[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
U.S. GOVERNMENT PRINTING OFFICE
52-173 WASHINGTON : 2009
-----------------------------------------------------------------------
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800
Fax: (202) 512�092104 Mail: Stop IDCC, Washington, DC 20402�090001
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.