    [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

                                   __________

                      U.S. GOVERNMENT PUBLISHING OFFICE
    98-759 PDF                  WASHINGTON : 2017

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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\
    ---------------------------------------------------------------------------
        \1\ https://www.whitehouse.gov/sites/default/files/omb/assets/
    budget_amendments/emergency_supplemental_2-22-16_zika.pdf
    ---------------------------------------------------------------------------
                                    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\).
    ---------------------------------------------------------------------------
        \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.
    ---------------------------------------------------------------------------
        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.
    ---------------------------------------------------------------------------
      --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.
    ---------------------------------------------------------------------------
        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.
    ---------------------------------------------------------------------------
        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\
    ---------------------------------------------------------------------------
        \7\ ``USDA Plan to Speed Up Poultry-Processing Lines Could Increase
    Risk of Bird Abuse.'' The Washington Post: October 29, 2013.
    ---------------------------------------------------------------------------
        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]