[Senate Hearing 114-696]
[From the U.S. Government Publishing Office]


                                                       S. Hrg. 114-696

   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2017

=======================================================================

                                HEARINGS

                                BEFORE A
                               
                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS

                             SECOND SESSION

                                   on

                           H.R. 5054/S. 2956

 AN ACT MAKING APPROPRIATIONS FOR AGRICULTURE, RURAL DEVELOPMENT, FOOD 
 AND DRUG ADMINISTRATION, AND RELATED AGENCIES PROGRAMS FOR THE FISCAL 
         YEAR ENDING SEPTEMBER 30, 2017, AND FOR OTHER PURPOSES

                               __________

 Department of Health and Human Services: Food and Drug Administration
                       Department of Agriculture

                               __________

         Printed for the use of the Committee on Appropriations
         
         
         
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT] 


   Available via the World Wide Web: http://www.gpo.gov/fdsys/browse/
        committee.action?chamber=senate&committee=appropriations

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                  U.S. GOVERNMENT PUBLISHING OFFICE                    
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                      COMMITTEE ON APPROPRIATIONS

                  THAD COCHRAN, Mississippi, Chairman

MITCH McCONNELL, Kentucky            BARBARA A. MIKULSKI, Maryland, 
RICHARD C. SHELBY, Alabama               Vice Chairwoman
LAMAR ALEXANDER, Tennessee           PATRICK J. LEAHY, Vermont
SUSAN M. COLLINS, Maine              PATTY MURRAY, Washington
LISA MURKOWSKI, Alaska               DIANNE FEINSTEIN, California
LINDSEY GRAHAM, South Carolina       RICHARD J. DURBIN, Illinois
MARK KIRK, Illinois                  JACK REED, Rhode Island
ROY BLUNT, Missouri                  JON TESTER, Montana
JERRY MORAN, Kansas                  TOM UDALL, New Mexico
JOHN HOEVEN, North Dakota            JEANNE SHAHEEN, New Hampshire
JOHN BOOZMAN, Arkansas               JEFF MERKLEY, Oregon
SHELLEY MOORE CAPITO, West Virginia  CHRISTOPHER A. COONS, Delaware
BILL CASSIDY, Louisiana              BRIAN SCHATZ, Hawaii
JAMES LANKFORD, Oklahoma             TAMMY BALDWIN, Wisconsin
STEVE DAINES, Montana                CHRISTOPHER MURPHY, Connecticut

                      Bruce Evans, Staff Director
              Charles E. Kieffer, Minority Staff Director

                                 ------                                

     Subcommittee on Agriculture, Rural Development, Food and Drug 
                  Administration, and Related Agencies

                     JERRY MORAN, Kansas, Chairman
ROY BLUNT, Missouri                  JEFF MERKLEY, Oregon
THAD COCHRAN, Mississippi            DIANNE FEINSTEIN, California
MITCH McCONNELL, Kentucky            JON TESTER, Montana
SUSAN M. COLLINS, Maine              TOM UDALL, New Mexico
JOHN HOEVEN, North Dakota            PATRICK J. LEAHY, Vermont
STEVE DAINES, Montana                TAMMY BALDWIN, Wisconsin
                                     BARBARA A. MIKULSKI, Maryland
                                       (ex officio)

                           Professional Staff

                            Carlisle Clarke
                            Patrick Carroll
                             Rachel Santos

                   Jessica Arden Schulken (Minority)
                        Dianne Nellor (Minority)

                         Administrative Support

                              Carlos Elias
                         Teri Curtin (Minority)
                           
                           
                           C O N T E N T S

                              ----------                              

                                hearings

                        Wednesday, March 2, 2016

                                                                   Page

Department of Health and Human Services: Food and Drug 
  Administration.................................................     1

                        Wednesday, March 9, 2016

Department of Agriculture........................................    57
                              ----------                              
Nondepartmental Witnesses........................................    99

 
   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2017

                              ----------                              


                        WEDNESDAY, MARCH 2, 2016

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 1:58 p.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Jerry Moran (chairman) presiding.
    Present: Senators Moran, Daines, and Merkley.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                      Food and Drug Administration

STATEMENT OF HON. DR. ROBERT CALIFF, M.D., M.A.C.C., 
            COMMISSIONER
ACCOMPANIED BY JAY TYLER, CHIEF FINANCIAL OFFICER


                opening statement of senator jerry moran


    Senator Moran. Good afternoon, everyone. We are having an 
abbreviated hearing today as a result of four votes being 
announced at 2:30.
    Dr. Califf, congratulations on your confirmation. Welcome 
to the Food and Drug Administration (FDA). Senator Merkley and 
I have agreed to withhold our opening statements, which should 
be to the benefit of all in the audience.
    [Laughter.]
    Senator Moran. And we will submit those for the record.
    And we are going to start with your testimony, then we will 
have a round of questions for as long as we are able until the 
votes are called. We will go a little bit until that time.
    So, Dr. Califf, we welcome your testimony as we begin the 
appropriations process for this year.


              summary statement of hon. dr. robert califf


    Dr. Califf. Thank you, Chairman Moran and Ranking Member 
Merkley. I was advised that my testimony could be sidelined, 
too, but I am happy to give it if you would like. I know your 
time is limited.
    Senator Moran. We would welcome you perhaps highlighting 
the things you want to make certain we know, and perhaps if you 
can do that rather than reading your statement, that is to all 
of our benefit.
    Dr. Califf. Great. Well, I will try to do this in one 
minute instead of five, and I appreciate being here. I also 
want to acknowledge Dr. Ostroff sitting behind me, who has just 
finished his term as Acting Commissioner, and I think he has 
done a wonderful job. We all owe him a debt of gratitude for 
stepping in with such equanimity and grace.
    You have got the budget in front of you. We think it is a 
very responsible budget, and several of the main priorities 
that I have in this, as you well know, are, first of all, the 
workforce at the FDA. Due to the increasing intensity of 
biological, agricultural, and engineering advances, we need a 
topnotch workforce, and much of our activity is devoted to 
that. And the second is shoring up the science base, which 
includes a heavy emphasis on quantitative analytics. One of our 
biggest priorities for this year is implementation of the Food 
Safety Modernization Act (FSMA).
    At the core of that is a quality system, which you have all 
participated in helping us develop. We appreciate the funding 
increase that we got last year. It has made a big difference, 
but we still have work to do there. And at the core of it is a 
quality system built on high-level analytics so that we can 
deploy FDA forces in the most efficient and effective manner.
    So at the core of it for me is that we are in a continuing 
evolution of the FDA as a science-based public health 
organization with a very broad scope of activities. There is an 
amazing array of details that we can talk about. They are 
specified in my testimony that we have submitted, and I look 
forward to taking your questions.
    [The statement follows:]
              Prepared Statement of Hon. Dr. Robert Califf
                            i. introduction
    Good afternoon Chairman Moran, Ranking Member Merkley, and Members 
of the Subcommittee, I am Dr. Robert Califf, Commissioner of the Food 
and Drug Administration (FDA). Thank you for the opportunity to appear 
before you today to discuss the President's fiscal year (FY) 2017 
Budget Request for FDA. I would like to thank the Subcommittee for its 
past investments in FDA, most recently for fiscal year 2016 funding, 
which have helped us meet the demands of our increasingly complex and 
diverse mission at home and abroad. For fiscal year 2017, FDA is 
requesting $5.1 billion to support our essential functions and priority 
needs.
    I am honored to have been chosen by the President and confirmed by 
Congress to lead the FDA. Thank you all for your willingness to share 
with me and my predecessor, Dr. Ostroff, your perspectives on ways the 
FDA can better serve the American people. My first priority as 
Commissioner is to strengthen and better support the FDA's talented and 
dedicated workforce. I will focus on the need to carry our critical 
priorities over the finish line. FDA's ambitious agenda currently 
includes implementation of the Food Safety Modernization Act, 
finalizing the Tobacco Deeming Rule, facilitating the development of 
medical counter measures, and making progress on the Combating 
Antibiotic Resistant Bacteria (CARB) initiative, and the Precision 
Medicine Initiative. I also want to further development of the FDA's 
science base that informs decisionmaking across drugs, medical devices, 
food safety, and more. FDA's work on the groundbreaking Sentinel 
system, supported by your mandate, demonstrates the power of the use of 
our new national digital infrastructure. We are increasingly able to 
rapidly develop evidence to inform FDA's decisionmaking, and giving us 
the ability to act quickly on safety issues, rather than having to wait 
for a new study every time a safety issue arises. I look forward to 
continued dialogue with you to gain support for FDA's important public 
health mission.
    ii. fda plays a critical role in america's public health system
    FDA is a science-based regulatory agency charged with an enormous 
and significant responsibility: to promote and protect public health. 
Our goal in carrying out our mission is to ensure the safety, 
effectiveness, and quality of human and veterinary drugs, biological 
products and medical devices; the safety of dietary supplements; as 
well as the safety and security of the vast majority of our nation's 
food supply. Additionally, the Agency regulates the manufacturing, 
marketing, and distribution of tobacco products, and seeks to reduce 
the use of tobacco products by minors and the detrimental effects of 
tobacco on the general population. FDA's relatively new authority to 
oversee tobacco products, as well as the Agency's heightened role in 
the food supply, has tremendously increased FDA's responsibilities and 
opportunities to promote and protect public health.
    FDA plays a unique and vital role in facilitating the availability 
of safe and effective products and treatments, while also protecting 
people from products that are promoted using false claims or may cause 
harm. FDA works with a broad array of stakeholders including industry, 
other government agencies, and the public, in order to achieve the best 
possible outcomes.
    Congress has recognized the dynamic role that FDA plays and the 
increasingly complex and inter-connected global environment in which we 
operate. As a result, FDA has been tasked with a multitude of new 
responsibilities and authorities in the public health arena, including 
the Drug Quality and Security Act (DQSA); the FDA Safety and Innovation 
Act (FDASIA); the FDA Food Safety Modernization Act (FSMA); and the 
Family Smoking Prevention and Tobacco Control Act (TCA). While FDA has 
stepped up to meet these essential public health responsibilities under 
current funding levels, successful implementation of these new 
authorities requires additional resources.
    III. FDA Has a Proven Track Record of Success
    FDA's accomplishments over the past year have been as substantial 
as any in the Agency's recent history. Across the areas of food safety 
and nutrition, medical product safety and innovation, tobacco control, 
and other areas of our work, our accomplishments demonstrate our 
ability to respond to evolving needs and opportunities--including the 
embrace of new approval pathways, innovative technologies, and cutting-
edge science.
    Moreover, given the importance of our work, FDA's budget is a 
bargain for American taxpayers. The products regulated by FDA account 
for more than 20 percent of every consumer dollar spent on products in 
the U.S.; individual Americans only pay about 2 cents per day to 
support oversight to help ensure that those products are safe and 
effective. This is a small price for life-saving medicines and 
treatments approved as fast as or faster than anywhere in the world, 
confidence in medical products that are relied on daily, and a food 
supply that is among the safest in the world.
    iv. fda's innovations improve and protect america's food supply
    Food Safety Modernization. Congress enacted FSMA in response to 
dramatic changes over the last 25 years in the global food system and 
in our understanding of foodborne illness and its consequences, 
including the realization that foodborne illness is a significant 
public health problem, is preventable, and is costly. FDA is 
modernizing our food-safety system, using quality systems and analytics 
to prevent foodborne illness before it occurs. These food system 
changes and the new FSMA mandates require transformative change in how 
FDA does its work.
    FDA published seven major proposed rules in 2013 and, after much 
stakeholder input, five of those became final in 2015: the preventive 
controls rules for human and animal food, the produce safety rule, the 
foreign supplier verification program rule and the third-party 
accreditation rule. These groundbreaking final rules will help food 
manufacturers, produce farmers, and food importers take steps to 
prevent food safety problems. The produce safety and foreign supplier 
verification rules, for the first time, establish enforceable science-
based safety standards for the growing and harvesting of produce and 
make importers accountable for conducting risk-based verification to 
determine that imported food meets U.S. safety standards. In addition, 
as part of these rulemakings we are establishing a program for the 
accreditation of third-party certification bodies to conduct food 
safety audits of foreign food facilities.
    Nutrition. Americans eat and drink about one-third of their 
calories away from home. To this end, on December 1, 2014, FDA carried 
out a congressional mandate to publish rules requiring that calorie 
information be listed on menus and menu boards in chain restaurants and 
similar retail food establishments, and on signs for vending machines. 
In 2015, FDA issued two guidances to help affected industries implement 
the menu labeling rule, one aimed at small businesses, and the second 
providing more detailed advice on how the rule works in the context of 
a diverse industry. FDA also listened to stakeholders and extended the 
compliance date for menu labeling.
          v. promoting innovative medical product development
    Medical Product Application Review. This year, through application 
of our efficient and flexible approval process, we again were able to 
approve a broad range of innovative medical products and treatments 
with the potential to make a positive difference in the lives of 
patients. These products included a new generation of targeted 
therapies that will be used to treat or prevent diseases that affect 
only a few individuals and additional products that will be used to 
treat diseases that affect large portions of the population. They 
involve novel approaches to therapy developed from the rapidly 
accelerating science of genomics and even new product categories, such 
as our approval of the first biosimilar biological product.
    We also enhanced engagement of patients in the development, 
approval and evaluation process. And we continued to make progress in 
our application of some of the most cutting edge areas of science and 
technology, such as precision medicine, which is helping us to advance 
biomedical understanding and provide targeted therapies that will allow 
us to better treat individual patients and diseases.
    FDA's rapid drug reviews and use of expedited programs for certain 
categories of drugs haves helped provide meaningful new products to 
U.S. patients quickly without compromising our safety and efficacy 
standards. In 2015, FDA approved 56 novel new drugs. These approvals 
included four new treatments for patients with multiple myeloma, two 
new drugs for patients with heart failure, and another robust year of 
approvals of drugs for rare or ``orphan'' diseases.
    In 2015, we also approved several important vaccines, including one 
for serogroup B meningococcal disease, the first seasonal influenza 
vaccine to contain an adjuvant (intended for people 65 years and 
older), and a new indication for anthrax vaccine to prevent disease 
following exposure to anthrax--the first vaccine to receive an approved 
indication based on the Animal Rule, which allows efficacy data 
generated in animal models to serve as the basis for the approval of 
medical countermeasures against chemical, biological, radiological or 
nuclear threats when human efficacy studies aren't ethical or feasible. 
We also saw the approval of several innovative devices that will make a 
positive difference in the lives of patients, including a device that 
extends the survival time of patients with brain cancer, and a 
transcatheter pulmonary valve that can be placed in certain patients 
with congenital heart disease, without requiring open heart surgery.
    We have also seen important progress in our device review program. 
Our average time to reach decisions on premarket approvals (PMAs) has 
dropped 36 percent since 2009. And in 2015, FDA approved 79 novel 
devices, the most since the start of the Medical Device User Fee 
Program. Most importantly, enhanced flexibility and an efficient 
approval process have come without lowering our standards for safety 
and efficacy.
    An important component of all of the medical product reviews is the 
use of interaction between product developers and our expert staff at 
FDA at critical points in product development. Our expert review teams 
``see it all'' and therefore play an important role in providing 
guidance and feedback to companies that is enabling more effective 
product development. The enhanced communication and growing expertise 
within FDA promotes earlier exit of products that will not pass muster 
and a much higher rate of approval on first review for products that do 
meet our rigorous criteria for safety and efficacy. The success of this 
approach highlights the need for talented people at the FDA--as medical 
products become more sophisticated the need for talented reviewers at 
FDA will grow.
    Opioid Medications. Prescription opioid analgesics are an important 
part of modern pain management; however, misuse and abuse of these 
products contribute to a serious and growing public health epidemic. 
After extensive internal review, the Agency has issued a detailed 
action plan that includes a new framework for considering the 
consequences of addiction, abuse and misuse not only on the individuals 
for whom the treatment is intended, but also upon the larger society 
that is affected by abuse and misuse. Additional post-market 
requirements for studies have been added. FDA continues to support 
development of antidotes to treat overdose, abuse deterrent 
formulations, non-addictive pain relievers, and medication-assisted 
treatments for dependence.
    Biosimilars. FDA has been developing its biosimilar program, an 
effort which led to the approval of the first biosimilar biological 
product in March 2015. And there are more applications in the pipeline. 
To prepare, FDA has produced a variety of guidancesin this area. FDA 
remains committed to strengthening the biosimilars pathway by 
continuing to work diligently to provide development phase advice to 
sponsors and evaluate applications submitted under this abbreviated 
pathway, and issue additional guidance as needed to provide clarity to 
stakeholders.
    Next Generation Sequencing and Precision Medicine. Our strengthened 
focus on regulatory science is helping to drive innovation. One 
illuminating example is our growing ability to apply the sophisticated 
technologies of next generation sequencing and precision medicine. FDA 
today is better prepared for and more engaged than ever in facilitating 
the development of these new technologies (as well as new uses for 
older technologies), with reasonable assurance of safety and 
effectiveness. These efforts help to achieve more precise diagnosis or 
treatment, through the development and review of state of the art 
diagnostics and drugs that are targeted to an individual's genetic 
blueprint. We continue to move forward on the White House's Precision 
Medicine Initiative to advance biomedical understanding by leveraging 
genomic advances, health information technologies, and new methods of 
analyzing large volumes of data. Recently, we launched FDA's 
precisionFDA web platform, a cloud-based portal that has already 
succeeded in enabling scientists from industry, academia, government 
and other partners to come together to foster innovation and develop 
the science behind next-generation sequencing. PrecisionFDA provides a 
clear example of regulatory science stimulating innovation.
    We are also working to refine clinical trial design and statistical 
methods of analysis to create more efficient studies that take 
advantage of advances in genomics and information technology to provide 
more rapid, less expensive and more reliable answers about medical 
products. For instance, we continue to support collaborative efforts in 
clinical trials, such as the NIH's Lung-MAP protocol for lung cancer.
    Drug Quality and Security Act. FDA is implementing the DQSA and 
working diligently to reduce the risks of compounded drug products in 
the U.S. Since enactment of the DQSA, FDA has conducted over 230 
inspections of compounders, many in response to reports of serious 
adverse events, product quality problems, or other complaints. FDA 
continues to identify serious problems during these inspections, 
including contamination in purportedly sterile drugs and in the sterile 
compounding environment, and other insanitary conditions that put 
patients at risk. FDA has also investigated serious adverse events 
associated with non-sterile drugs that were superpotent, as much as 
1000 times the labeled strength. As a result of these inspections, FDA 
has taken aggressive action to protect the American public from 
compounded drugs that could cause harm. Since enactment of the DQSA, 
FDA has issued over 75 warning letters to compounders and has worked 
closely with the Department of Justice on civil and criminal 
enforcement actions. Many compounders have recalled all of their 
sterile drugs and ceased sterile operations at FDA's recommendation. 
FDA has also been working diligently to implement sections 503A and 
503B of the Federal Food, Drug, and Cosmetic Act (as added by DQSA) by 
publishing draft and final policy documents while taking into 
consideration stakeholder input. FDA has issued 12 draft guidance 
documents, five of which were finalized, a proposed rule, and a draft 
memorandum of understanding related to interstate distribution of drugs 
compounded by state-licensed pharmacies and Federal facilities. FDA has 
consulted with the Pharmacy Compounding Advisory Committee, convened 
three intergovernmental working meetings with state representatives, 
and has actively engaged with more than 50 stakeholder groups during 
listening sessions. FDA will continue to work diligently on draft and 
final policy documents to implement the DQSA, and to engage with 
stakeholders on our proposed policies. We have also put out a draft 
guidance on the appropriate use of compounded products for animals. 
Even though not specifically included in the legislation, stakeholders 
have asked us to clarify our policy on animal drug compounding for 
years, which we are now doing.
   vi. fda works to reduce the impact of tobacco on the public health
Family Smoking Prevention and Tobacco Control Act.
    FDA closely monitors retailers' compliance with restrictions on 
tobacco product marketing and sales to youth--and takes strong 
corrective action when violations occur. In late 2015, FDA issued its 
first ever no-tobacco-sale-orders to retailers who continually violate 
the law. In addition, the Agency launched a second major public 
education campaign, ``Fresh Empire,'' targeting multicultural youth 
with powerful messaging about the dangers of tobacco products, all as 
part of the effort to reduce the number of young people who use tobacco 
products.
    Also for the first time, in 2015, FDA authorized the marketing of 
eight new tobacco products under the premarket tobacco application 
pathway. We have made significant progress and have taken many steps to 
improve timeframes in reviewing marketing applications. Our actions 
include increasing scientific staffing; providing feedback to industry; 
issuing multiple guidance documents; holding meetings with industry; 
hosting webinars; sending letters and other communications to clarify 
expectations for industry; and, finally, establishing performance goals 
that include timeframes for review of Substantial Equivalence (SE) 
reports for products that are not on the market.
       vii. fda tackles emerging, unique, and complex challenges
    Combating Antibiotic-Resistant Bacteria (CARB). FDA has made 
progress on each of the five goals of the President's National Action 
Plan for CARB. These goals are to slow the emergence of resistant 
bacteria and prevent the spread of infections caused by resistant 
bacteria; strengthen national one-health surveillance efforts to combat 
resistance; advance development and use of rapid and innovative 
diagnostic tests for identification and characterization of resistant 
bacteria; accelerate basic and applied research and development for new 
antibiotics, other therapeutics, and vaccines; and improve 
international collaboration and capacities for antibiotic-resistance 
prevention, surveillance, control and antibiotic research and 
development.
    On June 2, 2015, both human and animal health stakeholders came 
together in support of a one-health antibiotic stewardship forum hosted 
by the White House. Additionally, CDC and FDA launched the 
antimicrobial-resistant isolate bank of over 160 isolates composed of 
collections of carbapenem-resistant Enterobacteriaceae and other multi-
drug resistant bacteria of antibiotics that are approved for use in 
food- producing animals. FDA also is working closely with CDC and USDA 
on a data collection plan to verify the changes in on-farm antibiotic 
use that are expected to result from FDA's initiative to eliminate 
animal production uses (e.g., growth promotion) of medically important 
antibiotics in food-producing animals and to require 
veterinaryoversight for therapeutic uses of these drugs for the 
treatment, control or prevention of a specifically-identified disease. 
In support of this effort, FDA finalized changes to the Veterinary Feed 
Directive (VFD) regulation in June 2015 which took effect in October 
2015. FDA also published a proposed rule in May 2015 that includes 
additional reporting requirements regarding the sale and distribution 
of antibiotics that are approved for use in food-producing animals.
    Responding to Ebola. In a world where disease knows no borders, 
FDA's response to the Ebola outbreak in West Africa demonstrated how we 
used our scientific expertise and regulatory authorities to the fullest 
extent possible to address a tragic public health crisis of global 
impact. Our response involved collaborating with partners across 
government, pharmaceutical and diagnostic companies, international 
organizations like the World Health Organization, and our international 
regulatory counterparts. We played a key role in encouraging the 
appropriate study of and expediting the availability of diagnostic 
tests, investigational therapeutics, and vaccines, as well as 
investigating fraudulent products marketed to diagnose, prevent and 
treat Ebola. And many FDA commissioned corps officers of the U.S. 
Public Health Service served on the front lines, deployed in a 
humanitarian mission to provide care to patients at the Monrovia 
Medical Unit in Liberia, one of the West African nations that were hard 
hit by the outbreak.
    Medical Countermeasures. FDA's Medical Countermeasures mission is 
to promote national health and security by facilitating the development 
and availability of medical countermeasures (MCMs) such as drugs, 
biologics, vaccines, devices, and diagnostic tests. These products are 
used to diagnose, prevent, or treat conditions stemming from an attack 
with a chemical, biological, radiological, or nuclear material, or a 
naturally occurring emerging infectious disease, such as Ebola or the 
most recent outbreak of Zika virus in the Americas. Sixteen diagnostic 
tests have been authorized under FDA's Emergency Use Authorization 
authority in response to emerging infectious disease threats. MCMs have 
been approved for anthrax, plague, botulism, Acute Radiation Syndrome, 
and pandemic influenza, and several others are on an 
accelerateddevelopment track. FDA finalized the guidance ``Product 
Development Under the AnimalRule''; to date, eleven drug and biologic 
products have been approved under thisregulation. We also established a 
publicly available microbial DNA reference database to help advance 
diagnostic test development.
        viii. fda's fiscal year 2017 president's budget request
    The fiscal year 2017 Budget Request for FDA is $5.1 billion, an 
increase of 8 percent or $358.3 million compared to the fiscal year 
2016 enacted level. The budget includes $2.7 billion for budget 
authority--an increase of one-half of 1 percent or $14.6 million 
compared to fiscal year 2016; $2.3 billion for user fees \1\ an 
increase of twelve percent or $268.7 million compared to fiscal year 
2016. Mindful of the larger pressures on the Federal budget, we have 
focused our request on the most urgent needs for fiscal year 2017.
---------------------------------------------------------------------------
    \1\ Includes proposed Food Facility Registration and Inspection, 
Food Import, International Courier, Cosmetics, and Food Contact 
Substance Notification fees and proposed increase to the Export 
Certification fee.
---------------------------------------------------------------------------
    Food Safety. The fiscal year 2017 Budget provides $1.5 billion for 
food safety, an increase of $211.6 million above the fiscal year 2016 
level. The budget includes $1.3 billion for budget authority--an 
increase of 1 percent or $18.4 million compared to the fiscal year 
2016Enacted budget--and $209.8 million for user fees--an increase of 
$193.2 million compared to the fiscal year 2016 Enacted budget. The 
budget includes an increase of $25.3 million to improve food and feed 
safety through continued FSMA implementation.
    FDA's fiscal year 2017 budget will build on the fiscal year 2016 
investments and focus on two strategic areas of investment that are 
essential to the success of FSMA: state capacity to partner with FDA 
and the safety of imported food. The fiscal year 2017 budget request 
for state capacity building will be used primarily to fund state 
cooperative agreements and grants that support the essential state role 
in implementing FSMA's new produce safety rule requirements.
    Additionally, the fiscal year 2017 request will enable FDA to 
continue progress toward implementing the multifaceted new import 
safety system mandated by Congress, including the Foreign Supplier 
Verification Program (FSVP) rule, foreign food facility and produce 
inspections, and partnerships with foreign governments. Under the FSVP 
rule, importers must verify that imported food has been produced in a 
manner consistent with FSMA's new standards for produce safety and 
preventive controls.
    The user fee request for food safety includes $105.3 million in new 
resources to support the new import safety system and $61.3 million in 
new resources to further modernize the FDA inspection program.
    Medical Product Safety and Innovation. The fiscal year 2017 Budget 
request for FDA for Medical Product Safety and Availability is $2.8 
billion, an increase of $116.2 million above the fiscal year 2016 
Enacted level. The request includes $1.3 billion for budget authority--
an increase of 0.2 percent or $3.2 million compared to the fiscal year 
2016 Enacted level, $1.4 billion for user fees--an increase of 3 
percent or $38.0 million compared to the fiscal year 2016 Enacted 
level, and $75.0 million in new mandatory funding for the Vice 
President's Cancer Moonshot. With this request, FDA will improve 
medical product safety and innovation in five key areas: evaluating 
Precision Medicine-based diagnostics, improving the safety of 
compounded drugs, combating antibiotic resistant bacteria, supporting 
animal drug and medical device review, and improving cancer diagnostics 
and treatments.
    FDA requests $4 million in fiscal year 2017, an increase of $2.0 
million above fiscal year 2016 for Precision Medicine. With the 
majority of the increase, FDA will help advance Precision Medicine by 
establishing the National Medical Device Evaluation System (NMDES) to 
identify patients who benefit most or do not benefit from specific 
types of devices. FDA will also continue to invest in precisionFDA, 
which provides a crowd- sourced, cloud-based platform to advance 
regulatory science around NGS-based analytical tools and datasets.
    FDA requests $18 million, an increase of $1 million above fiscal 
year 2016, to enhance oversight of human drug compounding through 
increased inspection and enforcement activities, policy development and 
implementation, and state collaboration and coordination.
    For CARB, FDA requests $42 million to support continued work to 
address public health concerns associated with antimicrobial drug use 
in animals and to better protect antibiotic effectiveness for both 
human and animal populations. FDA will work in collaboration with USDA 
to support efforts to monitor antimicrobial drug use in food- producing 
animals.
    FDA requests an additional $2.9 million to support ongoing 
activities within the Animal Drugs Review Program and the Devices 
Program to achieve enhanced and predictable review performance that 
meets industry, congressional, and public expectations. The increased 
funding requested will enable FDA to continue to meet premarket animal 
drug review requirements by having the necessary review staff to carry 
out these activities. The request will also support ongoing review 
activities in theDevices Program to meet statutory requirements for the 
review of medical device applications.
    In fiscal year 2017, FDA requests $75.0 million in mandatory 
resources as part of the Vice President's Cancer Moonshot in order to 
accelerate progress in cancer--to reduce the number of people who 
develop cancer and to improve the outcome for those who do. In order to 
support the dramatic increase in the number, complexity, and strength 
of cancer diagnostics and therapeutics, FDA will establish an Oncology 
Center of Excellence to streamline collaboration across FDA's Human 
Drugs, Biologics, and Devices and Radiological Health Programs and to 
interface more effectively with the NIH and the clinical environment. A 
highly effective interface will be needed to deal with the 
proliferation of highly effective but complex combinations of targeted 
drug and biological therapies and immunotherapy, driven by 
sophisticated diagnostic testing and monitoring devices. There is hope 
that many forms of cancer will be cured or changed to chronic diseases.
    Infrastructure, Rent and Facilities. The fiscal year 2017 Budget 
Request provides an increase of $3 million over the fiscal year 2016 
Enacted level, for a total of $12 million, for urgent facility 
investments that will provide functioning offices and labs across the 
country to ensure FDA can execute its Food Safety and Medical Product 
Safety mission. This $3.0 million increase will be used to address 
repairs, improvements and mission support needs at FDA's owned 
laboratories and other critical owned facilities across the U.S.
                             ix. conclusion
    FDA's public-health mission is indispensable to the health and 
well-being of every American. We carry out our broad and expanding 
public health responsibilities effectively and with relatively few 
taxpayer dollars, despite dramatic expansions in our responsibilities 
as a result of new legislation, scientific and technological advances, 
and a globalized marketplace. The fiscal year 2017 Budget Request plans 
for efficient spending on programs that are essential to providing 
Americans with the safe foods and safe and effective medical products 
they expect. We look forward to answering your questions today and to 
working with you in the coming year.

    Senator Moran. Commissioner, thank you very much. Let me, 
first of all, agree with you and express my appreciation for 
the relationship and the work by Dr. Ostroff at FDA. I very 
much value his service to the Agency and to the American 
people, who, in my view, are safer because of his work. And so, 
thank you for that service, and we look forward to it 
continuing.
    Let me start with a complaint, however.
    [Laughter.]
    Senator Moran. And one of the things that I have, at least 
in my view when I became chairman of this committee, we have 
worked at developing a relationship with FDA, and I appreciate 
that we have that. But I am concerned that the FDA is often 
slow in communicating with us and with our staff, that many 
times, in fact today was a perfect example. I would guess that 
many questions will be submitted to the FDA in writing for the 
record. A timely response is not always the case, and 
specificity of answering those questions is often lacking.
    And so, in an attempt to suit you up today on your first 
hearing before this subcommittee, Dr. Califf, I would ask if 
you would assure me that you will do everything as the 
commissioner to see that our subcommittee, its members, get 
appropriate, full, complete, and timely responses to inquiries 
we make to the FDA.
    Dr. Califf. In my consideration of joining the FDA and 
taking this job, outspokenness was one of the criteria that was 
said about me, and it is the case that I do think the FDA can 
do a better job of explaining what it is doing and of 
communicating. I have also had a hard lesson coming to the FDA 
in learning about issues with regard to trade secrets, and I 
will just call them social mores that exist about how things 
roll out that you are well aware of.
    But taking all that into account, we are going to step up 
our communications. I can promise you that we will do that. I 
am an old intensive care unit doctor. I carry a cell phone. I 
am used to being called 24 by 7, and if you feel that 
communication is slow, just call me. I am here.

                            ARSENIC IN RICE

    Senator Moran. Thank you very much. Let me ask a specific 
question about rice and arsenic. Last week during the budget 
meeting in the House, Dr. Ostroff noted that the FDA was making 
the risk assessment for arsenic in rice a priority. When do you 
plan to move, and what exactly are you planning to release in 
that regard?
    Dr. Califf. Well, as you well know, the issue here is 
estimating the risk associated with arsenic that is in rice, 
and estimating the benefits of rice, which has been a staple of 
the American diet. My ancestors down between Charleston and 
Hilton Head actually farmed rice for a living, so I have a 
little history here.
    The assessment is complicated because the data are 
imperfect. It is in a multiagency review. I think you are well 
aware of that. It is a very high priority for us to get this 
out. We know that people are waiting. I am not able to give you 
the specifics of what will be in it, but we are working on it 
very hard with other Federal agencies.
    Senator Moran. This decision potentially has significant 
consequence to a lot of people, from producers to consumers, 
and I would ask that you initiate a broad discussion among 
those affected by this decision before a conclusion is reached. 
Is that something you intend to do?
    Dr. Califf. Yes, I would say there has already been a good 
bit of discussion, but there certainly will be a lot of 
discussion about it.
    Senator Moran. Are there other foods that are involved in 
this topic besides rice?
    Dr. Califf. This particular decision is a rice decision, 
which, of course, comes in many preparations, including infant 
formulas and nutritional aspects, so, you know, it is an 
important decision. We are well aware of that. It will affect 
people, and we want to make sure we take that into account.
    Senator Moran. Thank you very much. Let me now turn to the 
ranking member, Senator Merkley.

                         TOBACCO RELATED ISSUES

    Senator Merkley. Thank you, Mr. Chairman, and 
congratulations, Dr. Califf. There are plenty of fascinating 
and really important issues that the FDA deals with, and the 
one I wanted to start off with is related to the tobacco 
deeming regulation. That regulation has now been in the Office 
of Management and Budget (OMB) since October 2015. The basic 
rules are that it is not supposed to be there more than 90 days 
with one 30-day extension. That would be 120 days. As of today 
we are at 134 and counting.
    So it has been a mystery year after year after year that 
this deeming regulation has not been finished because while 
essentially we have been not acting, the addiction rate for e-
cigarettes has increased dramatically. They are targeted at 
kids with all kinds of flavors--Scooby Doo, Double Dutch 
Chocolate. You name it, you can find it. And to have a product 
targeted to children that is that effective is troublesome 
since it means the likelihood of a lifetime of nicotine 
addiction with related health consequences, and certainly a lot 
of expenses for our healthcare system as well.
    So what is going on? Is this ever going to emerge from OMB?
    Dr. Califf. I can assure that it will emerge, and just--as 
I think you know, I am a cardiologist. I had a very busy 
clinical practice and intensive care units, so I have probably 
seen as many people die or have strokes, or heart attacks, or 
renal failure due to tobacco-related issues as almost anyone on 
earth at this point. So I am strongly committed to get this 
out. You are also well aware of the complexity. We had 135,000 
comments. There are many views about the details that were 
aired that we have been working through.
    But I do not think you will find anybody more committed to 
getting this out than I am. I have seen the consequences of 
tobacco-related illnesses, and we need to take care of this.
    Senator Merkley. Well, I do appreciate that your personal 
background gives you that direct insight because some type of 
special change is needed here because for 2011, 2012, 2013, 
2014, 2015, now we are in 2016, very responsible individuals 
who have said they care a lot about this issue, that they care 
a lot about kids, they care a lot about people, say we are 
doing everything we can, we will have it in a short period of 
time. And it just never happens. So I am hoping the new energy 
you bring and your perspective can say let us get this done.
    Let me just note that between 2013 and 2014, e-cigarette 
use tripled among middle and high school students in 1 year. 
And so, obviously the targeting of children is very effective, 
and it is hurting a lot of people, and this is something where 
we can actually make a difference for the good. So I do hope 
you take your personal experiences and pry this out into the 
public space, and hopefully it will include a ban on all of 
these kid targeting flavors, and hopefully it will include caps 
that are difficult for children to take off so that we do not 
have as many poison cases as we have had with children. That is 
my hope, my hope and my prayer.
    Dr. Califf. Well, I mean, as you know, we are instructed by 
law to take care of the children with the Tobacco Act, and we 
plan to do it. Chairman Upton this morning in a meeting--I was 
with him--pointed out that we can all understand the FDA better 
if we think about our own families. And I have a son, a 
brilliant rocket scientist son, who became addicted to nicotine 
at age 12 in North Carolina, so this is not a matter of 
intelligence or willpower. It is something that we need to 
protect children from. And 400,000 people a year are dying from 
tobacco-related illnesses even now, so we have work to do here.
    Senator Merkley. Thank you, doctor.

                     AGRICULTURE AND BIOTECHNOLOGY

    Senator Moran. The Senator from Montana.
    Senator Daines. Thank you, Mr. Chairman. Thank you for the 
efficiency with which you run this committee. I greatly 
appreciate it.
    Dr. Califf, congratulations to you as well on your recent 
confirmation, and thank you for coming before this committee.
    As you know, the United States is a world leader in food 
production, in food safety, and the FDA plays a critical role 
in maintaining our global leadership in those fields. In my 
home State of Montana, agriculture is our number one industry, 
and our farmers, our ranchers, whether they produce wheat, 
cattle, sugar, beets, pulse crops, or other products, play a 
critical role in not only feeding the United States, but also 
the world.
    And one important way Montana is able to do that is by 
having a world-class research facility at the land grant 
university, Montana State University (MSU). In fact, I was 
particularly proud when I heard that MSU was able to endow its 
first Montana plant sciences chair who is a world leader in 
cereal genetics and started earlier this year.
    Moving forward, it is critical that Washington not get in 
the way and push policies that have the potential to hinder or 
even discriminate against ag research and technology that has 
proven to be effective, proven to be safe, and proven to be 
productive. In particular, the prospects for biotechnology 
continue to be bright. Whether it is enhancing production by 
increasing crop yields or helping protect the environment by 
requiring fewer pesticides, or reducing demand for water, for 
example, or even lower food costs for families, I view biotech 
as essential to the future of our food supply.
    So with that as background, my question is, there was a 
decision made in November of 2015 by the FDA to deny a petition 
to require mandatory labeling of biotech in food products. Do 
you agree with that decision?
    Dr. Califf. Well, this is a decision that was really 
mandated by law in the opinion of the FDA because in order for 
the FDA to mandate a label, it would be required that there be 
a material difference, for example, as measured by a change in 
the nutritional composition of what you eat for a genetically 
engineered product versus a non-genetically engineered product. 
And we have been unable to detect such differences at this 
point, which explains our decision.
    Senator Daines. So as a food safety agency, it sounds like 
you would believe, and I do not want to put words in your 
mouth, but do you believe the FDA should make its decisions 
based on sound science rather than unsubstantiated claims that 
might not be supported by evidence?
    Dr. Califf. We are firmly committed at the FDA to base our 
decisions and policies on the best science that we can possibly 
get.
    Senator Daines. Yeah, it is good to have a doctor running 
it. Thank you, and I agree with you. And to bring this issue 
home, for example, in Montana on the eastern side of our State, 
sugar beets are a major crop. They are an economic driver for 
our State, and, in fact, the source of hundreds of jobs, and 
most sugar beets are grown utilizing biotechnology. But the 
sugar that results from the processing of a conventional sugar 
beet versus a biotech sugar beet is identical in both 
nutritional value and composition, I think to the point that 
were just describing there.
    If a biotech food product, like sugar beets in the example 
provided, is deemed by the FDA to be safe for human 
consumption, meet the same quality standards as a non-biotech, 
and is nutritionally and essentially the same as a non-biotech 
counterpart, should it be regulated by the FDA any differently?
    Dr. Califf. Well, the law tells us it should not be labeled 
specifically for that if the quality is as you described. But I 
also want to take the chance here to stress something that you 
said. This is vitally dependent on a robust agricultural, 
biomedical research enterprise, which is not predominantly 
located at the FDA. We have great people, and Susan Main is 
here today who leads that.
    But it is very important to have first-rate universities 
that are doing the kind of research that you described where 
you are. In my previous career at Duke University, we had great 
biology and botany, but NC State, you know, is world class in 
the broader agricultural sciences, and I had the chance to do a 
lot of work with those folks. So what we are really dependent 
on is a first-rate research enterprise that delivers the 
science that we need to make good decisions, so any decision 
would depend on the specifics of what was measured about the 
plant that you are discussing.
    Senator Daines. Well, I am out of time, but I want to thank 
you, Commissioner Califf, for the thoughtful remarks. And 
moving forward, I do believe it is important that the FDA 
remains focused on its mission to helping ensure the United 
States has a safe food supply and abstains from marketing or 
labeling mandates that would have no bearing on food safety. So 
thanks for your remarks.
    Dr. Califf. I would like to add, Senator, that we did issue 
a guidance on voluntary labeling so those who wish to do so 
have a specified way to do that for those. Who think it should 
be labeled as such.
    Senator Daines. Thank you.

                   FOOD SAFETY MODERIZATION ACT CFSMA

    Senator Moran. Thank you, Senator. Commissioner, let me 
turn my attention, our attention, to FSMA and the topic of 
guidance documents. How many guidance documents is FDA working 
on, and does FDA anticipate releasing--how many do they intend 
to release in regard to FSMA implementation?
    Dr. Califf. Well, Senator Moran, this has been a 
fascinating issue for me because essentially thanks to 
Congress, we are implementing an entire new structure to 
prevent food-borne illness and problems, rather than reacting 
to it. So this means an entire system is having to be put into 
place.
    As you know, five out of the seven major rules have already 
been issued. We have two more rules to come out shortly, and 
then emanating from those rules will be a whole series of 
guidance documents. And what I have come to understand about 
this particular area that is really fascinating and of 
emblematic of where America should be, is a system that starts 
at the farm, works at the county, works at the State, and 
includes the Federal Government.
    And as guidance documents are put out, and I cannot give 
you an exact number because it will depend somewhat on how 
things go. It is really the interpretation of the rules that 
gives people the information they need to for implementation. 
And since this is not the Federal Government saying here is 
exactly how you have to do it, it is really a discussion 
occurring among multiple parties. There has to be some 
flexibility in here so that we get it right.
    And you might even imagine the exact way things are 
implemented could vary depending on the circumstances in 
particular regions or with particular issues. So we are 
committed to issuing the guidance documents that are needed so 
that this is done right and it prevents food-borne illness.
    Senator Moran. And something you just said is a reminder to 
me to remind you and FDA, when your inspectors are reviewing 
practices and making a determination whether compliance is 
occurring, the guidance documents are just guidance. And the 
entity being reviewed can perform compliance in a different way 
than the guidance documents. That is true?
    Dr. Califf. Yes. So let me tell you why--I am actually 
excited about this topic. A lot of my career was built on doing 
multinational human clinical trials, and the first one we did 
was so big about 20 years ago, the FDA was not prepared for the 
inspection. So we ended up with meat inspectors looking at our 
electrocardiograms out in hospitals around the world, and it 
just was not ideal.
    And so, you know, before I got here, wise people figured 
out that our inspectors need to be aligned with a particular 
center so that there is a continuity between the expertise and 
the center and what the inspectors are doing. And when you have 
that expertise, it gives you the flexibility for the inspectors 
to look at the built-in quality as opposed to just reading a 
document and saying you have to do it this way.
    And, you know, I am really pleased to say this is well 
under way. It is a critical part of FSMA, so people inspecting 
farms and food places will have expertise in that area, and 
they will be connected to the center so that if there are 
issues rather than just relying on rote memory, they will be 
able to deal with it. Now, you know, whenever you have a 
complex system it is never perfect. People will need to let us 
know so we can adjust if there are problems.
    Senator Moran. You are making the point that I wanted to 
make sure was clear because even though a producer or a 
processor may not follow the guidelines, they still could be in 
compliance. And I want to make sure that your inspector would 
know that.
    Dr. Califf. Yeah, so----
    Senator Moran. It is about the result. It is not about--I 
mean, FSMA is designed in a way to create safe food, not a 
regulatory checklist. And I think that is what you just told me 
that you agree with.
    Dr. Califf. I agree with that, but I do want to pick a 
little finer point here----
    Senator Moran. Okay.
    Dr. Califf. [continuing]. Because in general, I can speak 
to this from hospital quality which has similar issues. The 
process typically is closely related to the outcome that you 
want. So when you deviate from a standard process that has been 
proven to be effective, then you need to have a good reason for 
doing it, and there often are good reasons. And I have been on 
the other side of the inspection, so I feel like I understand 
when a good reason may be in play.
    But I would not want anybody to believe that we can throw 
the process out the window here. I mean, the whole reason to 
have FSMA is so that we can share knowledge, and people on the 
farms and in the food processing places can know what the best 
standard for quality is. And our inspectors should know that 
quite well, too, because if we did not have that, we would have 
total chaos and no standard.
    So we are going to be flexible, but, you know, we have got 
to have people understand that process leads to the quality. 
Does that make sense?
    Senator Moran. It does. Related topic, what is the status 
of the personnel necessary to pursue compliance of FSMA? Are 
you in hiring mode?
    Dr. Califf. We have done a lot of hiring. We are still in 
hiring mode, and again, thanks for the funding because it is 
has made a huge difference. We are having to increase the 
workforce and the realignment. Remember previously it was 
geographically organized. Now we are saying, you know, you have 
got a particular job to do with a particular industry. And so, 
it is not just hiring people. It is also a tremendous amount of 
team building, and the things that you would do if you are 
building a first rate in a company.
    Senator Moran. Education and training.
    Dr. Califf. Yeah, and, you know it is a complex process. We 
have States and counties involved in doing a lot of the work. 
It is well underway, and I think it is going really well. We 
are excited about it.
    Senator Moran. Thank you, doctor. Senator Merkley.

                          OPIODS AND ADDICTION

    Senator Merkley. I want to turn to the current Senate 
conversation about opioids and opioid addiction and the 
overdoses that are occurring. The FDA has come under criticism 
for not always using an advisory panel on opioids. With Zohydro 
approved back in 2013, the FDA did have an advisory panel. It 
recommended 12-2 against approval, but FDA approved it anyway. 
And then the following year the FDA approved two additional 
opioids, but decided not to convene an advisory panel. What was 
the reason? Was it that FDA did not want to hear about the 
concerns from medical professionals, or why would on such an 
important issue--with so many addiction-related issues, why 
would the FDA have wanted to trash their advisory panel system?
    Dr. Califf. Well, let me be clear. There is no interest at 
the FDA in trashing the advisory panel system. As you know, we 
have recently taken a very deep look at opioids. It is right 
that people are upset. I know you are dealing with it today on 
the Senate floor. It is a national epidemic, more people dying 
from overdoses than from auto accidents, which is a startling 
statistic.
    So we have a very deep eight-point plan that was just 
published in the New England Journal with everything from 
having advisory panels on almost everything to reframing the 
whole issue. You know, the question is how do you consider a 
situation where maybe half of opioids that are prescribed are 
actually diverted to someone for whom the prescription was not 
written. How do you consider the societal effects in addition 
to the effects on the person for whom the treatment is 
prescribed?
    So this is a major point of emphasis. We are changing our 
tactic on this. And I guess the way I like to describe it is we 
are fighting a battle here against a very tough opponent. I 
think the FDA has always tried to do the best job it could, but 
the opponents have gotten tough very quickly, and we are having 
to change our tact here. We are going to do that.
    Senator Merkley. So I know you were not at the FDA last 
year when the FDA approved OxyContin for children without an 
advisory panel. It just kind of defies logic, and so I want to 
ask the question again. Why did the FDA decide to do away with 
advisory panels on these dangerous drugs?
    Dr. Califf. Let me address the two that you brought up 
specifically, Zohydro and pediatric OxyContin. And it will take 
just a minute, if it is okay. I know we are pressed for time.
    This Zohydro issue, it is true the panel took a vote that 
you have recited, but it also specified that there were 
criteria that might make it okay. Their problem was they were 
concerned about the post-market system that was in place. And I 
have learned there was a feeling at the FDA that the 
requirements of the advisory panel were met, so it was not felt 
that it was really disagreeing with the advisory panel. It was 
listening to the advisory panel and making the changes.
    But on that one, we are in complete agreement. If had we to 
do it over again, we would have met with the advisory panel 
again and reviewed the issues.
    And on the pediatric OxyContin, this is a very important 
one, and I think technically I do not think it is correct to 
simply call it an approval. OxyContin has been available for 
children. There are about 10,000 children a year, and if you 
have ever seen a child with sickle cell disease, for example, 
which is one of the serious illnesses for which chronic opioids 
are needed for very severe pain, or a child dying of cancer, 
the drugs are being prescribed, and we think for children, 
mostly appropriately so. Pediatricians would not use these 
drugs ad hoc.
    So the only change that was made was to make proper dosing 
available in the label as opposed to changing fundamentally the 
way the drug was used. And it was associated with a very 
profound post-market commitment to make sure we are able to 
track what is done with OxyContin. Having said that, we learned 
a lot by seeing what happened, and I should note that I was at 
the FDA when this happened because I was at Medical Products 
and Tobacco. So I do not want to be shirking responsibility 
here.
    But seeing the public reaction to this, we are going to 
have two consecutive pediatric advisory panels to review all of 
our approaches to opioids and children. They are already 
scheduled. They will be very intensive, and we will certainly 
listen to the advice.
    Finally, if I could just note one other thing about this, 
we do have a letter that was recently in the Boston Globe from 
the American Academy of Pediatrics and from the chair of the 
Standing Pediatric Advisory Committee of the FDA saying that 
they thought our decision was the correct decision to give 
doctors dosing information so they would know the right doses 
to use when these drugs are indicated. But, you know, having 
said that, we are going to use advisory panels to review these 
things.
    Senator Merkley. Mr. Chairman, could I ask one more 
question here?
    Senator Moran. Yes.

                              OPIOD LABELS

    Senator Merkley. So I am glad to hear the commitment to 
advisory panels going forward. Did you require on the label 
warnings about the addiction properties? Is that on all the 
opioids now?
    Dr. Califf. Yes.
    Senator Merkley. And if not, is that something that can be 
done right away?
    Dr. Califf. It is on all the opioids, but we are going to 
strengthen the labels, which is part of the plan that you see. 
And one thing that happened is there were a whole series of 
things done for long-acting opioids, so-called ER/LA, extended-
release and long-acting. And we are just updating this 
information to put out sterner warnings.
    So I think if you read what is in the label, it is pretty 
clear what the problems are, but we have learned that it has 
not gotten through, and we need to get to prescribers because 
the prescribing really needs to be brought under control.
    Senator Merkley. Well, I can tell you it does not get 
through because just recently, for example, my daughter had her 
wisdom teeth extracted, and so when she came home and she had 
her prescription, I said to her, you know, we have to be very 
careful of these because of the dangers of addiction, and it 
was one of those, ``oh, Dad'' moments. Now, if the dentist had 
talked to her about the dangers of addiction that would have 
carried some weight, if the pharmacist had talked with her 
about the dangers of addiction.
    But it was crazy to her. What is this crazy idea that she 
is hearing from her dad. And as I have talked to people, very 
few get any sort of education from their doctors about the 
substantial risks involved. And just think in Oregon, four 
million people last year, 100 million opioid pills prescribed. 
One hundred million.
    Dr. Califf. Well, if I may, I feel qualified to talk about 
this because up until 10 months I was a pretty busy practicing 
doc. I started in intensive care, and then had an outpatient 
practice. So, you know, recently it was not so big because I 
had administrator responsibilities, but still saw it all.
    The medical practice issue here is profound, and I know you 
all are going to be dealing with it actually today. It is our 
stated position in the New England Journal there should be 
mandatory education. And a really critical thing as you talk 
about this, to back up one second, we spent all day yesterday 
with our science board in a public meeting. One of your 
colleagues actually came out to the FDA to give some public 
testimony.
    A really critical thing here is mandatory education, but 
not just about opioids because, you know, the pain that people 
have is real. There are 10 to 12 million Americans with severe 
chronic pain, and we also heard from them. And so, the doctors 
need to be trained about how to deal with pain and then how to 
deal with the opioid part of pain.
    We have a voluntary program which is part of the RIMS 
commitment that companies have to pay for it, but independent 
CME providers do it. But one problem with voluntary education 
is that people most likely to volunteer to take it are the ones 
who probably need it the least. So we are officially in favor 
of mandatory education, and we think it is one of the most 
important things that could be done.
    Senator Merkley. Thank you.

                     CENTER FOR VETERINARY MEDICINE

    Senator Moran. Commissioner, I saw recently that the 
Director of the Center for Veterinary Medicine announced that 
she was leaving the agency. And I would ask you and encourage 
you to consider the appointment of a veterinary medicine 
practitioner, a doctor of veterinary medicine, to that 
position. Have you thought about what is next in this regard?
    Dr. Califf. I have. We will do a national search, and, you 
know, by standard we need to have it open to all types of 
people who might apply. I will note that I have a proclivity 
towards veterinarians right now. My future daughter-in-law, we 
have a family wedding coming up in Colorado. She is actually a 
Wyoming native, has just graduated from the Cornell Veterinary 
School. So I have heard the veterinarians' perspective on this, 
and personally I have sort of a love of veterinarians because 
of that, but we have to open it up to everyone.
    Being a medical doctor and now in charge of the FDA, I 
understand what you are saying, the concerns, the deep science 
concerns, you know. It would mean that someone from that 
background could be very helpful and someone with experience 
out in the field.

                              BIOSIMILARS

    Senator Moran. Thank you. Let me talk a moment about 
biosimilars and highlight language that was included in the 
omnibus spending bill directing the commission to respond, the 
FDA to respond. And what the language says is--first of all, I 
would preface this by saying there are lots of folks in the 
industry who would like to have input, understanding analysis 
as the biosimilar program is developed, naming labeling, 
interchangeability, and indication extrapolation. And our 
language in the appropriation bill that you are now operating 
under directed that the committee be provided with an estimated 
timeline by which the Agency will finalize all pending draft 
biosimilar guidance documents and regulations.
    The committee expects to receive this report no later than 
60 days after enactment. Enactment occurred in December, and we 
have not had a response to that directive. What is the status, 
and what can we expect?
    Dr. Califf. Well, it sounds lame to say I am going to have 
to get back with you on the details of the timing, but we will 
get back with you. I will just point out, I was in charge of 
the clinical trial for the first biologic in cardiology, and 
ended up working a lot with biologics. So I am well aware of 
the issues. They are complex, but I think we are very close.
    I will give a shout out to Janet Woodcock and her team who 
have been working on this. They are not only regulators. They 
are world authorities on the chemistry and biology of biologic 
drugs.
    So we are going to get this as quickly as we can. I mean, 
after all, we have 59 compounds in the pipeline now for the 
biosimilar program. So if we do not get this out soon, it is 
going to be difficult for people to navigate and know what they 
need to do.
    So I hear you, and we will get back with you.
    [The information follows:]
    
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

                 GAO REPORT ON FDA'S IT INFRASTRUCTURE

    Senator Moran. Let me highlight a Government Accountability 
Office (GAO) report that was released in December of 2015 on 
FDA's information technology infrastructure. That report made a 
recommendation that FDA define schedules and milestones for 
incorporating into its IT plan elements that align the Agency's 
mission and business strategies, and fully implement the plan.
    I have gotten interested in IT. We have seen lots of 
problems in Federal agencies and their use of IT, and I would 
highlight the GAO report for your consideration and 
information, and encourage the FDA to take an active role in 
meeting the recommendations of the GAO report. This matters a 
lot to efficiency and good government.
    Dr. Califf. Well, let me just say it was an interesting 
experience to come from a major university with a lot of 
Federal funds and then to step inside of the Federal system on 
IT, so I appreciate your concerns. And what I would say is that 
in the past, the primary issue at the FDA has been considered 
to be protecting all of the highly protected trade secret 
information that is under constant attack, and that has gone 
well. We have done that well.
    But I am pleased to say we hired a new CIO just as I came 
on board. He is a great guy. He has experience in the Federal 
Government and the private sector. We read the GAO report and 
we are complying with it. Not only that, we are working closely 
with the GAO to close the gaps.
    And what it pointed out was there was a plan for IT inside 
the FDA, but not a marriage of the IT plan with the overall 
strategic plan of the organization. And I can assure you in a 
science-based organization, if you do not have good knowledge 
management infrastructure, and the way the FDA works it is a 
lot of transactions, a lot like a business. People put in 
applications, and they have to be dealt with. If you do not 
have those systems working, you have got a real deficit that is 
going to hurt you, so we are very focused on it. And I am 
confident we will comply.
    Senator Moran. We have just a few more minutes. The vote 
has been called, but let me ask Senator Merkley if he has any 
brief, short follow-up questions that he would like to make 
sure he asks.

                                 OPIODS

    Senator Merkley. Thank you, Mr. Chairman. I want to go back 
to the opioid situation, and I mentioned the number of pills in 
Oregon, the 100 million pills prescribed for the population in 
1 year of 4 million. It seems like there must be ways to take 
this on. So many people say, hey, I needed eight pills, and I 
had 30 left over or whatever. And not only are they not getting 
from their doctors about the addiction risk, they are also not 
being told, and these represent a significant problem, these 
leftover pills, so this is what I want you to do. This is how 
you get rid of those pills. This is how you return them to me, 
or this is how you----
    So is it worth thinking about a smaller number of 
prescribed initially? And the way, I was shocked to read that 
the number--the percent--that virtually everyone who suffered 
an opioid overdose--I think it was 90 percent of those who 
suffered an overdose, were able to go back and easily fulfill--
get a prescription filled again even after their overdose. In 
other words, there is something--maybe we do not have a 
tracking database, people are getting prescriptions in various 
places.
    What can we do? It is crazy, 100 million pills in the State 
of Oregon?
    Dr. Califf. There is no doubt about this, and I should 
reveal that in my academic career just before coming to FDA, I 
was involved in the National Institute on Drug Abuse (NIDA) 
network to deal with opioid abuse, the National Institutes of 
Health (NIH)-funded network. We oversaw a project Kaiser was 
doing to organize its health system to offer alternative team-
based approaches to pain to reduce opioid prescription. And we 
had a grant from NIDA together with the CMS Innovation Center 
to develop electronic health record systems to identify and 
intervene people who were high risk in rural southern counties 
in West Virginia, Mississippi, and North Carolina. So I have 
done a lot of work on this topic.
    You are fair to call it crazy, and if I could take 1 
minute. I know you have got to go vote. Ten years ago there was 
a call for America's doctors to stamp out pain. It was a 
quality measure in hospitals. Doctors were taught that you had 
to get the pain level down to zero, and that was the goal. 
There obviously was an overreaction. It is extreme. It has 
created a national epidemic. We have got to rein it in.
    The FDA has a role. We are not going to shirk our 
responsibility. I believe our directions are currently clear, 
but if you talk to doctors, none of them read medical drug 
labels. I did not either. It is the derivative instructions 
that go to the doctor and the education.
    So we are one of multiple Federal agencies, and the 
Congress, and the States that need to work together. Remember 
that medicine is regulated mostly at the State level. We are 
prohibited from regulating the practice of medicine. We are 
going to be very outspoken about this along with you, and we 
have got to put practical things in place.
    One just quick comment about arbitrary restrictions on 
numbers of days. It is complicated because many of the people 
actually do need opioids for chronic pain. We had amazing 
testimony by someone from Walter Reed yesterday who was 
involved with tens of thousands of veterans that have had 
amputations. And many of them are in extended living facilities 
or other places where they cannot easily get back to the doctor 
to get their prescriptions refilled.
    So I would urge against an arbitrary restriction, but we 
have got to work together to convince doctors that they need to 
exert the most care with the fewest possible pills prescribed. 
And there are clear instructions for disposal of the medication 
if you do not need everything that is in your bottle.

                               CONCLUSION

    Senator Moran. Dr. Califf, thank you very much. Thank you 
for your testimony today. I was impressed with your level of 
knowledge and expertise, and I wish you well as you lead the 
Food and Drug Administration. My intention, as I indicated when 
we visited in my office, that I would have expected to have a 
conversation today about Zika, about opioids, which Senator 
Merkley clearly was interested in, and about cancer--the cure 
of cancer, and the moonshot effort. I welcome those 
conversations to continue. We can do that one-on-one.
    But my hope is that a few months into your job as we get 
through the appropriations process, that we would invite you 
back, that you would accept that invitation, and we would give 
not only Senator Merkley and I, but other members of this 
subcommittee the chance to have a more in-depth conversation 
about a variety of issues facing the FDA.
    Dr. Califf. I would really appreciate that opportunity. As 
my testimony submitted for the record says, we need the 
interchange and the guidance to get it right because we base 
everything we do on science, and we must insist that we get 
better and better at the science. But policy obviously involves 
an intersection of culture and science, and you are the 
intersection. So we look forward to working with you.
    Senator Moran. Thank you very much. And, Mr. Tyler, thank 
you for joining us. You have been very good at handing notes to 
the Commissioner.
    [Laughter.]

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Moran. I would take the opportunity to formally 
conclude this hearing as soon as I find the magic words.
    For members of the subcommittee, any questions that you 
would like to submit for the record should be turned into the 
subcommittee staff within 1 week, which is Wednesday, March the 
9th. We would appreciate if we could have responses from the 
FDA within 4 weeks of that time.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
               Questions Submitted by Senator Jerry Moran
                            cancer moonshot
    Question. The budget requests $755 million in mandatory funds for 
new cancer-related research activities, of which $75 million would be 
transferred from NIH to FDA to develop a virtual Oncology Center of 
Excellence.
    It is my understanding that the $75 million in mandatory funding 
for the Cancer Moonshot would be available for 5 years. How does that 
work? Would this funding only be used for infrastructure/IT, or would 
it be used for staffing? Would the mandatory funding need to be 
reauthorized, or is it a one-time cost?
    Answer. FDA is conducting a needs assessment to ensure a successful 
implementation of the Oncology Center of Excellence. Until business and 
systems requirements are fully documented, funding should be 
distributed equally across all 5 years, allocating $15 million per 
year.
    Preliminary budget estimates for fiscal year 2017 include a mix of:
  --IT funding to support system enhancements and innovation for 
        oncology related activities and improve analytic capabilities 
        in CBER, CDER and CDRH (each Center has multiple IT systems 
        that may need major or minor enhancements to support oncology 
        efforts)
  --Funding for executive recruitment search efforts to hire a 
        dedicated Oncology Center of Excellence Program Director and 
        senior staff
  --Funding for FTEs to support oncology activities across medical 
        product areas: drugs, biologics, and devices
  --Funding for FTEs to document business and systems requirements: 
        business project managers, information technology specialists, 
        systems engineers and other support disciplines.
    After the first 5 years, FDA will assess whether additional funding 
is necessary for the Oncology Center of Excellence.
    Question. Should Congress not move forward with the mandatory 
funding for the Cancer Moonshot, how much money would you need in 
fiscal year 17 to begin moving forward with the virtual Oncology Center 
of Excellence?
    Answer. Mandates such as the Oncology Center of Excellence can be 
challenging to implement without appropriate funding. Based on the 
magnitude of establishing a new structure to support the Oncology 
Center of Excellence, the minimum funding needed in fiscal year 2017 
would be $15million in budget authority, consistent with the 
distribution methodology over 5 years as described above. FDA regulates 
multiple product areas for drugs, biologics and devices, in addition to 
building, enhancing and maintaining various IT systems needed to 
automate the regulatory review processes.
                             fsma--produce
    Question. The produce industry has expressed concerns about the 
possibility of having some of their packinghouses subject to the 
preventive controls rule while other packinghouses would be subject to 
the produce rule. The produce industry has worked closely with FDA to 
ensure that there are commodity specific, risk based standards put in 
place under the produce rule.
    Would you agree that it makes no sense for produce facilities, 
because of ownership structure, to not be handled under the produce 
rule and instead under the preventive controls rule?
    Answer. In September, 2015 FDA launched a FSMA Technical Assistance 
Network (TAN) to provide technical assistance to industry, regulators, 
academia, consumers and others regarding FSMA implementation. FDA is 
using information specialists and subject matter experts to respond to 
questions related to the FSMA rules and programs. These questions are 
being tracked and trended to assist FDA in prioritizing FSMA guidance 
and training. FDA is also establishing a technical assistance network 
to support FDA food safety staff (FDA and State) performing inspections 
and compliance activities. FDA is identifying a cadre of experts to be 
available to assist inspectors and compliance staff with technical and 
policy questions including queries about regulation requirements and 
applicability.
    Question. Don't you think this would create added complexity, 
confusion, and cost when the real focus should be on food safety?
    Answer. Under FSMA, farms packing and holding covered produce are 
subject to the produce safety rule, and facilities required to register 
are subject to the preventive controls for human food rule. Our 
preventive controls and produce safety regulations adhere to the 
statutory framework. Accordingly, produce packing houses that fall 
under the new farm definition and pack covered produce are covered by 
the produce safety rule. Produce packing houses that do not fall under 
the new farm definition are facilities covered by the preventive 
controls for human food rule.
    We acknowledge the circumstances that result from the framework and 
have used our authority to minimize the practical effect of this 
dichotomy to the extent possible. First, we expanded our definition of 
``farm'' to include more packinghouses than before. However, it was 
important to us for the definition to reflect what farms are in the 
real world. As a result, we did not include all packinghouses, such as 
those businesses with a limited relationship to a farm, within that 
definition.
    Second, we expect that the specific steps necessary to ensure the 
safety of produce would generally be the same for on-farm and off-farm 
produce packing houses. For example, several of the CGMP requirements 
in the preventive controls rule that would apply to an off-farm produce 
packing facility (like provisions for employee health and hygiene, the 
plant and its grounds, sanitary operations and facilities, and 
equipment and utensils) have analogous counterparts in the produce 
safety rule. In addition, although an off-farm produce packing facility 
would be required to establish and implement a food safety plan and 
establish preventive controls food safety management components, we 
expect that, in general, off-farm produce packing houses can look 
toward the produce safety rule for guidance. We expect that an off-farm 
produce packing facility's food safety plan would focus on a few key 
preventive controls, which reflect similar measures in the produce 
safety rule. For example, we expect that the food safety plan for an 
off-farm produce packing facility would include preventive controls 
such as maintaining and monitoring the temperature of water used during 
packing. We also expect that an off-farm produce packing facility would 
establish sanitation controls to address the cleanliness of food-
contact surfaces (including food-contact surfaces of utensils and 
equipment) and the prevention of cross-contamination from insanitary 
objects and from personnel to food, food packaging material, and other 
food-contact surfaces. These preventive controls are also reflected in 
the produce safety rule.
                      fsma--supplier verification
    Question. There is a great deal of concern and confusion regarding 
the provisions in the final rule for Human Consumption dealing with 
situations when a facility is not required to implement a preventive 
control specifically with respect to the requirement for written 
assurances from customers.
    Does FDA intend to issue additional guidance on this section and if 
so when? With the final rule effective in close to 6 months, would FDA 
exercise enforcement discretion for this provision?
    Answer. FDA understands there is some concern about written 
assurances from customers required under certain provisions of the 
regulations on preventive controls for human and animal food as well as 
the regulation on foreign supplier verification programs, and we 
continue to have dialogue with industry to better understand their 
concerns and identify areas of confusion. We are considering guidance 
in this area, as well as other options for addressing the written 
assurance provisions before the first facilities have to comply with 
the preventive controls regulations on September 19, 2016.
                   fsma--technical assistance network
    Question. FDA has developed a Technical Assistance Network (TAN) to 
share information among consumers, industry, regulators and other 
stakeholders working to implement FSMA.
    Are the questions and answers submitted to TAN made public? If not, 
what is FDA's rationale for not making the questions and answers 
public?
    Answer. The individual questions and answers submitted to FDA's 
Technical Assistance Network (TAN) are not currently posted on FDA's 
web site. The TAN process is intended to address questions from 
individuals and firms. The posting of questions and answers FDA 
provides through the TAN process is not a substitute for FDA following 
the good guidance practice requirements (21 USC 371(h); 21 CFR 10.115) 
for communicating its current thinking on regulatory issues to a wider 
audience. In addition, FDA is in the process of developing answers to 
frequently asked questions for posting on the web site. Further, FDA is 
developing guidance documents that are being informed by the questions 
received through TAN. FDA will be better able to provide comprehensive, 
organized information through guidance documents to a broad audience 
while using a process that includes public input.
    The Department of Agriculture Food Safety Inspection Service (FSIS) 
has a similar system called ``AskFSIS'' which functions very well as a 
way to share information with industry and provide answers in a timely 
fashion. It's a helpful, searchable tool, and the content is public so 
everyone has access to the same answers. This also provides 
efficiencies so that the same questions aren't asked again and again.
    Question. Have you engaged in any discussions with FSIS to learn 
from their experience?
    Answer. Yes, FDA engaged in lengthy and productive discussions with 
FSIS from May through September 2015 before launching the FDA FSMA 
Technical Assistance Network in September 2015. Representatives from 
FDA visited the FSIS Technical Service Center in Omaha, Nebraska in May 
2015 to learn about their system and processes. The following features 
of the AskFSIS system and processes were adopted by FDA: the staffing 
structure including administrators and Subject Matter Experts to answer 
questions; the use of an IT platform (Knowledge Management System) that 
provides an internal searchable database of questions and answers to 
promote consistency in responses and tracking of responses; and 
trending responses to identify those that are frequently occurring so 
as to inform FDA's guidance documents. The FDA TAN has been well-
received by our stakeholders, and we believe that our early engagement 
with FSIS helped us build a solid foundation for our success.
                        fsma--inspection process
    Question. Under FSMA FDA is tasked to develop and implement a 
comprehensive program to train investigators on a wide range of issues 
including what the regulations require and how inspections should be 
conducted. It is essential that regulations are enforced consistently 
from one region to another, and by both Federal and state officials.
    Given the breadth of the new FSMA rules, what specific resources 
will inspectors have at their disposal during facility inspections when 
technical questions arise?
    Answer. For Preventive Controls inspection and compliance work, FDA 
is developing an electronic resource library that will include the 
following resource tools to aid FDA's food safety staff (including 
state employees performing inspections on FDA's behalf) before, during, 
and after inspections: special instructions and assignments; FDA 
guidance documents; links to commodity specific processing videos; fact 
sheets describing commodity specific processes and potential hazards 
and controls; and a contact list identifying subject matter experts by 
area of expertise.
    For issues relating to sprouts, FDA also plans to have a resource 
library that would include resources such as the Produce Safety Rule, 
FDA guidance, Sprout Safety Alliance training materials and resources, 
and subject matter expert contacts lists to provide technical and 
policy support to regulators inspecting sprout operations for 
compliance with the Produce Safety Rule and the Federal Food, Drug and 
Cosmetic Act.
    For Produce Safety, FDA is establishing a network of regionally-
based FDA personnel who will coordinate with state and other partners 
to fully implement and foster industry compliance with the Produce 
Safety Rule. This network will provide scientific and technical support 
to regulators performing inspections.
    Question. Has the FDA considered creating a hotline or phone number 
for inspectors to contact FDA experts?
    Answer. In September 2015, FDA launched a FSMA Technical Assistance 
Network (TAN) to provide technical assistance to industry, regulators, 
academia, consumers and others regarding FSMA implementation. FDA is 
using information specialists and subject matter experts to respond to 
questions related to FSMA rules and programs. FDA is tracking and 
trending these questions to assist FDA in prioritizing FSMA guidance 
and training. FDA is also establishing a technical assistance network 
to support FDA food safety staff (FDA and State) performing inspections 
and compliance activities. FDA is identifying a cadre of experts that 
will be readily available to assist inspectors and compliance staff 
with technical and policy questions including queries about regulation 
requirements and applicability.
    Question. It is foreseeable that a facility may disagree with an 
inspector's conclusions and/or interpretation of the rules.
    How will these differences be resolved?
    Answer. If a facility disagrees with the interpretations of the 
rules and conclusions reported during an inspection, the first step in 
the process should be contacting the District Office or state if 
applicable. Technical experts in the relevant Center (i.e., Center for 
Food Safety and Applied Nutrition or Center for Veterinary Medicine) 
would be engaged in questions regarding rule interpretation and 
application.
    If the facility does not believe the District Office or state has 
been responsive, or they do not understand the process for how to 
proceed next, then the facility should contact the ORA Ombudsman's 
office. The facility also may contact the ORA Ombudsman's office (or 
the FDA Ombudsman's office) for matters it believes are appropriate to 
raise in a different venue.
    Question. When a facility disagrees with an observation reported on 
a FDA Form 483 (Notice of Inspectional Observations), how should it 
appeal that decision?
    Answer. If a facility disagrees with an observation reported on a 
FDA Form 483, it would be able to appeal that decision using the same 
mechanisms utilized for all other inspections. As stated in the 
previous response, the first step in the process should be contacting 
the District Office or state if applicable. If that does not resolve 
the matter, for an FDA decision, a firm can file a formal request for 
review. FDA regulations (21 CFR 10.75) provide a mechanism for any 
interested person to obtain formal review of any FDA decision by 
raising the matter with the supervisor of the employee who made the 
decision.
    Question. Will the FDA provide a centralized, timely mechanism for 
companies/facilities to appeal an FDA enforcement action?
    Answer. If a facility disagrees with an observation reported on a 
FDA Form 483, it would be able to appeal that decision using the same 
mechanisms utilized for all other inspections. First, the firm can 
contact the issuing district office, as stated in the previous 
response. If that does not resolve the matter, the firm can file a 
formal request for review. FDA regulations (21 CFR 10.75) provide a 
mechanism for any interested person to obtain formal review of any FDA 
decision by raising the matter with the supervisor of the employee who 
made the decision.
    Question. Do you agree that a formal appeals process would also 
help identify areas where additional inspector training would be 
helpful?
    Answer. See our responses to previous questions describing the 
review process. FDA agrees that if a state, District Office, or ORA 
Ombudsman Office have been routinely contacted by regulated entities 
challenging inspectors' conclusions and/or interpretation of the rules 
for similar reasons it would potentially help identify areas for 
improvement. FDA could then consider this information when designing 
and administering subsequent inspector trainings to help prevent 
similar future disputes.
                        fsma--deficiency letters
    Question. On May 2, 2014, FDA released its Operational Strategy for 
Implementing the FDA Food Safety Modernization Act, and that document 
contained a list of administrative compliance tools including 
``voluntary correction achieved at the district level through 
deficiency letters . . . . to document significant safety-related 
deficiencies and request corrective action within a specified period of 
time.''
    What is a ``deficiency letter''? Please explain why this new 
enforcement tool is necessary and provide specific examples of 
situations that would lead to a deficiency letter?
    Answer. A deficiency letter is a potential new tool that FDA is 
considering using to inform a firm of observed violations that appear 
to pose a significant public health concern and FDA's expectations 
regarding a timely and effective response to address the identified 
concern. The deficiency letter would be issued within a relatively 
short time period after FDA made observations of non-compliance which, 
if not corrected quickly, could affect public health. Further, a 
deficiency letter would describe the enforcement tools available to FDA 
if, after Agency review, the firm has not adequately corrected the 
violation(s) and FDA continues to have the same level of concern.
    As contemplated, the intent of the deficiency letter would be to 
immediately, and in a formal way, advise the firm of the situation and 
to seek expedited compliance for those violations that present a 
significant public health concern. If the firm does not resolve the 
deficiency promptly, and further review within FDA supports the 
seriousness of the violation, FDA would determine what additional 
Agency action is necessary.
    The deficiency letter would have the potential to expedite FDA 
actions to protect public health. We believe the deficiency letters 
could enhance FDA's existing tools which include the Form FDA-483, 
Advisory Letters, and other enforcement tools, potentially decreasing 
the need for their use, but not replacing them.
    Our current thinking is that FDA would issue a deficiency letter 
only when the likely outcome of the observed violation would have 
significant public health implications. The specific criteria that 
would trigger a deficiency letter are still under development.
    Question. Please explain in detail the process FDA will be using 
for issuing deficiency letters including the following: who will issue 
them, who will review them, under what circumstances will they be 
issued, how much time will a facility be given to respond, will they be 
publicly available?''
    Answer. FDA is still considering whether to use deficiency letters 
as a possible compliance tool. If we decide to use deficiency letters, 
we will establish written standards for determining when to use 
deficiency letters, including the level of substantiation needed to 
support issuance. We also would establish written procedures for 
issuing and responding to deficiency letters.
    Question. How will deficiency letters fit into FDA's current 
administrative process?
    Answer. As contemplated, the intent of the deficiency letter would 
be to achieve expedited compliance for those violations that present 
the most significant public health concern. Thus, deficiency letters, 
if employed, would be a more targeted tool than warning letters. If a 
firm does not expeditiously correct the violation, FDA would be 
prepared to take further administrative or enforcement action to 
protect public health.
    Question. What is the implication/consequence of getting a 
deficiency letter?
    Answer. As deficiency letters are currently contemplated, a firm 
receiving a deficiency letter would be informed of any violations that 
pose the most significant public health concern. The deficiency letter 
would inform the firm that it should address such a violation in an 
expeditious manner. If the firm does not correct the violation in an 
appropriate timeframe, the firm would likely be subject to further 
administrative or enforcement action.
                           fsma--spent grain
    Question. The Committee understands that FDA is working on 
clarifying guidance on its dried Distiller's Grains rules. The 
Committee took action last year on delaying the implementation of the 
new rule while distillers awaited this guidance.
    Please inform the Committee when this guidance will be completed, 
provide response to what it would contain, and if the intent of the 
limitation contained in Sec. 750 will be complied with.
    Answer. Animal food, including distillers grains used for animal 
food, must be safe for its intended use and not adulterated. In 
September 2015, FDA finalized the Preventive Controls for Animal Food 
(PCAF) rule that established new regulations for current good 
manufacturing practices (CGMPs) and hazard analysis and risk-based 
preventive controls for animal food. This rule addressed a range of 
animal food, including byproducts of human food production used as 
animal food. Distillers grains from the alcoholic beverage industry are 
considered human food byproducts.
    FDA is currently developing guidance for industry to assist 
implementation of the rule. In the coming months, we are planning to 
issue draft guidance on compliance with the CGMPs and draft guidance 
for human food producers with byproducts going to animal food. Other 
guidance documents, including a draft guidance document on the hazard 
analysis and risk-based preventive controls requirements, will follow. 
We intend to issue these draft guidances before the applicable 
compliance dates for the PCAF rule. The guidance documents are part of 
a broader effort to foster and support compliance that also includes 
education, training, and FDA's Technical Assistance Network (through 
which firms can get answers to how the rule applies to their particular 
operation).
    FDA also assures the Committee that as we move forward with 
implementation of the PCAF rule, we will comply with the requirements 
of Sec. 750.
                                listeria
    Question. Did FDA's 2013 quantitative risk assessment study include 
data regarding the risk of Listeriosis associated with consumption of 
frozen vegetables and frozen food entrees?
    Answer. No. The 2013 quantitative risk assessment, issued jointly 
with the USDA Food Safety and Inspection Service, focused on deli foods 
and did not include data on frozen vegetables or frozen food entrees. 
The ``Interagency Risk Assessment: Listeria monocytogenes in Retail 
Delicatessens'' may be viewed at http://www.fda.gov/downloads/food/
foodscienceresearch/risksafetyassessment/ucm370243.pdf.
    Question. What relative risk of Listeria monocytogenes related 
illnesses does FDA believe frozen foods such as frozen vegetables and 
frozen food entrees pose compared to other foods historically known to 
be associated with Listeria monocytogenes?
    Answer. The quantitative risk assessments on Listeria monocytogenes 
that FDA has conducted to date have addressed frozen foods such as ice 
cream and other frozen dairy products, but have not addressed other 
frozen foods such as frozen vegetables and frozen food entrees.
    Question. Will FDA continue to distinguish between frozen ready-to-
eat foods (RTE) and frozen not ready-to-eat (NRTE) foods when frozen 
NRTE foods bear validated cooking instructions?
    Answer. FDA evaluates each situation in which a hazard, such as 
Listeria monocytogenes or Salmonella, is detected in a frozen food on a 
case-by-case basis. Where cooking instructions are present on the label 
of a frozen food, FDA will consider such factors as whether it is 
reasonable that a consumer or food service facility would thaw the 
frozen food for consumption without following package cooking 
instructions, or whether a consumer would follow recipes in which a 
frozen food would be thawed and included as an ingredient in a fresh, 
uncooked food such as salsa or a dip.
    Question. Will FDA align with global regulatory policy and treat 
the presence of Listeria monocytogenes in RTE foods on the basis of 
whether the RTE food does or does not support the growth of Listeria 
monocytogenes?
    Answer. FDA currently is discussing international standards on 
Listeria monocytogenes in RTE foods that vary based on whether the RTE 
food does or does not support the growth of Listeria monocytogenes. To 
further internal dialogue, in December 2015, FDA convened a meeting of 
the CFSAN Food Advisory Committee (FAC) to consider, among other 
things, whether FDA should treat the presence of Listeria monocytogenes 
differently in RTE foods, depending on whether the food supports the 
growth of Listeria monocytogenes. A majority of the FAC voting members 
(7 of 11 voting members) recommended that FDA should not treat the 
presence of Listeria monocytogenes differently in RTE foods, depending 
on whether the food supports the growth of Listeria monocytogenes. FDA 
intends to take the recommendations of the FAC into account in its 
internal deliberations.
    More information about the December 2015 FAC meeting, including the 
agenda, presentations, background information, transcripts and final 
FAC recommendations, can be found at: http://www.fda.gov/
advisorycommittees/
committeesmeetingmaterials/foodadvisorycommittee/ucm471769.htm.
    Question. Will FDA align its testing guidance to reflect current 
USDA practice? Specifically, will FDA change its recommendation on when 
a firm should speciate Listeria and encourage food manufacturers to 
follow up on a single finding of Listeria spp. on a food contact 
surface with corrective actions followed by additional testing?
    Answer. FDA currently is internally discussing better alignment of 
FDA's 2008 draft testing guidance to current USDA practices. To inform 
those discussions, in December 2015, FDA convened a meeting of the 
CFSAN Food Advisory Committee (FAC) to consider, among other things, 
whether FDA should change its recommendations on speciation of Listeria 
and appropriate follow up to a positive finding of Listeria species 
(spp.) on a food contact surface. The FAC recommended that ``FDA should 
follow the Food Safety and Inspection Service (FSIS) approach for 
Listeria spp. detected on a food-contact surface, if it tests positive 
then corrective action should be taken.'' FDA intends to take the 
recommendations of the FAC into account in its internal deliberations.
                                  zika
    Question. It is my understanding that several vaccine platform 
technologies have been developed over the last several years and could 
now be called upon to try to quickly develop vaccines for medical 
countermeasures, as well as emerging infectious diseases, like Zika.
    Can you explain FDA's role working with other agencies and 
companies to advance vaccine candidates for emerging infectious 
diseases?
    Answer. FDA works closely with other components of the Department 
of Health and Human Services--including the Office of the Assistant 
Secretary for Preparedness and Response (ASPR) and its Biomedical 
Advanced Research and Development Authority (BARDA), the National 
Institutes of Health (NIH), and the Centers for Disease Control and 
Prevention (CDC)--as well as with medical product developers, 
counterpart national regulatory authorities, and other international 
organizations (e.g., World Health Organization (WHO)) to advance the 
development and availability of medical products (including drugs, 
vaccines, and diagnostic tests) to respond to emerging infectious 
disease outbreaks as quickly and effectively as possible.
    FDA's efforts include providing scientific and regulatory advice to 
product developers and U.S. government agencies that support medical 
product development to help speed development programs. Specific 
activities include clarifying regulatory requirements through agency 
guidance and meetings, reviewing and providing input on pre-clinical 
and clinical trial designs, and expediting the regulatory review of 
data as they are received from product developers. As needed, FDA 
expedites the review of Investigational New Drug (IND) applications and 
related amendments, which are required for FDA-regulated clinical 
trials of drugs and vaccines to proceed. In addition, FDA collaborates 
with WHO and international regulatory counterparts--including the 
European Medicines Agency, Health Canada, and many others--under 
confidentiality agreements to provide technical support and scientific 
advice and to exchange information about investigational products in 
support of international product development efforts.
    Question. What resources are needed to respond quickly and nimbly 
to emerging infectious diseases and other potential threats to our 
public health security?
    Answer. Emerging infectious diseases and other threats to our 
public health security--such as the deliberate use of chemical, 
biological, radiological/nuclear agents--may occur without warning. 
Responding quickly and effectively to such no-notice events has 
required resources beyond what base resources can support. For example, 
to support the response to the Ebola epidemic in West Africa, Congress 
authorized $5.4 billion in supplemental funding in fiscal year 2015, 
which included $25 million for FDA. FDA is using this supplemental 
funding to support ongoing Ebola response activities, including:
  --Working closely with interagency partners, product developers, the 
        World Health Organization (WHO) and international regulatory 
        counterparts to encourage and facilitate the development and 
        assessment of vaccines, drugs and diagnostic tests;
  --Collaborating with West African health authorities to facilitate 
        access to investigational products as necessary (e.g., for 
        flare-ups) through appropriate mechanisms until approved 
        products are available;
  --Maintaining the availability of diagnostic tests under FDA's 
        Emergency Use Authorization authority; and
  --Supporting regulatory science to help facilitate Ebola medical 
        product development and review.
    To support response to the Zika virus outbeak, the Administration 
has requested approximately $1.9 billion in supplemental funding 
including $10 million for FDA. If appropriated, FDA will use the $10 
million supplemental Zika funding to support highly targeted regulatory 
science research required to enhance the efficient development and 
regulatory review of medical products and blood screening assays for 
Zika virus; collaboration with and technical support to international 
partners' response efforts; and FDA staff to support the development, 
review, regulation, and surveillance of vaccines, diagnostics and 
therapies.\1\
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    \1\ https://www.whitehouse.gov/sites/default/files/omb/assets/
budget_amendments/emergency_supplemental_2-22-16_zika.pdf
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                                tobacco
    Question. Public Health England, the English version of the U.S. 
Center for Disease Control and Prevention, stated that e-cigarettes are 
95 percent less harmful than a combustible cigarette. Moreover, 
England's government health plan, the National Health Service states 
that, ``There is evidence that e-cigarettes can help people stop 
smoking.'' And it is reported that the National Health Service will 
likely begin prescribing e-cigarettes as a cessation tool in 2016.
    Do you share the view of Public Health England and the National 
Health Service related to reducing the harm associated with combustible 
tobacco through e-cigarettes?
    Answer. Specific to individual health risk, the Public Health 
England Report's estimate of 95 percent lower risk of e-cigarettes 
compared to tobacco cigarettes relied upon evidence from a prior paper 
(Nutt, D. J., L. D. Phillips, D. Balfour, et al., ``Estimating the 
Harms of Nicotine-Containing Products Using the MCDA Approach,'' 
European Addiction Research, 20(5):218-225, 2014) to assess the 
relative harm of electronic nicotine delivery systems (ENDS) products. 
The Nutt et al (2014) paper employed an analysis model that quantified 
the relative health harms of 12 tobacco products using a series of 14 
harm criteria. The expert panel determined that while cigarettes scored 
100 percent in their assessment of maximum relative harm, ENDS products 
were rated to have only 4 percent maximum relative harm, which 
contributed to Public Health England's assessment that ENDS are around 
95 percent safer than smoking combusted cigarettes. The Report's use of 
the Nutt et al (2014) paper has several limitations, and the Nutt et al 
(2014) paper itself observed that it was reporting outcomes based on 
the decision-conferencing process from a group of experts who were 
selected without any ``formal criterion,'' though ``care was taken to 
have raters from many different disciplines'' and primarily based on 
geographic location ``to ensure a diversity of expertise and 
perspective''. In addition, the authors of the Nutt et al (2014) paper 
acknowledge that there is a ``lack of hard evidence for the harms of 
most products on most of the criteria''. The authors of the Nutt et al 
(2014) paper did not explain what scientific information was available 
to the experts upon which they should base their ratings and they did 
not explain the derivation of the quantitative assessment of each harm 
criterion. It is unclear if the authors of Nutt et al (2014) paper 
carried out or referenced a quantitative risk analysis, a standard 
practice when assessing relative risk, nor did the authors indicate 
that they used mean levels of exposure to harmful or potentially 
harmful constituents HPHCs in users or other quantitative evidence as 
an approximation of risk. FDA does not find the results reported in the 
Nutt et al (2014) paper to be sufficiently conclusive on the relative 
risks of using different tobacco products.
    FDA is also aware of the National Health Service's position on 
prescribing e-cigarettes as a cessation tool. No e-cigarettes have been 
approved by FDA as a cessation product. Moreover, consumers often don't 
know how much nicotine these devices deliver, making them unreliable 
for cessation efforts. There are a number of FDA-approved cessation 
tools on the market that have proven safety and effectiveness and FDA 
will continue to support and encourage research into cessation tools, 
including the potential role of e-cigarettes.
    The final deeming rule gives FDA the tools it needs to answer 
important questions about e-cigarettes and how they are made, marketed 
and used to help establish whether, how, and to what extent they are 
beneficial or harmful and to whom. Furthermore, subjecting e-cigarettes 
to FDA's tobacco product authorities will give manufacturers an 
incentive to conduct research and submit data to establish any 
potential public health benefit of e-cigarettes.
    There are distinctions in the hazards presented by various 
nicotine-delivering products. Cigarette smoking is the major 
contributor to the death and disease attributable to tobacco use. Given 
this, some have advanced the view that certain new non-combustible 
tobacco products (including ENDS products such as e-cigarettes) may be 
less hazardous, at least in certain respects, than combustible 
products, given the known carcinogens in smoke and the dangers of 
secondhand smoke.
    Scientific evidence may demonstrate that certain products are less 
harmful than others at an individual level, but the Tobacco Control Act 
directs FDA to also take into account the impact on the health of the 
population as a whole, including both users and non-users of tobacco 
products, in making regulatory decisions about these products.
    Much remains to be learned about the risks of e-cigarettes to 
health, as well as their possible benefits. E-cigarettes could benefit 
public health if they encourage people who would otherwise not quit 
smoking to stop smoking altogether, while not encouraging youth or 
others to start use of tobacco products or encouraging former users to 
relapse back to tobacco use. On the other hand, e-cigarettes could be a 
detriment to public health. E-cigarettes have the potential to re-
normalize smoking, encourage youth to initiate smoking, and/or prompt 
users to continue or to escalate to cigarette use--in effect, reversing 
the meaningful progress tobacco control initiatives have achieved to 
date. Other reported e-cigarette risks include dermal exposure to 
nicotine, childhood poisoning events, and physical harm from defective 
products (such as exploding batteries). Anecdotes illustrating both 
benefits and harms abound, but it is empirical scientific evidence that 
should drive the actions taken with respect to e-cigarettes.
    Question. FDA is committed to using an evidence-based approach to 
the application of the principles of harm reduction to tobacco 
regulatory policy.
    Does the FDA believe in the concept of tobacco harm reduction? Do 
you believe that adult smokers have the right to know about the risks 
and relative risks of different tobacco products and products with 
nicotine derived from tobacco?
    Answer. Section 911 of the Federal Food, Drug, and Cosmetic Act, as 
amended by the Tobacco Control Act, provides a pathway for companies to 
seek FDA authorization to market a modified risk tobacco product. In 
deciding whether to issue an order authorizing the marketing of a 
modified risk tobacco product, FDA takes into account a variety of 
factors such as the relative health risks to individuals of the 
product, the likelihood that existing users of tobacco products who 
would otherwise stop using tobacco products will switch to the product, 
and the likelihood that persons who do not use tobacco products will 
start using the product.
    FDA is committed to using an evidence-based approach to the 
application of the principles of harm reduction to tobacco regulatory 
policy. The Agency is also committed to providing the public with the 
most accurate health information and evaluating the products under our 
jurisdiction based on sound scientific evidence.
    FDA has communicated the existence of a continuum of risk of 
nicotine-delivering products to the public. For example, in the 
proposed deeming rule, FDA asked for comments, data, and research 
regarding how various new tobacco products should be regulated based on 
the continuum of nicotine-delivering products and the potential 
benefits associated with these products, especially e-cigarettes.
    There are distinctions in the hazards presented by various 
nicotine-delivering products. Cigarette smoking is the major 
contributor to the death and disease attributable to tobacco use. Given 
this, some have advanced the view that certain new non-combustible 
tobacco products (such as e-cigarettes) may be less hazardous, at least 
in certain respects, than combustible products, given the known 
carcinogens in smoke and the dangers of secondhand smoke.
    Scientific evidence may demonstrate that certain products are 
indeed less harmful than others at an individual level, but FDA must 
also take into account the impact on the health of the population as a 
whole, including both users and non-users of tobacco products, in 
making regulatory decisions about these products.
    Much remains to be learned about the risks of e-cigarettes to 
health, as well as their possible benefits. E-cigarettes could benefit 
public health if they encourage people who would otherwise not quit 
smoking to stop smoking altogether, while not encouraging youth or 
others to start use of tobacco products or encouraging former users to 
relapse back to tobacco use. On the other hand, e-cigarettes could be a 
detriment to public health. E-cigarettes have the potential to re-
normalize smoking, encourage youth to initiate smoking, and/or prompt 
users to continue or to escalate to cigarette use--in effect, reversing 
the meaningful progress tobacco control initiatives have achieved to 
date. Other reported e-cigarette risks include dermal exposure to 
nicotine, childhood poisoning events, and physical harm from defective 
products (such as exploding batteries). Anecdotes illustrating both 
benefits and harms abound, but it is empirical scientific evidence that 
should drive the actions taken with respect to e-cigarettes.
    CTP has identified e-cigarettes as an immediate research priority 
area, and has funded over 75 research projects since 2012 to better 
understand e-cigarette initiation, use, perceptions, dependence, and 
toxicity. This ongoing and funded research will provide important 
information about these products including a better understanding of e-
cigarette users, reasons for use, abuse liability, user perceptions, 
and health effects.
    Question. How will FDA share with adult tobacco consumers the 
different risks associated with different tobacco products?
    Answer. FDA is committed to providing the public with the most 
accurate health information and evaluating the products under our 
jurisdiction based on sound scientific evidence.
    FDA has communicated the existence of a continuum of risk of 
nicotine-delivering products to the public. For example, in the 
proposed deeming rule, FDA asked for comments, data, and research 
regarding how various new tobacco products should be regulated based on 
the continuum of nicotine-delivering products and the potential 
benefits associated with these products, especially e-cigarettes.
    Under the Tobacco Control Act, FDA has authority to issue an order 
authorizing a product to be marketed as a modified risk tobacco product 
after taking into account a variety of factors such as the relative 
health risks to individuals of the product, the likelihood that 
existing users of tobacco products who would otherwise stop using 
tobacco products will switch to the product, and the likelihood that 
persons who do not use tobacco products will start using the product. 
To date, FDA has not authorized the marketing of any modified risk 
tobacco product. FDA is currently conducting scientific review of eight 
modified risk tobacco product applications to determine whether the 
applicant has provided sufficient scientific evidence for FDA to issue 
an order allowing the products to be marketed as modified risk tobacco 
products.
    Although industry has introduced newer forms of tobacco products 
that are not currently regulated under FDA's tobacco product 
authorities, it is important to note that, if such products are deemed 
subject to FDA's tobacco product authorities, manufacturers may not 
market these products as modified risk tobacco products unless they 
request and receive authorization from the Agency.
                              biosimilars
    Question. The joint explanatory statement of the House and Senate 
Appropriations Committee on the Consolidated Appropriations Act, 2016 
(Public Law 114-113), expresses the need for FDA to provide the public 
with a greater opportunity to review and comment on all regulatory 
standards for the approval and oversight of biosimilar drugs. 
``Therefore, FDA is directed to provide the Committees with an 
estimated timeline by which the agency will finalize all pending draft 
biosimilars guidance documents and regulations. The Committee expect[s] 
to receive this report no later than 60 days after enactment.'' This 
law was enacted on December 18, 2015.
    Please provide your response to this request. If you do not have 
that information, please explain why you have not responded to this 
request and when you intend to do so.
    Answer. The requested report is currently in clearance. The Draft 
Guidance on Labeling for Biosimilar Products was released on FDA's 
website on March 31, 2016.
    Question. Please provide us with an estimated timeline for 
publishing draft and final biosimilars guidances for the topics that 
are listed on FDA's 2016 guidance agenda.
    Answer. The Food and Drug Administration (FDA) has worked 
diligently to issue multiple guidances on biosimilar products since 
enactment of the Biologics Price Competition and Innovation Act of 2009 
(BPCI Act). While FDA will continue to work on drafting guidances, 
reviewing submitted comments, and finalizing guidances in fiscal year 
2016, FDA anticipates issuing the biosimilar guidances listed in our 
guidance agenda within the next 12 months. Please keep in mind that 
while these are our best estimates, they are subject to change and 
factors such as workload and a shift in priorities could influence the 
timeframe.
     internet/social media advertising and promotional labeling of 
                           prescription drugs
    Question. In 2014 the FDA issued draft guidance for industry usage 
of Internet/social media platforms. Earlier this year, the FDA put out 
its guidance agenda for 2016 listing new and revised guidance's that 
are to be published this year. This list included a bullet on 
``Internet/Social Media Advertising and Promotional Labeling of 
Prescription Drugs and Medical Devices--Use of Links to Third-Party 
Sites''.
    Can you tell us what the timeline is for producing this guidance, 
and will this be the final guidance for the draft put out in 2014?
    Answer. The draft guidance issued in 2014 referenced above is the 
``Internet/Social Media Platforms with Character Space Limitations--
Presenting Risk and Benefit Information for Prescription Drugs and 
Medical Devices'' draft guidance. This draft guidance is not the 
document listed on the guidance agenda for 2016. The guidance agenda 
lists the ``Internet/Social Media Advertising and Promotional Labeling 
of Prescription Drugs and Medical Devices--Use of Links to Third-Party 
Sites'' draft guidance. FDA continues to work toward publishing this 
and other draft and revised draft guidances listed on the 2016 guidance 
agenda.
    Question. Are you working with stakeholders in crafting this 
guidance, and if so do you intend to do so further before putting out 
the updated guidance?
    Answer. FDA has worked with stakeholders since November 2009, when 
we held a Part 15 public hearing to gather input from our stakeholders 
(e.g., industry, healthcare professionals, consumers, patient groups, 
Internet vendors, advertising agencies, and other interested parties) 
on how FDA can best provide guidance on the promotion of FDA-regulated 
medical products (including prescription drugs for humans and animals, 
prescription biologics, and medical devices) using the Internet and 
social media tools.
    When this draft guidance is published, FDA will invite comments 
from our stakeholders on the draft. After providing this opportunity 
for public comment, we will review all comments received and carefully 
consider suggested changes, if any, as we prepare a final version of 
the guidance document.
                  inspections--risk based inspections
    Question. As FDA moves toward a more, targeted, risk-based, and 
efficient inspection model for importing drugs, food, and medical 
devices this will require better data about these facilities and the 
companies we are importing from. In the Omnibus, $5 million was 
included for foreign high-risk inspections to continue efforts to 
develop and ``utilize a targeted, risk-based, and efficient inspection 
model that incorporates commercially available information on high-risk 
establishments for onsite verifications.''
    Can you elaborate on the risk-based decisionmaking and how you are 
utilizing commercial data to prioritize inspections?
    Answer. FDA continues to improve our risk-based decisionmaking 
inspection models for multiple product areas. In our drug inventory, 
FDA is employing a site selection surveillance inspection model that 
runs annually on all facilities in the FDA's inventory allowing for 
risk-adjusted parity between the foreign and domestic inventory. 
Several ongoing efforts target improvements to the quality and scope of 
data feeding into the risk models. Improved accuracy and completeness 
of data related to the inventory of foreign manufacturing sites under 
FDA oversight leads to improved risk model outcomes and enhanced 
inspection planning efficiencies. To that end, FDA uses commercially 
available data (e.g., the data on businesses available through FDA's 
enterprise contract with Dun and Bradstreet) and commercial in-country 
services to verify the accuracy of firm information that feeds into the 
risk models.
    In the food arena, FDA continues to work with our foreign 
counterparts to develop and implement Systems Recognition agreements. 
Systems Recognition agreements allow FDA to leverage the findings of 
the country with whom we have an agreement to help target Agency 
resources and increase efficiencies in our inspection model. We 
continue to work towards identifying a Unique Facility Identifier (UFI) 
that will allow for more comprehensive commercial data to be attached 
to an entity. In addition, the Agency continues to work to incorporate 
Geographic Information System (GIS) data with our inventory to extend 
the capabilities of our risk model. GIS data allows for the analysis of 
additional layers of data that can be pivotal in making risk-based 
determinations.
                    inspections--data bounce process
    Question. It is my understanding that in 2013 the FDA's Southwest 
Import District Dallas Office created a program called the Data Bounce 
Process. Please provide a summary of this program, and input on whether 
it is something that could be replicated or expanded upon.
    Answer. Several years ago, FDA's Southwest Import District (SWID) 
initiated a project in which some SWID offices accepted entry data from 
importers of medical devices prior to entry. Via a stand-alone 
automated process, the SWID staff checked this entry data against 
existing FDA databases in an effort to verify accuracy of the importer-
supplied data. This process helped provide short-term feedback on 
whether importer-supplied data matched what FDA has in its own systems. 
Some firms have requested that FDA make this available to all firms 
importing products FDA regulates. While the agency appreciates this 
feedback, we have concluded that this limited operation cannot be 
effectively replicated on a large scale. FDA currently processes more 
than 34 million import admission decisions each year, and we do not 
have the IT capability to process a large number of additional test 
cases. If the program was expanded, additional test cases could easily 
number several million each year. Therefore, FDA is honing its 
targeting system to allow for the automated processing of entries where 
data are complete, accurate, and could fall into lower risk categories. 
In doing so, we may provide automated releases which increase 
efficiencies in terms of minimizing delays and enhancing targeting of 
high risk goods.
    We also believe it is helpful where possible to provide instant 
feedback regarding the acceptability of data necessary for import 
processing. We are pursuing a similar process through the Automated 
Commercial Environment (ACE) system. ACE has the capability to screen 
electronic import submissions and indicate where data is lacking or 
fails to match syntax such that the entry is not acceptable for 
processing. This functionality is currently available in ACE. We also 
are examining opportunities to enhance our IT systems and develop 
outreach programs to provide immediate feedback to the import filer 
when the data they provide does not match the information in our 
systems.
                       medical device inspection
    Question. Concerns exist with the lack of consistency, 
transparency, and predictability in the FDA medical device inspection 
process, including discrepancies in how facilities inside the US are 
inspected versus facilities outside the US, as well as FDA barriers to 
markets outside the US for products that are available to patients in 
the US. For example, typically five days is sufficient for the FDA to 
complete an overseas inspection and determine the suitability of the 
location to provide product into the US market while inspections inside 
the US can run several weeks, and even months. These discrepancies lead 
to variations in inspection standards and potentially competitive 
advantages for those who choose to manufacture outside the US.
    How does the FDA plan to address the discrepancies between 
inspections performed by FDA within and outside the US?
    Answer. A variety of factors are considered when planning and 
conducting inspections inside and outside the US. The majority of both 
domestic and foreign FDA inspections last 1 week or less but some 
inspections both inside and outside the US can last several weeks or 
longer. Medical Device inspections are conducted using FDA's Quality 
System Inspection Technique (QSIT), where some (Level I) or all (Level 
II) subsystems of the firm's quality system are evaluated. The average 
time to complete a domestic QSIT Level I inspection is 37 hours; 52 
percent of domestic inspections are QSIT Level I. The average time to 
complete a domestic QSIT Level II inspection is 58.5 hours; the 
remaining 48 percent of domestic inspections are QSIT Level II. Foreign 
inspections are always QSIT Level II and take an average of 61.4 hours. 
In situations where a firm has had a previous inspection with a 
significant number of violations or a firm has received a warning 
letter, the inspection may last longer because the agency needs to 
confirm the completion of promised corrective actions and ensure no 
additional problems create a public health risk. In addition, when FDA 
identifies a large number of violations in the first few days of an 
inspection, FDA may extend the length of the inspection to ensure we 
can fully assess all quality systems and rule out additional concerns.
    FDA is also engaged in an extensive Program Alignment initiative, 
which will create commodity-specific programs for the inspection of 
medical devices and radiological health products. Program Alignment 
allows FDA to address the increasing breadth and complexity of our 
mandate to protect the public health, address the impact of 
globalization on the food and medical product supply chains, and the 
ongoing trend of rapid scientific innovation and increased biomedical 
discovery. Program Alignment allows investigators with specialized 
knowledge of medical devices and radiological health products and 
related policies and procedures to focus on inspections of those 
products rather than expecting investigators to specialize in multiple 
product areas. Additionally, FDA is working to streamline existing 
processes, which are intended to improve effectiveness and consistency 
of inspections performed inside and outside the US.
    Further, FDA allows sponsors to submit the results of a third party 
audit in lieu of a routine surveillance inspection conducted by FDA 
personnel. Specifically, certain types of audits conducted under the 
Medical Device Single Audit Plan (e.g., those that are accepted as 
substitutes for routine inspections) may be deemed to satisfy 
regulatory requirements of multiple international jurisdictions, and 
provide flexibility to device sponsors and establishments.
    Question. There are reports of FDA withholding/rescinding a 
company's Certificate for Foreign Governments (CFG), essentially 
prohibiting the ability to serve markets outside the US, in instances 
when their products are able remain on the market in the US.
    What is the FDA's process for rescinding and reinstating CFG?
    Answer. A Certificate to Foreign Government (CFG) is an indication 
to a foreign government that FDA requirements are met at the time of 
its issuance. Firms request certificates to facilitate shipments to 
foreign countries.
    FDA/CDRH will not issue a CFG to a firm that has been issued a 
Warning Letter for Quality Systems violations. Before FDA/CDRH will 
issue that firm a CFG, FDA/CDRH must have assurance that the firm 
addressed the violations. Once FDA/CDRH confirms the issues are 
addressed through an inspection or a submission to FDA from the firm, 
FDA will issue a letter stating that the violations appear to have been 
adequately addressed. Only then will FDA issue a CFG to the firm.
    FDA/CDRH does not currently rescind CFGs once issued and we have 
not rescinded any certificates since 2009. CDRH previously rescinded 
certificates if we became aware that a firm was in violation of the 
Quality System regulation. It was difficult to physically retrieve 
rescinded certificates, however, because in most cases CDRH found the 
certificate had already been sent to the foreign country.
                                generics
    Question. Recently the FDA has proposed a series of initiatives, 
which, together with the slowdown in generic drug approvals, are 
contributing to cost increases (labeling rule, same size guidance, 
Quality Metrics Guidance, delay in guidance for interchangeable 
generics).
    Has FDA examined the collective effects of public health and cost 
to patients from the implementation of all these proposals? If not, can 
FDA undertake that examination and report back to the committee?
    Answer. One of the initiatives identified in your question is a 
rule and the other three initiatives are guidance documents. The 
processes governing consideration of the economic impact of proposed 
rules and guidance documents are different, as outlined below.
    With respect to the proposed rule on Supplemental Applications 
Proposing Labeling Changes for Approved Drugs and Biological Products, 
any final rule that is adopted will reflect FDA's consideration of 
public comments and would be accompanied by an analysis of the economic 
impact of the regulatory change described in the final rule. This 
regulatory impact analysis would be based on the framework described in 
Executive Orders 12866 and 13563, and use the best available techniques 
to quantify anticipated present and future benefits and costs. The 
regulatory impact analysis would help ensure that any regulation is 
adopted only upon a reasoned determination that its benefits justify 
its costs, and is tailored to impose the least burden on society, 
consistent with obtaining regulatory objectives. As part of the final 
regulatory analysis, FDA will estimate all of the benefits and all of 
the costs of the final rule. These benefits and costs will include any 
potential effects on public health and cost to patients from the 
implementation of the final rule but will not include the cumulative 
effects of other proposals or guidance documents. The effects of 
regulations and guidance documents currently in place are included in 
the baseline used as the starting point for estimating the effects of 
the rule.
    The process for consideration of guidance documents, including 
those mentioned in your question, is governed by FDA's Good Guidance 
Practices (GGP) regulations (see 21 CFR 10.115). FDA's GGP regulations 
do not require an examination of the costs or impact to the public 
health associated with following the recommendations described in 
guidance. Should the recommendations described in guidance cause a 
particular hardship to its relevant stakeholders, those stakeholders 
may propose an alternative approach as long as that alternative 
approach satisfies the relevant statutes and regulations. If a guidance 
requests or requires that members of the public obtain, maintain, 
submit, retain, report, or publicly disclose information, the Office of 
Management and Budget (OMB) must first grant approval of these requests 
or requirements as an information collection request (ICR) in 
accordance with the Paperwork Reduction Act. Before the ICR is reviewed 
and approved by OMB, FDA estimates the total time, effort, or financial 
resources involved in providing the information and publishes a notice 
in the Federal Register requesting comments from the public on specific 
elements outlined in the Paperwork Reduction Act.
    Industry, consumers and other stakeholders play a significant role 
in the agency's guidance development processes. FDA welcomes 
suggestions of topics for guidances, and in certain instances solicits 
draft proposals. For example, FDA may issue a ``Request for 
Information'' in the Federal Register to gain input on certain topics 
or participate in public workshops to engage with industry and other 
stakeholders on topics for which the Agency is considering developing 
guidance. After a draft guidance is published, comments are reviewed 
and considered by FDA in preparing the final guidance documents. The 
public can provide comments on any guidance document at any time.
                          dietary supplements
    Question. Within FDA's Center for Food Safety and Nutrition 
(CFSAN), how many FTE's are dedicated to enforcement activities? Of 
that number, how many are focused specifically on enforcing dietary 
supplement regulations?
    Answer. The Office of Compliance is the focal point for enforcement 
activities within CFSAN, with eight (8) FTEs dedicated to dietary 
supplement enforcement. The Office of Dietary Supplement Programs 
(ODSP) is the CFSAN lead for policy development and strategic 
management of the dietary supplement program, which includes compliance 
strategy and safety assessments as well as guidelines and regulations. 
ODSP has authorization for 26 FTEs. Most of ODSP's FTE's devote at 
least some of their efforts towards enforcement, but none are focused 
specifically on enforcement. CFSAN leverages its dietary supplement 
enforcement activities by partnering with other organizations within 
FDA, including the Office of Regulatory Affairs, that work on 
compliance and enforcement matters.
    Question. In 2015, how many enforcement actions did FDA bring 
against dietary supplement manufacturers and marketers? How many 
dietary supplement good manufacturing practice inspections did FDA 
conduct in 2015? How many serious adverse events were reported to FDA 
last year? How many unique dietary supplement formulations were 
involved in these reports? How many new dietary ingredient 
notifications were filed with the Agency in 2015? And lastly, how many 
FTEs are devoted to dietary supplement enforcement and regulatory 
programs (including inspections of dietary supplement facilities)?
    Answer. In fiscal year 2015 FDA issued the following warnings and 
brought the following enforcement actions against dietary supplement 
(DS) manufacturers and marketers:
  --49 Import Detentions (detentions without physical examination)
  --6 Untitled Letters
  --83 Warning Letters
  --6 Injunctions [Entered by District Courts]
(Data retrieved from FDA's Compliance Management Services database)
    In fiscal year 15, FDA:
  --Conducted 482 Dietary Supplement GMP inspections. Of those, 445 
        were of domestic facilities and 37 were of foreign facilities.
  --Received 5,336 serious adverse event (AE) reports for products 
        regulated by FDA's Center for Food Safety and Applied 
        Nutrition. Of those serious adverse events reported, 3,098 were 
        for dietary supplements with 3,529 unique product names 
        reported (some AEs report multiple products).
  --Received 35 new dietary ingredient notifications.
    FDA devotes just over 100 FTEs to dietary supplement enforcement 
and regulatory programs, including inspections of dietary supplement 
facilities. Approximately 26 of those FTEs are located in CFSAN's 
Office of Dietary Supplement Programs (ODSP), which serves as the CFSAN 
lead for policy development and strategic management of dietary 
supplement program, including enforcement and regulatory programs. 
CFSAN's Office of Compliance has approximately 8 FTEs focused on 
dietary supplement enforcement activities.
    Additionally, ORA devotes several FTEs to dietary supplement 
enforcement and regulatory programs, allocated in fiscal year 15 as 
follows: approximately 8.45 FTE for sample collections and analyses; 54 
FTEs expended for inspections for domestic and foreign dietary 
supplement firms; and 5 FTEs in the Office of Enforcement and Import 
Operations, Division of Enforcement, providing support for dietary 
supplement enforcement and regulatory program activities.
    Question. Given that the Office of Dietary Supplement Programs 
(ODSP) within the Center for Food Safety and Applied Nutrition (CFSAN) 
at FDA was only created in December 2015, what is the budget and FTE 
count for ODSP for the remainder of 2016? What is the proposed budget 
and FTE count for fiscal year 2017?
    Answer. In fiscal year 2016, the Center for Food Safety and Applied 
Nutrition provided the Office of Dietary Supplement Programs (ODSP) a 
budget of $4.6 million to include funding for payroll and non-payroll 
requirements. The fiscal year 2016 budget includes 26 approved 
positions (FTE). The proposed fiscal year 2017 budget for ODSP is $5.9 
million and includes additional funds for hiring to reach the approved 
level of 26 FTE.
    Question. What does the Office of Dietary Supplement Programs 
(ODSP) within the Center for Food Safety and Applied Nutrition (CFSAN) 
at FDA consider to be the top enforcement priorities in the dietary 
supplement industry for fiscal year 2017? How were these priorities 
selected?
    Answer. Using risk based prioritization, the Office of Dietary 
Supplement Programs (ODSP) has determined that in fiscal year 2017 it 
will use its current authorities and available resources to monitor the 
safety of dietary supplement products and take compliance and 
enforcement actions, such as:
  --Taking action to remove from the market supplement products that 
        are dangerous to consumers;
  --Taking action, in conjunction with FDA's Center for Drug Evaluation 
        and Research, to remove from the market products that contain 
        undeclared pharmaceutical agents and are labeled as dietary 
        supplements;
  --Enforcing the dietary supplement good manufacturing practices (GMP) 
        regulations, giving priority to cases with GMP violations that 
        meet the following criteria:
        --Potentially compromise product safety;
        --Fail to ensure product quality due to lack of testing, 
            procedures, and records; and
        --Result in consumer deception, when, for example, 
            manufacturers do not verify the identity of their raw 
            materials
  --Taking action against supplement products that bear claims to treat 
        diseases which can result in serious risk of harm to the 
        consumer (such as egregious claims of benefit in treating 
        serious diseases) or widespread economic fraud.
    These priorities reflect a risk-based determination of how ODSP's 
limited resources can best be deployed to protect the public health.
    Question. What is the status of FDA's effort to finalize the draft 
New Dietary Ingredient notification guidance?
    Answer. FDA published its draft guidance for industry entitled 
``Dietary Supplements: New Dietary Ingredient Notifications and Related 
Issues'' (the NDI Draft Guidance) for public comment in July of 2011. 
FDA reviewed public comments and met on several occasions with 
industry, consumers, and members of Congress to better understand the 
concerns raised. We considered the views expressed at those meetings 
and the many public comments received on the draft guidance as we 
worked on revisions to provide additional explanation and 
clarification. The comments received on the original draft guidance 
caused FDA to conclude that the best course of action would be to 
reissue the guidance as a revised draft that contains clarifications on 
several key issues that were the subject of confusion or 
misinterpretation. We are currently in the later stages of preparing a 
revised draft guidance, and we hope to publish the revised draft 
guidance in the near future. All interested individuals and groups will 
have an opportunity to review and comment on the revised draft guidance 
before FDA issues any final guidance.
    Question. How many facilities are registered as dietary supplement 
manufacturers with FDA through biannual registration as required by the 
Food Safety Modernization Act?
    Answer. As of March 2, 2016, there are a total of 12 744 
(6,522domestic and 6,222 foreign) facilities that have selected food 
product categories that indicate that they manufacture/process, pack, 
or hold dietary supplements. Of this total, 7,164 (3,876 domestic and 
3,288 foreign) registrations were renewed during the 2014 Biennial 
Registration Renewal period (October 1, 2014 through December 31, 
2014). Under current food facility registration regulations at 21 CFR 
1.233(g), the type of activity conducted at a facility is optional 
information and is not required to be submitted with a registration 
submission; therefore not all registrations include this information. 
Currently, there are a total of 4,953 (1,482 domestic and 3,471 
foreign) facilities that manufacture/process, pack, or hold dietary 
supplements that have provided activity type information identifying 
themselves as ``manufacturers/processors.''
                      over-the-counter antiseptics
    Question. The Food and Drug Administration (FDA) is currently re-
writing the 1994 tentative final monograph for over-the-counter (OTC) 
antiseptics. In the 1994 tentative final monograph, FDA delineated 
several categories associated with antiseptic hand washes, including 
one specific to food handlers and recognized that different categories 
of users need different regulatory treatment due to the possible risk 
to public health (78 Fed.Reg.76444).
    Does the FDA intend to recognize the different categories 
associated with antiseptic hand washes included in the 1994 tentative 
Final Monograph?
  --If not, does FDA intend to include food handlers as a part of the 
        2013 Consumer Hand Wash Monograph?
  --If so, does FDA intend to specify different regulatory conditions 
        that would be associated with antiseptic washes used in the 
        context of food preparation?
  --And, if this is the case, does FDA intend to have a more 
        substantive dialogue with stakeholders to ensure clarity about 
        how the rule will be applied in the consumer and food 
        preparation sectors?
    Answer. In 1994, FDA identified a category of nonprescription 
(over-the-counter) antiseptics marketed for use in food handling and 
processing, and requested relevant data and information regarding these 
antiseptic products (59 FR 31402 at 31440). FDA continues to consider 
antiseptics for use by food handlers to be a separate and distinct 
monograph category from consumer antiseptic monographs, which are 
labeled and marketed for different intended uses and which raise 
different issues. The consumer wash rulemaking is not intended to 
affect products indicated for use by the food industry. In fact, the 
2013 consumer antiseptic wash proposed rule specifically mentions that 
antiseptics for use by the food industry would not be discussed in that 
proposed rule (78 FR 76444 at 76446). We intend to consider over-the-
counter antiseptic products for use by the food industry separately 
from consumer wash antiseptics. FDA intends to communicate with 
stakeholders at the time of publication of the final rule on consumer 
antiseptic hand washes.
    Question. If FDA does not intend to include food handlers in the 
final monograph, will it be explicitly stated in the regulation and 
material associated with its release in order to prevent confusion 
about what should or should not be used by food establishments?
    Answer. In 1994, FDA identified a category of nonprescription 
(over-the-counter) antiseptics marketed for use in food handling and 
processing and requested relevant data and information regarding these 
antiseptic products (59 FR 31402 at 31440). FDA continues to consider 
antiseptics for use by food handlers to be a separate and distinct 
monograph category from consumer antiseptic monographs, which are 
labeled and marketed for different intended uses and which raise 
different issues. The consumer wash rulemaking is not intended to 
affect products indicated for use by the food industry. In fact, the 
2013 consumer antiseptic wash proposed rule specifically mentions that 
antiseptics for use by the food industry would not be discussed in that 
proposed rule (78 FR 76444 at 76446). We intend to consider over-the-
counter antiseptic products for use by the food industry separately 
from consumer wash antiseptics. FDA intends to communicate with 
stakeholders at the time of publication of the final rule on consumer 
antiseptic hand washes.
                                 ______
                                 
                Questions Submitted by Senator Roy Blunt
    Question. In the Ag-Omnibus end-of-year funding bill for the FDA, 
we included language to have the compliance date for the FDA final menu 
labeling regulations be in-line with FDA completing and publishing 
final guidance that has been in the works for over a year. We thought 
it is only fair for those who are regulated to have the answers to 
their numerous questions/concerns, to allow them to forward and allow 
adequate time to properly comply with these regulations.
    Can you tell us the status of the guidance?
    Answer. On September 11, 2015, FDA issued the draft guidance for 
industry, ``A Labeling Guide for Restaurants and Retail Establishments 
Selling Away-From-Home Foods--Part II (Menu Labeling Requirements in 
Accordance with 21 CFR 101.11).'' FDA received a wide range of 
substantial comments from a variety of stakeholders. FDA is carefully 
considering all comments received as we work to finalize the guidance. 
We expect to publish the final guidance in the spring of 2016.
    Question. Are you planning to incorporate some of the comments and 
provide some flexibility that many of the regulated establishments are 
seeking, into the final document?
    Answer. FDA appreciates the extensive input received from 
stakeholders throughout the process of establishing requirements for 
menu labeling and in developing guidance to assist industry in 
complying with the regulations. The menu labeling regulations provide 
flexibility for covered establishments, such as the ability to choose 
among several options for determining calorie and other nutrition 
information for standard menu items. The draft guidance reflects the 
flexibility of the regulations. We are carefully considering the 
comments and will incorporate changes as appropriate. We will also work 
flexibly and cooperatively with establishments covered by the menu 
labeling final rule to facilitate compliance. We will provide 
educational and technical assistance for covered establishments and for 
our state, local, and tribal regulatory partners. We believe this 
cooperative approach will facilitate successful implementation in a 
practical way.
    Question. I am concerned that many believe the industry has been 
the only reason for the delay in the menu labeling implementation. Do 
you agree that the FDA had a predominant role in the delay? The FDA 
took 3\1/2\ years to finalize the regs (April 1, 2011 Proposed Rule 
followed by Dec. 1, 2014 Final Rule) and then another 10 plus months to 
issue draft guidance when the FDA itself could not answer the questions 
from the regulated businesses such as grocery stores and others?
    Answer. The successful development and implementation of a complex 
rulemaking such as menu labeling requires sustained dialogue and close 
collaboration with the affected industry and other key stakeholders. We 
recognize that implementing menu labeling requirements nationwide in a 
collaborative manner has taken a significant amount of time and 
resources.
    As we developed the menu labeling rule, we became increasingly 
aware of the complexity of the American retail food industry, 
particularly with respect to foods prepared away from home. FDA 
received a wide range of substantial comments on the proposed rule from 
consumers, various food industries, trade associations, and other key 
stakeholders.
    As we move toward implementation, to assist stakeholders with 
further understanding the menu labeling requirements we have been 
meeting and will continue to meet with industry groups to discuss the 
requirements. We will also continue to provide webinars and 
presentations and respond to industry questions submitted to the 
Agency's menu labeling inbox. We will work flexibly and cooperatively 
with establishments covered by the menu labeling final rule to 
facilitate compliance. We will also provide educational and technical 
assistance for covered establishments and for our state, local, and 
tribal regulatory partners. We believe this collaborative approach will 
facilitate compliance with the requirements in a flexible and practical 
way.
    As you know, the House passed legislation to make some changes to 
the FDA menu labeling regs so certain entities would have a better 
opportunity to implement and comply with these regulations. I was 
joined by Senator King in introducing the Senate companion bill. The 
bill does not exempt supermarkets, convenience stores, or delivery 
operations from the menu labeling regulations, but allows some 
practicality for providing nutritional information to customers based 
on the different ways that foods are prepared and sold across various 
venues and formats.
    For instance, the House passed bill has provisions such as:
  --Preserving local foods or fresh items that may only be sold at one 
        or two store or restaurant locations.
  --Allowing for use of a menu or menu board in a prepared foods area 
        or next to a salad bar instead of individually labeling every 
        item
  --Allowing an establishment 90-days to take corrective actions to fix 
        an error and clearly stating that oversight authority rests 
        with FDA (and states/municipalities that work with FDA) ;
  --Allowing items that are normally ordered off-premises (pizza 
        delivery) to have nutritional information posted as the 
        ordering decision is made online as a means for compliance.
    None of these provisions impact FDA's oversight or enforcement 
authority and no entity that is currently regulated under the menu 
labeling regulations would be exempt.
    Question. FDA did not provide flexibility in these areas in the 
draft guidance that the agency released last September. Are there any 
provisions in this bill that FDA is planning on adopting as part of 
this final guidance you are working on?
    Answer. FDA's menu labeling draft guidance reflects the Agency's 
current thinking on the menu labeling regulation (21 CFR 101.11) and 
does not impose new requirements. Rather, the draft guidance explains 
the Agency's interpretation of the regulation and contains 
recommendations for ways that industry can meet the menu labeling 
requirements. Industry may use other approaches that satisfy the 
regulations.
    We understand that H.R. 2017, referred to as the ``Common Sense 
Nutrition Disclosure Act of 2015,'' is still under consideration in 
Congress. If this bill, as currently written, should become law, FDA 
would have to engage in rulemaking to amend the current requirements 
and revise any associated guidance.
                                 ______
                                 
              Questions Submitted by Senator Steve Daines
         fda final rule deadlines and market stability lead-in:
    Question. On May 1, 2015, the FDA published a Proposed Rule to be 
added to their 1994 Tentative Final Monograph (TFM) for Healthcare 
Antiseptics. Yet, the FDA as indicated that this proposed rule will not 
be finalized until January 2018, despite having received significant 
public input and concerns with the proposed rule. This delay has left 
companies in limbo, not knowing whether their new products will need to 
meet a coming finalized rule to enter the market or for existing 
products to remain on the market and whether that finalized rule will 
address their concerns. As an example, this turbulence in the market 
has caused a 25 percent revenue reduction in 2015 for BioScience 
Laboratories, a Montana company, and they are currently facing 
additional staff reductions.
    Mr. Commissioner, will the FDA continue to delay addressing 
concerns with this proposed rule regarding the 1994 Temporary Final 
Monograph (TFM) for Healthcare Antiseptics and continue to delay 
publishing a final rule?
    Answer. In 1994, FDA published a proposed rule with the agency's 
tentative determinations as to which ingredients were generally 
recognized as safe and effective for use in nonprescription 
antiseptics. Since 1994, FDA's safety standards, our ability to detect 
and measure antiseptics in the body, and the scientific knowledge about 
the impact of widespread antiseptic use have evolved. For the past 
several years, FDA has been actively engaged in this issue. In 2005 and 
again in 2014, FDA sought the advice of an FDA advisory committee made 
up of outside scientific and medical experts. As you know, on May 1, 
2015, we published a healthcare antiseptics proposed rule (HCA PR(80 
FR25166), which is part of a larger, ongoing review of antiseptic 
active ingredients by FDA. The HCA PR proposed that all active 
ingredients used in healthcare antiseptic products marketed under the 
OTC drug monograph system need additional safety and effectiveness 
data. In doing so, it proposed to revise certain testing criteria, 
identified important scientific data gaps for active ingredients used 
in certain over-the-counter healthcare antiseptic products, and 
requested additional data to support the ingredients' safety and 
effectiveness.
    Because of the complexity of the HCA PR, FDA provided a public 
comment period of 180 days after publication, which closed on October 
28, 2015. Moreover, the public and regulated industry had 12 months 
after publication of the proposed rule, or until April 30, 2016, to 
submit data or new information. Responsive comments on any new data or 
information may now be submitted for an additional 60 days, until June 
30, 2016. Upon the close of the final comment period, FDA will review 
all data and information submitted to the record in order to complete a 
final rule. FDA intends to issue the final rule on healthcare 
antiseptics by January 15, 2018, which is approximately 18 months after 
the final comment period closes.
                               follow-up
    Question. Additionally, will you commit to reducing market 
turbulence to the full extent possible by preventing such delays in 
addressing public concerns with proposed rules and publishing final 
rules in a timely manner, as well as clearly indicating when those 
final rules will go into effect?
    Answer. Senator, we understand your concerns. However, because of 
the complexity of the healthcare antiseptics proposed rule, FDA 
provided a public comment period of 180 days after publication, which 
closed on October 28, 2015. Moreover, the public and regulated industry 
had 12 months after publication of the proposed rule, or until April 
30, 2016, to submit data or new information, and comments on any new 
data or information may now be submitted for an additional 60 days, 
until June 30, 2016. Upon the close of the final comment period, FDA 
will review all data and information submitted to the record in order 
to complete a final rule. FDA intends to issue the final rule on 
healthcare antiseptics by January 15, 2018, which is approximately 18 
months after the final comment period closes. In the proposed rule, FDA 
proposed that any final rule would become effective 1 year after the 
date of the final rule's publication in the Federal Register.
    Notice and comment rulemaking is a lengthy and multistep process. 
Major steps for FDA rulemaking generally include determination that a 
rule is needed and what the rule should say; review of relevant data; 
drafting, reviewing, and finalizing the proposed rule; publishing the 
proposed rule; a public comment period and review of the comments; 
revising the proposed rule as appropriate; possibly convening an 
advisory committee meeting, meeting with interested parties, or both; 
reviewing the draft final rule and finalizing it, and publishing the 
final rule in the Federal Register.
    Even while FDA is moving forward to finalize the healthcare 
antiseptic rule, FDA has a very broad mandate and multiple public 
health priorities, with limited resources to address these priorities. 
FDA's Center for Drug Evaluation and Research (CDER) is responsible for 
regulating the safety and efficacy of both prescription and 
nonprescription human drugs. Like FDA as a whole, CDER must continually 
balance multiple important public health priorities, of which the OTC 
Drug Review, which includes healthcare antiseptics, is one. CDER does, 
and will continue to, consider the OTC Drug Review, and the antiseptic 
rulemakings in particular, among its priorities as it endeavors to 
appropriately allocate staff and resources within the context of all 
CDER responsibilities.
                                 ______
                                 
              Questions Submitted by Senator Jeff Merkley
                                tobacco
    Question. The longer the tobacco deeming regulation takes, the more 
attempts there will be to include things like the House's language last 
year, which would have changed FDA's deeming date, and kept e-
cigarettes essentially unregulated.
    What effect the House's provision last year would have had on 
access to tobacco products, and the deeming regulation?
    Answer. This language contained in last year's House bill aimed to 
treat newly deemed products in a way roughly modeled on how the TCA 
treated newly regulated products when the law was enacted. 
Specifically, the grandfather date of February 15, 2007, would be 
changed to the effective date of the deeming final rule, and new 
tobacco products introduced between the new grandfather date and 21 
months afterwards would be permitted to stay on the market as long as 
an SE report was submitted by the end of the 21 month period. This 
proposed language would have eroded FDA's ability to regulate certain 
tobacco products to protect public health. Specifically, the House bill 
would exempt from FDA review those tobacco products that were marketed 
before the effective date of the deeming final rule. As a result, these 
products, including currently marketed flavored e-cigarettes, and novel 
tobacco products like certain dissolvables, would have been allowed to 
stay on the market indefinitely without oversight or a scientific 
evaluation of their risks, potentially threatening public health. Those 
tobacco products that come on the market after the 21 month transition 
period would be subject to FDA's premarket authority and would need a 
marketing order before being sold.
                                opioids
    Question. FDA has been under fire recently for approving opioids 
without convening, or against the recommendations of, your advisory 
panels, especially when the pills are flooding the market. In response, 
the Agency recently announced a series of steps including re-examining 
the ``risk-benefit'' paradigm for opioids to consider public health 
effects; convening an advisory panel for any new opioids that don't 
have abuse deterrent properties; and adding additional warnings on 
labels, among other things.
    Could you walk us through each of these decisions and the outcomes 
you expect they will provide? Specifically, on the risk-benefit 
paradigm, what will FDA consider that it wasn't already--addiction 
potential, number of opioids already on the market, anti-deterrence 
methods?
    Answer. These actions are part of a number of actions the Agency 
outlined in a plan to reassess the approach to opioid medications 
announced in February. The plan is focused on policies aimed at 
reversing the epidemic, while still providing patients in pain access 
to effective medication. This comprehensive action plan will help to 
mitigate the problem of opioid abuse and confront the epidemic. There 
are four main pillars to the plan described below.
  --Transparency: FDA will be more transparent and open in the approval 
        process for this category of drugs. FDA plans to convene an 
        expert advisory committee before approving any new drug 
        application for an opioid that is not in an abuse-deterrent 
        formulation (ADF). Additionally, we're going to engage the 
        Pediatric Advisory Committee to make recommendations on 
        pediatric opioid labeling before any new labeling is approved. 
        The advisory committee process is going to provide opportunity 
        for public input, which is going to help us better understand 
        and answer the concerns people have about these drugs.
  --Improving Communication: Requiring labeling changes and updates to 
        Risk Evaluation and Mitigation Strategies (REMS), FDA hopes to 
        improve communication with the medical community about opioids. 
        Through labeling, our goal is to provide better information to 
        doctors about the risks of these drugs and how to safely 
        prescribe them. In March 2016, FDA released new labeling 
        changes to immediate release opioid labeling that incorporate 
        elements similar to the labeling of the extended-release/long-
        acting opioid analgesic products. In addition, FDA will 
        evaluate updates to our Risk Evaluation and Mitigation Strategy 
        (REMS) program requirements for opioids with the goal of 
        increasing the number of prescribers who receive training on 
        pain management and improve the safe prescribing of opioids to 
        decrease inappropriate prescribing. That effort will complement 
        work being done at the Department level and at the CDC to help 
        ensure that opioids are prescribed appropriately. We believe 
        that improving prescribing practices is a key component of 
        ending this public health crisis. The nearly 250 million 
        prescriptions for these types of pain killers written each 
        year--enough for every adult in the U.S. to have a bottle of 
        pills--is clear evidence of the work ahead of us.
  --Post Marketing: FDA recently strengthened the requirements for 
        drugmakers to conduct post-market analysis of opioid 
        analgesics. This information, especially about long-term use, 
        is currently lacking and we need more and better evidence on 
        the risks of misuse and abuse associated with long-term opioid 
        use and to better understand predictors of addiction, among 
        other issues.
  --Product Development: In March, the FDA issued draft guidance with 
        its recommendations for studies that should be conducted to 
        show that a generic copy of a brand-name abuse-deterrent opioid 
        formulation is as abuse-deterrent as the brand-name drug. We 
        believe the availability of less costly generic products with 
        abuse-deterrent properties may help accelerate prescribers' 
        uptake of abuse deterrent formulations. In addition, FDA is 
        working to improve access to naloxone, which is effective at 
        treating overdoses. The FDA is reviewing options, including the 
        possibility of over-the-counter availability, to make naloxone 
        more accessible.
    Question. Is there anything FDA could do to try to curb the number 
of pills that doctors prescribe, such as shortening the standard course 
of treatment for acute injuries, so there aren't as many pills left 
over?
    Answer. There is no standard course of treatment for acute injuries 
described in labeling for opioid analgesics. That is because the 
duration of treatment will vary depending on the type of injury. It is 
generally left to the discretion of the treating healthcare provider to 
decide how many pills to prescribe once the decision has been made to 
prescribe an opioid analgesic.
    Question. FDA has contributed significantly to improving the safety 
and safe use of opioid analgesics. We are continuing our work to ensure 
prescribers have the information they need to understand the risks 
associated with opioid analgesics, as evidenced by the recently 
announced sweeping changes FDA is requiring to the immediate-release 
(IR) opioid analgesic labeling, which include safety-related 
information similar to that added to the extended-release and long-
acting (ER/LA) opioid analgesic labeling in 2014. FDA is also requiring 
changes to the indications for these products to better emphasize that 
opioid analgesics should be prescribed in situations where non-opioid 
analgesics are not adequate. Further, the ER/LA Opioid Analgesics Risk 
Evaluation and Mitigation Strategy (REMS) requires that drug sponsors 
make available prescriber education to better inform healthcare 
professionals about the risks and appropriate use of these drugs. It is 
the Agency's hope that the significant actions it has taken, along with 
broader Departmental efforts, will lead to more careful and thoughtful 
prescribing, and more appropriate use of these drugs.
    What role does FDA play in educating doctors and pharmacists about 
the risks of these drugs?
    Answer. The primary tool FDA uses to educate doctors and 
pharmacists about the risks of prescription drugs, including opioids, 
is the FDA-approved product labeling. The purpose of the drug labeling 
is to give healthcare professionals the information they need to 
prescribe drugs appropriately; to understand the patients for whom the 
drugs are considered safe and effective; the way the drugs are intended 
to be used; and the risks and benefits associated with their use. In 
April 2014, FDA finalized sweeping changes to the labeling for 
extended-release and long-acting (ER/LA) opioid analgesics to help 
prescribers better understand the risks of misuse, abuse, neonatal 
opioid withdrawal syndrome, addiction, overdose, and death associated 
with these drugs and to more clearly describe the patient population in 
whom these drugs should be used. On March 22, 2016, FDA sent letters to 
sponsors of immediate-release (IR) opioid analgesics requiring changes 
similar to those finalized for the ER/LA opioid analgesics in 2014. 
These changes to the labeling, once finalized, are expected to 
emphasize that opioid analgesics should be prescribed only when other 
treatment options are inadequate or ineffective. For both ER/LA and IR 
opioid analgesics, the new labeling better enables prescribers to make 
decisions based on a patient's individual needs, given the serious 
risks associated with opioids. FDA intends these changes to enable not 
only a more careful and thorough approach to determining whether opioid 
analgesics should be prescribed for a particular patient, but also to 
allow prescribers to better assess whether the serious risks associated 
with opioids, are offset by the benefits opioids may provide in 
managing pain for an individual patient.
    FDA also uses other tools to educate prescribers about opioid 
risks. For example, the ER/LA Opioid Analgesics Risk Evaluation and 
Mitigation Strategy, approved in 2012, requires manufacturers of the 
ER/LA opioid analgesics to make available, for free or at nominal cost, 
education courses from for healthcare professionals who prescribe ER/LA 
opioid analgesics. These continuing education courses educate 
prescribers about the risks of these opioid analgesics, as well as 
safer prescribing and use practices for these drugs. Manufacturers of 
ER/LA opioid analgesics are also required to conduct an assessment of 
the REMS and submit a REMS assessment report to the Agency for review. 
On May 3-4, 2016, FDA convened a joint session of the Anesthetic and 
Analgesic Drug Products and the Drug Safety and Risk Management 
Advisory Committees to discuss the results of the 36th month ER/LA 
Opioid Analgesics REMS Assessment submitted by the manufacturers of the 
ER/LA opioid analgesics in July 2015. The Agency sought the committees' 
comments as to whether the REMS for this class of drugs assures safe 
use; is not unduly burdensome to patient access to the drug; and, to 
the extent practicable, minimizes the burden to the healthcare delivery 
system. In addition, the Agency sought the committees' comments on any 
modifications to the ER/LA Opioid Analgesics REMS, including possible 
expansion of the scope and content of prescriber education, and whether 
to expand the REMS program to include immediate-release opioids. FDA is 
evaluating potential modifications to the REMS program requirements for 
opioids after considering advisory committee recommendations and 
reviewing existing requirements.
    In addition, the Agency utilizes publications such as drug safety 
communications (DSCs) to inform prescribers and patients of safety 
issues that should be considered when prescribing and using these 
drugs. For example, on March 22, 2016, FDA issued a DSC regarding risks 
of serotonin syndrome for some opioids, and for adrenal insufficiency 
and androgen deficiency for all opioids, regardless of indication. 
Further, FDA officials recently published a note in the Journal of the 
American Medical Association expressing the Agency's dedication to 
improving the safety of these drugs, and setting forth the Agency's 
plan to achieve this goal in the coming months.
    Question. Why not require an advisory panel for all new opioids, 
whether or not they have an abuse deterrent formula?
    Answer. Seeking advice from external experts on matters related to 
opioids, including related to this emerging area of science, is a 
cornerstone of the FDA's 2016 Opioids Action Plan. While we're 
continuing to learn more about the impact that approved abuse-deterrent 
(AD) products are having in the community, and supporting research and 
development of additional technology, the agency plans to seek advisory 
committee recommendations on new, non-AD brand-name products, and on 
new AD brand-name products when they raise novel issues. We hope that 
this public discussion will allow for greater transparency around the 
FDA's decisionmaking regarding opioid products during this period of 
reassessment of our policies and regulatory approach to 
opioids.Judicious use of Advisory Committees is grounded in the 
recognition that advisory committee meetings demand significant 
resource commitments by advisory committee members, sponsors and other 
public participants, as well as for the FDA itself. FDA works to ensure 
that the finite resources of its advisory committee program are devoted 
to consideration of the matters in which the agency would most benefit 
from the advice of outside experts.
    Question. Are there new abuse deterrence methods on the horizon?
    Answer. Ultimately, the FDA looks forward to a future in which 
substantially all opioid medications are less susceptible to abuse than 
the conventional formulations that dominate the market today. However, 
we are still in the early stages of abuse-deterrent product 
development--the market has a small number of products using abuse-
deterrent technologies, and the agency is assessing each opioid drug 
product's safety and efficacy on a case-by-case basis. Since the draft 
guidance on the evaluation and labeling of abuse-deterrent opioids was 
issued on January 9, 2013, the FDA has approved six extended-release 
long-acting opioids with labeling describing the product's abuse-
deterrent properties consistent with the draft guidance: OxyContin 
(April 16, 2013); Targiniq ER (July 23, 2014); Embeda ER (October 17, 
2014); Hysingla ER (November 20, 2014); MorphaBond (October 2, 2015); 
and Xtampza (April 26, 2016).
    The abuse-deterrent properties of those six products are based on 
data and described in terms consistent with those set forth in the 
FDA's 2015 guidance on the topic, Abuse-Deterrent Opioids--Evaluation 
and Labeling. FDA is prohibited by law from disclosing confidential 
information about a unapproved applications (e.g., 21 CFR 314.430) and 
is therefore unable to comment on drugs in development or in the FDA 
review process. Further, consistent with longstanding Agency practice, 
we do not discuss the substance of any matters pending before the 
Agency. However, FDA expects these technologies to improve and expects 
products containing abuse deterrent properties (both innovator and 
generic) to become more widely available.
    Abuse-deterrent does not mean abuse-proof. Abuse-deterrent opioids 
are intended to deter abuse by making the products less vulnerable to 
attempts to manipulate the product for abuse by the oral, nasal, or 
intravenous routes. However, the products must be able to deliver the 
opioid in order to provide analgesia and so will remain susceptible to 
abuse to some extent.
    While FDA is gathering data on the impact that approved ADFs are 
having in practice, and supporting research and development of 
additional ADF technology, the agency is also asking for advisory 
committee recommendations on all new non-ADF products to determine 
whether the benefit of non-AD products continues to offset the risks. 
FDA hopes that this public discussion will allow for greater 
transparency around the agency's decisionmaking regarding opioid 
products during this period of reassessment of our policies and 
regulatory approach to opioids.
                     food safety modernization act
    Question. The budget request for FSMA implementation is modest, to 
say the least. Last year, when FDA's budget was submitted, I was very 
appreciative that it finally included a realistic request to implement 
FSMA, and not one that relied on user fees that didn't stand a chance 
of happening. Congress took that request very seriously and provided 
full funding--so you know what our commitment is.
    Even then, according to FDA's own documents--there was still going 
to be a funding gap of approximately $166 million needed to 
successfully implement FSMA. So in a lot of ways, this budget request 
feels like a step backwards, even though I know we are all in agreement 
that FSMA has to be done right.
    What happens, or does not happen, if you get exactly what you ask 
for in budget authority, and no new user fees? How much additional 
funding, no matter the source, would be a responsible level this year 
to continue to fully support FSMA implementation?
    Answer. The fiscal year 2017 President's Budget includes a total of 
$1.5 billion in proposed resources for food safety. The budget would 
increase food safety funding by $211.6 million over fiscal year 2016. 
Specifically to support FSMA implementation, the budget proposed an 
increase of $25 million in budget authority. The budget also includes 
two key proposed user fees to support implementation, an import user 
fee ($105.3 million) and food facility registration and inspection fee 
($61.3 million). The sum of these increases represents the total 
resources needed for FDA to effectively implement FSMA. For example, if 
FDA does not receive the additional integrated food safety funds 
requested, we will have to reduce our planned support of State produce 
safety regulatory programs aligned with FDA's Produce Safety rule. It 
would in turn hamper education and outreach efforts to farmers.
    Question. The biggest part of your proposed increase is $11.3 
million for cooperative agreements and grants to implement the produce 
safety rule. While state and local efforts are no doubt critical, it's 
concerning that there is no money to train FDA staff. Was the money 
provided last year for this effort enough? Are FDA staff fully trained 
and prepared for this entirely new way of doing business?
    Answer. Training on the Produce Safety rule will be very important 
for both FDA and State regulators, as FDA will be working 
collaboratively with the National Association of State Departments of 
Agriculture and our State, local, and tribal partners to implement a 
produce safety regulatory program. fiscal year 16 investments support 
ongoing work on training plans and materials for the Produce Safety 
Alliance pre-requisite training; the Produce Safety Regulator Training 
will be developed and delivered to FDA and State personnel beyond 
fiscal year 16. As compliance requirements phase in, additional FDA and 
State personnel will be identified for training.
    Quesiton. Enforcement of the both Preventative Control for Human 
and Animal Foods rules begins in September of this year, but guidance 
documents, which are important for industry to understand what's 
expected of them, haven't been published yet. When do you expect to 
publish them, and how long will that process take? Does FDA, and in 
turn the states and localities, have everything needed to begin 
enforcement of this rule, in a consistent way?
    Answer. FDA is currently developing guidance documents related to 
the key FSMA rules, including the preventive controls rules for both 
human and animal food. These documents are part of a broader effort to 
foster and support compliance that also includes outreach; education 
and training programs, particularly for small and midsized firms; and 
FDA's Technical Assistance Network, through which regulated industry 
and other members of the public can get answers to specific questions 
about how the rules apply. The outreach and guidance development 
process will continue for years to come, but our goal is for key draft 
guidance documents to be available before the applicable compliance 
dates.
    We are currently on track to issue draft implementation guidances 
on preventive controls for human food and on Current Good Manufacturing 
Practices for animal food in the coming months. Additional draft 
guidance documents on specific hazards and controls are on target for 
issuance later this year.
    We are working with our state, local, and tribal partners to ensure 
that the new FSMA rules are implemented consistently and in a manner 
that encourages voluntary compliance. Adequate funding will help ensure 
the success of these efforts.
    Question. Funding was provided to train approximately 1,000 state 
and local inspectors in fiscal year 16 or about 20 in each state. More 
than 3,000 state, local and tribal entities will be involved in FSMA 
implementation. How many additional people will be trained this year?
    Answer. FDA's regulator training is being phased in over 3 years 
based on the staggered compliance dates in the Preventive Controls for 
human food rule, with a focus on large firm inspections in year 1 
(fiscal year 2017). FDA is on target to train 2,000 FDA and State food 
safety staff in 2016 in the Food Safety Preventive Controls Alliance 
Human and Animal Food courses, as a pre-requisite to the Preventive 
Controls regulator courses. In addition, the 2,000 FDA and State food 
safety staff will also receive modernized Good Manufacturing Practice 
(GMP) training for human food facilities and new GMP training for 
animal food facilities. In fiscal year 2016, FDA's Preventive Controls 
regulator courses will be offered to the subset of the 2,000 FDA and 
State food safety staff that will cover the large firm inventory. Food 
Safety staff is defined as investigators/inspectors, managers, 
compliance officers and Subject Matter experts, in both FDA and State.
    Question. The budget also proposes $14 million to implement the 
Foreign Supplier Verification Rule, which is vital considering that 
food imports continue to grow. The first enforcement of this rule is 
slated to begin in early 2017, although that timeline varies. Will this 
request be enough?
    Answer. In fiscal year 2017, FDA is proposing an additional $14 
million in budget authority to support the Foreign Supplier 
Verification Program (FSVP). FDA would use these additional resources 
to hire staff to perform FSVP inspections, provide training and 
technical assistance to FDA staff and importers, and continue outreach 
on the new FSVP requirements.
    Since FSVP is an entirely new program, FDA will need to assess the 
need for additional resources when we have more experience with the 
inventory of importers subject to FSVP and compliance rates.
                      genetically modified salmon
    Question. Obviously, I was concerned for multiple reasons when the 
FDA approved GMO salmon last year to go into our food supply. First, I 
have grave concerns about what will happen when one of these fish is 
inadvertently released, and second, I am concerned that it won't be 
labeled as GMO. So I worked to include language in the Omnibus to keep 
the salmon out unless it was labeled or FDA published final labeling 
guidance. In response, FDA issued an import alert to hold any GMO 
salmon at the border, or return it.
    To my first concern, how is FDA planning to work with the fish 
producers to make sure that none of these fish actually make it into 
the wild stock and do irreparable harm to the environment for native 
salmon?
    Answer. The approved application pertaining to AquAdvantage Salmon 
provides for specific conditions including that the GE salmon will be 
raised only in the two land-based, contained facilities in Canada and 
Panama that are described in the application. Under this approval, no 
other facilities or locations, in the United States or elsewhere, are 
authorized for breeding or raising AquAdvantage Salmon. There are no 
additional ``fish producers'' who may raise these salmon. As the 
sponsor and new animal drug application (NADA) holder, AquaBounty is 
the sole ``fish producer'' under the approved application.
    In terms of assuring that the GE salmon do not escape the two 
facilities allowed under the application, the facilities in Canada and 
Panama have a series of multiple and redundant levels of physical 
barriers to prevent eggs and fish from escaping. The facilities use 
land-based tanks--rather than ocean net pens, which are not allowed 
under the approved application. The first level of barriers (Primary 
Containment) includes items such as metal screens on tank bottoms, 
stand pipes, and incubator trays to prevent the escape of eggs and fish 
during hatching or rearing. Tanks also have covers, nets, jump fences, 
and screened overflow tanks to prevent escape over the sides of the 
tanks or incubators. Tank netting also keeps predators such as birds 
from entering the fish tanks at the outdoor facilities in Panama. All 
tank drains and stand pipes have covers or sleeves permanently attached 
to them. In order to prevent eggs or small fish from passing through 
the pipes or plumbing there is a closed septic system and additional 
screens and chlorine pucks are used to kill any escaped fish in the 
main drain area.
    Several additional sets of barriers, also in series (Secondary, 
Tertiary, and sometimes Quaternary Containment), add increased physical 
security to these primary containment measures described above. These 
barriers are designed to prevent fish from entering the drainage system 
or sedimentation pools and the local river (in the case of the Panama 
facility) and include floor drain covers, barrier screens inside the 
drains, drum and sock filters, and a series of sedimentation ponds with 
outlet filters.
    To augment physical containment, strict security measures and 
equipment are in place at both facilities. This includes locked gates 
for entry and exit to the properties, the presence of guard dogs, 
perimeter fences with barbed wire, and monitoring systems.
    In addition to these physical containment measures, the approval 
also includes biological containment measures: producing only one sex 
of fish and making the female fish sterile via triploidy induction (a 
method used in finfish and shellfish to prevent their sexual maturation 
and make them sterile).
    To ensure that AquaBounty maintains these physical and biological 
containment measures, they must follow record-keeping and reporting 
requirements, including ensuring that the triploidy process is within 
specifications and monitoring physical containment, including reporting 
of any likely or actual breaches of physical containment.
    Furthermore, even if AquAdvantage Salmon could somehow escape and 
migrate to the Pacific Ocean, there is no reasonable potential for 
hybridization between escaped AquAdvantage Salmon and native Pacific 
salmon, which are of a different genus, Oncorhynchus. Farm-raised 
Atlantic salmon on the west coast of the United States and Canada that 
have escaped in the Pacific Ocean have not interbred with wild Pacific 
salmon and, to date, there has been no compelling evidence of any 
colonization and establishment (i.e., self-sustaining populations) of 
Atlantic salmon in these areas
    As a result of these and other conditions included in the approval, 
there is a very low likelihood that AquAdvantage Salmon could escape 
their conditions of confinement and, in the unlikely event they did 
escape, it is extremely unlikely that they would establish and 
reproduce conditions at the facility sites.
    Question. Can you make a guarantee that these fish, grown in other 
countries, will be contained?
    Answer. The approved AquAdvantage Salmon application allows the GE 
salmon to be raised only in the two land-based, contained facilities in 
Canada and Panama that are described in the application. Additionally, 
these facilities are separately regulated by the relevant regulatory 
bodies in each respective country. Under this approval, no other 
facilities or locations, in the United States or elsewhere, are 
authorized for breeding or raising AquAdvantage Salmon.
    If other countries choose to produce GE salmon that will not enter 
U.S. commerce, those countries will regulate those facilities. FDA does 
not have jurisdiction to regulate products that are produced outside 
the United States and never enter the United States.
    Question. As you know, FDA approved AquaBounty's production plan to 
produce GM salmon eggs in Canada and ship them to Panama for fish 
production. If the company wanted to grow the fish in the U.S., what 
steps would it have to take to gain FDA approval?
    Answer. FDA's approval of the application pertaining to 
AquAdvantage Salmon does not allow production and grow out of the 
salmon in any facilities other than those in Canada and Panama. If the 
sponsor proposes to begin producing GE salmon in the United States (or 
at additional locations outside of the United States with the intent to 
import food from them into the United States), it first must submit a 
supplemental new animal drug application to FDA for the new production 
facilities, and this supplemental application will require its own 
National Environmental Policy Act analysis of potential environmental 
impacts of those facilities.
    Question. What repercussions will there be if there is an escape?
    Answer. Under the FD&C Act, a new animal drug that does not comply 
with its approved application is considered ``unsafe'' and an unsafe 
new animal drug is ``adulterated.'' 21 U.S.C. Sec. Sec. 360b(a); 
351(a).
    The FD&C Act also deems adulterated any food that contains an 
unsafe new animal drug. 21 U.S.C. 342(a)(2)(C)(ii). FDA may take 
enforcement action against adulterated drugs and foods, including 
refusing admission to imported foods and drugs that appear to be 
adulterated.
    Among the conditions included in the approval, AquaBounty must 
maintain physical and biological containment measures and report any 
likely or actual breaches of physical containment. If any such breach 
occurred in violation of a condition established in the approved 
application, AquAdvantage Salmon would be deemed ``unsafe'' and 
adulterated under these provisions and, therefore subject to FDA 
enforcement action, including seizure of adulterated product.
                                 ______
                                 
               Questions Submitted by Senator John Tester
                             premium cigars
    Question. Given that premium cigars are enjoyed by adults in 
moderation, and are inherently less attractive to underage smokers than 
other tobacco products, how are you taking into account the unique 
nature of cigars when promulgating tobacco regulations?
    Answer. Although all cigars are harmful and potentially addictive, 
it has been suggested that different kinds of cigars (e.g., small 
cigars, cigarillos, large cigars, premium cigars) may have the 
potential for varying effects on public health if there are differences 
in their effects on youth initiation, the frequency of their use by 
youth and young adults, and other factors.
    In the proposed deeming rule, FDA sought comment on two options for 
regulating categories of cigars: option one would deem all cigars 
subject to FDA's tobacco control authorities, and option two would 
exclude premium cigars. FDA also asked what additional restriction(s) 
may or may not be appropriate for different kinds of cigars.
    FDA reviewed all comments, data, and information submitted to the 
docket regarding this matter, and will address the issue in the final 
deeming rule.
                                 ______
                                 
            Questions Submitted by Senator Patrick J. Leahy
                                opioids
    Question. I have for years pushed the FDA to promote safer 
alternatives to powerful prescription painkillers, and to remove from 
the market older, less safe drugs. The FDA's announcement last month to 
expand access to abuse-deterrent formulations of these powerful drugs 
is a step in the right direction in response to my concerns. However, 
the FDA can and must do more.
    What plans do you have to ensure the FDA is doing everything in its 
power to help address the significant opioid crisis we are facing in 
this country?
    Answer. Prescription opioids with abuse-deterrent properties will 
not fix the problem, but they can be part of a comprehensive approach 
to combat the opioid epidemic. While the FDA has a responsibility to 
regulate drugs and help educate prescribers, addressing this epidemic 
requires the collaboration of multiple Federal agencies, state 
governments, professional organizations, and other stakeholders.
    FDA is changing the Agency's approach to opioid medications. The 
Agency's opioids action plan, announced on February 4, will focus on 
policies aimed at reversing the prescription opioid epidemic while 
still providing patients in pain access to effective relief. This plan 
includes concrete steps toward reducing the impact of opioid abuse on 
American families and communities. The plan includes a call for a re-
examination of the risk-benefit paradigm for opioids, changes to 
immediate-release opioid analgesic labeling, improved access to 
naloxone, and new advisory committee meetings to provide 
recommendations on pediatric approval issues and any new opioid that 
does not have abuse-deterrent properties. The Agency will provide 
updates on progress with the goal of sharing timely, transparent 
information on a regular basis.
    The Agency's action plan is part of the Health and Human Services 
(HHS) initiative to address the opioid epidemic which is working 
towards three broad goals: 1) opioid prescribing practices to reduce 
opioid use disorders and overdose 2) the expanded use of naloxone, used 
to treat opioid overdoses and 3) expanded use of Medication-assisted 
Treatment (MAT) to reduce opioid use disorders and overdose . 
Evaluation is a critical component of the initiative to identify what 
works and how the most effective interventions can be taken to scale.
                    fda standard for raw milk cheese
    Question. I continue to be very worried about the potential impact 
that the FDA's non-toxigenic E. coli standard for raw milk cheeses 
could have on cheese producers in Vermont and across the United States.
    The FDA's move to a standard for non-toxigenic E. coli that 
requires a thousand-fold decrease in the presence of non-toxigenic E. 
coli in raw milk cheeses could severely limit the production of raw 
milk cheeses across the country. In December, I helped to lead a 
bicameral and bipartisan letter to your Deputy Commissioner for Foods 
and Veterinary Medicine, Mike Taylor, asking several specific questions 
about the new standard and how it was developed, but the agency's 
response did not specifically answer all of our questions.
    In our letter, we asked whether the science upon which this 
standard is based has been subject to peer review. In response, the 
agency cited four different articles. While the articles do support the 
use of non-toxigenic E. coli as an indicator organism for food safety, 
they do not recommend the same level that the FDA has called for in raw 
milk cheeses. The first citation offered does not even seem to be in 
line with the agency's new standard, with the abstract specifically 
stating that with regards to raw cow milk samples, ``No relationship 
was detected between E. coli or the total bacterial count and the 
presence of pathogenic bacteria.'' In general, the scientific papers 
referenced do not seem to be particularly relevant to the issues laid 
out in our letter, with one article discussing the results from samples 
of raw milk in Malaysia. Therefore, I ask again:
    Does the body of scientific evidence specifically support a 
thousand-fold decrease in the presence of non-toxigenic E. coli in raw 
milk cheeses?
    Answer. First, we would like to clarify that the decrease in the 
level of non-toxigenic E. coli in cheeses in the Compliance Policy 
Guide (CPG) is not one thousand-fold, but instead is one hundred-fold, 
if one compares the maximum permissible levels. Prior to the 2010 
revision of the CPG, if one sample had a test result of 10,000 cfu/g or 
greater, the product was considered violative. Under the current CPG 
also, if one sample has a test result of 100 cfu/g or greater, the 
product would be considered violative. Of course, there is a second 
criterion in the 2010 CPG, namely, 10cfu/g. However, under this 
criterion, multiple samples from the same lot of product would have to 
exceed it before the product would be deemed violative.
    Regarding the references provided in the letter of Deputy 
Commissioner Michael Taylor, the references, including the abstract you 
quoted, were intended to show that there is support in the scientific 
literature for the use of non-toxigenic E. coli as an indicator of 
fecal contamination and insanitary conditions of production. For the 
2010 CPG, we relied on the available peer reviewed literature (over 70 
scientific papers), which showed that non-toxigenic E. coli is 
generally not present in raw milk, and that when it is present, it is 
usually at very low numbers, i.e. <100 cfu/g. The literature also shows 
that the cheese making process, coupled with aging, substantially 
reduces any non-toxigenic E. coli present. With this information, we 
concluded that there should not be E. coli in cheese unless the milk 
used was of poor quality, or the cheese was produced under unhygienic 
conditions. This conclusion has been supported by the results of our 
2014-15 cheese sampling program in which the vast majority of 1606 raw 
milk cheese samples met the 2010 criteria.
    That said, as you may be aware, we have paused our testing for non-
toxigenic E.coli in cheese as we take another look and engage 
stakeholders regarding what role this indicator organism should have in 
identifying insanitary conditions and process failures for both 
domestic and foreign cheese and how the results of such testing may be 
used in support of preventive measures. We intend to further engage our 
stakeholders in the artisanal sector and scientific experts in dialogue 
on this issue. We will seek public comment on such issues as the use of 
a single bacterial criterion for both pasteurized and raw milk cheese, 
and the appropriate use(s) of non-toxigenic E. coli as an indicator 
organism in pasteurized and raw milk cheese. Based on this dialogue and 
input, we will consider and make changes in the 2010 CPG as 
appropriate.
                    fda standard for raw milk cheese
    Question. There is a strong desire for transparency in rulemaking 
and in the process that leads to policy change. I feel strongly, as do 
our cheesemakers and food safety advocates, that science and data must 
guide these decisions. The American Cheese Society has requested data 
to be released on the FDA's raw milk sampling program. I have been told 
that your staff had initially agreed to share that data. Transparency 
in this case, and access to this data, could help American raw milk 
cheesemakers determine if and where changes need to be considered to 
ensure the production of safe cheese. Access to this data would also 
help to educate producers and inspectors to ensure that they are 
working together to continually enhance public health and welfare.
    Has the FDA been working to respond to the American Cheese 
Society's request for data? And if so when can they expect the FDA to 
finally release the data they had been promised?
    Answer. The FDA received a request from the American Cheese 
Society, dated February 22, 2016, for data from the Listeria 
Environmental Sampling Program and the Raw Milk Cheese Program. We are 
diligently working to compile the requested information. The request is 
currently being processed under the Agency's Freedom of Information Act 
program. In addition, an external report is being prepared for 
stakeholders that will discuss the results of the FDA's fiscal year 
2014/15 surveillance sampling assignment on raw milk cheese.
     generic competition/pharmaceutical products subject to a rems
    Question. An essential step for generic drug manufacturers seeking 
to create a low-cost generic drug is to obtain samples of the brand-
name drug they wish to replicate so they can conduct bioequivalence and 
other testing for FDA approval. Unfortunately, some brand-name 
companies appear to be impeding generic competition by refusing to 
provide such samples, either by imposing their own restrictions, or by 
claiming that distribution of their product is prohibited because of an 
FDA-approved safety protocol known as a ``REMS''.
    Additionally, some brand-name companies appear to be impeding 
generic competition by refusing to work with potential generic 
competitors to develop a single, shared safety REMS which in certain 
cases the FDA requires prior to approving the generic product.
    Federal law expressly bars pharmaceutical companies from using REMS 
restrictions to block generic competition. Furthermore, in December 
2014, the FDA issued guidance describing a process the Agency has 
developed to reassure brand-name drug companies that providing sample 
product to a generic competitor would not violate a REMS. Nevertheless, 
numerous generic companies continue to report difficulties in obtaining 
samples or negotiating a single, shared REMS, thus foreclosing 
competition.
    In your experience, are some brand-name companies engaging in the 
practices described above, even after the adoption of FDA's December 
2014 protocol?
    Answer. Yes. FDA has received more than a hundred inquiries from 
generic companies that want to develop generic drugs but tell us they 
are unable to because they cannot get access to supplies of the 
reference listed drug (RLD) to do testing. This is a problem that 
affects both REMS drugs and non-REMS drugs: in fact, the number of non-
REMS products about which we have received these inquiries is actually 
larger than the number of products subject to REMS about which we have 
received inquiries.
    The problem often arises when generic companies are not able to get 
access to the RLD through normal distribution channels (i.e., via 
wholesalers) because limitations on the distribution of the drug are in 
place. The brand company might limit the distribution of the product on 
its own initiative for a variety of different business reasons (for 
example, by selling through a central or small group of pharmacies, 
some of which may identify themselves as specialty pharmacies). For 
drugs with a REMS, an element to assure safe use (such as a pharmacy 
certification requirement) might impact the way the product is 
distributed.
    We understand that some brand companies have refused to sell the 
RLD to generic companies for testing or have included provisions in 
their contracts with pharmacies/third parties that prohibit the sale of 
the RLD to generic companies for testing purposes. We have referred 
such matters that have been brought to our attention to the Federal 
Trade Commission (FTC) and encouraged generic companies to also raise 
these matters with the FTC. We have taken a number of additional steps 
as well.
    Some brand companies have argued that selling the RLD to the 
generic firm for testing/development would be a violation of their 
REMS. To address this, we have developed a process, where appropriate, 
for informing the brand company in writing that FDA will not consider 
provision of the RLD for these purposes to be a violation of the REMS. 
We do this by reviewing the bioequivalence study protocols of companies 
that want to develop generic versions of these REMS drugs to assess 
whether their protocols have safety protections comparable to those in 
the applicable REMS. If we determine that they do, we send the brand 
company a letter stating so and informing them that selling the RLD to 
the generic company for testing and development will not be considered 
a violation of the REMS. (This process is described in the December 
2014 draft guidance referenced in this question).
    However, while these letters make clear that such sales will not 
subject the brand company to REMS-related enforcement action, some 
brand companies have argued that they have independent business reasons 
for not selling the RLD to the generic firm that are unrelated to their 
REMS and/or that they have no obligation to do so.
    Finally, we note that we also continue to have concerns about brand 
companies blocking or delaying approval of generic drugs using the 
single, shared system REMS requirement. This is a separate problem from 
the RLD access issue described above. The development of a single, 
shared system (which is mandated by the Federal Food, Drug, and 
Cosmetic Act for REMS that include certain elements, unless FDA waives 
the requirement for one of the reasons set forth in the Act \2\) 
necessitates discussion and negotiation between the competitor brand 
and generic company and agreement on the terms of the single shared 
system REMS and how it will operate before the generic product can be 
approved. Brand companies therefore have an incentive to delay generic 
competition for their products by refusing to agree to single, shared 
system REMS terms and otherwise prolonging the negotiations over a 
single, shared system REMS. We see prolonged negotiations and inability 
to agree on the terms of a single, shared system REMS regularly.
---------------------------------------------------------------------------
    \2\ Section 505-1(i)(1)(B)
---------------------------------------------------------------------------
    Question. If yes, would additional tools or legislative changes 
assist the Agency or other entities in addressing such behavior?
    Answer. The Administration has not taken a position on pending 
legislation in this area.
    Question. Could such practices be further addressed by creating a 
specific cause of action for generic manufacturers to sue in court to 
obtain the samples they need and/or to secure good faith and timely 
negotiation on developing a single, shared system of distribution for 
products that are subject to a REMS?
    Answer. The Administration has not taken a position on pending 
legislation in this area.
    Question. How long does the FDA's process normally take to review 
and approve a generic company's REMS protocol, and are there steps FDA 
could take to expedite this review?
    Answer. The timing of the review of bioequivalence study protocols 
for drug products subject to a REMS with elements to assure safe use 
varies based on several factors. These protocols require review by the 
two separate divisions within the Office of Generic Drugs' (OGD's) 
Office of Bioequivalence: the Division of Bioequivalence and the 
Division of Clinical Review. Because review staff in these divisions 
must prioritize workload to accommodate projects with GDUFA goal dates, 
the timing of protocol review therefore depends on the complexity of 
the protocols, the size of the queue, and competing workloads.
    OGD has taken a number of steps to streamline and shorten the 
process for submission and review of bioequivalence protocols. The 
December 2014 draft guidance described above provides step-by-step 
guidance to prospective generic applicants on how to submit these 
protocols and what to include in them. This draft guidance was issued 
in order to streamline the process, improve the quality of submissions 
received by the Agency, and thereby reduce review time. OGD has also 
assigned dedicated staff to coordinate the review of these protocols 
across the different OGD offices and divisions. OGD continues to 
evaluate the protocol review process and engage in process refinements 
and improvements where possible to assure timely and efficient protocol 
reviews.
                       labeling of generic drugs
    Question. In 2013, the FDA issued a proposed rule that would ensure 
that generic drug companies can update their safety labels when they 
learn new information. This proposed rule is tremendously important 
because more than 80 percent of consumers take the generic version of a 
drug when it is available. We need generics to be able to improve their 
labeling, and be held accountable when they fail to do so.
    Unfortunately, the FDA's proposed rule remains caught up in 
regulatory limbo. Last year, the FDA reopened its rulemaking to 
consider an industry-backed alternative that would turn existing 
labeling rules on their head. The industry proposal would ensure that 
after a generic drug enters the market, no drug company could update 
its label immediately upon learning of adverse side-effects. Labeling 
updates would be delayed, and drug companies could not be held 
accountable if they failed to update their safety information.
    One of my constituents, Diana Levine, was able to seek justice 
after she was injured by a mislabeled drug precisely because of the 
rules the drug companies are now trying to overturn.
    I am gravely concerned by the drug companies' proposal. I am also 
concerned by the FDA's delay in completing the rulemaking on its 
initial proposal, which is widely supported by patient groups and 
safety advocates.
    The Unified Agenda for Regulatory and Deregulatory Actions 
currently states a release date for the final rule of July 2016, 
following several previous postponements. Is the rule on track to be 
released at that time?
    Answer. The proposed rule is intended to improve the communication 
of important drug safety information to healthcare professionals and 
patients. FDA has received a great deal of public input from 
stakeholders during the comment periods on the proposed rule regarding 
the best way to accomplish this important public health objective.
    These comments include a summary of FDA's meeting with the Generic 
Pharmaceutical Association (GPhA) on September 8, 2014, to listen to 
their comments and views regarding the proposed rule. In addition, on 
March 27, 2015, FDA held a public meeting at which any stakeholder had 
the opportunity to present or comment on the proposed rule, or on any 
alternative proposals intended to improve communication of important, 
newly acquired drug safety information to healthcare professionals and 
the public. In the February 18, 2015, notice announcing the public 
meeting, FDA reopened the docket for the proposed rule until April 27, 
2015, to allow for the submission of written comments concerning 
proposals advanced during the March public meeting.
    FDA is carefully considering comments submitted to the public 
docket established for the proposed rule from a diverse group of 
stakeholders including: consumers and consumer groups, academia 
(including economists), healthcare associations, drug and pharmacy 
associations, brand and generic drug companies, law firms, state 
governments, and Congress, including comments proposing alternative 
approaches to communicating newly acquired safety-related information 
in a multi-source environment (see Docket No. FDA-2013-N-0500).
    Question. The Unified Agenda, available at http://www.reginfo.gov/
public/do/eAgendaViewRule?pubId=201604&RIN=0910-AG94, currently lists 
an anticipated publication date of April 2017 for the final rule on 
``Supplemental Applications Proposing Labeling Changes for Approved 
Drugs and Biological Products.'' The dates for rules in the Unified 
Agenda are projected dates that may be adjusted to reflect ongoing work 
on specific rules.Will the FDA commit to work expeditiously to complete 
the rulemaking process, with a focus on consumers and patient safety?
    Answer. The proposed rule is intended to improve the communication 
of important drug safety information to healthcare professionals and 
patients. FDA has received a great deal of public input from 
stakeholders during the comment periods on the proposed rule regarding 
the best way to accomplish this important public health objective.
    These comments include a summary of FDA's meeting with the Generic 
Pharmaceutical Association (GPhA) on September 8, 2014, to listen to 
their comments and views regarding the proposed rule. In addition, on 
March 27, 2015, FDA held a public meeting at which any stakeholder had 
the opportunity to present or comment on the proposed rule, or on any 
alternative proposals intended to improve communication of important, 
newly acquired drug safety information to healthcare professionals and 
the public. In the February 18, 2015, notice announcing the public 
meeting, FDA reopened the docket for the proposed rule until April 27, 
2015, to allow for the submission of written comments concerning 
proposals advanced during the March public meeting.
    FDA is carefully considering comments submitted to the public 
docket established for the proposed rule from a diverse group of 
stakeholders including: consumers and consumer groups, academia 
(including economists), healthcare associations, drug and pharmacy 
associations, brand and generic drug companies, law firms, state 
governments, and Congress, including comments proposing alternative 
approaches to communicating newly acquired safety-related information 
in a multi-source environment (see Docket No. FDA-2013-N-0500).
                                 ______
                                 
              Questions Submitted by Senator Tammy Baldwin
    Question. I am encouraged by the FDA's increased attention to the 
growing epidemic of prescription opioid misuse and abuse and the need 
to improve treatment options for chronic pain. As you mentioned in your 
recent article in the New England Journal of Medicine \3\, there is 
little high-quality evidence on the safety and efficacy of opioids as a 
long-term treatment for chronic pain. It is critical that we fill the 
gap in research and promote the development of safer treatments that 
pose less risk of addiction for patients experiencing chronic pain.
---------------------------------------------------------------------------
    \3\ Califf, Robert M., M.D., Janet Woodcock, M.D., and Stephen 
Ostroff, M.D. ``A Proactive Response to Prescription Opioid Abuse.'' 
New England Journal of Medicine, 4 Feb. 2016. .
---------------------------------------------------------------------------
    How is the FDA collaborating with other government agencies, 
including the National Institutes of Health, to prioritize the 
development of non-addictive therapies for chronic pain and to generate 
high-quality evidence to support their use?
    Answer. To help combat the opioid epidemic, the FDA is encouraging 
drug development efforts that make it harder to abuse opioids, and the 
agency looks forward to the day, hopefully soon, when the majority of 
opioids in the United States are marketed in effective abuse-deterrent 
forms. However, development of and transition to use of opioids with 
meaningful abuse-deterrent properties is only one component of a multi-
pronged approach to addressing abuse of opioid medications. For 
example, the FDA is also working to support the efficient development 
of non-opioid alternatives for treating pain that have lower (or no) 
abuse potential. Encouraging the development of these products requires 
both scientific and translational development work. FDA has past and 
ongoing work in this area, supported through our participation in the 
ACTTION Public Private Partnership \4\ (PPP) in a wide variety of 
areas.
---------------------------------------------------------------------------
    \4\ ACTTION: Analgesic, Anesthetic, and Addiction Clinical Trial 
Translations, Innovations, Opportunities, and Networks
---------------------------------------------------------------------------
    ACTTION is working to improve study methods for developing novel, 
safe, and effective analgesic drug products. Through scientific 
assessment of FDA's clinical trial databases and publically available 
data, the PPP plans to develop novel and evidence-based approaches to 
improve the design of analgesic clinical trials. The PPP also 
coordinates scientific workshops that bring together key experts, 
including stakeholders from industry, professional organizations, 
academia, and government agencies.
    Additionally, as part of the FDA's recently announced plan aimed at 
reversing the opioid epidemic, the agency has contracted with the 
National Academy of Medicine to provide us with advice on how we should 
incorporate current evidence about the public health impact of opioid 
use, both for people who are prescribed opioids and for non-patients, 
into regulatory activities concerning opioids. We look forward to the 
recommendations from NAM and other experts about reassessing our risk-
benefit paradigm for opioids based on the current state of the science.
    FDA also continuously strives for enhanced collaboration between 
NIH and FDA. FDA leadership recently participated in a meeting of the 
FDA-NIH Joint Leadership Council, an organization through which senior 
leaders from both agencies address ways to facilitate new processes, 
such as FDA review of combination therapies and its consideration of 
rare disease trials with fewer patients enrolled. The participants on 
the FDA-NIH Joint Leadership Council work together to help ensure that 
regulatory considerations form an integral component of biomedical 
research planning, and that the latest science is integrated into the 
regulatory review process. Such collaboration and integration advances 
the development of new products for the treatment, diagnosis, and 
prevention of common and rare diseases, as well as enhances the safety, 
quality, and efficiency of the clinical research and medical product 
approval process.
    Question. How will the FDA in fiscal year 2017 improve post-market 
surveillance of medical devices? And, in addition to recalling such 
devices when they are found to be unsafe for patients, how will the 
agency better protect patients from adverse effects and complications 
while said devices are under investigation?
    Answer. FDA takes device post market safety very seriously. There 
will always be limitations to how much CDRH can learn about a device 
before it goes to market, diligent postmarket surveillance can identify 
safety signals, prevent patient harm, and lead to device improvements. 
The Center for Devices and Radiological Health's (CDRH) current 
postmarket surveillance tools, such as passive reporting, limit our 
ability to rapidly address safety concerns.
    For this reason, FDA has proposed the development of a national 
evaluation system for medical devices (system).
    In 2011, the Institute of Medicine (IOM) published a report 
recommending that FDA develop and implement a comprehensive medical 
device postmarket surveillance strategy to collect, analyze, and act on 
medical device postmarket performance information. In 2012 and 2013, 
CDRH set out a vision and strategy \5\ for creating such a system. In 
2015, two multi-stakeholder groups issued reports \6\ supporting the 
vision and made recommendations providing further direction for 
establishing this system. Further, CDRH's 2016-2017 Strategic 
Priorities \7\ include increasing access to and use of real-world 
evidence to support regulatory decisionmaking. The development of the 
post market evaluation system is integral to meeting those goals.
---------------------------------------------------------------------------
    \5\ http://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm.
    \6\ http://www.brookings.edu/events/2015/02/23-future-of-medical-
device-safety-and-innovation;www.brookings.edu/about/centers/health/
projects/development-and-use-of-medical-devices/mds/2016-planning-
board.
    \7\ http://www.fda.gov /downloads/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/
UCM481588.pdf.
---------------------------------------------------------------------------
    The principal challenge for implementing the system is lack of 
funding. The system needs investment from various stakeholders to 
operate and build on existing infrastructure and to establish and 
operate a governing body. The fiscal year 17 President's Budget 
contains a request for $1.8 million for the system. While the long-term 
vision for the system involves multi-stakeholder participation and 
investment, in order to garner meaningful financial support from the 
private sector, the NES needs a core investment. We would like others 
in the medical device ecosystem, such as payers and professional 
societies, to also have an important role in the development of this 
system. Finally, this investment will support precision medicine. One 
of the biggest problems facing the success of Precision Medicine is the 
challenge of determining which devices are best suited for which 
patients because of the high cost of developing evidence. Data that can 
answer these questions is generated every day as a part of routine 
clinical practice (evidence from clinical experience or ``real world'' 
data).
    To better protect patients from potential adverse events or 
outcomes while a postmarket device safety issue is under evaluation, 
the FDA communicates clear and easily understood information about the 
risks and benefits of a device to patients and healthcare providers. 
FDA uses a range of tools to disseminate information widely, including 
our website and through letters and meetings with healthcare providers 
and patient groups.
    To support increased communication on potential safety issues, in 
December 2015, CDRH released a draft guidance called ``Public 
Notification of Emerging Postmarket Medical Device Signals (`Emerging 
Signals').'' An emerging signal is new information about a medical 
device used in clinical practice that the FDA is monitoring or 
analyzing; that has the potential to impact patient management 
decisions and/or alter the known benefit risk profile of the device; 
that has not yet been fully validated or confirmed; and for which the 
FDA does not yet have specific recommendations.
    Historically, FDA has communicated important information we learned 
about in the postmarket context after completing an analysis of 
available data and, in most cases, after having reached a decision 
about relevant recommendations for the device user community. This 
guidance is designed to inform the public of our evolving efforts to 
share information in a more timely way that allows patients to make the 
most informed medical decisions with their healthcare provider as close 
to real-time and based on the most current data as possible.
    FDA has taken additional important steps to facilitate the 
identification and evaluation of postmarket safety concerns. FDA issued 
a final rule establishing a unique device identification system to 
provide a standardized way to identify devices across different 
information sources including electronic health records and device 
registries using unique device identifiers (UDIs).
    Question. The 2015-2020 Dietary Guidelines recognized that sugar 
that is added to increase the palatability of naturally tart fruits, 
like cranberries, can aid a healthy dietary pattern by supporting the 
consumption of fruits and vegetables. In considering the proposed added 
sugar DV for labeling, what is the FDA doing to ensure that consumers 
will be not be misled on the healthfulness of nutrient dense products 
that contain added sugar, when comparing similar fruit products with 
equal or more intrinsic sugars and calories?
    Answer. An added sugars declaration on the Nutrition and Supplement 
Facts labels, if finalized, would be just one piece of information that 
consumers can use to help them construct a healthful dietary pattern. 
We recognize that the added sugars declaration would be new information 
that consumers would not have seen before; therefore, in collaboration 
with Federal and other partners, we plan to engage in educational and 
outreach activities for consumers and health professionals about the 
use of information on the Nutrition and Supplement Facts labels, 
including any information about added sugars, if finalized. In the 
education and outreach activities, FDA plans to indicate that consumers 
should consider all of the information on the label, including total 
sugars and calories, when constructing a healthful dietary pattern, and 
not focus on just one specific nutrient.
    Question. Artisan cheesemakers in Wisconsin have expressed concerns 
over the uncertain regulatory climate for raw milk cheese production. 
In particular, FDA's approach in conducting sampling at cheese 
facilities as it reviews raw milk cheese and non-toxigenic E. coli 
levels created a great deal of uncertainty and concern within the 
industry, despite the industry's attempts to work with FDA. Though 
cheese producers cooperated extensively in providing samples, FDA did 
not share the results from those tests in a timely way with individual 
businesses or the industry. When can cheesemakers and their industry 
groups expect to receive comprehensive results from the Listeria 
Environmental Sampling Program and the Raw Milk Cheese Sampling 
Program?
    Answer. An external report is being prepared for stakeholders that 
will discuss the results of the FDA's fiscal year 2014/15 surveillance 
sampling assignment on raw milk cheese. We expect that report to issue 
in the coming months. FDA will release results of Listeria sampling 
conducted at cheese firms, as resources allow.
    Question. As the FDA works to complete its guidance document on 
environmental Listeria, is there any quantitative data on incidence and 
levels of Listeria monocytogenes in frozen foods such as frozen 
vegetables and frozen food entrees? In frozen foods where Listeria 
monocytogenes has been implicated in the reportable food registry, does 
FDA have any quantitative data? If so, please share that data with the 
subcommittee.
    Question. FDA recently queried the database for Reportable Food 
Registry submissions and found thirty-eight (38) primary submissions 
for Listeria monocytogenes in frozen foods between 2009 and the 
present. Of these submissions, nine (9) met the criteria for reportable 
food and were classified as Class I recalls because there is a 
reasonable probability that the use of or exposure to the product will 
cause serious adverse health consequences or death to humans or 
animals. Twenty-seven (27) submissions were considered non-reportable 
because the food failed to meet the Class I recall standard or because 
it did not meet the criteria of a reportable food (e.g., the food is 
not regulated by FDA or the report is not submitted by a manufacturer, 
processor, packer or holder of food required to be registered with FDA 
under section 415 of the Federal Food, Drug, and Cosmetic Act). Two (2) 
submissions are awaiting decisions on recall classification.
    FDA occasionally collects quantitative data from frozen food 
products on an as needed basis to assist in an investigation but has 
not conducted a comprehensive survey of the frozen food industry. In 
two investigations in the past 2 years, FDA collected quantitative 
data. In one investigation involving an ice cream outbreak, the data 
revealed that 99.4 percent of samples of the ice cream involved in the 
outbreak contained detectable L. monocytogenes at levels ranging from 
less than 0.03 cells of L. monocytogenes per gram to greater than 208 
cells per gram. In the second investigation involving frozen vegetables 
subject to recall, FDA collected samples from thirty-three (33) product 
lots stored in the firm's warehouse freezer. Eight (8) lots (24 
percent) tested positive for the presence of L. monocytogenes.
    Question. The fiscal year 16 omnibus included report language that 
asked the Administration for a timeline for updating the dietary 
reference intake (DRI) for sodium as part of the fiscal year 17 budget 
request. An update was not included in the fiscal year 17 budget 
request. Can you share the specific 2016 timeline and plan for the 
update of the sodium DRI as requested in the Omnibus report?
    Answer. FDA has prioritized updating the DRI for sodium and is 
collaborating with the Centers for Disease Control and Prevention and 
other Federal agencies to update the DRI for sodium as expeditiously as 
possible. A detailed timeline is not yet available.

                          SUBCOMMITTEE RECESS

    Senator Moran. Again, Commissioner, thank you, and, Acting 
Commissioner Ostroff, thank you very much for your leadership 
of the agency.
    And we stand adjourned.
    [Whereupon, at 2:42 p.m., Wednesday, March 2, the 
subcommittee was recessed, to reconvene subject to the call of 
the chair.]



   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2017

                              ----------                              


                        WEDNESDAY, MARCH 9, 2016

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.

    The subcommittee met at 2:05 p.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Jerry Moran (chairman) presiding.
    Present: Senators Moran, Blunt, Cochran, Hoeven, Daines, 
Merkley, Tester, Udall, and Baldwin.

                       DEPARTMENT OF AGRICULTURE

STATEMENT OF HON. THOMAS VILSACK, SECRETARY
ACCOMPANIED BY:
        DR. ROBERT JOHANSSON, CHIEF ECONOMIST
        MICHAEL YOUNG, BUDGET OFFICER

                OPENING STATEMENT OF SENATOR JERRY MORAN

    Senator Moran. I call this Committee hearing together, and 
we appreciate the Secretary joining us once again.
    As you would expect, the purpose of our hearing is to 
examine the Administration's fiscal year 2017 budget request.
    In addition to Secretary Vilsack, we welcome Dr. Johansson. 
Thank you very much for joining us last week in a discussion 
about agricultural economics.
    Mr. Young, thank you very much for your presence today.
    Agriculture supports 16 million jobs nationwide. It is 
certainly the backbone of my State, my community and States and 
communities across the country. We also know, unfortunately, as 
Dr. Johansson indicated to us last week, farmers are facing a 
dramatic reduction in commodity prices and falling revenues. We 
know the facts indicate that from 2013 through 2015, net farm 
income fell 54 percent.
    In these times, it is critical that our Nation's safety net 
for farmers and ranchers perform well and allow them to 
continue to grow and raise the safest, most affordable and 
abundant food supply in the world.
    As I indicated in our conversation with the agriculture 
(ag) economists, in the absence of doing that, they will not be 
around in good times. Therefore, I would express my 
disappointment that, once again, the President's budget 
proposes significant cuts to crop insurance, even though we had 
a grassroots effort that successfully reversed a reduction. 
That reduction pales in comparison to what this year's proposal 
in the budget requests.
    As this Subcommittee works to craft this year's 
appropriations bill, my priorities will be to focus on 
supporting agricultural producers and the rural communities in 
which they live, and keeping a strong safety net will be at the 
forefront of that effort.
    I look forward to discussing these issues and others at 
today's hearing. When Senator Merkley arrives, we will give him 
the opportunity to make any statements that he would like to 
make, then we will turn to Secretary Vilsack.
    [The statement follows:]
               Prepared Statement of Senator Jerry Moran
    This hearing will come to order. Good afternoon. The purpose of 
today's hearing is to discuss the Department of Agriculture's fiscal 
year 2017 budget request.
    Secretary Vilsack, Dr. Johansson, and Mr. Young--thank you for 
being here today.
    Agriculture supports more than 16 million jobs nationwide and forms 
the backbone of our rural communities. However, as you well know, our 
nation's farmers and ranchers have faced a drastic downturn in 
commodity prices and falling revenues. From 2013 to 2015, net farm 
income fell by a staggering 54 percent.
    In times like these, it is critical that our nation's safety net 
for farmers and ranchers performs well and allows them to continue to 
grow and raise the safest, most affordable, and abundant food supply in 
the world.
    I'm disappointed that once again the president's budget proposes 
massive cuts to the crop insurance program--even after the grassroots 
effort by so many last fall successfully reversed a reduction that 
pales in comparison to the proposals in this year's budget request.
    As the subcommittee works to craft this year's appropriations bill, 
my priorities will focus toward supporting agriculture producers and 
rural communities. Keeping a strong safety net intact will be one of 
those priorities.
    I look forward to discussing these issues and others at today's 
hearing. I would now like to turn to our Ranking Member, Senator 
Merkley, for his opening statement.
    Senator Moran. Secretary Vilsack, we are going to begin 
with your testimony. Thank you very much. Welcome.

                SUMMARY STATEMENT OF HON. THOMAS VILSACK

    Secretary Vilsack. Mr. Chairman, thank you very much. To 
Senator Merkley and other members of the committee, thank you 
for the opportunity to be here today.
    I thought I would take this opportunity to point out that 
budgets are oftentimes a lot about numbers. But behind each of 
these numbers, there are individuals and people that we care 
deeply about. So I thought I would take a little bit of my time 
today to discuss the people who will be benefited from the 
agricultural budget.
    The budget we submitted to the Senate and to the House will 
support 43,000 farm loans. We already, over the last 7 years, 
provided 239,000 farmers with the credit that they need to be 
able to operate and own their farm operation, 80 percent of 
those resources going to those beginning in the farming 
business and socially disadvantaged producers.
    This budget will continue to support our export assistance 
efforts. Every dollar we invest in export assistance generates 
$35 of activity. We are excited about the possibility during 
the last 7 years of reaching nearly $1 trillion of ag exports, 
which is a record, a 45-percent increase over the previous 7-
year period. This budget does provide adequate coverage for the 
$92 billion crop that will be grown and raised this year 
through crop insurance and provides what we estimate to be an 
18-percent return on investment for the company's crop 
insurance.
    It will provide enough resources to add 44 million acres to 
an already record number of enrolled acres in our conservation 
program. We are particularly pleased with the reaction and 
response to the Regional Conservation Partnership Program 
(RCPP), which is now leveraging nearly $2 for every $1 that we 
are investing in conservation.
    In addition to providing opportunities for credit, we also 
will, as the Chairman indicated, continue to administer the 
farm bill safety net programs. Last year, we provided 900,000 
farms agriculture risk coverage (ARC) or price loss coverage 
(PLC) payments, totaling $5.2 billion. Our expectation is that 
that amount will increase this year to provide the necessary 
bridge to better times.
    At the same time, we are also going to make sure that we 
create more innovation and opportunity in rural America. The 
budget we propose will support 55,000 new jobs added to the 
450,000 jobs that we have saved or created as a result of 
investments in over 100,000 businesses in the last 7 years 
through rural development.
    This budget will finance 167,000 home loans, which will 
allow us to exceed 1 million home loans in the last 7 years.
    We finance nearly 1,000 community facilities, provide safer 
and better water for 1.7 million rural Americans, which will 
reach nearly 20 million rural Americans who have benefited from 
over 5,000 water and wastewater projects that have been 
financed by the U.S. Department of Agriculture (USDA) since I 
have been Secretary.
    Our budget proposes a threefold increase in broadband 
grants. There are a multitude of reasons for business, for 
farmers as well as potential expansion of distance-learning and 
telemedicine, which will become critically important in rural 
America if we are to make sure that our youngsters are well-
prepared for a very competitive future, and if we are able to 
deal with the opioid issue, which I know is an issue that many 
of you are very, very concerned about, as I am.
    This budget will also fully fund our research initiative, 
our competitive research initiative, meeting the goal that was 
set when the National Institute of Food and Agriculture (NIFA) 
was first established of $700 million of assistance for 
research. There has never been a more important time in 
agriculture for additional research, whether it is pollinators, 
antimicrobial resistance, pests and diseases that we are 
dealing with as a result of a changing climate.
    We have already netted 429 patents, 953 inventions, and 714 
new plant varieties just in the time that I have been 
Secretary, through our research initiative.
    We will also continue to support and provide additional 
resources for the important role of the Agricultural Research 
Service (ARS) within USDA.
    On the nutrition side, this budget will support 8.1 million 
WIC (Women, Infants and Children Program) participants with 
continued expanded access to our school lunch and school 
breakfast program. I am particularly interested and hopeful 
that we are able to see an expansion of our summer program. The 
President has proposed an approach that will allow 1 million 
youngsters the opportunity to access food during the summer 
months.
    This also will provide an opportunity for us to focus on 
senior citizens and their access to the Supplemental Nutrition 
Assistance Program (SNAP). Only 41 percent of eligible senior 
citizens are currently receiving the benefits of SNAP. We would 
like to see the percentage increase.
    This is a budget, Mr. Chairman, that also will allow for an 
expansion of local and regional food systems in the bio-based 
economy.
    I would say that even though this is not the purview of 
this particular Subcommittee, I would hope that this is the 
year that we finally fix the fire budget, because that has 
implications and impacts on every other aspect of USDA's 
budget.
    Candidly, I am at the point now where folks have raised 
concerns about trails and a variety of other facets of the 
Forest Service that we are not going to do what we have done in 
the past, which is transfer money for fire suppression. 
Hopefully, this is the year that Congress get serious about 
fire suppression.
    This is also a budget, I might add, that is $1.8 billion 
less than the budget that was submitted in the first full year 
of this Administration. So we have been dealing with 
constrained budgets, but we have done this through the 
administrative services process, which has saved $1.4 billion, 
and through a process improvement program, which has saved over 
300,000 hours of time and which also saved $65 million to 
constituents and customers that we serve, all in an effort to 
try to continue to do better and more with less.
    I look forward to questions from the Subcommittee, and I 
appreciate the opportunity to be here.
    [The statement follows:]
              Prepared Statement of Hon. Thomas J. Vilsack
    Mr. Chairman and distinguished members of this Subcommittee, I 
appreciate the opportunity to appear before you to discuss the 
Administration's priorities for the Department of Agriculture (USDA) 
and provide you an overview of the President's 2017 budget proposals 
for the Department. Joining me today are Robert Johansson, USDA's Chief 
Economist, and Michael Young, USDA's Budget Officer.
    For more than 7 years, I have had the honor and privilege of 
serving as Secretary of Agriculture. I have traveled to all 50 states 
and heard from farmers, ranchers and Americans far and wide, from all 
walks of life about the impact that USDA's staff, programs and services 
have on their lives. I could not be more proud of the work the men and 
women of USDA do each and every day.
    Seven years ago I first appeared before this Subcommittee to 
present this Administration's first budget request for USDA. I made a 
commitment to make sure that USDA's programs provide a high level of 
service to advance rural economic opportunity, improve family farm 
profitability, ensure the safety of our food, expand export 
opportunities, strengthen local food systems, protect our natural 
resources, address civil rights and combat hunger and malnutrition.
    Seven years later, I can say that the men and women of USDA have 
made significant advancement in achieving our goals and they have done 
it with essentially the same discretionary funding level in fiscal year 
(FY) 2015 as in fiscal year 2009, and with 9,354 fewer total staff 
years in 2015 than in 2009. Critical to our success was the Blueprint 
for Stronger Service that allowed us to reduce spending, streamline 
operations and cut costs. Through the Blueprint for Stronger Services 
we completed a thorough review of the Department's administrative 
functions so that we could build a more efficient and effective 
workplace. Our savings and cost avoidance results for the American 
taxpayer have totaled over $1.4 billion since 2010. Through these 
results and the institutional changes resulting from the Department's 
focus on process improvement, shared services, and strategic sourcing, 
the impacts of the Blueprint will continue to grow into the future.
    Before getting to our fiscal year 2017 budget request, I want to 
highlight some of the great work that we have done to expand 
opportunities in rural America since fiscal year 2009. In fiscal year 
2015, American agricultural producers achieved $139.7 billion in 
exports, the third highest year on record. Agricultural exports climbed 
more than 45 percent in value, totaling over $911 billion, between 2009 
and 2015, the best seven year stretch in history. In addition, 
agricultural exports have increased in volume, demonstrating an 
increasing global appetite for American-grown products. Between 2009 
and 2015, U.S. companies participating in USDA-endorsed trade shows 
reported total on-site sales of more than $1.7 billion and more than 
$8.7 billion in 12-month projected sales. An independent study found 
that U.S. agricultural exports increase $35 for every market 
development dollar expended by government and industry.
    USDA has worked to open new markets worldwide for farm and ranch 
products. Trade agreements, like those with Panama, Colombia and South 
Korea, create opportunities for trade growth. U.S. agricultural exports 
to these three countries grew by nearly 28 percent, from $7.6 billion 
in fiscal year 2012, when the trade agreements were first going into 
effect, to $9.7 billion in fiscal year 2015, supporting approximately 
73,000 American jobs in 2015. USDA assisted with the recently concluded 
negotiations on the Trans-Pacific Partnership (TPP). When implemented, 
the TPP agreement, with 11 Pacific Rim countries representing nearly 40 
percent of global GDP, will provide new market access for America's 
farmers and ranchers by lowering tariffs and eliminating other 
barriers. Rural America needs the good deal laid out in the TPP 
agreement. We are committed to working closely with Congress to obtain 
support for this historic deal so that our businesses can sell more 
rural-grown and rural-made goods around the world, and we can help more 
American workers compete and win. Rural exports support farm income, 
which translates into more economic activity in rural areas. It is 
estimated that for each dollar of agricultural exports another $1.27 in 
business activity is stimulated.
    Access to credit is critical to the sustainability of small and 
beginning farmers. To make agriculture a reality for new and beginning 
farmers and ranchers, we have provided about 237,000 direct and 
guaranteed farm ownership and operating loans totaling $33.3 billion, 
80 percent of which have been made to beginning farmers and ranchers 
and socially disadvantaged producers.
    New and beginning farmers and ranchers are a fundamental part of 
the agricultural marketplace and are needed to carry-on America's 
strong legacy of agriculture productivity. However, according to the 
2012 Census of Agriculture, their numbers are continuing a 30 year 
downward trend. To reverse this trend, we need to equip the next 
generation of farmers and ranchers with the tools they need to succeed. 
Under the leadership of Deputy Secretary Krysta Harden, USDA has 
increased access to our programs by collaborating with partners and 
improving customer service to increase opportunities for all sizes, 
segments, and types of farmers and ranchers to break down the barriers 
they face during the first 10 years of business. For example, USDA 
initiated a microloan program that has provided more than 16,800 low-
interest operating loans, totaling over $373 million to producers 
across the country, and has recently expanded this to include farm 
ownership loans. We have also developed an innovative web tool and 
conducted other outreach activities, to help support key groups like 
veterans, women, and the socially disadvantaged, as well as facilitate 
intergenerational transfer of farms and ranches. To ensure the success 
and sustainability of beginning farmers and ranchers, USDA has created 
an agency priority goal that will publically share USDA performance 
goals and progress in support of new and beginning farmers.
    We recognized that a spark was needed to transform rural America 
from a primarily agri-based economy to one that makes, creates and 
innovates. That is why we focused our efforts on taking advantage of 
the emerging bioeconomy, including biomanufacturing and advanced 
biofuels, local and regional food systems, broadband, and telemedicine. 
Our efforts not only supported the most productive agricultural sector 
in the world, but also assisted rural communities to be places where 
all businesses, farm and non-farm alike, have prospered and created 
jobs. We also saw the need to provide increased opportunities to allow 
everyone to share in the prosperity of the growing economy. So we 
targeted our efforts to the poorest communities, invested in new and 
beginning farmers, and supported our veterans, which have increased 
opportunities for hard working Americans. Our efforts are bearing 
fruit. Over the last 5 years unemployment rates in rural areas have 
fallen considerably and fairly consistently in rural areas, with 
unemployment rates falling by a full percentage point or more in each 
of the last 2 calendar years. These efforts have contributed to the 
employment gains in rural America that have happened since 2009 and 
have led to increased economic activities in high poverty communities.
    We have also recognized rural opportunities beyond agriculture by 
making historic investments in rural communities, making them more 
attractive to non-farm businesses and talented hard-working individuals 
looking to get ahead. USDA has sought to revitalize rural areas and 
diversify our nation's agriculture by making significant investments in 
rural infrastructure. Since 2009, we invested a total of $13.3 billion 
in new or improved infrastructure in rural areas through 10,623 water 
projects. These improvements helped nearly 18 million rural residents 
gain access to clean drinking water and better waste water disposal. 
Modernized electric service was delivered to more than 5.5 million 
subscribers and over 180,000 miles of electric lines were funded. We 
helped nearly 103,000 rural small businesses grow, creating or saving 
nearly 450,000 jobs between fiscal year's 2009 and 2015. Since 2009, 
USDA assisted more than 1.1 million rural families to buy or refinance 
a home, helping 141,000 rural Americans become homeowners in fiscal 
year 2015 alone.
    USDA continues to lead the way for renewable energy by supporting 
the infrastructure needed to grow the new energy economy. Since 2009, 
RD has supported over 15,000 renewable energy projects to help 
producers and rural businesses save energy and increase their 
profitability and increase the production of renewable fuels. The 
Department has helped thousands of rural small businesses, farmers and 
ranchers improve their bottom lines by installing renewable energy 
systems and energy efficiency solutions, which will generate and save 
more than 9.4 billion kWh, enough energy to power 820,000 American 
homes annually. Under expanded authority provided by the 2014 Farm 
Bill, we are working to expand the number of commercial biorefineries 
in operation that produce advanced biofuels from non-food sources 
through the Biorefinery Assistance Program. This focus on renewable 
energy has resulted in support for the construction of 6 advanced 
biofuels production facilities, over 2,200 wind and solar renewable 
electricity generation facilities, and 93 anaerobic digesters to help 
farm operations capture methane to produce electricity.
    In addition, we made available $100 million in grants under Biofuel 
Infrastructure Partnership (BIP) to nearly double the number of fueling 
pumps nationwide that supply renewable fuels to American motorists, 
such as E15 and E85. Twenty one states are participating in the BIP, 
with matching funds from state and private partners, providing $210 
million to strengthen the rural economy by increasing the demand for 
advanced biofuels and expanding marketing opportunities for farmers. We 
also took new steps to support biobased product manufacturing that 
promises to create new jobs across rural America, including adding new 
categories of qualified biobased products for Federal procurement and 
establishing reporting by Federal contractors of biobased product 
purchases. We released a study of the bioeconomy last year and found 
the biobased products industry generates $369 billion and 4 million 
jobs each year for our economy. The expanding bioeconomy means more 
choices for customers and new jobs for rural America. Shifting just 20 
percent of the current plastics produced into bioplastics could create 
an increase of 104,000 jobs.
    USDA's place-based efforts are making sure that the programs that 
help alleviate the impact of poverty are available and accessible even 
in the poorest and persistently poor areas. In 2016, we expanded the 
StrikeForce Initiative to four additional states to include a total of 
970 counties, parishes, boroughs, and census areas in 25 states and 
Puerto Rico. We know that place-based efforts work and we have seen 
StrikeForce bring economic opportunity directly to rural Americans 
where they live and help rural communities leverage their assets. In 
2015, in StrikeForce target areas, USDA partnered with more than 1,000 
organizations to support 56,600 investments that directed more than 
$7.5 billion to create jobs, build homes, feed kids, assist farmers and 
conserve natural resources in some of the nation's most economically 
challenged areas. Since the initiative was launched in 2010, USDA has 
invested more than $23 billion in high-poverty areas, providing a 
pathway to success and expanding the middle class.
    Between 2009 and 2014, USDA invested more than $800 million in more 
than 29,100 local and regional food businesses and infrastructure 
projects. In fiscal year 2015, USDA directly supported nearly 10,000 
farms and ranches, food entrepreneurs and communities through local 
food-related projects, which reflects the implementation of FSA 
microloans. As a result, the market for local food has grown to at 
least $12 billion in 2014 from $5 billion in 2008. Given the current 
growth of local foods, some industry sources estimate that the market's 
value could hit $20 billion by 2019. In addition, USDA has made 
expanding SNAP recipients' access to fresh fruits and vegetables 
through farmers markets a priority in recent years. In 2008, about 750 
farmers markets and direct marketing farmers accepted SNAP. In 2015, 
almost 6,500 of these markets and farmers accepted SNAP.
    Research provides the foundation for developing innovative 
practices needed to feed the growing global population, while 
protecting and conserving our natural resources. USDA's in-house 
research and our work with land-grant universities have delivered 
science-based knowledge and practical information to farmers, ranchers 
and forest landowners to support decisionmaking, innovation and 
economic opportunity. Between fiscal year 2009 through fiscal year 
2015, USDA filed 883 patent applications with the U.S. Patent and 
Trademark Office and was issued 429 patents. In fiscal year 2015, USDA 
held 421 income-bearing licenses. It also had 301 cooperative research 
and development agreements, of which 106 involved small businesses.
    USDA has facilitated the adoption of new technologies by 
streamlining the process for making determinations on petitions 
involving biotechnology. These improvements provided more rapid and 
predictable availability of biotechnology products to farmers, 
ultimately providing technologies to growers sooner and more choices to 
consumers. In fiscal year 2015 alone, USDA reviews found safe 
genetically enhanced varieties of potato, corn, soybean, cotton, and 
alfalfa. USDA estimates that the cumulative number of actions taken to 
deregulate biotechnology products based on a scientific determination 
that they do not pose a plant pest risk will increase from a cumulative 
total of 82 actions in fiscal year 2009 to an estimated cumulative 
total of 126 actions in 2017.
    Since 2009, USDA has worked to safeguard America's food supply, 
prevent foodborne illnesses and improve consumers' knowledge about the 
food they eat. For example, USDA adopted a zero tolerance policy for 
raw beef products containing six strains of shiga-toxin producing E. 
coli, giving products that test positive for any of these strains the 
same illegal and unsafe status USDA has long given products testing 
positive for E. coli O157:H7. Additionally, USDA set tougher standards 
for Salmonella and new standards for Campylobacter on poultry 
carcasses, and developed the first ever Salmonella and Campylobacter 
standards for chicken parts, which are more commonly purchased than 
whole carcasses. Together, USDA estimates these new standards will 
reduce illnesses by about 75,000 annually, and help the agency meet 
Healthy People 2020 goals. The total number of illnesses attributed to 
USDA-regulated products fell nearly 11 percent from 2009 to 2015, which 
equates to more than 46,000 avoided illnesses on an annual basis.
    The Administration continues its strong support for the 
Supplemental Nutrition Assistance Program (SNAP), the Special 
Supplemental Nutrition Program for Women, Infants, and Children (WIC), 
and other critical programs that reduce hunger and help families meet 
their nutritional needs. SNAP kept at least 4.7 million people, 
including nearly 2.1 million children, out of poverty in 2014. Because 
hunger does not take a vacation during the summer months when school 
meals are unavailable, we have expanded the Summer EBT for Children 
demonstration pilots over the last 2 years, in tandem with the Summer 
Food Service Program. Summer meal participation has increased by almost 
16 percent since 2009. In total, summer meals sites have served over 
1.2 billion meals to low-income children since 2009. During the school 
year, over 97 percent of schools are successfully meeting nutrition 
standards by serving meals with more whole grains, fruits, vegetables, 
lean protein and low-fat dairy, and less sodium and fat. I am pleased 
the Senate Agriculture Committee passed a bill that ensures progress 
will continue improving our children's diets and urge Congress to 
reauthorize these programs for our young people without delay.
    America's farmers, ranchers and landowners have led the way in 
recent years to conserve and protect our soil, water and wildlife 
habitat. With the help of Farm Bill programs, USDA partnered with a 
record number of producers since 2009 to create not only a cleaner, 
safer environment, but to create new economic opportunities. We have 
enrolled a record number of private working lands in conservation 
programs and implemented strategies--such as landscape-scale efforts--
to restore our forests and clean our water supply. In fiscal year 2015, 
one such landscape-scale effort provided a noteworthy achievement in 
that 90 percent of the greater sage-grouse's breeding habitat in the 
western United States is protected as a result of our Working Land for 
Wildlife efforts and the work of our many partners. Due to this 
achievement, the U.S. Fish and Wildlife Service has determined this 
species does not warrant protection under the Endangered Species Act 
(ESA). In addition to wildlife benefits, conservation practices have 
reduced the amount of nitrogen leaving fields by about 26 percent, 
phosphorus by 46 percent, and the estimated amount of eroded soil by 60 
percent over the past 7 years. Through the Regional Conservation 
Partnership Program (RCPP), we leveraged $800 million to support 115 
high-impact conservation projects across the nation that will improve 
the nation's water quality, support wildlife habitat and enhance the 
environment. We have also offered producers multiple new opportunities 
to utilize the Conservation Reserve Program to retire marginal 
agricultural lands, restore grasslands and forests, and protect 
valuable wildlife habitat. But just as important as protecting our 
natural resources, we have increased economic opportunities for rural 
America by boosting outdoor recreation, which adds more than $640 
billion in consumer spending each year.
    To build on these accomplishments, we need to do more to transform 
rural America and increase opportunities for families. To do this, the 
2017 Budget will continue to expand opportunity for America's 
agricultural producers, rural communities, and the most vulnerable 
populations. Critical investments are made to strengthen rural 
communities, expand agricultural trade, provide more opportunities for 
hard working American families, modernize key infrastructure, and build 
resilience in the face of a changing climate.
    USDA's total budget for 2017 we are proposing before this 
Subcommittee is $146.8 billion, of which approximately $127 billion is 
mandatory funding. The majority of these funds support crop insurance, 
nutrition assistance programs, farm commodity and trade programs and a 
number of conservation programs. The budget includes mandatory funds to 
fully support estimated participation levels for SNAP and Child 
Nutrition Programs. For discretionary programs of interest to this 
Subcommittee, our budget proposes $19.7 billion, approximately $309 
million below the 2016 enacted level. That level fully funds expected 
participation in WIC. It includes the funding needed to meet our 
responsibility for providing inspection services to the Nation's meat 
and poultry establishments.
    The budget also includes $1.4 billion to renew approximately 
271,000 rental assistance agreements. This funding is critical to 
ensure housing stability for elderly and disabled tenants without the 
means to otherwise obtain safe, affordable housing. I appreciate the 
Subcommittee's assistance in ensuring we have the resources and 
flexibility in fiscal year 2016 needed to address challenges facing the 
Rental Assistance Program. The budget also funds single family housing 
at the 2016 enacted level, providing over 166,000 homeownership 
opportunities.
    The 2017 budget provides a strong farm safety net and makes 
investments to meet challenges of a competitive global market, changing 
climate, and making agriculture a reality for new and beginning 
farmers. The budget proposes a loan level of approximately $6.4 billion 
for direct and guaranteed farm ownership and operating loans, about 80 
percent of the loans will be made to beginning farmers and ranchers and 
socially disadvantaged producers. The Farm Service Agency will offer 
mentorship opportunities, support landowners who wish to sell or rent 
their land to beginning farmers and ranchers, increase local outreach 
and educational efforts, support agricultural youth organizations, 
provide loan fee waivers for veterans, and target additional farm loan 
funding to veteran farmers and ranchers. The budget doubles the funding 
for the Socially Disadvantaged Farmers and Ranchers and Veteran Farmers 
and Ranchers Grant Program for a total of $20 million. Funding will be 
used to assist these groups in owning and operating farms and ranches, 
while increasing their participation in agricultural programs and 
services provided by USDA. The 2017 budget also includes a $5 million 
increase for the Sustainable Agriculture Research and Education Program 
to help beginning farmers and ranchers adopt sustainable agricultural 
practices.
    The rural economy will be even stronger because of the investments 
in rural infrastructure made by USDA. We will make over $1 billion in 
investments in rural businesses estimated to provide over 55,000 jobs 
in rural areas. We will facilitate the growth of the bioeconomy with a 
$25 million increase in competitive research funding to support 
development of biobased energy sources. In addition, the budget 
includes $91 million in discretionary funding and $359 million in 
mandatory funding for a total of $450 million for REAP to assist 
agricultural producers and rural small businesses to take advantage of 
renewable energy. We also propose $6.5 billion in loans to rural 
electric cooperatives and utilities that will support the transition to 
clean-energy generation and increased energy efficiency. Funding for 
broadband grants is more than tripled to assist in bringing critically 
needed broadband service to more rural communities. In addition, the 
budget includes a total of $35 million for Distance Learning and 
Telemedicine grants to support improved education and medical services 
in rural areas which may help partially address the particular 
challenges tied to rural America's opioid abuse epidemic. Over $2.2 
billion is targeted to community facilities, which will expand 
educational opportunities for students, facilitate delivery of 
affordable healthcare, and ensure the availability of reliable 
emergency services. Through a pilot called Rural Corps, USDA will work 
in partnership with local organizations to deploy highly trained staff 
and increase the likelihood that investments in infrastructure and 
economic development are strategic, creating jobs and long-term 
economic benefits.
    Additional resources are proposed to address the acute and long-
term needs of socially disadvantaged populations, including $20 million 
for a new competitive grant Home Visits for Remote Areas Program that 
will provide support for high-need maternal, child, and family health 
in remote rural areas and Indian country. It should be noted that such 
populations are more likely to experience poverty in rural areas where 
over 18 percent of the total population and over 25 percent of children 
live in poverty. We are also proposing $25 million to support a Rural 
Child Poverty demonstration project to implement multi-generational 
strategies to addressing rural child poverty, which includes $5 million 
to support alignment of data and eligibility determination systems 
across programs. The budget also includes increased support to build 
the capacity of 1890 Institutions to meet the growing need for 
agriculture assistance in high poverty areas. Further, we propose an 
increase of about $7 million to enhance research, education, and 
extension efforts in tribal areas through long-term capacity building 
at 1994 Institutions and expansion of the federally Recognized Tribes 
Extension Program (FRTEP). This will lead to increased professional 
training opportunities, a 25 percent increase in the number of Indian 
students working on summer internships, and a doubling of the number of 
FRTEP staff engaged in 4-H activities to 72.
    Access to nutritious food is essential to the well-being and 
productivity of all Americans. The budget makes substantial investments 
in address child hunger in the summer. It provides an increase of $3 
million in discretionary funding to continue the successful Summer 
Electronic Benefit Transfer for Children (SEBTC) demonstration pilots. 
Beyond the expansion of the pilots, the 2017 budget proposes to invest 
$12.2 billion over 10 years to make the program permanent and begin 
phased-in nationwide implementation. Rigorous evaluations of SEBTC 
pilots have proven effective in reducing very low food security in 
children for about one-third of the children who would have otherwise 
experienced it and in improving children's nutrition. The proposal 
would reach almost one million low-income children beginning in the 
summer of 2017, increasing to nearly 20 million children after 10 
years. Given the harm that hunger imposes on children, this is a smart, 
evidence-based investment.
    The budget includes an increase of $30 million to strengthen animal 
disease preparedness and response capabilities funding needed to stem 
the impacts of significant pests and diseases. Minimizing such impacts 
allows for an abundant food supply as well as provides trade 
opportunities for our producers. Over the last few years, USDA has 
addressed some of the worst animal disease outbreaks in recent history 
with the emergence of novel swine enteric coronavirus disease in the 
swine industry and the highly pathogenic avian influenza outbreak last 
year that infected 232 flocks and resulted in the depopulation of 
approximately 50 million birds.
    Food for Progress and the McGovern-Dole International Food for 
Education and Child Nutrition Program will continue to provide benefits 
to millions of people overseas. These programs have helped to engage 
recipient countries not only by delivering food assistance, but also by 
fostering stronger internal production capacity and infrastructure, 
generating employment, boosting revenue, and developing new markets and 
productive economic partnerships. The budget provides $20 million, $5 
million through the McGovern-Dole program, to support the local and 
regional procurement of food aid commodities for distribution overseas 
to complement existing food aid programs and to fill in nutritional 
gaps for targeted populations or food availability gaps caused by 
unexpected emergencies. Also, the budget proposes the authority to use 
up to 25 percent of Title II resources for these types of flexible 
emergency interventions that have proven to be so critical to effective 
responses in complex and logistically difficult emergencies.
    The budget recognizes that there is a direct correlation between 
the capacity of this country to continue to sustainably meet a growing 
demand for food, feed and fiber and the amount of resources that we put 
into agricultural research. Long-term agricultural productivity growth 
relies on innovation through research funded by both public and private 
sectors. Analysis by the Economic Research Service shows that long-term 
agricultural productivity is fueled by innovations in animal/crop 
genetics, chemicals, equipment, and farm organization that result from 
public and private research and development. The 2017 budget includes 
$700 million for competitive grants through the Agriculture and Food 
Research Initiative, including $325 million in mandatory funding that 
would bring the program up to its authorized level. This significant 
investment is needed to ensure tools are in place to adapt to 
challenges faced by agricultural producers, while still feeding a 
growing population. A portion of this funding will support the 
President's clean energy efforts through the development of commercial-
scale advanced biofuels and biobased products that are compatible with 
existing infrastructure. Also, the budget more than doubles the funding 
available to address antimicrobial resistance in pathogens of humans 
and livestock, and to seek answers to key questions about the 
relationships among microbes and livestock, the environment, and human 
health. Further, the budget includes $36 million for research to 
address the decline of pollinator health by understanding, preventing, 
and recovering from pollinator losses.
    We appreciate the Subcommittee's action to fund critical research 
infrastructure in 2016. To continue the process of laboratory 
improvement, the budget proposes additional investments in research 
infrastructure to further reduce the backlog of USDA's laboratory 
construction and renovation needs. These investments include $30.2 
million for the Agricultural Research Technology Center in Salinas, CA, 
where research is done on alternatives to methyl bromide and 
development of scientifically based organic crop production practices 
for weed, insect, and disease control, as well as $64.3 million for the 
Foreign Disease-Weed Science Research Laboratory in Ft. Detrick, MD.
    The 2017 budget fully funds the EQIP and CSP programs at the Farm 
Bill authorized levels. The unprecedented level of funding provided for 
EQIP will support conservation practices on an additional 11.5 million 
acres, which will help farmers and ranchers make their operations more 
resilient to climate change, increase access to greenhouse gas markets, 
and protect wildlife habitat, among other benefits. The funding for CSP 
will allow 10 million more acres to be enrolled. The budget also 
provides an increase of $11 million to support conservation planning, 
which will result in over 8,000 additional conservation plans. This 
translates into 2.9 million additional acres of planned conservation. 
The strong support for conservation planning as well as robust funding 
for the mandatory conservation programs follows through with the 
principles laid out in USDA's Building Blocks for Climate Smart 
Agriculture and Forestry.
    Science and data are the primary tools that the Food Safety and 
Inspection Service (FSIS) uses to prevent foodborne illness and protect 
public health. As part of this effort, the budget includes $8.5 million 
to further modernize FSIS' science-based decisionmaking process by 
developing and deploying new tools to reduce the prevalence of 
foodborne illnesses.
    To enhance nutrition education and the provision of healthy meals, 
the budget includes a $4 million increase to promote healthful 
behaviors that can reduce incidence of chronic disease and obesity, and 
lower healthcare costs. Included in this is an initiative to research 
and implement cutting-edge initiatives to help Americans put healthy 
eating behaviors, based on the Dietary Guidelines for Americans and 
MyPlate, into practice. We will also develop the first-ever dietary 
guidelines for the birth to age two group and pregnant women. In 2013, 
The Pew Charitable Trusts and the Robert Wood Johnson Foundation 
released a report that found 88 percent of schools need at least one 
additional piece of kitchen equipment to serve healthier meals that 
meet science-based nutrition standards. The budget also requests an 
increase of $5 million, for a total of $35 million, for grants to help 
schools purchase needed equipment to prepare and serve healthier meals.
    The budget requests funding to establish an in-country presence in 
Cuba to cultivate key relationships, gain firsthand knowledge of the 
country's agricultural challenges and opportunities, and develop 
programs for the mutual benefit of both countries. U.S. agricultural 
exports have grown significantly since trade with Cuba was authorized 
in 2000. In fiscal year 2014, Cuba imported over $2 billion in 
agricultural products including $300 million from the U.S., and an in-
country presence will capitalize on opportunities this nearby market 
provides for U.S. agricultural exporters.
    We have identified additional opportunities to modernize and 
strengthen the Department. The budget includes resources to pursue 
these efforts, including $20 million to continue the modernization of 
the Headquarters complex that when finalized could yield annual savings 
of over $45 million through a reduction in rent and security costs. The 
budget also provides an increase of $18 million to fund a relocation or 
renovation of FNS headquarters in 2017. In addition, the Department is 
proactively addressing the cyber security threats posed against the 
network and systems of USDA. Through an investment of an additional $10 
million in 2017, the Department will enhance its ability to monitor and 
prevent breaches of the systems used to house data of importance to our 
employees and customers.
    The 2014 Farm Bill included several reforms to the Federal crop 
insurance program; however, there remain further opportunities for 
improvements and efficiencies. The President's 2017 budget includes two 
proposals to reform crop insurance, which are expected to save $18 
billion over 10 years. This includes reducing subsidies for revenue 
insurance that insure the price at the time of harvest by 10 percentage 
points and reforming prevented planting coverage. These reforms will 
make the program less costly to the taxpayer while still maintaining a 
quality safety net for farmers.
    We have accomplished much over the last 7 years. The budget 
presented to you will continue our progress. I would be happy to answer 
any questions you may have about our budget proposals.

                      SNAP CONVENIENCE STORE RULE

    Senator Moran. Mr. Secretary, we appreciate your presence 
here, and I appreciate the number of times you have reached out 
to me and provided me with information and meeting in the 
office and the phone calls, and I am grateful for the working 
relationship that we have.
    Let me just ask a couple questions and then we will move to 
my colleagues quickly, and I will have an opportunity to ask 
more again later.
    But let me start with the SNAP issue. February 17, the Food 
and Nutrition Service (FNS) published proposed rules in regard 
to SNAP. As you will recall, this was a significant, 
contentious issue in the farm bill.
    My question to you is, my understanding is that those 
proposed rules have a significant consequence on potentially 
the convenience store setting, perhaps small grocery store 
setting. And I have a particular interest in that because in 
many rural communities, there is no grocery store. A 
convenience store is one of the sole providers of food in many 
communities across rural America.
    I would be interested in hearing your thoughts, but my 
specific question is, would you entertain positively the idea 
of a longer comment period than the 60 days that you are 
currently proposing?
    Secretary Vilsack. Mr. Chairman, obviously, we will respect 
your request and certainly take a look at what extension would 
make sense. We obviously want to take a look at the comments 
and find out what people think and feel about this. But we 
obviously want to give people appropriate time to comment on 
this.
    This is an important issue. It is an important issue from 
the standpoint of the convenience store. It is also an 
important issue in terms of access to good, wholesome food, as 
we deal with this obesity crisis and the health care costs that 
are associated with obesity and the diseases that result from 
obesity.
    Part of the challenge is that folks who do live in rural, 
remote areas do not have access to the wide array and diversity 
of food that others are fortunate to have, and we believe it is 
not asking too much for convenience store owners and operators 
to be able to provide a broader array of resources and choices 
for people who are SNAP beneficiaries.
    So that is the purpose of the rule. I think there is also 
the belief that we can partner with these convenience stores in 
an effort to increase and enhance the nutritional value of what 
is being sold at the convenience stores.

                          GIPSA PROPOSED RULES

    Senator Moran. I appreciate what I took as a positive 
comment, that you will take a look at potentially extending the 
comment period. I appreciate that, Mr. Secretary.
    Let me ask about another rule. On Monday, you indicated in 
conversations in front of an organization here, I think in 
Washington, DC, that you anticipated that there would be 
revised Grain Inspection, Packers and Stockyards Administration 
(GIPSA) rules, and you expected them to be finalized before you 
leave office.
    Given the overwhelming congressional opposition to the 
previously proposed rules, what changes to GIPSA rules do you 
plan to make? And what discussions and outreach have you had 
with stakeholders in this regard?
    Secretary Vilsack. Mr. Chairman, that process is still 
ongoing, and no commitments, specifically, have been made in 
terms of what those rules will look like.
    We realize that Congress lifted the restriction on our 
ability to work on these issues. I have asked the team to take 
a look at what modifications or changes would be appropriate, 
given the concerns that have been expressed in the past, and 
also to determine whether or not what we were considering a 
couple years ago, whether or not that still makes sense in 
today's market.
    They are putting together that work plan, and I will be 
more than happy when that process is completed to obviously 
provide you additional information on precisely what we are 
thinking.
    But the key here is to make sure that the playing field is 
level between those who are owners and those who are producers, 
to make sure that there is not an unfair advantage in that 
relationship and to make sure, especially in difficult times, 
that those who invested a lot of hard-earned resources and time 
are treated fairly if a contract is terminated or for some 
reason a contract is modified.
    We have had examples where folks have been dealt a very 
serious and difficult blow in tight circumstances. The avian 
influenza situation was sort of a reminder to us about the 
importance of that relationship, particularly as we did 
indemnification payments for those who lost birds. We found 
that not all those indemnification payments were going to the 
producers who were economically suffering as well.
    So we want to make sure it is a fair and equitable 
relationship, and that is the purpose of our review of those 
rules.
    Senator Moran. Mr. Secretary, what do you expect the 
timeframe to be? What schedule are you on?
    Secretary Vilsack. I would say that I suspect that some of 
these rules may very well be finalized and some of these rules 
may be proposed, given the nature of the concerns that were 
expressed in the past.
    I would hope that we would be able to get work plans 
completed and we would get something over to the Office of 
Management and Budget (OMB) relatively soon. I would hope that 
we would be able to get that done sometime in early spring. And 
then there is the review by OMB, which can take sometimes up to 
90 days or longer.
    Then hopefully that process is expedited so that sometime 
in late summer, early fall, we are in a position to provide 
information specifically to the public for their comment and 
review. At that point, any adjustments that need to be made can 
be made. And hopefully by the time of year end, we will know 
what the rules will be or what they are at least proposed to 
be.

                            AVIAN INFLUENZA

    Senator Moran. Mr. Secretary, you mentioned avian flu. This 
is a topic of conversation that you and I have had one-on-one, 
but certainly in the hearing that we had a year ago on your 
budget, this was a significant issue and concern.
    Is there something that USDA has learned that we would now 
be in a better position, should this kind of occurrence 
reappear? And then if you would bring us up-to-date on what has 
transpired in other countries in regard to our exports in 
regard to avian flu?
    Secretary Vilsack. We have learned a great deal, Mr. 
Chairman.
    First of all, we have learned the necessity of making 
earlier determinations and quicker determinations, so we have 
beefed up our laboratory capacity. We would like to be able to 
make determinations within a 24-to-48-hour time period when 
something arises on a farm. We then would like to be able to 
work with that producer to be able to depopulate within 24 
hours. And we have learned that there are a multitude of ways 
in which that can potentially be done under each particular 
circumstance.
    We have learned the need to pre-position assets, or at 
least have an awareness and understanding of how disposal will 
be handled in advance as opposed to after the fact, which can 
delay disposal, which can in turn create potential greater 
risk.
    We have learned our indemnification systems needed to be 
altered a bit to reflect a more appropriate balance between the 
producer, the taxpayer, and USDA. We were cleaning up 
situations in some of these poultry facilities that had not 
been cleaned up for a decade, as opposed to cleaning up the 
specific cause or problem with avian influenza. So there was a 
better balanced approach there.
    The difference between providing the owner of the birds all 
of the indemnification and now some kind of equitable ratio, if 
you will, between owner and producer in terms of 
indemnification so we can keep producers in business.
    We have learned the necessity of constantly researching 
this, because it is constantly mutating and evolving.
    And we have also learned the necessity of at least having 
pre-positioned vaccine, not that we would necessarily use it, 
but there may be a circumstance or situation where it is 
appropriate. And we have basically wargamed what that would 
look like and what we would have to do in order to utilize 
vaccine.
    In terms of the trade issue, we are seeing many of those 
who initially banned all poultry sales beginning to understand, 
from an international rules standpoint, the need to look at 
this regionally. We have actually seen some that have become 
even State-specific and some bans that have even become very 
specific to the county or counties.
    So we have seen an expansion of opportunity. About 77 
percent of the poultry exports are currently in the right 
place. We are still working with some of our friends in China, 
for example.
    But for the most part, I think people have taken the right 
approach to regionalization or Statewide bans as opposed to 
countrywide bans.
    Senator Moran. Mr. Secretary, it seems as if you have 
learned a lot, which I assume means the USDA, the Federal 
Government, are better prepared for another occurrence, should 
it arise.
    Are there any legislative changes that are required to help 
you accomplish a better response?
    Secretary Vilsack. I would only say, Mr. Chairman, I think 
the research aspect of USDA needs to continue to be beefed up, 
because we are constantly dealing with things like this. But I 
do not know that we necessarily need a legislative change. But 
if there are, we will be happy to get some information to you. 
I do not know of anything, off the top my head.
    [The information follows:]

    We do not foresee needing any legislative changes to enhance our 
response to HPAI.

    Senator Moran. Thank you very much.
    Senator Merkley.

               OPENING STATEMENT OF SENATOR JEFF MERKLEY

    Senator Merkley. Thank you very much, Mr. Chairman.
    Thank you, Mr. Secretary. We are well along in the journey 
now, an 8-year journey serving President Obama, and I believe 
you are the only member of the Cabinet who has been there from 
the starting line and is still with us, and I assume is 
planning to go across the finish line. I want to thank you for 
these 8 years of service.
    Secretary Vilsack. Thank you.

                       RENTAL ASSISTANCE PROGRAM

    Senator Merkley. As you indicated to the Chairman, I know 
you have learned a lot in the post over these many years on so 
many different issues. Certainly, in your introduction you 
mentioned food, water, and shelter, that is everything from 
SNAP to water purification programs to housing programs. It 
really reflects on the essential functions that your Department 
has for millions, millions of Americans.
    I just wanted to note your March 7 speech where you called 
upon Congress to pass mandatory genetically modified organism 
(GMO) labeling. I know you and I have very different 
definitions of what that would look like, but I stand with you 
shoulder-to-shoulder in the cause of mandatory labeling.
    I wanted to turn to the housing component. One of the 
issues we had last year is that, under rental assistance, the 
project-based rent subsidy program, we had a situation where, 
essentially, we ran out of money to pay the share of the rent 
that we were responsible for as the Federal Government.
    That appears to be fully addressed in the budget for fiscal 
year 2017, but I just wanted to raise it and ask if people 
across the country who were involved in providing project-based 
housing can rest assured that we have it covered this time?
    Secretary Vilsack. Senator, I think we do. That is what I 
have been told. We certainly appreciate the work of yourself 
and Members of this Subcommittee to resolve that aspect of our 
Rental Assistance Program.
    We have, as you know, the other issue of maturing mortgages 
and loan payoffs, which will result potentially, unless we deal 
with those, in a lot of these units coming out of the program, 
in which case you are going to have a lot of families that are 
going to be looking for housing and not be able to afford it.
    Senator Merkley. You turned immediately to my second topic. 
We have recently been able to get some data from the Department 
on maturing mortgages in Oregon, but it is important that 
across the Nation we know when mortgages are maturing so 
nonprofits can attempt to buy them in places where they would 
go to much higher market rates.
    I know your team has been working on this issue, but I just 
wanted to emphasize how hard it is to recover this housing if 
we lose it out of the affordable portfolio.
    Years ago, I worked on a program called LIHPRHA, Low-Income 
Housing Preservation. It was a very similar situation, only in 
urban settings. Now we have this in rural settings. So anything 
I can do, and I am sure many members would say the same, to 
assist the Department in trying to make sure we identify the 
expiring projects and do everything possible to preserve them 
certainly would like to see happen.
    Secretary Vilsack. Senator, 75 percent of these loans 
potentially will become due and paid off in the next 10 years, 
so that is 75 percent of the units.
    One thing that you may want to think about is the ability 
of vouchering for those folks who are in a position where their 
unit ultimately gets out of the program. Another way that we 
are looking at it is being able to extend these mortgages and 
refinancing, so that improvements can be made to the property 
with the savings that results from extension and refinancing.
    So there are some creative solutions here, but we need to 
get focused on this in the very near future.

                      RURAL ENERGY SAVING PROGRAM

    Senator Merkley. I look forward to exploring with the 
Subcommittee the possibilities, because this will be very 
important to the housing stock in America.
    I wanted to turn to the Rural Energy Savings Program. The 
Rural Energy Savings Program, the concept was that we could 
create a lot of jobs in rural America if people could take 
loans on their electric bill and be able to replace their 
windows or add installation. It put a lot of people to work, 
and often the energy savings would pay for the improvements 
themselves, plus virtually all these products are made in 
America, so we get more bang for the buck because we get the 
local construction contractor employed but it also creates jobs 
in American manufacturing.
    We had the initial program funded last year. I was 
wondering if you have any information whether we have been able 
to get it stood up on its feet and have it running?
    Secretary Vilsack. Senator, as you know, we worked with a 
program that was similar to what you proposed with an interest 
rate that was higher. We were in the process of implementing 
that and learning from that, recognizing that there were some 
serious learning curves for the research and extension centers 
(RECs) that we were dealing with.
    We recently announced a statewide initiative in Vermont, 
where we learned quite a bit and created sort of a template.
    The proposal that you were the leader on last year, we 
expect and anticipate to stand up sometime this spring. We 
would anticipate and expect that there will be quite an 
interest in a interest-free or zero-interest loan program. But 
now that we know how to set it up, I think we will see more of 
these projects, because I think it is popular, and I think 
there is a great deal of potential there.
    Senator Merkley. I can tell you, in Oregon, the employment 
rate has not rebounded at all in rural areas the way it has in 
urban areas. I know you know this to be the case across the 
country, so it is a win-win program on several levels.
    Secretary Vilsack. Help us fix the fire budget, and that 
situation in rural Oregon will change.
    Senator Moran. Senator Blunt.
    Senator Blunt. Thank you, Chairman.

                         STREAMING FARM PROGRAM

    Secretary Vilsack, I want to join Senator Merkley and 
Senator Moran in appreciating your service, appreciating really 
how much you bring to this job, I think every year more than 
the year before. It is amazing how much there is still to 
learn, and I am impressed by how you dedicated yourself to 
learning how important this is.
    The future challenges and opportunities for agriculture are 
great, if not greater than they have ever been. Hopefully, we 
can figure out how to make the most of that.
    Just two or three pretty quick questions here. One is, I 
continue to hear from our friends in agriculture the desire for 
more streamlining in the reporting process.
    My good friend Blake Hurst, who is the president of the 
Missouri Farm Bureau, was telling me the other day he has to go 
into the Farm Service Agency (FSA) office and file his report 
on crop insurance, and then he has to go to his crop insurance 
agent, and then the crop insurance agent has to refile the same 
information with Risk Management.
    Are we making any progress in trying to streamline that 
time cost, both to Federal employees and to the people that 
they work for?
    Secretary Vilsack. We are, Senator. Last year we launched 
and this year we implemented FSA Plus, which is allowing folks 
to access their records at home. This year we started with a 
pilot project in Iowa and Illinois, to try to test market how 
we would be able to have better coordination between the Risk 
Management Agency (RMA) and FSA and the reporting. We then 
extended that to a number of other States. Now we are prepared 
this year to go Nationwide.
    So the concerns that he has expressed, I think by the end 
of this year, he will be much happier than he has been, and he 
will also be able to access all of his records, all of his 
maps, all of his information from his home computer with FSA 
Plus.
    Senator Blunt. I know that is a project that has been out 
there all the time you have been running the Department.
    Secretary Vilsack. It has.

                     NATIONAL SCHOOL LUNCH PROGRAM

    Senator Blunt. It is frustrating and challenging for all of 
us. I look forward to seeing it come to a conclusion.
    Now, you will remember my mom and dad were dairy farmers, 
so I come to this next topic with my own personal point of 
view, which is pretty strongly held.
    But I believe that there are significant parts of the 
country now where packaged bottled water is being offered as a 
substitute for milk in school cafeterias. Historically, USDA 
has recommended school children consume 2.5 to 3 servings of 
milk or other dairy products every day because of the 
potassium, vitamin D, and calcium.
    I guess my two questions are, because I believe the facts 
are that is an accurate statement about water as an alternative 
to milk, is packaged bottled water a reimbursable item in the 
National School Lunch Program?
    Secretary Vilsack. I believe it is, but I do not for a fact 
know that. We can check.
    I do know that we are encouraging more dairy products. It 
does not necessarily have to be milk. Greek yogurt is now a 
protein substitute, so there is a lot of interest--and, 
frankly, we are trying to be responsive to what school 
districts are asking us to provide them with and for.
    But I will check on the reimbursement issue.
    Senator Blunt. I am not a big advocate for us buying water 
as one of the alternatives at lunch. There are other ways to 
get water, I would think.
    USDA funds being used, do you think that is through the 
National School Lunch Program then? Or it might be and you are 
going to check and get back to us on that?
    Secretary Vilsack. I will check on that.
    [The information follows:]

    Water is not a food component or food item that is required for the 
reimbursable meal under the National School Lunch Program. As required 
by the Healthy, Hunger-Free Kids Act of 2010, potable water must be 
made available to students during meal service at no cost to students. 
However, school districts may not promote or offer water or other 
beverages as an alternative selection to the required fluid milk 
component on the meal service line. Most schools meet the potable water 
requirement by providing a water fountain or a cooler filled with tap 
water in the cafeteria. For the majority of operators, USDA expects 
compliance with the potable water requirement to incur minimal or no 
costs. However, USDA does not prohibit use of the nonprofit school 
foodservice account to purchase non-program food such as water. USDA is 
working with State agencies and local school districts during the 
Administrative Review process to provide technical assistance and 
corrective action when necessary to eliminate the occurrence of choices 
between milk and water or other beverages during meal service.

                           BROADBAND PROGRAM

    Senator Blunt. So Senator McCaskill and I wrote a letter 
recently to Federal Communications Commission (FCC) Chairman 
Tom Wheeler. Our concern is that the remaining funds available 
under phase II of the Connect America Fund, it is critically 
important that rural constituents all over--our letter was 
specifically focused on Missouri--have the same access to fiber 
optics and other advanced broadband networks as their urban 
counterparts at a comparable price.
    Secretary Vilsack. I certainly agree. We have conveyed 
those same sentiments to the Chairman. Our hope is that as they 
look at the Connect America and some of the other programs that 
we will continue to see an expansion of broadband.
    Also, we believe it is going to be important for us to 
continue to stay in that game from a grant and loan 
perspective. That is why our budget reflects a significant 
increase in the broadband projects.

                       DRUG USE IN RURAL AMERICA

    Senator Blunt. I think social access, economic opportunity, 
all those things matter. It may be that social access may lead 
to my last question, which is one--you and I talked right after 
the President asked you to play a leadership role in this 
effort to curb heroin and opioid use.
    On the floor of the Senate this morning, as we were trying 
to move through this bill, I made the point that actually more 
people die of drug overdoses now in rural America than urban 
America. More people die outside a metropolitan statistical 
area, even if that area may be quite far from the hub of that.
    Do you want to talk a little bit about the challenge to 
rural America of this epidemic of opioid and heroin use and 
overdose?
    Secretary Vilsack. Well, it is a complicated problem. It is 
one that requires a series of steps. We have to have more 
prescribers trained in the appropriate prescription of pain 
medication. I think we have to have, frankly, reasonable 
expectations on the part of patients as well, in terms of 
precisely what doctors can and cannot do in terms of pain 
relief.
    I think it is going to be important for us, particularly in 
rural areas, for our first responders to have access to the 
overdose reversal drugs that are available, that are now in a 
nasal spray, now more readily available. In fact, we might want 
to consider a general prescription that would allow family 
members to have access to that reversal drug, just in case, 
knowing that if a loved one is in trouble, being able to 
respond quickly.
    It is going to be necessary for us to look at ways in which 
we can encourage States, and specifically the State of 
Missouri, to have a better monitoring program, so we can 
prevent doctor shopping, and that we have interoperability 
between States. We have many States with these programs, but 
they do not necessarily communicate, so if you are on a border 
community, you can potentially game the system.
    I think it is going to be important for us to look at ways 
in which we can increase support for medication-assisted 
treatment, and perhaps not just limit it to physicians but 
perhaps physician assistants or some other medical 
professional, particularly in rural areas, to be able to be 
involved in the basic prescribing of those things in terms of 
trying to meet the needs.
    You mentioned broadband, telemedicine, and access to 
services. That may be a way of providing services without 
necessarily brick-and-mortar investment.
    We need to make sure people understand that mental health 
services and substance abuse services are now covered by 
insurance. There is, I think, a lack of understanding about 
that. We frankly need to engage the entire community, 
particularly the faith-based community, in making recovery 
support efforts more readily available.
    I know in my own personal situation, my mother struggled. 
She would have never been able to recover but for Alcoholics 
Anonymous (AA) and some of the support that she had from people 
similarly situated. There are not places today in many rural 
communities where those meetings can take the place. Faith-
based organizations I think have a particularly interesting 
role and opportunity there.
    So it takes a broad approach. I think the Administration 
looks forward to working with you and others to try to make 
sure we put the resources behind all of these solutions, 
because it is a horrendous problem and tens of thousands of 
people are dying, and hundreds of thousands of families are 
being impacted and affected by this.
    Senator Blunt. Thank you for your leadership there and in 
other areas, Mr. Secretary.
    Mr. Chairman, thank you for the time.
    Senator Moran. Thank you, Senator Blunt.
    Senator Tester.
    Senator Tester. Thank you, Mr. Chairman, for allowing me to 
speak and giving me these glasses so I can read.

            NORTHERN PLAINS AGRICULTURAL RESEARCH LABORATORY

    It is good to have you here, Secretary Vilsack. I am going 
to start out a little parochial right now with an ARS station 
in Sidney.
    I do not know all the information about it because it was 
just pointed out to me today by a producer from eastern 
Montana, that it is being repurposed or potentially may be 
taking a step toward closure. So I just want to get some input 
from you on what is going on. If you do not know, you can 
certainly get back to me.
    But these guys do incredible research. It is an incredible 
facility, as I am sure they all are. It does research on saw 
fly and other kinds of pests. You now the issue with barley 
scab showing up in Montana. So these research facilities are 
really, really important.
    Can you give me an idea what the plans are for that?
    Secretary Vilsack. The budget that we proposed requested an 
increase in the ARS budget. Part of that increase would be 
targeted actually toward the facility that you mentioned.
    It currently supports 41 scientists. I do not know of any 
plan to reduce that number, or reduce the support for those 41 
folks.
    Obviously, research projects come in. Some get concluded 
and new ones begin. So I am not sure that is necessarily 
repurposing, but perhaps there is a different focus given a 
particular disease or pest. But I do not know of any desire to 
close or reduce the importance of that.

                            RESEARCH BUDGET

    Senator Tester. That is what I wanted to hear. You answered 
that very, very well.
    The research for Smith-Lever dollars and Hatch are flat at 
about $302 million and $44 million, respectively. These are 
also very, very important. Could you shed some light? Has the 
use of those also flattened out? Or does demand far exceed? 
Tell me what is going on.
    Secretary Vilsack. Yes, it is a combination of having an 
overall number for our budget, and the challenge in our budget 
where fire suppression, WIC, rental assistance, and food safety 
eat up to 50 percent of the budget. Oftentimes, when those 
items have to be increased, it impacts and affects the other 50 
percent.
    It is also a fact that we are trying to look at our 
competitive grant programs as a way of encouraging more 
collaboration between universities. Many universities are 
receiving resources from that that ultimately help to support 
the university and support the capacity university, so it is a 
balance.
    Senator Tester. I got you. I think that you have done some 
positive things for research in here. But you know, you know 
how important research is. For farmers to do trial and error is 
a good way to go broke.
    So moving forward, you are in office for another 10 months.
    Secretary Vilsack. I am in office for another day, for 
sure. I serve at the pleasure of one guy.
    Senator Tester. One never knows what might happen to you. I 
stand corrected.
    But moving forward, are you confident that this budget that 
you are putting forward, those priorities on research 
particularly, will be heading in the right direction, moving 
into the next administration, whoever that might be?
    Secretary Vilsack. I am confident, because I think we have 
addressed both short-term and long-term, traditional and 
nontraditional, challenges that agriculture is going to face.
    This is an incredibly complex and changing world that our 
farmers are living in. I think we have figured out a way in 
which we can provide them assistance and help, if our research 
budget is adequately funded.

                    WATER AND WASTE DISPOAL PROGRAMS

    Senator Tester. Okay. I want to talk about rural 
development and water infrastructure, critically important in 
rural America, as you well know. $244 million for loans and 
grants to rural businesses, tripling of funding of broadband 
grants, which is really important.
    There is a reduction though in grants and loans for water 
and waste disposal programs. If you look around this country, 
and I know I am preaching to the choir here, these systems are 
for the most part wore out. So why the reduction?
    Secretary Vilsack. Well, because in the past several years, 
we reduced the business and industry loan programs, and we have 
reduced and not adequately funded some, so it is about balance, 
number one.
    Number two, we are looking for leveraged opportunities. We 
are trying to get the private sector more engaged in investing 
in these water projects. We are finding that there is interest 
in this. Pension plans, some of the private investment that we 
have been cultivating at USDA to leverage our scarce resources 
are now seeing 3-percent or 4-percent payment on a 30-year loan 
quite attractive.
    We are actually working to try to look at our own portfolio 
to see whether or not we can maximize the value of that 
portfolio and create an incentive for the private sector to 
invest hundreds of millions if not billions of dollars.
    So it does not necessarily mean that less work is going to 
be done, Senator. It just means that we have to be creative 
about where the financing is going to come from. We are being 
very creative at USDA.

                      RURAL COMMUNITY POPULATIONS

    Senator Tester. We appreciate that creativity. I just want 
to talk about something. We had a roundtable that the Chairman 
and Ranking Member put on. Dr. Johansson was at it here a 
couple weeks ago.
    One of the things that is going on in rural America that I 
also know you know about is depopulation in a big, big way. We 
are seeking rural communities dry up, I think at a faster rate 
than I have ever seen in my lifetime.
    In the last 40 years since I graduated from high school, 
the little town I am from, if you go by enrollment in high 
school, is two-thirds smaller than it was when I went to school 
there, more than two-thirds.
    I know there is big equipment out, and I know it is more 
efficient, and we do have more technology that makes things 
move. But I mean, where I live, and it is different in every 
area, but you know, 1,000 acres was an average farm. I have 
folks around me that farm 20,000 acres and north of that even.
    So is this just something that is going to continue? Are 
there things that we can do to encourage smaller farms maybe? 
Or encourage more people to move into rural America?
    Because you have schools that are closing down. You have 
cities that have to build schools. They are just all sorts of 
social problems that all cost money.
    Secretary Vilsack. Senator, in my lifetime, American 
agriculture has increased its productivity 170 percent, with 22 
million fewer farmers----
    Senator Tester. Yes.
    Secretary Vilsack  [continuing]. On 26 percent less land.
    Here is the problem. In the past, we did not create a 
companion economy to the extraction economy that was part and 
parcel of rural America.
    We now have a companion economy. It involves local and 
regional food assistance. We supported nearly 1,000 
infrastructure investments in local and regional food systems 
supporting 162,000 producers. We are beginning to see that 
prosper.
    We are seeing conservation. Howard Buffett came to our 
Outlook Forum and talked about the need for people to 
understand that conservation can actually be profitable. He is 
proving it in his operation.
    And the bio-based economy, the ability to transfer and 
produce a multitude of materials and chemicals and fabrics and 
fibers and fuels from bio-based systems.
    So we are headed in the right direction on two data points. 
One, the unemployment rate is coming down, which is good. And 
two, the poverty rate in rural America in the last 2 years has 
come down faster than in any preceding 25 years.
    So we are beginning slowly to turn around. Now, we are not 
going to get out of the fix that you mentioned overnight 
because we did not get into it overnight. But I think we are 
headed in the right direction.
    And I am hopeful that this companion economy that you all 
have helped to support with farm bills and budgets continues.
    Senator Tester. Thank you.
    Thank you, Mr. Chairman.
    Senator Moran. The Senator from Montana, Senator Daines.
    Senator Daines. Montana and Montana, Jon. All good.
    Senator Tester. Back to back.

                              BRUCELLOSIS

    Senator Daines. Secretary Vilsack, thanks for being here 
today.
    Agriculture is Montana's number one industry. It is a $5 
billion a year economy for us.
    Last year, I was pleased to be able to work with the 
Montana Grain Growers and other stakeholders to reform and 
reauthorize the Grain Standards Act to ensure that Montana 
farmers are protected from disruptions in federally mandated 
grain inspections, like what happened at the Port of Vancouver.
    I remember having literally farmers jumping off of a 
combine in the middle of the harvest running to Great Falls to 
meet with you and talk about the crisis we had. I was glad to 
see we got it resolved, and I look forward to ensuring this new 
law is implemented effectively moving forward, so we can 
prevent the crisis from happening again. Thank you for your 
help on that.
    I want to shift gears and talk about brucellosis. I live 
about an hour north of the Yellowstone National Park. I went 
from kindergarten through college there in Bozeman.
    As you know, there is significant bison herd within 
Yellowstone National Park and the greater Yellowstone 
ecosystem.
    My question is, how is your Department and the Animal and 
Plant Health Inspection Service (APHIS), in particular, 
coordinating and cooperating with State agencies in Montana 
like the Fish, Wildlife and Parks in Montana and the Department 
of Livestock on disease management efforts, particularly 
regarding brucellosis in the greater Yellowstone area?
    Secretary Vilsack. A number of years ago, we entered into 
an arrangement with the folks at Yellowstone, the State 
officials and others, to address this. I can get you more 
information, Senator, on the success of that, but I think we 
were able to isolate and provide a much better environment 
relative to the bison and other animals.
    So I would be happy to get you more detail about that, but 
I know that we have been working collaboratively with folks on 
this.
    [The information follows:]

    The Greater Yellowstone Area (GYA) wild elk and bison populations 
have persistent levels of brucellosis and the potential for continued 
exposure to livestock. To address this unique challenge, we assist with 
the Interagency Bison Management Plan (IBMP) operations in the GYA in 
cooperation with our fellow IBMP partners. These partners include the 
National Park Service; the U.S. Forest Service; the Montana Department 
of Livestock; the Montana Department of Fish, Wildlife, and Parks; the 
Intertribal Buffalo Council, the Confederated Salish and Kootenai 
Tribes, and the Nez Perce Tribe. We also facilitate and participate in 
studies to develop brucellosis risk mitigation measures.
    The ultimate goal of the IBMP activities is to reduce the risk of 
brucellosis transmission from wild bison and elk in the GYA, while 
maintaining a viable wild bison population. In addition to the 
cooperative effort, each IBMP agency is actively conducting activities 
that are in line with their own agency's mission. Recently, we 
sponsored a review of brucellosis control in the GYA by a National 
Academy of Sciences panel, and we are waiting on the report's release 
later this year. This report will describe the likely effectiveness and 
trade-offs of options that could be used to address brucellosis in the 
GYA. It will also describe and prioritize further research needed to 
reduce uncertainties and advance the knowledge base on brucellosis 
vaccines, vaccine delivery mechanisms, and diagnostics. APHIS will use 
the findings from this report to help guide the development of a 
unified strategy to deal with brucellosis in the GYA.
    Specific to Montana, APHIS provides cooperative agreement funds to 
support brucellosis mitigation activities. APHIS personnel also work 
with the State on every aspect of the brucellosis program, such as 
sample collection and testing for surveillance, responding to 
detections, and conducting epidemiological investigations. In 
collaboration with the Agricultural Research Service and the States of 
Montana and Wyoming, APHIS has developed and continues to develop non-
lethal techniques to detect and eliminate the disease from bison and 
elk populations.

    Senator Daines. Speaking of collaboration, I am going to 
throw something out there, something to consider. In prior 
years, there was extensive collaborative effort. I think 
actually we had better communication. There are a lot of moving 
parts here between State agencies, Federal agencies, and 
private groups.
    It was called the Greater Yellowstone Interagency 
Brucellosis Committee. It brought together a diverse group of 
stakeholders, including representatives from Montana, Idaho, 
Wyoming--obviously, this crosses borders--as well as USDA and 
the Interior. The working group improved communication and 
furthered efforts to provide sound science surrounding wildlife 
disease management throughout the Greater Yellowstone area.
    Unfortunately, this effort lapsed in 2006, 10 years ago, 
and no similar working group has filled that void. I have heard 
concerns in talking to farmers, ranchers, and stakeholders that 
the result has been a deterioration in communication between 
agencies, Federal, State, as well as private groups, regarding 
disease management in the Greater Yellowstone Ecosystem.
    So my question is, would the USDA be supportive of 
reestablishing that Greater Yellowstone Interagency Brucellosis 
Committee, or perhaps something similar?
    Secretary Vilsack. Senator, I appreciate you bringing this 
up. My understanding was that we were in the process of a 
focused, collaborative effort. But if that is not the case, I 
will certainly go back and ask our team to figure out a way in 
which we can be more collaborative as a working group or 
whatever it is.
    We have been trying to stress collaboration with the local 
folks at every level. So if that is not happening, we need to 
make it happen.

                     GENETICALLY MODIFIED ORGANISMS

    Senator Daines. I appreciate that, if that would be an 
outcome from this hearing. We could certainly have that 
communication and bring that concern and try to bring those 
groups together again. The word from back home is that it 
really was valuable.
    I want to shift gears now and talk a bit about what is 
going on in the area of GMOs and biotech. Last weekend, you 
were quoted at a commodities conference, referring to GMOs, 
stating, ``I am here to say unequivocally they are safe to 
consumers.''
    With that in mind and notwithstanding marketing efforts or 
the hurdles of getting legislation through Congress, which is a 
topic of discussion here as we sit here today, are there any 
safety concerns or any sound scientific research that would 
warrant the mandatory labeling of GMOs?
    Secretary Vilsack. No, but that is not obviously the issue. 
The issue is that folks in States have made decisions based on 
referendums and State legislators to create labeling systems 
that are applicable within State borders.
    That creates a circumstance and situation, as you know, 
where we are going to have a hodgepodge and chaotic 
circumstance were individual States and/or individual companies 
are going to make their own decision about what they are going 
to put on the package. It is going to create confusion. It is 
going to create additional expense. It may limit access to 
food, or it may increase the cost of food. It does not have to 
be.
    There is a way, in my view, where you can respect a 
consumer's right to know, if they have interest in knowing the 
production process by which their food has been produced, but 
doing it in a way that does not convey the wrong impression 
about the safety of the food.
    Senator Daines. So I guess getting to this issue of 
mandatory versus voluntary, I mean I think to be clear, a 
decision to implement mandatory labeling would then not be 
based on safety concerns or sound science, but on other 
factors?
    Secretary Vilsack. It would be based on balancing the 
desire on the part of a growing amount of consumers who want to 
know, and companies are in the business of selling to 
consumers--obviously, the customer is always right kind of 
thing--with doing it in a way that does not send the wrong 
message about the safety.
    In the past, we have labeled, we have put something on the 
package, either to talk about caloric content or nutrition or a 
known risk. That is not what this is about, which is why I have 
suggested the establishment of the smart label process, which 
would essentially give consumers who are interested information 
that they are interested in, but not in a way that conveys a 
false impression about the safety of the product.
    Senator Daines. I think we agree it is critical we address 
this issue in a timely manner, given what is going on in 
Vermont.
    Secretary Vilsack. Absolutely.
    Senator Daines. And I have no issue with the voluntary 
programs that meet market demands or consumer preferences.
    That being said, I do believe the USDA's priority should be 
with making determinations based on sound science regarding the 
safety of biotech products within its jurisdiction, not on 
marketing or mandatory labeling efforts that really have no 
bearing on food safety or plant pest risk.
    Secretary Vilsack. Well, I am trying to avoid a chaotic 
circumstance, Senator. I am certainly hopeful that there are at 
least 60 of you who feel the same way I do.
    Senator Daines. All right. Thank you.
    Senator Moran. We are pleased to have the Chairman of the 
Full Committee with this.
    Senator Cochran, you are recognized.

               OPENING STATEMENT OF SENATOR THAD COCHRAN

    Senator Cochran. Mr. Chairman, thank you.
    Thank you to the panel for being here and helping us sort 
through the requests we have for funding of various activities 
administered by the Department of Agriculture.
    One of the bright spots in what appeared to be some 
questions that all seemed to be having trouble being 
administered or costing too much or contributing to the deficit 
and all kinds of bad things, what we found out is that the 
Department of Agriculture has won a big victory in the labeling 
of domestically produced farm fish grown and sold in the United 
States.
    They were having to compete with fish from overseas that 
were mislabeled or suggested that they were superior in some 
ways to domestically produced fish.
    So thank you for the good, strong support and effort in 
defining the new limits and the new requirements that help to 
give customers and consumers an opportunity to choose. They are 
finding out that they are choosing to buy American, and that is 
encouraging in this day of real tough international competition 
in so many areas of agriculture and food production and 
marketing.
    The end of my speech.
    Senator Moran. Mr. Chairman, thank you for joining us.
    We now recognize the Senator from New Mexico.
    Senator Udall. Thank you very much, Chairman Moran.
    And thank you, Senator Vilsack, for your service.
    Secretary Vilsack. I am a Secretary. I am not a Senator.
    Senator Udall. Secretary. I understand. I understand, and 
you were a Governor before that. And you like to get things 
done, I know.
    Senator Moran. Would you like those words stricken from the 
record?
    [Laughter.]

                        STRIKE FORCE INITIATIVE

    Senator Udall. Secretary Vilsack, thank you very much for 
your service and thank you for being here. Just a couple things 
I wanted to ask your support on.
    The New Mexico delegation recently sent you a letter in 
support of the Navajo Promise Zone applications submitted by 
the Navajo Technical University and also submitted by the 
Navajo Nation for what is called a Tribal Promise Zone.
    It is an extremely high priority for me. Let me tell you 
why here.
    The Navajo Nation faces significant challenges, high 
poverty, lack of basic infrastructure, lack of housing, public 
safety deficiencies, among other things. The unemployment rate 
there is totally unacceptable. It is near 50 percent. And an 
equally large percentage of the population is below the poverty 
level.
    They have made steady progress on economic development in 
recent years, but they really needed a boost. I think this 
Promise Zone would really make a difference.
    As part of the President's efforts, this Promise Zone will 
help the Navajo Nation help tackle the issues outlined in their 
application, which I have talked a little bit about here.
    I simply urge you to give consideration to their request. I 
know there are many communities in need, but few face the 
extremely difficult conditions we see on the Navajo Nation.
    Secretary Vilsack. That is one of the reasons why we have 
already included that area in our StrikeForce Initiative at the 
USDA. But you are right, the Promise Zone would extend that 
kind of approach to all Federal agencies.
    I appreciate the comment, Senator, and I will take that 
back to the team.
    Senator Udall. Secretary Vilsack, could you tell me a 
little bit about the StrikeForce effort there?
    Secretary Vilsack. Sure. StrikeForce was designed to focus 
on the areas of persistent poverty in this country. The reality 
is 85 percent of persistently poor areas in this country are, 
in fact, in rural areas.
    What we found early in the Administration was that we were 
not doing enough work in those areas to get folks to understand 
how to basically apply for programs where they could get help.
    So we instructed our team, our FSA team, our nutrition 
team, our rural development teams, and our NRCS team, to go to 
communities across the country where there is persistent 
poverty and basically work with a community-building 
organization to identify projects and needs that we could 
address through USDA programs.
    It is now operating in 920 counties, 21 States, and several 
tribal areas. The result is that we have invested $26.3 billion 
in over 190,000 investments that have been made in the 
StrikeForce areas.
    I would imagine a significant percentage of those would 
never have been made but for the attention and intense work 
relationship that we have created.
    We are now working with over 1,500 community-building 
organizations and partners. It has been I think a successful 
endeavor.
    And I think that has led us to take a look at the Promise 
Zone and some place-based initiatives as well throughout the 
entire Federal Government.

                                COLONIAS

    Senator Udall. Thank you very much for that initiative, 
because I have many communities in my State that I think need 
that kind of initiative and kind of push that you are making 
there.
    This next issue is an issue that I raised last year, and it 
is yet to be resolved. Two communities in New Mexico, Chaparral 
and Sunland Park, our designated colonias. I think you are 
probably familiar with that term. It is on your USDA rural Web 
site. But it means neighborhoods or communities within 150 
miles of the United States-Mexico border that are economically 
distressed.
    They both have been designated colonias, and they are 
ineligible for some USDA rural development funds because of the 
USDA's formula for determining a rural community based on 
proximity to a municipality.
    In this case, because of their proximity to El Paso, Texas, 
even though they are in New Mexico, even though they do not 
benefit from any support or municipal services from a city or 
county like El Paso, which they are close to, and because they 
are not in the same State, these communities have high poverty 
rates, limited public sector funding, separated by over 40 
miles from Las Cruces, the nearest city.
    These communities need rural development funds for critical 
housing projects, economic development funding, infrastructure 
improvements. The area is seeing increasing traffic at the 
nearby Santa Teresa Port of Entry, which is positive, but 
really underscores the need for infrastructure.
    So waivers have been used for similar situations in the 
past, but we are experiencing difficulty with waivers in these 
cases. Would you work with me and within your authority to 
ensure that these two communities do not fall through the 
cracks and are made eligible for rural development assistance?
    Secretary Vilsack. Senator, as you were outlining your 
request, I turned to my staff to ask whether or not waivers 
were available, and we will certainly work with you and your 
team to figure out, if they are, how to use them, and if they 
are not, what else we could potentially do to provide--because 
colonias is part of our StrikeForce Initiative. So we obviously 
are cognizant of the challenges of that particular area, so we 
will be happy to try to find a creative solution to the problem 
they are facing there.
    Senator Udall. Thank you very much. I could not think of a 
better person to be Secretary of Agriculture because you served 
as Governor from a rural State. You know rural communities and 
how they are struggling. I sure appreciate this effort in terms 
of the StrikeForce and look forward to working with you. Thank 
you very much.
    I yield back, Mr. Chairman.
    Senator Moran. You had no time to yield back, but thank you 
for the effort.
    The Senator from North Dakota.

                       FARM PROGRAMS SURVEY DATA

    Senator Hoeven. Thank you, Mr. Chairman.
    Good to see you, Mr. Secretary. Thank you for your work on 
behalf of our farmers and ranchers. As you know, we want to 
make the farm bill as farmer-friendly as possible.
    That is particularly important right now with low commodity 
prices. We are seeing real stress out there in the ag world on 
the part of our farmers and ranchers with these low commodity 
prices.
    One area that we can help in terms of making sure that the 
farm bill is farmer-friendly is with the National Agricultural 
Statistics Service (NASS) data. I think that you are already 
working on this with your FSA Administrator Val Dolcini.
    But in some cases, that NASS data, because there are not 
enough survey forms sent in for some counties, we are getting a 
bad result.
    It is not unique to North Dakota. It is occurring in other 
States as well. I believe in Iowa, and I do not know about 
Kansas, but a number of States. We have counties, and there are 
not enough of the survey forms that come back and so the NASS 
information is not used. Instead, we are using Risk Management 
Agency (RMA) information. And we are getting a bad result.
    What I mean by that is if you take counties, for example, 
in North Dakota, Logan and Lamoure, and you compare them to 
similar counties in terms of the average for corn, for example, 
for the year. If we do not have enough NASS data, we use the 
RMA data, and we are getting a result that does not correlate 
with like counties. So other counties that typically have about 
the same yield, those farmers get an ARC payment. But because 
the RMA data is so high, it is disqualifying farmers in Logan 
and Lamoure counties, for example, from getting in an ARC 
payment on corn.
    That is one example. There are other examples around the 
country.
    So we have asked Val Dolcini at FSA to allow us to work 
with the FSA Director in the respective State and use 
comparable counties that have adequate NASS data, so we do not 
get a skewed result. It is very important to farmers, 
particularly with low commodity prices.
    So what can you tell me in terms of your willingness to 
provide this flexibility? I know you are doing an interagency 
analysis or study, I think is the term for it. But what can you 
do to help here, Secretary, so we can get this fixed?
    Secretary Vilsack. Well, as you know, Congress made the 
decision to do a county program as opposed to an individual 
program. I think they probably did that because of the cost of 
the individual program and the need to generate savings in the 
overall program. So we obviously have to deal with the county 
program, and we have to have some kind of process by which we 
can try to treat as many of the several thousand counties that 
we are dealing with as fairly and equitably as we can.
    So we have come up with a proposal, the outline that you 
have addressed, which we have looked at NASS data first. If 
there are inadequate numbers of surveys, we ought to focus on 
making sure we get farmers to respond to those surveys, so we 
have adequate information.
    If we do not, we go to RMA information. If we are not 
satisfied that that is appropriate or correct, we have 
empowered our State Committees to basically take a look and 
provide some direction.
    So we think we have some degree of predictability and 
consistency without necessarily creating a circumstance where 
we cannot address the anomaly or the inaccuracy of information.
    I am more than happy to go back to our team and basically 
make sure that we are in a position to be able to explain why 
we are making the decisions we are making. If we cannot, then 
we obviously need to do something different.
    Senator Hoeven. My understanding is it is currently in this 
interagency review. I do not know what the results of that are.
    If, in fact, the State Committee is empowered to make a 
decision, I think that is where we need to go. Again, it is 
making sure you are giving discretion out there in the field to 
your directors to make a good decision.
    Secretary Vilsack. That is the key, a good decision. We do 
not necessarily want to create a circumstance where everybody 
is not happy with whatever it is they ultimately get, because 
then you create a very confusing circumstance and you end up 
getting an individual program when you really, by statute, are 
directed to have a county program.
    So I think there is a balance here. I am more than happy to 
try to be flexible, but I think we do have to have some system.
    Senator Hoeven. I hear you. Of course, we want the NASS 
survey forms to come in, so you have adequate data and you have 
good data. But where that has not occurred, just so that that 
State Committee or FSA Director, however you decide you want to 
do it, is empowered to say, okay, this is a nonsensical result. 
We will make an adjustment.
    My question is, I do not think we have gotten that response 
back from FSA. They are still doing this interagency review. 
This has been going on since November. I am asking for your 
help to get an answer.
    Secretary Vilsack. You deserve an answer, Senator. We will 
try to get you one quickly.
    Senator Hoeven. All right, thank you very much, Secretary.

                         CROP INSURANCE PROGRAM

    The other thing I will just mention, if you have any 
reaction, that is great. I am very concerned about any 
reductions to the support for crop insurance. That is the 
number one risk-management tool for our farmers. You are 
probably not surprised to hear me say that because you and I 
have had this discussion before.
    But I am very concerned about that and I am going to make 
sure we do everything we can to support crop insurance. In 
fact, we included language in the farm bill to make sure that 
did happen.
    On the positive side, though, I appreciate the support that 
you have provided for Agricultural Research Service, ARS, and 
for NIFA, National Institute of Food and Agriculture. I think 
that research area is incredibly important, incredibly 
impactful for our farmers and ranchers. So if you have some 
thoughts there, I would welcome them.
    Secretary Vilsack. Just briefly on the crop insurance, 
there are two areas. One is on the prevented planning. Our 
Inspector General, and I think the Government Accountability 
Office, have been critical of the way in which that program 
operates. So I think it is appropriate for us to be responsive 
to those criticisms. What we have proposed in the budget is our 
effort at being responsive.
    On the price harvest loss option, where we are proposing a 
slightly different arrangement between the producer, the 
government, and the insurance company, where we are currently 
financing 62 percent of the premium, we think it is probably 
fair to taxpayers that it be more of a 50/50 partnership. Those 
are the two proposals.
    Senator Hoeven. I would point out that since 2008, $12 
billion has been taken out of crop insurance support. And you 
want a robust number of companies out there providing crop 
insurance to have a competitive market, and we have to be 
careful or you are not going to have enough competition out 
there to have a robust market.
    Secretary Vilsack. That is true. Our projections I think 
for return on investment with this budget is 18 percent.
    Senator Hoeven. For which they have to cover all of their 
costs.
    Secretary Vilsack. Well, not all their costs, because there 
is also an additional resource for administrative and operating 
costs.
    Senator Hoeven. Right. But again, at the end of the day, if 
they cannot make enough money to continue to stay in that 
business and to cover costs, you are going to have fewer and 
fewer agencies. You are not going to have a robust insurance 
group out there providing crop coverage.
    Secretary Vilsack. I am not sure either one of these two 
proposals necessarily impacts the issue that you have raised, 
but I am certainly sensitive to the fact. That is why we are 
continuing look at the return on investment. We had a couple of 
years where it was difficult, but we are beginning to see more 
profitability in that part of the operation. I think it was 15 
percent or 13 percent last year, 18 percent projected for this 
year.
    Senator Hoeven. Again, I appreciate that. I understand your 
point of view, though I do not agree with it.
    I do want to again emphasize that crop insurance support 
has been reduced by $12 billion since 2008. I think there are a 
lot of programs across the Federal Government that have not 
contributed as much in terms of help with finding savings as 
crop insurance.
    Secretary Vilsack. You do not have to tell me about 
reductions, Senator. My overall operating budget is less than 
it was in 2010.
    Senator Hoeven. Secretary, again, thanks for what you do. 
Thanks for your willingness to take a look at the NASS data. I 
appreciate it.
    Senator Moran. Senator Merkley.

                        RURAL BROADBAND PROGRAM

    Senator Merkley. Thank you, Mr. Chairman.
    I thought I would turn to a piece of the picture that I 
hear about a lot that has not been mentioned yet, and that is 
rural broadband. Everywhere I go in Oregon, folks note the 
importance of it to the success of their rural communities.
    So I wanted to explore this a little bit, because, as I 
understand it, USDA recently rewrote the broadband loan program 
regulations to reflect the changes in the 2014 Farm Bill. It 
really has just kind of gotten going, but I believe you are now 
proposing eliminating this.
    Meanwhile, the grant program, which has increased, is a 
distinctly different program. The grant program serves a small 
number of poor, unconnected communities. The number of 
communities it focused on in fiscal year 2015 was five 
communities.
    So I think there is concern that there is going to be a 
sacrifice of a program that serves large expanses for assisting 
a small number of communities, and whether or not that really 
reflects the demand for rural broadband. There is probably a 
lot more thinking behind it. I thought I would just give you a 
chance to explain it.
    Secretary Vilsack. Senator, I appreciate the question. What 
we have found is that it is not impossible for companies to 
secure loans. But to the extent that they can get grant funds 
that either reduce the amount they have to borrow or to reduce 
the interest rate on the loan, that makes it much more likely 
that they are in a position to do significant improvements and 
expansions.
    So listening to what we believe the industry is telling us 
is necessary to get more broadband in more places, combining 
that with hopefully with what the FCC is attempting to do and 
hoping it works properly to create more incentive and more 
resource for expansion of broadband, the combination of those 
two.
    So that is why we are proposing an increase in the grant 
program, because we think that will generate more activity than 
simply a loan program.
    Senator Merkley. Thank you for that explanation. I look 
forward to tracking that because it is of so much importance.
    My colleague from Wisconsin has arrived, and I am going to 
turn this over to her. Just in closing out my comments, thank 
you again for your service over 7-plus years and counting. 
There are many more questions I have that I will be submitting 
to you for the record, but I do not need to address them at 
this point. Thank you.
    Senator Moran. The Senator from Wisconsin.
    My intention is to have the Senator from Wisconsin ask her 
questions. I have a few follow-up questions, and then we would 
anticipate concluding the hearing.

                WATER AND WASTE WATER TREATMENT PROGRAM

    Senator Baldwin. I thank the Chair.
    Mr. Secretary, in Wisconsin, water issues are on everyone's 
mind, as our rural communities are facing many challenges to 
protect their water quality.
    In particular, Kewaunee and Door Counties in Wisconsin's 
northeastern region have nitrate and bacteria contamination in 
their groundwater. Testing is showing that more and more 
private wells are contaminated.
    Local stakeholder groups are working with the State 
Department of Natural Resources (DNR) to talk about long-term 
solutions. But as those deliberations continue, rural families 
remain without immediate solutions to these very pressing 
concerns and the obvious need for safe drinking water.
    Mr. Secretary, I believe your Department can help, but it 
is going to take some really, really hard work. So I would ask 
you how you see the USDA playing a role in these communities in 
Wisconsin, and would you commit to working with me and the 
local communities to offer both immediate and long-term 
solutions that help watersheds in this vital region of our 
State and our country?
    Secretary Vilsack. Senator, do you know offhand what the 
population is of those two communities? Is it greater than 
10,000 or less than 10,000?
    Senator Baldwin. Both counties I believe would be greater, 
but they might be close. They are sparsely populated.
    Secretary Vilsack. Well, the first line of response to your 
question is, to the extent that the infrastructure that treats 
water can be modernized, obviously, the USDA has our water and 
wastewater treatment programs that are available.
    We also have a partnership with CoBank and other farm 
credit agencies that are providing infrastructure loans that 
USDA cannot do or will not do or does not have enough resources 
to do. It is leveraging our resources.
    We have had a series of partnerships with the farm credit 
system where we will fund half a project and the CoBank will 
fund the other half. They made a $10 billion commitment to 
infrastructure in rural areas across the United States.
    The third alternative, on this side of the equation, is to 
work with us to identify potentially private sector investors 
who might be willing to provide the financing to improve the 
systems.
    So those are three basic avenues of financing 
infrastructure. We will be more than happy to work with you and 
have our rural development people work with those two counties 
in those two areas.
    You asked for a short- and long-term solution. Obviously, 
long-term is to try to work with conservation programs to try 
to prevent the problem from getting worse and ultimately 
reversing it.
    Actually, Wisconsin has a number of communities like Green 
Bay that are working with the Fox River that are trying to 
create ecosystem markets where essentially regulated industries 
would be able to pay farmers for conservation that would allow 
them to satisfy a particular ecosystem regulation, or there may 
be a corporate entity that is looking from a social 
responsibility perspective.
    We just did an event with Chevrolet on carbon credits, for 
example, in North Dakota, a working ranch in North Dakota.
    So we are trying to create more ecosystem market 
opportunities in Wisconsin. That requires us to be able to 
measure and verify and quantify the conservation results. If 
you can do that, and I would encourage those folks to consider 
a Conservation Innovation Grant, a CIG grant, which we have 
used in the past to help create a measurement and certification 
and qualification system.
    Let me just give one other piece of this. There is also the 
regular Natural Resources Conservation Service (NRCS) programs 
and the Conservation Reserve Program (CRP). There is a 
continuous program that potentially could be used to develop 
bioreactors in those conservation programs that would allow for 
better filtering of contaminants, nitrates and so forth.
    So there is a body of steps that can be taken short term 
and long term to try to address this.
    Senator Baldwin. I appreciate that, and there has been, as 
I was mentioning, a good local collaboration not only with our 
State DNR but I know a real interest in these collaborations on 
long-term solutions at the Federal level.
    I will just restate that many of the residents impacted 
have private wells. They, therefore, have an immediate need for 
clean drinking water. So I hope we can follow up this exchange 
with ways in which the USDA can help meet those very important 
and immediate needs.
    Secretary Vilsack. What we were able to do in a slightly 
different situation in California where it was drought and they 
had private wells, but they just did not have any water in the 
well, we were able to take a look at whether they were 
adjoining an area of municipal systems that could potentially 
be extended to those private homes that were serviced by a 
private well.
    So I do not know if that is possible at all in what you are 
talking about, but that is something.

                      CLASSICAL BREEDING RESEARCH

    Senator Baldwin. I appreciate your commitment to work with 
me and local communities, and we will certainly follow up.
    I did have one other question that I wanted to address to 
you, Mr. Secretary. In addition to being America's dairyland, 
Wisconsin also produces a lot of specialty crops, and we have a 
very vibrant and rapidly growing organic sector, second only to 
the State of California in the number of organic farms within 
our State.
    The specialty crops and organic farmers have a great need 
for new varieties and breeds that are adapted regionally and 
respond to market demands that can help them grow their 
markets, so-called seeds and breeds.
    In response to this Subcommittee's work last year and 
direction in the fiscal year 2016 spending bill, I know that 
the USDA is producing a report on classical breeding 
investments, but this committee also directed the agency to 
create a specific competition for classical breeding so that 
proposals for this specific type of research compete against 
each other and not against other different research fields.
    So we have yet to see progress on that particular front. 
For Wisconsin farmers, it is not about the academic 
competition. It is about having the varieties that they need 
right on the farm to help them make it through tough years.
    So I hope that you will commit to resolving this issue this 
year, and pushing forward with that specific competition for 
classical breeding research.
    Secretary Vilsack. I will certainly take a look at that. I 
will tell you that there is an intent and interest in this 
area. We are investing a bit more time and energy in it.
    We are also making sure that our own seed banks are 
available, in the event there is a situation where we do not 
have seed in the past. So it is a combination of preserving the 
past and also preparing for new varieties.
    I said earlier that our research has already created, over 
the time I have been Secretary, 714 different plant varieties, 
so we are involved and engaged in this. I think there is a good 
balance between where we have genomic information, using that, 
where we do not, using the classical breeding. So it is a 
combination and balance.

                         AGRICULTURAL RESEARCH

    Senator Baldwin. I thank the Chairman and Ranking Member 
for their leniency in watching the clock.
    Senator Moran. Thank you, Senator Baldwin, for joining us 
today, and thank you for your questions of the Secretary.
    Mr. Secretary, let me editorialize just for a moment.
    In regard to agriculture research, our fiscal year 2016 
agriculture appropriation bill provided $350 million for the 
Agriculture and Food Research Initiative (AFRI), a $25 million 
increase. That is the highest funding level this program has 
received since its inception. We worked hard under the 
allocation that we had to provide additional support for 
agriculture research. You mentioned its importance, as have a 
number of my colleagues.
    My editorial comment is that we cannot compete with the 
Administration's budget when they use mandatory spending as the 
solution to funding this and many other programs, not just in 
your budget but across the Federal Government, Federal 
Government-wide.
    Again, this is a budgetary issue beyond your scope, but it 
is important that the Administration recognize that when they 
make a budget request to us as appropriators, we do not have 
the ability to provide funding with mandatory spending. I think 
they know that. It sets a bar. Perhaps it is just posturing to 
suggest that the Administration, your Department is more 
interested in agricultural funding than we are. But when we 
come to the amount of money that we have within our 
jurisdiction to provide support for agriculture research, in my 
view, we have been there.

                              CUBA OFFICE

    You have been kind enough to attempt to include me in a 
visit to Cuba. I appreciate that invitation. I have been a 
longtime advocate for lifting the embargo, particularly as it 
relates to food, medicine, and agriculture commodities to Cuba. 
I had some success in that regard when I was a member of the 
House of Representatives.
    Your budget includes some funding for changes that may 
occur in our relationship or is occurring in our relationship 
with Cuba. What is the circumstance by which you ask for 
dollars for agricultural representation in Cuba?
    And secondly, knowing that the appropriations process in 
which you are asking for this money to be included, that may be 
a controversial request, I am not certain. But even if it is 
not, this process takes a long time. So what is USDA doing in 
Cuba today to help assist in the export, sale of agriculture 
commodities.
    Secretary Vilsack. Senator, the embargo statute basically 
prohibits the Department of Agriculture from using any of its 
market assistance programming money, so we cannot directly help 
promote, as we do in other countries. That is one of the 
reasons why we need to get rid of the embargo.
    But even if we get rid of the embargo tomorrow, we would 
not necessarily be prepared to do everything we are potentially 
able to do in Cuba, in terms of regaining market share that we 
have lost over the years because we do not have the 
relationships and people on the ground to basically know the 
people that we need to know on the Cuban side to be able to 
effectuate more trade. That is the reason why we have asked for 
personnel to be down in Cuba, to be permanently located down 
there, so they can create the relationships so that when the 
embargo is in fact lifted and we can use promotion resources, 
that we are in a position to move expeditiously to take full 
advantage.
    Senator Moran. I do not know off the top my head the amount 
of dollars you have requested.
    Secretary Vilsack. I think it is $1.5 million for five or 
six people.
    Senator Moran. I think that is right. So the point you are 
making is that is not to assist directly in support 
subsidization of any sale to Cuba or to any marketing program.
    Secretary Vilsack. Correct.
    Senator Moran. It is directly related to the ability to 
have USDA personnel in Cuba, developing relationships with 
potential customers.
    Secretary Vilsack. And also to do an evaluation of the 
pests and diseases that we may potentially confront when our 
relationship becomes more bilateral.
    The second piece of this is that there are commodity groups 
that are quite interested in doing business down there, because 
they realize that we have a competitive advantage that we have 
not taken full advantage of. They are asking us to explore ways 
in which they themselves, apart from what we cannot do, can 
they be more aggressive in their promotion efforts.
    We are looking for ways we can find--a way for them to be 
more aggressive, so that without necessarily direct support 
from USDA, commodity groups, State ag commissioners, State ag 
secretaries, individual farm groups will be able to promote 
product.
    Senator Moran. Mr. Secretary, in that regard, my 
understanding of the current state of the law in regard to Cuba 
is that we can sell agriculture commodities, food, and medicine 
to Cuba for cash.
    Secretary Vilsack. It is harder, but we can.
    Senator Moran. So commodity groups could promote those 
sales today. Is that true?
    Secretary Vilsack. Yes. The question is whether or not any 
of the resources, the check off dollars, for example, could 
potentially be used by those commodity groups. We are in the 
process of trying to figure out the answer to that question. We 
do not want to unnecessarily create a circumstance where we are 
violating the law. We want to make sure we understand the law.
    But this is a tremendous opportunity for us. It is just 
nuts that we do not have more of a market share than we do down 
there.
    Senator Moran. Dr. Johansson, in his commentary to us, in 
his conversation with us last week, indicated significant 
opportunities and compared it to the Dominican Republic, as I 
recall.
    Secretary Vilsack. Eighty percent of Cuban food is 
imported, 80 percent. And I think we do 10 percent, 15 percent 
of their needs today. We should be doing 50 percent.

                        BROADBAND OPPORTUNITIES

    Senator Moran. We have seen significant improvements in the 
opportunity to sell. I think it was 2010, maybe 2011, the law 
was changed to allow the sales. And regulations were altered 
about that point in time, money had to be received upfront, 
whether it was when the ship left the United States or when it 
arrived in Havana. Then the third-party financing issues.
    But those are regulatory issues that perhaps will be 
addressed. But this issue of Cuba will be one of broad interest 
in Congress. It has its opponents, which I discovered in my 
time working on this issue.
    Let me return to a topic that we visited about last year in 
this same setting. I encouraged you, and you indicated that you 
do and would, continue your conversations with the Federal 
Communications Commission. I have expressed an ongoing concern 
about the ability for particularly rural telephone companies to 
be able to repay loans they owe the Rural Utilities Services 
(RUS) based upon decisions that the FCC has and is continuing 
to make.
    I would again highlight this issue for you in the sense 
that it is important I assume to you that we allow those 
companies to expand broadband opportunities in rural America, 
but also you may have a default rate of significant magnitude 
if the FCC makes decisions, particularly as it relates to the 
Universal Service Fund that would have consequences to a 
telephone company, a broadband provider, let me be broader than 
that, a broadband provider's ability to repay RUS.
    Secretary Vilsack. We are cognizant of that. I can assure 
you that we indicate to FCC concern in that space. So we are 
keeping an eye on it. We have advised them of your concerns and 
of our concern.
    Senator Moran. On the same topic of broadband, I am an 
advocate, obviously, for expansion of those opportunities in 
places that are unserved. I have worried from time to time that 
various programs, perhaps more related to the Stimulus package 
than the programs under your Department, have provided loans 
and subsidization for companies to compete in already existing 
territory in which broadband services exist.
    Could you tell me the current state of at least your 
programs, those that you are responsible for, and their ability 
to obtain support from your Department to compete with existing 
broadband providers?
    Secretary Vilsack. Yes. We do not have unlimited resources, 
so we have to make sure that they do the job. We are mostly 
focused on unserved and underserved areas. I do not believe we 
are creating circumstances where we are encouraging competition 
here. We are trying to meet an unmet need.
    Senator Moran. You used a few words there that cause me to 
ask you to confirm that to me.
    Secretary Vilsack. Sure. I am not trying to be evasive 
here. I am reasonably certain that our focus is on unserved and 
underserved areas. It is not based on places where there is 
already service.
    Now, I would say that we may be in a situation where we are 
trying to upgrade the service that is being provided, so that 
download speeds and upload speeds are increased. I do not think 
that falls within the scope of your question, because it is not 
competition. It is about working with an existing operation to 
improve their service.
    Senator Moran. I know of circumstances in which loans or 
grants were made to provide service to areas that had no 
service. But in order to make that financially possible, the 
territory in which the loan could be used included areas that 
already had service. So areas that already had service got 
competition. They were larger communities, and I assume the 
theory was that revenue generated in that larger area makes it 
economically more viable for service to be provided in places 
that are much smaller that have no service.
    But my view is that the government program is the subsidy, 
not creating additional service in places that are already 
served, and taking the revenue that is generated there to 
support areas that do not have service.
    Secretary Vilsack. You deserve a more detailed answer. We 
will make sure you get it.
    [The information follows:]

    The Farm Bill Broadband Loan Program funds broadband facilities in 
rural service territories with at least 15 percent unserved 
households,as per statute in Title VI of the Agricultural Act of 2014 
(Public Law 113-79, Section 6104 2(B)i). A household is considered 
unserved if it is not receiving broadband service as defined in the 
latest Notice of Funding Available (NOFA). The program offers 
incentives for loan applicants to go into areas with at least 50 
percent unserved households. Areas with three existing broadband 
service providers are not eligible for funding. Applications that are 
proposing to provide service at the Broadband Lending Speed as defined 
in the NOFA will receive priority consideration for funding.

                         MCGOVERN DOLE PROGRAM

    Senator Moran. I appreciate that. I am almost done, Mr. 
Secretary.
    Food aid, and particularly the McGovern-Dole--in Kansas, we 
would say the Dole-McGovern program. You are proposing 
reductions in the spending in that area.
    If we agree with your position, your budget request, how 
would USDA absorb those cuts? Are there ongoing programs that 
would be affected? Do you have countries that you would 
specifically exclude from the program? So if there is less 
money, how would you spend the money that you would have 
remaining?
    Secretary Vilsack. As you well know, the Dole-McGovern, 
McGovern-Dole program is designed not to be a permanent level 
of support for countries, but it is designed to show the wisdom 
of basically linking education and food with the hope that the 
host country would eventually take over that responsibility. So 
there very well may be countries where we have been active and 
involved in providing assistance for an extended period of 
time, but which we think it is time for them to basically pick 
up the mantle, if you will. That may be a consequence.
    So it may be that there is not a circumstance where we are 
necessarily going to cut off or cut out people who are 
currently receiving service or assistance without some 
substitute from the host country.
    The other possibility is that we are proposing to use a 
small portion of McGovern-Dole for local purchases, which may 
potentially leverage those dollars more effectively as well.
    So I would be more than happy to give you a more detailed 
response to that question, but it does point out the challenge. 
Whenever we have conversations about budgets, we always focus 
on individual programs. But the reality is your circumstance 
and our circumstance in putting a budget together, it is all 
about choices.
    If we did not have a finite number that we had to deal 
with, if we could fix the fire budget, it creates more 
flexibility in our budget.

                         FOREST FIRE BORROWING

    Senator Moran. Is there another opportunity you would like 
to say that, Mr. Secretary?
    Secretary Vilsack. Yes. To be very, very candid, Mr. 
Chairman, this is one area that has frustrated me more than any 
since I have been Secretary, because everybody--everybody--
knows this is a problem.
    The reason I feel so strongly about this is last year 
during our award ceremony, I had to give out seven American 
flags to family members who lost loved ones in forest fires. 
The reason why some of them were lost was because we have not 
been able to do the job that we need to do in restoring and 
making our forests more resilient because every year we borrow 
money from those very accounts to put fires out.
    To me, a fire is no doggone different than a flood or 
tornado or hurricane, where we fund not out of an operating 
budget, but out of an emergency budget.
    If we could just create a circumstance where those large, 
uncontrolled, very expensive fires could be dealt with, it 
would create more flexibility within this budget, and many of 
the concerns that you all have addressed here, which we share, 
could potentially be more adequately addressed.

                 NATIONAL BIO AND AGRO-DEFENSE FACILITY

    Senator Moran. Thank you for your passion and for your 
compassion.
    Mr. Secretary, I appreciate you being in Manhattan, Kansas, 
when we cut a ribbon on the National Bio and Agro science 
facility. Thank you very much, soon to be a Department of 
Agriculture operation.
    I just would highlight, as transition occurs from Plum 
Island to the National Bio and Agro-Defense Facility (NBAF), my 
impression is that there may be USDA employees who do not 
relocate. We want to work with you to make certain that the 
training and recruitment, retention opportunities exist at USDA 
to make certain that when the day comes that you are fully 
staffed with the highly capable and significant expertise in 
this important issue of protecting our homeland.
    Secretary Vilsack. Well, that is certainly an appropriate 
request, Mr. Chairman. Thank you.

            NEW, BEGINNING, AND VETERAN FARMERS AND RANCHERS

    Senator Moran. Finally, your budget proposes a $5 million 
increase in the Office of the Secretary. This sounds like a 
difficult question, but it is for something that I find very 
appealing, for new, beginning, women, and Veteran farmers. I am 
not certain how you intend to utilize those dollars, but I 
would highlight for you that our Subcommittee intends to have a 
hearing in the next several weeks on this topic of how to bring 
veterans into agriculture.
    Secretary Vilsack. We have finally, after a good deal of 
effort, secured commitments from the Department of Defense to 
begin the process of going on base. As service men and women 
are leaving the service, they receive a series of briefings on 
opportunities. In the past, agriculture has not been part of 
that process. Now we are getting permission to be part of that 
process.
    We want to be able to provide those veterans with the 
opportunity to know how they might be able to access a chance 
to be a farmer.
    If you go on our Web site, probably the most popular aspect 
of our Web site in the last 6 months has been are Beginning 
Farmer Web site that we revamped. You can actually go in now 
and you can plug in your wish list of what kind of farmer you 
would like to be, what you would like to grow, how big you 
would like to be. It will give you essentially a personalized 
plan for the programs within USDA that can provide help and 
assistance, whether it is a microloan, conservation, help with 
crop insurance, whatever it might be.
    We think the combination of more education of those 
returning veterans about opportunities that do, in fact, exist 
within agriculture, the greater the interest will be.
    So to the extent that we can sort of spread our tentacles 
in a much wider base than we have in the past, I think that 
will be helpful.
    We also know that 70 percent of the world's farmers are 
women, and there is an increasingly greater interest among 
women in this country to participate. Again, it requires 
outreach. It requires a little time. It requires access to 
information and providing an easy way for people to get 
information.
    So that is the purpose of this. The Deputy, Secretary 
Krysta Harden, who is no longer with the agency, was a great 
proponent of this. I think her work has been very successful.
    If you look at the recent census, you are going to see an 
increase in women farmers. You are going to see an increase in 
farmers of color. And you are also going to see an increased 
interest in working with other veterans' groups to see bring 
veterans into the farming business.
    Senator Moran. Mr. Secretary, I applaud those efforts. We 
have seen a number of just individuals--Gary LaGrange, who is 
retired military in my hometown, has created opportunities for 
veterans returning with traumatic injuries to enter farming, in 
this case, beekeeping, in a very successful way.
    Incidentally, legislation that I have introduced has passed 
the Small Business Committee to create an opportunity for 
veterans to use their G.I. Bill. I welcome my colleagues who 
are still here to join us in this effort, to use their G.I. 
Bill to get education, training vocationally to become farmers, 
or other business men and women to become entrepreneurs, which 
farming is.
    So we look forward to working with the Department to 
accomplish that.
    I would be less than polite if I did not give my colleagues 
a chance--I hope they say no--but does anybody have anything to 
follow up before I conclude the hearing?
    Senator Merkley.

                         FOREST FIRE BORROWING

    Senator Merkley. Thank you, Mr. Chair.
    Since you offered, I just wanted to address the fire 
borrowing. Senator Wyden and I have been working with Senator 
Murkowski and have been chief advocates of ending fire 
borrowing. We worked very hard to persuade the Administration 
to back this plan. The Administration backed it. Thank you.
    It is not in this Subcommittee's jurisdiction, but it is 
absolutely important. I hope every meeting you go into, you 
will be talking about it.
    We did make a significant change last year. That is that 
the firefighting was funded at 100 percent of the previous 10-
year average, plus a $600 million buffer. Given the impact of 
the Pacific blob and its change in precipitation in the forests 
of the Northwest, there is a chance that there will be no fire 
borrowing this year. We will wait and see. We will see what the 
summer looks like.
    But you are absolutely right. I will just put a huge 
exclamation point. The mega-fires, the large fires, should be 
treated as the natural disasters they are. We have constantly 
robbed fire health and hazardous fuel buildup on the floor of 
the forests, we have constantly robbed that to pay for fighting 
fires. People say, why do you always go to the backend when it 
is at the point of disaster, rather than treat the forest right 
on the front end?
    So thank you for your advocacy on it. Please continue in 
every possible setting. All of us from the Northwest who suffer 
these terrible fires are grateful.
    Secretary Vilsack. Senator, I appreciate those comments. I 
just want to underscore, I am not going to authorize transfers.
    Senator Merkley. Oh, yes, not from this committee to 
another. But that is not the point. Yes, I understand. You are 
saying you are going to block----
    Secretary Vilsack. I am not going to authorize it because 
basically that takes everybody off the hook.
    Senator Merkley. Well, I think that should focus a lot of 
minds here on Capitol Hill.
    Secretary Vilsack. I hope so.
    Senator Merkley. Thank you.
    Senator Moran. Senator Baldwin.
    Senator Baldwin. Thank you. At the risk of not saying no to 
your offer, I want to also add my words of agreement with 
tackling the fire borrowing issue.
    Certainly, Wisconsin is not a State where we have many 
forest fires, but we have a significant part of our Northwoods 
with a very active timber industry and small businesses 
dependent upon sustainable management of our forests. I feel 
like we absolutely must tackle this.
    I just want to say, not only to the Secretary, but to the 
Chair and Ranking Member, how pleased I am to be on the 
Subcommittee, and how much I look forward to working on a 
number of issues with you over this appropriations season. I 
wanted to just call attention to two that I did not have a 
chance to refer to during my question period, which is 
promoting agricultural innovation through the Value-Added 
Producer Grant program, and everything we can do to help new 
producers get their start with the Beginning Farmer programs, 
in addition to the ones the chairman and the Secretary just 
discussed. I am a big fan and look forward to working with all 
of you on that.

                CLOSING STATEMENT OF SENATOR JERRY MORAN

    Senator Moran. Senator Baldwin, we appreciate your 
participation and presence on the Subcommittee. We look forward 
to working with you on that and other issues.
    Senator Merkley, thank you very much for your kindness and 
the working relationship that we have.
    Mr. Secretary, you have been complimented by members of 
this Subcommittee on both sides of the aisle. I would add my 
compliments to you. This is the only the second year that I 
have chaired this Subcommittee, so while I have been on it, 
this is the time I have had the most opportunity to get 
acquainted with you, mostly in this setting.
    What I would say is that I am impressed, pleased, about the 
level of your knowledge, the amount of detail that you know. 
There is something perhaps to what Senator Blunt said about 
experience, 7 years. I guess I should not assume this is your 
last opportunity to appear in a budget hearing before this 
Subcommittee. Perhaps it is. But I would like to thank you for 
being a Secretary who apparently, seemingly, knows what is 
going on to a large extent at the Department that you head. 
That is pleasing to me.
    We are going to try to do everything that I can do to 
become comparable in level of knowledge as a member of this 
Appropriations Committee, so that I can have a full and 
complete understanding as best as possible on the details of 
what goes on at USDA, and, in our case, the Food and Drug 
Administration (FDA). I want to be knowledgeable as well and 
look forward to developing greater expertise as you have 
developed over the last 7 years. I thank you for your public 
service.
    Secretary Vilsack. Mr. Chairman, thank you very much. It 
has been an honor to appear before this Subcommittee.
    I really feel blessed that I get to work with incredibly 
dedicated people at USDA. We all work for just an amazing group 
of people who live, work, and raise their families in rural 
areas who do so much for this country and oftentimes what they 
do is underappreciated or not appreciated at all. So I 
appreciate this privilege that I have, and I consider it a deep 
honor. Thank you.
    Senator Moran. Mr. Secretary, thank you very much.
    I will not diminish what you just said by sounding very 
formal now, but I have magic words I must say.
    For Members of the Subcommittee, any question that you 
would like to submit for the hearing record should be turned 
into Subcommittee staff within 1 week, which is Wednesday, 
March 16. We would appreciate it if you would have responses 
back from USDA within 4 weeks of that time.

                          SUBCOMMITTEE RECESS

    Senator Moran. I thank the gentlemen who accompanied you 
today, and I believe that concludes our hearing.
    Thank you.
    [Whereupon, at 3:45 p.m., Wednesday, March 9, the 
subcommittee was recessed, to reconvene subject to the call of 
the chair.]



   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2017

                              ----------                              

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.

                       NONDEPARTMENTAL WITNESSES

    [The following testimonies were received by the 
Subcommittee on Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies for inclusion in the 
record. The submitted materials relate to the fiscal year 2017 
budget request for programs within the subcommittee's 
jurisdiction.]
        Prepared Statement of Academy of Nutrition and Dietetics
    The Academy of Nutrition and Dietetics appreciates the opportunity 
to submit testimony for the fiscal year 2017 appropriations. The 
Academy is the world's largest organization of food and nutrition 
professionals, and is committed to improving the nation's health with 
nutrition services and interventions provided by registered dietitian 
nutritionists. Nationwide, The Academy has over 75,000 members. As 
Congress begins work on fiscal year 2017 appropriations, we strongly 
urge you to fully fund Federal nutrition programs that will provide a 
return on investment to improve health and build strong economies. 
Investment in these programs through the appropriations process will 
help prevent costly healthcare expenses due to chronic diseases.
special supplemental nutrition program for women, infants and children 
                                 (wic)
    WIC serves low-income women and young children until the age of 
five, providing them with a nutritious monthly food package, nutrition 
education, healthcare and social service referrals to ensure that this 
at-risk population receives the quality nutrition and healthcare 
essential for healthy growth and development. We are asking you to 
please:
  --Fund WIC at $6.350 billion to support a projected caseload of 8.02 
        million participants. Monitor food cost inflation and caseload 
        to ensure that appropriated levels meet anticipated needs.
        --Provide $150 million to replenish the WIC Contingency Fund 
        for unforeseen food cost or participation increases.
        --Provide $80 million for breastfeeding peer counselors to 
        improve breastfeeding initiation and duration among the target 
        population,
        --$75 million for Management Information Systems/Electronic 
        Benefits Transfer (EBT) funding to improve client access, 
        retailer efficiency, and program integrity,
        --$14 million for infrastructure improvements
        --$26 million for program initiatives and evaluation
                agriculture, food and nutrition research
    As you consider the fiscal year 2017 budget, we ask for your 
support of the President's budget for the National Institute of Food 
and Agriculture (NIFA). The National Institute of Food and Agriculture 
(NIFA) funds agriculture and nutrition research that is vital for 
communities and the nation to have new technologies and intervention to 
improve the health and food security of Americans. In doing so, we ask 
that you:
  --Support the President's budget to the Agriculture and Food Research 
        Initiative (AFRI). These research efforts work with local 
        communities and states to conduct high-quality research to help 
        assure that our food supply is adequate for the future; and
  --Consider restoring the funding for Agricultural Research Services 
        (ARS) to 2014 levels. ARS is an essential in-house, scientific 
        research agency. This agency often provides the solutions to 
        food and nutrition problems that affect Americans every day, 
        from field to table.
    supplemental nutrition assistance program (snap) and nutrition 
        education and obesity prevention grant program (snap-ed)
    We recognize that Supplemental Nutrition Assistance Program (SNAP) 
is a mandatory program, but we want convey the importance of the 
program, and urge you to protect this vital lifeline for families. SNAP 
helps to put food on the table for about 47 million people each month. 
SNAP participation closely follows changes in unemployment and 
underemployment and so is responsive to changes in need. SNAP-Ed 
empowers participants to make healthy food choices using this knowledge 
received from the innovative and engaging nutrition education to 
purchase, prepare and store nutritious foods. SNAP-Ed is targeted to 
fit the local communities it serves in all 50 states and territories, 
and outcomes include sustained changed behavior change towards 
healthier habits.
    During this appropriations cycle, we ask that you:
  --Support SNAP as it continues to respond to the need for food 
        assistance with timely benefits; and
  --Support SNAP-Ed and protect mandatory investments in this program.
                        child nutrition programs
    Child nutrition programs operate in school, daycare, after school, 
and summer settings, providing nutritious meals and snacks to fuel 
children with the energy they need to thrive in the classroom and 
beyond. We ask that you:
  --Support the National School Lunch Program, School Breakfast 
        Program, Summer Food Service Program, Child and Adult Care Food 
        Program, and the Fresh Fruit and Vegetable Program to provide 
        children with nutritious meals and snacks; and
        --Continue to provide funding, at $35 million, for grants that 
        would allow schools to purchase kitchen equipment. This will 
        allow schools to serve healthier meals at a more reasonable 
        price, and is a long overdue need for schools.
        --Provide adequate funding for training and technical 
        assistance to states for successful implementation of the 
        Healthy Hunger-Free Kids Act. This can be done by:
        --Increasing funding to the National Food Service Management 
        Institute, which successfully ran the USDA's Team Up for 
        Success mentorship program for food service operators;
        --Fully fund Team Nutrition program, up to $25 million, in 
        order to provide nutrition education competitive grants to 
        states and localities.
  --Summer Food Service Program EBT Demonstrations are innovative ways 
        to tackle the hunger gap that occurs for children when school 
        is out of session. Please meet the request to expand, over a 
        ten-year window, this program to provide monthly food 
        assistance to low-income children in the summer via an 
        electronic benefits transfer (EBT) card. This is an easy way 
        for families to have access to healthy foods in the summer 
        months.
                     commodity assistance programs
    The Emergency Food Assistance Program (TEFAP) is a win/win for 
farmers, producers, processors and low-income consumers to assure 
access to healthy foods through our nation's charitable food system, 
delivering nutrient-rich food through pantries, shelters, and kitchens 
and providing support for storage and distribution. The TEFAP program 
staff works in tandem with SNAP-Ed staff to help assure the consumption 
of these foods through nutrition education including preparation and 
safe storage. In order to help mitigate declining resources for the 
purchase of TEFAP foods, the President's Budget includes a legislative 
proposal to add an additional $30 million for the purchase of TEFAP 
foods in fiscal year 2017 and returns future funding to fiscal year 
2015 levels.
We ask that you:
  --Fund TEFAP commodities at $329 million, as provided by the 2014 
        farm bill. TEFAP commodities are distributed to low-income 
        people through food banks, pantries, kitchens and shelters.
    Commodity Supplemental Food Program (CSFP) CSFP provides a 
nutritious monthly food package to low-income seniors living at or 
below the poverty line. The CSFP food package is designed to meet the 
specific nutritional needs of this target population, combating the 
poor health conditions often found in food insecure seniors. As the 
senior population continues to grow, we ask that you:
  --Fund CSFP at $236 million. This funding level is enough to support 
        caseload in the existing 46 States, the District of Columbia, 
        and two Indian reservations
             supporting local farmers and improving health
To support local farmers while improving the health of Americans, we 
ask that you:
  --Provide $17 million for WIC Farmers' Market Nutrition Program 
        (FMNP), which provides vouchers to low-income women, infants, 
        and children;
  --Provide $21 million for the Seniors Farmers' Market Nutrition 
        Program, which provides vouchers for low-income seniors; and
  --Provide $9 million for Community Food Projects to meet food needs 
        of low-income people, increase community self-reliance, and 
        promote comprehensive responses to food, farm and nutrition 
        issues.
  --Provide funding for Healthy Food Financing Initiative
                  food and drug administration funding
  --The Academy supports the President's request to the Food and Drug 
        Administration's (FDA) regarding implementation of the Food 
        Safety Modernization Act (FSMA).
                           developing leaders
    To ensure a pipeline of leaders dedicated to improving health and 
reducing hunger in our country, we ask that you:
  --Provide $2 million for the Congressional Hunger Center for the 
        operation of the Bill Emerson National Hunger Fellowships and 
        Mickey Leland International Hunger Fellowships, which focus on 
        developing solutions to hunger based on experience at local 
        field placements and national policy organizations.
    We appreciate your support on these recommendations. We know that 
these expenditures will make for smart, long-term investments into the 
health of Americans.

    [This statement was submitted by Mary Pat Raimondi MS, RD Vice 
President, Strategic Policy and Partnerships Academy of Nutrition and 
Dietetics.]

                                 ______
                                 
   Prepared Statement of American Commodity Distribution Association
    On behalf of the American Commodity Distribution Association 
(ACDA), I respectfully submit this statement regarding the budget 
request of the Food and Nutrition Service for inclusion in the 
Subcommittee's official record. ACDA members appreciate the 
Subcommittee's support for these vital programs.
    We urge the subcommittee to provide $329 million for the purchase 
of commodities to be distributed by the Emergency Food Assistance 
Program (TEFAP), to fully fund administrative expense funding for TEFAP 
at $100 million; to approve the President's request for $236,120,000 
for the Commodity Supplemental Food Program (CSFP) including an 
additional 20,000 caseload slots to allow modest expansion of the 
program; and to continue to actively monitor two matters: flexibility 
in the operation of school meal programs; and recommendations of the 
Multiagency Task Force on commodity procurement required by Section 
4205 of the Agricultural Act of 2014 (Public Law 113-79).
    ACDA is a non-profit professional trade association, dedicated to 
the growth and improvement of USDA's Commodity Food Distribution 
Program. ACDA members include: state agencies that distribute USDA-
purchased commodity foods; agricultural organizations; industry; 
associate members; recipient agencies, such as schools and soup 
kitchens; and allied organizations, such as anti-hunger groups. ACDA 
members are responsible for distributing over 2.2 billion pounds of 
USDA-purchased commodity foods annually through programs such as 
National School Lunch Program (NSLP), the Emergency Food Assistance 
Program (TEFAP), Summer Food Service Program (SFSP), Commodity 
Supplemental Food Program (CSFP), Charitable Institution Program, and 
Food Distribution Program on Indian Reservations (FDPIR).
                     funding for tefap commodities
    ACDA strongly supports the proposal in the President's budget to 
provide $30 million to offset declines in 2014 Farm Bill-authorized 
funding for commodities under The Emergency Food Assistance Program 
(TEFAP). When coupled with the $299 million provided by the Farm Bill, 
TEFAP commodity funding would total $329 million. TEFAP operators 
continue to find a significant need for TEFAP foods, and without the 
additional $30 million these needs are likely to go unmet. We agree 
with USDA's claim that the need for TEFAP is increasing as certain 
adult SNAP recipients lose eligibility due to the reestablishment of 
time limits on their participation.
         fully fund tefap administrative funds at $100 million
    We continue to urge the subcommittee to fully fund TEFAP 
Administrative Funds at $100 million. TEFAP providers face significant 
needs for food handling and storage, and have experienced increased 
costs in recent years.
    ACDA appreciates the increase to $54,401,000 provided in the fiscal 
year 2016 Consolidated Appropriations Act and the President's request 
for $59,401,000 for fiscal year 2017, but food banks, Community Action 
Agencies, and other TEFAP operators continue to find that they have had 
little choice but to convert food dollars to administrative expense 
funds in order to maintain their operations. Using food dollars for 
operating expenses is too often necessary, and reduces the ability of 
these operators to provide food assistance to more individuals and 
families who continue to face difficult times. We urge the Committee to 
not force this choice upon operators that are experiencing reduced 
private donations in addition to increased demands.
          funding for the commodity supplemental food program
    ACDA supports the President's request for $236,120,000 which would 
provide for a modest caseload increase for the Commodity Supplemental 
Food Program (CSFP). We thank the Congress for having provided an 
additional $900,000 in fiscal year 2016. That increase has allowed 
Virginia to begin CSFP operations. We know that many states have 
requested caseload increases given the need for this program now 
focused on seniors. Virginia, along with the seven states that started 
programs following your action in fiscal year 2015--Connecticut, 
Florida, Hawaii, Idaho, Maryland, Massachusetts and Rhode Island--would 
be candidates for this expansion, along with other long-operating 
programs.
        providing reasonable flexibility in school meal programs
    ACDA appreciates the action taken in the fiscal year 2015 and 
fiscal year 2016 Acts to provide reasonable and responsible flexibility 
in school meal standards, and remains hopeful that these matters will 
be addressed as part of the reauthorization of child nutrition 
programs. ACDA appreciates and supports the inclusion of Section 309 of 
the ``Improving Child Nutrition Integrity and Access Act of 2016'', as 
approved unanimously by the Senate Agriculture Committee, providing 
flexibility in school meal programs. ACDA supports the delay in the 
Target 2 sodium standard contingent upon the latest scientific research 
indicating that further reduction in sodium is necessary to safeguard 
the health of children. However, ACDA members remain concerned about 
the practicality of meeting a more stringent standard. We also 
appreciate the whole grain flexibility because various regions continue 
to experience problems with specific grain items such as bagels, grits, 
biscuits, and tortillas that are difficult to obtain as whole grain 
rich products or are not readily accepted by students. ACDA continues 
to support emphasizing the importance of fruits and vegetables in all 
forms--fresh, frozen, canned and dried--as noted in the 2015-2020 
Dietary Guidelines for Americans. However, we remain concerned about 
mandating not just what children are offered in school meals but what 
they must take, whether they intend to eat it or not. Increasing 
flexibility to program sponsors in planning menus that meet high 
nutrition standards but still are within cost targets is of critical 
importance.
  interagency panel for evaluation and improvement of the usda foods 
                                program
    As a result of Section 4205 of the Agricultural Act of 2014, a 
multiagency task force has been established at USDA for continuous 
evaluation and improvement of the USDA Foods program. The first annual 
report was submitted to Congress last year, and work has been 
undertaken on several important matters. FNS, AMS, and FSA are now 
engaging in Business Process Reengineering to determine improvements in 
the ordering, procurement, and receiving of USDA Foods. ACDA expects to 
actively participate in this project. We encourage the Committee to 
monitor this and other actions taken by this task force.
    We look forward to continuing to partner with you and USDA in the 
delivery of these important food assistance programs.

    [This statement was submitted by Ed Herrera, President, American 
Commodity Distribution Association.]

                                 ______
                                 
         Prepared Statement of American Farm Bureau Federation
    The American Farm Bureau Federation (AFBF) would like to 
acknowledge and thank the subcommittee for its historical work directed 
to the support of agriculture, our nation's food supply and the well-
being of rural America.
                        2014 farm bill programs
    AFBF strongly opposes reopening the 2014 Farm Bill. That law is a 
careful balance of priorities and should not be reopened before its 
expiration in 2018 to achieve additional budget savings. Overall Farm 
Bill spending--including the nutrition programs--comprises just 2 
percent of the total Federal budget. The entirety of the farm safety 
net constitutes less than one-third of 1 percent of the overall budget. 
The law was crafted to make a significant contribution to deficit 
reduction from the farm titles above and beyond the continuing 
contributions made through sequestration. No other sector of the 
economy has made similar efforts toward deficit reduction, yet many who 
benefit from the food, fuel, feed and fiber produced in rural America 
continue to look to agriculture for additional cuts.
                  program that promotes biotechnology
    AFBF supports funding for the Animal and Plant Health Inspection 
Service's (APHIS) Biotechnology Regulatory Services if there are 
appropriate levels of congressional oversight to ensure APHIS' new 
regulatory considerations are science- and risk-based, transparent and 
predictable, while promoting innovation in plant breeding and 
facilitating trade.
                    agricultural research priorities
    Agricultural research has enabled America's farmers to become the 
most efficient in the world. However, without a commitment to further 
agricultural research and technological advancement, even America's 
farmers could be hard-pressed to meet the challenges of feeding the 
world's growing population.
    AFBF supports funding USDA's Agriculture and Food Research 
Initiative at the level authorized when the program was established in 
the 2008 Farm Bill.
    AFBF supports funding for the National Agricultural Statistics 
Service and the Economic Research Service, which provide essential 
information to farmers.
                  programs that promote animal health
    AFBF supports adequate funding for APHIS' work on the USDA 
Antimicrobial Resistance Action Plan.
    AFBF supports funding at the authorized level for the Veterinary 
Medicine Loan Repayment Program and the Veterinary Services Grant 
Program, which allow veterinarians to ensure animal health and welfare, 
while protecting the nation's food supply.
    AFBF supports funding for the National Animal Health Laboratory 
Network, which provides an early warning system for emerging animal 
diseases, at the authorized level.
    AFBF supports funding for Section 1433 Continuing Animal Health and 
Disease, Food Security, and Stewardship Research, Education and 
Extension Programs to address critical priorities in food security, 
zoonotic disease and stewardship.
    AFBF supports funding for the FDA's Center for Veterinary Medicine, 
which oversees the safety of animal drugs, feeds and biotechnology-
derived products.
     programs that expand international markets and safeguard u.s. 
                              agriculture
    AFBF supports funding at authorized levels for the following 
programs and activities:
  --The Foreign Agricultural Service, Market Access Program, Foreign 
        Market Development Program, Emerging Markets Program and 
        Technical Assistance for Specialty Crops Program, all of which 
        increase demand for U.S. agriculture and food products abroad.
  --USDA to open and staff an office in Cuba. This office will help U.S 
        agriculture to expand access, understand opportunities and 
        increase sales into the Cuban marketplace.
  --Public Law 480 programs, which provide foreign food aid by 
        purchasing U.S. commodities.
  --APHIS Plant Protection and Quarantine personnel and facilities, 
        which protect U.S. agriculture from costly pest problems that 
        enter from foreign lands.
  --APHIS trade issues resolution and management activities that are 
        essential for an effective response when other countries raise 
        pest and disease concerns (i.e., sanitary and phytosanitary 
        measures) to prohibit the entry of American products.
  --The U.S. Codex Office, which is essential to improving the 
        harmonization of international science-based standards for the 
        safety of food and agriculture products.
      programs that enhance and improve food safety and protection
    AFBF supports funding for food protection at the Food and Drug 
Administration and Food Safety and Inspection Service (FSIS) directed 
to the following priorities:
  --Implementation of the Food Safety Modernization Act
  --Increased education and training of inspectors
  --Additional science-based inspection, targeted according to risk
  --Effective inspection of imported food and feed products
  --Research and development of scientifically based rapid testing 
        procedures and tools
  --Accurate and timely response to outbreaks that identify 
        contaminated products, remove them from the market and minimize 
        disruption to producers
  --Indemnification for producers who suffer marketing losses due to 
        inaccurate government-advised recalls or warnings.
    AFBF supports funding for a National Antimicrobial Residue 
Monitoring System to detect trends in antibiotic resistance among 
foodborne bacteria.
    AFBF supports adequate funding for the Food Animal Residue 
Avoidance Databank, which aids veterinarians establish science-based 
recommendations for drug withdrawal intervals.
    AFBF opposes the administration's request for new user fees for 
inspection activities. Food safety is for the public good, and as such, 
it is a justified use of public funds.
    AFBF opposes any provision that would prohibit FSIS from inspecting 
equine processing facilities under the Federal Meat Inspection Act. 
Prohibiting the harvest of livestock for reasons unrelated to food 
safety or animal welfare sets an extremely dangerous precedent.
               programs that ensure crop protection tools
    AFBF supports funding the Minor Crop Pest Management Program (IR-4) 
because developing pest control tools has high regulatory costs, and 
this funding ensures safe and effective agrichemicals and biopesticides 
are available for small, specialty crop markets.
    AFBF supports funding the Office of Pesticide Management Policy, 
which promotes the development of new pest management approaches and is 
critical for crop protection.
    AFBF supports funding the APHIS Plant Pest and Disease programs, 
which eradicate, suppress and contain plant pests.
      programs that strengthen rural communities and rural housing
    AFBF supports funding for the following rural development programs:
  --Value-Added Agricultural Producer Grants, the Rural Innovation 
        Initiative, the Rural Microentrepreneur Assistance Program, 
        Business and Industry Direct and Guaranteed Loans, the Resource 
        Conservation and Development Program, the Beginning Farmer and 
        Rancher Development Program and Cooperative Services, which 
        foster business development in rural communities.
  --The Rural Utilities Service for rural broadband and 
        telecommunications services, and the Distance Learning and 
        Telemedicine Program.
  --Community Facility Direct and Guaranteed Loans, which fund the 
        construction, enlargement or improvement of essential community 
        facilities.
  --Agriculture in the Classroom, which helps students gain greater 
        awareness of the role of agriculture in the economy and 
        society.
    AFBF supports modifying USDA Section 514 financing to allow farmers 
who are entering the H-2A program to use the housing built with these 
funds to house H-2A workers. AFBF also supports allowing famers to 
obtain this financing to build new housing for H-2A workers. These 
modifications will eliminate some of the main impediments from entering 
the H-2A program.
                programs that support wildlife services
    AFBF supports funding the Wildlife Services programs that prevent 
and minimize an estimated $1 billion worth of wildlife damage, while 
protecting human health and safety from conflicts with wildlife.
                program that encourages renewable energy
    AFBF supports funding the Renewable Energy for America Program, 
which offers a combination of grants and guaranteed loans for farmers 
to purchase renewable energy systems.

    [This statement was submitted by Zippy Duvall, President, American 
Farm Bureau Federation.]

                                 ______
                                 
         Prepared Statement of American Farm Bureau Federation
    Chairman Moran, Ranking Member Merkley, and members of the 
Subcommittee, thank you for your continued leadership and support for 
U.S. agriculture. The above signed steering committee members of the 
Agriculture Workforce Coalition appreciate this opportunity to submit 
our views regarding the fiscal year 2017 Agriculture, Rural 
Development, Food and Drug Administration and Related Agencies 
appropriations bill, and respectfully requests this statement be made 
part of the official hearing record.
    The labor situation in agriculture has been a concern for many 
years, but is moving towards a breaking point. Today, large segments of 
American agriculture face a critical lack of workers, a shortage that 
makes our farms and ranches less competitive with food from abroad and 
that threatens the abundant, safe and affordable domestic food supply 
American consumers enjoy today.
    Repeated evidence over the past decades has shown that there are 
some jobs in agriculture that Americans simply do not want to do. 
Although many of these jobs offer wages competitive with similar, non-
agricultural occupations, they are physically demanding, conducted 
outdoors in all seasons and weather, and are often seasonal or 
transitory. It is for this reason that farmers have grown to rely on 
foreign workers to perform this work.
    The overarching challenge to workforce stability in agriculture is 
the widely acknowledged lack of authorized work status by a large 
number of agricultural workers despite the prevalence of documentation 
presented by workers to the contrary. The only option for farmers and 
ranchers to legally find the workers they need is the H-2A temporary 
work visa program, a program that has not worked for many agricultural 
employers.
    The H-2A program's basic framework is overly restrictive and 
difficult to maneuver. In recent years the program has become even more 
bureaucratic, burdensome and costly to use. But, each year, more and 
more farms have to turn to the H-2A program for legal foreign labor to 
meet their workforce needs.
    The demand on the program is increasing as producers have nowhere 
else to turn; yet the administrative weight of the program cannot keep 
up. H-2A employment has doubled in the past 4 years and will double 
again in the next 2 years or less. This means bureaucratic red tape and 
delays in the program result in workers showing up at the farm well 
after the date they were needed to be there, and millions of dollars in 
agricultural production is lost in the interim.
    To improve access to the H-2A program, specifically the housing 
requirements, we seek the following:
                       farm labor housing program
    The U.S. Department of Agriculture's (USDA) Farm Labor Housing 
(FLH) program provides loans and grants for the development of on-farm 
and off-farm housing. The program is operated by USDA's Rural 
Development Housing and Community Facilities Program office.
    Specifically, Section 514 loans are provided to buy, build, 
improve, or repair housing for farm laborers. The range of eligible 
tenants was expanded in the 2008 farm bill but legally admitted 
temporary laborers, such as H-2A workers, remain ineligible.
    Amending the list of eligible tenants who can use Section 514 
housing to include H-2A workers will incentivize use of the program as 
a means of accessing a legal workforce. We recommend the following 
language be included in the fiscal year 2017 appropriations bill:

        42 U.S.C 1484(f)(3)(A) is amended to read: (A) such person 
        shall be a citizen of the United States, a person legally 
        admitted for permanent residence or a person legally admitted 
        and authorized to work in agriculture;
                           housing allowance
    Currently, the H-2A Program does not allow for the use of housing 
allowances. Working through USDA's Rural Development Housing and 
Community Facilities Program office, we recommend the use of housing 
allowances be allowed under the H-2A program unless the Secretary of 
Agriculture determines insufficient community based housing exists. The 
housing allowance could be based on HUD fair market rental rates for a 
two bedroom dwelling occupied by four individuals.
    This change would provide greater flexibility to workers within the 
H-2A program and removes one of the more significant program barriers. 
Specifically, we seek the following language as part of the fiscal year 
2017 appropriations bill:

        8 USC 1188(c)(4) is amended as follows: Provided further that 
        an employer may provide a housing allowance unless the 
        Secretary of USDA determines insufficient community based 
        housing exists.
                               conclusion
    We remain steadfast in our pursuit of broader immigration reform 
that meets both the short- and long-term workforce requirements of all 
of agriculture--both those producers with seasonal labor needs, and 
those with year-round needs. Yet we recognize such reforms may not come 
to fruition in the near term.
    Left with no other alternative, we seek your support for the 
inclusion of these modest adjustments as you prepare fiscal year 2017 
appropriations legislation.
    Thank you again, and members of the Subcommittee, for the 
opportunity to share our views. We look forward to working with the 
committee to ensure continued benefits for rural communities, 
consumers, American agriculture and our nation as a whole.

    [This statement was submitted by Lisa Van Doren, Vice President & 
Chief of Staff, Government Affairs, National Council of Farmer 
Cooperatives.]

                                 ______
                                 
             Prepared Statement of American Farmland Trust
                 natural resources conservation service
    I am John Larson, Executive Director of Programs of American 
Farmland Trust. I am writing in support of full mandatory funding for 
agricultural conservation programs administered by the Natural 
Resources Conservation Service (NRCS) as enacted in the Agriculture Act 
of 2014. We also urge the subcommittee to support the discretionary 
appropriation of $860 million for NRCS's Conservation Operations (CO) 
account.
    American Farmland Trust is the only national conservation 
organization dedicated to protecting farmland, promoting sound farming 
practices, and keeping farmers on the land. Since its founding in 1980 
by a group of farmers and citizens concerned about the rapid loss of 
farmland to development, AFT has helped save millions of acres of 
farmland from development and led the way for the adoption of 
conservation practices on millions more.
    Mandatory conservation program funding provided by the Agricultural 
Act of 2014 is invaluable to producers and landowners in helping 
implement conservation practices on private agricultural land. 
Agricultural producers and other private landowners share in the cost, 
and thus help leverage the Federal investment in conservation. 
Conservation systems provide protection and restoration of soil health, 
water quality, water conservation, air quality, wildlife habitat and 
other natural resource concerns. These are real public benefits. 
Further, the voluntary adoption of conservation practices can help 
avoid the need for governmental intervention and regulation on private 
lands while protecting the landscape.
    The American Farmland Trust is keenly aware of the budget deficits 
plaguing this country and that is why American Farmland Trust supported 
the Agricultural Act of 2014, which saved taxpayers $23 billion and 
consolidated or eliminated over 100 programs. As part of these 
reductions, mandatory conservation programs were cut by over $6 billion 
and close to a dozen conservation programs were eliminated or 
consolidated. Sequestration has also reduced conservation funding 
significantly. Additional cuts or Changes in Mandatory Programs 
(CHIMPS) imposed on conservation programs will seriously reduce the 
Federal share of investment in conservation on working lands.
    As the Subcommittee on Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies deliberates on fiscal year 
2017 agricultural program funding, I urge you to refrain from imposing 
caps or other limits on the mandatory funding already established and 
enacted by Congress in the Farm Bill. These programs include the 
Agricultural Conservation Easement Program (ACEP), the Environmental 
Quality Incentives Program (EQIP), and the Conservation Stewardship 
Program (CSP). Imposing caps not only cuts fiscal year 2017 funding for 
needed conservation work, it also has the effect of reducing baseline 
in future years that further undermines these essential programs.
    For example, through the Agricultural Land Easement component of 
ACEP (and the earlier Farmland Protection Program), millions of acres 
of productive farmland has been protected from being converted to non-
agricultural use. This has occurred primarily though state and local 
farmland protection programs and land trusts that have partnered with 
USDA and shared the cost of easements as well as covered most of the 
transaction costs like appraisals, recording fees, and the like. The 
proceeds from easements have also allowed producers to install 
conservation measures on protected lands as well as cover other 
important business and family expenses while keeping the land in 
agricultural use.
    American Farmland Trust also asks for your support of the full $860 
million in the President's budget proposal for the Conservation 
Operations account of the Natural Resources Conservation Service 
(NRCS). Conservation Technical Assistance supports the critical, 
voluntary conservation practices that ensure soil health, water 
quality, water conservation, air quality, wildlife habitat and other 
natural resource concerns. Funding for Conservation Operations allows 
for the delivery of critical conservation programs and helps ensure the 
best technical and scientific knowledge is available to producers and 
landowners. This account funds the ``boots on the ground'' work of NRCS 
and it is critical to delivery of conservation benefits.
    American Farmland Trust believes conservation of our natural 
resources requires a strong public-private partnership and mandatory 
farm bill conservation funding along with the technical assistance 
provided by the Conservation Operations account is key to providing on-
the-ground conservation benefits.

    [This statement was submitted by John Larson, Executive Director 
for Programs, American Farmland Trust.]

                                 ______
                                 
            Prepared Statement of American Forest Foundation
    The American Forest Foundation (AFF) urges the Subcommittee to 
support strong funding for fiscal year 2017 for programs that are 
essential to helping America's 22 million family forest owners, some 
282 million acres, conserve and manage their forests to provide the 
clean water and air, wildlife habitat, sustainable wood supplies, and 
other benefits, that all Americans benefit from.. Maintenance of these 
programs will help family forest owners adequately prepare for 
increasing threats and save landowners, communities, and industries 
from expensive restoration in the future. We urge the Subcommittee to 
support:
  --Animal and Plant Health Inspection Service Tree and Wood Pests 
        program at the fiscal year 2016 level of $54 million and 
        Specialty Crops program at the fiscal year 2016 level of $156 
        million;
  --Farm Bill authorized levels for the Environmental Quality and 
        Incentives Program (EQIP), Conservation Stewardship Program 
        (CSP), and the Agricultural Conservation Easement Program 
        (ACEP);
  --NRCS, Conservation Operations at $761 million to grow conservation 
        technical assistance;
  --National Institute for Food and Agriculture (NIFA), Renewable 
        Resources and Extension Program at $4 million;
  --NIFA, McIntire-Stennis, Cooperative Forestry Research at $34 
        million; and
  --Continuation of the Joint Chief's Landscape Restoration 
        Partnership.
    The American Forest Foundation is a nonprofit conservation 
organization that works on the ground with family woodland owners 
through a variety of programs, including the American Tree Farm 
System, to protect the values and benefits of America's family 
forests, including the clean water, wildlife habitat, and sustainable 
wood supplies these lands provide all Americans. Families and 
individuals own over one-third of our nation's forests, stewarding more 
acres than the Federal government or forest industry\1\. Recent 
analysis by AFF and other partners shows these lands are at risk. In 
the West, for example, over 4 million acres of family woodlands that 
are essential for protecting the west's already scarce water supply, 
are at high fire risk. The US Forest Service predicts by 2020, more 
than 18 million acres of family forests are threatened by housing 
development. These are just a few of the growing threats to family 
woodlands. To combat these ever increasing pressures, we must ensure 
these families have the financial tools, technical information, and 
policy support to keep their forests as forests, for both current and 
future generations.
---------------------------------------------------------------------------
    \1\ USDA, USPRS National Woodland Owner Survey. 2013 Updated Data.
---------------------------------------------------------------------------
                aphis invasive pest and pathogen funding
    According to the National Woodland Owner Survey, the threat of 
forest pests is a top concern for family forest owners. When an 
invasive species infests a family's forest, it can destroy their 
investment, making recovery difficult, as most families don't generate 
regular income.
    To provide family forest owners with the tools needed to fight this 
growing threat, Congress should at least provide level funding for the 
APHIS Tree and Wood Pests program. This program funds eradication 
efforts for invasive species and works to prevent the further spread of 
invasive species like the Asian Long-Horned Beetle and the Emerald Ash 
Borer. Close to 500 species of foreign insects and diseases have become 
established in the U.S., and a new damaging pest is introduced, every 2 
to 3 years. It is APHIS' responsibility to prevent such introductions 
and to respond effectively when pests are introduced.
    We ask the Subcommittee to continue providing $156 million to the 
``Specialty Crops'' budget account, which funds APHIS' program to stop 
spread of the sudden oak death pathogen via trade in nursery plants. 
Since 1975, U.S. imports (excluding petroleum products) have risen 
almost six times faster than APHIS staff capability to conduct 
inspections of those imports. In just 3 years, from 2009 to 2012, more 
than 90 new plant pests have been detected in the United States.
                    farm bill conservation programs
    Farm Bill Conservation Programs provide tools to family forest 
owners, leveraging the family's own resources to implement conservation 
activities on their lands--treatments that can protect the numerous 
public benefits we all enjoy. Forest owners participate in programs 
like the EQIP and CSP, to help them manage invasive insect 
infestations, reduce wildfire risks, implement water quality 
improvements, and improve species habitat. The 2014 Farm Bill 
strengthened these programs for forest owners and increased 
opportunities to use resources for collaborative conservation efforts 
on a landscape scale. To realize the full impact, we urge Congress to 
support full-funding of these programs at the levels authorized in the 
Farm Bill. Congress should also provide strong support for NRCS 
Conservation Operations, which fund technical assistance for landowners 
and support the implementation of Farm Bill conservation programs.
               nifa renewable resources extension program
    The Renewable Resources Extension Program supports outreach and 
education to forest owners, so they have the education and tools they 
need to be good stewards. This is especially important for family 
forest owners who are currently unengaged in the management of their 
forests. The extension foresters supported by this program are 
essential to landowners, providing them with valuable information--
everything from dealing with forest management issues to tax advice for 
new forest owners. This why it is key to support the program with $4 
million in funding.
          nifa mcintire-stennis cooperative forestry research
    The forestry research carried out by the nation's land grant 
universities is funded through the McIntire-Stennis Program. This 
program provides essential tools and information for family forest 
owners, and also supports critical family forest research, so that we 
may identify barriers to stewardship. Finally, it helps train the next 
generation of forestry professionals to provide forest owners the tools 
and technical assistance they need. Maintaining the funding level at 
$34 million will ensure that the research conducted will help family 
forest owners improve their stewardship.
            joint chief's landscape restoration partnership
    While we don't offer a specific funding level, we also want to 
recognize the important work happening through the Joint Chief's 
Partnership. This Partnership between NRCS and the U.S. Forest Service 
is making significant strides in landscape-scale conservation--allowing 
these agencies to work together to cross boundary lines and implement 
conservation and management at a significant scale. For example, in the 
Blue Mountains of Oregon, with support from the U.S. Forest Service to 
conduct outreach and engagement with family forest owners, and with 
cost-share resources from NRCS, a collaborative of Federal and state 
agencies, university extension programs, and national, state, and local 
non-profits are partnering to help landowners restore their forests and 
reduce their fire risk across nearly 200,000 acres, complementing the 
work of their neighbors- both public or private- all in an effort to 
increase by four-fold the pace and scale of cross-jurisdictional forest 
restoration. This is just one of many examples of the incredible 
success this initiative is having and will have, not just on individual 
owners, but on a significant scale to protect water, wildlife, wood 
supplies, and many other benefits.
    Thank you for considering these requests. We recognize that the 
Subcommittee must find areas to reduce spending, but we hope that the 
Subcommittee will consider the impact these reductions have on millions 
of family forest owners, along with all other Americans who benefit 
from well-managed, working forests. We, at AFF, thank the Subcommittee 
for the opportunity to provide some insight on these programs, and 
appreciate consideration of our testimony.

    [This statement was submitted by Tom Martin, President & CEO, 
American Forest Foundation.]

                                 ______
                                 
       Prepared Statement of American Forest & Paper Association
                              introduction
    AF&PA supports $6.9 million to provide for implementation of the 
declaration requirement of the Lacey Act, as amended by the 2008 Farm 
Bill; recommends maintaining funding for the ``Tree and Wood Pests'' 
category to aid in combating these, and other pests and diseases; 
requests $33.9 million for the McIntire-Stennis Cooperative Forestry 
Research Program; support the Public-Private Partnership for an 
Innovation Institute focused on nanocellulosics proposed in the U.S. 
Department of Agriculture budget, and we would like your support and 
assistance in ensuring that robust funding is included for the Center 
for Food Safety and Applied Nutrition and that Congress expresses its 
intention to continue funding the operation of the Food Contact 
Notification (FCN) program.
    The American Forest & Paper Association (AF&PA) is the national 
trade association of the forest products industry, representing pulp, 
paper, packaging and wood products manufacturers, and forest 
landowners. Our companies make products essential for everyday life 
from renewable and recyclable resources that sustain the environment.
    The forest products industry accounts for nearly 4 percent of the 
total U.S. manufacturing GDP, manufactures approximately $210 billion 
in products annually, and employs nearly 900,000 men and women. The 
industry meets a payroll of approximately $50 billion annually and is 
among the top 10 manufacturing sector employers in 47 states. Within 
the jurisdiction of this subcommittee, continued resources for 
protecting forest health and providing adequate resources to enforce 
existing trade laws are essential. Specific recommendations follow.
     animal and plant health inspection service (aphis)--lacey act 
                              enforcement
    AF&PA supports $5.5 million to provide for implementation of the 
declaration requirement of the Lacey Act, as amended by the 2008 Farm 
Bill. Full and effective implementation and enforcement of the Lacey 
Act will enable American forest product companies to compete fairly in 
the global marketplace, help keep jobs in the United States, and deter 
the destructive impacts of illegal logging on forests and forest-
dependent communities in developing countries. When fully implemented, 
the law requires U.S. importers of wood and wood products to file a 
declaration identifying the genus/species name and country of harvest--
a critical measure intended by the law's sponsors to increase supply 
chain transparency and assist Federal agencies in fair and strong 
enforcement. The prohibition and the declaration requirement affect a 
wide array of American industries, so it is critical that the 
declaration process generates data in a streamlined, cost-effective 
manner without unduly burdening legitimate trade. To that end, APHIS--
which is responsible for implementing the declaration provision--needs 
$6.9 million in funding to fully implement congressional mandates, 
including to establish an electronic declarations database and to add 
internal capacity to perform data analysis needed for monitoring and 
enforcement purposes.
                          aphis --plant pests
    AF&PA recommends maintaining funding for the ``Tree and Wood 
Pests'' category to aid in combating these, and other pests and 
diseases. As world trade continues to expand, global weather patterns 
shift, and an increasingly affluent world population has the ability to 
travel to--and demand products from--the far corners of the globe, the 
inadvertent, yet inevitable introduction of nonnative pests and 
diseases into the United States continues. Additional funding is 
vitally needed to aid in combating pests such as the Asian longhorn 
beetle, the Emerald Ash borer, and the Sirex woodwasp, as well as 
diseases such as Phytopthora ramorum. These are but a sampling of the 
diseases that harm commercial timber stands, community parks, and 
private forest landowners. American citizens most certainly will bear 
the cost of combating these and other emergent threats. We believe a 
comprehensive, coordinated response to each is more effective and more 
economical.
    We also support the Public-Private Partnership for an Innovation 
Institute focused on nanocellulosics proposed in the U.S. Department of 
Agriculture budget. A collaborative national institute will carry out 
transformative research, supporting fundamental science and providing 
opportunities to apply science, technology and advanced practices to 
create opportunities for new business ventures funded by industry. This 
institute will ensure that the United States is the leading source of 
commercial cellulosic nanomaterials research, innovation and 
production. A National Institute focused on nanocellulosics will 
promote economic growth, increase the productivity of the agricultural 
and forestry sector, create new jobs and support existing employment in 
rural communities and contribute to conservation of the forest 
resource.
     national institute of food and agriculture--mcintire-stennis 
                     cooperative forestry research
    AF&PA requests $33.9 million for the McIntire-Stennis Cooperative 
Forestry Research Program. Approximately one-third of the United States 
is forested and these forests enhance our quality of life and economic 
vitality and are an invaluable source of renewable bioproducts, outdoor 
recreation, clean water, fish and wildlife habitat, and carbon 
sequestration. Sustaining these forests in a healthy and productive 
condition requires a strong, continuing commitment to scientific 
research and graduate education. Foundational financial support for 
university-based forestry research and graduate education comes from 
the McIntire-Stennis Cooperative Forestry program, funded through the 
USDA's National Institute of Food and Agriculture. Funds are 
distributed each of the 50 states with a dollar-for-dollar match 
required from the states. Additional funding is needed to provide the 
additional scientific research needed to address critical forest issues 
such as fires, storms, insects, diseases, urbanization, fragmentation, 
and lost economic opportunities; and develop new knowledge and 
innovations to sustain healthy, productive forests and address the 
challenges facing forest owners, forest products manufacturers and all 
Americans who benefit from our forest resources.
    food and drug administration--food contact notification program
    AF&PA supports continued funding of the Food Contact Notification 
Program. The Food Contact Notification (FCN) program protects consumer 
health, food safety and quality while providing packaging manufacturers 
with an efficient process that is less burdensome than the food 
additive approval process. It has allowed packaging manufacturers to 
bring new, more environmentally-friendly products to market that have 
extended product shelf life, thereby increasing consumer value.
    As Congress begins work on appropriations legislation for FDA in 
the coming weeks, we would like your support and assistance in ensuring 
that robust funding is included in the Appropriations bills for the 
Center for Food Safety and Applied Nutrition, and that Congress 
expresses its intention to continue the operation of the FCN program. 
Congress should reject a proposal, included in the Administration's 
fiscal year 2016 budget request, calling for industry user fees to 
cover certain costs of administering the FCN program. AF&PA appreciates 
that the subcommittee has previously rejected proposals to eliminate 
the FCN program.

    [This statement was submitted by Elizabeth Bartheld, Vice 
President, Government Affairs, American Forest & Paper Association- 
Government Affairs Department.]

                                 ______
                                 
   Prepared Statement of American Indian Higher Education Consortium
    This statement includes a summary of our fiscal year 2017 funding 
requests for increasing the capacity of the 1994 Institutions so that 
they might truly begin to fulfill their land-grant vision and mission 
of self-sufficient, place-based peoples employing an Indigenous model 
that incorporates holistic planning, traditional knowledge, and the 
integration of education, research, and extension activities.
                          summary of requests
    The Equity in Educational Land-Grant Status Act, the legislation 
that created the 1994 (tribal college) land-grant institutions, was 
signed into law over two decades ago. In those 20 years, the number of 
1994s has grown to 34, but funding for the five 1994-specific programs 
has grown very little and remains wholly inadequate. We recognize the 
current economic constraints and believe that the increases recommended 
in the President's fiscal year 2017 Budget are a solid first step to 
ultimately achieving a level of equity within the nation's land-grant 
system. The 1994s' programs are administered by USDA's National 
Institute of Food and Agriculture (NIFA) and Rural Development. In 
NIFA, the TCUs request: 1994s' competitive Extension, $6.7 million in 
fiscal year 2017; 1994s' competitive Research program, $3.9 million in 
fiscal year 2017; 1994s Education Equity Grants, $3.7 million in fiscal 
year 2017; a doubling of the corpus in the Native American Endowment 
fund; and in Rural Development, Rural Community Advancement Program 
(RCAP), $8 million for the TCU Essential Community Facilities Grants 
program to help address the critical facilities and infrastructure 
needs that advance their capacity to participate as full land-grant 
partners.
    Additionally, funding levels are not the only inequities that exist 
within the nation's land-grant system. The 1994 institutions are the 
only Federal land-grant institutions that are prohibited from 
participating in the McIntire-Stennis (forestry) grants program and 
from competing for Children, Youth and Families at Risk (CYFAR) and 
federally Recognized Tribes Extension Program (FRTEP) grants.
  --McIntire-Stennis: In 2008, McIntire-Stennis was amended to include 
        Tribal lands in the formula calculation for funding of state 
        forestry programs. However, the 1994 institutions, which are 
        the Tribal Land-Grant colleges, were not included in the 
        funding formula; nor were states required to include them in 
        funding distributions. This oversight is significant, because 
        75 percent of Tribal land in the U.S. is either forest or 
        agriculture holding. In response to the dearth of American 
        Indian professionals in the forestry workforce in Montana and 
        across the United States, Salish Kootenai College (SKC) 
        launched a Forestry baccalaureate degree program in 2005. In 
        2013, SKC became the first tribal college land-grant to join 
        the National Association of University Forest Resource 
        Programs, a consortium of 85 forestry schools, the vast 
        majority of which receive McIntire-Stennis funding. However, 
        when SKC recently sought specialty accreditation for its 
        program, the college was told that it was ``one forestry 
        researcher short'' of the optimum number needed. Participation 
        in the McIntire-Stennis program, even with the required 1-1 
        match, would help SKC secure the researcher it needs to gain 
        this accreditation. Although currently, only SKC has a 
        baccalaureate degree in forestry, considering the wealth of 
        forested land on American Indian reservations, other such 
        programs could arise at the nation's other 1994 (Tribal 
        College) Land-Grant institutions, to further advance the growth 
        of the Native workforce in this vital area.
  --Children, Youth, and Families at Risk (CYFAR) and federally 
        Recognized Tribes Extension Program (FRTEP): The 1994 
        Institutions are the only land-grant institutions that are 
        statutorily barred from participating in programs administered 
        under Smith-Lever 3(d). However, certain programs therein are 
        intended to address serious situations that are prevalent in 
        Tribal communities. Access to two programs in particular would 
        be especially valuable to the 1994s.
        CYFAR: In some of the 1994 tribal communities, suicide among 
        Native youth is nine to 19 times as frequent as among other 
        youth. Native youth have more serious problems with mental 
        disorders, including substance abuse and depression, than other 
        youth, and perhaps surprisingly, are more affected by gang 
        involvement than any other racial group. American Indians also 
        have the highest high school drop-out rates in the nation and 
        some of the highest unemployment and poverty rates, as well. 
        Yet, our Native children and youth are the only group in the 
        country essentially excluded from the benefits of the CYFAR 
        program, because the 1994 institutions cannot apply for 
        competitively awarded CYFAR grants. CYFAR supports 
        comprehensive, intensive, community-based programs and promotes 
        building resiliency and protective factors in youth, families, 
        and communities. There is no argument that the 34 Tribal 
        College and University land-grant institutions (1994s) are 
        truly community-based institutions.
        FRTEP: The USDA's federally-Recognized Tribes Extension Program 
        is only open to 1862 and 1890 Land-Grants. The program's stated 
        purpose is: ``supports extension agents on American Indian 
        reservations and tribal jurisdictions to address the unique 
        needs and problems of American Indian tribal nations. Emphasis 
        is placed on assisting American Indians in the development of 
        profitable farming and ranching techniques, providing 4-H and 
        Youth development experiences for tribal youth, and providing 
        education and outreach on tribally-identified priorities (e.g., 
        family resource management and nutrition) using a culturally 
        sensitive approach.'' Ironically, the 1994 Land-Grants, which 
        are chartered by and directly serve federally recognized 
        American Indian tribes and are located on or near Indian 
        reservations are barred from participating in this program. 
        This apparent oversight in eligibility rights needs to be 
        rectified. A clear step toward recognizing the 1994 
        Institutions as true partners in the Land-Grant system would be 
        to afford them eligibility to compete for grant funding under 
        the Smith-Lever 3(d) programs, particularly the Children, 
        Youth, and Families at Risk (CYFAR) program; and (2) federally 
        Recognized Tribes Extension Program (FRTEP). We strongly urge 
        the committee to include language in the fiscal year 2017 
        Agriculture Appropriations bill or accompanying report, to 
        recognize the 1994 Land-Grant Institutions as full partners in 
        the land-grant system by making them eligible to finally 
        participate in these programs open to all other land-grants.
    Illustration of Inequities in Land-Grant System Funding: The first 
Americans were not granted Federal Land-Grant status until 1994. As 
earlier stated, initial funding of programs established under this Act 
was very modest and today, over 20 years since the enactment of the 
Equity in Educational Land-Grant Status Act of 1994, funding remains 
untenably inadequate. A clear illustration of the inequity in land-
grant programs funding can be found in the latest appropriations for 
land-grant programs. In fiscal year 2016, Congress appropriated $476 
million for extension activities. The 1862s (state) received $300 
million in formula-driven extension funds; 1890s (18 HBCUs) received 
$46 million; and 1994s (34 TCUs) received $4.5M for competitively 
awarded grants. Further, the 1994s cannot access over $85.5M in Smith-
Lever 3(d) grant funds. These inequities cannot be justified or allowed 
to continue. The first Americans, last to join the nation's land-grant 
family, deserve parity.
            programs--solid investment in economic capacity
    In the past, due to lack of expertise and training, millions of 
acres on Indian reservations lay fallow, underused, or had been 
developed using methods that caused irreparable damage. The Equity in 
Educational Land-Grant Status Act of 1994 is helping to address this 
situation and is our hope for the continued improvement of our 
reservation lands. Our current land-grant programs remain very small, 
yet critically important to us. It is essential that American Indians 
explore and adopt new and evolving technologies for managing our lands 
and natural resources. With increased capacity and program funding, we 
will become even more fundamental contributors to the agricultural base 
of the nation and the world.
                               conclusion
    The 1994s have proven to be efficient and effective vehicles for 
bringing educational and career opportunities to American Indians/
Alaska Natives and the promise of self-sufficiency to some of this 
nation's poorest and most underserved regions. The small Federal 
investment in the 1994s has already paid great dividends in terms of 
increased employment, access to quality higher education, and economic 
development. American Indian reservation communities are second to none 
in their potential for benefiting from effective land-grant programs; 
and no institutions better exemplify the original intent of Senator 
Morrill's land-grant concept than the 1994s. We truly appreciate your 
support and recognition of the 1994s' important role in the nation's 
land-grant system. We ask you to renew your commitment to help move our 
students and communities toward self-sufficiency and request your full 
consideration of our fiscal year 2017 appropriations requests.

    [This statement was submitted by Meg Goetz, AIHEC Vice President 
for Advocacy, American Indian Higher Education Consortium.]

                                 ______
                                 
         Prepared Statement of American Seed Trade Association
    The American Seed Trade Association respectfully submits the 
following requests for the U.S. Department of Agriculture fiscal year 
2017 appropriations. Founded in 1883, ASTA's mission is to enhance the 
development and movement of quality seed worldwide. ASTA's diverse 
membership consists of over 700 companies involved in seed production, 
distribution, plant breeding and related industries in North America. 
ASTA represents all varieties of seeds, including grasses, forages, 
flowers, vegetables, row crops and cereals. For more information about 
this request, please contact Jane DeMarchi, Vice President for 
Government and Regulatory Affairs at the American Seed Trade 
Association.
    USDA intramural research programs conduct research that requires a 
long-term investment leading to high-impact payoff. Management and 
utilization of vast collections of genetic resources are the type of 
research that can't be done by an individual university or company. It 
is important that Congress recognize how vital these collections are to 
the ability of the U.S to provide the essential materials for food, 
feed, and fiber for the world.
      
Agricultural Research Service
National Plant Germplasm System (NPGS)
Request: At least $44 million
      
    The Agricultural Research Service (ARS) National Plant Germplasm 
System (NPGS), a network of 26 labs that preserve the genetic diversity 
of crop plants, is a critical resource for scientists to access genetic 
diversity. This access helps bring forth new varieties that can resist 
pests, diseases, and environmental stresses for all types of cropping 
systems, including organic, conventional and biotech. In addition, it 
is a vital resource for horticulture and conservation research.
    The NPGS is currently funded at approximately $44 million. This 
amount is insufficient to maintain and distribute the collections to 
U.S. researchers who are developing varieties for conventional and 
organic farmers and other landscape uses. ASTA recommends increasing 
funding for the NPGS so it can better fulfill its mission.
      
Agricultural Research Service
National Plant Germplasm System (NPGS)
Germplasm Enhancement of Maize (GEM)
Request: $2.7 million
      
    The Germplasm Enhancement of Maize (GEM) program within the funding 
for the ARS NPGS focuses on adapting exotic corn germplasm for use in 
the U.S. and on identifying useful genetics in exotic landraces to 
develop new hybrids. These resources are then made available to any 
breeders who request them. Over 500 inbred lines have been released to 
date. Because these materials are adapted to temperate U.S. conditions, 
U.S. seed companies are saved 6-8 years in the breeding cycle.
    The continued success of American agriculture is intimately linked 
to corn production. USDA estimates that 13.6 billion bushels were 
harvested in 2015. However, U.S. corn production is based predominantly 
on two races of maize from more than 250 New World races. This limited 
genetic diversity renders the U.S. corn crop, and therefore, the global 
food supply, more vulnerable to attack by new diseases. The GEM 
materials can play an important role in fighting new diseases in the 
U.S. and globally. Examples include the catastrophic Maize Lethal 
Necrosis which is causing significant crop losses in Africa, and Late 
Wilt, a very devastating disease in Egypt which has now been reported 
in Spain.
    GEM is a model public-private partnership between the Federal 
government, universities, and companies of all sizes. In addition to 
its significant research contributions, GEM also facilitates 
development of future researchers. So far, the GEM project has trained 
18 Ph.D. and 14 M.S. students. The current funding for GEM is 
approximately $1.6 million. Private industry provides over $625,000 of 
in-kind support annually for this effort, and industry germplasm 
contributions to GEM are currently valued at over $3 billion.
    Demand for maize germplasm continues to increase, and GEM has 
already distributed more than 21,000 seed samples. ASTA supports an 
increase in GEM funding for both research and operations costs, and the 
need to establish consistent winter nurseries for seed increases and 
regeneration. We recommend increasing funding of the Germplasm 
Enhancement of Maize to $2.7 million.

GEM Private Cooperators:
3rd Millennium Genetics             Santa Isabel, Puerto Rico
AgiWise, L.L.C.                     Ames, IA
AgReliant Genetics, LLC             Lebanon, IN
1BASF Plant Science Breeding, 
L.L.C.                              Research Triangle Park, NC
Beck's Superior Hybrids, Inc.       Atlanta, IN
Brownseed Genetics                  Bay City, WI
CRD Advisors, LLC                   Kelley, IA
DKD Genetics, Inc.                  Vincennes, IN
Dow AgroSciences                    Indianapolis, IN
DuPont Pioneer                      Johnston, IA
FFR Cooperative                     Lafayette, IN
Forage Genetics                     Nampa, ID
Genetic Enterprises Int'l           Luther, IA
Global Investors, LP                Des Moines, IA
Hoegemeyer Enterprises              Hooper, NE
Ingredion Inc.                      Indianapolis, IN
Illinois Foundation Seeds, Inc.     Tolono, IL
JFS and Associates, LTD             Harlan, IA
MBS Genetics, LLC.                  Story City, IA
Monsanto Company                    St. Louis, MO
PANNAR Seed                         Johnston, IA
Professional Seed Research, Inc.    Sugar Grove, IL
SEEDirect                           Woodstock, IL
Summit Genetics                     Carroll, IA
Syngenta Seeds, Inc.                Minnetonka, MN
Terrell Seed Research               Wabash, IN
Trimble Genetics International, LLC Johnstown, IA
Wyffels Hybrids                     Geneseo, IL

National GEM Public Cooperators:
Cornell University
Iowa State University
Louisiana State University
North Carolina State University
North Dakota State University
Ohio State University
Purdue University
Texas A&M University
The University of Delaware
The University of Illinois
The University of Missouri
The University of Nebraska
The University of Tennessee
The University of Wisconsin
Truman State University
USDA-ARS multiple locations
      
USDA-Natural Resources Conservation Service
Plant Material Centers
Request: $14.5 million
      
    ASTA recommends that the USDA-NRCS Plant Material Centers be fully-
funded at $14.5 million. The network of 25 PMCs across the country seek 
out and test plants and plant technologies that restore and sustain 
healthy natural regional ecosystems. A key function of the centers is 
to evaluate plants for conservation traits and to make these materials 
available to commercial growers, who in turn provide plant materials to 
the public.
    The materials developed by the Plant Material Centers are critical 
to many USDA goals, including improving soil health, increasing 
pollinator and wildlife habitat and expanding the availability of new 
cover crop solutions.
    Nationwide, 500 of the 700 releases from the PMCs are currently 
under commercial production. This work can't be duplicated by the 
private sector seed industry, which lacks the resources to develop and 
test materials to address such an extensive range of concerns for the 
entire United States.

    [This statement was submitted by Andrew W. LaVigne, President & CEO 
American Seed Trade Association.]

                                 ______
                                 
    Prepared Statement of the American Society for Microbiology (AG)
    The American Society for Microbiology (ASM) urges Congress to 
approve the President's proposed fiscal year 2017 budget for research 
and food safety programs at the Department of Agriculture (USDA). The 
proposed budget would ensure that the USDA is able to adequately fund 
programs that support research and development critical to sustaining a 
safe and competitive food and agriculture system in the United States. 
The ASM strongly supports funding the National Institute of Food and 
Agriculture (NIFA) with $1.379 billion, including $700 million for the 
Agriculture and Food Research Initiative (AFRI), the level authorized 
by Congress when it was established in the 2008 Farm Bill. The ASM 
recommends $1.256 billion for the Agricultural Research Service (ARS), 
USDA's in house research. Agriculture remains a strong and consistent 
contributor to the US economy, with the USDA estimating a total of 
$775.8 billion in economic activity annually and the source of one in 
twelve US jobs. However, agriculture research only accounts for 2 
percent of Federal R&D spending, regardless of clear links among 
innovative research, productivity, public health and market value.
         usda research advances us agriculture and productivity
    AFRI funding has been well below the $700 million level authorized 
by Congress when it established AFRI in the 2008 Farm Bill, re-
authorized in 2014. In fiscal year 2014, AFRI received 3,875 proposals, 
of which 1,640 were recommended for funding, but only 390 won support 
due to budget constraints. Currently, AFRI is able to fund only one out 
of 10 grant proposals.
    Economic analyses cited by USDA show that investment in agriculture 
research and extension yields $20 in returns for every dollar spent. 
The economic potential is evident in the agency's 883 patent 
applications and 429 issued patents during 2009-2015. Last year, the 
USDA technology transfer portfolio included 421 licenses generating 
income and 301 cooperative R&D agreements, many with small businesses. 
The value of US exports has risen more than 45 percent since 2009; in 
2009-2015, exports totaled over $911 billion.
    Increased funding is needed for NIFA's mission to assure food 
safety and nutritional security, advance food and agricultural systems 
through science and technology, support rural economies and create jobs 
and train the next generation of food and agriculture scientists by 
supporting research, education and extension activities at US 
universities and colleges. In its farm bills, Congress outlined the 
priority areas for AFRI grants: plant health and production and plant 
products; animal health and production and animal products; food 
safety, nutrition and health; bioenergy, natural resources and 
environment; agriculture systems and technology; and agriculture 
economics and rural communities. AFRI has awarded grants to 
universities, businesses, foundations, non-profits, community groups, 
associations and Federal and international partners.
    AFRI studies include food processing technologies like irradiation 
and microwave pasteurization and how pathogens survive on fresh 
produce. A major effort currently focuses on Huanglongbing (HLB), a 
bacterial infection commonly known as citrus greening, which last year 
infected more than 75 percent of the Florida citrus crop. Researchers 
are developing bactericides, therapeutic delivery systems and new 
genetic approaches to stop this economically devastating disease.
    Each year, AFRI provides funding for the education and training of 
nearly 2,500 undergraduate, graduate and postdoctoral students for 
careers in the agricultural, food, natural resource and human sciences. 
Federal projections through 2020 indicate that, at present funding 
levels, US education institutions will not graduate sufficient numbers 
of new workers in agricultural fields, in fact falling short by 22,500. 
The fiscal year 2017 budget will continue USDA's education of the 
general public and agricultural producers. NIFA just announced creation 
of five centers across the United States to conduct training, education 
and technical assistance tailored toward small farm owners, food 
processors and other specific audiences.
    The Agriculture Research Service employs more than 6,500 staff to 
conduct approximately 700 research projects at 90-plus USDA 
laboratories in the United States and abroad. USDA scientists either 
access existing or innovate new leading edge science and technology to 
advance the agency's basic and applied research. This year, as example, 
ARS will continue development and use of genomics technologies to 
improve livestock and crop production. Genetically engineered (GE) 
crops that can resist pests became commercially available for major 
crops in 1996. By 2013, farmers had planted 170 million acres with GE 
crops, about half of US farmland in crop use.
    The ARS fiscal year 2017 request outlines priority areas that 
include antimicrobial resistance, climate change, water supplies, avian 
influenza and foreign animal diseases. Drug resistance is growing and 
ASM applauds the additional $22 million requested to address this 
problem in humans and livestock. Two million Americans have drug 
resistant illnesses every year and more than 23,000 die. The increase 
will support vaccines to help reduce nontherapeutic antibiotics in food 
animals, studies on the gut microbiome and its effects on immune 
development and identification of specific nutrients with immune 
benefits. A recent report from the Food and Drug Administration 
reiterated that US sales of medically important antibiotics approved 
for livestock use rose by 23 percent between 2009 and 2014, reinforcing 
concerns about risks to humans. The fiscal year 2017 funding will 
facilitate much needed research on possible connections and solutions.
          usda research protects food security and food safety
    USDA regulates the nation's supply of domestic and imported meat, 
poultry, catfish and processed eggs, to ensure products are wholesome, 
safe and properly labeled. Each year, there are new reminders of the 
potentially serious consequences of contaminated food supply systems. 
One in six Americans gets sick with foodborne illnesses each year, with 
about 128,000 hospitalized. USDA partners with numerous public health 
stakeholders to reduce the societal and economic costs of these 
illnesses.
    USDA research that provides science based strategies to stop 
foodborne threats, preserve productivity and safeguard food security. 
USDA food guidelines and rules depend upon science; examples are the 
new Federal standards to further reduce Salmonella and Campylobacter 
bacteria in certain poultry products. Based on risk assessments, the 
agency estimates that implementation could prevent an average of 50,000 
illnesses annually.
    FSIS coordinates its far flung activities, including inspections of 
food production establishments, with other USDA and non-USDA programs 
to ensure an integrated farm to table approach. Annual FSIS budgets 
support approximately 8,000 Federal in plant and field personnel, many 
of them stationed at about 6,400 slaughtering and processing 
establishments, import houses and other facilities. FSIS also supports 
state inspection programs and helps strengthen data infrastructure for 
nationwide food safety. FSIS relies upon the latest scientific 
knowledge and capabilities, especially screening technologies that 
detect contaminants faster and more accurately, are field ready and 
real time and provide more quantitative data. Currently, USDA is 
seeking techniques that identify all contaminants in a sample, whether 
microbiological or chemical. Sample analyses are increasingly reliant 
upon cutting edge genetics. The fiscal year 2017 request includes USDA 
implementation of a whole genome sequencing initiative to identify 
pathogens with great precision and improve the speed and accuracy of 
outbreak investigations. This also is relevant to USDA's role in the 
national antimicrobial resistance initiative.
    Protecting animal and plant health from threats inside the United 
States and beyond consistently improves both food safety and food 
security. The fiscal year 2017 budget proposes additional support 
against the threat of avian influenza and other animal diseases found 
in other nations that could enter US agriculture, decimating production 
and export markets. The 2015 outbreak of highly pathogenic avian 
influenza was the worst animal disease outbreak in US history, costing 
the Federal government over $1 billion in eradication efforts and the 
industry huge losses in poultry flocks and export income. More than 400 
USDA staff and nearly 3,000 USDA contracted personnel worked with 
states and industry to eliminate infected flocks at more than 200 
locations, killing 50 million birds.
    Facing the specter of foot and mouth disease (FMD) is one AFRI 
supported effort that showcases the need for robust research funding. 
This highly contagious viral disease is considered the most important 
animal disease in the world. The US eradicated FMD in 1929, but its 
persistence around the world makes it very difficult to control. A 2001 
outbreak in the United Kingdom cost an estimated $6 billion. FMD in the 
United States would shut down our exports of fresh beef, pork and dairy 
products. When US beef exports dropped in 2003 due to a single case of 
mad cow disease, the cumulative loss to the economy was an estimated 
$16 billion. Some estimates of possible US economic impacts from an 
uncontrolled FMD outbreak approach $200 billion. The fiscal year 2017 
budget includes additional funds for the Animal and Plant Health 
Inspection Service (APHIS) to acquire FMD vaccines for the FMD Vaccine 
Bank. FMD vaccines must be matched to the specific type and subtype of 
virus causing the outbreak and available vaccines are not adequate to 
respond effectively to an outbreak of FMD in the US.
    Long term investments in agriculture R&D programs benefit the 
producers on US farms and ranches, our expansive food industry and 
individual consumers. USDA food safety programs directly protect the 
public daily. The ASM asks Congress to fully support the fiscal year 
2017 budget requested to guarantee the health and productivity of US 
agriculture.

    [This statement was submitted by Public and Scientific Affairs 
Board, American Society for Microbiology.]

                                 ______
                                 
   Prepared Statement of the American Society for Microbiology (FDA)
    The American Society for Microbiology (ASM) recommends that 
Congress appropriate at least an additional $100 million for the Food 
and Drug Administration (FDA) in the fiscal year 2017 budget. This 
increase would fund the FDA at $2.8 billion, instead of the $2.7 
billion, or 1 percent increase, proposed by the Administration. 
Although the total FDA budget, which relies heavily upon user fees, is 
$4.8 billion, $80 million over fiscal year 2016, the Administration's 
proposed budget would result in flat or lower funding for numerous FDA 
programs that continue to grow in order to protect the public health 
and safety and because of legislated responsibilities. FDA regulated 
products account for about 20 cents of each consumer dollar. FDA 
oversees all drugs, vaccines, medical devices and cosmetics as well as 
80 percent of the nation's food supply. Every year, these product 
sectors are increasing in volume, diversity and global sourcing and 
intensifying FDA's regulatory role. The ASM believes it is critical to 
appropriate additional Federal appropriations for the FDA.
    The ASM appreciates that the FDA request does include funding 
earmarked for important efforts like food safety, the Cancer Moonshot 
and precision medicine. However, we are disappointed by the lack of 
substantial increased support for public health related problems under 
FDA purview, such as the threat of growing drug resistance among 
infectious diseases and a more forceful implementation of the 2011 Food 
Safety Modernization Act (FSMA) passed by Congress.
    The ASM asks that Congress provide FDA with the resources needed to 
fulfill its mission to safeguard the public health, contribute to the 
discovery of new healthcare and consumer products, and boost US global 
competitiveness in science and technology.
              fda actions protect and serve public health
    In the past year, FDA efforts have targeted Zika and Ebola viruses, 
infections acquired in healthcare settings and nontherapeutic 
antibiotic use in food animals. Contaminated cucumbers, cilantro, ice 
cream and salad greens were among the newsworthy causes of foodborne 
outbreaks reminding us that foodborne illnesses require rapid FDA 
responses. FDA has unique input into the healthcare continuum, by 
evaluating the safety and efficacy of new and marketed drugs, vaccines, 
medical devices and other products for human and animal use. As of 
February, the agency's evaluation of Ebola related products had 
included at least ten diagnostics and three vaccine candidates, 
clinical trials of the ZMapp therapeutic and review of unsuccessful 
drug candidates and blood donor Ebola guidance issued in December. The 
agency had fast tracked evaluation of ZMapp, granting it an ``orphan 
drug'' designation to accelerate testing of the experimental drug. Its 
collaborative efforts with other stakeholders stimulated R&D on 
possible countermeasures and broadened patient access to better 
healthcare. FDA has begun work on improved Zika diagnostics, including 
assays built upon reverse transcription polymerase chain reaction (RT-
PCR). FDA is also evaluating proposed vector control through 
genetically engineered mosquitoes. When new candidate vaccines and 
drugs have been developed, the FDA will be ready to expedite their 
review as well.
    In 2015, FDA issued approvals for 56 new drugs and biologics, 
compared to 50 in 2014. Among the approved products are treatments for 
hepatitis C, multiple myeloma, HIV infection and plague as well as a 
vaccine for use after anthrax exposure. Two other drugs were the fifth 
and sixth approved under the Qualified Infectious Disease Product 
protocol for rare but serious infections, aimed at stimulating drug R&D 
through priority review. Also approved were a diagnostic test to 
differentiate among types of HIV infection and an improved duodenoscope 
design to reduce infection risk during medical procedures.
    In the United States, nearly 40 percent of our finished drugs and 
80 percent of active ingredients used in drug manufacture are imported. 
The heightened global sourcing of US consumer products is clear to any 
shopper, but the chore of FDA oversight is far more complex. FDA 
regulated products originate from more than 200 countries, entering 
through more than 300 US ports. FDA estimates that shipments have more 
than tripled in the past decade, from 8 million import entry lines per 
year to more than 29 million today. At present, fewer than 2 percent of 
incoming shipments are inspected by the available FDA staff, often 
cited as proof of FDA budget shortfalls.
    The ASM recognizes the monumental task of guaranteeing our food 
supply's safety and security. Chronically understaffed, FDA foods 
inspection, regulatory and investigation programs are challenged daily. 
FDA registered food producing and manufacturing sites comprise 133,000 
foreign and 97,000 domestic facilities. FDA currently has resources to 
inspect about 1,000 foreign facilities per year. The Department of 
Agriculture (USDA) estimates that foods grown or processed outside the 
country account for about 20 percent of the US food supply, including 
about half of fresh fruits, 20 percent of fresh vegetables and 80 
percent of seafood.
    Last fall, FDA finalized five of the seven major rules that 
implement the core mandates of the FSMA legislation. Following huge 
effort by the agency, interagency partners and public comment, the 
rules address both domestic and foreign sources. Two of the preventive 
controls rules focus on modern food manufacturing processes for both 
human and animal foods, holding food companies more accountable for 
monitoring facilities. The third rule establishes science based 
standards to reduce contamination in produce, a frequent source of 
foodborne illnesses. The others specifically target imports through the 
Foreign Supplier Verification Program and accreditation of third party 
certification bodies to audit foreign foods and facilities. The ASM 
acknowledges the effort leading to these crucial food safety measures. 
However, the most effective implementation of FSMA goals depends upon 
both cutting edge FDA science and adequate fiscal support.
                  fda science advances product safety
    In September, the advisory FDA Science Board released its in depth 
report on the current state of FDA science, Mission Possible: How FDA 
Can Move at the Speed of Science. Report authors were tasked to 
evaluate how FDA can best review products from emerging and future 
trends in science and technology, elevate its own scientific culture, 
and leverage collaborations with other stakeholders. Also included was 
assessment of intra-agency progress made since the Board's 2007 report, 
FDA Science and Mission at Risk. The report commended proactive moves 
like the new Office of the Chief Scientist and FDA offices in other 
countries, plus the effort to better regulate cutting edge technologies 
like genome sequencing, computing and stem cells.
    The ASM agrees with the report's warning that some serious problems 
persist, indictments of ongoing funding shortfalls. Noted examples are 
failures to allocate the substantial amounts of FDA funding needed for 
the FSMA mandate's complete implementation and FDA's own scientific 
methods and technologies too often lagging behind industry and others. 
As the agency responsible for the safety and efficacy of huge consumer 
sectors, FDA clearly must have routine access to the latest science and 
technologies to best serve the public. The US responses to the 2014-
2015 Ebola epidemic, and now the Zika virus, rely upon FDA science to 
help guide policy development, facilitate clinical trials and undertake 
fast track reviews of candidate drugs, diagnostics and vaccines. More 
broadly, next-generation diagnostics now being developed by industry 
often are based upon metagenomic sequencing that FDA must be prepared 
to evaluate. Another instance of FDA activities that must be based on 
sound science is reviewing foods from genetically engineered (GE) 
plants and animals. In November, FDA announced its approval of GE 
salmon, the agency's first for a GE animal for human consumption, as 
well as related guidance documents on labeling. It also released a 
final guidance for labeling foods derived from GE plants. Beyond the 
needed laboratory expertise, FDA regulatory actions increasingly 
require newer types of highly sought technical personnel like 
bioinformaticians.
    Since 2008, the FDA foods program has utilized whole genome 
sequencing (WGS) to identify the microbial causes of foodborne 
illnesses faster and more accurately. Continued WGS improvements are 
dramatically reducing times required for identification from 14 days to 
just a few days, as well as pinpointing the source of outbreaks down to 
the farm or facility level. Last year, WGS was used extensively in 
outbreak investigations, linking contaminated imported cucumbers to a 
few specific firms and Listeria infections to certain ice cream 
manufacturers. FDA established the first national lab network of whole 
genome sequencers, called GenomeTrakr, which has accumulated more than 
43,000 sequenced microbial isolates since 2013. FDA scientists are also 
using other next generation technologies like flow cytometry and 
fluorescence. FDA recently reduced the average number of days to 
serotype food pathogens to three days.
       fda partnerships support national initiatives, legislation
    Under its regulatory role, FDA reinforces multiple national efforts 
against threats to our collective health and quality of life. Some, 
like FSMA implementation, require extensive FDA actions that seriously 
stretch agency resources. Another example is FDA's participation in the 
National Action Plan for Combating Antibiotic Resistant Bacteria (CARB) 
and other efforts to address rising drug resistance among pathogens. 
Related FDA efforts encompass the areas of drugs, biologics, medical 
devices, and veterinary medicine. In 2015, the agency published its 
final Veterinary Feed Directive rule and an industry guidance to 
further promote judicious use of antimicrobials in food producing 
animals, placing their use under veterinary supervision.
    To support the newly launched National Cancer Moonshot Initiative, 
FDA will develop a virtual Oncology Center of Excellence, to leverage 
collective expertise in drugs, biologics and medical devices to 
expedite R&D of novel products. The Center additionally will contribute 
to FDA's current support of the 2015 Precision Medicine Initiative, 
under which FDA has already approved a targeted therapy and companion 
diagnostic test for certain lung cancers.
    The ASM appreciates that some FDA responsibilities would receive 
earmarked funding in the fiscal year 2017 budget, but we urge Congress 
to increase Federal appropriations for the FDA, which includes so many 
programs that have needs and are critical to public health and safety.

    [This statement was submitted by Public and Scientific Affairs 
Board, American Society for Microbiology.]

                                 ______
                                 
          Prepared Statement of American Society for Nutrition
    The American Society for Nutrition (ASN) respectfully requests that 
the U.S. Department of Agriculture (USDA)/National Institute of Food 
and Agriculture/Agriculture and Food Research Initiative receive $700 
million and that the Agricultural Research Service receive $1.161 
billion in fiscal year 2017, the Administration's proposed funding 
levels. ASN has more than 5,000 members working throughout academia, 
clinical practice, government, and industry, who conduct research to 
advance our knowledge and application of nutrition.
                agriculture and food research initiative
    The USDA has been the lead nutrition agency and the most important 
Federal agency influencing U.S. dietary intake and food patterns for 
years. Agricultural research is essential to address the ever-
increasing demand for a healthy, affordable, nutritious and sustainable 
food supply. The Agriculture and Food Research Initiative (AFRI) 
competitive grants program is charged with funding research, education, 
and extension and integrated, competitive grants that address key 
problems of national, regional, and multi-state importance in 
sustaining all components of agriculture. These components include 
human nutrition, farm efficiency and profitability, ranching, renewable 
energy, forestry (both urban and agro forestry), aquaculture, food 
safety, biotechnology, and conventional breeding. AFRI has funded 
cutting-edge, agricultural research on key issues of timely importance 
on a competitive, peer-reviewed basis since its establishment in the 
2008 Farm Bill. Adequate funding for agricultural research is critical 
to provide a safe and nutritious food supply for the world population, 
to preserve the competitive position of U.S. agriculture in the global 
marketplace, and to provide jobs and revenue crucial to support the 
U.S. economy.
    In order to achieve those benefits, AFRI must be able to advance 
fundamental sciences in support of agriculture and coordinate 
opportunities to build off of these discoveries. Therefore, ASN 
requests that the AFRI competitive grants program receive $700 million, 
the Administration's proposed funding of AFRI, in fiscal year 2017, 
which would double AFRI funding. Current flat and decreased funding for 
AFRI hinders scientific advances that support agricultural funding and 
research.
                     agricultural research service
    The Agricultural Research Service (ARS) is the Department of 
Agriculture's lead scientific research agency. The ARS 7conducts 
research to develop and transfer solutions to agricultural problems of 
high national priority. USDA's program of human nutrition research is 
housed in six Human Nutrition Research Centers (HNRCs) across the 
nation, that link producer and consumer interests and form the core for 
building knowledge about food and nutrition. HNRCs conduct unparalleled 
human nutrition research on the role of food and dietary components in 
human health from conception to advanced old age, and they provide 
authoritative, peer-reviewed, science-based evidence that forms the 
basis of our Federal nutrition policy and programs. Funding for ARS 
supports all of the USDA/HNRCs and ensures that these research 
facilities have adequate funding to continue their unique mission of 
improving the health of Americans through cutting-edge food, nutrition 
and agricultural research.
    Nutrition monitoring conducted in partnership by the USDA/ARS with 
the Department of Health and Human Services (HHS) is a unique and 
critically important surveillance function in which dietary intake, 
nutritional status, and health status are evaluated in a rigorous and 
standardized manner. (ARS is responsible for food and nutrient 
databases and the ``What We Eat in America'' dietary survey, while HHS 
is responsible for tracking nutritional status and health parameters.) 
Nutrition monitoring is an inherently governmental function and 
findings are essential for multiple government agencies, as well as the 
public and private sector. Nutrition monitoring is essential to track 
what Americans are eating, inform nutrition and dietary guidance 
policy, evaluate the effectiveness and efficiency of nutrition 
assistance programs, and study nutrition-related disease outcomes. 
Because of past funding deficiencies, some food composition database 
entries do not reflect the realities of the current food supply, which 
may negatively impact programs and policies based on this information. 
It is imperative that needed funds to update USDA's food and nutrient 
databases and the ``What We Eat in America'' dietary survey, both 
maintained by the USDA/ARS, are appropriated to ensure the continuation 
of this critical surveillance of the nation's nutritional status and 
the many benefits it provides.
    It is the job of ARS to ensure high-quality, safe food, and other 
agricultural products; assess the nutritional needs of Americans; 
sustain a competitive agricultural economy; enhance the natural 
resource base and the environment; and provide economic opportunities 
for rural citizens, communities, and society as a whole. Therefore, ASN 
requests that ARS receive at least $1.161 billion in fiscal year 2017, 
with Congress directing the use of some of these funds for both intra-
and extramural human nutrition research. Resources above current 
funding levels are necessary to ensure the critical surveillance of the 
nation's nutritional status and to continue the many other benefits 
that ARS provides. With such funding, the ARS will be able to support 
its vision of leading America towards a better future through 
agricultural research and information.

    [This statement was submitted by Patrick J. Stover, Ph.D., 
President, American Society for Nutrition.]

                                 ______
                                 
       Prepared Statement of American Society of Plant Biologists
    On behalf of the American Society of Plant Biologists (ASPB), we 
submit this statement for the official record in support of funding for 
agricultural research by the U.S. Department of Agriculture (USDA). 
ASPB supports the fiscal year 2017 requested level of $700 million for 
the Agriculture and Food Research Initiative (AFRI), which administers 
competitive funding for innovative research on issues such as food 
security, global health, and renewable energy. ASPB also supports the 
fiscal year 2017 requested level of $1.286 billion for the Agricultural 
Research Service (ARS).
    This testimony highlights the critical importance of plant biology 
research and development to addressing vital issues including: 
achieving a sustainable food supply and food security; energy security, 
attaining reduced reliance on all petrochemical products through game-
changing sustainable renewable biomass utilization approaches; and 
protecting our environment.
    food, fuel, environment, and health: plant biology research and 
             america's competitiveness and self-sufficiency
    We often take plants for granted, but they are vital to our very 
existence, competitiveness, and self-sufficiency. New plant biology 
research is now addressing the most compelling issues facing our 
society, including: identifying creative and imaginative approaches to 
reaching Congress's goals of achieving domestic fuel security/self-
sufficiency; environmental stewardship; sustainable and secure 
development of even better foods, feeds, building materials, and a host 
of other plant products used in daily life; and improvements in the 
health and nutrition of all Americans.
    Our bioeconomy and Federal partnership is based upon foundational 
plant biology research--the strategic research USDA funds--to make 
needed key discoveries. Yet limited funding committed to basic 
discovery now threatens our national security and leadership. Indeed, 
Bill Gates wrote, ``Given the central role that food plays in human 
welfare and national stability, it is shocking--not to mention short-
sighted and potentially dangerous--how little money is spent on 
agricultural research.'' \1\ This is especially true considering the 
significant positive impact crop and forest plants have on the nation's 
economy (the agricultural sector is responsible for one in 12 American 
jobs \2\).
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    \1\ Gates, Bill. (Jan 2012). 2012 Annual Letter from Bill Gates. 
Retrieved from http://www.gatesfoundation.org/annual-letter/2012/Pages/
home-en.aspx.
    \2\ Vilsack, Tom. (Mar. 9, 2012). Public Comments Before PCAST. 
Retrieved from http://www.tvworldwide.com/events/pcast/120309/
globe_show/default_go_archive.cfm?gsid=1977&
type=flv&test.
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    Given these concerns and our nation's fiscal situation, the plant 
science community has been working toward addressing our nation's 
looming challenges. With funding from USDA, the National Science 
Foundation, the Department of Energy, and the Howard Hughes Medical 
Institute, ASPB brought together representatives from across the full 
spectrum of plant science research to develop a community agenda 
document, Unleashing a Decade of Innovation in Plant Science: A Vision 
for 2015-2025 (plantsummit.files.wordpress.com/2013/07/
plantsciencedecadalvision10-18-13.pdf). The report, part of an ongoing 
and iterative process, puts forth a ten-year consensus plan to fill 
critical gaps in our understanding of plant biology toward addressing 
the grand challenge of sustainably feeding the world and providing 
other useful plant products in the face of burgeoning population 
growth, diminishing natural resources, and climate change.
                       immediate recommendations
    The ASPB membership has extensive expertise and participation in 
the academic, industry, and government sectors. Consequently, ASPB is 
in an excellent position to articulate the nation's plant science 
priorities and standards needed as they relate to agriculture. Our 
recommendations are as follows:
  --Since the establishment of the National Institute of Food and 
        Agriculture (NIFA) and AFRI, interest in USDA research has 
        increased dramatically--a trend ASPB hopes to see continue in 
        the future. However, an increased, strategic and focused 
        investment in competitive funding and its oversight is needed 
        if the nation is to continue to make ground-breaking 
        discoveries and accelerate progress toward resolving urgent 
        national priorities and societal needs. ASPB encourages the 
        Committee to fund AFRI at the requested $700 million level in 
        fiscal year 2017.
  --The Agricultural Research Service (ARS) provides vital strategic 
        research to serve USDA's mission and objectives and as well as 
        the nation's agricultural sector. The need to bolster and 
        enhance ARS efforts to leverage and complement AFRI is great 
        given the challenges in food and energy security. ASPB is 
        supportive of a strong ARS and recommends a congressional 
        appropriation of the requested $1.286 billion in fiscal year 
        2017.
  --USDA has focused attention in several key priority areas, including 
        water for food production, food safety, childhood obesity, 
        climate variability and change, and sustainable energy. 
        Although ASPB appreciates the value of such strategic focus, we 
        give our most robust support for AFRI's Foundational Program. 
        This program provides a basis for outcomes across a wide 
        spectrum, often leading to groundbreaking developments that 
        cannot be anticipated in advance. Indeed, it is these 
        discoveries that are the true engine of success for our 
        bioeconomy.
  --Current estimates predict a significant shortfall in the needed 
        agricultural scientific workforce as the demographics of the 
        U.S. workforce change.\3\ For example, there is a clear need 
        for additional training of scientists in the areas of 
        interdisciplinary energy research and plant breeding. ASPB 
        applauds the ongoing support of the NIFA Fellows program and 
        calls for additional funding for specific programs (e.g., 
        training grants and fellowships) to provide this needed 
        workforce over the next 10 years and to adequately prepare 
        these individuals for careers in the agricultural research of 
        the future.
---------------------------------------------------------------------------
    \3\ President's Council of Advisors on Science and Technology. 
(Dec. 2012). Report to the President on Agricultural Preparedness and 
the Agricultural Research Enterprise, p. 41.
Retrieved from http://www.whitehouse.gov/sites/default/files/
microsites/ostp/pcast_agriculture
_20121207.pdf.
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  --Considerable research interest is now focused on the use of plant 
        biomass for energy production. However, if we are to use crops 
        and forest resources to their full potential, we must expend 
        extensive effort to improve our understanding of their 
        underlying biology and development, their agronomic 
        performance, and their subsequent processing to meet our goals. 
        Therefore, ASPB calls for additional funding targeted at 
        efforts to increase the utility and agronomic performance of 
        bioenergy crops using the best and most imaginative science and 
        technologies possible.
  --ASPB encourages some flexibility within NIFA's budget to update and 
        improve its data management capabilities.

    [This statement was submitted by Tyrone C. Spady, PhD, Director of 
Legislative and Public Affairs.]

                                 ______
                                 
Prepared Statement of American Society for the Prevention of Cruelty to 
                                Animals
    On behalf of the American Society for the Prevention of Cruelty to 
Animals (ASPCA) and our 2.5 million supporters nationwide, thank you 
for the opportunity to submit this written testimony. Founded in 1866, 
the ASPCA was the first humane organization in North America. Our 
mission, as stated by founder Henry Bergh, is ``to provide effective 
means for the prevention of cruelty to animals throughout the United 
States.'' As you craft the fiscal year 2017 Agriculture Appropriations 
bill, the ASPCA asks that you please consider the following provisions.
 continue the current ban on federal funding for horse slaughterhouse 
                              inspections
    Congress included in the fiscal year 2016 Consolidated 
Appropriations Act a provision continuing the long-standing ban on 
Federal funding for USDA inspections at domestic horse slaughterhouses.
    Americans do not eat horse meat, and national polling indicates 
that 80 percent of American voters oppose the slaughter of horses for 
human consumption. Cruelties associated with horse slaughter are well-
documented. Whether in the U.S. or over the border, horses are forced 
into cramped trailers and trucked long distances to slaughter with 
insufficient food, water, or rest. Many horses are injured, trampled, 
and even killed during the journey. Horses that survive endure an 
inherently cruel slaughter process. As extreme flight animals, horses 
are ill-suited for stunning. In USDA-regulated plants, many endured 
repeated blows, sometimes remaining conscious during dismemberment. 
USDA documented rampant violations and cruelty in domestic horse 
slaughter facilities, including photos of protruding broken bones, 
eyeballs hanging by a thread of skin, and open wounds.
    As American horses are not raised for food, throughout their lives 
they are routinely given numerous drugs prohibited by the FDA for use 
in animals intended for human consumption. A 2010 Food and Chemical 
Toxicology Journal article detailed the ubiquitous use of 
phenylbutazone in race horses subsequently sent to auction and then to 
slaughter only days after medication.\1\ A New York Times investigation 
revealed a virtual arms race of illegal drug use in horses to mask pain 
and evade drug tests including ``cobra venom, Viagra, blood doping 
agents, stimulants, and cancer drugs,'' and the resulting food safety 
threats.\2\ The Food Safety and Inspection Service (FSIS) cannot test 
for these harmful substances without a system to track horses' health 
histories, and trainers are constantly experimenting with new 
stimulants to gain a competitive edge.
---------------------------------------------------------------------------
    \1\ Dodman, N., Blondeau, N., Marini, A.M., ``Association of 
Phenylbutazone Usage with Horses Bought for Slaughter: A Public Health 
Risk.'' Food and Chemical Toxicology: May 2010.
    \2\ ``Death and Disarray at America's Racetracks.'' The New York 
Times: March 24, 2012.
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    The European Union (EU) announced a ban on imports of horse meat 
from Mexico to the EU as of January 1, 2015, following a scathing audit 
of EU-certified Mexican horse slaughter plants, which kill tens of 
thousands of American horses each year. The report stressed that 
because horses are not raised as food-producing animals in Mexico or 
the United States, they are routinely given many medications that are 
illegal for use in food animals. U.S. tax dollars should not be used to 
prop up an industry that has no regard for animal welfare or human 
health.
    The ASPCA requests that the Subcommittee continue the prohibition 
on Federal funding for horse slaughterhouse inspections by the USDA by 
including the following language:
    None of the funds made available in this Act may be used to pay the 
salaries or expenses of personnel--
    (1) to inspect horses under section 3 of the Federal Meat 
Inspection Act (21 U.S.C. 603);
    (2) to inspect horses under section 903 of the Federal Agriculture 
Improvement and Reform Act of 1996 (7 U.S.C. 1901 note; Public Law 104-
127); or
    (3) to implement or enforce section 352.19 of title 9, Code of 
Federal Regulations (or a successor regulation).
     ensure that ars research complies with the animal welfare act
    A 2015 New York Times expose revealed appalling abuse of animals at 
USDA's U.S. Meat Animal Research Center (USMARC).\3\ The article 
revealed a shocking array of animal experiments occurring at the USMARC 
with little regard for welfare, e.g., a live, unanaesthetized pig 
dissected and then improperly euthanized, and lambs left to die of 
exposure to extreme weather and predation in order to develop ``easy-
care'' sheep. The research at the USMARC inflicts terrible suffering on 
animals at taxpayer expense. Since 2006, USDA's Agricultural Research 
Service (ARS) has spent nearly $200 million at USMARC.
---------------------------------------------------------------------------
    \3\ ``U.S. Research Lab Lets Livestock Suffer in Quest for 
Profit.'' The New York Times: January 19, 2015.
---------------------------------------------------------------------------
    The cows, sheep, and pigs used in these experiments are exempt, by 
statute, from the basic standards of the Animal Welfare Act (AWA), 
which exempts animals used in agriculture production research. Though 
exempted by statute, USDA's internal policies mirror some of these 
basic protections. However, investigative reports from USDA last year 
noted that USMARC filed to follow its own animal welfare standards.\4\ 
\5\ \6\ In particular, these reports showed a need for further review 
of internal animal welfare policies and that USMARC's Institutional 
Animal Care and Use Committee (IACUC) was not properly constituted.
---------------------------------------------------------------------------
    \4\ ``Findings and Recommendations on the Animal Care and Well-
Being at the U.S. Meat
Animal Research Center to the Secretary of Agriculture and the REE 
Under Secretary.''
Agricultural Research Service--Animal Handling and Welfare Review 
Panel. 
Pre-Public Hearing Report. March 9, 2015. 
  \5\ ``Findings and Recommendations on the Phase II Review of the 
Animal Care and Well-Being at the Agricultural Research Service to the 
REE Under Secretary.'' Agricultural Research Service--Animal Handling 
and Welfare Review Panel. Pre-Public Hearing Report. July 6, 2015. 
  \6\ ``ARS: U.S. Meat Animal Research Center Review--Interim Report'' 
USDA Office of Inspector General. Audit Number: 02007-0001-31 (1). 
September 28, 2015.
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    The ASPCA appreciates the Subcommittee's continued attention to 
this important issue. We supported the inclusion of language in the 
fiscal year 2016 Consolidated Appropriations Act which compels USDA to 
provide written certification to Congress that its animal welfare 
policies have been updated to comply with the AWA--including properly 
constituting IACUCs--and provides funding to facilitate inspection of 
ARS facilities by the Animal and Plant Health Inspection Service 
(APHIS).
    The ASPCA requests that the Subcommittee continue to include 
language to ensure that all ARS facilities comply with the Animal 
Welfare Act, including regular APHIS inspections, and we encourage the 
continuation of funding to support these inspections.
    increase awa enforcement funding for the inspection of licensed 
                                breeders
    One of the functions of USDA's Animal and Plant Health Inspection 
Service (APHIS) is to ensure the humane care and treatment of animals 
by enforcing the requirements of the Animal Welfare Act (AWA). Included 
in this mandate is the inspection of large-scale commercial dog 
breeding operations. Dogs raised in these facilities typically spend 
their entire lives in small, crowded cages, continually producing 
litters of puppies for the pet trade. Although the AWA provides very 
minimal standards which should be improved, those operations not in 
compliance with even the very limited Federal requirements must be held 
accountable. When facilities fall out of compliance, dogs can suffer 
for extended periods in deplorable conditions, without veterinary care, 
exercise, food, water, and socialization.
    In September 2013, USDA issued a final rule that, for the first 
time, required commercial breeders who sell puppies directly to the 
public--sight unseen over the Internet or mail--to be licensed and 
inspected. At the time, the Department estimated that 2,600-4,640 
additional dog breeders, as well as 325 cat breeders, would require 
licensure. With already limited resources, the addition of thousands of 
new licensees will make it nearly impossible for USDA to provide the 
necessary enforcement without an increase in funding.
    The ASPCA requests that the Subcommittee increase the current 
funding for APHIS's AWA enforcement.
      prohibit increased line speeds for poultry slaughter plants
    USDA's Food Safety and Inspection Service (FSIS) Modernization of 
Poultry Slaughter Inspection Rule, finalized in 2014, stopped short of 
increasing already-too-fast line speeds for certain poultry slaughter 
plants from 140 to 175 birds per minute. Faster slaughter speeds will 
lead to more live birds entering the scalding tank. As noted in a 
recent Washington Post article, nearly 1 million chickens are 
unintentionally boiled alive each year because already-fast-moving 
slaughter lines fail to kill the birds before they are dropped into 
scalding water to facilitate defeathering.\7\
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    \7\ ``USDA Plan to Speed Up Poultry-Processing Lines Could Increase 
Risk of Bird Abuse.'' The Washington Post: October 29, 2013.
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    The ASPCA requests that the Subcommittee prohibit FSIS from 
increasing line speeds at poultry slaughter plants.
     exceed the statutory funding cap for horse soring enforcement
    APHIS is also charged with protecting horses through its 
enforcement of the Horse Protection Act (HPA) of 1970. Since passage of 
the HPA in 1970, a $500,000 statutory funding cap on activities under 
the Act has hampered USDA's effective enforcement of horse soring 
activities. Congress can choose to ignore the cap and fund the program 
at higher levels, which it did in the fiscal year 2016 Consolidated 
Appropriations Act by funding HPA enforcement at $697,000.
    The ASPCA requests that the Subcommittee continue to exceed the 
statutory funding cap to allow the USDA to better enforce the Horse 
Protection Act and prevent the cruel practice of horse soring.

    [This statement was submitted by Nancy Perry, Senior Vice 
President, Government Relations.]

                                 ______
                                 
        Prepared Statement of Animal Welfare Information Center
    Thank you for the opportunity to submit testimony on fiscal year 
2017 funding priorities for the U.S. Department of Agriculture's (USDA) 
Agricultural Research Service (ARS), Animal and Plant Health Inspection 
Service (APHIS), and Food Safety Inspection Service (FSIS).
  usda-ars-national agricultural library--animal welfare information 
                                 center
    The Animal Welfare Information Center (AWIC) serves as a training 
and education resource for those who use animals for research, testing, 
and teaching, and the need for its services continues to outstrip its 
resources. AWIC's activities are vitally important, as they facilitate 
science-based decisionmaking and compliance with Federal animal welfare 
regulations. We request that AWIC funding remain consistent with the 
fiscal year 2017 budget proposal.
                       usda-aphis-animal welfare
    APHIS's Animal Welfare activities are critical to the proper 
regulation and care of animals protected under the Animal Welfare Act 
(AWA), 7 U.S.C. Sec. Sec. 2131-2159, and the Horse Protection Act 
(HPA), 15 U.S.C. Sec. Sec. 1821-1831. We request that, consistent with 
the Department's request, $29 million be allocated to Animal Welfare 
activities.
  usda-aphis-animal welfare--animal welfare act enforcement--class b 
                                dealers
    We are grateful that Congress maintained in the fiscal year 2016 
omnibus a provision prohibiting the renewal of existing licenses or the 
issuance of new licenses to Class B dealers who sell random source dogs 
and cats for use in research, experimentation, teaching, and testing. 
One existing license doesn't expire until December, so it will be 
necessary to continue this prohibition into fiscal year 2017. Moreover, 
it will also be needed to ensure that there is no lapse during which 
these dealers try to get back into business or others are tempted to 
apply for new licenses. It is true that very few of these dealers 
remain--all the more reason to head off challenges to the progress that 
has been made in shutting down this abuse-ridden industry that has 
trafficked in stolen pets, consigned animals to misery, and was found 
to be ``not necessary'' to NIH-related research. Therefore, we ask you 
to include the following language in the agriculture appropriations 
bill for fiscal year 2017: None of the funds made available by this Act 
may be used to carry out any activities or incur any expense related to 
the issuance of licenses under section 3 of the Animal Welfare Act (7 
U.S.C. 2133), or the renewal of such licenses, to class B dealers who 
sell random source dogs and cats for use in research, experiments, 
teaching, or testing. Nothing in this provision, however, should be 
construed as preventing the Department from carrying out all necessary 
oversight, inspection, compliance, and enforcement activities with 
respect to any entity holding a valid class B license who sells random 
source dogs and cats for use in research, experiments, teaching, or 
testing, or with respect to any entity doing so without a license as 
required under 7 U.S.C. 2133.
      usda-aphis-animal welfare--horse protection act enforcement
    We support and incorporate by reference the testimony submitted by 
The Humane Society of the U.S. on behalf of AWI and our partner 
organizations concerning fiscal year 2017 funding for HPA enforcement. 
The HPA was enacted to end soring, the cruel practice of applying 
chemical and mechanical irritants to the legs and hooves of horses to 
produce an exaggerated gait. Yet soring, condemned as ``one of the most 
significant welfare issues affecting any equine breed or 
discipline,''\1\ has continued as limited funding has hampered 
enforcement. Because USDA inspectors are able to attend a mere fraction 
of Tennessee Walking Horse shows, monitoring responsibility often falls 
to ``Designated Qualified Persons'' (DQPs), usually industry insiders 
willing to ignore violations. Reliance on DQPs has been an abysmal 
failure. Statistics show that USDA inspectors' presence at shows 
results in a far higher rate of violations than occurs when DQPs are 
present. For example, at the 2013 Tennessee Walking Horse National 
Celebration, 86 of 128 horses tested positive for soring agents.\2\ We 
ask that Congress appropriate $705,000 for HPA enforcement.
---------------------------------------------------------------------------
    \1\ American Association of Equine Practitioners, Putting the Horse 
First: Veterinary Recommendations for Ending the Soring of Tennessee 
Walking Horses (2008).
    \2\ Id.
---------------------------------------------------------------------------
        usda-aphis-wildlife services--wildlife damage management
    APHIS's Wildlife Services (WS) program allocates millions of 
dollars each year to lethal wildlife management, relying on methods 
that are cruel, ineffective, costly, and outdated. WS uses poisons, 
traps, snares, and firearms to indiscriminately kill animals--including 
endangered species, family pets, and countless non-target animals--
while ignoring humane and cost-efficient alternatives. WS' 
irresponsible practices even threaten public safety and national 
security (e.g., the use of Compound 1080). Last year, two individuals 
died during an aerial gunning operation that WS was conducting to 
exterminate coyotes in New Mexico; unfortunately, this most recent 
fatal accident is not the first such case. In view of the most recent 
fatal plane crash, as well as the overall lack of transparency 
surrounding WS's activities, we urge the Subcommittee to include report 
language requiring the agency to provide detailed information about its 
aerial gunning operations. Specifically, WS should identify any 
additional safety measures the agency has instituted since the most 
recent fatal accident; the dollar amount spent per operation (e.g., for 
aircraft rental or lease, fuel costs, personnel costs including fees 
paid for pilots if not agency personnel, and other payments made to 
private aerial companies or individuals contracted by WS); funding 
received from outside sources to carry out aerial gunning activities 
(whether through cooperator agreements or from state agencies, local 
governments, or private landowners); specific locations where 
operations were conducted; the number and species of animals killed per 
operation; and information regarding whether targeted animals were 
identified in a specific conflict or were part of a preemptive shooting 
mission.
           usda-aphis-investigative and enforcement services
    APHIS' Investigative and Enforcement Services (IES) handles 
investigations related to APHIS programs, which involves: evidence 
collection; civil and criminal investigations; and investigations in 
collaboration with Federal, state and local enforcement agencies. IES 
also works with USDA's Office of General Counsel to handle stipulations 
and administrative proceedings. Consistent with the fiscal year 2017 
budget proposal, we request $16,410,000 so that the Service may fulfill 
its responsibilities, particularly its increasing HPA and AWA 
investigatory demands.
usda-ars--animal welfare for farm animals used in agricultural research
    Last year the New York Times released an investigation that 
revealed shocking instances of animal abuse at the U.S. Meat Animal 
Research Center (MARC). Experiments at this Federal facility over the 
last several decades were the subject of a year-long investigation by 
the Times, involving the review of thousands of pages of internal 
records obtained through the Freedom of Information Act. MARC has 
received almost $200 million in Federal funding since 2006, and it is 
one of approximately 40 Agricultural Research Service facilities that 
conduct agricultural research involving animals. The Committee took 
seriously the allegations raised by the Times piece and responded by 
making 5 percent of the ARS budget for fiscal year 2016 contingent on 
ARS updating its animal care policies and requiring that all ARS 
facilities at which animal research is conducted have a fully 
functioning Institutional Animal Care and Use Committee (IACUC) to 
ensure compliance with animal welfare standards. The Committee also 
provided $400,000 to APHIS to conduct inspections consistent with the 
AWA at each ARS facility that uses animals in research. We request a 
continuation in fiscal year 2017 of that $400,000 to APHIS, as well as 
a renewed requirement for a fully functioning IACUC at each ARS 
facility where animal research is conducted, along with the following 
bill language: ``Provided further, That the Animal and Plant Health 
Inspection Service and Agricultural Research Service shall work 
together to ensure an effective animal welfare inspection program for 
ARS facilities and ensure that these facilities are in full compliance 
with the Animal Welfare Act.''
         usda-fsis--humane methods of slaughter act enforcement
    USDA allots an extremely small portion of its resources to Humane 
Methods of Slaughter Act (HMSA) enforcement. In fiscal year 2015, for 
instance, only 2.6 percent of all FSIS verification procedures were 
performed for activities related to humane handling and slaughter. 
Uneven enforcement among districts, repeat violators, and inadequate 
training and humane slaughter expertise among inspectors remain serious 
problems. The problems of inadequate and inconsistent enforcement can 
be resolved by increasing the number and qualifications of personnel 
assigned to humane handling and slaughter duties. We request that no 
fewer than 160 full-time equivalent positions be dedicated to 
inspections and HMSA enforcement. In addition, a minimum of two 
District Veterinary Medical Specialists should be assigned per district 
to provide for increased auditing and training to help uncover problems 
before they result in egregious humane handling incidents.
            usda-fsis--horse slaughter facility inspections
    For years, Congress has approved language to prevent the use of tax 
dollars to fund horse slaughter facility inspections. This language is 
critical to protect horses, taxpayers, communities and public health. 
We strongly support the continued inclusion of this prohibition in 
fiscal year 2017.

    [This statement was submitted by Christopher J. Heyde, Deputy 
Director, Government and Legal Affairs.]

                                 ______
                                 
             Prepared Statement of Catholic Relief Services
    Catholic Relief Services (CRS) requests a minimum of $1.716 billion 
in fiscal year 2017 appropriations for the Food for Peace program, and 
of this urges $375 million be designated for non-emergency development 
programs. CRS also requests $201 million for the McGovern-Dole Food for 
Education program, and $80 million for the USDA Local and Regional 
Procurement program.
                    crs and the u.s. catholic church
    CRS is the international relief and development agency of the U.S. 
Catholic Church. We are one of the largest implementers of U.S. funded 
foreign assistance. Our work reaches millions of poor and vulnerable 
people in over 100 countries. CRS works with people and communities 
based on need, without regard to race, creed, or nationality. CRS often 
partners with the local Catholic Church within the countries we operate 
in. This engenders substantial trust in us by local populations and 
gives us an expansive reach no other aid organization can duplicate.
            food for peace--agile, responsive, and impactful
    The Food for Peace (FFP) program is the flagship international food 
aid program of the US government. It provides funding for emergency 
food aid programs that assist communities in acute need and funds long-
term development programs to address underlying causes of hunger, both 
of which CRS currently implements. FFP programs are subject to 
comprehensive reporting requirements and are targeted to meet specific 
and measurable goals. More importantly though, FFP directs resources to 
the most vulnerable people and communities. As such, few other US 
foreign assistance resources are as important for poverty alleviation 
and saving lives. The following provides a brief snapshot of the 
critical work that CRS accomplishes in its FFP-funded projects.
                  ethiopia--joint emergency operation
    Ethiopia, a country with over 90 million people, has been 
particularly hard hit by the El Nino weather phenomena, leading to the 
most severe drought the country has faced in decades. About 80 percent 
of Ethiopia's population are subsistence farmers and 95 percent of 
farms are rain-fed. Due to El Nino, some regions have not seen rain in 
over a year, leading to steep declines in crop yields and hundreds of 
thousands of livestock deaths. Presently, over 10 million Ethiopians 
are in need of emergency food assistance. Further, while there are 
expectations that rains will return to dry areas during this year's 
rainy season (July-September), it is also projected that emergency 
conditions will persist in drought effected areas through at least 
September 2016 (see Chart 1).
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

                Chart 1--Projected Food Insecurity Levels, Ethiopia, 
                June-Sept 2016. Source: FEWS Net.

    Catholic Relief Services manages the Joint Emergency Operation 
(JEOP), an emergency food aid program funded by FFP. JEOP is 
implemented through a consortium of international and national NGOs. 
Its current operational service area includes 76 woredas (counties). 
Activities are coordinated with the Government of Ethiopia (GoE) and 
the World Food Program (WFP). In addition to the emergency food 
distributions targeting the most vulnerable, the JEOP has implemented a 
Behavior Change Communication strategy to improve nutrition for 
children, supported the formation of savings and internal lending 
communities (i.e., microfinance), and has trained community members to 
regularly provide information on food security indicators that feed 
into national food security warning systems.
    With the onset of the El Nino-driven drought, JEOP has ramped up 
food distribution operations (see Chart 2). By December 2015, JEOP 
served almost 2.6 million beneficiaries throughout Ethiopia. 
Beneficiaries generally receive a ration of wheat or sorghum, yellow 
split peas and vegetable oil, sourced largely from the United States. 
JEOP also provides Corn Soy Blend+ and vegetable oil to organizations 
implementing emergency supplementary feeding. Between September 2015 
and January 2016, Food for Peace has supplied the JEOP with three 
separate commitments for commodities totaling over 360,000 metric tons.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

                Chart 2--JEOP Beneficiary level 2015.

    The JEOP has provided much needed stability for millions of 
Ethiopians at a critical time. During this same period the GoE and WFP 
have devoted significant resources to address the country's acute food 
emergency needs. While the world community has come up short in 
answering GoE and WFP's calls for additional funding, the U.S., 
primarily through the JEOP, has remained steadfast in its support to 
Ethiopia. Despite overall resource constraints, the worst case scenario 
has thus far been avoided in Ethiopia, thanks in no small measure to 
the JEOP. Many Ethiopians are alive today thanks to this program. The 
JEOP presently has enough resources to continue operations through July 
2016, and we expect FFP to continue to help Ethiopia get over this 
hurdle.
               south sudan--jonglei food security program
    South Sudan, bordering Ethiopia to the southwest, is the newest 
country in the world, having secured independence from Sudan in 2011. 
To support the new country, USAID awarded Catholic Relief Services 
funding for a multi-year FFP development program, the Jonglei Food 
Security Program (JFSP). Operating in Jonglei State, the largest and 
most populous state in South Sudan, the program was to address root 
causes of food insecurity through food for work programs to build 
community assets and support for small farmers, among other things. 
However, in 2013 the country was plunged into a civil war.
    Jonglei was one of the epicenters of the conflict. The ensuing 
insecurity prevented CRS from continuing JFSP development activities 
and ultimately damaged or destroyed much of the community assets and 
farming improvements made through the program. Fleeing for their 
safety, many residents of Jonglei state left their homes for the safety 
of camps both inside South Sudan and in neighboring countries. Given 
the radically different nature of the needs in Jonglei, CRS worked with 
the Office of Food for Peace to convert JFSP into an emergency response 
program. From 2014-2015, JFSP funding was used to provide emergency 
food assistance to nearly 140,000 people. Some areas in need were 
impossible to reach by land because of the fighting. Partnering with 
WFP, food supplies were airlifted into remote areas of Jonglei to CRS 
staff, who then continued emergency food distributions to those hardest 
hit.
    In August 2015, government and opposition forces signed a peace 
agreement. While fighting continues in some places in the country, the 
peace has largely held in Jonglei State and staff and officials on the 
ground credit JFSP in part. The calm has allowed resumption of 
development activities in some areas, and relief convoys to enter other 
regions for the first time in over 2 years. Most people and officials 
in these areas did not believe aid convoys would be allowed in. When 
convoys began arriving earlier this year, they were met by people 
cheering and dancing. One local official commented that ``this is not 
food for work but food for hope.'' Our staff noted that ``at least in 
Jonglei, the food convoys have brought a feeling that real peace might 
be feasible.'' We have already seen a number of internally displaced 
people coming back to Jonglei, and it is our expectation that continued 
engagement through JFSP will direct most people's energy and focus back 
to preparing for the planting season instead of fighting.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

        Building a dike through Food for Work in South Sudan
         malawi--wellness and agriculture for life advancement
    In 2014, CRS completed Wellness and Agriculture for Life 
Advancement (WALA), a five-year development Food for Peace project in 
Malawi. As with most Food for Peace development projects, WALA took a 
multi-sectoral approach to food security. The project included helping 
farmers adopt new and better techniques and technology, connecting them 
to markets, addressing the nutritional needs of young children and 
expecting mothers, providing better access to water for agriculture and 
hygiene, helping communities build productive assets, and among other 
interventions. While most program success indicators showed strong 
results, one standout area was in watershed rehabilitation and 
management.
    Heavy rains characterize the wet season in Malawi. Communities 
targeted by WALA are prone to soil erosion from rushing water running 
off their land during these rains. In the lean season, many water 
sources for these communities would dry up and most small farmers could 
not produce enough food over the year to get them through this period. 
Given these circumstance, through food for work, WALA introduced a 
number of communities to techniques, like water absorption trenches, 
that slow and reduce run off and help water percolate into the soil. 
Check damns were constructed in areas where run-off had formed gullies. 
Native cover crops, grasses, and trees were introduced in key areas of 
farm land to help with soil retention and to improve nutrient content.
    The results of these efforts have been dramatic. The water table 
has risen, resulting in more water availability in wells. Wells and 
streams that would dry up during the lean season now flow year round. 
Water clarity in streams has increased also. Over just one or 2 years, 
check damns have filled gullies, helping farmers reclaim farmland. With 
more moisture and nutrients in the soil, and more land to cultivate, 
agricultural yields have increased. Neighboring communities not in the 
WALA program noted these successes and on their own adopted the 
knowledge and techniques used in WALA.
    These programs demonstrate huge successes--addressing the acute 
needs of people griped by severe drought in Ethiopia, being able to 
shift between emergency and development work as needs change and to 
capitalize on opportunities for peace in South Sudan, and in making a 
foundation for a better life more resilient life for people in Malawi. 
Unfortunately, needs are expanding. The world is seeing more people 
being impacted by shocks like conflict and weather patterns like El 
Nino, and potentially La Nina later in the year. The funding requested 
for FFP, $1.716 billion, will be critical for the US to respond to the 
growing emergency needs around the world. Further, directing more than 
the minimum level of funding to FFP development programs will help more 
communities get ahead, so that when shocks to strike, they are better 
prepared to meet their own needs.
                       mcgovern-dole and usda lrp
    McGovern-Dole Food for Education programs provide food for school 
lunch programs. In many cases, the lunch provided through McGovern-Dole 
is the only meal children receive all day. Parents who would not 
otherwise send their children to school are motivated to do so because 
they know their children will be fed. This has been especially true for 
girls, whose education is not traditionally encouraged in many parts of 
the world. Catholic Relief Services currently implements five McGovern-
Dole programs. In addition to school feeding, we also use McGovern-Dole 
resources to strengthen teacher training and to make improvements to 
schools.
    The USDA Local and Regional Procurement (LRP) program, made 
permanent by the 2014 Farm Bill, is intended to be used in conjunction 
with McGovern-Dole programming and we view it as critical to the 
sustainability of school lunch programs. Specifically, we believe these 
funds can be used to establish the systems needed to source food used 
in school lunches from local farmers. This will entail helping these 
farmer grow the quality and quantity needed for school lunches and 
organizing parent groups to manage school canteens. Ultimately, once 
these systems are in place, local governments can assume responsibility 
for these programs.
                           improving food aid
    Catholic Relief Services supports several improvements to the 
current food aid system, including the phasing out of requirements to 
monetize food aid commodities, reducing the burden of agricultural 
cargo preferences on food aid, and giving implementers greater 
flexibility to determine how food aid resources are used. We refer you 
to testimony Catholic Relief Services submitted to the Senate Foreign 
Relations Committee in April 2015 and the House Agriculture Committee 
in September 2015 for more details concerning these improvements.

    [This statement was submitted by Dr. Carolyn Woo, President and 
Chief Executive Officer.]

                                 ______
                                 
   Prepared Statement of United States Conference of Catholic Bishops
    On behalf of the United States Conference of Catholic Bishops' 
Committees on Domestic Justice and Human Development and International 
Justice and Peace, Catholic Charities USA, Catholic Relief Services and 
Catholic Rural Life, we wish to address the moral and human dimensions 
of fiscal year 2017 Agriculture Appropriations. We urge you to support 
robust funding for both domestic and international food aid, and for 
conservation and rural development programs, and to resist cuts to 
them. Many of these program areas have already been subject to 
reductions. Further cuts would be harmful to vulnerable people and 
communities.
    In For I Was Hungry and You Gave Me Food, the U.S. bishops wrote, 
``The primary goals of agricultural policies should be providing food 
for all people and reducing poverty among farmers and farm workers in 
this country and abroad.'' Adequate nutrition is essential to protect 
human life and dignity. We must also promote good stewardship of the 
land and natural resources. In our soup kitchens and parish food 
pantries, we see the faces of poor and hungry people every day. As a 
faith community, we feed those without work, pregnant women and 
children, and seniors on limited incomes.
    We acknowledge the difficult challenges Congress and the 
Administration face to match scarce resources with real needs. But a 
just spending bill cannot rely on disproportionate cuts in essential 
services to poor and vulnerable people.
    The nation continues to see historic levels of food insecurity that 
have persisted well beyond the end of the Great Recession, and this 
reality is confirmed by the experience of our food banks, pantries, and 
congregate meal sites. Catholic Charities agencies continue to provide 
food services well above pre-recession levels, with agencies reporting 
10.4 million food services delivered to clients, a 64 percent increase 
from 2007. Despite our increased efforts, more than 48 million 
Americans (nearly 1 in 6) live in food insecure households. With this 
reality, our nation must prioritize programs that assist poor and 
hungry people and promote good stewardship. In addition to refraining 
from making cuts that impact programs like SNAP, which provide greater 
levels of food security to millions of people, it is vital to provide 
robust funding for the following programs:
    WIC.--Fund the Women, Infants, and Children nutrition program at 
$6.37 billion to ensure that all qualified families receive vital 
nutritional support, investments are made in technology to improve 
program operations, and sufficient reserves are built to prepare for 
economic volatility. In particular, we urge investment of $75 million 
in management information systems and technology to assist with the 
transition to electronic benefit transfer (EBT) systems to help 
streamline operations.
    TEFAP.--Provide full funding levels as required by the 2014 Farm 
Bill for the Emergency Food Assistance Program and food distribution 
grants in local communities. Cuts to the program could force some of 
our parishes and other charities and food pantries to turn away hungry 
people when they continue to need our help.
    CSFP.--Fund the Commodity Supplemental Food Program at $236 million 
to ensure adequate food assistance is provided to the growing 
population of low-income seniors. Faith communities and other charities 
are essential in providing food packages to hungry seniors in their 
local communities and, as the population continues to age, our 
ministries are experiencing increasing demand for food services from 
seniors that must be addressed.
    CSP.--Provide adequate funding for the Conservation Stewardship 
Program to help farmers better conserve and care for farm land for 
future generations. Strong conservation programs are necessary to 
promote good stewardship of creation and provide needed support to 
family farms.
    VAPG.--Maintain current funding for the Value Added Producer Grants 
program to help farmers and ranchers develop new farm and food-related 
businesses to increase rural economic opportunity and help farm and 
ranch families thrive.
    We also ask you to prioritize international food security programs. 
With an estimated 805 million people chronically undernourished 
globally (UN-FAO), our nation must support:
    International Food Assistance.--The Administration has proposed 
funding Food for Peace at $1.35 billion in fiscal year 2017, $350 
million less than what Congress appropriated in fiscal year 2016. Food 
for Peace provides emergency assistance to people in crises, and is 
essential to the U.S. response to civil strife around the world as well 
as to the severe drought in many countries brought on by El Nino. Now 
is not the time to make drastic cuts to this program. We ask Congress 
to maintain Food for Peace funding at $1.716 billion for fiscal year 
2017. Similarly, we encourage Congress to reverse the Administration's 
proposed cut to school feeding and maintain funding for the McGovern-
Dole program at $201.6 million in fiscal year 2017.
    Developmental Food Aid.--Congress must protect and direct an 
adequate amount of Food for Peace funding to development food 
assistance programs. These programs build resilience, strengthen 
agricultural capacity, and improve livelihoods for the most vulnerable, 
reducing the need to provide future emergency assistance. Pursuant to 
the 2014 Farm Bill, a minimum of $350 million of Food for Peace 
resources must be used in development programs, but more may be 
directed for this purpose. We request that Congress direct a total of 
$375 million of Food for Peace resources to development purposes, and 
that USAID have the flexibility to use Development Assistance resources 
to reach part of this total.
    Reforms to Food Aid System.--A key reform in the 2014 Farm Bill is 
the USDA Local and Regional Procurement program, to be implemented in 
conjunction with McGovern-Dole, which will help responsibly transition 
school feeding programs to local governments. We request that the full 
authorized level of $80 million be provided to the USDA LRP program. 
Further, we support making food aid programs like Food for Peace more 
efficient by allowing them to use local and regional procurement when 
appropriate to local circumstances and efficiency gains should also be 
reinvested in programs to expand their reach and not used to justify 
funding cuts. We also encourage Congress to explore changes to 
agricultural cargo preferences to reduce costs to food aid programs, as 
a means to achieve greater efficiencies.
    At a time of continuing budgetary constraints and competition for 
agricultural resources, the needs of those who are hungry, poor and 
vulnerable should come before assistance to those who are relatively 
well off. With other Christian leaders, we urge the committee to draw a 
``circle of protection'' around programs that serve those in greatest 
need and to prioritize their needs first. We urge you to protect and 
fund programs that feed hungry people, help the most vulnerable 
farmers, strengthen rural communities and promote good stewardship of 
God's creation.

    Most Reverend Thomas G. Wenski
    Archbishop of Miami
    Chairman, Committee on Domestic Justice and Human Development

    Most Reverend Oscar Cantu
    Bishop of Las Cruces
    Chairman, Committee on International Justice and Peace

    Sr. Donna Markham, OP, Ph.D.
    President & CEO
    Catholic Charities USA

    Dr. Carolyn Y. Woo
    President
    Catholic Relief Services

    Mr. James Ennis
    Executive Director
    National Catholic Rural Life

                                 ______
                                 
   Prepared Statement of Central Arizona Water Conservation District
    On behalf of the Central Arizona Water Conservation District 
(CAWCD), I am writing to ask that you include at least $15.2 million 
from the U.S. Department of Agriculture's Environmental Quality 
Incentive Program Financial Assistance (EQIP FA) for the Colorado River 
Basin Salinity Control Program in the fiscal year 2017 Appropriation 
bill. Funding for the salinity control program will help protect the 
water quality of the Colorado River that is used by approximately 40 
million people for municipal and industrial purposes and used to 
irrigate approximately 5.5 million acres in the United States.
    CAWCD manages the Central Arizona Project (CAP), a multi-purpose 
water resource development and management project that delivers 
Colorado River water into central and southern Arizona. The largest 
supplier of renewable water in Arizona, CAP delivers an average of more 
than 1.5 million acre-feet of Arizona's 2.8 million acre-foot Colorado 
River entitlement each year to municipal and industrial users, 
agricultural irrigation districts, and Indian communities.
    Our goal at CAP is to provide an affordable, reliable and 
sustainable supply of Colorado River water to a service area that 
includes more than 80 percent of Arizona's population.
    These renewable water supplies are critical to Arizona's economy 
and to the economies of Native American communities throughout the 
state. Nearly 90 percent of economic activity in the State of Arizona 
occurs within CAP's service area. The canal provides an economic 
benefit of $100 million annually, accounting for one-third of the 
entire Arizona gross state product. CAP also helps the State of Arizona 
meet its water management and regulatory objectives of reducing 
groundwater use and ensuring availability of groundwater as a 
supplemental water supply during future droughts. Achieving and 
maintaining these water management objectives is critical to the long-
term sustainability of a state as arid as Arizona.
                 negative impacts of concentrated salts
    Natural and man-induced salt loading to the Colorado River creates 
environmental and economic damages. EPA has identified that more than 
60 percent of the salt load of the Colorado River comes from natural 
sources. With the significant Federal ownership in the Basin, most of 
this comes from federally administered lands. Human activity, 
principally irrigation, adds to the salt load of the Colorado River. 
Further, natural and human activities concentrate the dissolved salts 
in the River.
    The U.S. Bureau of Reclamation (Reclamation) has estimated damages 
at about $382 million per year. Modeling by Reclamation indicates that 
damages will rise to approximately $614 million per year by the year 
2035 without continuation of the Program. These damages include:
  --A reduction in the yield of salt sensitive crops and increased 
        water use to meet the leaching requirements in the agricultural 
        sector;
  --Increased use of imported water and cost of desalination and brine 
        disposal for recycling water in the municipal sector;
  --An increase in the use of water and the cost of water treatment, 
        and an increase in sewer fees in the industrial sector;
  --An increase in the cost of cooling operations and the cost of water 
        softening, and a decrease in equipment service life in the 
        commercial sector;
  --A reduction in the useful life of galvanized water pipe systems, 
        water heaters, faucets, garbage disposals, clothes washers, and 
        dishwashers, and increased use of bottled water and water 
        softeners in the household sector;
  --A decrease in the life of treatment facilities and pipelines in the 
        utility sector, and
  --Difficulty in meeting wastewater discharge requirements to comply 
        with National Pollutant Discharge Elimination System permit 
        terms and conditions, and an increase in desalination and brine 
        disposal costs due to accumulation of salts in groundwater 
        basins.
    Funding for salinity control will prevent the water quality of the 
Colorado River from further degradation and significant increases in 
economic damages to municipal, industrial and irrigation users.
  history of the usda's colorado river basin salinity control program
    Recognizing the rapidly increasing salinity concentration in the 
Lower Colorado River and its impact on water users, Arizona joined with 
the other Colorado River Basin States in 1973 and organized the 
Colorado River Basin Salinity Control Forum (Forum). In 1974, the Forum 
worked with Congress in the passage of the Colorado River Basin 
Salinity Control Act (Act) to offset increased damages caused by 
continued development and use of the waters of the Colorado River.
    In implementing the Act, Congress directed that the Colorado River 
Basin Salinity Control Program should be implemented in the most cost-
effective way. The Program at the United States Department of 
Agriculture is currently funded under the Environmental Quality 
Incentives Program (EQIP) of the Natural Resources Conservation Service 
(NRCS) and under Reclamation's Basinwide Program.
    Congress authorized a salinity control program (Program) for the 
United States Department of Agriculture (USDA) through an amendment of 
the Act in 1984. With the enactment of the Federal Agriculture 
Improvement and Reform Act of 1996 (FAIRA), Congress directed that the 
Program should continue to be implemented as part of the newly created 
EQIP. Since the enactment of the Farm Security and Rural Investment Act 
(FSRIA) in 2002, there have been, for the first time in a number of 
years, opportunities to adequately fund the Program within EQIP.
    In 2008, Congress passed the Food, Conservation and Energy Act 
(FCEA). The FCEA addressed the cost sharing required from the Basin 
Funds. In so doing, the FCEA named the cost sharing requirement as the 
Basin States Program (BSP). The BSP will provide 30 percent of the 
total amount that will be spent each year by the combined EQIP and BSP 
effort. With the passage of the Agricultural Act of 2014 the 
authorities for USDA to implement salinity control activities in the 
Colorado River Basin were continued.
    The Program, as set forth in the Act, is to benefit Lower Basin 
water users hundreds of miles downstream from the sources of salinity 
in the Upper Basin. The salinity of Colorado River waters increases 
from about 50 mg/L at its headwaters to more than 700 mg/L in the Lower 
Basin. There are very significant economic damages caused downstream by 
high salt levels in the water. EQIP is used to improve upstream 
irrigation efficiencies which in turn reduce leaching of salts to the 
Colorado River. There are also local benefits in the Upper Colorado 
River Basin from the Program in the form of soil and environmental 
benefits, improved agricultural production, improved water 
efficiencies, lower fertilizer and labor costs, and water distribution 
and infrastructure improvements. The mix of funding under EQIP, cost 
sharing from the Basin States and efforts, and cost sharing brought 
forward by local producers have created a most remarkable and 
successful partnership.
    The threat of salinity continues to be a concern in both the United 
States and Mexico. In 2012, a five-year agreement, known as Minute 319, 
was signed between the U.S. and Mexico to guide future management of 
the Colorado River. Among the key issues addressed in Minute 319 
included an agreement to maintain salinity standards. The CAWCD and 
other key water providers are committed to meeting these goals.
                               conclusion
    Implementation of salinity control practices through EQIP has 
proven to be a very cost-effective method of controlling the salinity 
of the Colorado River. CAWCD urges the subcommittee to include at least 
$15.2 million from the USDA's Environmental Quality Incentive Program 
Financial Assistance for the Colorado River Basin Salinity Control 
Program in the fiscal year 2017 Appropriation bill. Additionally, there 
is needed sufficient Technical Assistance dollars to adequately 
implement the program. Continuation of EQIP at the requested funding 
level will prevent the further degradation of water quality of the 
Colorado River, and significantly increased damages from the higher 
salt concentrations to municipal, industrial and irrigation users.

    [This statement was submitted by Theodore C. Cooke, General 
Manager, Central Arizona Project.]

                                 ______
                                 
          Prepared Statement of Center for Progressive Reform
    A national network of advocates including Oxfam America, the 
National Employment Law Project, and Nebraska Appleseed have called 
your attention to the dangerous conditions that workers face in poultry 
slaughter facilities, owing to the speed with which young chickens and 
turkeys are processed. The stories presented in their testimonies and 
comments, along with the data they have provided, should be enough to 
warrant rejection of any proposal to allow line speeds to increase at 
those facilities through the appropriations process as it relates to 
the Food Safety Inspection Service's New Poultry Inspection System.
    These comments approach the issue from a slightly different 
perspective, but arrive at the same conclusion: using the 
appropriations process to increase line speeds at poultry slaughter 
facilities violates principles of good government and will cause 
lasting damage to workers, their families, and their communities.
    On both sides of the aisle, Members of Congress for years have 
derided the use of ``earmarks'' to direct government spending toward 
favored projects and policies. As explained below, such derision should 
apply with greater force to the abuse of the appropriations process to 
direct spending away from projects and policies that are opposed by a 
determined minority of members of Congress. Such actions upend the 
normal legislative process and entrench a system of policymaking that 
undermines core principles of representative democracy. Last summer, 
the Center for Progressive Reform published a report on the misuse of 
appropriations riders to direct agency policymaking.\1\ The report's 
length precludes inclusion in these comments, per the committee's 
rules, but its key findings are worth noting here:
---------------------------------------------------------------------------
    \1\ ``Earmarking Away the Public Interest: How Congressional 
Republicans Use Antiregulatory Appropriations Riders to Benefit 
Powerful Polluting Industries'' by CPR Member Scholars Thomas McGarity 
and Richard Murphy, and CPR Senior Policy Analyst James Goodwin (July 
2015), available at http://progressivereform.org/articles/Anti-
Reg_Riders_1503.pdf.
---------------------------------------------------------------------------
  --Prohibiting agencies from taking actions disfavored by the rider's 
        sponsors is legislating by extortion
        Appropriations bills offer ideal vehicles for the use of 
        extortionate riders, because they must be enacted on an ongoing 
        and periodic basis or else the government will cease 
        functioning. As the deadline for completing appropriations 
        bills approaches, the leverage that proponents of particular 
        riders wield to coerce acquiescence in their demands grows 
        greater. With the threat of government shutdown looming, other 
        legislators will feel increasingly compelled to vote in favor 
        of the bill even though they are opposed to a particular rider 
        and would not support it as a stand-alone measure. Similarly, 
        the president may find it difficult to veto an appropriations 
        bill simply because of the antiregulatory riders it contains.
  --Negative riders enable secret sabotage of popular safeguards
        In contrast to the procedures that govern traditional 
        authorizing legislation, a distinct lack of transparency and 
        accountability marks the appropriations process. In particular, 
        the process of adding riders to appropriations bills is clouded 
        in secrecy, which can make it nearly impossible for the public 
        to hold legislators accountable for sponsoring especially 
        controversial proposals. Because antiregulatory riders are 
        often buried in appropriations bills that run hundreds of pages 
        in length, it is easy for them to slip past the scrutiny of 
        concerned citizens and lawmakers. These bills thus offer the 
        proponents of antiregulatory riders an ideal opportunity to 
        conceal their attacks on popular protections.
        The caps on poultry slaughter line speeds, for instance, were a 
        major point of contention when the Department of Agriculture's 
        Food Safety Inspection Service (FSIS) developed the New Poultry 
        Inspection System. The rulemaking process that FSIS followed, 
        rooted in the Administrative Procedure Act, ensured that the 
        final safeguards reflected the views of stakeholders ranging 
        from workers to experts from the Department of Labor's 
        Occupational Safety and Health Administration. No such process 
        for engaging experts, much less the workers who would be 
        affected by a line-speed increase, is in place here.
  --Riders lobotomize the deliberative process that should govern 
        lawmaking
        The use of antiregulatory riders also enables lawmakers to 
        engage in a powerful form of substantive policymaking but 
        without the due deliberation that normally accompanies the 
        enactment of authorizing legislation. Broadly speaking, 
        Congress divides the labor of preparing bills for full 
        consideration between the authorization committees--which are 
        responsible for considering substantive legislation creating, 
        modifying, or eliminating Federal programs--and the budget and 
        appropriations committees--which are responsible for funding 
        authorized programs. The institutional design and processes of 
        authorization committees renders them far more suitable to 
        engage in substantive policymaking. Antiregulatory riders 
        generally do not receive anywhere near the same level of 
        deliberative consideration from appropriations committees that 
        usually takes place in authorization committees for the 
        provisions of substantive legislation.
  --Antiregulatory riders encourage pandering to corporate interests
        Because they are adopted with little transparency or 
        deliberation, antiregulatory riders are uniquely well designed 
        to provide individual lawmakers with the ability to confer 
        benefits on favored special interests. Much like traditional 
        earmarks, which Congress has effectively banned, antiregulatory 
        riders are thus highly susceptible to abuse by Members of 
        Congress looking for an easy way to curry favor with 
        politically powerful businesses or industries.
    Thank you for the opportunity to provide these comments.

    [This statement was submitted by Matthew Shudtz, Executive 
Director, Center for Progressive Reform.]

                                 ______
                                 
           Prepared Statement of Choose Clean Water Coalition
    The undersigned members of the Choose Clean Water Coalition request 
continued support for clean water in the Chesapeake Bay watershed 
through the Agricultural Act of 2014 (2014 Farm Bill) conservation 
programs. There are 87,000 farms in the six-State Chesapeake region; 
those that are well run protect their water resources and add much to 
our landscape, environment and economy. We want to ensure that these 
responsible farms and farmers remain economically viable. Stopping cuts 
to these conservation programs is critical to maintain and restore 
clean water to the rivers and streams throughout the Chesapeake Bay 
region, and for the Bay itself. These programs are essential for 
regulated agricultural operations to meet Federal regulations under the 
Clean Water Act and help farmers meet state regulations that address 
both farm health and water quality.
    We urge you to maintain full funding for mandatory agricultural 
conservation programs in fiscal year 2017. The 2014 Farm Bill set us on 
a new path toward clean water in our region, but only if key 
conservation programs are funded as Congress intended. With the support 
of much of the conservation community and clean water advocates, the 
2014 Farm Bill eliminated nearly a dozen conservation programs 
(including the Chesapeake Bay Watershed Initiative) and reduced 
mandatory funding overall to save American taxpayers approximately $6 
billion.
    Two-thirds of the 18 million people in the Chesapeake region get 
their drinking water directly from the rivers and streams that flow 
through the cities, towns and farms throughout our six State, 64,000 
square mile watershed. The quality of this water is critical to both 
human health and to the regional economy. Much of the work and funding 
necessary to achieve and maintain clean and healthy water in this 
region would be accomplished through the Farm Bill's new Regional 
Conservation Partnership Program (RCPP). The President's fiscal year 
2017 budget proposes full funding for mandatory conservation programs 
that are critical to maintaining a fully funded RCPP. In particular, we 
urge you to fund the Environmental Quality Incentives Program at $1.65 
billion to help willing producers implement conservation practices on 
their farms.
    In May 2014, the Chesapeake Bay Watershed was designated as one of 
eight Critical Conservation Areas under the new RCPP. For the first 3 
years of RCPP funding, the Chesapeake received $27.6 million, with a 
few million more going to other projects partially in the Chesapeake 
Bay watershed. This is a precipitous drop from the Chesapeake Bay 
Watershed Initiative where our region's producers received $47.6 
million annually for conservation practices. This is a huge shortfall 
for conservation in our region and any further cuts to the RCPP will 
exacerbate this funding drop off. We urge you to maintain the 2014 Farm 
Bill's negotiated mandatory funding levels for all conservation 
programs, including the RCPP.
    In order to follow a common sense path to maintain economically 
viable well run farms and to have healthy local water and a restored 
Chesapeake Bay, which is critical for our regional economy, we request 
full funding for all conservation programs in the Farm Bill for fiscal 
year 2017.
    Thank you for your consideration on this very important request to 
maintain funding for these programs which are critical to both our 
agricultural community and for clean water throughout the mid-Atlantic 
region.

American Rivers
Anacostia Watershed Society
Audubon Naturalist Society
Blue Heron Environmental Network Inc.
Blue Ridge Watershed Coalition
Blue Water Baltimore
Cecil Land Use Association
Chapman Forest Foundation
Chesapeake Bay Foundation
Chesapeake Wildlife Heritage
Citizens for Pennsylvania's Future
Clean Water Action
Coalition for Smarter Growth
Conservation Pennsylvania
Conservation Voters of Pennsylvania
Delaware Nature Society
Earth Forum of Howard County
Eastern Pennsylvania Coalition for Abandoned Mine Reclamation
Environment America
Environment Maryland
Environment Virginia
Friends of Accotink Creek
Friends of Dyke Marsh
Friends of the North Fork of the Shenandoah River
Green Muslims
Interfaith Partners for the Chesapeake
Izaak Walton League of America
James River Association
Lackawanna River Conservation Association
Lynnhaven River NOW
Maryland Conservation Council
Maryland League of Conservation Voters
Mattawoman Watershed Society
Mehoopany Creek Watershed Association
National Aquarium
National Parks Conservation Association
National Wildlife Federation
Natural Resources Defense Council
Nature Abounds
Otsego County Conservation Association
Otsego Land Trust
PennEnvironment
Pennsylvania Council of Churches
Piedmont Environmental Council
Potomac Conservancy
Potomac Riverkeeper
Potomac Riverkeeper Network
Rivanna Conservation Society
Rock Creek Conservancy
Sassafras River Association
Savage River Watershed Association
Shenandoah Riverkeeper
Shenandoah Valley Network
Sidney Center Improvement Group
Sierra Club--Maryland
Sierra Club--Pennsylvania
Sierra Club--Virginia
Sleepy Creek Watershed Association
South River Federation
St. Mary's River Watershed
Stewards of the Lower Susquehanna
Trout Unlimited
Upper Potomac Riverkeeper
Upper Susquehanna Coalition
Virginia Conservation Network
Virginia League of Conservation Voters
Water Defense
West & Rhode Riverkeeper
West Virginia Rivers Coalition

    [This statement was submitted by Peter J. Marx, Federal Affairs, 
Choose Clean Water Coalition.]

                                 ______
                                 
   Prepared Statement of Colorado River Basin Salinity Control Forum
    Waters from the Colorado River are used by approximately 40 million 
people for municipal and industrial purposes and used to irrigate 
approximately 5.5 million acres in the United States. Natural and man-
induced salt loading to the Colorado River creates environmental and 
economic damages. The U.S. Bureau of Reclamation (Reclamation) has 
estimated the currently quantifiable damages at about $382 million per 
year. Modeling by Reclamation indicates that the quantifiable damages 
will rise to approximately $614 million per year by the year 2035 
without continuation of the Program. Congress authorized the Colorado 
River Basin Salinity Control Program (Program) in 1974 to offset 
increased damages caused by continued development and use of the waters 
of the Colorado River. The USDA portion of the Program, as authorized 
by Congress and funded and administered by the Natural Resources 
Conservation Service (NRCS) under the Environmental Quality Incentives 
Program (EQIP), is an essential part of the overall effort. A funding 
level of $15.2 million in EQIP FA in 2017 is in keeping with the 
Program's Plan of Implementation and is required to prevent further 
degradation of the quality of the Colorado River and increases in 
downstream economic damages.
    In enacting the Colorado River Basin Salinity Control Act in 1974, 
Congress directed that the Colorado River Basin Salinity Control 
Program should be implemented in the most cost-effective way. The 
Program is currently fundedunder EQIP through NRCS and under 
Reclamation's Basinwide Program. The Act requires that the Basin States 
cost share 30 percent of the overall effort. Historically, recognizing 
that agricultural on-farm improvements were some of the most cost-
effective strategies, Congress authorized a program for the United 
States Department of Agriculture (USDA) through amendment of the Act in 
1984. With the enactment of the Federal Agriculture Improvement and 
Reform Act of 1996 (FAIRA), Congress directed that the Program should 
continue to be implemented as part of the newly created Environmental 
Quality Incentives Program. Since the enactment of the Farm Security 
and Rural Investment Act (FSRIA) in 2002, there have been, for the 
first time in a number of years, opportunities to adequately fund the 
Program within EQIP. In 2008, Congress passed the Food, Conservation 
and Energy Act (FCEA). The FCEA addressed the cost sharing required 
from the Basin Funds. In so doing, the FCEA named the cost sharing 
requirement as the Basin States Program (BSP). The BSP will provide 30 
percent of the total amount that will be spent each year by the 
combined EQIP and BSP effort. With the passage of the Agricultural Act 
of 2014 the authorities for USDA to implement salinity control 
activities in the Colorado River Basin were continued.
    The Program, as set forth in the Act, is to benefit Lower Basin 
water users hundreds of miles downstream from the sources of salinity 
in the Upper Basin. The salinity of Colorado River waters increases 
from about 50 mg/L at its headwaters to more than 700 mg/L in the Lower 
Basin. There are very significant economic damages caused downstream by 
high salt levels in the water. EQIP is used to improve upstream 
irrigation efficiencies which in turn reduce leaching of salts to the 
Colorado River. There are also local benefits in the Upper Colorado 
River Basin from the Program in the form of soil and environmental 
benefits, improved agricultural production, improved water 
efficiencies, lower fertilizer and labor costs, and water distribution 
and infrastructure improvements. Local producers submit cost-effective 
applications under EQIP in Colorado, Utah, and Wyoming and offer to 
cost share in the acquisition of new irrigation equipment. The mix of 
funding under EQIP, cost share from the Basin States and efforts and 
cost share brought forward by local producers has created a most 
remarkable and successful partnership.
    After longstanding urgings from the States and directives from 
Congress, NRCS has recognized that this Program is different than small 
watershed enhancement efforts common to EQIP. In the case of the 
Colorado River salinity control effort, the watershed to be considered 
stretches more than 1,400 miles from the Colorado River's headwaters in 
the Rocky Mountains to the Colorado River's terminus in the Gulf of 
California in Mexico. Each year the NRCS State Conservationists for 
Colorado, Utah, and Wyoming prepare a 3-year funding plan for the 
salinity efforts under EQIP. The Forum supports this funding plan which 
recognizes the need for $15.2 million in EQIP FA allocations in fiscal 
year 2017. Additionally, there is needed sufficient TA dollars to 
adequately implement the program. State and local cost-sharing is 
triggered by the Federal appropriation. The Forum appreciates the 
efforts of NRCS leadership and the support of this Subcommittee in 
implementing the Program.
    The Forum is composed of gubernatorial appointees from Arizona, 
California, Colorado, Nevada, New Mexico, Utah, and Wyoming. The Forum 
is charged with reviewing the Colorado River's water quality standards 
every 3 years. In so doing, it adopts a Plan of Implementation 
consistent with these standards. The level of appropriation requested 
in this testimony is in keeping with the adopted Plan of 
Implementation. If adequate funds are not appropriated, significant 
damages from the higher salinity concentrations in the water will be 
more widespread in the United States and Mexico.
    Concentration of salt in the Colorado River causes approximately 
$382 million annually in quantified damages and significantly more in 
unquantified damages in the United States and results in poor water 
quality for United States users. Damages occur from:
  --a reduction in the yield of salt sensitive crops and increased 
        water use to meet the leaching requirements in the agricultural 
        sector;
  --increased use of imported water and cost of desalination and brine 
        disposal for recycling water in the municipal sector;
  --a reduction in the useful life of galvanized water pipe systems, 
        water heaters, faucets, garbage disposals, clothes washers, and 
        dishwashers, and increased use of bottled water and water 
        softeners in the household sector;
  --an increase in the cost of cooling operations and the cost of water 
        softening, and a decrease in equipment service life in the 
        commercial sector;
  --an increase in the use of water and the cost of water treatment, 
        and an increase in sewer fees in the industrial sector;
  --a decrease in the life of treatment facilities and pipelines in the 
        utility sector; and
  --difficulty in meeting wastewater discharge requirements to comply 
        with National Pollutant Discharge Elimination System permit 
        terms and conditions, and an increase in desalination and brine 
        disposal costs due to accumulation of salts in groundwater 
        basins.
    Over the years, NRCS personnel have developed a great working 
relationship with farmers within the Colorado River Basin. Maintaining 
salinity control achieved by implementation of past practices requires 
continuing education and technical assistance from NRCS personnel. 
Additionally, technical assistance is required for planning and design 
of future projects. Lastly, the continued funding for the monitoring 
and evaluation of existing projects is essential to maintaining the 
salinity reduction already achieved.
    In summary, implementation of salinity control practices through 
EQIP has proven to be a very cost effective method of controlling the 
salinity of the Colorado River and is an essential component to the 
overall Colorado River Basin Salinity Control Program. Continuation of 
EQIP with adequate funding levels will prevent the water quality of the 
Colorado River from further degradation and significantly increased 
economic damages to municipal, industrial and irrigation users.

    [Testimony Submitted by Don A. Barnett, Executive Director, 
Colorado River Basin Salinity Control Forum.]

                                 ______
                                 
        Prepared Statement of Colorado River Board of California
    This testimony is in support of fiscal year (FY) 2017 funding for 
the Department of Agriculture (USDA) associated with the activity that 
assists Title II of the Colorado River Basin Salinity Control Act of 
1974 (Public Law 93-320). This long-standing and cost-effective 
salinity control program in the Colorado River Basin is being carried 
out pursuant to the Colorado River Basin Salinity Control Act and the 
Clean Water Act (Public Law 92-500). Congress authorized the Colorado 
River Basin Salinity Control Program (Program) in 1974 to offset 
increased damages caused by continued development and use of the waters 
of the Colorado River. The USDA portion of the Program, as authorized 
by Congress and funded and administered by the Natural Resources 
Conservation Service (NRCS) under the Environmental Quality Incentives 
Program (EQIP), is an essential part of the overall effort. A funding 
level of $15.2 million in EQIP Financial Assistance (FA) annually is 
required to prevent further degradation of the quality of the Colorado 
River and increased downstream economic damages.
    The Colorado River Board of California (Colorado River Board) is 
the state agency charged with protecting California's interests and 
rights in the water and power resources of the Colorado River system. 
In this capacity, California participates along with the other six 
Colorado River Basin states in the Colorado River Basin Salinity 
Control Forum (Forum), the interstate organization responsible for 
coordinating the Basin States' salinity control efforts. In close 
cooperation with the U. S. Environmental Protection Agency (EPA) and 
pursuant to requirements of the Clean Water Act, the Forum is charged 
with reviewing the Colorado River's water quality standards every 3 
years. The Forum adopts a Plan of Implementation consistent with these 
water quality standards. The level of appropriation being supported in 
this testimony is consistent with the Forum's 2014 Plan of 
Implementation. The Forum's 2014 Plan of Implementation can be found on 
this website: http://coloradoriversalinity.org/docs/
2014%20Final%20REVIEW%20-%20complete.pdf. If adequate funds are not 
appropriated, significant damages associated with increasing salinity 
concentrations of Colorado River water will become more widespread in 
the United States and Mexico.
    The Program benefits both the Upper Basin water users through more 
efficient water management and the Lower Basin water users through 
reduced salinity concentration of Colorado River water. The salinity of 
Colorado River waters increases from about 50 mg/L at its headwaters to 
more than 700 mg/L in the Lower Basin. There are very significant 
economic damages caused downstream by high salt levels in the water. 
There are also local benefits in the Upper Colorado River Basin from 
the Program in the form of soil and environmental benefits, improved 
agricultural production, improved water efficiencies, lower fertilizer 
and labor costs, and water distribution and infrastructure 
improvements. Local producers submit cost-effective applications under 
EQIP in Colorado, Utah and Wyoming and offer to cost share in the 
acquisition of new irrigation equipment. The mix of funding under EQIP, 
cost share from the Basin States and efforts and cost share brought 
forward by local producers has created a most remarkable and successful 
partnership.
    After longstanding urgings from the states and directives from 
Congress, NRCS recognized that this Program is different than small 
watershed enhancement efforts common to EQIP. In the case of the 
Colorado River salinity control effort, the watershed to be considered 
stretches more than 1,400 miles from the Colorado River's headwater in 
the Rocky Mountains to the Colorado River's terminus in the Gulf of 
California in Mexico. Each year the NRCS State Conservationists for 
Colorado, Utah and Wyoming prepare a three-year funding plan for the 
salinity efforts under EQIP. The Colorado River Board supports this 
funding plan which recognizes the need for $15.2 million in EQIP FA 
allocations in fiscal year 2017. Additionally, there is needed 
sufficient Technical Assistance dollars to adequately implement the 
program.
    Over the thirty-two years since the passage of the Colorado River 
Basin Salinity Control Act, much has been learned about the impact of 
salts in the Colorado River system. Currently, the salinity 
concentration of Colorado River water causes about $382 million in 
quantifiable damages in the United States annually. Economic and 
hydrologic modeling by Reclamation indicates that the quantifiable 
damages could rise to more than $614 million by the year 2035 without 
the continuation of the Salinity Control Program. For example, damages 
can be incurred related to the following activities:
  --a reduction in the yield of salt sensitive crops and increased 
        water use to meet the leaching requirements in the agricultural 
        sector,
  --increased in the amount of imported water,
  --an increased cost of desalination and brine disposal for recycling 
        water in the municipal sector,
  --a reduction in the useful life of galvanized water pipe systems, 
        water heaters, faucets, garbage disposals, clothes washers, and 
        dishwashers, and increased use of bottled water and water 
        softeners in the household sector,
  --an increase in the cost of cooling operations and the cost of water 
        softening, and a decrease in equipment service life in the 
        commercial sector,
  --an increase in the use of water and the cost of water treatment, 
        and an increase in sewer fees in the industrial sector,
  --a decrease in the life of treatment facilities and pipelines in the 
        utility sector,
  --difficulty in meeting wastewater discharge requirements to comply 
        with National Pollutant Discharge Elimination System permit 
        terms and conditions, and
  --an increase in desalination and brine disposal costs due to 
        accumulation of salts in groundwater basins.
    The Colorado River is, and will continue to be, a major and vital 
water resource to the nearly 20 million residents of southern 
California, including municipal, industrial, and agricultural water 
users in Imperial, Los Angeles, Orange, Riverside, San Bernardino, San 
Diego, and Ventura Counties. The protection and improvement of Colorado 
River water quality through an effective salinity control program will 
avoid the additional economic damages to users in California and the 
other states that rely on Colorado River water resources.

    [This statement was submitted by Tanya Trujillo, Executive 
Director, Colorado River Board of California.]

                                 ______
                                 
            Prepared Statement of Cystic Fibrosis Foundation
    On behalf of the Cystic Fibrosis Foundation and the approximately 
30,000 people with cystic fibrosis (CF) in the United States, we are 
pleased to submit the following testimony to the Senate Appropriations 
Committee's Subcommittee on Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies for fiscal year 2017. In 
order to encourage efficient review of drugs for cystic fibrosis and 
other rare diseases, we urge the Committee to prioritize the Food and 
Drug Administration (FDA) by providing at least $2.85 billion in fiscal 
year 2017. We encourage special consideration and support for the 
Center for Drug Evaluation and Research (CDER), its Office of New Drugs 
(OND), and the Office of Orphan Products Development (OOPD).
    Drug approvals by the FDA reached an 18 year high in 2014, and more 
than 400 rare disease drugs and biologics have been approved in the 
last 30 years. As the agency's responsibilities continue to grow and we 
enter an unprecedented era of innovation in drug development for rare 
diseases, even more needs to be done.
    Cystic fibrosis is a rare genetic disease that causes the body to 
produce thick mucus that clogs the lungs and other bodily systems, 
resulting in life-threatening infections and other complications. There 
are nearly 2,000 mutations of the CF gene that can impact those with 
CF, and with the advent of precision medicine, therapies are being 
customized to treat a patient's specific genetic makeup.
    As this new concept in drug development quickly becomes a reality, 
it opens the door for the advancement of new targeted therapies in many 
important areas of medicine, including cancer and rare diseases like 
CF.
    There are currently two therapies that have been approved to treat 
the underlying cause of CF in more than 30 percent of those with the 
disease. One such therapy, Kalydeco, was approved in 2012 to treat 4 
percent of patients with CF based on their underlying CF-causing 
mutation. The approval was subsequently expanded to treat 8 percent of 
those with the disease soon after. Kalydeco's initial review time was 3 
months, one of the fastest in the FDA's history. A second targeted 
therapy, Orkambi, was approved in 2015 to treat the most common 
mutation that causes cystic fibrosis. Orkambi was the first drug to 
receive the FDA's breakthrough therapy designation, and it underwent a 
six-month expedited review.
    This success is a testament to what can be achieved when 
stakeholders collaborate across sectors to ensure a swift review of 
critical drugs for patients. Throughout the review processes for 
Kalydeco and Orkambi, the Cystic Fibrosis Foundation and renowned CF 
experts worked closely with the drugs' sponsor Vertex Pharmaceuticals 
and the FDA to provide valuable insight on specific issues related to 
CF, clinical research on CF treatments, and other issues related to the 
product and its review. We believe that the collaboration and 
efficiency displayed throughout these trials can serve as a model for 
best practices in clinical trials for rare diseases.
    Since its creation, the Breakthrough Therapy Designation at the FDA 
has been widely successful at accelerating the approval of new 
treatments that demonstrate substantial improvement over existing 
medications. Cystic fibrosis treatments were the first designated as 
breakthrough therapies, and the process has effectively increased 
efficiency and communication between the FDA and drug sponsors. 
Unsurprisingly, sponsor requests for the Breakthrough Therapy 
Designation have increased dramatically since the program's inception 
in 2012. In the program's first 2 years alone, CDER received more than 
200 requests for breakthrough designation, and more than half of the 
therapies that were granted an expedited review through this program 
were for rare or orphan diseases, like cystic fibrosis. Sponsor 
requests for breakthrough therapy designation are expected to increase 
further in the coming years, and expanded funding and support for this 
program is critical to ensure that new breakthrough therapies receive 
an efficient yet rigorous review.
    As new, more advanced personalized treatments like Kalydeco and 
Orkambi move through the pipeline, it is critical that the FDA has the 
resources necessary to further develop innovative methods for reviewing 
and evaluating the safety and efficacy of targeted therapies. The CF 
Foundation has significantly expanded its research investments with 
leading companies to accelerate the discovery and development of new 
genetically-targeted treatments. The Foundation is supporting 45 
studies in 2016, including examination of several new targeted 
therapies. One series of studies planned for 2016 has the potential to 
treat the underlying cause of the disease in more than 85 percent of 
those with CF. It is crucial that the FDA have sufficient funding to 
provide a swift and efficient review of new treatments for rare, life 
threatening conditions, where there is an urgent need for new, targeted 
therapies.
    A number of clinical trial design issues have been identified that 
may arise in review of rare and precision medicine therapies. As 
precision medicine continues to develop, robust funding is particularly 
crucial as the FDA will need to find new, innovative ways to handle 
unprecedented challenges in drug development and review.
    For example, recruiting sufficient numbers of participants to 
support a classic clinical trial design for a rare disease population 
is often not possible, simply because there is a smaller pool of 
patients. This issue becomes even more significant with the advent of 
precision medicine as therapies become targeted to smaller populations 
based on unique genetic mutations within the CF population. As 
potential new therapies come under review, it may be necessary to test 
combinations of drugs in populations that include patients with several 
different CF mutations and develop and test single and combination 
therapies in n of 1 trials (those that consist of a single patient). 
The FDA needs adequate funding to develop new regulatory pathways and 
approaches to handling variations in trial design that both maintain 
safety and efficacy standards while facilitating the development of 
treatments for patients with rare diseases.
    Researchers and clinicians are also concerned about the challenges 
inherent in executing placebo-controlled trials for genetically-
targeted treatments when successful, genetically-targeted drugs are 
already approved and on the market. In addition to the ethical question 
of asking trial participants to suspend their use of the best available 
therapies, there is also a concern that such a request would dissuade 
participation in clinical trials for the next generation of targeted 
therapies.
    As evaluating the safety and efficacy of targeted therapies becomes 
more challenging, there is also greater need for the use of biomarkers 
and the development of additional outcome measures. Biomarkers with the 
potential to reasonably predict clinical outcomes could play a 
tremendous role in accelerating drug development and review. However, 
the FDA needs adequate funding to accelerate classification of 
biomarkers and ensure that they are being examined throughout the 
clinical trials process. Similarly, Patient Reported Outcomes (PROs) 
are a largely untapped source of valuable data and information that can 
help advance understanding of efficacy throughout a clinical trial. As 
the FDA is looking at new and innovative ways of evaluating treatments, 
the agency needs the resources to consider new sources of valuable data 
to further inform and accelerate the review process.
    Overall, as drug development advances, the FDA must be supplied 
with the proper resources to balance the need for an efficient and 
rigorous review process with the flexibility required to accommodate 
deviations from the standard clinical trial process.
    To this end, we commend the regulatory science initiative formed by 
the NIH and the FDA, which aims to accelerate the development and use 
of new approaches to evaluate drug safety, efficacy, and quality. With 
additional funding, the FDA will have greater ability to partner with 
key stakeholders to promote discussions and workshops of study designs 
that will maximize the progression of multiple effective and safe 
therapies through the development pipeline. Continued collaboration of 
the FDA with the NIH as well as external stakeholders offers immense 
promise for helping to expedite the drug development process and put 
safe and effective drugs in the hands of patients. However, this type 
of collaboration cannot move forward without adequate funding.
    In addition, the CF Foundation is enthusiastic about the potential 
for clinical trial, clinical care, claims, and other healthcare-related 
data to be utilized to improve drug discovery, development, and 
delivery. The Foundation has been a pioneer in the development and 
utilization of a robust data repository through the CF patient 
registry, and our therapeutics development network (TDN) has 
successfully encouraged clinical trial partners to share data. We ask 
that Congress support efforts by the FDA to explore strategies and 
guidelines for clinical trial data sharing. As drug development 
research advances, data sharing is vital to the acceleration and 
efficiency of new discovery.
    This is a time of great hope and optimism for the cystic fibrosis 
community and those with other rare diseases as more therapies that 
treat the underlying cause of CF move through the pipeline. However, 
the FDA faces critical challenges as targeted therapies are being 
brought up for review, including small patient populations and the need 
for greater flexibility in trial design. Additional funding to foster 
stakeholder collaboration to find solutions to these challenges and 
encourage clinical trial data sharing will help move much-needed 
treatments more efficiently to those who need them most.
    Once again, we urge the Committee to make funding for the Food and 
Drug Administration a priority in fiscal year 2017 by providing at 
least $2.85 billion in funding for the agency through the 
appropriations process. The CF Foundation stands ready to work with the 
Committee, FDA, and Congressional leaders on the challenges ahead. 
Thank you for your consideration.

    [This statement was submitted by Preston W. Campbell, III, MD., 
President and CEO, Cystic Fibrosis Foundation.]

                                 ______
                                 
         Prepared Statement of Entomological Society of America
    The Entomological Society of America (ESA) respectfully submits 
this statement for the official record in support of funding for 
agricultural research at the U.S. Department of Agriculture (USDA). ESA 
requests discretionary appropriations of at least $1.884 billion in 
fiscal year (FY) 2017 for USDA's National Institute of Food and 
Agriculture (NIFA), including at least $700 million for the Agriculture 
and Food Research Initiative (AFRI). The Society also supports a 
discretionary funding level of at least $1.286 billion for the 
Agricultural Research Service (ARS), including funding for the ARS Crop 
Protection budget at a minimum of the fiscal year 2016 enacted level of 
$195 million to preserve valuable pest management research programs in 
fiscal year 2017.
    The international stature of the United States as a producer and 
exporter of food, fiber, and other agricultural commodities has long 
been associated with innovation-fueled increases in productivity. 
Steady growth in agricultural output over the past half-century has 
been accompanied by substantially smaller increases in inputs1, so that 
today fewer farmers are producing more food, without expanding land in 
cultivation, at lower costs to consumers. Increased productivity has 
been achievable through improved technology, spurred by Federal 
investment in research and development. There are signs, though, that 
longstanding growth in productivity may be slowing, at a time when 
demands on the agricultural sector are steadily increasing. Ensuring 
food safety, security, quality, and environmental sustainability are 
among today's greatest challenges to U.S. agriculture--yet the U.S. 
global share of public investment in agriculture and food research and 
development has declined significantly in the past three decades.
    Cutting-edge agriculture science, including entomology, is critical 
to meeting these challenges. Globalized trade has led to major 
redistribution of pest species, from indigenous areas where they are 
kept in check by natural enemies to new areas where they can rapidly 
expand their ranges. Beyond competing directly with humans by consuming 
crop plants, invasive insect pests also threaten food security by 
acting as vectors of plant diseases. The Asian citrus psyllid, the 
principal vector of the invariably fatal bacterial citrus greening 
disease, for example, has already caused over $9 billion in losses to 
citrus growers in Florida alone.\1\ Moreover, by outcompeting and 
displacing native species, invasive arthropods compromise ecosystem 
services provided by biotic communities, including pollination, 
nutrient cycling, and water regulation and purification.
---------------------------------------------------------------------------
    \1\ National Academy of Sciences, 2014. Spurring Innovation in Food 
and Agriculture: A Review of the USDA Agriculture and Food Research 
Initiative Program. Washington: National Academies Press.
---------------------------------------------------------------------------
    As NIFA's premier competitive research program, AFRI funds a wide 
range of agricultural research, education, and extension projects at 
universities and research institutions nationwide. In addition, AFRI's 
Education and Literacy Initiative supports more than 2,000 trainees 
annually that will become the next generation workforce of agricultural 
and food scientists. ESA appreciates the Subcommittee's efforts to 
increase the AFRI budget since the program's establishment and 
enthusiastically supports the requests for $700 million for AFRI in 
fiscal year 2017, the full amount authorized in the 2008 Farm Bill. ESA 
also supports the proposed inclusion of pollinator health as a special 
area of emphasis within the AFRI Foundational Program, including plans 
to allocate $10 million for new grants in the area of pollinator health 
to continue to support the government-wide initiative. America's insect 
pollinators contribute to the production of over 90 fruit, vegetable, 
nut, and fiber crops; collectively, pollination services of managed and 
wild pollinators in the US have been valued at more than $17 billion 
annually. Populations of many of these pollinators, however, have been 
declining even as demand for pollination services for expanding 
acreages of fruit, nut, and vegetable crops has increased.
    To maximize its limited resources, AFRI supports projects that 
address key societal challenges and build foundational knowledge in 
high-priority areas of the food and agricultural sciences, such as food 
safety and food security. For example, annual honey bee colony losses 
due, in part, to infestation by the varroa mite have created enormous 
problems for U.S. beekeepers and for the growers dependent on honey 
bees for pollination services. Scientists funded by AFRI have used 
genomic resources to identify receptor targets in the nervous system 
unique to the mite and are designing and testing synthetic analogues of 
the neuropeptides that interact with those receptors for mite control, 
thereby sparing honey bees and other non-target species.\2\ In addition 
to AFRI, other NIFA grants support programs to study and implement 
scientifically based approaches to reduced-risk integrated pest 
management (IPM), which has implications for human health, the 
environment, and the economy.
---------------------------------------------------------------------------
    \2\ AFRI Competitive Grant, 2016, ``Development of honey bee-safe 
acaricidal peptidomimetics,'' http://portal.nifa.usda.gov/web/
crisprojectpages/1009168-development-of-honey-bee-safe-acaricidal-
peptidomimetics.html.
---------------------------------------------------------------------------
    As USDA's intramural research agency, ARS funds research of broad 
consequence to our nation's agriculture enterprise, including in the 
areas of crop and livestock production and protection, human nutrition, 
food safety, and environmental stewardship. The ARS Crop Protection 
research program builds knowledge and develops approaches that are made 
available to crop producers, enabling better control of pest and 
disease outbreaks as they occur. In addition, the ARS Crop Production 
research program develops and approves safe and effective strategies 
for reducing crop loss and providing a dependable food supply. ESA 
supports maintaining level funding with President's fiscal year 2016 
budget request, with $195 million for the Crop Protection account and 
$218 million for the Crop Production account. In addition to the 
additional funding proposed within AFRI and ARS, ESA supports USDA's 
participation in multi-agency activities to investigate pollinator 
health and develop implementation plans to prevent, slow, or reverse 
pollinator population decline.
    ESA, headquartered in Annapolis, Maryland, is the largest 
organization in the world serving the professional and scientific needs 
of entomologists and individuals in related disciplines. Founded in 
1889, ESA has over 7,000 members affiliated with educational 
institutions, public health agencies, private industry, government 
laboratories, the U.S. military, and many nonprofit organizations. 
Members include academic scientists, teachers, extension service 
personnel, administrators, marketing representatives, research 
technicians, consultants, students, pest management professionals, and 
hobbyists, among others.
    Thank you for the opportunity to voice support from the 
Entomological Society of America for USDA research programs.

    [This statement was submitted by May Berenbaum, PhD, President, 
Entomological Society of America.]

                                 ______
                                 
Prepared Statement of Federation of American Societies for Experimental 
                            Biology (FASEB)
      department/office addressed in testimony: usda afri and ars
    The Federation of American Societies for Experimental Biology 
(FASEB) is composed of 30 societies with 125,000 members, making it the 
largest coalition of biomedical research associations in the United 
States. FASEB enhances the ability of scientists and engineers to 
improve health, well-being, and productivity through research and is 
recognized as the policy voice of biological and biomedical 
researchers.
    The United States Department of Agriculture (USDA) funds research 
through a competitive grants system, the Agriculture and Food Research 
Initiative (AFRI), and an ``in-house'' effort administered by the 
Agricultural Research Service (ARS). These programs support research 
that addresses some of the grand challenges of our time: food 
production, global food security, human nutrition, agriculture 
economics, and sustainable bioenergy. Grants are awarded to state 
agricultural experiment stations, colleges, university research 
foundations, and other research institutions, as well as private 
organizations. AFRI funded over 1,200 research projects in all 50 
states between 2009 and 2011. ARS currently supports more than 2,000 
scientists at 90 laboratories throughout the country.\1\
---------------------------------------------------------------------------
    \1\ http://www.ars.usda.gov/is/np/ARSImpacts/ARSImpacts.pdf.
---------------------------------------------------------------------------
    Since AFRI was established in 2008, the program has supported 
research to develop new varieties of wheat and barley that will better 
tolerate changes in climate and lettuce that requires less water, which 
will allow farmers to conserve resources and save money. Other projects 
established methods to improve communication, analysis, and data 
sharing about corn farming practices in order to ensure production can 
be sustained despite the threat of extreme weather events. In addition, 
a USDA-funded team of engineers and scientists created a mobile 
application to help farmers comply with Environmental Protection Agency 
regulations that mandate the collection and submission of data on soil, 
crops, and nutrient management plans. ARS scientists have discovered 
genes and molecular markers in honey bees that have led to the breeding 
of new bees that are resistant to the adverse effects of mites and 
chalkbrood disease, as well as the application of technologies to help 
reduce exposure of the bees to pesticides.
    Examples of promising USDA-funded research include:
  --Laser Tool Detection of Salmonella: Scientists funded by USDA at 
        Purdue University have developed a new method for the detection 
        of Salmonella bacterial contamination in food. By using a laser 
        to scan bacteria isolated from food samples, the new technology 
        can identify potential contamination about three times faster 
        than traditional methods. This rapid screening could ultimately 
        lead to more thorough and rapid food inspections, thus reducing 
        morbidity from Salmonella food poisoning.\2\
---------------------------------------------------------------------------
    \2\ http://www.purdue.edu/newsroom/releases/2014/Q1/laser-tool-
speeds-up-detection-of-salmonella-in-food-products.html.
---------------------------------------------------------------------------
  --Molecular Mechanisms of Herbicide Resistance: Compounds called 
        safeners are routinely applied to cereal crops to protect them 
        from weed-killing herbicides. However, the precise mechanism by 
        which these safeners work remained largely unknown. Recently, 
        USDA-supported researchers at the University of Illinois have 
        discovered that specific molecules for detoxifying herbicides 
        in cereal plants are upregulated when safeners are applied. 
        This insight will aid in the management of herbicide use, and 
        similar detoxification processes in plants may prove to be 
        useful traits for resistance to other stressors, including 
        drought, pests, or disease.\3\
---------------------------------------------------------------------------
    \3\ http://www.grainnet.com/articles/University-of-Illinois-
Researchers-Learn-More-About-Herbicide-Defense-Switch-in-Cereal-Crops-
146822.html.
---------------------------------------------------------------------------
  --Computer Modeling of Food-borne Pathogen Growth: One of the 
        greatest challenges in food safety is to ensure that different 
        foods are handled properly to prevent the growth of harmful, 
        contaminating microbes. In order to enhance the ability of food 
        companies to ensure the safety of their products, ARS 
        scientists at the USDA Eastern Regional Research Center have 
        developed a software package that models the growth and 
        proliferation bacteria in different environments. These models 
        can then be used to develop effective management practices that 
        reduce the instance of foodborne illness.\4\
---------------------------------------------------------------------------
    \4\ http://portal.errc.ars.usda.gov/PMP.aspx.
---------------------------------------------------------------------------
  --Uncovering the Links between Maternal Traits and Fetal Development: 
        An important area of ongoing research seeks to understand how 
        mothers' health during pregnancy might affect children's growth 
        and development. Using advanced imaging techniques, USDA ARS-
        funded researchers at the Arkansas Children's Nutrition Center 
        have discovered a relationship between maternal obesity during 
        pregnancy and brain structure in newborns. This study is part 
        of a growing literature suggesting previously unknown ways in 
        which maternal health has profound neurological effects on 
        fetal development. Such studies therefore not only shed light 
        on fundamental mechanisms of human brain development, but also 
        could help with design of dietary and exercise interventions 
        for expecting mothers that improves infant health.\5\
---------------------------------------------------------------------------
    \5\ http://www.ncbi.nlm.nih.gov/pubmed/25919924.
---------------------------------------------------------------------------
  --Development of Drought and Disease Resistant Corn: Drought 
        represents a major threat to crop production. To begin to 
        address this problem, USDA-funded researchers at Texas A&M 
        University have been exploring the genetics of corn varieties 
        grown in different regions of the United States. Through this 
        work, the team has begun to breed more productive varieties of 
        corn that show greater resistance to drought and opportunistic 
        infections. These efforts will be especially important for 
        growers in the most drought prone regions.\6\
---------------------------------------------------------------------------
    \6\ http://nifa.usda.gov/blog/breeding-program-brings-better-safer-
corn-south.
---------------------------------------------------------------------------
  --Improving the Safety of Leafy Green Vegetables: Bleach, hydrogen 
        peroxide, or other toxic chemicals are often used to remove 
        bacteria from leafy vegetables. Researchers at the University 
        of Arizona supported by the USDA have discovered that non-toxic 
        plant antimicrobial and other organic compounds can be just as 
        effective in cleaning produce. Pursuing these alternative 
        strategies has the potential to both increase food safety and 
        reduce the adverse health and environmental impacts of using 
        harsh cleaning agents on food plants.\7\
---------------------------------------------------------------------------
    \7\ http://nifa.usda.gov/blog/improving-safety-leafy-greens.
---------------------------------------------------------------------------
  --Combating the Spread of Antimicrobial Resistance: The proliferation 
        of antibiotic-resistant microbes poses a significant threat to 
        both human and animal health. However, scientists are only 
        beginning to understand the details of how antibiotic 
        resistance emerges and spreads, both within agricultural and 
        non-agricultural settings. To address this, AFRI-funded 
        scientists are playing an integral role as part of broader 
        national efforts to deal with this critical challenge. For 
        example, researchers at the University of Minnesota have begun 
        to study the evolution of antibiotic resistant E. coli and 
        Salmonella on poultry farms in the hopes of developing better 
        management strategies that will improve both food safety and 
        public health.\8\
---------------------------------------------------------------------------
    \8\  http://portal.nifa.usda.gov/web/crisprojectpages/1005062-
systems-approach-to-identifying-targeted-interventions-for-minimizing-
antibiotic-resistance-in-the-poultry-production-system.html.
---------------------------------------------------------------------------
   new investments will accelerate the pace of agricultural research
    New technologies and improved techniques are needed to address 
serious agricultural-related crises facing our country including the 
ongoing drought in California, childhood obesity, pollinator collapse, 
and citrus greening. Other challenges include changing weather patterns 
that shift growing seasons and threats posed by increasing varieties of 
invasive weeds, pests, and pathogens. Investment in USDA will help us 
to better understand the relationship between food consumption and 
behaviors, dietary patterns, and various health outcomes, including 
those related to obesity and the development of chronic diseases. USDA-
funded research leads to nutrition education and obesity prevention 
strategies and interventions that advance public health.
    Federal funding for competitive agriculture research can provide 
the answers that will build the foundation of knowledge to help solve 
current and future societal problems. Harnessing this potential would 
generate new knowledge in the food, nutrition, and agricultural 
sciences, and translate those fundamental discoveries into practical 
solutions that benefit all sectors of society and every geographic 
region in the country. Sustaining a competitive agriculture economy is 
also critical in order to respond to new and emerging problems, such as 
identifying ways to better manage the avian flu epidemic.
    Accelerating the pace and productivity of agricultural research 
will require sustained increases for AFRI and ARS. A National Research 
Council (NRC) review of the AFRI program concluded that, ``ARFI plays a 
critical and unique role in the nation's overall research and 
development (R&D) portfolio because its mandated scope, mission, and 
responsibilities are focused on the most important national and 
international challenges facing food and agriculture. But it has not 
been given the adequate resources needed to meet contemporary and 
likely future challenges.'' \9\ The NRC report further recommended that 
the U.S should strengthen its public investment in agricultural R&D to 
ensure that it continues its ability to remain a global leader in 
innovation, food production, and health promotion.
---------------------------------------------------------------------------
    \9\ The National Academies Press. Spurring Innovation in Food and 
Agriculture: A Review of the USDA Agriculture and Food Research 
Initiative (2014).
---------------------------------------------------------------------------
    Opportunities for agricultural research are growing, as Congress 
recognized by expanding USDA's research mandate in the 2014 Farm Bill 
to include diseases that can be transmitted from animals to humans and 
the effectiveness of conservation practices in addressing nutrient 
losses. Despite receiving increased funding over the last few years, 
AFRI's budget is still only half of the level authorized in the 2014 
Farm Bill, limiting the program's capacity to satisfy the expanded 
research focus areas mandated by Congress. In addition, inadequate 
funding combined with AFRI's multi-year commitments to existing 
projects have reduced the availability of funds for individual, 
investigator-initiated grants.
    AFRI's continued success will depend on securing additional funding 
to meet the recommended authorization level. With a budget of $700 
million (an increase of $350 million over fiscal year 2016), AFRI could 
support more than 500 new research grants. An ARS budget of $1.2 
billion ($60 million above fiscal year 2016) will allow for the 
continued growth of agricultural research efforts.
    FASEB recommends a minimum of $700 million for AFRI and $1.2 
billion for ARS in fiscal year 2017. These funding levels represent a 
first step toward a longer-range commitment to sustain the vital field 
of agricultural research.
    Thank you for the opportunity to offer our support and 
recommendations for USDA research programs.

                                 ______
                                 
          Prepared Statement of Food for Peace Title II (FFP)
    As you prepare appropriations legislation for fiscal year 2017, we 
thank you for your past leadership in protecting poverty-focused 
international development and humanitarian assistance accounts 
specifically related to food security and nutrition. As a group of 
organizations that are supportive of these programs, we would like to 
thank Congress for the increase to Food for Peace Title II (FFP) 
funding we saw in fiscal year 2016, and call upon Congress to continue 
to provide similarly robust funding for Food for Peace in fiscal year 
2017. Further, we request that Congress direct at least $375 million of 
Food for Peace funding to long-term development oriented non-emergency 
programs.
    For over 60 years, Food for Peace has enabled the United States to 
reach more than 3 billion people with food assistance, addressing not 
only food security needs, but helping to build stability in regions 
that might otherwise pose greater national security concerns. As we 
consider the protracted conflicts in Syria, South Sudan, Yemen, and 
Iraq, as well as ongoing cyclical weather patterns like El Nino and a 
potential La Nina, projected global needs in fiscal year 2017 will be 
significant. Providing robust funding of FFP as was done in fiscal year 
2016 will allow the U.S. to reach over 47 million people with 
lifesaving food aid and maintain its global leadership.
    As the largest U.S. government food aid program, Food for Peace 
Title II also provided funding for non-emergency development programs 
that focus on the underlying sources of chronic hunger through 
multiyear investments in nutrition, agricultural productivity, and 
diversification of household incomes. These programs help poor 
communities build resilience to droughts and floods, improve farming 
practices and integrate into local markets, allowing them to better 
withstand shocks and reduce the need for emergency assistance. These 
programs move poor farmers away from poverty and help them realize the 
dignity of providing for their families. In parallel with robust 
funding to the overall Food for Peace budget, we request at least $375 
million of FFP funding--a small increase over the minimum level of $350 
million required by the Farm Bill--be directed to development, non-
emergency programming. Additionally, we remain supportive of the 
Community Development Fund including its use within non-emergency food 
assistance programming.
    We look forward to continuing to work with you in advancing efforts 
that address food insecurity, and we once again thank you for your 
leadership in protecting international humanitarian and development 
assistance accounts including Food for Peace Title II.

    1.) Mercy Corps
    2.) Food for the Hungry
    3.) ADRA International
    4.) Catholic Relief Services
    5.) CNFA
    6.) World Vision US
    7.) PCI
    8.) ACDI/VOCA

                                 ______
                                 
         Prepared Statement of Food for Peace (Public Law 480)
    The undersigned organizations support sustained funding for the 
Food for Peace (Public Law 480) and Food for Progress international 
food aid programs and oppose proposals to reduce funding or to shift 
these resources to overseas commodity procurement and cash assistance. 
These bedrock food aid programs have enjoyed strong bipartisan support 
for over 60 years because they share America's agricultural bounty with 
those who need it most.
    Our food aid programs have constantly evolved and improved over the 
years. They provide well-honed and dependable systems for identifying 
the appropriate commodities for targeted populations, and for procuring 
and shipping these commodities through an aid pipeline that is second 
to none. The transparency, accountability, and reliability of this 
system are the result of decades of cooperation through a uniquely 
sustainable public-private partnership among tens of thousands of 
committed Americans at faith-based and other non-governmental 
organizations, and in agriculture, labor, industry, and government.
    Growing, manufacturing, bagging, and shipping nutritious U.S.-grown 
food creates jobs and economic activity here at home, provides crucial 
cargo for our U.S. Merchant Marine, which is essential to our national 
defense sealift capability, and sustains a robust domestic constituency 
for these programs not easily replicated in alternative foreign aid 
programs. Overseas, Food for Peace has an established track record of 
preventing childhood starvation and providing life-saving tools that 
families need to work their way out of the most dire poverty. Food for 
Progress fights hunger by promoting free enterprise in emerging 
democracies through development of the agricultural sector. Both of 
those programs are proven methods for tackling food insecurity head-on 
with concrete results.
    In addition to feeding the hungry and facilitating developmental 
programs to end the cycle of hunger, U.S. food aid programs are also 
some of our most effective, lowest-cost national security and 
diplomatic tools. Bags of U.S.-grown food bearing the U.S. flag and 
stamped as ``From the American People'' serve as ambassadors of our 
Nation's goodwill, which can help to address the root causes of 
instability. In a time of growing global food insecurity and extremism, 
these programs need to be expanded, not eliminated or slashed to fund 
dubious proposals.
    We therefore oppose shifting food aid resources to overseas 
commodity procurement and cash assistance, and strongly encourage 
sustained funding for Food for Peace and Food for Progress, preserving 
the unique qualities that have made them the world's most successful, 
most dependable humanitarian assistance programs.

American Association of Port Authorities
National Council of Farmer Cooperatives
American Great Lakes Ports Association
National Potato Council
American Maritime Congress
National Sorghum Producers
American Maritime Officers
Navy League of the United States
American Maritime Officers' Service
North American Millers' Association
American Soybean Association
Potomac Maritime, LLC
APL Limited
Potomac Shipping International, LLC
Central Gulf Lines, Inc.
Sailors' Union of the Pacific
Euro-America Shipping & Trade, Inc.
Schuyler Line Navigation Company, LLC
Hapag-Lloyd USA, LLC
Seafarers International Union
Intermarine, LLC
Teras Cargo Transport (America), LLC
International Organization of Masters,
Transfer Logistics LLC
Mates & Pilots
Transportation Institute
Liberty Maritime Corporation
US Dry Bean Council
Maersk Line, Ltd.
US Rice Producers Association
Marine Engineers' Beneficial Association
USA Dry Pea and Lentil Council
Maritime Institute for Research and
USA Maritime
Industrial Development
USA Rice
National Association of Wheat Growers
Virginia Port Authority
National Barley Growers Association
Waterman Steamship Corporation
National Corn Growers Association

    [This statement was submitted by Bryant E. Gardner, Partner, 
Winston & Strawn LLP.]

                                 ______
                                 
                Prepared Statement of Food & Water Watch
    On behalf of the non-profit consumer advocacy organization Food & 
Water Watch, I welcome this opportunity to express our views on the 
fiscal year 2017 appropriations bill under your jurisdiction.
                   food safety and inspection service
    We remain opposed to the New Poultry Inspection System (NPIS) that 
is being implemented for several reasons: 1) there is still no proof 
that this privatized inspection model will make poultry safer. In fact, 
when we asked agency officials at a recent meeting for testing 
statistics from plants that have actually shifted to NPIS to 
demonstrate that poultry that is slaughtered under this new system is 
safer, they could not do so; 2) the agency still has not addressed the 
issue of designating certain strains of Salmonella and Campylobacter as 
adulterants. It is baffling to us that the Obama Administration has 
failed to request this authority from the Congress; 3) we remain 
concerned that the company sorters who are taking over inspection 
responsibilities on the slaughter lines have not received proper 
training; 4) the reticence of the poultry industry to shift to this new 
system illustrates to us that it is not confident that NPIS will work. 
The excuses that the agency lists in its fiscal year 2017 Explanatory 
Notes for not achieving its salary savings goals for fiscal year 2016 
are not accurate; 5) the agency still seems to be interested in 
increasing line speeds in poultry facilities. There are rumors that 
there might be a rider attached to the fiscal year 2017 Agriculture 
Appropriations bill to revoke the 140 birds per minute cap for young 
chicken plants shifting to NPIS. We strongly oppose any such efforts. 
The one remaining USDA inspector left on the slaughter line in NPIS 
plants is responsible for inspecting 2.33 birds every second. This is 
an impossible task. To increase the line speed to 175 is totally 
irresponsible. We urge the subcommittee to provide vigorous oversight 
over the implementation of NPIS because it is not achieving the food 
safety goals that the agency touted when the rule was finalized.
    We support the agency's $4.5 million funding request so that it can 
perform genomic sequencing in its pathogen identification work, and its 
$3 million request to expand laboratory analysis. We do not support its 
$1 million request for advanced analytics for its Public Health 
Information System (PHIS). As we have alerted the subcommittee on 
several occasions in the past, the implementation of PHIS has been 
problematic. Our concerns were corroborated by the USDA Office of 
Inspector General in its August 2015 audit report of the IT system. 
When we recently asked agency officials what this additional money 
would be used for, they were equivocal. Instead of giving the agency 
additional money to prop up a failed IT system, we strongly urge that 
the subcommittee get concrete answers from the agency regarding this 
funding request. We should not be throwing good money after bad for a 
system that has already cost substantially more than originally 
estimated.
    We also urge the subcommittee to request from the agency a detailed 
plan on how it intends to deal with the chronic staffing shortages in 
the inspection workforce across the country. There are some FSIS 
regions that continually have double-digit vacancy rates. This is 
impacting the ability of the remaining inspectors to complete their 
inspection tasks. Food & Water Watch published an analysis of the 
impact of the staffing shortages in September 2015.\1\
---------------------------------------------------------------------------
    \1\ See http://www.foodandwaterwatch.org/news/usda-records-reveal-
staffing-shortages-undermining-food-safety.
---------------------------------------------------------------------------
    Food & Water Watch supported the rule to transfer the inspection of 
siluriformes from the U.S. Food and Drug Administration to FSIS. We 
were disappointed with the length of time for the final rule to be 
published and with the interference of the Office of U.S. Trade 
Representative in the development of that rule. We are concerned with 
the length of the transition period contained in the rule, especially 
for exporting countries. We did not see in the agency's budget request 
additional funding for more import inspection personnel to deal with 
imported siluriformes. We urge the subcommittee to ask the agency how 
intends to deal with the inspection of imported siluriformes at our 
ports-of-entry.
    We are concerned with the agency's recent publication of audit 
reports for the poultry inspection system in the People's Republic of 
China (PRC), in which it has concluded that it intends to move forward 
with rulemaking to permit the PRC to export its own poultry to the U.S. 
The food safety system in the PRC is weak at best and corrupt at worst. 
On March 7, a story appeared in a food trade publication in which the 
head of the PRC's Food and Drug Administration admitted that his agency 
could not keep up with investigating all of the cases of adulterated 
food that had entered into that country's food supply.\2\ We have 
always been suspicious that the PRC poultry equivalency determination 
has had a nexus with the re-opening of the Chinese market to U.S. beef. 
Trade cannot trump food safety and we urge the subcommittee to insert 
statutory language in the fiscal year 2017 bill to require the agency 
to provide regular reports to Congress on this issue.
---------------------------------------------------------------------------
    \2\ See http://www.foodnavigator-asia.com/Policy/Food-safety-chief-
FDA-struggling-to-cope-with-scale-of-adulteration.
---------------------------------------------------------------------------
    Furthermore, we urge the subcommittee to continue to prohibit USDA 
from purchasing poultry products from the PRC for the various nutrition 
programs it administers, including the National School Lunch Program.
         grain inspection packers and stockyards administration
    We urge the subcommittee to exclude any legislative riders that 
limit the authority of the Secretary of Agriculture under the Packers & 
Stockyards Act (P&SA) of 1921. The P&SA is a vital Federal statute that 
protects livestock farmers and ranchers from unfair, deceptive, 
fraudulent and anticompetitive business practices by the meatpacking 
and poultry companies. The 2008 Farm Bill directed USDA to write rules 
to address the market power and predatory business practices of the 
highly consolidated and vertically integrated meatpacking and poultry 
industries that were finalized in a considerably diminished form in 
2011, but previous agricultural appropriations provisions have hindered 
USDA from providing basic protections and safeguards for U.S. farmers 
and ranchers. The 2014 Farm Bill did not revisit these provisions and 
the Consolidated Appropriations Act of fiscal year 2016 did not include 
any version of the prior policy riders. The subcommittee should 
continue to exclude any policy riders that undermine the work of the 
Secretary and the Agriculture Committees.
                      food and drug administration
    We are concerned that the funding request made by the 
administration for the implementation of the Food Safety Modernization 
Act (FSMA) is not adequate. The administration, again, is relying on 
user fees to fund most of the implementation work for fiscal year 2017 
even though it knows that Congress will not enact such fees. We urge 
the subcommittee to work with the agency to determine a realistic 
appropriations request so that the implementation of FSMA can continue.
    We are requesting $10 million to help small and mid-size farms and 
small processing facilities comply with new proposed food safety 
regulations. This training program, authorized in FSMA, is one of the 
best and least costly ways to improve food safety outcomes without 
resorting to excessive farm regulation. The program received $5 million 
in fiscal year 2016. The President's fiscal year 2017 budget requests 
$5 million. We are requesting $10 million for fiscal year 2017, because 
food safety training for family-scale operations is critical at this 
stage of FSMA implementation.

    [This statement was submitted by Wenonah Hauter, Executive 
Director, Food & Water Watch.]

                                 ______
                                 
   Prepared Statement of Friends of Agricultural Research--Beltsville
    Mister Chairman and Members of the Subcommittee, thank you for this 
opportunity to present our statement supporting funding for the 
Department of Agriculture's Agricultural Research Service (ARS), and 
especially for its flagship research facility, The Henry A. Wallace 
Beltsville Agricultural Research Center in Beltsville, Maryland. We 
strongly recommend full fiscal-year 2017 funding for the Beltsville 
center.
    The world-famous agricultural research center has led national 
agricultural progress for well over a century. A national and world 
treasure--home to the world-famous Beltsville Small White Turkey--the 
center generates enormous benefits for our country.
                     notable recent accomplishments
    The American Chemical Society recently named Beltsville a National 
Historic Chemical Landmark for the discovery and isolation of the 
light-sensitive plant pigment phytochrome. Hailed as a leading plant 
science discovery of the 20th century, the research required 41 years 
of intensive research effort.
    A natural nitrogen-fixing strain of Rhizobium bacteria identified 
and patented at Beltsville is used to inoculate some 55 million acres 
of soybeans in the United States. A reduced reliance on petroleum-based 
nitrogen fertilizer remains an essential goal for our country.
    The Food Components and Health Laboratory of the Beltsville Human 
Nutrition Research Center recently found that tree nuts have lower 
calorie content than currently listed on food labels. These findings 
improve food labeling and help consumers make better food choices.
    Dr. Hyun Soon Lillehoj, a Beltsville senior research molecular 
biologist, received a 2015 Samuel J. Heyman Service to America Medal in 
Career Achievement (``the Sammies''), for her research to reduce the 
use of antibiotics in commercial poultry.
    Yet, Beltsville faces devastating decline and obsolescence from 
long-deferred essential maintenance and repairs to buildings, roadways, 
and its electrical grid infrastructure. Roadways are in great need of 
repairs and an independent assessment of some of the bridges revealed 
such disrepair as to become ``life safety issues.''
    These issues cry out for attention. We estimate and recommend that 
a dedicated annual appropriation of $3 million is needed to address 
long-delayed repairs and maintenance. The Beltsville campus consists of 
approximately 6,000 acres and 308 buildings containing laboratories, 
offices, greenhouses, animal facilities, repair shops, farm buildings, 
and other specialized facilities. There are 37.6 miles of paved 
roadways, many of which are in an urgent need of repair. Most buildings 
were constructed in the 1920s and 1930s, the oldest in 1805.
 we turn now to selected items within the president's fiscal year 2017 
                            budget proposal
    First, we would confirm our sincere appreciation and gratitude that 
the Consolidated Appropriations Act of 2016 includes $37.1 million in 
Federal funding to modernize research laboratories at the Beltsville 
Agricultural Research Center. As mentioned before many Beltsville 
laboratories were built in the 1920s, 1930s 1950s and 1960s and are now 
more than 60 years old. This funding will be used to modernize Building 
307, which has been largely vacated because its space is no longer 
functional for research activities.
    We also are very pleased that the President's fiscal year 2017 
budget includes increases in critically important research initiatives, 
which would lead to creating new jobs, enhancing American agriculture 
competitiveness in the global economy, assuring future food security, 
protecting crops and animals from diseases and reducing their 
vulnerability to climate change, while improving the economic and 
environmental sustainability of American agriculture. The scientists of 
the Henry A. Wallace Beltsville Agricultural Research Center are 
recognized world leaders in the scientific disciplines that are 
necessary to successfully execute the President's proposed research 
initiatives. Specifically, we would like to highlight the following 
initiatives that will enhance the Center's research programs.
   climate change-resilience crops that respond and adapt to climate 
                                 change
    The proposed budget provides $292,500 for the Henry A. Wallace 
Beltsville Agricultural Research Center to identify and evaluate 
management practices that maximize plant genetic potential to achieve 
optimal yield. This will be achieved by determining how rising 
temperatures and carbon dioxide alter physiological processes, growth, 
and crop quality and how genetic make-up makes plants adaptable or 
resistant to environmental changes. Also, these additional funds will 
be used to advance our understanding of the effects of climate change 
on pests and beneficial insects, so crops can be better protected 
against insect pests.
   climate change-reduce vulnerability of agro-ecosystems to climate 
                                 change
    The budget proposes $90,000 in new funding to the Henry A. Wallace 
Beltsville Agricultural Research Center to model the impact of long-
term weather, using Long-Term Agro-Ecosystem Research (LTAR) data, on 
crop and livestock productivity. In 2012, ARS organized ten of its 
existing research watersheds, ranges, and farms into a LTAR network to 
conduct research to support sustainable agricultural production. In 
fiscal year 2014, ARS added eight additional LTAR sites, thereby 
increasing coverage in key agricultural production regions, while 
strengthening ties between USDA science and the Nation's land grant 
university system. Thus ARS began to transform existing long-term 
research infrastructure, both within and outside of USDA, to address 
all components of agricultural sustainability (i.e., productivity, 
economics, environmental quality, ecosystem services, and human and 
social well-being). The fiscal year 2017 $90,000 increase will fund the 
newly designated unfunded site in the Chesapeake Bay.
                   combating antimicrobial resistance
    The budget proposes $2,890,800 of new funding for the Henry A. 
Wallace Beltsville Agricultural Research Center to create new tools to 
combat antimicrobial resistance in animals and the environment. Among 
expected benefits are novel approaches to boosting animal natural 
immune systems for resistance to parasitic infections, gut 
stabilization against pathogens, or novel strategies using 
antimicrobial growth promoters to limit the consequences of host 
reactivity to pathogens and protection of public health.
                    safe and abundant water supplies
    A $225,000 increase is provided for the Henry A. Wallace Beltsville 
Agricultural Research Center to develop safe and abundant water 
supplies to support U.S. agricultural production by using non-
traditional water sources.
    Mr. Chairman, this concludes our statement. Thank you for 
consideration and support for the educational, research, and outreach 
missions of The Henry A. Wallace Beltsville Agricultural Research 
Center.

    [This statement was submitted by Allan Stoner, Ph.D., President, 
Friends of Agricultural Research--Beltsville, Inc.]

                                 ______
                                 
 Prepared Statement of Friends of Agricultural Statistics and Analysis
    The undersigned groups, which include various members of the 
Friends of Agricultural Statistics and Analysis, strongly support 
Federal investment to advance agricultural statistics and research in 
the United States Department of Agriculture's (USDA) Economic Research 
Service (ERS) and the USDA National Agricultural Statistics Service 
(NASS). We support funding for these agencies in fiscal year 2017 
(fiscal year 17) at levels that are at least $91.3 M for ERS and $176.6 
M for NASS.
    USDA produces valuable data that directly informs decisions by food 
and agricultural market participants; agricultural input and food 
businesses; banks and other credit institutions; and those who make 
food, farm, economic development, and trade policy. American 
agriculture, rural America, food, and resource-based industries depend 
on the reliable production of timely, accurate, and objective food, 
agricultural, rural economic, and resource statistics and market 
information. Additionally, the statistics and analysis made possible by 
these agencies provides a greater understanding of farm household 
dynamics, advances evidence-based policy approaches, and gives insight 
into the health of the farm economy.
    The National Agricultural Statistics Service (NASS) is committed to 
providing timely, accurate, and useful statistics in service to U.S. 
agriculture. The agency conducts hundreds of surveys every year and 
prepares reports and information to communicate the survey results. 
Production and supplies of food and fiber, prices paid and received by 
farmers, farm labor and wages, farm finances, chemical use, and changes 
in the demographics of U.S. producers are only a few examples of the 
information gathered. NASS reports the facts on American agriculture, 
facts needed by people working in and depending upon U.S. agriculture. 
A primary concern of NASS is to ``safeguard the privacy of farmers, 
ranchers, and other data providers, with a guarantee that 
confidentiality and data security continue to be our top priorities.''
    The mission of the Economic Research Service (ERS) is to inform and 
enhance public and private decisionmaking on economic and policy issues 
related to agriculture, food, the environment, and rural development. 
To accomplish this mission, ERS manages a comprehensive program of 
economic research and analysis (including development of economic and 
statistical indicators), which is coordinated with NASS efforts. ERS 
also works with NASS to develop the content of and covers the cost of 
more than half of the Agricultural Resource Management Survey (ARMS), 
NASS's largest farm operator survey. Also, ERS independently conducts 
its own National Household Food Acquisition and Purchase Survey. 
Connecting with and working closely with researchers across the U.S., 
ERS issues cooperative agreements and grant awards and works with land-
grant partners on many projects. These essential collaborations could 
be threatened if support waivers. Finally, the ERS is a primary source 
of economic information and research in USDA; the work it does improves 
the Department's program effectiveness.
    USDA's data products and analytical programs provide the U.S. with 
an important edge against increasingly fierce global agricultural 
competition. These programs benefit the entire supply chain, starting 
at the farm gate and enhancing decisions throughout national and 
international food, feed, fiber, and fuel economies. Public data 
products and projections serve to improve the accuracy of the 
expectations of market participants, reducing market pricing errors. 
The U.S. agricultural data information and analysis system is second to 
none, worldwide. Today, NASS is experiencing increased demand for its 
statistical products and reports. Similarly, ERS is experiencing 
significant requests for its research, data products, and services. To 
continue to build future trade and finance capacity in an increasingly 
competitive marketplace, the U.S. must invest in and leverage all of 
its strengths, including the food and agricultural data and information 
system.
    We encourage you to support these agencies so that they can 
continue to provide essential information to farm and agribusiness, 
government agricultural program, and food policy decision makers.
    Thank you in advance for your thoughtful consideration of this 
information.

    Agricultural & Applied Economics Association
    American Association of Mycobacterial Diseases
    American Dairy Science Association
    American Society of Agronomy
    American Society of Animal Science
    American Society of Farm Managers and Rural Appraisers
    American Statistical Association
    American Sugar Alliance
    Consortium of Social Science Associations
    Council of Professional Associations on Federal Statistics
    Crop Science Society of America
    Deere & Company
    FASS
    Global Cold Chain Alliance
    International Association of Refrigerated Warehouses
    Mycobacterial Disease of Animals Multistate Initiative
    National Association for the Advancement of Animal Science
    National Association of State Departments of Agriculture
    National Coalition for Food and Agriculture Research
    National Farmers Union
    National Sustainable Agriculture Coalition
    North American Regional Science Council
    Poultry Science Association
    Restaurant Services, Inc.
    Soil Science Society of America
    The Fertilizer Institute

    [This statement was submitted by Steve Pierson on behalf of the 
undersigned members of the Friends of Agricultural Statistics and 
Analysis.]

                                 ______
                                 
     Prepared Statement of The Humane Society of the United States
    On behalf of the undersigned horse industry, veterinary, and animal 
welfare organizations, and former Senator Joseph Tydings, we submit the 
following testimony seeking funding for the USDA/APHIS Horse Protection 
Program of $705,000 for fiscal year 2017. We recognize that Congress is 
focused on the imperative of cutting Federal spending. But we believe 
that it should be possible to achieve meaningful reductions in the 
overall budget while still addressing shortfalls in very specific 
accounts that are vital and have been seriously underfunded. This 
$705,000 is urgently needed to begin to fulfill the intent of the Horse 
Protection Act--to eliminate the cruel practice of soring--by allowing 
the USDA to strengthen its enforcement capabilities for this law.
    In 1970, Congress passed the Horse Protection Act to end soring, 
the intentional infliction of pain to the hooves and legs of a horse to 
produce an exaggerated gait, practiced primarily in the ``big lick'' 
segment of the Tennessee Walking Horse show industry. Caustic 
chemicals--such as mustard oil, diesel fuel, and kerosene--are painted 
on the lower front legs of the horse, then the legs are wrapped for 
days in plastic wrap and bandages to ``cook'' the chemicals deep into 
the horse's flesh. This makes the horse's legs extremely painful and 
sensitive, and when ridden, the horse is fitted with chains that slide 
up and down the horse's sore legs, forcing him to produce an 
exaggerated, high-stepping gait in the show ring. Additional tactics 
include inserting foreign objects such as hard acrylic between a heavy 
stacked shoe and the horse's hoof; pressure shoeing--cutting a horse's 
hoof down to the sensitive live tissue to cause extreme pain every time 
the horse bears weight on the hoof; and applying painful chemicals such 
as salicylic acid to slough off scarred tissue, in an attempt to remove 
evidence of soring.
    The Horse Protection Act authorizes the USDA to inspect horses, 
including the three specific breeds known to be involved in soring--
Tennessee Walking Horses, Racking Horses, and Spotted Saddle Horses--in 
transport to and at shows, exhibits, auctions and sales--for signs of 
soring, and to pursue penalties against violators. Unfortunately, since 
its inception, enforcement of the Act has been plagued by underfunding. 
As a result, the USDA has never been able to adequately enforce the 
Act, allowing this extreme and deliberate cruelty to persist on a 
widespread basis.
    To eliminate soring and meet the goals of the Act, USDA officials 
must be present at more shows. However, limited funds allow USDA 
attendance at less than 20 percent of the approximately 400 Tennessee 
Walking Horse shows held annually. So the Agency set up an industry-run 
system of certified Horse Industry Organization (HIO) inspection 
programs, which are charged with inspecting horses for signs of soring 
at the majority of shows. These groups license examiners known as 
Designated Qualified Persons (DQPs) to conduct inspections. To perform 
this function, some of these organizations hire industry insiders who 
have an obvious stake in preserving the status quo. Statistics clearly 
show that when USDA inspectors are in attendance to oversee shows 
affiliated with these organizations, the numbers of noted violations 
are many times higher than at shows where industry inspectors alone are 
conducting the inspections. By all measures, the overall DQP program as 
a whole has been a failure--the only remedy is to abolish the 
conflicted industry-run inspection programs charged with self-
regulation and have USDA oversee a legitimate inspection program.
    USDA appears to have attempted to step up its enforcement efforts 
in recent years, and has begun to work with the Department of Justice 
in prosecuting criminal cases as provided for under the Act. In 2011, a 
Federal prosecutor sought the first-ever criminal indictments under the 
Act and as a result, a well-known, winning trainer in the Spotted 
Saddle Horse industry served a prison sentence of over 1 year. A former 
Walking Horse Trainers' Association Trainer of the Year and winner of 
the Tennessee Walking Horse World Grand Championship, Jackie McConnell, 
was indicted in 2012 on 52 counts (18 of them felony) of violating the 
Act and pleaded guilty to felony conspiracy to violate the Act. He was 
sentenced to 3 years of probation and a $75,000 fine in Federal court. 
In 2013, another Tennessee trainer, Larry Wheelon, and three of his 
employees were indicted on 19 counts of aggravated animal cruelty 
charges under state law in a case flowing from a USDA Office of 
Inspector General investigation. While Wheelon's case was dismissed on 
a technicality, evidence of soring in his barn was plentiful and 
horrifying.
    These are significant actions that should have a deterrent effect, 
but there are many other violators who go undetected and many cases 
that go unprosecuted due to a lack of resources. USDA needs enhanced 
resources to carry out its responsibilities under this Act as Congress, 
and the public, expects.
    In years past, inspections were limited to physical observation and 
palpation by the inspector. Protocols for the use of new technologies, 
such as thermography and ``sniffer'' devices (gas chromatography/mass 
spectrometry--or GC/MS--machines), have been implemented, which can 
help inspectors identify soring more effectively and objectively. The 
results of USDA's recent GC/MS testing for prohibited foreign 
substances used by violators on the legs of horses (either to sore 
them, or to mask underlying soring and evade detection by inspectors) 
are staggering: 175 of the 200 random samples (87.5 percent) taken by 
the USDA at the industry's pinnacle event--the 2015 Tennessee Walking 
Horse National Celebration--tested positive for illegal foreign 
substances including soring, masking, and numbing agents.
    Effective though this inspection protocol may be, due to budget 
constraints, USDA has been unable to purchase and put enough of this 
testing into use in the field, allowing for industry players to 
continually evade detection. In 2015 and 2014, USDA was able to afford 
to collect and test samples at only 11 of the Big Lick industry's 
largest shows; in 2013, only 17; and in 2012, only 24. With increased 
funding, the USDA could purchase more equipment and dispatch more 
inspectors to use it properly, greatly increasing its ability to 
enforce the HPA.
    Currently, when USDA inspectors arrive at shows affiliated with 
some industry organizations, many of the exhibitors load up and leave 
to avoid being caught with sored horses. While USDA could stop these 
trailers on the way out, Agency officials have stated that inspectors 
are wary of going outside of their designated inspection area, for fear 
of harassment and physical violence from exhibitors. Armed security is 
frequently utilized in the designated area to allow such inspections, 
at additional expense to this program. The fact that exhibitors feel 
they can intimidate government officials without penalty is a testament 
to the inherent shortcomings of the current system.
    Lack of a consistent presence by USDA officials at events featuring 
Tennessee Walking Horses, Racking Horses, and Spotted Saddle Horses has 
fostered a cavalier attitude among industry insiders, who have not 
stopped their abuse, but have only become more clandestine in their 
soring methods. The continued use of soring to gain an advantage in the 
show ring has tainted this segment of the horse industry, and creates 
an unfair advantage for those who are willing to break the law in 
pursuit of victory. Besides the indefensible suffering of the animals 
themselves, the continued acceptance of sored horses in the show ring 
prevents those with sound horses from competing fairly for prizes, 
breeding fees and other financial incentives, while those horse owners 
whose horses are sored may unwittingly suffer property damage and be 
duped into believing that their now abused, damaged horses are 
naturally superior.
    The egregious cruelty of soring is not only a concern for horse 
industry and animal protection organizations, but also for 
veterinarians. In 2008, the American Association of Equine 
Practitioners (AAEP) issued a white paper condemning soring, calling it 
``one of the most significant welfare issues faced by the equine 
industry.'' It called for the abolition of the DQP Program, saying 
``the acknowledged conflicts of interest which involve many of them 
cannot be reasonably resolved, and these individuals should be excluded 
from the regulatory process.'' The AAEP further stated, ``The failure 
of the HPA to eliminate the practice of soring can be traced to the 
woefully inadequate annual budget . . .allocated to the USDA to enforce 
these rules and regulations.''
    The USDA Office of Inspector General conducted an audit of the 
Horse Protection Program, and issued its final report in September of 
2010. The report recommends the abolition of the DQP program, and an 
increase in funding for APHIS enforcement of the Horse Protection Act. 
The Agency concurred with the findings and recommendations in the 
report, specifically Recommendation 2: ``Seeking the necessary funding 
from Congress to adequately oversee the Horse Protection Program,'' 
indicating that it would develop a budgeting and staffing plan to phase 
in the resources needed to adequately oversee the Horse Protection 
Program.
    It is unacceptable that more than 40 years after passage of the 
Horse Protection Act, the USDA still lacks the resources needed to end 
this extreme form of abuse. It is time for Congress to give our public 
servants charged with enforcing this Act the support and resources they 
want and need to fulfill their duty to protect these horses as 
effectively and safely as possible.
    We appreciate the opportunity to share our views about this serious 
problem, and thank you for your consideration of our request.

    Keith Dane, Senior Advisor, Equine Protection
    The Humane Society of the United States

    Former U.S. Senator Joseph Tydings
    Original sponsor of the Horse Protection Act

    Teresa Bippen, President
    Friends of Sound Horses, Inc.

    W. Ron DeHaven, DVM MBA
    Executive Vice President
    American Veterinary Medical Association

    Kathleen Anderson, DVM, President
    American Association of Equine Practitioners

    Chris Heyde, Deputy Director, Government and Legal Affairs
    Animal Welfare Institute

    Nancy Perry, Senior Vice President, Government Relations
    American Society for the Prevention of Cruelty to Animals (ASPCA)

    Robin Lohnes, Executive Director
    American Horse Protection Association

    Donna Benefield, Vice President
    International Walking Horse Association

    Angie Biddison, President
    Plantation Walking Horses of Maryland

    Jayme Clark, President
    National Plantation Walking Horse Association

    Susan Crotty, President
    Plantation Walking Horse Association of California

    Ian Walker, President
    United Pleasure Walking Horse Association

    Lucy Rangel, President
    Gaitway Walking Horse Association, Inc.

    Bonnie Yeager, President
    International Pleasure Walking Horse Registry

    Penny Austin, President
    One Horse At a Time, Inc. Horse Rescue

    Kristin Herman, M.D., Vice President
    Northern California Walking Horse Association

    Raydene Walker
    Tennessee Walking Horse Association of Oklahoma

    Wayne Eastman, President
    New York State Plantation Walking Horse Club

    Libby Wright
    San Francisco Bay Area Tennessee Walking Horse Club

    Burl Latshaw, President
    Pennsylvania Pleasure Walking Horse Association

    David Green, Director
    Tennessee Walking Horse Exhibitors' Association of Oregon

    [This statement was submitted by Keith Dane, Vice President of 
Equine Protection, The Humane Society of the United States.]

                                 ______
                                 
     Prepared Statement of The Humane Society of the United States
    Thank you for the opportunity to provide testimony on fiscal year 
2017 funding for the following USDA accounts of great importance to The 
Humane Society of the United States:
  --FSIS/Horse Slaughter--language mirroring fiscal year 2016 omnibus 
        provision
  --APHIS/Animal Welfare Act Enforcement--$28,696,000
  --APHIS/Horse Protection Act Enforcement--$705,000
  --ARS/Animal Welfare for Farm Animals Used in Agricultural Research--
        language maintaining APHIS inspections of ARS facilities to 
        ensure AWA compliance, including fully functioning IACUCs for 
        each facility at which animal research is conducted
  --APHIS/Investigative and Enforcement Services--$16,410,000
  --FSIS/Humane Methods of Slaughter Act Enforcement--language to 
        ensure compliance with humane handling rules for live animals 
        as they arrive and are offloaded and handled in pens, chutes, 
        and stunning areas; robust national training in humane handling 
        and inspection techniques; and annual program evaluation for 
        humane handling inspections
  --OIG/including Animal Fighting Enforcement--$100,998,000
  --NIFA/Veterinary Medical Services Act--$6,500,000
  --APHIS/Emergency Management Systems/Disaster Planning for Animals--
        $969,000
  --APHIS/Animal Welfare Act Enforcement--language to maintain bar on 
        licensing Class B dealers of ``random source'' dogs and cats
    At this time of intense budget pressure, we appreciate your 
outstanding past support for enforcement of key animal welfare laws by 
USDA and urge you to sustain this effort in fiscal year 2017. While we 
understand the focus on reducing Federal spending, we believe there 
should be room for careful decisionmaking within the budget to achieve 
macro-level cuts and at the same time ensure adequate funding for 
specific accounts that are vital and have previously been underfunded. 
We therefore request the following for fiscal year 2017:
                          fsis/horse slaughter
    We request inclusion of the same language barring USDA from the 
expenditure of funds for horse slaughter inspections as was included in 
the fiscal year 16 omnibus. This provision is vital to prevent renewed 
horse slaughter activity in this country, particularly given 
discoveries of horsemeat in other food products in the EU and U.S. 
Horse slaughter is cruel and poses serious public health risks. 
American horses are raised to be companions, athletes and work horses, 
and they are often treated with drugs, both legal and illegal, that can 
endanger the food supply. There is currently no system in the U.S. to 
track drugs and veterinary treatments given to horses to ensure that 
their meat is safe for human consumption. Horse slaughter is also 
inherently inhumane and cannot be made humane for horses. The methods 
used to kill horses rarely result in quick, painless deaths, as horses 
are skittish animals and often endure repeated blows to make them 
unconscious, sometimes remaining conscious during the slaughtering 
process. USDA reports show that over 92 percent of horses going to 
slaughter are healthy and could have gone on to lead productive lives. 
However, ``kill buyers'' profit by selling horsemeat from healthy 
horses that bring the best price per pound for their meat, and they 
frequently outbid rescue groups at auctions. Inclusion of language to 
bar the expenditure of funds on horse slaughter inspections would 
protect consumers and horses, and would prevent the needless waste of 
American taxpayer dollars (particularly at a time when budget pressures 
are so great) on a practice that 80 percent of the American public 
opposes.
               aphis/animal welfare act (awa) enforcement
    We request $28,696,000 for AWA enforcement under APHIS. We commend 
the Committee for responding in recent years to the urgent need to 
properly fund the Animal Care division to improve its inspections of 
approximately 10,399 sites, including commercial breeding facilities, 
laboratories, zoos, circuses, and airlines, to ensure compliance with 
AWA standards. In May 2010, USDA's Office of Inspector General released 
a report criticizing the agency's history of lax oversight of dog 
breeders--finding that inhumane treatment and horrible conditions often 
failed to be properly documented and yielded little to no enforcement 
actions. Secretary Vilsack called for more inspections and a tougher 
stance on repeat offenders and the agency must have the resources to 
follow through on that commitment. USDA is also implementing new 
regulations to cover large-scale commercial dog breeders selling 
puppies directly to the public via the Internet and other means, and to 
end imports from foreign puppy mills where puppies are mass produced 
under inhumane conditions and forced to endure harsh long-distance 
transport. Animal Care is actively licensing new facilities that now 
require USDA regulatory oversight under the retail pet store rule. 
Animal Care currently maintains 112 inspectors (with 12 vacancies) who 
perform and oversee animal welfare compliance inspections, compared to 
64 inspectors at the end of the 1990s. Animal Care also maintains 
cadres of species specialists (6) who support inspectors with complex 
regulatory compliance issues and compliance specialists (9) who support 
the pre-licensing process and other aspects of compliance assurance. An 
appropriation at the requested level would allow the agency to continue 
to address the concerns identified by the OIG, enforce the new rule on 
direct sales and the puppy import ban, and provide adequate oversight 
of the many licensed/registered facilities.
              aphis/horse protection act (hpa) enforcement
    We request $705,000 for strengthened enforcement of the Horse 
Protection Act. Congress enacted the HPA in 1970 to make illegal the 
abusive practice of ``soring,'' in which unscrupulous trainers 
deliberately inflict pain on Tennessee Walking Horses' hooves and legs 
to create an exaggerated, high-stepping gait and gain unfair 
competitive advantage at horse shows (e.g., applying caustic chemicals, 
using plastic wrap and tight bandages to ``cook'' those chemicals deep 
into the horse's flesh for days, attaching heavy chains to strike 
against the sore legs and heavy, stacked horseshoes that force the 
horse's legs into unnatural angles, jamming hard objects into the 
sensitive areas of the feet, cutting the hooves down to expose the live 
tissue, and using salicylic acid or other painful substances to slough 
off scarred tissue or numbing agents in an attempt to disguise the 
sored areas). A report released in October 2010 by USDA's OIG documents 
significant problems with the industry self-monitoring system on which 
the APHIS inspection program currently relies, and calls for funding to 
enable the agency to more adequately oversee the law. Several horse 
show industry groups, animal protection groups, and the key 
organization of equine veterinarians have also called for funding to 
enable USDA to do a better job enforcing this law. With the current 
level of funding, Animal Care has been able to attend less than 20 
percent of the approximately 400 Tennessee Walking Horse shows held 
annually. Sustained support is essential to ensure that this program 
doesn't lose ground now that it is finally beginning to address the 
need for additional inspectors, training, security (for threats of 
violence against inspectors), and advanced detection equipment 
(thermography and gas chromatography/mass spectrometry machines).
   ars/animal welfare for farm animals used in agricultural research
    We request language to ensure that Federal dollars are not used for 
agricultural research without conforming to AWA standards. An 
investigation last year by the New York Times revealed shocking 
instances of animal mistreatment and neglect associated with 
experiments conducted on farm animals at the USDA/ARS U.S. Meat Animal 
Research Center, and repeated disregard for objections raised by the 
Center's own veterinary staff. We appreciate that the Committee took 
these concerns seriously and commend the Committee for its ongoing 
oversight. In the omnibus, 5 percent of the ARS budget for fiscal year 
2016 was made contingent on ARS updating its animal care policies and 
requiring that all ARS facilities at which animal research is conducted 
have a fully functioning Institutional Animal Care and Use Committee to 
ensure compliance with standards and principles of scientific integrity 
equivalent to the AWA. In addition, $400,000 was allocated to APHIS to 
conduct inspections at each ARS facility using animals in research. We 
request a continuation in fiscal year 2017 of that $400,000 to APHIS 
(included in the request above for $28,696,000), as well as a renewed 
requirement for a fully functioning IACUC at each ARS facility where 
animal research is conducted, along with the following bill language: 
``Provided further, That the Animal and Plant Health Inspection Service 
and Agricultural Research Service shall work together to ensure an 
effective animal welfare inspection program for ARS facilities and 
ensure that these facilities are in full compliance with the Animal 
Welfare Act.''
           aphis/investigative and enforcement services (ies)
    We request $16,410,000 for APHIS Investigative and Enforcement 
Services. We appreciate the Committee's consistent support for this 
division, which handles many important responsibilities, including the 
investigation of alleged violations of Federal animal welfare laws and 
the initiation of appropriate enforcement actions. The volume of animal 
welfare cases is rising significantly, and an appropriation at the 
requested level would enable the agency to keep pace with the 
additional enforcement workload.
        fsis/humane methods of slaughter act (hmsa) enforcement
    We request language to ensure strengthened HMSA enforcement. We 
appreciate the committee's inclusion of language in the fiscal year 16 
committee report regarding humane slaughter. USDA oversight of humane 
handling rules for animals at slaughter facilities is vitally important 
not only for animal welfare but also for food safety. Effective day-to-
day enforcement can prevent abuses like those previously documented in 
undercover investigations, and reduce the chance of associated food 
safety risks and costly recalls of meat and egg products. We therefore 
urge inclusion of language directing FSIS to ensure that inspectors 
hired with funding previously specified for HMSA enforcement focus 
their attention on overseeing compliance with humane handling rules for 
live animals as they arrive and are offloaded and handled in pens, 
chutes, and stunning areas, and that all inspectors receive robust 
national training in humane handling and inspection techniques. In 
addition, past OIG and GAO audits have revealed inconsistent 
enforcement and documentation, and recommended that USDA develop more 
objective criteria and metrics for determining HMSA enforcement 
actions. We therefore also request that the agency develop an annual 
program evaluation for its humane handling inspections program that 
includes document review, field staff surveys, and monitoring to assess 
the degree of consistency and objectivity of implementation of the HMSA 
by all levels of inspection staff.
                    oig/animal fighting enforcement
    We request $100,998,000 for the Office of Inspector General to 
maintain staff, improve effectiveness, and allow investigations in 
various areas, including enforcement of animal fighting laws. We 
appreciate the Committee's inclusion of funding and language in recent 
years for USDA's OIG to focus on animal fighting cases. Congress first 
prohibited most interstate and foreign commerce of animals for fighting 
in 1976, established felony penalties in 2007, and strengthened the law 
as part of the Farm Bills enacted in 2002, 2008, and 2014. We are 
pleased that USDA is taking seriously its responsibility to enforce 
this law, working with state and local agencies to complement their 
efforts and address these barbaric practices, in which animals are 
drugged to heighten their aggression and forced to keep fighting even 
after they've suffered grievous injuries. Dogs bred and trained to 
fight endanger public safety, and some dogfighters steal pets to use as 
bait for training their dogs. Cockfighting was linked to an outbreak of 
Exotic Newcastle Disease in 2002-2003 that cost taxpayers more than 
$200 million to contain. It's also been linked to the death of a number 
of people in Asia reportedly exposed through cockfighting activity to 
bird flu. Given the potential for further costly disease transmission, 
as well as the animal cruelty involved, we believe it is a sound 
investment for the Federal government to increase its efforts to combat 
illegal animal fighting activity. We also support the OIG's auditing 
and investigative work to improve compliance with the AWA, HPA, HMSA 
and downed animal rules.
                  nifa/veterinary medical services act
    We request $6,500,000 to continue implementation of the NVMSA 
(Public Law 108-161). We appreciate that Congress is working to address 
the critical maldistribution of veterinarians practicing in rural and 
inner-city areas, as well as in government positions at FSIS and APHIS. 
A 2009 GAO report identified that an inadequate number of veterinarians 
to meet national needs is among the foremost challenges facing 
veterinary medicine. Having adequate veterinary care is a core animal 
welfare concern. To ensure adequate oversight of humane handling and 
food safety rules, as well as our nation's defense against bioterrorism 
(the Centers for Disease Control estimates that 75 percent of potential 
bioterrorism agents are zoonotic--transmitted from animals to humans) 
and public health problems such as those associated with pet 
overpopulation, parasites, rabies, chronic wasting disease, and bovine 
spongiform encephalopathy (``mad cow'' disease), USDA must be able to 
fill vacancies in its veterinary positions. Educational debt has more 
than doubled since 2003 when Congress authorized this program. 
Veterinary school graduates face a crushing debt burden of $135,000 on 
average (for 88 percent of them, the burden averages $170,000), with an 
average starting salary of just $70,000. Nearly 1,000 veterinarians 
have applied for assistance under this program since 2010; at current 
funding levels, fewer than 60 awards can be made each year. We also 
support the Veterinary Services Grant Program authorized in the 2014 
Farm Bill to help address gaps in veterinary shortage situations by 
preparing veterinarians for rural practice.
    aphis/emergency management systems/disaster planning for animals
    We request $969,000 for Animal Care under APHIS' Emergency 
Management Systems line item. Hurricanes Katrina and Rita demonstrated 
that many people refuse to evacuate if they are forced to leave their 
pets behind. The Animal Care division develops infrastructure to help 
prepare for and respond to animal issues in a disaster and incorporate 
lessons learned from previous disasters. These funds are used to 
support state and local governments' efforts to plan for protection of 
people with animals, and to enable the agency to participate, in 
partnership with FEMA, in the National Response Plan.
          aphis/animal welfare act enforcement/class b dealers
    We request language to maintain the bar on expenditures for 
licensing of Class B dealers who sell ``random source'' dogs and cats 
for use in research, teaching, or testing. We commend the Committee for 
including language to protect pet owners and animals from Class B 
dealers who sell ``random source'' dogs and cats for use in research 
and are notorious for subjecting animals to shocking cruelty and using 
fraudulent means (including pet theft) to acquire them. This language 
also protects taxpayers, since overseeing Class B dealers has been an 
unjustifiable drain on USDA resources and the National Academy of 
Sciences determined that there is no scientific need for these dealers. 
We urge inclusion of the following language: ``None of the funds made 
available by this Act may be used to carry out any activities or incur 
any expense related to the issuance of licenses under section 3 of the 
Animal Welfare Act (7 U.S.C. 2133), or the renewal of such licenses, to 
class B dealers who sell random source dogs and cats for use in 
research, experiments, teaching, or testing. Nothing in this provision, 
however, should be construed as preventing the Department from carrying 
out all necessary oversight, inspection, compliance, and enforcement 
activities with respect to any entity holding a valid class B license 
who sells random source dogs and cats for use in research, experiments, 
teaching, or testing, or with respect to any entity doing so without a 
license as required under 7 U.S.C. 2133.''
    We are very grateful for the Committee's past support, and hope you 
will be able to accommodate these modest requests to address some very 
pressing problems affecting millions of animals in the United States. 
Thank you for your consideration.

    [This statement was submitted by Mimi Brody, Director of Federal 
Affairs, The Humane Society of the United States.]

                                 ______
                                 
          Prepared Statement of Izaak Walton League of America
    funding for farm bill conservation programs & natural resources 
               conservation service technical assistance
    The Izaak Walton League of America thanks the House Appropriations 
Subcommittee on Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies for the opportunity to submit 
testimony regarding fiscal year (FY) 2017 appropriations. With 43,000 
members in nearly 240 chapters nationwide, the League is one of the 
most established conservation organizations in the United States. Our 
membership recognizes the important role of conservation initiatives in 
maintaining and enhancing both the environmental integrity and economic 
viability of agricultural landscapes.
    Securing full mandatory funding for Farm Bill conservation programs 
in fiscal year 2017 is an appropriations priority for the League. 
Additionally, a modest increase in discretionary technical assistance 
funding for the Natural Resources Conservation Service (NRCS) is 
essential to meet the demand from producers who voluntarily seek to 
incorporate conservation planning on their farms and ranches. 
Therefore, we urge the Subcommittee to support full mandatory 
conservation program funding in the fiscal year 2017 appropriations 
cycle, and support the President's budget request to fund Conservation 
Technical Assistance (CTA), part of the Private Lands Conservation 
Operations account, at $761.7 million.
Mandatory Conservation Program Funding
    The 2014 Farm Bill provides mandatory funding for critical existing 
conservation programs--including the Conservation Stewardship Program 
(CSP) and Environmental Quality Incentives Program (EQIP)--as well as 
new conservation initiatives, such as the Regional Conservation 
Partnership Program (RCPP) and Agricultural Conservation Easement 
Program (ACEP). These programs offer essential opportunities for 
farmers and ranchers to voluntarily implement valuable conservation 
practices on their land with financial and technical assistance. 
However, the funding levels set in the most recent Farm Bill amount to 
$6 billion in cuts to conservation programs when accounting for 
sequestration,\1\ making it impossible for these programs to meet the 
demand from the many farmers.
---------------------------------------------------------------------------
    \1\ National Sustainable Agriculture Coalition, 2014 Farm Bill 
Drill Down: The Bill by the Numbers, published February 4, 2014. http:/
/sustainableagriculture.net/blog/2014-farm-bill-by-numbers/.
---------------------------------------------------------------------------
    Shortly after these reduced funding levels were agreed to in the 
Farm Bill, the fiscal year 2015 appropriations cycle cut nearly $600 
million more from programs like CSP and EQIP through direct funding and 
acreage reductions.\2\ Both programs serve as covered programs for 
RCPP, meaning these cuts effectively reduced funding for this popular, 
innovative program early in its implementation. While the League was 
encouraged that cuts were not made to CSP in fiscal year 2016, the 
substantial $321 million cut to EQIP will further limit access to 
conservation funding for producers and, in turn, reduce the 
environmental benefits delivered to the American public.
---------------------------------------------------------------------------
    \2\ National Sustainable Agriculture Coalition, Final Budget Bill 
Guts Conservation Funding and Farming Protections, published December 
11, 2014. http://sustainableagriculture.net/blog/fy15-final-cromnibus/.
---------------------------------------------------------------------------
    For the first time in recent memory, the President's fiscal year 
2017 budget proposes no cuts to Farm Bill conservation programs.\3\ We 
urge the Subcommittee to follow suit and support full funding for these 
programs. Changes in mandatory program spending (CHIMPS) have become 
all too common, with disproportionate impacts on the Farm Bill's 
Conservation Title.\4\ The more than five billion dollars cut from 
conservation programs since the 2002 Farm Bill \5\ have had real 
consequences for farmers interested in protecting natural resources on 
their land. This is money that could help producers take voluntary 
actions to improve wildlife habitat. It is money that could help 
farmers install buffer strips along rivers and streams, protecting 
water quality for rural residents and downstream municipalities. And it 
is money that could promote soil health practices, such as cover crops, 
that improve the long-term productivity of our nation's agricultural 
lands--productivity that will be essential to feeding a growing 
population and supporting rural economies.
---------------------------------------------------------------------------
    \3\ Izaak Walton League of America, President's Budget Fully Funds 
Agriculture Conservation Programs, published February 9, 2016. http://
www.iwla.org/news-events/news/2016/02/10/budget-fully-funds-
agriculture-conservation-programs.
    \4\ From fiscal year 2003-2010, over 50 percent of all farm bill 
CHIMPS targeted the Conservation Title. Between fiscal year 2007-2010, 
that number increased to 83 percent. National Sustainable Agriculture 
Coalition report using Jim Monke and Megan Stubbs, Reductions in 
Mandatory Agriculture Program Spending, CRS Report for Congress 
(Congressional Research Service, May19, 2010).
    \5\ National Sustainable Agriculture Coalition comparing budget 
authority to appropriations bills.
---------------------------------------------------------------------------
Conservation Technical Assistance Funding
    Farmers developing conservation plans for their operations rely on 
assistance from NRCS staff. Funding for this technical assistance comes 
from the CTA portion of the Conservation Operations account and also 
supports implementation of the Farm Bill conservation programs. The 
President's fiscal year 2017 budget proposes a modest increase in CTA 
funding, setting aside $761.7 million for this critical agency 
function.
    Providing landowners with technical assistance to develop and 
implement conservation plans promotes efficiency by helping producers 
tailor best management practices to meet their needs, fit their 
property, and address specific resource concerns. It is estimated that 
the proposed increase in CTA funding will put an additional 8,300 
conservation plans on as many as 2.9 million additional acres.\6\ The 
League strongly supports this much needed increase in discretionary 
spending for CTA.
---------------------------------------------------------------------------
    \6\ Office of Budget and Program Analysis, USDA. 2017 President's 
Budget, Natural Resources Conservation Service. http://
www.obpa.usda.gov/27nrcs2017notes.pdf.
---------------------------------------------------------------------------
    Farm Bill conservation programs are delivering tremendous benefits, 
but have yet to reach their full potential due to consistent and 
excessive cuts. In fiscal year 2017, the League urges the Subcommittee 
to support full mandatory funding levels for conservation programs, 
honoring the commitment to these programs agreed upon by Congress in 
the 2014 Farm Bill. Furthermore, CTA provides critical assistance to 
producers attempting to protect natural resources on their farm through 
conservation planning and practice implementation. We urge the 
Subcommittee to provide $761.7 million for CTA, which is consistent 
with the President's fiscal year 2017 budget request.

    [This statement was submitted by John Sisser, Conservation 
Associate, Izaak Walton League of America.]

                                 ______
                                 
                  Prepared Statement of MEadvocacy.org
    There is an urgent need for a systemic overhaul at the Department 
of Health and Human Services (HHS), including the National Institute of 
Health (NIH) and the Centers for Disease Control (CDC), in regards to 
its funding and handling of the disease myalgic encephalomyelitis (ME).
    Myalgic Encephalomyelitis (ME) is chronic, serious disabling, 
neuroimmune disease that affects an estimated one million American men 
women and children in the U.S. Yet, the past three decades, since the 
major Lake Tahoe outbreak where the disease was defined, there have 
been very little scientific advances and no FDA approved treatments for 
this heavily burdened disease. This is due to the fact HHS, NIH and CDC 
have marginalized, neglected, underfunded and mistreated this patient 
community.
    Advances in the science of the disease have been mostly squashed by 
the gross lack of funding by NIH for this severely disabling disease. 
In addition, misinformation and badly outdated information published by 
the CDC, along with the lack of education about the disease in medical 
schools, have caused a dearth of palliative care for patients 
nationwide. Most importantly, after 30 years, we still are not any 
closer to finding a possible treatment or cure to help the millions of 
ME patients.
    MEadvocacy.org is a growing grassroots movement of advocates and 
patients who are rising up and saying it is time for a change. We are 
lawyers, laborers, teachers, students, fathers, mothers, and children. 
Our productive lives have been cut short by this debilitating disease 
and we have no hope of treatment or cure. We have had enough and are 
saying, ``No More!''
                      me incidence and prevalence
    ME, also known in the U.S. as chronic fatigue syndrome (CFS) and 
myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), sickens an 
estimated 850,000 to 2.5 million people in the U.S. and 17 million 
worldwide. A majority of patients are disabled, unable to work, attend 
school or participate in activities of daily life. A quarter are so 
severely affected as to render them bedbound, unable to care for 
themselves.
                     me history, criteria and name
    ME has a long history, appearing worldwide in epidemic and endemic 
forms. A 1955 outbreak in London resulted in Dr. A. Melvin Ramsay 
describing it as an infectious neuromuscular illness and coining the 
term ``myalgic encephalomyelitis.'' Disregarding this, the CDC broadly 
redefined the disease and renamed it the marginalizing name, chronic 
fatigue syndrome (CFS), in response to 1985 cluster outbreaks of the 
disease in Incline Village, Nevada and Lyndonville, New York. This 
redefinition resulted in three decades of confused research findings 
rather than answers to the cause and treatment of this disease. In 
addition, the undignified name and poor criteria caused stigmatization 
and marginalization of patients.
                       disease burden and funding
    Some ME patients have died prematurely from complications of ME. 
Others have died at their own hands due to the severity and length of 
their suffering without proper palliative care, as well as dismissal 
and stigmatization by the medical community. If we do not act on behalf 
of these severely affected patients, we are complicit in their 
suffering and untimely deaths. The patients will not carry this burden 
quietly any longer and we are looking at Congress to require HHS to 
properly fulfill their duty to ME sufferers.
    In 2009, Dr. Nancy Klimas, the director of AIDS research at the 
Miami Veterans Affairs Medical Center stated:

        ``My H.I.V patients for the most part are hale and hearty 
        thanks to three decades of intense and excellent research and 
        billions of dollars invested. Many of my CFS patients, on the 
        other hand, are terribly ill and unable to work or participate 
        in the care of their families. I split my clinical time between 
        the two illnesses, and I can tell you if I had to choose 
        between the two illnesses, (in 2009) I would rather have HIV. 
        But CFS, which impacts a million people in the United States 
        alone, has had a small fraction of the research dollars 
        directed towards it. ""(http://consults.blogs.nytimes.com/2009/
        10/15).

    In the intervening 7 years, nothing has changed. It is very clear 
that real change at HHS regarding this disease will not come about 
naturally. We have come to you, the Subcommittee on Agriculture, Rural 
Development, Food and Drug Administration, for help in addressing this 
dire need for oversight and investigation.
    It is estimated that the burden to the economy for ME is between 
$17 to 24 billion, yet NIH funding for research has stagnated at a mere 
$5 million a year, less than funding for hay fever. HHS has placed 
funding for ME at the rock bottom of their funding budget list. The 
yearly allocation for ME/CFS is a fraction of what other similarly 
burdened diseases receive.

        HHS/NIH funding data for 2014 US patient population Funding per 
        patient--HIV/AIDS--$2 billion 978 million 1,200,000 $2,481; 
        M.S.--$102 million 400,000 $255; Parkinson's--$139 million 
        1,000,000 $139; Alzheimer's $564 million 5,300,000 $106; ME/
        CFS--$5 million 1,000,000 $5.

    The great divide between NIH funding for ME and other diseases 
cannot be explained away. Simply advising and recommending that NIH 
increase funding for ME, has not worked. The Secretaries of Health and 
Human Services have not responded to most of the nearly 100 
recommendations made by the Chronic Fatigue Syndrome Advisory Committee 
(CFSAC) during the past 10 years. It ignored specific requests by 
CFSAC, medical experts, patient advocates, patients and their families 
to adopt ME expert-authored, well-defined criteria for the disease.
    The department did not heed the call by President Obama as a result 
of a call out at a townhall meeting by the wife of a patient. It has 
not listened to the many recommendations by this Appropriation 
Committee over the past twenty years. In order to fund ME on par with 
MS, a similarly serious disease, ME would need $250 million a year to 
bring them on par with other similarly burdened diseases yet, gets a 
mere $5 million.
    We need a different approach and a complete overhaul at all agency 
levels. We need an investigation by Congress into the mishandling and 
neglect of ME by HHS, NIH and CDC and active, ongoing Congressional 
oversight until HHS' negative bias is rectified. We are therefore 
coming to you for help in this matter.
    The following are the recommendations and goals that we at 
MEadvocacy.org feel the Appropriations Committee needs to require that 
HHS meet, in order to bring Myalgic Encephalomyelitis back on par with 
other similarly burdened diseases:
    1. Fund biomedical research for ME commensurate with its severity 
and burden to patients and the economy. We are asking for specific 
funding in the amount of $250 million, the amount we believe is needed 
to bring ME on par with other similarly burdened diseases. HHS should 
clearly allocate funds to study patients from past ME cluster outbreaks 
as well as the study of the epidemiology of patients with severe ME. 
The additional funding needed for ME might be accomplished by means of 
a sliding scale of allocation from other diseases related to immune, 
cognitive and nervous system dysfunctions.
    2. Heed the ME stakeholders' request to adopt the diagnostic and 
research criteria authored by those experienced in the disease, namely 
the 2003 Canadian Consensus Criteria (CCC), which has been adopted by 
the International Association of Chronic Fatigue Syndrome/Myalgic 
Encephalomyelitis (IACFS/ME). In a letter to the Secretary of HHS, 50 
experts in the disease declared their consensus agreement to adopt the 
CCC. This was endorsed by a letter signed by 171 advocates as well as a 
petition signed by over 6,000 patients. The 2011 revision known as the 
International Consensus Criteria (ICC) would be an alternatively 
acceptable criteria for adoption.
    3. Retain the historical name for this disease, myalgic 
encephalomyelitis, which has been coded since 1969 by the World Health 
Organization under neurological disease with the code G93.3. In 
addition, ME appears in the 2015 U.S. ICD Codes as U.S. ICD-10-CM with 
the same coding. Additionally, we request that the Appropriation 
Committee recommends HHS:
    4. Return ME to the National Institute of Allergy and Infectious 
Disease (NIAID) or place it in the National Institute of Neurological 
Disorders and Stroke (NINDS), which also manages similar neuroimmune 
diseases such as MS, fibromyalgia, and Lyme Disease. The Office of 
Research on Women's Health, where ME is currently housed, is entirely 
inappropriate for disease, which also strikes men and children.
    5. Provide opportunities for dissemination of information through 
the development of a curriculum for all U.S.-based medical schools, as 
well as physician continuing education, about ME as defined solely by 
disease experts, in order to provide the tools needed for physicians 
and other medical professionals to appropriately recognize and treat 
this disease. Currently, this would mean using either the 2003 Canadian 
Consensus Criteria or the 2011 International Consensus Criteria, not 
the overly broad criteria developed by the non-expert IOM panel. In 
addition, the CCC or ICCPrimer should be widely distributed and made 
available to clinicians, particularly primary care physicians, 
nationwide in order to facilitate the best care for their ME patients.
    6. Partner openly and transparently with stakeholders within 1 year 
to establish a comprehensive, aggressive and fully-funded cross-agency 
strategy and implementation plan, with well-defined objectives and 
milestones, and to develop a plan to monitor progress and provide for 
Congressional oversight.
    ``We've documented, as have others, that the level of functional 
impairment in people who suffer from CFS is comparable to multiple 
sclerosis, AIDS, end-stage renal failure, chronic obstructive pulmonary 
disease. The disability is equivalent to that of some well known, very 
severe medical conditions.''

    [This statement was submitted by Dr. William Reeves, former CDC 
Chief of Viral Diseases Branch MEadvocacy.org.]

                                 ______
                                 
   Prepared Statement of National Association for the Advancement of 
                         Animal Science (NAAAS)
    As President of the National Association for the Advancement of 
Animal Science (NAAAS), I am writing to request the subcommittee's 
support for critical animal science research within the National 
Institute for Food and Agriculture (NIFA) and the Agricultural Research 
Service (ARS). Specific programmatic requests for NIFA include:

------------------------------------------------------------------------
 
------------------------------------------------------------------------
Hatch Act...............................................    $244,000,000
Agriculture and Food Research Initiative................     700,000,000
Smith Lever, Section 3(b) and (c).......................     300,000,000
Section 1433............................................      10,000,000
Veterinary Medicine Loan Repayment Program..............       5,000,000
Veterinary Services Grant Program.......................       2,500,000
Food Animal Residue Avoidance Database Program..........       2,500,000
Food and Agriculture Defense Initiative.................      10,000,000
------------------------------------------------------------------------

    The 2014 farm bill includes an important expansion of Section 1433 
to establish a new competitive research grants mechanism to address 
critical priorities in food security, one health and stewardship. The 
expanded authority came in response to a historic funding disparity for 
the animal sciences and represents a strong opportunity to address 
significant challenges facing animal agriculture.
    The new competitive grants program in Section 1433 provides a 
mechanism to focus resources on high priority areas to help animal 
agriculture meet future challenges. It is important to get the new 
competitive program started as soon as possible. We respectfully 
request that $10 million for Section 1433 in fiscal year 2017, as an 
important step toward the goal of meeting the program's authorized 
level of $25 million.
    For ARS, NAAAS recommends $1,286,000,000 for fiscal year 2017. ARS 
has the potential to make significant progress towards solving problems 
facing America's livestock and poultry producers but is consistently 
receiving funding disproportionate to its contributions to the farm 
economy. ARS intramural research is uniquely suited for projects that 
require a long term investment leading to high-impact payoffs, while 
maintaining the capacity and readiness to respond to emerging and 
pressing problems. ARS also plays a critical role in partnering with 
the universities and industry to advance science and address emerging 
issues. NAAAS requests that the committee to provide funding at least 
$1.286 billion for ARS in fiscal year 2017. Within this total, NAAAS 
supports the President's budget request for $95 million for buildings 
and facilities. This level would enable ARS to continue its work to 
address high priority facility needs.
                      background and justification
    As the world's population grows and natural resources become 
limited, animal agriculture research is necessary now more than ever to 
improve efficiency in order to continue providing safe and abundant 
food supplies for the growing global community. It is imperative that 
the increased food production be done in a manner that will protect our 
natural resources while maintaining America's global competitiveness in 
producing animals and animal products. Global demand for food is 
expected to increase from 70 to 100 percent by 2050. Meat consumption 
is estimated to increase by 73 percent, dairy consumption is estimated 
to increase 57 percent, and per capita egg consumption in developing 
countries is expected to rise by almost 40 percent.
    Innovations in animal science will play an important role in the 
future success of animal agriculture and the rural economy. Livestock 
and poultry sales account for 40 percent of all farm income. When feed 
crops consumed by livestock are included, the contribution to farm 
income is 60 percent. The United States must step up its investments in 
agricultural research to maintain its status as a leading producer of 
safe, affordable and abundant food and meet increasing demands.
    Unfortunately, current funding by the United States Department of 
Agriculture (USDA) to support the animal sciences is not proportionate 
with the economic contributions of animal agriculture. In fact, 
investment in the animal sciences has been declining for many years, 
even for programs such as the Agriculture and Food Research Initiative 
(AFRI) that have received increased appropriations. This trend was 
highlighted by National Academy of Sciences in its report ``Critical 
Role of Animal Science Research in Food Security and Sustainability'' 
(see http://www.nap.edu/openbook.php?record_id=19000) that was released 
in January 2015. The report recognizes the historic underfunding of 
animal sciences and calls for increased investments. This imbalance in 
support for animal science puts U.S. animal agriculture at a major 
disadvantage at a critical time when livestock and poultry producers 
are striving for global competitiveness, improving sustainability and 
working to feed a growing global population.
    To address this shortfall in Federal investments supporting the 
animal sciences, new resources must be dedicated to meet critical 
priorities in animal science. The National Association for the 
Advancement of Animal Science (NAAAS) has identified a series of value 
propositions where additional Federal investments can drive innovation 
in the high priority areas of Food Security, One Health and 
Stewardship.
              food security--challenges and opportunities
    With a projected increase in global population by 2050, food 
production must double which requires increased efficiency of the use 
of limited natural resources to meet expected increases in meat and 
milk consumption by 73 percent and 58 percent, respectively. With land, 
water and other natural resources being limited relative to this 
demand, maintaining or reducing the environmental impact of increased 
production will be challenging. New knowledge and technology offers 
meat and dairy producers and the allied pre- and post-harvest 
industries that support them an opportunity to increase income using 
sustainable production methods while meeting expanding demand.
    Accelerated research in systems biology and genomics can provide 
sustainable increases in overall production efficiency by 50 percent in 
2025 through enhanced performance. Such applications will provide 
abundant, safe, nutritious and affordable food from animal sources to 
consumers across the world.
                one health challenges and opportunities
    The one health concept recognizes that animal, human and ecological 
health are inextricably linked and are best addressed using a systems 
approach as alluded to in the National Institutes of Health Roadmap 
(see http://nihroadmap.nih.gov). The human and livestock genome 
projects are providing revolutionary insights for improving human 
health; however, the application of genomics biology to animal 
agriculture offers much more for our global society. It is clear that 
an abundant, affordable and safe food supply continues to be the 
foundation for human health, economic stability and political stability 
necessary for improved quality of life in the United States and 
worldwide. A major opportunity of the One Health concept is to enhance 
vital agricultural and biomedical capabilities that embrace functional 
genomics, proteomics and bioinformatics to sequence, map and explore 
genomes of important species of animals, crops and microbes. This is 
essential for increasing profitability of livestock enterprises through 
improved production efficiencies and approaches to enhance animal 
health and wellbeing.
    Modern transportation, global movement of animals and people, and 
intensive livestock management systems create increased risks for 
either accidental or intentional introduction of infectious diseases. 
Zoonoses pose risk of disease transmission from animals to people and 
vice versa, with both health and economic impacts. Some 58 percent of 
new human diseases are zoonotic, and environmental conditions influence 
the transmission of disease. The results of outbreaks of highly 
infectious diseases in animals cause mortality and morbidity, as well 
as catastrophic trade and other economic impacts. A major concern with 
such outbreaks is the need to employ systems of containment and 
eradication that ensure continuity of business operations during 
intervention, especially in intensive livestock production systems. 
Interdisciplinary research can help understand how pathways are 
integrated in complex organisms, determine how disturbances in these 
pathways lead to disease and disease resistance, and desired phenotypes 
that enhance production agriculture and animal health, as well as 
mitigate transmission of zoonotic diseases.
    Through this approach of using systems biology to generate new 
knowledge and technologies, major opportunities will be forthcoming to 
improve human and animal health using sustainable management practices, 
as well as advanced methods for early detection, prevention, and 
recovery from outbreaks of disease and to produce safer foods of animal 
origin.
                stewardship challenges and opportunities
    Livestock operations must continue to make major advances in the 
efficiency and sustainable use of natural resources for both extensive 
and intensive production systems. More effective use of land, water, 
energy and other natural resources that generate inputs to animal 
production as well as for animal production itself are needed. 
Stewardship of the animals and their relationship to the communities in 
which they exist are key elements of the total equation. As demand for 
food increases, animal production will be increasingly forced to use 
marginal lands where stewardship is even more challenging. New 
innovations and technologies are urgently needed to meet future demands 
for foods of animal origin, stewardship of natural resources, and 
economic survival of food animal production. Science-based information 
for appropriate policy and regulatory paradigms is required. Modern 
science, ranging from basic research in plant and animal genomics, 
transcriptomics and bioinformatics is essential to underpin genetic 
selection for development of new and more drought-resistant feeds and 
forages to improve overall food animal production efficiencies and 
management practices. This approach is essential to realizing advances 
in animal and plant agriculture required to meet demands and maintain a 
healthy, natural resource base.
    In order to realize the innovations and outcomes identified, 
increased public funding of agricultural research will be needed. NAAAS 
appreciates the opportunity share its views on the drivers for 
innovation in animal science and the need for increased Federal 
investments. Please let us know if you have any questions or if NAAAS 
can be of any assistance as the committee continues its work on the 
Federal investment in science.

    [This statement was submitted by Ken Odde, President of the 
National Association for the Advancement of Animal Science.]

                                 ______
                                 
   Prepared Statement of National Association of Nutrition and Aging 
                       Services Programs (NANASP)
    On behalf of the National Association of Nutrition and Aging 
Services Programs (NANASP), an 1,100-member nonpartisan, nonprofit, 
membership organization for national advocates for senior health and 
well-being, and on behalf of the Academy of Nutrition and Dietetics, a 
76,000 member organization of food and nutrition professionals, 
committed to improving the nation's health through healthy and safe 
food choices, we thank you for the opportunity to offer testimony in 
support of the Department of Agriculture's proposed increases for the 
following programs within the Food and Nutrition Services:
  --$900 million for the Supplemental Nutrition Assistance Program 
        (SNAP), including $10 million to implement state options to 
        streamline application processes for older adults;
  --$14 million for the Commodity Supplemental Food Program
    We also support the $20.6 million request for the Senior Farmers' 
Market Nutrition Program.
    One in six older Americans struggles with hunger and food 
insecurity. These numbers continue to grow with the growth of the aging 
population; more than 10,000 seniors turn 65 every day. However, only 
39 percent of eligible seniors are enrolled in SNAP--meaning that 
millions of seniors are going hungry.
    One reason commonly given for lack of older adult enrollment in 
SNAP is lack of ability to fill out the application. Therefore, the 
President's request for $10 million to implement state options to 
streamline application processes for seniors based on successful state 
demonstrations in increasing senior participation in SNAP is incredibly 
important. By streamlining the process, seniors will be able to apply 
more easily, thus making it more likely that they will complete the 
application and receive the benefits they desperately need.
    We also support the proposed increase for the Commodity 
Supplemental Food Program. It currently serves more than 600,000 low-
income people nationwide, and it is the only USDA nutrition program 
that provides monthly food assistance specifically targeted at low-
income seniors. However, the program is funded at a set level annually 
and therefore cannot serve all eligible seniors. It is also unavailable 
in Alabama, Virginia, West Virginia and Wyoming. This increase would 
address current demand and fund new caseloads to a total of 639,000 
participants.
    Finally, at a minimum, we support the President's request for $20.6 
million for the Senior Farmers' Market Nutrition Program. This program 
puts fresh produce into the hands of low-income seniors and supports 
local markets, roadside stands, and community-supported agriculture 
operations (CSAs). However, fewer than 836,000 seniors were able to 
participate in 2013 and received an average benefit of only $31/year in 
groceries since the program is funded at a set level. Further, it is 
unavailable in seven states. Thus, we support its expansion and higher 
funding for this program if at all possible.
    Investments in these nutrition programs are cost-effective because 
many common chronic conditions such as hypertension, heart disease, 
diabetes, and osteoporosis can be effectively prevented and treated 
with proper nutrition. The Academy of Nutrition and Dietetics estimates 
that 87 percent of older adults have hypertension, high cholesterol, 
diabetes, or some combination of all of these. These seniors need 
healthy meals to avoid serious medical care--and this care would place 
an expensive burden on Medicare and Medicaid.
    Older adults who are not receiving proper meals can also become 
malnourished and undernourished. This makes it harder for them to 
recover from surgery and disease, makes it more difficult for their 
wounds to heal, increases their risk for infections and falls, and 
decreases their strength that they need to take care of themselves. 
Malnourished older adults are more likely to have poor health outcomes 
and to be readmitted to the hospital--their health costs can be 300 
percent greater than those who are not malnourished on entry to the 
healthcare system.
    As more than 10,000 seniors turn 65 every day, now is the time to 
provide a greater investment in these proven and cost-effective 
programs.
    Thank you for your past and future support.

    [This statement was submitted by Ann Cooper, Chair and Robert 
Blancato, Executive Director National Association of Nutrition and 
Aging Services Programs.]

                                 ______
                                 
  Prepared Statement of National Association of State Departments of 
                              Agriculture
    As Congress prepares legislation for fiscal year 2017 
appropriations for Federal agencies, the National Association of State 
Departments of Agriculture (NASDA) encourages you to support important 
programs to ensure a safe, affordable, and abundant food supply. NASDA 
represents the Commissioners, Secretaries, and Directors of agriculture 
in all fifty states and four territories. As elected and appointed 
officials, our members are strong advocates for agriculture and partner 
with a number of Federal agencies in regulating, marketing, and serving 
the agricultural industry.
                      food and drug administration
    Integrated Food Safety System: Increase for the Food Safety 
Modernization Act (FSMA) state implementation programs at $100 million 
NASDA estimates state programs will need an investment of $100 million 
annually. The requested amount is necessary for the development and 
operation of programs which will implement the three major FSMA 
programs (Preventive Controls: Human Food, Preventive Controls: Animal 
Food, and Produce Safety). The sooner FDA's expenditures to states 
reach the $100 million per year mark, the more systematic and timely 
the implementation of FSMA will be at the state level. While the U.S. 
arguably has the safest food system in the world we can do better if we 
focus on prevention.
    Center for Veterinary Medicine (CVM): Fund CVM program areas at 
$196.7 million; National Antimicrobial Resistance Monitoring System 
(NARMS) funding at $10.8 million; Combating Antibiotic Resistance 
Initiative at $35 million for USDA CVM oversees the safety of animal 
drugs, feeds and biotechnology-derived products. Further, we request 
that the new user fees established by the Animal Drug User Fee Act 
(ADUFA) of $22.977 million be included in the fiscal year 17 
appropriations bill. ADUFA establishes a system of performance 
standards to improve the new animal drug review process at CVM. NASDA 
thanks Congress for increasing NARMS funding for meat testing by $3 
million last year and supports the Administration's request for an 
additional $35 million for the USDA and $1 million for the CVM for 
research, monitoring, and surveillance under the CARB.
                     u.s. department of agriculture
    Agricultural Marketing Service (AMS): Fully fund the Specialty Crop 
Block Grant Program at the authorized amount of $72.5 million; fully 
fund the Specialty Crop Multi-State Program at the authorized amount of 
$4 million. The SCBG Program is critical to the expanding the 
availability of high quality, safe, and nutritious specialty crops to 
consumers while adding value to producers through research and 
extension activities.
    Agricultural Research Service (ARS): Fully fund ARS at $1.426 
billion; fully fund Office of Pest Management Policy (OPMP) at $3 
million; fully fund National Agricultural Law Center (NALC). ARS works 
towards solving problems facing America's crop, livestock and poultry 
producers as well as natural resources, human nutrition, food 
production and food processing. NASDA urges the committee to fully fund 
the OPMP at $3 million as they provide crucial leadership in the 
coordination of interagency activities between USDA, EPA, FDA, and 
state agencies. NASDA encourages continued extramural funding for the 
NALC and its partners in the Agricultural & Food Law Consortium through 
the USDA-ARS National Agricultural Library. Requested report language: 
The Committee expects USDA-ARS National Agricultural Library extramural 
research consortium projects to be funded at no less than the fiscal 
year 2014 levels.
    Animal and Plant Health Inspection Service (APHIS): Fund APHIS 
program areas at $901 million; fully fund Cooperative Agricultural Pest 
Survey (CAPS) Program; fully fund Wildlife Services at $105 million; 
fully fund Feral Swine Control at $20 million; new research funding for 
National Animal Health Monitoring System (NAHMS). Any reductions to 
APHIS' budget could result in deterioration of essential services and 
impair the Agency from carrying out its fundamental mission, which is 
``to protect the health and value of American agriculture and natural 
resources.'' The CAPS program, WS programs and the national control 
program for feral swine programs are crucial to state, industry and 
Federal coordination in researching, detecting and resolving conflicts 
with pests and animals. NASDA supports fully funding NAHMS for 
antibiotic research which conducts studies on the health and management 
of U.S. livestock populations.
    Food Safety Inspection Service (FSIS): Remove Prohibitions on USDA 
Horse Meat Inspections; fully fund State Food Safety and Inspection at 
$63 million. We encourage the committee to resist attempts to include 
language that would prohibit funding for USDA ante-mortem horse 
inspection. Further, NASDA urges the committee to restore funding for 
State Food Safety and Inspection programs to $63 million, which is 
critical for states that provide state meat inspections under a variety 
of programs regulated by FSIS.
    Foreign Agricultural Service (FAS): Market Access Program (MAP) at 
$200 million; Foreign Market Development (FMD) program at $34.5 
million. MAP and FMD encourage the development and expansion of 
commercial agricultural export markets and assists small businesses in 
accessing foreign markets.
    National Agricultural Statistics Service (NASS): Funding for NASS 
of at least $176.6 million. NASS statistics provide the information 
necessary for producers, agribusinesses, farm organizations, 
economists, and others for critical decisionmaking in agricultural 
marketing and investing. NASS data is vital to keeping agricultural 
markets stable, efficient, and fair by making available objective data 
to commodity market buyers and sellers.
    National Animal Health Laboratory Network (NAHLN): Fully fund NAHLN 
at $15 million. NAHLN is a cooperative effort between USDA-APHIS, NIFA, 
university, and state veterinary diagnostic labs. NAHLN is an early 
warning system for emerging and foreign animal diseases and we urge the 
committee to fund NAHLN at the authorized amount.
    National Institute for Food and Agriculture (NIFA): Fund National 
Agriculture in the Classroom (AIC) at $1 million; Fully fund 
Agriculture and Food Research Initiative (AFRI) at $700 million; 
Funding for Veterinary Medical Loan Repayment Program (VMLRP) at $5 
million; the Veterinary Services Grant Program (VSGP) at $2.5 million; 
Fund Food Animal Residue Avoidance Database (FARAD) at $2.5 million and 
Section 1433 at $10 million. AIC is a critical educational tool in 
inspiring our next generation of farmers, workforce members and 
consumers. Further, NASDA is supportive of language directing AFRI to 
address pollinators, antibiotic resistance and advancing drug approvals 
to treat minor species. Also, the expanded Section 1433 maintains the 
program for animal health and disease and adds a competitive grant 
program focusing on priorities in food security, one health and 
stewardship.
    Natural Resources Conservation Service (NRCS): Fully fund--the 
Environmental Quality Incentives Program (EQIP) at $1.65 billion; the 
Conservation Stewardship Program (CSP) at 10.34 million acres; the 
Regional Conservation Partnership Program (RCPP), the Agriculture 
Conservation Easement Program (ACEP) at $500 million. Farm Bill Title 
II conservation programs are invaluable programs in helping farmers, 
ranchers, and landowners address conservation concerns. Voluntary, 
incentive-based conservation programs are the bedrock for agriculture's 
efforts to improve water and air quality, soil health, and address 
water quantity concerns and resist overly burdensome regulatory 
efforts.
    U.S. Forest Service: Forest Inventory and Analysis (FIA) program at 
$83 million. The FIA program surveys America's forests and provides 
information for monitoring trends in habitat, wildfire risk, insect and 
disease threats and other resource questions.
                               conclusion
    NASDA asks that you give our requests careful consideration as work 
to fund the nation's agricultural policy priorities in fiscal year 17. 
NASDA is a partner and co-regulator with Federal agencies in the 
implementation of a host of food, agricultural and natural resources 
programs. NASDA Members have a unique wealth of information, 
experience, and expertise. NASDA stands ready to work with you and your 
staff to expeditiously pass the agriculture appropriations bill. Thank 
you for your consideration, and please let us know if you have any 
questions.

    [This statement was submitted by Barbara P. Glenn, Ph.D., Chief 
Executive Officer--NASDA.]

                                 ______
                                 
 Prepared Statement of National Association of State Energy Officials 
                                (NASEO)
    Chairman Moran and Ranking Member Merkley, I am David Terry, 
Executive Director of the National Association of State Energy 
Officials (NASEO), and I am testifying in support of fiscal year'17 
funding for the energy title of the Farm Bill. The mandatory levels of 
the energy title of the Farm Bill should be preserved. Specifically, we 
support funding of at least $19 million in additional discretionary 
spending for the Rural Energy for America (REAP) program (Section 9007 
of the last multi-year Farm Bill), in addition to $49 million in 
mandatory funding for REAP. The REAP program was created in the 2002 
Farm Bill and it has been a huge success. Over 10,000 energy efficiency 
and renewable energy projects have been implemented in every state 
since 2003. With a required $3 match of non-Federal funds for every 
Federal dollar invested in REAP, over $1.6 billion in matching funds 
have been provided. This program has specifically benefitted farmers, 
ranchers and rural small businesses. NASEO's State Energy Office 
members work directly with eligible entities, as well as state 
agricultural agencies and rural interests to promote this successful 
program. REAP is about rural economic development. The Biomass Crop 
Assistance Program supports producers who will supply biomass 
feedstocks for advanced biofuels. We urge the Subcommittee to provide 
$50 million for this effort in fiscal year'17, $24 million above the 
mandatory funding. Finally, we support $15 million in mandatory funding 
and $4 million in discretionary funding, a total of $19 million for the 
Rural Energy for America Loans program.
    NASEO represents the energy offices in the states, territories and 
the District of Columbia. The REAP program, and the other critical 
programs in the energy title of the last multi-year Farm Bill, helps 
create jobs, increases agricultural productivity, saves energy for 
farmers, ranchers and rural small businesses, generates energy, 
promotes use of alternative fuels, reduces our dependence on imported 
petroleum and saves money in rural America. The cost is very low and 
the payback is very high.
    In fiscal year 2017, we urge your support for the REAP program, the 
Rural Energy for America Loans program, the Biomass Crop Assistance 
Program.

    [This statement was submitted by David Terry, Executive Director, 
National Association of State Energy Officials.]

                                 ______
                                 
      Prepared Statement of National Association of Wheat Growers
    The National Association of Wheat Growers joins the National Wheat 
and National Barley Improvement Committees in urging the Committee to 
provide an additional $3.3 million over the budget request for funding 
the USDA-ARS US Wheat & Barley Scab Initiative (USWBSI). This increase 
would provide the full $10 million authorized by section 7303 of the 
Agricultural Act of 2014. We are also requesting an additional $3.44 
Million to support a Small Grains Genomic Initiative within the 
Agricultural Research Service.
    Wheat is a very important crop and source of economic activity. As 
USDA's Economic Research Service has reported, the United States is a 
major wheat-producing country, with output typically exceeded only by 
China, the European Union, and India. Almost half of the U.S. wheat 
crop is exported. Wheat is the principal food grain produced in the 
United States. In the last decade, wheat ranked third among U.S. field 
crops in both planted acreage and gross farm receipts, behind corn and 
soybeans. According to the National Agricultural Statistics Service, 
more than 2 billion bushels of wheat with a weighted average farm price 
value of approximately $12 billion was harvested from more than 46 
million acres across 42 states.
    We appreciate that you have provided important support for scab 
research over the past several years. Since fiscal year 2003, Congress 
has annually provided $6.7 million. The mission of the USWBSI is to 
enhance food safety and supply by reducing the impact of Fusarium Head 
Blight (scab) on wheat and barley. The USWBSI is an organization of 
grower, researcher, and industry stakeholders, providing annual 
recommendations to ARS for a mission directed competitive grant 
program. The USWBSI is the consortium of land-grant colleges and 
universities authorized in farm bills over the years, in partnership 
with USDA-ARS scientists and research locations throughout the US.
    However, the increase of $3.3 million is necessary because scab is 
an emerging threat in new regions of the country, including the Western 
states of Colorado, Idaho, Montana, Oregon, California and Washington. 
Wet conditions throughout the US in 2014 resulted in widespread scab 
outbreaks, negatively impacting yields and resulting in high levels of 
the mycotoxin deoxynivalenol (DON, aka vomitoxin) in grain that was 
rejected by elevators, mills, and maltsters, causing disruptions in 
supply, economic losses to growers, and increased costs for end users.
    The additional programmatic funding of $3.3 million requested is 
proposed to be allocated 50 percent to the USWBSI and 50 percent in 
permanent base funding increases to ARS units conducting scab and 
supporting research.
    For the $1.65 million increase proposed for the multi-institutional 
and multi-discipline directed competitive grant program of the USWBSI, 
we recommend the following allocations to enhance research in states 
currently receiving funding and to expand to other states where 
research is needed.

------------------------------------------------------------------------
                         Budget                             Allocation
------------------------------------------------------------------------
Accelerated Breeding....................................        $500,000
Scab Management.........................................         500,000
Genomic Selection.......................................         300,000
Research infrastructure in emerging areas...............         100,000
Additional DON testing..................................         250,000
                                                         ---------------
Total USWBSI Request....................................       1,650,000
------------------------------------------------------------------------


    We also propose that ARS, in consultation with the USWBSI 
Executive and Steering Committees (comprised of grower, 
researcher, and industry stakeholders), determine how to 
allocate the $1.65 million proposed for permanent base funding 
increases to ARS locations conducting scab research or 
supporting research.
    We also request an additional $3.44 Million to Support a 
Small Grains Genomic Initiative under the ARS Salaries and 
Expenses Account. Those funds would be distributed as follows.
  --Next Generation Genotyping--Funding of $1.5 million is needed so 
        that all four USDA-ARS Small Grains Regional Genotyping 
        Laboratories (Fargo, ND; Manhattan, KS; Raleigh, NC; Pullman, 
        WA) can meet their mission to facilitate application of genomic 
        information and DNA marker technologies for improvement and 
        breeding of wheat, barley, and oat varieties. Small grains 
        breeders must be equipped with genotypic data that give them 
        rapid access to traits of value so they can be incorporated 
        into improved varieties to counter threats to the crops from 
        diseases, insects, and climate; maintain grain quality; 
        increase yields, and improve other agronomic characters. Of 
        particular importance is the hiring of a bioinformatics support 
        scientist to analyze and interpret data to meet the needs of 
        scientists doing research on breeding and genetics of small 
        grains, and to integrate the enormous amounts of generated data 
        into the nationwide ``Big Data'' network being developed by the 
        USDA-ARS. The scientist will also oversee and maintain local 
        genotyping lab computing resources.
  --Barley & Wheat Quality Phenotyping and Research--Funding of $1.79 
        million is needed so that all five USDA-ARS Barley and Wheat 
        Quality Laboratories (Madison, WI; Fargo, ND; Manhattan, KS; 
        Wooster, OH; Pullman, WA) can meet their missions to advance 
        the quality and utilization of barley and wheat grain in the 
        U.S. for the betterment of U.S. consumers, farmers, and the 
        brewing, milling, baking, and processing industries.
    In this age of modern genomics, substantial resources have been 
directed at cutting edge DNA technologies, but adequate resources for 
the phenotyping (measurable characterization) of barley and wheat 
quality have not been provided. Wheat and malting barley varieties 
developed with the aid of genomic technology, but lacking the quality 
characteristics required for domestic and export market end-users, are 
of little value.
    The remaining $150,000 of our request for the Small Grains Genomic 
Initiative would be for barley doubled haploid work.
    The National Association of Wheat Growers, working with its team of 
22 state wheat grower organizations to benefit the wheat industry at 
state and national levels, appreciates your consideration of our 
requests.

    [This statement was submitted by Gordon Stoner, President National 
Association of Wheat Growers.]

                                 ______
                                 
  Prepared Statement of National Commodity Supplemental Food Program 
                              Association
    Mister Chairman and Subcommittee members, thank you for this 
opportunity to present information regarding the USDA/FNS Commodity 
Supplemental Food Program (CSFP). The National Commodity Supplemental 
Food Program Association (NCSFPA) requests that the Senate Agriculture 
Appropriations Subcommittee fund CSFP for fiscal year 2017 at 
$236,120,000 as requested by the U. S. Department of Agriculture. 
NCSFPA would also like to thank the Subcommittee for providing 
sufficient funding in fiscal year 2016 to bring on 1 additional new 
state with a previously approved plan of operation by USDA. Low-income 
seniors in the state of Virginia will begin receiving the nutritionally 
balanced CSFP food packages this year.
    CSFP is a unique program which brings together Federal and state 
agencies, along with public and private entities. In fiscal year 16, 
the CSFP provides services through 150 non-profit community and faith-
based organizations at 1,800 sites located in 47 states, the District 
of Columbia, and two Indian Tribal Organizations (Red Lake, Minnesota 
and Oglala Sioux, South Dakota). Each month 619,000 participants are 
authorized to receive a nutritionally balanced food box. The program 
has moved to serve exclusively elderly participants, as required by the 
Agricultural Act of 2014. Our association thanks the Subcommittee for 
funding that enables us to continue serving our vulnerable population. 
Even though the budget request would provide assistance to an 
additional 20,000 seniors, it is important to note that current 
participating states have requested another 142,149 caseload slots to 
meet the need in their service areas. We are sure the additional 
caseload will be well used.
    CSFP continues to be a testimony to the power of community 
partnerships with faith-based organizations, farmers, private industry 
and government agencies. The CSFP offers a unique combination of 
advantages unparalleled by any other food assistance program:
  --The CSFP specifically targets one of our nation's most 
        nutritionally vulnerable populations: low-income seniors.
  --The CSFP provides a monthly selection of food packages tailored to 
        specific nutritional needs.
  --The CSFP purchases foods at wholesale prices, directly supporting 
        American farmers. The average food package cost is estimated at 
        $23, while the retail value is approximately $50.00.
  --The CSFP involves the entire community. Thousands of volunteers and 
        private companies donate money, equipment, and most importantly 
        time and effort to deliver food to needy and homebound seniors. 
        These volunteers not only bring food but companionship and 
        other assistance to seniors who might have limited support 
        systems.
    The 2013 supplemental report by Ziliak and Gundersen for the 
National Foundation to End Senior Hunger; The State of Senior Hunger in 
America 2011: An Annual Report demonstrated that seniors continue to 
face ever increasing food insecurity challenges despite the end of the 
Great Recession. The proportion of seniors age 60 or older facing 
hunger increased by over 15 percent from 2010 to 2011. Additionally, 
from 2001 to 2011, the number of seniors experiencing the threat of 
hunger, the risk of hunger, and hunger has increased by 88 percent, 109 
percent, and 200 percent, respectively.
    The 1997 report by the National Policy and Resource Center on 
Nutrition and Aging at Florida International University, Miami-- Elder 
Insecurities: Poverty, Hunger, and Malnutrition indicated that 
malnourished elderly patients experience 2 to 20 times more medical 
complications, have up to 100 percent longer hospital stays, and incur 
hospital costs $2,000 to $10,000 higher per stay. Proper nutrition 
promotes health, treats chronic disease, decreases hospital length of 
stay and saves healthcare dollars.
    In a 2013 NCSFPA survey, more than half of seniors living alone 
reported an income of less than $750 per month. One-half of respondents 
from two-person households reported an income under $1,000 per month. 
25 percent were enrolled in the Supplemental Nutrition Assistance 
Program (SNAP) and 50 percent said they ran out of food during the 
month. 70 percent of senior respondents said they choose between 
medicine and food.
    In 2012, an informal NCSFPA senior participant survey revealed 
individual accounts of the value of CSFP benefits. An Arkansas 
recipient tells us that they would not otherwise be able to eat the 
balanced meals that CSFP provides each month. Arkansas program 
operators talk about the importance of interaction between seniors and 
program staff, saying this interaction is very important for the well-
being of recipients, and recipients are able to live more stable, self 
sufficient lives as a result. Colorado participants say that they would 
not be able to have juice and cereal without CSFP, and many appreciate 
the program because they are homebound. Seniors in St. Louis, Missouri, 
say that CSFP foods help them get through to their next checks. 
Participants in Nebraska say that they don't know what they would do 
without this food, calling the program a ``lifesaver''. New Hampshire 
participants tell us that they use CSFP as a primary source of 
nutrition each month and would see a dramatic loss in food availability 
without the program. One Wisconsin recipient said that they would 
starve without the program, while others said that CSFP on their 
limited income meant that they could pay their telephone and electric 
bills.
    America is aging and CSFP is an integral part of senior nutrition 
programming that is a cost effective and nutritionally sound way to 
ensure that today's seniors remain productive, healthy, and independent 
to maintain a good quality of life. It is of note that many seniors are 
now continuing to work at least part-time beyond retirement age to 
ensure that they can afford basic necessities. As such, CSFP is an 
important tool for them to remain healthy so that they may continue to 
be an active part of the work force.
    The CSFP Local Agencies are committed grassroots operators with 
dedicated volunteers fulfilling a mission to provide quality nutrition 
assistance economically, efficiently, and responsibly. In cooperation 
with USDA, NCSFPA seeks to meet the current and emerging needs of CSFP 
participants. NCSFPA wishes to commend the Food Distribution Division 
of Food and Nutrition Service of the Department of Agriculture for 
their continued innovations to strengthen the quality of the food 
package and streamline administration.
    The Senate Agriculture Appropriations Subcommittee has consistently 
supported CSFP, acknowledging it as a cost-effective way of providing 
nutritious supplemental foods. We urge the Subcommittee to provide 
$236,120,000 million for the Commodity Supplemental Food Program in 
order to allow us to provide needed services.
    Again, thank you for your continuing support. We look forward to 
working with you on behalf of CSFP participants.

                                 ______
                                 
             Prepared Statement of National Cotton Council
    The NCC is the central organization of the United States cotton 
industry. Its members include growers, ginners, cottonseed processors 
and merchandizers, merchants, cooperatives, warehousers and textile 
manufacturers. A majority of the industry is concentrated in 17 cotton-
producing states. The downstream manufacturers of cotton apparel and 
home furnishings are located in virtually every state. Farms and 
businesses directly involved in the production, distribution and 
processing of cotton employ almost 200,000 workers and produce direct 
business revenue of more than $27 billion. Annual cotton production is 
valued at more than $6 billion at the farm gate, the point at which the 
producer markets the crop. Accounting for the ripple effect of cotton 
through the broader economy, direct and indirect employment surpasses 
420,000 workers with economic activity well in excess of $100 billion. 
In addition to the cotton fiber, cottonseed products are used for 
livestock feed, and cottonseed oil is used as an ingredient in food 
products as well as being a premium cooking oil.
    The NCC welcomes the opportunity to provide the following 
recommendations and requests for fiscal year 2017 appropriations for 
programs which make important contributions to our industry's ability 
to compete and prosper in a world market.
                           funding priorities
    Cotton Pests (APHIS): The National Cotton Council requests $11.52 
million (level with the fiscal year 2016 and fiscal year 2015 
appropriations) for the APHIS Cotton Pests Account. This will allow 
APHIS to continue to provide coordination, technical assistance and 
funds for Boll Weevil Eradication and Pink Bollworm Eradication 
programs. Grower assessments provide the balance of program funds. As 
these programs near completion, the Federal funding becomes even more 
critical to ensure the complete eradication of these cotton pests for 
the benefit of those in post eradication maintenance. Additional 
details for the Boll Weevil Eradication Program and the Pink Bollworm 
Eradication Program are provided below:
    Boll Weevil Eradication (APHIS--Cotton Pests): The NCC requests 
$8.1 million (level with the fiscal year 2016 and fiscal year 2015 
appropriations) for APHIS to provide Federal support to the National 
Buffer Zone in the Lower Rio Grande Valley (LRGV) in Texas, the last 
``frontier'' for Boll Weevil Eradication efforts since 97 percent of 
the U.S. cotton acreage is now free of boll weevils. This Zone is also 
the only remaining active eradication zone in the U.S. APHIS funds are 
only provided to this active eradication zone in keeping with a 
commitment that grower assessments provide 100 percent of the cost of 
maintenance programs once an area or region is declared ``weevil 
free.'' The program continues to produce documented economic and 
environmental benefits. Cotton in the United States is now produced 
with an average of less than three annual applications of pesticides 
per acre for all insects. This compares to the 15 to 20 applications 
per acre prior to boll weevil eradication and adoption of cotton 
varieties containing Bt technology for worm control.
    Continuation of Federal funding is critical as the program strives 
to complete eradication in the LRGV of Texas. The NCC recognizes that 
the movement of boll weevils from Tamaulipas, Mexico, into the LRGV has 
prolonged the eradication efforts of the U.S. However, the eradication 
efforts in the LRGV continue to make progress and the area also serves 
as the National Buffer, protecting the remainder of the U.S. cotton 
acreage from re-infestation of the boll weevil. The NCC's Boll Weevil 
Action Committee has created the International Technical Advisory 
Committee to share and coordinate technical procedures with the 
Tamaulipas, Mexico program in an effort to enhance their eradication 
progress thereby ending this weevil migration. In addition, the NCC is 
cooperating with APHIS in developing another liaison committee to 
include Mexico program officials to identify additional resources and 
technical assistance required by the Tamaulipas program.
    We also respectfully request that APHIS be directed to make every 
effort to minimize overhead and administrative expenses for boll weevil 
eradication to ensure field operations are funded to the fullest extent 
possible.
    Boll Weevil Eradication (FSA)--The NCC requests sufficient funding 
to allow FSA to make up to $60 million in loans to eligible producer-
controlled organizations carrying out Boll Weevil and Pink Bollworm 
eradication programs. This authority has existed since fiscal year 2005 
and has been critically important to the success of the programs. There 
has not been a forfeiture on any loan made by FSA for the purpose of 
carrying out Boll Weevil and Pink Bollworm eradication efforts.
    Pink Bollworm Eradication (APHIS--Cotton Pests): The NCC requests 
$3.42 million (level with the fiscal year 2016 and 2015 appropriations) 
be provided to APHIS to continue support for the pink bollworm program. 
The Pink Bollworm Eradication Program is based predominantly on the 
mass release of sterile insects generated by a Phoenix, AZ rearing 
facility.
    The funds requested for fiscal year 2017 will enable the Pink 
Bollworm Rearing Facility (PBRF) in Phoenix, AZ, to maintain a colony 
of pink bollworm moths with the capability to provide sterile moths for 
release if a wild moth is captured. The PBRF is a partnership between 
the California growers and APHIS. The cost share for pink bollworm is 
essential to provide APHIS' expertise and operational coordination in 
mass rearing and area-wide aerial releases of millions of sterile 
moths.

        The Pink Bollworm Eradication Program did not document the 
        capture of any native pink bollworm moths in 2013 for the U. 
        S., which allowed the program to begin a confirmation phase in 
        2014. There was no documented capture of any native pink 
        bollworm moths in 2014 or in 2015. The density of monitoring 
        traps remained high for the 2014 year in order to verify that 
        no native populations are present. The trapping density will 
        gradually decline over the next several years before 
        eradication is confirmed. A response plan has been developed by 
        technical experts to respond to localized areas as needed if a 
        native capture is documented during this confirmation phase. 
        Growers contribute funds through assessments and incur 
        significant expense associated with purchasing and planting 
        biotech seeds during the active eradication period.

    Market Access Program (MAP).--The NCC strongly supports the funding 
level in the Agricultural Act of 2014 of $200 million for MAP. Cotton 
Council International (CCI), the foreign market development arm of the 
NCC, has the critical mission of maintaining and expanding exports of 
US cotton and cotton products in Asia, Europe, Africa, and Central and 
South America. The value of U.S. cotton fiber exports exceeds $5 
billion, and exports of value-added cotton products contribute an 
additional $3 billion to the overall value of cotton exports. 
Activities carried out using MAP and Foreign Market Development (FMD) 
funds have been documented as contributing to increased export sales of 
cotton fiber and value-added manufactured cotton products. Independent 
studies reveal that for every dollar spent by USDA cooperators, 
including CCI, U.S. exports increase $35, a 35-to-1 return on 
investment. For the cotton industry, this represents over one billion 
dollars in export value or an additional 7,000 jobs to the U.S. 
economy. The cotton industry believes CCI's programs are an effective 
catalyst for private sector investments, with the industry investing 
$2.02 for every dollar of MAP funds received.
    Foreign Market Development (FMD).--The FMD program is used to 
encourage and support U.S. commodity groups to undertake long-term 
market development and trade servicing. These funds are used for 
programs with detailed market assessments, strategic program 
development and ongoing evaluations. These funds create unique market 
development and trade servicing value and, like the MAP funds, are 
closely monitored by USDA for compliance with U.S. laws. FMD is 
currently funded at $34.5 million and requires at least a dollar-for-
dollar industry match. The industry requests that funding for FMD be 
continued at the level authorized in the Agricultural Act of 2014. The 
cotton industry believes CCI's programs are an effective catalyst for 
private sector investments with industry investments totaling $1.31 for 
every dollar of FMD funds received.
    Foreign Agricultural Service (FAS).--The industry supports 
sufficient funding to ensure FAS is adequately staffed to carry out 
important market development and trade enhancing functions in 
headquarters and abroad. The industry supports the Presidential 
initiative to streamline and make U.S. export programs more effective. 
We believe FAS's market research and market development assistance 
combined with the MAP and FMD programs serve as a model for successful 
public-private partnerships. We believe it is important that U.S. 
agriculture continue to have an agency like FAS with close links to 
domestic USDA programs to promote U.S. exports, collect market data, 
assist exporters, remedy trade disputes and assist in the development 
of trade policy.
    Farm Service Agency (FSA).--The NCC supports adequate funding so 
that FSA can continue to deliver essential farm and conservation 
programs and services.
    Risk Management Agency (RMA).--The NCC supports adequate funding so 
that RMA can continue to administer essential insurance products.
    Agricultural Research Service (ARS).--The cotton industry continues 
to be concerned with the financial support of this important intramural 
research agency. ARS programs and facilities conduct vital research 
programs in fiber quality, production agronomic systems and textiles 
that ultimately support U.S. cotton production and post-harvest 
processing as well as the U.S. textile industry's efforts to remain 
competitive in global markets. We urge the Committee to instruct USDA 
not to close any facilities or discontinue any projects without first 
consulting with industry stakeholders.
    The NCC specifically requests an increase of $1.68 million in 
funding for the three cotton ginning research units to be distributed 
as follows: Southwestern Cotton Ginning Research Laboratory, Mesilla 
Park, NM, $468,000; Cotton Production and Processing Research Unit, 
Lubbock, TX, $752,000; and the Cotton Ginning Research Unit, 
Stoneville, MS, $460,000. All three ginning research units need 
additional funding immediately to address scientific personnel needs, 
conduct research, and offset the impact of inflation after years of 
flat or decreasing budgets.
    We request that the Committee maintain funding for the research 
units managing cotton programs conducted at the Southern Regional 
Research Center in New Orleans, LA, and the various cotton breeding and 
cotton entomology programs including support for the Cotton Germplasm 
Collection managed by the Southern Plains Crop Germplasm Unit housed at 
the Southern Plains Agricultural Research Center in College Station, 
TX.
    We agree with the President's Council of Advisors on Science and 
Technology (PCAST) December 2012 report, ``Agricultural Preparedness 
and the Agricultural Research Enterprise,'' that significant additional 
funding for agricultural research is warranted for maintaining a viable 
U.S. industry. However, we differ with the report's emphasis on 
increasing competitive funding of research. We continue to urge a 
balanced approach among intramural, competitive and formula funding in 
order to maintain an effective research infrastructure while 
encouraging innovative research at the highest levels. For ARS to 
continue its part in this research enterprise, additional funding is 
needed. We urge the Committee to provide ARS with additional overall 
funding as soon as economic conditions allow the Committee to respond 
to the PCAST report's funding level recommendations.
    Thank you for your consideration of our recommendations and of our 
funding requests for fiscal year 2017. Please contact me with any 
questions or if additional information is needed.

    [This statement was submitted by Reece Langley, Vice President--
Washington Operations.]

                                 ______
                                 
         Prepared Statement of National Employment Law Project
    The National Employment Law Project (NELP) submits the following 
testimony on the fiscal year 2017 Appropriations for the Food Safety 
and Inspection Service regarding the New Poultry Inspection System 
Program. NELP conducts research, education and advocacy to assure that 
the basic protections afforded by our nation's labor and employment 
laws extend to all workers, including low wage workers.
    NELP opposes any amendment to the Appropriations bill that would 
allow poultry plants entering the U.S. Department of Agriculture's 
(USDA) New Poultry Inspection System (NPIS) program to increase their 
lines speeds in defiance of the recently promulgated USDA standard: 
Modernization of Poultry Slaughter Inspection. We strongly urge the 
Committee to oppose this amendment that would rewrite the USDA's rule, 
subverting the normal rulemaking process without any formal public 
comment or input from the public, who along with poultry line workers, 
will be negatively affected by any change to this rule.
    In August of 2014, the USDA's Food Safety and Inspection Service 
(FSIS) promulgated the final rule for the Modernization of the Poultry 
Slaughter Inspection System. The final rule went through almost 2 years 
of public comment. When the final rule was published, it did not permit 
an increase in maximum line speeds in poultry plants.
    When this rule was first proposed for public comment in 2012, it 
contained a proposed increase in maximum line speeds in poultry plants. 
FSIS asked for comment on this provision, specifically acknowledging 
the potential for an increase in line speeds to effect employee health 
and safety. According to USDA, this proposed provision increasing 
allowable line speeds received the most comments from the public. The 
comments were focused on the negative effects the increased line speeds 
would have on the health and safety of workers in the poultry slaughter 
establishments as well as consumer safety.
    In response to all the comments received in the rule making, USDA 
FSIS decided not to increase the line speed from 140 to 175 birds per 
minute (bpm) in poultry slaughtering facilities. In the preamble to the 
final rule, the agency further noted concerns regarding 20 plants that 
are already in a pilot program (HIMP) that allowed these pilot 
facilities to increase line speeds to 175 bpm. USDA noted that the data 
from this existing pilot program found that the average line speed in 
these plants is 131 bpm--well below the currently allowed 140 bmp and 
far below the 175 permitted.
    The primary concern echoed in the many comments from academia, 
worker organizations and consumer organization was the detrimental 
effect of increased line speed on the health and safety of the tens of 
thousands of workers in the industry. Poultry slaughter and processing 
workers face many serious job hazards that can lead to serious injury, 
illness and death. In fact workers in poultry plants are injured at 
almost twice the rate of workers in private industry. Further the 
incidence rate of occupational illness cases reported by the industry 
is more than six times the national average for all U.S. industries. 
And it is well established, that these rates are under reported. As 
USDA noted in the preamble to the final rule, and OSHA stated in its 
new emphasis program in the poultry industry ``the literature suggests 
the likelihood of substantial under-reporting of worker injuries and 
illnesses by poultry industry employers.''
    Poultry processing workers make thousands of forceful cuts a day, 
using knives and scissors, in cold and damp conditions, with acidic 
chemicals being sprayed over the meat, and incidentally their bodies, 
as it moves down the line. Work related musculoskeletal disorders 
(MSD's) are of significant concern among poultry processing workers. 
These disorders, including carpal tunnel syndrome, tendonitis, and 
epicondylitis, affect the nerves, tendons and muscles. Poultry workers 
face incidence rates seven times higher than other manufacturing 
workers for work related carpal tunnel syndrome. In 2014 and 2015, in 
cooperation with the USDA, the National Institute of Occupational 
Safety and Health (NIOSH) conducted studies at two different poultry 
processing facilities and found high prevalence rates among production 
workers for carpal tunnel syndrome (CTS): 42 percent and 34 percent, 
respectively of CTS among workers.
    USDA acknowledged the danger to workers of increased line speeds in 
the preamble of its final rule, and also acknowledged that more study 
and review was needed before any change in line speed would be made. 
There has been no such study or review done since this rule was 
promulgated. Such a review would have to be prospective and take 
years--to assure that the safety of the tens of thousands of workers is 
not sacrificed on the altar of decreased government spending.
    Just last month, OSHA sent a hazard alert letter to a poultry 
company in Ohio for exposing workers to hazardous campylobacter 
bacteria. Workers at the poultry processing plant had contracted the 
infection--which can lead to serious gastrointestinal infection. This 
same company has racked up nearly $1.9 million in fines from the U.S. 
Department of Labor's Occupational Safety and Health Administration 
from its two plants in Ohio. OSHA had earlier found that this same 
company fired a 17 year old after his leg was amputated because of a 
failure by the company to install a safety mechanism.
    That is not an isolated instance. The speed of work in poultry 
plants already causes far too many workplace injuries and may be 
impacting consumer safety as well. OSHA citations and newly released 
reports have found that to keep the lines going at full speed, workers 
are often denied their legal right to use a bathroom, soiling 
themselves at work. Poultry processing plants also penalize workers for 
taking any sick days, so workers come to work sick while handling the 
meat on the line.
    As workers get injured because companies don't comply with basic 
safety precautions, they don't file workers compensation and heal. The 
companies do everything they can to preclude that. So instead, workers 
leave the plants. Many plants report turnover between 50-100 percent.
    Poultry processing workers are among the most vulnerable people in 
the country. Most are minorities and immigrants; some are newly 
resettled refugees. They are pursuing the American dream--working hard, 
arduous jobs in a harsh environment--all to help put food on our table.
    Congress should not allow the industry to speed up its lines after 
the USDA studied the issue, heard from the American public, and 
promulgated a rule that would not allow such an increase. This would be 
a subversion of the entire rule making process, it would demonstrate 
utter disregard for the rule of law, and would be a direct slap in the 
face to the workers and communities that sacrifice to feed America.

    [This statement was submitted by Deborah Berkowitz, Senior Fellow 
National Employment Law Project.]

                                 ______
                                 
         Prepared Statement of National Young Farmers Coalition
    Thank you for the opportunity to share our appropriations 
priorities for fiscal year 2017. Congress and the USDA have made 
significant progress in recent years towards better serving young, 
beginning farmers. The National Young Farmers Coalition (NYFC) is 
excited for the role Federal funding can play furthering this growth.
    NYFC represents, mobilizes, and engages young farmers to ensure 
their success. We envision a country where young people who are willing 
to work, get trained and take a little risk can support themselves and 
their families in farming. NYFC has 29 local chapters across the 
country and represents more than 1,400 dues-paying members.
    NYFC requests the following funding be included in the fiscal year 
2016 Agriculture Appropriations bill:
    1. New, Beginning, and Veteran Farmers and Ranchers Regional 
Coordinators ($3.9 mil)
    2. NRCS's Agricultural Conservation Easement Program (ACEP) at the 
mandatory program level ($500 mil)
    3. FSA's Direct Operating Loans (to provide $1.46 billion in loans) 
and Direct Farm Ownership Loans (to provide $1.5 billion in loans)
    4. Beginning Farmer and Rancher Individual Development Accounts 
($1.5 mil)
    5. Food Safety Outreach Program ($10 mil)
New, Beginning, and Veteran Farmers and Ranchers Regional Coordinators
        ($3.9 mil)
    NYFC has been working with the USDA to better serve young and 
beginning farmers. In contrast to established farmers or those coming 
from a farm family, beginning first-generation farmers require 
different services from the USDA and need more help than others finding 
these services. For example, young farmers often seek smaller operating 
loans when launching a business than an established farmer. With this 
in mind, NYFC helped create the popular microloan program at the Farm 
Service Agency (FSA) that provides operating loans at an appropriate 
scale for young farmers. Innovative program design and outreach has a 
proven track record of reaching previously underserved young farmers.
    To build on this success, NYFC has been urging the USDA, and FSA in 
particular, to provide specialized resources for young, beginning 
farmers and dedicated staff to help these farmers navigate the USDA. 
The proposed regional coordinators do precisely this. The twenty-five 
staff positions funded by this request will help young farmers access 
the services that are already available to them, but underutilized, 
such as conservation programs and farm loans. The $3.9 million in 
funding for the proposed outreach staff, as requested in the 
President's budget, is critical to amplify and leverage the resources 
already provided for farmers at the USDA and build the next generation 
of our nation's farmers.
NRCS's Agricultural Conservation Easement Program (ACEP) at the 
        Mandatory
        Program Level ($500 mil)
    Between 2007 and 2012, over 7 million acres of agricultural land 
were developed to nonfarm use in the United States.\1\ This contributes 
to the more than 24 million acres converted from agriculture between 
1982 and 2010, a disproportionately high amount of which contained 
prime soils.\2\ Agricultural conservation easements are a proven tool 
to stem this tide and protect farmland from development. ACEP provides 
a critical source of matching funds for the land trusts and state and 
local programs that are purchasing these easements across the country.
---------------------------------------------------------------------------
    \1\ USDA National Agriculture Statistics Service. (2014). 2012 
Census of Agriculture. http://www.agcensus.usda.gov/Publications/2012/
Full_Report/Volume_1,--Chapter_1_US/st99_1--001_001.pdf.
    \2\ American Farmland Trust. (n.d.). Farmland by the Numbers. 
http://www.farmland.org/programs/protection/American-Farmland-Trust-
Farmland-Protection-Farmland-by-the-numbers.asp.
---------------------------------------------------------------------------
    The 2014 Farm Bill provided $500 million in mandatory funding for 
ACEP in fiscal year 2017. It is critical that this program retains its 
full, mandatory funding. Even with this full mandatory funding level, 
this program is funded at $81 million less than its component programs 
prior to the 2014 Farm Bill. An additional reduction in funding would 
be devastating to this program.
FSA's Direct Operating Loans (to provide $1.46 billion in loans) and 
        Direct Farm Ownership Loans (to provide $1.5 billion in loans)
    FSA operating and ownership loans are crucial for young farmers. 
Without these loans, many of these individuals would not be able to 
access credit for their farm. In fiscal year 2015, the funding 
available for Direct Farm Ownership Loans was dramatically increased--
from approximately $.5 billion to $1.5 billion. NYFC was excited to see 
this increase, since we have heard numerous complaints from farmers 
about insufficient funds in past years.
    While this increased loan level met the demand for Direct Farm 
Ownership Loans in fiscal year 2016, we faced a shortfall for Direct 
Farm Operating Loans. With the recent fluctuations in crop prices, the 
lending market has grown more cautious and more farmers have needed to 
turn to FSA for their credit needs. Without an increase in loan 
authority, we expect a shortfall in Direct Farm Operating Loans in 
fiscal year 2017 and a significant backlog of loan applications by 
beginning farmers and others not served by commercial credit. This 
would be a serious problem for both these individual farmers and our 
broader agricultural community, which is facing a shortage of beginning 
farmers. We strongly support funding for these loan programs sufficient 
to provide $1.46 billion in Direct Farm Operating Loans and $1.5 
billion in Direct Farm Ownership Loans.
Beginning Farmer and Rancher Individual Development Accounts ($1.5 mil)
    Individual development accounts (IDAs) help young and beginning 
farmers become successful entrepreneurs by matching funds that they put 
into a savings account while taking required business planning courses. 
IDA programs have been instrumental in helping young people start 
businesses in states including Michigan, Iowa, and California. The 
Beginning Farmer and Rancher IDA pilot program was created in the 2008 
Farm Bill and reauthorized in 2014. In spite of the successes of 
privately run programs around the country, the Federal IDA pilot 
program has never been funded. As the existing farmer population 
continues to age and the need for young farmers grows, it has never 
been more important that the Federal IDA pilot program receive $1.5 
million in funding.
Food Safety Outreach Program ($10 mil)
    Food safety training has become a particularly important concern 
for young farmers. The new food safety regulations, finalized by the 
Food and Drug Administration (FDA) last year, set forth expansive new 
requirements for farms. Farmers are going to need training and outreach 
in order to understand the maze of new requirements being asked of 
them. The Food Safety Outreach Program, administered by USDA's National 
Institute for Food and Agriculture (NIFA), was authorized to meet this 
need. It funds farmer and food processor training efforts focused on 
helping small and mid-sized family farms; beginning farmers; 
diversified, sustainable, and organic agricultural operations; and on-
farm processors adapt to new regulatory pressures.
    We are very grateful for the $5 million funding that was 
appropriated to this program last year. However, this only scratches 
the surface of the on-the-ground need for training and outreach. We 
request the Food Safety Outreach Program be funded at $10 million. At 
this funding level, the Food Safety Outreach Program would reach 
roughly 16,600 farmers across the country. While this number is small 
relative to the need, without any training, the final FDA regulations 
will hurt small and mid sized producers and processors and fall far 
short of the goal of improving food safety.
---------------------------------------------------------------------------
    \1\ USDA National Agriculture Statistics Service. (2014). 2012 
Census of Agriculture. http://www.agcensus.usda.gov/Publications/2012/
Full_Report/Volume_1,--Chapter_1_US/st99_1--001_001.pdf/
    \2\ American Farmland Trust. (n.d.). Farmland by the Numbers. 
http://www.farmland.org/programs/protection/American-Farmland-Trust-
Farmland-Protection-Farmland-by-the-numbers.asp.

    [This statement was submitted by Eric Hansen Policy Analyst, 
---------------------------------------------------------------------------
National Young Farmers Coalition.]

                                 ______
                                 
            Prepared Statement of National Organic Coalition
    I am submitting this testimony on behalf of the National Organic 
Coalition (NOC) to detail our fiscal year 2017 funding requests for 
USDA programs of importance to the organic sector.
               usda/agricultural marketing service (ams)
  
National Organic Program
Request: $9.094 million
  
    Organic agriculture is one of the fastest growing sectors of 
agriculture, fueled by strong consumer demand. Over the last decade, 
sales of organic food and beverages have averaged double-digit annual 
growth. The organic sector has grown to over $36 billion industry in 
annual sales with over 21,764 certified organic family farmers and 
other businesses.
    The National Organic Program (NOP) is the agency charged with 
regulating and enforcing the USDA organic label. NOP was funded at 
about $9.02 million for fiscal year 2016. We are requesting $9.094 
million for NOP, consistent with the Administration's fiscal year 2017 
budget request.
                         usda (ams, nass, ers)
  
Organic Data Initiative
Request: Report language for AMS--Continue and Expand Organic Price 
Reporting
Request: Report language for NASS--Continue and Expand Organic Data 
Collection
Request: Report language for ERS--Continue and Expand Organic Data 
Analysis Work
  
    Authorized by Section 7407 of the 2002 Farm Bill, the Organic 
Production and Marketing Data Initiative states that the ``Secretary 
shall ensure that segregated data on the production and marketing of 
organic agricultural products is included in the ongoing baseline of 
data collection regarding agricultural production and marketing.'' In 
addition to providing mandatory funding, Section 10004 of the 2014 Farm 
Bill authorizes $5 million annually in discretionary funding for this 
effort.
    As the organic industry matures and grows at a rapid rate, the lack 
of national data for the production, pricing, and marketing of organic 
products has been an impediment to further development of the industry 
and to the effective functioning of many organic programs within USDA. 
Organic data collection and analysis at USDA has made significant 
strides in recent years, but remains in its infancy.
    We are requesting report language urging AMS, NASS, and ERS to 
continue to expand their organic data collection within its base 
activities.
         usda/national institute of food and agriculture (nifa)
  
Organic Transitions Program
Request: $5 million
  
    The Organic Transition Program, authorized by Section 406 of the 
Agricultural Research, Education and Extension Reform Act (AREERA) for 
Integrated Research Programs, is a research grant program to help 
farmers address some of the challenges of organic production and 
marketing. As the organic industry grows, the demand for research on 
organic agriculture is experiencing significant growth as well. This 
research has broad applications to all sectors of agriculture, even 
beyond the organic sector.
    The Organic Transition Program was funded at $5 million in fiscal 
year 2010, and about $4 million for fiscal years 2011 through 2016. The 
Administration's fiscal year 2017 budget requests level funding. We are 
seeking $5 million to restore the program to its fiscal year 2010 
level.
    As demand for organic food and beverages continues to grow at a 
very fast rate, domestic production of organic food has not kept pace, 
requiring a greater percentage of organic product to be imported to 
meet the consumer demand. USDA's National Organic Standards Board has 
identified a list of organic research priorities, many of which would 
address challenges that have limited the growth in domestic production.
    The funding increase that we are requesting would help to address 
these needs. In addition, we are requesting the following report 
language to accompany the increase in funding for the program:

        ``As domestic consumption of organic food and beverages 
        continues to grow, domestic supply is not able to keep up with 
        the demand. USDA's National Organic Standards Board (NOSB) has 
        identified key organic research priorities, many of which would 
        help to address issues that have limited growth in organic 
        production in this country. The Committee provides an increase 
        in funding for the Organic Transition Program, and urges the 
        agency to strongly consider the NOSB organic research 
        priorities when crafting the fiscal year 2017 RFA for the 
        program.''
  
Agriculture and Food Research Initiative (AFRI)
Request: Report language on public cultivar development
  
    In recent decades, public resources for cultivar development have 
dwindled, while resources have shifted toward genomics and 
biotechnology, with a focus on a limited set of major crops. This 
problem has been particularly acute for organic and sustainable 
farmers, who seek access to germplasm well suited to their unique 
cropping systems and their changing local environments and climates.
    In Section 7406 of the Food, Conservation, and Energy Act of 2008, 
the National Research Initiative was merged with the Initiative for 
Future Agriculture and Food Systems to become the Agriculture and Food 
Research Initiative (AFRI). Congress included language within AFRI to 
make ``conventional'' plant and animal breeding a priority for AFRI 
research grants, consistent with the concerns expressed by the 
Appropriations Committee in preceding appropriations cycles.
    Unfortunately, USDA has made only modest progress toward addressing 
the classical breeding Farm Bill and appropriations directives. We are 
requesting the following report language stressing that funding for 
classical breeding and public cultivar development should be a distinct 
priority and funding stream within AFRI, consistent with report 
language included in the fiscal year 2016 Senate report:

        Section 7406 of the Food, Conservation, and Energy Act of 2008 
        specifies priority areas with the Agriculture and Food Research 
        Initiative [AFRI], including an emphasis on conventional 
        (classical) plant and animal breeding. The Committee strongly 
        concurs with the intent of this section, and notes the 
        importance of having publicly available cultivars and breeds 
        that are specifically bred to be adapted to the soils, 
        climates, and farming systems of farmers of all regions. The 
        Committee reiterates the request made in the fiscal year 2016 
        Senate report, and strongly urges NIFA to make public cultivar 
        and breed development an increased priority for funding within 
        the AFRI program and to create a separate priority area for 
        this important work. The Committee further requests a report 
        from the agency as to its plans for implementing this important 
        requirement. [NOTE: Most of this is identical to the language 
        in the fiscal year 2016 Senate Report, except for the bolded 
        text, which is updated.]
  
Agriculture and Food Research Initiative (AFRI)
Request: Report language on organic research
  
    Organic agriculture is one of the fastest growing, and most 
promising, sectors of the U.S. agricultural economy. The benefits for 
organic research benefit not only the organic sector, but conventional 
farmers as well. Research to help farmers with the latest science on 
addressing pest problems and nutrient needs on their farms without 
expensive off-farm inputs is extremely helpful to organic and 
conventional farmers alike. We are requesting the following report 
language urging NIFA to increase funding for the organic research 
through the AFRI program, to help keep pace with the rapidly growing 
organic sector, and to help address the shortage of domestic supply to 
meet growing demand for organic products:
    As in recent years, the Committee continues to prioritize funding 
for the Agriculture and Food Research Initiative (AFRI), as the 
flagship competitive grants research program for agriculture. However, 
in doing so, it is critical that the agency take actions to ensure that 
AFRI meets the needs of the full spectrum of the U.S. food and 
agriculture sector. The Committee notes that only about 0.1 percent of 
AFRI funding was used for research to address challenges of the U.S. 
organic sector during the period of fiscal years 2010-2014. As the 
organic sector struggles to boost domestic production in order to 
respond to the growing consumer demand for organic products, funding 
for organic research is critical, and the AFRI program should be part 
of that solution. The Committee urges the agency to execute a plan to 
incorporate organic research needs into the AFRI program more fully, 
and requests a report on the progress toward that goal.
  
Sustainable Agriculture Research and Education (SARE)
Request: $30 million
  
    The SARE program has successfully funded on-farm research on 
environmentally sound and profitable practices and systems, including 
organic production. The reliable information developed and distributed 
through SARE grants is very helpful to organic farmers. The President's 
fiscal year 2016 budget requests $30 million for SARE, and we are 
supporting that $30 million request for the combined activities of 
SARE.
  
Food Safety Outreach Program
Request: $10 million
  
    We are requesting $10 million to help small and mid-size farms and 
small processing facilities comply with new proposed food safety 
regulations. This training program, authorized in the Food Safety 
Modernization Act of 2010 (FSMA), is one of the best and least costly 
ways to improve food safety outcomes without resorting to excessive 
farm regulation. The program received $5 million in fiscal year 2016. 
The President's fiscal year 2017 budget requests $5 million. We are 
requesting $10 million for fiscal year 2017, because food safety 
training for family-scale operations is critical at this stage of FSMA 
implementation.
  
Hatch Act Formula Grants
Request: 10 percent increase in funding, targeted to increase the 
public plant and animal breeding capacity of land grant institutions to 
address farmers' need for regionally adapted cultivars and breeds.
  
    The capacity of our nation's land grant institutions (LGUs) to 
address the needs of local farmers for locally and regionally adapted 
cultivars and breeds has reached crisis levels, and funding for these 
efforts has been in a steady decline. As a result, farmers must rely on 
seeds and breeds that are outdated, and have not been improved to 
address changing climates, pest challenges, farming systems, and 
consumer demands. For all regions of our nation to optimize their 
productive capacity in an environmentally sustainable manner, it is 
critical that the farmers of the region have access to the most up-to-
date cultivars that have been breed in that region to meet ever-
changing conditions. A recent survey of LGUs shows that since 1994, the 
U.S. has lost 33 percent of its public plant breeding programs. On a 
regional basis, the analysis shows a 47 percent loss in public plant 
breeding programs in the Northeast, a 33 percent loss in the Midwest, a 
35 percent loss in the West, and a 21 percent loss in the Southeast.
    Therefore, we are requesting a 10 percent increase in funding for 
Hatch Act formula grants, to be targeted to foster the next generation 
of public plant and animal breeders at our national LGUs by focusing on 
the development of publicly available, regionally adapted cultivars and 
breeds.
                usda/rural business cooperative service
  
Appropriate Technology Transfer for Rural Areas (ATTRA)
Request: $2.5 million
  
    ATTRA, authorized by Section 6015 on the Agricultural Act of 2014, 
is a national sustainable agriculture information service providing 
practical information and technical assistance to farmers, ranchers, 
Extension agents, and educators interested in sustainable agriculture. 
ATTRA interacts with the public through its call-in service and 
website, and provides excellent publications to address some of the 
frequently asked questions of farmers and educators. We request $2.5 
million for fiscal year 2017 for ATTRA.

    [This statement was submitted by Steven Etka, Policy Director, 
National Organic Coalition.]

                                 ______
                                 
    Prepared Statement of National Sustainable Agriculture Coalition
    Thank you for the opportunity to present our fiscal year 2017 
funding requests. On behalf of our 44 member organizations from around 
the country, we submit the following USDA requests, in the order they 
appear in the appropriations bill:
                      departmental administration
    Office of the Secretary--Outreach Services Supporting New, 
Beginning, and Veteran Farmers and Ranchers. We urge you to meet USDA's 
request for $5 million for Department-wide enhanced outreach to 
beginning, women, and military veteran farmers.
    Office of Advocacy and Outreach. The Office of Advocacy and 
Outreach coordinates policy and outreach in four vital areas--small 
farms and beginning, socially disadvantaged, and veteran farmers. We 
urge that $1.2 million be provided for the OA&O, as requested by USDA.
    Outreach and Assistance for Socially Disadvantaged Farmers and 
Ranchers and Veteran Farmers and Ranchers. We strongly support USDA's 
request of $10 million in discretionary funding. Combined with no 
limitation in mandatory spending, this appropriation would restore the 
historical program funding level to meet increased demand for technical 
assistance by military veteran farmers, and other underserved 
producers.
               national institute of food and agriculture
    Sustainable Agriculture Research and Education Program. We strongly 
urge you to meet USDA's request of $30 million for this competitive 
grants research program. SARE has helped turn farmer-driven research, 
education, and extension into profitable practices for over 25 years. 
The program consistently yields practical farm innovations on a more 
accelerated timeframe than other competitive research programs. At $30 
million, SARE would be at half its authorized level and half the level 
recommended by the National Academy of Sciences. Due to high demand and 
inadequate funding, USDA has been able to fund only 6 percent of SARE 
pre-proposals for research and education competitive grants in recent 
years. Increasing funding to $30 million would begin to address this 
disparity. It would enable SARE to expand its prized work on soil 
health, cover cropping, and rotational grazing. It will also allow USDA 
to expand its backing for research to support beginning farmers, 
including on-farm research in which innovative young farmers can work 
with others in the SARE team to experiment with new production and 
management systems on a portion of their farm. The increase would also 
help SARE expand its unique graduate student research program, helping 
create the next generation of agricultural scientists who will make the 
breakthrough sustainability discoveries of the future.
    Organic Transitions Integrated Research Program. We request $5 
million to invest in innovative organic research with strong farmer 
delivery mechanisms built in. Restoring this funding level will keep 
organics from falling further behind in its fair share of the research 
budget.
    Food Safety Outreach Program. We strongly urge you to provide $10 
million to help small and mid-size farms and small processing 
facilities comply with the new FSMA food safety regulations. We are 
pleased Congress appropriated $5 million for FSOP for fiscal year 16. 
However, the major FSMA rules are final now and are in the process of 
being implemented; at $10 million in fiscal year 2017, FSOP would reach 
roughly 16,600 farmers across the country. While still small relative 
to the need, this funding level addresses the magnitude of the 
situation, namely that without adequate training, the FSMA regulations 
will hurt small and mid sized producers and processors and fall far 
short of the goal of improving food safety--no matter how much more 
money gets appropriated for FSMA implementation and enforcement 
overall.
                          farm service agency
    Direct Farm Ownership Loans, Direct Operating Loans, and Individual 
Development Accounts. Direct farm loans provide crucial capital for 
beginning farmers and others not adequately served by commercial 
credit. This is critical in light of the increasing age of farmers and 
the land access challenges faced by new and aspiring farmers. USDA's 
fiscal year 2017 budget proposes increased funding for Direct Farm 
Operating loans in order to meet the high demand by farmers unable to 
obtain commercial credit due to low commodity prices and a more 
constrained lending market. Without this increase, FSA will face a 
substantial funding shortfall and many farmers will be unable obtain 
the operating capital they need to make it through the growing season. 
Similarly, the Beginning Farmer and Rancher Individual Development 
Account (IDA) program, if funded, will enable limited-resource 
beginning farmers and ranchers to save for asset-building purchases, 
including equipment and breeding stock, to jump start their operations. 
The IDA program requires a 50 percent local match as well as financial 
management training as the core component of the program. We support 
USDA's request for program levels of $1.5 billion for Direct Farm 
Ownership loans, $1.46 billion for Direct Operating Loans, and $1.5 
million for the IDA program. We also support the USDA request for 
guaranteed ownership and operating loans.
    New, Beginning, and Veteran Farmer and Rancher Initiatives. We 
support the Administration's request for $3.9 million for a 
certification program to help veteran farmers prequalify for loans, FSA 
staff devoted to providing outreach to beginning and veteran farmers, a 
pilot for a new farmer mentoring network, and funding for cooperative 
agreements to support assistance to new farmers and to work with 
landowners to help them transition their farm to the next generation. 
This combined package will serve as a critical tool for supporting 
veterans and investing in the next generation of farmers.
                 natural resources conservation service
    Conservation Technical Assistance. CTA, a subset of Conservation 
Operations, is the backbone of USDA's conservation programs. Through 
CTA, NRCS field staff work with farmers to develop and implement 
conservation plans to conserve resources on their farms. NRCS also uses 
CTA funds to assess conservation practices and systems, and to collect, 
analyze, and disseminate data on the condition of the nation's natural 
resources. USDA's fiscal year 2017 budget request proposes to increase 
CTA funding by 2.5 percent from $741.6 million to $760.7 million. We 
urge you to approve this increase, which will help more producers 
develop site-specific plans to conserve water, prepare for extreme 
weather, and address natural resource concerns on their land.
                  rural business--cooperative service
    Appropriate Technology Transfer for Rural Areas. For nearly 30 
years, the ATTRA program has provided practical, cutting edge 
information to farmers, extension agents, and others. In fiscal year 
2015, ATTRA provided assistance to more than 2.2 million agricultural 
producers and businesses, and organized presentations, workshops, and 
field days in 25 locations across the U.S. attended by at least 15,000 
people. For fiscal year 2017, we urge you to provide $2.75 million, and 
increase of $250,000 over the President's request and last year's 
funding level. This increase will support the expansion of ATTRA's 
Armed to Farm program that trains returning military veterans to farm. 
The small increase will enable ATTRA to expand its work to meet the 
needs of aspiring veteran farmers. To date, veterans from 22 states 
have attended these week-long trainings. A recent survey of Armed to 
Farm participants found that 80 percent have continued to farm, have 
started farming, or are in the process of starting a farm.
    Value-Added Producer Grants. VAPG offers competitive grants to 
farmers and ranchers developing farm- and food-related businesses that 
boost farm income and create jobs in rural America. These grants may be 
used to fund business and marketing plans and feasibility studies or to 
acquire working capital to operate a value-added business venture or 
alliance. Despite its proven success as a driver of rural economic 
development, the President has not requested a funding increase for 
VAPG since fiscal year 2014. We request $15 million in discretionary 
funding and no changes in mandatory program spending, to bring the 
program up to its 2014 funding levels.
    Rural Microentrepreneur Assistance Program. RMAP provides business 
training and microloans to owner-operated businesses with up to ten 
employees. It targets very small business development, the leading job 
creator in rural communities, and is the only Federal program that 
finances the capitalization of revolving microloan funds for rural 
areas. We support USDA's fiscal year 2017 budget request for $2.9 
million for microlending and $2 million for grants to support 
microbusiness training and technical assistance, as well as no changes 
in mandatory program spending.
                           general provisions
    A suite of distinct but interrelated farm bill programs, including 
the Environmental Quality Incentives Program (EQIP) and Conservation 
Stewardship Program (CSP), work together to give farmers the tools they 
need to protect and rebuild soil, provide clean water, and enhance 
wildlife habitat. Congress should not re-open the 2014 Farm Bill 
through the appropriations process. That bill cut $6 billion from 
conservation programs, including over $2 billion from the CSP. The 
fiscal year 2015 CRomnibus cut an additional 23 percent from CSP and 16 
percent from EQIP, forcing USDA to turn away 75 percent of the eligible 
producers who applied. Additional cuts to mandatory spending for 
conservation will mean that the number of farmers denied access to the 
programs will grow even larger; and less participation in voluntary 
conservation programs means more pollution and more regulation, as well 
as less productive and profitable farmlands. We strongly oppose changes 
in mandatory program spending to these critical conservation programs.
    Finally, we oppose the inclusion of any policy riders that limit 
implementation and enforcement of the Packers & Stockyards Act. 
Limiting USDA's ability to protect market transparency has no rightful 
place in the appropriations bill or any other legislation.

                                 ______
                                 
         Prepared Statement of Oregon Water Resources Congress
    The Oregon Water Resources Congress (OWRC) strongly supports the 
fiscal year 2017 budget for the U.S. Department of Agriculture's (USDA) 
Natural Resources Conservation Service (NRCS) programs. It is crucial 
that the Regional Conservation Partnership Program (RCPP) has adequate 
resources and we request a minimum of $200 million to leverage 
partnerships and tackle the complex natural resources conservation 
issues facing the nation. Furthermore, we are strongly supportive of 
coordinated Federal agency watershed planning and request funding for 
the Small Watershed Rehabilitation Program, a minimum of $250 million.
    OWRC was established in 1912 as a trade association to support the 
protection of water rights and promote the wise stewardship of water 
resources statewide. OWRC members are local governmental entities, 
which include irrigation districts, water control districts, drainage 
districts, water improvement districts, and other agricultural water 
suppliers that deliver water to roughly 1/3 of all irrigated land in 
Oregon. These water stewards operate complex water management systems, 
including water supply reservoirs, canals, pipelines, and hydropower 
production.
                         rcpp benefits & needs
    OWRC strongly supports the RCPP, and while we are encouraged by the 
request for $100 million in fiscal year 17 in the President's budget, 
an increase of $7 million from 2016 enacted levels, additional funding 
is still needed. The RCPP is a critical tool for districts and other 
agricultural water suppliers in developing and implementing water and 
energy conservation projects in Oregon. In the past, the Agricultural 
Water Enhancement Program (AWEP) has been highly successful in 
developing cooperative approaches on a basin-wide scale, and 
historically, the Cooperative Conservation Partnership Initiative 
(CCPI) partnerships allowed Federal, State and Local interests to 
address Endangered Species Act (ESA) and Clean Water Act (CWA) issues 
in watershed basins and sub basins.
    Federal support of water conservation activities funded through 
NRCS programs, including the RCPP, is essential to the conservation of 
our natural resources and critical to protecting our food, energy and 
water supply. Financial assistance has diminished in recent years and 
there is a backlog of unmet need. For example, in February 2016, USDA 
announced that they received 265 applications requesting nearly $900 
million dollars, which was four times the amount of available funding. 
They were able to only fund 84 projects.
    OWRC would like to thank the Administration for not cutting funding 
to Environmental Quality Incentives Program (EQIP), in accordance with 
the 2014 Farm Bill. As demonstrated by the huge demand for RCPP 
funding, programs like EQIP need to remain in light of the need for 
investment in conservation projects. While we applaud the continued 
existence of EQIP, $1.65 billion is not enough to keep the program 
effective. It is essential the EQIP have at least $2 billion in 
appropriations funding if Congress would like to see widespread 
results. Furthermore, with the numerous new and potential listings 
under ESA and increased water regulations under the CWA, there is a 
dire need for additional funding to support conservation efforts 
nationwide.
    While we recognize that the Administration has increased funding 
for some NRCS programs, the need for additional financial assistance 
still far outweighs the proposed budget. NRCS programs are essential to 
irrigation districts in developing and implementing conservation 
projects that benefit not only the individual farmers they serve but 
also the entire watershed and community as a whole. Furthermore, 
conservation projects also benefit the economy through job creation and 
ensuring the future viability of American agriculture.
    RCPP helps fill a funding void for multi-partner conservation 
projects and allow farmers to pool together and leverage the dollars 
invested in the off-farm project with the addition of EQIP on-farm 
projects. The effects of drought and climate change combined with ESA 
and CWA regulation has created a daunting set of circumstances for 
irrigated agriculture in the West. RCPP and EQIP have become an 
essential lifeline for farmers to adapt to climate change. It is 
critical to increase funding for new eligible RCPP projects that 
benefit the environment and economy and alleviate some of the negative 
effects of drought and climate change.
             examples of successful awep projects in oregon
    Oregon has had several successful AWEP projects over the past 
several years, including three from our member districts (described 
below). Additionally, in Oregon, NRCS is helping develop the Save 
Water, Save Energy Initiative, a multi-agency cooperative effort to 
develop a clearinghouse of information on financial incentives and 
technical expertise to assist districts and their water users in 
implementing conservation measures. Additional innovative projects like 
these could be developed and implemented in Oregon if more funding is 
made available.

  --The Whychus Creek/Three Sisters Irrigation District Collaborative 
        Restoration Project focuses on irrigation water efficiency with 
        irrigation improvements in the Upper Division of the Three 
        Sisters Irrigation District, which is the project partner. The 
        effort will improve stream flows and water quality for native 
        fish while providing farmers a reliable supply of water. Fiscal 
        year 2013 Funding: $180,000; fiscal year 2012 $251,300
  --The Talent Irrigation District Project works with agricultural 
        producers to install conservation practices that will properly 
        utilize limited surface water resources, improve water quality 
        on flood irrigated land by converting to more efficient 
        irrigation systems, and apply irrigation water management to 
        eliminate irrigation runoff. Fiscal year 2013 Funding: $0; 
        Fiscal year 2012 Funding: $4,470
  --The Willow Creek Project helps landowners in the Lower Willow Creek 
        Watershed portion of Malheur County convert to water-saving 
        irrigation systems, reduce irrigation runoff, and improve water 
        quality in Willow Creek and Malheur River. The project partner 
        is the Vale Oregon Irrigation District. Fiscal year 2013 
        Funding: $180,000; Fiscal year 2012 $251,300
  small watershed rehabilitation program and watershed planning needs
    OWRC also strongly supports the Small Watershed Rehabilitation 
Program. Two of our members, Sutherlin Water Control District (SWCD) 
and Middle Fork Irrigation District (MFID) have dams that were built 
under PL-566. SWCD and MFID have received funds to begin the long and 
expensive process of updating their 50 year old dams to today's 
standards for safety, however; both districts will need continued 
funding from the Small Watershed Rehabilitation Program to fully update 
their infrastructure.
    SWCD has two dams built under PL-566 and while they were built to 
seismic standards 50 years ago, they do not meet today's standards for 
earthquakes. SWCD's dams serve as multi-purpose storage for the 
community; providing flood control, irrigation water, municipal water 
and recreation. Additionally, it is important to note that even a small 
earthquake has the potential to severely damage the dams and cause 
intensive flooding and damage in the surrounding area. To date, SWCD 
has been authorized to receive funding for planning, design and 
construction of one of their dams and planning and design on the other. 
However, SWCD will still need considerable funding dollars to complete 
construction on the second dam.
    MFID is responsible for the management and maintenance of Clear 
Branch Dam, a PL-566 dam within the Hood River watershed, which 
provides a clean, dependable water supply and distribution system for 
the irrigation of pears, apples, cherries and other crops. 
Rehabilitation of the dam is needed to protect the public from 
flooding, for access to a clean and dependable water supply, and to 
maintain agricultural productivity. Additionally Laurance Lake, which 
is formed by Clear Branch Dam, and its tributaries, are the primary 
spawning and rearing habitat for Hood River Basin Bull Trout, a 
threatened species under ESA. Rehabilitation of Clear Branch Dam will 
improve fish passage connectivity for Bull Trout and improve water 
temperature for spawning, rearing and migration.
    Once planning and design studies are complete, both MFID and SWCD 
will know what the costs will be to make the necessary improvements to 
their dams, which is currently estimated at over $10 million for both 
SWCD dams and $9.8 million for MFID. In light of the high costs to fix 
just 3 of the PL-566 dams, a minimum of $250 million is needed to 
address and repair high priority dams like the ones here in Oregon.
    Our member districts, the farms and other water users they serve, 
and the communities in which they are located benefit greatly from the 
NRCS programs described in our testimony. Oregon's agricultural 
community is actively committed to water conservation programs, but 
those programs require robust Federal participation if the agricultural 
community is to be able to continue its efforts to address Oregon's 
water supply needs through conservation. Increasing the budget for NRCS 
programs is a strategic investment that will pay both environmental and 
economic dividends to Oregonians and America as a whole. Thank you for 
the opportunity to provide testimony on the proposed fiscal year 17 
budget for the USDA's NRCS Programs.

    [This statement was submitted by April Snell, Executive Director, 
Oregon Water Resources Congress.]

                                 ______
                                 
       Prepared Statement of Organic Farming Research Foundation
    I am submitting this testimony on behalf of the Organic Farming 
Research Foundation (OFRF) to detail our fiscal year 2017 funding 
requests for USDA programs of importance to the organic farming sector.
    usda/national institute of food and agriculture (nifa) organic 
                transitions program request: $5 million
    The Organic Transition Program, is a critical research grant 
program that helps farmers address some of the challenges of organic 
production and marketing. The demand for research on organic 
agriculture is outpacing the available funds in this program. According 
to NIFA, only 38 percent of the applicants to this program receive 
funding. USDA's National Organic Standards Board (NOSB) has identified 
a number of organic research priorities that cannot be funded due to a 
lack of resources. An increase in the Organic Transition Program would 
allow the NOSB to address some of the research issues that limit the 
growth of the organic industry. And given the innovative nature of 
organic agriculture, many of these research projects benefit all 
farmers, not just those in the organic sector. The Organic Transition 
Program was funded at $5 million in fiscal year 2010, and about $4 
million for fiscal years 2011 through 2015. We are seeking $5 million 
to restore the program to its fiscal year 2010 level to in order to 
address the current low funding rate for this program.
  usda/agricultural marketing service (ams) national organic program 
                          request: $15 million
    The National Organic Program is the regulatory program housed 
within the USDA Agriculture Marketing Service responsible for 
developing national standards for certified agricultural organic 
products. These standards assure consumers that products within the 
USDA organic seal meet consistent, uniform standards. The NOP is vital 
for meeting the growing consumer demand for organic products. 
Recognizing continued growth of the industry, we ask for $15 million, 
the full amount authorized in the 2014 Farm Bill. This amount reflects 
the strong growth of the sector. The industry current returns over $200 
for every $1 spent on the NOP so an increased investment would garner a 
strong return for the Federal government. Moreover, this would give NOP 
the resources it needs to fully enforce the organic regulations 
globally, to continue to develop international equivalence arrangements 
to expand the market for American organic products worldwide; and to 
develop organic standards for emerging sectors.
usda/national institute of food and agriculture (nifa)--agriculture and 
food research initiative- public cultivar and breed development--report 
                                language
    Section 7406 of the Food, Conservation, and Energy Act of 2008 
specifies priority areas with the Agriculture and Food Research 
Initiative [AFRI], including an emphasis on conventional (classical) 
plant and animal breeding. The Committee strongly concurs with the 
intent of this section, and notes the importance of having publicly 
available cultivars and breeds that are specifically bred to be adapted 
to the soils, climates, and farming systems of farmers of all regions. 
The Committee reiterates the request made in the fiscal year 2016 
Senate report, and strongly urges NIFA to make public cultivar and 
breed development an increased priority for funding within the AFRI 
program and to create a separate priority area for this important work. 
The Committee further requests a report from the agency as to its plans 
for implementing this important requirement.
usda/national institute of food and agriculture (nifa)--agriculture and 
               food research initiative- organic research
    As in recent years, the Committee continues to prioritize funding 
for the Agriculture and Food Research Initiative (AFRI), as the 
flagship competitive grants research program for agriculture. However, 
in doing so, it is critical that the agency take actions to ensure that 
AFRI meets the needs of the full spectrum of the U.S. food and 
agriculture sector. The Committee notes that only about 0.1 percent of 
AFRI funding was used for research to address challenges of the U.S. 
organic sector during the period of fiscal years 2010-2014. As the 
organic sector struggles to boost domestic production in order to 
respond to the growing consumer demand for organic products, funding 
for organic research is critical, and the AFRI program should be part 
of that solution. The Committee urges the agency to execute a plan to 
incorporate organic research needs into the AFRI program more fully, 
and requests a report on the progress toward that goal.
usda/sustainable agriculture research and education (sare) request: $30 
                                million
    The SARE program is another valuable research program with a focus 
on environmentally sound practices and systems, with organic production 
research as one of the beneficiaries. Consistent with the increased 
demand for organic research, as well as the challenges presented by a 
changing climate, we are requesting $30 million for the SARE Program to 
assist farmers as they try to improve and adjust their growing 
practices.
    usda/rural business cooperative service--appropriate technology 
         transfer for rural areas (attra)request: $2.75 million
    ATTRA, a national sustainable agriculture information service, is 
an important source of information and technical assistance for for 
farmers, ranchers, Extension agents, and educators on sustainable 
agriculture.
     usda/conservation technical assistance request: $760.7 million
    Conservation Technical Assistance (CTA), a subset of Conservation 
Operations, is the backbone of USDA's conservation programs. Through 
CTA, NRCS field staff work with farmers to develop and implement 
conservation plans to conserve resources on their farms. NRCS also uses 
CTA funds to assess conservation practices and systems, and to collect, 
analyze, and disseminate data on the condition of the nation's natural 
resources. The President's fiscal year 2017 budget request proposes to 
increase CTA funding by 2.5 percent from $741.6 million to $760.7 
million. We urge you to approve this increase, which will help more 
producers develop site-specific plans to conserve water, prepare for 
extreme weather, and address natural resource concerns on their land.

    [This statement was submitted by Jane E. Shey Policy Associate, 
Organic Farming Research Foundation.]

                                 ______
                                 
            Prepared Statement of Organic Trade Association
    Chairman Moran, Ranking Member Merkley, and Members of the 
Subcommittee, I am Laura Batcha, Executive Director and CEO of the 
Organic Trade Association (OTA).\1\ The organic sector continues to be 
one of the fastest-growing sectors of American agriculture, a vibrant 
market that has grown to $39 billion in sales, at double digit growth 
rates in recent years. The industry is comprised of over 19,500 
American organic businesses, and creates jobs at four times the rate of 
the economy as a whole.
---------------------------------------------------------------------------
    \1\ The Organic Trade Association (OTA) is the membership-based 
business association for organic agriculture and products in North 
America. OTA is the leading voice for the organic trade in the United 
States, representing over 8,500 organic businesses across 50 states. 
Its members include growers, shippers, processors, certifiers, farmers' 
associations, distributors, importers, exporters, consultants, 
retailers and others. OTA's Board of Directors is democratically 
elected by its members. OTA's mission is to promote and protect ORGANIC 
with a unifying voice that serves and engages its diverse members from 
farm to marketplace.
---------------------------------------------------------------------------
    Despite the growth in production, demand outpaces supply. Organic 
food sales make up nearly 5 percent of total food sales, while organic 
acreage is less than 1 percent of total U.S. cropland, and consumer 
demand continues to grow. Over 80 percent of U.S. families, spanning 
racial and economic lines, buy organic. Organic is a mainstream market, 
and a production system with independent marketplace dynamics. When 
viewed as a distinct class, organic ranks fourth in food/feed crop 
production at farm-gate values. This parallel stream of commerce and 
production is a bright spot in the American marketplace of innovation 
and entrepreneurship.
    The 2014 Farm Bill offered an enhanced array of resources to help 
the organic sector continue to grow, innovate, create new markets and 
jobs, provide certified operations new tools to succeed, and ensure 
consumers access to safe and nutritious food supply. To facilitate 
this, we respectfully request the following funding levels: USDA (AMS) 
National Organic Program--$15 million; USDA (NIFA) Organic Transition 
Research Program--$5 million; USDA (AMS) Organic Data Initiative--
$309,000; and USDA (NASS) Organic Data Initiative--$250,000. We also 
request report language urging USDA to ensure organic operations have 
full access to a variety of programs at the Department.
                     national organic program (nop)
    OTA requests $15 million for NOP, which enforces the organic 
regulations and ensures they evolve to keep pace with consumer 
expectations. Recognizing the strong growth of the industry, we ask for 
the full amount authorized in the 2014 Farm Bill. These resources would 
allow NOP to fully enforce the organic regulations globally, develop 
international equivalence arrangements to expand the market for 
American organic products, and develop organic standards for emerging 
sectors. Moreover, increased NOP funding is a strong investment, as 
there is a return on investment of $200 for every dollar spent on NOP.
       national organic certification cost-share program (noccsp)
    The NOCCSP assists producers and handlers in obtaining 
certification, but is not currently being implemented using all 
congressionally-granted authority. Report language directing USDA to 
act to the full extent of its authority would support both the 
Department-wide desire to utilize all available programs to support 
transition, and State organic programs, which are critical to 
enforcement. We request the following language: ``Congress directs the 
USDA to act to the full extent of its authority in administering the 
NOCCSP to producers and handlers of agricultural products obtaining 
certification under the national organic production program. This 
includes reimbursing State organic program fees as well as 
certification costs associated with transition to organic production 
and handling. In particular, USDA should revise their NOCCSP Terms and 
Conditions document in accordance with the letter and intent of the 
law.''
               organic transition research program (org)
    OTA requests that ORG, which supports research, extension and 
higher education programs for organic producers, be funded at $5 
million. ORG consistently receives many more funding requests than it 
can accommodate, and while organic sales have grown to nearly 5 percent 
of retail agriculture sales, research funding provided to organic 
agriculture has never exceeded 2 percent.
                     organic data initiative (odi)
    ODI has been successful in providing valuable information to 
Congress, government agencies, and the organic industry. We ask for a 
modest amount $309,000 in discretionary funding for AMS (to continue 
and expand collections of organic pricing information) and $250,000 for 
NASS (to continue to collect and disseminate data regarding organic 
agriculture).
                additional requests for report language
    Farm to School: ``The Farm to School program seeks to build healthy 
communities by strengthening schools' supply chain and educational 
linkages to fresh fruits, vegetables and other commodities; however, 
increased access to organic foods in schools has not been fully 
realized. Organic operations are well-positioned to create 
opportunities for students to directly engage in agricultural STEM 
opportunities and create lasting healthy eating habits, additional 
goals of the law. The Committee understands the need for improved 
access to and interaction with certified organic operations and directs 
USDA to improve participation by certified organic operations in an 
effort to reduce hunger and improve access to local healthy food.''
    Beginning Farmer and Rancher Development Program: ``The Committee 
recognizes that to meet increasing consumer demand for organic 
products, domestic producers must either shift to organic production or 
enter organic production. Beginning farmers and ranchers selecting 
organic production should be given the tools they need. USDA should 
prioritize the needs of beginning farmers and ranchers opting for 
organic production and support programs and services that address their 
specific needs.''
    Environmental Quality Incentives Program: ``The Committee 
recognizes that the Organic Initiative is not intended to be the only 
way for organic producers to access EQIP funding. USDA is encouraged to 
track usage of all EQIP funds by certified organic producers, in order 
to determine how to best meet their needs.''
    Regional Conservation Partnership Program: ``RCPP allows for 
conservation projects which leverage public and private funding. 
Organic farmers implement a wide variety of creative methods to improve 
the environment. The Committee urges that 5 percent of the RCPP budget 
be allocated to projects focused on organic production and its 
conservation benefits. In particular, NRCS funds may be used to provide 
technical assistance to ``explore opportunities to diversify 
agricultural operations and develop and apply sustainable agricultural 
systems,'' which is particularly relevant to certified organic farmers 
and those seeking to transition to organic. USDA should ensure that no 
barriers exist to certified organic and transitioning farmers receiving 
5 percent of RCPP funds.''
                               conclusion
    Organic agriculture creates economic opportunities for farmers and 
rural communities, while improving and conserving the environment and 
giving consumers additional choice in the market. Meeting these 
requests will help to ensure the continued growth of U.S. organic 
agriculture by promoting and supporting the integrity of the organic 
label, providing important data, and continuing to support research for 
organic agriculture. I thank the Committee and look forward to working 
with you to advance the organic industry.

    [This statement was submitted by Laura Batcha, Executive Director & 
CEO.]

                                 ______
                                 
                  Prepared Statement of Oxfam America
    On behalf of Oxfam America, Greater Minnesota Worker Center, 
Nebraska Appleseed Center for Law in the Public Interest, Northwest 
Arkansas Workers' Justice Center, Southern Poverty Law Center, and 
Western North Carolina Worker Center.
    The following comments are submitted on behalf of a coalition of 
organizations working to improve the conditions of workers in poultry 
processing. We remain concerned by recent comments made by members of 
Congress, about the need to increase poultry processing plant 
evisceration line speeds, currently regulated by the USDA Food Safety 
and Inspection Service.
    In August 2014, USDA finalized a new rule on Modernization of 
Poultry Slaughter Inspection after a full public comment period and 
significant input from occupational health experts and workers. The new 
rule explicitly removed the originally proposed line speed increase and 
kept line speeds for plants choosing to adopt the modernized inspection 
regime at 140 birds per a minute, the same rate that had preceded the 
rulemaking. USDA kept in place this line speed despite a draft rule 
that would have increased line speed to 175 birds per a minute after 
reviewing evidence on the threat to worker health and safety by 
increased speeds.
    A new report by Oxfam America, ``Lives on the Line: The Human Cost 
of Cheap Chicken, and recent worker survey by the Northwest Arkansas 
Workers' Justice Center echoed nearly every study about labor in the 
poultry industry: current line speed presents a constant threat to 
workers' health and safety. It is fast, relentless, and dangerous.\1\ 
Any additional increase in line speeds will only add to those threats.
---------------------------------------------------------------------------
    \1\ Oxfam America, ``Lives on the Line: Human Cost of Cheap 
Chicken'', October 26, 2015, http://www.oxfamamerica.org/explore/
research-publications/lives-on-the-line/.
---------------------------------------------------------------------------
    The high speed exacerbates dangers to workers from repetitive 
motions, sharp tools, and chemicals; heightens risks to consumers as 
workers cut corners while handling food; and increases liability for 
the companies as risks grow. Poultry workers already suffer 
occupational illnesses at six times the national average; carpal tunnel 
syndrome at seven times the average; and amputations at three times the 
average. Line speed directly impacts these numbers. In a survey of 302 
workers in Alabama, the Southern Poverty Law Center (SPLC) found that 
``78 percent of workers surveyed said that the line speed makes them 
feel less safe, makes their work more painful and causes more 
injuries.'' \2\
---------------------------------------------------------------------------
    \2\ Fritzsche, Unsafe at These Speeds.
---------------------------------------------------------------------------
    We urge the members of this Committee to reject any attempts to use 
the Appropriations process to legislate an increase in the maximum 
allowable line speed in poultry processing plants, as such an increase 
will only further exacerbate the well-documented risk of permanently 
crippling injuries to poultry workers and undermine USDA's recent 
rulemaking on this very issue.
    Workers commonly say that they are treated like ``perpetual motion 
machines'', doing the same motions an estimated 20,000 times per shift, 
unable to pause or slow down for even a few seconds.\3\ Workers report 
averaging between 35 and 45 birds per minute (BPM), meaning they 
process a chicken every two seconds. The higher the line speed the 
faster each worker must operate. More motions mean a greater likelihood 
of developing musculoskeletal disorders (MSDs). The constant pace means 
workers rarely can step back, change position, or stretch. These risks 
are exacerbated by cold and humid plant conditions. Dozens of medical 
studies have documented the elevated rate of painful and crippling MSDs 
in the workforce.\4\ They are also at risk of cuts, lacerations, and 
amputations that increase as speed accelerates. The constant repetitive 
motions cause pain in hands, fingers, arms, shoulders, backs, as well 
as swelling, numbness, and loss of grip. These injuries affect the 
ability to work, do chores, and even lift children.
---------------------------------------------------------------------------
    \3\ Hall, Alexander, and Ordonnez, ``The Cruelest Cuts,'' Charlotte 
Observer, September 30, 2008, http://www.charlotteobserver.com/news/
special-reports/cruelest-cuts/article9012839.html.
    \4\ See, for example, the National Institute for Occupational 
Safety and Health (NIOSH) report conducted by Kristin Musolin et al., 
Musculoskeletal Disorders and Traumatic Injuries Among Employees at a 
Poultry Processing Plant, Health Hazard Evaluation 2012--0125, April 
2013; Schulz et al., ``Upper Body Musculoskeletal Symptoms of Latino 
Poultry Processing Workers and a Comparison Group of Latino Manual 
Workers,'' American Journal of Industrial Medicine 56, no. 2 (July 
2012); van Rijn et al., ``Associations Between Work-Related Factors and 
Specific Disorders of the Shoulder--A Systematic Review of the 
Literature,'' Scandinavian Journal of Work, Environment & Health 36, 
no. 3 (2010); GAO, Workplace Safety and Health: Safety in the Meat and 
Poultry Industry; Punnett and Wegman, ``Work-Related Musculoskeletal 
Disorders: The Epidemiological Evidence and the Debate,'' Journal of 
Electromyography and Kinesiology 14, no. 14 (2004); National Research 
Council and Institute of Medicine, Musculoskeletal Disorders and the 
Workplace: Low Back and Upper Extremities (2001); Latko et al., 
``Cross-Sectional Study of the Relationship Between Repetitive Work and 
the Prevalence of Upper Limb Musculoskeletal Disorders,'' American 
Journal of Industrial Medicine 36, no. 2 (1999); Frost et al., 
``Occurrence of Carpal Tunnel Syndrome Among Slaughterhouse Workers,'' 
Scandinavian Journal of Work, Environment & Health 24, no. 4 (1998): 
285; Werner et al., ``Median Mononeuropathy Among Active Workers: Are 
There Differences Between Symptomatic and Asymptomatic Workers?'' 
American Journal of Industrial Medicine 33, no. 4 (1998): 374; Chiang 
et al., ``Prevalence of Shoulder and Upper-Limb Disorders Among Workers 
in the Fish-Processing Industry,'' Scandinavian Journal of Work, 
Environment & Health 19, no. 2 (1993).Hagberg, Morgenstern, and Kelsh, 
``Impact of Occupations and Job Tasks on the Prevalence of Carpal 
Tunnel Syndrome,'' Scandinavian Journal of Work, Environment & Health 
18, no. 6 (1992); Chiang et al., ``The Occurrence of Carpal Tunnel 
Syndrome in Frozen Food Factory Employees,'' Kaohsiung Journal of 
Medical Sciences 6, no. 2 (1990). Silverstein et al., ``Occupational 
Factors and Carpal Tunnel Syndrome,'' American Journal of Industrial 
Medicine 11, no. 3 (1987).
---------------------------------------------------------------------------
    The Government Accountability Office documented how fast line 
speeds prevents workers from taking precautions like sharpening knives: 
``The faster the pace at which the production line moves, the less able 
workers may be to perform tasks needed for safety.'' \5\
---------------------------------------------------------------------------
    \5\ GAO, Workplace Safety and Health: Safety in the Meat and 
Poultry Industry.
---------------------------------------------------------------------------
    Two-thirds (66 percent) of the poultry workers interviewed by 
Southern Poverty Law Center in 2013 described suffering from hand or 
wrist pain, swelling, numbness or an inability to close their hands. 
This rate was even higher among workers doing the jobs most affected by 
line speed reaching as high as 86 percent for workers cutting chicken 
wings.
    OSHA studied musculoskeletal disorder risk factors for years and 
found that employers could protect workers from musculoskeletal issues 
``by reducing the speed at which the employer performs the tasks.'' 
Still employer-mandated processing quotas and rapid line speeds mean 
that workers often have to rush and strain themselves to keep up. 
Workers who reported an injury due to line speed also reported higher 
mean and median piece/pound processing rates per minute, in some cases 
almost double the rates reported by workers who did not experience 
injury due to line speed. Women also reported higher rates of line 
speed related injury than men.
    Over half (54 percent) of workers surveyed answered yes to the 
question, ``Have you ever been forced to do things because of time 
pressure or line speed that might harm the health and safety of the 
consumer?''
    Poultry workers from across the country have felt the consequences 
of excessive line speed:
  --One worker in reported that the speed inched up as the hours went 
        by: ``As soon as the first shift leaves, around six o'clock, 
        that's when it speeds up and starts to get hard. You can't 
        stand the pain on your shoulders, your hands, because of that 
        repetitive movement.''
  --``There are so many problems happen as the lines go so fast,'' one 
        worker said. ``There might be 20-plus chickens that we cut [in] 
        one minute. The line is going so fast that sometimes we 
        accidentally cut our hands.''
  --Another worker offered, ``Sometimes I get headache because the line 
        is fast. I would almost pass out sometimes [because] the line 
        is fast.''
  --``These jobs were very repetitive,'' said a worker, who cut chicken 
        wings and breasts. ``My hands swelled up and were extremely 
        painful. When I was in so much pain that I had to stop, I asked 
        for breaks, but the company told me I had to keep working. 
        Because of the pressure to work fast, I can't use my arms, 
        wrists and hands the way I could before I worked in the poultry 
        plant.''
  --Current worker: ``The majority of people who work there harm their 
        fingers and their hands due to the line speed. Everyone knows 
        this1A. . .It's too much chicken . . .Too fast.''
    We recommend the members of this Committee reject any attempts to 
use the Appropriations process to legislate an increase the maximum 
allowable line speed in poultry processing plants, as such an increase 
will only further exacerbate the well documented risk of permanently 
crippling injuries to poultry workers and undermine USDA's recent 
rulemaking.

    [This statement was submitted by Jeffrey Buchanan, Senior Domestic 
Policy Advisor, Oxfam America.]

                                 ______
                                 
        Prepared Statement of Pickle Packers International, Inc.
                                summary
    Sustained and increased funding is desperately needed to maintain 
the research momentum built over recent years and to defray rising 
fixed costs at laboratory facilities. Companies in the pickled 
vegetable industry generously participate in funding and performing 
short-term research, but the expense for long-term research needed to 
insure future global competitiveness is too great for individual 
companies to shoulder on their own.
Additional Budget Requests for fiscal year 2017
    Funding needs for USDA/ARS laboratories are as follows:

          REQUESTS FOR PROGRAM ENHANCEMENT--PICKLED VEGETABLES
------------------------------------------------------------------------
                                                              Amount
------------------------------------------------------------------------
Emerging Disease of Crops...............................        $500,000
Quality and Utilization of Agricultural Products & Food          500,000
 Safety.................................................
DApplied Crop Genomics..................................         500,000
DSpecialty Crops........................................         500,000
                                                         ---------------
      Total Program Enhancements Requested--Pickled           $2,000,000
       Vegetables.......................................
------------------------------------------------------------------------


    USDA/ARS Research Provides:
  --Consumers with over 150 safe and healthful vegetable varieties 
        providing vitamins A, C, folate, magnesium, potassium, calcium, 
        and phytonutrients such as antioxidant carotenoids and 
        anthocyanins.
  --Genetic resistance for many major vegetable diseases, assuring 
        sustainable crop production with reduced pesticide residues--
        valued at nearly $1 billion per year in increased crop 
        production.
  --Classical plant breeding methods combined with bio-technological 
        tools, such as DNA markers, genetic maps, and genome sequencing 
        to expedite traditional breeding and increase efficiency.
  --New vegetable products with economic opportunities amidst 
        increasing foreign competition.
  --Improved varieties suitable for machine harvesting, assuring post 
        harvest quality and marketability.
  --Fermentation and acidification processing techniques to improve the 
        efficiency of energy use, reduce environmental pollution, and 
        reduce clean water intake while continuing to assure safety and 
        quality of our products.
  --Methods for delivering beneficial microorganisms in fermented or 
        acidified vegetables and producing reduced sodium, healthier 
        products.
  --New technology and systems for rapid inspection, sorting and 
        grading of pickling vegetable products in the field and at the 
        processing facility.
Health and Economical Benefits
  --Health agencies continue to encourage increased consumption of 
        fruits and vegetables, useful in preventing heart disease, 
        cancer, stroke, diabetes and obesity.
  --Vegetable crops, including cucumbers, peppers, carrots, onions, 
        garlic and cabbage (sauerkraut), are considered ``specialty'' 
        crops and not part of commodity programs supported by taxpayer 
        subsidies.
  --Current farm value for just cucumbers, onions and garlic is 
        estimated at $2.4 billion with a processed value of $5.8 
        billion. These vegetables are grown and/or manufactured in all 
        50 states.
    The pickled vegetable industry strongly supports and encourages 
your committee in its work of maintaining and guiding the Agricultural 
Research Service. To accomplish the goal of improved health and quality 
of life for the American people, the health action agencies of this 
country continue to encourage increased consumption of fruits and 
vegetables in our diets. Accumulating evidence from the epidemiology 
and biochemistry of heart disease, cancer, diabetes and obesity 
supports this policy. Vitamins (particularly A, C, and folic acid), 
minerals, and a variety of antioxidant phytochemicals in plant foods 
are thought to be the basis for correlation's between high fruit and 
vegetable consumption and reduced incidence of these debilitating and 
deadly diseases.
    As an association representing processors that produce over 85 
percent of the tonnage of pickled vegetables in North America, it is 
our goal to produce new products that increase the competitiveness of 
U.S. agriculture as well as meet the demands of an increasingly diverse 
U.S. population that is encouraged to eat more vegetables. The profit 
margins of growers continue to be narrowed by foreign competition. This 
industry can grow by meeting today's lifestyle changes with reasonably 
priced products of good texture and flavor that are high in nutritional 
value, low in negative environmental impacts, and produced with assured 
safety from pathogenic microorganisms and from those who would use food 
as a vehicle for terror. With strong research to back us up, we believe 
our industry can make a greater contribution toward reducing product 
costs and improving human diets and health for all economic strata of 
U.S. society.
    Many small to medium sized growers and processing operations are 
involved in the pickled vegetable industry. We grow and process a group 
of vegetable crops, including cucumbers, peppers, carrots, onions, 
garlic, cauliflower, cabbage (Sauerkraut) and Brussels sprouts, which 
are referred to as `minor' crops. None of these crops are in any 
``commodity program'' and do not rely on taxpayer subsidies. However, 
current farm value for just cucumbers, onions and garlic is $2.4 
billion with an estimated processed value of $5.8 billion. These crops 
represent important sources of income to farmers and rural America. 
Growers, processing plant employees and employees of suppliers to this 
industry reside in all 50 states. To realize its potential in the 
rapidly changing American economy, this industry will rely upon a 
growing stream of appropriately directed basic and applied research 
from four important research programs within the Agricultural Research 
Service.
                         applied crop genomics
    The USDA/ARS has the only vegetable crops research unit dedicated 
to the genetic improvement of cucumbers, carrots, onions and garlic. 
ARS scientists account for over half of the total U.S. public breeding 
and genetics research on these crops. Their efforts have yielded 
cucumber, carrot and onion cultivars and breeding stocks that are 
widely used by the U.S. vegetable industry (i.e., growers, processors, 
and seed companies). These varieties account for over half of the farm 
yield produced by these crops today. All U.S. seed companies rely upon 
this program for developing new varieties, because ARS programs seek to 
introduce economically important traits (e.g., pest resistances and 
health-enhancing characteristics) not available in commercial varieties 
using long-term high risk research efforts. The U.S. vegetable seed 
industry develops new varieties of cucumbers, carrots, onions, and 
garlic and over twenty other vegetables used by thousands of vegetable 
growers. Their innovations meet long-term needs and bring innovations 
in these crops for the U.S. and export markets, for which the U.S. has 
successfully completed.
    ARS scientists have developed genetic resistance for many major 
vegetable diseases that is estimated at $670 million per year in 
increased crop production, not to mention environmental benefits due to 
reduction in pesticide use. New research has resulted in cucumbers with 
improved disease resistance, pickling quality and suitability for 
machine harvesting. New sources of genetic resistance to viral and 
fungal diseases, tolerance to environmental stresses, and higher yield 
have recently been identified along with molecular tools to expedite 
delivery of elite cucumber lines to U.S. growers.
    There are still serious vegetable production problems which need 
attention. For example, losses of cucumbers, onions, and carrots in the 
field due to attack by pathogens and pests remains high, yield and 
nutritional quality needs to be significantly improved and U.S. 
production value and export markets should be enhanced. Genetic 
improvement of all the attributes of these valuable crops are at hand 
through the unique USDA lines and populations (i.e., germplasm) that 
are available and the new biotechnological methodologies that are being 
developed by the group. The achievement of these goals will involve the 
utilization of a wide range of biological diversity available in the 
germplasm collections for these crops. Classical plant breeding methods 
combined with bio-technological tools such as DNA markers, genetic 
maps, and genome sequences to expedite traditional cucumber, carrot and 
onion breeding and increase its efficiency. With this, new high-value 
vegetable products based upon genetic improvements developed by our 
USDA laboratories can offer vegetable processors and growers expanded 
economic opportunities for U.S. and export markets.
     quality and utilization of agricultural products & food safety
    The USDA/ARS maintains a food science research unit that our 
industry looks to for new scientific information on the safety of our 
products and development of new processing technologies related to 
fermented and acidified vegetables. Major accomplishments include: 
pasteurization treatments currently used for most acidified vegetables; 
the preservation technology used for manufacturing shelf stable sweet 
pickles; fermentation technology (purging) used to prevent the 
formation of air pockets within fermented pickles; and a fermentation 
technology that eliminates the use of sodium chloride for commercial 
cucumber brining operations. With the passage of the Food Safety 
Modernization Act, commercial producers of acidified foods must prove 
that they meet critical limits established for microbial safety. USDA/
ARS has provided technical expertise and the scientific data currently 
used to support required process filings, and have helped establish a 
scientific basis for acidified food regulations. Further research is 
needed to evaluate safe and efficient processing conditions for 
environmentally friendly low salt and calcium salt vegetable 
fermentation technologies. Additional funding is needed for this and 
other important research initiatives detailed below.
    First, nearly all retail pickled vegetables are pasteurized for 
safety and shelf stability. Current steam and water bath pasteurizers 
rely on technology from the 1940s and 50s. Promising new technologies 
include continuous flow microwave technology and ``hot-fill-and-hold'' 
pasteurization. Research efforts to further develop these technologies 
will reduce water use and significantly improve energy efficiency with 
new, scientifically validated thermal processing technologies.
    Second, additional research that offers significant economic and 
environmental advantages to the U.S. industry includes the reduction or 
replacement of salt in commercial vegetable fermentations and bulk 
acidification. Calcium substitution of salt in commercial vegetable 
processing has the potential to significantly reduce chloride levels in 
waste waters and sludge currently delivered to landfills; and create 
opportunities to manufacture reduced sodium, fermented vegetable 
products. Reducing environmental impact and production costs for the 
manufacture of healthier vegetable products is essential to the 
sustainability of the U.S. industry.
    Third, the market for fermented vegetable products is rapidly 
growing in the U.S. These products are attractive to consumers seeking 
``natural'' or ``traditional'' foods. Novel fermented foods are being 
imported, manufactured and sold by small business (farmer's markets) 
and large companies. For many of these fermented foods, little is known 
about the safe fermentation conditions, appropriate storage times and 
temperatures and shelf life. While these fermented foods may contain 
healthful probiotic bacteria and offer new flavors and expanded markets 
for vegetable grown in the US, the potential microbial hazards are 
undefined. Little data is available in the scientific literature to 
define safe fermentation practices. Research is needed to help both 
producers and regulatory agencies define safe fermentation practices to 
meet food safety modernization act standards for novel imported and 
locally manufactured fermented vegetable products.
                            specialty crops
    The USDA/ARS conducts research on the development and application 
of innovative engineering technologies for rapid, nondestructive 
measurement and grading of fruits and pickling vegetables to ensure and 
enhance product quality and marketability, reduce food loss, and 
achieve labor cost savings. The research program is well recognized for 
its pioneering research and development and technology transfer effort 
in imaging and spectroscopic inspection technologies, which have found 
wide applications in food quality and safety inspection. Currently, ARS 
researchers are developing a new generation of sensing technologies, 
which are much more effective and efficient than the current inspection 
systems, for quality evaluation and grading of pickling vegetables and 
fruits at the processing facility and in the field.
    Sensor and automation is critical to ensuring and enhancing food 
quality and safety, reducing product loss and production cost, and 
improving traceability. Modern automated food quality inspection 
systems have been in use for some time, but they have not been able to 
fully meet the increasing demands for food quality, safety and 
traceability from the consumer and by the governmental regulatory 
agencies. The ARS engineering research program will provide new, 
cutting-edge food quality inspection technology for pickling vegetable 
and specialty crop growers and processors, helping them deliver best 
quality, consistent products to the consumer at affordable prices. 
Expansion of the ARS research in food quality sensing and automation 
would enable addressing key technical challenges in the development of 
new generation food quality inspection technology and allow fast 
transfer and dissemination of the developed technologies to the U.S. 
specialty crop industries. This would help the U.S. specialty crop 
industries maintain competitive advantages in the global marketplace.
                       emerging disease of crops
    USDA/ARS vegetable research addresses national problems confronting 
the vegetable industry of the southeastern U.S. The mission of the 
laboratory is to develop disease and pest resistant vegetables, and 
also new, reliable, environmentally-sound disease and pest management 
practices that do not rely on conventional pesticides. Programs 
currently address 14 crops, including those in the cabbage, cucumber, 
and pepper families, all of major importance to the pickling industry. 
USDA/ARS research is recognized world-wide, and its accomplishments 
include over 150 new vegetable varieties and many improved management 
practices.
    Increasing current funding levels for this program will directly 
benefit the southeastern vegetable industry. Vegetable growers depend 
heavily on synthetic pesticides to control diseases and pests. Without 
the availability of certain pesticides that have been eliminated for 
use, producers are likely to experience crop failures unless other 
effective, non-pesticide control methods are readily identified. In 
this context, the research on improved, more efficient and 
environmentally compatible vegetable production practices and resistant 
varieties continues to be absolutely essential. This research can help 
provide U.S. growers with a competitive edge they need to sustain and 
keep their industry vibrant, allowing it to expand in the face of 
increasing foreign competition. Current cucumber varieties are highly 
susceptible to a new strain of the downy mildew pathogen which has 
caused considerable damage to commercial cucumber production in 
eastern, midwestern, as well as western states in recent years. 
Increasing funding to allow hiring a new plant pathologist will 
facilitate the conduct of key research to address this critical 
situation.
                      funding needs for the future
    It remains critical that USDA/ARS funding continues the forward 
momentum in pickled vegetable research that the U.S. now enjoys and to 
increase funding levels as warranted by planned expansion of research 
projects to maintain U.S. competitiveness.
    It is important to note that fiscal year 2015 Enacted/fiscal year 
2016 Estimated funding for USDA/ARS laboratories totaled $11,247,000. 
However, fiscal year 2015 Enacted/fiscal year 2016 Estimated funding 
for all cucurbits equaled just $3,916,000 with only $2,112,000 directed 
toward cucumber and pickled vegetable research. For fiscal year 2017, 
PPI is requesting an additional $2,000,000 in program enhancements that 
will provide needed research for cucumber and pickled vegetables.
                       emerging disease of crops
    There is a critical need to increase funding to support plant 
pathology research to address cucumber diseases, especially the disease 
caused by a new strain of the downy mildew pathogen responsible for 
recent extensive damage to cucumber and other cucurbit productions in 
the eastern states. A pathologist is especially needed to characterize 
pathogen strains and to develop new management approaches, as well as 
resistant cucumber varieties, to combat the disease. Ultimately, a new 
plant pathologist position will accomplish research that results in 
more effective protection of cucumbers from disease without the use of 
conventional pesticides.

------------------------------------------------------------------------
                                                       Amount
------------------------------------------------------------------------
Fiscal year...............................
  2015 Enacted............................  $598,000
  2016 Estimate...........................  598,000
  2017 (Proposed budget)..................  To be determined
                                           -----------------------------
      2017 Additional Request (Plant        500,000
       Pathologist & support).
------------------------------------------------------------------------


    quality and utilization of agricultural products and food safety
    The current funding includes research and development for a variety 
of vegetable products, including fermented and acidified vegetables. 
For new research initiatives to reduce energy and water use, reduce 
environmental impact from commercial fermentations, and develop new 
health-promoting food (probiotic) technology, we request additional 
support of $500,000 to fully fund the scientists and support staff, 
including graduate students and post-doctorates, for carrying out the 
research and acquiring necessary equipment.

------------------------------------------------------------------------
                                                       Amount
------------------------------------------------------------------------
Fiscal year...............................
  2015 Enacted............................  $595,000
  2016 Estimate...........................  595,000
  2017 (Proposed budget)..................  To be determined
                                           -----------------------------
    2017 Additional Request (Post-doctoral  ............................
     and Pre-doctoral Research Associate,   500,000
     new equipment & support).
------------------------------------------------------------------------


                         applied crop genomics
    Emerging diseases, such as downy mildew, southern root knot 
nematode, and angular leaf spot of cucumber, threaten production of the 
crop in all production areas. Yield and quality traits found in diverse 
cucumber germplasm must be bred into U.S. crop cultivars. We request an 
additional $500,000 to fully fund the scientists and support staff, 
including graduate students and post-doctorates for identifying, 
researching and applying genomic tools to develop new sources of 
genetic resistance to emerging diseases, improve yield and quality.

------------------------------------------------------------------------
                                                       Amount
------------------------------------------------------------------------
Fiscal year...............................
  2015 Enacted............................  $458,000
  2016 Estimate...........................  458,000
  2017 (Proposed budget)..................  To be determined
                                           -----------------------------
    2017 Additional Request (Post-doctoral  ............................
     and Pre-doctoral Research Associate &  500,000
     support).
------------------------------------------------------------------------

                            specialty crops
    The current funding is far short of the level needed to carry out 
research on inspection, sorting and grading of pickling cucumbers and 
other vegetable crops to assure the processing and quality of pickled 
products. An increase of $500,000 in the current base funding level 
would be needed to fund the research engineer position.

------------------------------------------------------------------------
                                                       Amount
------------------------------------------------------------------------
Fiscal year...............................
  2015 Enacted............................  $145,000
  2016 Estimate...........................  145,000
  2017 (Proposed budget)..................  To be determined
                                           -----------------------------
      2017 Additional Request (Research     500,000
       Engineer & support).
------------------------------------------------------------------------


    [This statement was submitted by Brian Bursiek, Executive Vice 
President, Pickle Packers International, Inc.]

                                 ______
                                 
    Prepared Statement of Society for Women's Health Research (SWHR)
    The Society for Women's Health Research (SWHR) urges the Committee 
to prioritize and provide an increase to the fiscal year 2017 budget 
authority (BA) appropriations (non-user fees) for the Food and Drug 
Administration (FDA) of $2.85 billion, an increase of $120 million over 
fiscal year 2016. Our request is based on FDA's current workload, 
planned programs, and emerging public health priorities. Additionally, 
SWHR supports an allocation of $10 million for the FDA Office of 
Women's Health (OWH) for fiscal year 2017.
    For over 25 years, SWHR has been widely considered a thought-leader 
in promoting research on biological differences in disease and we are 
dedicated to transforming women's health through science, advocacy, and 
education.
    Our organization has long advocated that drug and device scientific 
advancements should demonstrate adequate subpopulation testing prior to 
approval by FDA. The Agency has made great improvements in improving 
the completeness and quality of demographic subgroup data collection, 
reporting and analysis of subgroup data collection, identifying 
barriers to subgroup enrollment in clinical trials, employing 
strategies to encourage greater participation, and making demographic 
subgroup data more available to the public. However, in order for 
greater improvement, Congress must invest in FDA's core functions. SWHR 
is committed to the belief that the FDA, as regulator of products 
representing approximately 20 percent of American consumer spending, 
should receive priority funding as its responsibilities are critical to 
the health and well-being of all Americans.
    The FDA has broad jurisdiction and is responsible for:
  --Protecting public health by assuring the safety, efficacy and 
        security of human and veterinary drugs, biological products, 
        medical devices, our nation's food supply, cosmetics, and 
        products that emit radiation.
  --Advancing public health by helping to speed innovations that make 
        medicines more effective, safer, and more affordable and 
        providing accurate, science-based information needed by 
        patients and consumers to safely use medicines and foods to 
        maintain and improve their health.
  --Regulating the manufacturing, marketing and distribution of tobacco 
        products to protect public health and to reduce tobacco use by 
        minors.
  --Ensuring the security of the food supply and by fostering 
        development of medical products to respond to deliberate and 
        naturally emerging public health threats.
    Each year, Congress adds ever increasing responsibilities to the 
Agency (most recently food safety, sunscreen labeling, drug safety, and 
compounding) but fails to provide appropriate funds to meet those 
demands reasonably, thereby straining the FDA's abilities and forcing 
it to choose among competing public health priorities. This is a 
dangerous precedent which poorly serves the health and safety of the 
America people. Many of the mandated programs that Congress has tasked 
the Agency with are not covered by user fees, leaving FDA in need of a 
larger budget authority appropriation in order to fulfill its duty. 
SWHR believes that sustained investment in the FDA and its regulatory 
responsibilities is absolutely essential if the U.S. is to meet the 
needs of its citizens, especially women, and maintain its gold standard 
in scientific transformation and medical product advancement.
    SWHR is a strong supporter of stakeholder engagement with the 
Agency, and are active in the user fee agreement process for 
prescription and generic drugs, as well as medical devices and 
biologics. Such opportunities allow for FDA to discuss process 
improvements that will speed the approval of safe and effective medical 
products for patients and consumers. The increased emphasis on patient-
focused drug development, risk/benefit analysis, and innovative 
clinical trial design will only further efforts to bring lifesaving 
treatments to market.
    However, Congressionally-allocated funds are desperately needed to 
support FDA post-market surveillance activities, improve technical 
assistance to industry to reduce review times, and enhance its 
communications with patients and consumers. Post-market surveillance is 
critical to ensure that drugs and devices, when available to a wider 
patient population, are truly safe and effective for all populations. 
The American public cannot, and should not, rely on industry to conduct 
the bulk of these activities. The 21st Century Cures Act, recently 
passed by the House, and its companion Senate Innovation's effort, 
focus on the need to bring medical products to the market more quickly. 
A large part of that process is improving clinical trials to be faster 
and less expensive. The biopharmaceutical and biopharmaceutical 
services industries, along with the FDA and other key stakeholders, 
have made great strides in improving the clinical trial process; 
however, clinical trials will never be able to give us the information 
that is obtained once the drug or device is approved and used in the 
population. This makes it more critical that FDA has a strong and 
robust post marketing surveillance program. While the MedWatch and 
similar programs do exist, they will need additional resources to 
ensure FDA staff and others as appropriate can quickly respond to 
reduce morbidity and mortality related to potential safety issues.
    Additional FDA funding will also support improved technical 
assistance for its industry partners by supporting staff resources to 
develop, review, and approve guidance. Timely release of guidance 
documents is critical to ensure industry partners can develop processes 
and submit applications with the most pertinent information for review. 
Such releases would also allow for increased opportunities for 
innovation by promptly responding to a changing drug/device development 
environment.
    Finally, additional funding would allow FDA to enhance its 
communications with the public. Such funding could support building a 
consumer-friendly FDA interface; making it much easier for patients and 
consumers to navigate. Funding could also be used to continue the 
patient-focused drug development meetings and other workshops and 
listening sessions, allowing FDA to connect directly with the American 
public it serves.
 action plan to enhance the collection and availability of demographic 
                             subgroup data
    FDA, working with industry, must ensure that clinical trials 
examine differences in subpopulations ensuring appropriate 
representation to achieve statistical significance and analysis. In 
2014, FDA released its ``Action Plan to Enhance the Collection and 
Availability of Demographic Subgroup Data'' (Action Plan), as directed 
by section 907 of the Food and Drug Administration Safety and 
Innovation Act of 2012 (FDASIA). The Action Plan, largely developed and 
implemented by the OWH and the Office of Minority Health, provided an 
outline of long and short term actions and implementation strategies 
the FDA is undertaking to examine sex, race, ethnicity and age-based 
differences through medical research, to allow subgroup-specific data 
to be more widely available for use in medical practice, and to improve 
the participation of women, minorities and the elderly in research 
trials.
    SWHR hopes that FDA will continue to work towards the goals 
outlined in that plan which will be beneficial for patients, consumers, 
and the healthcare community at large. The Agency has worked with 
stakeholders to ensure that the subgroup data is appropriately 
analyzed, reported and presented by FDA and sponsors in a meaningful 
way to patients and the medical community. However, many components of 
the Action Plan remain, for example, it is critical that the Agency 
update its 2005 Guidance for Industry on the Collection of Race/
Ethnicity Data in Clinical Trials.
    As part of the Action Plan, FDA also has a critical regulatory role 
in human subject research. Women and minority populations have 
historically been underrepresented in medical research, and although 
women and minorities are now being enrolled in clinical trials at 
greater rates, much work remains to ensure that these groups are 
included and retained in trials at appropriate levels to provide 
statistically significant results. Through the Action Plan, FDA 
recognized the need to increase representation of these population 
groups in clinical trials and the need for more analyses on how medical 
drugs and devices in development affect women and men differently as 
well as racially, ethnically and by age. Women should have confidence 
that drugs, devices and biologics approved for patient use have been 
appropriately analyzed for sex differences and the finding publicly 
reported in a meaningful way for usage by both healthcare providers and 
patients.
    SWHR has long sought the transparency of demographic subgroup data 
that FDA uses as the basis of its approval decision. This issue was a 
priority area of the Action Plan and in 2014, the Agency launched the 
``Drug Trial Snapshot'' website to provide information about who 
participated in clinical studies for new molecular entities and 
original biologics. The Snapshot website also includes information on 
study design, results of efficacy and safety studies, and information 
on any differences in efficacy or safety that were apparent in subgroup 
populations.
    The Snapshot website is a step in the right direction; however, we 
believe that the website could be improved to revolutionize the way 
Snapshots benefits patients. SWHR believes that Snapshots could be 
improved by contextualizing the data presented with all relevant 
information relating to the intersection of age, race, and sex to 
provide those using the website a thorough understanding of their 
benefits and risk as individual users of a certain drug or biologic. 
Additionally, the website is not easily found on FDA's webpage. FDA has 
signaled that they view the website as an iterative process, and are 
open to hearing stakeholder feedback on how to improve the site. 
However, these efforts require the Agency to receive sustained funding 
and resources and SWHR believes that Congress must commit to continued 
and robust investment in FDA to provide for the advancement and 
increased transparency of drug development.
                      fda office of women's health
    OWH has proven itself to be vital player in advancing women's 
health issues at the Agency; including the expansion of existing 
research projects and helping to foster new collaborations related to 
advancing the science of women's health. OWH's programs ensure that sex 
and gender differences in the efficacy of drugs (such as metabolism 
rates), devices (sizes and functionality), and diagnostics are taken 
into consideration in reviews and approvals.
    American women rely on the tools OWH provides to them to help with 
their healthcare decisions. Each year, OWH consumer pamphlets are the 
most requested of any documents at the government printing facility in 
Colorado; with more than 8 million distributed to women across America, 
including target populations such as Hispanic communities, seniors and 
low-income citizens. These pamphlets discuss topics such as breast 
cancer screening, diabetes, menopause hormone therapy, and medication 
use during pregnancy. In addition, OWH's website is a vital tool for 
consumers and physicians, providing free, downloadable fact sheets on 
over one hundred different illnesses, diseases, and health related 
issues for women. Among the most popular, OWH provides medication 
charts on select chronic diseases, listing all the treatment options 
available for each disease. We must maintain these vital functions that 
healthcare professionals and the public understand and utilize daily to 
make healthcare decision.
    In partnership with the National Institutes of Health Office of 
Research on Women's Health, OWH created a website for on-line sex and 
gender courses to provide additional educational tools for medical 
practice and scientific innovation. All three courses offer free 
continuing education credits for physicians, pharmacists and nurses.
    Last year, OWH unveiled the Women's Health Research Roadmap 
(Roadmap) to build on knowledge gained from previously funded research 
and assist OWH in coordinating future research activities with other 
FDA research programs and external partners. The Roadmap outlined 
priority areas where new or enhanced research is needed, creates 
strategic direction for OWH to help maximize the impact of OWH 
initiatives, and ultimately promote optimal health for women. It was 
also designated a key FDA commitment in FDA's August 2014 Action Plan.
    To fully implement the Research Roadmap and continues it's 
important work, SWHR requests an allocation of $10 million for the FDA 
Office of Women's Health (OWH) for fiscal year 2017. We believe these 
recommended budget allocations would enable the FDA to address resource 
shortages across its centers, but also implement critical improvements 
in infrastructure and support a substantial investment in the OWH, the 
office responsible for advancing the health of women through policy, 
science, and outreach and one of the leading voices in increasing the 
participation and analysis of women and other subpopulations in 
clinical trials.
    In conclusion, we thank the Committee for its past support of the 
FDA and its centers. It is our hope that the Committee continue to 
invest in the Agency to help ensure a healthier future for all 
Americans. We look forward to continuing to work with you.

    [This statement was submitted by Leslie S. Ritter, Vice President, 
Public Policy, Society for Women's Health Research.]

                                 ______
                                 
               Prepared Statement of The Wildlife Society
    The Wildlife Society appreciates the opportunity to submit 
testimony concerning the fiscal year 2017 budgets for the Animal and 
Plant Health Inspection Service (APHIS), National Institute of Food and 
Agriculture (NIFA), Natural Resources Conservation Service (NRCS), and 
Farm Service Agency (FSA). The Wildlife Society was founded in 1937 and 
is an international non-profit scientific and educational association 
representing nearly 10,000 professional wildlife biologists and 
managers. Our mission is to inspire, empower, and enable wildlife 
professionals to sustain wildlife populations and habitats through 
science-based management and conservation. We respectfully request the 
following programmatic funding in fiscal year 2017 to ensure that the 
Federal budget supports the important work of managing and conserving 
our nation's wildlife resources. Thank you in advance for considering 
the views of wildlife professionals.
               animal and plant health inspection service
    Wildlife Services, a unit of APHIS, resolves human/wildlife 
conflicts and protects agriculture, human health and safety, personal 
property, and natural resources from wildlife damage and wildlife-borne 
diseases in the United States. The Wildlife Society recognizes wildlife 
damage management as an important part of modern wildlife management.
    In fiscal year 2017, the President has proposed a decrease in 
funding for Wildlife Damage Management by approximately $15 million. 
While we acknowledge this decrease partially reflects the removal of a 
one-time capital investment of $5.8 million in aircraft equipment from 
fiscal year 2016, we are highly concerned by the additional extent of 
this proposed decrease and the effect it might have on the continued 
success of programs managed by Wildlife Services, like the National 
Rabies Management Program. Therefore, we encourage Congress to fund 
Wildlife Damage Management at or beyond the fiscal year 2015 funding 
levels of $90 million for fiscal year 2017.
    Before wildlife damage management programs are undertaken, careful 
assessment should be made of the problem, including the impact to 
individuals, the community, and other wildlife species. A key budget 
line in Wildlife Service's operations is Methods Development, which 
funds the National Wildlife Research Center (NWRC). Much of the newest 
research critical to state wildlife agencies is being performed at 
NWRC. In order for state wildlife management programs to be the most 
up-to-date, the work of the NWRC must continue. The Wildlife Society 
recommends the continued funding of Methods Development at $19 million 
in fiscal year 2017.
               national institute of food and agriculture
    The Renewable Resources Extension Act (RREA) provides an expanded, 
comprehensive extension program for forest and rangeland renewable 
resources. RREA funds, which are apportioned to State Extension 
Services, effectively leverage cooperative partnerships at an average 
of four to one, with a focus on private landowners. The need for RREA 
educational programs is greater than ever because of continuing 
fragmentation of land ownership; urbanization; diversity of landowners 
needing assistance; increasing societal concerns about land use; and 
increasing human impacts on natural resources. Authorized at $30 
million, RREA has been appropriated at roughly $4 million per year 
since fiscal year 2008. To meet the growing need for sustainable 
outreach initiatives, The Wildlife Society recommends that Congress 
increase the funding for RREA to at least $10 million for fiscal year 
2017.
    The McIntire-Stennis Cooperative Forestry Program is essential to 
the production, utilization, and protection of forestry resources, 
including fish and wildlife, on non-industrial, private forestlands. As 
the demand for forest products grows, the nation will increasingly rely 
on privately held forests to supplement resources obtained from 
national forest lands. However, commercial trees take many decades to 
produce. In the absence of long-term research, such as that provided 
through McIntire-Stennis, the nation may have difficulty meeting future 
forest-product needs in a sustainable manner. We appreciate the $34 
million provided for McIntire-Stennis in fiscal year 2016 and urge 
Congress to continue this funding in fiscal year 2017.
                 natural resources conservation service
    The Natural Resources Conservation Service (NRCS) is the primary 
Federal agency that works with private landowners to help them 
conserve, maintain, and improve their natural resources, thereby making 
them more resilient and valuable to society. NRCS emphasizes science-
based conservation, and through a variety of voluntary, incentive-based 
programs, offers technical assistance and cooperative problem solving 
at the community level. Demand for NRCS programs and the backlog of 
qualified applicants has far outnumbered the agency's present capacity 
under current funding. With increased pressure on farmlands from 
biofuel development, urban sprawl, and the concurrent declines in 
wildlife habitat and water quality, the need for NRCS conservation 
programs continues to grow.
    For fiscal year 2017, the President has requested $1.9 billion for 
Private Lands Conservation Operations (PLCO), including $1.0 billion of 
mandatory funding and $860 million of discretionary funding; which 
includes the Conservation Technical Assistance (CTA) program. CTA 
provides discretionary funding for NRCS to support implementation of 
Farm Bill programs. The Wildlife Society is strongly supportive of the 
fiscal year 2017 budget proposal of $761 million in funding for CTA, a 
slight increase from fiscal year 2016. An increase in funds will allow 
for further implementation of the changes that resulted from the 2014 
Farm Bill. In the 2014 Farm Bill, Congress demonstrated strong support 
for the use of mandatory funds for Technical Assistance (TA), but these 
funds can only be used in association with a specific Farm Bill 
program. Appropriated funds for CTA are still essential for NRCS to 
provide efficient customer service and strong conservation results. The 
Wildlife Society therefore encourages Congress to provide $860 million 
for discretionary TA, including $761 million for CTA, and $1.0 billion 
for mandatory TA in fiscal year 2017, per the President's request.
    The Wildlife Society also recommends that all Farm Bill 
conservation programs be funded at levels mandated in the 2014 Farm 
Bill, including $500 million for the Agriculture Conservation Easement 
Program (ACEP) and 1.65 billion for the Environmental Quality 
Initiatives Program (EQIP). Demand for these programs continues to 
grow, yet during a time when greater assistance is needed to address 
natural resource challenges and conservation goals, the NRCS can only 
fund a small portion of the overall demand for these popular programs.
                          farm service agency
    The President's request would provide funding for the Conservation 
Reserve Program (CRP) at $1.9 billion in fiscal year 2017. Lands 
enrolled in CRP are important for the conservation of soil on some of 
the Nation`s most erodible cropland. These lands also contribute to 
water quantity and quality; provide habitat for wildlife that reside on 
agricultural landscapes; sequester carbon; and provide a strategic 
forage reserve for periodic compatible use in times when other 
livestock forage is limited due to drought or other natural disasters. 
We strongly encourage Congress to fund CRP at $1.9 billion per the 
President's request, or at a level that fully utilizes the program's 
general enrollment authority.

                      FISCAL YEAR 2017 APPROPRIATIONS RECOMMENDATIONS--THE WILDLIFE SOCIETY
----------------------------------------------------------------------------------------------------------------
                                                                                                    fiscal year
                                                           fiscal year  fiscal year  fiscal year     2017 The
         USDA Agency/Unit                  Program             2015         2016      2017 POTUS     Wildlife
                                                             Enacted      Estimate                    Society
----------------------------------------------------------------------------------------------------------------
APHIS/Wildlife Services             Wildlife Damage
                                    Management...........          90M         101M          86M             90M
                                    Methods Development            19M          19M          19M             19M
 
NIFA/Formula Grants                 RREA                            4M           4M           4M             10M
                                    McIntire-Stennis               34M          34M          34M             34M
                                     Coop. Forestry.
 
NRCS/PLCO                           PLCO-Discretionary TA         846M         851M         860M            860M
                                    PLCO-Mandatory TA....         900M         903M       1,034M          1,034M
                                    PLCO-Total...........       1,746M       1,754M       1,894M          1,894M
 
NRCS/Farm Bill                      ACEP                          394M         419M         500M            500M
Conservation Programs               EQIP.................       1,347M       1,329M       1,650M          1,650M
                                    TOTAL-Farm Bill             3,184M       3,123M       3,885M          3,885M
                                     Programs.
 
FSA/Conservation
Programs                            Conservation Reserve        1,741M       1,841M       1,923M          1,923M
                                     Program.
----------------------------------------------------------------------------------------------------------------


    [This statement was submitted by Byron Ken Williams, PhD, 
Chief Executive Officer, The Wildlife Society.]

                                ------                                

              Prepared Statement of World Food Program USA
                                request
    World Food Program USA (WFP USA) is a non-profit organization that 
works to solve global hunger by raising U.S. support for the mission of 
the UN World Food Programme. Specifically, we request the following 
funding levels for three essential programs within the jurisdiction of 
the subcommittee:
  --Title II Food for Peace--$1.75 billion
  --McGovern Dole Food for Education and Child Nutrition Program--
        $209.5 million
  --Local and Regional Procurement Program--$80 million
  --We also request bill language be included in the General Provisions 
        regarding non-emergency, development activities in the Title II 
        Food for Peace account.
    To maintain strong U.S. leadership in solving hunger and to respond 
to critical emergency needs worldwide, WFP USA urges the subcommittee 
to provide the strongest possible funding for global food security 
programs. Our specific funding requests mirror those in the InterAction 
Choose to Invest fiscal year 2017 recommendations, which have been 
formally endorsed by a coalition of 168 U.S.-based, non-governmental 
and faith-based organizations.
                               background
    Strong bipartisan support for a comprehensive approach to ensuring 
global food security has made the United States a global leader in the 
effort to solve hunger, catalyzing significant progress worldwide. 
Today there are over 200 million fewer hungry people compared to 1990 
estimates. Undernourishment and child mortality have been nearly halved 
during this time. These trends demonstrate that the goal of zero hunger 
is achievable if the positive policies and programs the U.S. has put 
into place are sustained.
    Despite this dramatic progress, there are still 795 million 
chronically hungry people in the world today. Undernourishment still 
affects 12.9 percent of developing country populations. And in 2015, 
5.9 million children under five died prematurely, with nearly half of 
these child deaths associated with undernutrition.
    In addition, there are now four ongoing crises classified at the 
most severe level of humanitarian emergency. These crises in Syria, 
Iraq, South Sudan, and Yemen are the result of internal conflicts that 
have caused massive population displacements. In fact, there are now 
over 60 million displaced people worldwide, including both refugees and 
those internally displaced: the highest number since World War II. In 
response to these and other crises, the 2016 UN humanitarian 
consolidated appeal estimated global humanitarian needs at $17.2 
billion, which was more than double the estimated need level in 2012.
    The United Nations World Food Programme (WFP) is the world's 
largest humanitarian organization, providing critical food and 
nutrition support to roughly 80 million of the world's hungriest people 
each year. WFP estimates that total global food assistance requirements 
for 2017 will exceed $8 billion.
                             food for peace
    Food for Peace (FFP) provides emergency food and development 
assistance to millions suffering from hunger and malnutrition. For the 
past 60 years, Food for Peace has been the primary vehicle for 
providing food aid in response to natural disasters, crises, and 
conflicts around the world. Maintaining robust funding for Food for 
Peace Title II and finding ways to stretch that funding further is 
imperative.
    While the United States remains the largest donor of global food 
assistance, the reach of U.S. food assistance has been stretched by 
record levels of need in 2016. Supporting FFP at $1.75 billion would 
allow the U.S. to reach 45-50 million people with lifesaving food aid 
and maintain its global leadership.
    The United Nations World Food Programme (WFP) is the largest U.S. 
food aid partner, implementing programs that account for roughly 90 
percent of Food for Peace emergency food aid funding. WFP estimates 
$6.5 billion will be required to fund its 2017 emergency food 
assistance programs. About $1.2 billion--almost 20 percent of total WFP 
emergency needs--will be required just for the humanitarian crisis in 
Syria and the Syrian refugees in neighboring countries. Needs from both 
weather-related disasters and conflicts will continue to persist across 
Sub-Saharan Africa, and Southwest Asia.
    Food for Peace provides the bulk of funding for the U.S. to 
contribute its historical average of about 30 percent of WFP emergency, 
relief, and recovery programs. Other countries provide over 60 percent 
of the annual contributions to WFP, which means that U.S. food aid 
channeled through WFP helps leverage additional international 
assistance.
    We also support the inclusion of administration-requested bill 
language to address section 412(e) of the Food for Peace Act, 7 U.S.C. 
1736f(e). It is our view that other U.S. Agency for International 
Development resources which support non-emergency, development 
activities can be used to satisfy the statutory requirements of this 
section in a manner that maximizes flexibility to support both 
emergency and non-emergency food activities.
  mcgovern dole international food for education and child nutrition 
                                program
    The McGovern-Dole International Food for Education and Child 
Nutrition Program provides U.S. agricultural products and technical 
assistance for school feeding projects in low-income, food-deficit 
countries that are committed to universal education. The McGovern-Dole 
program provides school-age children in poverty-stricken countries with 
what is often their only full meal of the day and protects vulnerable 
children, especially during times of natural disasters and economic 
shocks.
    Serving food at school helps solve chronic hunger and can be life-
changing for the world's poorest children. School meals also help get 
students into the classroom, giving them an important key to a better 
future: an education. In areas where enrollment rates for girls are 
low, McGovern-Dole supported programs work with families and 
communities to make it possible for more girls to attend school. This 
sometimes includes giving girls take-home rations that encourage 
families to send daughters to school and also benefit younger children 
at home. Girls' education has a powerful ripple effect on families and 
communities. One study has shown that the more education girls have, 
the less likely their children will be malnourished.
    The UN World Food Programme calculates that $3.2 billion is needed 
per year to reach all 66 million primary school-age children that go to 
school hungry every day. While an investment of $209.5 million for 
school feeding represents a small fraction of overall global investment 
in school feeding programs by donor and host country governments, U.S. 
resources remain critical for low-income countries to continue school 
feeding programs. We urge the committee to fund the McGovern-Dole 
program at a level of $209.5 million in fiscal year 2017.
              local and regional food procurement program
    We recommend fully funding the Local and Regional Procurement (LRP) 
Program, which was newly authorized at $80 million in the Agricultural 
Act of 2014. The 2014 Farm Bill conference report's statement of 
managers affirms that the intent of LRP programming is to complement 
existing food aid programs, especially the McGovern-Dole Food for 
Education and Child Nutrition Program.
    Linking the new USDA LRP program to the McGovern-Dole program 
improves the chances of long-term sustainability of school feeding 
programs supported by McGovern-Dole. A fundamental objective of U.S. 
support to international school feeding is for countries to eventually 
take over, manage, and fund their own school feeding programs. This 
means developing locally sustainable systems for the purchase and 
management of food used in school feeding programs to move away over 
time from reliance on U.S.-donated commodities. U.S. support for LRP 
can help countries make that transition to national ownership. While 
Congress funded LRP activities in fiscal year 16, more is needed to 
demonstrate its full potential. Continued funding of the newly 
authorized LRP program will strengthen the McGovern-Dole supported 
programs and hasten this transition to recipient country responsibility 
and ownership.

    [This statement was submitted by Richard Leach, President and CEO, 
World Food Program USA.]

       LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS

                              ----------                              
                                                                   Page

Academy of Nutrition and Dietetics, Prepared Statement of the....  99
American:
    Commodity Distribution Association, Prepared Statement of the 101 
      Farm Bureau Federation, Prepared Statement of the 



    Farmland Trust, Prepared Statement of the.................... 106
    Forest Foundation, Prepared Statement of the................. 107
    Forest & Paper Association, Prepared Statement of the........ 109
    Indian Higher Education Consortium, Prepared Statement of the 111    
      Seed Trade Association, Prepared Statement of the.......... 113
      Society:
        For:
          Microbiology (AG), Prepared Statement of the........... 115
          Microbiology (FDA), Prepared Statement of the.......... 117
          Nutrition, Prepared Statement of the................... 119
          Prevention of Cruelty to Animals, Prepared Statement of 
            the.................................................. 122
        Of:
          Plant Biologists, Prepared Statement of the............ 120
Animal Welfare Information Center, Prepared Statement of the..... 124

Baldwin, Senator Tammy, U.S. Senator from Wisconsin, Questions 
  Submitted by...................................................  52
Blunt, Senator Roy, U.S. Senator from Missouri, Questions 
  Submitted by...................................................  39

Califf, Hon. Dr. Robert, M.D., M.A.C.C., Commissioner, Department 
  of Health and Human Services, Food and Drug Administration.....  1
    Prepared Statement of........................................  2
    Summary Statement of.........................................  1
Catholic Relief Services, Prepared Statement of the..............126
Central Arizona Water Conservation District, Prepared Statement 
  of the.........................................................132
Center for Progressive Reform, Prepared Statement of the.........134
Choose Clean Water Coalition, Prepared Statement of the..........135
Colorado River:
    Basin Salinity Control Forum, Prepared Statement of the......136
    Board of California, Prepared Statement of the...............138
Cystic Fibrosis Foundation, Prepared Statement of the............139
Daines, Senator Steve, U.S. Senator from Montana, Questions 
  Submitted by................................................... 40

Entomological Society of America, Prepared Statement of the......141

Federation of American Societies for Experimental Biology 
  (FASEB), 
  Prepared Statement of the......................................143
Food For:
    Peace Title II (FFP), Prepared Statement of the..............145
    Peace (Public Law 480), Prepared Statement of the........... 146
Food & Water Watch, Prepared Statement of the....................147
Friends of Agricultural:
    Research--Beltsville, Prepared Statement of the..............148
    Statistics and Analysis, Prepared Statement of the...........150

Humane Society of the United States, Prepared Statement of the 




Izaak Walton League of America, Prepared Statement of the........158
Johansson, Dr. Robert, Chief Economist, Department of Agriculture 57
Leahy, Senator Patrick J., U.S. Senator from Vermont, Questions 
  Submitted by................................................... 48

MEadvocacy.Org, Prepared Statement of the........................159
Merkley, Senator Jeff, U.S. Senator from Oregon, Questions 
  Submitted by................................................... 41
Moran, Jerry U.S. Senator from Kansas:
    Closing Statement............................................ 97
    Opening Statements of 



    Prepared Statement........................................... 58
    Questions Submitted by....................................... 24

National:
    Association:
        For:
            Advancement of Animal Science (NAAAS), Prepared 
              Statement of the...................................162
        Of:
            Nutrition and Aging Services Programs (NANASP), 
              Prepared Statement of the..........................164
            State Departments of Agriculture, Prepared Statement 
              of the.............................................165
            State Energy Officials (NASEO), Prepared Statement of 
              the................................................167
            Wheat Growers, Prepared Statement of the.............167
    Commodity Supplemental Food Program Association, Prepared 
      Statement of the...........................................169
    Cotton Council, Prepared Statement of the....................170
    Employment Law Project, Prepared Statement of the............173   
      Organic Coalition, Prepared Statement of the...............176
    Sustainable Agriculture Coalition, Prepared Statement of the.179  
      Young Farmers Coalition, Prepared Statement of the.........174

Oregon Water Resources Congress, Prepared Statement of the.......181
Organic:
    Farming Research Foundation, Prepared Statement of the.......183
    Trade Association, Prepared Statement of the................ 185
Oxfam America, Prepared Statement of the.........................186

Pickle Packers International, Inc., Prepared Statement of the....188

Society for Women's Health Research (SWHR), Prepared Statement of 
  the............................................................193

Tester, Senator John, U.S. Senator from Montana, Questions 
  Submitted by...................................................47
Tyler, Jay, Chief Financial Officer, Department of Health and 
  Human 
  Services....................................................... 1

United States Conference of Catholic Bishops, Prepared Statement 
  of the.........................................................130

Vilsack, Hon. Thomas, Secretary, Department of Agriculture....... 57
    Prepared Statement........................................... 60
    Summary Statement............................................ 58

Wildlife Society, Prepared Statement of the......................196
World Food Program USA, Prepared Statement of the................198

Young, Michael, Budget Officer, Department of Agriculture........ 57

                             SUBJECT INDEX

                              ----------                              

                       DEPARTMENT OF AGRICULTURE

                                                                   Page

Agricultural Research............................................  89
Avian Influenza..................................................  69
Broadband:
    Program......................................................  73
    Opportunities................................................  91
Brucellosis......................................................  78
Colonias.........................................................  82
Crop Insurance Program...........................................  85
Classical Breeding Research......................................  89
  Cuba Office..................................................... 90
Drug Use in Rural America........................................  74
Farm Programs Survey Data........................................  83
Forest Fire Borrowing 



Genetically Modified Organisms...................................  79
GIPSA Proposed Rules.............................................  67
McGovern Dole Program............................................  93
National:
    Bio and Agro-Defense Facility................................  94
      School Lunch Program........................................ 73
New, Beginning, and Veteran Farmers and Ranchers.................  94
Northern Plains Agricultural Research Laboratory.................  75
Research Budget..................................................  75
Rental Assistance Program........................................  70
Rural:
    Community Populations........................................  77
    Broadband Program............................................  86
    Energy Saving Program........................................  71
Snap Convenience Store Rule......................................  67
Streaming Farm Program...........................................  72
Strike Force Initiative..........................................  81
Subcommittee Recess..............................................  97
Water and Waste:
    Dispoal Programs.............................................  76
    Treatment Program............................................  87
                               __________

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                      Food and Drug Administration

Additional Committee Questions...................................  24
Agriculture and Biotechnology....................................  10
Arsenic in Rice..................................................   9
Biosimilars 



Cancer Moonshot..................................................  24
Center for Veterinary Medicine...................................  17
Dietary Supplements..............................................  36
FDA:
    Final Rule Deadlines and Market Stability Lead-in............  40
    Standard for Raw Milk Cheese 



Food Safety:
    Modernization Act............................................  45
    Moderization Act CFSMA.......................................  12
Follow-up........................................................  41
FSMA:
    Deficiency Letters...........................................  27
    Inspection Process...........................................  26
    Produce......................................................  25
    Spent Grain..................................................  28
    Supplier Verification........................................  25
    Technical Assistance Network.................................  26
GAO Report on FDA's IT Infrastructure............................  21
Generics.........................................................  36
    Competition/Pharmaceutical Products Subject to a REMS.......   49
Genetically Modified Salmon......................................  46
Internet/Social Media Advertising and Promotional Labeling of 
  Prescription Drugs.............................................  33
Inspections:
    Risk Based Inspections.......................................  34
    Data Bounce Process..........................................  34
Labeling of Generic Drugs........................................  51
Listeria.........................................................  29
Medical Device Inspection........................................  35
Opiods 




    and Addiction................................................  14
    Labels.......................................................  16
Over-the-Counter Antiseptics.....................................  38
Premium Cigars...................................................  47
Subcommittee Recess..............................................  55
Tobacco 



    Related Issues...............................................   9
Zika.............................................................  30

                                  
                                  
                              [all]