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


 
                     HEARING TO REVIEW FOOD SAFETY
           STANDARDS FOR HORTICULTURE AND ORGANIC AGRICULTURE

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

                                HEARING

                               BEFORE THE

                            SUBCOMMITTEE ON
                  HORTICULTURE AND ORGANIC AGRICULTURE

                                 OF THE

                        COMMITTEE ON AGRICULTURE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 14, 2009

                               __________

                           Serial No. 111-14


          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

                                 ______

          Subcommittee on Horticulture and Organic Agriculture

                DENNIS A. CARDOZA, California, Chairman

ERIC J.J. MASSA, New York            JEAN SCHMIDT, Ohio, Ranking 
JIM COSTA, California                Minority Member
KURT SCHRADER, Oregon                JERRY MORAN, Kansas
FRANK KRATOVIL, Jr., Maryland        TIMOTHY V. JOHNSON, Illinois
SCOTT MURPHY, New York               CYNTHIA M. LUMMIS, Wyoming

                Keith Jones, Subcommittee Staff Director

                                  (ii)


                             C O N T E N T S

                              ----------                              
                                                                   Page
Cardoza, Hon. Dennis A., a Representative in Congress from 
  California, opening statement..................................     1
    Prepared statement...........................................     3
Costa, Hon. Jim, a Representative in Congress from California, 
  opening statement..............................................     6
Lummis, Hon. Cynthia M., a Representative in Congress from 
  Wyoming, prepared statement....................................     8
Peterson, Hon. Collin C., a Representative in Congress from 
  Minnesota, prepared statement..................................     8
Schmidt, Hon. Jean, a Representative in Congress from Ohio, 
  opening statement..............................................     5

                               Witnesses

Acheson, M.D., F.R.C.P., David W.K., Associate Commissioner for 
  Foods, U.S. Food and Drug Administration, Rockville, MD; 
  accompanied by Steven M. Solomon, D.V.M., M.P.H., Assistant 
  Commissioner for Compliance Policy, Office of Regulatory 
  Affairs, U.S. Food and Drug Administration.....................     9
    Prepared statement...........................................    11
Shipman, David R., Acting Administrator, Agricultural Marketing 
  Service, U.S. Department of Agriculture, Washington, D.C.......    17
    Prepared statement...........................................    20
Pezzini, Joseph, COO, Ocean Mist Farms, Castroville, CA; 
  Chairman, California Leafy Greens Marketing Agreement; on 
  behalf of Western Growers Association..........................    40
    Prepared statement...........................................    43
Hirsch, Steve, Member, Ohio Produce Growers and Marketers 
  Association; Vice President, Ohio Farm Bureau Federation; 
  Partner, Hirsch Fruit Farm, Chillicothe, OH....................    48
    Prepared statement...........................................    50
Ratto, Ronald A., President, Ratto Bros., Inc., Modesto, CA......    53
    Prepared statement...........................................    54
LoBue, Philip, President, LoBue Bros., Inc., Lindsay, CA.........    57
    Prepared statement...........................................    58
Maravell, Nicholas C., Owner and Operator, Nick's Organic Farm, 
  LLC, Potomac, MD...............................................    60
    Prepared statement...........................................    62
Wingard, Charles A., Director of Field Operations, Walter P. Rawl 
  & Sons, Inc., Pelion, SC.......................................    65
    Prepared statement...........................................    67
Stovicek, Ph.D., Robert F., President and Chairman, Primus Group, 
  Inc., Santa Maria, CA..........................................    70
    Prepared statement...........................................    70

                           Submitted Material

King, D.V.M.,, Lonnie J., Director, National Center for Zoonotic, 
  Vector-borne & Enteric Diseases, Centers for Disease Control 
  and Prevention, U.S. Department of Health and Human Services, 
  submitted statement............................................    79


                     HEARING TO REVIEW FOOD SAFETY
           STANDARDS FOR HORTICULTURE AND ORGANIC AGRICULTURE

                              ----------                              


                         THURSDAY, MAY 14, 2009

                  House of Representatives,
          Subcommittee on Horticulture and Organic 
                                       Agriculture,
                                  Committee on Agriculture,
                                                   Washington, D.C.
    The Subcommittee met, pursuant to call, at 10:05 a.m., in 
Room 1300 of the Longworth House Office Building, Hon. Dennis 
A. Cardoza [Chairman of the Subcommittee] presiding.
    Members present: Representatives Cardoza, Massa, Costa, 
Schrader, Murphy, Peterson (ex officio), Schmidt, and Lummis.
    Staff present: Alejandra Gonzalez-Arias, Keith Jones, John 
Konya, Scott Kuschmider, John Riley, April Slayton, Rebekah 
Solem, Patricia Barr, John Goldberg, Pam Miller, Pete Thomson, 
and Jamie Mitchell.

 OPENING STATEMENT OF HON. DENNIS A. CARDOZA, A REPRESENTATIVE 
                  IN CONGRESS FROM CALIFORNIA

    The Chairman. Good morning. I would like to call this 
hearing of the Subcommittee on Horticulture and Organic 
Agriculture to review food safety standards for those two 
areas, and this hearing will now come to order.
    I would like to thank you all for taking time from your 
busy schedules to attend today's hearing of the Subcommittee. 
Today we will review the current strategies and standards used 
by the horticulture and organic sectors to prevent, monitor and 
control potential food safety hazards.
    This is the third hearing the Committee on Agriculture has 
held to help our Members gain better understanding of how to 
move forward on improving and modernizing the current food 
safety system. Maintaining the integrity of our nation's food 
supply is a paramount concern of mine, not only as the Chairman 
of this Subcommittee, but as a consumer and as a father.
    In America, we spend over $1 trillion every year on food 
both at home and in restaurants and we place our faith in food 
processors, producers, retailers and the Federal and state 
regulators to ensure those products are safe to consume. While 
consumers must play an active role in food safety efforts to 
handle products properly and to prevent cross-contamination, 
without strong controls throughout the system, consumers can 
fall victim to foodborne illnesses from unexpected sources; as 
we have seen with the recent disease outbreaks caused by peanut 
products and there was the tomato and then there was--well, it 
wasn't tomatoes, it was peppers instead.
    I believe that it is safe to say that, in general, we have 
the safest, highest quality food supply in the world. However, 
there are times when the system fails. Part of the problem may 
be that there are currently 15 different agencies tasked with 
monitoring the safety and security of our food supply. From the 
Food and Drug Administration to the Department of Agriculture 
and to the National Oceanographic and Atmospheric 
Administration, there are multiple agencies with various 
requirements for different food products that all share in the 
responsibility for food safety. Each year, thousands of Federal 
employees, most of them at USDA, inspect, verify and approve 
products at multiple points in the food distribution chain. 
However, when the system fails, consumers' confidence in the 
food supply suffers. Furthermore, the impact on farmers and 
processors, who often have nothing to do with the problem, are 
often unable to recover from the financial strains of severe 
market disruptions caused by these outbreaks.
    In 1998, the Food and Drug Administration issued fresh 
produce safety guidance. However, this guidance does not have 
the force of law, FDA has failed to meet its goals it set for 
itself for food safety inspections, and has not adequately 
supervised the states that do most of the inspection on behalf 
of FDA. Over the past 11 years, faced with weak guidance and 
safety standards, private stakeholders have stepped in using 
their own resources to fill this void. Following a number of 
financially devastating disease outbreaks, many in the fresh 
fruit and produce industry have created their own food safety 
standards and enforcement mechanisms. Their actions should 
serve as a model to other food industries that have not engaged 
proactively in food safety efforts.
    Shortly after the spinach crisis, the affected industries 
in California organized the California Spinach and Leafy Green 
Marketing Agreement which licenses first handlers to certify 
compliance with best management practices for fresh produce. 
Last year in Florida, the state implemented guidelines for 
fresh tomato supply chain and tomato best practices. These 
efforts are a solid first step towards commodity-specific risk 
and science-based standards to assure consumers of the safety 
of domestic produce.
    But food safety standards for fresh produce should not be 
limited to just leafy greens and tomatoes. Instead, these 
concepts, if proven to be effective, should serve as a 
nationwide model for improving food safety. I am pleased to 
have Joe Pezzini, Vice President of Ocean Mist Farms and 
Chairman of the Leafy Green Marketing Agreement, and Ron Ratto 
here to discuss food safety standards and protocols included 
within the California agreement.
    While examining the food safety needs of horticulture or 
the specialty crop sector, Congress must recognize that one 
standard does not fit all. The unique risk profiles of tree 
fruits and other producers must be recognized. Indeed, the old 
saying that you can't compare apples to oranges is most 
appropriate when discussing food safety. The unique nature of 
the organic sector with its existing Federal Government-
sanctioned third-party certification also has its own story to 
tell. Today we will also have the opportunity to examine the 
role of third-party audits and how those audits play into 
assuring compliance with food safety standards, such as Good 
Agricultural Practices and Good Manufacturing Practices, in a 
wide range of products under varying conditions.
    Overall, I believe consumer confidence in fresh produce is 
growing and is stronger than ever. Americans recognize and 
appreciate the benefits of fresh fruit and vegetables in their 
diets, and have recognized the efforts of the regulators and 
industry to correct the flaws in the food safety surveillance 
system. But unfortunately, it will only take one incident to 
break down this progress and move us back to square one and 
revive unproven fears that our food supply is susceptible to 
dangerous pathogens. As the Administration and Congress begin 
to identify administrative, regulatory and legislative changes 
to strengthen the nation's food supply, I remain extremely 
concerned that our food safety oversight must firmly reside in 
an agency that understands agriculture and the supply chain. 
That it leads to a better understanding, generally, with regard 
to food safety. A patchwork arrangement of multiple agencies 
leading to a systemic lack of responsibility over the safety of 
food supply is intolerable. However, tasking the wrong agency 
with food safety oversight responsibilities is just as bad. I 
am anxious to hear from our Federal witnesses about the 
capacities, capabilities and cultures of their respective 
agencies in understanding and working with the nation's food 
producers.
    In closing, every individual within the food supply chain 
from farm to fork has the responsibility to do their part to 
ensure that food served on America's dining tables is safe, 
wholesome and the best that it can be for the American people. 
We in Congress are committed to doing our part to oversee and 
direct the Federal efforts to improve food safety. I thank all 
of our witnesses for taking the time to appear before this 
panel today and for their efforts.
    [The prepared statement of Mr. Cardoza follows:]

   Prepared Statement of Hon. Dennis A. Cardoza, a Representative in 
                        Congress from California

    Thank you all for taking time from your very busy schedules to 
attend today`s hearing of the Subcommittee on Horticulture and Organic 
Agriculture. Today the Subcommittee will review the current strategies 
and standards used by the horticulture and organic sectors to prevent, 
monitor and control potential food safety hazards. This is the third 
hearing the Committee on Agriculture has held to help our Members gain 
a better understanding of how to move forward on improving and 
modernizing the current food safety system.
    Maintaining the integrity of our nation's food supply is a 
paramount concern of mine, not only as the Chairman of this 
Subcommittee, but as a consumer and as a parent. In America, we spend 
over $1 trillion every year on food--both at home and in restaurants--
and we place our faith in food producers, processors, retailers, and 
Federal and state regulators to ensure those products are safe to 
consume. While consumers must play an active role in food safety 
efforts to handle products properly and prevent cross-contamination, 
without strong controls throughout the system, consumers can fall 
victim to foodborne illness from unexpected sources, as we've seen with 
recent disease outbreaks caused by peanut products and pistachios.
    I believe that it is safe to say that in general, we have the 
safest, highest quality food supply in the world. However, there are 
times when the system fails. Part of the problem may be that there are 
currently 15 different Federal agencies tasked with monitoring the 
safety and security of our food supply. From the Food and Drug 
Administration to the Department of Agriculture to the National Oceanic 
and Atmospheric Administration--there are multiple agencies with 
various requirements for different food products that all share in the 
responsibility for food safety. Each year, thousands of Federal 
employees--most of them at USDA--inspect, verify and approve products 
at multiple points in the food distribution chain.
    However, when the system fails, consumer confidence in the food 
supply suffers. Furthermore, the impact on farmers and processors who 
often have nothing to do with the problem are often unable to recover 
from the financial strains of severe market disruptions caused by the 
outbreaks.
    In 1998, the Food and Drug Administration issued fresh-produce 
safety guidance. However, this guidance does not have the force of law, 
and FDA has failed to meet the goals it set for itself for food safety 
inspections and has not adequately supervised the states that do most 
inspections on behalf of FDA.
    Over the past 11 years, faced with weak guidance and safety 
standards, private stakeholders have stepped in, using their own 
resources to fill this void. Following a number of financially 
devastating disease outbreaks, many in the fresh produce industry have 
created their own food safety standards and enforcement mechanisms. 
Their actions should serve as a model to other food industries that 
have not engaged proactively in food safety efforts. Shortly after the 
spinach crisis, the affected industries in California organized the 
California Spinach and Leafy Green Marketing Agreement, which licenses 
first handlers to certify compliance with Best Management Practices for 
fresh produce. Last year in Florida, the state implemented guidelines 
for the fresh tomato supply chain and tomato best practices. These 
efforts are a solid first step toward commodity specific, risk and 
science based standards to assure consumers of the safety of domestic 
fresh produce. But food safety standards for fresh produce should not 
be limited to just leafy greens and tomatoes.
    Instead, these concepts, if proven to be effective, should serve as 
a nationwide model for improving food safety. I am pleased to have Joe 
Pezzini, Vice President of Ocean Mist Farms and Chairman of the Leafy 
Green Marketing Agreement, and Ron Ratto here to discuss the food 
safety standards and protocols included within the California 
Agreement.
    While examining the food safety needs of the horticulture or 
specialty crop sector, Congress must recognize that one standard 
doesn't fit all. The unique risk profiles of tree fruit and other 
producers must be recognized. Indeed, the old saying that you can't 
compare apples and oranges is most appropriate when discussing food 
safety strategies.
    The unique nature of the organic sector with its existing Federal 
Government sanctioned third-party certification also has its own story 
to tell. Today, we will also have the opportunity to examine the role 
of third-party audits play in assuring compliance with food safety 
standards, such as Good Agricultural Practices and Good Manufacturing 
Practices, in a wide range of products and under varying conditions.
    Overall, I believe consumer confidence in fresh produce is growing 
and stronger than ever. Americans recognize and appreciate the benefits 
of fresh fruits and vegetables in their diets and have recognized the 
efforts of the regulators and industry to correct flaws in their food 
safety surveillance. But unfortunately, it will only take one 
``incident'' to break down this progress, move us back to square one, 
and revive unproven fears that our food supply is susceptible to 
dangerous pathogens.
    As the Administration and Congress begins to identify 
administrative, regulatory and legislative changes to strengthen the 
nation's food supply, I remain extremely concerned that our food safety 
oversight must firmly reside in an agency that understands agriculture 
and the supply chain that leads to the dinner table. A patchwork 
arrangement of multiple agencies leads to a systemic lack of 
responsibility over the safety of the food supply. However, tasking the 
wrong agency with food safety oversight responsibilities is just as 
bad. I am anxious to hear from our Federal witnesses about the 
capacities, capabilities and cultures of their respective agencies in 
understanding and working with the nation's food producers.
    In closing, every individual within the food supply chain, from 
farm to fork, has a responsibility to do their part to ensure that food 
served on American's dining tables is safe and wholesome. We in 
Congress are committed to doing our part to oversee and direct Federal 
efforts to improve food safety, and I thank all of our witnesses for 
taking the time to appear before this panel today to help us in that 
effort.

    The Chairman. I would like to now introduce my Ranking 
Member of the Committee, Mrs. Jean Schmidt, and Jean, would you 
please proceed to make your opening statement?

  OPENING STATEMENT OF HON. JEAN SCHMIDT, A REPRESENTATIVE IN 
                       CONGRESS FROM OHIO

    Mrs. Schmidt. Thank you, Mr. Chairman, and thank you for 
holding this hearing as part of the Committee's series on food 
safety hearings. In my role as Ranking Member of the 
Horticulture and Organic Agriculture Subcommittee, I look 
forward to working with you and other Members as we examine 
this issue and any other issues that need our attention.
    This morning the Subcommittee will consider issues 
associated with the safety of fresh fruits and vegetables. I 
want to personally thank all of our witnesses for being here 
today to give us your insight. I am sure that every Member and 
witness will agree the United States enjoys the safest, highest 
quality, most abundant, affordable and diverse food supply in 
the world. However, the recent foodborne illness outbreaks 
involving Salmonella in serrano peppers last year, the peanuts 
processed by the Peanut Corporation of America, and most 
recently pistachios and raw alfalfa sprouts have caused concern 
among constituents about our food safety regulatory system.
    I think it is useful for us to review the current system to 
better understand what changes may improve food safety and 
restore consumer confidence versus those changes which are 
unnecessary and unscientific and impose regulatory costs and 
burdens. As Members of the Agriculture Committee, we must 
ensure that any proposed legislation does not hinder the 
ability of our producers to continue to provide our consumers 
with a safe and plentiful food supply. I know many producers in 
my state have concerns about the FDA regulating on-farm 
activities. I share these concerns based on the recognition 
that while the FDA has vast expertise regulating food 
processing, the agency has limited expertise or infrastructure 
to fairly and effectively regulate farm production practices. 
While one agricultural sector or region of the country may 
believe the FDA regulation is the right approach for their 
business, another sector or region may have a completely 
different view. A one-size-fits-all regulatory approach may 
work for processing, but given the diversity in crops, 
geography, climate and many other differences, it is simply 
wrong to believe that this approach would work in regulating 
on-farm production practices.
    I am very pleased that Steven Hirsch from Chillicothe, 
Ohio, will be ale to testify this morning. Mr. Hirsch grows a 
variety of fruits and vegetables in Ohio, and I know he will be 
a great voice for Ohio's produce industry.
    Mr. Chairman, while I know your home state is the largest 
producer of specialty crops, I am sure you are aware that we 
also grow specialty crops in Ohio. I want to thank you for 
allowing us to hear from other regions of the country to ensure 
a balanced approach to what the needs are of all the growers 
across the country large and small; from those selling in major 
retail outlets to those selling on local farm markets. I know 
this is a busy time of year for our producers in Ohio. 
Thankfully it is raining today. And I greatly appreciate Mr. 
Hirsch in taking the extra time to join us today.
    I look forward to today's discussion. I am going to be 
brief so that we can get started. I hope this hearing will give 
us a better understanding of what, if any, changes may be 
needed to keep our food safe. Thank you, again to all the 
witnesses that are here for joining us, and thank you, Mr. 
Chairman, for holding this timely hearing.
    The Chairman. Thank you, Mrs. Schmidt. I am very pleased 
that you can be with us today and welcome to the ranking 
membership on our Committee.
    I would like to now recognize the other Members of the 
Committee who would like to make brief opening statements. I 
would also like to mention though that I have been told that 
votes are imminent at any minute, and we are going to have to 
suspend the hearing during the votes. So, anyone who would make 
their statements brief, we would like to get into the testimony 
if possible before we break for votes. Any Member who would 
like to be recognized this time is welcome. Mr. Costa.

   OPENING STATEMENT OF HON. JIM COSTA, A REPRESENTATIVE IN 
                    CONGRESS FROM CALIFORNIA

    Mr. Costa. Thank you very much, Mr. Chairman. I too want to 
commend you for holding this hearing. It is a part of the 
critical debate, I believe, this year as we look at how we 
improve food safety in America as the Energy and Commerce 
Committee is contemplating several pieces of legislation by the 
Chairman, by former Chairman Dingell, Congresswoman DeLauro and 
Senator Durbin on the Senate side. You and I have introduced 
legislation, H.R. 1332, that also attempts to, we think, bring 
an important perspective in terms of how we approach food 
safety in our country.
    Certainly, horticulture and specialty crops have unique 
challenges as we deal with the question of food safety. I 
think, as you have indicated and the Ranking Member, we believe 
that food produced and processed and consumed in America is 
among the safest of food products anywhere in the world, but 
that doesn't mean that we can't improve. That doesn't mean that 
in the past that we have not had contamination issues that we 
have had to deal with, whether they be E. coli or Salmonella or 
other factors.
    I just want to make a couple of quick points as we discuss 
and listen to the witnesses both on the first panel and the 
second panel. You and I have witnesses on the second panel that 
are particularly involved and experienced with the California 
experience. Along with Florida, and a number of other states, 
they have among the highest standards anywhere in the country, 
and therefore anywhere in the world. But I think as we discuss 
this very, very important issue of food safety, we need to 
remind ourselves of several factors.
    First of all, American farmers and producers of food are 
consumers. They consume the food products that they grow, so 
they have a direct focus to make sure that they eat the very 
best food that they produce as do their families, their 
friends, their neighbors, and their employees. So it is 
illogical to think that people that produce this food would 
somehow be careless about that safety factor. In addition to 
that, guess what happens if in fact you have a contamination 
problem, as took place last year as you noted with the issue of 
what was first thought to be contaminated tomatoes, which later 
turned out to be jalapeno peppers imported from Mexico. It 
dropped the bottom out of the tomato market. Anyone who 
produces food knows that any time you have a potential 
contamination, it will dramatically impact their market. 
Therefore, they have not only their personal interest to make 
sure that they produce the very safest food possible, but they 
also have an economic interest to make sure in fact that that 
takes place.
    So as we discuss this issue, I am going to be looking 
forward to the panel testimony, both in the first and the 
second panel, of looking at risk assessment versus risk 
management, how do we do that best to improve our safety 
standards, to have the best gold standard in the country that 
is uniform, and not only is uniform but by the same token 
requires that any food that is imported to America meet the 
same standards that we do, as we intend to raise the bar.
    In addition, I think that it is important that we 
understand that there are differences. There are differences 
between how you apply best management practices on the farm 
whether it is products that are grown above the ground, i.e., 
permanent crops, citrus products, pistachios, walnuts, almonds, 
versus products that are grown in the ground, leafy greens, 
carrots, potatoes, those things. In addition, there are also 
distinctions between how that product is grown and harvested 
and then processed. It is much more controllable to deal with 
safety standards as food is being processed than when food is 
being harvested. So one size doesn't fit all as we try to 
increase and improve the safety standards.
    Let me close by making two other points that I think are 
critical in this discussion and in this debate: traceback, 
otherwise known as the ability to track potential products that 
are contaminated. American agriculture has made amazing strides 
in this effort. We can, whether it is tomatoes or oranges, 
within hours--if there is a potential concern or a 
contamination--traceback from the product that is in the 
grocery store to where it was processed, at what plant, in what 
orchard it grew in. I mean, we will be able at some point in 
time to be able to determine which tree that orange came from. 
So the ability to use best science and best traceback abilities 
has made phenomenal progress on a whole host of American 
products, fruits and vegetables that we grow.
    Now, one of the key issues as we improve food safety 
standards, and the Chairman mentioned this, the 13 agencies 
that are overlapping, that are cumbersome, that make it 
difficult to really do the better job that we need to do, is 
who is going to pay for this. We certainly need to improve the 
ability to monitor and to ensure consumer protection. However, 
the new Administration has provided additional funding to the 
Food and Drug Administration. That is good. We also need to 
figure out where the hand-in-glove operation is between the 
United States Department of Agriculture together with the Food 
and Drug Administration. That relationship, in the past, 
oftentimes has been lacking. We heard yesterday from the White 
House summit that they want to do a better job of coordinating 
their efforts between Secretary Vilsack and Secretary Sebelius. 
That is a good thing, but we need to ensure that when they do 
this that they understand that farmers are price takers and not 
price makers.
    Therefore, as we try to develop an improved and more robust 
food monitoring effort to protect consumers in America and when 
we export our products, that the ability to ensure that farmers 
have the ability to deal with those costs if they are increased 
can be done in such a way that they don't have to take the 
brunt of those additional costs.
    Those are the key areas I think we have to deal with, Mr. 
Chairman. I look forward to your active involvement. I know you 
are passionate about this subject matter as am I, and obviously 
we have some work to do as this larger debate continues. Thank 
you.
    The Chairman. Thank you, Mr. Costa. I appreciate your 
comments.
    I would like to welcome one of our newest Members to the 
Committee, Mr. Schrader. You can't say that you are the newest 
Member anymore because there are several others that just 
joined us today, but as they come in I will introduce them. 
Thank you for being here with us. I understand you are giving 
up your right to make an opening statement and we will let you 
ask many questions as the hearing goes forward. The Chairman 
requests that other Members submit their opening statements for 
the record.
    [The prepared statements of Mr. Peterson and Mrs. Lummis 
follow:]

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

    Thank you, Chairman Cardoza, for holding this hearing today to 
focus on food safety efforts in the horticulture and organic 
agriculture industries.
    Last month, the Committee held a Full Committee hearing and a 
Livestock, Dairy and Poultry Subcommittee hearing on food safety 
issues, so we are committed to looking at this issue from all angles 
before we decide how best for the Committee to move forward. Food 
safety is an important issue on the minds of many in Congress as well 
as in the Obama Administration. We've all witnessed the impact of 
recent foodborne disease outbreaks, both on the public and the growers 
involved.
    These incidents have highlighted the gaps in our current food 
safety system and the important role of government, industry and 
consumers to prevent foodborne illness.
    Time and again, we've seen evidence that the Food and Drug 
Administration does not have the capacity to take the preventive 
measures needed to adequately protect the food supply. In many cases, 
states and industry groups have stepped in to fill the void.
    The need to improve and modernize food safety at the Federal level 
is clear, and the Agriculture Committee is one of the Committees 
responsible for developing a roadmap to accomplish this. We will be 
open and transparent in our approach, working with everyone who is 
interested in this important issue.
    I look forward to hearing from our witnesses today and to working 
together as Congress considers action on this important issue.
                                 ______
                                 
   Prepared Statement of Hon. Cynthia M. Lummis, a Representative in 
                         Congress from Wyoming

    Thank you Mr. Chairman,

    It is an honor to serve on this Subcommittee with you and Ranking 
Member Schmidt. I am pleased that this first hearing delves into the 
important task of ensuring our nation's produce continues to be safe 
for consumers. I look forward to hearing from today's industry 
witnesses about how their own efforts to bolster food safety have been 
successful.
    I am particularly interested to hear the opinions of today's panels 
about the costs to producers and consumers associated with food safety 
efforts. American farmers already produce the safest food supply in the 
world. Many producers exercise stringent, voluntary food safety 
procedures because they understand that the quality of their product is 
the primary determinant to the success of their business.
    I certainly agree that in light of recent outbreaks of foodborne 
illnesses that these issues require careful attention by consumers, 
industry, and the government. I am concerned that overreach on the part 
of the Federal Government with regard to on-farm practices would raise 
the cost of doing business to unsustainable levels. As we all know, the 
costs of producing are simply passed on to consumers in the form of 
higher food prices. I think we all understand the need to pay for the 
continued safety of our food, but I'm not certain a one-size-fits all 
approach, foisted on producers by the Federal Government will be the 
most cost-effective solution.
    This is especially true in light of current efforts to impose a 
national energy tax on all Americans through a cap and trade system. 
Energy related inputs are the single largest operating costs most 
producers incur. A government imposed energy tax would, by any 
estimation, increase the cost of energy to plant, grow, harvest and 
deliver food. Under the burdensome weight of a national energy tax, I 
am concerned that producers seeking any means to recover capital will 
have less incentive to voluntarily invest in food safety precautions. 
Worse, a national energy tax combined with a one-size-fits-all food 
safety mandate would clearly be a double edged sword, slicing 
producer's profitability at every turn and raising food prices at the 
grocery store at precisely the wrong time for our economy.
    I look forward to hearing the thoughts of the panelists about these 
important issues facing the agriculture industry. I yield back.

    I now would like to introduce our witnesses today and 
welcome them to the Committee. The first witness that we would 
like to welcome is David Acheson, who is Associate Commissioner 
for Foods at U.S. Food and Drug Administration, Rockville, 
Maryland. Thank you, Dr. Acheson, for being here with us today. 
Mr. David Shipman, acting Administrator of the Agriculture 
Marketing Service at the U.S. Department of Agriculture here in 
Washington. Accompanying Dr. Acheson is Dr. Steven Solomon, 
D.V.M., Assistant Commissioner for Compliance and Policy, 
Office of Regulatory Affairs, U.S. Food and Drug 
Administration, also in Rockville. Welcome all three gentlemen 
for being here. Dr. Acheson, please begin when you are ready.

        STATEMENT OF DAVID W.K. ACHESON, M.D., F.R.C.P.,
     ASSOCIATE COMMISSIONER FOR FOODS, U.S. FOOD AND DRUG 
    ADMINISTRATION, ROCKVILLE, MD; ACCOMPANIED BY STEVEN M. 
               SOLOMON, D.V.M., M.P.H., ASSISTANT
         COMMISSIONER FOR COMPLIANCE POLICY, OFFICE OF
             REGULATORY AFFAIRS, U.S. FOOD AND DRUG
                         ADMINISTRATION

    Dr. Acheson. Thank you, and good morning, Chairman Cardoza 
and Members of the Subcommittee. I am Dr. David Acheson, 
Associate Commissioner for Foods at FDA. It is part of Health 
and Human Services. With me today is Dr. Steven Solomon, 
Assistant Commissioner for Compliance Policy in FDA's Office of 
Regulatory Affairs, which oversees the agency's field staff.
    We are very pleased to be with you to discuss the issues 
relating to the safety of fresh produce. My testimony will 
briefly describe some of the challenges that we face in 
preventing fresh produce from becoming contaminated, as well as 
some of the specific measures the agency is taking to prevent 
future outbreaks.
    Improving our food safety system is a high priority for the 
Administration. The President has established a working group 
on food safety and asked that it make recommendations on 
updating our food safety laws, fostering coordination 
throughout the government, strengthening surveillance and 
enhancing enforcement. FDA is playing an integral part in that 
working group's efforts.
    The President's Fiscal Year 2010 budget includes an 
increase of approximately $260 million for food safety efforts 
at FDA. This funding will enable the agency to increase the 
number and scope of food inspections, improve domestic food 
surveillance, lab capacity and domestic response capabilities 
to prevent and control foodborne illness. The budget will allow 
FDA to increase the number of field staff working in the foods 
program by 400 full-time equivalents.
    Supply chain safety and security rely on the principle of 
risk-based prevention with verification. The budget will 
strengthen food safety by improving the science upon which 
regulatory decisions and enforcement rely. FDA will conduct 
additional risk analyses and modeling and evaluation to improve 
decision making and better target our resources.
    Food can become contaminated at many different steps, on 
the farm, in processing, distribution facilities, during 
transit, at retail or in the home. Changes in consumer 
preferences and industry practices, and the rising volume of 
imports, pose challenges that require us to adapt our current 
food protection strategies.
    Fresh produce presents specific safety challenges and the 
number of illnesses associated with fresh produce is a 
continuing concern for FDA. The fact that produce is often 
consumed raw or with minimal processing contributes to its 
potential as a source of foodborne illness. Because most 
production is grown in an outdoor environment, it is 
susceptible to contamination from pathogens that may be present 
in soil, water, animals, in or near fields or packing areas. 
Produce is vulnerable to contamination from environmental 
conditions, inadequate production safeguards or inadequate 
sanitation of equipment and facilities. Traceback 
investigations are more difficult when they involve fresh 
produce because the food is perishable, its labeling is minimal 
or no longer available for review.
    I want to emphasize the critical role of food producers and 
processes in ensuring the safety of foods they introduce into 
commerce. Strong food safety programs begin with the promotion 
of strong food safety throughout each farm, processor or 
distributor in the supply chain. Establishing such a culture 
requires a strong sense of corporate responsibility and 
continuous oversight.
    In recent years, FDA has initiated numerous activities to 
address the safety concerns associated with production of fresh 
produce. I would like to describe some of these efforts to 
strengthen the research that supports the food safety programs. 
Many of these efforts are conducted in collaboration with 
industry and our state and Federal regulatory partners. FDA's 
current research agenda is focused on improving the 
identification and detection of disease-causing bacteria and 
contaminants in a variety of foods. We are undertaking 
extensive research on the detection, characterization and 
behavior of foodborne pathogens, microbial genetics and 
molecular biology.
    For instance, FDA has developed rapid methods for 
serotyping Salmonella in produce such as cantaloupes, tomatoes 
and peppers. These rapid methods will aid in the analysis of 
domestic and imported produce samples, and are vital in our 
attempt to develop risk assessment models for pathogens and 
intervention strategies that protect public health.
    Collaborative research efforts further strengthen the 
science base for our food safety programs. FDA works closely 
with several USDA agencies including analysis of water samples 
from California's Salinas watershed for E. coli O157:H7 and to 
relate the location of bacteria to geographical, seasonal and 
rainfall variations.
    In September 2008, FDA established the Western Center for 
Food Safety at the University of California, Davis to conduct 
research, education outreach addressing issues that interface 
production agriculture and food safety. In its first year the 
Center will conduct produce safety research addressing the 
science behind Good Agricultural Practices and develop outcome 
metrics, and an updated literature review related to 
perchlorate and its impact on food safety. The Center quickly 
responded to our need for help on the validation of processes 
to destroy Salmonella in pistachios and is working with both 
the pistachio and almond industries to control Salmonella on 
those tree nuts.
    FDA is currently working on updating our Guide to Minimize 
Microbial Food Safety Hazards for Fresh Fruits and Vegetables 
based again on the input of industry, states and other 
stakeholders. FDA has assisted industry in developing 
commodity-specific food safety guidelines for commodities such 
as lettuce, melons and tomatoes and we are working on similar 
guidance for herbs and green onions.
    Building food safety partnerships with our Federal, state 
and local colleagues is key to having a comprehensive food 
safety system. FDA looks forward to strengthening these 
partnerships by building up each other's skills to further 
improve the safety of the U.S. food supply.
    Thank you for the opportunity to discuss these important 
issues and I would be happy to answer any questions that you 
may have.
    [The prepared statement of Dr. Acheson follows:]

  Prepared Statement of David W.K. Acheson, M.D., F.R.C.P., Associate
 Commissioner for Foods, U.S. Food and Drug Administration, Rockville, 
                                   MD

Introduction
    Good morning, Chairman Cardoza and Members of the Subcommittee. I 
am Dr. David Acheson, Associate Commissioner for Foods at the Food and 
Drug Administration (FDA or the Agency), which is part of the 
Department of Health and Human Services (HHS). With me today is Dr. 
Steven Solomon, Assistant Commissioner for Compliance Policy in FDA's 
Office of Regulatory Affairs, which oversees the Agency's field staff. 
We are pleased to be with you today to discuss issues related to the 
safety of fresh produce.
    FDA is the Federal agency that has statutory responsibility for the 
safety of almost everything we eat, except for meat, poultry, and 
processed egg products, which are regulated by our partners at the U.S. 
Department of Agriculture (USDA). FDA is committed to ensuring that the 
U.S. food supply continues to be among the safest in the world.
    My testimony will describe some of the challenges we face both in 
preventing fresh produce from becoming contaminated in the first place 
and in investigating outbreaks associated with fresh produce. I will 
also discuss some of the specific measures FDA is taking to enhance the 
safety of fresh produce and other foods to prevent future outbreaks and 
to improve product tracing when an outbreak occurs or there is a 
product recall.
    Food can become contaminated at many different steps--on the farm, 
in processing or distribution facilities, during transit, at retail and 
food service establishments, and in the home. In recent years, we have 
done a great deal to prevent both intentional and unintentional 
contamination of food at each of these steps. FDA has worked with other 
Federal, state, local, tribal, and foreign counterpart food safety 
agencies, as well as with law enforcement and intelligence-gathering 
agencies, and with industry, consumer groups, and academia to 
significantly strengthen the nation's food safety and food defense 
system across the entire distribution chain.
    This cooperation has resulted in greater awareness of potential 
vulnerabilities, the creation of more effective prevention programs, 
new surveillance systems, and the ability to respond more quickly to 
outbreaks of foodborne illness. However, changes in consumer 
preferences, changes in industry practices, and the rising volume of 
imports pose challenges that are requiring us to adapt our current food 
protection strategies.
    Improving our food safety system is a high priority for the new 
Administration. The President has established a Food Safety Working 
Group and asked that it make recommendations on updating our food 
safety laws, fostering coordination throughout the government, 
strengthening surveillance and enhancing enforcement. FDA is playing an 
integral part in the working group's efforts.
    The President's Fiscal Year (FY) 2010 budget includes an increase 
of $259 million for food safety efforts under the ``Protecting 
America's Food Supply'' initiative. The level of new funding will 
increase the number and scope of food inspections, and improve domestic 
food surveillance, laboratory capacity, and domestic response 
capabilities to prevent and control foodborne illness. The budget will 
allow FDA to increase the number of field staff working in the Foods 
Program by 404 full-time equivalents (FTEs), an approximate 20 percent 
increase compared to FY 2009 appropriations.
    The overall goal of the Protecting America's Food Supply initiative 
is to better protect American consumers by preventing intentional and 
unintentional contamination. This effort invests in priorities that 
strengthen the safety and security of the supply chain for foods. 
Supply chain safety and security relies on the principle of risk-based 
prevention with verification. Under this principle, FDA will hold all 
segments of industry accountable for ensuring that their products meet 
U.S. safety standards.
    The initiative focuses on foreign and domestic sources of food 
ingredients, components, and finished products at all points in the 
supply chain, including their eventual use by the American public. 
Within this initiative, the budget provides for $94 million in new user 
fees to register food facilities and increase food inspections, issue 
food and feed export certifications, and reinspect food facilities that 
fail to meet FDA's safety standards.
    The budget also will allow FDA to strengthen the safety and 
security of the supply chain by working with domestic and foreign 
industry to develop new control measures for all levels of food 
production and processing, and verify that these control measures are 
effective when implemented.
    The Agency will strengthen food safety by improving the science 
upon which regulatory decisions and enforcement rely. FDA will conduct 
risk analysis, modeling and evaluation to improve risk-based decision-
making and better target our resources. This work will also include 
improving FDA's ability to attribute contamination to specific foods 
and thereby promote faster response and better resource targeting.
    Finally, the budget provides resources for FDA to work with state 
and other Federal agencies to collect baseline data to measure the 
impact of our food safety efforts and measure the reduction of 
foodborne illnesses in the United States. This will allow the Agency to 
adjust food safety priorities and ensure that food programs achieve the 
best results for public health.

Challenges of Fresh Produce
    Fresh produce presents special safety challenges, and the number of 
illnesses associated with fresh produce is a continuing concern for 
FDA. For example, consumption of produce in its fresh (or raw) form, 
particularly ``ready-to-eat'' products, has increased substantially 
during the past decade. The fact that produce is often consumed raw or 
with only minimal processing, without intervention that would eliminate 
pathogens (if they are present) prior to consumption, contributes to 
its potential as a source of foodborne illness. New products and new 
consumption patterns challenge our food safety efforts.
    Because most produce is grown in an outdoor environment, it is 
susceptible to contamination from pathogens that may be present in the 
soil, in agricultural water or water used for post-harvest practices 
(e.g., washing or cooling), in manure used as fertilizer, or due to the 
presence of animals in or near fields or packing areas. Produce also 
may be vulnerable to contamination due to inadequate worker health and 
hygiene protections, environmental conditions, inadequate production 
safeguards, or inadequate sanitation of equipment and facilities. Fresh 
produce is produced on tens of thousands of farms, and contamination at 
any one step in the growing, packing, and processing chain can be 
amplified throughout the subsequent steps.
    We also note that traceback investigations for contaminated food, 
which we discussed with this Subcommittee last year, are more difficult 
when they involve fresh produce because the food is perishable and the 
produce item (along with any packaging or labels) is usually no longer 
available for testing by the time illnesses are reported. In addition, 
fresh fruits and vegetables are often sold loose without any packaging 
that could provide information about its source. Further, practices 
such as packing or repacking produce from multiple sources add 
complexity to traceback investigations.
    Consequently, addressing the way fresh produce is grown, harvested, 
and moved from field to fork is crucial to minimizing the risk of 
microbial contamination. In recent years, FDA has initiated several 
activities to address safety concerns associated with the production of 
fresh produce. Some of these activities include: working with industry 
and others to develop commodity specific guidance on ways to prevent or 
minimize potential contamination; conducting educational outreach to 
consumers on safe food handling practices; intensively investigating 
farms and packing sheds implicated in outbreaks to learn how the 
produce may have been contaminated; sampling and analyzing both 
domestic and imported produce for pathogens; and working with industry 
and foreign countries to promote the use of good growing, harvesting, 
packing, transporting, and processing practices.
    It also is important to emphasize the critical role of food 
producers and processors in ensuring the safety of the foods they 
introduce into commerce. Strong food safety programs in food production 
facilities begin with the promotion of a strong culture of food safety 
throughout each farm or firm in the supply chain, including the need 
for preventive measures and ways to detect and correct problems before 
they cause harm. Establishing this culture requires a strong sense of 
corporate responsibility and continuous management oversight.
    One of the key messages that FDA has been emphasizing over the last 
few years is that all food companies, both large and small, must know 
their suppliers. In today's complex, global market, this may require 
close interaction with entities throughout the food supply chain, 
including growers, manufacturers, distributors, retailers, food service 
providers, and importers.
    From the perspective of both public health and the food industry, 
preventing foodborne illness from occurring is much more desirable than 
having to minimize the damage caused by such outbreaks by undertaking 
food recalls, which can often bring production to a halt, disrupt 
markets, affect consumer confidence, and cause financial loss. It is 
critical that all segments of the food production industry, from farm 
to retailer, take measures to ensure the safety of their ingredients 
and their finished products.

Initiatives To Enhance Produce Safety
    To reduce the risk of foodborne illness at all points in the food 
chain, FDA utilizes a ``farm-to-fork'' approach to food safety. This 
approach systematically applies risk management principles at each step 
as food moves from growers and producers to consumers. While FDA has 
been working to enhance produce safety for a number of years, the 
Agency has sharpened its focus in response to recent produce-related 
outbreaks.
    I will elaborate on the following key areas where FDA has focused 
its food safety efforts:

   strengthening the research programs that support FDA's food 
        safety program with an emphasis on prevention; and

   enhancing effective partnerships.
Strengthening the Scientific Basis for FDA's Program to Improve Food 
        Safety
    Strengthening the research programs that support FDA's program to 
improve food safety is essential to improving the Agency's 
effectiveness at protecting public health. Our current research agenda 
is focused on improving the identification and detection of disease-
causing bacteria and contaminants in a variety of foods. Current 
research topics include questions related to how and where in the food 
chain microbiological and chemical contamination of foods takes place, 
biotechnology and allergenicity issues, seafood safety, dietary 
supplement safety, color additive safety, and consumer studies. The 
determination of microbiological and chemical risks and their 
mitigation drives our research program.
    FDA and our regulatory partners are doing extensive research on the 
detection, characterization, and behavior of foodborne pathogens, 
microbial genetics, and molecular virology. For instance, the Centers 
for Disease Control and Prevention (CDC) and FDA have developed rapid 
methods for serotyping Salmonella in produce (such as cantaloupes, 
tomatoes, and peppers). These rapid methods will aid FDA as we perform 
analysis of both domestic and imported produce samples. These efforts 
also are vital in our attempt to develop risk assessment models for 
pathogens and intervention strategies to reduce the public health risk 
that these pathogens present. FDA's research in the area of chemical 
contaminants focuses on the development of detection methods and 
toxicology studies. More rapid and precise testing methods to identify 
contaminants are important for minimizing the spread of foodborne 
disease once it occurs.
    Collaborative research efforts further strengthen the scientific 
basis for our food safety programs. For example, for the past decade, 
FDA has worked closely with USDA's Agricultural Research Service (ARS) 
and Cooperative State Research, Education, and Extension Service 
(CSREES) to coordinate and mutually support our respective research 
efforts related to produce safety. In this spirit, we collaborated with 
ARS and CSREES to analyze water samples from California's Salinas 
watershed for E. coli O157:H7, and to relate the location of bacteria 
to geographical, seasonal, or rainfall variation. An extension of this 
research will look for sources of E. coli O157:H7 in the Salinas 
Valley. Information obtained from this study will be used to inform 
produce growers about strategies to prevent pre-harvest microbial 
contamination.
    In addition, we are working with academia, industry, other Federal 
agencies, and state governments to develop both risk-based 
microbiological research programs and technology transfer programs to 
ensure that the latest food technology reaches the appropriate end-
users along the supply chain. We strengthen the scientific basis for 
our program by collaborating and learning with others, such as 
participating in many scientific and technical meetings on food safety.
    In 2006, FDA began working with officials in California and with 
industry to assess the prevalence of factors in and near the field 
environment, which may contribute to potential contamination of leafy 
greens with E. coli O157:H7 and the extent to which Good Agricultural 
Practices and other preventive controls were being implemented as part 
of a multi-year Leafy Greens Safety Initiative. In 2007, FDA began a 
similar initiative, in collaboration with state health and agriculture 
officials from Florida and Virginia, CDC, and several universities, to 
prevent foodborne illness associated with tomatoes from those states. A 
significant component of these ongoing initiatives is assessing factors 
(including irrigation water, drought and flooding events, the proximity 
of animals to growing fields, and post-harvest water use) that are most 
likely to have been associated with previous contamination of tomatoes 
and leafy greens. We have made significant progress in our 
understanding of how Salmonella contaminates tomatoes on the farm. We 
also have improved testing methods to recover Salmonella from fresh 
tomatoes. These findings have already been factored into our regulatory 
surveillance testing and farm inspections and underscore the importance 
of our Good Agricultural Practices guidance.
    Through the safety initiative, FDA has learned that farms and 
processing firms are committing resources to implement current Good 
Manufacturing Practices (cGMPs) and Good Agricultural Practices (GAPs). 
The initiative also revealed that the extent to which growers 
implemented GAPs was variable and that improvement could be made. FDA 
currently is evaluating information that was gathered through the 
initiative and plans to utilize this information to develop produce 
safety-related policy and outreach. By identifying practices and 
conditions that can lead to product contamination, FDA and our safety 
partners hope to further improve guidance and policies intended to 
minimize chances of future disease outbreaks, as well as ascertain 
future produce-safety research, education and outreach needs.
    In 2007, the FDA-affiliated Joint Institute for Food Safety and 
Applied Nutrition (JIFSAN) and the University of Florida sponsored a 
workshop to improve understanding of how tomatoes become contaminated 
with Salmonella and other pathogens. Also that year, FDA, the National 
Center for Food Safety and Technology (NCFST), and the University of 
Georgia's Center for Food Safety cosponsored a workshop on microbial 
testing to reach a consensus on the role of microbial testing in 
ensuring the safety of produce.
    Last year, FDA convened an Interagency Risk Assessment Consortium 
(lRAC) and, working with JIFSAN, held a workshop to identify and 
prioritize research needs for conducting a quantitative risk assessment 
of foodborne illness caused by E. coli O157:H7 from the consumption of 
leafy green vegetables. In September 2008, FDA established the Western 
Center for Food Safety at University of California in Davis to conduct 
research, education and outreach that addresses issues that interface 
production agriculture and food safety. In its first year, the Center 
will focus on conducting produce safety research addressing the science 
behind Good Agricultural Practices and develop outcome metrics and an 
updated literature review related to perchlorate and its impact on food 
safety. The Center quickly responded to our need for work on the 
validation of processes to destroy Salmonella on pistachios and is 
working with both the pistachio and almond industries to control 
Salmonella on those tree nuts.
    In June 2009, FDA and NCFST will participate in a Food Safety and 
Technology Day in conjunction with the annual meeting of the 
International Sprout Growers Association in Chicago.
    FDA also has conducted a number of activities to share information 
with, and solicit information from, our stakeholders. In 2007, FDA held 
two public hearings concerning the safety of fresh produce to share 
information about recent outbreaks of foodborne illness related to 
fresh produce and to solicit comments, data, and additional scientific 
information on this issue. In late 2008 and early 2009, FDA held two 
public hearings requesting data and other information on industry 
practices and available technologies relevant to improving our ability 
to more quickly and accurately track fresh produce through the supply 
chain, especially during a produce-associated foodborne illness 
outbreak. Through these and other meetings, we are soliciting input 
from, and actively engaging, all our stakeholders on ways to improve 
the safety of fresh produce.

Enhancing Effective Partnerships
    To succeed in our science-based efforts to promote food safety, we 
need to enhance our collaborations with stakeholders interested in food 
safety, particularly with respect to fresh produce. FDA has worked with 
the public and private sector to encourage industry to follow the 
recommendations and standards contained in FDA guidances. After 
enlisting the help of the scientific community and industry, FDA 
published the ``Guide to Minimize Microbial Food Safety Hazards for 
Fresh Fruits and Vegetables.'' This guide (published in 1998) 
recommends GAPs and cGMPs that growers, packers, and shippers can take 
to address common risk factors in their operations. The guide was 
issued in several languages and FDA has conducted outreach, both 
domestically and internationally, to encourage its implementation. In 
September 2008, FDA published a Federal Register Notice soliciting 
comments and data to inform the agency in updating the 1998 guidance. 
We are currently drafting revised, proposed guidance based on these 
comments and other input. In addition, FDA has assisted industry in 
developing a number of commodity-specific food safety guidelines for 
the commodities most often associated with foodborne illness outbreaks. 
These include guidelines for lettuce and leafy greens, melons, and 
tomatoes. We will be working with industry on similar guidelines for 
herbs and green onions in the near future.
    In 1999, there were six outbreaks and 390 reported illnesses 
associated with eating contaminated fresh sprouts. FDA published two 
guidance documents for seed and sprout producers that year. Following 
release of the sprout guidances, the number of outbreaks associated 
with the consumption of sprouts and the number of illnesses in an 
outbreak appeared to decline. There were no reported outbreaks 
associated with sprouts in 2005, 2006, or 2007. In late 2008, however, 
there was one sprout-associated Salmonella outbreak. In 2009, an 
ongoing Salmonella outbreak linked to sprouts has resulted in more than 
200 confirmed cases of illness reported to CDC. Sprouts have also been 
linked to Listeria illnesses in 2009. On May 1, 2009, FDA issued a 
letter to seed suppliers, distributors, and sprouters urging them to 
review their operations in light of FDA's guidance and other available 
information. FDA will be conducting outreach to other industry members, 
retailers, consumer groups, and state partners. FDA intends to continue 
to work closely with all parties to identify, and promote adoption of, 
effective preventive controls.
    FDA's efforts in this area are ongoing. In February 2008, FDA 
finalized its ``Guide to Minimize Microbial Food Safety Hazards of 
Fresh-cut Fruits and Vegetables'' (the Fresh-cut Guide). This guidance 
complements FDA's cGMPs for food processing facilities. It is intended 
to assist firms in minimizing the microbial food safety hazards of 
fresh-cut produce by providing recommendations specific to fresh-cut 
processing operations. In addition, FDA is leading an effort through 
the Codex Alimentarius Commission, the international food safety 
standards body, with support of the Food and Agriculture Organization/
World Health Organization (FAO/WHO) to develop commodity-specific 
annexes to the Codex hygienic code for fresh fruit and vegetable 
production, starting with an annex for fresh leafy vegetables and 
herbs.
    We will continue to work with Federal, state, local and 
international food safety partners and with industry to develop 
guidance, conduct research, develop educational outreach materials, and 
initiate other commodity- or region-specific programs to enhance the 
safety of fresh produce.
    The close collaboration between Federal and state food safety 
officials in response to the E. coli O157:H7 outbreak associated with 
fresh spinach is a good example of the effective working relationships 
we enjoy with our food safety partners. On March 23, 2007, FDA and 
California's Department of Health Services (CDHS) released a joint 
report on an extensive investigation into the causes of the 2006 E. 
coli O157:H7 outbreak that was associated with contaminated Dole brand 
baby spinach and resulted in 204 confirmed illnesses and three deaths. 
The inquiry was conducted by the California Food Emergency Response 
Team (CalFERT), a team of experts from FDA's district offices in San 
Francisco and Los Angeles and CDHS. Potential environmental risk 
factors for E. coli O157:H7 contamination identified in the report 
included the presence of wild pigs and the proximity of irrigation 
wells to surface waterways potentially exposed to feces from cattle and 
wildlife. FDA has established agreements with six additional states to 
establish emergency response teams, similar to CalFERT, around the 
country.
    Another important example of a food safety partnership we continue 
to enhance is the FDA/USDA Food Emergency Response Network (FERN). FERN 
is a network of Federal, state, and local laboratories capable of 
testing food samples for microbiological, chemical, and radiological 
threat agents. This partnership provides essential analytical expertise 
and surge capacity in case of emergencies. The number of participating 
laboratories has increased to 151 laboratories and 19 cooperative 
agreement laboratories in FY 2009, compared to 30 participating 
laboratories in March 2004 (near FERN's inception). The FERN network 
proved to be a critical asset in the E. coli O157:H7 outbreak 
associated with fresh spinach. FERN analysts worked closely with CDC's 
Laboratory Response Network personnel to harmonize and approve a 
modified FERN method for detecting E. coli O157:H7 in spinach. This 
method substantially improved the testing of spinach samples as it 
allowed for the detection of E. coli O157:H7 at lower levels. FDA, with 
CDC, has provided technical assistance to USDA's Agricultural Marketing 
Service's Microbiological Data Program by providing information 
important to the planning of microbiological testing of fresh produce.

Legislative Initiatives
    As noted earlier, the President has established a working group on 
food safety and asked that it make recommendations on updating our food 
safety laws, fostering coordination throughout the government, and 
enhancing enforcement. FDA's experience with recent foodborne disease 
outbreaks and related investigations and recalls have highlighted the 
need to enhance FDA's statutory authority to better protect consumers. 
We are reviewing with HHS, as well as other Federal and state food 
safety partners, prior requests to Congress to strengthen the Agency's 
ability to protect Americans from foodborne illness. At this time, we 
want to highlight the previously identified need for new or enhanced 
authority in several areas:

    1. Authority for FDA to require preventive controls for foods;

    2. Authority for enhanced access to records during routine 
        inspections to ensure that inspectors have access to all 
        information that bears on food safety; and

    3. Authority for FDA to require food facilities to renew their 
        registrations more often, and to allow FDA to modify the 
        registration categories.

    In addition, we note that mandatory recall authority would be a 
useful tool that in some circumstances could result in faster removal 
of implicated products from commerce.

Conclusion
    FDA is working hard to ensure the safety of food, in collaboration 
with its Federal, state, local, and international food safety partners, 
and with industry, consumers, and academia. As a result of this 
effective collaboration, the U.S. food supply continues to be among the 
safest in the world. We have made progress, but recent incidents of 
contaminated food demonstrate the challenges we face and the need to 
enhance our efforts. We will continue to strive to reduce the incidence 
of foodborne illness to the lowest level possible. Thank you for the 
opportunity to discuss FDA's continuing efforts to improve the safety 
of fresh produce. I would be happy to answer any questions.

    The Chairman. Thank you, Dr. Acheson.
    We are going to allow Mr. Shipman to briefly present his 
testimony. The bells have rung, although we didn't hear them in 
this room, and so there is a vote on so we are going to have 
break. There in fact are five votes. Mr. Shipman, if you could 
make your opening statement. Make sure you keep it within the 
allotted time. We have your full testimony in the record with 
your written copy, but I want to give you as much time as you 
need now, but unfortunately we may have to break and then come 
back. We will all ask questions after the votes. Mr. Shipman, 
please proceed.

     STATEMENT OF DAVID R. SHIPMAN, ACTING ADMINISTRATOR, 
AGRICULTURAL MARKETING SERVICE, U.S. DEPARTMENT OF AGRICULTURE, 
                        WASHINGTON, D.C.

    Mr. Shipman. Mr. Chairman and Members of the Subcommittee, 
good morning and thank you for the invitation to appear here 
today. I will just briefly cover the AMS programs and services. 
As you indicated, my written testimony provides more detail.
    As you know, the Food and Drug Administration is a Federal 
agency with primary responsibility for food safety of fruits 
and vegetables. Within USDA the Food Safety Inspection Service 
holds similar responsibility for meat, poultry and egg 
products. The mission of the Agricultural Marketing Service is 
to facilitate the strategic marketing of agricultural products 
in the domestic and international market. AMS is not a food 
safety agency. We are an agency with a long, successful history 
of working with producers and processors on marketing programs 
that involve inspection of product quality, and verification of 
production processes. Some of these programs do incorporate 
food safety-related elements such as those involving the 
verification that growers, handlers and processors are 
following FDA guidance and commodity-specific agricultural best 
practices.
    In the area of specialty crops, our program is carried out 
with a Federal workforce of 800 full-time and part-time 
employees plus an additional 3,500 federally licensed state 
employees. These individuals are highly trained professionals 
that adhere to strict ethical standards and have a proven 
record of providing impartial, high-quality service on a user-
fee basis.
    One example of an audit-based program fashioned around 
food-handling processes is our Good Agricultural Practices and 
Good Handling Practices Audit Verification program. This 
program verifies adherence of farms and packing houses to FDA's 
Guide to Minimize Microbial Food Safety Hazards for Fresh 
Fruits and Vegetables. It also permits the use of an AMS seal 
as a marketing claim. It is a uniform nationwide program that 
is voluntary and it is run on a user-fee basis. The impetus of 
these programs originated because various state governments and 
industry organizations were seeking better ways to meet the 
increasing demand of retail customers for verification of 
product quality and safety. Participants in the program 
demonstrate control in several safety areas of their operation 
to minimize microbial hazards including: water supplies, manure 
management, worker health and hygiene, sanitation of 
facilities, field and packing area sanitation, transportation 
and product traceback. The minimum that we conduct audits under 
these programs is twice a year. Facilities failing an audit are 
subject to additional audits, and all facilities participating 
in the program are subject to unannounced audits.
    Primary users of the program are fresh fruit and vegetable 
growers, packers, shippers and others in the marketing chain. 
For the Fiscal Year 2008, we conducted audits on 1,131 separate 
farms and facilities. The audits were performed in 36 states 
and in Puerto Rico. The trend for this program is increasing. 
In 2006 we did only 352, last year we did 400 audits and this 
year in the first 5 months we have done over 800. So the trend 
is continuing up.
    Another example of an audit-based program that AMS runs is 
our Qualified-Through-Verification program. This one is used 
primarily by fresh-cut plants participating and we have seven 
of them. The QTV, or the Qualified-Through-Verification, is a 
voluntary, again, user-fee program that provides third-party 
verification of fresh-cut processors that they adhere to their 
own Hazard Analysis Critical Control Point, or HACCP plans. 
Under the program, processors identify and document critical 
points in their production process, measure performance of 
their operation at the critical points, and position themselves 
to detect and address the deficiencies.
    Now I would like to look for a moment at our marketing 
orders and agreements. Under the authority of the Agricultural 
Marketing Agreement Act of 1937, marketing orders and 
agreements assist farmers and handlers by allowing them to 
collectively address marketing problems. Through an order or an 
agreement, farmers and handlers may set minimum quality 
requirements, standardize packaging, regulate the flow of 
product to the market, and implement other regulations 
including consumer education, research and advertising. 
Marketing agreements only apply to handlers who voluntarily 
sign an agreement, while marketing orders set regulations on 
handlers in a specific region once the program is approved in a 
grower referendum. We currently have 32 fruit and vegetable 
marketing orders.
    Under the authority of the Act, the presence or absence of 
harmful pathogens, toxins or other contaminants is considered a 
quality characteristic. In response to producer requests, we 
have incorporated food quality-related requirements in the 
marketing agreements and marketing orders over many years. For 
example, testing for Aflatoxin, considered a possible human 
toxin, has been required for U.S.-grown peanuts since 1965. 
Beginning in 2005, pistachio handlers were required to test all 
nuts destined for human consumption for Aflatoxin, and then in 
the 2007 and 2008 crop almond handlers were required to treat 
almonds prior to shipment to reduce the chance of Salmonella 
contamination.
    Following the September 2006 E. coli outbreak linked to 
fresh spinach, as you mentioned earlier, Mr. Chairman, the 
California Department of Food and Agriculture worked with the 
California leafy green market and they developed the California 
Leafy Greens Marketing Agreement in February. At the same time 
California was starting up their program----
    The Chairman. Mr. Shipman, I apologize for interrupting you 
but we have less than 5 minutes left on the vote and the 
Members are going to need to get to the Floor to cast their 
votes. What I would like to do is call a temporary recess in 
the Committee proceedings. We will give you an opportunity to 
pick up right where you have left off and we will be back as 
soon as we conclude the five votes. It may be a while. This 
process does take a while on the Floor. We will try to make it 
as quick as possible.
    [Recess.]
    The Chairman. We will call the meeting back to order. I 
would like to let Mr. Shipman continue his testimony. Mrs. 
Schmidt is on her way and she will be here shortly, but we will 
make sure that it is in the record and that everyone gets a 
copy.
    Mr. Shipman. Thank you, Mr. Chairman. As I was saying, the 
California Leafy Greens Marketing Agreement was established in 
February 2007, and at that same time that the program was 
starting, we at AMS published an advanced notice of proposed 
rulemaking to assess the interest in a nationwide Good 
Agriculture and Handling Practice program. We received over 
3,500 comments indicating strong support for the program but 
the comments also raised some challenges that needed to be 
addressed such as the cost and the impact on small entities.
    A coalition of U.S. produce industry members began drafting 
a proposed national marketing agreement. Requirements 
implemented under the program would be science based, would 
conform to FDA's Guide to Minimize Microbial Food Safety 
Hazards for Fresh Fruits and Vegetables and would be subject to 
USDA inspection and audit verification and oversight. As a 
marketing agreement, the proposed rule would only be binding to 
handlers who voluntarily signed the agreement. In addition to 
the good handling practices, it is anticipated that the program 
would require signatories to verify that any product handled 
comes from producers or other handlers using verified good 
agriculture handling practices. The program would authorize 
unannounced audits and apply to imports, creating a need to 
audit growing facilities outside the United States.
    The program would allow handlers to use an official mark to 
certify compliance with the program. Those found in violation 
of the agreement would be subject to withdrawal from the audit 
services, would lose the privilege to use the official mark and 
may be subject to misbranding or trademark violations. Any 
product deemed an immediate threat to public health by USDA 
inspectors would be reported to the Food and Drug 
Administration.
    We anticipate receiving a proposal on a nationwide 
agreement to be submitted later this month. Once the request is 
received, AMS will proceed with conducting nationwide hearings 
to gather public information and any future program will 
include an extensive outreach effort to make businesses, 
especially small entities, aware of the marketing agreement and 
the audit requirements. Our 2010 budget request includes $2.3 
million to support marketing agreements, some of which would be 
used for this national effort.
    A final area I would like to highlight today involves our 
Microbiological Data Program, or MDP, a monitoring program to 
collect information regarding the incidence, number and species 
of foodborne pathogens and indicator organisms on domestic and 
imported fresh fruits and vegetables. The collection and 
analysis of these samples began in April 2001. The MDP program 
was established and helps establish benchmarks by which to 
evaluate the efficacy of procedures to reduce or eliminate 
harmful foodborne microorganisms. The data are provided to 
stakeholders for decision-making purposes such as the Federal 
and state public health agencies, growers, processors, retail 
stores and food handlers. Data collection and testing 
activities are carried out with the support of 11 states--
California, Colorado, Florida, Maryland, Michigan, Minnesota, 
New York, Ohio, Texas, Washington, and Wisconsin--through 
cooperative agreements with us at AMS. AMS provides quality 
assurance oversight and laboratory administrative support for 
the program.
    Recent examples of the value provided by the MDP program 
occurred in April of this year during routine monitoring when 
Salmonella was found in alfalfa sprouts and spinach by the Ohio 
and Wisconsin laboratories testing samples collected by the 
program. The Centers for Disease Control and Prevention and the 
Food and Drug Administration, as well as health officials in 
both states, were notified. The MDP information was used for 
traceback and notification to customers who had received the 
affected products, and in both cases the affected products were 
voluntarily recalled.
    To conclude, Mr. Chairman, I would like to reiterate that 
the Food and Drug Administration is the key agency with 
jurisdiction over food safety policies for fruits and 
vegetables. AMS has a nationwide network of skilled inspectors 
and auditors that both certify quality and verify product 
processes. We also incorporate food safety-related elements in 
several of our marketing programs to verify that industries 
adhere to FDA requirements and guidelines. I would be pleased 
to respond to any questions. Thank you.
    [The prepared statement of Mr. Shipman follows:]

     Prepared Statement of David R. Shipman, Acting Administrator,
    Agricultural Marketing Service, U.S. Department of Agriculture,
                            Washington, D.C.

    Mr. Chairman and Members of the Subcommittee, good morning and 
thank you for the invitation to appear before you today. I appreciate 
the opportunity to share with you a brief overview of the U.S. 
Department of Agriculture's (USDA) activities and services that assist 
the fruit and vegetable industry in meeting U.S. Food and Drug 
Administration (FDA) and commercial marketplace requirements. The 
Agricultural Marketing Service (AMS) is the primary USDA agency working 
in this area.
    As you know, FDA is the Federal agency with primary responsibility 
for the food safety of fruits and vegetables. Within USDA, the Food 
Safety and Inspection Service holds similar responsibility for meat, 
poultry, and egg products.
    The mission of AMS is to facilitate the strategic marketing of 
agricultural products in the domestic and international marketplace. 
AMS is not a food safety agency. The agency does respond to requests 
from producers to support their product quality control efforts for use 
as marketing claims. For example, producers have asked AMS to establish 
programs to provide independent verification that FDA guidance is being 
followed.

AMS Audit-Based Programs
    AMS has significant experience in the design and delivery of 
marketing programs that involve inspections for product quality and 
verification of production processes. At industry's request, AMS has 
incorporated food safety-related elements into several of its marketing 
programs. AMS independent third-party audits provide impartial 
verification that growers, handlers and processors are following FDA 
guidance and commodity specific agricultural best practices. The Agency 
has developed the AMS Industry Services Audit and Accreditation Program 
to provide a range of audit and accreditation services. AMS auditor 
qualifications and training are based on International Organization for 
Standardization (ISO) auditing principles and activities with an 
emphasis on process-based auditing, program specific training, and 
annual program-specific refresher training. To maintain Agency 
credentials, each auditor must complete a minimum of 80 hours of 
continual professional development and course work every 3 years, plus 
meet annual performance criteria according to the U. S. Office of 
Personnel Management (OPM) Qualification Standards performance criteria 
as mandated by USDA.
    AMS experienced staff in fruit vegetable inspection and 
agricultural practices have provided the foundation to evolve 
inspectors into International Standards Organization (ISO) trained 
auditors. The evolution of inspectors into auditors came at the request 
of the food industry that was in need of independent third-party 
verification. Plant sanitation surveys are one of the first audit-based 
services that assess food processing facility's compliance with FDA's 
current Good Manufacturing Practices (GMP's), and ensures their ability 
to provide consistent quality and wholesome products by verifying food 
safety systems.
    Audit-based programs focus on the management of production and 
handling systems. They provide a basis for third-party verification of 
conformance to production and handling standards, methods, or 
procedures. Through these programs, it is possible to verify that 
processes are working within established limits. Production and 
handling systems are documented, specific processes are monitored and 
measured, and product identity and traceability are required. Processes 
specifically relating to the management and minimization of food safety 
hazards may be included.
    In the horticultural or specialty crops area, AMS product grading, 
plant sanitation review, and audit-based programs are conducted with a 
Federal workforce of some 800 full and part time employees. 
Additionally, AMS has cooperative agreements with nearly all State 
Departments of Agriculture, under which their fruit and vegetable 
inspectors receive training and are granted Federal licenses to assist 
in the delivery of AMS services and programs, adding another 3,500 
skilled professionals to the agency's deployable workforce.

Good Agricultural Practices and Good Handling Practices Audit 
        Verification Program
    One example of an audit-based program fashioned around food 
handling processes is the Good Agricultural Practices and Good Handling 
Practices (GAP/GHP) Audit Verification Program. This program assists 
farms and packinghouses through verification of their adherence to 
FDA's Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits 
and Vegetables to be used as a marketing claim. It is a uniform, 
nationwide program that is voluntary and funded by user fees.
    The GAP/GHP Program originated from requests from various state 
governments and industry organizations. A program was sought that would 
enable growers and packers to demonstrate adherence to Good 
Agricultural Practices and Good Handling Practices, as was being 
required by their retail customers.
    As identified in FDA's guidance materials, participants in this 
program demonstrate control in several areas of their operations to 
minimize microbial hazards, including water supplies, manure 
management, worker health and hygiene, sanitary facilities, field and 
packing area sanitation, transportation, and product traceback.
    The minimum audit frequency for GAP and GHP audits is twice each 
season. Should a facility or growing operation fail to pass either the 
initial or subsequent audits, additional audits will be undertaken. In 
addition, in many instances, the same auditors are in and around these 
facilities in the course of other, routine quality grading activities. 
This provides many more opportunities to provide feedback on food 
safety problems that emerge between audits. The initial GAP or GHP 
audit is scheduled to ensure that the grower or packer has a clear 
understanding of when they need to have their operation in order. 
Subsequent audits are unannounced.
    Primary users of this program include fresh fruit and vegetable 
growers, packers, shippers, and others in the marketing chain. For the 
2008 Fiscal Year, AMS audited a total 1,131 separate farms or 
facilities with the total number of commodities audited being 
approximately 105. Audits were performed in 36 states and Puerto Rico. 
AMS staff and AMS-licensed and trained state employees perform the on-
site audits.

Outreach to Small Farmers
    In cooperation with the Department's Office of Civil Rights, AMS 
conducted three educational outreach sessions for small, disadvantaged 
farmers in March 2007. These sessions were held in Raleigh, North 
Carolina, Marianna, Arkansas, and Thomasville, Georgia and were 
attended by 20-25 farmers at each session.
    The purpose of this outreach was to educate the participants in 
Good Agricultural Practices, Food Defense, and 3rd party audits, 
specifically the USDA-AMS GAP & GHP audit program. As a direct result 
of this effort, approximately 25 farms in Arkansas, Mississippi, 
Georgia, and North Carolina have successfully passed the USDA-AMS GAP & 
GHP audit over the past 2 years.
    AMS staff also participated in training and outreach to small 
farmers in the New England and Mid-Atlantic regions at over 20 
different grower meetings sponsored by the various state extension 
services over the past 3 years. These growers are generally 
participating in regional retail outlets ``buy local'' farm to store 
programs. Approximately 800 participants were given an overview of the 
USDA-AMS GAP & GHP audit program and had the opportunity to ask 
specific questions regarding the program.

Qualified-Through-Verification Program
    Another example of an audit-based program offered by AMS is the 
Qualified-Through-Verification (QTV) Program. There are currently seven 
fresh-cut plants participating in the QTV program.
    QTV is a voluntary, user-fee program that provides third-party 
verification of a fresh-cut processor's adherence to its Hazard 
Analysis Critical Control Point (HACCP) plan. Under the QTV program, 
processors identify and document critical points in their production 
process, measure performance of their operation at these critical 
points, and position themselves to detect and address any deficiencies 
as they might emerge.
    Third-party verification by AMS involves initial document review 
and subsequent on-site audits. The frequency of audits begins at 2 week 
intervals, with reduced frequency possible based on a firm's 
performance. AMS auditors performing QTV audits must complete training 
in HACCP principles (including hazard analysis, preventive measures, 
critical control point determination, sanitation Standard Operating 
Procedures, critical limits, monitoring procedures, corrective actions, 
record keeping), in addition to AMS audit training requirements.
    The QTV Program reflects the latest FDA guidelines. For example, 
with FDA's March 2007 release of its draft final Guide to Minimize 
Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables 
(finalized in February 2008), AMS immediately modified its QTV program 
to incorporate this updated guidance regarding the identification and 
implementation of appropriate measures to minimize the hazard of 
microbial contamination during the processing of fresh-cut produce. In 
addition, participants in the QTV program will be required to source 
products only from growers that adhere to Good Agricultural Practices 
as outlined in FDA's Guide to Minimize Microbial Food Safety Hazards 
for Fresh Fruits and Vegetables.

Impartiality
    All AMS' inspectors, including its Federal-licensed state partners, 
undergo an extensive combination of hands-on training and classroom 
instruction in commodity grading. In addition, inspectors receive 
training in ethics, conduct, and customer service. To ensure 
consistency and integrity in audit-based inspection services, AMS 
instituted minimum auditor requirements through its Industry Services 
Audit & Accreditation Program (ISAAP). The ISAAP requirements are based 
on internationally recognized standards for the training and evaluation 
of auditors.

Marketing Orders and Agreements
    Authorized by the Agricultural Marketing Agreement Act of 1937 (the 
Act), marketing orders and agreements assist farmers and handlers by 
allowing them to collectively address marketing problems. These 
programs are initiated by industries that chose to have Federal 
oversight of certain aspects of their operations. AMS oversees 
marketing orders and agreements to ensure that they operate in the 
public interest and within legal bounds.
    Marketing orders and agreements may set minimum quality 
requirements, standardize packaging, regulate flow of product to 
market, and implement other regulations including consumer education, 
research and advertising. Marketing agreements only apply to handlers 
who voluntarily sign an agreement, while marketing orders set 
regulations on all handlers in a specified region once the program is 
approved in a grower referendum. Fees are collected from handlers to 
cover the local costs of administering these programs. AMS currently 
administers 32 fruit and vegetable marketing orders, covering 25 
specialty crop commodities.

Food Quality and Safety Issues Under Federal Marketing Orders
    Section 608c(6) of the Act provides authority to regulate the 
quality of various commodities through Federal marketing orders and 
agreements. The presence or absence of harmful pathogens, toxins, or 
other contaminants is considered a quality characteristic. In response 
to producer requests, AMS has incorporated food quality-related 
requirements in marketing agreement and marketing order regulations for 
many years. For example, testing for Aflatoxin, considered a possible 
human toxin, has been required for U.S. grown peanuts since 1965, 
originally under a Federal marketing agreement and subsequently through 
separate legislation administered by AMS.
    A large majority of the currently active Federal marketing order 
programs include minimum grade requirements with most U.S. grade 
standards having criteria related to food safety (e.g., lack of mold, 
insects, foreign material, etc.). Since 1961, for example, the 
marketing order for California prunes has had inspection and fumigation 
requirements relative to live insect infestations. Beginning in 2005, 
Pistachio handlers were required to test all nuts destined for human 
consumption for Aflatoxin. Also, starting with the 2007-08 crop, almond 
handlers were required to treat almonds prior to shipment to reduce the 
chance of Salmonella contamination.

California Leafy Greens Marketing Agreement
    Following the September 2006 E. coli outbreak linked to fresh 
spinach grown in the Salinas Valley (and subsequent collaboration among 
industry, FDA, and California Department of Public Health to enhance 
existing recommendations for the safety of leafy greens), the spinach 
and related leafy green industries collectively worked with the 
California Department of Food and Agriculture (CDFA) to begin designing 
a state marketing agreement that would require adherence to Good 
Agricultural Practices for most companies involved in shipping leafy 
greens in the state. The California Leafy Greens Marketing Agreement 
(Agreement) became effective in February 2007. Arizona implemented a 
similar program in October 2007.
    The CDFA Agreement is a voluntary program. This program licenses 
signatory handlers to use a certification mark to certify the member's 
use of Good Agricultural Practices on all of the product handled. The 
use of the certification mark would be denied to those firms found in 
violation. The Agreement also mandates that handlers source their leafy 
greens produced in California from growers who comply with a specified 
set of Good Agricultural Practices. According to CDFA, to date, 
handlers representing more than 99 percent of the leafy greens produced 
in California have signed the Agreement.
    AMS has cooperated with CDFA in the verification aspects of the 
Agreement, including the design and delivery of training for the 
California State auditors who monitor compliance.
    AMS worked with the California and Arizona leafy greens industries, 
the California tomato industry, and the American mushroom industry to 
develop a framework for providing audit services. Each industry 
developed a ``best practices'' document and requested AMS to develop an 
audit protocol to monitor compliance with these practices. As a result, 
AMS is providing auditing services which recognize operator's adherence 
to industry-defined best practices and FDA guidance targeted to 
minimize food safety hazards. FDA specialists have interacted with 
industry as ``subject matter experts'' in the development of the best 
practices documents and AMS maintains an active working relationship 
with these same specialists.

Proposed National Marketing Agreement for Leafy Greens
    In response to interests expressed by segments of the leafy green 
vegetable industries, AMS, in October 2007, published an advanced 
notice of proposed rulemaking (ANPR) that resulted in the submission 
and consideration of 3,500 public comments on the need and level of 
support for a nationwide good agricultural and handling practices 
program. In short, AMS' review of the comments received indicated 
public backing for such a measure could be favorable if certain issues, 
such as the cost and impact on small entities, the need for science-
based guidelines and other factors, were addressed in the development 
and implementation of any Federal regulation.
    Subsequent to the publication of the ANPR, a coalition of U.S. 
produce industry members began drafting a national marketing agreement 
proposal that would further minimize the hazards of foodborne 
contamination in leafy green vegetables. The purpose of the proposed 
marketing agreement would be to verify industry adherence to good 
agricultural and handling practices. Requirements implemented under the 
program would be science-based, would conform to FDA's Guide to 
Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables 
and would be subject to USDA inspection audit verification and 
oversight. As a marketing agreement, the proposed program would only be 
binding to handlers who voluntarily sign the agreement. In addition to 
good handling practices, the program would require signatories to 
verify that any product handled comes from producers or other handlers 
using verified good agricultural and handling practices. The program 
would authorize unannounced audits and apply to imports, creating the 
need to audit growing facilities outside of the United States.
    The program would license signatory handlers to use a certification 
mark to certify the member's compliance with the program. As a result 
of agreement violation, a signatory would be subject to withdrawal of 
audit services, would lose the privilege of the official certification 
mark, and may be subject to misbranding or trademark violations. Any 
product deemed an immediate threat to public health by USDA inspection 
would be reported by USDA to FDA.
    Any requirements under a Federal marketing agreement for leafy 
greens would reinforce those industries' abilities to meet FDA 
requirements. Authorities and regulations under such a program would be 
consistent with FDA guidance and regulations.
    AMS anticipates that proponents of the proposal will submit an 
official request for rulemaking in May 2009. Once the request is 
received, AMS will proceed with conducting nationwide hearings to 
gather evidence and advance the rulemaking process accordingly. This 
process will allow all interested parties the opportunity to provide 
input. Any future program would include an extensive outreach effort to 
make businesses, especially small entities, aware of the marketing 
agreement and audit requirements. AMS has requested $2.3 million in 
funding for 2010 to support the marketing agreement.
    In both February 2008 and 2009, the Department of Agriculture-
chartered Fruit and Vegetable Industry Advisory Committee, a group of 
25 members of the U.S. produce industry, expressed strong support for 
making Federal marketing agreements and marketing orders available to 
industries to facilitate national adoption and compliance with food 
safety standards, such as GAPs, GHPs and Good Manufacturing Practices 
(GMPs).

Microbiological Data Program
    In Fiscal Year 2001, AMS implemented the Microbiological Data 
Program (MDP), a monitoring program to collect information regarding 
the incidence, number, and species of important foodborne pathogens and 
indicator organisms on domestic and imported fresh fruit and 
vegetables. The collection and analysis of samples began in April 2001.
    MDP was primarily designed to provide data on microbial presence in 
order to establish a microbial baseline to assess the risks of 
contamination, if any, in the domestic food supply. The data are used 
to establish ``benchmarks'' by which to evaluate the efficacy of 
procedures to reduce or eliminate harmful foodborne microorganisms. The 
data are provided to stakeholders for decision-making purposes (e.g., 
Federal and state public health agencies, growers, processors, retail 
stores, and food handlers).
    Data collection and testing activities are carried out with the 
support of 11 statesCalifornia, Colorado, Florida, Maryland, Michigan, 
Minnesota, New York, Ohio, Texas, Washington, and Wisconsinthrough 
cooperative agreements with their respective Departments of 
Agriculture. AMS provides quality assurance oversight and laboratory/
administrative support to the program.
    Recent examples of the value provided by MDP occurred in April this 
year during routine monitoring when Salmonella was found in alfalfa 
sprouts and spinach by the Ohio and Wisconsin laboratories testing 
samples collected by the program. The Centers for Disease Control and 
Prevention (CDC) and FDA as well as health officials in both states 
were notified. MDP information was used for trace back and notification 
to customers who had received the affected products and in both cases, 
the affected products were voluntarily recalled. The Salmonella strain 
found by Ohio was determined to be linked to a cluster of foodborne 
illnesses in Arizona and New Mexico. There are no reported illnesses 
linked to the spinach strain. Since spinach from this lot was 
distributed in Illinois, FDA is assisting in product recall for that 
state. Quick intervention by FDA and state officials and voluntary 
cooperation by distributors reduce risks to consumers' health and 
minimize economic impact on growers.
    In the aftermath of these incidents, the FDA Associate Commissioner 
for Foods asked for a more interactive approach between the two 
agencies to develop plans and communication strategies for MDP. 
Building on their prior programmatic collaboration, FDA and AMS agreed 
to have designated points of contact always available so that FDA can 
respond quickly when MDP finds harmful pathogens during routine 
monitoring. CDC became actively engaged in MDP during the Salmonella 
saintpaul outbreak in 2008 and has continued participating in program 
planning by providing feedback on foods that need to be monitored by 
the program. The PFGE fingerprint patterns of enteric bacterial 
pathogens isolated by MDP are entered into CDC's PulseNet database to 
be compared with pathogens isolated from humans.
    To conclude, Mr. Chairman, I would like to reiterate that Federal 
food safety policies for fruits and vegetables fall under the 
jurisdiction of the FDA. AMS has developed significant experience in 
the design and delivery of marketing programs, including those 
involving inspections for product quality and verification of 
production processes. At industry's request, AMS has incorporated food 
safety-related elements in several of its marketing programs to verify 
that industries adhere to FDA requirements and guidelines.
    I would be pleased to respond to questions.

    The Chairman. Thank you, Mr. Shipman.
    Dr. Acheson, you testified that the President's budget 
request would allow FDA to increase the number of field staff 
working on food by 404 full-time equivalents. I want to be 
clear on this number. Would those full-time equivalents, those 
404 folks, conduct inspections for drugs and medical devices or 
will they be dedicated exclusively to food safety?
    Dr. Acheson. Currently, the intent is that those 400 or so 
individuals would be added to the Office of Regulatory Affairs 
from which my colleague, Steve Solomon, is here so he could 
provide you with more specifics. They would not all be 
inspectors because obviously there needs to be the 
infrastructure within Office of Regulatory Affairs to support 
what they are doing, but it would certainly be all devoted to 
foods, yes.
    The Chairman. It would be all devoted to food?
    Dr. Acheson. Yes, but they would not all be inspecting. 
That is an important point, that you have to have personnel to 
support the infrastructure for the inspectors.
    Dr. Solomon. If I could just add to that, 200 of those 
would be investigators all doing food and feed work.
    The Chairman. Would you describe the types of activities 
these folks will do in the facilities? How does that process 
work? What are their protocols? Do inspectors review records or 
do they sample a product? Do they go out and verify the 
effectiveness of process controls? How do they conduct their 
activities?
    Dr. Solomon. Thank you for the question. FDA investigators 
do a number of activities. They do routine inspections at 
facilities. They respond to consumer complaints. They conduct 
audits associated with recalls to evaluate the effectiveness of 
those recalls. So during a typical food inspection, say, of a 
processing facility that may be handling something like 
spinach, they are evaluating the facility. They do a walk-
through of the facility to evaluate the entire facility. They 
look at records associated with that facility. They do 
specifically look at the processing equipment, the testings on 
hand at the processor to make sure there is adequate, say, 
chlorination if there is an issue about that. They also may be 
taking environmental samples at that facility to evaluate it.
    The Chairman. Thank you, sir. I have two questions to 
follow up with that. What would you say the percentage of their 
time is looking at documents versus actually doing what I would 
call field inspections where they are in the plants? And as I 
recall the last time a number of you were here and we were 
talking specifically about peanuts, and we were also talking 
about the pepper and tomato issue at that time as well, one of 
the plants had not been looked at in 18 months or 2 years. How 
often is this protocol that these inspectors--how often would 
the average plant be inspected?
    Dr. Solomon. It is difficult to say how much time is 
looking at records versus actually walking through and looking 
at the processing facility itself because it depends on what 
our interests are doing that period of time. So, for example, 
in a low-acid canned-food plant, looking at the historical 
records and processing during that facility is very critical. 
Other plants, they spend less time looking at records and more 
time actually in the facility. So there is no set time, no 
prescribed time. It depends on the circumstances, what the 
investigator is finding. We are spending more and more time 
doing more environmental sampling as part of our current 
protocols. And the frequency of inspection, we try to associate 
with the risk associated with that so we try and get into high-
risk facilities on a more frequent basis. And, then a facility 
like a warehouse or a lower risk facility we are going in less 
frequently. So in the higher risk facilities we have 
identified, we are trying to get in there as close to an annual 
basis as we can.
    The Chairman. Thank you, Dr. Solomon. I regret to inform 
everyone assembled here that we have just been called to 
another vote, and so as of right now it is one vote. We will go 
cast our votes and come back as soon as possible. The Committee 
is temporarily adjourned.
    [Recess.]
    The Chairman. We will call the hearing back to order and 
resume questioning. Before I do that, I want to welcome three 
individuals to the Committee proceedings today. We have our 
newest Member with us, Mr. Scott Murphy from upstate New York. 
Thank you for being a Member of our Committee. We welcome you 
to our hearing and look forward to your input.
    Also, I would like to recognize a former member of the 
state legislature who served with Mr. Costa and I. He was also 
the Director of Parks for the State of California, Mr. Rusty 
Areias. Welcome, Rusty, for being here. And he has with him his 
daughter, Alexis, and Alexis, welcome to you too. You come from 
a great political family. I am sure you will do wonderful 
things as you get older.
    Okay. We stopped in the middle of question. Dr. Solomon, do 
you have anything further that you wanted to say in response? 
And then I have a few other questions.
    Dr. Solomon. Thank you. I think we covered the two points 
about high-risk frequency of inspections, and what is covered 
during inspection.
    The Chairman. Very good.
    Dr. Acheson, does FDA currently have the data necessary to 
conduct risk assessment and modeling on products within its 
jurisdiction, and how is FDA using that data today?
    Dr. Acheson. FDA does not currently have enough data to 
adequately assess all the risk factors. I think it is very 
clear that the agency needs to gather more information, needs 
to be gathering that from multiple sources from working with 
the industry and working with the states, Federal partners, 
academia. Further, that information needs to be used for 
building more-sophisticated models of food safety because 
clearly we need a risk-based approach to make maximum use of 
resources. And while we, as Dr. Solomon says, use what we have 
to drive those inspectors into the facilities that are the 
greatest risk, there is more that needs to be done to gather 
information.
    The Chairman. Very good. You testified in your budget 
request, which included that you needed more resources for FDA 
to work with Federal and state partners to measure the 
reduction of foodborne illnesses. Please describe this 
proposal, how the funding would be used, and if you have made a 
formal request to Ms. DeLauro's Committee. And I am going to 
ask you to be brief because we have a couple more questions and 
I want to allow time for my colleagues.
    Dr. Acheson. Are you talking about in the context of the 
2010 budget?
    The Chairman. Yes.
    Dr. Acheson. Well, clearly, that hearing hasn't occurred so 
I don't want to preempt anything that may be said there. But, 
let me speak to the importance of attribution and how states 
and locals as well as other Federal agencies, particularly CDC, 
play a key role there. This gets back to the risk. It is 
critical to know who is getting sick from what food and where 
on the production lifecycle is the problem occurring. If we 
stick with the example of fresh produce, is it at the farm, the 
processor, the distributor or the retailer, to be simplistic. 
That is what attribution is about. There are fairly 
sophisticated systems for simply measuring the number of O157 
and Salmonella cases that are present but very limited 
sophistication in the information on the second part, which is 
critical if you are going to target your preventive strategies 
to the areas of greatest risk of exactly where is that 
contamination occurring and how. The states and the locals play 
a huge part in that because they are front and center, on the 
front line of investigations, where that information is usually 
the most easy to get.
    The Chairman. In your testimony, you discussed the benefits 
of cooperation and coordination with the Federal and state 
industry partners. In fact, in the last hearing that we 
conducted I advocated for the same thing, indicating that I 
thought in California, for example, where nearly 50 percent of 
the fruits and vegetables in this country are grown, that CDFA 
does a fabulous job in what they do and the partnerships they 
worked out with growers. Can you envision a food safety 
framework in which FDA sets standards for fresh produce and 
USDA does the inspection and enforcement for those standards?
    Dr. Acheson. I can see part of that. I can certainly 
envision a situation where FDA sets the standards and the 
components of other regulatory bodies or potentially third 
parties would be undertaking some level of inspections. That is 
how I would see those partnerships working with other Federal 
colleagues and states and the locals. I believe that when it 
comes to enforcement, that is largely an FDA role, but I think 
that that would be a detail that would have to be worked out. 
But, unquestionably, the inspection part, the training part, 
the education, and as you pointed out, the relationships that 
many of those people already have with farmers is a huge piece 
of talent that we should build into any partnership.
    The Chairman. I would like to submit this question to you, 
the one I just asked and the one I am going to ask, for follow-
up and have you get back to me a written response. I think it 
really requires a lot of time for detailed thought and 
examination and sort of some soul searching within the 
organization. We are going to have to do the same thing in 
Congress to figure out what is the best role, who has the best 
expertise, who has the technical knowledge in whatever area. 
There has been some suggestion amongst Members that have 
discussed this topic of having a bifurcated system not crop by 
crop linearly up and down, but possibly side to side where FDA 
may establish standards, USDA would take those standards, and 
they would regulate field production generally. Then, 
processing above that level when you take the products and have 
a secondary process, that those might be legitimately and more 
properly regulated by FDA. I would like to have more 
discussions where we can talk about those different potential 
models and see what makes the best sense, because certainly you 
want the folks with the most expertise and the most inspectors 
and the most ability to keep the public safety to do the 
regulatory response in those areas. So, I would like to pursue 
this with you in much greater detail.
    Dr. Acheson. We would certainly look forward to that. I 
think those are excellent points and I would be happy to engage 
in a dialogue with you on that.
    The Chairman. Thank you. I have a number of questions that 
I want to ask you with regard to some other issues, 
specifically pistachios and leafy greens, but what I am going 
to do now is turn it over to my colleagues to ask their 5 
minutes of questions, and then we will have a second round with 
you all.
    So Mr. Costa, are you prepared for questions?
    Mr. Costa. Yes. You talk about risk assessment and risk 
management and you said you need more data. What in the way of 
data are you talking about? Are you talking about data that is 
contained where the products are grown? Are you talking about 
data in terms of your ability to have this information? Are you 
talking about the traceback ability that I mentioned in my 
opening commitments?
    Dr. Acheson. Are you addressing that question to me?
    Mr. Costa. Yes. You raised the issue that you need more 
data.
    Dr. Acheson. Absolutely, and I think is all of the above, 
because if you are truly going to do a risk-based approach, you 
need information. If you pick a specific commodity and you want 
to establish preventive controls, you clearly want to establish 
those based on risk, so----
    Mr. Costa. Right, but when you establish based on risk, you 
also make an assessment on risk, do you not?
    Dr. Acheson. Yes. It is a culmination----
    Mr. Costa. Between every part per billion or trillion when 
you may know that you have a much greater potential 
contamination because of other factors, you would go there 
first before you would--I mean, you don't have unlimited 
resources.
    Dr. Acheson. Absolutely, and that is the whole point of 
this, is that in order to make that judicious use of resources, 
you have to take them to the areas of greatest risk, and you 
can't do that without adequate data input in terms of where are 
those areas of greatest risk. For example, with leafy greens 
growing in a field, is it the water supply, is it the proximity 
of the cattle, is it the wild animals, is it the human contact, 
is it the machinery. Those sorts of data inputs are absolutely 
key in terms of making decisions about what you would inspect, 
what samples you would take and what preventative controls are 
going to work optimally.
    Mr. Costa. You had mentioned earlier in response to the 
Chairman's comment about cooperation and collaboration with 
state and local agencies. As you may know, we have a rather 
sophisticated, I would argue, maybe the most sophisticated food 
safety efforts in California because of our fruits and 
vegetables and our traceability effort. But we also have 
another program that we have worked with over the years on 
harmonization that is required for registration of herbicides 
and pesticides with the Federal Government. That harmonization 
program historically had worked well. Is that what you are 
advocating here in terms of a harmonization, a hand in glove 
working with not only California but other major ag producing 
states?
    Dr. Acheson. I am not specifically familiar with the 
pesticide program that you referred to, but the concepts are 
probably very similar and would run in parallel. As we said 
earlier, it is using the expertise at the state, local and 
Federal colleague level, so that you are essentially not 
reinventing the wheel but you are building a seamless, 
integrated system that is going to allow you to build off that 
skill set.
    Mr. Costa. And so if you want to take advantage of that, 
the data and the other efforts to improve the programs, have 
you developed a matrix to see what best management practices 
are, taking a look at states like California and Florida and 
others so that we don't reinvent that wheel?
    Dr. Acheson. I think that is part of the process that we 
have to embark on. Over the last 12 months, there has been real 
movement in trying to engage more actively with the states in a 
number of areas. We held a meeting a year ago with all 50 
states to begin to get into that information sharing, training, 
risk-based approaches and response elements. This is going to 
gain momentum, and if we get the money that we have asked for 
2010, a portion of that would be used----
    Mr. Costa. Well, the money has been--well, we don't know if 
we will appropriate it but----
    Dr. Acheson. Well, that is what I mean.
    Mr. Costa.--the request has been made. My time is expiring 
so let me move on here. You talked about potential kill steps 
for fresh produce. What concerns do you foresee being raised on 
some of the new technologies that are being developed?
    Dr. Acheson. I think the concerns that we would have, if 
any, are, are they safe in terms of from a public health 
perspective. If it does the job and it is safe from a public 
health perspective, then I don't see that FDA would have a 
concern with that.
    Mr. Costa. And what criteria are we using to make that 
determination?
    Dr. Acheson. Well, I mean, if you pick an example like 
using polypropylene oxide as a treatment that has been used 
very successfully in almonds, can you apply that to pistachios, 
and do you use it at a level that is ultimately going to result 
in residue that could prove to be hazardous to health. That is 
the kind of assessment that would need to be done.
    Mr. Costa. Since you mentioned pistachios, I want to 
commend you for taking a more targeted approach as it relates 
to the most recent incident on the various brands. I think that 
is a part of making a risk assessment and targeting.
    My time has expired, Mr. Chairman. I obviously have other 
questions and I will wait for the second round or submit them 
after the hearing.
    The Chairman. Thank you, Mr. Costa.
    Mrs. Schmidt, I would like to call on you for your 
questions and apologize to you. The culture of different 
committees--in this Committee we always recognize the Ranking 
Member first. In Rules Committee, we do it the other way, and I 
have been on that committee more than on this Committee lately, 
and I called Mr. Costa first and I apologize, but thank you 
for----
    Mr. Costa. I apologize. I walked in late. I thought she had 
asked the last question.
    Mrs. Schmidt. You know what, it doesn't matter as long as 
you get to the dinner table and you get some food, it is okay.
    Dr. Acheson. As long as that food is safe.
    Mrs. Schmidt. Exactly. Growing up on a farm, our food was 
always safe.
    Dr. Acheson, I have a couple of questions for you. First 
off, is it possible that irradiation could be used in the fresh 
fruit and vegetable industry, particularly with leafy greens, 
and what do you see as the pros and cons of using such 
technology?
    Dr. Acheson. Well, as I am sure you are aware, FDA has 
already approved the use of irradiation for certain types of 
leafy greens following a petition that was submitted several 
years ago. So that is already approved and FDA doesn't have a 
problem with it being used. So from a public health 
perspective, per the previous conversation, we don't have 
concerns that that will introduce a public health risk. There 
are obviously many other factors around whether or not such a 
technology would be used in terms of consumer acceptance, 
technological availability and economic impact.
    Mrs. Schmidt. Okay. In previous testimony before the full 
Committee, sir, there was a call for the FDA to mandate HACCP 
for fresh fruits and vegetable growers. HACCP is a process 
control model typically applied to food processing. How do you 
see HACCP being applied on the farm?
    Dr. Acheson. I think HACCP is a very specific term that 
speaks to a very specific approach to preventive controls. We 
would see that while preventive controls are necessary on the 
farm, it needs to be done in a slightly broader way, again 
looking for what are the critical control points and how does 
one manage them. I could envision a situation on a farm where 
one wouldn't necessarily have all the mitigation practices be 
figured out to truly apply authentic, rigid HACCP. But the 
concept of risk-based approach in terms of preventive controls, 
which is the HACCP principle, absolutely, I think it could be 
used to great effectiveness on farms.
    Mrs. Schmidt. Along the same lines, if HACCP were applied 
to the farm, what more are we going to get from this than from 
Good Agricultural Practices already in place?
    Dr. Acheson. What you get is, if it is mandatory and if it 
is enforced then there is verification that is being followed.
    Mrs. Schmidt. And along those same lines, what kind of 
paperwork is going to be involved with the farmer to make sure 
that all of these things have been met?
    Dr. Acheson. I think that that would be a part of the 
discussion around such rulemaking if that was to proceed. I 
mean, I think reading between the lines of your question, what 
would be the economic impact and the paperwork impact on 
individual farmers, which could vary depending on the size of 
the facility and the level of sophistication and the demand for 
what is required. And, to be honest with you, I think that that 
would be part of the debate as one moves forward to actually 
putting this into practice.
    Mrs. Schmidt. Do you see a difference between large farms, 
small farms, or would there be the same universal application 
across all farms, and then how do you mitigate the impact on 
the cost of doing business on a small farm versus the cost of 
doing business on a large farm?
    Dr. Acheson. I think again, that all has to be part of the 
economic analysis that is looked into when these things move 
into a rulemaking process. The impact on small business, 
whether it is a farm or a processor or what it is, is always a 
factor that is taken into account. But let us not lose sight of 
that argument that size does not equate with safety. Small 
facilities could clearly be a risk as we have seen over and 
over again, is it doesn't take much of a corner of a spinach 
field to cause havoc with spinach and create a lot of 
illnesses. We saw exactly the same with peanut butter earlier 
this year where a relatively small facility was distributing 
very widely. So, we have to be cautious about that, yet 
recognize that we have to also consider the economic 
consequences.
    Mrs. Schmidt. And nobody should ever sacrifice safety for a 
dollar amount. I wasn't meaning to suggest that you would do 
that.
    Dr. Acheson. No, I didn't take it that way.
    Mrs. Schmidt. Thank you. One more quick question. In the 
rulemaking process, what kind of input do you get from the 
farmers during the process, is it just behind closed doors?
    Dr. Acheson. No, it is very public, and this hasn't started 
yet, but I would anticipate this would be a very public process 
with public hearings, Federal Register notices. It is really a 
system that facilitates getting comment from everybody who has 
something to say.
    Mrs. Schmidt. Thank you.
    The Chairman. Thank you very much, Mrs. Schmidt.
    We will continue with questions. Dr. Acheson, the recent 
recall of peanuts processed by the Peanut Corporation of 
America due to contamination with Salmonella was associated 
with over 700 serious illnesses, one of which was yours truly. 
There was also a recent recall of pistachios processed by 
Setton Farms due to contamination with Salmonella. How many 
illnesses have been linked to the recent recall of pistachios?
    Dr. Acheson. I am aware of one potential illness that was 
associated with pistachios, a young infant on the East Coast 
who reportedly consumed the product and became sick, and 
actually had the same serotype isolated from a stool sample as 
we had seen in the facilities.
    The Chairman. I had not heard of that. I had heard that 
there was only one complaint but no serious illness. Is that 
what you mean?
    Dr. Acheson. No. I am aware of numerous complaints but the 
only one that looked like where there was actually a positive 
stool sample in a young infant. It doesn't mean that it was 
from pistachios.
    The Chairman. I see. So you don't have a direct link there, 
it is a potential?
    Dr. Acheson. The infant reportedly consumed product that 
was part of the recall, got sick, had gastroenteritis, was 
positive for Salmonella with the same Salmonella strain that 
was found in the pistachios. So is it an absolute dead-straight 
line? No, but it is suspicious.
    The Chairman. Okay. Did the pistachio industry fully 
cooperate with FDA?
    Dr. Acheson. Absolutely, yes.
    The Chairman. Given that there were few illnesses, as I 
said, there is this one, may consumers now safely eat 
pistachios that aren't subject to a recall?
    Dr. Acheson. Indeed. We recognized right from the beginning 
here that this was going to have an impact on pistachio 
consumption, and immediately within days worked with the 
pistachio industry to develop a tool that was on 
pistachiorecall.org. We were directing consumers to where they 
could look and determine that there was product that was not 
associated with the facility in which we had the concerns with 
ongoing recalls.
    The Chairman. Has the FDA formally made that announcement 
in general to the public in press releases that pistachios are 
now safe to eat?
    Dr. Acheson. We have always said that pistachios that are 
not subject to the recall can be consumed. We said that right 
from the beginning. One of the challenges that we have right 
now is that we are still seeing pistachio products being 
recalled that are stemming back from that original recall, as 
we are still seeing peanut butter samples and peanuts, and that 
speaks to the complexity of the distribution systems and the 
difficulties with product tracking. One could ask, why don't 
people know where the product is coming from, and if they did 
and could do the recalls more quickly, we could shut these 
things down faster and get more positive consumer messages out 
there to protect the public and the industry.
    The Chairman. I am somewhat concerned because about a 40 
percent reduction in pistachio consumption occurred around that 
time. That is one of the devastating things that can happen to 
an industry. When one bad actor potentially has done something 
or missed something, it can just devastate the whole industry. 
Pistachios, have a little bit more shelf life than, say, a 
tomato does, but we certainly saw the effects to the industry 
of getting one incorrect. It wasn't the tomatoes, it was the 
jalapenos, as I recall. We have to be very judicious in how we 
protect the public, and at the same time, on how we don't 
devastate industries that are trying to be good participants 
with us in making their product as safe as possible. Balance is 
always difficult but it must be determined correctly. You might 
want to speak to that.
    Dr. Acheson. I agree with you. Our mission at FDA is to 
protect public health, and I think the pistachio situation was 
a great example of how the industry informed us of the problem. 
We tracked it back pretty quickly, again working with 
California, to a specific facility, and at that point we were 
able to work with the firm so they initiated recalls to get 
potentially contaminated product off the market. At the early 
stages of this, we knew that there were potentially millions of 
pounds of pistachios in the market, potentially, contaminated 
with Salmonella, and the prudent public health approach is to 
issue that information to consumers and to advise them to avoid 
consuming pistachios while this is gaining greater clarity. 
That is the approach that is going to maximize public health 
protection.
    The Chairman. Thank you.
    I would now call Mrs. Lummis to ask her questions.
    Mrs. Lummis. Thank you, Mr. Chairman. It is an honor to 
serve on this Subcommittee with you and Ranking Member Schmidt. 
I do have an opening statement that I would like to submit for 
the record.
    [The prepared statement of Mrs. Lummis is located on p. 8.]
    The Chairman. Without objection.
    Mrs. Lummis. Thank you.
    The first question I have is not leading, I am just 
curious. I have no opinions about this so don't feel like I am 
trying to lead you to something. I just have a genuine question 
here. Do you think it would be a better fit for the U.S. Food 
and Drug Administration to shift all responsibilities for food 
inspection to the USDA? That would allow the FDA to focus 
exclusively on drugs and consumer products. Since that is the 
big focus of the FDA, I wonder sometimes whether food gets lost 
in the FDA. It doesn't get lost in the USDA, so it is just an 
open-ended point of curiosity and I would like to start with 
Dr. Acheson.
    Dr. Acheson. I think that is an easy one to answer. In 
short, no. I think that would be a retrograde step for public 
health. The Food and Drug Administration obviously has 
oversight of medical products and foods for humans and for 
animals. It also has a great deal of expertise at the 
scientific level and the inspection level with regards to 
foods. Simply moving the inspection of foods from the Food and 
Drug Administration to the Department of Agriculture the way 
that you outlined it would, I believe, be a retrograde step for 
public health.
    Mrs. Lummis. Dr. Solomon, do you agree with that?
    Dr. Solomon. I do agree with that.
    Mrs. Lummis. And Mr. Shipman?
    Mr. Shipman. I don't disagree with it, but I think that we 
need to recognize that the Administration has their food safety 
working group ongoing right now. Some of the issues that they 
are looking at is looking at the structure both from a 
statutory standpoint, a regulatory standpoint, and then how do 
you carry that out. I would defer answering specifically as to 
whether I agree or disagree until I see what that working group 
has to say.
    Mrs. Lummis. Thank you. My next question is for Mr. 
Shipman. Have you seen a growth in participation in the Good 
Agricultural Practices and Good Handling Practices Audit 
Verification program and the Qualified-Through-Verification 
program?
    Mr. Shipman. Yes, we have since we put into place the Good 
Agricultural Practices and Good Handling Practices program. 
Just to give you an example, in 2006 we only did 52 audits, and 
in 2008 we did over 1,500 audits. So yes, we are seeing growth 
and we see that growth continuing this year.
    Mrs. Lummis. And a second question, Mr. Shipman. Can you 
describe the relationship with the FDA when AMS incorporates 
FDA's guidance into verification programs and marketing orders 
and agreements?
    Mr. Shipman. Yes, we have a very close consultative process 
where if they are changing any of their requirements, our 
staffs are working together to ensure that we incorporate the 
latest requirements into the verification systems or programs 
that we have. We also have a standing Memorandum of 
Understanding, so that not only would these auditing programs 
but with our thousands of quality inspectors that are 
throughout the country, if they encounter anything that would 
be a violation of FDA requirements, action limits through that 
MOU, we notify the local FDA officials.
    Mrs. Lummis. Thank you. Further, Mr. Shipman, when it comes 
to farm practices, I admit that I am skeptical of government 
mandates. That is why I am particularly interested in your 
testimony about voluntary marketing agreements. Do you have any 
data that would indicate how much a producer invests, on 
average, to comply with a marketing agreement?
    Mr. Shipman. I would have to get you for the record how 
much folks invest for that, but I would like to state that 
under the voluntary agreements, the uniqueness of those 
agreements is, that number one, they are voluntary, and number 
two, in the actual development of those programs, it is a 
collective input from all of the industry. We are going through 
one right now where we are addressing the leafy greens program 
on potentially a national basis. That is something that would 
be developed by bringing all parties to the table and working 
through whether an agreement is necessary, and then developing 
standards at a later time. That is not a one-size-fits-all 
program. It would be unique to the particular crops and, 
potentially, regionally.
    Mrs. Lummis. My time is up, but Mr. Chairman, if would 
indulge one more follow-up question?
    The Chairman. Yes.
    Mrs. Lummis. Thank you.
    Mr. Shipman, have you found that compliance with voluntary 
marketing agreements is high?
    Mr. Shipman. Again, I would have to get for you for the 
record the exact record of how many noncompliances, but it is 
my understanding that yes, when people sign up and they enter 
into these voluntary agreements, they are prepared to do what 
needs to be done to comply with it, and then the auditors are 
out there reviewing, I believe we do have a very high 
compliance rate but I would like to submit that for the record.
    Mrs. Lummis. I would appreciate it if you would. Thank you 
so much.
    Thank you, Mr. Chairman.
    The Chairman. Thank you.
    Mr. Massa, this would be your appropriate time to ask 
questions.
    Mr. Massa. Thank you, Mr. Chairman. Good afternoon, 
gentlemen, and I approach these panels as an opportunity to be 
educated myself. I am from New York, where we have one of the 
highest concentration of family-owned and organic farms in the 
country. And it seems like almost every year for the past 6 or 
7 years there has been at least one major, I call CNN moment, 
headline-grabbing food safety or food contamination news week-
long issue--tomatoes, peanuts, pistachios as they are.
    Dr. Acheson, could you please comment, have any of those 
been driven by small organic farms?
    Dr. Acheson. I am not aware that any of those have been 
driven by small organic farms, no.
    Mr. Massa. And if there are, feel free. I don't want to 
have a ``gotcha'' moment. If there is one, feel free to get 
back to me. It is not a rhetorical question. There is potential 
of significant pending legislation that will change how the 
locally sustainable grown foods and organic farm entities are 
looked at. I am relatively concerned that we don't drive them 
out of business, but that we also supply public safety. What 
issues are you looking at surrounding that segment of our farm 
economy?
    Dr. Acheson. I would have to get back to you with specifics 
on that, but my belief is that from a public health food safety 
perspective, we have not differentiated between farms that grow 
organic crops versus farms that grow conventional crops. We are 
looking at both in the context of how do you ensure that 
whatever is being grown is being grown in a way to ensure that 
it is safe.
    Mr. Massa. Can you commit to me as I report back to my 
constituents that one size does not fit all? There are a lot of 
regulations in the marketplace and in farm America. Some are 
much more easy to implement in large--I don't want to say 
factory farms, that is an improper characterization--but the 
smaller owned farms sometimes have a much harder time 
implementing these regulations. Can you commit to me that some 
measure of common sense will be, is and perhaps even has been 
applied with the formulation and implementation of these kinds 
of regulations?
    Dr. Acheson. I would certainly give you my commitment that 
as much common sense as can be brought to bear, hopefully, be 
brought to bear, as this dialogue continues. I think in answer 
to an earlier question is that this is typically a very public 
process which facilitates the opportunity for the very 
stakeholders you are concerned about to vocalize their 
concerns, whether they be economic or application. In that 
context, I think we have to be looking at as if it doesn't 
matter whether a product is organic is not, is there still a 
potential risk for the product to be contaminated by microbial 
pathogens or chemical agents, depending on the circumstance, 
and that preventive controls need to be in place whether you 
are an organic farmer or a regular farmer. One would certainly 
hope that during that public process, common sense will prevail 
and that the practical consequences of passing legislation that 
is non-implementable or non-enforceable are taken into account 
because that would be counterproductive.
    Mr. Massa. Last question, sir, and then I will ask if your 
associates would like to add to the conversation. You mentioned 
that there were problems in recalling products as far as 
tracing them back through processors towards point of origin. I 
am guessing that the focus of that comment really was on 
domestic produce. However, as you know much better than I, a 
large amount of the green leafy produce and citrus is now 
opened up to international markets. Are you equally or more 
concerned as I am about the traceability of foreign-produced 
food or that of domestically produced food?
    Dr. Acheson. We are concerned about both.
    Mr. Massa. Would you quantify the--I understand the concern 
about both but if you could offer me a quantification, I would 
appreciate it.
    Dr. Acheson. I would have to do that in writing, but I 
think that would be very difficult. The more complex a supply 
chain, the harder it is to track something back. We have 
already demonstrated that domestically the supply chain for 
certain types of fresh produce is incredibly complex, whereas 
on the other hand, the supply chain for certain imported 
products is relatively straightforward. So I don't think there 
is a clear rule of imports versus domestic. Having said that, 
if you are going to put in a system that is looking at how do 
you track a product back or forward rapidly, it cannot simply 
stop at the border. That would make no sense.
    Mr. Massa. And do your associates have any thoughts on 
these issues? Gentlemen?
    Dr. Solomon. Nothing else. I agree.
    Mr. Shipman. Nothing else.
    Mr. Massa. Thank you very much.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Mr. Massa.
    I have further questions for acting Administrator Shipman. 
Some proposed food safety legislation envisions the use of 
third-party auditors to ensure compliance of foreign imports 
with regard to mandatory standards. Can you explain in greater 
detail AMS's industry audit and accreditation program, 
particularly its accreditation function?
    Mr. Shipman. In terms of the auditing programs I talked 
about today in terms of the GAP/GHP and the QTV, those are 
state employees and Federal employees that are doing those 
reviews and audits. We are not using an additional third-party 
accreditation system. We are using Federal employees or state 
employees that have been trained to certain specifications 
including ISO auditing practices.
    The Chairman. You stated that once an official request for 
rulemaking is made, say in the case of national leafy green 
marketing agreements, you would conduct a nationwide hearing. 
How is the public comment obtained during these hearings used 
to inform and determine the requirements?
    Mr. Shipman. The public meetings that we would hold would 
be to gather further information in terms of the interest in 
and the structure of one of these marketing agreements. Once we 
have that, we would actually draft the agreement and it would 
be published in the Federal Register for a complete public 
comment.
    The Chairman. You stated that AMS is not a food safety 
agency, and yet AMS has taken a leading role in developing and 
auditing microbiological data programs for the fruit and 
vegetable industry. For the Good Agricultural Practices and 
Good Handling Practices Audit Verification program, what 
training do AMS auditors receive?
    Mr. Shipman. We want folks that work for us that have a 
real background in quality determinations, so we typically work 
with our commodity graders or marketing specialists, they have 
a real strong understanding of quality assurance, quality 
control and food processing. They will receive, at a minimum, 
basic auditor's training and they will receive ISO 9001 lead 
auditor training as well as training in the Good Agriculture 
Practices (GAP) and Good Handling Practices (GHP). They work 
with a lead auditor for a while to ensure that they have 
adequate education before they provide auditing service. In 
addition, they are required to have 120 hours a year additional 
training and education to retain auditor status.
    The Chairman. Mr. Shipman, I am very interested in the 
Microbiological Data program that you discussed, in light of 
the rapid identification of Salmonella in two products in 
April. Can you describe how the program works? Are samples 
taken and tested by AMS? Is it the state partners who do this 
work or is it by industry participants? And second, how and 
when do you communicate these results of the samplings with FDA 
and CDC?
    Mr. Shipman. The program involves 11 states, each with 
laboratories. USDA also has one laboratory. The states are 
partners. We will go out and sample. We collected, for example, 
last year 7,000 samples. In a typical year we try to collect in 
the neighborhood of 11,000 samples. They are collected at 
wholesale and retail locations. They are brought back, and 
tested in the lab. The results, if we have any sort of positive 
indication, are shared with CDC and FDA and confirmation 
testing has occurred because it is--you need to be careful 
about having false positives. So we want to ensure that they 
are accurate results so there is repeated testing and 
verification that occurs before those results are used for any 
sort of policy decision.
    The Chairman. A follow-up to Dr. Acheson, does FDA have a 
parallel sampling program for fruits and vegetables, and if so, 
are the data from that program shared in the other direction 
with AMS?
    Dr. Acheson. FDA does not have the same level of 
surveillance that my colleague has just alluded to. What we 
have is assignments that are issued on a regular basis for 
different types of foods including fresh produce from time to 
time. It is usually targeted. It is usually based on the 
specific risk or concern, but it is not as extensive as the AMS 
program. In terms of whether that information is shared with 
AMS, certainly we are happy to do that. I don't know whether 
there is an active process to do that, and I will check into 
that and get back to you.
    The Chairman. Please. I would like to have that 
information.
    That concludes my questions. Mrs. Schmidt, do you have 
further questions?
    Mrs. Schmidt. Thank you. Yes, I do.
    This is for Mr. Shipman. Based on your testimony, sir, it 
appear AMS incorporates food safety under marketing orders and 
agreements as part of your authority to verify quality. Do you 
believe legislation is needed to allow for the implementation 
of food safety programs under marketing orders and agreements?
    Mr. Shipman. We have had that question posed to us. We have 
engaged our legal counsel at the Department and we have 
concluded that there is adequate authority now under the 
Marketing Agreements Act for us to incorporate quality related 
requirements.
    Mrs. Schmidt. Thank you. And one more question, growers are 
usually quick to mention their concern about a one-size-fits-
all approach to food safety. Given the variability of crops, 
climate, geography and size of the farms, et cetera, can you 
explain how AMS accommodates commodity-specific approaches for 
food safety in various marketing orders and agreements?
    Mr. Shipman. Yes. Again, I want to make sure I emphasize 
that we are not a food safety agency. We don't set food safety 
policy. But we do work with producers, and if producers are 
interested in entering and establishing a marketing agreement 
or a marketing order, it is up to the producers to do so. 
Agreements are voluntary. And when we work with those 
producers, we bring them together. We will determine if it has 
a food safety element to it. We will look at Good Agricultural 
Practices and Good Handling Practices and the criteria for 
those and how they are adapted. The standards that would be 
developed would be done collectively, with a committee or a 
board that is overseeing those marketing orders or marketing 
agreements, and ensure it is the representation of the 
producers. So you naturally, out of the process, end up with 
regional commodity-specific criteria that you are working with 
in these agreements and orders.
    Mrs. Schmidt. When you say the board makes the decision, 
sir, is there input from the community on it or is it just a 
straight board function?
    Mr. Shipman. There is an open, transparent process to 
collect the information and gather the information, and as far 
as actually setting up the order or the agreement, we go 
through the Federal Register. It is a regular rulemaking 
process. When you are actually working with standards and 
specifications, the board that is made under the order or under 
the agreement is participating in that process, but you are 
gathering information from the public at large.
    Mrs. Schmidt. Thank you.
    The Chairman. Thank you, Mrs. Schmidt.
    I now recognize the gentlelady from Wyoming for 5 minutes.
    Mrs. Lummis. Thank you, Mr. Chairman.
    I am following up on Mr. Massa's questions, first of all to 
Dr. Acheson. If FDA were to make Good Agricultural Practices 
mandatory, would the agency enforce these requirements on farms 
operating in foreign countries? I thought I heard you say they 
would.
    Dr. Acheson. FDA's approach to preventive controls is that 
they need to be applied equally whether it be domestic or 
foreign. There aren't two sets of standards here, and I want to 
make that very clear.
    Mrs. Lummis. Thank you. And further, your testimony 
mentioned the need for authority to require preventative 
controls for food. Would this authority extend to the farm or 
just within processing facilities?
    Dr. Acheson. That will ultimately depend on where Congress 
decides to take that point in terms of how far it extends. Our 
belief is that one has to look at preventative controls from 
one end of the food supply chain to the other. It starts at the 
farm and it ends at the retail, and you need to have adequate 
preventative controls from one end to the other in order to do 
the job appropriately to safeguard public health.
    Mrs. Lummis. And Dr. Acheson, has there been an analysis of 
the costs of that to farmers, the cost of compliance?
    Dr. Acheson. I am not aware that there has been analysis of 
the cost because at this stage we don't know what the rule 
might look like or what the legislation would look like, but 
again, as part of the public process and the rulemaking 
process, economic considerations are taken into account. It is 
part of actually moving it through the public rule and comment 
period in which economic impacts on small and large businesses 
are examined and the economic impact on the business versus the 
economic gain from a public health perspective. So at this 
stage that process has simply not happened because we are not 
there yet, but it will.
    Mrs. Lummis. Thank you. And finally, I am just curious 
about how would the FDA enforce its rules on another sovereign? 
If we are going to try to have a level playing field and 
mandatory rules, how could we apply them off our shores to food 
that is brought in?
    Dr. Acheson. I think that is a very important question, and 
it is a very complex one. We currently import foods from over 
150 different countries all over the world, and the complex 
answer to that is that it is going to need a significant 
ramping up of approach as to how you do that. You have two 
bites of this. Essentially, you have oversight of what is 
happening in that foreign facility, whether it be a grower or a 
processor or manufacturer of some other food or food 
ingredient. That potentially is a combination of working with 
foreign governments, working with the industries. One of the 
suggestions it to appropriately use third-party inspections to 
inform that process, and the third element to that is FDA 
inspections themselves. We currently inspect a small number of 
foreign establishments. We are increasing that by about ten-
fold over the next 2 or 3 years. So I would say that it would 
be a combination of those three elements. You then have the 
second level of control at the port of entry where all foods 
have to be--FDA has to be informed when a food is showing up. 
The system that I would see that we would try to build here is 
to use that information through foreign governments, FDA 
inspections, third parties to inform the risk-based decision 
making at the port of entry, and if you have concerns, you can 
hold a sample, hold the food, inspect it and potentially test 
it. That system is not currently in place, but if this is going 
to work, those are the types of models that one would have to 
use and it would require a lot of work and adequate resources.
    Mrs. Lummis. So Dr. Acheson, I assume that that means that 
you would hold up food at the port that was not verified as 
having participated.
    Dr. Acheson. We would be looking to hold up food at the 
port if we had concerns about whether it was unsafe. I think 
that is the key criteria here is, what assurance do we have 
that it is safe, and if there are concerns, then it should be 
inspected and tested.
    Mrs. Lummis. Thank you very much, Mr. Chairman.
    The Chairman. I would like to thank the gentlelady.
    At this point I would like to dismiss the panel. We look 
forward to your answers in writing that we have requested 
throughout the day's hearing. I would like to call up the 
witnesses in panel number two. While you are coming forward, I 
would like to introduce you all. We have with us today Joe 
Pezzini, Chief Operating Officer of Ocean Mist Farms, 
Castroville, California; Ron Ratto, President, Ratto Brothers 
Incorporated, Modesto, California; Phil LoBue, President of 
LoBue Brothers Incorporated, Lindsay, California; Nicholas 
Maravell, Owner and Operator of Nick's Organic Farm, Potomac, 
Maryland; Steve Hirsch, Partner, Hirsch Fruit Farm Inc., on 
behalf of Ohio Producer Growers and Marketers Association and 
the Ohio Farm Bureau, from----
    Mrs. Schmidt. Chillicothe, Ohio.
    The Chairman. From Chillicothe, Ohio. Thank you, Mrs. 
Schmidt, for giving me the pronunciation of that community. We 
have also Charles Wingard, Director of Field Operations, Walter 
P. Rawl and Sons, Pelion, South Carolina; and Robert Stovicek, 
Ph.D., President and Chairman of Primus Group, Santa Maria, 
California.
    Mr. Pezzini, are you in place and ready to go? Very good. I 
ask you and all of our witnesses today, we have received and 
reviewed your testimony in detail. We would like you to 
summarize, if possible, your information at this point because 
we anticipate that there is going to be additional votes. I am 
concerned about the length of the hearing going on throughout 
the day. We haven't had much actual testimony time. We have had 
a whole lot of time going back and forth to votes, which has 
cut into our hearing time. I am fearful that we are not going 
to be able to complete the hearing if we don't summarize. Also, 
we won't be able to ask an adequate number of questions. So 
please try and extemporaneously summarize your testimony, and 
Mr. Pezzini, we will begin with you.

      STATEMENT OF JOSEPH PEZZINI, COO, OCEAN MIST FARMS, 
 CASTROVILLE, CA; CHAIRMAN, CALIFORNIA LEAFY GREENS MARKETING 
                AGREEMENT; ON BEHALF OF WESTERN
                      GROWERS ASSOCIATION

    Mr. Pezzini. Thank you very much. Good afternoon, Mr. 
Chairman and Committee Members. My name is Joe Pezzini and I am 
the Chief Operating Officer for Ocean Mist Farms.
    Ocean Mist Farms is a family-owned company based in 
Castroville, California, that has been producing vegetables 
since 1924. We are committed to both the art and science of 
agriculture and have invested heavily in the plant breeding, 
growing, harvesting, cooling and shipping operations which are 
all state of the art. I am also Chairman of the California 
Leafy Greens Marketing Agreement, the organization formed a 
little over 2 years ago to regulate the leafy greens industry 
in California and to verify that our growers are all 
implementing the highest food safety practices in growing, 
harvesting and handling of lettuce, spinach and other leafy 
green vegetables.
    Two years ago to the day, I testified before this 
Subcommittee about a new public-private partnership created to 
verify that the best practices in food safety on the farm were 
being followed for the production of lettuce and leafy greens. 
At that time the program was just starting. Now I am here today 
to give you an update on the California Leafy Greens Marketing 
Agreement.
    Let me start by providing some background. In September of 
2006, an outbreak ultimately tied to California-grown spinach 
resulted in a national recall that brought our industry to a 
halt. The outbreak had huge financial costs but more important 
were the human costs. Over 300 consumers were ill from the 
tainted spinach, and tragically, three people died. Since that 
time outbreaks associated with other products have continued to 
keep a national focus on food safety policy. Given that debate, 
the steps we have taken in California to raise the bar for food 
safety may be instructive as we have created a program with 
strong government involvement to certify that our members are 
doing all they can to reduce the risk of foodborne illnesses in 
California's leafy green products.
    Following the spinach outbreak in 2006, our industry joined 
with the California Department of Food and Agriculture and the 
U.S. Department of Agriculture to create the Leafy Greens 
Marketing Agreement. As an industry, our goals were to create a 
program with strong management oversight and involvement in 
order to rebuild confidence in our products, adopt of science-
based food safety standards that would become a universal 
standard adopted by all leafy green growers in the state, 
incorporate government inspections to verify compliance with 
the new standards, and build a program with effective and 
transparent penalties for noncompliance.
    It is important to note that the Leafy Greens Marketing 
Agreement is not industry self-regulation. Although membership 
in the organization is voluntary, once a company joins the 
requirements of the agreement, compliance is mandatory for all 
members and the results are backed by the force of law. As an 
industry, we insisted on the use of government agriculture 
inspectors who are independent, credible, unbiased rather than 
private company auditors.
    Since its creation 2 years ago, the Leafy Greens Marketing 
Agreement has had several significant achievements. Almost 100 
percent of the leafy greens products in our state are marketed 
by companies that are signatories to the marketing agreement, 
meaning that virtually all California leafy green are being 
shipped by companies inspected by USDA inspectors and certified 
to be in compliance with Good Agricultural Practices. In the 
past 2 years we have completed almost 1,000 food safety audits 
of our handlers and growers in California, all done by 
government inspectors, and those audits resulted in issuance of 
over 1,800 individual citations, mostly for fairly minor 
nonconformities. Since the marketing agreement requires 
corrective action on all of these nonconformities, we have 
required that our members undertake corrective action on any 
and all issues cited by inspectors. The Leafy Greens Marketing 
Agreement program does have teeth. We have not hesitated to 
punish through decertification with public notification of 
companies that commit flagrant penalties or fail to correct 
minor problems as required by the marketing agreement.
    Let me give you some of my company's experience as a member 
of the Leafy Greens Marketing Agreement. Because the Leafy 
Greens Marketing Agreement audit standards are comprehensive 
and very specific, this has become the most rigorous inspection 
we face on the farm as we deal with many different audits for 
various companies. It can be tedious and very document-
intensive. The other compelling feature is that we are subject 
to scheduled and unannounced audits as part of the program. 
This means vigilance must always be maintained as inspectors 
will show up at any time. And compliance is very real to us. If 
we lose our certification, not only is it made public, it has 
huge consequences to our business. We would not be able to sell 
our products to buyers in Canada or Mexico and domestic 
customers like Markon Foodservice would stop doing business 
with us.
    To conclude, we accept these responsibilities with a 
doubling of our resources and staff dedicated to food safety 
programs over the past 2 years, but no company can take food 
safety for granted. When an outbreak occurs, it impacts the 
whole industry. Our livelihoods and reputations depend on our 
ability to produce safe food, but most importantly we are 
committed to protecting public health as this is the same food 
we feed to our families.
    I would like to thank the Committee for allowing my 
testimony and I am pleased to answer any questions you might 
have.
    [The prepared statement of Mr. Pezzini follows:]

    
    
     Thank you, Mr. Pezzini. I appreciate you being here.I would like 
at this time to take the witnesses out of normal order. I am told, by 
staff, that Mr. Hirsch, has an impending flight he needs to catch. I am 
going to ask you to summarize your testimony so that we can have time 
for Mrs. Schmidt to ask you some questions. We will give her her 5 
minutes and then we will go back to regular order in the panel.
    So Mr. Hirsch, would you please proceed?

 STATEMENT OF STEVE HIRSCH, MEMBER, OHIO PRODUCE GROWERS AND MARKETERS 
                           ASSOCIATION; VICE
  PRESIDENT, OHIO FARM BUREAU FEDERATION; PARTNER, HIRSCH FRUIT FARM, 
                            CHILLICOTHE, OH

    Mr. Hirsch. Thank you, Mr. Chairman.
    Good afternoon, Mr. Chairman and Members of the Subcommittee. Thank 
you for inviting me here to testify on the very important issue of food 
safety. My name is Steve Hirsch and my family and I operate Hirsch 
Fruit Farm in Chillicothe, Ohio, where we have raised both fruits and 
vegetables since 1872.
    I am testifying today as a member of the Ohio Produce Growers and 
Marketers Association and as the Vice President of the Ohio Farm Bureau 
Federation. My family operates two farm markets, one located at the 
farm and a second several miles away. We sell 85 percent of our 
production directly to the public and the rest wholesale. We are 
members of the Chillicothe Farmers Market and buy and sell products at 
a local produce auction. We embrace a suite of food safety practices on 
our farm, in our markets, at the produce auction and at the farmers 
market. Though there are many common themes among these practices, they 
can vary because these environments differ and require food safety 
practices tailored to these different settings, and that is the theme 
of my testimony today.
    In my view, compliance is the key component of any new food safety 
system and any new system should be flexible in nature so growers of 
all sizes can comply. The Ohio Produce Growers vary greatly in size, 
ranging from large operations that ship their produce both in state and 
across states to very small farmers that sell all their produce 
directly to the local public. Some are located in urban areas or near 
the shores of Lake Erie, while mine is in the hills of southern Ohio. 
Some irrigate from surface water, some use groundwater. Some are near 
livestock operations and some are nowhere near any livestock. My point 
is that a single national one-size-fits-all structure will not work and 
a national food safety system that allows for specific on-farm 
practices to be developed at the state level will achieve the best 
results.
    To this regard, let me make several points: First, flexibility for 
on-farm practices. Flexibility regarding best management practices is 
key to the success of any new food safety system as different growing 
regions' practices vary significantly. Ohio Produce Growers, for 
example, tend to be involved in growing, packing and shipping of the 
product, and this may not be the case in other areas of the country. In 
Ohio, we have one of the largest concentrations of Amish farmers in the 
country. These growers do not use electricity and therefore must pick, 
pack and ship or sell all of their produce in one day. These are a few 
of the examples that highlight the need for flexibility.
    There are several issues within the draft national Leafy Greens 
Marketing Agreement that are of concern to Ohio growers, such as: water 
use issues, animal intrusion issues and border distances surrounding 
crops. These specifics are designed around California's cultural 
practices and are not conducive to Ohio and many other states. The 
draft also subdivided the country into zones that have far too much 
variance and cultural practices. These vertical slices across the 
United States should be redefined to a state-by-state division which 
can better recognize more localized management issues.
    Second, sound science: We believe any new practices should be based 
upon proven food safety practices and sound science. Currently, some of 
the science assumptions behind the California leafy greens approach are 
now being called into question. I would suggest the Federal Government 
take the time to fund and complete the science needed to determine the 
most appropriate practices to assure a safe food supply before moving 
forward with any new system.
    Third, state coordination: Any new program should be coordinated 
with state departments of agriculture or other agencies responsible for 
food safety, inspection and enforcement. This coordination will be 
crucial to the success of new programs with any inspections conducted 
by and coordinated with state lead agencies versus an FDA inspector on 
the farm. The Ohio Farm Bureau office receives calls daily from small 
growers, organic growers and backyard hobbyists all very concerned with 
some of the legislative ideas in regard to new food safety systems. 
Flexibility would go a long way to addressing many of these concerns.
    Fourth, economic impact: Any new system should consider the 
economic impact on various size operations across the country. Ohio, 
and likely other states, is at a distinct disadvantage regarding 
possible compliance costs because we must spread our costs over a 
shorter growing season, as opposed to states that can spread costs over 
the entire year given their longer growing season. A new system should 
be economically viable within existing industry structures that vary 
across the country.
    I would like to note that this testimony only represents a portion 
of Farm Bureau's policy on food safety and that the American Farm 
Bureau will be following up with Committee Members regarding our 
complete position on these important issues. In closing, as we move 
forward in improving upon the safest, most abundant food system in the 
world, let us remember to be practical, cost effective, use sound 
science, allow flexibility for states to work with growers in 
developing best practices, and to recognize, embrace and build upon the 
diverse food production system that we have in this country.
    Thank you, and I will be happy to take any questions.
    [The prepared statement of Mr. Hirsch follows:]

 Prepared Statement of Steve Hirsch, Member, Ohio Produce Growers and 
  Marketers Association; Vice President, Ohio Farm Bureau Federation; 
              Partner, Hirsch Fruit Farm, Chillicothe, OH

    Good morning Mr. Chairman and Members of the Subcommittee, thank 
you for inviting me here today to testify on the very important issue 
of food safety. I am Steve Hirsch, together with my family we operate 
Hirsch Fruit Farm in Chillicothe, Ohio where we raise both fruit and 
vegetables including asparagus, tomatoes, peppers, cucumbers, apples, 
peaches, berries and more. I am testifying today as a member of Ohio 
Produce Growers and Marketers Association (OPGMA) and as the Vice 
President of the Ohio Farm Bureau Federation.
    The Ohio Farm Bureau Federation (OFBF) is the largest general farm 
organization in the state of Ohio with more than 200,000 members 
representing all of Ohio's 88 counties. Our members produce virtually 
every kind of agricultural commodity and as a result, OFBF is very 
interested in the nation's food safety policy.
    The Ohio Produce Growers & Marketers Association (OPGMA) is an 
organization of produce growers and marketers whose goal is to produce 
exceptional quality crops, for consumers and processors, utilizing 
environmentally friendly practices.
    My family operates two farm markets, one located at our farm and a 
second several miles away. We sell 85% of our produce and fruit 
directly to the public and the rest whole sale. We are members of the 
Chillicothe Farmers Market and buy and sell products at our local 
produce auction. We embrace a suite of food safety practices on our 
farm, in our markets, at the produce auction, and at the farmers 
market. There are many common themes among these practices but they can 
vary. They vary because these environments differ and require food 
safety practices tailored to provide the customer the safest and 
highest quality food possible per these different settings. Which is 
the theme of my testimony today.
    In my view compliance is the key to the success of any new food 
safety system and any new system should be flexible in nature so 
growers can comply. Ohio produce growers vary in size ranging from 
larger operations that grow, pack, and ship their produce both in-state 
and across state lines, to very small farmers who sell all their 
produce directly to the local public. These farms are located 
throughout the state and are situated sometimes in the middle of 
suburbs to very rural areas. Some are located near the shores of Lake 
Erie, while mine is literally on a mountain top in southern Ohio. Some 
irrigate from surface water, others use ground water, some are near 
livestock operation and others nowhere near livestock.
    My point, of course is that a single national, one-size-fits-all 
structure will not work and a national food safety system that allows 
for specific on-farm practices to be developed at the state level will 
achieve the best results. To this regard let me make several points:
    First, State-by-State Flexibility Per On-Farm Practices. 
Flexibility per best management practices (BMPs) is key to the success 
of any new food safety system, as different growing regions on a 
national, even at a state level, vary significantly. For example, Ohio 
produce growers tend to be involved in growing, packing and shipping of 
the product, this isn't the case in other areas of the country. 
Different regions of the country use production land very differently 
as well, such as continual use of specific land for produce production 
versus shifting use of land between pasture, other crops and production 
of vegetables. One of our Ohio leafy green growers has noted that his 
production systems are vastly different from another grower just 50 
miles away. A state-based program could better recognize more localized 
management issues such as the locations of feedlots, wildlife 
challenges and more.
    To even more specifically illustrate this point there are several 
issues within the draft National Leafy Greens Marketing Agreement 
(NLGMA) that are of concern to Ohio growers such as several water use 
issues, animal intrusion and boarder distances surrounding crops. These 
specifics were designed around California's cultural practices and are 
not conducive to Ohio and many other state's accepted practices. The 
draft also subdivided the country into zones that are far too large 
with far too much variance in cultural practices between the northern 
and southern states which are all included in single zones. The zone 
that includes Ohio, for example, stretches as far north as Wisconsin 
and a far south as Alabama. These vertical slices across the U.S. need 
to be redefined to a state-by-state division.
    Second, Sound Science. We believe any new practices should be based 
upon proven and effective food safety practices and sound science. Most 
of our produce is not produced in an indoor or enclosed environment and 
should not be regulated in a manner that is unrealistic to achieve. 
Currently some of science assumptions behind the California Leafy 
Greens approach are now being called into question. These challenges 
question the contamination threat related to water quality and animal 
intrusion. I suggest the Federal Government take the time to fund and 
complete the science and research needed to determine the most 
appropriate and safe practices to assure a safe food supply before 
moving forward with any vast new system.
    Third, State Coordination. Any new program should be coordinated 
with state departments of agriculture or other agencies responsible for 
food safety, inspection and enforcement. Such coordination will be 
crucial to the success of new programs and will prevent redundancy in 
programming. We need to bolster the funding, education and training for 
inspectors and when inspections are needed, such inspection should be 
conducted by and coordinate with state lead agency, such as the Ohio 
Department of Agriculture in Ohio, versus an FDA inspector on the farm. 
The Ohio Farm Bureau office receives calls daily from small growers, 
organic growers, backyard hobbyists and gardeners all very concerned, 
right or wrong, with some of the legislative ideas being proposed on 
Capitol Hill per new food safety systems. Flexibility would go a long 
way to addressing many of these concerns.
    Fourth, Economic Impact. We emphasize the need for any new program 
to be organized in a manner that allows the strength of existing state-
based systems to aid in the success of improved food safety, especially 
given the severe budget challenges that states currently face. 
Furthermore. the development of any new system should consider the 
economic impact on various size operations across the county. In Ohio, 
we have one of the largest, if not the largest, concentration of Amish 
farmers in the country. These produce growers do not use electricity 
and use horses in the fields to cultivate. They must pick, pack and 
sell their produce all in one day. They also keep horses outside the 
production areas during harvest time. These are a few of the many 
specific examples that highlight the need for flexibility. We also want 
to make it clear that Ohio, and likely other states, are at a distinct 
disadvantage per possible compliance costs because we must spread costs 
over a shorter growing season, as opposed to some states like 
California, that can spread costs over the entire year, given their 
longer growing season. Any new system should be economically viable 
within existing industry structures that vary across the country.
    In closing, as we move forward in improving upon the safest, most 
abundant food system in the world, let's remember to be practical, 
cost-effective, use sound science, allow flexibility for states to work 
with growers in developing best practices and recognize, embrace and 
built-upon the diverse food production system we have in this county. 
Thank you. I'll be happy to take any questions.

    The Chairman. Sir, you state that flexibility would go a 
long way in addressing the concerns of the small market and 
organic growers. What do you mean by flexibility?
    Mr. Hirsch. Well, as you will see from some of the other 
testimony, most of the growers in the panel other than the 
gentleman to my right are very large growers. They have the 
ability to comply with larger cost structure involved in 
complying with some of the regulations. We also process apple 
cider or apple juice, and we are federally regulated through 
the FDA. The Ohio Department of Agriculture, or ODA, actually 
does the FDA inspection on our food processing facility. We 
have a HACCP plan. It was 5 to 8 years ago when the FDA came 
out with their regs that you either had to develop a HACCP plan 
and have a 5-log kill step in your juice processing or you have 
to label your product with a warning label and can only sell it 
at the farm. We decided to go with that 5-log kill step because 
we sell at two different markets, a farmers market and other 
places. We do some wholesale. So we made that commitment. But 
it is still flexible enough that if you are a grower that makes 
cider at your market for 4 months a year, you can still sell it 
there, you would have to label it. So there is some flexibility 
in that program, you know. That would be an example of that.
    The Chairman. Mrs. Schmidt, would you like to ask your 
questions of Mr. Hirsch at this time?
    Mrs. Schmidt. Thank you.
    Thank you so much for coming. There is some understanding 
that there are some ideas out there to move the new marketing 
agreements forward. How involved have the midwestern growers 
been in this process?
    Mr. Hirsch. There has been some involvement but there are 
also some concerns with a number of growers that there hasn't 
been enough involvement. What we would like to see is the 
process work where we have the ability to make comments and to 
add some flexibility to a program that is based on what growers 
in the West are doing, and growers in the Midwest and the 
Northeast may not be doing those same type of cultural 
practices.
    Mrs. Schmidt. I will shift gears just a second. There has 
been some talk of a greater role of the FDA in farming. Do you 
believe that the FDA has the resources and expertise to develop 
on-farm production practice standards, taking into account all 
the variables of crop diversity, climate, region and geography?
    Mr. Hirsch. They would have to develop some flexible 
standards because of that diversity that is inherent in 
American agriculture right now. You know, we have a lot of 
local food systems developing around the country, so they would 
have to be flexible. The diversity of crops in Ohio and 
California and Florida and those states is immense, and I think 
that some of the marketing agreements that are set up are just 
part of a food safety system that could be implemented, a 
flexible food safety system that could be implemented for all 
of those other crops.
    Mrs. Schmidt. If we were to adopt the proposal of some in 
the fruit and vegetable sector and require the FDA to issue 
mandatory food safety standards for produce farmers, it will be 
necessary for the FDA or state regulators acting on this behalf 
to inspect farms for compliance. Considering the budgetary 
climate, are you prepared to pay for these inspections?
    Mr. Hirsch. Well, my feeling is that the food safety is for 
the public good and should be publicly funded.
    Mrs. Schmidt. Mandatory FDA inspections on farms, do you 
have any support among your individual grower members for that? 
Is there support for that or is there a nervousness for it, 
or----
    Mr. Hirsch. I would imagine that there would be some 
trepidation toward mandatory FDA farm inspections.
    Mrs. Schmidt. And finally, just to show the diversity of 
the United States, when the tobacco settlement was issued over 
10 years ago, there was a push for tobacco growers to diversify 
into something else. Isn't that a reason why we have a stronger 
presence of farms like yours in Ohio?
    Mr. Hirsch. That is one of the reasons. I had mentioned the 
Amish communities and also the Mennonite communities. There are 
five or six produce auctions around the State of Ohio, most of 
them developed by the Amish or Mennonite communities. At each 
community, the one that we participate in, there are 70 
Mennonite families that are in that area and probably 50 of 
those 70, the main thing that they do is raise fruits and 
vegetables and sell through those auctions to other smaller 
retailers, larger retailers. Jungle Jim's in Cincinnati buys at 
that produce auction.
    Mrs. Schmidt. And I have the Kline family and one of the 
Miller families that left Amish to be Mennonites, so I have 
Amish and Mennonites in my own district as well.
    Thank you so much for coming here. I really appreciate it.
    Mr. Hirsch. Well, than you for having me, and thank you, 
fellow panel members for indulging.
    The Chairman. Mr. Hirsch, thank you as well, and you are 
excused so you can catch your plane.
    Mr. Hirsch. Thank you, sir.
    The Chairman. Mr. Ratto, please proceed.

  STATEMENT OF RONALD A. RATTO, PRESIDENT, RATTO BROS., INC., 
                          MODESTO, CA

    Mr. Ratto. Mr. Chairman, Ranking Member Schmidt, thank you 
for the opportunity to appear today.
    Ratto Brothers takes its origin from 1905 when my 
grandfather, Antone Ratto, quit school at the age of 16, much 
to the chagrin of his mother, and went to work full time in the 
vegetable gardens of Bay Farm Island in Alameda, California.
    Today, we remain in the same kind of vegetable business 
doing basic food production. We grow food for people. We want 
to provide healthy, fresh, wholesome and low-cost vegetables to 
the communities where we live, to communities in California and 
beyond. We farm about 1,000 acres, growing a large variety of 
truck garden, leafy green, fresh vegetable crops such as beets, 
chard, dandelions, mustard greens, turnips, parsley, celery 
root, the leaf lettuces, and cabbages. Do we do anything 
unique? Well, we grow lots of different kinds of crops, 35 or 
40. We plant many of the crops weekly. We have small fields, 
usually from a half acre to 3 acres in size, so we have lots of 
fields and lots of crops growing at any one time. This creates 
a very busy farm operation and lots of activity. We have 
customers of all sizes from the very large that order by the 
truckload to the very small ordering five to ten boxes at a 
time.
    We do many things ourselves instead of hiring them out. We 
farm on land we own. We grow crops ourselves. We harvest the 
crops. We have our own cold storage, do our own sales, have our 
own mechanic shop, and we operate trucks for delivery. We are 
vertically integrated and a 100 year-newer version of how our 
ancestors operated. We bridge from the large to the small in 
many ways. We invest in facilities, equipment and people. We 
invest in capacity including food safety capacity, the ability 
of people to develop, implement, maintain, operate and improve 
food safety systems and in the system's infrastructure. If we 
are unique, it might be in the complexity of our operation due 
to the number and mix of crops we grow, the multitude of 
activities that we perform ourselves and the standards we hold 
ourselves to achieve.
    Our predominant experience with food safety is with the 
California Leafy Greens Marketing Agreement, or LGMA, program. 
We believe the interest of food safety is implicit to our food 
production and must be an integral part of growing the 
vegetables that provide for our livelihood. We feel an 
obligation and responsibility to offer safe food products to 
our customers and to the consuming public. The food safety 
practices we follow do not occur without commitment and hard 
work, and as a company principal I have regular involvement in 
our food safety program. Commitment is essential, and we are 
committed.
    The LGMA guidelines and requirements serve as the core of 
our food safety program. We think this public-private 
partnership between the leafy green industry and state and 
Federal Government brings the best from all realms to the 
program and government oversight provides a key feature to the 
program. Our approach is to fully integrate the LGMA program 
elements into our operational practices. A well-operating food 
safety program encourages communication between and among 
employees at all levels. Since food safety practices relate to 
all areas of our operation, employees in all areas are expected 
to contribute in their own particular way to the overall 
program.
    Even though we grow food in the outdoors where there is the 
influence of wildlife, human life and weather, and where it is 
difficult to control external variables, there is much we can 
do and do do in the way of farm practices that contribute to 
safe food. We test water. We get ingredients documentation for 
soil amendments. We monitor surrounding lands and our own land 
for animals and environmental influences. We have health and 
sanitation standard operating practices for our workforce and 
we follow many other procedures, guidelines and requirements.
    Our food safety program relies on people. We train and 
retrain employees. We check employees. We monitor internal 
systems. We self-audit. We talk about situations and we strive 
for perfection in our details. We can be perfect in what we do 
and we sometimes are perfect but we are not always. To attain 
perfection day after day, time after time is a challenge but 
that is what we strive for, and food safety seeks perfection.
    The test of our performance is in the audit verification 
program. We are motivated to do well and our employees take 
pride in their food safety achievements. These mandatory audits 
are performed by government inspectors, sometimes announced in 
advance and sometimes unannounced and happen as a walk-in 
inspection. Both types of audits make sure that we are 
complying with the LGMA food safety standards. Implementation 
of the LGMA program has moved our food safety practices to a 
much higher level and we believe it has elevated the practices 
of others as well.
    With that, Mr. Chairman, thank you very much for the 
opportunity to appear.
    [The prepared statement of Mr. Ratto follows:]

 Prepared Statement of Ronald A. Ratto, President, Ratto Bros., Inc., 
                              Modesto, CA

    Good morning, Mr. Chairman, distinguished Committee Members and the 
assembled public. My name is Ron Ratto, and I am with Ratto Bros., Inc. 
from Modesto, California. Thank you for the invitation to appear today.

1. So who are we?
    Ratto Bros. takes its origin from 1905 when my grandfather Antone 
L. Ratto quit school at the age of 16, much to the chagrin of his 
mother, and went to work full time in the vegetable gardens of Bay Farm 
Island in Alameda, California. His father, uncles and grandfather were 
also all vegetables gardeners in the area of Alameda, West Oakland, 
East Oakland and Berkeley, and my grandfather spent his youth in their 
vegetable gardens and delivering produce with them.

2. What do we do today?
    We remain in the same kind of vegetable business today, over 100 
years later, doing basic food production. We grow food for people. We 
want to provide fresh, healthy, wholesome and low-cost vegetables to 
the communities where we live, to communities in California and beyond. 
We farm about 1,000 acres, growing a large variety of truck garden 
leafy green fresh vegetable crops such as Beets, Chard, Dandelions, 
Mustard Greens, Turnips, Parsley, Celery Root, Leaf Lettuces, and 
Cabbages.

3. Do we do anything unique?
    We grow lots of different kinds of crops, 35-40. We plant many of 
the crops weekly. We have small field sizes, usually from \1/2\ acre to 
3 acres in size. We have lots of fields and lots of crops growing at 
anyone time. This creates a very busy and productive farm operation, 
with lots of activity. We have customers of all sizes, from the very 
large that order vegetables by the truck load, to the very small, 
ordering five to ten boxes at a time.
    We do many things ourselves instead of hiring them out. We farm on 
land we own. We grow the crops ourselves, we harvest the crops, we have 
our own cold storage, we do our own sales, we have our own mechanics 
shop and we operate trucks for delivery. We are vertically integrated, 
in a 100 year newer version of how our ancestors operated. We bridge 
from the large to the small in many ways.
    We invest. We invest in facilities, equipment and people. We invest 
in capacity. The last several years, we have invested in food safety 
capacity--the ability of people to implement, maintain, operate and 
improve food safety systems, and in systems infrastructure.
    If we are unique, it might be in the complexity of our operation 
due to the number and mix of crops we grow, the multitude of activities 
we perform ourselves and the standards we hold ourselves to achieve.

4. Our experience, perspective and approach on food safety and the 
        LGMA.
    Our recent and current experience with food safety is with the 
California Leafy Greens Marketing Agreement program. Our company food 
safety program and systems today are much more comprehensive than they 
were before the establishment of the LGMA program.
    We believe the interest of food safety is implicit to our food 
production and must be an integral part of growing the vegetables that 
provide for our livelihood. We feel an obligation and responsibility to 
offer safe food products to our customers and to the consuming public. 
The food safety practices we follow do not occur without commitment and 
hard work, and as a company principal, I have regular involvement in 
our food safety program.
    Commitment is essential and we are committed.
    We chose to commit to the LGMA program and to adopt the LGMA 
guidelines and requirements as the core of our food safety program. We 
think that the public-private partnership between the leafy green 
industry and state and Federal Government brings the best from all 
realms to the program. Government oversight of the program provides 
another key feature to the program.
    The LGMA program is a substantial food safety program and we had to 
gear up to meet its challenges. We had to design and re-design our 
internal systems to link up to the program guidelines and requirements, 
and then disperse the responsibilities within our internal systems.
    Our approach is to fully integrate the program elements into our 
operational practices. The development and operation of a food safety 
program encourages communication between and among employees at all 
levels. Since food safety practices relate to all areas of our 
operation, employees in all areas are expected to contribute in their 
own particular ways to the overall program.
    Even though we grow food in the outdoors, where there is the 
influence of wild life, human life, and weather, and where it is 
difficult to impose control on external variables, there is much we can 
do and do do in the way of farm practices that contribute to the 
production of safe food. We test water, we get ingredients 
documentation for soil amendments, we monitor surrounding lands and our 
own land for animals and environmental influences. We have health and 
sanitation Standard Operating Practices for our work force. And we 
follow many other procedures, guidelines and requirements.
    Our food safety program relies on people. There are many food 
safety routines that must be performed daily. We try to strengthen our 
routines so that they are an expected, embedded, re-occurring part of 
our employee's daily work life.
    We train and re-train employees? we check employees, we monitor 
internal systems, we self-audit, we talk about situations and we strive 
for perfection in our details. We can be perfect in what we do, and we 
sometimes are perfect, but we are not always. To attain perfection day 
after day, time after time, is a challenge, but that's what we strive 
for. And food safety seeks perfection.
    This is all part of the ``food safety culture'' we are building.
    And the test of our performance is in the audit verification 
program. We are motivated to do well and our employees take pride in 
their food safety achievements. These mandatory audits are performed by 
government inspectors, sometimes announced in advance, and sometimes 
unannounced and happen as walk-in inspections. Both types of audits 
make sure that we are complying with the program food safety standards.
    Implementation of the LGMA program has moved our food safety 
practices to a much higher level, and we surmise it has moved higher 
the level of most others in the leafy green business as well.

5. Financial Burden
    Is there a cost to food safety? Yes, of course there is. Should 
consumers have to pay extra for food safety? Maybe not, but the reality 
is that the cost of food reflects all the various costs that go into 
its production, and ultimately the consumer must bear the total cost of 
food production. The costs of food production are a constantly changing 
blend of increasing and decreasing cost components, the total of which 
seems to keep rising over time.
    For us, examples of the costs of food safety include (1) supplies, 
such as gloves and hairnets and chlorine test strips, (2) equipment, 
such as a chlorine pump, an ORP meter and stainless steel work 
surfaces, (3) laboratory tests, such as for micro-organisms, and (4) 
personnel, to administer and keep records of the food safety program.
    Are the costs significant? Yes. Is it worth the expense? Yes, 
because we want to take extra steps to produce safe food.
    And while the cost of food safety might be measured in dollars, the 
value of food safety is almost immeasurable as it affects so many 
people every day, both producers and consumers.
    And with that, at this point I would like to stop. I hope this 
testimony is useful to the Committee, and I thank you again for the 
invitation to appear.

                               Attachment

Additional Comments To Submit As Written Testimony
Comments: Features of the LGMA program that could be considered in food 
        safety legislation:
    Food safety program guidelines and requirements are based on known 
scientific and academic work.
    Program entities develop and operate their own food safety programs 
to attain the program requirements.
    State inspectors under USDA overview compose the audit staff.
    Program entities are subject to periodic audits.
    Program entities are subject to unannounced audits.
    If audit deficiencies are found, they must be corrected.
    Corrections of deficiencies are audited.
    If a program entity has serious violations, it is subject to 
disciplinary procedure, including suspension and termination from the 
program.
    The program will name names--serious offenders that are de-
certified are named as such.
Comments: Other points to consider in food safety legislation:
    Governance of food safety programs:

   Authorize food safety programs with shared collaboration, 
        involvement, participation and responsibility between Federal 
        Government, state government and industry.

   Authorized national food safety programs to operate as U.S. 
        wide.

   Prohibit individual state standards that would restrict the 
        interstate movement or sale of food.

    Scope of food safety legislation:

   Allow food safety programs for the production and harvest of 
        food crops.

   Allow food safety programs for the handling and distribution 
        of food crops.

    Determination of who should be subject to food safety legislation:

   Encourage inclusion of all commercial food producers.

   Discourage exclusion or non-participation of selected groups 
        of food producers.

    Standards and requirements:

   Do not set food safety practices by Act of Congress.

   Allow food safety programs to establish processes to develop 
        food safety standards that are flexible, efficient and open to 
        industry and public participation.

   Allow food safety standards to be based on science and 
        applied academic work.

   Allow processes for the flexible revision of food safety 
        standards to enable the updating and changing of guidelines, 
        standards and requirements based on new knowledge.

    Food safety program elements:

   Regulates, inspects and enforces food safety standards.

   Provides training materials, resources and guidance to food 
        producers on best practices and how to meet the standards or 
        regulations

   Flexible implementation: Allow flexibility in how food 
        producers meet food safety requirements.

   Audit function-verification of food safety practices by 
        producers and handlers.

   Determine audit scheme and frequency.

   Establish process development, review and change to the 
        audit scheme.

   Announced and unannounced audits.

   Timely follow-upon audit deficiencies.

   Supervise auditor staff.

   Set qualification and performance standards for auditors.

   Administer audit results to subject entities.

   Develop and administer consequences system to food producers 
        with poor audit performances or deficiencies.

   Identify research needs.

   Investigate food contamination episodes and food related 
        human illness outbreaks.

   Determine causes of outbreaks, write reports and make 
        recommendations and changes to standards based on findings.

    The Chairman. Thank you very much, Mr. Ratto.
    Mr. LoBue. Again, I would like to remind everyone to do 
their best to summarize their testimony. We now have votes that 
were just called. We are going to take your testimony, Mr. 
LoBue, and then we are going to see where we stand. I don't 
know how long we are going to be gone and I don't know how much 
time the Members are going to have. I will be informing you all 
as to how we are going to proceed as the votes progress. Mr. 
LoBue.

   STATEMENT OF PHILIP LoBUE, PRESIDENT, LoBUE BROS., INC., 
                          LINDSAY, CA

    Mr. LoBue. Thank you, Mr. Chairman.
    Good afternoon. My name is Philip LoBue and I am President 
of LoBue Brothers, a family-run citrus operation located in 
Lindsay, California, which is the heart of the fresh orange 
citrus industry. I am a second-generation producer and now a 
partner in our family growing, packing and shipping operation. 
What my father and his brothers started in 1932, my brother and 
I, along with my cousins, are now operating. We farm 
approximately 1,000 acres. We pack our own fruit along with 
that of another 150 growers, all of which manifest itself into 
four million cartons of fresh citrus sold domestically and 
internationally. During the peak season we employ approximately 
250 people in the packing operation and another 100 plus in the 
field harvesting fruit. Collectively, the industry directly 
employs 12,000 people, sells an estimated $1.8 billion of 
product. We harvest fruit from trees that are 50 to 60 years 
old and in some cases over 100 years old. We and my former 
3,500 farmer colleagues have done this without any food safety 
problems.
    Believe me, we take our food responsibility seriously. We 
currently have a complete traceback system from the carton to 
the field, and soon data bar technology will allow for each 
piece of fruit to be identified and traced back to the field. 
Coupling this with GPS technology, we can get it pretty close 
to the tree. Our employees wear gloves in the field and at the 
packing house. Our fruit washing systems in the packing house 
are constantly monitored by a third party to ensure they are 
performing correctly. Field and packing house sanitary 
conditions are constantly monitored and recorded. The safety of 
our product is never taken for granted and the industry has an 
enviable food safety reputation.
    Our industry certainly understands the concern and need for 
a viable food safety program. We believe any food safety 
program mandated by the government should be risk based and 
commodity specific. Citrus grows on a tree above the ground in 
a sealed package that is peeled before consumption. Our areas 
of vulnerability are entirely different and considerably less 
than that of other commodities. We shouldn't be saddled with a 
system that is more rigorous for a more risky commodity. 
Government-imposed costs are a pet peeve of ours as they now 
represent 25 percent of our farming costs as documented by Cal 
Poly, San Luis. Presently, our company incurs in excess of 
$50,000 of direct costs for two different audits. Every food 
safety audit company stresses different areas and they all seem 
to be trying to establish a name for themselves. We have 
shopped audit companies and have switched only to find that the 
next is worse than the one we had. Some of our customers 
specify certain audit companies and will not accept the results 
of others. Many of the things we do in the name of food safety 
I find hard to figure out the bearing on the safety of the 
product.
    So we need to develop standards that are specific to the 
industry in order to harmonize the audits so that any third-
party audit would produce the same results. So we would support 
this effort. If a food safety audit is necessary, then let us 
make it happen once and let us standardize it to the 
satisfaction of all concerned. I am sure the government has the 
resources current available to undertake this task. For us, 
because of the familiarity and the knowledge of the industry, 
we believe USDA is best suited to perform this task. This can 
be done with existing personnel. USDA already has contracts 
with CDFA, California Department of Food and Agriculture, who 
has agreements with the local farm advisors. It doesn't have to 
be an expansion of personnel. Just as I have learned new 
tricks, I am certain that within the existing government 
structure there are individuals who can be retrained or 
elevated to do the desired job.
    Thank you for me allowing me this opportunity, and I look 
forward to answering any of your questions.
    [The prepared statement of Mr. LoBue follows:]

   Prepared Statement of Philip LoBue, President, LoBue Bros., Inc., 
                              Lindsay, CA

    Good afternoon, my name is Philip LoBue and I am President of LoBue 
Brothers, a family run citrus operation located in Lindsay California 
which is the heart of the fresh citrus industry. I am a second 
generation producer and now partner in the family growing, packing and 
shipping operation. What my father and his brothers started in 1932 my 
brother and I along with three cousins are now operating. We farm 
approximately 1,000 acres; pack our own fruit and that of another 150 
growers all of which manifests into four million cartons of fresh 
citrus sold domestically and internationally. We employ 250 people in 
the packing house and another 100 plus in the field harvesting fruit.
    During my 30 years in the industry we have NEVER had a food safety 
issue. Never in my 30 years as a member of our industry have we had a 
food safety issue. The California citrus industry is the number one 
fresh citrus producing area in the nation. Each year an estimated $1.8b 
of product is sold which creates another $1.2b of economic activity. 
Collectively we employ 12,000 people and our activity supports another 
13,000 jobs. And, again, we've never had a food safety issue. The 
safety of our product is never taken for granted and the industry has 
an enviable food safety reputation.
    We do this without support payments or government assistance. We do 
this while facing tariffs approaching 54% and we do this while so many 
of our off shore competitors receive government assistance; in the EU 
the support level exceeds $lb. Our regulatory costs are over $400 per 
acre now.
    Many years ago our own Citrus Research Board published a Food 
Safety directive for the industry at both the grove and packing house. 
In March 2007 they updated it with the statement Good Agricultural 
Practices are an insurance policy, not a burden. That's our belief, our 
responsibility and our commitment. We fulfill it every day.
    This is the environment in which I and my family have farmed for 
almost 100 years. We harvest fresh fruit from trees that are 50-60 
years old. We and my 3,500 farmer colleagues all do this without any 
food safety problems. I think we are a pretty good example of what 
sustainability is all about and yet we feel threatened by too much 
government involvement. Believe me Committee Members we take our food 
safety responsibility seriously. We have a complete traceback system 
from carton to field and soon data bar technology will allow for each 
piece of fruit to be identified and traced back to the block from which 
it was harvested. Add to that state of the art GPS technology and we 
will soon tell you what tree a piece of fruit came from. All this is 
being done without government rules, regs, mandates and costs. Our 
employees wear gloves in the field and at the packing house. Our fruit 
washing systems in the packinghouses are monitored by ourselves and a 
third party to insure they do the cleaning process necessary. Field and 
packing house sanitary conditions are constantly monitored.
    Food safety begins at the grove as we producers are the first step 
in the farm to table food chain. It continues into the packing house 
with documentation, traceability, monitoring and communication. Our 
overall objective is to provide the public with a safe and nutritious 
product in a manner that sustains productivity and economic viability.
    Our industry certainly understands the concern and need for a 
viable food safety program. We believe our industry's track record 
clearly supports my contention that we have a viable effort in place. 
Right now we are reviewing it to determine areas of vulnerability. We 
know things change, we know pathogens exist or change to create new 
challenges. We know we must be ever diligent to protect the consumer 
and our industry's integrity. We believe we do that. As an industry we 
should be willing to share our common program with the appropriate 
officials so that they may learn how one commodity accomplishes the 
desired objective.
    We believe a food safety program mandated by government should be 
risk based. Committee Members, we are on a tree, above ground in a 
package that is peeled before consumption. Our areas of vulnerability 
are entirely different than other commodities. Not only are they 
different but there are considerably fewer areas of vulnerability as 
well. Government shouldn't impose a program on an entity that has 
demonstrated continued success towards the food safety objective. We 
should share, review and monitor. We shouldn't be told to change 
something that works and incur additional costs.
    Government imposed costs are a pet peeve of ours. They now 
represent 25% of our farming costs. In the past few years as others set 
themselves up as the consumer protector, or to protect themselves from 
liability or choose a new marketing theme they have imposed marketplace 
mandates that are duplicative and expensive. Presently our company 
incurs $50,000 for two different audits. Every third party audit 
company and individual auditor stress different areas and it seems all 
of them are trying to establish a name for them by trying to out do the 
other. Many of our customers specify certain audit companies and will 
not accept results from others.
    Many of the things we do in the name of food safety have no bearing 
on the safety of the product. Standards need to be developed that are 
specific to our industry in order to harmonize the audits so that any 
third party can conduct the audit. Finally we have to say enough is 
enough. On one hand we think a double standard exists for what we must 
do to satisfy our customer versus what others are doing to protect the 
consumer. Second, we are asked to absorb these duplicative costs.
    We have a saying in our industry, costs are fixed locally while 
prices are determined globally and the margin between the two is almost 
non existent. Imposing costs on us makes our product more expensive. 
Having those costs imposed more than once is doubling the expense 
without adjusting the margin as off shore competition can do everything 
for less expense. So we would support an effort to harmonize or 
standardize this cottage industry of food safety audits. If a food 
safety audit is necessary then make it happen once and make it 
standardized to the satisfaction of the government and the consumer.
    Members of the Committee, I'm not so naive to stipulate that a food 
safety problem will never occur in the citrus industry. We must 
maintain our standards. We must review them and we must improve them. 
But we shouldn't be saddled with a system that is more rigorous for a 
more risk prone commodity. We shouldn't be burdened with a multitude of 
audits so others can market their food safety awareness program. We 
shouldn't be burdened for a bureaucratic cost that cannot be passed on 
and we shouldn't be burdened by a program that buries our 
administrative staff in paperwork.
    Allow me to conclude with one additional thought. I've been around 
to witness the formation of the Department of Education, Environmental 
Protection Agency and most recently Homeland Security. Before me USDA 
and FDA were developed. Surely you can't envision another government 
growth mandate. Existing agencies should be redirected to this mission. 
For us, because of familiarity and their knowledge of location, people 
and industry, we believe USDA is best suited to perform the food safety 
oversight tasks. This can be done with existing personnel. It can be 
done by contracting with state or local governments. It doesn't have to 
include an expansion of personnel. Just as I have had to learn new 
tricks on computers and electronic dissemination of information so 
should government personnel be retrained for today's needs.
    Thank you for allowing me this opportunity and I look forward to 
answering any questions you may have.

    The Chairman. Thank you very much, sir. At this time I am 
going to recess the hearing because we have three votes. This 
may take a bit of time. I have other commitments later this 
afternoon so I am checking with staff to determine how we to 
proceed with the question portion of the hearing. We want to 
make sure that your testimony is heard because we care very 
much about what you have to say. We will get back to you as 
things will be in flux here until we can get our schedules 
determined. We will be keeping you informed about how we are 
going to work everything out. I apologize for the 
inconvenience. The hearing is temporarily in recess.
    [Recess.]
    The Chairman. With apologies, I will reconvene the hearing. 
I am going to release Mr. Pezzini, Mr. Ratto and Mr. LoBue from 
further questions. We are going to submit our questions to the 
three of you in writing and circulate them with the rest of the 
Committee because of the situation we have had today with the 
impending votes. You are welcome to stay but I was going to 
release you in case you needed to catch flights. We are going 
to go to Mr. Maravell's statement and then we will have Mr. 
Wingard and Dr. Stovicek. I ask you once again to summarize and 
limit your testimony. We have them in writing and the Members 
of the Committee will in fact read them. We are intending to 
submit an extensive number of questions to you through written 
questions.
    Mr. Maravell, please proceed with your testimony, and once 
again my apologies for the inconvenience.

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

    Mr. Maravell. Thank you, Mr. Chairman.
    Mr. Chairman, Mrs. Schmidt, my name is Nick Maravell. I 
have been an organic farmer for the past 30 years. I appreciate 
the opportunity to provide testimony regarding organic 
agriculture and food safety to an Agriculture Subcommittee.
    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. I will try 
to show how our farming practices, organic certification and 
direct marketing give us unique and effective built-in 
advantages in the area of food safety. And finally, I will 
offer a few recommendations. I hope will shape any 
Congressional changes to food safety policy.
    We raise grass-fed Angus beef, pastured chickens and 
turkeys, free-range eggs. We grow various mixed hays. We 
maintain different types of pastures. We produce field corn, 
soybeans, barley, rye, hairy vetch. We grow fresh, edible 
vegetable soybeans. On the farm, we process and package our own 
chickens, turkeys, eggs, fresh soybeans, cover crop seeds and 
poultry feeds.
    As a certified organic operation, we are part of the 
organic industry which is proactive and uniquely positioned on 
food safety in ways that are not standard in other food 
sectors. All of these provisions are required of organic 
operations, but not conventional operations. One, organic 
farmers and processors are required by law to maintain 5 year 
records that allow one-up, one-down traceability for all inputs 
and for all sales. From field to fork, every entity in the 
supply chain or in the stream of commerce must maintain an 
audit trail that permits full traceability and accountability. 
Two, raw livestock manure cannot be used on crops for human 
consumption without an extended waiting period before harvest. 
Three, compost made with animal manure must meet temperature, 
mixing and time requirements to ensure its safety or else be 
treated as raw manure.
    I am going to summarize some other points in my testimony 
concerning issues that Congress should take into account when 
considering pending legislation regarding food safety. First, 
legislative measures should be appropriate to the size, scope 
and nature of an operation. The one-size-fits-all approach is 
fraught with unintended consequences, and in this case 
consumers could find it more difficult to obtain the products 
they want. Two, unless there is a specific, scientifically 
documented need to solve a clearly defined problem, solutions 
should not be imposed. Three, local--sorry. I am going to skip 
three. Four, the organic industry has in place legally mandated 
safeguards necessary to ensure food safety including full 
traceability and accountability of food products and strict 
controls on known potential sources of food contamination such 
as manure and pesticide residues. The organic certification 
system allows all producers and processors small and large the 
flexibility to maintain traceability records appropriate to the 
type and scale of operation.
    Five, Congress should be very cautious in drawing organic 
food safety conclusions from studies that did not look at 
organic food production systems. For example, manure 
mineralization rates and counts of antibiotic-resistant 
bacteria on conventional farms and processing plants are not 
reliable indicators of what would be found on organic 
operations. The ecological science base for organic 
agriculture, in general, and for organic food safety, in 
specific, is expanding rapidly. The organic community has begun 
advancing research proposals to Federal competitive grant 
programs, and we can expect to see appropriate organic food 
safety studies funded this year and in the coming years. These 
studies can both document the level of safety of the organic 
food supply and develop additional procedures and processes 
that can make organic products available to a wider audience at 
a more cost-effective price.
    [The prepared statement of Mr. Maravell follows:]

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

    Mr. Cardoza, Mrs. Schmidt, and Members of the Committee, I am Nick 
Maravell, an organic farmer for the past 30 years.
    I appreciate the opportunity to provide testimony regarding organic 
agriculture and food safety to an Agriculture Committee.
    I own and operate Nick's Organic Farm, located in Montgomery and 
Frederick Counties, Maryland--not too far from here. It is a relatively 
small operation. I have 170 acres in production, the vast majority of 
which is in farmland preservation.
    To give you an idea of where I am coming from, I thought a little 
background about myself would be helpful. Over the last 30 years, I 
have been active at the national and state level in establishing 
organic legislation and regulations, advancing scientific organic 
research, and increasing awareness of organic methods and improving 
markets for organic products. I have worked through such organizations 
as the Organic Trade Association, the Organic Farming Research 
Foundation, and the Maryland Organic Food and Farming Association. [As 
a life long member of the Organic Trade Association, I worked on a 
variety of policy and regulatory issues with the Farming Practices 
Committee. As a member of the Organic Farming Research Foundation, I 
have actively participated in the drafting of the National Organic 
Research Agenda, published in 2007. And I am a founding Board Member of 
our state association, the Maryland Organic Food and Farming 
Association, where I have worked in a variety of leadership capacities 
to advance the interests of organic farming and to expand markets for 
organic products.] Today I am testifying as an individual representing 
no organization.
    I am a strong supporter of food safety, and I often think that I am 
more concerned about food safety than my customers are--and that is the 
way it should be--my customers should not have to worry about the 
safety of my products. I would like to explain to how various aspects 
of food safety are built into the way we farm and market our products. 
To do this I need to briefly tell you what we produce, how we produce 
it, how we market it, and generally what is behind our thinking.
    Hopefully, I will be able to show that our farming practices, our 
organic certification, and our direct marketing give us unique and 
effective built in food safety advantages. And finally, I would like to 
offer a few observations which I believe should shape the 
Subcommittee's thinking regard changes to food safety policy, 
especially with regard to organic and family sized operations.
    We raise grass fed Angus beef, pastured chickens and turkeys, and 
free range eggs. We grow various types of grass/clover and alfalfa/
grass 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, also known as edamame.
    Our system of farming has evolved over the decades. We started with 
all vegetables, added small grains, then added large grains and hay, 
and finally added livestock. Our system is constantly gaining more 
diversity and complexity. We started with 2 year rotations, then 3 
year, then 5 year, and now 8-12 year. We used to moldboard and chisel 
plow, now we rarely do either. Our earthworms and our mix of crops do 
the deep tillage.
    As or system evolved, we recognized the tremendous gaps in 
scientific knowledge to help guide our future development. So we began 
experiments on the farm. Now we conduct ongoing long-term research on 
the farm in cooperation with USDA's Beltsville Agricultural Research 
Center and with personnel from the University of Maryland. We also 
cooperate in demonstrations with the Maryland Natural Resource 
Conservation Service.
    We have found that by extending our rotations to include hay and 
pasture, we have been able to break weed, disease, and insect cycles in 
both our row crops and our forages. Consequently we use no 
insecticides, herbicides, or fungicides on our crops.
    We have found that leaving our cattle on pasture, never putting 
them in inside, and feeding no grain, even during the cold winter 
months, results in an annual veterinary bill of zero. We have found 
that management intensive rotational grazing improperly used simply 
spreads intestinal parasites to all of our pastures. We have found that 
grazing poultry across our pastures, rotating pastures through hay and 
row crop cycles, and carefully selecting beef genetics for parasite 
resistance has resulted in never having to use parasiticides on any 
organic cattle born on our farm.
    We have found that proper use of winter and summer cover crops can 
suppress weeds, increase nitrogen available for subsequent crops, add 
to soil organic matter, and improve soil tilth, and increase water 
penetration and moisture retention. We have found that multi-species 
cover cops with 2-4 different plant types are almost always better that 
single species covers.
    We have found that virtually all of our fall and summer cover crops 
can be planted with organic no-till methods, helping to maintain good 
soil structure, reducing microbiological disruption and soil 
compaction, reducing organic matter depletion and CO2 
releases, saving energy, and making it more difficult for small seeded 
annual weeds to become established.
    By using nitrogen fixing legumes such as soybeans, alfalfa, clover 
and hairy vetch in both our crop rotations and our cover crops, we do 
not need to purchase any nitrogen fertilizer. We add naturally 
occurring and slow release minerals, such as high calcium lime, rock 
phosphate, and potassium sulfate. The latter two minerals are added to 
selected fields maybe once every 10-20 years.
    Pardon me if I have given you what appear to be random examples of 
how we farm. Now at the risk of using some jargon, I will attempt to 
explain how this fits together and is related to food safety.
    We operate a diversified and integrated farm. This means we raise 
several types of crops and animals together. Generally our system 
demonstrates the advantages of encouraging diversity and 
decentralization, of fostering synergy and symbiosis, and of relying on 
nutrient recycling and self-regulating systems. These terms simply mean 
the parts of our system are designed to work well together and require 
little re-direction to maintain the system once it is established. Our 
crops and livestock are chosen only partially for economic 
marketability. More importantly the mix of plants and animals is 
intended to compliment each other as a self-sustaining system. People 
often ask me, what is the main thing that we do that makes our organic 
system work? My response is: ``No one thing we do is very important--
everything we do is important, each in its own small way.''
    I view half of our farm operation as living above the ground as 
crops and animals. I view the other half as living below the ground in 
the soil. While both halves are important, I begin constructing my 
farming system around the long term sustainability of the soil because 
it very often takes longer to produce desired changes in the soil than 
in crops and animals. A rich active living soil is a prerequisite to 
producing healthy plants and animals. As we will see, healthy plants 
and animals are a first step towards food safety.
    In general, adding organic matter is a good way to achieve a 
biologically active and healthy soil because it feeds the microbiota, 
such as bacteria and fungi, and the macrobiota, larger organisms, such 
as earthworms. The micro biota are organisms, that are so small a 
million could live in a teaspoon of healthy soil rich in organic 
matter. These two types soil organisms digest decaying organic matter 
and release nutrients that plants use to grow. Quite simply, Feed the 
Earth and it will feed us.
    So for example, we leave our corn stover and barley straw on the 
surface of the field and no-till our cover crops through it. When we 
later incorporate our cover crops into the soil, we use shallow 
tillage. This tillage leaves some organic matter on the surface to 
reduce soil erosion and run off and places the rest of the organic 
residues in the top 4 inches where air, moisture and temperature create 
ideal conditions for the soil biota to digest the organic matter 
quickly. From the mixture of mature plant matter with fresh plant 
matter, including legumes, the soil biota create longer lasting carbon 
compounds and associated stable plant nutrients which will not easily 
leach away. Stable soil nutrients mean less need to add additional 
fertility from organic sources, such as manure, and less run off to 
contaminate water, both leading to safer food crop production.
    Our animals are not fed antibiotics, and our ground is not treated 
with pesticides. Both antibiotic and pesticide residues can impede the 
growth of certain species of micro and macro biota, thereby suppressing 
their activity. We are grazeirs. Our animals are managed to spread 
their own manure on an active soil with plenty of vegetative cover to 
take up the nutrients. Except in the coldest months of winter, manure 
breaks down quickly. We move our animals all the time. Water and feed 
for the animals is constantly moved so there are no concentrations of 
manure to collect large masses flies and diseases. We cannot collect 
manure, we do not spread manure, and our animals do not graze in areas 
that will be used for human crop production within the next year. These 
measures, designed to build a healthy soil, also help ensure the safety 
of food products by not encouraging antibiotic resistant bacteria in 
our animals and by preventing bacterial contamination of our food 
crops.
    As a small diversified and integrated farm, our marketing strategy 
must add on farm value to our products to be economically viable. We do 
this by making the products organic and by selling most of them 
directly to the final user, either a consumer or another organic farm. 
About 90% of our sales are direct. For example, we process our chickens 
and turkeys, and pack our eggs, and clean and pack our fresh vegetable 
soybeans. Customers come to our farms and pick up our products and a 
small amount of our products are delivered to local retailers and 
regional wholesalers. In most cases, we are only one step down from the 
final consumer. This direct marketing system builds in ultimate 
accountability and traceability for the customer, another factor in 
food safety.

Unique Food Safety Characteristics of Certified Organic Food
    However, the organic industry as a whole is proactive and uniquely 
positioned on food safety in ways that are not yet standard in other 
food sectors.

    (1) Organic farmers and processors are required by law to maintain 
        records that allow ``one up, one down'' traceability for all 
        inputs and for all sales. From field to fork, every entity in 
        the supply chain or in the stream of commerce must maintain an 
        audit trail that permits full traceability and accountability.

    (2) Raw manure cannot be used on crops for human consumption 
        without an extended waiting period before harvest.

    (3) Compost made with animal manure must meet temperature, mixing, 
        and time requirements to ensure its safety or else be treated 
        as raw manure.

    (4) Synthetic pesticides are prohibited, reducing the risk of over-
        application or excessive pesticide residues.

    (5) Antibiotics are prohibited in livestock feed and routine 
        organic health programs. Organic farms do not increase the risk 
        of creating antibiotic resistant bacteria.

    (6) Organic livestock cannot be fed animal by-products, adding a 
        layer of protection against the possibility of transmission of 
        certain diseases. This prohibition exceeds current non-organic 
        rules which, for example, allow nonmammalian animal by products 
        to be fed to cattle and vice versa.

Recommendations for Future Congressional Action
    Consumers over the past 2 decades have clearly exercised new 
choices with their food dollars. Witness the explosive growth of 
organic sales, the tremendous resurgence of farmer's markets, the 
continued growth of Community Supported Agriculture (CSAs), and the 
strong emergence of the Buy Local and Slow Food movements. Organic, 
direct marketing, and small family sized operations have almost 
exclusively met these consumer demands.
    At the same time, I think it is fair to say that the pressing food 
safety concerns facing Congress today have not emerged from organic or 
family sized producers and processors. Consumers have, not 
surprisingly, gravitated to these areas that provide several unique 
characteristics, including certain food safety assurances. In devising 
changes to food safety laws, Congress should consider the specific 
impact these change could have on organic, direct marketing and family 
sized operations.

    (1) Legislative measures should be appropriate to the size, scope 
        and nature of an operation. The ``one size fits all'' approach 
        is fraught with unintended consequences. And in this case, 
        consumers could find it more difficult to obtain the products 
        they want.

    (2) Unless there is a specific scientifically documented need to 
        solve a clearly defined problem, solutions should not be 
        imposed. For example, while new technologies, like bar coding 
        and electronically tracking palletized fresh products, may 
        assist certain food sectors in attaining better food safety, 
        these same measures may be burdensome, costly and unnecessary 
        for smaller, direct marketing, and organic operations. Farmers 
        say, ``If it ain't broke, don't fix it.''

    (3) Local and state food safety laws currently regulate direct 
        sales from farmers to consumers. Direct farmer to consumer 
        sales are inherently traceable, and largely accountable, and 
        should not require any further traceability measures. Special 
        disposition should be afforded to clearly defined local markets 
        which just happen to be multi-jurisdictional, such as my market 
        which is a ``tri-state'' area, so that interstate commerce 
        requirements do not automatically apply when they are clearly 
        not appropriate or needed.

    (4) The organic industry already has in place legally mandated 
        safeguards necessary to ensure food safety, including full 
        traceability and accountability of food products, and strict 
        controls on known potential sources of food contamination such 
        as manure and synthetic pesticide residues. The organic 
        certification system allows all producers and processors, small 
        and large, the flexibility to maintain traceability records 
        appropriate to the type and scale of operation. The record 
        keeping system is outlined in the organic system plan. 
        Independent third party onsite inspections verify each of these 
        organic system plans annually providing excellent 
        accountability. These procedures should be left intact and 
        should be allowed to satisfy any corresponding new requirements 
        that Congress may institute on the larger food sector.

    (5) Congress should be very cautious in drawing organic food safety 
        conclusions from studies that did not look at organic food 
        production systems. For example, manure mineralization rates 
        and counts of antibiotic resistant bacteria on conventional 
        farms and processing plants are not reliable indicators of what 
        would be found on organic operations. The science base for 
        organic agriculture in general, and for organic food safety in 
        specific, is expanding rapidly. The organic community has begun 
        advancing research proposals to Federal competitive grant 
        programs, and we can expect to see appropriate organic food 
        safety studies funded this year and in the coming years. These 
        studies can both document the level of safety of the organic 
        food supply and develop additional procedures and processes 
        that can make organic products available to a wider audience at 
        a more cost effective price.

    The Chairman. Thank you very much, sir, for your testimony. 
I thought it was very interesting to hear how the organic 
community deals with some of their fertilizer issues. I don't 
know what Mrs. Schmidt would think of this, but I certainly 
would be prepared, since you just live down the road in 
Potomac, for you to come back and have a private meeting with 
us so that we can share, further, some of the concerns that you 
have as the legislation moves forward.
    Mr. Maravell. That would be quite appropriate, and I can 
certainly work with staff to arrange that.
    The Chairman. Excellent. We would love to do that, in 
addition to any answers to written questions that we will 
submit to you. Thank you.
    Now I would like to introduce and ask Mr. Charles Wingard, 
Director of Field Operations for Walter Rawl and Sons from 
South Carolina, to please submit your testimony to the 
Committee.

STATEMENT OF CHARLES A. WINGARD, DIRECTOR OF FIELD OPERATIONS, 
            WALTER P. RAWL & SONS, INC., PELION, SC

    Mr. Wingard. Thank you, sir. Good afternoon, Chairman and 
Ranking Member Schmidt. My name is Charles Wingard and I am 
Director of Field Operations at Walter P. Rawl in Pelion, South 
Carolina. This is a family-owned and operated business. I am 
one of nine who work there every day.
    We grow a lot of different vegetables but we specialize in 
southern leafy greens which are sold fresh bulk and fresh cut 
processed. I brought with me a sample of a bag of collards for 
you to see. In addition to this, we control everything from 
seed all the way to delivery. I also have a sample of collard 
seed as well, and we do everything in between. I will get to 
what is in the middle of that in a second.
    As a grower, we have watched with great interest over the 
last several years the debate in Washington on food safety laws 
and the changes to them, and we support many of those changes. 
Yet we are reminded every day that our produce is very, very 
safe with over one billion servings being consumed daily here 
in this country, almost universally without any food safety 
incident. But it is still critical that the entire produce 
industry commit to ensuring that our products are grown and 
handled properly at every step of the way, all through the 
supply chain.
    We have a very comprehensive food safety program at my 
company, and I am not going to go through all of that. I will 
highlight one point. At about 20 steps between seed and 
delivery, we keep records, manual records. In addition to the 
manual records, there are computerized records kept as well. It 
is about 35 sets of records kept in those 20 steps, and this is 
an example of what some would look like. It goes from this 
through this to that. And during the food safety audit, I could 
literally line up this entire table with three-ring binders. It 
would total about 50 or 60 three-ring binders of information 
that we keep non-computerized, and that would be in addition to 
our computer records. We do traceability. We do all kinds of 
tests and we have GAPs, SOPs, SSOPs, HACCP, GMPs, all that 
stuff. We have all that in place.
    It is kind of interesting that about 8 years ago we had our 
first food safety audit, and we spent about $100,000 that year 
on food safety, and we scored a 900. In those 8 years our 
company has grown in size about three times, yet our food 
safety spending has grown almost ten fold, and we just had an 
audit 5 weeks ago, and we didn't score but 930. It sort of 
seems the more you do, the more you have to do.
    There are challenges for us today in food safety. We have 
multiple audits from different customers. We have third-party 
auditors that come in to audit us against their standards, not 
necessarily the government's, and we have about nine or ten 
audits a year from three or four different third-party 
auditors, and that is down from about 15 three years ago. We 
see a big problem with consistency of different auditing 
companies and inconsistency of different inspectors within one 
auditing company. The cost varies tremendously, even though 
that is not the big portion of our food safety budget, but the 
cost varies tremendously, and we don't get to choose who we 
want to audit us because our customers tell us which audit they 
will recognize. It is sort of like a little monopoly going on, 
and it is not a very good situation at times.
    We need to work a little bit better within our industry, 
but it is going to take Federal oversight to make sure that 
everybody in the industry is committed. I know of producers who 
don't do the steps that we do in food safety and then they end 
up with an economic advantage at the end of the day. We must 
allow Federal oversight, must allow for clear commodity-
specific approaches based on the best available science. It 
must be consistent and applicable to the entire commodity or 
the commodity sector regardless of where it is grown or packed. 
It can vary in production techniques, but it must apply to the 
entire commodity and it must be federally mandated, it must be 
credible enough and fair enough to the growers yet maintain 
consumers' confidence in our food supply.
    Thank you again for the opportunity to participate in this 
hearing, and I look forward to answering any questions.
    [The prepared statement of Mr. Wingard follows:]

Prepared Statement of Charles A. Wingard, Director of Field Operations, 
                Walter P. Rawl & Sons, Inc., Pelion, SC

Introduction and History of Walter P. Rawl & Sons
    Good morning Chairman Cardoza, Ranking Member Schmidt and Members 
of the Subcommittee. My name is Charles Wingard and I am Director of 
Field Operations for Walter P. Rawl & Sons in Pelion SC. Three 
generations of our family have farmed in this area since the 1920s, and 
nine family members oversee our operations today in a hands-on manner. 
We specialize in southern leafy greens such as collards, kale, mustard 
& turnip greens, and also produce a variety of summer vegetables in 
season along with a few other year round vegetable crops.
    We have farm operations in several South Carolina counties and have 
farming relationships in Florida, Virginia, & New York. Our produce is 
marketed and delivered throughout the Eastern United States, and about 
\1/2\ of our leafy greens are washed and packaged in our own facility 
and sold as fresh-cut chopped greens, with the rest sold in bulk.
    We are also active in our industry's national association to lead 
efforts to help bring safe, healthy, affordable and great-tasting 
fruits and vegetables to the public. My cousin serves on the Board of 
Directors of the United Fresh Produce Association, and I serve as a 
member of its Government Relations Council.

General Thoughts on Food Safety and Produce
    As a grower member of that council, I have watched with great 
interest over the last several years the policy debate here in 
Washington, D.C. about potential changes in our food safety laws. We 
support many of those changes. Yet, I am reminded everyday that produce 
consumed in the United States is an extraordinarily safe and healthy 
food! Every major worldwide public health authority advises that the 
health benefits of eating produce far outweigh risks; and over one 
billion servings of produce are consumed daily in the U.S., almost 
universally without a food safety incident. These statistics do not 
lie, but we also must recognize that consumer confidence in their food 
is at an all-time low. According to a recent survey conducted for 
United Fresh Produce Association, 88% of the respondents indicated they 
are at least somewhat concerned about the safety of produce while 21% 
are at least very concerned about food safety and produce. This must 
change as fear has no place in the fresh produce department.
    Ensuring the safety of fresh produce is an ongoing and integral 
focus for the entire industry. With a product that is grown in a 
natural environment and usually eaten raw, it is critical that the 
produce industry take every opportunity to ensure that our products are 
grown and handled properly at every step of the supply chain From 
grower to retailer, the produce industry is making tremendous 
investments to assure that the highest quality and safest produce is 
available to consumers to enjoy everyday.

Our Current Food Safety Practices
    As our farm has evolved over 80+ years, so have the food safety 
challenges. My family and our employees take food safety seriously and 
are dedicated to providing our customers with the safest produce 
possible, as well as trying to help advance food safety issues within 
our industry. The following list gives you an idea of our company's 
commitment to food safety:

   approximately $750,000 invested every year for food safety 
        and quality assurance.

   Intensive, bi-lingual food safety & food security training 
        for all harvesters.

   Comprehensive production records kept.

   Good Agricultural Practices & HACCP plans in place.

   Periodical microbial testing of all water sources.

   Use of chlorinators for surface water irrigation sources 
        when appropriate.

   Production inputs such as ag chemical are kept secure and 
        applied with all appropriate controls.

   Records kept documenting food safety compliance at 
        approximately 20 steps between field production and 
        distribution of fresh products.

   Daily sanitation & testing prior to startup.

   Traceability for all of our products to the farm.

   Collaboration with the leafy greens industry across the 
        country to develop national standards and metrics that could be 
        applied through a National Leafy Greens Marketing Agreement 
        (NLGMA) or potential regulation.

Challenges for Food Safety
   Multiple food safety audits from customers--One of our 
        greatest challenges today is the lack of a consistent and 
        agreed-upon standard for Good Agricultural Practices. Without 
        that government endorsed standard, different customers demand 
        different food safety audits which are burdensome to our 
        company. My food safety personnel could do a better, more 
        efficient job if they had one standard to adhere to instead of 
        trying to make sure that our controls will meet the nuances of 
        several sets of metrics.

   Consistency of auditing and inspections--Although many of 
        the metrics in different audits are identical, we have found it 
        difficult to deal with multiple third party auditors due to the 
        fact that different auditors focus on different parts of the 
        metrics. This would be a challenge for either third-party 
        auditors or government inspectors. For example, one third party 
        auditor will focus heavily on land use and water quality while 
        another third party auditor will focus heavily on paperwork, & 
        records. I was told during a recent audit that my portable 
        toilet facility (PTF) was located at the wrong place and lost 
        points. The inspector suggested that I place it in a particular 
        area. Six months later, during another audit by the same third 
        party company but by a different inspector, the second 
        inspector suggested that my PTF go back to where the first 
        inspector said to move it from.

   Cost--Range of cost varies tremendously when all audits 
        intend to do about the same thing. I believe that with a 
        consistent and agreed-upon government standard, the cost of 
        food safety inspections should be borne by the general public 
        since it is the general public's health that is being 
        protected. The current system without that government standard 
        allows the private auditing industry to charge whatever they 
        can, especially when customers dictate to producers which third 
        party audit they will accept. There are no checks and balances 
        in place to prevent price gouging.

   Industry commitment--The produce industry is committed to 
        food safety. Our company has been involved in proactive 
        industry-wide efforts to improve our country's food safety 
        system to include all the supply chain and to reinstall 
        consumer confidence in the produce industry. Personally, I 
        invest hundreds of thousands of dollars into food safety 
        programs so that our consumers will have confidence in my 
        brands. However, our industry is only as strong as our weakest 
        link, and unfortunately, one bad actor can cost an entire 
        industry millions of dollars. The produce industry needs 
        Federal food safety oversight to boost consumer's confidence 
        and to level the playing field for all producers.

Key Recommendations for Food Safety Reform
    Put simply, we are at a point where we must work to rebuild public 
confidence in our system of food safety government oversight, such that 
when another outbreak occurs, the public can have confidence that it is 
the result of an isolated breakdown in one situation, not an endemic 
problem causing them to question the safety of all the produce they 
eat. With an analogy of the airline industry, we must have rigorous 
government oversight and strong industry compliance with the clear, 
scientifically vetted safety practices. But, when an isolated tragedy 
occurs, we must get back on the airplane knowing that next flight is 
inordinately safe--just as spinach, tomatoes, or peppers from thousands 
of farms were safe on the day of the tragedy in our industry, and the 
next day, and the next day. Therefore the industry has focused on three 
major policy principles that are aimed to protect public health and 
ensure consumer confidence.

    1. Must allow for a commodity-specific approach, based on the best 
        available science--Produce safety standards must allow for 
        commodity-specific food safety practices based on the best 
        available science. In a highly diverse industry that is more 
        aptly described as hundreds of different commodity industries, 
        one size clearly does not fit all. For example, the food safety 
        requirements of products grown close to the ground in contact 
        with soil are far different from those grown on vines or trees. 
        And, the large majority of produce commodities have never been 
        linked to a food borne disease. In fact, a recent FDA Federal 
        Register notice in 2007 confirmed that five produce commodities 
        have been associated with 90% of all food borne disease 
        outbreaks in the past 10 years, and that is where we must 
        direct our resources.

    2. Must be consistent and applicable to commodity or commodity 
        sector, no matter where grown or packaged in the United States, 
        or imported into the country--Produce safety standards must be 
        consistent for an individual produce commodity grown anywhere 
        in the United States, or imported into this country. Consumers 
        must have the confidence that safety standards are met no 
        matter where the commodity is grown or processed. I want to 
        know that if I am required to comply with food safety 
        requirements, my competitors are complying with the same 
        standard.

    Because of the variation in our industry's growing and harvesting 
        practices in different climates and regions, flexibility is 
        very appropriate and necessary. For example, some production 
        areas use deep wells for irrigation while others use surface 
        water and flowing rivers. Some farms use sprinkler irrigation, 
        others use a drip system laid along the ground, and still 
        others use water in the furrows between rows of produce. But 
        the common factor must be that all sources of irrigation water 
        must meet safety standards that protect the product. That must 
        be true whether the produce is grown in South Carolina, 
        California, or Mexico.

    3. Must be federally mandated with sufficient Federal oversight of 
        compliance in order to be most credible to consumers--Achieving 
        consistent produce safety standards across the industry 
        requires strong Federal Government oversight and responsibility 
        in order to be most credible to consumers and equitable to 
        producers. The U.S. Food and Drug Administration, which is the 
        public health agency charged by law with ensuring the safety of 
        the nation's produce supply, must determine appropriate 
        nationwide safety standards in an open and transparent process, 
        with full input from the states, industry, academia, consumers 
        and all other stakeholders. For this work, FDA must also have 
        strong relationships with the USDA, state agriculture and 
        regulatory officials, and foreign governments to ensure that 
        compliance is taking place. Cooperative agreements between FDA 
        and the states have been extremely effective in providing 
        oversight of food safety standards. In particular, USDA has 
        been a strong ally and has offered a number of means to assist 
        the produce industry in safely growing, handling and processing 
        fresh produce.

    For example USDA through AMS offers several auditing programs that 
        assist the industry in measuring Good Agricultural Practices, 
        good handling practices, and HACCP programs in processing 
        plants. These are good education and training programs, as well 
        as a means to measure individual operators' understanding and 
        implementation of food safety practices.

Conclusion
    None of us can deny that our fresh produce industry faces a 
different business world today than we did before September 2006. Each 
time any fruit or vegetable is implicated in a food borne illness 
outbreak, we all suffer from lost consumer confidence in our industry 
as a whole. In the long run, this simply is not sustainable and 
certainly not acceptable. In turn, the fresh produce industry must 
continue to take responsibility to do all we can on our own. 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.
    Thank you again for the opportunity to participate in this hearing 
and look forward to answering your questions.

    The Chairman. Thank you, sir. I will tell you that I 
consume your product. It is of extremely high quality. My 
grandma taught me to eat greens a long time ago, and I think it 
is a fabulous product that you provide and I couldn't agree 
more with your testimony.
    Mr. Robert Stovicek, Ph.D., President and Chairman of 
Primus Group from Santa Monica, California, welcome, sir. I 
would ask the same thing of you, to summarize your testimony 
and we will in fact be in contact with you to provide you with 
written questions.

STATEMENT OF ROBERT F. STOVICEK, Ph.D., PRESIDENT AND CHAIRMAN 
            OF PRIMUS GROUP, INC., SANTA MONICA, CA

    Dr. Stovicek. Thanks for the invitation. Thanks for letting 
me speak.
    The auditing companies are quite often managing auditing 
companies managing auditors. One of the statements that we put 
in the first page of our audit is, when laws, commodity-
specific guidelines or best-practice recommendations exist and 
are derived from reputable sources, then these practice 
parameters should be used. There is a way to set up an audit so 
you are taking into account both commodity differences and 
regions. But, you have to have auditors who understand the 
commodity groups that they are dealing with, and must 
understand the culture and languages where they are auditing.
    Primus audits throughout the Western Hemisphere. Last year, 
2008, we audited over 10,000 operations. We operate and have 
companies in Chile and Mexico. We have laboratories in Florida, 
Arizona, two in California, one in Mexico. We are audited 
ourselves by ANSI in the United States under the ISO 65 
guidelines, in Mexico by EMA under ISO 65, which is an auditing 
scheme that audits auditors. We have over 2,000 paying clients 
in the fresh produce industry. We are a company that has 
existed for 20 years. We have one sole function: we service the 
fresh produce industry and we service it with regards to food 
safety.
    If this is a crisis that needed to be dealt with fast and 
you brought the military in, they would outsource portions of 
what they had to do to a Blackwater or someone like that. 
Instead, what you hear is discussion after discussion, decade 
after decade, about how are we going to get it here, how are we 
going to get it there, how are we going to deal with 
commodities that are different, et cetera. Perhaps if you 
outsourced it to somebody you could fire at the end of the day 
if they didn't do their job, then it would get done, and that 
is my abbreviated presentation. Thank you.
    [The prepared statement of Dr. Stovicek follows:]

    Prepared Statement of Robert F. Stovicek, Ph.D., President and 
             Chairman, Primus Group, Inc., Santa Maria, CA

    Chairman Cardoza and Members of the Subcommittee:

    On behalf of myself and my staff, I would like to thank you for the 
invitation and opportunity to address this Subcommittee.
    Introduction. Few industries have gone through as radical a change 
as the fresh produce industry in the past 10 to 15 years. Fresh 
produce's image as the most wholesome of the food categories has 
evolved to one that is repeatedly associated with disease outbreaks. 
Considering how natural it is to resist change, no one should be blamed 
for asking how responsive the fresh produce industry has been to the 
issue of foodborne illness.
    Studying the history of a firm that limits its service to providing 
the fresh produce industry technical assistance in the area of food 
safety would provide a measure of the industry's responsiveness. Primus 
Group, Inc. is just such a firm.
    Primus Group, Inc. recognized in the early 1990s that the consumer 
perspective of fresh produce was going to change. New technologies in 
microbial testing, telecommunications and computerization enhanced the 
health official's investigative capabilities enabling them to identify 
what acts as vectors of human pathogens despite the fact that the foods 
themselves provide a poor medium for pathogen growth. Health officials 
had been speculating since at least the mid 1980s that fresh produce 
was vectoring human pathogens. These new tools have provided the data 
to prove the theory.
    Primus' anticipation of these changes and the firm's success in 
selling services designed to address food safety is a reflection of the 
fresh produce industry's receptiveness to acknowledging its need to 
change.
    History. Less than a year from incorporation in 1988, Primus hired 
a young doctoral candidate from Michigan State University majoring in 
Crop Science and Environmental Toxicology to assist in a shift from 
clinical services to agricultural testing. Prior to 1989, the firm had 
discontinued all clinical services and focused 100% on providing 
pesticide residue tests for the fresh produce industry.
    In response to the early 1990s cantaloupe industry crisis, which 
resulted in 30,000 to 40,000 mid-westerners developing salmonellosis, 
Primus expanded its laboratory capabilities. These included human 
pathogen testing and assistance to fresh produce processors in 
developing their Hazard Analysis Critical Control Point (HACCP) 
programs and Good Manufacturing Practices (GMP). As the 1990s 
progressed, Primus expanded its consulting services from facilities to 
developing what we initially called Good Farming Practices, which now 
is referred to as Good Agricultural Practices (GAP).
    Recognizing that in the process of consolidating, the fresh-cut 
produce industry was becoming too sophisticated to hope to build a 
business providing consulting assistance. Primus converted what 
intellectual material we felt was of value to Internet-based 
interactive training and safety manual development programs and offered 
them for free. At the same time, while continuing to offer 
microbiological and pesticide residue testing, Primus shifted resources 
into the realm of third party auditing. Since just before 1998, Primus 
has been auditing fresh produce operations with regards to their safe 
production and handling practices. Primus supported this third party 
auditing development by providing all the auditing checklists, 
guidelines and self-audit tools via the Internet, again free of charge.
    Current. After over 20 years, Primus Group, Inc. remains a firm 
providing the fresh produce industry with food safety services. In 
2008, Primus Group, Inc. invoiced over 2,000 fresh produce companies 
operating throughout the supply chain (see Flow Diagram). Services 
range from extensive food safety programs to individual audits or 
tests. Primus has grown to include subsidiaries in Mexico and Chile; 
Primus Laboratorios de Mexico, Azzule, and PrimusLabs.com Chile. Primus 
operates laboratories in Lakeland-Florida, Yuma-Arizona, Culiacan-
Sinaloa, Mexico as well as in Salinas and Santa Maria, California. 
Within Primus' databases are the auditing results of more than 11,000 
unique fresh produce growing and handling operations (see Chart). We 
work extensively throughout the Western Hemisphere, and on rare 
occasions, in Asia, Europe and Africa (see Map).
    Value. With well over a billion servings of fresh produce per day, 
adverse events are actually rare when viewed on a per serving basis. 
Frequently, fresh produce operations are complex organizations 
consisting of numerous independent firms. Any given brand may have 
dozens or even thousands of growers. Commonly, the brand owner will 
subcontract with an independent harvesting company to harvest, and then 
with another independent firm, to cool and provide cold storage. Last, 
an independent trucking company is hired to transport the fresh produce 
to the retail or food service distribution center. Each of these 
operations has the potential to contribute to an adverse event (see 
Flow Diagram). Finding and acting to prevent a contamination in such a 
complex system is a challenge. A failed audit within such a complex 
system is far less meaningful than how the auditee responds to the non-
conforming responses (NCR) (see Table). NCRs bring to attention issues 
that may become possible sources of contamination. Reducing the number 
of outbreaks in fresh produce will depend on how players within the 
supply chain react to the NCRs within the audits.
    Cost. Implementing a food safety program is the major expenditure, 
while actual audit costs are a fraction of the food safety investment. 
For example the California Leafy Greens Marketing Agreement (LGMA) 
provides the best general sense for the cost of fresh produce auditing. 
The LGMA imposed a $0.02 per carton charge on the suppliers to pay for 
the Federal and State of California Inspection Program. The 
participants then requested that the fresh produce buyers pay an 
additional charge of approximately $0.30 per carton to cover the costs 
associated with changing the growing practices required to audit 
successfully. Primus has estimated the cost of our auditing program at 
approximately $0.005 per carton. Either way the auditing cost is a 
fraction of the cost of changing farming practices to assure successful 
auditing results.
    Quality Control. Primus' United States based laboratories each 
participate in state administered accreditation programs. Our Culiacan, 
Sinaloa Mexico laboratory, in addition to participating in the state of 
Sinaloa's accreditation program, is also an ISO 17025 accredited 
laboratory. Furthermore, each laboratory participates in independent 
proficiency sample testing programs.
    Primus Group, Inc. is the first firm to gain approval in the USDA 
National Organics Program (NOP) without being ``grandfathered'' in. 
Primus was the first EUREPGAP certification body in North America 
(2002) and remains the only North American based certification body. 
Primus is also a certification body under the MexBest auditing program. 
The EUREPGAP (now renamed GlobalGAP) auditing program and the MexBest 
auditing program require the certification body to be ISO 65 
accredited. On an annual basis, Primus' food safety testing and 
auditing services are reviewed by four states, two accreditation bodies 
(i.e., American National Standards Institute (ANSI) and Entitad 
Mexicana de Acreditacion (EMA)). The USDA review of Primus' 
certification program is done once every 5 years. In 2008, Primus began 
the process of benchmarking our auditing program against the Global 
Food Safety Initiative (GFSI). On the 20th of May, the technical 
committee will review Primus' auditing program. When Primus achieves 
recognition from GFSI, it will be our firm's third ISO 65 auditing 
system.
    All of these quality review systems help Primus understand how 
differently government, private sector, Europeans, Americans, Latin 
Americans and others set their priorities. While these formal auditing 
systems provide an excellent guide for expectations and have helped us 
understand expectations from other cultures, it is Primus' aggressive 
use of the Internet and commitment to transparency in all processes of 
the business, which encourages a plethora of quality reviewers. This 
reviewing emanates from all levels of the supply chain including 
clients and supporters in the buying community. Establishing systems 
that are auditee-friendly invite a universe of opinions but over time 
it is the frontline feedback that makes a responsive innovative firm 
successful. These folks come at us from so many varied perspectives 
that it would be cost prohibitive to hire the in-house equivalent.
    Who's Story. Primus' success is appropriately attributed to our 
rapid response. Response to suppliers and buyers that recognized the 
need to change years before fresh produce safety issues became routine 
news stories. Primus' success is a direct result of fresh produce 
suppliers and buyers who have been working with us for over a decade to 
perfect the ability to convey their concerns to their growers and 
handlers. Working together, we refine computer-based systems that 
accurately convey back to the buyers the supplier's acknowledgement of 
their expectations and implementation of corrective actions.
    While this has been Primus' story, the reality is that this is the 
fresh produce industry's story. It represents only one service 
provider's (Primus) effort to address the challenge of food safety. 
There are even more compelling stories being carried out daily at 
different fresh produce companies throughout North and South America. 
Stories that one would assume to be a pleasant surprise for many 
American consumers.
    On behalf of myself and my staff, again, thank you for this 
opportunity to make this presentation.
    Corporate Website: www.primuslabs.com

                               Attachment



 Thank you very much to all the panelists for providing your testimony 
 today. We very much appreciate your time and we very much appreciate 
 the fact that you have accommodated us on this difficult day that has 
been interrupted numerous times by votes. That is not unusual here, but 
today, I think it affected our hearing more than is regularly the case. 
 So for that, I want to apologize even though I had nothing to do with 
    the schedule.Before we adjourn, I will briefly allow the Ranking 
Member to give any closing remarks she would like to do before I 
adjourn the hearing.
    Mrs. Schmidt. Thank you so much, and I thank everyone for this 
wonderful testimony on this very important subject. Like the Chairman, 
I apologize for the disruption. Some days are smoother than others and 
today you hit one of those rocky roads, but we managed to get the 
people's work done here both here in Committee as well as in the full 
House, and we will break. Thank you very, very much. I look forward to 
Mr. Maravell coming to my office, and if any other individual wishes to 
come to my office, please feel free. We can teleconference or whatever. 
Thank you so much and good luck.
    The Chairman. Thank you. Under the rules of the Committee, 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. This hearing of the 
Subcommittee on Horticulture and Organic Agriculture is hereby 
adjourned.
    [Whereupon, at 2:45 p.m., the Subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
      
   Submitted Statement of Lonnie J. King, D.V.M., Director, National 
   Center for Zoonotic, Vector-borne & Enteric Diseases, Centers for 
                                Disease

  Control and Prevention, U.S. Department of Health and Human Services
Findings from CDC's Foodborne Diseases Active Surveillance Network 
        (FoodNet)
Introduction
    Thank you for the opportunity to submit testimony for the record on 
CDC's activities related to the prevention of foodborne disease and 
CDC's role in collecting and reporting FoodNet data.

Background
    Diseases spread by contaminated foods continue to challenge the 
public health system. Large foodborne outbreaks are often attributed to 
fresh produce and processed foods, as well as foods of animal origin. 
Numerous factors are responsible for these large outbreaks such as 
changing production systems, changing ecologies, and changing food 
consumption patterns.
    As an agency within the Department of Health and Human Services 
(HHS), CDC leads Federal efforts to gather data on foodborne illnesses, 
investigate foodborne illnesses and outbreaks, and monitor the 
effectiveness of prevention and control efforts. CDC relies on local 
and state health departments, which have varying capacity to detect and 
respond to food-related illnesses.
    CDC is not a food safety regulatory agency, but CDC works closely 
with the food safety regulatory agencies, in particular with HHS' Food 
and Drug Administration (FDA) and the Food Safety and Inspection 
Service within the United States Department of Agriculture (USDA/FSIS). 
CDC also plays a key role in building state and local health department 
epidemiology, laboratory, environmental health, and communication 
capacity to support foodborne disease surveillance and outbreak 
response. CDC surveillance data can help attribute the burden of 
foodborne illness to specific food commodity groups to support 
regulatory risk-based inspection efforts and help document the 
effectiveness of prevention interventions.
    Much of what CDC does to detect and monitor foodborne illness 
depends on critical partnerships with state and local public health 
departments that collect surveillance data, conduct laboratory testing, 
investigate most outbreaks, and take public health action. CDC has 
worked with the Association of Public Health Laboratories (APHL) and 
the Council of State and Territorial Epidemiologists (CSTE) to develop 
networks for foodborne disease surveillance. For example, PulseNet, the 
national network for molecular subtyping of foodborne bacteria 
coordinated by CDC, allows every state health laboratory to test 
strains of bacteria from sick persons in that state and to compare them 
with DNA ``fingerprint'' patterns in the national database at CDC. This 
has greatly improved the ability to detect clusters of illness that may 
be related, even if they are dispersed across multiple states. 
Similarly, other related networks [OutbreakNet team] help coordinate 
the investigation of the large, multi-state clusters detected by 
PulseNet, facilitate state reporting of outbreaks to CDC [National 
Outbreak Reporting System], develop baseline information on what foods 
are commonly consumed and trends in foodborne illness [FoodNet], and 
assess policies and practices of retail foodservice establishments that 
could lead to or prevent foodborne outbreaks [Environmental Health 
Specialist Network]. These networks and systems, among others, provide 
data to help CDC and our regulatory partners better understand 
foodborne disease in the United States.
    CDC also works with a broad range of other partners to improve 
capacity and knowledge regarding foodborne disease control and 
prevention. In collaboration with the National Environmental Health 
Association (NEHA), CDC conducts team training programs for local and 
state health department officials including specialists in 
environmental health, laboratory science, and epidemiology. CDC works 
with the World Health Organization (WHO) and a variety of other 
international partners to conduct similar training programs in other 
countries. CDC supports the Council to Improve Foodborne Outbreak 
Response (CIFOR), which was created to help develop model programs and 
processes that will facilitate the investigation and control of 
foodborne disease outbreaks. CSTE and the National Association of 
County and City Health Officials (NACCHO) are co-chairing CIFOR, and it 
includes representatives from CDC, FDA, USDA, APHL, NEHA, the 
Association of State and Territorial Health Officials, the Association 
of Food and Drug Officials, and industry.

FoodNet
    The Foodborne Diseases Active Surveillance Network (FoodNet) of 
CDC's Emerging Infections Program collects data from ten U.S. sites, 
representing approximately 15 percent of the U.S. population. Sites 
locations include Connecticut, Georgia, Maryland, Minnesota, New 
Mexico, Oregon, Tennessee, and selected counties in California, 
Colorado, and New York. FoodNet is an active, population-based 
surveillance system for laboratory-confirmed infections caused by 
pathogens transmitted commonly through food. Preliminary data for 2008 
were released last month and show that the estimated incidence of 
infections caused by Campylobacter, Cryptosporidium, Cyclospora, 
Listeria, Shiga toxin-producing Escherichia coli (STEC) O157, 
Salmonella, Shigella, Vibrio, and Yersinia did not change significantly 
when compared with the preceding 3 years.
    The lack of significant change in recent years is in contrast to 
trends from 1996, when FoodNet surveillance began, to 2004. Models show 
that rates of infection with Yersinia, Shigella, Listeria, 
Campylobacter, and STEC O157 had decreased 25 to 48 percent. However, 
Vibrio had increased 47 percent. The estimated incidence of infection 
with Cryptosporidium and Salmonella did not change significantly over 
this period.
    Despite ongoing activities aimed at preventing foodborne human 
infections, progress toward the national health objectives has 
plateaued, suggesting that fundamental problems with food contamination 
persist. Although significant declines in the incidence of certain 
pathogens have occurred since establishment of FoodNet, these all 
occurred before 2004. The lack of recent progress toward national 
health objective targets and the occurrence of large multi-state 
outbreaks caused by E. coli in shredded lettuce, frozen pizza, and 
ground beef; Salmonella in tomatoes, peanut butter, cantaloupe, and 
jalapenos; and botulinum toxin in carrot juice and canned chili sauce 
point to gaps in the current food safety system and the need to 
continue to develop and evaluate food safety practices as food moves 
from the farm to the table.
    Enhanced and food-specific measures are needed to (1) control or 
eliminate pathogens in domestic and imported food; (2) reduce or 
prevent contamination during growing, harvesting, and processing; and 
(3) continue the education of restaurant workers and consumers about 
risks and prevention measures. In particular, continued efforts are 
needed to understand how contamination of fresh produce and processed 
foods occurs and to develop and implement measures that reduce it. More 
outbreaks can be recognized and their causative foods identified with 
rapid and complete subtyping of pathogens and with rapid standardized 
interviews of ill persons and appropriately selected controls.
    Consumers can reduce their risk for foodborne illness by following 
safe food-handling and preparation recommendations and by avoiding 
consumption of unpasteurized milk, raw or undercooked oysters, or other 
raw or undercooked foods of animal origin such as eggs, ground beef, 
and poultry. Risk also can be decreased by choosing pasteurized eggs, 
high pressure-treated oysters, and irradiated meat and produce. 
Everyone should wash hands before and after contact with raw meat, raw 
foods derived from animal products, and animals and their environments.

Conclusion
    There is a continued need for robust public health surveillance at 
all levels--local, state, and Federal--to ensure prompt recognition, 
response, and investigation of foodborne illness. CDC will continue its 
efforts to:

   focus on research, education, and training that will assist 
        with Federal strategies to prevent foodborne illnesses;

   incorporate food industries into prevention, response and 
        information sharing; and

   bolster state health infrastructures to effectively and 
        promptly identify and respond to outbreaks.

    This will entail continued cooperation between regulatory 
authorities, state and local partners, food and environmental 
microbiologist scientists, and the food industry to prevent future 
foodborne illness outbreaks. CDC is working closely with the White 
House Food Safety Working Group established by President Obama and is 
strongly committed to strengthening our national food safety system. 
President Obama established the working group to coordinate the efforts 
of Federal agencies and to advise the President on improving 
coordination throughout the government. Thank you again for the 
opportunity to submit written testimony for the record.

                                  
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