[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]


 
            HEARING TO REVIEW CURRENT ISSUES IN FOOD SAFETY

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

                                HEARING

                               BEFORE THE

                        COMMITTEE ON AGRICULTURE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             JULY 16, 2009

                               __________

                           Serial No. 111-25


          Printed for the use of the Committee on Agriculture
                         agriculture.house.gov


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                        COMMITTEE ON AGRICULTURE

                COLLIN C. PETERSON, Minnesota, Chairman

TIM HOLDEN, Pennsylvania,            FRANK D. LUCAS, Oklahoma, Ranking 
    Vice Chairman                    Minority Member
MIKE McINTYRE, North Carolina        BOB GOODLATTE, Virginia
LEONARD L. BOSWELL, Iowa             JERRY MORAN, Kansas
JOE BACA, California                 TIMOTHY V. JOHNSON, Illinois
DENNIS A. CARDOZA, California        SAM GRAVES, Missouri
DAVID SCOTT, Georgia                 MIKE ROGERS, Alabama
JIM MARSHALL, Georgia                STEVE KING, Iowa
STEPHANIE HERSETH SANDLIN, South     RANDY NEUGEBAUER, Texas
Dakota                               K. MICHAEL CONAWAY, Texas
HENRY CUELLAR, Texas                 JEFF FORTENBERRY, Nebraska
JIM COSTA, California                JEAN SCHMIDT, Ohio
BRAD ELLSWORTH, Indiana              ADRIAN SMITH, Nebraska
TIMOTHY J. WALZ, Minnesota           ROBERT E. LATTA, Ohio
STEVE KAGEN, Wisconsin               DAVID P. ROE, Tennessee
KURT SCHRADER, Oregon                BLAINE LUETKEMEYER, Missouri
DEBORAH L. HALVORSON, Illinois       GLENN THOMPSON, Pennsylvania
KATHLEEN A. DAHLKEMPER,              BILL CASSIDY, Louisiana
Pennsylvania                         CYNTHIA M. LUMMIS, Wyoming
ERIC J.J. MASSA, New York
BOBBY BRIGHT, Alabama
BETSY MARKEY, Colorado
FRANK KRATOVIL, Jr., Maryland
MARK H. SCHAUER, Michigan
LARRY KISSELL, North Carolina
JOHN A. BOCCIERI, Ohio
SCOTT MURPHY, New York
EARL POMEROY, North Dakota
TRAVIS W. CHILDERS, Mississippi
WALT MINNICK, Idaho

                                 ______

                           Professional Staff

                    Robert L. Larew, Chief of Staff

                     Andrew W. Baker, Chief Counsel

                 April Slayton, Communications Director

                 Nicole Scott, Minority Staff Director

                                  (ii)


                             C O N T E N T S

                              ----------                              
                                                                   Page
Boswell, Hon. Leonard L., a Representative in Congress from Iowa, 
  supplemental material..........................................   133
Goodlatte, Hon. Bob, a Representative in Congress from Virginia, 
  opening statement..............................................     3
Peterson, Hon. Collin C., a Representative in Congress from 
  Minnesota, opening statement...................................     1
    Prepared statement...........................................     2
Walz, Hon. Timothy J., a Representative in Congress from 
  Minnesota, prepared statement..................................     4

                               Witnesses

Wooten, Larry B., President, North Carolina Farm Bureau 
  Federation; Member, Board of Directors, American Farm Bureau 
  Federation, Raleigh, NC........................................     5
    Prepared statement...........................................     6
Boyle, J. Patrick, President and CEO, American Meat Institute, 
  Washington, D.C................................................    12
    Prepared statement...........................................    13
    Submitted report.............................................    27
Tucker-Foreman, Carol L., Distinguished Fellow, The Food Policy 
  Institute, Consumer Federation of America, Washington, D.C.; on 
  Behalf of Center for Foodborne Illness Research & Prevention; 
  Center for Science in the Public Interest; Consumers Union; 
  Food & Water Watch; Government Accountability Project; National 
  Consumers League; The Pew Charitable Trusts; Safe Tables Our 
  Priority; Trust for America's Health; and The United Food & 
  Commercial Workers International Union.........................    40
    Prepared statement...........................................    41
Ives, D.V.M., Ph.D., Samuel E., Director of Veterinary Services 
  and Associate Director of Research, Cactus Feeders, Ltd., 
  Amarillo, TX; on behalf of National Cattlemen's Beef 
  Association....................................................    47
    Prepared statement...........................................    48
Peppler, Kent, President, Rocky Mountain Farmers Union, Mead, CO; 
  on behalf of National Farmers Union............................    52
    Prepared statement...........................................    53
Reinhard, Robert G., Director of Food Safety and Regulatory 
  Affairs, Sara Lee Corporation; Co-Chairman, Technical and 
  Regulatory Committee, National Turkey Federation, Downers 
  Grove, IL......................................................    59
    Prepared statement...........................................    60
Maravell, Nicholas C., Owner and Operator, Nick's Organic Farm, 
  LLC, Potomac, MD...............................................    63
    Prepared statement...........................................    65
McDonald, Drew, Vice President, National Quality Systems, Taylor 
  Farms, Salinas, CA.............................................    78
    Prepared statement...........................................    80
Mande, Jerold R., Deputy Under Secretary for Food Safety; and 
  Cindy Smith, Acting Under Secretary for Marketing and 
  Regulatory Programs and Administrator, APHIS, U.S. Department 
  of Agriculture, Washington, D.C................................   110
    Prepared statement...........................................   112
Taylor, J.D., Michael R., Senior Advisor to the Commissioner, 
  U.S. Food and Drug Administration, Department of Health and 
  Human Services, Rockville, MD..................................   116
    Prepared statement...........................................   119

                           Submitted Material

National Council of Farmer Cooperatives, submitted statement.....   135
Submitted questions..............................................   137


            HEARING TO REVIEW CURRENT ISSUES IN FOOD SAFETY

                              ----------                              


                        THURSDAY, JULY 16, 2009

                          House of Representatives,
                                  Committee on Agriculture,
                                                   Washington, D.C.
    The Committee met, pursuant to call, at 10:08 a.m., in Room 
1300, Longworth House Office Building, Hon. Collin C. Peterson 
[Chairman of the Committee] presiding.
    Members present: Representatives Peterson, McIntyre, 
Boswell, Baca, Cardoza, Scott, Herseth Sandlin, Cuellar, Costa, 
Walz, Kagen, Halvorson, Dahlkemper, Bright, Markey, Kratovil, 
Schauer, Kissell, Boccieri, Minnick, Goodlatte, Moran, Johnson, 
King, Neugebauer, Conaway, Fortenberry, Schmidt, Smith, Latta, 
and Luetkemeyer.
    Staff Present: Andy Baker, Robert L. Larew, Nathan Fretz, 
Chandler Goule, Alejandra Gonzalez-Arias, Tyler Jameson, Scott 
Kuschmider, James Ryder, April Slayton, Rebekah Solem, Patricia 
Barr, Tamara Hinton, John Goldberg, Pam Miller, and Pete 
Thomson.

OPENING STATEMENT OF HON. COLLIN C. PETERSON, A REPRESENTATIVE 
                   IN CONGRESS FROM MINNESOTA

    The Chairman. The Committee will come to order. This 
hearing of the Committee on Agriculture today is to review the 
current issues on food safety and will come to order.
    I am going to be brief in my statement. I welcome everybody 
to the Committee. I welcome our witnesses.
    There is a lot going on with food safety right now, both in 
policy and legislation. The President's Food Safety Working 
Group has been working on policies to improve food safety. The 
House Energy and Commerce Committee has approved legislation 
related to food safety at the FDA, and this is the fourth 
hearing this year held by this Committee to look at this topic. 
And I can tell you that it won't be the last hearing we have on 
the subject either. It is a complicated issue with a lot of 
interacting and moving parts; so I want to be sure that our 
Members have a clear understanding of what is going on and what 
we can do to play a role in the process.
    So I hope Members are ready to get involved. We all want to 
do whatever we can to make our food safety system better. We 
have the safest food in the world, but it can always be better 
and that is a priority of this Committee, and we will do 
whatever we can to facilitate that process.
    So I am going to do something a little out of the ordinary 
here. I have constituent, sort of, from Minnesota here and I 
wanted to recognize him. His mother was in my district and 
passed away because of the peanut situation that happened here 
not too long ago, and he has joined us today. So I just want to 
give the rest of my time to him to tell us a little bit about 
his mother and the situation, and he is also an accountant so 
we are brothers that way as well. So Jeffrey Almer from 
Minnesota, you are recognized.

 STATEMENT OF JEFFREY ALMER, MEMBER, S.T.O.P.--SAFE TABLES OUR 
                      PRIORITY, SAVAGE, MN

    Mr. Almer. Thank you, Mr. Chairman. I thank everyone for 
inviting me. I am just, very obviously, interested in how this 
progresses. I know it is a long process. My main reason to be 
here is to let you folks know that--and you probably do know 
this already--things can be done so much better, and I know 
there has been some rumors going around on the Internet and 
things like that about how it will affect small farmers and 
things like that. I just want to see that we turn food safety 
in this country around and make it safe like it needs to be. I 
don't want to have any political parties influenced one way or 
the other. I just want to have it done right.
    But my mother Shirley, she was a business woman and she had 
defeated cancer twice, lung cancer 1 year and brain cancer the 
next year. She overcame a lot of struggles and was in a rehab 
facility for a urinary infection, a simple infection. And she 
consumed some peanut butter that was in an industrialized 
container, and that took her. It is very hard to imagine to see 
somebody struggle to get that far beat cancer and then have 
something as simple as peanut butter take her life. She had a 
lot more life to live and was loved by all of us.
    So I am here in her honor, I am here on her behalf and for 
the other people that have been affected by food, and there are 
quite a few people. One out of four every year will be affected 
by food illness. So I have joined up with S.T.O.P.--Safe Tables 
Our Priority. They have done expert work. I am not an expert by 
any means but just as an average layman I can see we can do 
better. I know we can. So I appreciate your time thank you very 
much, Mr. Chairman.
    The Chairman. Thank you very much for taking time to be 
with us and for honoring your mother. We sympathize with your 
situation and I can assure you this Committee will do whatever 
we can to improve the food safety system in this country. Thank 
you.
    [The prepared statement of Mr. Peterson follows:]

  Prepared Statement of Hon. Collin C. Peterson, a Representative in 
                        Congress from Minnesota

    Good morning and welcome to today's hearing of the House 
Agriculture Committee. Because we have a lot to get to today, I am 
going to keep my remarks brief.
    There is a lot going on with food safety policy and legislation 
right now. The President's Food Safety Working Group has been working 
on policies to improve food safety. The House Energy and Commerce 
Committee has approved legislation related to food safety at FDA. And 
this is the fourth hearing this year held by this Committee to look at 
this topic. It won't be the last hearing we have on this subject 
either. This is a complicated issue with a lot of interacting and 
moving parts, so I want to be sure that our Members have a clear 
understanding of what is going on and what we can do to play a role in 
this process. I hope that Members of the Committee are ready to roll up 
their sleeves, learn all that they can, and ask the questions that need 
to be asked.
    I want to thank all of our witnesses for being here today, and I 
look forward to their testimony.

    The Chairman. I now recognize the gentleman who is sitting 
in today as the Ranking Member, former Chairman of the 
Committee, former Ranking Member of the Committee and my good 
friend, Mr. Goodlatte from Virginia.

 OPENING STATEMENT OF HON. BOB GOODLATTE, A REPRESENTATIVE IN 
                     CONGRESS FROM VIRGINIA

    Mr. Goodlatte. Thank you, Mr. Chairman. I very much 
appreciate that this Committee is continuing to devote its 
attention to such an important issue as the safety of our food 
supply. Every Member of this Committee recognizes that food 
safety is approximately the single most important issue for 
which we have jurisdiction. Likewise, I don't think there is a 
single member of this panel who wouldn't support reasonable 
proposals that improve the safety of what is already the safest 
food supply in the world. It is unfortunate that the 
legislation passed out by the Energy and Commerce Committee, 
H.R. 2749, the Food Safety Enhancement Act of 2009, does so 
little to enhance food safety. Most observers agree that to 
improve food safety, we must focus on preventing contamination 
and cross contamination during food processing and preparation. 
However, it appears that the overwhelming majority of this bill 
seems to misdirect the attention of the regulatory agency to 
reacting after a foodborne illness outbreak in punishing those 
who may or may not have anything to do with it.
    Another area of considerable concern with this legislation 
is that the authors seem to believe that the Food and Drug 
Administration has the resources and expertise to be able to 
implement and enforce regulations on the more than 2.2 million 
farms in this country. Section 103 of this legislation will 
direct the FDA to issue mandatory on-farm food safety 
performance standards. Due to severe resource constraints 
within the FDA, this will undoubtedly ignore the complexity and 
diversity of farming operations. Section 103 will direct the 
FDA to adapt a food processing regulatory model to agricultural 
production practices.
    Let me be clear about the consequences of this legislation. 
Directing the Food and Drug Administration to tell farmers how 
to farm will make food more expensive. It will threaten our 
food security. It will increase our reliance on foreign food. 
It will not make our food supply safer.
    The FDA does have the expertise, and if this legislation is 
crafted correctly, will have the resources to facilitate the 
processing, distribution and preparation of safer food. That to 
me is where we need to be directing our attention to avoid the 
kind of tragedies that some have experienced. But a live 
animal, a plant actively growing in a field, or a piece of 
fruit developing high up in a tree, is not yet food and is 
therefore beyond the expertise of the FDA to oversee its 
production.
    I am continually frustrated by advocates who believe that 
Congress should enact legislation that attempts to extend the 
food processing regulatory model to agricultural production 
practices. This is simply not the way to go, no matter how good 
the intentions.
    On this Committee and at the USDA, our colleagues 
understand the nature of farming in America. We know about the 
complexity and diversity of our farming operations and fully 
appreciate that a one size fits all regulatory model would be a 
disaster. The Committee can take pride in the fact that our 
country is blessed to have farmers who continually produce the 
safest, highest quality, most abundant and affordable food 
supply in the history of the world. We must make clear one 
important fact regarding a recent incident of foodborne illness 
that seems to be driving this legislation.
    That incident was not the result of inadequate legal 
authority or even inadequate regulation. It was the result of 
intentional disregard of food safety standards by the food 
processor and a complete failure of the FDA to enforce its own 
regulations.
    As we consider this legislation, I will be evaluating this 
and any other proposal on three key principles: One, does the 
legislation make food safer? Two, does the legislation hold the 
regulator accountable? And three, does the legislation 
adequately account for geographic differences and weather 
differences in food production, as well as the diversity of the 
crops being grown?
    Mr. Chairman, again, I thank you for this hearing and I 
look forward to today's testimony and the considerate informed 
debate that will follow.
    The Chairman. I thank the gentleman for his statement. All 
other Members are advised that they can submit statements for 
the record.
    [The prepared statement of Mr. Walz follows:]

    Prepared Statement of Hon. Timothy J. Walz, a Representative in 
                        Congress from Minnesota

    Mr. Chairman, Mr. Ranking Member, Members of the Committee, our 
witnesses here, thank you for this very important hearing.
    A series of high-profile outbreaks of foodborne illness over the 
past 3 years resulting in thousands of individuals sickened and 
multiple deaths has demonstrated the need to improve food safety. I am 
glad that we are here today looking at legislation to improve our food 
safety system. We have an obligation to our children to address this 
problem, to set an example for the world, and to strengthen our 
economic security and energy independence. However, we must do it 
wisely, it must make sense, and it must not do more harm than good.
    I do have concerns about certain provisions in H.R. 2749, the Food 
Safety Enhancement Act of 2009. It is important that Congress get it 
right. Mr. Chairman, I thank you for bringing together these experts to 
address food safety legislation as it relates to the agriculture 
community.
    So far, USDA has set a good example as a regulating agency. It is 
important to use their expertise to help shape any food safety 
legislation that affects our producers.
    I know the farmers in my district in southern Minnesota want to be 
part of the solution and want to assure the public that they are doing 
everything possible to keep our food safe. They understand we need new 
mechanisms to stop the bad actors. However, we need mechanisms that 
work, not mechanisms that simply add heavy-handed regulation to low-
risk commodities.
    Mr. Chairman, I look forward to the opportunity to hear the 
testimony of our witnesses today and the chance to ask them questions 
about how they believe food safety regulation should be addressed.

    The Chairman. And we will move to the witnesses.
    We would like to welcome them all again to the witness 
table. Mr. Larry Wooten, the President of the North Carolina 
American Farm Bureau Federation. Welcome, Larry.
    Mr. Wooten. Glad to be here.
    The Chairman. Patrick Boyle, President of the American Meat 
Institute. Ms. Carol Tucker-Foreman, Distinguished Fellow with 
the Food Policy Institute, Consumer Federation of America. Dr. 
Sam Ives, Director of Veterinary Services and Associate 
Director of Research for the Cactus Feeders, Limited, on behalf 
of the National Cattlemen's Association. Mr. Kent Peppler, 
President of the Rocky Mountain Farmers Union. Mr. Bob 
Reinhard, Director of Food Safety for Sara Lee and Chairman of 
the Technical and Regulatory Committee of the National Turkey 
Federation. Mr. Nicholas Maravell, Owner and Operator of Nick's 
Organic Farm in Potomac, Maryland. And Mr. Drew McDonald, Vice 
President of National Quality Systems, Taylor Farms, Salinas, 
California.
    So welcome all to the Committee. Mr. Wooten you are on 
first. Your full statements will be all made part of the 
record. And we have votes coming up at 11:30; so we are going 
to try to move this. So we would like to have you observe the 5 
minute rule and your full testimony will be made part of the 
record. So welcome to the Committee.

         STATEMENT OF LARRY B. WOOTEN, PRESIDENT, NORTH
 CAROLINA FARM BUREAU FEDERATION; MEMBER, BOARD OF DIRECTORS, 
                AMERICAN FARM BUREAU FEDERATION,
                          RALEIGH, NC

    Mr. Wooten. Thank you very much. Good morning, Chairman 
Peterson, Mr. Goodlatte, and Members of the Committee. I am 
Larry Wooten, a tobacco and grain producer from North Carolina. 
I am President of the North Carolina Farm Bureau and testifying 
today as a Member of the Board of Directors of the American 
Farm Bureau Federation. We appreciate your scheduling this 
hearing to review the current food safety issues.
    As the nation's largest general farm organization and the 
representative of farmers and ranchers in every state in the 
nation, Farm Bureau has a vital interest in how food safety is 
practiced, perceived, and regulated. We represent growers of 
virtually every commodity from apples to zucchini and pigs to 
peanuts. My home State of North Carolina is a microcosm of Farm 
Bureau's diversity as we proudly claim the nation's third most 
diversified agricultural economy. North Carolina's rural 
landscape is made up of many small farms due to our state's 
history with the Federal tobacco and peanut programs. North 
Carolina is a perfect example of the need for any food safety 
legislation to recognize the different needs of farmers based 
on the size and scope of their operations. One size does not 
fit all. Regional differences in production and cultural 
methods must certainly be considered.
    Farm Bureau supports efforts to strengthen the country's 
food and animal feed safety systems utilizing sound science in 
a risk-based approach. We also recognize the importance of 
providing adequate resources in a manner that increases 
efficiencies. The nation's food safety system must have the 
capacity, the authority, and the structural organization to 
safeguard the health of American consumers against foodborne 
illness. Evaluating food safety laws to determine whether they 
have kept pace with significant changes in food production is a 
priority both for agriculture and the food industry, as well as 
for government.
    However, there is concern that too many new standards will 
unnecessarily complicate the marketplace without increasing the 
overall safety of the food supply. While we understand the need 
for continuous food safety improvement, the farm level impact 
on producers must certainly be considered in any new 
initiatives. Legislation currently pending in the House of 
Representatives contains some very troubling provisions that 
could undermine our ability to provide a safe, affordable and 
abundant food supply. Although numerous bills have been 
introduced in Congress to address a variety of food safety-
related issues, we will focus our comments today on the Food 
Safety Enhancement Act. Farm Bureau supports of goal of H.R. 
2749 to provide additional food safety resources both 
internally and through cooperative relationships.
    We appreciate the bill's requirement that FDA establish a 
program to recognize laboratory accreditation bodies and 
encourage that third-party certification be extended to 
domestic testing and inspections. Much of the additional 
research required in this legislation has been necessary for 
several years and is critical to any effective food safety 
initiatives in the future. Bipartisan negotiations that took 
place prior to the Committee passage of H.R. 2749 to address 
numerous concerns raised by the Farm Bureau and other groups 
was important. Most notably livestock operations and the 
livestock portion of diversified farming operations are 
generally exempted from the bill. Despite substantial and 
significant progress from the legislation's original discussion 
draft, unresolved issues that could increase costs and increase 
paperwork burdens on farmers and ranchers remain.
    As approved by the full Committee on June 17, H.R. 2749 
would significantly expand authorities for FDA to regulate and 
oversee on-farm production practices. Farms are explicitly 
included in extensive new record-keeping, reporting and 
traceability measures which may not be feasible or practical 
for many of our producers. FDA does not have the personnel, the 
funding, the expertise or the time to regulate agricultural 
production practices particularly given its overall volume of 
increased responsibilities contemplated in H.R. 2749.
    Mr. Chairman and Members of the Committee, we thank you for 
arranging--again, for arranging this public hearing to better 
understand food safety issues, and for allowing us to share 
producers' views of the current legislation. We are committed, 
at American Farm Bureau, to improving food safety in a targeted 
scientific and risk-based manner, and we stand ready to work 
with Congress in that effort. Thank you very much.
    [The prepared statement of Mr. Wooten follows:]

 Prepared Statement of Larry B. Wooten, President, North Carolina Farm
  Bureau Federation; Member, Board of Directors, American Farm Bureau 
                        Federation, Raleigh, NC

    Good morning, Chairman Peterson, Ranking Member Lucas and Members 
of the Committee. I am Larry Wooten, a tobacco and grain producer from 
North Carolina. I am President of the North Carolina Farm Bureau and 
testifying today as a Member of the Board of Directors of the American 
Farm Bureau Federation (AFBF).
    On behalf of Farm Bureau's more than six million members, thank you 
for your dedication and commitment to farmers, ranchers and the related 
industries that provide the U.S. with the world's most abundant, 
affordable and safe food supply. We appreciate you scheduling this 
hearing to review current food safety issues. AFBF is pleased to 
present producers' perspectives on this issue and we thank you for 
inviting us to share our views on a topic that is important to our 
members, producers and consumers alike.
    As the nation's largest general farm organization and the 
representative of farmers and ranchers in every state in the nation, 
AFBF has a vital interest in how food safety is practiced, perceived 
and regulated. We represent growers of virtually every commodity, from 
apples to zucchini and pigs to peanuts.
    My home State of North Carolina is a microcosm of Farm Bureau's 
diversity, as we proudly claim the nation's third most diversified 
agriculture economy. Agriculture is North Carolina's number one 
industry accounting for about $70.8 billion in annual economic activity 
and just under \1/5\ of our state's jobs.
    North Carolina's rural landscape is made up of many small farms due 
to our state's history with the Federal tobacco and peanut programs. It 
is a perfect example of the need for any food safety legislation to 
recognize the different needs of farmers based on the size and scope of 
their operations. One size does not fit all, and agencies with 
experience in the diversity of farming operations--including USDA--
appreciate regional differences in production and cultural methods.

The Safety of the U.S. Food Supply
    American consumers deserve to have confidence that their food is 
safe and that the best science is used to ensure that the most 
wholesome product possible is produced and offered. Consumers 
reasonably expect that their food is safe, whether grown domestically 
or imported.
    By their nature, food systems are biological and thus, not failsafe 
nor can they ever be ``zero risk.'' However, food today is safer than 
in the past and food safety is constantly improving, particularly 
through reporting and tracing when food problems occur. In 1996, the 
Centers for Disease Control (CDC) improved its data collection of 
foodborne illnesses. The results since then indicate a 25 percent 
decline in E. coli ailments, Campylobacter cases are down 32 percent, 
and Listeria has shown a 36 percent decrease in illnesses. Other 
bacterial infections are down by about 33 percent.
    These improvements have occurred despite new challenges for food 
safety, such as changes in the typical American diet to include more 
imported foods and more food consumed away from home. The U.S. now 
imports food from more than 150 different countries through more than 
300 ports of entry. About half of fresh fruits eaten in America are 
grown outside of the country, and if you've ever been to a mid-Atlantic 
farmers market in January an explanation of why this happens becomes 
clear--these imports allow us to enjoy our favorite produce year-round. 
Trade in food permits a more varied and customized diet suited to 
today's consumer preferences. It permits our farmers and other food 
producers to sell their goods abroad. Yet, it also means that food 
safety requires enhanced attention to the global food supply.
    Adding to the complexity presented by increased food sources, the 
number of people involved in preparing the food we consume has also 
increased. Approximately 50 cents of every food dollar today is spent 
on foods prepared outside the home in places like restaurants, vending 
machines, and schools. This development increases the need to ensure 
adequate training for food service workers across the country and to 
consider the potential widespread impact of deliberate contamination of 
the food supply. As the supply chain gets longer, there are more 
opportunities (both accidental and intentional) for the introduction of 
public health threats.
    Though the U.S. food production system is among the best in the 
world, producers and consumers agree that improvement is always an 
important goal. In addition to the new trends previously noted, recent 
food recalls have increased consumer awareness of food safety. The 
nation's food safety system must have the resources, authority and 
structural organization to safeguard the health of American consumers 
against foodborne illness. Evaluating food safety laws to determine 
whether they have kept pace with significant changes in food 
production, processing and marketing--such as new food sources, 
advances in production and distribution methods, and the growing volume 
of imports--is a priority for the agriculture and food industry, as 
well as government.
    However, there is concern that too many new standards will 
unnecessarily complicate the marketplace without improving food safety 
overall. While we understand the need for continuous food safety 
improvement, the farm-level impact on producers must be considered in 
any new food safety regulations or legislation.

Farm Bureau Policy
    AFBF supports:

   Adequate funding of the government's food and feed safety 
        and protection functions;

   Increased education and training for inspectors;

   Additional science-based inspection, targeted according to 
        risk;

   Research and development of scientifically based rapid 
        testing procedures and tools;

   Increased funding for the Food Animal Residue Avoidance 
        Databank (FARAD);

   Accurate and timely responses to outbreaks that identify 
        contaminated products, remove them from the market and minimize 
        disruption to producers; and

   Indemnification for producers who suffer marketing losses 
        due to inaccurate government-advised recalls or warnings.

    Farm Bureau strongly opposes efforts to eliminate years of food 
safety expertise by creating a new, single food safety regulator. 
Rather than streamlining authorities, the result would be less 
organization, more energy expended in transition than inspections, and 
the cumulative loss of valuable technical knowledge.
    While we believe that import inspections must be increased in a 
risk-based manner, we have concerns about food safety bills which could 
threaten trade. Port closures and discriminatory treatment of 
international products are especially problematic.

Food Safety Responsibilities
    Food safety is a shared responsibility of everyone in the food 
chain, from producer to consumer and each step in between. The 
government also plays a vital oversight and regulatory role.

It Starts with the Producer
          America's farmers and ranchers are committed to producing 
        safe and affordable food for consumers in the U.S. and around 
        the world. There are several reasons for their strong support 
        for food safety. They have the same desire as other consumers 
        to have a safe, abundant and affordable food supply. They also 
        have an economic interest because the demand for their products 
        is determined by consumer confidence that food is safe.
          Food safety is paramount for everyone involved in the 
        agriculture industry. We have an obligation to produce a safe, 
        nutritious product for domestic and international consumers, 
        and that obligation is at the core of all that we do.

Government Role
          The Government Accountability Office (GAO) has identified 15 
        Federal agencies that administer at least 30 laws related to 
        food safety. The Food and Drug Administration (FDA) within the 
        Department of Health and Human Services and the Food Safety 
        Inspection Service (FSIS) within the Department of Agriculture 
        (USDA) handle most of the government's food safety regulatory 
        system.
          FDA regulates 80 percent of the food supply. The agency is 
        responsible for ensuring that all domestic and imported food 
        products--except for most meat and poultry derived from the 
        major animal species--are safe, nutritious, wholesome and 
        accurately labeled. FDA share responsibility for the safety of 
        eggs with FSIS.
          FSIS regulates 20 percent of the food supply, ensuring the 
        safety, wholesomeness and proper labeling of most domestic and 
        imported meat and poultry and their products sold for human 
        consumption. FSIS inspects all cattle, sheep, swine, goats and 
        horses before and after they are slaughtered. FSIS also 
        maintains oversight during meat and poultry processing into 
        food products.
          Among the other agencies that play a role in food safety are 
        USDA's Agricultural Research Service, the Center for Disease 
        Control, the Environmental Protection Agency, the National 
        Marine Fisheries Service and the Department of Homeland 
        Security (DHS).

Consumers are the Ultimate Step
          Once a safe food product leaves the retail shelf, the final 
        responsibility for safe storage, handling and preparation 
        ultimately rests with the consumer. The amount of time (less) 
        and methods used (more) to prepare food have changed 
        considerably, requiring consumers to increase their knowledge 
        and vigilance. Yet, consumers' knowledge about food storage and 
        preparation has declined markedly in the past 30 years. This 
        results in greater chance for human error in food choices and 
        preparation. Many of the estimated 76 million cases of 
        foodborne illnesses in the U.S. each year are contracted in the 
        home, and many can be prevented through proper kitchen health, 
        storage and cooking.
          The entire food industry is committed to not only offering a 
        safe product to consumers, but also doing all that we can to 
        ensure the safety of that product until it is consumed. On 
        February 10, AFBF launched a consumer website, Your 
        Agriculture, at www.fb.org/yourag, which includes safety 
        guidelines for food preparation, cooking, serving and storage 
        in the home. Our biannual publication ``Farm Facts,'' dedicated 
        to educating the public about all facets of agriculture in 
        layman's terms, details the four simple food safety steps: 
        clean, separate, chill and cook. Last year, we began publishing 
        a monthly e-newsletter, ``Foodie News.'' AFBF also produces a 
        brochure, ``Farmers Provide Safe and Abundant Food,'' to help 
        educate the public about food safety.

    It is important to note that everyone plays a role in food safety, 
including the food industry and regulatory agencies. Therefore, we 
support Congress' efforts to strengthen the country's food- and animal 
feed-safety systems utilizing sound science and a risk-based approach. 
We also recognize the importance of structuring and providing adequate 
resources to our food- and feed-safety systems to increase 
efficiencies. However, legislation currently pending in the House of 
Representatives contains some very troubling provisions that could 
undermine our ability to provide a safe, affordable and abundant food 
supply.

Legislative Action in the House of Representatives
    Although numerous bills have been introduced in Congress to address 
a variety of food safety related issues, we will focus our comments 
today on the Food Safety Enhancement Act (H.R. 2749) as it appears to 
be the primary vehicle for food safety reform in the House. We 
appreciate the interest of both the majority and minority Members and 
staff of the Energy & Commerce Committee in learning about how and why 
we do what we do to produce safe food. We remain engaged in ongoing 
discussions to continue improving H.R. 2749 before it comes to the 
House floor for a vote.
    Farm Bureau is encouraged by several provisions in H.R. 2947 to 
increase FDA resources, both internally and through cooperative 
relationships. We support the goal of the legislation to strengthen and 
provide additional resources for food safety functions. We appreciate 
the bill's requirement that FDA establish a program to recognize 
laboratory accreditation bodies and encourage that third-party 
certification be extended to domestic testing and inspections. Much of 
the additional research required in the legislation--to develop 
efficient rapid methods for detecting contaminants; determine the 
sources of contamination; identify common and emerging zoonotic 
diseases; and develop methods for destroying pathogens--has been 
necessary for several years and is critical to any effective food 
safety initiatives in the future.
    Bipartisan negotiations took place prior to House Energy and 
Commerce Committee passage of H.R. 2749 to address numerous concerns 
raised by Farm Bureau and other agriculture groups. Most notably, 
livestock operations and the livestock portion of diversified 
operations are generally exempted from the bill. Other improvements 
include the removal of troubling restrictions on modified atmosphere 
packaging and clarification that country-of-origin labeling (COOL) 
requirements not conflict with what is already required by the USDA 
program.
    Despite substantial and significant progress from the legislation's 
original discussion draft, unresolved issues that could increase cost 
and paperwork burdens on farmers and ranchers remain. As amended and 
approved by the full Committee on June 17, H.R. 2749 would 
significantly expand authorities for FDA to regulate and oversee on-
farm production activities. Farms are explicitly included in extensive 
new record-keeping, reporting and traceability measures which may not 
be feasible or practical for many producers.
    Furthermore, H.R. 2749 paints the entire food supply system with a 
very broad brush. As you know, each segment of the food and agriculture 
spectrum is unique.
    The bill would for the first time permit the Food and Drug 
Administration (FDA) oversight of many on-farm production activities 
with which it has little to no experience and which have not 
traditionally been under its jurisdiction on a routine basis. Many of 
these authorities are duplicative and overlapping with the jurisdiction 
of the U.S. Department of Agriculture and the Congressional Agriculture 
Committees.
    Not only are the authorities redundant with existing USDA 
authority, but FDA does not have the personnel, funding, knowledge, 
expertise or time to regulate agricultural production practices--
particularly given its overall volume of increased responsibilities 
contemplated in H.R. 2749. While that view is certainly widely held 
within the agriculture community, it is not limited to the production 
audience. Even the National Federation of Independent Businesses noted 
the business impracticalities in a letter on June 17 which noted that 
H.R. 2749 ``will do little to improve food safety but (would) impose 
significant costs on small farms and food producers.''
    Last month, Farm Bureau and a coalition of 18 other agriculture 
organizations expressed written concerns about the scope of H.R. 2749 
on production agriculture activities. As currently written, H.R. 2749 
would:

   Expand FDA's on-farm authorities to potentially include 
        production practices;

   Lower the existing on-farm inspection trigger threshold from 
        the 2002 Bioterrorism Act which requires that FDA have a 
        reasonable belief that a product presents threat of serious 
        adverse health consequences of death to humans or animals;

   Require additional record-keeping, including new 
        requirements for farms;

   Increase FDA's access to records without sufficient 
        guarantee of confidentiality;

   Require FDA to create a food traceability system which could 
        include farms (except most direct sales and farmers markets);

   Greatly expand FDA authority to quarantine geographic areas 
        for food safety problems; and

   Delegate to FDA District Offices the authority to issue 
        subpoenas and mandatory recalls, including to farms.

    A more detailed discussion of these specific concerns follows.
Safety Standards for Agricultural Commodities:
    The bill (Sec. 104) would require FDA to promulgate science and 
risk-based safety-standard regulations for seven activities, including 
the safe growing, harvesting, packing, sorting, transporting and 
holding of raw agricultural commodities. The performance standards are 
not limited to produce, but extend to any plant or fungus.
    ``Reasonably necessary'' regulations would be determined at FDA's 
discretion for both broad and specific safety standards, including 
manure use, water quality, animal control and temperature controls. 
These types of activities are all outside of FDA's realm of expertise, 
and most are redundant with existing USDA, EPA and Interior Department 
jurisdiction. While FDA would be required to consider impacts on small-
scale and diversified farms and on a variety of environmental criteria, 
there is no guarantee that FDA will produce fair or necessary standards 
that ultimately result in safer food.

Recordkeeping:
    The bill (Sec. 106) would require farmers to keep records 
regardless of the commodity they are producing and its associated risk 
profile, or lack thereof. FDA has unprecedented routine access to 
business records without justification of cause. Producers are required 
for the first time to allow a Federal official to access and copy all 
records, including production and sales records that may be related in 
any way to food or feed safety. By deleting the farm exemption in the 
Bioterrorism Act of 2002, each farmer would be required to maintain 
records showing every buyer to which the farm's products are sold 
(except products sold directly to final consumers or restaurants). 
Further, the bill would allow FDA to require that farmers retain 
records for up to 2 years.
    In a change from traditional practice dating back to 2002, FDA is 
not required to show cause prior to requesting records. Indeed, the 
bill would delete the current Bioterrorism Act threshold that requires 
that FDA first have a ``reasonable belief'' that a food article ``is 
adulterated and presents a threat of serious health consequences or 
death to humans or animals'' before having the authority to access 
records.
    Finally, confidentiality remains a serious concern in the 
Committee-passed bill. The ability of FDA to appropriately protect the 
privacy of producers' information from unauthorized release and/or 
access is unclear, at best, and not explicitly guaranteed.

Food Traceability:
    FDA is required (Sec. 107) to create a new system to track any food 
or feed contamination incident to its source within 2 business days. 
Because this provision exceeds the current Bioterrorism Act 
requirements to trace ``one-step-forward/one-step-back,'' it could 
require producers to maintain a complete history of where farm inputs 
originated and where farm-production outputs are sold. Electronic 
record-keeping is not specifically required, but farm records would 
likely need to be electronic to facilitate traceability in the 
specified time frame.
    This system would increase production costs for diversified farmers 
and grain farmers, most of whom operate small businesses. The 
requirement is overly burdensome considering the plethora of records 
that producers currently maintain. Yet, most farms do not have the 
technical or financial resources to make their record-keeping systems 
interoperable with others in the food chain. According to USDA Census 
of Agriculture data, less than 60 percent of farmers and ranchers have 
a computer, and only \1/3\ have high-speed Internet access.

Quarantine Authority:
    The quarantine authority (Sec. 133) is broad and far exceeds the 
authority granted to USDA. If FDA had this authority and had chosen to 
utilize it in 2008--when it erroneously suspected, based on what it 
believed at the time was ``credible information'' that tomatoes were a 
source of Salmonella contamination--entire regions of the country could 
have been quarantined, further decimating a sector of agriculture that 
already had suffered severe economic damage. Although livestock are 
exempt, it is unclear if the bill would allow FDA to conduct an on-farm 
inspection of or quarantine the livestock side of a diversified 
operation that has a food-safety issue with the grain side of its 
business. Unlike USDA, FDA is not required or even able to provide any 
indemnification, whether a quarantine is justified or erroneous.

Penalties:
    FDA is required (Sec.134 and 135) to issue fines for criminal and 
civil penalties. Unintentional as well as intentional violations may be 
fined, including up to $20,000 per individual for a record-keeping 
mistake. Each violation cited and each day during which it continues 
shall be considered to be a separate offense. Although penalties per 
event are capped, the cap is high enough ($50,000 for individuals for 
unintentional violations) to severely damage producers financially or 
put them out of business.

Delegation of Authority:
    The bill (Sec. 311, 418 and 420) gives wide latitude to the 
discretion of district office personnel for many authorities, including 
the right to recommend prescriptive preventive controls and the 
authority to issue mandatory recalls and subpoenas. This empowerment at 
the FDA District Office Director level is particularly troubling given 
the removal of the previous threshold for FDA action and records 
access. We strongly urge that authorities with broad and significant 
impact on the regulated entities be non-delegable beyond, at a minimum, 
the Center Director level and ideally retained within the office of the 
Secretary or Commissioner.

Trade Impacts:
    The latest version of H.R. 2749 removes the separate user 
registration for importers and production facilities, a very positive 
development. However, several provisions of the bill still violate U.S. 
trade commitments and would invite retaliation by our trading partners 
against exports of U.S. agricultural products.
    The food safety regime should be science based and flexible enough 
to recognize equivalence between food safety authorities. For example, 
there is no need for redundant inspections between countries like the 
U.S. and Canada. In addition, the frequency of inspections does not 
seem to be scientifically justified. The bill sets an arbitrary 
timeline for recurring inspections.
    There is serious concern that the user fee currently in the bill 
does not provide enough additional service to justify the fee. User 
fees that do not generate additional benefit for the importer may be 
trade restricting.
    As Congress works to finalize this legislation, Farm Bureau urges 
lawmakers to remain conscious of the international implications that 
food safety regulations have. Congress should ensure that the 
mechanisms put in place to regulate food safety do not treat importers 
more harshly than domestic facilities. To do so would be a violation of 
our World Trade Organization obligations.

Conclusion
    Thank you again for arranging this public hearing to better 
understand food safety issues, and for allowing us to share producers' 
views of current legislation. We are committed to improving food safety 
in a targeted, scientific, and risk-based manner, and we stand ready to 
work with Congress in that effort. We look forward to working with you 
and your colleagues as food safety legislation continues to be 
developed.

    The Chairman. Thank you, Mr. Wooten. That was a good job, 4 
seconds over, so you get an A+.
    Mr. Boyle, welcome to the Committee.

STATEMENT OF J. PATRICK BOYLE, PRESIDENT AND CEO, AMERICAN MEAT 
                  INSTITUTE, WASHINGTON, D.C.

    Mr. Boyle. Thank you, Mr. Chairman, and I appreciate the 
opportunity to provide perspective upon, and hopefully insight, 
into the Federal inspection system for meat and poultry 
products. Food safety is the institute's number one priority. 
For the past 10 years, it has been addressed by AMI members in 
a noncompetitive manner by sharing best practices and new 
technologies to improve food safety for the good of the 
industry and our customers.
    Today with the accompanying PowerPoint presentation, I 
would like to discuss the important oversight role of the Food 
Safety and Inspection Service as well as highlight the 
significant food safety improvements in meat and poultry 
products.
    The 8,000 field employees of FSIS inspect approximately 
6,300 domestic meat and poultry operations. An additional 2,000 
Federal employees provide supervision and support services at a 
total annual cost of $1.1 billion. Plants processing animals 
are not inspected during all hours the plant is operating. 
Plants processing meat and poultry products are inspected at 
least daily. For imported meat and poultry products, Federal 
law requires the foreign countries' inspection system to be 
equivalent to the U.S. system. Currently 33 foreign countries 
are approved to ship products to the U.S. and each foreign 
inspection system is audited annually. All meat and poultry 
products arriving at our borders are also subject to 
reinspection and laboratory analysis.
    Seventy-five import inspectors conduct these activities at 
150 official import establishments. More than a decade ago, 
FSIS and the industry embraced a major shift in the approach to 
food safety programs by adopting the principles of prevention 
embodied in HACCP. In fact, in 1993 AMI petitioned USDA to 
mandate HACCP to modernize the meat and poultry food and safety 
inspection system. FSIS oversight does not stop with HACCP 
regulations. FSIS assures processes are scientifically 
validated. Teams of expert auditors conduct periodic in-depth 
food safety assessments which can take days or weeks to 
complete and may involve extensive microbiological sampling of 
the plant's environment and finished products. Annually, FSIS 
conducts more than 8,000 microbiological tests to verify the 
production processes are under control. This is in addition to 
the several million microbiological tests that industry 
conducts each year.
    In addition to process control programs, the plant is 
required to have written standard sanitation operating 
procedures that prescribe how the operating environment will be 
maintained in a sanitary condition.
    Mr. Chairman, I ask your consent that we insert in the 
record a book entitled Protecting Consumers, which provides a 
more detailed oversight of FSIS in the meat and poultry 
industry.
    The Chairman. Without objection.
    Mr. Boyle. Thank you, Mr. Chairman.
    We clearly have an intensive meat and poultry inspection 
system, but it is important to recognize that only industry can 
produce safe food, and we have been making noteworthy progress. 
Since 2000 the industry has reduced the prevalence of E. coli 
O157:H7 in ground beef by 45 percent to less than \1/2\ 
percent. The prevalence of Listeria monocytogenes in ready to 
eat products has been reduced by 69 percent to \4/10\ of 1 
percent. We have seen similar improvements in the incidence of 
foodborne illness reported by the CDC. Since 2000 illnesses 
caused by E. coli are down by 44 percent. Listeriosis is down 
by three percent, though with much greater reductions occurring 
before the year 2000. In fact, we have not had a single product 
recall associated with an outbreak of listeriosis in the last 6 
years.
    As Congress considers various bills to reform FDA 
oversight, additional regulatory authorities are being proposed 
for FDA. AMI believes that many of them are unnecessary if 
applied to the FSIS inspection regimen. First, user fees are 
inappropriate. AMI does not support funding a $1 billion 
federally mandated inspection program by imposing fees on the 
regulated industry. Second, HACCP programs should be designed 
by food companies, not by the government, and then subjected to 
the review of the regulatory agency as is currently the 
situation with FSIS. Third, microbiological performance 
standards can be effective if properly constructed to achieve a 
public objective and are scientifically based to measure food 
safety. Our experience with FSIS performance standards is that 
those related to E. coli and LM have worked to improve public 
health. On the other hand, the Salmonella performance, while 
dramatically reducing the incidence on chicken, pork and beef 
has not reduced the number of cases of salmonellosis.
    Fourth, mandatory recall for meat and poultry products is 
needlessly redundant. Industry has every incentive to remove 
contaminated products from the marketplace to reduce potential 
liability, and the detention and seizure authority of FSIS 
provides the agency with more than sufficient leverage to 
compel the so-called voluntary recall.
    And fifth, civil money penalties within a continuous 
inspection program like FSIS are unnecessary. As noted on this 
slide, severe penalties are already in place for meat and 
poultry plants.
    Finally, AMI looks forward to working with this Committee 
and the Obama Administration's Food Safety Working Group about 
food safety initiatives that benefit consumers, the food 
industry, and the regulatory agencies that oversee the nation's 
food supply.
    Thank you very much, Mr. Chairman.
    [The prepared statement of Mr. Boyle follows:]

  Prepared Statement of J. Patrick Boyle, President and CEO, American 
                    Meat Institute, Washington, D.C.

    Good morning Mr. Chairman, Ranking Member, and Members of the House 
Committee on Agriculture. Thank you for allowing me the opportunity to 
appear before this Committee. My name is Patrick Boyle and I am the 
President and CEO of the American Meat Institute (AMI). AMI has 
provided service to the nation's meat and poultry industry--an industry 
that employs more than 500,000 individuals and contributes more than 
$832 billion to our nation's economy--for more than 100 years.
    AMI's 200 members include the nation's most well-known meat and 
poultry food manufacturers. Collectively, they produce 90 percent of 
the beef, pork, veal, and lamb food products and 75 percent of the 
turkey food products in the U.S. AMI's membership is extremely diverse, 
ranging from large, publicly traded companies that employ thousands to 
very small companies with as few as two employees. Indeed, more than 
half of AMI's members are small, family-owned businesses employing 
fewer than 100 individuals. We have one member company with just three 
employees. These companies operate, compete, sometimes struggle, and 
mostly thrive in one of the toughest, most competitive and certainly 
the most scrutinized sectors of our economy: meat and poultry packing 
and processing.
    AMI appreciates the opportunity to provide perspective and 
hopefully insight into our nation's food safety inspection system for 
meat and poultry products. Food safety is the Institute's number one 
priority. Each year, the AMI Board of Directors establishes priorities 
to direct the Institute. Food safety has topped the list for the past 
decade. In 1999, food safety was made a non-competitive issue by the 
organization which provided top management commitment to share best 
practices and new technology to improve food safety for the good of the 
industry.
    We all know that food safety has been in the news and because of 
that publicity a common refrain heard in Washington and other venues is 
that the U.S. food safety regulatory system is broken and has failed 
the American people. Indeed, a great deal of attention has been devoted 
to what is wrong and the changes needed to assure us that the food we 
consume is safe. Although some of the criticism may be warranted, a 
closer look at our meat and poultry food safety systems yields a 
different conclusion.
    Illnesses associated with meat and poultry consumption have 
declined. Nearly one billion meals are consumed each day in the United 
States without incident (Slide 1). For context, human illness 
statistics published by the Centers for Disease Prevention show that 
the pathogens most commonly associated with meat and poultry make up 
only a fraction of the total foodborne illnesses and deaths in the U.S. 
(Slide 2). These statistics are not provided to minimize each and every 
illness, hospitalization, or death associated with food consumption, 
but to put the risk into proper context.
    Is the sky falling? No, but most rational individuals still believe 
that food safety can be improved. I would like to discuss with you 
today some of the real improvements the meat and poultry industry has 
made and the important role government oversight plays in assuring that 
the industry meets its responsibility to produce safe food.
    First, the meat and poultry industry supports a strong Federal 
oversight system--and we have a strong system. The approximately 8,000 
employees of USDA's Food Safety Inspection Service (FSIS) inspect 
approximately 6,300 domestic meat and poultry operations and an 
additional 2,000 Federal employees provide supervision and support 
services, at a total cost of more than $1 billion. Plants processing 
animals are inspected during all hours the plant is operating. Plants 
preparing meat and poultry products are inspected at least daily (Slide 
3).
    For imported meat and poultry products, Federal law requires the 
foreign country's inspection system to be equivalent to the U.S. 
system. Thirty-three foreign countries are currently approved to ship 
products to the U.S. and each foreign inspection system is audited 
annually. All meat and poultry products arriving at our borders also 
are subject to reinspection and are routinely inspected and sampled for 
laboratory analysis. Seventy-five import inspectors conduct these 
activities at 150 official import establishments (Slide 4).
    Another comment often heard is that the food safety system must be 
preventative. We agree. More than a decade ago FSIS and the industry 
embraced a major shift in the approach to food safety programs by 
adopting the principles of prevention embodied in the Hazard Analysis 
and Critical Control Point, or HACCP. In fact, in 1993 AMI petitioned 
USDA to mandate the implementation of HACCP in federally-inspected 
plants in an effort to modernize the meat and poultry food safety 
inspection system (Slide 5).
    Mandatory HACCP provides a framework for identifying potential 
hazards and implementing measures to control those potential hazards 
during the production process. The process is continually monitored to 
assure that critical food safety standards are met. Pre-planned 
corrective actions are prescribed if critical limits are not met. 
Records are kept and available to FSIS inspectors for review and 
procedures are established to verify that the system is working 
properly. However, AMI believes that this prevention and control system 
must be uniquely suited to address the hazards specific to any 
facility. Uniform government controls are detrimental to individualized 
HACCP planning, thus food safety planning must remain the 
responsibility of the producing company. The proper role of the 
government in a HACCP-based food safety system is to verify that 
companies have conducted a proper hazard analysis, identified the 
hazards reasonably likely to occur in their operation, and have 
developed and implemented an appropriate HACCP plan to control those 
hazards. We do not believe it is the proper role of the government to 
establish hazards that are reasonably likely to occur and mandate 
preventive controls, as these vary by establishment.
    FSIS oversight does not stop at mandatory HACCP. FSIS assures 
processes are scientifically validated. Teams of expert auditors 
conduct periodic in-depth food safety reviews to complement the 
activities performed by the FSIS inspectors permanently stationed at 
the plant. These food safety assessments, or FSAs, can take days or 
weeks to complete and may involve extensive microbiological sampling of 
the environment and product (Slide 6).
    During the course of a year, FSIS conducts more than 80,000 
microbiological tests to verify that federally inspected 
establishments' production processes are under control. FSIS conducts 
these verification tests in addition to the several million 
microbiological tests the industry does each year (Slide 7).
    There is no finished product testing regime, however, that can 
guarantee that food products are pathogen-free or that they can be 
mishandled and remain safe to eat. Finished product testing is an 
important tool because it can show that process controls are effective 
and working, but it cannot eliminate every risk to a meaningful degree 
of certainty.
    In addition to process control programs, the plant is required to 
have written standard sanitation operating procedures that prescribe 
how the operating environment will be maintained in a sanitary 
condition. FSIS monitors plant sanitation before operations begin and 
while the plant is operating. Any deficiencies noted require immediate 
corrective action and failure to react appropriately can result in the 
plant being shut down by FSIS officials until the deficiencies are 
corrected (Slide 8).
    We have a strong Federal meat and poultry inspection system, but it 
is important to recognize that only the industry can produce safe food. 
Although food processors and handlers can minimize risks through the 
use of systems discussed above and other good management practices, 
there can be no absolute certainty that all food products are free from 
all risks. Notwithstanding that caveat, progress has been and is being 
made.
    Specifically, government data show a decline in pathogen prevalence 
on meat and poultry products. Since 2000, the industry has reduced the 
prevalence of E. coli O157:H7 in ground beef by 45 percent to less than 
\1/2\ percent (Slide 9). The prevalence of Listeria monocytogenes in 
ready-to-eat products has been reduced by 69 percent to less than 0.5 
percent (Slide 10). We have seen similar improvement in the incidence 
of foodborne illness reported by the Centers for Disease Control and 
Prevention. In that regard, since 2000, illnesses caused by E. coli 
O157:H7 are down by 44 percent and listeriosis is down by three percent 
with much of the improvement occurring before 2000 (Slides 11-12).
    A question often debated is whether microbiological performance 
standards are needed to improve public health. To answer that question, 
it is instructive to look at the existing Salmonella performance 
standards that are codified in the meat and poultry regulations.
    Since the performance standards were promulgated, the prevalence of 
Salmonella in chicken is down by 63 percent, in pork it is down by 70 
percent, and in ground beef it is down by 68 percent (Slides 13-15). 
Looking at these numbers one might conclude the Salmonella performance 
standards are a great success. Of significance, however, is the fact 
that the incidence of foodborne illness associated with Salmonella has 
actually increased slightly over the same time period (Slide 16).
    One might ask whether microbiological performance standards are a 
useful tool. The answer is they can be if properly constructed to 
achieve a public health objective and if they are scientifically based 
to measure whether food is safe and not injurious to public health. 
Conversely, I would suggest that a performance standard based solely on 
achieving an arbitrary outcome that yields no public health benefit is 
inappropriate.
    As the food safety debate heats up, some Congressional Members and 
others have called for enhancing the enforcement powers of the 
inspection agencies, including civil monetary penalties and other 
sanctions. For meat and poultry plants, however, very severe penalties 
already are in place.
    Specifically, FSIS can detain and seize adulterated products in 
commerce, as well as retain product at the plant thereby preventing it 
from entering commerce. Federal inspectors also have the authority to 
shut down a plant at a moment's notice if food safety violations such 
as insanitary conditions are identified. More serious violations can 
result in Federal inspectors being withdrawn from the plant, which 
results in the plant not being able to operate. And, plant management 
can be criminally prosecuted for food safety violations. It is 
difficult to comprehend how additional remedial penalties would improve 
food safety.
    Another subject of some controversy is mandatory recall. The cry 
for mandatory recall ignores a simple fact: Industry has every 
incentive to remove contaminated product from the marketplace to reduce 
potential liability. Experience shows us that the speed with which 
contaminated meat and poultry product is removed from the market will 
not improve with mandatory recall. In most cases, meat and poultry 
products are recalled within hours after a problem is discovered. And 
industry cooperation to execute recalls has been excellent (Slide 17).
    To date, no meat company has ever refused to conduct a warranted 
recall and in the highly unlikely event such a circumstance ever were 
to occur, the previously mentioned threat of FSIS product detention and 
seizure, coupled with the agency's ability to directly inform the 
public not to consume the product because the company refused to recall 
the affected product, not to mention the ramifications for the company 
at the producing plant, is more than sufficient leverage for FSIS. To 
my knowledge, such a situation has never occurred. In short, the 
concept of mandatory recall is a solution in search of a problem.
    A final concern as it relates to food safety is the imposition of a 
user fee that would be paid by the regulated industry for food safety 
inspection services. Similar proposals for meat and poultry inspection 
at USDA have been rejected by Congress annually for nearly 30 years. 
USDA inspection services have long been paid for with government funds 
because those inspections are activities that benefit of the general 
public. Inspection activities should be funded not from user or 
registration fees that, in effect, are a food tax, but from monies 
appropriated out of the general treasury.
    Earlier in the year, President Obama formed the White House Food 
Safety Working Group to recommend a new, public health-focused approach 
to food safety based on prevention, strengthening surveillance and 
enforcement, and improving response and recovery. We appreciate the 
recommendations put forth by the Working Group to date, and we 
reemphasize that any changes in our food safety system must show 
measured improvements in public health. AMI looks forward to working 
with the Obama Administration on implementing effective programs that 
benefit consumers, the industry, and our public institutions that 
safeguard the nation's food supply.
    Let me conclude with some suggestions on what will improve food 
safety.

    (1) With respect to government inspection programs the focus must 
        be on systems designed and implemented to protect public 
        health. Inspection activities that do not have a direct impact 
        on public health waste scarce resources and divert attention 
        from issues of public health importance.

    (2) Continual improvement of preventive process control systems is 
        needed. Mandatory HACCP and SSOP that focus on prevention 
        versus detection is critical and the rigor of the control 
        system should be proportional to the public health risk.

    (3) Government agencies must be fully funded to help assure the 
        safety of domestically produced and imported food.

    (4) Resources should be allocated based on the public health risk 
        posed by a particular food and the control measures that are 
        used during the manufacturing and distribution process to 
        control such risk.

    (5) Objective and achievable food safety standards that are 
        scientifically determined to measure whether the food is safe, 
        not adulterated, and non-injurious to public health are needed. 
        Food safety standards must be based on quantifiable, measurable 
        criteria and have a direct impact on public health.

    (6) The U.S. must assure that such standards are compatible with 
        internationally recognized standards, such as Codex 
        Alimentarius, to protect the health of consumers, ensure fair 
        trade practices, and promote the coordination of food standards 
        development by the international community.

    (7) Efforts should be focused on conducting a more thorough 
        analysis to identify how and why a foodborne disease outbreak 
        occurred. Each government agency involved in investigations of 
        foodborne disease outbreaks or product recalls should be 
        required to report the reasons such incidents occurred and 
        those reports should focus on how the food product was 
        harvested, processed, distributed, prepared, and consumed to 
        provide detailed information that will assist food handlers in 
        preventing future occurrences.

    (8) Rigorous government inspection and testing is needed to verify 
        that consumer-ready products are safe. Test results should be 
        performed under accepted sampling and analytical protocols and 
        should meet objective food safety standards. Testing to 
        determine the adequacy of process control at interim points 
        during harvesting, manufacturing, and distribution should be 
        conducted by the industry.

    (9) Establishment of a public-private partnership to design and 
        implement a comprehensive research program to improve food 
        safety is needed. The research program should be directed by a 
        board of qualified food safety experts from government, 
        academia, and industry. The program should focus on developing 
        risk mitigation and intervention strategies to prevent 
        foodborne disease outbreaks.

    Let me provide some parting thoughts. It is indisputable that 
producing safe food is good for customers and good for business. To 
that end, the meat and poultry industry has been working to meet the 
challenge of continuously improving the safety of the products 
produced, but the job is not done. Industry pledges to cooperate with 
all parties to ensure that the U.S. maintains the safest meat and 
poultry supply in the world.
    Thank you for the opportunity to testify before the Committee 
today. I am happy to answer any questions that Members may have 
regarding my testimony and the food safety system for meat and poultry 
products.

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    The Chairman. Thank you Mr. Boyle.
    Ms. Tucker-Foreman, welcome back to the Committee. We 
appreciate your testimony.

STATEMENT OF CAROL L. TUCKER-FOREMAN, DISTINGUISHED FELLOW, THE 
                FOOD POLICY INSTITUTE, CONSUMER
 FEDERATION OF AMERICA, WASHINGTON, D.C.; ON BEHALF OF CENTER 
                FOR FOODBORNE ILLNESS RESEARCH &
          PREVENTION; CENTER FOR SCIENCE IN THE PUBLIC
   INTEREST; CONSUMERS UNION; FOOD & WATER WATCH, GOVERNMENT 
                ACCOUNTABILITY PROJECT; NATIONAL
 CONSUMERS LEAGUE; THE PEW CHARITABLE TRUSTS; SAFE TABLES OUR 
  PRIORITY; TRUST FOR AMERICA'S HEALTH; AND THE UNITED FOOD & 
                       COMMERCIAL WORKERS
                      INTERNATIONAL UNION

    Ms. Tucker-Foreman. Thank you, Mr. Chairman and thank you 
as well for allowing Mr. Almer to address the Committee. I am 
Carol Tucker-Foreman with Consumer Federation of America. I 
was, formerly, Assistant Secretary of Agriculture with 
responsibility for meat and poultry inspection. I am testifying 
today on behalf of ten consumer public health and trade union 
organizations representing millions of Americans who are 
concerned about the safety of the food we eat every day.
    Foodborne illness has reached near crisis proportions in 
this country. It kills Americans at the rate of one every 2 
hours every day of the year, and that is likely to continue 
until you tell the Food and Drug Administration to institute a 
preventative program and give them the authority to do it. 
Foodborne illness outbreaks hit everybody in the food chain. 
The Kellogg Company reports that the Peanut Corporation of 
America outbreak cost them $65 to $70 million. Sales of peanut 
butter have been down ever since. The E. coli outbreak from 
bagged spinach cost the leafy greens industry more than $350 
million, and last year Florida tomato farmers were devastated 
when they were incorrectly--when tomatoes were incorrectly 
implicated in an outbreak of Salmonella saintpaul.
    You have heard from Jeff Almer today. I would like to 
introduce you to two other families who are here today. First, 
Robin and Jeff Allgood from Chubbuck, Idaho, and Nancy Donley 
from Chicago.
    Would you all stand up, please.
    Robin and Jeff have come from Idaho today. Their son Kyle, 
a mischievous and energetic 2 year old, died of E. coli 
poisoning after his mother gave him a smoothie that contained 
bagged spinach, that was contaminated with that deadly 
pathogen. Nancy Donley's only child, 6 year old Alex, also died 
of E. coli poisoning after eating contaminating ground beef. 
Since then, Nancy has taken the time that she would have spent 
raising Alex helping other families deal with their loss and 
trying to persuade the government to institute additional 
protections to prevent others from suffering.
    Thank you all.
    Americans are very aware that people are dying from 
foodborne illness. Two weeks ago, IBM announced a poll that 
showed that 60 percent of Americans are concerned about the 
safety of the food they purchase. Less than 20 percent trust 
food companies to develop and sell food products that are safe 
and healthy for themselves and their families; 63 percent 
confirmed that they would not purchase a food until the source 
of--recalled food until the source of contamination was found; 
and 57 percent said they had stopped purchasing foods, even for 
a short time within the past 2 years, because of safety 
considerations.
    These illnesses are almost completely preventable if you 
have a good preventative health system. And the GAO and the NAS 
have listed key elements for such a preventative system 
including process--company process control and regular 
inspection, better controls over imported foods. These 
provisions and additional ones are all included in H.R. 2749. 
It gives FDA--it requires FDA to begin a preventative program 
that will stop these problems. The agriculture community has 
objected to a number of items in the legislation, and the 
Energy and Commerce Committee has heard you and made major 
changes in the legislation to address your concerns, including 
keeping all jurisdictions as they are now and requiring the 
Secretary of HHS to coordinate with the departments of 
agriculture in the states in setting up regulations.
    Frankly, consumer groups have chosen not to oppose a number 
of requirements in the legislation that we think limit its full 
protection of consumers. We are very sympathetic to the 
concerns of those in the food industry who may have to change 
the way they do business. It is clear that the legislation has 
been structured to assure it doesn't place an undue burden on 
small farms and businesses. On behalf of all the families here 
today and the others around the country who suffered because of 
outmoded food safety law that has failed to protect consumers. 
We think that a reasonable and appropriate balancing of 
interests has been worked out. We urge you to please act on 
this legislation quickly and provide additional protection. 
Thank you.
    [The prepared statement of Ms. Tucker-Foreman follows:]

 Prepared Statement of Carol L. Tucker-Foreman, Distinguished Fellow, 
The Food Policy Institute, Consumer Federation of America, Washington, 
 D.C.; on Behalf of Center for Foodborne Illness Research & Prevention;
  Center for Science in the Public Interest; Consumers Union; Food & 
  Water Watch; Government Accountability Project; National Consumers 
League; The Pew Charitable Trusts; Safe Tables Our Priority; Trust for 
       America's Health; and The United Food & Commercial Workers
                          International Union

    Chairman Peterson, Ranking Member Lucas and Members of the 
Committee. I am Carol Tucker-Foreman, Distinguished Fellow in the Food 
Policy Institute at Consumer Federation of America (CFA). From 1977-
1981, I was Assistant Secretary for Food and Consumer Services at the 
United States Department of Agriculture. My responsibilities included 
oversight of the nation's meat, poultry and egg inspection and food 
assistance programs.
    I am testifying on behalf of eleven consumer, public health and 
trade union organizations representing millions of Americans who are 
concerned about the safety of the food their families eat every day. A 
list and description of the organizations supporting this testimony is 
attached. We commend the Committee for holding this hearing to explore 
current congressional efforts to address the serious food safety 
problems that confront the country.
    Mr. Chairman, foodborne disease kills one American every 2 hours, 
every day of the year.\1\ The vast majority of these deaths are 
preventable. There has been limited progress in reducing the toll 
because the Food Drug and Cosmetic Act (FDCA), which governs the safety 
of over 80 percent of the food we consume, was designed to address 
problems prevalent at the beginning and middle of the last century and 
hasn't been amended to keep up with changes that have altered the way 
we live and eat today. In 1906 the primary food safety danger arose 
from companies adding dangerous chemicals to meat to mask decay and 
substituting cheap ingredients to defraud consumers. The FDCA 
provisions don't adequately address the most pressing current food 
safety problem, protecting consumers from illness caused by food 
contaminated with disease-causing bacteria.
---------------------------------------------------------------------------
    \1\ Based on Centers for Disease Control and Prevention estimates 
that foodborne disease kills 5,000 people each year.
---------------------------------------------------------------------------
    Current law does not give the Food and Drug Administration (FDA) 
specific authority to establish requirements to prevent foodborne 
illness. As a result, the Agency's program is almost entirely reactive. 
FDA often doesn't act until after there are confirmed reports of 
illness and death. That system doesn't work in a global marketplace 
where food is mass produced and travels around the world in a matter of 
hours. By the time we know a contaminated product is on the market, it 
is too late to keep people from getting sick.
    Our country has experienced an almost constant stream of foodborne 
illness outbreaks traced to FDA regulated foods over the past few 
years, including:

   June 2009--E. coli O157:H7 contaminated Nestle chocolate 
        chip cookie dough has made 72 people in 30 states sick.

   September 2008-March 2009--Salmonella contaminated peanut 
        products from Peanut Corporation of America sickened 691 people 
        and caused nine deaths in 46 states and Canada.

   April to August 2008--Imported Jalapeno and Serrano peppers, 
        contaminated with Salmonella saintpaul sickened 1,442 people in 
        43 states, the District of Columbia and Canada. Originally 
        thought to be caused by contaminated tomatoes, the outbreak 
        virtually destroyed the market for summer tomatoes in several 
        states.

   June 2007--Veggie Booty snacks contaminated with Salmonella 
        caused 65 illnesses in 20 states.

   February 2007--Peter Pan Peanut Butter contaminated with 
        Salmonella sickened 425 people in 44 states.

   Dec. 2006--Salmonella found in tomatoes sickened 183 people 
        in 21 states.

   August-September 2006--E. coli O157:H7 in bagged spinach 
        sickened 204 people in 26 states and killed three.

        (Source--CSPI Building a Better Food Safety System)

    All of these outbreaks were the result of poor sanitation or 
mishandling at some point in the food chain. None resulted from 
consumer mishandling.
    In addition, we have been threatened by high levels of drug 
residues and toxic chemicals in fish and dairy products imported from 
South East Asia.
    Some food industry representatives insist we are on the way to 
solving the problem of foodborne illness. In support of this claim, 
they cite reductions in illnesses caused by some pathogens since the 
Centers for Disease Control first began tracking illnesses through the 
FoodNet system and comparing the base years 1996-1998 to the most 
recent year. However, the CDC acknowledges that, after initial 
reductions, progress has stalled and there has been virtually no 
further decline in the last 5 years.\2\
---------------------------------------------------------------------------
    \2\ CDC, ``Preliminary FoodNet Data on the Incidence of Infection 
with Pathogens Transmitted Commonly Through Food--10 States, 2008'' 
MMWR, 58(13), 333-337, April 10, 2009.
---------------------------------------------------------------------------
    The CDC is reviewing the data but has not reduced the annual total 
of 76 million cases of foodborne illness each year, 350,000 
hospitalizations and 5,000 deaths. That means someone dies every 2 
hours. The best estimate for the human illness costs of foodborne 
pathogens for all CDC estimated cases is $357 billion each year in 
medical costs, lost productivity, and pain and suffering.\3\
---------------------------------------------------------------------------
    \3\ Roberts, Tanya (2007) ``The Economic Costs of Long-term 
Sequellae of Selected Foodborne Pathogens,'' Invited Speech, 
International Association of Food Protection, Orlando, Florida.
---------------------------------------------------------------------------
    It is hard to comprehend numbers this large. Millions of illnesses 
and billions of dollars seem unconnected to what goes on in our daily 
lives. It is important to remember that these enormous numbers 
represent individual Americans whose lives have been altered forever by 
the simple act of having consumed common, everyday foods that appear 
regularly on family dinner tables--beef, chicken, spinach, lettuce, 
tomatoes, peppers and peanut products--that were contaminated with 
deadly pathogens.
    The victims of foodborne illness live in your states and 
congressional districts. They are your friends and possibly members of 
your family. The known victims of the Peanut Corporation of America 
outbreak included 100 Ohioans; 76 Californians; 43 Minnesotans. The 
2008 Salmonella saintpaul pepper outbreak hit 559 Texans, 120 people in 
Illinois, 42 in Georgia, 59 in Arizona. Last April, 84 Nebraskans, 27 
Iowans, and five Kansans and South Dakotans were among the victims of a 
Salmonella saintpaul outbreak traced to eating contaminated fresh 
sprouts. And these cases are just the tip of the iceberg--for every 
reported illness, there are far more that the CDC never knows about.
    In the hearing room today are representatives of three families for 
whom the foodborne illness numbers are crushingly real. Jeff Almer has 
come here from Perham, Minnesota. Jeff's mother Shirley Almer had run 
the family business for years after the death of her husband in 1990. 
When she retired, she remained active in her bowling league, continued 
to garden and bird watch, and spent time with her five children and 
four grandchildren. In October last year Shirley was declared cancer 
free after fighting off both brain and lung cancer. Two months later, 
on December 21, 2008, she was dead at age 72. Cancer did not kill 
Shirley Almer. According to the Minnesota Department of Public Health, 
the woman who fought off cancer died as a result of eating Salmonella 
contaminated peanut butter.
    Robyn and Jeff Allgood have come here from Chubbuck, Idaho. Their 
son, Kyle, was a mischievous and energetic 2 year old whose favorite T-
shirt read, ``I do all my own stunts.'' Eager to meet her children's 
nutritional needs, Robyn often mixed fresh spinach and other vegetables 
into fruit smoothies. In September 2006, she unknowingly used spinach 
contaminated with E. coli O157:H7. Kyle became sick the next day. A 
week later he was dead from a heart attack after the E. coli poisoning 
developed into Hemolytic Uremic Syndrome (HUS).
    Nancy Donley's only child, 6 year old Alex, also died of E. coli 
O157:H7 poisoning he contracted after eating contaminated ground beef. 
After Alex's death, Nancy decided to invest the time she would have 
spent raising Alex in comforting other victims, informing the public 
about HUS and educating public officials about the need to make basic 
changes in the nation's food safety system to prevent others from 
suffering the same loss.
    These are four courageous Americans. None is a public person. None 
has great resources. They decided not to take the easy way out and 
nurse their grief in private. You hear every day from representatives 
of the food industry and farm organizations. Today, the Almers, 
Allgoods and Donleys are here to ask you to consider the millions of 
foodborne illness victims whose concerns they represent. All bring you 
the same message. Congress must act now to prevent more and more 
illnesses and deaths.
    They would welcome the opportunity to meet with Members of the 
Committee after the hearing to respond to your questions and will take 
questions from the media and interested people, as well.
    The problems that robbed the Allgoods and Nancy of their children 
and the Almers of their mother and grandmother have caused Americans to 
become increasingly aware of and anxious about the weaknesses of our 
current food safety system.
    Two weeks ago the technology giant IBM published the results of a 
new survey they sponsored, showing:

   60 percent of consumers are concerned about the safety of 
        the food they purchase.

   Less than 20 percent of consumers trust food companies to 
        develop and sell food products that are safe and healthy for 
        themselves and their families.

   83 percent of consumers were able to name a food that had 
        been recalled in the last 2 years. 63 percent confirmed they 
        would not purchase a food until the source of the contamination 
        was found, and 57 percent said they had stopped purchasing 
        foods, even for a short time, within the past 2 years because 
        of safety considerations.\4\
---------------------------------------------------------------------------
    \4\ IBM, Food Safety Awareness Survey, June 2009.

    The failure of our food safety system and the increasing loss of 
public trust and confidence is bad for the food business and for 
farmers. The CEO of Kellogg's told the House Energy & Commerce 
Committee that the Peanut Corporation of America recall cost the 
company $65-$70 million.\5\ Although no major brands of jarred peanut 
butter sold at retail were involved in the PCA outbreak, sales of those 
products also plunged after the outbreak became known.
---------------------------------------------------------------------------
    \5\ Statement of David Mackay, President & CEO, Kellogg Company, 
before the House Committee on Oversight and Investigations, ``The 
Salmonella Outbreak: The Role of Industry in Protecting the Nation's 
Food Supply.'' U.S. House of Representatives, March 19, 2009.
---------------------------------------------------------------------------
    Foodborne illness outbreaks can be disastrous for farmers who grow 
the crops implicated. Florida tomato farmers were devastated by the 
connection of their product to the Salmonella saintpaul outbreak that 
came at the height of their growing season. Spinach and lettuce farmers 
experienced a drop in demand after their products were implicated in 
2006 outbreaks and, 3 years later, sales of these products have yet to 
recover.
    Perhaps the greatest tragedy here is that foodborne illnesses are 
almost completely preventable if farmers, food companies and government 
exercise some care. Congress can reduce the toll--both physical and 
economic--by substantially modernizing outmoded laws that are part of 
the problem, starting with passing H.R. 2749.
Congress Must Begin Now to Create a 21st Century Food Safety System
    The need to revise the Food Drug and Cosmetic Act has been 
documented in reports to Congress by the GAO, in studies by the 
National Academy of Sciences, and in a dozen hearings before the Energy 
and Commerce Committee.
    Nearly a dozen bills to improve food safety have been introduced 
this year, some by Members of this Committee. All the bills embrace at 
least some of the common elements identified by the NAS and GAO as 
necessary for securing the safety of both domestic and imported foods.
    H.R. 2749, reported unanimously by the House Energy and Commerce 
Committee, includes the key elements most frequently noted by experts 
as essential to an effective food safety system. The bill:

   Focuses on preventing FDA regulated foods from causing 
        foodborne illness.

   Requires food companies to develop and implement process 
        controls to assure that the food they sell is safe.

   Requires the FDA to establish and enforce microbial 
        performance standards that will reduce pathogens to a minimum 
        and assure an acceptable level of public health protection.

   Assures the integrity of the food system and the food supply 
        through comprehensive enforcement, including regular oversight 
        (inspection) conducted by public officials and based on the 
        risk presented by the product; sampling and testing for 
        pathogens and reporting; access to company food safety records; 
        and mandatory recalls of contaminated food.

   Ensures the food we import is as safe as that produced and 
        processed here.

   Provides a research capacity to develop the best means to 
        address current and emerging pathogens.

   Assures continuing revenue to support part of the program 
        costs by instituting a $500 annual registration fee for all 
        food processing companies, with no company required to pay more 
        than $175,000 annually. While some of us have long harbored 
        reservations about any kind of fee to support food safety 
        activities, we are convinced that, given large budget deficits 
        for the foreseeable future, this fee is a modest request and 
        justified by the pressing need for stronger Federal oversight 
        and the benefits of reduced illness and death.

    We think the legislation would be more effective if it included 
detailed language and resources to ensure data collection, sharing and 
analysis necessary for developing robust food attribution models.
    In recent weeks some concerns have been raised about H.R. 2749, 
many on the Internet, suggesting almost apocalyptic outcomes for 
farmers if the bill becomes law. While our groups originally had some 
disagreement about the impact that the discussion draft might have had 
on small farmers, the Energy and Commerce Committee amendments went a 
long way to addressing concerns that provisions would disadvantage 
small farmers, especially organic farmers. We also have chosen not to 
oppose some provisions, made to address farmer concerns, that we think 
compromise the bill's ability to fully protect consumers.
    Further, before reporting the bill, your colleagues on the Energy 
and Commerce Committee met with Members of this Committee and with farm 
and industry groups and made numerous changes to address the concerns 
raised by farmers and food processors. These changes:

   Exempt from provisions of H.R. 2749 the parts of food 
        facilities and farms regulated by USDA.

   Provide that nothing in this bill changes existing 
        jurisdictional lines between FDA and USDA.

   Require the Secretary of HHS to coordinate with USDA and the 
        states in setting commodity-specific standards for the safe 
        growing, harvesting and packaging of fruits and vegetables.

   Require the Secretary of HHS, before issuing any proposed 
        regulations establishing new traceability requirements, to 
        conduct information gathering to determine the feasibility and 
        cost/benefit of the system. Previous prescriptive requirements 
        have been moved to the information gathering process.

   Exempt farmers who sell direct to consumers, such as at 
        roadside stands, from the traceability requirements of the 
        legislation.

   Limit the FDA's authority to restrict the movement of food 
        in interstate commerce only if the food presents an imminent 
        threat of serious adverse health consequences or death. The 
        language was changed to address farmer and processor concerns 
        by limiting the FDA's actions to situations where there is an 
        imminent threat and providing that the authority can only be 
        exercised by the Commissioner. It cannot be delegated to lower 
        officials.

   Require the FDA to consider the impact of regulations on 
        small businesses and organic farmers.

   Require the FDA to take into account the impact of produce 
        regulations on small-scale and diversified farms, wildlife 
        habitat, conservation practices, watershed protection efforts, 
        and organic production methods.

    Mr. Chairman, your Committee has oversight over the USDA's meat and 
poultry inspection program, which emphasizes inspection, requiring the 
USDA to be in every meat and poultry processing plant at least once a 
day and to examine all slaughtered carcasses to assure they do not have 
animal disease or visible problems that would make them dangerous to 
serve the family for dinner. Our groups tend to support the far more 
intensive inspection regime that USDA applies to both domestic and 
imported meat and poultry products. The FDA, notably, does not conduct 
regular, onsite inspection of the companies it regulates. We believe 
intensive inspection by Federal officials, coupled with appropriate 
corporate process controls and Federal standards, offers the best 
protection for the future.
    Despite the fact that the Energy and Commerce Committee has made 
changes to address legitimate concerns, the Internet and some print 
media are full of specious charges against the bill. It is clear the 
legislation has become a target for people who are angry and frustrated 
about a multitude of other problems that would not be affected by the 
law.
    For example, on Monday, July 13, the San Francisco Chronicle ran a 
long article charging that farmers are being forced to dismantle 
important conservation practices and destroy wildlife habitat. The 
article was passionate, but not accurate, in suggesting that H.R. 2749 
is responsible for these changes. H.R. 2749, of course, has not passed 
Congress and is not in effect. Moreover, provisions of H.R. 2749 
protect against the gross actions described in the article. The bill 
requires the FDA, if it promulgates produce safety regulations, to use 
science based standards that take into account the impact the 
regulations would have on small-scale and diversified farms, wildlife 
habitat, conservation practices, watershed protection efforts, and 
organic production methods.
    The problems cited by the Chronicle reporter and the people she 
interviewed arise from private, not government, actions. Private 
customers--food processors and supermarkets--have imposed contractual 
requirements on their suppliers to create sterile borders. If the 
farmer wants to sell to the companies, he has to meet his customer's 
requirements. Private contractual requirements do not have to be 
science-based or consider environmental impact.
    Some who oppose efforts to improve food safety law have larger 
concerns about the global and industrial nature of our current food 
system. The IBM survey shows that people increasingly want to know 
where their food comes from. Other polls indicate people would like to 
buy locally produced food. That yearning is reaching levels that may 
require Congress to address these more basic issues.
    However, it has taken many years for the current system to build to 
this point. The changes that many seek would alter farming and food 
processing completely. That kind of change is not likely to come 
quickly or easily. Today we have a global food system and most of us, 
now and for the foreseeable future, will continue to purchase at least 
some mass produced food from enormous corporations at major 
supermarkets, many of them owned by foreign corporations. The immediate 
need, therefore, is for Congress to take steps to make our existing 
food supply safe. This requires giving the FDA the authority and the 
resources to address the problems created by a modern, mass production, 
international food system.
    The need is now and the need is urgent. While we are sympathetic to 
the concerns of those in the food industry who may indeed have to make 
some changes in the way they do business, it is clear that H.R. 2749 
has been structured to assure it does not place an undue burden on 
small farms or businesses. On behalf of the families here today and all 
the others who have suffered because of an outmoded food safety law 
that has failed to protect American consumers, we suggest that a 
reasonable and appropriate balancing of interests has been worked out 
in H.R. 2749.
    The time has come for Congress to act responsibly, consider the 
interests of those who consume food as well as those who produce and 
process it, and pass the Food Safety Enhancement Act promptly.

                               Attachment

Supporting Organizations
    Center for Foodborne Illness Research & Prevention was founded in 
2006 to promote science-based solutions for the food safety challenges 
of the 21st Century. CFI is a national, nonprofit health organization 
dedicated to preventing foodborne illness through research, education, 
advocacy and service. CFI's co-founders, who have advanced degrees in 
biostatistics and education, were personally impacted by foodborne 
illness and have dedicated themselves to improving food safety for the 
past 7 years.
    Center for Science in the Public Interest, founded in 1971, has 
been a strong advocate for nutrition and health, food safety, alcohol 
policy, and sound science. Its award-winning newsletter, Nutrition 
Action Healthletter, is the largest-circulation health newsletter in 
North America, providing reliable information on nutrition and health. 
CSPI manages Outbreak Alert, the most comprehensive foodborne illness 
attribution database, listing over 5,000 outbreaks.
    Consumer Federation of America is a nonprofit association of 300 
local, state and national consumer groups, consumer cooperatives, 
public health organizations, farm groups and trade unions, representing 
more than 50 million Americans. CFA was established in 1968 to advance 
the consumer interest through research, education and advocacy. The 
organization's policy positions are established by vote of member 
representatives attending the annual meeting or by the board of 
directors elected at the meeting.
    Consumers Union, publisher of Consumer Reports, is an independent, 
nonprofit testing and information organization serving only consumers. 
Consumers Union is a comprehensive source for unbiased advice about 
products and services, personal finance, health and nutrition, and 
other consumer concerns. Since 1936, CU's mission has been to test 
products, inform the public, and protect consumers.
    Food & Water Watch is a nonprofit consumer organization that works 
to ensure clean water and safe food. Food & Water Watch works with 
grassroots organizations around the world to create an economically and 
environmentally viable future. Through research, public and policymaker 
education, media, and lobbying, FWW advocates policies that guarantee 
safe, wholesome food produced in a humane and sustainable manner and 
public, rather than private, control of water resources including 
oceans, rivers, and groundwater.
    Government Accountability Project was founded in 1977 in response 
to White House scandals in the United States. From the beginning GAP 
has focused upon the unique contributions of employees of conscience 
within governments, large corporations, and international institutions. 
GAP's mission is to protect the public interest by promoting public 
accountability at workplaces and advancing the rights of employees to 
speak out about serious problems. These employees are often the most 
credible witnesses to corruption, public health dangers, and 
environmental threats.
    National Consumers League seeks to protect and promote social and 
economic justice for consumers and workers in the United States and 
abroad. NCL is a private, nonprofit advocacy group representing 
consumers on marketplace and workplace issues. It is the nation's 
oldest consumer organization.
    The Pew Charitable Trusts, an independent nonprofit, is the sole 
beneficiary of seven individual charitable funds established between 
1948 and 1979 by two sons and two daughters of Sun Oil Company founder 
Joseph N. Pew and his wife, Mary Anderson Pew. Pew applies a rigorous, 
analytical approach to improve public policy, inform the public and 
stimulate civic life. Pew's Health and Human Services Policy program 
seeks to improve the health and well-being of all Americans. Based on 
research and critical analysis, the program advocates policies that 
reduce unacceptable health risk, focusing on areas that include 
consumer, medical and food safety.
    Safe Tables Our Priority (S.T.O.P.) is a national nonprofit public 
health organization dedicated to preventing illness and death from 
foodborne pathogens. S.T.O.P. supports its mission by advocating public 
health-based changes in public policy, educating and conducting 
outreach and providing victim assistance. S.T.O.P. was founded in 1993 
in the aftermath of the Jack in the Box E. coli O157:H7 epidemic.
    Trust for America's Health is a nonprofit, non-partisan 
organization dedicated to saving lives by protecting the health of 
every community and working to make disease prevention a national 
priority.
    United Food and Commercial Workers International Union is the 
largest private sector union in North America. With over 1.3 million 
members, UFCW represents workers in every state and community in the 
United States. The majority of UFCW members work in the retail food 
stores and meatpacking and food processing sectors. The UFCW is 
committed to continuing and building upon its long history of 
involvement in food safety and regulatory issues.

    The Chairman. Thank you very much for your statement, 
Carol.
    Dr. Ives, welcome to the Committee.

    STATEMENT OF SAMUEL E. IVES, D.V.M., Ph.D., DIRECTOR OF 
         VETERINARY SERVICES AND ASSOCIATE DIRECTOR OF
        RESEARCH, CACTUS FEEDERS, LTD., AMARILLO, TX; ON
        BEHALF OF NATIONAL CATTLEMEN'S BEEF ASSOCIATION

    Dr. Ives. Good morning, Chairman Peterson, Mr. Goodlatte, 
and Members of the Agriculture Committee. I am Sam Ives and I 
am the Director of Veterinary Services and Associate Director 
of Research for Cactus Feeders. Cactus Feeders is headquartered 
in Amarillo, Texas, and we have nine large-scale cattle 
feedyards across the Texas High Plains and southwest Kansas 
where we produce one million head of cattle annually for 
slaughter. A subsidiary to our feeding operations includes 
three ranches in Texas and New Mexico. The ranches produce 
30,000 stocker calves annually and maintain 2,000 mama cows. I 
appreciate the opportunity to represent the National 
Cattlemen's Beef Association at today's hearing to discuss the 
beef industry's commitment to beef safety. I would like to 
start out by emphasizing that everyone plays an important role 
in the safety of food. And it starts with producers raising 
healthy cattle. Cattlemen are committed to producing the 
safest, most wholesome nutritious and affordable beef products 
in the world.
    There is no question that the United States has the safest 
food supply in the world and other countries consider the U.S. 
the gold standard. Cattle producers support the establishment 
of realistic food safety objectives designed to protect public 
health to the maximum extent possible. Several food safety 
bills that have been introduced in the Congress, and one in 
particular, H.R. 2749 is of interest to beef producers. We 
appreciate the willingness of the Energy and Commerce Committee 
to discuss and learn more about how meat and poultry products 
are regulated by USDA, and we understand the intent of the bill 
is to exempt livestock and poultry from this FDA-focused bill.
    However, we are concerned the current bill language does 
not go far enough to ensure Congressional intent is not 
misinterpreted. The bill must contain clear legislative 
language to ensure that FDA is not granted the authority to 
regulate livestock on-farm by mandating production standards 
for cattlemen across the country. Live animals are not food 
until the point of processing, and we would like to see 
language that explicitly excludes livestock and poultry from 
the definition of food under this bill and the Federal Food 
Drug and Cosmetic Act. Additionally, exempting livestock and 
poultry from food would also clarify the record-keeping 
requirements of this bill and their application to food. Under 
the Federal Food Drug and Cosmetic Act, farms are exempt, but 
this legislation eliminates that exemption. H.R. 2749 raises 
concerns about the treatment of state-inspected facilities as 
the bill only exempts official establishments as defined by 
this legislation. Many beef producers, especially in rural 
areas, rely on state-inspected facilities to process their 
cattle. The definition needs to be expanded to ensure state-
inspected facilities are included in the exemption of this 
bill. Section 133 of the bill grants FDA with a redundant 
authority regarding quarantine of a geographical area where 
food presents serious adverse health consequences to humans and 
animals. This new responsibility of FDA is concerning, as under 
the Animal Health Protection Act, USDA can impose a Federal 
quarantine for animal health reasons when they deem necessary 
and work closely with state authorities. Under the Animal 
Health Protection Act the government is mandated to pay 
indemnity to producers when the government takes the animal. 
This provision does not require the FDA to pay indemnity.
    Again, we appreciate the willingness of the Energy and 
Commerce Committee to work with the livestock groups to address 
some of the duplicative and unnecessary regulatory authority 
this bill's grants the FDA. We urge both the Agriculture and 
Energy and Commerce Committees to ensure the true intent of the 
bill is made very clear before any further action is taken on 
the legislation. My written testimony provides more information 
about the concerns that I, and my fellow cattle producers, have 
with this bill.
    In closing, the U.S. has the safest food supply in the 
world which is an achievement worth noting. Science is a 
critical component of the beef industry, and through science-
based improvements and animal genetics, management practices, 
nutrition and health, beef production per cow has increased 
from 400 pounds of beef in the mid 1960s to 585 pounds of beef 
in 2005. As beef producers, we have our work cut out for us in 
order to feed our ever-growing population. Cattlemen will 
continue to increase efficiencies based on science in order to 
produce high-quality beef with fewer resources being consumed. 
The beef industry will continue to dedicate time and resources 
to ensure the safety of beef. We look forward to working with 
the Committee to ensure Congressional intent of this bill is 
not misunderstood.
    Many thanks for the opportunity to testify here today, and 
I look forward to answering any questions that you may have.
    [The prepared statement of Dr. Ives follows:]

   Prepared Statement of Samuel E. Ives, D.V.M., Ph.D., Director of 
Veterinary Services and Associate Director of Research, Cactus Feeders, 
                                 Ltd.,
    Amarillo, TX; on Behalf of National Cattlemen's Beef Association

     Chairman Peterson, Ranking Member Lucas and Members of the 
Committee, I'm Sam Ives and I am the Director of Veterinary Services 
and Associate Director of Research for Cactus Feeders. Cactus Feeders 
is headquartered in Amarillo, Texas and we have nine large-scale cattle 
feedyards across the Texas High Plains and Southwest Kansas where we 
produce 1,000,000 head of cattle for slaughter annually. A subsidiary 
to our feeding operations includes three ranches in Texas and New 
Mexico. The ranches produce 30,000 stocker calves annually and maintain 
2,000 mother cows. My responsibilities are focused on animal health and 
well-being of the cattle in our operations. These responsibilities 
include advising the feeding and ranching operations on best practices 
for preventing, controlling, and treating diseases that occur in the 
cattle during the feeding period. Much time is spent training employees 
and evaluating our health programs to assure that we are providing 
cattle that will become a safe and wholesome meat product for our 
consuming public. Many of the recommendations used in our operations 
are supported by studies conducted at Cactus Research which I manage 
along with Dr. Spencer Swingle. Cactus Research is managed as a 12,000 
head research feedlot in the Texas panhandle. Together Dr. Swingle and 
I are responsible for investigating and coordinating sponsored and 
internal research studies including diet formulation, growth promoting 
technologies, direct-fed microbials, feed additives, the incidence and 
control of important food safety pathogens, and medications for control 
and treatment of cattle diseases.
    I appreciate the opportunity to represent the National Cattlemen's 
Beef Association (NCBA) at today's hearing to discuss the beef 
industry's commitment to beef safety. NCBA is the oldest and largest 
national trade association for cattle producers and represents over 
230,000 cattle producers through direct membership and state and breed 
affiliates. Cattlemen are committed to producing the safest, most 
wholesome, nutritious and affordable beef products in the world. There 
is no question that the United States has the safest food supply in the 
world and other countries consider the U.S. the ``gold standard.'' 
Science is a critical component of the beef industry and through 
science-based improvements in animal genetics, management practices, 
nutrition and health, beef production per cow has increased from 400 
pounds of beef in the mid-1960s to 585 pounds of beef in 2005.\1\ As 
beef producers we have our work cut out for us in order to feed our 
ever growing population. In 1960 there were 3.9 million farms feeding a 
U.S. population of 183 million and in 2005 there were 2.1 million farms 
feeding an estimated population of 296 million--a population increase 
of 61 percent.\2\ In 1960 the average farmer fed 25.8 people. Today's 
American farmer feeds about 144 people worldwide.\3\ Cattlemen will 
continue to increase efficiencies based on science in order to produce 
high-quality beef with fewer resources being consumed. In addition, our 
industry continues to focus on our long-term efforts to improve our 
knowledge and ability to produce healthy cattle, which are the 
foundation of a safe food supply.
---------------------------------------------------------------------------
    \1\ Cattle-Fax: http://www.beefusa.org/uDocs/
cattlenumbersandbeefproduction347.pdf. 
    \2\ NASS: http://www.nass.usda.gov:8080/QuickStats/PullData_US.jsp.
    \3\ ACA: http://www.agday.org/media/agfactsheet.htm.
---------------------------------------------------------------------------
    Since 1993, cattle producers have invested more than $27 million in 
beef safety research and the beef industry as a whole spends 
approximately $350 million every year on beef safety. It is important 
to note that everyone plays an important role in the safety of beef. It 
starts with producers raising healthy cattle, and everyone who plays a 
role in the production chain is committed to producing safe beef 
products. Consumers also play a critical role to ensure the safety of 
their meat products by using safe storage, handling and preparation 
techniques.
    All beef is subject to strict government oversight by the U.S. 
Department of Agriculture (USDA) and every meat processing facility 
undergoes on-going USDA inspection. The inspection process includes 
review of their Hazard Analysis Critical Control Point plans also known 
as HACCP plans. HACCP plans were pro-actively developed by the food 
industry as a method to identify potential hazards and prevent them. In 
1996, USDA's Food Safety and Inspection Service (FSIS) enacted a rule 
requiring HACCP plans for all beef processing plants.
    In 1997, the Beef Industry Food Safety Council (BIFSCo) was formed 
to coordinate a broad effort to solve pathogen issues, and to focus on 
research and consumer education. Representatives from all segments of 
the beef industry belong to BIFSCo and work together under the founding 
principles that safety is a non-competitive issue to develop industry-
wide, science-based strategies to address safety challenges, 
particularly E. coli O157:H7. Cattlemen and the entire beef industry 
have dedicated significant time and resources to a variety of research 
areas including building our knowledge of E. coli O157:H7 by 
identifying where, why and how it survives from pre- to post-harvest; 
the relationship between the live animal and the pathogen in order to 
develop pre-harvest interventions; and the impact that production 
practices, processing systems and interventions have on the pathogens.
    NCBA continues to evaluate how to optimize food safety systems not 
only for the current safety challenges but also for any potential 
future ones. Cattle producers and our partners will continue to 
dedicate time and resources to reduce the incidence of pathogens and 
other food safety issues. The beef industry and our government share 
the common goal of producing safe beef products. With the current 
budget and economic situation there has never been a more important 
time for our government and the industry to work together to achieve 
this goal.
    NCBA supports the establishment of realistic food safety objectives 
designed to protect public health to the maximum extent possible. It is 
vital that the objectives be based on sound science with the realistic 
understanding that even under the best science-based operating 
procedures achieving zero risk is not possible. However, utilizing 
science-based principles and validating interventions used throughout 
the process will effectively control the associated risks of pathogens 
like E. coli O157:H7. In addition, it is more important to focus 
resources on the validation of process controls rather than testing as 
a means to protect public health. Beef packing plants and processors 
vary in size and design, and their safety plans must be tailored to 
their set-up. Nearly 100 percent of beef establishments use one or more 
of the post-harvest safety interventions the beef industry has helped 
research, implement and validate.
    NCBA's members remain committed to beef safety, we take a lot of 
pride in the amount of time and resources we have dedicated to making 
beef an even safer product. As Congress continues to debate food safety 
legislation we encourage you to continue working with all relevant 
stakeholders to increase efficiencies and the effectiveness of our food 
safety system. There are several food safety bills being discussed that 
would result in unintended consequences for cattlemen as well as other 
livestock and poultry producers.
    As legislation is developed, it is important to understand the Food 
and Drug Administration's (FDA) role in food safety and how their role 
differs from USDA's Food Safety Inspection Service (FSIS). H.R. 2749 
passed the House Energy and Commerce Committee on June 17, 2009. There 
are several sections of this bill of concern to cattle producers and we 
appreciate the Energy and Commerce Committee's willingness to discuss 
and learn more about how the meat and poultry industries are regulated. 
We understand the intent of the Committee is to exempt livestock and 
poultry from this bill as meat and poultry products are already 
regulated by USDA with the authority granted to them by Congress in the 
Federal Meat Inspection Act, the Poultry Inspection Act and the Egg 
Products Inspection Act.
    However, we are concerned the current bill language does not go far 
enough to ensure Congressional intent. The bill must contain clear 
legislative language ensuring that FDA is not granted the authority to 
regulate livestock on-farm by mandating production standards for 
cattlemen across the country. Live animals are not ``food'' until the 
point of processing, which is why this bill needs to clarify that the 
FDA does not have regulatory authority on our farms, ranches or 
feedlots. Cattle producers support language that explicitly excludes 
livestock and poultry from the definition of ``food'' under this bill 
and the Federal Food Drug and Cosmetic Act (FFDCA). This important 
change is essential to resolve the ambiguity to keep the more than 
century old and successful animal health and meat, poultry, and egg 
inspection a functioning partnership between USDA and state 
authorities.
    The exemption of livestock and poultry from ``food'' would also 
clarify the record-keeping requirements and their application to 
``food''. Under the FFDCA record-keeping requirements apply to 
``food,'' the FFDCA also exempts ``farms'' but this legislation 
eliminates that exemption. It is our concern the ``livestock'' 
exemption from the definition of ``farm'' in this bill is not clear. 
The exemption of ``livestock'' should also apply to ``food'' as the 
record-keeping requirements of this bill are applicable to ``food''. We 
urge the Committee to exclude livestock from the definition of ``food'' 
under the FFDCA and modify the facility requirements of this bill to 
ensure ``preventative controls'' and ``inspections'' requirements of 
this bill are not applicable to USDA regulated facilities. In addition, 
cattle producers are concerned with the definition of ``facility'' as 
the ``preventative controls'' and ``inspections'' requirements of this 
bill will apply to USDA facilities with FDA operations. For example, a 
beef slaughter facility with a rendering operation would be subject to 
FDA preventative controls and inspections for all aspects of their 
operations. This is unnecessary and duplicative as USDA has regulatory 
authority now. We ask the Committee to modify the definition of 
``food'' and to modify the facility requirements of this bill to ensure 
``preventative controls'' and ``inspections'' requirements of this bill 
are not applicable to USDA regulated facilities. H.R. 2749 raises 
concerns about the treatment of state inspected facilities as the bill 
only exempts ``official establishments'' as defined by this 
legislation. This definition refers to the ``regulations promulgated 
under this subchapter'' and does not include state inspected 
facilities. Many beef producers, especially in rural areas, rely on 
state inspected facilities when processing their cattle. State 
inspected facilities are not ``official establishments'' and the 
definition needs to be expanded to include these facilities in the 
exemption.
    Section 133 of the bill grants FDA with another redundant authority 
regarding quarantine of a geographical area where food presents serious 
adverse health consequences. This new responsibility of FDA is 
unnecessary, confusing and will disrupt the decades of cooperative 
efforts between USDA and state authorities. Currently, under the 
authorities of the Animal Health Protection Act (AHPA), USDA can impose 
a Federal quarantine for animal health reasons when they deem necessary 
and USDA works very closely with state agencies. Additionally, under 
AHPA statute USDA must provide indemnity to affected producers when the 
Federal Government ``takes'' an animal. In this bill FDA would not be 
required to pay indemnity or even have a qualified reason to extend the 
quarantine to the live animal area. USDA has the expertise, resources 
and current regulatory authority to impose an animal health quarantine, 
and granting this authority to FDA is unnecessary. As pointed out in 
the full Committee markup this provision would extend to retailers and 
there is no indication in the bill as to how the quarantine would be 
removed once put into place. As written this provision creates 
confusion between the roles of USDA and FDA and needs to be thought 
through carefully so there are not any unintended consequences created 
by this bill. Again, specifically exempting livestock and poultry in 
these new regulations would eliminate duplication into current USDA 
authority.
    We appreciate the Energy and Commerce Committee working with the 
livestock groups to address some of the duplicative and unnecessary 
regulatory authority this bill grants the FDA. We look forward to 
working with both the Energy and Commerce and Agriculture Committees to 
add clarifying language to ensure there is not any confusion as to 
Congress' intent of this bill.
    While I have this opportunity to address the Committee on food 
safety, I would like to discuss several topics that are being linked to 
the food safety debates. First is the misconception that an animal 
identification system is a necessary component for food safety. Animal 
identification programs are tools to help monitor and trace disease in 
the event of an animal health emergency. Animal identification systems 
do not enhance food safety, nor were they ever intended to. In 
addition, animal identification systems do not prevent animal disease; 
they are only a tool to help trace and contain them. Producers 
currently utilize animal identification for herd management, genetic 
improvement and as a positive tool for their operations' marketing 
program.
    Another topic that is receiving a lot of interest from the media 
and activist groups is the use of antibiotics in the beef industry. 
Animal health and well-being are top priorities for cattle producers 
across the country. Without healthy animals, we do not have healthy 
food for American families, so we judiciously utilize important tools 
like vaccines, antimicrobials, and other drugs to control disease, 
treat disease, and provide a higher quality of life for our cattle 
while keeping the food supply safe. Additionally, all products approved 
by FDA for use in food producing animals must first pass significant 
human food safety benchmarks. It is also important to recognize that 
animal drugs go through a rigorous, science-based testing process 
before they are approved for use. FDA, USDA, veterinarians, animal 
health companies, producer organizations, and other stakeholders have 
implemented several layers of human health protections. The issue of 
antimicrobial resistance is very concerning to cattle producers. To 
date extensive international research on the topic of antimicrobial 
resistance shows no link between antimicrobial use in livestock and 
antimicrobial resistance in humans. NCBA producers and The Beef 
Checkoff proactively work to increase our knowledge of antimicrobial 
resistance in both animals and humans. We encourage and advocate for 
judicious use of all medications. In fact, NCBA producer-made policy 
supports the Producer Guidelines for Judicious Use of Antimicrobials 
which have been in place since 1987. In addition, NCBA participates in 
the Codex Alimentarius Task Force on Antimicrobial Resistance.
    Antimicrobial resistance is not a black and white issue. It is a 
multi-faceted and extremely complex issue that cannot be solely focused 
on the use of drugs in animal agriculture. Unfortunately, animal 
agriculture has been a primary target in this fight, with little or no 
consideration given by the public to the use, misuse, and mishandling 
of human drugs by the general population. To ensure that the issue of 
antimicrobial resistance is properly addressed, it is imperative that 
we gather accurate, appropriate, and complete data to identify any 
problems and all contributing factors. To date, only limited data 
exists. These data need to be gathered and scientifically evaluated 
without bias or a pre-determined agenda before any further action is 
taken by Congress.
    Cattle producers have a long history of proactively providing 
solutions to issues when science-based evidence shows there is an issue 
that needs to be addressed. Again, to date there is no scientific 
evidence linking the judicious use of antimicrobials in the beef 
industry to antimicrobial resistance in humans. The international 
scientific community continues to actively research and discuss this 
issue. It is important that we have strong conclusive science-based 
information before any legislative actions are taken that could impact 
the health of our animals and food supply.
    In closing, I would like state again, that the U.S. has the safest 
food supply in the world, which is an achievement worth noting. The 
beef industry will continue to dedicate time and resources to address 
food safety issues to ensure the U.S. maintains the safest food supply 
in the world. It is imperative for our government to use sound science 
when evaluating the effectiveness of our food safety systems, and to 
realize the differences between FDA's and USDA's regulatory authority 
of food safety. Science-based intervention and management strategies 
coupled with safe food handling techniques, will help our industry 
maintain its goal of providing a safe, high-quality product for the 
consumer. Everyone plays an important role in food safety and our 
industry will continue our research and educational outreach efforts to 
consumers.
    I appreciate the opportunity to testify today about the beef 
industry's role in food safety and some of our areas of concern with 
H.R. 2749. Cattle producers are concerned that unnecessary duplication 
of USDA's regulatory authorities will undermine our common goal of 
creating a more effective and efficient food safety system. We are 
happy to provide additional information and look forward to working 
with both the Energy and Commerce and Agriculture Committees to clarify 
some of the provisions so there is not any misunderstanding of 
Congressional intent.

    The Chairman. Thank you, Dr. Ives, for your statement.
    Mr. Peppler, welcome to the Committee.

          STATEMENT OF KENT PEPPLER, PRESIDENT, ROCKY
         MOUNTAIN FARMERS UNION, MEAD, CO; ON BEHALF OF
                     NATIONAL FARMERS UNION

    Mr. Peppler. Good morning, Mr. Chairman, and Members of the 
Committee. My name is Kent Peppler. I am President of Rocky 
Mountain Farmers Union, which represents family farmers and 
ranchers in Colorado, Wyoming, and New Mexico. I am here today 
on behalf of Rocky Mountain Farmers Union and National Farmers 
Union, and I am also a fourth generation farmer in northern 
Colorado and we have also fed cattle and sheep and hogs in the 
past.
    As a farmer, it is my best interest to maintain the 
confidence of American consumers that the food on our supper 
table is safe. About 3 weeks ago, USDA announced that JBS Swift 
Beef Company, based in my neighborhood in Greeley, Colorado, 
was voluntarily recalling approximately 380,000 pounds of 
assorted beef products that may have been contaminated with E. 
coli. Unfortunately, USDA has wasted time, attention, and 
efforts on this recall by focusing on the origin of the cattle. 
This reminds me of the story of the guy who loses his wallet on 
the east side of the street and decides to look for it on the 
west side of the street because the light is better.
    I urge you not to get distracted in this debate by those 
who argue that it is the farmers who are the problem. Farmers 
are the first line of defense in addressing food safety issues, 
and I would argue that we have done a heck of a job. You don't 
see headlines of food contaminated when it's going straight 
from the farm to the consumer. The headlines we have been 
seeing too often lately typically appear with the logos of big 
corporate vertically integrated ag processors. Placing 
unnecessary, onerous, costly and burdensome regulations on 
farmers will not yield the results we all need and want in this 
issue. The lack of outreach to the independent farm production 
sector by those in Congress, who are intent on moving food 
safety legislation forward, is problematic.
    Provisions that adversely impact independent family farmers 
and ranchers will be counterproductive in improving the safety 
of our food. A punitive or one-size-fits-all approach for 
traceability, penalties or other efforts seeking to improve 
food safety will not yield successful results. Specifically, 
small and mid-size operations that focus on sustainable and 
organic production methods are concerned with potentially 
excessive burden and expense associated with legislative 
efforts on food safety. Congressional leaders must do a better 
job in reaching out to our producer community. You might be 
surprised with what you find, common sense solutions and ideas 
for achieving better food safety that those inside the beltway 
hadn't considered. NFU's policy supports two key components for 
improving food safety: One, creating a new regulatory body, 
single food agency to oversee the entire U.S. food system 
including imports, and two, providing the regulator with 
mandatory recall authority.
    My written testimony details additional policy suggestions. 
Concerns we have with the Food Safety Modernization Act of 
2009, include the following: Traceability requirements have 
been improved by allowing producers to maintain records either 
electronically or on hard copies for 6 months; however, the 
focus of improving food safety should not be misdirected on 
independent farmers and ranchers. Registration fees are 
woefully deficient in recognizing the difference between small 
processors and large corporate multi-national processors. The 
legislation needs to recognize the uniqueness of small 
processing facilities and exempt those from any fees, so as not 
to discourage those facilities from participating in an already 
consolidated and concentrated food processing system.
    Unintentional barriers to producers interested in 
transitioning into organic production methods: Requirements or 
encouragement of producers to eliminate certain environmental 
practices under the guise of safer food production. The FDA has 
no background, knowledge, or expertise of real world 
environmental practices by farmers, and I strongly urge this 
Subcommittee, and others who understand the benefits of 
environmental practices like buffer strips, to engage your 
colleagues to articulate the consequences of pursuing this 
misdirected path.
    Farmers are the first link of the food safety chain and can 
be a valuable resource as Congress determines what policies 
will yield the greatest results. As an organization that 
represents independent family farmers and ranchers, RMU and NFU 
are eager to provide an on-farm real-world perspective to the 
food safety debate.
    [The prepared statement of Mr. Peppler follows:]

 Prepared Statement of Kent Peppler, President, Rocky Mountain Farmers 
          Union, Mead, CO; on Behalf of National Farmers Union

    Good morning, Mr. Chairman and Members of the Committee. My name is 
Kent Peppler, I serve as the President of Rocky Mountain Farmers Union, 
which represents family farmers and ranchers in Colorado, Wyoming and 
New Mexico. I am a fourth generation farmer from Mead, Colo., my 
operation consists of 500 acres of corn, wheat, alfalfa hay and barley. 
In the past my family raised sugar beets and sunflowers; we also fed 
cattle, sheep and hogs. I am here today on behalf of Rocky Mountain 
Farmers Union and National Farmers Union (NFU)--a nationwide 
organization representing more than 250,000 farm, ranch and rural 
residents.
    There is no question that doing more to protect our food supply is 
necessary. The solutions to achieving this goal are as diverse as the 
perspectives of impacted communities. America's farmers and ranchers 
are the best in the world at what they do; it is in our best interests 
to maintain the confidence of American consumers that the food on their 
supper table is safe.
    Many in agriculture would agree that food safety concerns could be 
addressed at minimum by adequate and appropriate enforcement of 
existing regulations. A vast array of regulations and laws exist today, 
yet the Federal agencies tasked with enforcing those laws are not given 
adequate resources to accomplish the job. I must also note that 
existing regulations, even when enforced, have not yielded appropriate 
protections for consumers--as demonstrated by the recent cookie dough 
and peanut butter outbreaks. The failure to inspect and regulate food 
processing facilities is a concern held by producers across the 
country. However, adding additional mandates from Congress, without 
equipping the agencies to do the job, will yield the same failed 
results we are experiencing today.
    The complexities of our modern food supply system have outpaced the 
ability of regulators to sufficiently address supply safety controls. 
Last summer, during the Salmonella saintpaul outbreak, Rocky Mountain 
Farmers Union called on consumers to demand more local and seasonal 
food production rather than rely upon the status quo of food 
distribution. In response to other recent food safety outbreaks, some 
have suggested the solution is nationwide marketing orders. Our members 
have worked to prevent such regulations being imposed on family farmers 
because of evidence from the Food and Drug Administration (FDA) that 
demonstrates E. coli O157:H7 outbreaks have been associated with 
products coming from processing facilities, not the farm. Efforts to 
establish a nationwide set of mandatory food safety marketing orders 
for all produce farms is the wrong approach to addressing food safety 
concerns.
    A growing concern with the direction of legislative food safety 
action is the impact on farmers' environmental practices. Attached to 
my testimony is a July 13, 2009 article published in the San Francisco 
Chronicle titled, ``Crops, Ponds Destroyed in Quest for Food Safety.'' 
If producers are required to eliminate environmentally beneficial 
practices based upon no evidence the revised production practices will 
yield safer food, the consequences will be severe. The FDA has no 
background, knowledge or expertise of real-world environmental 
practices by farmers and I strongly urge this Subcommittee and others 
who understand the benefits of environmentally beneficial practices 
like buffer strips, wildlife habitat and water quality protection to 
engage your colleagues to articulate the consequences of pursuing this 
misdirected path.
    Three weeks ago yesterday, the U.S. Department of Agriculture's 
(USDA) Food Safety and Inspection Service (FSIS) announced that JBS 
Swift Beef Company, based in my neighborhood of Greeley, Colo., was 
voluntarily recalling approximately 380,000 pounds of assorted beef 
products that may have been contaminated with E. coli 0157:H7. While 
not the largest beef recall our nation has faced, it serves as an 
unwelcome reminder that the time to act on food safety is now. 
Unfortunately, time, attention and focus have been wasted by USDA on 
this recall by focusing on the origin of the cattle. It reminds me of 
the story of the guy who loses his wallet on the east side of the 
street, and decides to look for it on the west side because the light 
is better. Consumers and producers would be better served if 
slaughterhouses are no longer allowed to self-regulate and the entire 
regulatory system is updated to reflect the complexities of today's 
modern food supply.
    NFU's policy has called on Congress to create a new regulatory body 
to oversee the U.S. food system. In order to be successful, such a 
system must be adequately funded to carry out its mission. This will 
require the Federal Government to make food safety a fiscal priority 
and not demand user fees or registration fees to cover the entire cost 
of providing safe food to American consumers.
    Our members also support the creation of a single food agency to 
regulate the food supply as a whole, including increasing amounts of 
imported foods. The agency should be granted authority for issuing a 
mandatory recall in the event of a food safety outbreak. With the 
recent voluntary beef recall in my state, we know the meat was 
processed approximately 65 days prior to the voluntary recall and 
distributed to at least 13 states and international markets. The 
inability to issue a mandatory recall perpetuates both consumer fear 
and depressed product sales. Mandatory recall authority should also 
include a requirement for timely notification at points of sale to 
minimize distribution of product to consumers. Reduced product sales 
lead to lower market prices received by producers and can last for 
weeks or months, devastating producers' income. Mandatory recall 
authority could mitigate the economic impact on producers while at the 
same time containing consumer fear.
    Any food safety legislation must recognize implications for farmers 
and their ability to continue to provide an affordable, safe and 
abundant food supply. Farmers are the first link of the food safety 
chain and can be a valuable resource as Congress determines what 
policies will yield the greatest results. As an organization that 
represents independent family farmers and ranchers, RMFU and NFU are 
eager to provide an ``on-the-farm,'' real-world perspective as the food 
safety debate proceeds. An aggressive outreach and education effort 
must be made to producers regarding food safety measures that can be 
implemented on the farm. An affiliate of NFU, the Community Alliance 
with Family Farmers based in Davis, Calif., has been developing an 
educational outreach campaigned, geared toward producers, to mitigate 
food safety concerns on the farm. Their efforts should be replicated 
across the country and would require no legislative action.
    We are concerned with the lack of outreach to the independent farm 
production sector by those in Congress who are intent on moving food 
safety legislation forward. Provisions that adversely impact 
independent family farmers and ranchers will be counterproductive in 
improving the safety of our food. A punitive or one-size-fits-all 
approach for traceability, penalties or other efforts seeking to 
improve food safety will not yield successful results. Specifically, 
small and mid-sized operations focused on sustainable and organic 
production methods are concerned with potential excessive burden and 
expense associated with legislative efforts on food safety. While the 
language in the Food Safety Enhancement Act of 2009 (H.R. 2749) to 
account for organic production methods and size are needed, more must 
to be done to address these concerns. Congress must ensure new food 
safety legislation does not prescribe a separate set of standards that 
would unintentionally discourage producers from transitioning to 
organic production methods. I encourage this Subcommittee to reach out 
to all food producers, including small scale and organic producers, to 
ensure legislative efforts do not disproportionately burden these good 
actors.

Traceability
    H.R. 2749 includes language to establish a higher standard of 
traceability of food in order to quickly identify and contain the 
source of an outbreak. While working through the Energy and Commerce 
Committee process, the bill was improved to provide an accommodation 
for producers that sell directly to grocery stores, restaurants or 
consumers. The modified section allows producers to maintain records 
either electronically or in hard copy format for a 6 month period. This 
section was also improved by requiring a cost/benefit analysis, public 
hearings, a pilot project and information gathering effort prior to 
publishing regulations.
Imports
    According to an April 2009 Congressional Research Service report, 
the FDA physically inspects approximately one percent of all imported 
food items with 450 inspectors covering more than 300 ports of entry. 
According to USDA's Economic Research Service, the value of agriculture 
imports went from approximately $37 billion in 1998 to $80 billion in 
2008. Combined with frequent headlines of tainted imports such as pet 
food ingredients, baby formula, shrimp--our food safety efforts cannot 
continue to fail to acknowledge the increasing amount of food entering 
our country from places around the globe that either have no food 
safety standards or standards in name only.

Registration Fees
    As currently drafted, H.R. 2749 does not appropriately recognize 
the differentiation between small and large processors. To require all 
food facilities, regardless of size, pay an annual registration fee of 
$500 demonstrates a deficiency in the legislation. Congress should 
recognize the uniqueness of small processing facilities and exempt such 
facilities from this fee so as not to discourage small-scale processors 
from participating in an already consolidated and concentrated food 
processing system.

Additional Policy Suggestions
    In order to maintain the high quality of our food supply, NFU 
supports the following standards for production, processing and 
transportation of food products:

   Vigorous action by U.S. regulatory agencies to prevent the 
        introduction of bovine spongiform encephalopathy (BSE) into 
        U.S. livestock and livestock products;

   A moratorium on mechanical de-boning until the process can 
        be improved to ensure that no undesired portions of the carcass 
        are present in the final product;

   Labeling of irradiated products and further research on its 
        long-term effects on human health;

   Opposition to the transportation of food in containers that 
        have carried incompatible substances;

   Protecting our nation's food supply and the rigorous 
        inspection of all imported food, fiber, Milk Protein 
        Concentrate (MPC), animal products and by-products to ensure 
        they meet our nation's sanitary and phyto-sanitary standards 
        including safe pesticide levels. USDA inspection stamps/seals 
        should be placed only on the individual items inspected;

   Permitting states to implement food safety regulations more 
        stringent than comparable Federal regulations where states deem 
        consumer health and safety to be at risk or when individual 
        agricultural producers strive to set a higher bar for the 
        safety of food products destined for specialty or export 
        markets; and

   Labeling the use of all additives, such as carbon monoxide 
        injected in meat and seafood or packaging for appearance or 
        shelf-life purposes.
Labeling
    Thorough and accurate food labels are an important tool that help 
consumers make informed decisions and allows producers to differentiate 
their products. We support mandatory labeling for food products to 
include all ingredients, additives and processes such as:

   Carbon Monoxide;

   Artificial growth hormones;

   Products derived from cloned animals;

   Irradiation;

   The identity of the parent company; and

   Country-of-origin.

Agri-Terrorism
    With increased attention and focus on potential agri-terrorism 
attacks on our nation's food chain, rural America must be educated, 
prepared and vigilant of all potential circumstances. National Farmers 
Union supports:

   The Department of Homeland Security (DHS) and USDA 
        immediately developing mechanisms to combat agro-terrorism with 
        full funding provided by DHS. Such mechanisms should ensure the 
        safety of the consumer and agricultural industry;

   Increased cooperation between USDA, DHS, Department of 
        Health and Human Services (HHS) and the Federal Emergency 
        Management Agency (FEMA) to establish, expand and continue to 
        determine vulnerabilities within the agricultural and food 
        industries;

   Establishing a USDA public awareness and education campaign 
        for producers;

   Providing Federal guidance and funding to states and 
        localities to develop and implement plans for agricultural 
        disease prevention, recovery and response, based upon already 
        established state animal response activities; and

   A requirement of representatives of Federal, state and 
        county agencies to notify landowners prior to non-emergency 
        access of their private property. Representatives and vehicles 
        used for access should also display appropriate agency signage 
        and identification.

    I thank you for the opportunity to testify today and look forward 
to responding to any questions Committee Members may have.
                               Attachment
San Francisco Chronicle
Crops, ponds destroyed in quest for food safety
Carolyn Lochhead, Chronicle Washington Bureau

Monday, July 13, 2009

    (07-13) 04:00 PDT Washington--Dick Peixoto planted hedges of fennel 
and flowering cilantro around his organic vegetable fields in the 
Pajaro Valley near Watsonville to harbor beneficial insects, an 
alternative to pesticides.
    He has since ripped out such plants in the name of food safety, 
because his big customers demand sterile buffers around his crops. No 
vegetation. No water. No wildlife of any kind. ``I was driving by a 
field where a squirrel fed off the end of the field, and so 30 feet in 
we had to destroy the crop,'' he said. ``On one field where a deer 
walked through, didn't eat anything, just walked through and you could 
see the tracks, we had to take out 30 feet on each side of the tracks 
and annihilate the crop.''
    In the verdant farmland surrounding Monterey Bay, a national marine 
sanctuary and one of the world's biological jewels, scorched-earth 
strategies are being imposed on hundreds of thousands of acres in the 
quest for an antiseptic field of greens. And the scheme is about to go 
national.
    Invisible to a public that sees only the headlines of the latest 
food-safety scare--spinach, peppers and now cookie dough--ponds are 
being poisoned and bulldozed. Vegetation harboring pollinators and 
filtering storm runoff is being cleared. Fences and poison baits line 
wildlife corridors. Birds, frogs, mice and deer--and anything that 
shelters them--are caught in a raging battle in the Salinas Valley 
against E. coli O157:H7, a lethal, foodborne bacteria.
    In pending legislation and in proposed Federal regulations, the 
push for food safety butts up against the movement toward biologically 
diverse farming methods, while evidence suggests that industrial 
agriculture may be the bigger culprit.

`Foolhardy' approach

    ``Sanitizing American agriculture, aside from being impossible, is 
foolhardy,'' said UC Berkeley food guru Michael Pollan, who most 
recently made his case for smaller-scale farming in the documentary 
film ``Food, Inc.'' ``You have to think about what's the logical end 
point of looking at food this way. It's food grown indoors 
hydroponically.''
    Scientists do not know how the killer E. coli pathogen, which 
dwells mainly in the guts of cattle, made its way to a spinach field 
near San Juan Bautista (San Benito County) in 2006, leaving four people 
dead, 35 with acute kidney failure and 103 hospitalized. The deadly bug 
first appeared in hamburger meat in the early 1980s and migrated to 
certain kinds of produce, mainly lettuce and other leafy greens that 
are cut, mixed and bagged for the convenience of supermarket shoppers. 
Hundreds of thousands of the bug can fit on the head of a pin; as few 
as ten can lodge in a salad and end in lifelong disability, including 
organ failure.

Going national

    For many giant food retailers, the choice between a dead pond and a 
dead child is no choice at all. Industry has paid more than $100 
million in court settlements and verdicts in spinach and lettuce 
lawsuits, a fraction of the lost sales involved.
    Galvanized by the spinach disaster, large growers instituted a 
quasi-governmental program of new protocols for growing greens safely, 
called the ``leafy greens marketing agreement.'' A proposal was 
submitted last month in Washington to take these rules nationwide. A 
food safety bill sponsored by Rep. Henry Waxman, D-Los Angeles, passed 
this month in the House Energy and Commerce Committee. It would give 
new powers to the Food and Drug Administration to regulate all farms 
and produce in an attempt to fix the problem. The bill would require 
consideration of farm diversity and environmental rules, but would 
leave much to the FDA.
    An Amish farmer in Ohio who uses horses to plow his fields could 
find himself caught in a net aimed 2,000 miles away at a feral pig in 
San Benito County. While he may pick, pack and sell his greens in 1 day 
because he does not refrigerate, the bagged lettuce trucked from 
Salinas with a 17 day shelf life may be considered safer.
    The leafy-green agreement is based on available science, but it is 
just a jumping-off point. Large produce buyers have compiled secret 
``super metrics'' that go much further. Farmers must follow them if 
they expect to sell their crops. These can include vast bare-dirt 
buffers, elimination of wildlife, and strict rules on water sources. To 
enforce these rules, retail buyers have sent forth armies of food-
safety auditors, many of them trained in indoor processing plants, to 
inspect fields.

Keeping children out

    ``They're used to working inside the factory walls,'' said Ken 
Kimes, owner of New Natives farms in Aptos (Santa Cruz County) and a 
board member of the Community Alliance With Family Farmers, a 
California group. ``If they're not prepared for the farm landscape, it 
can come as quite a shock to them. Some of this stuff that they want, 
you just can't actually do.'' Auditors have told Kimes that no children 
younger than 5 can be allowed on his farm for fear of diapers. He has 
been asked to issue identification badges to all visitors.
    Not only do the rules conflict with organic and environmental 
standards; many are simply unscientific. Surprisingly little is known 
about how E. coli is transmitted from cow to table.

Reducing E. coli

    Scientists have created a vaccine to reduce E. coli in livestock, 
and a White House working group announced plans Tuesday to boost safety 
standards for eggs and meat. This month, the group is expected to issue 
draft guidelines for reducing E. coli contamination in leafy greens, 
tomatoes and melons.
    Some science suggests that removing vegetation near field crops 
could make food less safe. Vegetation and wetlands are a landscape's 
lungs and kidneys, filtering out not just fertilizers, sediments and 
pesticides, but also pathogens. UC Davis scientists found that 
vegetation buffers can remove as much as 98 percent of E. coli from 
surface water. UC Davis advisers warn that some rodents prefer cleared 
areas.
    Produce buyers compete to demand the most Draconian standards, said 
Jo Ann Baumgartner, head of the Wild Farm Alliance in Watsonville, so 
that they can sell their products as the ``safest.''
    State agencies responsible for California's water, air and wildlife 
have been unable to find out from buyers what they are demanding.
    They do know that trees have been bulldozed along the riparian 
corridors of the Salinas Valley, while poison-filled tubes targeting 
rodents dot lettuce fields. Dying rodents have led to deaths of owls 
and hawks that naturally control rodents.

Unscientific approach

    ``It's all based on panic and fear, and the science is not there,'' 
said Dr. Andy Gordus, an environmental scientist with the California 
Department of Fish and Game. Preliminary results released in April from 
a 2 year study by the state wildlife agency, UC Davis and the U.S. 
Department of Agriculture found that less than \1/2\ of 1 percent of 
866 wild animals tested positive for E. coli O157:H7 in Central 
California. Frogs are unrelated to E. coli, but their remains in bags 
of mechanically harvested greens are unsightly, Gordus said, so ``the 
industry has been using food safety as a premise to eliminate frogs.''
    Farmers are told that ponds used to recycle irrigation water are 
unsafe. So they bulldoze the ponds and pump more groundwater, opening 
more of the aquifer to saltwater intrusion, said Jill Wilson, an 
environmental scientist at the Central Coast Regional Water Quality 
Control Board in San Luis Obispo.
    Wilson said demands for 450 foot dirt buffers remove the agency's 
chief means of preventing pollution from entering streams and rivers. 
Jovita Pajarillo, associate director of the water division in the San 
Francisco office of the Environmental Protection Agency, said removal 
of vegetative buffers threatens Arroyo Seco, one of the last remaining 
stretches of habitat for steelhead trout.

Turning down clients

    ``It's been a problem for us trying to balance the organic growing 
methods with the food safety requirements,'' Peixoto said. ``At some 
point, we can't really meet their criteria. We just tell them that's 
all we can do, and we have to turn down that customer.'' Large 
retailers did not respond to requests for comment. Food trade groups in 
Washington suggested calling other trade groups, which didn't comment.
    Chiquita/Fresh Express, a large Salinas produce handler, told the 
advocacy group Food and Water Watch that the company has ``developed 
extensive additional guidelines for the procurement of leafy greens and 
other produce, but we consider such guidelines to be our confidential 
and proprietary information.''
    Seattle trial lawyer Bill Marler, who represented many of the 
plaintiffs in the 2006 E. coli outbreak in spinach, said, ``If we want 
to have bagged spinach and lettuce available 24/7, 12 months of the 
year, it comes with costs.''
    Still, he said, the industry rules won't stop lawsuits or eliminate 
the risk of processed greens cut in fields, mingled in large baths, put 
in bags that must be chilled from packing plant to kitchen, and shipped 
thousands of miles away.
    ``In 16 years of handling nearly every major foodborne illness 
outbreak in America, I can tell you I've never had a case where it's 
been linked to a farmers' market,'' Marler said. ``Could it happen? 
Absolutely. But the big problem has been the mass-produced product. 
What you're seeing is this rub between trying to make it as clean as 
possible so they don't poison anybody, but still not wanting to come to 
the reality that it may be the industrialized process that's making it 
all so risky.''

Some major recent outbreaks of foodborne illness

    The Food and Drug Administration lists 40 foodborne pathogens. 
Among the more common: E. coli O157:H7, Salmonella, Listeria, 
Campylobacter, botulism and hepatitis A.
    June 2009: E. coli O157:H7 found in Nestle Toll House refrigerated 
cookie dough manufactured in Danville, Va., resulted in the recall of 
3.6 million packages. Seventy-two people in 30 states were sickened. No 
traces found on equipment or workers; investigators are looking at 
flour and other ingredients.
    October 2008: Salmonella found in peanut butter from a Peanut Corp. 
of America plant in Georgia. Nine people died, and an estimated 22,500 
were sickened. Criminal negligence was alleged after the product tested 
positive and was shipped.
    June 2008: Salmonella saintpaul traced to serrano peppers grown in 
Mexico. More than 1,000 people were sickened in 41 states, with 203 
reported hospitalizations and at least one death. Tomatoes were 
suspected, devastating growers.
    April 2007: E. coli O157:H7 found in beef, sickening 14 people. 
United Food Group recalled 5.7 million pounds of meat.
    December 2006: E. coli O157:H7 traced to Taco Bell restaurants in 
New Jersey and Long Island, N.Y. Green onions suspected, then lettuce. 
Thirty-nine people were sickened, some with acute kidney failure.
    September 2006: E. coli O157:H7 found in Dole bagged spinach 
processed at Earthbound Farms in San Juan Bautista (San Benito County). 
The outbreak killed four people, sent 103 to hospitals, and devastated 
the spinach industry.
    E-mail Carolyn Lochhead at [email protected].

http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/07/13/MN0218DVJ8.DTL

This article appeared on page A-1 of the San Francisco Chronicle

    The Chairman. Thank you very much, Mr. Peppler.
    Mr. Reinhard, welcome to the Committee.

 STATEMENT OF ROBERT G. REINHARD, DIRECTOR OF FOOD SAFETY AND 
                  REGULATORY AFFAIRS, SARA LEE
            CORPORATION; CO-CHAIRMAN, TECHNICAL AND
             REGULATORY COMMITTEE, NATIONAL TURKEY
                 FEDERATION, DOWNERS GROVE, IL

    Mr. Reinhard. Good morning, Chairman Peterson, Congressman 
Goodlatte, and the Members of the House Agriculture Committee. 
My name is Bob Reinhard, and I will be testifying on behalf of 
the National Turkey Federation. In the interest of time, I will 
abbreviate my opening comments to a few short remarks and ask 
that my entire testimony be accepted for the record.
    The National Turkey Federation is a nonprofit trade 
association representing nearly 100 percent of the U.S. turkey 
industry. We greatly appreciate the opportunity to provide 
comments today.
    Federal inspection of turkey and other meat and poultry 
products by the USDA Food Safety Inspection Service has 
undergone major changes in the last 13 years. The collaborative 
efforts of the industry and FSIS have resulted in major 
accomplishments related to food safety and pathogen reduction. 
Both government and industry have shown they are capable of 
implementing scientific food safety programs and that a modern 
science-based inspection service, within the framework of the 
existing statutes, can be effective.
    However, work remains to be done on all sides and there 
should be a role for Congress to play in this process. Yet, we 
believe the mindset and commitment that has been established by 
both the regulators and the regulated has created a foundation 
for continuous improvement of meat and poultry inspection.
    On March 14, 2009, President Obama announced the creation 
of the Food Safety Working Group to focus on food safety based 
on the need to improve the existing food safety system. The 
Food Safety Working Group is chaired by the Secretaries of the 
Department of Health and Human Services and the Department of 
Agriculture. The purpose of the Food Safety Working Group is to 
provide information to the President on how the food safety 
system can be modified for the 21st century, a system fostering 
coordination on food safety issues throughout all government, 
and to work to ensure the existing food safety laws are 
enforced.
    In the last week, the Food Safety Working Group announced 
several new initiatives founded on three core principles: 
prevention, strengthening surveillance, and improving response 
and recovery. The National Turkey Federation supports and 
believes in these same principles. The use of scientific data 
analysis is particularly critical in making informed decisions 
towards the improvement of our food safety system. To that end 
the agencies need to continue to strive to have more specific 
information about attribution, as well as work together to 
share data, not only with each other, but more broadly with the 
regulated industry and other interested parties.
    HACCP is a science-based food safety system, first 
implemented in 1998, that clearly has enhanced food safety and 
public health. HACCP implementation was not always pretty and 
might not have been so successful without the extensive 
meetings and consultations between FSIS, industry, and 
consumers during implementation, along with the effective 
oversight of this Committee. We bring this up to only caution 
that any changes to the existing laws and regulations should be 
done so carefully and all due diligence should be exercised.
    Given the nature of this hearing it would not be 
appropriate to close without discussing H.R. 2749, the Food 
Safety Enhancement Act of 2009, recently passed by the Energy 
and Commerce Committee. One thing of note in the bill is the 
exemption in section 5 regarding products that are inspected 
under the Meat and Poultry Inspection Acts and the farms 
raising these products. We applaud the efforts of Chairman 
Waxman, Ranking Member Barton and the entire Energy and 
Commerce Committee to include this exemption, and we would 
encourage Congress to preserve and, if possible, strengthen 
this exemption as the bill moves through the legislative 
process.
    The opportunity for Congress to pass significant food 
safety legislation rarely comes along. It is NTF's position 
that with an opportunity that is presented, legislation should 
give USDA and FDA additional tools to collaborate with 
industry, consumers, academia and all other stakeholders to 
prevent food safety problems from occurring in the first place. 
Before adding new regulations we strongly encourage this 
Committee and all Members of Congress to consider whether 
those--whether that legislation provides measurable public 
health outcomes.
    In closing, it should be reiterated that the U.S. meat and 
poultry supply is one of the safest in the world; however, the 
turkey industry recognizes changes could be made to further 
enhance confidence to the consuming public. As the food safety 
reform debate moves to the forefront in the Congressional 
agenda, any changes that are enacted should ensure demonstrable 
improvements in food safety and public health.
    Mr. Chairman and other Members of the Committee, again, let 
me thank you for allowing the National Turkey Federation the 
opportunity to provide testimony today. The number one goal of 
the U.S. turkey industry is to provide safe, wholesome 
nutritious quality products at an affordable cost to our 
customers. Thank you very much, and I will be happy to answer 
questions.
    [The prepared statement of Mr. Reinhard follows:]

 Prepared Statement of Robert G. Reinhard, Director of Food Safety and 
 Regulatory Affairs, Sara Lee Corporation; Co-Chairman, Technical and 
  Regulatory Committee, National Turkey Federation, Downers Grove, IL

     Good morning Chairman Peterson, Ranking Member Lucas, and Members 
of the House Agriculture Committee. My name is Bob Reinhard and I am 
the Director of Food Safety and Regulatory Affairs for Sara Lee 
Corporation. Today I will be testifying on behalf of the National 
Turkey Federation, as Co-Chairman of the federation's Technical and 
Regulatory Committee, which oversees all scientific and technical food 
safety activities for the federation. The National Turkey Federation is 
a nonprofit, U.S. trade association located in Washington, D.C., 
representing the entire turkey industry, including local farmers, 
processors, marketers, retailers and industry allied services. 
Currently, NTF represents nearly 100 percent of the U.S. turkey 
industry and we greatly appreciate the opportunity to provide comments 
today.
    The U.S. turkey industry raises more than 260 million turkeys, 
which after processing represents approximately 6 billion pounds of 
safe, wholesome, nutritious protein products for domestic and 
international consumers. Food safety is NTF's number-one priority and 
federation members' future success is directly linked to customer 
confidence in the safety of the food supply and turkey products. Since 
the inception of the National Turkey Federation in 1940, science-based 
food safety has been an industry priority and over the years the 
membership has agreed food safety is an issue on which they would 
cooperate, share best practices, and developing science-based, state-
of-the-art food safety interventions from the farm to the consumer.
    Federal inspection of turkey and other meat and poultry products by 
the USDA Food Safety Inspection Service (FSIS) has undergone major 
changes in the last 13 years, and the collaborative efforts of industry 
and FSIS have resulted in some major accomplishments related to food 
safety and pathogen reduction. Both the government and industry have 
shown they are capable of implementing scientific food safety programs 
and that a modern, science-based inspection system within the framework 
of the existing inspection statutes can be effective. However, work 
remains to be done on all sides, as we will discuss momentarily, and 
there should be a role for Congress to play in this process. Yet, we 
believe that the mindset and commitment that has been established by 
both the regulators and the regulated has created a foundation for the 
continuing improvement of the meat and poultry inspection.
    Going back more than a decade, it was a coalition from the food 
industry that included the National Turkey Federation, which petitioned 
the USDA's FSIS for a preventive, science-based food safety system and 
in 1996 FSIS promulgated the Pathogen Reduction/Hazard Analysis 
Critical Control Point (HACCP) requirements. With this ``HACCP rule,'' 
which was implemented by industry in 1998, certain naturally occurring 
pathogens in raw meat and poultry products were identified as potential 
food safety hazards and if those hazards were likely to occur, process 
controls to eliminate or control those hazards were implemented at the 
production facility. Further, a processing establishment was also 
required to have programs for ensuring they maintain the highest 
sanitary conditions in their facility, known as Sanitation Standard 
Operating Procedures (SSOPs). We feel these programs have been highly 
successful, but again recognize that further progress is and can be 
accomplished.
    On March 14, 2009, President Obama announced the creation of a Food 
Safety Working Group (FSWG) to focus on food safety based on the need 
to improve the existing food safety systems. The FSWG is chaired by the 
Secretaries of the Department of Health and Human Services and the 
Department of Agriculture. The purpose of the FSWG is to provide 
information to the President on how the food safety system can be 
modified for the 21st century, assist in fostering coordination on food 
safety issues throughout all of government, and to work to ensure that 
existing food safety laws are enforced.
    In the last week, the FSWG announced several new initiatives, 
founded on three core principles: prevention, strengthening 
surveillance, and improving response and recovery.
    Examples fostering these principals, which were shared by the 
Secretaries included:

   Preventing harm to consumers;

   Food safety inspection and enforcement dependent on data and 
        analysis; and

   Outbreaks identified quickly and stopped.

Industry supports and believes in these same principles. The use of 
scientific data analysis is particularly critical in making informed 
decision towards the improvement of our public health system. To that 
end, the agencies need to continue to strive to have more specific 
information on attribution, as well as work together to share data, not 
only with each other but more broadly with the regulated industry and 
with other interested parties.

    The industry is confident and optimistic that the White House FSWG, 
the Secretary of Agriculture, and the Secretary of Health and Human 
Services will continue to take a leadership and preventive role on food 
safety issues and work to break down barriers in working across 
different government agencies. The FSWG should monitor implementation 
of their recommendations, as well as ensure coordination of food safety 
policies between the different parties overseeing the implementation of 
recommended measures.
    At this point, it is very important to note, HACCP and SSOPs have 
yielded significant and measurable successes, as shown by USDA FSIS 
pathogen testing data. Specifically, on an annual basis, the Office of 
Public Health and Science analyzes more than 125,000 products and 
conducts more than 650,000 combined analyses on these meat and poultry 
products and in the processing environment in federally inspected 
establishment. These FSIS analyses include testing for chemical and 
biological food safety hazards, including pathogens of public health 
concern like Listeria monocytogenes and Salmonella. Using this 
scientific quantitative data as a benchmark, since turn of the century 
(2000 to 2007) we have seen a 74 percent reduction in the incidence of 
Listeria monocytogenes in ready-to-eat meat and poultry products. 
Additionally, since an initial baseline study by FSIS in 1996 on 
Salmonella prevalence on raw turkey carcasses, we have seen a 64 
percent reduction in this pathogen's presence. However, we need better 
attribution data to confirm what our best instincts tell us--that these 
food safety improvements have a correlation to the decline in foodborne 
illness. The development of attribution information will be of critical 
importance as we continue to make improvements in food safety.
    We share this information to show that we are not in need of re-
building a system, but in need of enhancing a system that is already 
working. Everyone wants to do better, but we need to build on our 
successes and use data with attribution information to drive the 
changes that will lead to improvements in public health.

Modernization
    HACCP is a science-based proven food safety system that has 
enhanced the safety of the meat and poultry products produced in the 
United States. And since initial implementation in 1998, there have 
been ongoing efforts to improve the way regulatory oversight is 
executed and how a processing establishment performance is measured. 
During HACCP's implementation period in 1998, FSIS hosted numerous 
public meetings across the country and provided countless supporting 
documents to assist the regulated entities in achieving compliance with 
the new requirements. The process was phased-in based on plant size, 
with specific focus on small and very small establishments. Today, all 
federally inspected meat and poultry establishments have implemented a 
hazard analysis and preventive control system.
    We bring this up to only caution that any such changes to the 
existing laws and regulations should be done carefully and all due 
diligence should be exercised. Any changes to the existing statue 
should be done with a scalpel, not an axe, to ensure that the current 
level of inspection is not compromised.
    When the current food safety statutes were passed, no one 
envisioned HACCP, yet the law proved flexible enough to accommodate it. 
As science and technology improves, it is highly plausible that the 
food safety inspection process would and should be improved as well. 
Changes to FSIS and FDA statutory authority should not be so 
prescriptive that they stifle innovation and prevent industry, the 
Secretary of Agriculture, or the Secretary of Health and Human Services 
from making science-based improvements with definable public health 
outcomes that are deemed appropriate. Currently, as reiterated by the 
White House FSWG, FSIS has embarked on further refining its inspection 
process using science, risk and other appropriate data. The agency has 
been moving to utilize public health risk in determining how to best 
utilize their inspection resources. In today's economic environment, it 
is prudent that the government and industry focus more of their limited 
resources toward processes to prevent food safety concerns and that we 
focus specifically on interventions that have a measurable outcome 
related to public health. This clearly is the way of the future. FSIS' 
efforts offer instructive lessons for anyone interested in food safety. 
All food safety systems should be designed to manage and reduce risk to 
the food supply. Congress may want to consider giving FSIS expanded 
authority to allocate inspection resources according to risk so that 
inspectors are focused most closely on those tasks that will have the 
biggest impact on food safety. For example, federally inspected 
establishments could be allowed to share bird-by-bird inspection duties 
in a joint effort, working with and under the close supervision of FSIS 
employees to assure the safety of poultry caresses. Such a system would 
permit inspection resources to be shifted to inspection processes that 
have a higher risk related to food safety and a measurable public 
health outcome.

Current Legislation
    Given the nature of this hearing, it would not be appropriate to 
close without discussing H.R. 2749, the ``Food Safety Enhancement Act 
of 2009'' recently passed by the Energy and Commerce Committee.
    One thing of note is the exemption in Section 5 regarding products 
that are inspected under the Meat and Poultry Inspection Acts and the 
farms raising these products. We applaud these exemptions and the 
efforts of Chairman Waxman, Ranking Member Barton and the entire Energy 
and Commerce Committee to include this exemption, and we would 
encourage Congress to preserve and, if appropriate, strengthen the 
exemption as the bill moves through the legislative process.
    The opportunity for Congress to pass significant food safety 
legislation rarely comes along. It is NTF's position that with an 
opportunity like what is presented; legislation should give USDA and 
FDA additional tools to collaborate with industry, consumers, academia 
and all other stakeholders to prevent food safety problems from 
occurring in the first place. Before adding new regulations, we 
strongly encourage this Committee and all Members of Congress consider 
whether legislation provides measurable public health outcomes.
    In closing, it should be reiterated that the U.S. meat and poultry 
supply is one of the safest in the world. However, the turkey industry 
recognizes changes could and should be made to further enhance 
confidence in the consuming public. As the food safety reform debate 
moves to the forefront of the Congressional agenda, any changes that 
are enacted should ensure demonstrable improvements in food safety and 
that a measurable public health outcome is achieved.
    Mr. Chairman and other Members of the Committee, again, let me 
thank you for allowing the National Turkey Federation the opportunity 
to provide this testimony today. The number one goal of the U.S. turkey 
industry is to provide safe, wholesome, nutritious, quality products at 
an affordable cost to our customers. Thank you very much and I will be 
happy to answer any questions.

    The Chairman. Thank you very much, Mr. Reinhard, for your 
testimony.
    Mr. Maravell, welcome to the Committee.

 STATEMENT OF NICHOLAS C. MARAVELL, OWNER AND OPERATOR, NICK'S 
                 ORGANIC FARM, LLC, POTOMAC, MD

    Mr. Maravell. Thank you, Chairman Peterson and Members of 
the Committee. I am Nicholas Maravell, an organic farmer for 
the past 30 years. I appreciate the opportunity to provide 
testimony on H.R. 2749 especially with regard to organic, 
sustainable, and family-sized operations and on-farm value-
added processing. I own and operate Nick's Organic Farm located 
in Montgomery and Frederick Counties, Maryland. I have 170 
acres in production. We raise grass fed Angus beef, pastured 
chickens and turkeys, free range eggs. We sell various types of 
mixed hays. We produce field corn, soybeans, barley, rye grain, 
and hairy vetch. We grow fresh vegetable soybeans.
    We operate a diversified and integrated farm, raising 
several types of crops and types of animals together. As an 
ecologically-based operation, we rely on crop and animal 
diversity and longer and more varied crop rotations to build a 
farming system that stands up to the test in good times and in 
bad, while maintaining or improving the quality of our soil and 
our environment. We are not highly concentrated in one product. 
Our diversity allows us to design a system where the parts work 
well together. Our marketing strategy must complement our 
production diversity. Given our small size and our varied 
product mix we must add value on the farm to be economically 
viable.
    We do this by making the products organic, by selling about 
90 percent directly to the final user and by on-farm 
processing. We process our own organic chicken and turkeys, 
pack our eggs and vegetable soybeans, condition organic seed, 
and grind our grains into poultry feed. In most cases, we are 
only one step down from the final consumer. This direct 
personal marketing relationship allows us to develop trust with 
our customers based on full accountability and traceability. 
The customer has no doubt where to find accurate information 
about our operation or products.
    What concerns me most about this bill is that could be 
perilously close to making our nation's food safety more 
difficult to achieve in the long run. While the Food Safety 
Enhancement Act of 2009 will have some positive impacts it will 
also have unanticipated consequences. In my opinion, as a 
farmer, this legislation needs more refinement before going 
forward. Over the last 30 years I have seen tremendous growth 
and vitality in small and diversified farms, in on-farm value-
added processing, and in decentralized direct to consumer 
marketing channels. None of these growth areas have been 
associated with major food safety issues. These innovations and 
alternatives to the mainstream food system have already 
implemented transparency and connection between the producer 
and the consumer. As long as they provide safe food these 
approaches should be given incentives, not barriers, to 
continue their growth by adding new entrepreneurs and expanding 
existing operations.
    As a certified organic grower and on-farm processor, I 
already meet the major concerns raised in this bill. To have to 
meet them again would be cost and time prohibitive. I have 
attached an analysis of the food safety aspects of the organic 
certification program.
    To the extent that this bill does not recognize and 
encourage diversity in our food system; to the extent this bill 
economically favors further industry consolidation and 
centralization, because smaller more diverse operations cannot 
efficiently meet the added regulatory costs, restrictions and 
burdens; then our food supply becomes more susceptible to large 
shocks whether from unintended contamination or from 
bioterrorism.
    Another concern with this bill is its one-size-fits-all 
solution to food safety. The flat $500 registration fee is an 
example. For modest family-sized operations that may conduct 
only minimal and occasional processing, the cost and ensuing 
paperwork are very burdensome. Estimates indicate the vast 
majority of fees to be generated under this bill would come 
from facilities with gross sales of under a million dollars. 
And yet the vast volume of food with potential safety 
weaknesses is concentrated in operations generating more than 
$1 million in sales. If true, then smaller operators are being 
asked to disproportionately pay for the monitoring of larger 
operations. This is fundamentally unfair, I repeat, 
fundamentally unfair.
    I have specific recommendations in my written testimony on, 
one, a revised fee structure; two, taking into account fees 
already paid and data already collected; three, the need to 
make explicit all of the exemptions that would apply to farms; 
four, the need to specify explicit coordination with the USDA 
Secretary in certain sections; and, five, additional language 
for safety standards to ensure small scale diversified and 
organic producers would be able to continue their practices in 
a safe economical and responsible manner.
    [The prepared statement of Mr. Maravell follows:]

Prepared Statement of Nicholas C. Maravell, Owner and Operator, Nick's 
                     Organic Farm, LLC, Potomac, MD

    Mr. Peterson, Mr. Lucas, and Members of the Committee, I am Nick 
Maravell, an organic farmer for the past 30 years.
    I appreciate the opportunity to provide testimony on H.R. 2749 
regarding food safety to an Agriculture Committee.
    I own and operate Nick's Organic Farm, located in Montgomery and 
Frederick Counties, Maryland. I have 170 acres in production.
    I am a strong supporter of food safety, and in all my years of 
organic production and on-farm processing, I have never had a food 
safety issue or problem arise. I would like to offer a few observations 
and recommendations which I believe should shape the House Member's 
thinking regarding changes to the food safety policy contained in H.R. 
2749, especially with regard to organic, sustainable, and family sized 
operations and on-farm value added processing.
    We raise grass fed Angus beef, pastured chickens and turkeys, and 
free range eggs. We grow and sell various types of mixed hays, and we 
maintain different types of pastures. We produce field corn, soybeans, 
barley, rye grain, and hairy vetch. We grow fresh edible vegetable 
soybeans.
    We operate a diversified and integrated farm, raising several types 
of crops and types of animals together. As an ecologically based 
operation, we rely on crop and animal diversity, and longer and more 
varied crop rotations, to build a farming system that stands up to the 
test in good times and bad, while maintaining or improving the quality 
of our soil and environment. We are not highly concentrated in one 
product, such as beef or dairy, or in two or three main cash crops. Our 
diversity allows us to design a system where the parts work well 
together and require little re-direction once the system is 
established.
    Our marketing strategy must complement our production diversity. 
Given our small size and our varied product mix, we must add value on-
farm to be economically viable. We do this by making the products 
organic, by selling about 90% directly to the final user, either a 
consumer or another farm, and by on-farm processing. We process our own 
organic chickens and turkeys, pack our eggs and vegetable soybeans, 
condition organic seed, and grind our grains into poultry feed. Our 
beef is processed off the farm under USDA inspection. In most cases, we 
are only one step down from the final consumer. This direct personal 
marketing relationship allows us to develop trust with our customers 
through accountability and traceability. The customer has no doubt 
about where to find accurate information about our operation or 
products.

Observations on Food Safety Provisions in H.R. 2749
    What concerns me most about this bill is that it could be 
perilously close to making our nation's food safety more difficult to 
achieve in the long run. While the Food Safety Enhancement Act of 2009 
will have some positive impacts on the safety of our nation's food 
supply, it will also have some unintended consequences. In my opinion 
as a farmer, this legislation needs more refinement before going 
forward. I do not make this statement lightly or out of self-interest, 
but out of deep concern for the ultimate safety and security of our 
country's food supply.
    Over the last 30 years, I have seen tremendous growth and vitality 
in small and diversified farms, in on-farm value added processing, and 
in decentralized direct to consumer marketing channels. Growth of 
farmers markets, community supported agriculture (CSAs), the Buy Local 
and Slow Food movements, and the expansion of organic and sustainable 
food and farming practices have given the consumer many choices. None 
of the growth areas, especially those direct-to-consumer areas, have 
been associated with major food safety issues. Part of the reason for 
this safety record has to do with the approaches they take to 
producing, processing, and marketing food. These approaches represent 
innovations and alternatives to the mainstream food chain because, at 
the core, they have already implemented transparency and connection 
between the producer and the final consumer. As long as they provide 
safe food, these approaches should be given incentives, not barriers, 
to continue their growth by adding new entrepreneurs and expanding 
existing operations.
    To the extent that this bill does not recognize and encourage the 
diversity in our food system, to the extent this bill economically 
favors further industry consolidation and centralization because 
smaller more diverse operations can not efficiently meet the added 
regulatory costs and burdens, then our food supply becomes more 
susceptible to large shocks--whether from unintended contamination or 
from bioterrorism.
    In my case, as a certified organic grower and on-farm processor, I 
already meet the major concerns raised in this bill. To have to meet 
them again through an additional program would be cost and time 
prohibitive. I have attached a detailed analysis prepared by the 
Organic Trade Association which shows the food safety aspects of the 
USDA organic certification program that are already in place.

Fees and Registration
    Another of my concerns with this bill is that it proposes to 
legislate a ``one size fits all'' solution to food safety. The flat 
$500 registration fee structure is one good example of this approach. 
For larger corporate facilities, this fee may be insignificant. For 
modest family sized operations that may conduct only minimal and 
occasional processing, the cost and the ensuing paperwork are very 
burdensome. Estimates indicate the vast majority of fees to be 
generated under this bill would come from facilities with gross sales 
of under $1 million, and yet the vast volume of food with potential 
safety weaknesses is concentrated in operations generating more than $1 
million in sales. If the Committee can determine that this situation is 
true, then smaller operators are being asked to disproportionately pay 
for the monitoring of larger operations. This is fundamentally unfair. 
I repeat, fundamentally unfair. My recommendation is to charge no 
registration fees for operations with sales less that $500,000, to 
charge a $250 fee for facilities with sales between $500,000 and 
$1million, and to charge appropriately scaled fees for facilities with 
sales of over $1 million.
    In my case, I already pay modest fees and am already registered for 
most aspects of my food production and on-farm processing operations 
with the Maryland Agriculture and Maryland Health Departments and with 
the Federal level through my USDA organic certification program. Again, 
treating all operations as ``one size fits all'' ignores other state 
and Federal programs already in place and leads to potentially 
unnecessary costs and paperwork burden. I recommend the Secretary of 
HHS, with explicit coordination with the USDA Secretary, be directed to 
take into account fees already paid and data already collected to 
accomplish the purposes of registration and data collection wherever 
feasible.

Exemptions
    In an attempt to make policy appropriate to the type and scale of 
food production and processing activity, the bill provides for some 
exemptions, particularly for farms that meet certain conditions and for 
livestock programs administered by USDA. I know the exemption 
provisions rely on the definitions of ``facility'' contained in the 
Bioterrorism Act of 2002 and regulations at 21 CFR 1.226 and 227. I 
also know that, in at least one instance, a Federal court has 
interpreted the definition of food to apply to livestock, creating a 
fuzzy line between USDA and FDA program jurisdiction. I am not sure 
what aspects of my farm production and on-farm processing will be 
exempt from Sec. 414--Maintenance and Inspection of Records (including 
Tracing System for Food); Sec. 415--Registration of Food Facilities; 
Sec. 418--Hazard Analysis and Risk-Based Preventative Controls; Sec. 
418A--Food Safety Plan (and associated compliance with Sec. 419--
Performance Standards). I recommend that the language of this bill make 
all the exemptions explicit so that farmers and processors know what 
exactly to expect. I further recommend that this bill state explicitly 
that the definition of ``food'' in the Food, Drug, and Cosmetic Act 
(FDCA) does not apply to livestock. This latter recommendation is made 
notwithstanding the jurisdictional division already contained in the 
FDCA and this bill regarding USDA's livestock inspection programs.

Explicit Coordination With USDA
    As a farmer, I am concerned that the bill does not seem to utilize 
the expertise of other agencies, especially the USDA. Vast new 
authority is given to the Secretary of HHS regarding areas in which 
USDA has relevant expertise:

    Sec. 403 (i)--Quarantine of Geographic Location

    Sec. 414(c)--Tracing System for Food

    Sec. 419A--Safety Standards for Produce and Certain other Raw 
        Agricultural Commodities

    I recommend that the bill specify that the Secretary of HHS 
explicitly coordinate policy in these areas with the Secretary of USDA.

Safety Standards
    I strongly endorse the language in 419A(b)(7), (8) and (9) which 
permits flexibility, coordination, and could prevent duplicative 
efforts by (i) recognizing the special impacts on small-scale and 
diversified farms, wildlife habitat, and organic production methods, 
(ii) allowing coordination for education and training with other 
entities that have experience working directly with farmers, and (iii) 
allowing the HHS Secretary to recognize other publicly available 
procedures and practices to implement safety standards. I would 
recommend adding the words ``direct farmer to consumer distribution 
channels'' to the impacts listed in paragraph (7). If combined with 
explicit coordination with the USDA Secretary, these provisions would 
help ensure small scale, diversified and organic producers would be 
able to continue their practices in a safe, economical, and responsible 
manner.

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    The Chairman. Thank you very much, Mr. Maravell. We 
appreciate your being with us.
    Mr. McDonald, welcome to the Committee.

 STATEMENT OF DREW McDONALD, VICE PRESIDENT, NATIONAL QUALITY 
               SYSTEMS, TAYLOR FARMS, SALINAS, CA

    Mr. McDonald. Good morning, Chairman Peterson, Mr. 
Goodlatte, and Members of the Committee. My name is Drew 
McDonald, and I am Vice President of the National Quality 
Systems for Taylor Farms in Salinas, California. Thank you for 
allowing me the opportunity to testify today.
    We are the world largest salad and fresh cut vegetable 
processor, with ten processing plants operating in seven states 
and Mexico. Taylor's valued network of local, independent 
family-run farms who supply produce to extend across more than 
a dozen states as well as from outside the United States, in 
Canada, Chile, and Mexico. We provide fresh healthy products to 
a hundred million Americans, to provide enjoyment and promote 
healthy lifestyles. We are also active in the major produce 
trade organizations, including United Fresh Produce, Western 
Growers, and Produce Marketing Association.
    I want to start out by saying that the fresh produce 
industry has been at the forefront of developing comprehensive 
food safety programs for many years. The industry has worked 
side by side with Federal Government regulators and scientists 
as well as academia to develop best practices and extensive 
commodity-specific guidelines for various produce items. My 
written statement outlines a number of challenges that are 
important for the Committee to consider.
    Today I would like to focus on three areas of great 
concern. First of all, audit cost and consistency. One of our 
greatest challenges is agreed-upon standards for food safety 
audits. Without a government-endorsed standard the produce 
industry faces multiple, redundant audits, which in most cases 
are not interchangeably acceptable to different buyers. In 
addition, many producers are financially challenged to comply 
with these requirements, and perhaps most importantly, it's not 
clear that the increased cost of these audits result in better 
compliance or safer food.
    Next, under the topic of accountability and transparency, 
over the last few years regulatory requirements have spurred 
industry improvements in the areas of prevention and traceback. 
The primary focus has been on prevention of foodborne disease 
and experts agree this is the most important investment. The 
key to this has been stronger industry-government 
collaboration. One very good example of this is the California 
Leafy Greens Marketing Agreement. This was implemented 
following the spinach outbreak a few years back. It provides an 
excellent model that achieves a HACCP-like risk-based approach. 
It enforces measurable food safety mitigation steps from 
growing to processing.
    Under the program produce handlers are audited by USDA 
trained inspectors to ensure that they are complying with the 
standards. It is a model approach that involved industry 
coordination with FDA, CDC, CDFA, and university food safety 
experts. It is not an easy, task but it is a critical in 
preventive measures and provides assurance to the public that 
our industry is doing everything we can to make our products 
safe.
    Now, concerning the current Congressional efforts on food 
safety, the fresh produce industry has been a leading proponent 
of strong, credible food safety standards. In fact as you know, 
the industry has developed a set of policy principles that call 
for mandatory, science based, and commodity specific standards. 
We are pleased that the consensus in Congress has grown in 
support of these principles. In particular, the Food Safety 
Enhancement Act, passed by the House Energy and Commerce 
Committee, addressed a number of critical issues related to 
produce, but there are still several issues that Congress needs 
to consider which will provide a strong foundation for the 
legislation.
    Regarding finished product testing, as someone who deals 
with testing on a regular basis, I continue to be concerned 
with the concept of trying to test our way to a safe product. 
Testing has very process specific implications and the 
Committee-passed bill contains language on testing that, if 
implemented, will not improve food safety, but will generate 
confusion and ultimately costs that do not correspond to 
enhanced food safety.
    Scientists and FDA continue to recommend a HACCP approach 
with finished product testing as a prudent validation that the 
process and associated HACCP plan is working. Taylor Farms--we 
utilize the HACCP plan throughout all our plants and it 
includes various testing points along the way. The goal must 
always be on preventing food safety issues during the process 
rather than trying to detect them after the process. As such, 
the Federal Government should not rely on testing as a 
cornerstone for the improvement of safety in our food supply.
    Concerning traceback and outbreak investigation, as 
discussed earlier, efforts to date have focused on prevention. 
What we have not done enough of is spend time on how to 
investigate and manage an outbreak when it does occur. FDA and 
its stakeholders must figure out how we can better address a 
foodborne illness outbreak to protect both public health and 
maintain consumer confidence.
    Regarding the geographic quarantine, based on recent 
outbreaks and actions by FDA, we would have serious 
reservations about the impact that the quarantine power would 
have on a particular commodity sector or region, and how that 
impact would do little to actually enhance food safety.
    In conclusion, it's in everyone's interest to maintain a 
safe supply of healthy fruits and vegetables, and starting with 
the fresh produce industry, we must continue to take 
responsibility to do all we can. We must provide safe food. 
Each time any fruit or vegetable is implicated in a foodborne 
illness outbreak, industry suffers from lost consumer 
confidence in our industry as a whole and consumer health 
suffers due to a reduction in the consumption of healthy fresh 
produce. In the long run this is simply not sustainable and 
certainly not acceptable. A Federal food safety system must be 
elevated that maintains the confidence in eating healthy fresh 
fruits and vegetables, and, yet, can deal with the rare 
problems without destroying public confidence.
    Thank you again for the opportunity to participate in this 
hearing, and I look forward to your questions.
    [The prepared statement of Mr. McDonald follows:]

 Prepared Statement of Drew McDonald, Vice President, National Quality 
                   Systems, Taylor Farms, Salinas, CA

Introduction and History of Taylor Farms
    Good morning Chairman Peterson, Ranking Member Lucas and Members of 
the Committee. My name is Drew McDonald and I am Vice President of 
National Quality Systems for Taylor Farms Salinas California. We are 
the world's largest salad and fresh cut vegetable processor with ten 
processing plants operating in six states and Mexico. Taylor's valued 
network of independent, family-run farms who supply produce to us 
extend across more than nine states including California, Arizona, 
Oregon, Washington, Colorado, New Mexico, Michigan, New Jersey, Florida 
as well as other countries such as Canada, Chile, and Mexico. We 
provide fresh healthy products to 100 million Americans each week to 
provide enjoyment and promote healthy lifestyles.
    We are active in the major produce trade organizations including 
serving on the board of directors for United Fresh Produce Association, 
Western Growers, and Produce Marketing Association. These organizations 

have help lead industry efforts to bring safe, healthy, affordable and 
great-tasting fruits and vegetables to the public.
Taylor Farm Food Safety Investment
    Taylor Farms is committed to the development of processes and 
systems that promote the prevention of product failure. It is our 
belief that it is both impossible and impractical to inspect quality 
into a product. As such, we employ a three-stage approach to assure 
product performance. We start with a development process that clearly 
defines the requirements of the product. The product is then integrated 
into our established quality systems where each key step of the process 
is carefully monitored and controlled. Finally, the product is 
subjected to a rigorous hazard analysis and incorporated into our 
company wide HACCP program to insure food safety. Before any product is 
processed for commercial distribution, quality control points and food 
safety critical control points have been thoroughly documented and 
shown to be effective. Subsequent periodic audits and verification of 
key finished product attributes are conducted to assure the on-going 
adequacy of the procedures and systems. Together, these programs assure 
that the products packaged and distributed by Taylor Farms meet our 
exacting standards for quality, customer performance and food safety 
day in and day out.
    Over the last few years we have invested over $100 million in new, 
state-of-the-art processing facilities. The Taylor Farms' facilities, 
operations and work practices have been developed according to Good 
Manufacturing Practices. These FDA regulations cover the design, 
maintenance and sanitary operation of our facilities, equipment, 
processes, storage areas and distribution practices. Each of these 
areas is audited and results documented on a daily basis by Taylor 
Farms' staff. These daily audits include both visual inspections as 
well as random microbiological sampling of equipment surfaces. On a 
monthly basis, environmental samples are taken throughout the facility 
to verify the effectiveness of our overall sanitation program. 
Additionally, Taylor Farms commissions audits by accredited independent 
auditors to insure a fresh look at our sanitary practices.

What are Some of our Food Safety Challenges
    First and foremost, the fresh produce industry has been at the 
forefront of developing comprehensive food safety programs for many 
years. In fact the first Food Safety Guidelines for the Fresh-Cut 
Produce Industry were published in 1992, and recently updated by FDA in 
February 2008. The industry also developed Good Agricultural Practices 
(GAPs) in the mid-1990s to minimize on-farm microbiological food safety 
risks for fruit and vegetables, and worked closely with FDA as the 
agency published its overarching GAPs document in 1998. More recently, 
the industry has worked with scientists from government, academia and 
industry to develop extensive commodity-specific food safety guidelines 
for tomatoes, melons, sprouts, and leafy greens, and have implemented 
strong compliance systems based on state inspections and audits by 
government personnel. Put simply, food safety has been at the forefront 
of our industry's commitment to serve the American public for many 
years.
    Despite this ongoing industry commitment, there continue to be 
significant challenges associated with preventive control practices 
along with how the government responds to outbreaks once they occur. 
Below are few of examples of challenges we continue to see related to 
food safety.
    Audit Consistency and Cost--One of our greatest challenges today is 
the lack of a consistent and agreed-upon standard for food safety 
audits. Without that government endorsed standard, different customers 
demand different food safety audits which are burdensome to our 
company. Today, the produce industry faces multiple, redundant audits, 
which in most cases are not interchangeably acceptable to different 
buyers. Most buyers will only accept the results and certification of 
certain certification bodies, thus leading to a proliferation of 
different audits for different buyers. In some cases, the same auditor 
will visit a facility multiple times to perform different audits to 
verify compliance with different and potentially conflicting standards. 
In addition, inconsistencies in audit standards among the different 
certification bodies have created frustration and confusion, have 
unnecessarily increased operational costs, and may create an obstacle 
to training in food safety practices. To date, every effort to create a 
harmonized set of produce food safety audit standards has only added 
another set of standards to the list. If third-party certification 
programs are to be successful, there must be a system in place that 
requires buying companies to recognize and approve the results of these 
audits without requiring their own duplicative audits to recognize the 
same results.
    In addition, produce industry food safety certification programs 
range in cost (auditor/certification fees alone) from a few hundred 
dollars per audit (generally by the not-for-profit organizations) to 
tens of thousands of dollars (generally by the more complex 
certification bodies like SQF or ISO). Yet, we do not have evidence 
that the increased costs of some audits result in better evidence of 
compliance with standards or better evidence of safer food. The 
tremendous range in audit fees can have a significant impact on the 
ability of particularly small businesses to participate. If exorbitant 
audit fees were required, we fear that many producers would be 
financially challenged to comply with these requirements.
    Need for Improved Accountability and Transparency--The produce 
industry has a decades-long history of implementing food safety 
improvements to prevent both deliberate and unintentional contamination 
of produce as it makes it way from the field to the retail store or 
restaurant. We have a commercial interest in ensuring that only safe 
wholesome fresh fruits and vegetables are delivered to our customers' 
tables. As a result, industry is driven to constantly improve and 
refine its own food safety programs and food safety defense 
capabilities.
    In addition, there are legal requirements, such as the Perishable 
Agricultural Commodities Act, the Bioterrorism Act, and new 
governmental mandates that call for industry action including the FDA 
Produce Safety Action Plan and the more recent Food Protection Plan. 
These Federal actions have spurred industry improvements in the areas 
of prevention and trace back; each integral parts of comprehensive food 
safety programs. These efforts, conducted in cooperation and 
consultation with FDA, DHS, USDA, state departments of health and 
agriculture and food safety experts, have also resulted in greater 
awareness of potential vulnerabilities, the creation of more effective 
prevention programs, and the ability to respond more quickly to 
outbreaks of foodborne illness.
    Yet, as I look at all of the work that has gone into industry 
driven initiatives along with our collaborations with the government, I 
am left with an observation that our priority has been almost 
exclusively on prevention of foodborne disease from the farm up through 
the distribution chain. This is a good thing as both the industry and 
FDA agree that the most important investment in food safety is on 
prevention. Accordingly, the industry has implemented best agricultural 
practices for tomatoes, leafy greens, and other products to prevent 
contamination, and devoted extensive resources to auditing systems to 
measure compliance against these standards. However, we also need to 
focus on the management of outbreaks after they occur. As the industry 
and government work towards enhancing food safety, what we have not 
done, is spend a commensurate amount of time on how best to investigate 
and manage an outbreak when it does occur. It is time for government, 
industry and all stakeholders to figure out how we can better fight a 
foodborne disease outbreak to both protect public health and minimize 
damage to consumer confidence and industry profitability. Let me 
provide some examples.
    In recent experiences with outbreaks and during the investigations, 
it has become clear that no one is in charge, leaving local, state, and 
Federal officials vying for leadership; various agencies pursuing 
different priorities; and well-meaning individuals reacting 
independently to events rather than as part of a coordinated 
investigation moving forward in a logical and expeditious direction. 
Local and state governments are usually first to discover illnesses, 
and are free to draw their own conclusions and issue press releases at 
any time. But how can CDC or FDA stand by when a state seems to be 
``more protective'' of its citizens? Yet, not just today's experience 
but past history shows us that premature mistakes have consequences. 
When local officials first blamed strawberries for a cyclospora 
outbreak in the mid 1990s, their advice may have actually pushed 
consumers to eat more raspberries that were eventually found to be the 
cause.
    The government's failure to use industry's expertise in outbreak 
investigations is one of the most important problems we have today. 
There is an abundance of knowledge in the industry about specific 
commodities, growing regions and handling practices, and specific 
distribution systems that can be used to protect public health in an 
outbreak. FDA and CDC should also welcome outside expertise not just 
from industry, but also from academia, from USDA experts who certainly 
better understand produce distribution systems, and even from the 
states themselves.
    Finally, every health or safety regulatory decision requires an 
assessment of risks and benefits. Agencies make risk management 
decisions every day that attempt to balance risks and benefits broadly 
to society, whether in automobile design, toy manufacturing, airline 
safety, or even FDA approval of food additives. Yet in the case of 
foodborne disease, FDA and CDC seem ill-prepared to grapple with any 
risk management approach other than ``all or nothing.'' In the cases 
such as spinach in 2006 and then tomatoes/peppers from last summer, it 
seems that internal agency decisions on when to warn the public, how 
broadly to make a warning, and what specifically to advise, are based 
as much on fear of being second-guessed rather than careful risk 
analysis. That inevitably leads one toward extreme measures--in effect 
banning all spinach, tomatoes or peppers--in the quest for zero risk of 
immediate illness. But, is such a consumer message truly without risk, 
when it needlessly scares the public away from a healthy food that may 
help prevent disease? We simply must develop risk management systems 
that can distinguish those producers or distributors who can assure the 
safety of their produce in the marketplace from those who cannot.
    Stronger Industry/Government Collaboration--No company can take 
food safety for granted because when an outbreak occurs it impacts the 
industry as a whole, and we all suffer. It is incumbent upon us as an 
industry to do all we can to prevent these outbreaks and to ensure that 
our products are safe every bite, every time. That is why we should 
support strong industry and government collaboration to prevent 
outbreaks from occurring. One example that we think is very important 
is the California Leafy Greens Marketing Agreement.
    The California Leafy Greens Marketing Agreement serves as a means 
of setting rigorous measurements of safety for leafy greens from this 
major production region. These science-based standards include careful 
attention to site selection for growing fields based on farm history 
and proximity to animal operations, appropriate standards for 
irrigation water and other water sources that can come in contact with 
crops, prohibition of raw manure with use of only certified safe 
fertilizers, good employee hygiene in fields and handling, and of 
course, strong food safety controls in all processing plants. The 
program is based on GAPs and essentially serves as a standard risk 
assessment similar to HACCP. Hazards in the growing and harvest 
operations have been identified and specific control points have been 
established. Under the Leafy Greens Agreement, produce handlers are 
required to ensure that their product is meeting these standards. They 
are audited by the California Department of Food and Agriculture to 
ensure that they are complying with these standards. It should be noted 
that not only are the auditors CDFA employees but they are USDA trained 
and the process by which they audit is USDA-certified. And, the produce 
suppliers will face penalties if found not to be in compliance, with 
the ultimate consequence of not being allowed to sell product if they 
cannot do so safely. Taking this risk-based process approach involved 
industry coordination with FDA, CDC, CDFA and university food safety 
experts was not an easy task for the private industry sector. But we 
believe this is a critical step in continuing to assure the public that 
our industry is doing everything we can to make our products safe.
    Food Safety Research--In recent years, Federal funding for food 
safety research has been woefully inadequate, with little to no 
research focused directly on mitigating risk factors associated with 
potential field contamination of fresh produce, or to developing 
effective microbial reduction and elimination techniques after harvest 
and in processing. While there's no obvious silver bullet around the 
corner, developing a ``kill step'' akin to pasteurization while still 
protecting the natural texture and flavor of our product would be a 
critical advancement in preventing even rare future illness outbreaks. 
As a nation, we need Congress to fund scientific research to help 
prevent future outbreaks. Specific produce safety research at FDA that 
is field oriented and implemented to find practical solutions is 
critically important, and we urge Congress to include a robust research 
agenda when considering reforming our nation's food safety laws.
    We believe that boosting produce safety research is a vital part of 
reducing risk in the future but we are not waiting for the government 
to act. Taylor Farms contributed $2 million to the creation of the 
Center for Produce Safety at the University of California at Davis. 
This is a public-private partnership that funds applied research 
directed at the most acute needs of the produce industry's food safety 
agenda. The food safety regulatory body not only needs to be able to 
address food safety today but also food safety in the future. This 
means they need be able to understand the economic and market impacts 
of food safety, have the means to develop meaning advances in food 
safety while supporting the industry in commercializing these advances. 
They must also be a vocal national and international advocate of the 
safety of the U.S. food supply. Any enhancement of the U.S. regulatory 
scheme must be driven by a central focus to insure that the U.S. food 
supply remains the preeminent example of safety and wholesomeness.

Current Legislation Before Congress
    Over the past several years, you know that the fresh produce 
industry has been a leading proponent of strong, credible food safety 
standards. In fact, the industry has developed a set of policy 
principles that call for mandatory, science-based and commodity-
specific standards. We are pleased that the consensus in Congress has 
grown in support of these principles, which have largely been 
incorporated into all major food safety legislative vehicles before the 
House and Senate.
    Let me now turn specifically to the Food Safety Enhancement Act of 
2009 which the House Energy and Commerce Committee passed in June. 
During the debate on this legislation, the Committee addressed a number 
of critical issues including commodity specific produce standards, 
flexibility for industry to utilize best practices/innovation in 
traceability programs, and allowing individual experience for fresh 
produce processors in developing HACCP based food safety programs. 
However, there are several issues that Congress needs to continue to 
consider which will provide a strong foundation for this legislative 
proposal.
    Finished Product Testing--The Committee-passed bill contains 
language on testing that, if implemented, will not improve food safety 
but will generate confusion and costs. First, the bill requires that 
companies include a description of the facilities' environmental and 
product testing programs. Second, the Secretary would be required to 
conduct a pilot project and a study to evaluate the feasibility, 
benefits and costs of collecting finished product testing results from 
Category 1 facilities that are required to comply with Good 
Manufacturing regulations. After completion of the study, the Secretary 
could require the submission of finished product test results of 
Category 1 facilities that must comply with Good Manufacturing 
regulations.
    As someone who deals with testing on a regular basis, I continue to 
be concerned that one cannot test their way to a safe product. A 1985 
National Academy of Science report came to that conclusion when they 
recommended HACCP as an alternative to product acceptance testing. 
Since then, scientists and FDA have recommended finished product 
testing as a prudent validation that the process and associated HACCP 
plan is working; neither recommended it as a routine measure of lot 
safety.
    Taylor Farms employs and rigorously maintains a HACCP program for 
all of our products at all of our facilities. As part of this program, 
Taylor Farms periodically verifies compliance with and the validity of 
our Critical Control Points and Pre-Requisite Programs by sampling for 
indicator microorganisms. It is Taylor Farms' belief that HACCP 
provides greater security of control over product safety than is 
possible with traditional product testing. The Taylor Farms' HACCP 
program was independently developed along the guidelines established by 
the National Advisory Committee on Microbiological Criteria. This plan 
is periodically re-evaluated and validated for changes and/or newly 
available information. All HACCP documentation is maintained at the 
production site for a period of 365 days after the end of shelf life of 
the product. When FDA inspects us, which is at least once per year per 
plant, these programs are review. The Taylor Farms' position on HACCP 
and finished product testing is consistent with the recommendations of 
the Joint FAO/WHO Codex Alimentarius Commission, the USDA and the U.S. 
Food and Drug Administration.
    Companies with good food safety plans may decide to do finished 
product testing for this purpose but, again, this doesn't improve food 
safety, just verifies the plan is working, and punishes good companies 
for their surveillance when a positive is found. The bill requires 
rigorous food safety plans, but I believe the inclusion of finished 
product testing runs counter to the rest of the bill and will actually 
discourage testing. Where to test, when to test, what to test, and what 
to test for, are very much product and process specific questions. 
There is no blanket answer other than to say do not expect testing in 
and of itself to distinguish safe food products from unsafe food 
products. In some instances testing of raw materials may provide more 
insight into the safety process than finished product testing.
    The goal must always focus on preventing food safety issues during 
the process rather than trying to detect them after the process. From 
this perspective one might say that finished product lot testing has 
little to no benefit in an ongoing food safety program. Even the most 
rigorous microbiological testing programs as outlined by the 
International Commission on Microbiological Specifications for Foods 
can only ensure the detection of contamination 95% percent of the time 
when that adulterant has contaminated over 5% of the lot in question. 
Traceback on recent foodborne illness outbreaks consistently tell us 
that contamination levels far lower than 5% are involved, suggesting 
that finished product testing would have absolutely no impact on the 
rate of future foodborne illness outbreaks. Congress or the Federal 
Government should not rely on testing as a cornerstone for the 
improvement of our food supply's safety.
    Funding of Food Safety Requirements--Food safety is a public health 
issue affecting our entire society and accordingly the cost of any 
increased Federal regulatory oversight should be borne by U.S. general 
revenues. Public funding will have the advantage of making consistent 
funding available for food safety oversight and not be subject to the 
same inconsistent production that the produce industry faces. The 
funding structure for the Committee-passed bill uses a both 
appropriations and mandatory fee-based structure. While the fee 
structure is more reasonable than where it started, fee increases are 
pegged to inflation and FDA compensation shortages. The appropriations 
funding is not. One can envision that, very quickly, facility fees will 
become the funding vehicle for food safety, shifting fruit and 
vegetable production in favor of larger, more complex farming 
operations and away from many smaller operations. This shift could work 
against product diversity and support for local agriculture, and act as 
a barrier to entry for smaller operations that today already contribute 
substantially to the safe and wholesome supply of fruits and 
vegetables.
    Geographic Quarantine--This section gives FDA the power to restrict 
the movement of food from states or regions if it believes that the 
type of food presents an imminent threat of serious adverse health 
consequences or death. While the bill demands that the commissioner or 
deputy commissioner may take this action only when a food may cause 
serious adverse health impacts, that evidentiary standard applies only 
to the particular food. As written, the bill provides no evidentiary 
finding that comparable food within that region or state carries that a 
risk of adverse health impacts. Based on recent outbreaks and actions 
taken by FDA, we would have serious reservations about the intent of 
this provision and the impact it could have on particular commodity 
sectors or regions. In particular tomatoes would have qualified under 
this scenario last summer and thus the entire domestic tomato industry 
would have been under a nation-wide quarantine. What is more, the bill 
elsewhere allows FDA to stop distribution of product based on a 
reasonable belief that it may cause serious adverse health effects, 
which makes the quarantine language unnecessary. The produce industry 
supports reasoned action based on science and evidence but we must 
object to quarantining all growers based on nothing more than 
conjecture.
    In addition, FDA currently, has a number of actions available to 
them such as a Public Health Advisory, Import Alert, Detention without 
Examination that would allow them to alert the public, if that is 
necessary. For instance, last year's Public Health Advisory press 
release from FDA recommended consumers not eat tomatoes was strong 
enough guidance for consumers to stop eating tomatoes while the entire 
distribution chain to stop moving tomatoes throughout the country. 
Similar actions occurred in the 2006 spinach outbreak. As discussed 
above, the bill's mandatory and emergency recalls provisions along with 
administrative detention authority empower FDA to stop movement of a 
food product quickly and efficiently. Further, with the new mandate 
that food companies must incorporate traceability systems, one would 
conclude that effective traceback/tracefoward system will be 
implemented to render the need for a Geographic Quarantine Authority 
unnecessary.
    Finally, by providing FDA with the ability to ``quarantine'' a 
particular food in a geographic region would be extremely harmful to a 
multitude of the innocent producers, handlers, distributors, and 
packers of a particular commodity under this authority and could have a 
long-term impact on consumer confidence of that region's ability to 
produce or process safe food. Again, we would cite the tomato situation 
from last summer and what that could have done for the tomato industry 
of this country had this been in effect.
    Need for Improved Accountability, Transparency, and Industry 
Partnership--I have already described the need for improved 
accountability and transparency by FDA during its foodborne illness 
outbreak responses and recovery activities, and the need for FDA to use 
industry's expertise in outbreak investigations. None of these is 
addressed in the Committee-passed bill.

Conclusion
    It is in everyone's interest to maintain a safe supply of healthy 
fruits and vegetables and starting with the fresh produce industry we 
must continue to take responsibility to do all we can on our own. Each 
time any fruit or vegetable is implicated in a foodborne illness 
outbreak, industry suffers from lost consumer confidence in our 
industry as a whole and consumer health suffers due to a reduction in 
the consumption of healthy produce. In the long run, this simply is not 
sustainable and certainly not acceptable. As has been mentioned today 
from my industry colleagues, stakeholders should continue developing 
commodity specific best practices and marketing agreements such as the 
LGMA and self-imposed regulation is an important positive step. 
Industry action is our most important defense. At the same time a 
Federal food safety system must also be elevated that maintains the 
confidence in eating healthy fresh fruits and vegetables; can deal with 
the rare problems without destroying public confidence; and doesn't 
kill the industry or sweep all products into the same bucket. Given the 
ongoing discussions on health care reform the benefits of fresh produce 
to the American diet cannot be stressed enough. How many lives can be 
extended with increased consumption? Imagine how regular consumption of 
fresh fruits and vegetables can extend quality of life in old age? What 
if fruits or vegetables are removed from the diet out of fear the 
consequences will be the cost to society?
    Thank you again for the opportunity to participate in this hearing 
and look forward to answering your questions.

    The Chairman. Thank you very much, Mr. McDonald.
    We thank all of the witnesses for their testimony. I would 
like to announce that we are going to try something new here as 
of today, because of some--I keep getting tons of questions 
every time we have been doing things, based on who gets here, 
and concerns about where you are on the list and whether you 
got counted on time or not.
    So, from now on, or at least for the time being, we are 
going to recognize Members by seniority, and we will see how 
that works for a while.
    Mr. Kratovil. In reverse order.
    The Chairman. You know, I am up for maybe every once in a 
while reversing the order. I am not opposed to that; I am just 
trying to make it a little more predictable.
    But anyway, Ms. Tucker-Foreman, I was struck--you made a 
statement that has been made to me by Mr. Dingell that he did 
not want FDA on the farm, and he did not want to get into our 
jurisdiction. But having read this bill, there is no way for me 
to come to any conclusion but the way the bill is in the 
current form; despite their efforts to try to clarify this, 
they are clearly, in my opinion, going to be on the farm.
    And Dr. Ives, sitting next to you, I think if I heard you 
correctly, you came to that conclusion, and others brought this 
up.
    So--you are sitting next to each other, so let's try to get 
to the bottom of this. Why do you think I am wrong? You know, 
it just--it is kind of like what we have been involved in here 
with the SEC and the CFTC, where these folks that want to take 
the CFTC that never caused any problem at all--that didn't have 
any collapses in this financial crisis--and give them to the 
SEC, which screwed everything up.
    Now, I would not say that FSIS is perfect or that the work 
that we have done is perfect, but I would argue it is a heck of 
a lot better than what FDA has been doing. So, where we are 
coming from here is, we want to be helpful to make FDA more 
productive, but we think if it gets--if it muddles up the 
situation, we are actually going to be worse off.
    I am going to be meeting with Mr. Dingell and Mr. Waxman 
tomorrow to propose some language to them to clarify this, and 
we will see whether we can do that.
    But would you support further efforts to clarify that?
    Ms. Tucker-Foreman. Mr. Chairman, I would not support ever 
giving FDA any of the authority that USDA currently has to 
inspect and regulate meat and poultry, the safety of meat and 
poultry products.
    I think their system of HACCP-plus-inspection works 
reasonably well.
    You know that there are other things we want there. FDA has 
had some authority for on-farm activities as long as I can 
remember. If they think, for example, that drugs, animal drugs, 
are being misused, they can go on the farm. There is a reason 
and they have some expertise at FDA to have them involved in 
produce safety.
    The Agricultural Marketing Services and the Leafy Greens 
Agreement are completely voluntary. If somebody doesn't want to 
follow the rules, the only penalty is they don't get to use the 
label anymore. David Shipman, the acting Administrator of the 
agency, was before this Committee a month ago saying FDA is the 
food safety agency and FDA ought to have the primary 
responsibility for assuring the safety of produce on-farm. And 
they do have the expertise; they developed draft guidance 
documents, two of them now over the past several years to do 
this.
    I don't think anybody anticipates that FDA is going to have 
a flock of personnel out on farms. They have spoken about 
working with state agencies to enforce these regulations when 
they get them, and I think that is entirely appropriate.
    The Chairman. Well, thank you.
    What I am going to suggest to them is to clarify this in 
terms of livestock and grain. The food and vegetable people 
acknowledge there is a place for FDA, and they actually, as 
part of what we are going to suggest, in making sure that we 
get that in the legislation. It is a combination of clarifying 
it for grain farms, livestock farms, and then having the 
regulation that the food and vegetable people want brought into 
the legislation in a way that they think is workable. So that 
is what we are going to try to achieve.
    And, I just hope that people will work with us and the 
Committee will, because if they don't fix this, I am thinking 
about having a markup and reporting this bill unfavorably if we 
don't get this resolved.
    I don't see any reason why we can't get this resolved. Mr. 
Dingell seems to want to work with us on this, and we will try 
to do that.
    But, from my reading of this at the present time, in terms 
of livestock and grain farms, I think there is a potential 
problem; and we would like to get it clarified.
    Ms. Tucker-Foreman. I certainly thought the language was 
dispositive in maintaining current jurisdiction and exempting 
anything that is regulated by the Federal Meat and Poultry 
Inspection Acts.
    So I am curious to know what the problems are.
    The Chairman. Well, we can visit about that.
    Ms. Tucker-Foreman. Okay. Thank you.
    The Chairman. But my time has expired.
    The gentleman from Virginia, Mr. Goodlatte.
    Mr. Goodlatte. Thank you, Mr. Chairman. I would like to 
follow up on that with the entire panel.
    I think everybody agrees that there are some things that 
can and should be done here to improve food safety. A lot of 
things are being done, and it is important that the public know 
that we have, based upon the statistics on foodborne illness, 
the safest food supply in the world. But there are always going 
to be ways you can improve on that and help to avoid more of 
the families that we are seeing here today. So I don't think 
there is anybody who would disagree that we can do more.
    My question to each and every one of you is--and we will 
start with you, Mr. Wooten--do you support the bill that was 
reported out of the Energy and Commerce Committee, the Waxman 
bill, in its current form? Not how you would like it to be, not 
with some changes you would like to see; do you support it or 
oppose it in its current form?
    Mr. Wooten. In its current form, we really have some 
reservations about supporting it. There are questions that we 
feel need to be resolved before American Farm Bureau could 
support this bill.
    Mr. Goodlatte. In its current form then, I take it you 
would oppose it.
    Mr. Boyle?
    Mr. Boyle. Mr. Goodlatte, we have expressed concerns to the 
Committee, prior to the markup, about a number of the 
provisions, not so much because of how they would apply to the 
companies we represent, who are regulated under FSIS 
authorities, but because of the precedent that they may 
establish that may one day apply to the companies that we 
represent.
    And I articulated my concerns in both my written and oral 
testimony. They concern the very prescriptive nature of the 
HACCP authority that is in that bill, the availability of civil 
penalties that FDA could apply to food companies under its 
regulations, mandatory recall.
    The user fee precedent is extremely troubling.
    Mr. Goodlatte. I am going to cut you off because I don't 
have very much time. I have to go all the way down the line, 
and I have some other questions I want to ask, too.
    So in your current form, do you support it or oppose it?
    Mr. Boyle. We have not taken a position in favor or 
opposition, but we do have concerns about the precedent.
    Mr. Goodlatte. Ms. Tucker-Foreman?
    Ms. Tucker-Foreman. The ten organizations I am here 
representing support the passage of the bill.
    Mr. Goodlatte. Dr. Ives?
    Dr. Ives. NCBA does not support the current bill.
    Mr. Goodlatte. Mr. Peppler?
    Mr. Peppler. National Farmers Union has not taken a 
position on the bill. And as it is right now, we have some 
severe reservations on it.
    Mr. Goodlatte. So you would not support it in its current 
form?
    Mr. Peppler. Probably not.
    Mr. Goodlatte. Mr. Reinhard?
    Mr. Reinhard. The National Turkey Federation has concerns 
with the bill as it exists and thinks it could be strengthened, 
but we have not taken an official position to support or oppose 
the bill.
    Mr. Goodlatte. But you would not support it in its current 
form?
    Mr. Reinhard. We would like to work with the Committee and 
Congress.
    Mr. Goodlatte. I am not taking that away from you at all. I 
know that is a concern each and every one of you has. But you 
don't support it the way it is right now?
    Mr. Reinhard. That is correct.
    Mr. Goodlatte. Mr. Maravell?
    Mr. Maravell. I can speak just for myself, so this is easy.
    I have severe reservations about the bill, and I could not 
support it as is. And I have communicated some of those 
reservations with my fellow farmers, and tried to communicate 
those with the Committee and Committee staff as well.
    Mr. Goodlatte. Mr. McDonald?
    Mr. McDonald. There has definitely been great improvement 
in it, but at this point we are not in a position to support 
it.
    Mr. Goodlatte. Okay. All right. Thank you very much.
    Let me ask Mr. Wooten, representing the Farm Bureau, is it 
appropriate for the Food and Drug Administration to establish 
mandatory food production practices on the farm? And if so, 
what resources and expertise does the FDA need in order to set 
and enforce such standards?
    Mr. Wooten. Well, the FDA obviously is not equipped at this 
point to look at agricultural practices. We certainly think 
they ought to work, as one of the witnesses said, closer with 
those folks that are on the ground, the state agencies, in some 
type of partnership with the state agencies and, where 
appropriate, the private industry to make it work.
    Mr. Goodlatte. In your testimony about record-keeping, you 
expressed concerns about the lack of confidentiality 
protections in H.R. 2749. What sorts of information are farmers 
typically worried about being disclosed?
    Mr. Wooten. It would be difficult. I mean, the types of 
information that may be disclosed would be production methods, 
some costs, types of products used. I mean, there would be some 
real questions there.
    Mr. Goodlatte. Okay.
    Dr. Ives, I am concerned about the Waxman proposal for FDA 
to establish mandatory on-farm production practices.
    Is it fair to say that there is a great deal of variety 
among cow/calf operations? Is it possible for the FDA to write 
a one-size-fits-all standard for cattlemen?
    Dr. Ives. No. You are exactly right, there is a tremendous 
amount of diversity within our organization, all the way from 
the cow/calf through the stocker phases into the feed yard. And 
there is absolutely no way one size will fit all.
    Mr. Goodlatte. Mr. Chairman, if I might, I have one more 
question I would like to ask to Mr. Peppler.
    In your testimony, you refer to a lack of resources 
hampering the effectiveness of our Federal food safety system. 
To the best of your knowledge, has the FDA or the USDA been 
receiving less funding than they have requested for food safety 
activities?
    Mr. Peppler. Could you repeat it again, sir?
    Mr. Goodlatte. Sure.
    The question is, you refer to a lack of resources hampering 
the effectiveness of our Federal food safety system; and I am 
wondering if you can help us quantify that.
    To your knowledge, has the FDA or the USDA been receiving 
less funding than they have requested for food safety 
activities?
    Mr. Peppler. I can't answer that. But I am working off the 
statistic that on the imported food we are only inspecting one 
percent of it.
    Mr. Goodlatte. I saw a chart that was put up by Mr. Boyle 
that showed there were about 8,000 workers inspecting 6,300 
facilities related to meat processing, and 1,800 inspectors, 
less than a quarter, inspecting 136,000 nonmeat or other food 
processing plants.
    Would you say that the biggest disparity, the biggest 
problem here, exists on the FDA side of not adequately 
providing the number of inspectors that are needed for those 
types of facilities?
    Anybody else want to try that one?
    Ms. Tucker-Foreman. If I could, sir, we certainly agree 
that the FDA needs additional resources. And in the last year, 
Congress has begun--in the last 2 years, Congress has begun to 
give them additional resources.
    The biggest problem is that FDA has no specific 
responsibility to prevent foodborne illness, and they do have 
an arrangement under law where they have to provide services to 
meet the user fees that are collected under the drug and device 
laws.
    So part of the reason they don't have the resources is that 
Congress has set up a system that has sucked the resources out 
of FDA. But until they have a responsibility to prevent, I 
don't know that just resources will fix the problem.
    Mr. Goodlatte. Well, I agree that resources alone will not 
fix the problem. But if you have one inspector responsible for 
60 or 70 food processing facilities, it is awfully hard for 
them to either play a role in food prevention or inspection.
    So it is certainly a key ingredient. And, you and I could 
probably agree on some other things that could be done as well.
    Where you and I would disagree is whether that FDA 
inspector of any kind would be in any way fit to go onto farms 
and set up systems that would in any way be effective at 
preventing food illness.
    I yield back, Mr. Chairman.
    Mr. Holden [presiding.] I thank the gentleman.
    Mr. McDonald, there is a company in my home State of 
Pennsylvania, Hanson Technologies, that has developed 
technology that can test the wash water of produce for 
Salmonella and E. coli at the processing level. Their 
technology has the ability to perform screening of the entire 
produce lot, without culturing, in 2 hours or less after sample 
collection, which is the fastest, most comprehensive testing 
available.
    And, Mr. McDonald, in your testimony you seem to disagree 
with final product testing. But do you think that the produce 
processing industry would benefit from being able to rapidly 
test for common pathogens? And do you think they should be 
required to do so in order to verify that their food safety 
plans are working?
    Mr. McDonald. Thank you for the question, Mr. Holden.
    I actually have pretty intimate knowledge of their process. 
We have a research facility that we set up with them, and spent 
more than a month; and I am actually on their advisory board as 
a technical--in a technical capacity.
    And it is a great concept. It is essentially using a 
biotracer to identify in a very rapid manner.
    It is not as simple as a finished product test. In fact, 
what it really is testing is the water, the wash water, which I 
agree with to some extent; technically, it is in the right 
direction. It is a great example, though, where the technology 
is not quite ready yet for prime time, so to speak.
    So we absolutely are looking at those kinds of approaches. 
Is it the answer that is going to solve it? Any finished 
product testing, again, it is going to tell you what happened 
already; and it may have some preventative components, but 
really what you have to do is go to the process before that.
    Mr. Holden. Thank you.
    I have one more question for members of the panel. I think 
Mr. Peppler might have referred to this in his testimony.
    Some recommended food safety practices on the farm may be 
in direct contradiction with good conservation practices. For 
example, removing wildlife habitat from around farm fields to 
reduce the possibility of animal contact with produce might be 
encouraged for food safety purposes, but runs directly counter 
to environmental conservation principles.
    I am just wondering if anyone on the panel has any opinion 
about that.
    Ms. Tucker-Foreman. If I could, sir, there has been some 
criticism of that in the media just this week.
    The complaints that are being made about the sterile 
borders around fields are steps that have been taken solely in 
response to private contractual obligations; that is, if you 
want to sell to a particular company, the farmer says you got--
the company says you have to take these steps to make sure that 
your field is sterile.
    We favor a science-based system there. And in fact, one of 
the requirements in H.R. 2749 is that the FDA establish 
science-based requirements. That they take into consideration 
the environmental impact, and that they consult with the USDA 
in the development of these activities. So this is something we 
have been extremely sensitive to, because none of us has any 
interest at all in encouraging practices that would take away 
important wetlands or wildlife habitat.
    But what is happening right now is happening as a result of 
private contracts. If FDA set standards, it might encourage a 
change in those private contracts.
    Mr. Holden. Anyone else? Mr. Peppler or anyone?
    Go ahead, sir.
    Mr. Maravell. Okay. Thank you, sir.
    With regard to organic and various types of sustainable 
production, we have to have a diversity of habitat in our 
production system, which would include both wildlife and, for 
insects, beneficial insects.
    So our system is based upon bringing in natural elements 
that keep pathogens and destructive pests in balance. And if we 
have to take away those purposefully kept wildlife habitat 
areas, it would decrease--I mean, we would have to find another 
way to control pathogens and pests.
    Mr. Holden. Mr. Peppler, were you trying to respond?
    Mr. Peppler. Yes, sir.
    I believe in my written testimony there is a copy of an 
article that talks about exactly what you are talking about, 
concerning a farmer in California that had a private marketing 
order and was forced to destroy his environmental buffers 
around his field.
    So, definitely, that would be a concern.
    Mr. Holden. Thank you.
    Mr. McDonald. May I? Is the time up?
    Mr. Holden. Briefly.
    Mr. McDonald. Just very briefly, I agree with Ms. Tucker-
Foreman and the other comments.
    I will say, having been involved in the Leafy Greens 
Marketing Agreement, this issue did come up very much in the 
beginning and quite aggressively. And a lot of it was left, 
because of misinterpretation of the standards, the marketing 
agreement went above and beyond that to kind of address it.
    It is probably a small percentage at this point. It is 
something that needs to be addressed, but there is no reason 
that they can't be--they shouldn't contradict each other. 
Environmental policy and food safety buffer zones, these kinds 
of things, should not be in conflict.
    Mr. Holden. Thank you.
    The gentleman from Kansas, Mr. Moran.
    Mr. Moran. Mr. Chairman, thank you. I yield my time to the 
gentleman from Texas, Mr. Conaway, who believed he had arrived 
prior to me, and was entitled to my time.
    Mr. Conaway. I did point that out to him. I hope that the 
Chairman will be open to some conversation about his unilateral 
decision to alter the Committee rules, because it is nice to be 
able to get here, on time, and sit through the witnesses and 
listen, and not have some ranking------
    Mr. Moran. Reclaiming my time------
    Mr. Conaway. Ms. Foreman, in all seriousness, thank you for 
bringing three examples of heartbreaking stories of where the 
system either didn't work or couldn't have worked, showing how 
important it is for us to get this right and setting a backdrop 
for us to have this conversation. If we have disagreements as 
to how we get to where we want to get to, it is not because we 
are callous and heartless and insensitive to the heartbreaks 
that these three families have suffered as a result of these 
tragedies, but it will be legitimate differences of opinion 
between informed individuals where we might wind up.
    I am concerned, as some of the others have testified, that 
particularly when you use the word ``anticipate'' having a 
legion of FDA folks running around--legislation doesn't really 
allow you to write in anticipations. I am worried about the 
unintended consequences this legislation may have by having FDA 
reach into the farm prior to conversion of farm products into 
food, that would be detrimental to the system and the overall 
regulatory impact that has.
    I was curious, Mr. McDonald, you mentioned there weren't 
any audit standards for the industry to comply with; and yet 
later on in your conversation, you said the industry had in 
fact come up with some standards in other areas. And I am 
curious as to why the processors, the growers, the producers of 
a particular product that wanted to have an audit system in 
place so that the buyers could use it and rely on it, wouldn't 
come up with a voluntary set of standards that the collective 
group could agree to, and then have that rolled out, as opposed 
to each company that buys setting up its own standards.
    Is it not a possibility for something like that to occur, 
where the industry itself could self-regulate the process?
    Mr. McDonald. Yes. Thank you for the question. It is 
absolutely possible. And that is the example I gave in the 
Leafy Greens Marketing Agreement.
    There is a perfect example where actually not only 
industry, but industry and government came together, along with 
academia, to develop standards. Essentially, they took the FDA 
guides, existing guides, that are very good, and came up with 
specific metrics that everyone agrees upon, and then using 
government auditors to actually inspect against.
    Mr. Conaway. Okay. You had mentioned that there were 
multiple audits available and that some of the audits--and 
maybe I misunderstood------
    Mr. McDonald. Yes. So the first part of it is, there is a 
redundancy, and numerous amounts of audits that are driven 
mainly by kind of the buying community, because there isn't an 
FDA standard approach.
    So it is two extremes. You have no standard as far as the 
government, something that is not very clearly measurable; and 
then you have a proliferation of third-party audits that are 
driven by the buying community.
    Mr. Conaway. I guess that is the group I am focusing on. 
Why wouldn't that group, along with the growers and the folks 
that have to comply with those audits, why wouldn't you work 
through a process so that everybody gets it as close to as 
workable as you can? And I trust that system far more than I 
trust FDA coming up with those audit standards.
    Mr. McDonald. Exactly. And the Leafy Greens Marketing 
Agreement is that scenario.
    Mr. Conaway. Okay.
    Mr. McDonald. It still takes time to get everyone convinced 
of it.
    Mr. Conaway. Even though there is the economic reason why 
it is clearly better. Okay.
    Mr. McDonald. Absolutely. Yes.
    Mr. Conaway. Thank you, Mr. Chairman. I yield back. And I 
appreciate--yield back to the gentleman from Kansas my minute 
and a half.
    Mr. Moran. Mr. Chairman, I yield back the balance of my 
time.
    Mr. Holden. The chair thanks the gentleman and recognizes 
the gentleman from North Carolina, Mr. McIntyre.
    Mr. McIntyre. Thank you, Mr. Chairman.
    And I want to say to Larry Wooten thank you for your 
leadership, your commitment to agriculture, and your service to 
our nation's farmers and ranchers through your work with the 
Farm Bureau.
    Some of you may not realize, but Larry Wooten grew up on a 
small farm in Pender County in the Congressional district in 
southeastern North Carolina that I have the opportunity and 
privilege to represent.
    And thank you personally and professionally for the 
commitment I know you have and the service you give. I wanted 
to ask you a question.
    On page six of your testimony, you discuss your concerns 
about the bill that the Energy and Commerce Committee has put 
forward as it relates to FDA authority to come onto a farm and 
search production records. Specifically, the bill would remove 
language in the Bioterrorism Act that requires FDA to have a, 
``reasonable belief'' that a product is harmful to public 
health before they can inspect a farmer's production records.
    As you know, I have had serious concerns about the FDA 
coming on the farm. That has been a battle cry that many of us 
have had in North Carolina in our concerns, as well as 
nationwide, about the FDA coming onto the farm.
    Would you please elaborate on what your concerns are about 
the FDA coming on the farm, and this specific provision that 
would remove that requirement?
    Mr. Wooten. Well, obviously those of us in North Carolina, 
we are working, particularly tobacco producers, are working 
with FDA on FDA coming on the farm dealing with tobacco, as 
well you know, Congressman McIntyre.
    We just think that this bill says explicitly that FDA can 
come on the farm. There is explicit record-keeping. We have 
just got real concerns about a Federal bureaucracy that can 
come to any farm in North Carolina or another state without a 
reasonable reason for being there.
    Mr. McIntyre. Let me ask you this. I know our time is 
limited.
    Last summer, the FDA falsely advised consumers against 
consuming raw tomatoes--all of us in this room will probably 
remember that--when tomatoes were never part of the food safety 
incident in question.
    Could you elaborate on this situation and the hardship it 
caused producers? And would you support some type of indemnity 
initiative for producers who have been negatively impacted by 
mistaken determinations by the FDA?
    Mr. Wooten. No question about it, that was a terrible 
thing. It caused terrible financial hardship on many producers 
not only in our state, but around the country. And myself, as 
well as American Farm Bureau, we have in policy to support 
indemnification back to producers where agencies of 
government--whether it be FDA, CDC or whatever other agency of 
government--makes erroneous accusations that hurt farmers, that 
there needs to be an indemnification program there.
    Mr. McIntyre. Thank you.
    Mr. Maravell, in order to comply with the new food safety 
rules, producers such as you would have to keep significant 
records on production and handling practices that must be 
available to FDA inspectors on demand. We know that failure to 
produce accurate records may result in serious monetary fines, 
even if those record-keeping errors do not directly endanger 
food safety at all.
    As a producer, are you concerned about your ability to 
comply with these potential regulations and civil penalties?
    Mr. Maravell. Yes, I am. Let me just state that as an 
organic producer, we already have a close relationship with the 
USDA program. And I don't want to overstate this, but after one 
of my inspections, because we are inspected annually, one of my 
employees said, ``You don't really need a farm to be certified, 
all you if need is a file cabinet.'' Because we have--and I 
have multiple file cabinets; we have tremendous documentation.
    If documentation on my production practices were to have an 
inadvertent mistake, I am not subject to a fine unless it 
produces an adverse effect and I violated the law somehow--I 
mean, if I put something in the wrong file, put the wrong 
number on something, if there is no harm.
    So let me just say that, yes, I am very concerned about 
this. And I am also concerned about not understanding what 
aspects--because I run a diversified operation, I don't know 
what aspects of my program are going to be subject to the new 
provisions in this bill. And so I am a little concerned that 
FDA comes in and requires information on demand, and I may not 
have it in the format that they want it, because I have the 
information, but I have it fed into a different program. And my 
program has a very good safety record.
    And I don't know--as the Chairman was referring to--I have 
grain storage facilities, I have feed grinding facilities. Does 
that automatically put me under new types of record-keeping? I 
already provide all that information to my certifier. My 
certifier is already accredited by USDA under the organic 
program.
    So, yes, I am very concerned. I spend a lot of time putting 
all of this information together.
    I would like to make one point about that, however. This is 
a voluntary program. I don't have to be an organic farmer. I 
choose to be an organic farmer, and so I am willing to make 
that extra effort to be in an organic program. And it is a 
program that is a public-private partnership. It is a program 
where we have private certifiers, as well as my certifier 
happens to be public, the Maryland Department of Agriculture, 
working together with the Federal Government. And our record-
keeping responsibilities are appropriate to the size, scale, 
and scope of operation and the type of production methods that 
we use. So I feel comfortable with the record-keeping that I am 
currently engaged in.
    If I have to do this all over again, I feel very 
uncomfortable, because I feel as if I already have the 
information, I just don't have it the way they want it, or I 
can't get it fast enough or something like that.
    Mr. McIntyre. Thank you.
    Thank you, Mr. Chairman.
    The Chairman [presiding.] I thank the gentleman.
    The gentleman from Texas, Mr. Neugebauer.
    Mr. Neugebauer. Thank you.
    One of the things, as I looked at the proposed legislation 
and listened to the testimony that we had today, it occurs to 
me that even in this bill everything is looking back. In other 
words, it is based on, if an event happens, we can go and 
identify where that source was, and that then, hopefully, we 
mitigate something after it has happened.
    The question I have is, if we implement this legislation as 
it is, how significant of an increase in food safety are we 
actually going to have in relation to the cost? And when I talk 
about cost, I am not trying to put a value on anybody's life. I 
mean, anytime we lose anybody for any reason it is a tragedy.
    But what I wonder is, sometimes in government we try to 
throw a bunch of government at a problem, and what we find in 
the end is, we just threw a bunch of government at the problem 
and we really didn't basically improve what we were actually 
trying to accomplish.
    Everyone in the food business or in the agriculture 
business has a huge vested interest in getting this right. And 
as I heard--and I appreciate Mr. Goodlatte asking that 
question--how many of you supported this bill. But, the most 
important question I have today is, is this bill going to make 
a significant difference, or do we--are we still not where we 
need to be? Do we need to take more time if we are going to 
have a comprehensive food safety program in this country--have 
more hearings and make sure that we are actually addressing the 
problems where they are? Because in any system there are 
sometimes gaps.
    And so the best policy to me is filling the gaps, not just 
throwing another blanket over the problem.
    So just in the remaining time, just kind of to get a 
feedback, does this bill do it or do we need more study and 
more work to make sure we are filling the gaps?
    Mr. Wooten?
    Ms. Tucker-Foreman. Is that to me, sir? I didn't know if 
you were addressing that to me.
    Mr. Neugebauer. To the panel. Anybody who wants to jump in.
    Mr. Boyle. I will take a shot at a response, not so much 
specifically about the bill, but about your overarching concern 
and question: Do the government standards really result in a 
demonstrable improvement in public health? And in terms of two 
of the strictest standards with which my members deal, E. coli 
and Listeria, there has been some demonstrable improvement in 
foodborne illness data associated with those two pathogenic 
bacteria.
    We also have invested a lot of money on reducing the 
incidence of Salmonella in our beef, pork and chicken products 
and turkey products. There have been significant reductions 
over the last 10 years, Congressman, between 60 and 70 percent 
in each one of those product categories. Yet, the incidence of 
illness associated with Salmonella has increased about 14 
percent over the last 8 years.
    So we have reduced the presence in our products, but yet we 
haven't had a positive impact, a positive public health impact. 
And that is a legitimate area of inquiry for the Congress and 
for the regulators.
    You impose costs, but you have to be able to demonstrate 
benefits, too. And that is a concern that we have in the 
industry.
    It is also an area where we could make better regulatory 
and legislative decisions if we had more specific food 
attribution data from the CDC. They can estimate how many 
Salmonella illnesses occur a year, but they can't tell you 
which food products are associated with those numbers of 
illnesses. Therefore, you can't target your resources to the 
products that are causing the incidence of those illnesses.
    Mr. Maravell. Congressman, as a farmer, everybody knows the 
saying, ``If it ain't broke, don't fix it.'' I guess my feeling 
and my reaction in reading this bill is that if there are 
science-based and identified high-risk areas, we should 
investigate how to go after those and solve those.
    My concern is that, in 30 years, I have never--as an 
organic producer, I have never had a food safety issue arise. 
Food safety is always on my mind. And as a small operator, I am 
responsible for the growing, the harvesting, the slaughter, the 
packaging, the processing, and the marketing. If I detect 
anything in that which I feel is faulty from a food safety 
perspective, I can make the decision like that to change it. I 
don't need to go through a corporate committee or an outside 
consulting study. You know, I can effect it and do it right 
away.
    And I probably shouldn't say this, but I am probably more 
concerned about food safety than most of my customers are. I 
have to constantly--I have personal contact with my customers, 
and I must say that you need to always remind your customers of 
proper food handling characteristics. And we do things that go 
beyond what we would be required to do, because if there ever 
were a food safety issue, the customer isn't going to be 
wondering what they did, they are going to be wondering what I 
did. And so that is why we have to be extra vigilant.
    But getting back to your question, if there is legitimate 
scientifically-based areas, or problem identified in certain 
production practices, then we should definitely investigate 
those areas and go after those areas.
    In my case, I am not aware of any in the types of products 
that I produce; and so I feel that this is a broad-brush 
approach, where we should be focusing mainly on those areas 
where we can get the biggest bang for the increased expenditure 
of funds and increasing the authority of the FDA.
    Mr. Reinhard. I would just like to reiterate that the 
National Turkey Federation, as Mr. Boyle said and others have 
said, really does believe in the principles of preventive-based 
food safety systems. And certainly when you are looking at 
where you are going to put resources, how you are going to go 
about dealing with those issues that occur, preventive is where 
everyone wants us to be. And to drive consumer confidence, it 
is most important that the preventive-based methods be what we 
focus on.
    Anything after product is produced is after the fact. And 
it didn't really achieve what is the desire of everyone in this 
room.
    Mr. Wooten. At American Farm Bureau, we have looked at all 
these bills dealing with food safety; and our preference to 
this one would be the Putnam-Costa bill, H.R. 1332, because it 
engages the industry in helping figure out more of these 
solutions.
    The Chairman. I thank the gentleman.
    The gentleman from Iowa, the Subcommittee Chairman, Mr. 
Boswell.
    Mr. Boswell. Thank you, Mr. Chairman, and thank you for 
having this hearing today. And thank the panel. You have given 
great testimony; and it is important to us.
    To save time, I would like to associate my remarks, Mr. 
Chairman, to what you have said and Mr. Goodlatte. I certainly 
feel the same. I would like to point that out, before I ask--I 
will have one question.
    But last Monday I appeared before the Rules Committee to 
deal with some of these issues. Antibiotics was the issue of 
the day; and I want to say now, so it is in this record, that 
there weren't others invited that had the opportunity to 
represent farmers and ranchers and us.
    And so I would like to ask, Mr. Chairman, to have the 
testimony I gave there, in the interests of time, be entered 
into our record here today.
    The Chairman. Without objection, so ordered.
    Mr. Boswell. Thank you very much. I appreciate that.
    [The information refered to is located on p. 133.]
    Mr. Boswell. And I just want to say that the discussion we 
have just had--and I think Mr. Maravell made a good comment--
applies to all farmers and ranchers. We do not want to have 
unsafe food. It is just as simple as that.
    We are stewards of that. We take it seriously. And I think 
every one of you would agree with that, and everybody that is 
familiar with what goes on out on the farm or the ranch knows 
that is a true statement. We do not want to send bad product 
down the road. If we see something going on, we do something 
about it.
    And we don't want to waste money either. So, as Mr. Cardoza 
said, who is a Member of the Committee--I am glad he was there 
that day--that we are kind of tight-fisted when it comes to 
spending money we don't need to spend. And on the antibiotic 
issue, for example, we wouldn't do that if we didn't think it 
was safe.
    And we have science. We got into the discussion about the 
Denmark situation--you will see that when you read the record--
and the science there and the science here. Let's just talk 
about the science as we talk about other areas.
    Maybe we ought to talk about energy or global climate 
change. Who do you want to represent? I happen to think there 
is global warming going on, and there is science to prove it. 
Then you go over here, and there are scientists brought forward 
that say, ``No, I don't think that is the case.''
    Well, we have to have a lot of confidence in having an 
excellent Secretary of Agriculture--and I've known him 
personally for years and years--and a Department that is ready 
to deal with this. And we have that. And we must do all we can, 
working together, to be sure that these kinds of issues are 
handled by the people that have the hands-on, the know-how, the 
staff, the experience, the presentation made here this morning; 
and it is something that is very, very important to us.
    I do have one question. I will direct this, if I could, to 
Ms. Tucker-Foreman. FSIS is mandated by law to have equivalent 
standards with foreign countries for imports for beef, pork, 
and chicken. Fact?
    Ms. Tucker-Foreman. Absolutely.
    Mr. Boswell. Why shouldn't the same standard apply to 
seafood?
    Ms. Tucker-Foreman. I couldn't agree with you more. We 
think that the USDA system, which requires equivalency before a 
country can send their products to the United States, is an 
appropriate protection for American consumers.
    We supported your efforts last year to move catfish 
inspection to FSIS simply because FDA didn't have the resources 
and wasn't applying any resources to enforcing it; and we got 
continuous inspection for catfish.
    Now the problem, sir, is that USDA began, before we had 
huge amounts of international trade, and instituted this system 
of prior certification. FDA had no such system. You now have 
food coming in here from 100 countries. I think--I am trying to 
remember, and I just can't, the number of foreign plants that 
export to the U.S. And you can't go back at this point and say 
that they have to stop exporting to the U.S. until they can go 
back and be certified.
    So we think there has to be some system that starts from 
the point where we are that is not totally disruptive of trade, 
but does a hell of a lot better job of protecting Americans 
from unsafe imported food than we are having right now. Eighty-
four percent of our seafood is imported, and there have been 
serious questions raised about the contamination with 
pesticides and other chemicals.
    And we join you in any support you can give for that.
    Mr. Boswell. Thank you.
    Because of the clock, I just want to make--if I could, Mr. 
Chairman--one more comment.
    I doubt--maybe there is, but I doubt there is anybody in 
the room that has spent more time in Vietnam than I have--a 
couple years to start with, and I was all over that country 
because I was flying helicopters.
    In my second tour, I was in the delta. And it is not to 
brag, I could probably take you to any major city in Vietnam 
without a map or navigation aid. I have seen the country.
    I went back in December, as you know, you just mentioned, 
and Mr. Goodlatte was along, and we went down just to have a 
look. And what has caused me to want to make a comment about 
this is what was in the CongressDaily today.
    And people took exception. We don't want to start a trade 
war, of course not, but we want safe food. We want safe food. 
And we made comments--I made comments, their processing looked 
pretty good, providing I don't know about the quality of the 
water going through that processor, but it looked pretty good.
    But the spawning and their growing places for those fish we 
are talking about is putrid. I don't know what else to say. So 
let's not have a trade war. Let's not worry about that. Let's 
invite them to come and see how we do it. And maybe they would 
like to invite our people to come over and see in detail how 
they do it. That wouldn't be a bad idea. And maybe that would 
be a good place to start.
    But this statement from the other side of the rotunda about 
this, I think maybe they ought to go have a look and see what 
they think.
    But I see no controls, no regulation of what is going into 
those waters where those fish are spawned and raised. I think 
it is something that we ought to be responsible to do. You 
know, let's do it in a delicate way if we can, but I don't 
think we should be ignoring it.
    And I wanted that to be part of our record today.
    Thank you, Mr. Chairman.
    The Chairman. I thank the gentleman and thank him for his 
leadership and tenacity on these issues.
    The gentleman from Texas, Mr. Conaway.
    Mr. Conaway. Mr. Chairman, the gentleman from Kansas has 
already yielded me time.
    The Chairman. He yielded it to you?
    Mr. Conaway. He did. He was out of order.
    The Chairman. I am finding more problems with my new 
system.
    Mr. Conaway. Exactly.
    The Chairman. Mr. Fortenberry.
    Mr. Conaway. I will yield to Mr. Fortenberry.
    Mr. Fortenberry. So I get 10 minutes?
    The Chairman. No.
    We have a series of seven votes coming up. I will announce 
at this point, we will continue as soon as those votes are over 
with. And I might as well say at this point as well, too, that 
we purposely put--we reversed the order, which is, I guess, 
something you are not supposed to do, to put the Administration 
witnesses after this panel so that the Members could have the 
input from these folks and would set us up better to ask 
questions of the Administration.
    So that is kind of why we did what we did.
    So Mr. Fortenberry?
    Mr. Fortenberry. All right. Thank you, Mr. Chairman.
    Mr. Boyle, thank you for your insightful comments about how 
any new framework for addressing the essential issue as to how 
we improve food safety has to look at how that framework 
actually produces that benefit. I thought that was particularly 
insightful.
    But I would like to turn my attention to you, Mr. Maravell. 
You have a degree and background in urban studies and you are 
now a farmer?
    Mr. Maravell. That is correct. Yes, I am a boy from New 
York that went astray.
    Mr. Fortenberry. Well, I congratulate you. Clearly, your 
choice in life is an indication of what I think is a new 
movement in society, and the way in which you are conducting 
your operation as well.
    And I thought you were very insightful, in addition to the 
other comments, with this particular framework of your 
language. You said these approaches--talking about farmers 
markets, buying local, as well as community-supported 
agriculture--represent innovations and alternatives to the 
mainstream food chain. At the core, they have already 
implemented transparency and connection between the producer 
and the final consumer. As long as they provide safe food, 
these approaches should be given incentives, not barriers.
    I think, again, one of the growing opportunities in 
agriculture is related to this broader philosophical movement 
of a desire for a reconnection with the land between the urban 
and the rural, between the family and the farm. And to the 
degree that that actually is an assist in improving food 
safety, it should be looked at through another paradigm, 
perhaps.
    We oftentimes follow into a logical, sequential decision-
making process here, where if you have a problem with food 
safety, you tighten up the existing structure rather than 
reexamine the paradigm. I think you are doing that, along with 
a number of other people in their desire to clearly understand 
where their food is coming from and to have a role not just in 
consuming it, but being a part of its growth and processing.
    So, with that said, I am getting a number of people who 
have expressed concerns that this particular bill is going to 
adversely impact--and you have laid out some specific ways, 
such as the fee being necessarily unfair, the added burden of 
record-keeping--but also the lack of clarity of jurisdiction, 
who is defining what. I think those are important points to 
make. And, it is important that we ensure, as this particular 
bill goes forward, that we are not detracting from this new 
growth area of farming for entrepreneurs and innovators who are 
bringing new types of food production--which are really old 
food production methodologies--back into the mainstream of 
consumer products.
    So is that a fair summary of what you suggested? The fee, 
the record-keeping, added burden of record-keeping, as well as 
the jurisdictional questions that remain as to what you are 
going to actually have to do with the variety of platforms of 
food that you grow?
    People are writing, and they are concerned that they are 
growing their own food, is this going to impact them? ``I am an 
organic producer, how is this going to impact me? Is this going 
to basically shut down--because of increased barriers, again--
this new entrepreneurial option that is growing because of 
consumer demand out there?''
    Mr. Maravell. Let me comment on that a little bit.
    People often ask me, where are the new farmers going to 
come from, because the average age of the farmer is getting 
older in America. And I tell them they are going to come from 
the cities. And I am an example of that, but also I see that 
happening all the time, people transitioning from the cities 
into agriculture on the urban fringe.
    Last weekend I had a lot of customers show up, and what we 
try to do is, we try to talk to each customer about what we do, 
how we do it, and understand what their concerns are. We get a 
tremendous reception, because the customers very rarely have an 
opportunity to talk to the owner or the producer of the food 
that they eat. And they have a lot of questions. They can't 
figure all of this stuff out. And indeed, some of them are 
saying, Well, have you seen on the Internet--and there is a lot 
of misinformation going on on the Internet--that Congress is 
going to make it so you can't produce organic food anymore and 
things like this?
    There are some legitimate concerns about being able to 
communicate effectively with the consumer to say that, yes, we 
are going to encourage multiple models for delivering food to 
the American public. And that diversity will ultimately build 
the strength of our food system and make our food system more 
secure.
    And as long as the efforts of this bill can continue along 
those lines, recognizing the diversity of our agriculture and 
the diversity of models for delivering our food to our people, 
and not provide barriers so that people will say--I don't want 
to go far afield here, but people thinking about entering into 
the profession of agriculture who are currently perhaps, like I 
was, a city boy, way back when--don't feel that the barriers 
are insurmountable.
    I am now considering adding additional enterprises to my 
operation to make it more diverse. The first thing I come up 
against are regulatory barriers. I don't have knowledge 
barriers, I don't have production-based barriers. I have a 
customer base that would support my going into new enterprises.
    They are already buying my products. They buy other types 
of products I produce. And the first thing I run into--and it 
is not just food safety; I am going to run into planning and 
zoning, I am going to run into farmland preservation. I mean, I 
have to consult with so many different places just because I 
would want to start a small dairy herd, for example, or I would 
want to put some of my grains into a baked product.
    Mr. Fortenberry. I am about to run out of time, so I am 
going to cut you off. Thank you for your insights. Thank you 
for your work.
    I think, again, as we look at how to strengthen 
opportunities and widen the horizons, for not only new 
producers that are coming in, but alternative delivery 
systems--you are on the leading edge of that--that forms 
another chapter of our very important overall agricultural 
production system.
    So that is one end of it, ensuring that--and we certainly 
want to clamp down rumors that people aren't going to be able 
to grow organically, but at the same time ensure that this bill 
is not putting up artificial barriers to what is already 
achieving, at least to the degree that we can know it, safe 
delivery of a food system. And along with the other comments 
that were made, particularly by Mr. Boyle, if we implement 
something new, make sure that the implementation actually 
corresponds with the benefits.
    So thank you all.
    Thank you, Mr. Chairman.
    The Chairman. I thank the gentleman.
    And we are going to recess for these votes. My guess is we 
will be back about 12:30. So we will recess the Committee until 
the end of the series of votes.
    [Recess.]
    Mr. Costa [presiding.] The House Agriculture Committee will 
now return to order after our recess.
    I hope those of you have had an opportunity to get some 
lunch. We had a series of seven votes; and, absent any 
procedural votes, we should be able to finish this panel and 
then move to the second panel.
    I have a list of Members here who I will follow the order 
based upon when they arrive, and some Members may not be able 
to return because of other committee hearings or other 
scheduled meetings. But the Chairman asked me to begin the 
hearing again, and we will do that. I know my Republican 
colleagues will join us soon, those that can make it.
    But let me make a couple observations here. Chairman 
Peterson and I have been working, along with Members of this 
Committee, on food safety issues for, in a number of cases, 
many, many years. Comprehensive food safety policy is job 
number one as it relates to farmers, ranchers, and dairymen and 
the panoply of agriculture in America.
    As I am fond of saying, common sense tells you that farmers 
are, first and foremost, consumers. They eat the food they 
grow, as do their families and their neighbors. Second, they 
have an economic interest in the event that there is an issue 
on food safety regarding pathogens that impact the food line in 
which illness or more horrific deaths may result.
    So when that happens, clearly, it is something that we all 
ought to guard against to ensure that we produce the safest 
food in the world. And, obviously, anytime there are illnesses 
as a result of food contamination, as we witnessed in the 
situation with the peanut butter earlier, the market is 
devastated. It is impacted.
    Let me talk about the issues that are of most concern, that 
Chairman Peterson and I and others have been talking about with 
members of this panel. Certainly the Energy and Commerce 
Committee with Chairmen Waxman and Dingell are offering to 
continue to work with us, and we thank them for their efforts 
to reach out, because there are overlapping issues that both 
Committees have in concern.
    The Food Safety Enhancement Act that has been introduced, I 
believe, makes several important steps in the right direction. 
But I do think I speak for many other Members of this Committee 
on a bipartisan level that there are concerns. There are 
concerns about the legislation that has come from the Energy 
and Commerce Committee.
    It is a fact that the United States Department of 
Agriculture has more knowledge and experience on on-farm 
practices than does the Food and Drug Administration. I don't 
believe it is contrary to the mission of the FDA--the 
Department that is in contradiction with efforts they focus on 
food production and processing and packing, critical steps on 
the food chain, that they are contrary to ensuring an important 
role in maintaining the safety of that food.
    I know my constituents, in what is one of the most robust 
agricultural regions in the country, producing over half the 
nation's fruits and vegetables, want to ensure that safety is 
job number one. They are playing an active role in continuing 
to raise the bar to ensure that that food safety happens in 
terms of production, distribution patterns, traceability, all 
the critical issues that are important in ensuring and 
improving food safety in America.
    We noticed last year, last summer, to take as an example, 
the tomato industry as proof that the Food and Drug 
Administration can make mistakes. Far-reaching provisions like 
the emergency recall that is in this current legislation, 
without due process, I find troubling.
    I think the bill also contains provisions that deal with 
geographic quarantines, which is an authority that already the 
United States Department of Agriculture has for animals, which 
in some instances is duplicative for products that don't--are 
impacted when the Food and Drug Administration gives recall 
authority or administrative detention.
    There are not provisions in the current legislation that 
require or shore up accountability for the FDA should they make 
another error, as occurred in the tomato example last July. So 
while there are a number of important provisions, we need to 
work together and Chairman Dingell and Chairman Peterson have 
spoken about reaching out to one another in that effort.
    Fees are another critical question. How do you provide 
fees? There is an appropriate role to ensure that we do our 
part, whether it be specialty crops or others, but we know that 
the Food and Drug Administration's budget is short and, because 
of the budget issues, fees that can be adjusted yearly without 
any sort of accountability I find troubling, especially for 
small farms.
    There are other issues, including trade, finished product 
testing, and others which I think need to be addressed in this 
legislation.
    Finally, I think we can all agree that, at the end of the 
day, we want to try to improve food safety in America. We want 
to deal with qualitative analysis that ensures that American 
food and fiber is the best it can be when we look at the world 
markets that we compete in. We want to ensure that the 
partnership that exists between American farmers and ranchers 
and dairymen, the partnership that exists between them and 
consumers is improved. Because, at the end of the day, of 
course, the consumers are the people that we produce the food 
and fiber for.
    The qualitative analysis is critical here as we weigh the 
issues of risk assessment and risk management, and we will be 
working with Chairman Dingell and Members of the Energy and 
Commerce Committee to try to iron out these differences that I 
wanted to highlight here this afternoon.
    With that said, I want to begin on the list here as I see 
the Members who are next in line based upon the time that they 
came in here.
    Mr. Boswell, you have asked to yield your 5 minutes to Mr. 
Kissell?
    Mr. Boswell. Yes.
    Mr. Costa. Mr. Kissell.
    Mr. Kissell. Thank you, Mr. Chairman.
    Seniority tends to work a little quicker when there are 
maybe a few chairs empty.
    Mr. Costa. Take advantage of it.
    Mr. Kissell. I appreciate the panel staying here through 
our votes.
    Our special guests today, Robin and Jeff and Mr. Almer and 
our guests from Chicago, whose name I did not get written down, 
thank you all for being here today; and we especially think of 
you as we go through this process, because this is the ultimate 
example of what can happen and what we are here today for.
    Once again, my thanks to the panel. I especially want to 
thank Mr. Wooten for being here today. Being from North 
Carolina myself, I want to associate myself with what Mr. 
McIntyre said earlier about the great job that you do for us in 
North Carolina. Mr. Wooten, we think in North Carolina that we 
have a food safety program that is as good as anybody's in the 
nation and is recognized nationally and internationally. I am 
wondering just what thoughts might you have about what we do 
right in North Carolina, that you would want to share with the 
panel and the Committee, that we ought to take into 
consideration as we look at this legislation.
    Mr. Wooten. Well, thank you, Congressman Kissell; and we 
must be doing some things right.
    I saw yesterday that the head of the Food and Drug Division 
of North Carolina, Mr. Reardon, offered his resignation and is 
coming to Washington to work with FDA. So, apparently, that 
news was announced yesterday.
    But, you have to realize for it to be a good working 
relationship it has got to be a partnership that one--as I said 
earlier in my testimony, we think FDA may have some oversight, 
but it needs to be in conjunction and cooperation with those 
state agencies. And I know that is already in the bill, those 
state agencies that have jurisdiction, that are close to the 
ground.
    Where we have had problems in the states, whether it be 
North Carolina or other states, the local folks are on the 
ground first. And I think, where appropriate, to be effective 
you have to engage the private sector working with state 
agencies and Federal agencies to get to the bottom of the 
problem as quickly as you can for the benefit of the consumers 
out there and the producers. For farmers, this is devastating. 
When these type of things happen, it is devastating to those 
producers, financially and otherwise. So it is important that 
we get on it quickly.
    Mr. Kissell. And, Mr. Wooten, also, in North Carolina we 
have the opportunity for the occasional hurricane or tropical 
storm, that it creates a situation where the different agencies 
have to work together. And what do you think we can learn from 
that in terms of being able to respond to an emergency in terms 
of a problem with our food system?
    Mr. Wooten. Well, I think you have to have almost an 
emergency response team similar to, as you said, what happens 
when you have natural disasters. Any problem with the food 
supply in the country is certainly a disaster. It certainly 
calls for a national concern. And, we are going to have to have 
that emergency response mentality to get on it, involving all 
agencies.
    Mr. Kissell. One last question. And, once again--I 
appreciate all the panel, and I know all my questions have gone 
to Mr. Wooten, but, once again, I am very proud of what has 
taken place in North Carolina. But last year when we had 
problems in North Carolina, along with so many other people, 
the tomatoes and peppers, I believe, what was the impact on our 
farmers and what do you think needs to be a way that, when 
farmers have a situation that crops are pulled, what 
compensation should they get?
    Mr. Wooten. Well, as I said, we believe, and I said in the 
testimony, we believe that an indemnification program--when 
mistakes are made by agencies of government, whether it is FDA, 
CDC, whatever agency of government, that farmers need to be 
indemnified for the losses when those mistakes are made.
    Mr. Kissell. Once again, thank you, panel. Thank you, Mr. 
Chairman. I yield back my time.
    Mr. Costa. I thank the gentleman.
    I have a number of questions.
    First, to the panel, and you need not opine if you don't 
have some quick examples to provide us. But I think it is 
important, as I said in my opening comments, to understand 
where there are duplicative functions that exist in food safety 
legislation and that are being proposed in the legislation. 
Because, given the importance to improve food safety, I don't 
think anyone should--I would think that no one would believe 
that we want to have duplicative efforts as it relates to food 
safety.
    Anyone care to comment?
    Ms. Tucker-Foreman. Mr. Costa, under existing law, FDA is 
the only agency that has responsibility for the safety of 
commodities raised on the farm. USDA has a number of agencies 
that are involved with those commodities, but they are service 
agencies. I am sure you are going to hear that from the 
Agricultural Marketing Service. Their purpose is not safety. It 
is what the title of the agency says, ``Marketing.''
    Sometimes they come together, and it is very important for 
AMS and FDA to be cooperative. And if I could give you an 
example that is old, but I think it is still good. When I was 
at USDA, they had a problem of sulfur residues in hogs, and it 
was being picked up by the meat inspectors, and people were 
being penalized for it. Farmers couldn't bring their hogs to 
the slaughterhouse for a period of time after that happened.
    And farmers were saying, but we followed the rules. We 
withdrew when we were supposed, to and we worked with--in this 
case APHIS, FDA, and FSIS got together; and FSIS has no on-farm 
authority. FDA knew if they went on the farm, it would be 
viewed as they were looking for a violation of the law. So we 
got together with APHIS and got them to go and try to find out 
why this was happening.
    Mr. Costa. But, Ms. Tucker-Foreman, you would say that 
either today in existing law with the Federal law, or in 
conjunction or cooperation with state law as in California as 
in the proposed legislation, there are no duplicative efforts 
that either exist or could be created as a result of this 
legislation?
    Ms. Tucker-Foreman. Agricultural Marketing Service------
    Mr. Costa. I am not talking about the Marketing Service. 
You made that statement. That is clear.
    We have food safety as it relates to herbicides, 
pesticides. We have food safety as required by monitoring with 
USDA inspectors and meat plants. That has nothing to do with--
----
    Ms. Tucker-Foreman. I thought I was specific to crop 
commodities. The FSIS has no on-farm authority. FSIS's 
authority begins at the slaughterhouse door. It has no on-farm 
capacity at all.
    Mr. Costa. But I am taking the interpretation of my 
question, being to go beyond on-farm.
    Ms. Tucker-Foreman. I am sorry. I thought you were 
specifically asking about on-farm authorities, Mr. Costa. I may 
have misunderstood your question.
    Mr. Costa. I was talking about in terms of the full gamut 
of our efforts to provide food safety.
    Ms. Tucker-Foreman. I think there is not a lot of overlap 
now. There is very little with FDA and FSIS, and they have 
worked cooperatively for years together. So I don't know that 
this law creates a problem there. I can't find it in this 
proposed law.
    Mr. Maravell. Congressman Costa, this is Nick Maravell. I 
am an organic producer, and I look at the registration and 
information reporting requirements in this bill, and I provide 
all of that information both to state agencies and to my 
certifier, which is the Maryland Department of Agriculture, 
which is certified by the U.S. Department of Agriculture or 
accredited by the U.S. Department of Agriculture.
    So the location of my facility--because I do on-farm 
processing, the location of my production areas, the exact 
types of crops that I produce, the exact types of animals that 
I produce, all my emergency contact information, a complete--I 
maintain a complete list of all of my customers with their 
addresses and telephone numbers in case there is a problem in 
terms of having to do a recall.
    All of this information I keep, some of which I have to 
submit to my state agencies or to my organic certification, my 
certifier. So I am keeping maybe not in the exact format that 
this bill might require in terms of electronic, although some 
of mine is in electronic form, but it may not meet the 
compatibility with the Federal system. So I maintain all of 
this information and a lot more information because of my 
organic certification.
    I pay a fee also for my organic certification as well, and 
this information that I submit is submitted annually. I am 
inspected annually.
    Mr. Costa. Bottom line?
    Mr. Maravell. The bottom line is that I would have to find 
out what the new formats were from FDA and to provide yet an 
additional report and additional fees for information that I am 
already submitting. That is my opinion. And that is with regard 
to the registration area. I am not sure if you have specific 
other areas that you are also referring to, Congressman.
    Mr. Costa. Ms. Tucker-Foreman, I want to move on, but go 
ahead.
    Ms. Tucker-Foreman. I will pass and let you go. Thank you.
    Mr. Costa. Dr. Ives and Mr. Reinhard, in your testimony you 
talked about the concern of livestock being defined as food and 
that the bills that have been proposed were meant to exempt 
livestock as food. Can you explain why that is needed and what 
the pending legislation--what areas that you have concerns on 
in terms of why it is needed and why the pending legislation 
doesn't go far enough, as it relates to those issues you 
outlined in your testimony?
    Dr. Ives. I will speak for NCBA. With regard to the 
definition of food, we feel very firmly that livestock are not 
food until the point they get to the packing plant, and that by 
not having that further defined that would give the FDA 
potential ability to come on the farm and potentially place 
regulations on-farm that right now would be duplicative of what 
is going on right now with USDA.
    Mr. Reinhard. Related to livestock specifically for Federal 
inspection under the meat or poultry act, it does read that 
they are exempted by the existing bill that came out of Energy 
and Commerce. The concern is how that is interpreted and how 
that language should go. Because at some point in time 
determination has to be made when that product is turned into a 
food to fall under the Federal Meat Inspection Act or the 
Poultry Products Inspection Act. So Congress being able to 
strengthen that and to deal with the other part that my 
colleagues have testified on the fruits and vegetables and that 
side of the business where the bill does specifically talk 
about on-farm could be improved.
    Mr. Costa. Thank you.
    Mr. Wooten, I mentioned earlier about the problems last 
year associated with the efforts when the FDA, I think, falsely 
advised consumers against consuming raw tomatoes when they were 
never actually a part of the food safety in question. I am 
wondering if you could talk about the hardships that has caused 
producers, and if one should consider some sort of an 
indemnification effort when there are false claims such as that 
that have obviously been a mistake that was made.
    Mr. Wooten. Yes, sir. As I said earlier, there were 
millions of dollars lost by producers in this effort. We have 
some farmers--I know one farmer who is still paying back a loan 
today that he incurred because he couldn't sell his tomatoes. 
So it just devastated many producers not only in the State of 
North Carolina but around the country.
    As I said earlier, we at American Farm Bureau and our 
organizations all across the country very much believe that an 
indemnification program is needed as we consider this 
legislation, in terms of mistakes that are made by government 
agencies that wrongly cause financial hardship on producers.
    Mr. Costa. Mr. Boswell, for questions or comments.
    Mr. Boswell. Thank you, Mr. Chairman.
    Just a couple of things to wrap up for me to Ms. Tucker-
Foreman.
    Again, all of you, thank you. I am sorry we had that long 
interruption there, but we don't really control that.
    Do you think that the FDA has the data necessary to rate 
products based on risk?
    Ms. Tucker-Foreman. I just want to be sure I understood. Do 
I think FDA today has the data------
    Mr. Boswell. The data necessary to do this.
    Ms. Tucker-Foreman. Not completely, no. And the legislation 
directs them to do studies to determine what pathogens are the 
greatest risk and to also assess food products.
    Mr. Boswell. Thank you.
    And just to move on then, Dr Ives------
    Mr. McDonald. Mr. Chairman, may I answer on that as well?
    Mr. Costa. You may.
    Mr. McDonald. I agree completely with what was just said. 
And specifically for us, as we have seen in the last few years, 
it seems that the category for establishing risks--categorizing 
it is based on outbreaks.
    And I would just like to give an example of a customer call 
that I had recently regarding onions up in Canada related to an 
outbreak in a small chain up there. And this customer called 
and said, oh, I see that onions were implicated; so now that is 
a risk item, correct? And I said, well, not necessarily. If we 
go by the kind of method that FDA has used, then yes. But we 
are just going to keep adding to a list. The list will just 
keep growing with any subsequent outbreak, and that is not 
necessarily what risk is about as far as categorizing it.
    What we really want to do and what I answered to my 
customer, I said, what we want to look at is that not onions 
are the risk but maybe certain practices associated with that 
product. I think, at this point, FDA does not have that 
information or enough of it.
    Thank you.
    Mr. Boswell. Thank you.
    Dr. Ives, a question, if FDA considers livestock as food, 
what impact would H.R. 2749 have on cattle and ranching 
operations, in your opinion?
    Dr. Ives. Well, it is difficult to say, because it depends 
on what regulations would come down from their ability to then 
regulate what we do. Currently, we have both APHIS as well as 
the state agencies that regulate the movement of cattle across 
the United States. It is not so much of an issue within state 
but of course the international--we do get a lot of Mexican-
origin steers as well as Canadian cattle, and we are just 
concerned that there is going to be an abundance of regulation 
that could come down from their ability to regulate.
    Mr. Boswell. Thank you, Mr. Chairman. I yield back.
    Mr. Costa. Before I dismiss this panel and begin with the 
second panel, I want to focus in on something that in the years 
that I have served in the California State Legislature, and now 
in Congress, that I always think is the crucible, the bottom 
line, in terms of ensuring that we have the highest food 
efficacy and safety standards that science and technology will 
allow us to have. In that discussion, obviously, the science 
and the technology today is different than it was 30 years ago 
or 50 years ago, and it all comes down to, in my view, the 
issue between risk assessment and risk management.
    And, Ms. Tucker-Foreman, with your experience and 
background, let me ask you first a question. When we are 
measuring risk assessment versus risk management, when we are 
trying to do a qualitative analysis in terms of what government 
can do, whether it be at a Federal or state level, in terms of 
the dollars available, the best bang for the buck to minimize 
risk for the best safety standards we can achieve, I think 
there is a threshold question here. Do you think it is possible 
to achieve zero risk?
    Ms. Tucker-Foreman. Absolutely not.
    Mr. Costa. Do you think that there is a perception 
oftentimes out there that somehow, just as we would wake up in 
the morning and get into our car and go to work or travel 
wherever, that there is some risk associated with that 
exercise?
    Ms. Tucker-Foreman. I should--I do. I should qualify my 
statement. I think there are some foods where, in fact, there 
should be a zero risk. I think all of us understand that------
    Mr. Costa. What foods may they be?
    Ms. Tucker-Foreman. Foods that have been cooked to a 
temperature that kills the pathogens in them and not been 
exposed to situations where they could get into the food after 
that.
    Mr. Costa. I think that is a good example. I am glad you 
raised that.
    Where does the responsibility then lie if, in fact, the 
consumer is made aware that the food has to be cooked to a 
certain level to eliminate those pathogens?
    You know, I tend to like my beef medium rare, pink and 
juicy. Maybe that is borderline as it relates to the pathogens. 
But just as a person would get into a car, if they operate that 
car in a way that they are driving it too fast, or they are 
driving it recklessly or they are driving it under the 
influence, great harm can result in what would be the ill-
advised practices of operating that vehicle just as cooking the 
food that you just described, would it not?
    Ms. Tucker-Foreman. Let me respond first by saying I heard 
the phrase several times this morning ``we have the safest food 
in the world,'' and I think that we take pride in this country 
in having a safe food supply.
    With regard to meat and poultry products, I think there is 
a very high standard there, because every item of meat and 
poultry comes to you with an endorsement that says USDA 
inspected and approved. It is the only product I know that says 
to you your government has checked this for safety. They don't 
check every car for safety before it goes out. And so, there is 
a very high standard with regard to meat and poultry products 
because they carry that seal, and I think USDA------
    Mr. Costa. But whose responsibility is it--getting back to 
the point, though, if the consumer is made aware that they need 
to cook that food at a certain temperature for a certain length 
of time and they don't follow those--I mean, is that any 
different than a person that gets in a car and drives 120 miles 
an hour?
    Ms. Tucker-Foreman. It is because the law says that USDA 
shall not affix the seal of inspection to an unsafe product and 
that product------
    Mr. Costa. But it depends how the product is operated. If a 
person drives a vehicle at 120 miles an hour in an urban 
setting, and the vehicles are inspected, and there are laws 
that say you shouldn't drive faster than 35 or 60 or whatever--
----
    Ms. Tucker-Foreman. I hope there is a policeman there to 
catch them, which is why we have inspectors.
    Mr. Costa. Right. I agree. But who is responsible? The 
person operating the car, the person cooking the food, or the 
person that produced the food, or the person that manufactured 
the car?
    Ms. Tucker-Foreman. I think, under the meat inspection law, 
the food is not supposed to be contaminated with E. coli 
O157:H7, even if it is a raw product.
    Now, for most pathogens, Salmonella, for example, USDA 
doesn't set a standard in a raw product. For E. coli, there is.
    But this is not going to be a very fruitful conversation. 
Let me suggest that my organization for a long time has been 
active in something called Partnership for Food Safety 
Education. We think it is important that all consumers practice 
self-defense, and we urge people to cook their meat not until 
it is no longer pink but until their ground beef is 160 
degrees. So just as a matter of self-protection, you need to 
cook your food and handle it carefully.
    Mr. Costa. You are probably correct. We may have to agree 
to disagree on this point.
    Ms. Tucker-Foreman. I think so.
    Mr. Costa. But I thank you for your response.
    I want to thank all of the members for their response. You 
have been patient. I hope you did get a lunch during our vote 
break. If you didn't, you can get one now, unless you would 
like to sit around and hear the second panel.
    So we will take your testimony. Members may have further 
questions that they would like to ask of this panel. We will 
ask the Members to submit the questions as expeditiously as 
possible, and there are 10 days in which panel members will 
have to respond to questions posed by Members of the Committee, 
and of course that will be part of the record. So thank you for 
your patience and your testimony.
    Let us begin with the next panel. All right, if we can 
remove those folks and please find your seats so we can begin 
with the second panel.
    We have Mr. Jerold Mande, Deputy Under Secretary for Food 
and Safety with the United States Department of Agriculture.
    In addition to that, we have Ms. Cindy Smith, acting Under 
Secretary for Marketing and Regulatory Programs with the United 
States Department of Agriculture. It is my understanding that 
Ms. Smith will be available for questions and that she will not 
present testimony.
    And then we will have Mr. Taylor, Senior Advisor to the 
Commissioner for the U.S. Food and Drug Administration, who 
will opine on behalf of the FDA.
    So we will have two of our panel members out of the three 
who will make their 5 minute presentations at this time.
    Mr. Mande, can we please begin with you.

           STATEMENT OF JEROLD R. MANDE, DEPUTY UNDER
   SECRETARY FOR FOOD SAFETY; AND CINDY SMITH, ACTING UNDER 
      SECRETARY FOR MARKETING AND REGULATORY PROGRAMS AND 
     ADMINISTRATOR, APHIS, U.S. DEPARTMENT OF AGRICULTURE, 
                        WASHINGTON, D.C.

    Mr. Mande. Mr. Costa, Mr. Goodlatte, Members of the 
Committee, thank you for inviting me to appear before you today 
as you review current issues in food safety. Food safety is an 
important topic, and we welcome your interest.
    My name is Jerold Mande, and I am the new Deputy Under 
Secretary for Food Safety at USDA. With me is Cindy Smith, 
USDA's acting Under Secretary for Marketing and Regulatory 
Programs, who will be available to answer any questions you 
might have on USDA's current activities and authorities on the 
farm.
    Since this is my first time before your Committee, I want 
to briefly introduce myself. My career has been devoted to 
public service and public health. Before coming to USDA, I 
worked in positions affecting public health and food safety 
policy at Yale University School of Medicine, the White House, 
the U.S. Department of Labor, Food and Drug Administration, and 
the U.S. Congress.
    This really is an important time for food safety. I am 
proud to be joining the team at USDA and to be responsible for 
the Food Safety and Inspection Service, which is the public 
health-focused inspection agency in the Department.
    President Barack Obama, Agriculture Secretary Tom Vilsack, 
and Health and Human Services Secretary Kathleen Sebelius have 
made food safety reform a top priority; and they are to be 
commended for taking on this difficult and challenging issue. 
Members of this Committee have also demonstrated their 
dedication to improving the food safety system. I think that we 
all agree that we need the tools in place to achieve a virtual, 
single food safety system through cooperation and 
collaboration, and we cannot let this unique window of 
opportunity pass us by.
    Just last week, the President's Food Safety Working Group 
released its Key Findings, which identified three core 
principles: first is prioritizing prevention; second, 
strengthening surveillance and enforcement; and third, 
improving response and recovery. The Key Findings highlight 
steps that USDA and FDA will take in the near future to improve 
food safety by preventing Salmonella, E. coli O157:H7, and 
building a national traceback and response system.
    Let me tell you what we will be doing at USDA. The most 
important conclusion reached by the Working Group is the 
critical importance of prevention.
    FSIS is moving aggressively to implement sensible measures 
designed to prevent outbreaks of foodborne illness. FSIS will 
develop or update performance standards to reduce the 
prevalence of Salmonella and Campylobacter in turkeys and young 
chickens. Performance standards demonstrate the plant's process 
control by measuring the presence of the pathogen in product. 
By revising current performance standards and setting new ones, 
FSIS will ensure food safety improvements in the products it 
regulates.
    By the end of July, we will also take steps to further 
combat E. coli O157:H7 in beef. For example, FSIS will provide 
our inspection program personnel with streamlined, consolidated 
instructions to inspect, sample, and act to reduce E. coli 
O157:H7 in beef. At the same time, we will begin sampling of a 
new beef component, one not previously sampled. That component 
called ``bench trim'' is comprised of pieces left over from 
steaks and other cuts that are then used to make ground beef.
    These actions to combat E. coli O157:H7 build on a series 
of previous steps FSIS has taken to ensure our meat is safe. We 
have started with the most common beef cuts that are used to 
make ground beef and added additional cuts step by step when 
the evidence supported it. We will continue to do that.
    We have carefully reviewed the current food safety bills 
before Congress. In particular, we have studied H.R. 2749, the 
Food Safety Enhancement Act, which I recognize is of great 
interest to this Committee. We have concluded that this bill 
will not change FSIS's and FDA's current food safety 
jurisdictions. I know that has been a key concern of yours, so 
let me state that again: H.R. 2749 would not, in our opinion, 
alter the current jurisdictions of FDA or FSIS.
    The President's Working Group also examined the laws that 
are the foundation of our system. We need 21st century laws to 
run a 21st century food safety system. With this in mind, USDA 
will be seeking to modernize its food safety statutes to 
address emerging threats to the food supply, new scientific 
understanding of those threats, and new technologies to combat 
those threats.
    We seek the support and help of this Committee to find ways 
to modernize our current laws. We are developing concepts 
stemming from the legislative principles of the Working Group 
on priorities that we think should be addressed to modernize 
the statutes for the 21st century. I look forward to meeting 
with each of you in the near future to discuss our ideas.
    My USDA colleagues and I are committed to on all-out effort 
to stop foodborne pathogens from reaching grocery store shelves 
and the dinner tables of American families. An effective food 
safety system is critical for all Americans, from farmers to 
processors to consumers.
    Mr. Costa, Mr. Goodlatte, and Members of this Committee, I 
want to thank you for allowing me the opportunity to be here to 
discuss current food safety system enhancements; and I look 
forward to your questions.
    [The prepared statement of Mr. Mande follows:]

Prepared Statement of Jerold R. Mande, Deputy Under Secretary for Food 
        Safety, U.S. Department of Agriculture, Washington, D.C.

    Chairman Peterson, Ranking Member Lucas, and Members of the 
Committee, thank you for inviting me to appear before you today at this 
hearing to review the current issues in food safety.
    First of all, I would like to introduce myself to the Committee. My 
name is Jerold Mande, and I am the new Deputy Under Secretary for Food 
Safety at USDA as of last week. Before coming to USDA, I was the 
Associate Director for Public Policy at the Yale Cancer Center, where I 
developed a national model to increase support for cancer prevention 
and control, including diet, exercise, and obesity. Prior to Yale, I 
served on the White House staff as a health policy adviser specializing 
in key food safety, tobacco control, and cancer initiatives. Among the 
food safety initiatives were the expansion of FoodNet and PulseNet. I 
was also Deputy Assistant Secretary for Occupational Health at the U.S. 
Department of Labor, and I was Senior Advisor and Executive Assistant 
to the Commissioner of the Food and Drug Administration (FDA), where I 
led the design of the Nutrition Facts food label. I began my career 
right here in Congress where I was first hired to work on food safety 
legislation. Having the opportunity to serve as Deputy Under Secretary 
for Food Safety returns me to the topic that originally attracted me to 
public service and I continue to remain passionate about food safety 
issues. I look forward to working with the Committee in the coming 
months and years.
    Food safety is a priority for this Administration and the USDA's 
Food Safety and Inspection Service (FSIS). I commend President Barack 
Obama and Secretary Tom Vilsack for taking on this difficult issue and 
making review of the current state of our food safety system a top 
priority. I also appreciate this Committee's work to support FSIS and 
to explore ways to improve the nation's food safety system.
    I would like to begin my testimony today with a description of the 
mission and a brief overview of FSIS and then I will move on to discuss 
the President's Food Safety Working Group and the important 
recommendations it has proposed to improve food safety.

Mission and Overview of FSIS
    FSIS is the public health-focused inspection agency within the U.S. 
Department of Agriculture. It is responsible for ensuring that the 
nation's commercial supply of meat, poultry, and processed egg products 
is safe, secure, wholesome, and accurately labeled and packaged, 
whether those products are domestic or imported. We administer and 
enforce the Federal Meat Inspection Act, the Poultry Products 
Inspection Act, the Egg Products Inspection Act, portions of the 
Agricultural Marketing Act, the Humane Methods of Slaughter Act, and 
the regulations that implement these laws.

FSIS Workforce
    Our statutes require us to be present for all slaughter operations 
and to inspect each carcass, and we inspect each processing 
establishment at least once per shift. Inspection program personnel 
perform approximately nine million food safety and 1.5 million food 
defense verification procedures annually at these plants. In Fiscal 
Year (FY) 2008, FSIS personnel inspected about 50 billion pounds of 
livestock carcasses, about 59 billion pounds of poultry carcasses, and 
about 4.3 billion pounds of processed egg products. Additionally, FSIS 
personnel inspected 3.3 billion pounds of imported meat and poultry 
products at our borders.
    In addition to in-plant personnel in federally-inspected 
establishments, FSIS employs a number of other field personnel, such as 
laboratory technicians and investigators. Program investigators conduct 
surveillance, investigations, and other activities at food warehouses, 
distribution centers, retail stores, and other businesses operating in 
commerce that store, handle, distribute, transport, and sell meat, 
poultry, and processed egg products to the consuming public. These in-
commerce businesses do not operate under grants of inspection and are 
not inspected on a daily basis by FSIS. However, the agency verifies 
that FSIS-regulated products moving in consumer distribution channels 
continue to be safe and wholesome.
    All products that FSIS inspection program personnel find to be not 
adulterated receive the USDA mark of inspection. This is one of our 
most powerful tools in protecting the public health. Denying the mark 
of inspection means that the product cannot legally be shipped in 
commerce and sold to the consuming public.

Data-Driven Science-Based Policies
    Since 2000, FSIS has required that all meat and poultry plants 
operate under the Hazard Analysis and Critical Control Point (HACCP) 
system. Under HACCP, plants are responsible for identifying the hazards 
presented by the products they produce and the processes they 
implement, and for determining how to prevent, eliminate, or control 
the occurrence of those hazards. Our responsibility is to verify that 
plants are following their own food safety or HACCP plans. The HACCP 
system is designed to both prevent problems from occurring and 
facilitate the rapid identification and correction of problems before 
they occur.
    In late 2001, FSIS began to employ food safety assessments (FSAs), 
further strengthening the public health protection provided by FSIS' 
program. These FSAs, carried out by highly trained scientific 
personnel, thoroughly assess the design of the plant's food safety 
plan, looking closely at whether the establishment has fully assessed 
the relevant hazards, and they verify that the establishment has put in 
place controls or preventive measures that are effective. These 
intensive reviews, now done on a routine basis, are valuable not only 
for what they accomplish but also because they provide data that the 
agency analyzes and uses to determine whether changes or refinements in 
agency policy are necessary. FSIS has committed to conducting routine 
FSAs in every plant every 4 years, and more frequently as needed.
    Our policies at FSIS are rooted in science and based on data. 
Through science-based initiatives and efforts to continue to strengthen 
our infrastructure, FSIS works to prevent adulterated food from 
reaching the consumer. In 2008, FSIS personnel tested about 21,300 
ready-to-eat product and environmental samples using risk-based 
criteria for Listeria monocytogenes and approximately 49,000 raw 
product samples for E. coli O157:H7 in ground beef and Salmonella in 
raw meat and poultry.

Recalls
    Recalls are the last weapon that FSIS uses to combat foodborne 
illness and protect public health. The purpose of a recall is to remove 
meat or poultry from commerce as quickly as possible when FSIS has 
reason to believe it is adulterated or misbranded. The agency issues 
information about a recall as quickly as possible to the public, 
stakeholders and public health partners through press releases which 
are also posted on FSIS' website at www.fsis.usda.gov. FSIS also posts 
lists of retail stores that received product if the product presents a 
significant (Class I) public health risk.

Imports
    Finally, FSIS ensures the safety of imported meat, poultry, and 
processed egg products through a three-part approach. First, FSIS 
establishes the initial equivalence of the meat, poultry, or processed 
egg inspection system of a country that wishes to export to the United 
States. Equivalence is the foundation for FSIS' system of import 
safety. Second, we verify continuing equivalence of the foreign system 
through annual audits. Finally, FSIS import inspectors perform re-
inspection of all shipments of meat, poultry, and processed egg 
products at the border, including statistically-based random sampling 
that is intended to verify the effectiveness of the foreign inspection 
system.
    The country-to-country approach to food safety that FSIS applies is 
an efficient and effective means to ensure the safety of the products 
that FSIS regulates and illustrates that our trading partners' 
governments have appropriately invested in and exercised control of 
their food safety infrastructure. The equivalence principle recognizes 
that an exporting country can employ different sanitary measures than 
the U.S. to address food safety hazards if the country can objectively 
demonstrate that its safety measures achieve the same level of public 
health protection as the measures used by the United States for its 
meat, poultry, and processed egg products.

Food Safety Working Group
    The Obama Administration has already begun to act on food safety. 
President Obama announced the formation of the Food Safety Working 
Group in March and called on Agriculture Secretary Vilsack and Health 
and Human Services Secretary Kathleen Sebelius to co-chair the Working 
Group. While FSIS and FDA have a major role in the Working Group, input 
from other agencies and stakeholders is critically important. At a 
Listening Session hosted by the White House on May 13, representatives 
from industry, consumer advocacy groups, state governmental agencies, 
and even members of your own staffs participated in breakout sessions 
to discuss important food safety priorities. The members of the Working 
Group value all the comments heard that day and are dedicated to 
bringing all stakeholders into the picture. The public can post their 
comments on the interactive website, www.foodsafetyworkinggroup.gov. 
Summaries of the Listening Day breakout sessions are also available on 
the same website.
    Just last week, the Key Findings of the Working Group, which 
incorporated some of the comments from the Listening Day, was released 
and identified three core principles: (1) prioritizing prevention; (2) 
strengthening surveillance and enforcement; and (3) improving response 
and recovery. The Key Findings highlights steps that FSIS, FDA, and 
other Federal agencies will take in the near future to improve food 
safety by preventing Salmonella contamination, reducing the threat of 
E. coli O157:H7, and building a national traceback and response system.

Focus on Prevention
    The most important conclusion reached by the Working Group is the 
critical importance of prevention. Too often in the past, the food 
safety system has focused on reacting to problems rather than 
preventing them from occurring. The Working Group recommends a shift to 
prioritizing prevention and moving aggressively to implement sensible 
measures designed to prevent outbreaks of foodborne illness.
    FSIS fully supports the Working Group's recommendation to focus on 
preventing foodborne illnesses from occurring. In fact, FSIS has 
already begun moving in the direction of prevention by increasing its 
focus on risk. As stated previously, the agency has already implemented 
HACCP for meat and poultry products. In addition, FSIS has used 
performance standards for some foodborne pathogens to reduce the 
occurrence of those pathogens in meat and poultry products. The agency 
is conducting baseline studies that will provide the data necessary to 
establish new and up-dated performance standards for the foods that 
FSIS regulates.
    FSIS will continue to develop and implement other preventative 
measures. The Key Findings highlighted two recommendations that will 
work to prevent the prevalence of two common foodborne pathogens in 
meat and poultry products. FSIS is moving forward to implement these 
recommendations. First, FSIS will develop a performance standard for 
use in reducing the prevalence of Salmonella in turkeys and will revise 
the current Salmonella performance standard for young chickens. In 
addition, FSIS will develop performance standards for Campylobacter for 
both turkeys and young chickens. Performance standards demonstrate the 
plant's process control by measuring the presence of the pathogen in 
product. By revising current performance standards and setting new 
ones, FSIS will ensure food safety improvements in the products it 
regulates. The agency will also enhance its Salmonella verification 
program with the goal of having 90 percent of poultry establishments 
meeting the new standards by the end of 2010. FSIS will also provide 
our inspection program personnel with streamlined, consolidated 
instructions to inspect, sample, and act to reduce E. coli O157:H7 in 
beef. At the same time, we will begin sampling of a beef component not 
previously sampled. That component, called ``bench trim,'' are the 
pieces left over from steaks and other cuts that are then used to make 
ground beef. These actions build on a series of previous steps FSIS has 
taken to ensure our meat is safe. We have started with the most common 
beef cuts that are used to make ground beef, and added additional cuts 
step-by-step when the evidence supports it. We will continue to do 
that.

Strengthening Surveillance and Enforcement and Improving Response and 
        Recovery
    FSIS is just as committed to the other two core principles 
identified by the Working Group. The agency will be implementing 
regulatory and administrative actions over the next 2 years to 
strengthen its surveillance, inspection, and enforcement activities and 
to improve outbreak response and recovery such as enhancing the 
national surveillance networks for foodborne diseases like FoodNet and 
PulseNet and improving coordination and communication with food safety 
and public health partners in an outbreak.
    To strengthen its surveillance through inspection, FSIS has been 
working on a number of actions related to data integration and 
analysis. The most significant initiative is the development of a 
Public Health Information System (PHIS), which will integrate the 
agency's data systems to allow FSIS to quickly and accurately identify 
trends, including vulnerabilities in establishments' food safety 
systems, and thus allow us to more efficiently and effectively protect 
public health. It will be a truly remarkable new tool that will 
revolutionize how our inspection program personnel work by dramatically 
increasing the value of their observations in the field.
    The Key Findings identified the following other recommendations for 
FSIS. First, within 3 months, FSIS will work with other Federal 
agencies to create a new incident command system to address outbreaks 
of foodborne illness. This approach will link all relevant agencies, as 
well as state and local governments, more effectively, facilitating 
communication and decision-making in an emergency. Second, FSIS, FDA, 
and the Centers for Disease Control & Prevention will work with state 
and local agencies to update their emergency operations procedures to 
be consistent with the new ``Guidelines for Foodborne Disease Outbreak 
Response'' to be issued by the Council to Improve Foodborne Outbreak 
Response this month. Implementation of these guidelines will lead to 
quicker response, better communication, and better coordination by all 
Federal, state, and local agencies. Third, FSIS will improve 
collaboration with states by increasing the capacity of its successful 
public health epidemiology liaison program to state public health 
departments and expanding outreach within 6 to twelve months. Finally, 
the website www.foodsafety.gov will be enhanced to better communicate 
information to the public and include an improved individual alert 
system allowing consumers to receive food safety information, such as 
notification of recalls. Agencies will also use social media to expand 
public communications. The first stage of this process will be 
completed in 90 days.

Modernizing Food Safety Laws
    The Working Group was charged with examining the whole picture of 
the U.S. food safety system and emphasizes the need to upgrade our food 
safety laws for the 21st century. The current system is hamstrung by 
outdated laws, some of which were enacted over 50 years ago. While the 
meat and poultry acts have been amended many times, they do not allow 
us to address the significant risks facing our food supply as 
effectively and efficiently as possible. These laws should be 
modernized to allow for improved flexibility and coordination and to 
enable USDA to move quickly to address the emerging threats to the food 
supply.
    We seek the support and commitment of this Committee to find ways 
to modernize the current laws. We are developing concepts, stemming 
from the legislative principles of the Working Group, on priorities we 
think should be addressed to modernize our statutes for the 21st 
century. I look forward to meeting with you in the near future to 
discuss our ideas. There are currently bills before Congress to address 
FDA's authorities, such as H.R. 2749, the Food Safety Enhancement Act 
of 2009, but we must also modernize FSIS' statutory authorities to 
create a national food safety system. There are many valuable 
provisions in H.R. 2749 and we would like to see similar legislation 
for FSIS. There has been unprecedented cooperation and collaboration 
between USDA and HHS on the Food Safety Working Group.
    In the future, once Congress passes a bill and it is enacted into 
law, the cooperation and collaboration will continue as FSIS will work 
closely with Congress and FDA to implement the new legislation. We 
think that this modernization will be facilitated if we gather ideas 
from the public and our workforce through listening sessions and other 
means. For example, this hearing, as well as the one held by the 
Subcommittee on Livestock, Dairy, and Poultry in April, is very useful 
to gauge the input from Congress.
    Not only will the modernization of FSIS' authorizing statutes 
improve public health outcomes, but, in conjunction with modernization 
of the Federal Food, Drug, and Cosmetic Act, it will be an opportunity 
to better coordinate food safety laws and regulations across the 
Federal Government.

Next Steps
    Mr. Chairman and Members of the Committee, I am proud to be joining 
the team at USDA and to have the opportunity to oversee the Food Safety 
and Inspection Service. It is an exciting time for food safety in this 
country. President Barack Obama, Secretary Tom Vilsack, and Secretary 
Kathleen Sebelius have clearly expressed a willingness to tackle food 
safety, and they are to be commended again for taking on this difficult 
and challenging issue. Members of Congress have also demonstrated their 
dedication to improving the food safety system. We cannot let this 
window of opportunity pass us by.
    High profile outbreaks in everything from FSIS-inspected ground 
beef to FDA-inspected peanut products and cookie dough cause American 
consumers to lose confidence in the safety of their food supply. For 
its part, FSIS is ready to continue this dialogue and will remain 
committed to improving its preventative public health infrastructure in 
an all out effort to stop foodborne pathogens from reaching grocery 
store shelves and the dinner tables of American families.
    Chairman Peterson, Ranking Member Lucas, and Members of the 
Committee, thank you again for allowing me the opportunity to be here 
today to discuss our current food safety system and future 
enhancements. I look forward to your questions.

    Mr. Costa. Thank you, and we look forward to asking the 
questions.
    Next is Mr. Taylor, Senior Advisor to the Commissioner of 
the U.S. Department of Food and Drug Administration.
    Mr. Taylor.

  STATEMENT OF MICHAEL R. TAYLOR, J.D., SENIOR ADVISOR TO THE 
                COMMISSIONER, U.S. FOOD AND DRUG
   ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, 
                         ROCKVILLE, MD

    Mr. Taylor. Good afternoon, Mr. Costa, Mr. Goodlatte. I am 
Mike Taylor, Senior Advisor to the Commissioner at the Food and 
Drug Administration; and I want to thank you for the chance to 
be here and particularly to join my colleagues at USDA.
    Just last week, I started work as Senior Advisor to the 
Commissioner. It really is an exciting time to be back at the 
Food and Drug Administration, where I happened to work twice 
before in my career. I look forward especially this time to 
working closely with USDA and all of our food safety partners, 
especially Congress, as we move forward to modernize the 
nation's food safety system.
    As you know, I also had the honor from 1994 to 1996 to 
serve as Administrator of the USDA's Food Safety and Inspection 
Service and to appear before this Committee in that capacity, 
so it is a pleasure to be back before you as well.
    Mr. Chairman, I greatly value my experience at USDA, both 
because of the opportunity that I had then to work with the 
dedicated people at FSIS on important improvements in the 
inspection program, but also because of what I learned about 
how the major elements of the nation's food safety system work 
together. There is, in fact, a long history of collaboration 
between FDA and various components of USDA to manage and 
prevent food safety problems, and both agencies, in fact, have 
a long history of working with the agricultural sector.
    I am especially delighted to be coming back into government 
at a time when the President, as Mr. Mande indicated, has not 
only made food safety a high priority, but has called for even 
greater collaboration among the food safety agencies. We at FDA 
embrace that charge enthusiastically, because we know that the 
vision of a modern, science-based and prevention-oriented food 
safety system simply demands that we all work together.
    As you also know, FDA is the Federal agency that is 
responsible for most of the food supply except for the meat, 
poultry, and processed egg products, which are overseen by our 
partners at USDA. Ensuring the safety of FDA-regulated products 
is really central. It is a vital part of FDA's public health 
mission; and, importantly, our work on such topics as animal 
drug approvals, animal drug residues, and animal feed supports 
USDA's mission in turn in ensuring the safety of meat, poultry, 
and processed egg products.
    As Mr. Mande indicated, the President's Food Safety Working 
Group recently issued its Key Findings, which we at FDA of 
course embrace fully and Mr. Mande has outlined: prioritizing 
prevention, strengthening surveillance and enforcement, and 
improving response and recovery.
    The Working Group noted the need to modernize the food 
safety statutes to provide key tools that both FDA and USDA 
need to keep food safe. At FDA, the new statutory tools that we 
need, broadly speaking, include enhanced ability to require 
science-based preventive controls for food safety at food 
facilities; enhanced ability to establish and enforce 
performance standards that ensure the proper implementation of 
preventive controls; better tools to foster compliance with 
science-based standards, including enhanced inspection and 
access to basic food safety records; and, finally, new tools to 
strengthen FDA's ability to oversee food imports.
    H.R. 2749, the bill we are focusing on today, addresses all 
of these authorities. But I also note, Mr. Costa, the bill that 
you introduced with many of your colleagues on this Committee, 
H.R. 1332, the Safe Food Enforcement, Assessment, Standards, 
and Targeting Act of 2009, also addresses many of these points, 
as does the bill introduced by Chairwoman Rosa DeLauro of the 
Appropriations Subcommittee that oversees the budgets of our 
two agencies. These bills are really important to note because 
they illustrate the broad agreement that exists today on the 
general direction of food safety reform toward risk-based 
preventive controls to reduce foodborne illness, which is a 
public health goal that, as evident from this hearing today, we 
all share. That is a common objective for all of us.
    Now, for FDA, one of the most important elements of the 
legislation that is before the Congress that has come out of 
Energy and Commerce is that it provides a mandate for FDA to 
achieve specified frequencies of inspection. The legislation 
also provides a funding source to help FDA fulfill its new 
responsibilities. A greater investment in inspection is 
critical to ensuring high rates of compliance with preventive 
control standards and other food safety performance standards 
that will help drive improvement in food safety and drive 
reduced rates of foodborne illness. FDA thus supports the 
bill's inspection frequencies for domestic facilities.
    However, food imports present a significant resource 
challenge. FDA plans to increase inspection of foreign food 
facilities, but we are concerned that the bill's foreign 
inspection mandate may not result in the best use of FDA's 
resources in light of the approximately 200,000 registered 
foreign facilities, and the high cost of overseas inspections.
    We believe we can achieve cost-effective oversight of 
imports by working with foreign governments, increasing 
targeted risk-based foreign inspections by FDA, strengthening 
importer accountability for the safety of the food they import, 
and supporting strong third-party inspections. We think it will 
take a mix of these initiatives to provide the oversight of 
imports that we need.
    Before closing my oral statement, I just want to say that I 
look forward to the discussion that we started earlier in this 
hearing, and I hope we will continue now with the scope and the 
impact of this legislation on the farm. I think that is an 
important discussion to have, and I hope that we can allay some 
of the concerns that I have heard expressed about the scope and 
impact of the bill.
    There are three points that I will just touch on briefly 
and we can hopefully go into a little bit more.
    First of all, there is nothing new about FDA's presence on 
the farm. We have already mentioned FDA's role with animal 
drugs, animal feed regulated by FDA, feed additives, and 
produce. FDA has a long history of being present on farms with 
respect to produce and shell egg safety. Most recently, FDA 
issued a new rule to address shell egg safety.
    The second point is that there is a history of 
collaboration with USDA with respect to on-farm matters in 
cooperation with the agriculture sector in ways that have 
yielded real benefit, both for food safety, for public health, 
and for the agricultural sector. And we could talk about the 
collaboration between FDA, APHIS, and FSIS on BSE control and 
prevention, which has been a real success story that has been 
very collaborative; the whole issue of animal drug and tissue 
residues, which again FDA set certain standards. FSIS inspects. 
We investigate when there are problems. There is a very 
cooperative relationship that has ensured high compliance with 
the standards to limit animal drug residues in meat and poultry 
products.
    I could go on. Dairy regulation--I mentioned eggs--there 
are a number of examples of this sort of cooperation; most 
recently, produce. With good agricultural practice and 
guidance, we will be coming out with some more of those soon.
    The final point that I just want to flag and I know you 
will want to probe is that the bill that, as it has emerged 
through the process so far, has actually done a very good job 
of being very judicious about the way the bill would reach the 
farm.
    First of all, farms continue to be exempted from the 
registration requirement and the requirements that come with 
that including the fee concern I heard expressed earlier. Farms 
are exempt from registration and from the fee. That applies 
only to facilities as defined in the Act. Farmers are exempted 
from the comprehensive preventive control requirement that 
applies to all food facilities. That does not apply to farms.
    Those authorities that FDA would be given to address food 
safety problems that do arise on the farms, such as potentially 
with produce, are authorities that require FDA to meet a 
certain risk threshold to do rule making, to devise anything 
but one-size-fits-all controls that really address the 
particular hazard. I think that is very much in keeping with 
the science-based approach that FDA believes is important for 
food safety.
    There are other ways in which the authorities that FDA has 
to pursue traceability, to potentially require record-keeping, 
these all require not only that FDA meet some test of its being 
risk-based, really serving a food safety purpose, but will 
require FDA to consult with USDA, which we would do anyway, and 
would require us to engage the community through rule-making.
    So, we have a bill here that has gone a long way towards 
addressing some of the concerns here, and I look forward to 
further discussion of that. Thank you.
    [The prepared statement of Mr. Taylor follows:]

  Prepared Statement of Michael R. Taylor, J.D., Senior Advisor to the
 Commissioner, U.S. Food and Drug Administration, Department of Health 
                   and Human Services, Rockville, MD

Introduction
    Good morning, Chairman Peterson and Members of the Committee. I am 
Mike Taylor, Senior Advisor to the Commissioner, at the Food and Drug 
Administration (FDA or the agency), which is part of the Department of 
Health and Human Services (HHS). Thank you for the opportunity to 
appear before you today to review current issues in food safety, 
especially pending food safety legislation. I am pleased to be here 
with my colleagues at the U.S. Department of Agriculture (USDA).
    Last week I was appointed as a Senior Advisor to the Commissioner 
of Food and Drugs. I am happy to be back at FDA to continue my work in 
the food safety arena. When I served as FDA's Deputy Commissioner for 
Policy from 1991 to 1994, I was involved in the issuance of regulations 
to address seafood safety and to implement nutrition labeling 
requirements. From 1994 to 1996, I served at USDA as the Administrator 
of the Food Safety and Inspection Service and as Acting Under Secretary 
for Food Safety. While at USDA, I led the development of new safety 
requirements for meat and poultry. Since 2000, my food safety work has 
been in the academic and research arenas. It is an exciting time to be 
back at FDA, and I look forward to working closely with USDA and all of 
our food safety partners, including Congress, as we move forward to 
modernize the nation's food safety system.
    By way of background, FDA is the Federal agency that is responsible 
for most of the food supply except for meat, poultry, and processed egg 
products, which are overseen by our partners at USDA. Ensuring that 
FDA-regulated products are safe and secure is a vital part of FDA's 
mission, and FDA's work on animal drug approvals, animal drug residues, 
animal feed, and other issues also supports USDA's vital food safety 
responsibilities with respect to meat, poultry, and processed egg 
products.
    Food safety is a core public health issue. Every year, millions of 
our friends and neighbors in the United States suffer from foodborne 
illness, hundreds of thousands are hospitalized, and thousands die. 
Public health has been defined by the Institute of Medicine as 
``fulfilling society's interest in assuring the conditions in which 
people can be healthy.'' A precondition for health is having access to 
safe food.
    President Obama has made a personal commitment to improving food 
safety. On July 7, 2009, the Food Safety Working Group, which he 
established, issued its key findings on how to upgrade the food safety 
system for the 21st century. The Working Group recommends a new public-
health focused approach to food safety based on three core principles: 
prioritizing prevention, strengthening surveillance and enforcement, 
and improving response and recovery.
    The Working Group noted the need to modernize the food safety 
statutes to provide key tools for FDA, the Food Safety and Inspection 
Service at USDA, and other components of the Federal Government to keep 
food safe. Some of the necessary legislative authorities highlighted in 
the findings include:

   the ability to require sanitation and preventive controls at 
        food facilities, based on a scientific hazard analysis;

   the ability to access basic food safety records at 
        facilities;

   the ability to use resources flexibly to target food at the 
        highest risk and achieve the maximum gain for public health;

   the ability to establish performance standards to measure 
        the implementation of proper food safety procedures; and

   the ability to require mandatory recalls.

    A food safety bill recently passed by the Committee on Energy and 
Commerce in the House of Representatives, H.R. 2749, the ``Food Safety 
Enhancement Act of 2009,'' addresses all of the above authorities and 
includes many of the other key recommendations of the Working Group. 
This legislation's primary sponsors include Chairman Henry Waxman of 
the Committee on Energy and Commerce, Chairman Emeritus John Dingell, 
Chairman Frank Pallone of the Health Subcommittee, and Chairman Bart 
Stupak of the Subcommittee on Oversight and Investigations.
    Another comprehensive food safety bill is H.R. 1332, the ``Safe 
Food Enforcement, Assessment, Standards, and Targeting Act of 2009'' or 
``SAFE FEAST Act.'' Its sponsors include many Members of this 
Committee, including Representative Jim Costa, Chairman Collin 
Peterson, and Subcommittee Chairmen Dennis Cardoza, Leonard Boswell, 
Joe Baca, and David Scott, as well as other Members. H.R. 1332 also 
includes many of the authorities identified as important by the Working 
Group, such as preventive controls and mandatory recall authority.
    The Chairwoman of the House Appropriations Committee's Subcommittee 
on Agriculture, Rural Development, FDA and Related Agencies, 
Representative Rosa DeLauro, also has introduced legislation, H.R. 875, 
the ``Food Safety Modernization Act of 2009,'' which provides 
comprehensive reform to the food safety statutes.
    These bills illustrate that there is broad agreement on the general 
direction of food safety reform toward an improvement of risk-based 
preventive controls to reduce foodborne illness, a public health goal 
we all share. These legislative initiatives share the core principles 
identified by the Working Group: prioritizing prevention, strengthening 
surveillance and enforcement, and improving response and recovery.
    A coalition of consumer groups is fighting for improvements in the 
food safety system so that more families do not have to suffer tragic 
consequences from foodborne disease. Major sectors in the food industry 
also support and are advocating for fundamental change.
    But even with the President's support . . . even with the full 
efforts of HHS and USDA and other Federal, state, local, tribal, and 
territorial food safety partners . . . and even with the backing of 
consumer groups and industry, our efforts will fall short unless 
Congress modernizes food safety laws to deal with the challenges of the 
21st century.

Food Safety Legislation
    From FDA's perspective, there are three key questions to ask about 
food safety legislation:

   First, does the legislation support a new system focused on 
        prevention?

   Second, does the legislation provide FDA the legal tools 
        necessary to match its existing and new food safety 
        responsibilities?

   Third, does the legislation provide or anticipate resources 
        for the agency to match its responsibilities?

    As H.R. 2749 was recently passed by the Committee on Energy and 
Commerce, I will focus on that bill for a discussion of these 
questions. I will address each of these three questions in turn and 
highlight a few of the many important new authorities in this bill.

    Does the legislation support a new food safety system focused on 
prevention?

    The legislation would indeed transform our nation's approach to 
food safety from responding to outbreaks to preventing them. It would 
do so by requiring and then holding companies accountable for 
understanding the risks to the food supply under their control and then 
implementing effective measures to prevent contamination.
    FDA is eager to further the development of this modern system. 
Working with USDA, industry, consumers, states, localities, and other 
key partners, we will establish basic standards for preventive 
controls. We will then join with states and localities to create an 
integrated national system of inspection, verification, and 
enforcement.
    Key relevant provisions in the legislation include section 102, 
which requires facilities to conduct hazard analyses and implement 
preventive controls. It also requires companies to have a comprehensive 
food safety plan. Section 104 requires adherence to science-based 
safety standards issued by the Secretary for fresh produce and certain 
other raw agricultural commodities to prevent contamination. Section 
112 improves FDA's ability to share key information on food safety 
between levels of government. These, and other provisions, are critical 
to modernizing our nation's food safety system.

    Does the legislation provide FDA the legal tools necessary to match 
its existing and new responsibilities?

    In a new food safety system, FDA has the fundamental responsibility 
of overseeing and verifying the implementation of preventive measures 
by hundreds of thousands of companies. The agency also retains the 
existing critical role of protecting the public during an outbreak. FDA 
needs new legal authorities to be able to succeed in these roles and 
protect the public health. This legislation would provide these 
critical tools.
    The legislation recognizes the importance of modernizing FDA's 
efforts to protect the safety of the food supply. Under sections 102, 
103, and 104, the failure to comply with preventive controls, the food 
safety plan requirement, performance standards, or safety standards for 
produce would result in the food being deemed adulterated. An 
adulterated food is subject to seizure, condemnation, and forfeiture, 
and also may be refused admission when offered for import into the 
United States. Section 132 makes the agency's administrative detention 
authority more useful by expanding the circumstances under which the 
agency can detain a food, thereby preventing its movement or 
distribution while the agency takes appropriate regulatory action. 
Section 134 increases the criminal penalties for certain ``knowing'' 
violations, including distributing violative food, and section 135 
provides the agency with civil penalties when a person violates the 
Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act). Together, 
these authorities underscore the responsibilities of firms to only 
market safe food and give the agency essential tools to enforce these 
requirements to protect American consumers.
    The bill also recognizes the importance of providing FDA with 
improved access to information. Section 101 requires facilities to 
register annually, deems products of non-registered facilities 
misbranded and consequently prohibits their sale, and allows FDA to 
modify the food categories that firms provide during registration. 
These measures will help ensure that the agency has accurate 
information about who is making food for American consumers.
    Section 204 will provide FDA with important information about 
commercial importers and require that they comply with good importer 
practices as a condition of maintaining the registration. This section 
also prohibits importing a product without being properly registered, 
and deems a product misbranded if it is imported by an unregistered 
broker or importer.
    The requirements in this section of the bill represent significant 
enhancements to FDA's authorities with respect to imported products. At 
present, importers and brokers are not required to register with FDA. 
These changes will reduce risks to consumers from potentially harmful 
products by requiring importers to take appropriate steps to protect 
product safety, and by allowing FDA to take action against importers 
who do not implement appropriate measures to ensure the safety of the 
products they import--similar to FDA's ability to target domestic 
producers and facilities that have not taken these measures.
    Section 106 provides FDA with explicit authority to access food 
records during routine inspections, thereby addressing one of the most 
significant gaps in FDA's existing authority. The authority provided in 
this provision is essential to enable FDA to identify problems and 
require corrections before people become ill. It also enables the 
agency to verify during routine inspections that firms are maintaining 
required records.
    Although FDA has routine records access for certain other FDA-
regulated products, and USDA has routine records access for USDA-
regulated products, FDA does not have explicit authority for routine 
access to records for the vast majority of foods under its 
jurisdiction. This provision provides FDA with access to critical 
information to identify problems before an emergency occurs. Under 
current limited authority, FDA generally only has access to required 
records during an emergency situation involving serious threats to 
health or life. Records access and record-keeping by all persons in the 
distribution chain are the key mechanisms of providing regulators with 
information on plant operations, product safety, and product 
distribution. Such information is necessary to verify compliance and 
identify problems.
    The requirement in section 107 to implement a product tracing 
system for food will also provide FDA with enhanced information that 
will help the agency trace foods more quickly during an outbreak. The 
current requirement to keep records for the immediate previous source 
and immediate subsequent recipient (one up/one back) requires the 
agency to go to each point in the distribution chain during an outbreak 
to trace the source and distribution of the contaminated product, which 
is not a sufficiently expedient process when trying to prevent more 
people from becoming ill. The ability to trace the path of any food, 
including tomatoes, other fresh produce, and peanut butter, back 
through every point in the supply chain to the source, or forward 
through the supply chain to the retailer or food service establishment 
is crucial for limiting foodborne illness during an outbreak, for 
preventing future outbreaks, and for reducing the impact on the 
segments of the industry whose products were not associated with the 
illnesses.

    Does the legislation provide or anticipate resources for the agency 
to match its new responsibilities?

    One of the most important elements of the legislation is that it 
provides FDA, for the first time, a mandate to achieve specified 
frequencies of inspection. The legislation also provides a funding 
source to help FDA fulfill its new responsibilities. A greater 
investment in inspection is critical to ensuring high rates of 
compliance with the preventive control standards and other food safety 
performance standards that will help drive improvement in food safety 
and reduced rates of foodborne illness.
    Section 105 proposes a rigorous inspection schedule for food 
facilities, ranging from at least every 6 to 12 months for high-risk 
processing facilities, every 18 months to 3 years for low-risk 
processing facilities and food labelers and packers, to at least every 
5 years for warehouses. These requirements start 18 months after 
enactment. To meet these requirements, section 105 allows the agency to 
use inspections conducted by inspectors from recognized state, local, 
and other Federal agencies, and foreign government officials.
    FDA supports the bill's inspection goals for domestic food 
facilities. We also welcome the challenge and opportunity provided by 
the bill to develop and apply the most modern approaches to inspection, 
including wider use of microbial testing, to verify that companies are 
meeting their prevention responsibilities and to achieve our public 
health goals.
    We also appreciate the flexibility the bill provides to adjust 
inspection frequencies based on solid information about where we can 
achieve the greatest public health benefit through wise use of our 
finite resources. This flexibility would allow for more frequent 
inspection of foods, facilities, and processes that we find to be high 
risk and possibly less frequent inspection of facilities that we can 
have confidence, based on evidence, pose low risk.
    Food imports present a significant resource challenge. It is 
important that food imports meet the same requirements as domestic 
products, and we are pleased that the bill provides FDA with new tools 
to help achieve this, including the requirement that importers observe 
good importer practices and authorization to require certification of 
compliance for imported food under certain circumstances. FDA plans to 
increase inspection of foreign food facilities, but we are concerned 
that the bill's foreign inspection mandate may not result in the best 
use of FDA's resources, in light of the approximately 200,000 
registered foreign facilities and the high cost of overseas 
inspections. We think we can achieve cost-effective oversight of 
imports by working with foreign governments, using the bill's new tools 
for import oversight, supporting strong third-party inspections, and 
increasing targeted, risk-based foreign inspections.
    The bill authorizes three fees that are also requested in the 
President's FY 2010 budget. For example, section 101 provides for a 
registration fee. This fee is of critical importance to enable the 
agency to increase its inspection coverage of the approximately 378,000 
registered facilities and to enhance its other food safety activities. 
Section 108 provides for a reinspection fee for a food facility that 
commits a violation that requires additional inspections by FDA. This 
will help cover the costs of reinspecting FDA-regulated facilities that 
fail to meet Current Good Manufacturing Practices (CGMPs) or other FDA 
requirements. Section 203 authorizes the Secretary to charge and 
collect a fee for the issuance of export certificates for food and 
animal feed which would facilitate trade. This fee will help cover the 
cost of this program, which is necessary for firms to do business with 
countries that require such certificates.
    We are committed to working with Congress to ensure that FDA has 
sufficient resources, including fees, to carry out its inspection 
mandate.

Conclusion
    This is a historic moment for food safety in the United States--a 
moment for FDA and its sister agencies in the Federal Government to 
rise to the challenge of the 21st century. Success means fewer 
hospitalizations and deaths, fewer economically devastating recalls, 
and greater health for the American people. As Secretary Sebelius 
recently noted at a Food Safety Working Group listening session, ``with 
the leadership and commitment by our President and so many Members of 
Congress, and this renewed partnership across HHS, USDA, and our sister 
Federal agencies, I know that this is the time when we will finally 
make real progress and strengthen our nation's food safety system.''
    The legislation is a major step in the right direction toward 
achieving the recommendations of the President's Food Safety Working 
Group. I look forward to working with you to address both the issues 
raised here today and any other matters of concern.
    Thank you again for the opportunity to discuss FDA's perspective on 
pending food safety legislation. I would be happy to answer any 
questions.

    Mr. Costa. All right. I think you hit at the heart of a 
number of our questions, but let me first go back to Mr. Mande.
    In your oral testimony, I thought you mentioned that the 
goal was to move toward a single food safety agency.
    Mr. Mande. No, I said sort of a single food safety system, 
a seamless system.
    Mr. Costa. A seamless system but not a single agency; is 
that correct?
    Mr. Mande. What I said was a single system so that 
producers and the public can look at one food safety approach.
    Mr. Costa. So it is not the Administration's intent, then, 
with this collaborative effort that you have spoken of, that 
you have participated in to produce this report, to, in fact, 
produce a plan that would create a single food agency.
    Mr. Mande. That recommendation is not in the President's 
Working Group report.
    Mr. Costa. All right.
    Mr. Taylor, you hit the nail on the head as it relates to 
many of the concerns related to the certain proposed 
legislation. Are you saying or am I to take from your last 
comments that the FDA does not believe that it is necessary to 
have the authority to inspect farms, from our grain farms in 
the Midwest to our vegetable farms, where a great deal of 
specialty crops are raised, to our livestock?
    Mr. Taylor. No, sir, that is not what I am saying, Mr. 
Costa. In fact, FDA has long had the authority under the 
current Federal Food, Drug, and Cosmetic Act to inspect farms, 
inspect anywhere--anyplace where food is produced or held. It 
is authority that traditionally has not been exercised very 
much, but it is authority that is important. Because when there 
is a problem that arises and--for example, when we have 
problems with a produce situation, it is essential that FDA be 
able to get back to the farm, the source of production, so that 
we can know what the source is, contain the problem for the 
benefit of the public health.
    Mr. Costa. So is it the intention of the agency, then, to 
promulgate rules and regulations for on-farm food safety 
practices and then to begin conducting inspections to see if 
those on-farm safety practices are being followed?
    Mr. Taylor. The bill will give FDA the authority to 
establish on-farm safety practices with respect to produce, and 
they require the agency to, on a risk basis where we believe it 
would make a meaningful difference in improving the safety of 
the product, to establish regulations with respect to 
particular commodities or classes of commodities.
    And then the question is, how do we ensure compliance with 
those standards? And this is where I think we would envision 
working closely with state agencies, devising a way to ensure 
there is adequate oversight to verify compliance.
    Mr. Costa. So it is the intention then for the agency to 
promulgate rules and regulations that will provide for on-farm 
inspections, and then I would assume with the fees the Food and 
Drug Administration would intend to send those inspectors to 
those farms to determine whether or not those rules are being 
followed?
    Mr. Taylor. Well, again, the first step is setting 
standards; and there are a number of ways that we would go 
about seeking to ensure compliance.
    One role, one function of the standards would be to say to 
the commercial sector, the purchasers, that these are the 
standards that products are required to meet; and we would 
expect, as is often the case with these standards, the private 
sector would do a lot of the enforcement, if you will------
    Mr. Costa. So have you taken the time to envision how many 
new inspectors the Food and Drug Administration would need to 
provide these on-farm inspections?
    Mr. Taylor. Again, the scope of the on-farm inspection 
activities can't be mapped out at this stage because we haven't 
decided what commodities will be subject to the new standard.
    Mr. Costa. Do you think in determining risk assessment and 
risk management that that is the best way to address these 
issues of safety?
    Mr. Taylor. Yes. That in effect is what the bill calls upon 
us to do, is to identify where the risks are and to establish 
appropriate controls and standards to minimize those on the 
basis of science, on the basis of where we can demonstrate this 
for the benefit of food safety.
    Mr. Costa. In addition to the legislation that we have been 
discussing, there has been talk about FDA's authority to have 
quarantine in geographical regions, the ability to provide that 
quarantine for various products. Some products do move, as 
animals do. Shouldn't the goal be to move away from, it seems 
to me, a negative or a reinforcement or a punishment to a 
geographic region in the use of this quarantine?
    Mr. Taylor. Well, again, what we want to be doing is 
preventing problems and not having to deal with situations that 
might arise where some sort of a reaction to a problem is 
needed. As I read the quarantine provision, though, that is a 
provision that is aimed at a very unusual situation where there 
is an imminent risk of very significant harm to the public 
health.
    Mr. Costa. But don't you think if you have a significant 
traceback program that people have confidence in that a 
quarantine is not necessary?
    Mr. Taylor. Quarantine simply addresses what you do if you 
do traceback to a situation where the only way that you can 
protect the ag sector and the public is to contain the food 
that you believe is at most risk.
    Mr. Costa. But if you can traceback--we had an example last 
year where Members of the Committee, not this Committee, I 
believe the Committee that has jurisdiction of the bill, went 
on farm; and they looked at tomatoes grown in various stores 
that were being sold and traced it back to five different farms 
within a period of a half an hour to a 5 hour period. Why would 
you want to put a quarantine over a region when you have the 
ability to trace the individual farms in which that product 
came from?
    Mr. Taylor. That is a very important point. One of the 
values of traceback would be to target where the problem is. 
Quarantine is going to be a very unusual remedy. I mean, in the 
ordinary case if you traceback and you know the scope of the 
problem and you can take care of the problem there is no need 
for quarantine. That would be a very unusual remedy where there 
was no other alternative way to contain a problem.
    Mr. Costa. My time has expired; and I think the gentleman 
from Kansas is next, Mr. Moran.
    Mr. Moran. Mr. Chairman, thank you very much.
    The on-farm performance standards that are being considered 
in this legislation, a couple of questions. What is the 
conclusion or the basis that FDA would be the better regulator 
than USDA in regard to those performance standards? And are 
those performance standards going to be compatible with what we 
can expect from foreign producers of agriculture products who 
import into the United States?
    Under current law, meat and poultry, we have some assurance 
that those meat and poultry products that are coming in are 
produced under similar standards. It seems to me that we are 
once again creating a significant competitive disadvantage, 
increasing costs for production of agriculture in the United 
States in a sector of our economy that continues to compete 
with foreign producers.
    Mr. Taylor. Let me address that second question first.
    Any standards we set domestically for domestic producers 
would have to be met by foreign producers. That is an absolute 
basic principle. We can't have a separate standard for domestic 
producers.
    Mr. Moran. And our ability to ensure that those standards 
are being met would be what?
    Mr. Taylor. Well, if this law were passed, it would be this 
combination of new authorities and tools that we would have to 
oversee and ensure compliance with those standards. So it would 
include working with foreign governments to step up what they 
do. It would include for the first time FDA clearly having 
legal authority to inspect foreign facilities and to prevent 
food coming in if companies overseas have prevented us from 
inspecting.
    We need to look at strengthening, very fundamentally, the 
importer's duty to manage that supply chain. That is another 
important part of the puzzle. And third-party certifications 
done in a rigorous accredited sort of way are all elements of 
doing this.
    When you have 200,000 overseas facilities, it is very clear 
that there is not one sort of simple way to provide the level 
of assurance that we need. And I agree with you completely. We 
need that. We have to look at putting together a set of 
elements to produce that result.
    Mr. Moran. Would the U.S. be able to enforce those 
performance standards in foreign countries?
    Mr. Taylor. We would do the enforceability at the point of 
entry. I mean, one of the elements of this bill is to require 
the importer to maintain good importer practices, which 
includes documentation of the controls that are in place 
overseas and the fact that those products have met our 
standards, so we have direct authority over the importer.
    Plus, the bill would give FDA extraterritorial jurisdiction 
over violations of the Act so that again we can begin to 
address those problems upstream. I think that one of the 
strengths of the bill is that it addresses FDA's need for 
strengthened legal tools to oversee imports.
    Mr. Moran. Are there scientific standards that are accepted 
globally in regard to food safety?
    Mr. Taylor. For some commodities and some hazards, yes, and 
for some, no. I think in the case of produce this issue of how 
you set specific, quantitative standards to try to give 
benchmarks for controlling pathogens, that is a work in 
progress. We have more work to do with the scientific 
community, with USDA, with the agricultural community.
    We have Good Agricultural Practices, sort of broad 
guidances and standards; and the industry itself has started to 
develop specific quantitative metrics for what would be the 
microbial quality of the water used in irrigation. And we need 
to move in that direction to use these science-based criteria 
so we can have objective benchmarks for safety. But that is a 
work in progress that this bill would really compel FDA to 
pursue; and, hopefully, we would invest in the science that 
makes that possible.
    Mr. Moran. We have been trying for a long time to utilize 
scientific-based standards in regard to, for example, meat 
export, our battles with Japan and Korea and others to accept 
meat products from the United States. It seems to me it has 
been very difficult to reach a conclusion, and particularly 
when there is a competitive advantage or disadvantage based 
upon that scientific standard.
    Mr. Taylor. Right. These are difficult issues, and there 
are always going to be disputes, and there is a long way to go 
to harmonize standards internationally. But that is a worthy 
goal.
    Mr. Moran. Then my question about USDA versus FDA. The FDA, 
it seems to me, doesn't have the tools, the personnel, the 
county FSA offices that USDA has. Is there a reason that FDA 
makes more sense than USDA?
    Mr. Taylor. Well, Congress in its wisdom gave FDA its 
jurisdiction decades ago that FDA has been exercising and 
working with the agricultural community, working with USDA on 
developing guidances. I think there is actually a lot of 
expertise at FDA on this subject. But FDA would not work in 
isolation. I think no one could work in isolation on this 
topic. We have to work with others.
    Mr. Moran. Let me ask a different question on a different 
topic of today's hearing. The prevention and pro-growth 
antibiotics, it seems to me--in fact, as I understand it, the 
President announced his support for the ban in recent days. 
What has happened scientifically? What study has arrived that 
says this is the new standard? Are we basing this belief on 
some--it seems to me that almost in a very short period of time 
we have changed our theory about the use of antibiotics; and my 
question is, what is the scientific basis for that change?
    Mr. Taylor. Well, actually, the scientific consensus on 
this issue, that we have a public health concern with 
nontherapeutic, nontreatment uses of antibiotics, that 
consensus has emerged over the last several years. The World 
Health Organization, our Institutes of Medicine, the National 
Academy of Sciences here have made this finding before. So in 
terms of scientific ground breaking, we really didn't break new 
scientific ground.
    FDA expressed its public health judgment really in line 
with the judgment of scientific bodies, consensus bodies, that 
this nontherapeutic, growth-promotion, feed-efficiency use 
presents a public health concern and is not a judicious use of 
antibiotics from a public health standpoint. So there is really 
not new scientific ground being broken, particularly.
    Mr. Moran. Was there consultation with, for example, Ms. 
Smith at USDA before reaching this conclusion?
    Mr. Taylor. Well, I have to take a little bit of a pass on 
exactly the details of what happened before I started a week 
ago last Monday, but this is--FDA has been part of an 
interagency task force on antibiotics. CDC is involved. I know 
there has been involvement of USDA in that process, and we can 
brief you happily on all the details of that.
    But, no, the FDA definitely doesn't work in isolation on 
this issue. The Center for Veterinary Medicine is very engaged 
with the whole animal production industry and with colleagues 
at USDA.
    Mr. Moran. Mr. Chairman, thank you for the time. I have not 
seen Mr. Boswell's, the gentleman from Iowa, testimony before 
the House Rules Committee, but I feel very comfortable in at 
least commending him for his leadership on this topic of 
antibiotics, and I appreciate his involvement in this 
discussion.
    I yield back. My time has expired.
    The Chairman [presiding.] I thank the gentleman.
    I think you folks, I guess, heard the testimony of the 
previous panel where the livestock, poultry people, and the 
grain people are concerned that the language that is in the 
current bill that was marked up by the Energy and Commerce 
Committee is not sufficient to take care of their concerns. How 
do you interpret the situation, all three of you? Their 
concerns, do you think they are valid enough?
    Mr. Taylor. I did hear a number of concerns expressed 
about--for example, from the standpoint of the gentleman who 
runs the organic farm business, that he had the impression that 
he would be required to register and pay a fee. Well, that is 
just not the case.
    I think there are a number of concerns about the reach of 
this that really go way beyond what the bill would actually do. 
Because, again as I indicated earlier, I think the bill has 
been very judicious about putting boundaries around the scope 
of this authority and exempting farms very broadly from the 
core requirements of registration and preventive controls. So I 
would like to think that we can dialogue to allay those 
concerns and answer those questions. And, it is still a work in 
progress, of course; but, we have come a long way to produce a 
pretty well-bounded bill.
    The Chairman. Do you two have any comments?
    Mr. Mande. I would add that, as I said in my testimony, we 
have looked at the bill, and we don't think it changes the 
jurisdiction between FDA and the Department of Agriculture. I 
think the one thought I'd add is I did hear some from the panel 
maybe a higher comfort level with some of the work that USDA 
has done over the years. And, while this legislation doesn't 
change that, I think what we are witnessing, and have seen a 
trend toward this, is growing cooperation between our two 
agencies.
    So I suspect that, as we have done in the past and will do 
more of, there will be the expertise and the experience that we 
have we will be sharing with FDA; and hopefully that will 
assure that they benefit from the experiences we have had in 
the past in carrying out new authority should Congress provide 
those to them.
    Mr. Taylor. Mr. Chairman, I can't help but note that your 
USDA witness once worked at FDA and your FDA witness once 
worked at USDA. So I think we have a good line of 
communication.
    The Chairman. Well, that could be, but we haven't convinced 
everybody.
    One of the concerns I guess the language in there where it 
says you guys are to consult with each. What it is, it says you 
``may'' consult. Why couldn't that say you ``shall'' consult?
    Mr. Taylor. You know, the President says we shall consult, 
so we shall consult. I------
    The Chairman. Would it be a problem if we made that change?
    Mr. Taylor. I--we are going to consult. So, if it is the 
wisdom of the Congress how you want to admonish us to do what 
we intend to do, we have to consult. We cannot implement these 
provisions without consulting.
    The Chairman. The FDA, on a livestock farm or a grain farm, 
you have no intention of changing what you are doing and going 
out there------
    Mr. Taylor. No. I think that is the point. For the vast 
majority of grain farmers, ranchers, they are not going to see 
this bill making--changing their practices. We are required 
under this bill to target what we do on the farm to those 
circumstances where we can identify risks that can be reduced 
through some appropriate intervention.
    The Chairman. One of the concerns is that there was 
apparently some court someplace, some judge that declared that 
live cattle was food. Now, I don't know how you eat a live cow, 
but that has created some concern. Do you know anything about 
that?
    Mr. Taylor. I am aware from my old food law days that there 
is such a court case. So, I mean, FDA doesn't--it regulates 
what those cattle eat, the animal feed. It regulates the drugs 
that are administered to them. And it is important that those 
regimes stay in place. They provide protections for farmers as 
well as consumers. But, again------
    The Chairman. What problem would it cause if we clarified 
this to make it clear that this does not apply to livestock and 
grain farms?
    Mr. Taylor. I think the important thing is in terms of the 
preventive control mandate and those new authorities. That is 
one question. One thing you don't want to do is take away 
existing authorities that FDA has had for years and has used 
successfully to deal with issues. Don't get in the way of FDA's 
ability, for example, I would suggest, to deal with BSE in the 
way it has done that, working with APHIS and FSIS.
    So I think real care needs to be exercised to not 
inadvertently trim away necessary authorities to deal with 
matters that, again, are important both to consumers and to the 
agricultural sector.
    The Chairman. All right. I thank the panel.
    The gentleman from Iowa, Mr. Boswell.
    Mr. Boswell. Thank you.
    Mr. Moran, I didn't follow all your questions, because I 
let this thing interrupt me. I apologize for that. So I may 
have to ask you to help me out here a little bit.
    Back to summarize that conversation, I guess I would direct 
this question to Ms. Smith. Did the FDA, in fact, consult with 
USDA before changing their policy?
    Ms. Smith. Before changing the policy on the------
    Mr. Boswell. On the use of antibiotics for feed efficiency 
and growth promotion.
    Ms. Smith. I am not personally familiar with what the level 
of collaboration was. I know we have very recently been working 
with FDA on this issue.
    Mr. Boswell. You are not sure they did or did not?
    Ms. Smith. I am not sure at what point in the process we 
were collaborating. I would be happy to go back and check with 
those that were more directly involved.
    Mr. Boswell. Is it normal operating procedure for decisions 
of this magnitude to be cleared through OMB's interagency 
process?
    Ms. Smith. Yes, it is.
    Mr. Boswell. I would like to know if that happened or not.
    Ms. Smith. Okay.
    Mr. Boswell. Do you know?
    Mr. Taylor. The testimony that was delivered Monday was 
cleared through OMB.
    Mr. Boswell. It was cleared.
    Mr. Taylor. Yes.
    Mr. Boswell. Well, I think some fence mending is going to 
have to take place around here. Because that total process was 
very offensive. It was like you deliberately tried to blindside 
some of us on this Committee, and we really don't appreciate 
that. But we have to go forward. We have to work together, and 
we need to do that. So I would suggest that we may have to have 
some continuing discussion about this. We may need to call the 
Secretary and visit with him. I don't know. But I was stunned.
    When I went over there Monday and found that out cold 
turkey, if you will, it didn't seem like that is the way you 
ought to be doing business here. So if that is not the way you 
should be doing business, it creates doubt in your sincerity or 
whether you are disingenuous or not, or just what in the heck 
is going on.
    This has a lot of potential impact on farmers and ranchers, 
and you know that. And I think with all the experience you tell 
us you have had--and I am glad for that--that you also know 
that those of us who do farming and ranching we, of all people, 
want the food to be safe. You heard some of that said this 
morning from the first panel. And I don't mean just the organic 
farmer but from all the farmers. And I have to wonder if you 
really get that. I am concerned about it.
    So I think we just have to take a hard look at this, Mr. 
Chairman, and see what we need to do. But I didn't hear any 
recommendation. Maybe I missed it, but I think your question 
was from ``may'' to ``shall'' and we probably ought to do that. 
I think that would be a wise thing for industry and for the 
country and for the whole process.
    So, with that, I am going to yield back. But I think you 
better come visit with us.
    Mr. Taylor. If I may------
    Mr. Boswell. No, I think I am done. Thank you.
    The Chairman. I will give you a chance to say what you want 
to say, and then we are going to wrap this up.
    Mr. Taylor. First of all, the statement Monday about FDA's 
position on the public health issue here is one thing, that the 
question of what the solution is to what is a difficult problem 
for everybody including--certainly, we understand the 
agricultural sector--I mean, what is the right solution and how 
does the community come together to address what is a long-
standing concern of the scientific and public health community? 
How do we address that?
    And, that is the question that I hope we can have dialogue 
on, and also I am sure that the folks involved in the decision 
and the statement that was made would be delighted to come and 
brief, and would welcome the chance to come and brief and have 
that communication.
    The Chairman. All right. Mr. Boswell.
    Mr. Boswell. There may be another question. Ms. Smith, 
could you discuss APHIS's current quarantine authority and how 
it is used?
    Ms. Smith. Sure, I would be happy to.
    The Animal and Plant Health Inspection Service has 
authority under two different areas, under the Plant Protection 
Act and under the Animal Protection Act. We have the authority 
to quarantine, which means we can prohibit or restrict the 
importation--exportation or interstate movement, and in the 
case of animals, depopulate those as well for plant and animal 
pest and disease purposes. We take the action under the 
authorities to maintain U.S. agricultural health and to protect 
exports, export opportunities for U.S. producers, as well as to 
work to protect human health in concert with other Federal 
agencies as well.
    In the case of livestock, we will quarantine animals to 
stop the spread of disease or depopulate the animals if other 
options such as testing quarantine will not mitigate the 
disease spread, or there is an imminent threat to public or 
animal health risk.
    In the case of plants, APHIS will quarantine an area to 
prevent the movement of plants and plant products such as 
firewood to prevent the further spread of a plant pest. We 
generally work in cooperation with states, because they 
typically will leverage an intrastate authority.
    The Chairman. All right. I thank the gentleman.
    If there are no further questions, under the rules, the 
record of today's hearing will remain open for 10 calendar days 
to receive additional material and supplementary written 
responses from the witnesses to any question posed by a Member 
to the panel.
    This hearing of the House Committee on Agriculture is 
adjourned.
    [Whereupon, at 2:38 p.m., the Committee was adjourned.]
    [Material submitted for inclusion in the record follows:]
      
     Supplmental Material Submitted by Hon. Leonard L. Boswell, a 
                  Representative in Congress from Iowa

Testimony for the Record of Hon. Leonard L. Boswell, Before the House 
        Committee on Rules, H.R. 1549, the Preservation of Antibiotics 
        for Medical Treatment Act of 2009

H-313, the Capitol, July 13, 2009, 2:30 p.m.
    Chairwoman Slaughter, Ranking Member Drier and Members of the Rules 
Committee, I would like to thank you for allowing me the opportunity to 
testify here today. I have spent most of my life involved in animal 
agriculture and have seen first-hand the responsible use of 
antibiotics.
    I understand the issues that affect the livestock, dairy and 
poultry industries having spent most of my youth working in livestock 
production and today I still have a hand in managing a cow/calf 
operation on my farm in Lamoni, Iowa. Once I retired from 20 years in 
the Army I moved back to Iowa to begin farming. I sat down with my 
local veterinarian to discuss the use of antibiotics to treat sick 
animals and prevent future illness. From my experience with producers 
and veterinarians, the thoughtful use of antibiotics is not the 
exception, it's the rule.
    During the 110th Congress, it was my privilege to serve as Chairman 
of the Agriculture Subcommittee on Livestock, Dairy and Poultry. On 
September 25th of last year, we held a hearing to review the advances 
in animal health within the livestock industry. We were specifically 
looking at how antibiotics are used on America's livestock farms. Our 
witnesses included veterinarians from USDA's Animal Health and Plant 
Inspection Service and FDA's Center for Veterinary Medicine (CVM), 
producers, veterinary practitioners and academics from across the 
country. We believe that we heard from a good cross-section of the 
users of the animal health products, the doctors responsible for the 
use of antibiotics and the experts studying the resistance trends from 
use of antibiotics in animals.
    As the Subcommittee Members listened to the witnesses, it became 
very clear that America's livestock, dairy and poultry producers have a 
responsibility to safeguard animal health and public health. A 
responsibility they take very seriously. They are committed to using 
antibiotics responsibly and have developed responsible-use guidelines 
for each of their respective industries. They didn't develop these 
guidelines because Congress told them to do so; they developed the 
guidelines because it was the right thing to do for their animals and 
their consumers.
    I think that the perspectives the witnesses shared at our hearing 
last year are important to the discussion here today about H.R. 1549, 
the Preservation of Antibiotics for Medical Treatment Act of 2009. I 
would like to take a few moments to take what we learned from that 
hearing in terms of what H.R. 1549 would do to the livestock industry.
    H.R. 1549 would remove seven classes of antibiotics from the market 
unless sponsors can demonstrate that they are safe and effective. Our 
witnesses clearly outlined the rigorous approval process that animal 
antibiotics must go through to gain approval already. All antibiotics 
used to keep animals healthy have passed the in-depth FDA process, and 
have been shown to be safe and effective and have undergone review for 
their potential to cause increased antibiotic resistance. H.R. 1549 
would require antibiotic sponsors to prove again what has already been 
proven during their initial FDA approval. This FDA process is a 
stringent, science-based regulatory review takes years and millions of 
dollars. Requiring another step undermines the FDA's process of 
reviewing the human health impacts of individual animal drugs based on 
science and risk assessment.
    Our witnesses also shared with us that not many antibiotics are 
currently available for use in livestock. H.R. 1549 overlooks the 
legitimate veterinary need to preserve these antibiotic classes for use 
in food animals to ensure that healthy animals enter the food chain. 
There are few new antibiotics anticipated for approval by FDA, so if 
H.R. 1549 is enacted and products are removed from the market place, 
America's livestock producers will be left with few, if any, medicines 
to prevent and control animal disease. H.R. 1549 will result in more 
sick animals and it is my fear that it will leave us with a potentially 
less safe food supply.
    In the mid-1990's the European Union made a decision to phase out 
the use of antibiotics as growth promoters. Denmark, which had a pork 
industry roughly equivalent to the size of the pork herd in Iowa (which 
is the largest pork producing state in the country), instituted a full 
voluntary ban in 1998 which became mandatory in 2000. Many proponents 
of restricting the use of certain animal antibiotics as a model often 
point to this ban instituted in Denmark, citing a drop in total tons of 
antibiotics used in pork production in that country. When you ban the 
use of a product, it is self-evident that usage rates would drop. 
Citing this obvious consequence as a rationale for restrictions in 
other countries borders on the illogical. Interestingly, what the 
proponents never seem to discuss are the other effects of that ban. I 
would like to call your attention to the testimony received in my 
Subcommittee where these effects were discussed in detail. Some of our 
witnesses had even visited Denmark and seen first-hand the downturn in 
swine health in that country.
    After the ban became fully implemented in 1999, Danish pork 
producers saw an immediate increase in post-weaning diarrhea and an 
increase in piglet mortality, which has had long lasting effects on the 
Danish pig industry. The increase in piglet deaths and the overall 
impact on animal well-being might be acceptable if it resulted in 
improvements to public health, but such improvements have not 
materialized. And while overall use of antibiotics in Denmark declined, 
there has been a marked increase in the therapeutic use of 
antibiotics--those used to treat and control diseases. Today, the use 
of therapeutic antibiotics in Danish pigs now surpasses what was used 
to prevent disease and promote growth prior to the ban in 1999 and 
continues to rise each year. I think the Danish pork industry can now 
attest to the validity of the age-old cliche: ``an ounce of prevention 
is worth a pound of cure!''
    As for costs, a 2009 Iowa State University study estimated that the 
effect of a ban in the United States similar to Denmark's would raise 
the cost of production by $6 per pig in the first year after such a 
prohibition; 10 years after the ban, the cumulative cost to the U.S. 
pork industry would exceed $1 billion.
    A recent study by Dr. Scott Hurd, associate professor at Iowa State 
University's College of Veterinary Medicine and former U.S. Department 
of Agriculture Deputy Under Secretary for Food Safety, demonstrated 
that when pigs have been sick during their life, those pigs will have a 
greater presence of food-safety pathogens on their carcasses. This is a 
serious implication that must be considered when looking at the costs 
and benefits of antibiotic use in livestock.
    In all discussions on antibiotic use in food animal production, we 
need to be clear what the issue really is. H.R. 1549 is confusing the 
problem of antibiotic resistance in general with the faulty proposition 
that blames human resistance issues on antibiotic use in animals. Most 
informed scientists and public health professions acknowledge that the 
problem of antibiotic resistance in humans is overwhelmingly an issue 
related to human drug use.
    A 2006 report from the Institute of Food Technologists, an 
international scientific society, said ``eliminating antibiotic drugs 
from food animal production may have little positive effect on 
resistant bacteria that threaten human health.'' In fact, eliminating 
animal antibiotics may be detrimental to public health.
    As our witnesses outlined for my Subcommittee, antibiotic-resistant 
bacteria develop from many factors, including human use of antibiotics 
and routine household use of disinfectants such as antibacterial soap. 
According to a paper published in 2001 in the Journal of the American 
Veterinary Medical Association, people and their pets on a per-pound 
basis use ten times the amount of antibiotics that are used in food 
animal production. More than 95 percent of the antibiotics used for 
animals are devoted to treating them for disease conditions, not as 
growth promoters as many claim.
    Protecting human health and providing safe food are paramount 
concerns of America's livestock producers. That is why we test for 
antibiotics residue as part of our food safety programs. The FDA 
establishes withdrawal times or withholding periods which are times 
after drug treatment when milk and eggs are not to be used for food, 
and during which animals are not to be slaughtered.
    If I may speak specifically to H.R. 1549, \2/3\ of the bill has 
been enacted into law and should be allowed to work before removing 
products from market. Provisions requiring more USDA research into the 
causes of and solutions to antibiotic resistance were passed as part of 
the farm bill in 2008. The Animal Drug User Fee Amendments of 2008 
require FDA to collect antibiotic sales data from companies and make a 
summary of that data public. The provisions were designed to provide 
better information to researchers conducting risk assessments and 
should be allowed to yield information before products are removed from 
the market. Congress has already taken action, and we should see the 
results from our action before we start removing antibiotics from the 
market.
    Risk assessments are an important tool in approving antibiotics and 
ensuring that they are not harming public health. Voluntary risk 
assessments have been done by sponsors, and FDA is now requiring 
specific risk assessments for new and existing antibiotic products. Dr. 
Randy Singer, a veterinarian and epidemiologist working at the 
University of Minnesota, testified last September about a risk 
assessment in which he participated. His team assessed the risk of the 
agricultural use of the macrolide family of antibiotics poses to human 
health. The research hypothesis was that since macrolide-antibiotics 
are also used in human medicine, the use of macrolide antibiotics in 
animal agriculture could compromise the efficacy of these antibiotics 
in human medicine and potentially increase the number of macrolide-
resistant bacterial infections in people. The team developed a risk 
assessment model following the format of FDA's guidance document #152. 
Dr. Singer and his team of researchers found that all macrolide 
antibiotic uses in animal agriculture in the U.S. posed a very low risk 
to human health. The highest risk was associated with macrolide-
resistant Campylobacter infections acquired from poultry, but this risk 
was still estimated to be less than 1 in l0 million and would thus meet 
the standard of ``reasonable certainty of no harm'' employed by FDA-
CVM.
    Dr. Singer also shared with us that animal illness likely plays a 
critical role in reducing the chances of contamination during 
processing. He participated with a team that developed a mathematical 
model relating animal illness to human illness. In this model, there 
was a large increase in human illness associated with small increases 
in animal illness. This suggested to the group that agricultural 
management strategies that fail to employ the judicious use of 
antibiotics may have significant negative impacts on human health. 
While I accept that there are those who will always believe that 
antibiotics administered in feed at low doses over several weeks raise 
hypothetical concerns about their potential to increase rates of 
resistance, in my opinion the evidence is undeniable that these 
applications improve animal health. Antibiotic uses in animals 
therefore have human health benefits. This goes back to our livestock 
producers' moral obligation to care for their animals and protect 
public health.
    If policy decisions are going to be made regarding antibiotic use, 
we need to use the proper tool for making those decisions; risk 
assessments are the most appropriate tool, as Dr. Singer described to 
my Subcommittee. Decisions made without considering the results of 
scientific risk assessments will result in unintended consequences, 
including increased animal death and disease and increased risks to 
public health as we saw in the Denmark example.
    As your witnesses today discuss a topic that is important to the 
livestock producers in not just my district and home state but yours as 
well, I sincerely hope that you consider what my Subcommittee learned 
last Congress. H.R. 1549 will have detrimental effects, not only on our 
farmers who feed the world safe and wholesome meat and meat products, 
but also on public health.
    Again I would like to thank you for allowing me the opportunity to 
testify before you today. I hope as a farmer and user of antibiotics I 
have offered you some insight into the livestock industry's 
perspective. In the United States we are very blessed to have the 
safest, most plentiful, and most affordable food supply in the world. 
As policy makers we must take a hard look at how our decisions affect 
human health and our ability to feed ourselves and the world.
    I'd be happy to answer any questions. Thank you.
                                 ______
                                 
     Submitted Statement of National Council of Farmer Cooperatives

    Chairman Peterson, Ranking Member Lucas and Members of the 
Committee, on behalf of the more than two million farmers and ranchers 
who belong to one or more farmer cooperatives, the National Council of 
Farmer Cooperatives (NCFC) thanks you for your continued leadership on 
issues affecting U.S. agriculture. NCFC appreciates this opportunity to 
submit its views regarding food safety, in particular H.R. 2749, the 
Food Safety Enhancement Act of 2009, and respectfully requests this 
statement be made part of the official hearing record.
    Since 1929, NCFC has been the voice of America's farmer 
cooperatives. Our members are regional and national farmer 
cooperatives, which are in turn composed of nearly 3,000 local farmer 
cooperatives across the country. NCFC members also include 26 state and 
regional councils of cooperatives.
    We believe farmer cooperatives offer the best opportunity for 
America to realize the farmer-focused ideal of American agricultural 
policy. Farmer cooperatives allow individual farmers the ability to own 
and lead organizations that are essential for continued competitiveness 
in both the domestic and international markets.
    America's farmer-owned cooperatives provide a comprehensive array 
of services for their members. These diverse organizations handle, 
process and market virtually every type of agricultural commodity 
produced. They also provide farmers with access to infrastructure 
necessary to manufacture, distribute and sell a variety of farm inputs. 
Additionally, they provide credit and related financial services, 
including export financing. Earnings from these activities are returned 
to their farmer members on a patronage basis, helping to improve their 
income from the marketplace.
    America's farmer cooperatives have a large stake in producing, 
handling, and processing our nation's food supply, and take pride in 
providing the most safe, abundant, and affordable food in the world. 
NCFC supports science-based, risk-based enhancements to our nation's 
food safety system, but some of the policies put forward in H.R. 2749 
are overly burdensome, duplicative, and may not actually result in a 
safer food supply. We appreciate the many changes that have already 
been incorporated into the bill, and the work that the Members of the 
Energy and Commerce Committee have done to make it more feasible for 
agriculture--but we continue to have the following concerns with the 
bill.
    NCFC is opposed to the inclusion of a facility registration fee in 
the Food Safety Enhancement Act. The bill currently requires all 
facilities to register with the Food and Drug Administration (FDA) 
annually and pay an annual registration fee of $500 per domestic or 
foreign facility, not to exceed $175,000 per company per year. For 
farmer cooperatives, any facility registration fee is a direct tax on 
cooperative members; we are opposed to such a tax.
    This registration fee is particularly onerous and burdensome for 
small- and medium-sized producers and cooperatives. One illustrative 
example comes from the National Grape Cooperative Association, Inc., 
which grows grapes and processes Welch's grape juice and other grape 
products. Along with the Concord grapes that made their cooperative 
into a well-known national brand, many of National Grape's members also 
grow smaller acreages of a white grape variety, the Niagara grape, 
which is used to make white grape juice products. One of the challenges 
of harvesting and processing any white grape variety is color 
retention--avoiding the darkening and browning of the juice that starts 
with oxidation as soon as the grapes are harvested. In order to control 
this oxidation and retain the desirable light color of the Niagara 
juice, the industry has always had to depend upon the addition of small 
quantities of potassium metabisulfite (PM) to the grapes in the field 
during harvesting. PM is one of the most widely used food 
preservatives, has been used for many years, and is classified as 
GRAS--Generally Recognized as Safe--by the FDA.
    As part the Bioterrorism Act of 2002, ``food facilities'' were 
required to register with the FDA. In reviewing the wording of this new 
registration requirement, National Grape found that the FDA defined 
food facilities in their regulations as any ``domestic or foreign 
facilities that manufacture, process, pack, or hold food for human or 
animal consumption.'' This left the cooperative wondering whether some 
of their members' farms might be considered ``food processing'' 
facilities.
    National Grape requested a ruling from the FDA at that time on 
whether their members' application of PM to their grapes in the field 
during harvest meant that their farms could be considered to be food 
``processing'' facilities under the new regulations. The FDA warned 
that the farms could be considered food facilities under a strict 
interpretation of the regulations and recommended that everyone 
involved should register as such.
    While this registration was not onerous--there were no big expenses 
to the cooperative or its members--the bill passed out of the Energy 
and Commerce Committee includes a $500 annual registration fee for all 
facilities. The 600 grower members of National Grape are now facing a 
$500 per farm annual registration fee that has the potential to add 
$300,000 annually to their cost of doing business at a time when the 
costs associated with labor, fuel, and other inputs are also 
increasing.
    This is one example of the ill effects of what a registration fee 
could mean for cooperatives. There are many other cooperatives, small 
and large, which would be severely impacted by a registration fee. We 
appreciate that the registration fee has been reduced as the bill has 
progressed through the drafting process. But any registration fee is 
unacceptable--particularly for cooperatives, where that fee is a direct 
hit on cooperative members--and we urge Congress to remove any 
registration or user fees from the bill.
    Another concern with the bill is the new authority granted to FDA 
to access confidential food safety records. The bill dramatically 
expands FDA's access to facility records and expressly encompasses 
farms in the records access requirement. The bill deletes the current 
limitation in the Bioterrorism Act that FDA first must have a 
``reasonable belief'' that a product is adulterated and presents a 
threat of serious adverse health consequences or death to humans or 
animals--inspectors would not need to have any indication that a food/
feed safety issue may exist as a precondition to accessing or 
photocopying records. FDA should only have access to records that 
directly bear upon product safety, and the bill must provide 
protections against unauthorized disclosure by FDA of proprietary or 
confidential business information to which the agency gains access when 
reviewing the contents of written food/feed safety plans and other 
records.
    We also are concerned with the mandatory recall and quarantine 
authority granted in H.R. 2749. The bill gives FDA mandatory recall 
authority as well as new authority to quarantine products within a 
geographic area. The bill should provide an opportunity for affected 
facilities to voluntarily recall products before FDA issues a mandatory 
recall. And because FDA is given recall authority, product quarantine 
is redundant and unnecessary, and could harm producers who are caught 
up in a geographic quarantine but are not part of the problem. Also 
concerning is that the bill lacks any kind of indemnification for 
producers who may be wrongly harmed in a regional quarantine.
    Additionally, the Food Safety Enhancement Act of 2009 requires FDA 
to develop and implement regulations setting standards for safe 
growing, harvesting and holding of raw agricultural commodities if they 
are required to minimize the risk of ``serious adverse health 
consequences or death to humans or animals.'' The bill also cites 
``manure, water quality and employee hygiene, sanitation and animal 
control and temperature controls'' that FDA determines to be 
``reasonably necessary.'' NCFC strongly urges that any standards set by 
FDA must be commodity-specific and risk-based. Also, FDA is not the 
expert agency to set standards for issues like manure and water 
quality--the setting of those standards should be deferred to the U.S. 
Department of Agriculture. NCFC is also concerned that the bill muddies 
the jurisdiction between USDA and FDA in the regulation of meat, and 
hopes Congress will strengthen the livestock exemption in the bill by 
clarifying that livestock is not ``food'' and thereby is exempt from 
these new FDA authorities.
    One final area of concern is product traceability. The bill 
currently requires FDA to establish a product-tracing system that far 
exceeds the current one-up-one-back system required by the Bioterrorism 
Act. Many commodities are already traceable and many others are in 
various stages of developing a commodity-specific traceback system. Any 
federally-mandated traceback program must take into account the 
feasibility and costs associated with implementing such a program. In 
addition, any new Federal program must also take into account the work 
that is currently under way and systems that are already in place.
    Again, America's farmer cooperatives have a large stake in 
producing, handling, and processing our nation's food supply, and take 
pride in providing the most safe, abundant, and affordable food in the 
world. We appreciate the Committees' attention to this critically 
important issue and urge the Committee to continue to push for 
agriculture's interest as this debate moves forward. NCFC looks forward 
to working with the Committee on food safety legislation that makes 
science-based, risk-based enhancements to our nation's food safety 
system.
                                 ______
                                 
                          Submitted Questions

Submitted Questions by Hon. Eric J.J. Massa, a Representative in 
        Congress from New York *
---------------------------------------------------------------------------
    * There was no response from the witnesses by the time this hearing 
went to press.
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    Question 1. H.R. 2749 gives the Secretary wide discretion to set 
packing standards. What is the likelihood that these ``standards'' 
would include mandatory disinfectant wash water. Such a standard, 
requiring a highly chlorinated wash water for instance, would put many 
of my farming constituents who are engaged in direct sales out of 
business. These farmers would be put out of business not only because 
of the cost of such a standard, but a mandatory disinfectant wash would 
adversely affect the ``freshness'' of their product:, not to mention 
the environment and those people engaged in washing the produce.
    Answer.

    Question 2. Specifically, how do the food safety standards in HR 
2749 take into account the specific variations and unique needs of 
different commodities, geographic locations and production methods, 
etc.? Agriculture is not a one size fits all industry.
    Answer.

                                  
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