase of $33.2 million above fiscal year 2015. Part of the 
proposed budget increase will support FDA implementation of key 
initiatives of the Food and Drug Administration Safety and 
Innovation Act, FDASIA, and also our important work on the 
national strategy for combating antibiotic-resistant bacteria, 
where we have made important strides on both the human and 
animal front. But this remains a pressing public health 
challenge.
    An additional $10 million is to support FDA's essential 
role in precision medicine and enable us to continue to speed 
the development of promising new diagnostics and treatments for 
patients with serious illnesses.
    Our exciting work in the medical product innovation and 
safety area is a testament both to new opportunities offered by 
dramatic advances in science and technology as well as our 
innovative approaches to expedite development and review of 
medical products to address unmet medical needs while adhering 
to established standards for safety and efficacy.
    In 2014, FDA approved the most new drugs and biologics in 
almost 20 years, and brought lifesaving drugs to market more 
quickly than ever. We have also made real progress in reducing 
times for medical devices to reach market. Enhanced funding 
will help us to maintain our Nation's preeminence in biomedical 
product innovation and safety, and will benefit us all.
    Let me close by underscoring that FDA's public health 
mission is indispensable to the health and well-being of every 
American. We carry out our mission effectively and with few 
taxpayer dollars despite dramatic expansions in our 
responsibilities as a result of new legislation, scientific and 
technological advances, and a globalized marketplace.
    Our budget request plans for efficient spending on programs 
that are essential to providing Americans with the safe foods 
and the safe and effective medical products that they expect 
and count on. And I know that with your ongoing support, FDA 
will continue to move forward in fulfilling its critical 
responsibilities to the American people even as I leave the 
Agency in the very capable hands of my successor.
    So thank you very much, and I am happy to try to answer any 
questions that you may have.
    [The information follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Aderholt. Thank you. And thanks for your testimony. And 
like I said, as everyone has said, we appreciate your service 
and look forward to a time of questioning.
    The Chairman reminded me that I do not sound very good this 
morning as I am recovering from a sore throat. So I am going to 
try to do less talking, but this will be a good opportunity for 
me to turn to Chairman Rogers and let me see if he has got any 
questions in case he needs to slip out.
    Mr. Rogers. Well, thank you very much, Mr. Chairman. I hope 
you feel better.
    Mr. Aderholt. I sound worse than I actually am.
    Dr. Hamburg. We might have something to offer you. 
[Laughter.]
    Mr. Aderholt. I need something.
    Mr. Rogers. You sound a little bit hurtful. It reminds me 
of Mark Twain's comment about Wagner's music. He said, ``It is 
really better than it sounds.''
    Mr. Aderholt. Thank you. I will take that as a compliment. 
[Laughter.]

                        PRESCRIPTION DRUG ABUSE

    Mr. Rogers. Well, Dr. Hamburg, as your tenure comes to a 
close here, it gives us all an opportunity to reflect somewhat 
on your legacy regarding an issue, as I mentioned, that is dear 
to my heart, and that is the prescription drug abuse. But you 
have up-scheduled hydrocodone combination products to make them 
more difficult to prescribe.
    You have also changed the indication for the strongest 
painkillers to severe pain only, which is a huge step forward, 
because doctors really were misled when OxyContin came out. A 
great pain-relief drug, but they were not aware that it was 
very addictive and just how difficult it was to kick it.
    So when the label said for moderate to severe pain, it was 
being prescribed for toothaches and toenail hurts or what have 
you when it was designed and meant to be just for terminally 
ill cancer patients in severe pain. So you changed the way 
doctors saw this drug, which was a huge educational opportunity 
and obligation.
    I spoke yesterday with Dr. Collins and Dr. Volkow, Collins 
at the Health Institute, Dr. Volkow at NIDA, the drug abuse 
group, about public investments in these important drug 
technologies. But can you assure us that this guidance will 
create the right conditions to incentivize the private sector 
investment and innovation to bring better products forward?
    Because that is where that research, of course, has to take 
place, is in private companies. And yet if there is not the 
proper incentive, financial incentive, then we will not get 
better drugs. FDA staff have indicated that despite five abuse-
deterrent products now on the market, uptake of these 
medications has been very slow. How do we get doctors and 
insurers to come around and prescribe these abuse-deterrent 
products?
    Dr. Hamburg. Well, thank you. As your question notes, this 
requires many different agencies and organizations coming 
together to address a really important shared problem that is 
devastating communities as your district in Kentucky, as you so 
well know.
    We think this is a high priority, and we have made it very 
clear that it is within FDA and in our conversations with the 
scientific research community and with our partners in 
government, and of course, in our work with industry.
    The abuse-deterrent guidance, which will be out by the date 
that you have indicated--in fact, we think well before--will be 
laying out clearly and explicitly for industry our expectations 
for what kind of studies need to be done, what kind of data 
needs to be collected, to demonstrate an abuse-deterrent 
effect, how best to go about creating these products with 
abuse-deterrent properties that can measurably make a 
difference so that these products are harder to abuse.
    And as you know, most of the technologies to date have been 
to make it harder to inject or snort. But the oral abuse, which 
is in fact the largest category of abuse and overdose, still 
remains very challenging in terms of an abuse-deterrent 
formulation.
    So we need continued innovation, and we are trying to do 
that by working with industry and the scientific community to 
point out where the gaps are, where the opportunities are. We 
also do need others--insurers, the healthcare community--to 
step up to the plate to start to insist on better formulations 
as well.
    And I think we really need to continue to find strategies 
to create some of the incentive framework so that companies 
really want to work in this area. One thing that I have 
actually talked about is with the X Prize Foundation, whether 
they should do an X Prize for this because we need some out-of-
the-box thinking.
    But we are encouraged. We are seeing progress in terms of 
new formulations, new approaches. There are some very exciting 
ideas in the pipeline. I think in partnership with NIH we can 
continue to really help move some of the scientific thinking 
and bring others on board in public-private partnerships.
    So I think there is progress made. But we have to remember 
that abuse deterrence is only that. It does not mean abuse-
proof. And we still need to work hard on the bigger picture of 
reducing inappropriate prescribing of opiates and assuring 
appropriate medical treatment and care, including 
identification and treatment of addiction when it does occur.
    Mr. Rogers. Well, prescription drug abuse is killing more 
people than car wrecks in our country. CDC calls it a national 
epidemic, and it is, certainly in my district, and I am sure 
elsewhere.
    And we do need that breakthrough. With the brilliance of 
the medical community and the pharmaceuticals, there has got to 
be a silver bullet out there. And I wonder whether the so-
called prodrug drugs are that silver bullet.
    A pill that apparently is being tested now--a pill, but it 
does not release its tranquilizing effect until it reaches the 
digestive tract and reacts with enzymes in the digestive tract. 
You cannot snort it or chew it or shoot it up. It does not 
work, only when it reacts with the digestive juices in the 
digestive tract. What do you think about that?
    Dr. Hamburg. Well, you and I, I think, both had the 
opportunity at your last prescription drug abuse summit last 
spring to speak with the scientists working on that. I think it 
is a very, very interesting approach that holds promise, and we 
have been very receptive to talking with the developers about 
what they are thinking about and what they should be thinking 
about as they design their research/development plan.
    We are eager to see that kind of new thinking and approach 
evolve. We are also interested in seeing if there are other 
approaches that perhaps have not really been thought of yet but 
that might make a real and enduring difference.
    Mr. Rogers. Well, we thank you, and we hope FDA continues 
as aggressively on this track as you have been because you are 
saving lives in the process. Thank you very much. But thank you 
for your service.
    Dr. Hamburg. Thank you.
    Mr. Rogers. We hope to see you around here time and again.
    In the meantime, Mr. Chairman, I have got to attend another 
hearing with the Secretary of Defense.
    Mr. Aderholt. Absolutely.
    Mr. Rogers. Thank you, madame.
    Dr. Hamburg. Thank you. Thank you so much.
    Mr. Aderholt. Thank you, Chairman Rogers.

                           DIETARY GUIDELINES

    Let me switch over to dietary guidelines. The Department of 
Health and Human Services--of course, FDA is a part of that--
has the lead role in developing the Dietary Guidelines for 
Americans in 2015. The Secretary of Agriculture appeared before 
this Subcommittee, was sitting where you are sitting just about 
a week ago. He made a commitment to adhere to the statutory 
directive for developing the Dietary Guidelines for Americans. 
And as he put it, and this was his quote, ``I know my role, and 
I will color within the lines.''
    I reminded him when he was here last week of the need to 
stay focused only on the dietary and nutritional 
recommendations of the Dietary Guideline Advisory Committee, 
and subsequent comments collected by USDA and the Department of 
Health and Human Services about these recommendations.
    To quote from former Senator Bob Dole, he said, ``I believe 
the Committee exceeded its mandate when it made dietary 
recommendations based on environmental concerns of 
sustainability.'' I urged the Secretary of Agriculture and the 
Secretary of Health and Human Services to omit those 
recommendations in issuing their final guidelines. The science 
of nutrition can be confusing to the average consumer. 
Integrating environmental consideration into dietary 
recommendations lessens the report's impact and usefulness.
    My question, Commissioner, would be: As a vital player in 
the development of these final guidelines, can we get an 
assurance from the Department of Health and Human Services that 
the final report will include only nutrient and dietary 
recommendations and not include environmental factors and other 
extraneous material?
    Dr. Hamburg. Well, our role in the nutrition space is a 
little bit different. We are involved, of course, in the 
Dietary Guidelines, but that is not our direct responsibility.
    We have many responsibilities directly in areas of 
nutrition and nutrition science, and I am really happy to be 
able to report to you that we have a very strong commitment to 
science-based decisionmaking in our nutrition programs; that, 
as we look at what matters to promoting health and protecting 
health of the American public with respect to health and 
nutrition, we spend a lot of time examining what is known, what 
does the literature show, soliciting input from other experts 
in helping to get additional information that we might not be 
aware of.
    We also do undertake research ourselves and in partnership 
with others. We also have just recruited a wonderful new 
director of our Center for Food Safety and Applied Nutrition, 
Dr. Susan Mayne, who is here, who we got from Yale University, 
who has a long and distinguished career in nutrition science 
and health.
    So I think we are well positioned to help advance 
understanding and to make sound policies based on evidence. And 
certainly we try very hard to color within the lines, too. We 
already have responsibilities that outstrip our resources. We 
have no desire to take on new activities that are outside of 
what we have been mandated and asked to do.
    Mr. Aderholt. I will take that as a yes, then.
    I find it interesting that the Advisory Committee has found 
that cholesterol is not a nutrient of concern for over-
consumption even though previous dietary guidelines have 
recommended limiting cholesterol intake to no more than 300 
milligrams per day. There are other such examples in the recent 
past where the Advisory Committee completely changed its focus 
despite claims of sound science.
    The Advisory Committee also recommended a diet higher in 
plant-based foods and lower in animal-based foods as more 
health-promoting even though lean meat has been included as 
part of a healthy, balanced diet in previous Dietary 
Guidelines. How are consumers supposed to feel confident about 
following the Dietary Guidelines when the recommendations 
contradict what was just put out five years ago?
    Dr. Hamburg. Well, I think one of the challenges in this 
arena, and other arenas as well, is that the science base is 
always changing. Also, with the vast array of different kinds 
of studies going on with different perspectives, it can get 
very confusing about emerging information and how to put it 
into context and what information consumers should rely on.
    Again, I come back to my earlier answer, that we really 
view as the foundation of the work we do establishing the 
database and the evidence for regulatory decisionmaking. But 
recognize that this is a dynamic process and new evidence 
emerges as understandings of the science and of human biology 
advance. And as that happens, we do think it is very important 
to periodically update the work we are doing.
    For example, not too long ago we put forward a proposal to 
update our nutrition facts label, which is the nutrition 
information on the back of various kinds of processed and other 
foods. That was first begun, I think, now more than 20 years 
ago, and some of the nutritional components being represented 
there did not represent advances in nutrition science, and also 
the serving size information did not reflect current practices 
and behaviors of American consumers. So I think that is very 
important so that Americans can have access to the most recent 
and updated information so they can make informed choices.
    Mr. Aderholt. I reminded Secretary Vilsack when he was here 
last week of the enormous impact the Dietary Guidelines have on 
individual diets; also, nutritionists and dieticians who plan 
and prepare food for schools and other institutions and 
elsewhere across the United States. I suggested to him that the 
45-day timeline for the comments is too short, and he committed 
to discussing extending that comment period for an additional 
60 days with Secretary Burwell.
    Can I get a commitment from you that you and your 
colleagues will convey that need to extend that comment period?
    Dr. Hamburg. Well, I will certainly reflect back to 
Secretary Burwell your comments and this discussion.
    Mr. Aderholt. Thank you. Well, as I say, the Secretary , I 
think, was in agreement that this additional 60 days was 
important because of the impact of this. And so we would 
appreciate your conveying that to the Secretary , and that many 
of us feel here on the committee that it is important as well.
    So with that, let me recognize Mr. Farr.
    Mr. Farr. Thank you very much, Mr. Buff. You transferred 
questioning to Mr. Lumpy. [Laughter.]
    Dr. Hamburg. I was trying figure that out.
    Mr. Farr. It is interesting. He is the healthy one, and is 
worried about too much Dietary Guidelines; I am the unhealthy 
one that thinks that they are probably a good idea. But maybe 
he follows them better than I do.
    Thank you for all of your service. I know you are leaving, 
and we are really going to miss you. You have been one of the 
more outstanding FDA directors we have ever had, and I think, 
as Mr. Rogers says, a lot has been accomplished under you.

                             BUDGET REQUEST

    In looking over your budget request in our discussion and 
in the office, it just seems that Congress, in our lawmaking, 
has given you, the FDA, just tons of authorities, but we never 
give you the money to carry them out. Maybe we have just over-
stretched your role.
    Yet if you poll the public, you are the most trusted part 
of the Federal Government, more than any--more than Congress, 
certainly a lot more than Congress. Since everybody trusts you, 
we are giving you more say about things in our society. But 
perhaps the mission is too big or the budget is too small. I 
happen to think the budget is too small.
    Can you tell me what level of resources FDA needs to do the 
job that Congress has mandated?
    Dr. Hamburg. Well, that is a question that is of huge 
importance to the Agency, although it would take some time to 
really work it out and offer you a meaningful answer. But I 
guess we also recognize we will never get everything we need.
    But I think you are correct when you recognize that our 
responsibilities, especially in an increasingly complicated 
environment in terms of the advances in science and technology 
of the products we are overseeing, and a new global 
marketplace, those demands, and the new laws that have given 
new authorities and responsibilities such as FDASIA and FSMA, 
are packed full of tasks for us to undertake.
    That all does outstrip the available resources that we 
have, and I really think we do an extraordinary job delivering 
for the American people with the resources that we have been 
given, and that we take our responsibility as stewards----
    Mr. Farr. But not having enough of those resources, what 
are going to be the consequences for the American public?

                                  FSMA

    Dr. Hamburg. Well, I think, taking FSMA, for example, we 
are asking for $109 million in budget authority from Congress 
to continue the implementation of what is a historic 
transformation of our food safety system in this Nation after 
more than 60 years, to turn it from a reactive system that 
responds after a problem has already occurred and is entrenched 
to a preventive system.
    It is something that industry and consumer advocates and 
the public health and scientific community came together to 
support, and Congress passed in a bipartisan way, with 
considerable ease, in fact, at the end of the day because 
everybody recognizes that this is a benefit for all.
    By strengthening food safety and reducing foodborne 
illness, we will save the healthcare system an estimated $78 
billion a year from foodborne illness. The food industry 
suffers every time there is a problem in the food system 
because it undermines public confidence; even if it was not 
your farm that has the contaminated food, there may be a huge 
decrease and a sustained decrease in purchasing.
    Mr. Farr. Yes. We saw that. My district produced 70 percent 
of the spinach in the United States, when we had the E. coli in 
the spinach recall. We have never since reached the level of 
sales in spinach that we had prior to that.
    Dr. Hamburg. Yes. So I think that while it may be a large 
number in terms of past asks by the FDA for this program, this 
is a critical time for implementation and it seems like there 
is a terrific return on investment. If we invest now, it will 
have broad tradeoffs for people, communities, healthcare, and 
industry.
    And we are trying to do this in the most responsible way 
possible. At the time the law was passed, CBO estimated a 
dollar amount for implementation of FSMA over a five-year 
period, and that was something north of $500 million, $583 
million over five years.
    Mr. Farr. Let me drill down----
    Dr. Hamburg. We have estimated that we can do it for less, 
and that is what we are striving for.

                       GMO AND MEDICAL MARIJUANA

    Mr. Farr. Yes. Let me drill down on two things that I think 
are symbolic of this. I think that the public distrust is borne 
out by all these local initiatives to require labeling of GMOs. 
We have not had the scientific evidence to show that a 
genetically modified product does any kind of harm, yet people 
are, because it is genetically modified, freaked out about it.
    I think California is going to have another ballot 
initiative. It failed the first time in California; this time I 
think it is probably going to pass. It would be interesting, 
one, to get a statement from the department on GMOs, or 
studies, or whatever we need to do because there is just a lot 
of confusion out there.
    And the second one I want to ask you about--because I do 
not think FDA has ever done any studies on it--is medical 
marijuana. We do not know about medical marijuana. We have 
Federal laws saying medical marijuana is evil, and in order to 
study it the Federal Government makes you bust down significant 
research barriers. And yet we have 33 States that say, no, 
medical marijuana is okay.
    We have a huge conflict in credibility. It seems to be that 
people are saying that it has some medical benefits. What would 
it take for the FDA to have a study on marijuana? What is 
holding it up?
    Dr. Hamburg. Well, we agree with you that research is very, 
very important to better understand medical marijuana and its 
appropriate uses, especially as more and more States are 
introducing law to support the use of medical marijuana. And of 
course, also recreational marijuana we still should learn more 
about.
    FDA historically has been an advocate for more research and 
has supported requests for research to be done when they come 
before us and represent quality research that could provide 
meaningful answers to important questions. I think it is also 
useful to note that we have actually approved a couple of 
products that have marijuana components in them.
    But the issue of the study of the botanical marijuana plant 
has been more challenging, and different agencies are involved 
in it. Our role is to address the approval of investigational 
new drug status for clinical studies to go forward in the 
context of potential product development.
    Mr. Farr. What would it take to get you to do a study on 
the plant that is being used?
    Dr. Hamburg. We do not generally do those kinds of studies 
ourselves, but we are a key player in establishing the 
appropriate conditions for those studies to go forward.
    Mr. Farr. What would that take?
    Dr. Hamburg. NIDA, as you may have heard when they 
testified yesterday, actually is responsible for the oversight 
of a farm in Mississippi that grows marijuana plants in a more 
controlled way in terms of potency, et cetera. And they can 
authorize use of those marijuana plants for research. And DEA 
has to provide licensure to the investigators and the sites who 
wish to undertake research with marijuana because it is a 
Schedule I drug.
    So all of those things have to align. But we are supportive 
of more research being done. I think we need to ask and answer 
a set of critical questions around appropriate use. And there 
are a couple of studies going on at the present time. One is 
involving marijuana components. One involves cannabidiol and a 
drug for epilepsy specifically, intractable childhood epilepsy. 
And then there is also a study going on for cancer pain.
    So I think that this is a critical time for this work to be 
done, and certainly are stepping up to the plate to try to make 
sure that research is done in a responsible way.
    Mr. Aderholt. Mr. Yoder.
    Mr. Yoder. Thank you, Mr. Chairman. Dr. Hamburg, let me 
echo the comments of my colleagues regarding your service and 
tenure, and we appreciate your work on behalf of our great 
country and wish you good luck in future endeavors.

                             SEQUESTRATION

    I wanted to start by just highlighting our efforts to 
ensure that as sequestration has impacted various levels of 
government, the one area that made no sense was the impact on 
the fees from industry that partners with the FDA. And when 
those fees were sequestered, they basically could not go to pay 
down debt. They could not go to the FDA. They would just sit in 
an Al Gore-style lockbox, for a better term.
    And I know that we worked to ensure that that would not 
happen again, and I want to make sure that the Committee is 
aware we need to continue to keep those provisions in law and 
in our ongoing bill to ensure that we do not get those fees 
locked out and cannot go back to the industry or the FDA. It 
makes no sense.

                              BIOSIMILARS

    I want to ask you a little bit about biosimilars, and I 
know that there was legislation passed in Congress to create an 
abbreviated licensure pathway for biological products that are 
demonstrated to be biosimilar or interchangeable with an FDA-
licensed biological product.
    FDA officials have stated several times that we would see a 
pending guidance on biosimilars before the end of the year last 
year. Can you inform the Committee when we can expect to see a 
guidance on interchangeability, naming, labeling, indication, 
extrapolation--when we can expect the FDA to release guidance 
on these key public health issues related to the implementation 
of biosimilars?
    Dr. Hamburg. Well, there has been a lot of work, as I think 
you know, in the biosimilar area, and it is very important in 
terms of making very critical drugs available to more people.
    And the ability to create a biosimilar pathway has been a 
priority for us and a huge amount of work has been done, 
including a lot of communications with industry about how to 
develop biosimilar products, lots of meetings with prospective 
companies. And we have, as I think is publicly known, received 
some applications as well.
    So it is going forward, we actually expect, very soon. I am 
always warned not to be overly optimistic, but very soon to be 
putting out some important guidance and decisions on 
biosimilar-related issues. So stay tuned.

                              E-CIGARETTES

    Mr. Yoder. We will be watching. I also wanted to make note 
of a conversation we had in the Committee last year regarding 
e-cigarettes and the emerging growth in that industry.
    I think both the industry and public health organizations 
are interested in the FDA's thoughts on the science, 
recommendations, and regulations that would ensure that 
children are not getting these products, and that we understand 
the potential risks or how these may be less risky than other 
alternatives. So we are looking forward to that, and we have 
had conversations about that in the past. We are looking 
forward to your scientific-based regulation and information on 
that.

                                 CIGARS

    I did want to come back to an issue we discussed last year 
as well regarding the cigars and the tobacco regulations that 
the FDA is currently engaging in, and those of course would be 
a variety of issues. One would be e-cigarettes. One would be 
cigarettes in general. There are all sorts of issues that are 
coming down.
    But on the issue of cigars, I have had concerns raised from 
local small businesses in my community that the one-size-fits-
all model that would be used to apply cigars to other tobacco 
products would have a dramatic impact on their ability to 
conduct business. And I have heard words like ``devastation'' 
and ``putting us out of business.'' And I know you have to 
balance public health concerns with specific items and to 
ensure that we are providing all the protections that Americans 
expect from the FDA.
    But I wonder if you could describe to the Committee the 
efforts that the FDA engages in to ensure that the impact on 
our small businesses at home, that you are taking that into 
consideration to ensure that those ideas will be represented in 
your effort. And in particular, these folks are talking about 
having to put their cigars in cases, and not let folks touch 
them, and just lots of things that would be inconsistent with 
how they do business. I wonder if you could discuss that for 
us.
    Dr. Hamburg. Well, as I think you know, we issued a while 
back a proposed deeming rule, which would give FDA the 
authority to regulate a broader range of tobacco products than 
were specifically mentioned in the tobacco law that was passed 
and signed into law back in 2009.
    That obviously would include e-cigarettes. But in that, we 
also addressed cigars, both little cigars and flavored cigars, 
but the premium cigars. And we specifically did ask for input 
on premium cigars in terms of what is known about their use, 
their health impact, and more information about the context of 
premium cigars.
    And we received a lot of comments back, not surprisingly, 
over 135,000, I think someone noted already, overall to the 
proposed deeming rule. So we are going very carefully through 
that and trying to add the new insights that we have gotten 
from the comments in many areas, but also specifically in the 
premium cigar area, to what information we already had. And we 
will be integrating that in and coming forward with a final 
rule soon.
    But as part of rulemaking, we always do an economic 
analysis as well, looking at the benefits and the costs of the 
rulemaking that we are undertaking.
    Mr. Aderholt. Ms. Pingree.
    Ms. Pingree. Thank you, Mr. Chair.

                         LYME DISEASE AND LDTS

    Thank you again for being here today. I want to ask you a 
question about Lyme disease tests. Coming from New England, and 
particularly as Lyme disease spreads more rapidly into some of 
the Northern New England States--Maine has seen a very high 
incidence in the disease and has many concerns about the 
handling, the treatment, the diagnosis of the disease.
    I want to say I share some of the Administration's concerns 
about the changing nature of laboratory-developed tests and 
stories we have heard about false reports or questionable 
interpretations. Many of us have heard about these from our 
constituents.
    I am glad to be revisiting the issue of their regulation in 
light of the expanded rule that LDTs now play in our healthcare 
system. But I am also concerned about how the FDA's exercise of 
authority in this area is going to impact patient access to new 
testing technology.
    For example, I know that there is a great deal of attention 
that has been paid to LDTs for Lyme disease, and questions 
about the accuracy of unapproved tests. I agree that having 
accurate and reliable test results is certainly critically 
important, and the risks associated with inappropriate or 
delayed treatment are grave.
    I would also like to mention that the accuracy of the two-
tiered testing system recommended by the CDC and cleared by the 
FDA is far from perfect. Both tests, and I am talking 
technically out of my range here, but the ELISA and the Western 
blot have the potential to yield false results.
    In light of the lack of certainty about current testing 
methods, I do not blame people who have symptoms of Lyme 
disease for looking at other options in order to find out what 
is making them sick. So with that in mind, just a couple of 
questions about the oversight framework for the LDTs.
    How will you ensure there is a level playing field that 
will ensure that effective new tests will be available to 
consumers without unnecessary delays? And can you detail how 
the Administration currently monitors adverse events from 
existing Lyme tests and how these adverse events are addressed?
    Dr. Hamburg. Well, as I think you probably know, we are in 
a process of reviewing the oversight of LDTs, an area where we 
over a period of many, many years exercised enforcement 
discretion because laboratory-developed tests, when FDA first 
got authority to regulate diagnostics, were mainly tests that 
were developed within a laboratory in a given facility for use 
in that facility, sometimes as a part of research and sometimes 
care. But they were relatively simple tests and they were not 
being marketed elsewhere.
    Since that time, the world has changed dramatically and 
laboratory-developed tests are now being developed and marketed 
broadly. They are often much more complex diagnostic tests that 
are being used as the basis for really critical medical 
decisions. And there is an increased number of these tests as 
well.
    So we felt it was a critical time, based in part because we 
were getting more and more reports of faulty tests, tests that 
did not do what they said they did. And we think that to serve 
the American people and their health, we need to make sure that 
diagnostics that will then lead to critical medical decisions 
about treatment, about other potential risks or activities, 
need to be overseen in terms of both analytical validity and 
clinical validity.
    So we have proposed a risk-based, phased-in approach, 
really focusing on the high-priority laboratory-developed 
tests. And our goal is to have a level playing field, to have 
any test that is used for a critical medical decision to be 
demonstrated, to do what it says it does, and to be accurate 
and reliable.
    And we feel that, actually, that will help to support 
innovation because that is the criteria the American people 
want. And it certainly is not good for anyone to have one set 
of product developers going through the FDA oversight and 
demonstrating that their diagnostic works, and others being 
able to just make the laboratory test without that same degree 
of rigor.
    So our goal is really not to try to make fewer tests 
available, but to just work with the producers of these tests 
to have them provide the data that is needed to do the 
assessment. But the critical thing is that we are in a process 
of learning more. We did a proposed guidance, and now we are 
responding to the comments that came in.
    The comment period closed on February 2 of this year, I 
think, and we did get a lot of comments, many detailed 
comments. And we have spent a lot of time listening to 
stakeholders and hearing different perspectives. And we will 
proceed, but with the best interests of the patients in mind, 
and with the desire to be able to support new and better tests 
that will make an important difference for health.
    Ms. Pingree. Great. Well, thank you for your answer. And my 
time is up, but I will just again reiterate I have learned a 
lot about this process, and I appreciate that you are looking 
into how to make sure it is a level playing field. And I know 
when it comes to diseases like Lyme, which are very hard to 
diagnose, people want all the tools available to them, and then 
they want to know that they are accurate. And that is 
important.
    Dr. Hamburg. And my colleagues just sent me a note, if I 
may, just to underscore that because the patient is our focus, 
that as we have been thinking about this problem, when there is 
an unmet medical need and there is not an approved diagnostic 
through the traditional pathway, we would exercise enforcement 
discretion for LDTs in that domain.
    But we certainly have been concerned about the problems you 
outlined with Lyme disease and other diagnostics, where 
patients have not been well served.
    Ms. Pingree. Thank you.
    Mr. Aderholt. Dr. Harris.

                             OLYMPUS SCOPE

    Mr. Harris. Thank you very much, Mr. Chairman. And thank 
you, Dr. Hamburg, for coming before the Committee. Just some 
brief questions on a variety of topics.
    There was actually an article on CNN this morning about the 
Olympus scope. I understand where it changed in the elevator 
channel, and they probably thought they were doing something 
good. It turned out it was something bad. I think prospectively 
probably no reason to know that, but we do know that now.
    What changes, if any, did this case--make to our device 
approval process? I think, pretty clearly, Olympus felt this 
was an improvement. It turned out to be detrimental. Is there a 
way we can change the process? Briefly, if you could----
    Dr. Hamburg. I will try to be brief. This is a complex 
topic, and we would be happy to come and give you a full 
briefing.
    I think it is important to first frame it that 
duodenoscopes are very important medical devices addressing 
serious problems and lowering risk for patients overall by 
doing the endoscopic approach as opposed to open surgery.
    Dr. Harris. Sure.
    Dr. Hamburg. And there are about 500,000 of these done a 
year to benefit patients. In the case of these duodenoscopes, 
in the very nature of the task they are trying to do in ERCP 
and getting into the biliary tract, the design has this 
intrinsic complexity of the elevator mechanism.
    The issue you are talking about that was on CNN today, I 
think, is not a clearcut issue. There are three products that 
are in the marketplace now. Olympus has the majority of the 
market share. But all of them had been approved through the 
510(k) process originally. Two of the products had a closed----
    Dr. Harris. Channel. Right.
    Dr. Hamburg [continuing.] Channel. Olympus' 510(k) was 
originally with an open channel, and they began to manufacture 
with a closed channel, I think reflecting the sense that that 
might help----
    Dr. Harris. Sure. It might actually help. So do you think 
we need to change the approval process shortly?
    Dr. Hamburg. Well, what is complicated here is they thought 
they were coming into alignment with the other products in the 
marketplace that were closed. They did not realize that it was 
a substantial modification, from the FDA perspective, that 
would require them coming to us for a 510(k). As soon as we 
learned about this problem, we told them that did need----
    Dr. Harris. To apply. Okay.
    Dr. Hamburg. [continuing]--To apply. They initially 
disagreed. There was back and forth. But now they are applying.
    Dr. Harris. Thanks. And I do not have time for you to get 
into any more of it. I have got a variety of questions.
    Dr. Hamburg. Yes.

                           HYDROGENATED OILS

    Dr. Harris. The next two, or three, really, deal with some 
scientific evidence. One is on partially hydrogenated oils. My 
understanding is that the FDA had announced a tentative 
determination to ban all partially hydrogenated oils. And my 
understanding is that there may be something coming out that 
would give only a year for a transition to eliminate all 
partially hydrogenated oils.
    But the scientific evidence is that below a level of 2 
grams a day--or, I am sorry, 2 percent total energy a day, 
which is 4 to 5 grams per day--the evidence is not good that 
you are achieving anything, that in fact, like a lot of things, 
if you take a whole lot it is bad for you, but a little bit is 
not bad for you at all.
    So there are industries like the baking industry that uses 
partially hydrogenated oils which would be severely handicapped 
by a one-year process. I do not bake, but my understanding is 
that the oils you use are very important, and that changing 
over to a new oil is not easy.
    A simple question: Why just one year? We have lived with 
partially hydrogenated oils. We have decreased the consumption 
by 75 percent over the past 10 years. Why rush to this? Why not 
give a couple years' transition, a two- to three-year 
transition?
    Dr. Hamburg. Well, partially answering Congressman Yoder's 
question also about the analyses we do, we have been working 
closely with the industry and hearing their concerns about 
product reformulation and access and use of other oil 
substitutes, et cetera.
    We are not locked into a phase-in period. We think, based 
on the available science, that decreasing partially 
hydrogenated oils to as close to zero in the diet as we can get 
and using other oils instead would be extremely----
    Dr. Harris. Well, I would appreciate you just to show me 
the studies that show that decreasing it to near zero is a 
substantial decrease in risk from, as I said, the 2 percent 
energy or 4 to 5 grams a day.

                             SODIUM INTAKE

    Finally, in terms of salt, intriguing article last year in 
New England Journal of Medicine from the PURE study. Look, I 
grew up learning in medical school, yes, salt is bad, and you 
tell everybody, eat a little less salt. Yet that study actually 
indicates that if you are a healthy person, you actually have 
an increased cardiovascular risk of salt restriction.
    That is not clear. I think the party line is that salt is 
bad and decreasing salt is good. But it appears that is not 
really true. Is the FDA thinking about working with the Dietary 
Guidelines to admit there is actually real uncertainty about 
which category of patients benefit and which actually may be 
harmed by limiting sodium intake?
    Dr. Hamburg. Well, I think that there is a very large body 
of evidence and literature that supports the value of 
reductions in sodium from the average intake of Americans 
today. There have been some studies that have raised questions, 
and it is very hard to realistically do some of the studies 
that might definitively show the one-to-one causation because 
these are cardiovascular risk, and risk of stroke is very 
multi-determined.
    But we do know a couple things--that most of the sodium 
that people take is from processed food, not from the salt 
shakers, and that if we are going to make a difference, we do 
need to look at that source of sodium. And we do know, as I 
said, that there is a very large body of literature that shows 
that reducing sodium has significant meaningful impacts on 
hypertension and other risks.
    So I think that we are deeply involved in examining the 
science. I mentioned our new center director for the Center for 
Food Safety and Applied Nutrition. She is already deep into 
these issues and reviewing all of the more recent studies as 
well.
    But I think that we should not, because of a new study or a 
suite of studies that have come out, fail to look at the full 
body of evidence. And I think that we are, as I said, committed 
to making sure that we look at all the data, evaluate the 
quality of the science, and make our decisions based on what we 
feel, with input from a large number of stakeholders and 
subject matter experts, make the best decisions that we can 
make.
    So it sounds like we need to come up and do some briefings 
with you on a couple of topics where your medical background 
may lead you to have some special expertise and interest.
    Dr. Harris. Thank you very much. And thank you, Mr. 
Chairman.
    Mr. Aderholt. Ms. DeLauro.
    Ms. DeLauro. Thank you very much, Mr. Chairman. And 
Commissioner, I apologize for being so late. But Secretary 
Duncan is next door at Labor, Health and Human Services, and 
Education. So we are tearing up the hallway here.
    But first let me say to you that I read your testimony, and 
I just want to say one thing, where you say that FDA is: ``A 
science-based regulatory Agency charged with an enormous and 
significant public health mission to promote and protect the 
health of the American people. Our goal in carrying out of 
mission is to ensure the safety, effectiveness, and quality of 
medical products as well as the safety and security of the vast 
majority of our Nation's food supply.'' And you go on.
    But I want to say to you, thank you. Thank you for 
restoring the mission, the original mission, of the Food and 
Drug Administration. And you have worked tirelessly to make 
sure that that scientific and regulatory effort has come 
together for the benefit of the people of this country. We owe 
you a real debt of gratitude. And my personal thanks to you for 
all that you have done.
    I am also happy to say hello to Dr. Susan Mayne of Yale 
University. Yes? Here we go. The new director of CFSAN, and 
your own science background will indeed lend so much to the 
direction that we need to go to instead of dealing with 
anecdotes, but deal with the science.

                     FOOD SAFETY MODERNIZATION ACT

    Let me ask a question. You know that, Commissioner, I have 
been a strong supporter of the Food Safety Modernization Act 
(FSMA) for many years, and I am excited that the pieces are 
falling into place this year. And now you have made a 
substantial budget authority request, as we asked you to do. We 
asked you to do this.
    The consent agreement requires you to implement the rules. 
You have been incredibly transparent with your budget materials 
and in your communication with this Committee. To some extent, 
the ball is in our court now. So let me ask you: What happens 
if you do not get the funding that you need in 2016? How will 
that affect public health? How will it affect growers and food 
makers who rely on the certainty of the rules that you have 
published and the law that we passed?
    Dr. Hamburg. Well, it is such an important question, and is 
certainly one of the great worries that we have because this is 
such an important new law, and implementing it right matters to 
everyone.
    If we could not get the resources that we need, we will not 
be able to undertake a set of really critical activities that 
will ensure a smooth, effective, and efficient implementation 
and the realization of the benefits of a system that in fact is 
based on prevention, a system that is based on partnership, 
leveraging resources at the local, State, Federal, and 
international level, and one that recognizes that the food 
safety system is far more complex than it has ever been, with a 
hugely increasing volume of imported food coming from countries 
around the world that do not have the kind of oversight and 
regulatory systems that we have to protect American consumers.
    So we are asking for this money to do an important set of 
tasks--to modernize our inspection system and do training 
necessary to have efficient, appropriate inspections; to do 
technical assistance and work with companies so they know what 
is expected and how to, in a streamlined way, implement this 
new law and be compliant.
    We need to give the States resources so they can be our 
partners in a national integrated food safety system, and do 
training and technical assistance with them as well so that we 
have a coherent and aligned program. We need to work on the 
import side with the foreign supplier verification program so 
that we can raise the standards and oversight overseas so that 
we have a level playing field for American firms and we have 
assurances of quality and safety for the American people.
    Ms. DeLauro. Also to protect our growers. Protect our 
growers.
    Dr. Hamburg. Protect our growers and protect our consumers. 
And also, we are trying to move as much as we can to using more 
risk analytics to streamline our systems for prioritizing high-
risk and lower-risk products that benefit industry so that 
companies with good track records and performance can move 
through the import process more quickly while, when there have 
been problems, we focus on those, or we have reasons to have 
concerns.
    So it will disrupt what could be a very smooth and 
efficient implementation process that would benefit all and 
create a fragmented effort that will not enable us to realize 
the benefits of FSMA, and it will not enable us to assure 
industry the benefits that they are looking for as well.
    Ms. DeLauro. My time is over. Let me put this out there, if 
you can get back.
    FDA is under court order to issue the regulations necessary 
to implement the Food Safety Modernization Act. The rule's 
preventive controls for human and animal food, produce safety 
standards, and the foreign supplier verification are essential 
to implementing the law. And you can get back: Will the FDA 
meet these court-imposed deadlines, and what are the hurdles to 
meeting the deadlines? So that we know and can be helpful in 
this regard.
    Dr. Hamburg. Thank you. An important question. I will be 
quick. We are committed, both because it is the right thing to 
do and because we are under court order, to getting those 
regulations finished on time. We took it very seriously to 
develop those regs with the right stakeholder input, and we 
took time and listened and learned. And I think that the final 
regs will reflect the best possible understanding of how to 
implement this law right.
    But we will get it done. And it has taken an enormous 
amount of effort, a lot of redirection of our FDA employees 
from other important work to get this job done.
    Ms. DeLauro. Thank you very much. And again, our very best 
wishes are with you. Thank you.
    Mr. Yoder [presiding]. The chair is now ready to welcome 
the distinguished Ranking Member to the Committee, and would 
recognize her for her comments and questions.
    Mrs. Lowey. Thank you so much, Dr. Hamburg, for joining us. 
And again, I apologize. As you probably heard, we have four 
hearings at the same time this morning. So it is a delight to 
be Ranking Member, but with that comes responsibilities, and I 
do apologize for being late. And I also want to take this 
opportunity to thank you for your outstanding service, and I do 
wish you well in the next chapter of your career. Thank you.

                              COMPOUNDING

    As you know, the FDA recently released draft guidance 
concerning the compounding or repackaging of biologics. The 
issue of drug compounding is of critical importance to our 
public health, particularly for injectable medication. So it is 
vital that patients receive safe and effective products that 
are manufactured to the highest standards.
    When can we expect the final guidance on compounding to be 
issued? Will the final guidance maintain the intent that there 
should be a single set of standards that all manufacturers of 
biologic products must meet?
    Dr. Hamburg. Well, we have been working very hard since 
Congress passed DQSA to implement it and to build on other work 
we were doing with respect to the compounding pharmacy issue. 
We have already put forward quite a number of guidances and 
taken a lot of relevant actions in terms of outlining a number 
of critical issues around GMPs, good manufacturing practices, 
fees, adverse event reporting, et cetera. But we have more work 
to be done.
    We recently held the first meeting of the Advisory 
Committee, which is going to be very important to us, and I 
think we have got a good, strong group with diverse points of 
view, but important to inform our decision-making as well. So I 
am not sure exactly which guidance you are referring to, but I 
would say that an extraordinary amount of work has gone on in a 
very short time as we try to build up this program.
    And in particular, I think your focus is on the outsourcing 
facilities, which is created as part of DQSA 503(b), to create 
a new category of facility, outsourcing facilities, where 
companies can choose to register with us, be subject to FDA 
oversight and regulation for the manufacture of sterile 
injectables.
    And I think that those products will reflect a level of 
quality and benefit for patients that will be much desired, 
especially when we look at the current environment and all of 
the many problems that we have seen with sterility practices in 
certain compounding pharmacies.

                              E-CIGARETTES

    Mrs. Lowey. E-cigarettes. These stores are popping up 
everywhere. And we know cigarette products are regulated by the 
FDA. Only e-cigarettes that are marketed for therapeutic 
purposes are currently regulated by the FDA.
    I have been in and out of those stores, and I am concerned 
that new tobacco products on the market may be able to do 
serious harm without being regulated by the FDA. How would the 
budget request support increased research and supervision of 
tobacco products? And have you been doing any work on these new 
e-cigarette stores that are opening up?
    Dr. Hamburg. Well, it is such an important question, such 
an area in terms of public health. We have a major set of 
activities going on, not part of the budget request because our 
Center for Tobacco Products and our tobacco program is fully 
funded by industry user fees.
    But I think it is important to note that with e-cigarettes, 
which is an emerging tobacco-related product, there are a lot 
of open questions and a lot of differing points of view about 
their risks and their potential benefits in terms of an 
alternative to combustible cigarettes.
    When the Family Smoking Prevention and Tobacco Control Act 
was passed in 2009, it only specifically gave FDA the authority 
to regulate, cigarettes, cigarette tobacco, smokeless tobacco, 
and roll-your-own, but said we could expand our own authorities 
through regulation.
    We recently did put forward a proposed deeming rule in that 
context to extend our regulatory authority over tobacco 
products, some of which were not even much present in the 
marketplace when the law was first passed. And that would 
include giving FDA the authority to regulate e-cigarettes. We 
got over 135,000 comments on that proposed deeming rule, which 
we are going through now, but will be finalizing. And that will 
then lay the foundation for regulation in certain areas, 
including e-cigarettes.
    I also want to underscore that we have invested a lot of 
resources in expanding the research base around e-cigarettes 
and other aspects of tobacco products, tobacco-related behavior 
and use, the ingredients in tobacco products, and of course the 
health impact of tobacco products.
    And in that regard, a lot of important work is currently 
going on around e-cigarettes to better understand them. And 
that will obviously be a huge contribution to our regulatory 
work and also to our understanding of this really important 
public health issue for the broader American people--and 
frankly, for the world because I think we have been funding the 
most advanced research program anywhere.
    Mrs. Lowey. So at this moment, the e-cigarette stores can 
keep multiplying?
    Dr. Hamburg. They are not subject to FDA regulation.
    Mrs. Lowey. Are they subject to anyone's regulations? I 
guess not.
    Dr. Hamburg. States and localities have established their 
own regulatory frameworks in some instances. But we think it is 
very important that we finalize the deeming rule in a timely 
way so that we can begin to have regulatory oversight of the e-
cigarette products and other products as well.
    Mrs. Lowey. Thank you very much.
    Mr. Yoder. Mr. Young.
    Mr. Young. Thank you, Mr. Chairman, and thank you for being 
here. Appreciate you coming.

                                  GMOS

    Ranking Member Farr mentioned GMOs, and I wanted to pick up 
on that. As you know, there has been a push by some States and 
some consumer groups to label foods with any GMO ingredient. 
Recently the National Association of State Departments of 
Agriculture passed a resolution supporting a national uniform 
labeling policy of foods derived from GMOs and reasserting the 
FDA's food labeling authority.
    Do you have plans to mandate GMO labels, even though these 
foods are proven safe and can help end hunger around the world?
    Dr. Hamburg. Well, historically the FDA's position in terms 
of its responsibilities around labeling have really been to 
address our mandate, which is that we prohibit false and 
misleading labeling. There needs to be a demonstration of a 
material change to the product.
    In the case of GMO--we like to say genetically engineered 
products because they are not organisms--we do not see, and 
actually the courts have supported this position in the past, 
that mandatory labeling would be indicated or appropriate if 
there is not a material change to the product. The process 
itself is not that.
    If the genetic engineering process changed the nature of 
the product--for example, if it was an oil and it no longer 
fried in the same way--or if it introduced something that was a 
material change, and particularly if it could represent a risk, 
like introduced a peanut antigen that someone would not expect 
in that product but could cause harm in someone who was 
allergic to peanuts, then that fact would have to be indicated 
on the label, not that it was genetically engineered but the 
nature of the material change to the product.
    We do understand that many consumers want to know what is 
in the foods they eat, and we support individual companies that 
want to voluntarily label their products to do so. And we are 
working on a guidance to industry with respect to voluntary 
labeling of genetically engineered products, starting first 
with plant-based products. So I hope that answers your 
question.
    Mr. Young. Thank you. A lot of us are trying to fight that 
misconception about GMOs and GEs, that they are unsafe. What 
can the FDA do to help combat this misconception?
    Dr. Hamburg. Well, as has been noted, we really do strive 
very hard to look at the science base for our decision-making, 
and we apply that in the area of genetically engineered foods 
as well.

                       SINGLE FOOD SAFETY AGENCY

    Mr. Young. My next question touches on an issue a lot of 
livestock groups are concerned about: the proposal 
consolidating the USDA FSIS and the FDA's food safety 
inspections into a new agency at HHS. The thought is: Is HHS 
the most appropriate agency to head food safety, with it not 
having that kind of inspection experience as other agencies 
have had?
    Can you comment on your current food safety mission and the 
interactions or overlap between the two agencies? Have you 
looked at potential efficiency gains that can be achieved under 
the current two-agency system?
    Dr. Hamburg. Well, as you know, USDA and FDA are the two 
largest organizations--we are an agency, they are a 
department--involved in food safety. We are responsible for 80 
percent of the food supply and they are responsible for about 
20 percent of the food supply. We do everything, basically, 
except meat, poultry, and processed eggs.
    But there are many other components of government that 
actually are involved in food safety as well. It has been 
historically a fragmented system, and people have talked about 
the need for better integration over time. And I think it is a 
discussion worth having in terms of how can we best align the 
different components of government that are involved in food 
safety, and what kind of an organizational structure would be 
necessary to best support that.
    I think it is very interesting to look at what we are doing 
in FSMA, and implementing the Food Safety Modernization Act is 
one example of how we can work together effectively. We 
recognize that while we have a huge amount of inspectional 
experience in the food area, we have not been on the farms 
nearly as much as USDA. And there is a huge amount of 
experience, expertise, and trust in the grower community of 
USDA.
    And so we have worked hard with USDA, as we have begun to 
develop our regs for FSMA and then as we move into the 
implementation phase, to take advantage of their expertise and 
their role in the communities, and to work in partnership. So 
we are in different agencies. We have different legal/
regulatory frameworks for our work. But we are working in 
partnership to try to get the job done.
    Mr. Young. Thank you. I believe my time is about up. Can I 
get 20 seconds, Mr. Chairman?
    Mr. Yoder. Fifteen.

                           MEDICAL MARIJUANA

    Mr. Young. I want to follow up on Mr. Farr's issue 
regarding medical marijuana.
    You talked about some other agencies and groups that have 
done studies on medical marijuana. Has the FDA ever done any 
research or studies on medical marijuana, and is that public? 
Do you need a mandate to do those studies?
    Dr. Hamburg. Well, we do a variety of different types of 
research. We do not generally undertake clinical studies of any 
drugs that are in development. That is usually undertaken by 
industry, often undertaken by industry in conjunction with 
private research.
    Mr. Young. So no clinical studies. Have you ever looked at 
the issue?
    Dr. Hamburg. No. As far as I know, we have not been 
involved ourselves in conducting clinical research on 
marijuana. We have been involved in reviewing clinical research 
proposals for potential products that include components of 
marijuana.
    Mr. Young. Well, they are out there, if you have been to 
Colorado.
    Thank you very much, Mr. Chairman.
    Mr. Yoder. The Chair recognizes Mr. Valadao.
    Mr. Valadao. Thank you, Chairman.

                                  FSMA

    I appreciate your taking some time out for us today. My 
first question is about FSMA. FSMA enables FDA to better 
protect public health by strengthening the food safety system 
and empowering the FDA to overhaul the existing program. This 
Subcommittee has provided a considerable amount of funding to 
support the implementation of FSMA. Commissioner Hamburg, could 
you please tell us how some of this additional funding has been 
used by FDA to implement FSMA?
    And you and your staff have visited many farms in 
California. And based on your meetings and experiences with 
farmers, how do you interpret their feelings about FSMA 
implementation, and do you believe they are confident that 
their input will be received?
    Dr. Hamburg. Well, answering your second question first, a 
number of us have spent time on farms across the country, 
including in California. I had actually the opportunity to go 
with Congressman Farr to his district and visit a number of 
farms and meet with the leafy green producers in particular.
    I would say that we have learned an enormous amount from 
those visits, both about what are best practices that we want 
to build on rather than reinvent the wheel, and also about the 
realities of implementation and how we can address a set of 
concerns that would make the implementation more cumbersome in 
ways that achieve all of the goals but understand more clearly 
where are the opportunities to reduce risks by changes in 
practice.
    So the visits have been enormously helpful. And as a result 
of some of our visits, our town halls, our discussions, and 
input, we actually put forward four supplementals in our 
rulemaking process that reflected changes in thinking in 
response to input so we could make the best rule possible.
    With respect to how have we used the resources already, we 
have been working flat out to meet the requirements of FSMA and 
to get these rules done and to get them done in the most 
responsible way possible, which has not been just sitting at 
our desks, as I was just describing to you, but really going 
out and walking the fields and the processing plants and other 
things to understand the issues, to hear the concerns, and have 
those integrated into our final approach.
    And I would say that we did not start to implement FSMA 
replete in terms of resources. We were already at a deficit. 
When FSMA passed back in 2011, our Center for Food Safety and 
applied Nutrition had fewer employees in it than it had 20 
years before that. So we redirected employees. We galvanized 
everyone. We had them, sadly, working through the Christmas 
holidays two years in a row in order to meet deadlines and 
achieve our goals.
    But we do need real money to get the job done. And I think 
that, as I said----
    Mr. Valadao. Thank you.
    Dr. Hamburg [continuing]. If we make this investment, it 
will benefit all.

                              BIOSIMILARS

    Mr. Valadao. And I also want to echo Representative Yoder's 
comments on biosimilars. That is an important issue, obviously, 
for us in California as well and a lot of folks that create a 
lot of jobs there. So it is something that I would like to 
echo.

                        SUBSTANTIAL EQUIVALENCE

    I also wanted to touch on another issue. According to the 
September 2013 GAO report, over 3800 substantial equivalence 
applications have been submitted as of January 7, 2013. My 
understanding is that today the number of applications is 
nearly 4500, of which only 95 have received final action.
    Do you feel that this amount of backlog is acceptable? Is 
there a reason that the Agency is not using its unobligated 
user fees for clearing this backlog, as is in the case of 
tobacco? And is there not a statutory deadline for FDA to issue 
a substantial equivalence order or for the FDA to grant or deny 
the exemption request? Given the delays in FDA's implementation 
of the time-sensitive application process procedure, do you 
feel that such a deadline should be imposed?
    Dr. Hamburg. Well, first let me say this is a very new 
program. We just stood up the center a few years ago, and it 
has been expanding rapidly. And this is a whole new area of 
undertaking, never done anywhere in the world before. And we 
are moving much more efficiently as we learn more about what to 
do and how to do it.
    I do want to turn, if I can take the liberty of asking 
Mitch Zeller, Director of the Center for Tobacco Products, to 
respond because he is much more familiar with some of the 
details, and I think in order to give you the best answer 
possible.
    Mr. Yoder. Is there objection? [No response.]
    Mr. Yoder. Without objection. Please, sir, go ahead.
    Mr. Zeller. Thank you so much for the question, Mr. 
Valadao. Here are the numbers.
    There are applications for products that are already on the 
market that we have made a lower priority than the applications 
for the products that are not currently on the market. For the 
applications for products that are not currently on the market, 
there is no backlog. As soon as a new application comes in, we 
commence a review immediately.
    And of the roughly 1,000 of those applications that are for 
products not currently on the market, we have resolved over 
half of them, and that is from zero a couple of years ago. We 
are up to either saying yes, saying no, or a company 
withdrawing them. So we are at 52 percent resolved, and there 
is no backlog for new applications coming in.
    Mr. Valadao. Thank you. I yield back.
    Mr. Yoder. Mrs. Lowey.
    Mrs. Lowey. Well, thank you.

                          DIETARY SUPPLEMENTS

    On another area, you probably do not know, but labeling has 
been a key issue of mine. It took me a long time the first time 
trying to get labeling on products. The FDA requires 
verification that products are safe and have adequate labeling, 
but unlike medications, supplements are not subject to the same 
evaluations process as medication.
    Now, in my home State of New York, a recent investigation 
found that 21 percent of the test results from store brand 
herbal supplements contained traces of the plant species listed 
on its label. The remainder, 79 percent of supplements tested, 
showed no DNA relationship with the plant listed or had 
contamination of other plant material.
    I am really concerned about what that means for those with 
allergies who may not know that supplements they consume may be 
contaminated by other substances which could cause the 
individual great harm. Should supplements, in your opinion, be 
evaluated at a higher standard? How should labeling standards 
be improved to make sure that allergens are properly declined?
    Dr. Hamburg. Very important questions. And I think many 
Americans are actually surprised to learn that dietary 
supplements are not subject to the same premarket review and 
approval process that drugs are by the FDA. We do have 
responsibilities with respect to claims and oversight of good 
manufacturing practices, and it is required that companies 
report serious adverse event reports to us.
    So we do monitor dietary supplements, and we are, sadly, 
called to action in terms of enforcement periodically because 
of findings that dietary supplements contain unapproved drugs, 
various kinds of contaminants, or are making claims that are 
false and misleading.
    The challenge is increased by the fact that many, many 
dietary supplements are now coming from countries all over the 
world, subject to these complex supply chains and increasing 
vulnerabilities to substandard contaminated or adulterated 
product. So it is an area that I think we are concerned about, 
and we continue to act within the responsibilities that we have 
been given for oversight of dietary supplements. And certainly 
when we hear of concerns, we respond.
    Mrs. Lowey. I appreciate it. But the question is, should 
they be evaluated at a higher standard, and is it the 
responsibility of your Agency? It is not now, I gather. Should 
it be, and is there something we should do about it or could do 
about it?
    Dr. Hamburg. It is not now, and I think that there are 
concerns. And we want to work closely with industry and the 
responsible players in industry to see how we can ensure a 
higher level of quality. But we do not have the authority for 
premarket review. We certainly do not at the present time have 
the resources, either, but that is a discussion that certainly 
Congress could undertake in light of some of the concerns that 
have emerged.
    Mrs. Lowey. So in order to change the standards and to 
expand your authority, Congress would have to give you 
directive? Is that what you are saying?
    Dr. Hamburg. Yes. We do not have the authority for 
premarket review and approval. And it would be a very large new 
set of tasks for us, but certainly these products----
    Mrs. Lowey. But should it be done, now that you are leaving 
and going on to other things? [Laughter.]
    Mrs. Lowey. Not that I am trying to----
    Dr. Hamburg. I have seen very serious concerns. And I think 
that there are a set of very reputable manufacturers out there. 
But especially in a globalized world, the quality of products 
is clearly inadequate. And I also do believe that there are the 
so-called snake oil salesmen out there as well that are pushing 
products with claims that simply do not reflect benefits to 
consumers. And consumers are spending a lot of money on these 
products.
    Mrs. Lowey. So we will work on that. So in other words, you 
think it would be a good idea.
    Dr. Hamburg. I think it should be examined. This comes up 
on a regular basis.
    Mrs. Lowey. Oh, I remember. Thank you very much, and thank 
you, Mr. Chairman.
    Mr. Yoder. Thank you. Dr. Harris.

                              COMPOUNDING

    Dr. Harris. Thank you very much. I guess this is the 
lightning round.
    First, in terms of drug shortages, I just want to bring to 
your attention one concern. As an anesthesiologist working in 
an operating room, the USP 797, the compounding regulation with 
the one-hour rule, does not make any exception at all for 
things done in an operating room, which is a sterile 
environment, different situation.
    Has the FDA done anything or plan to work with USP to 
create an exception with regards to certain environments with 
regards to the safety of compounding?
    Dr. Hamburg. No. I do not know the answer to the question, 
so I will be quick. We will get back thank you.
    [The information follows:]

    FDA has several staff participating as liaisions in the USP 
Compounding Expert Committee's efforts to revise USP Chapter 
797,Pharmaceutical Compounding--Sterile Preparations. The intent of all 
involved is to improve standards for pharmacy compounding, and 
especially for aseptic practice, where we have seen so many issues.

    Dr. Harris. You can get back to me. I appreciate that.
    And we talked in my office about drug shortages. Again, 
anything you can do to help because in the operating room 
environment, there are several drugs that we do not have ready 
availability to on occasion.
    With regards to the e-cigarettes, just a couple of followup 
questions. Is harm reduction potential going to be part of 
consideration when you look at product approval or not? Because 
there is some evidence that in some populations, people do give 
up smoking and use e-cigarettes. So there is some benefit. 
There might be risk, but there is some benefit. So I take it 
that that harm reduction potential is taken into consideration 
under certain circumstances.
    Dr. Hamburg. And there actually is--Mitch can correct me if 
I am wrong--a pathway for companies to actually seek a reduced 
harm label.

                        SUBSTANTIAL EQUIVALENCE

    Dr. Harris. And with regards to the substantially 
equivalent product consideration, GAO, as you know, has issued 
a report very critical of the backlog. Is that something you 
are working through?
    Dr. Hamburg. Well, that is. And I thought that Mitch gave a 
very--I do not know, you may not have heard--but a very nice 
overview of the progress that has been made, and that there 
actually are not backlogs in some of the critical areas that 
were present earlier. This was a program that was being started 
from scratch, and we had to build----
    Dr. Harris. Sure. No, I understand.
    Dr. Hamburg [continuing]. And the procedures. But I think 
it is----

                TROPICAL DISEASE PRIORITY REVIEW VOUCHER

    Dr. Harris. Keep going. The Tropical Disease Priority 
Review Voucher Program obviously increased the tension because 
of Ebola. Are you considering adding diseases to the program, 
and has the FDA begun work to add diseases to that program?
    Dr. Hamburg. We are very, very eager to continue to advance 
new antibiotic development, and particularly for under-met 
medical needs, including tropical diseases. And as you know, we 
are seeing diseases moving slowly but steadily into the United 
States and becoming endemic in many cases, and ones where we 
badly need treatments or vaccines.
    The process for the priority voucher may be one where 
actually--I think the list may be statutorily defined. There is 
another process that we have been using and we think has been 
working very effectively, which was part of the GAIN Act, in 
terms of qualified infectious diseases that creates a program 
to incentivize companies to develop new products in that area.
    And we have, I think, designated over 60 in that program 
and approved four new drugs. That was part of FDASIA, so it has 
only been in existence for a few years. So I think that is 
another very viable option for how to get more of these drugs 
developed and into use.

                          THREE-PARENT EMBRYO

    Dr. Harris. Thank you. Finally, one thing that was asked in 
last year's testimony--I was not on the Subcommittee last 
year--was about the whole three-parent embryo issue. Obviously, 
some ethical concerns. That will be discussed elsewhere. But 
the U.K. Parliament has approved it.
    Has the FDA received a request for approval here or for 
guidance of similar techniques? Are you considering further 
hearings or actions? Where does that stand?
    Dr. Hamburg. Yes. Well, I think the U.K. Parliament 
approved it for research. We have had an approach on this 
technology, and we did hold a public meeting I think some time 
last year where issues of science and ethics were discussed.
    We subsequently asked the Institute of Medicine at the 
National Academy of Sciences to actually look at the ethical 
issues because we do not think that the FDA is the right place 
for that, but we think they certainly need to be examined in 
some depth.
    So it is certainly a technology that is being examined. We 
will learn more from the U.K. experience. We await the input 
from the Institute of Medicine.
    Dr. Harris. But has FDA received a request for approval or 
guidance at this point from anyone?
    Dr. Hamburg. Well, we have received inquiries about the 
development of research in this area, and that was what led to 
the public meeting that I mentioned.
    Dr. Harris. And do they intend to have more meetings as 
this develops?
    Dr. Hamburg. Well, I think we are taking it one step at a 
time, and we need to look at both where is the science--this is 
for an approach that would enable women that have a 
mitochondrial disease that can be passed on, that would be 
passed on, to their offspring to have----
    Dr. Harris. Oh, I understand the science. Thank you very 
much. I yield back.
    Mr. Aderholt [presiding]. Before I go to Mr. Farr, let me 
just add--and thank you, Dr. Harris, for bringing this issue up 
because I am hearing more and more about it. And I think it is 
important that FDA does consider the ethical considerations of 
this three-parent embryo because from my colleagues I am 
hearing more and more concern about this. So I would encourage 
you to take that very seriously as we move on, and we may think 
of some ways that we can work together on that.
    Mr. Farr.
    Mr. Farr. Welcome to the hearing of drug du jour. I have 
something to ask you about, but I just wanted to--in fact, I 
will just go through my list and then you can respond.
    First, what struck me is you remember the panic with the 
Ebola, of all the patients arriving here? And we just panicked. 
This country just--we got lots of questions at home, our 
offices. People were scared. And yet we have had this measles 
outbreak and there does not seem to be a scare. What is the 
difference? Why does Ebola freak us out and measles not? We 
have not heard the hue and cry. That is just a generic 
question.
    The specific question on drugs is, I want to ask you about 
the female sexual dysfunction drug. I understand that there are 
26 FDA-approved drugs for the treatment of male sexual 
dysfunction, but there are zero, none, for women. There also 
seems to be disparities in the approval process requirements 
for these drugs between those for men and those for women.
    For example, the male drugs got all priority reviews. The 
female drugs all got denied. The female drugs had to go through 
a multitude of formal public meetings. The male drugs had none. 
Why are the drugs for the female problem being handled 
differently than those for the male problem?
    Second question. For years this Committee has asked about 
sunscreen approval, and for years the Committee has put strong 
language in the report directing the FDA to act affirmatively 
in moving the process along. Last year Congress passed, and the 
President signed, a new law on the issue. And yet this year we 
are at a dead stop. Why are the sunscreen ingredient 
applications still stuck? The last time a over-the-counter 
sunscreen ingredient was approved by FDA was in the 1990s.
    And the third one is on medical gas, and I understand that 
there is a regulation and certification of medical gas. But 
that is still bumping around even though Congress fast-tracked 
them in the FDASIA bill. Can you give me a sense of when the 
FDA intends to finalize the regulations on this?
    Dr. Hamburg. Okay.
    Mr. Farr. And I have a few more, but I will probably just 
put those in the record.
    Dr. Hamburg. All right. Well, let me try to answer those 
questions as succinctly as I can, although each of them has its 
complexities.

                              MEDICAL GAS

    On the medical gas, going backwards, we do have a 
certification program in place, and in 2013 draft guidance went 
out that outlined how we plan to administer the process. As I 
understand it, there are now over 60 designated medical gas 
products that have been certified, but there is still more work 
to be done.
    Mr. Farr. The problem is the industrial gases, which are 
dangerous. I guess this process runs into that problem. And 
these are for little personal packs that people carry--oxygen 
you see a lot of, but other kinds of medical gases that are 
trying to get fast-tracked get caught up in the industrial.
    Dr. Hamburg. Well, this is obviously important in the 
hospital setting and for individual patient needs. And it is an 
area that we have been working hard on. It is one of many. We 
talked earlier about the scope. It is incredible the range of 
things. And we do not have the person power always to move as 
quickly as we would want.
    But this is an important and priority area that has gotten 
more attention in recent years, and so we are working 
diligently. And we have been working with medical manufacturers 
and healthcare providers and other stakeholders as we address 
the problem.
    And we have conducted an extensive regulation review, and 
we have had a public meeting with followup with stakeholders to 
address it as well. So progress is being made, and you can see 
in both the number of designated medical gases that have been 
through the certification process and----

                       FEMALE SEXUAL DYSFUNCTION

    Mr. Farr. What about the female sexual dysfunction?
    Dr. Hamburg. Well, that is more complicated because the 
male ones that you mention are talking about a very mechanistic 
plumbing kind of issue. The female ones are looking at desire. 
I do not know if that is quite the right word. But we are 
talking apples and oranges in terms of the class of drug and 
what the drug is trying to achieve.
    And it is a harder scientific research question to develop 
the product that really works. We are very open to 
applications, and we have been working with one manufacturer 
over time whose product has not yet met our standards for 
approval in terms of safety and efficacy. But we would be 
delighted if we saw more products in this area.
    There are several products for painful sex, and that is 
another important aspect as well. But it is an area where I can 
assure you there is no prejudice against these products because 
of the nature of the product or the population that would be 
using them. It is a question of getting the science and the 
understanding of how to address the medical condition aligned 
with a product that really works.
    Mr. Farr. But the bureaucracy is--you say it is apples and 
oranges. But I think the concern that we have heard is just 
that the protocols make it much more difficult.
    Dr. Hamburg. They are very different products that you are 
talking about on the male side in terms of how they work and 
what is trying to be achieved. Of course, many of them--you 
cited a large number; a lot of them are generics, not all new 
molecular entities.
    But I think the important point is that we want to work 
with the consumer advocates and the stakeholder community, 
healthcare providers, and importantly, industry and research to 
try to advance the science to develop new and better products. 
And we want to work with anyone who is developing these 
products to help ensure the kind of research plan and studies 
that could help us really assess if it is safe and effective 
and appropriate for approval.
    But so far, we have not seen a product that can make it 
over the finish line. But we hope that we will, and we want to 
continue to work on that.
    Mr. Aderholt. Mr. Yoder.
    Mr. Yoder. Thank you, Mr. Chairman.

                             BUDGET REQUEST

    Dr. Hamburg, as we consider your budget proposal and some 
of the increases in authority that you have asked for, new 
personnel, I think it is really instructive of the impact that 
passing legislation has in Washington; as we grow the scope and 
responsibilities of your Agency, it requires more personnel and 
more dollars to meet the demands that have been placed upon 
you.
    And I think that sometimes it is forgotten when we debating 
bills on the floor, which is, what is the administrative price 
tag? Who is going to administer this? What is it going to cost? 
And I think Congress should take that into consideration more 
often.
    One of our biggest challenges on this Committee and in 
Congress is how we reduce the impact of the national debt and 
the ongoing Federal deficit in a town in which a $400 billion 
deficit is considered by some a victory because it was much 
higher than that before. And we know we have a lot of work to 
do, and it is one of my top priorities and I know my 
colleagues' as well.
    And so we will give due consideration to your budgetary 
increases, but we do so under the context of the larger 
challenges we face as a Nation in paying some of our bills. I 
do note that if we accept your budgetary request, personnel 
will have gone up nearly 95 percent since you took over in 
2009, starting at roughly 8,000-some personnel and ending up 
with 16,000 personnel.
    Obviously, we cannot be in the business of doubling agency 
sizes at that rate all across government or even the FDA over 
time, and so we have to figure out how to do more with less. 
And the budget increases would be about 85 percent since your 
time in your position. And if we had adopted the President's 
budget submissions overall, the entire Federal budget would be 
20 percent larger.
    And so we may not be able to accept some of your requests, 
but I want you to understand the larger context. And I think it 
is also important for the committee to understand the growth in 
the FDA. It has been larger than most agencies, and moreso than 
certainly businesses and families have been able to grow at 
home. We do not have a lot of businesses that have doubled 
their employees over that time. So government cannot keep 
outpacing private industry.

                                OPIOIDS

    I wanted to ask you a little bit about opioids and the 
issue related to prescription drugs. And I know that Chairman 
Rogers raised this issue, and I know we are looking at 
deterrent formulations.
    And I guess I want to just know: Can we expect the Agency 
to approve more abuse-deterrent formulations in the coming 
months and years? Is the FDA facing any challenges to the 
timely approval of abuse-deterrent formulations that the 
committee should be aware of? And what is your work with 
manufacturers? Are they struggling with any issues where the 
FDA has been unable to provide clear guidance? What advice do 
you give them, and are they interested in providing additional 
abuse deterrence?
    Dr. Hamburg. Yes. Well, this is a priority for us, and we 
have been working very closely with industry, and the research 
community more broadly, to try to stimulate work in this area 
to come up with more innovative approaches and new strategies 
to improve abuse deterrence and make these drugs less subject 
to abuse and misuse.
    We are finalizing guidance that really spells out for 
industry, with greater clarity, what is our thinking and how 
they should structure the studies that they do, and what we 
will be looking for in terms of assessing their abuse 
deterrence.
    But one of the barriers is stimulating the science to come 
up with these new approaches, and that is really, really key, I 
think. Everybody recognizes that what we have now is better 
than nothing, but it is not abuse-proof, and that it still 
allows abuse through the oral--just taking the pills. And that 
is the most common source of significant medical complications 
of prescription opiate use. So it is an ongoing process. But we 
have been very actively involved, working closely with industry 
to try to stimulate new work.
    Can I just say something on your other, or is that stepping 
on----
    Mr. Yoder. Absolutely. Sure. No, please.
    Dr. Hamburg. I just want to say, I appreciate completely 
where you are coming from. But I think it is really important 
to understand that the world has changed dramatically in recent 
years. And part of the task that I had as FDA Commissioner was 
really to make sure that we were positioned to fulfill our 
promise to the American people in a world where science has 
been advancing so quickly that we needed to be able to 
appropriately and efficiently regulate the products that come 
before us.
    And globalization has just shifted everything. There are 
several hundred thousand facilities around the world in more 
than 120 countries making products that are coming into the 
United States. And we have to be able to know that those 
products are being made according to the standards that we hold 
American companies to and that the American people expect.
    So this has been a very unusual time. I do not think anyone 
would anticipate the continuing transformation in terms of 
expansion of FDA. We got new authority for tobacco products, 
which of course is a whole new enterprise that has caused us to 
grow by more than 500 people in recent years.
    But in terms of what we do and our impact on Americans and 
what we are asking the American people to pay, it is about 
eight dollars a year per American to support FDA activities. A 
very large and increasingly large percentage of our budget is 
coming from industry because the industry actually does see the 
value of a modern, efficient, smart regulator. So they, through 
our user fee negotiations, have been putting money into our 
programs and activities, and they hold us accountable for 
appropriate use of those monies.
    But I think this is really important to understand, and I 
think it is really--we do actually represent good government at 
its best in many ways, and reflected in the Gallup poll.
    Mr. Yoder. Well, Mr. Chairman, if I might just conclude.
    And I think that is why you have seen your Agency grow 95 
percent in terms of personnel over the past seven years. I just 
make that point so we understand Congress has answered the 
requests and has answered the call and has put the resources 
forward. And industry has done so as well with the relationship 
that has been created.
    Sometimes we get in this Committee and we say, oh, we are 
cutting these agencies and we are slashing them. We are not 
giving them resources. I think most Americans would say, 
consistent with the points you just made, that almost a 
doubling of the size of personnel over seven years is Congress 
answering that call.
    And I also make that point to recognize that we cannot 
continue that pace. All right? We are not going to be----
    Dr. Hamburg. No. We are looking for efficiencies and taking 
some cuts in this budget.
    Mr. Yoder. And I appreciate that. 8,000 to 16,000 
employees, I cannot imagine seven years from now we will be 
talking about 32,000 employees.
    Dr. Hamburg. No, no.
    Mr. Yoder. So that has been a real J curve on that pace 
that we will not be able to keep up, and that is just good for 
all of us to know.
    Dr. Hamburg. And I believe it.
    Mr. Yoder. Thank you, Doctor.
    Dr. Hamburg. And fully appreciate the support you have 
given us in these recent years.
    Mr. Yoder. Thank you, Doctor. Thank you, Mr. Chairman.
    Mr. Aderholt. Mr. Farr.

                               SUNSCREEN

    Mr. Farr. Can you finish the sunscreen discussion? And 
maybe what you think the feeling about the Ebola versus 
measles.
    Dr. Hamburg. Well, on the sunscreen, just to try to be 
brief, you, I think, said that progress has stopped. It has not 
stopped. It was too slow before. Congress passed the Sunscreen 
Innovation Act and gave us a new framework with more clearly-
defined timelines for reviewing sunscreens in an effort to make 
a product that is really important more available in terms of 
the addition of new ingredients.
    We are systemically now looking at a number of 
ingredients--there are eight in all--in terms of their use in 
over-the-counter sunscreen products. And we are asking the 
companies for data to support the safety of the use, the 
chronic use, of these products.
    But we are committed to moving forward. We actually have 
redirected some of our limited resources to focus more 
attention on moving these reviews. We have to work very closely 
with the companies involved to get the data that we need to 
assess toxicity, which is not a trivial issue.
    People may think, what is sunscreen? It is used more, and 
that is a very good thing. And it needs to be effective to be 
used in a fairly substantial quantity. People use it a lot, and 
it gets absorbed into the body. So we do have to think about 
chronic----
    Mr. Farr. Is it being stuck because of the industry not 
being able to provide the information you are asking? Or is it 
stuck because of not enough personnel and time dedicated to it?
    Dr. Hamburg. Well, at the moment, with respect to these 
eight ingredients, I think that we are working with the 
companies to indicate to them what kinds of data that we need. 
And as soon as we get that data, we will embark on a rapid 
review with the right personnel mobilized to do those reviews 
and to meet the timelines that were put forth in the Sunscreen 
Innovation Act.

                             EBOLA/MEASLES

    Mr. Farr. How about the Ebola/measles?
    Dr. Hamburg. I think Ebola is really scary because it is a 
disease that most people do not know much about. And in recent 
experience, it has a very high lethality rate and a very 
horrifying mode of death. So I think people panicked. I think 
the risk to American citizens were always much lower, but it is 
understandable why there are concerns.
    I think we are too complacent about many, many infectious 
diseases. And I think that many have come to believe that in 
the era of vaccines and antibiotics, that the era of infectious 
diseases is over. Ebola is scary because there is no vaccine or 
treatment. People know what measles is and they think, well, 
how bad can it be?
    In fact, measles can be a very deadly disease, and if not 
deadly, it can have lifelong damage associated with measles. 
And we have a safe and effective measles vaccine. But I think, 
frankly, we have been complacent. Too many parents have chosen 
not to vaccinate their children because they felt that the 
risks of the vaccine were much more serious than they were, and 
that the risk of getting the disease was almost marginal.
    But we know that when vaccination rates go down and there 
is measles in a community or introduced into a community 
because of the amount of travel that occurs, including to other 
countries where measles is much more endemic, it can reignite. 
And we have seen that, and we have seen the devastating 
consequences of it.
    So I think we need to continue to educate the public. We 
need to continue to ensure that products that can make a 
difference in the health and safety of people are taken up by 
the medical community and understood and accepted by consumers. 
I think it is a teachable moment for this country about the 
importance of vaccination against preventable disease.
    Mr. Farr. Good point. I hope you can speak out about it. I 
think putting it in some kind of context with Ebola is very 
important. I think the consumer now is always comparison-
shopping, and how bad is this? And just the scare is not 
enough. It is what you are talking about. We seem to have 
downplayed things that we can treat versus things that we 
cannot treat. And maybe what we can treat is actually more 
serious than what we cannot treat. Thank you.
    Mr. Aderholt. Ms. Pingree.
    Ms. Pingree. Thank you, Mr. Chair.
    Thank you again. You have put in a long day and had a lot 
of very diverse questions, so I appreciate all your answers. 
Let me just bring a couple more points up.

                                  FSMA

    I know I have spent a lot of time talking with Mr. Taylor 
and others, and appreciate the focus you have given to the Food 
Safety Modernization Act. Representative DeLauro has brought up 
a lot of things about the quick implementation of the rules. 
And I have spent a lot of time looking at how they are going to 
impact some of our farmers and especially small- to medium-
sized farmers.
    I am very grateful for the fact that Mr. Taylor took a trip 
up to Maine and some of the other New England States to hear 
from a variety of people about their issues. And I know you 
have been doing a lot of work since then.
    The only thing I wanted to bring up--and I think this is 
already known since I have made some comments about it. The 
revised rule, which does more clearly reflect some of the 
actual issues around farming, and does improve guidance on 
manure and compost. Some things that I think sound scary to the 
consumer on the outside, but the use of manure on a field or 
making sure there is more wildlife in the field is just a big 
part of a healthy ecosystem.
    But the water rule still has some issues. And I think 
people are very concerned about whether or not the water 
quality metrics upon which the FDA is relying are still too 
stringent to be realistic for farms. For example, irrigation 
water is being held to the same standard as water used for 
recreational use, like swimming.
    So I am hoping the FDA will commit to pursuing a more 
practical water standard for agriculture that can be updated to 
reflect advances in science. I do not know if there is funding 
being allocated for the research on appropriate water 
standards, but that seems important to me.
    Do you have an estimate of the cost to the farmer for the 
water test? I hope that there is some flexibility in making 
sure this is not overly burdensome and prohibitive for some 
farmers. I realize you may not have all these answers on the 
tip of your tongue, but since this is a big topic of interest 
to many of my constituents, I wanted to put it out there.
    Dr. Hamburg. Well, I think, most importantly, we are still 
assessing a full range of comments that we have gotten on the 
proposed regs, and we will be moving towards finalization, as 
you know. But I hope and trust that you have submitted some of 
these comments to us as part of that process, or others that 
share your concerns you no doubt have. And certainly we are 
listening today.
    Ms. Pingree. Great. Well, we will certainly be keeping a 
close eye on it, and do appreciate the amount of listening that 
has gone in. But that is one of the concerns that people still 
have.
    Let me just pass along one last question that 
Representative DeLauro did not get a chance to ask, but I will 
put it out there in the mix and you can either reply to her or 
to all of us.

                              TANNING BEDS

    She is concerned about, as I think many of us are, tanning 
beds. She wants----
    Dr. Hamburg. It would not be a budget hearing if Rosa did 
not ask me about tanning beds.
    Ms. Pingree. There you go. So I do not even know if I need 
to explain to you that there are concerns about the high 
exposure which happens more commonly in teen and over-exposure 
in childhood. We all know that those things increase your 
chances of developing skin cancer.
    And tanning bed companies aggressively target girls. Ten 
States have forbidden tanning bed use by children under 18 
years of age. Forty-one States regulate use of tanning 
facilities by minors. And I guess we all want to know if the 
FDA is going to do the same.
    Dr. Hamburg. Well, we have up-scheduled tanning beds to put 
them in a category of medical device where they have more 
oversight, and also have required a black box warning on their 
use that includes a warning against people under the age of 18 
from using them.
     We are also trying to finalize some other--I do not know 
if it is a guidance or a rule--proposed rule. So we are trying 
to put forward a proposed rule that would more specifically 
address some of the Congresswoman's concerns. But that is still 
in process and hopefully will be available, maybe not before I 
leave but soon thereafter.
     Ms. Pingree. Great. Well, thank you again for your 
comments today.

                              MENU LABELING

     Mr. Aderholt. Let me switch gears and talk about Menu 
Labeling. As you know, the FDA published the final rule for 
nutrition labeling of standard menu items at chain restaurants 
on December 1 of last year. Since fiscal year 2014, Congress 
included report language instructing FDA to not expand the 
final regulations to supermarkets and grocery stores. Yet in 
the final rule, FDA disregarded this instruction and not only 
regulated chain restaurants but also supermarkets, grocery 
stores, convenience stores, gas stations, and a whole host of 
other retailers.
    My question would be: Can you explain why FDA chose to 
ignore the explicit statements accompanying the appropriations 
bill and expand the regulations even further?
     Dr.  Hamburg. Well, I think that we were following what 
was put forward in the law in terms of oversight of restaurants 
and restaurant-like establishments with chains of 20 or more, 
as well as vending machines. We tried hard to be very 
thoughtful and careful and mindful of some of the kinds of 
concerns that you were expressing about what were the 
appropriate places for Menu Labeling.
    But in some instances, the law was very specific about when 
there is a menu board and it is restaurant-type food that is 
prepared for consumption in individual-sized portions either 
onsite or for consumption as you are leaving or soon 
thereafter.
     So, for example, in the grocery stores, which I know has 
been a place of some concern, we tried to very clearly limit it 
to the components of the grocery store where there is a mini-
deli kind of a setting or a salad bar-type setting, which is 
explicitly in the law for coverage, and for the deli, where 
there is a menu.
    So if it is a ham and cheese sandwich that is prepared and 
there is a menu, then it would apply. If you are buying a pound 
of ham and a pound of cheese and a loaf of bread, that would 
not be subject to our oversight.
    So I think now that we have finalized the Menu Labeling 
rule, what is incumbent upon us is to work closely with the 
different stakeholders to achieve the most efficient way to 
implement and the greatest clarity about what the expectations 
are and how to do it.
    We have been working closely with FMI, that represents a 
lot of the chain grocery stores, to really find out what are 
the things that are difficult about implementation and how can 
we address them, including doing a walk-through recently and 
looking at the different types of food and what would apply, et 
cetera. But we want to work with stakeholders in order to 
implement this and to comply with the intent of the law.
    Mr. Aderholt. The FDA's final rule mandates that 
approximately 300,000 restaurants and similar retail food 
establishments comply with the rule by December 1, 2015. The 
Agency provides a December 1, 2016 compliance date for similar 
rules released simultaneously that apply to foods sold through 
vending machines.
    We have heard from a number of our constituents that are 
awaiting clarification from the FDA on many of these unresolved 
questions, and they are expressing serious concerns about their 
ability to comply with the Menu Labeling regulations by 
December 1, 2015.
    FDA has yet to provide regulated industries with additional 
compliance time as they await forthcoming guidance that is 
increasing the likelihood for errors, further corrections, and 
higher compliance costs due to the uncertainty.
    As I mentioned in my opening statements earlier this 
morning, FDA has to be aware of the comprehensive costs of 
regulations overall. In a vacuum, these regulations may be very 
logical and relatively easy to comply with. However, the 
Federal Government is forcing major cost on the industry from 
numerous sectors of the government and in aggregate places 
undue cost on these businesses.
    Granted, the Food and Drug Administration extended the 
implementation date beyond what was proposed. Why did FDA only 
allow for one year?
    Dr. Hamburg. Well, it is one year for restaurants and 
restaurant-like establishments, and two years for vending 
machines. But I recognize what you are saying, that the clock 
has already started ticking on the one year, and the guidances 
are not available.
    We want an orderly, realistic, and effective implementation 
process. That is why we are working closely with FMI, as I 
mentioned, and others. So we need to give them guidance. We 
need to work with them and hear their concerns. And we need to 
be, as I said, orderly and realistic about how we go about it.
    Mr. Aderholt. Would you support FDA extending or delaying 
the compliance date of the final menu labeling regulations 
until at least December 1, 2016 to provide the regulated 
entities----
    Dr. Hamburg. Well, I am not going to comment on that, and 
it will be someone else's decision as well. But I think what I 
am saying to you is that we want this to work. We want it not 
to disrupt industry but to enable industry to put in place an 
informational system that actually reflects, I think, what a 
growing number of consumers are already asking for. And of 
course, some companies have already moved towards doing this.
     So we are right now in a stage of really trying to--now 
that the final rule is out and these institutions and companies 
know what they are dealing with, we now need to work with them 
to understand, what are the barriers to implementation? What 
are the areas that need greater clarity? And how can we assure 
the right implementation so that it works?
    Mr.  Aderholt. Well, there is a great concern out there, 
let me just reiterate, because we are hearing--because of the 
impact of this language and the impact it has on them.
    Dr. Hamburg. Yes. Well, we do understand. I think I have 
said to this Committee before that when I first learned of this 
new responsibility for the FDA, I thought it was relatively 
straightforward. It turned out to be one of the most complex 
undertakings that I have been involved in in my tenure, and so 
I understand why industry is concerned and why there is anxiety 
about what does it mean and how do we implement it. So we get 
it, and we are going to work closely with them to assure a 
smooth implementation.

                                 CHINA

    Mr.  Aderholt. Last year our Subcommittee had raised some 
serious concerns about China creating delays and obstacles in 
the process necessary for FDA officials to gain visas into 
China and to allow them to inspect the facilities. In fact, it 
is my understanding that things were so bad that Vice President 
Biden reportedly had to negotiate with the Chinese on the visas 
in China to exchange for China visas in the United States. I 
understand there is some progress that has been made, but the 
progress that has occurred so far is really not that 
acceptable.
     In December of last year, the FDA entered into two 
implementing agreements with two agencies in the Chinese 
Government as it relates to inspections. According to the 
agreements with China, can U.S. inspectors, either based in 
China or on detail in China, inspect a Chinese facility without 
notifying the Chinese Government?
     Dr.  Hamburg. Yes, we can. We often, though, do work with 
these Chinese inspectors because I think it is a way of helping 
to train them to better understand what is expected in terms of 
our standards and quality concerns. And what we are trying to 
do is both achieve the necessary inspections and also help 
create a more rigorous oversight system in China in broadly.
    And why having offices in China is of great value is that 
we are able to work with our counterpart regulatory authorities 
on the medical product and the food side, and also to work with 
industry because industry can help drive this process as well.
     So we are making progress. We have the ability to get the 
visas that we need. We are staffing up. It does remain a 
continuing challenge for us to recruit the right FDA employees 
to live and work in China, India, other places where living can 
be more challenging in other ways.
    But we have been able to carry on a lot of inspections, not 
just with the people that are actually physically working out 
of our China office, but using that office as a hub for other 
inspections to go on. We send people for 30, 60, 90 days, or in 
some instances if it requires specialized expertise, someone 
may go over just to do a couple of inspections.
     But we think the ability to do unannounced can be very 
important. But we also want to use inspections as an 
opportunity not do to a ``got you,'' but to work with our 
counterpart regulatory authorities and industry to identify the 
kinds of concerns we have and fix them so that the company can 
do a better job going forward.
     Mr. Aderholt. And I understand the working with them to 
try to help them to understand what the concerns are. But the 
bottom line is, you are saying that unannounced inspections, 
surprise visits, we can do that?
     Dr. Hamburg. Yes.
    Mr. Aderholt. Without notifying the government ahead of 
time?
    Dr. Hamburg. Right. And the other thing--this, I think, was 
in FSMA; someone may need to correct me--but we now have the 
ability to refuse entry of a product if we have not been 
allowed to go into the facility to do the inspection.
    Mr. Aderholt. How many permanent FDA inspectors with visas 
do we now have in China?
    Dr. Hamburg. Right now we have eight staff in China, with 
five more pending. As I said, we also use those offices as a 
hub to support inspections with people who are not actually 
living and working in China. But this gets to the broader issue 
we were discussing. This is obviously a critical need.
     There are many, many manufacturers in China on both the 
medical product and the food side that we want to know more 
about, that we want to be inspecting regularly, where we want 
to make sure they are meeting our standard for the protection 
of the American public. Yet it is much more costly for us to do 
those inspections overseas.
     So we are working hard, in keeping with the mantra you 
laid out at the beginning of your remarks, not only to 
strengthen our presence there, but to also try to raise 
capacity through working with our counterparts in government 
and industry, and also working with our counterpart regulatory 
authorities from regulatory agencies around the world who share 
this problem.
    We have the biggest burden because of the volume of 
products coming from China into this country. But the European 
Union, Canada, Australia, Brazil, all are getting products from 
China, and they are not able to cover the waterfront in terms 
of inspections, either.
    So we are working on how can we leverage each other's 
inspections and information and intelligence about what is 
going on to enhance our overall knowledge of product quality 
and safety.
     Mr. Aderholt. So currently there are only eight permanent 
inspectors in the entire country of China?
    Dr. Hamburg. There are eight staff in China.
    Mr. Aderholt. How many food and drug inspections were 
conducted by the United States inspectors versus how many were 
planned?
    Dr. Hamburg. I think that we conducted the ones that were 
planned, and some that we had not plan but that were done for 
cause. In terms of the exact numbers, you want international 
numbers for all inspections done of all----
    Mr. Aderholt. U.S.
    Dr.  Hamburg. So inspections done domestically?
     Mr. Aderholt. Yes. How many were--I am sorry. It would 
also be helpful to know also China as well. How many were 
conducted by inspectors, yes, in China, by United States 
inspectors versus how many were planned and how many were----
    Dr. Hamburg. There were, I think, 456 total inspections 
that were done in China in the last year. As I said, we do gain 
some additional situational awareness from exchanging 
information with counterpart regulatory authorities.
    But obviously, there is more work to be done. And again, I 
am often asked, what are the issues that keep you up at night? 
Well, being able to respond to the globalized marketplace to 
ensure import safety is one of those issues for me. So I 
appreciate your interest, and I think it is one of those areas 
that explains why we have had expansions. But we need, 
actually, still more.
    We have adopted other strategies to address some of our 
import safety concerns, including more risk-based and 
information technology-driven screening at the borders so we 
know where to set priorities and target resources. But that is 
also a huge challenge because we have got more than 300 
different ports of entry--water, truck, airplane, train. And 
the volume of products coming over our borders has, I think, 
quadrupled in the last decade.
    So we are scrambling. And one of the things that I am proud 
of is that we have really repositioned FDA to address these 
challenges of the globalized world. But there is more work to 
be done.
    Mr.  Aderholt. Well, I think just the mere fact that we do 
so much trade with China, and especially regarding more and 
more food, I think the increased visibility of inspectors, food 
inspectors, U.S. food inspectors, is important. And I think 
that is something that FDA needs to take very seriously.
    Well, thank you. I know we have gone on now for quite a 
while, and appreciate your testimony here this morning. I know 
this is your last testimony before the Subcommittee, and we 
could draw it out all afternoon, probably, with different 
questions.
    But we do appreciate your testimony, your work, and your 
service to the Food and Drug Administration. And as my 
colleagues have said, we wish you the best in your further 
endeavors.
     And at this point, the subcommittee is adjourned.
    
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Alonzon, Anne....................................................   527
Avalose, Ed......................................................   527
Cochran, Norris..................................................   247
Hamburg, Margret.................................................   247
Johansson, Robert................................................     1
Mitchell, Larry..................................................   527
Shea, Kevin......................................................   527
Tyler, Jay.......................................................   247
Vilsack, Hon. Thomas.............................................     1
Weller, Jason....................................................   363
Young, Michael............................................. 1, 363, 527