[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
HEARING TO REVIEW CURRENT ISSUES IN FOOD SAFETY
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON AGRICULTURE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
JULY 16, 2009
__________
Serial No. 111-25
Printed for the use of the Committee on Agriculture
agriculture.house.gov
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COMMITTEE ON AGRICULTURE
COLLIN C. PETERSON, Minnesota, Chairman
TIM HOLDEN, Pennsylvania, FRANK D. LUCAS, Oklahoma, Ranking
Vice Chairman Minority Member
MIKE McINTYRE, North Carolina BOB GOODLATTE, Virginia
LEONARD L. BOSWELL, Iowa JERRY MORAN, Kansas
JOE BACA, California TIMOTHY V. JOHNSON, Illinois
DENNIS A. CARDOZA, California SAM GRAVES, Missouri
DAVID SCOTT, Georgia MIKE ROGERS, Alabama
JIM MARSHALL, Georgia STEVE KING, Iowa
STEPHANIE HERSETH SANDLIN, South RANDY NEUGEBAUER, Texas
Dakota K. MICHAEL CONAWAY, Texas
HENRY CUELLAR, Texas JEFF FORTENBERRY, Nebraska
JIM COSTA, California JEAN SCHMIDT, Ohio
BRAD ELLSWORTH, Indiana ADRIAN SMITH, Nebraska
TIMOTHY J. WALZ, Minnesota ROBERT E. LATTA, Ohio
STEVE KAGEN, Wisconsin DAVID P. ROE, Tennessee
KURT SCHRADER, Oregon BLAINE LUETKEMEYER, Missouri
DEBORAH L. HALVORSON, Illinois GLENN THOMPSON, Pennsylvania
KATHLEEN A. DAHLKEMPER, BILL CASSIDY, Louisiana
Pennsylvania CYNTHIA M. LUMMIS, Wyoming
ERIC J.J. MASSA, New York
BOBBY BRIGHT, Alabama
BETSY MARKEY, Colorado
FRANK KRATOVIL, Jr., Maryland
MARK H. SCHAUER, Michigan
LARRY KISSELL, North Carolina
JOHN A. BOCCIERI, Ohio
SCOTT MURPHY, New York
EARL POMEROY, North Dakota
TRAVIS W. CHILDERS, Mississippi
WALT MINNICK, Idaho
______
Professional Staff
Robert L. Larew, Chief of Staff
Andrew W. Baker, Chief Counsel
April Slayton, Communications Director
Nicole Scott, Minority Staff Director
(ii)
C O N T E N T S
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Page
Boswell, Hon. Leonard L., a Representative in Congress from Iowa,
supplemental material.......................................... 133
Goodlatte, Hon. Bob, a Representative in Congress from Virginia,
opening statement.............................................. 3
Peterson, Hon. Collin C., a Representative in Congress from
Minnesota, opening statement................................... 1
Prepared statement........................................... 2
Walz, Hon. Timothy J., a Representative in Congress from
Minnesota, prepared statement.................................. 4
Witnesses
Wooten, Larry B., President, North Carolina Farm Bureau
Federation; Member, Board of Directors, American Farm Bureau
Federation, Raleigh, NC........................................ 5
Prepared statement........................................... 6
Boyle, J. Patrick, President and CEO, American Meat Institute,
Washington, D.C................................................ 12
Prepared statement........................................... 13
Submitted report............................................. 27
Tucker-Foreman, Carol L., Distinguished Fellow, The Food Policy
Institute, Consumer Federation of America, Washington, D.C.; on
Behalf of Center for Foodborne Illness Research & Prevention;
Center for Science in the Public Interest; Consumers Union;
Food & Water Watch; Government Accountability Project; National
Consumers League; The Pew Charitable Trusts; Safe Tables Our
Priority; Trust for America's Health; and The United Food &
Commercial Workers International Union......................... 40
Prepared statement........................................... 41
Ives, D.V.M., Ph.D., Samuel E., Director of Veterinary Services
and Associate Director of Research, Cactus Feeders, Ltd.,
Amarillo, TX; on behalf of National Cattlemen's Beef
Association.................................................... 47
Prepared statement........................................... 48
Peppler, Kent, President, Rocky Mountain Farmers Union, Mead, CO;
on behalf of National Farmers Union............................ 52
Prepared statement........................................... 53
Reinhard, Robert G., Director of Food Safety and Regulatory
Affairs, Sara Lee Corporation; Co-Chairman, Technical and
Regulatory Committee, National Turkey Federation, Downers
Grove, IL...................................................... 59
Prepared statement........................................... 60
Maravell, Nicholas C., Owner and Operator, Nick's Organic Farm,
LLC, Potomac, MD............................................... 63
Prepared statement........................................... 65
McDonald, Drew, Vice President, National Quality Systems, Taylor
Farms, Salinas, CA............................................. 78
Prepared statement........................................... 80
Mande, Jerold R., Deputy Under Secretary for Food Safety; and
Cindy Smith, Acting Under Secretary for Marketing and
Regulatory Programs and Administrator, APHIS, U.S. Department
of Agriculture, Washington, D.C................................ 110
Prepared statement........................................... 112
Taylor, J.D., Michael R., Senior Advisor to the Commissioner,
U.S. Food and Drug Administration, Department of Health and
Human Services, Rockville, MD.................................. 116
Prepared statement........................................... 119
Submitted Material
National Council of Farmer Cooperatives, submitted statement..... 135
Submitted questions.............................................. 137
HEARING TO REVIEW CURRENT ISSUES IN FOOD SAFETY
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THURSDAY, JULY 16, 2009
House of Representatives,
Committee on Agriculture,
Washington, D.C.
The Committee met, pursuant to call, at 10:08 a.m., in Room
1300, Longworth House Office Building, Hon. Collin C. Peterson
[Chairman of the Committee] presiding.
Members present: Representatives Peterson, McIntyre,
Boswell, Baca, Cardoza, Scott, Herseth Sandlin, Cuellar, Costa,
Walz, Kagen, Halvorson, Dahlkemper, Bright, Markey, Kratovil,
Schauer, Kissell, Boccieri, Minnick, Goodlatte, Moran, Johnson,
King, Neugebauer, Conaway, Fortenberry, Schmidt, Smith, Latta,
and Luetkemeyer.
Staff Present: Andy Baker, Robert L. Larew, Nathan Fretz,
Chandler Goule, Alejandra Gonzalez-Arias, Tyler Jameson, Scott
Kuschmider, James Ryder, April Slayton, Rebekah Solem, Patricia
Barr, Tamara Hinton, John Goldberg, Pam Miller, and Pete
Thomson.
OPENING STATEMENT OF HON. COLLIN C. PETERSON, A REPRESENTATIVE
IN CONGRESS FROM MINNESOTA
The Chairman. The Committee will come to order. This
hearing of the Committee on Agriculture today is to review the
current issues on food safety and will come to order.
I am going to be brief in my statement. I welcome everybody
to the Committee. I welcome our witnesses.
There is a lot going on with food safety right now, both in
policy and legislation. The President's Food Safety Working
Group has been working on policies to improve food safety. The
House Energy and Commerce Committee has approved legislation
related to food safety at the FDA, and this is the fourth
hearing this year held by this Committee to look at this topic.
And I can tell you that it won't be the last hearing we have on
the subject either. It is a complicated issue with a lot of
interacting and moving parts; so I want to be sure that our
Members have a clear understanding of what is going on and what
we can do to play a role in the process.
So I hope Members are ready to get involved. We all want to
do whatever we can to make our food safety system better. We
have the safest food in the world, but it can always be better
and that is a priority of this Committee, and we will do
whatever we can to facilitate that process.
So I am going to do something a little out of the ordinary
here. I have constituent, sort of, from Minnesota here and I
wanted to recognize him. His mother was in my district and
passed away because of the peanut situation that happened here
not too long ago, and he has joined us today. So I just want to
give the rest of my time to him to tell us a little bit about
his mother and the situation, and he is also an accountant so
we are brothers that way as well. So Jeffrey Almer from
Minnesota, you are recognized.
STATEMENT OF JEFFREY ALMER, MEMBER, S.T.O.P.--SAFE TABLES OUR
PRIORITY, SAVAGE, MN
Mr. Almer. Thank you, Mr. Chairman. I thank everyone for
inviting me. I am just, very obviously, interested in how this
progresses. I know it is a long process. My main reason to be
here is to let you folks know that--and you probably do know
this already--things can be done so much better, and I know
there has been some rumors going around on the Internet and
things like that about how it will affect small farmers and
things like that. I just want to see that we turn food safety
in this country around and make it safe like it needs to be. I
don't want to have any political parties influenced one way or
the other. I just want to have it done right.
But my mother Shirley, she was a business woman and she had
defeated cancer twice, lung cancer 1 year and brain cancer the
next year. She overcame a lot of struggles and was in a rehab
facility for a urinary infection, a simple infection. And she
consumed some peanut butter that was in an industrialized
container, and that took her. It is very hard to imagine to see
somebody struggle to get that far beat cancer and then have
something as simple as peanut butter take her life. She had a
lot more life to live and was loved by all of us.
So I am here in her honor, I am here on her behalf and for
the other people that have been affected by food, and there are
quite a few people. One out of four every year will be affected
by food illness. So I have joined up with S.T.O.P.--Safe Tables
Our Priority. They have done expert work. I am not an expert by
any means but just as an average layman I can see we can do
better. I know we can. So I appreciate your time thank you very
much, Mr. Chairman.
The Chairman. Thank you very much for taking time to be
with us and for honoring your mother. We sympathize with your
situation and I can assure you this Committee will do whatever
we can to improve the food safety system in this country. Thank
you.
[The prepared statement of Mr. Peterson follows:]
Prepared Statement of Hon. Collin C. Peterson, a Representative in
Congress from Minnesota
Good morning and welcome to today's hearing of the House
Agriculture Committee. Because we have a lot to get to today, I am
going to keep my remarks brief.
There is a lot going on with food safety policy and legislation
right now. The President's Food Safety Working Group has been working
on policies to improve food safety. The House Energy and Commerce
Committee has approved legislation related to food safety at FDA. And
this is the fourth hearing this year held by this Committee to look at
this topic. It won't be the last hearing we have on this subject
either. This is a complicated issue with a lot of interacting and
moving parts, so I want to be sure that our Members have a clear
understanding of what is going on and what we can do to play a role in
this process. I hope that Members of the Committee are ready to roll up
their sleeves, learn all that they can, and ask the questions that need
to be asked.
I want to thank all of our witnesses for being here today, and I
look forward to their testimony.
The Chairman. I now recognize the gentleman who is sitting
in today as the Ranking Member, former Chairman of the
Committee, former Ranking Member of the Committee and my good
friend, Mr. Goodlatte from Virginia.
OPENING STATEMENT OF HON. BOB GOODLATTE, A REPRESENTATIVE IN
CONGRESS FROM VIRGINIA
Mr. Goodlatte. Thank you, Mr. Chairman. I very much
appreciate that this Committee is continuing to devote its
attention to such an important issue as the safety of our food
supply. Every Member of this Committee recognizes that food
safety is approximately the single most important issue for
which we have jurisdiction. Likewise, I don't think there is a
single member of this panel who wouldn't support reasonable
proposals that improve the safety of what is already the safest
food supply in the world. It is unfortunate that the
legislation passed out by the Energy and Commerce Committee,
H.R. 2749, the Food Safety Enhancement Act of 2009, does so
little to enhance food safety. Most observers agree that to
improve food safety, we must focus on preventing contamination
and cross contamination during food processing and preparation.
However, it appears that the overwhelming majority of this bill
seems to misdirect the attention of the regulatory agency to
reacting after a foodborne illness outbreak in punishing those
who may or may not have anything to do with it.
Another area of considerable concern with this legislation
is that the authors seem to believe that the Food and Drug
Administration has the resources and expertise to be able to
implement and enforce regulations on the more than 2.2 million
farms in this country. Section 103 of this legislation will
direct the FDA to issue mandatory on-farm food safety
performance standards. Due to severe resource constraints
within the FDA, this will undoubtedly ignore the complexity and
diversity of farming operations. Section 103 will direct the
FDA to adapt a food processing regulatory model to agricultural
production practices.
Let me be clear about the consequences of this legislation.
Directing the Food and Drug Administration to tell farmers how
to farm will make food more expensive. It will threaten our
food security. It will increase our reliance on foreign food.
It will not make our food supply safer.
The FDA does have the expertise, and if this legislation is
crafted correctly, will have the resources to facilitate the
processing, distribution and preparation of safer food. That to
me is where we need to be directing our attention to avoid the
kind of tragedies that some have experienced. But a live
animal, a plant actively growing in a field, or a piece of
fruit developing high up in a tree, is not yet food and is
therefore beyond the expertise of the FDA to oversee its
production.
I am continually frustrated by advocates who believe that
Congress should enact legislation that attempts to extend the
food processing regulatory model to agricultural production
practices. This is simply not the way to go, no matter how good
the intentions.
On this Committee and at the USDA, our colleagues
understand the nature of farming in America. We know about the
complexity and diversity of our farming operations and fully
appreciate that a one size fits all regulatory model would be a
disaster. The Committee can take pride in the fact that our
country is blessed to have farmers who continually produce the
safest, highest quality, most abundant and affordable food
supply in the history of the world. We must make clear one
important fact regarding a recent incident of foodborne illness
that seems to be driving this legislation.
That incident was not the result of inadequate legal
authority or even inadequate regulation. It was the result of
intentional disregard of food safety standards by the food
processor and a complete failure of the FDA to enforce its own
regulations.
As we consider this legislation, I will be evaluating this
and any other proposal on three key principles: One, does the
legislation make food safer? Two, does the legislation hold the
regulator accountable? And three, does the legislation
adequately account for geographic differences and weather
differences in food production, as well as the diversity of the
crops being grown?
Mr. Chairman, again, I thank you for this hearing and I
look forward to today's testimony and the considerate informed
debate that will follow.
The Chairman. I thank the gentleman for his statement. All
other Members are advised that they can submit statements for
the record.
[The prepared statement of Mr. Walz follows:]
Prepared Statement of Hon. Timothy J. Walz, a Representative in
Congress from Minnesota
Mr. Chairman, Mr. Ranking Member, Members of the Committee, our
witnesses here, thank you for this very important hearing.
A series of high-profile outbreaks of foodborne illness over the
past 3 years resulting in thousands of individuals sickened and
multiple deaths has demonstrated the need to improve food safety. I am
glad that we are here today looking at legislation to improve our food
safety system. We have an obligation to our children to address this
problem, to set an example for the world, and to strengthen our
economic security and energy independence. However, we must do it
wisely, it must make sense, and it must not do more harm than good.
I do have concerns about certain provisions in H.R. 2749, the Food
Safety Enhancement Act of 2009. It is important that Congress get it
right. Mr. Chairman, I thank you for bringing together these experts to
address food safety legislation as it relates to the agriculture
community.
So far, USDA has set a good example as a regulating agency. It is
important to use their expertise to help shape any food safety
legislation that affects our producers.
I know the farmers in my district in southern Minnesota want to be
part of the solution and want to assure the public that they are doing
everything possible to keep our food safe. They understand we need new
mechanisms to stop the bad actors. However, we need mechanisms that
work, not mechanisms that simply add heavy-handed regulation to low-
risk commodities.
Mr. Chairman, I look forward to the opportunity to hear the
testimony of our witnesses today and the chance to ask them questions
about how they believe food safety regulation should be addressed.
The Chairman. And we will move to the witnesses.
We would like to welcome them all again to the witness
table. Mr. Larry Wooten, the President of the North Carolina
American Farm Bureau Federation. Welcome, Larry.
Mr. Wooten. Glad to be here.
The Chairman. Patrick Boyle, President of the American Meat
Institute. Ms. Carol Tucker-Foreman, Distinguished Fellow with
the Food Policy Institute, Consumer Federation of America. Dr.
Sam Ives, Director of Veterinary Services and Associate
Director of Research for the Cactus Feeders, Limited, on behalf
of the National Cattlemen's Association. Mr. Kent Peppler,
President of the Rocky Mountain Farmers Union. Mr. Bob
Reinhard, Director of Food Safety for Sara Lee and Chairman of
the Technical and Regulatory Committee of the National Turkey
Federation. Mr. Nicholas Maravell, Owner and Operator of Nick's
Organic Farm in Potomac, Maryland. And Mr. Drew McDonald, Vice
President of National Quality Systems, Taylor Farms, Salinas,
California.
So welcome all to the Committee. Mr. Wooten you are on
first. Your full statements will be all made part of the
record. And we have votes coming up at 11:30; so we are going
to try to move this. So we would like to have you observe the 5
minute rule and your full testimony will be made part of the
record. So welcome to the Committee.
STATEMENT OF LARRY B. WOOTEN, PRESIDENT, NORTH
CAROLINA FARM BUREAU FEDERATION; MEMBER, BOARD OF DIRECTORS,
AMERICAN FARM BUREAU FEDERATION,
RALEIGH, NC
Mr. Wooten. Thank you very much. Good morning, Chairman
Peterson, Mr. Goodlatte, and Members of the Committee. I am
Larry Wooten, a tobacco and grain producer from North Carolina.
I am President of the North Carolina Farm Bureau and testifying
today as a Member of the Board of Directors of the American
Farm Bureau Federation. We appreciate your scheduling this
hearing to review the current food safety issues.
As the nation's largest general farm organization and the
representative of farmers and ranchers in every state in the
nation, Farm Bureau has a vital interest in how food safety is
practiced, perceived, and regulated. We represent growers of
virtually every commodity from apples to zucchini and pigs to
peanuts. My home State of North Carolina is a microcosm of Farm
Bureau's diversity as we proudly claim the nation's third most
diversified agricultural economy. North Carolina's rural
landscape is made up of many small farms due to our state's
history with the Federal tobacco and peanut programs. North
Carolina is a perfect example of the need for any food safety
legislation to recognize the different needs of farmers based
on the size and scope of their operations. One size does not
fit all. Regional differences in production and cultural
methods must certainly be considered.
Farm Bureau supports efforts to strengthen the country's
food and animal feed safety systems utilizing sound science in
a risk-based approach. We also recognize the importance of
providing adequate resources in a manner that increases
efficiencies. The nation's food safety system must have the
capacity, the authority, and the structural organization to
safeguard the health of American consumers against foodborne
illness. Evaluating food safety laws to determine whether they
have kept pace with significant changes in food production is a
priority both for agriculture and the food industry, as well as
for government.
However, there is concern that too many new standards will
unnecessarily complicate the marketplace without increasing the
overall safety of the food supply. While we understand the need
for continuous food safety improvement, the farm level impact
on producers must certainly be considered in any new
initiatives. Legislation currently pending in the House of
Representatives contains some very troubling provisions that
could undermine our ability to provide a safe, affordable and
abundant food supply. Although numerous bills have been
introduced in Congress to address a variety of food safety-
related issues, we will focus our comments today on the Food
Safety Enhancement Act. Farm Bureau supports of goal of H.R.
2749 to provide additional food safety resources both
internally and through cooperative relationships.
We appreciate the bill's requirement that FDA establish a
program to recognize laboratory accreditation bodies and
encourage that third-party certification be extended to
domestic testing and inspections. Much of the additional
research required in this legislation has been necessary for
several years and is critical to any effective food safety
initiatives in the future. Bipartisan negotiations that took
place prior to the Committee passage of H.R. 2749 to address
numerous concerns raised by the Farm Bureau and other groups
was important. Most notably livestock operations and the
livestock portion of diversified farming operations are
generally exempted from the bill. Despite substantial and
significant progress from the legislation's original discussion
draft, unresolved issues that could increase costs and increase
paperwork burdens on farmers and ranchers remain.
As approved by the full Committee on June 17, H.R. 2749
would significantly expand authorities for FDA to regulate and
oversee on-farm production practices. Farms are explicitly
included in extensive new record-keeping, reporting and
traceability measures which may not be feasible or practical
for many of our producers. FDA does not have the personnel, the
funding, the expertise or the time to regulate agricultural
production practices particularly given its overall volume of
increased responsibilities contemplated in H.R. 2749.
Mr. Chairman and Members of the Committee, we thank you for
arranging--again, for arranging this public hearing to better
understand food safety issues, and for allowing us to share
producers' views of the current legislation. We are committed,
at American Farm Bureau, to improving food safety in a targeted
scientific and risk-based manner, and we stand ready to work
with Congress in that effort. Thank you very much.
[The prepared statement of Mr. Wooten follows:]
Prepared Statement of Larry B. Wooten, President, North Carolina Farm
Bureau Federation; Member, Board of Directors, American Farm Bureau
Federation, Raleigh, NC
Good morning, Chairman Peterson, Ranking Member Lucas and Members
of the Committee. I am Larry Wooten, a tobacco and grain producer from
North Carolina. I am President of the North Carolina Farm Bureau and
testifying today as a Member of the Board of Directors of the American
Farm Bureau Federation (AFBF).
On behalf of Farm Bureau's more than six million members, thank you
for your dedication and commitment to farmers, ranchers and the related
industries that provide the U.S. with the world's most abundant,
affordable and safe food supply. We appreciate you scheduling this
hearing to review current food safety issues. AFBF is pleased to
present producers' perspectives on this issue and we thank you for
inviting us to share our views on a topic that is important to our
members, producers and consumers alike.
As the nation's largest general farm organization and the
representative of farmers and ranchers in every state in the nation,
AFBF has a vital interest in how food safety is practiced, perceived
and regulated. We represent growers of virtually every commodity, from
apples to zucchini and pigs to peanuts.
My home State of North Carolina is a microcosm of Farm Bureau's
diversity, as we proudly claim the nation's third most diversified
agriculture economy. Agriculture is North Carolina's number one
industry accounting for about $70.8 billion in annual economic activity
and just under \1/5\ of our state's jobs.
North Carolina's rural landscape is made up of many small farms due
to our state's history with the Federal tobacco and peanut programs. It
is a perfect example of the need for any food safety legislation to
recognize the different needs of farmers based on the size and scope of
their operations. One size does not fit all, and agencies with
experience in the diversity of farming operations--including USDA--
appreciate regional differences in production and cultural methods.
The Safety of the U.S. Food Supply
American consumers deserve to have confidence that their food is
safe and that the best science is used to ensure that the most
wholesome product possible is produced and offered. Consumers
reasonably expect that their food is safe, whether grown domestically
or imported.
By their nature, food systems are biological and thus, not failsafe
nor can they ever be ``zero risk.'' However, food today is safer than
in the past and food safety is constantly improving, particularly
through reporting and tracing when food problems occur. In 1996, the
Centers for Disease Control (CDC) improved its data collection of
foodborne illnesses. The results since then indicate a 25 percent
decline in E. coli ailments, Campylobacter cases are down 32 percent,
and Listeria has shown a 36 percent decrease in illnesses. Other
bacterial infections are down by about 33 percent.
These improvements have occurred despite new challenges for food
safety, such as changes in the typical American diet to include more
imported foods and more food consumed away from home. The U.S. now
imports food from more than 150 different countries through more than
300 ports of entry. About half of fresh fruits eaten in America are
grown outside of the country, and if you've ever been to a mid-Atlantic
farmers market in January an explanation of why this happens becomes
clear--these imports allow us to enjoy our favorite produce year-round.
Trade in food permits a more varied and customized diet suited to
today's consumer preferences. It permits our farmers and other food
producers to sell their goods abroad. Yet, it also means that food
safety requires enhanced attention to the global food supply.
Adding to the complexity presented by increased food sources, the
number of people involved in preparing the food we consume has also
increased. Approximately 50 cents of every food dollar today is spent
on foods prepared outside the home in places like restaurants, vending
machines, and schools. This development increases the need to ensure
adequate training for food service workers across the country and to
consider the potential widespread impact of deliberate contamination of
the food supply. As the supply chain gets longer, there are more
opportunities (both accidental and intentional) for the introduction of
public health threats.
Though the U.S. food production system is among the best in the
world, producers and consumers agree that improvement is always an
important goal. In addition to the new trends previously noted, recent
food recalls have increased consumer awareness of food safety. The
nation's food safety system must have the resources, authority and
structural organization to safeguard the health of American consumers
against foodborne illness. Evaluating food safety laws to determine
whether they have kept pace with significant changes in food
production, processing and marketing--such as new food sources,
advances in production and distribution methods, and the growing volume
of imports--is a priority for the agriculture and food industry, as
well as government.
However, there is concern that too many new standards will
unnecessarily complicate the marketplace without improving food safety
overall. While we understand the need for continuous food safety
improvement, the farm-level impact on producers must be considered in
any new food safety regulations or legislation.
Farm Bureau Policy
AFBF supports:
Adequate funding of the government's food and feed safety
and protection functions;
Increased education and training for inspectors;
Additional science-based inspection, targeted according to
risk;
Research and development of scientifically based rapid
testing procedures and tools;
Increased funding for the Food Animal Residue Avoidance
Databank (FARAD);
Accurate and timely responses to outbreaks that identify
contaminated products, remove them from the market and minimize
disruption to producers; and
Indemnification for producers who suffer marketing losses
due to inaccurate government-advised recalls or warnings.
Farm Bureau strongly opposes efforts to eliminate years of food
safety expertise by creating a new, single food safety regulator.
Rather than streamlining authorities, the result would be less
organization, more energy expended in transition than inspections, and
the cumulative loss of valuable technical knowledge.
While we believe that import inspections must be increased in a
risk-based manner, we have concerns about food safety bills which could
threaten trade. Port closures and discriminatory treatment of
international products are especially problematic.
Food Safety Responsibilities
Food safety is a shared responsibility of everyone in the food
chain, from producer to consumer and each step in between. The
government also plays a vital oversight and regulatory role.
It Starts with the Producer
America's farmers and ranchers are committed to producing
safe and affordable food for consumers in the U.S. and around
the world. There are several reasons for their strong support
for food safety. They have the same desire as other consumers
to have a safe, abundant and affordable food supply. They also
have an economic interest because the demand for their products
is determined by consumer confidence that food is safe.
Food safety is paramount for everyone involved in the
agriculture industry. We have an obligation to produce a safe,
nutritious product for domestic and international consumers,
and that obligation is at the core of all that we do.
Government Role
The Government Accountability Office (GAO) has identified 15
Federal agencies that administer at least 30 laws related to
food safety. The Food and Drug Administration (FDA) within the
Department of Health and Human Services and the Food Safety
Inspection Service (FSIS) within the Department of Agriculture
(USDA) handle most of the government's food safety regulatory
system.
FDA regulates 80 percent of the food supply. The agency is
responsible for ensuring that all domestic and imported food
products--except for most meat and poultry derived from the
major animal species--are safe, nutritious, wholesome and
accurately labeled. FDA share responsibility for the safety of
eggs with FSIS.
FSIS regulates 20 percent of the food supply, ensuring the
safety, wholesomeness and proper labeling of most domestic and
imported meat and poultry and their products sold for human
consumption. FSIS inspects all cattle, sheep, swine, goats and
horses before and after they are slaughtered. FSIS also
maintains oversight during meat and poultry processing into
food products.
Among the other agencies that play a role in food safety are
USDA's Agricultural Research Service, the Center for Disease
Control, the Environmental Protection Agency, the National
Marine Fisheries Service and the Department of Homeland
Security (DHS).
Consumers are the Ultimate Step
Once a safe food product leaves the retail shelf, the final
responsibility for safe storage, handling and preparation
ultimately rests with the consumer. The amount of time (less)
and methods used (more) to prepare food have changed
considerably, requiring consumers to increase their knowledge
and vigilance. Yet, consumers' knowledge about food storage and
preparation has declined markedly in the past 30 years. This
results in greater chance for human error in food choices and
preparation. Many of the estimated 76 million cases of
foodborne illnesses in the U.S. each year are contracted in the
home, and many can be prevented through proper kitchen health,
storage and cooking.
The entire food industry is committed to not only offering a
safe product to consumers, but also doing all that we can to
ensure the safety of that product until it is consumed. On
February 10, AFBF launched a consumer website, Your
Agriculture, at www.fb.org/yourag, which includes safety
guidelines for food preparation, cooking, serving and storage
in the home. Our biannual publication ``Farm Facts,'' dedicated
to educating the public about all facets of agriculture in
layman's terms, details the four simple food safety steps:
clean, separate, chill and cook. Last year, we began publishing
a monthly e-newsletter, ``Foodie News.'' AFBF also produces a
brochure, ``Farmers Provide Safe and Abundant Food,'' to help
educate the public about food safety.
It is important to note that everyone plays a role in food safety,
including the food industry and regulatory agencies. Therefore, we
support Congress' efforts to strengthen the country's food- and animal
feed-safety systems utilizing sound science and a risk-based approach.
We also recognize the importance of structuring and providing adequate
resources to our food- and feed-safety systems to increase
efficiencies. However, legislation currently pending in the House of
Representatives contains some very troubling provisions that could
undermine our ability to provide a safe, affordable and abundant food
supply.
Legislative Action in the House of Representatives
Although numerous bills have been introduced in Congress to address
a variety of food safety related issues, we will focus our comments
today on the Food Safety Enhancement Act (H.R. 2749) as it appears to
be the primary vehicle for food safety reform in the House. We
appreciate the interest of both the majority and minority Members and
staff of the Energy & Commerce Committee in learning about how and why
we do what we do to produce safe food. We remain engaged in ongoing
discussions to continue improving H.R. 2749 before it comes to the
House floor for a vote.
Farm Bureau is encouraged by several provisions in H.R. 2947 to
increase FDA resources, both internally and through cooperative
relationships. We support the goal of the legislation to strengthen and
provide additional resources for food safety functions. We appreciate
the bill's requirement that FDA establish a program to recognize
laboratory accreditation bodies and encourage that third-party
certification be extended to domestic testing and inspections. Much of
the additional research required in the legislation--to develop
efficient rapid methods for detecting contaminants; determine the
sources of contamination; identify common and emerging zoonotic
diseases; and develop methods for destroying pathogens--has been
necessary for several years and is critical to any effective food
safety initiatives in the future.
Bipartisan negotiations took place prior to House Energy and
Commerce Committee passage of H.R. 2749 to address numerous concerns
raised by Farm Bureau and other agriculture groups. Most notably,
livestock operations and the livestock portion of diversified
operations are generally exempted from the bill. Other improvements
include the removal of troubling restrictions on modified atmosphere
packaging and clarification that country-of-origin labeling (COOL)
requirements not conflict with what is already required by the USDA
program.
Despite substantial and significant progress from the legislation's
original discussion draft, unresolved issues that could increase cost
and paperwork burdens on farmers and ranchers remain. As amended and
approved by the full Committee on June 17, H.R. 2749 would
significantly expand authorities for FDA to regulate and oversee on-
farm production activities. Farms are explicitly included in extensive
new record-keeping, reporting and traceability measures which may not
be feasible or practical for many producers.
Furthermore, H.R. 2749 paints the entire food supply system with a
very broad brush. As you know, each segment of the food and agriculture
spectrum is unique.
The bill would for the first time permit the Food and Drug
Administration (FDA) oversight of many on-farm production activities
with which it has little to no experience and which have not
traditionally been under its jurisdiction on a routine basis. Many of
these authorities are duplicative and overlapping with the jurisdiction
of the U.S. Department of Agriculture and the Congressional Agriculture
Committees.
Not only are the authorities redundant with existing USDA
authority, but FDA does not have the personnel, funding, knowledge,
expertise or time to regulate agricultural production practices--
particularly given its overall volume of increased responsibilities
contemplated in H.R. 2749. While that view is certainly widely held
within the agriculture community, it is not limited to the production
audience. Even the National Federation of Independent Businesses noted
the business impracticalities in a letter on June 17 which noted that
H.R. 2749 ``will do little to improve food safety but (would) impose
significant costs on small farms and food producers.''
Last month, Farm Bureau and a coalition of 18 other agriculture
organizations expressed written concerns about the scope of H.R. 2749
on production agriculture activities. As currently written, H.R. 2749
would:
Expand FDA's on-farm authorities to potentially include
production practices;
Lower the existing on-farm inspection trigger threshold from
the 2002 Bioterrorism Act which requires that FDA have a
reasonable belief that a product presents threat of serious
adverse health consequences of death to humans or animals;
Require additional record-keeping, including new
requirements for farms;
Increase FDA's access to records without sufficient
guarantee of confidentiality;
Require FDA to create a food traceability system which could
include farms (except most direct sales and farmers markets);
Greatly expand FDA authority to quarantine geographic areas
for food safety problems; and
Delegate to FDA District Offices the authority to issue
subpoenas and mandatory recalls, including to farms.
A more detailed discussion of these specific concerns follows.
Safety Standards for Agricultural Commodities:
The bill (Sec. 104) would require FDA to promulgate science and
risk-based safety-standard regulations for seven activities, including
the safe growing, harvesting, packing, sorting, transporting and
holding of raw agricultural commodities. The performance standards are
not limited to produce, but extend to any plant or fungus.
``Reasonably necessary'' regulations would be determined at FDA's
discretion for both broad and specific safety standards, including
manure use, water quality, animal control and temperature controls.
These types of activities are all outside of FDA's realm of expertise,
and most are redundant with existing USDA, EPA and Interior Department
jurisdiction. While FDA would be required to consider impacts on small-
scale and diversified farms and on a variety of environmental criteria,
there is no guarantee that FDA will produce fair or necessary standards
that ultimately result in safer food.
Recordkeeping:
The bill (Sec. 106) would require farmers to keep records
regardless of the commodity they are producing and its associated risk
profile, or lack thereof. FDA has unprecedented routine access to
business records without justification of cause. Producers are required
for the first time to allow a Federal official to access and copy all
records, including production and sales records that may be related in
any way to food or feed safety. By deleting the farm exemption in the
Bioterrorism Act of 2002, each farmer would be required to maintain
records showing every buyer to which the farm's products are sold
(except products sold directly to final consumers or restaurants).
Further, the bill would allow FDA to require that farmers retain
records for up to 2 years.
In a change from traditional practice dating back to 2002, FDA is
not required to show cause prior to requesting records. Indeed, the
bill would delete the current Bioterrorism Act threshold that requires
that FDA first have a ``reasonable belief'' that a food article ``is
adulterated and presents a threat of serious health consequences or
death to humans or animals'' before having the authority to access
records.
Finally, confidentiality remains a serious concern in the
Committee-passed bill. The ability of FDA to appropriately protect the
privacy of producers' information from unauthorized release and/or
access is unclear, at best, and not explicitly guaranteed.
Food Traceability:
FDA is required (Sec. 107) to create a new system to track any food
or feed contamination incident to its source within 2 business days.
Because this provision exceeds the current Bioterrorism Act
requirements to trace ``one-step-forward/one-step-back,'' it could
require producers to maintain a complete history of where farm inputs
originated and where farm-production outputs are sold. Electronic
record-keeping is not specifically required, but farm records would
likely need to be electronic to facilitate traceability in the
specified time frame.
This system would increase production costs for diversified farmers
and grain farmers, most of whom operate small businesses. The
requirement is overly burdensome considering the plethora of records
that producers currently maintain. Yet, most farms do not have the
technical or financial resources to make their record-keeping systems
interoperable with others in the food chain. According to USDA Census
of Agriculture data, less than 60 percent of farmers and ranchers have
a computer, and only \1/3\ have high-speed Internet access.
Quarantine Authority:
The quarantine authority (Sec. 133) is broad and far exceeds the
authority granted to USDA. If FDA had this authority and had chosen to
utilize it in 2008--when it erroneously suspected, based on what it
believed at the time was ``credible information'' that tomatoes were a
source of Salmonella contamination--entire regions of the country could
have been quarantined, further decimating a sector of agriculture that
already had suffered severe economic damage. Although livestock are
exempt, it is unclear if the bill would allow FDA to conduct an on-farm
inspection of or quarantine the livestock side of a diversified
operation that has a food-safety issue with the grain side of its
business. Unlike USDA, FDA is not required or even able to provide any
indemnification, whether a quarantine is justified or erroneous.
Penalties:
FDA is required (Sec.134 and 135) to issue fines for criminal and
civil penalties. Unintentional as well as intentional violations may be
fined, including up to $20,000 per individual for a record-keeping
mistake. Each violation cited and each day during which it continues
shall be considered to be a separate offense. Although penalties per
event are capped, the cap is high enough ($50,000 for individuals for
unintentional violations) to severely damage producers financially or
put them out of business.
Delegation of Authority:
The bill (Sec. 311, 418 and 420) gives wide latitude to the
discretion of district office personnel for many authorities, including
the right to recommend prescriptive preventive controls and the
authority to issue mandatory recalls and subpoenas. This empowerment at
the FDA District Office Director level is particularly troubling given
the removal of the previous threshold for FDA action and records
access. We strongly urge that authorities with broad and significant
impact on the regulated entities be non-delegable beyond, at a minimum,
the Center Director level and ideally retained within the office of the
Secretary or Commissioner.
Trade Impacts:
The latest version of H.R. 2749 removes the separate user
registration for importers and production facilities, a very positive
development. However, several provisions of the bill still violate U.S.
trade commitments and would invite retaliation by our trading partners
against exports of U.S. agricultural products.
The food safety regime should be science based and flexible enough
to recognize equivalence between food safety authorities. For example,
there is no need for redundant inspections between countries like the
U.S. and Canada. In addition, the frequency of inspections does not
seem to be scientifically justified. The bill sets an arbitrary
timeline for recurring inspections.
There is serious concern that the user fee currently in the bill
does not provide enough additional service to justify the fee. User
fees that do not generate additional benefit for the importer may be
trade restricting.
As Congress works to finalize this legislation, Farm Bureau urges
lawmakers to remain conscious of the international implications that
food safety regulations have. Congress should ensure that the
mechanisms put in place to regulate food safety do not treat importers
more harshly than domestic facilities. To do so would be a violation of
our World Trade Organization obligations.
Conclusion
Thank you again for arranging this public hearing to better
understand food safety issues, and for allowing us to share producers'
views of current legislation. We are committed to improving food safety
in a targeted, scientific, and risk-based manner, and we stand ready to
work with Congress in that effort. We look forward to working with you
and your colleagues as food safety legislation continues to be
developed.
The Chairman. Thank you, Mr. Wooten. That was a good job, 4
seconds over, so you get an A+.
Mr. Boyle, welcome to the Committee.
STATEMENT OF J. PATRICK BOYLE, PRESIDENT AND CEO, AMERICAN MEAT
INSTITUTE, WASHINGTON, D.C.
Mr. Boyle. Thank you, Mr. Chairman, and I appreciate the
opportunity to provide perspective upon, and hopefully insight,
into the Federal inspection system for meat and poultry
products. Food safety is the institute's number one priority.
For the past 10 years, it has been addressed by AMI members in
a noncompetitive manner by sharing best practices and new
technologies to improve food safety for the good of the
industry and our customers.
Today with the accompanying PowerPoint presentation, I
would like to discuss the important oversight role of the Food
Safety and Inspection Service as well as highlight the
significant food safety improvements in meat and poultry
products.
The 8,000 field employees of FSIS inspect approximately
6,300 domestic meat and poultry operations. An additional 2,000
Federal employees provide supervision and support services at a
total annual cost of $1.1 billion. Plants processing animals
are not inspected during all hours the plant is operating.
Plants processing meat and poultry products are inspected at
least daily. For imported meat and poultry products, Federal
law requires the foreign countries' inspection system to be
equivalent to the U.S. system. Currently 33 foreign countries
are approved to ship products to the U.S. and each foreign
inspection system is audited annually. All meat and poultry
products arriving at our borders are also subject to
reinspection and laboratory analysis.
Seventy-five import inspectors conduct these activities at
150 official import establishments. More than a decade ago,
FSIS and the industry embraced a major shift in the approach to
food safety programs by adopting the principles of prevention
embodied in HACCP. In fact, in 1993 AMI petitioned USDA to
mandate HACCP to modernize the meat and poultry food and safety
inspection system. FSIS oversight does not stop with HACCP
regulations. FSIS assures processes are scientifically
validated. Teams of expert auditors conduct periodic in-depth
food safety assessments which can take days or weeks to
complete and may involve extensive microbiological sampling of
the plant's environment and finished products. Annually, FSIS
conducts more than 8,000 microbiological tests to verify the
production processes are under control. This is in addition to
the several million microbiological tests that industry
conducts each year.
In addition to process control programs, the plant is
required to have written standard sanitation operating
procedures that prescribe how the operating environment will be
maintained in a sanitary condition.
Mr. Chairman, I ask your consent that we insert in the
record a book entitled Protecting Consumers, which provides a
more detailed oversight of FSIS in the meat and poultry
industry.
The Chairman. Without objection.
Mr. Boyle. Thank you, Mr. Chairman.
We clearly have an intensive meat and poultry inspection
system, but it is important to recognize that only industry can
produce safe food, and we have been making noteworthy progress.
Since 2000 the industry has reduced the prevalence of E. coli
O157:H7 in ground beef by 45 percent to less than \1/2\
percent. The prevalence of Listeria monocytogenes in ready to
eat products has been reduced by 69 percent to \4/10\ of 1
percent. We have seen similar improvements in the incidence of
foodborne illness reported by the CDC. Since 2000 illnesses
caused by E. coli are down by 44 percent. Listeriosis is down
by three percent, though with much greater reductions occurring
before the year 2000. In fact, we have not had a single product
recall associated with an outbreak of listeriosis in the last 6
years.
As Congress considers various bills to reform FDA
oversight, additional regulatory authorities are being proposed
for FDA. AMI believes that many of them are unnecessary if
applied to the FSIS inspection regimen. First, user fees are
inappropriate. AMI does not support funding a $1 billion
federally mandated inspection program by imposing fees on the
regulated industry. Second, HACCP programs should be designed
by food companies, not by the government, and then subjected to
the review of the regulatory agency as is currently the
situation with FSIS. Third, microbiological performance
standards can be effective if properly constructed to achieve a
public objective and are scientifically based to measure food
safety. Our experience with FSIS performance standards is that
those related to E. coli and LM have worked to improve public
health. On the other hand, the Salmonella performance, while
dramatically reducing the incidence on chicken, pork and beef
has not reduced the number of cases of salmonellosis.
Fourth, mandatory recall for meat and poultry products is
needlessly redundant. Industry has every incentive to remove
contaminated products from the marketplace to reduce potential
liability, and the detention and seizure authority of FSIS
provides the agency with more than sufficient leverage to
compel the so-called voluntary recall.
And fifth, civil money penalties within a continuous
inspection program like FSIS are unnecessary. As noted on this
slide, severe penalties are already in place for meat and
poultry plants.
Finally, AMI looks forward to working with this Committee
and the Obama Administration's Food Safety Working Group about
food safety initiatives that benefit consumers, the food
industry, and the regulatory agencies that oversee the nation's
food supply.
Thank you very much, Mr. Chairman.
[The prepared statement of Mr. Boyle follows:]
Prepared Statement of J. Patrick Boyle, President and CEO, American
Meat Institute, Washington, D.C.
Good morning Mr. Chairman, Ranking Member, and Members of the House
Committee on Agriculture. Thank you for allowing me the opportunity to
appear before this Committee. My name is Patrick Boyle and I am the
President and CEO of the American Meat Institute (AMI). AMI has
provided service to the nation's meat and poultry industry--an industry
that employs more than 500,000 individuals and contributes more than
$832 billion to our nation's economy--for more than 100 years.
AMI's 200 members include the nation's most well-known meat and
poultry food manufacturers. Collectively, they produce 90 percent of
the beef, pork, veal, and lamb food products and 75 percent of the
turkey food products in the U.S. AMI's membership is extremely diverse,
ranging from large, publicly traded companies that employ thousands to
very small companies with as few as two employees. Indeed, more than
half of AMI's members are small, family-owned businesses employing
fewer than 100 individuals. We have one member company with just three
employees. These companies operate, compete, sometimes struggle, and
mostly thrive in one of the toughest, most competitive and certainly
the most scrutinized sectors of our economy: meat and poultry packing
and processing.
AMI appreciates the opportunity to provide perspective and
hopefully insight into our nation's food safety inspection system for
meat and poultry products. Food safety is the Institute's number one
priority. Each year, the AMI Board of Directors establishes priorities
to direct the Institute. Food safety has topped the list for the past
decade. In 1999, food safety was made a non-competitive issue by the
organization which provided top management commitment to share best
practices and new technology to improve food safety for the good of the
industry.
We all know that food safety has been in the news and because of
that publicity a common refrain heard in Washington and other venues is
that the U.S. food safety regulatory system is broken and has failed
the American people. Indeed, a great deal of attention has been devoted
to what is wrong and the changes needed to assure us that the food we
consume is safe. Although some of the criticism may be warranted, a
closer look at our meat and poultry food safety systems yields a
different conclusion.
Illnesses associated with meat and poultry consumption have
declined. Nearly one billion meals are consumed each day in the United
States without incident (Slide 1). For context, human illness
statistics published by the Centers for Disease Prevention show that
the pathogens most commonly associated with meat and poultry make up
only a fraction of the total foodborne illnesses and deaths in the U.S.
(Slide 2). These statistics are not provided to minimize each and every
illness, hospitalization, or death associated with food consumption,
but to put the risk into proper context.
Is the sky falling? No, but most rational individuals still believe
that food safety can be improved. I would like to discuss with you
today some of the real improvements the meat and poultry industry has
made and the important role government oversight plays in assuring that
the industry meets its responsibility to produce safe food.
First, the meat and poultry industry supports a strong Federal
oversight system--and we have a strong system. The approximately 8,000
employees of USDA's Food Safety Inspection Service (FSIS) inspect
approximately 6,300 domestic meat and poultry operations and an
additional 2,000 Federal employees provide supervision and support
services, at a total cost of more than $1 billion. Plants processing
animals are inspected during all hours the plant is operating. Plants
preparing meat and poultry products are inspected at least daily (Slide
3).
For imported meat and poultry products, Federal law requires the
foreign country's inspection system to be equivalent to the U.S.
system. Thirty-three foreign countries are currently approved to ship
products to the U.S. and each foreign inspection system is audited
annually. All meat and poultry products arriving at our borders also
are subject to reinspection and are routinely inspected and sampled for
laboratory analysis. Seventy-five import inspectors conduct these
activities at 150 official import establishments (Slide 4).
Another comment often heard is that the food safety system must be
preventative. We agree. More than a decade ago FSIS and the industry
embraced a major shift in the approach to food safety programs by
adopting the principles of prevention embodied in the Hazard Analysis
and Critical Control Point, or HACCP. In fact, in 1993 AMI petitioned
USDA to mandate the implementation of HACCP in federally-inspected
plants in an effort to modernize the meat and poultry food safety
inspection system (Slide 5).
Mandatory HACCP provides a framework for identifying potential
hazards and implementing measures to control those potential hazards
during the production process. The process is continually monitored to
assure that critical food safety standards are met. Pre-planned
corrective actions are prescribed if critical limits are not met.
Records are kept and available to FSIS inspectors for review and
procedures are established to verify that the system is working
properly. However, AMI believes that this prevention and control system
must be uniquely suited to address the hazards specific to any
facility. Uniform government controls are detrimental to individualized
HACCP planning, thus food safety planning must remain the
responsibility of the producing company. The proper role of the
government in a HACCP-based food safety system is to verify that
companies have conducted a proper hazard analysis, identified the
hazards reasonably likely to occur in their operation, and have
developed and implemented an appropriate HACCP plan to control those
hazards. We do not believe it is the proper role of the government to
establish hazards that are reasonably likely to occur and mandate
preventive controls, as these vary by establishment.
FSIS oversight does not stop at mandatory HACCP. FSIS assures
processes are scientifically validated. Teams of expert auditors
conduct periodic in-depth food safety reviews to complement the
activities performed by the FSIS inspectors permanently stationed at
the plant. These food safety assessments, or FSAs, can take days or
weeks to complete and may involve extensive microbiological sampling of
the environment and product (Slide 6).
During the course of a year, FSIS conducts more than 80,000
microbiological tests to verify that federally inspected
establishments' production processes are under control. FSIS conducts
these verification tests in addition to the several million
microbiological tests the industry does each year (Slide 7).
There is no finished product testing regime, however, that can
guarantee that food products are pathogen-free or that they can be
mishandled and remain safe to eat. Finished product testing is an
important tool because it can show that process controls are effective
and working, but it cannot eliminate every risk to a meaningful degree
of certainty.
In addition to process control programs, the plant is required to
have written standard sanitation operating procedures that prescribe
how the operating environment will be maintained in a sanitary
condition. FSIS monitors plant sanitation before operations begin and
while the plant is operating. Any deficiencies noted require immediate
corrective action and failure to react appropriately can result in the
plant being shut down by FSIS officials until the deficiencies are
corrected (Slide 8).
We have a strong Federal meat and poultry inspection system, but it
is important to recognize that only the industry can produce safe food.
Although food processors and handlers can minimize risks through the
use of systems discussed above and other good management practices,
there can be no absolute certainty that all food products are free from
all risks. Notwithstanding that caveat, progress has been and is being
made.
Specifically, government data show a decline in pathogen prevalence
on meat and poultry products. Since 2000, the industry has reduced the
prevalence of E. coli O157:H7 in ground beef by 45 percent to less than
\1/2\ percent (Slide 9). The prevalence of Listeria monocytogenes in
ready-to-eat products has been reduced by 69 percent to less than 0.5
percent (Slide 10). We have seen similar improvement in the incidence
of foodborne illness reported by the Centers for Disease Control and
Prevention. In that regard, since 2000, illnesses caused by E. coli
O157:H7 are down by 44 percent and listeriosis is down by three percent
with much of the improvement occurring before 2000 (Slides 11-12).
A question often debated is whether microbiological performance
standards are needed to improve public health. To answer that question,
it is instructive to look at the existing Salmonella performance
standards that are codified in the meat and poultry regulations.
Since the performance standards were promulgated, the prevalence of
Salmonella in chicken is down by 63 percent, in pork it is down by 70
percent, and in ground beef it is down by 68 percent (Slides 13-15).
Looking at these numbers one might conclude the Salmonella performance
standards are a great success. Of significance, however, is the fact
that the incidence of foodborne illness associated with Salmonella has
actually increased slightly over the same time period (Slide 16).
One might ask whether microbiological performance standards are a
useful tool. The answer is they can be if properly constructed to
achieve a public health objective and if they are scientifically based
to measure whether food is safe and not injurious to public health.
Conversely, I would suggest that a performance standard based solely on
achieving an arbitrary outcome that yields no public health benefit is
inappropriate.
As the food safety debate heats up, some Congressional Members and
others have called for enhancing the enforcement powers of the
inspection agencies, including civil monetary penalties and other
sanctions. For meat and poultry plants, however, very severe penalties
already are in place.
Specifically, FSIS can detain and seize adulterated products in
commerce, as well as retain product at the plant thereby preventing it
from entering commerce. Federal inspectors also have the authority to
shut down a plant at a moment's notice if food safety violations such
as insanitary conditions are identified. More serious violations can
result in Federal inspectors being withdrawn from the plant, which
results in the plant not being able to operate. And, plant management
can be criminally prosecuted for food safety violations. It is
difficult to comprehend how additional remedial penalties would improve
food safety.
Another subject of some controversy is mandatory recall. The cry
for mandatory recall ignores a simple fact: Industry has every
incentive to remove contaminated product from the marketplace to reduce
potential liability. Experience shows us that the speed with which
contaminated meat and poultry product is removed from the market will
not improve with mandatory recall. In most cases, meat and poultry
products are recalled within hours after a problem is discovered. And
industry cooperation to execute recalls has been excellent (Slide 17).
To date, no meat company has ever refused to conduct a warranted
recall and in the highly unlikely event such a circumstance ever were
to occur, the previously mentioned threat of FSIS product detention and
seizure, coupled with the agency's ability to directly inform the
public not to consume the product because the company refused to recall
the affected product, not to mention the ramifications for the company
at the producing plant, is more than sufficient leverage for FSIS. To
my knowledge, such a situation has never occurred. In short, the
concept of mandatory recall is a solution in search of a problem.
A final concern as it relates to food safety is the imposition of a
user fee that would be paid by the regulated industry for food safety
inspection services. Similar proposals for meat and poultry inspection
at USDA have been rejected by Congress annually for nearly 30 years.
USDA inspection services have long been paid for with government funds
because those inspections are activities that benefit of the general
public. Inspection activities should be funded not from user or
registration fees that, in effect, are a food tax, but from monies
appropriated out of the general treasury.
Earlier in the year, President Obama formed the White House Food
Safety Working Group to recommend a new, public health-focused approach
to food safety based on prevention, strengthening surveillance and
enforcement, and improving response and recovery. We appreciate the
recommendations put forth by the Working Group to date, and we
reemphasize that any changes in our food safety system must show
measured improvements in public health. AMI looks forward to working
with the Obama Administration on implementing effective programs that
benefit consumers, the industry, and our public institutions that
safeguard the nation's food supply.
Let me conclude with some suggestions on what will improve food
safety.
(1) With respect to government inspection programs the focus must
be on systems designed and implemented to protect public
health. Inspection activities that do not have a direct impact
on public health waste scarce resources and divert attention
from issues of public health importance.
(2) Continual improvement of preventive process control systems is
needed. Mandatory HACCP and SSOP that focus on prevention
versus detection is critical and the rigor of the control
system should be proportional to the public health risk.
(3) Government agencies must be fully funded to help assure the
safety of domestically produced and imported food.
(4) Resources should be allocated based on the public health risk
posed by a particular food and the control measures that are
used during the manufacturing and distribution process to
control such risk.
(5) Objective and achievable food safety standards that are
scientifically determined to measure whether the food is safe,
not adulterated, and non-injurious to public health are needed.
Food safety standards must be based on quantifiable, measurable
criteria and have a direct impact on public health.
(6) The U.S. must assure that such standards are compatible with
internationally recognized standards, such as Codex
Alimentarius, to protect the health of consumers, ensure fair
trade practices, and promote the coordination of food standards
development by the international community.
(7) Efforts should be focused on conducting a more thorough
analysis to identify how and why a foodborne disease outbreak
occurred. Each government agency involved in investigations of
foodborne disease outbreaks or product recalls should be
required to report the reasons such incidents occurred and
those reports should focus on how the food product was
harvested, processed, distributed, prepared, and consumed to
provide detailed information that will assist food handlers in
preventing future occurrences.
(8) Rigorous government inspection and testing is needed to verify
that consumer-ready products are safe. Test results should be
performed under accepted sampling and analytical protocols and
should meet objective food safety standards. Testing to
determine the adequacy of process control at interim points
during harvesting, manufacturing, and distribution should be
conducted by the industry.
(9) Establishment of a public-private partnership to design and
implement a comprehensive research program to improve food
safety is needed. The research program should be directed by a
board of qualified food safety experts from government,
academia, and industry. The program should focus on developing
risk mitigation and intervention strategies to prevent
foodborne disease outbreaks.
Let me provide some parting thoughts. It is indisputable that
producing safe food is good for customers and good for business. To
that end, the meat and poultry industry has been working to meet the
challenge of continuously improving the safety of the products
produced, but the job is not done. Industry pledges to cooperate with
all parties to ensure that the U.S. maintains the safest meat and
poultry supply in the world.
Thank you for the opportunity to testify before the Committee
today. I am happy to answer any questions that Members may have
regarding my testimony and the food safety system for meat and poultry
products.
Attachment 1
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The Chairman. Thank you Mr. Boyle.
Ms. Tucker-Foreman, welcome back to the Committee. We
appreciate your testimony.
STATEMENT OF CAROL L. TUCKER-FOREMAN, DISTINGUISHED FELLOW, THE
FOOD POLICY INSTITUTE, CONSUMER
FEDERATION OF AMERICA, WASHINGTON, D.C.; ON BEHALF OF CENTER
FOR FOODBORNE ILLNESS RESEARCH &
PREVENTION; CENTER FOR SCIENCE IN THE PUBLIC
INTEREST; CONSUMERS UNION; FOOD & WATER WATCH, GOVERNMENT
ACCOUNTABILITY PROJECT; NATIONAL
CONSUMERS LEAGUE; THE PEW CHARITABLE TRUSTS; SAFE TABLES OUR
PRIORITY; TRUST FOR AMERICA'S HEALTH; AND THE UNITED FOOD &
COMMERCIAL WORKERS
INTERNATIONAL UNION
Ms. Tucker-Foreman. Thank you, Mr. Chairman and thank you
as well for allowing Mr. Almer to address the Committee. I am
Carol Tucker-Foreman with Consumer Federation of America. I
was, formerly, Assistant Secretary of Agriculture with
responsibility for meat and poultry inspection. I am testifying
today on behalf of ten consumer public health and trade union
organizations representing millions of Americans who are
concerned about the safety of the food we eat every day.
Foodborne illness has reached near crisis proportions in
this country. It kills Americans at the rate of one every 2
hours every day of the year, and that is likely to continue
until you tell the Food and Drug Administration to institute a
preventative program and give them the authority to do it.
Foodborne illness outbreaks hit everybody in the food chain.
The Kellogg Company reports that the Peanut Corporation of
America outbreak cost them $65 to $70 million. Sales of peanut
butter have been down ever since. The E. coli outbreak from
bagged spinach cost the leafy greens industry more than $350
million, and last year Florida tomato farmers were devastated
when they were incorrectly--when tomatoes were incorrectly
implicated in an outbreak of Salmonella saintpaul.
You have heard from Jeff Almer today. I would like to
introduce you to two other families who are here today. First,
Robin and Jeff Allgood from Chubbuck, Idaho, and Nancy Donley
from Chicago.
Would you all stand up, please.
Robin and Jeff have come from Idaho today. Their son Kyle,
a mischievous and energetic 2 year old, died of E. coli
poisoning after his mother gave him a smoothie that contained
bagged spinach, that was contaminated with that deadly
pathogen. Nancy Donley's only child, 6 year old Alex, also died
of E. coli poisoning after eating contaminating ground beef.
Since then, Nancy has taken the time that she would have spent
raising Alex helping other families deal with their loss and
trying to persuade the government to institute additional
protections to prevent others from suffering.
Thank you all.
Americans are very aware that people are dying from
foodborne illness. Two weeks ago, IBM announced a poll that
showed that 60 percent of Americans are concerned about the
safety of the food they purchase. Less than 20 percent trust
food companies to develop and sell food products that are safe
and healthy for themselves and their families; 63 percent
confirmed that they would not purchase a food until the source
of--recalled food until the source of contamination was found;
and 57 percent said they had stopped purchasing foods, even for
a short time within the past 2 years, because of safety
considerations.
These illnesses are almost completely preventable if you
have a good preventative health system. And the GAO and the NAS
have listed key elements for such a preventative system
including process--company process control and regular
inspection, better controls over imported foods. These
provisions and additional ones are all included in H.R. 2749.
It gives FDA--it requires FDA to begin a preventative program
that will stop these problems. The agriculture community has
objected to a number of items in the legislation, and the
Energy and Commerce Committee has heard you and made major
changes in the legislation to address your concerns, including
keeping all jurisdictions as they are now and requiring the
Secretary of HHS to coordinate with the departments of
agriculture in the states in setting up regulations.
Frankly, consumer groups have chosen not to oppose a number
of requirements in the legislation that we think limit its full
protection of consumers. We are very sympathetic to the
concerns of those in the food industry who may have to change
the way they do business. It is clear that the legislation has
been structured to assure it doesn't place an undue burden on
small farms and businesses. On behalf of all the families here
today and the others around the country who suffered because of
outmoded food safety law that has failed to protect consumers.
We think that a reasonable and appropriate balancing of
interests has been worked out. We urge you to please act on
this legislation quickly and provide additional protection.
Thank you.
[The prepared statement of Ms. Tucker-Foreman follows:]
Prepared Statement of Carol L. Tucker-Foreman, Distinguished Fellow,
The Food Policy Institute, Consumer Federation of America, Washington,
D.C.; on Behalf of Center for Foodborne Illness Research & Prevention;
Center for Science in the Public Interest; Consumers Union; Food &
Water Watch; Government Accountability Project; National Consumers
League; The Pew Charitable Trusts; Safe Tables Our Priority; Trust for
America's Health; and The United Food & Commercial Workers
International Union
Chairman Peterson, Ranking Member Lucas and Members of the
Committee. I am Carol Tucker-Foreman, Distinguished Fellow in the Food
Policy Institute at Consumer Federation of America (CFA). From 1977-
1981, I was Assistant Secretary for Food and Consumer Services at the
United States Department of Agriculture. My responsibilities included
oversight of the nation's meat, poultry and egg inspection and food
assistance programs.
I am testifying on behalf of eleven consumer, public health and
trade union organizations representing millions of Americans who are
concerned about the safety of the food their families eat every day. A
list and description of the organizations supporting this testimony is
attached. We commend the Committee for holding this hearing to explore
current congressional efforts to address the serious food safety
problems that confront the country.
Mr. Chairman, foodborne disease kills one American every 2 hours,
every day of the year.\1\ The vast majority of these deaths are
preventable. There has been limited progress in reducing the toll
because the Food Drug and Cosmetic Act (FDCA), which governs the safety
of over 80 percent of the food we consume, was designed to address
problems prevalent at the beginning and middle of the last century and
hasn't been amended to keep up with changes that have altered the way
we live and eat today. In 1906 the primary food safety danger arose
from companies adding dangerous chemicals to meat to mask decay and
substituting cheap ingredients to defraud consumers. The FDCA
provisions don't adequately address the most pressing current food
safety problem, protecting consumers from illness caused by food
contaminated with disease-causing bacteria.
---------------------------------------------------------------------------
\1\ Based on Centers for Disease Control and Prevention estimates
that foodborne disease kills 5,000 people each year.
---------------------------------------------------------------------------
Current law does not give the Food and Drug Administration (FDA)
specific authority to establish requirements to prevent foodborne
illness. As a result, the Agency's program is almost entirely reactive.
FDA often doesn't act until after there are confirmed reports of
illness and death. That system doesn't work in a global marketplace
where food is mass produced and travels around the world in a matter of
hours. By the time we know a contaminated product is on the market, it
is too late to keep people from getting sick.
Our country has experienced an almost constant stream of foodborne
illness outbreaks traced to FDA regulated foods over the past few
years, including:
June 2009--E. coli O157:H7 contaminated Nestle chocolate
chip cookie dough has made 72 people in 30 states sick.
September 2008-March 2009--Salmonella contaminated peanut
products from Peanut Corporation of America sickened 691 people
and caused nine deaths in 46 states and Canada.
April to August 2008--Imported Jalapeno and Serrano peppers,
contaminated with Salmonella saintpaul sickened 1,442 people in
43 states, the District of Columbia and Canada. Originally
thought to be caused by contaminated tomatoes, the outbreak
virtually destroyed the market for summer tomatoes in several
states.
June 2007--Veggie Booty snacks contaminated with Salmonella
caused 65 illnesses in 20 states.
February 2007--Peter Pan Peanut Butter contaminated with
Salmonella sickened 425 people in 44 states.
Dec. 2006--Salmonella found in tomatoes sickened 183 people
in 21 states.
August-September 2006--E. coli O157:H7 in bagged spinach
sickened 204 people in 26 states and killed three.
(Source--CSPI Building a Better Food Safety System)
All of these outbreaks were the result of poor sanitation or
mishandling at some point in the food chain. None resulted from
consumer mishandling.
In addition, we have been threatened by high levels of drug
residues and toxic chemicals in fish and dairy products imported from
South East Asia.
Some food industry representatives insist we are on the way to
solving the problem of foodborne illness. In support of this claim,
they cite reductions in illnesses caused by some pathogens since the
Centers for Disease Control first began tracking illnesses through the
FoodNet system and comparing the base years 1996-1998 to the most
recent year. However, the CDC acknowledges that, after initial
reductions, progress has stalled and there has been virtually no
further decline in the last 5 years.\2\
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\2\ CDC, ``Preliminary FoodNet Data on the Incidence of Infection
with Pathogens Transmitted Commonly Through Food--10 States, 2008''
MMWR, 58(13), 333-337, April 10, 2009.
---------------------------------------------------------------------------
The CDC is reviewing the data but has not reduced the annual total
of 76 million cases of foodborne illness each year, 350,000
hospitalizations and 5,000 deaths. That means someone dies every 2
hours. The best estimate for the human illness costs of foodborne
pathogens for all CDC estimated cases is $357 billion each year in
medical costs, lost productivity, and pain and suffering.\3\
---------------------------------------------------------------------------
\3\ Roberts, Tanya (2007) ``The Economic Costs of Long-term
Sequellae of Selected Foodborne Pathogens,'' Invited Speech,
International Association of Food Protection, Orlando, Florida.
---------------------------------------------------------------------------
It is hard to comprehend numbers this large. Millions of illnesses
and billions of dollars seem unconnected to what goes on in our daily
lives. It is important to remember that these enormous numbers
represent individual Americans whose lives have been altered forever by
the simple act of having consumed common, everyday foods that appear
regularly on family dinner tables--beef, chicken, spinach, lettuce,
tomatoes, peppers and peanut products--that were contaminated with
deadly pathogens.
The victims of foodborne illness live in your states and
congressional districts. They are your friends and possibly members of
your family. The known victims of the Peanut Corporation of America
outbreak included 100 Ohioans; 76 Californians; 43 Minnesotans. The
2008 Salmonella saintpaul pepper outbreak hit 559 Texans, 120 people in
Illinois, 42 in Georgia, 59 in Arizona. Last April, 84 Nebraskans, 27
Iowans, and five Kansans and South Dakotans were among the victims of a
Salmonella saintpaul outbreak traced to eating contaminated fresh
sprouts. And these cases are just the tip of the iceberg--for every
reported illness, there are far more that the CDC never knows about.
In the hearing room today are representatives of three families for
whom the foodborne illness numbers are crushingly real. Jeff Almer has
come here from Perham, Minnesota. Jeff's mother Shirley Almer had run
the family business for years after the death of her husband in 1990.
When she retired, she remained active in her bowling league, continued
to garden and bird watch, and spent time with her five children and
four grandchildren. In October last year Shirley was declared cancer
free after fighting off both brain and lung cancer. Two months later,
on December 21, 2008, she was dead at age 72. Cancer did not kill
Shirley Almer. According to the Minnesota Department of Public Health,
the woman who fought off cancer died as a result of eating Salmonella
contaminated peanut butter.
Robyn and Jeff Allgood have come here from Chubbuck, Idaho. Their
son, Kyle, was a mischievous and energetic 2 year old whose favorite T-
shirt read, ``I do all my own stunts.'' Eager to meet her children's
nutritional needs, Robyn often mixed fresh spinach and other vegetables
into fruit smoothies. In September 2006, she unknowingly used spinach
contaminated with E. coli O157:H7. Kyle became sick the next day. A
week later he was dead from a heart attack after the E. coli poisoning
developed into Hemolytic Uremic Syndrome (HUS).
Nancy Donley's only child, 6 year old Alex, also died of E. coli
O157:H7 poisoning he contracted after eating contaminated ground beef.
After Alex's death, Nancy decided to invest the time she would have
spent raising Alex in comforting other victims, informing the public
about HUS and educating public officials about the need to make basic
changes in the nation's food safety system to prevent others from
suffering the same loss.
These are four courageous Americans. None is a public person. None
has great resources. They decided not to take the easy way out and
nurse their grief in private. You hear every day from representatives
of the food industry and farm organizations. Today, the Almers,
Allgoods and Donleys are here to ask you to consider the millions of
foodborne illness victims whose concerns they represent. All bring you
the same message. Congress must act now to prevent more and more
illnesses and deaths.
They would welcome the opportunity to meet with Members of the
Committee after the hearing to respond to your questions and will take
questions from the media and interested people, as well.
The problems that robbed the Allgoods and Nancy of their children
and the Almers of their mother and grandmother have caused Americans to
become increasingly aware of and anxious about the weaknesses of our
current food safety system.
Two weeks ago the technology giant IBM published the results of a
new survey they sponsored, showing:
60 percent of consumers are concerned about the safety of
the food they purchase.
Less than 20 percent of consumers trust food companies to
develop and sell food products that are safe and healthy for
themselves and their families.
83 percent of consumers were able to name a food that had
been recalled in the last 2 years. 63 percent confirmed they
would not purchase a food until the source of the contamination
was found, and 57 percent said they had stopped purchasing
foods, even for a short time, within the past 2 years because
of safety considerations.\4\
---------------------------------------------------------------------------
\4\ IBM, Food Safety Awareness Survey, June 2009.
The failure of our food safety system and the increasing loss of
public trust and confidence is bad for the food business and for
farmers. The CEO of Kellogg's told the House Energy & Commerce
Committee that the Peanut Corporation of America recall cost the
company $65-$70 million.\5\ Although no major brands of jarred peanut
butter sold at retail were involved in the PCA outbreak, sales of those
products also plunged after the outbreak became known.
---------------------------------------------------------------------------
\5\ Statement of David Mackay, President & CEO, Kellogg Company,
before the House Committee on Oversight and Investigations, ``The
Salmonella Outbreak: The Role of Industry in Protecting the Nation's
Food Supply.'' U.S. House of Representatives, March 19, 2009.
---------------------------------------------------------------------------
Foodborne illness outbreaks can be disastrous for farmers who grow
the crops implicated. Florida tomato farmers were devastated by the
connection of their product to the Salmonella saintpaul outbreak that
came at the height of their growing season. Spinach and lettuce farmers
experienced a drop in demand after their products were implicated in
2006 outbreaks and, 3 years later, sales of these products have yet to
recover.
Perhaps the greatest tragedy here is that foodborne illnesses are
almost completely preventable if farmers, food companies and government
exercise some care. Congress can reduce the toll--both physical and
economic--by substantially modernizing outmoded laws that are part of
the problem, starting with passing H.R. 2749.
Congress Must Begin Now to Create a 21st Century Food Safety System
The need to revise the Food Drug and Cosmetic Act has been
documented in reports to Congress by the GAO, in studies by the
National Academy of Sciences, and in a dozen hearings before the Energy
and Commerce Committee.
Nearly a dozen bills to improve food safety have been introduced
this year, some by Members of this Committee. All the bills embrace at
least some of the common elements identified by the NAS and GAO as
necessary for securing the safety of both domestic and imported foods.
H.R. 2749, reported unanimously by the House Energy and Commerce
Committee, includes the key elements most frequently noted by experts
as essential to an effective food safety system. The bill:
Focuses on preventing FDA regulated foods from causing
foodborne illness.
Requires food companies to develop and implement process
controls to assure that the food they sell is safe.
Requires the FDA to establish and enforce microbial
performance standards that will reduce pathogens to a minimum
and assure an acceptable level of public health protection.
Assures the integrity of the food system and the food supply
through comprehensive enforcement, including regular oversight
(inspection) conducted by public officials and based on the
risk presented by the product; sampling and testing for
pathogens and reporting; access to company food safety records;
and mandatory recalls of contaminated food.
Ensures the food we import is as safe as that produced and
processed here.
Provides a research capacity to develop the best means to
address current and emerging pathogens.
Assures continuing revenue to support part of the program
costs by instituting a $500 annual registration fee for all
food processing companies, with no company required to pay more
than $175,000 annually. While some of us have long harbored
reservations about any kind of fee to support food safety
activities, we are convinced that, given large budget deficits
for the foreseeable future, this fee is a modest request and
justified by the pressing need for stronger Federal oversight
and the benefits of reduced illness and death.
We think the legislation would be more effective if it included
detailed language and resources to ensure data collection, sharing and
analysis necessary for developing robust food attribution models.
In recent weeks some concerns have been raised about H.R. 2749,
many on the Internet, suggesting almost apocalyptic outcomes for
farmers if the bill becomes law. While our groups originally had some
disagreement about the impact that the discussion draft might have had
on small farmers, the Energy and Commerce Committee amendments went a
long way to addressing concerns that provisions would disadvantage
small farmers, especially organic farmers. We also have chosen not to
oppose some provisions, made to address farmer concerns, that we think
compromise the bill's ability to fully protect consumers.
Further, before reporting the bill, your colleagues on the Energy
and Commerce Committee met with Members of this Committee and with farm
and industry groups and made numerous changes to address the concerns
raised by farmers and food processors. These changes:
Exempt from provisions of H.R. 2749 the parts of food
facilities and farms regulated by USDA.
Provide that nothing in this bill changes existing
jurisdictional lines between FDA and USDA.
Require the Secretary of HHS to coordinate with USDA and the
states in setting commodity-specific standards for the safe
growing, harvesting and packaging of fruits and vegetables.
Require the Secretary of HHS, before issuing any proposed
regulations establishing new traceability requirements, to
conduct information gathering to determine the feasibility and
cost/benefit of the system. Previous prescriptive requirements
have been moved to the information gathering process.
Exempt farmers who sell direct to consumers, such as at
roadside stands, from the traceability requirements of the
legislation.
Limit the FDA's authority to restrict the movement of food
in interstate commerce only if the food presents an imminent
threat of serious adverse health consequences or death. The
language was changed to address farmer and processor concerns
by limiting the FDA's actions to situations where there is an
imminent threat and providing that the authority can only be
exercised by the Commissioner. It cannot be delegated to lower
officials.
Require the FDA to consider the impact of regulations on
small businesses and organic farmers.
Require the FDA to take into account the impact of produce
regulations on small-scale and diversified farms, wildlife
habitat, conservation practices, watershed protection efforts,
and organic production methods.
Mr. Chairman, your Committee has oversight over the USDA's meat and
poultry inspection program, which emphasizes inspection, requiring the
USDA to be in every meat and poultry processing plant at least once a
day and to examine all slaughtered carcasses to assure they do not have
animal disease or visible problems that would make them dangerous to
serve the family for dinner. Our groups tend to support the far more
intensive inspection regime that USDA applies to both domestic and
imported meat and poultry products. The FDA, notably, does not conduct
regular, onsite inspection of the companies it regulates. We believe
intensive inspection by Federal officials, coupled with appropriate
corporate process controls and Federal standards, offers the best
protection for the future.
Despite the fact that the Energy and Commerce Committee has made
changes to address legitimate concerns, the Internet and some print
media are full of specious charges against the bill. It is clear the
legislation has become a target for people who are angry and frustrated
about a multitude of other problems that would not be affected by the
law.
For example, on Monday, July 13, the San Francisco Chronicle ran a
long article charging that farmers are being forced to dismantle
important conservation practices and destroy wildlife habitat. The
article was passionate, but not accurate, in suggesting that H.R. 2749
is responsible for these changes. H.R. 2749, of course, has not passed
Congress and is not in effect. Moreover, provisions of H.R. 2749
protect against the gross actions described in the article. The bill
requires the FDA, if it promulgates produce safety regulations, to use
science based standards that take into account the impact the
regulations would have on small-scale and diversified farms, wildlife
habitat, conservation practices, watershed protection efforts, and
organic production methods.
The problems cited by the Chronicle reporter and the people she
interviewed arise from private, not government, actions. Private
customers--food processors and supermarkets--have imposed contractual
requirements on their suppliers to create sterile borders. If the
farmer wants to sell to the companies, he has to meet his customer's
requirements. Private contractual requirements do not have to be
science-based or consider environmental impact.
Some who oppose efforts to improve food safety law have larger
concerns about the global and industrial nature of our current food
system. The IBM survey shows that people increasingly want to know
where their food comes from. Other polls indicate people would like to
buy locally produced food. That yearning is reaching levels that may
require Congress to address these more basic issues.
However, it has taken many years for the current system to build to
this point. The changes that many seek would alter farming and food
processing completely. That kind of change is not likely to come
quickly or easily. Today we have a global food system and most of us,
now and for the foreseeable future, will continue to purchase at least
some mass produced food from enormous corporations at major
supermarkets, many of them owned by foreign corporations. The immediate
need, therefore, is for Congress to take steps to make our existing
food supply safe. This requires giving the FDA the authority and the
resources to address the problems created by a modern, mass production,
international food system.
The need is now and the need is urgent. While we are sympathetic to
the concerns of those in the food industry who may indeed have to make
some changes in the way they do business, it is clear that H.R. 2749
has been structured to assure it does not place an undue burden on
small farms or businesses. On behalf of the families here today and all
the others who have suffered because of an outmoded food safety law
that has failed to protect American consumers, we suggest that a
reasonable and appropriate balancing of interests has been worked out
in H.R. 2749.
The time has come for Congress to act responsibly, consider the
interests of those who consume food as well as those who produce and
process it, and pass the Food Safety Enhancement Act promptly.
Attachment
Supporting Organizations
Center for Foodborne Illness Research & Prevention was founded in
2006 to promote science-based solutions for the food safety challenges
of the 21st Century. CFI is a national, nonprofit health organization
dedicated to preventing foodborne illness through research, education,
advocacy and service. CFI's co-founders, who have advanced degrees in
biostatistics and education, were personally impacted by foodborne
illness and have dedicated themselves to improving food safety for the
past 7 years.
Center for Science in the Public Interest, founded in 1971, has
been a strong advocate for nutrition and health, food safety, alcohol
policy, and sound science. Its award-winning newsletter, Nutrition
Action Healthletter, is the largest-circulation health newsletter in
North America, providing reliable information on nutrition and health.
CSPI manages Outbreak Alert, the most comprehensive foodborne illness
attribution database, listing over 5,000 outbreaks.
Consumer Federation of America is a nonprofit association of 300
local, state and national consumer groups, consumer cooperatives,
public health organizations, farm groups and trade unions, representing
more than 50 million Americans. CFA was established in 1968 to advance
the consumer interest through research, education and advocacy. The
organization's policy positions are established by vote of member
representatives attending the annual meeting or by the board of
directors elected at the meeting.
Consumers Union, publisher of Consumer Reports, is an independent,
nonprofit testing and information organization serving only consumers.
Consumers Union is a comprehensive source for unbiased advice about
products and services, personal finance, health and nutrition, and
other consumer concerns. Since 1936, CU's mission has been to test
products, inform the public, and protect consumers.
Food & Water Watch is a nonprofit consumer organization that works
to ensure clean water and safe food. Food & Water Watch works with
grassroots organizations around the world to create an economically and
environmentally viable future. Through research, public and policymaker
education, media, and lobbying, FWW advocates policies that guarantee
safe, wholesome food produced in a humane and sustainable manner and
public, rather than private, control of water resources including
oceans, rivers, and groundwater.
Government Accountability Project was founded in 1977 in response
to White House scandals in the United States. From the beginning GAP
has focused upon the unique contributions of employees of conscience
within governments, large corporations, and international institutions.
GAP's mission is to protect the public interest by promoting public
accountability at workplaces and advancing the rights of employees to
speak out about serious problems. These employees are often the most
credible witnesses to corruption, public health dangers, and
environmental threats.
National Consumers League seeks to protect and promote social and
economic justice for consumers and workers in the United States and
abroad. NCL is a private, nonprofit advocacy group representing
consumers on marketplace and workplace issues. It is the nation's
oldest consumer organization.
The Pew Charitable Trusts, an independent nonprofit, is the sole
beneficiary of seven individual charitable funds established between
1948 and 1979 by two sons and two daughters of Sun Oil Company founder
Joseph N. Pew and his wife, Mary Anderson Pew. Pew applies a rigorous,
analytical approach to improve public policy, inform the public and
stimulate civic life. Pew's Health and Human Services Policy program
seeks to improve the health and well-being of all Americans. Based on
research and critical analysis, the program advocates policies that
reduce unacceptable health risk, focusing on areas that include
consumer, medical and food safety.
Safe Tables Our Priority (S.T.O.P.) is a national nonprofit public
health organization dedicated to preventing illness and death from
foodborne pathogens. S.T.O.P. supports its mission by advocating public
health-based changes in public policy, educating and conducting
outreach and providing victim assistance. S.T.O.P. was founded in 1993
in the aftermath of the Jack in the Box E. coli O157:H7 epidemic.
Trust for America's Health is a nonprofit, non-partisan
organization dedicated to saving lives by protecting the health of
every community and working to make disease prevention a national
priority.
United Food and Commercial Workers International Union is the
largest private sector union in North America. With over 1.3 million
members, UFCW represents workers in every state and community in the
United States. The majority of UFCW members work in the retail food
stores and meatpacking and food processing sectors. The UFCW is
committed to continuing and building upon its long history of
involvement in food safety and regulatory issues.
The Chairman. Thank you very much for your statement,
Carol.
Dr. Ives, welcome to the Committee.
STATEMENT OF SAMUEL E. IVES, D.V.M., Ph.D., DIRECTOR OF
VETERINARY SERVICES AND ASSOCIATE DIRECTOR OF
RESEARCH, CACTUS FEEDERS, LTD., AMARILLO, TX; ON
BEHALF OF NATIONAL CATTLEMEN'S BEEF ASSOCIATION
Dr. Ives. Good morning, Chairman Peterson, Mr. Goodlatte,
and Members of the Agriculture Committee. I am Sam Ives and I
am the Director of Veterinary Services and Associate Director
of Research for Cactus Feeders. Cactus Feeders is headquartered
in Amarillo, Texas, and we have nine large-scale cattle
feedyards across the Texas High Plains and southwest Kansas
where we produce one million head of cattle annually for
slaughter. A subsidiary to our feeding operations includes
three ranches in Texas and New Mexico. The ranches produce
30,000 stocker calves annually and maintain 2,000 mama cows. I
appreciate the opportunity to represent the National
Cattlemen's Beef Association at today's hearing to discuss the
beef industry's commitment to beef safety. I would like to
start out by emphasizing that everyone plays an important role
in the safety of food. And it starts with producers raising
healthy cattle. Cattlemen are committed to producing the
safest, most wholesome nutritious and affordable beef products
in the world.
There is no question that the United States has the safest
food supply in the world and other countries consider the U.S.
the gold standard. Cattle producers support the establishment
of realistic food safety objectives designed to protect public
health to the maximum extent possible. Several food safety
bills that have been introduced in the Congress, and one in
particular, H.R. 2749 is of interest to beef producers. We
appreciate the willingness of the Energy and Commerce Committee
to discuss and learn more about how meat and poultry products
are regulated by USDA, and we understand the intent of the bill
is to exempt livestock and poultry from this FDA-focused bill.
However, we are concerned the current bill language does
not go far enough to ensure Congressional intent is not
misinterpreted. The bill must contain clear legislative
language to ensure that FDA is not granted the authority to
regulate livestock on-farm by mandating production standards
for cattlemen across the country. Live animals are not food
until the point of processing, and we would like to see
language that explicitly excludes livestock and poultry from
the definition of food under this bill and the Federal Food
Drug and Cosmetic Act. Additionally, exempting livestock and
poultry from food would also clarify the record-keeping
requirements of this bill and their application to food. Under
the Federal Food Drug and Cosmetic Act, farms are exempt, but
this legislation eliminates that exemption. H.R. 2749 raises
concerns about the treatment of state-inspected facilities as
the bill only exempts official establishments as defined by
this legislation. Many beef producers, especially in rural
areas, rely on state-inspected facilities to process their
cattle. The definition needs to be expanded to ensure state-
inspected facilities are included in the exemption of this
bill. Section 133 of the bill grants FDA with a redundant
authority regarding quarantine of a geographical area where
food presents serious adverse health consequences to humans and
animals. This new responsibility of FDA is concerning, as under
the Animal Health Protection Act, USDA can impose a Federal
quarantine for animal health reasons when they deem necessary
and work closely with state authorities. Under the Animal
Health Protection Act the government is mandated to pay
indemnity to producers when the government takes the animal.
This provision does not require the FDA to pay indemnity.
Again, we appreciate the willingness of the Energy and
Commerce Committee to work with the livestock groups to address
some of the duplicative and unnecessary regulatory authority
this bill's grants the FDA. We urge both the Agriculture and
Energy and Commerce Committees to ensure the true intent of the
bill is made very clear before any further action is taken on
the legislation. My written testimony provides more information
about the concerns that I, and my fellow cattle producers, have
with this bill.
In closing, the U.S. has the safest food supply in the
world which is an achievement worth noting. Science is a
critical component of the beef industry, and through science-
based improvements and animal genetics, management practices,
nutrition and health, beef production per cow has increased
from 400 pounds of beef in the mid 1960s to 585 pounds of beef
in 2005. As beef producers, we have our work cut out for us in
order to feed our ever-growing population. Cattlemen will
continue to increase efficiencies based on science in order to
produce high-quality beef with fewer resources being consumed.
The beef industry will continue to dedicate time and resources
to ensure the safety of beef. We look forward to working with
the Committee to ensure Congressional intent of this bill is
not misunderstood.
Many thanks for the opportunity to testify here today, and
I look forward to answering any questions that you may have.
[The prepared statement of Dr. Ives follows:]
Prepared Statement of Samuel E. Ives, D.V.M., Ph.D., Director of
Veterinary Services and Associate Director of Research, Cactus Feeders,
Ltd.,
Amarillo, TX; on Behalf of National Cattlemen's Beef Association
Chairman Peterson, Ranking Member Lucas and Members of the
Committee, I'm Sam Ives and I am the Director of Veterinary Services
and Associate Director of Research for Cactus Feeders. Cactus Feeders
is headquartered in Amarillo, Texas and we have nine large-scale cattle
feedyards across the Texas High Plains and Southwest Kansas where we
produce 1,000,000 head of cattle for slaughter annually. A subsidiary
to our feeding operations includes three ranches in Texas and New
Mexico. The ranches produce 30,000 stocker calves annually and maintain
2,000 mother cows. My responsibilities are focused on animal health and
well-being of the cattle in our operations. These responsibilities
include advising the feeding and ranching operations on best practices
for preventing, controlling, and treating diseases that occur in the
cattle during the feeding period. Much time is spent training employees
and evaluating our health programs to assure that we are providing
cattle that will become a safe and wholesome meat product for our
consuming public. Many of the recommendations used in our operations
are supported by studies conducted at Cactus Research which I manage
along with Dr. Spencer Swingle. Cactus Research is managed as a 12,000
head research feedlot in the Texas panhandle. Together Dr. Swingle and
I are responsible for investigating and coordinating sponsored and
internal research studies including diet formulation, growth promoting
technologies, direct-fed microbials, feed additives, the incidence and
control of important food safety pathogens, and medications for control
and treatment of cattle diseases.
I appreciate the opportunity to represent the National Cattlemen's
Beef Association (NCBA) at today's hearing to discuss the beef
industry's commitment to beef safety. NCBA is the oldest and largest
national trade association for cattle producers and represents over
230,000 cattle producers through direct membership and state and breed
affiliates. Cattlemen are committed to producing the safest, most
wholesome, nutritious and affordable beef products in the world. There
is no question that the United States has the safest food supply in the
world and other countries consider the U.S. the ``gold standard.''
Science is a critical component of the beef industry and through
science-based improvements in animal genetics, management practices,
nutrition and health, beef production per cow has increased from 400
pounds of beef in the mid-1960s to 585 pounds of beef in 2005.\1\ As
beef producers we have our work cut out for us in order to feed our
ever growing population. In 1960 there were 3.9 million farms feeding a
U.S. population of 183 million and in 2005 there were 2.1 million farms
feeding an estimated population of 296 million--a population increase
of 61 percent.\2\ In 1960 the average farmer fed 25.8 people. Today's
American farmer feeds about 144 people worldwide.\3\ Cattlemen will
continue to increase efficiencies based on science in order to produce
high-quality beef with fewer resources being consumed. In addition, our
industry continues to focus on our long-term efforts to improve our
knowledge and ability to produce healthy cattle, which are the
foundation of a safe food supply.
---------------------------------------------------------------------------
\1\ Cattle-Fax: http://www.beefusa.org/uDocs/
cattlenumbersandbeefproduction347.pdf.
\2\ NASS: http://www.nass.usda.gov:8080/QuickStats/PullData_US.jsp.
\3\ ACA: http://www.agday.org/media/agfactsheet.htm.
---------------------------------------------------------------------------
Since 1993, cattle producers have invested more than $27 million in
beef safety research and the beef industry as a whole spends
approximately $350 million every year on beef safety. It is important
to note that everyone plays an important role in the safety of beef. It
starts with producers raising healthy cattle, and everyone who plays a
role in the production chain is committed to producing safe beef
products. Consumers also play a critical role to ensure the safety of
their meat products by using safe storage, handling and preparation
techniques.
All beef is subject to strict government oversight by the U.S.
Department of Agriculture (USDA) and every meat processing facility
undergoes on-going USDA inspection. The inspection process includes
review of their Hazard Analysis Critical Control Point plans also known
as HACCP plans. HACCP plans were pro-actively developed by the food
industry as a method to identify potential hazards and prevent them. In
1996, USDA's Food Safety and Inspection Service (FSIS) enacted a rule
requiring HACCP plans for all beef processing plants.
In 1997, the Beef Industry Food Safety Council (BIFSCo) was formed
to coordinate a broad effort to solve pathogen issues, and to focus on
research and consumer education. Representatives from all segments of
the beef industry belong to BIFSCo and work together under the founding
principles that safety is a non-competitive issue to develop industry-
wide, science-based strategies to address safety challenges,
particularly E. coli O157:H7. Cattlemen and the entire beef industry
have dedicated significant time and resources to a variety of research
areas including building our knowledge of E. coli O157:H7 by
identifying where, why and how it survives from pre- to post-harvest;
the relationship between the live animal and the pathogen in order to
develop pre-harvest interventions; and the impact that production
practices, processing systems and interventions have on the pathogens.
NCBA continues to evaluate how to optimize food safety systems not
only for the current safety challenges but also for any potential
future ones. Cattle producers and our partners will continue to
dedicate time and resources to reduce the incidence of pathogens and
other food safety issues. The beef industry and our government share
the common goal of producing safe beef products. With the current
budget and economic situation there has never been a more important
time for our government and the industry to work together to achieve
this goal.
NCBA supports the establishment of realistic food safety objectives
designed to protect public health to the maximum extent possible. It is
vital that the objectives be based on sound science with the realistic
understanding that even under the best science-based operating
procedures achieving zero risk is not possible. However, utilizing
science-based principles and validating interventions used throughout
the process will effectively control the associated risks of pathogens
like E. coli O157:H7. In addition, it is more important to focus
resources on the validation of process controls rather than testing as
a means to protect public health. Beef packing plants and processors
vary in size and design, and their safety plans must be tailored to
their set-up. Nearly 100 percent of beef establishments use one or more
of the post-harvest safety interventions the beef industry has helped
research, implement and validate.
NCBA's members remain committed to beef safety, we take a lot of
pride in the amount of time and resources we have dedicated to making
beef an even safer product. As Congress continues to debate food safety
legislation we encourage you to continue working with all relevant
stakeholders to increase efficiencies and the effectiveness of our food
safety system. There are several food safety bills being discussed that
would result in unintended consequences for cattlemen as well as other
livestock and poultry producers.
As legislation is developed, it is important to understand the Food
and Drug Administration's (FDA) role in food safety and how their role
differs from USDA's Food Safety Inspection Service (FSIS). H.R. 2749
passed the House Energy and Commerce Committee on June 17, 2009. There
are several sections of this bill of concern to cattle producers and we
appreciate the Energy and Commerce Committee's willingness to discuss
and learn more about how the meat and poultry industries are regulated.
We understand the intent of the Committee is to exempt livestock and
poultry from this bill as meat and poultry products are already
regulated by USDA with the authority granted to them by Congress in the
Federal Meat Inspection Act, the Poultry Inspection Act and the Egg
Products Inspection Act.
However, we are concerned the current bill language does not go far
enough to ensure Congressional intent. The bill must contain clear
legislative language ensuring that FDA is not granted the authority to
regulate livestock on-farm by mandating production standards for
cattlemen across the country. Live animals are not ``food'' until the
point of processing, which is why this bill needs to clarify that the
FDA does not have regulatory authority on our farms, ranches or
feedlots. Cattle producers support language that explicitly excludes
livestock and poultry from the definition of ``food'' under this bill
and the Federal Food Drug and Cosmetic Act (FFDCA). This important
change is essential to resolve the ambiguity to keep the more than
century old and successful animal health and meat, poultry, and egg
inspection a functioning partnership between USDA and state
authorities.
The exemption of livestock and poultry from ``food'' would also
clarify the record-keeping requirements and their application to
``food''. Under the FFDCA record-keeping requirements apply to
``food,'' the FFDCA also exempts ``farms'' but this legislation
eliminates that exemption. It is our concern the ``livestock''
exemption from the definition of ``farm'' in this bill is not clear.
The exemption of ``livestock'' should also apply to ``food'' as the
record-keeping requirements of this bill are applicable to ``food''. We
urge the Committee to exclude livestock from the definition of ``food''
under the FFDCA and modify the facility requirements of this bill to
ensure ``preventative controls'' and ``inspections'' requirements of
this bill are not applicable to USDA regulated facilities. In addition,
cattle producers are concerned with the definition of ``facility'' as
the ``preventative controls'' and ``inspections'' requirements of this
bill will apply to USDA facilities with FDA operations. For example, a
beef slaughter facility with a rendering operation would be subject to
FDA preventative controls and inspections for all aspects of their
operations. This is unnecessary and duplicative as USDA has regulatory
authority now. We ask the Committee to modify the definition of
``food'' and to modify the facility requirements of this bill to ensure
``preventative controls'' and ``inspections'' requirements of this bill
are not applicable to USDA regulated facilities. H.R. 2749 raises
concerns about the treatment of state inspected facilities as the bill
only exempts ``official establishments'' as defined by this
legislation. This definition refers to the ``regulations promulgated
under this subchapter'' and does not include state inspected
facilities. Many beef producers, especially in rural areas, rely on
state inspected facilities when processing their cattle. State
inspected facilities are not ``official establishments'' and the
definition needs to be expanded to include these facilities in the
exemption.
Section 133 of the bill grants FDA with another redundant authority
regarding quarantine of a geographical area where food presents serious
adverse health consequences. This new responsibility of FDA is
unnecessary, confusing and will disrupt the decades of cooperative
efforts between USDA and state authorities. Currently, under the
authorities of the Animal Health Protection Act (AHPA), USDA can impose
a Federal quarantine for animal health reasons when they deem necessary
and USDA works very closely with state agencies. Additionally, under
AHPA statute USDA must provide indemnity to affected producers when the
Federal Government ``takes'' an animal. In this bill FDA would not be
required to pay indemnity or even have a qualified reason to extend the
quarantine to the live animal area. USDA has the expertise, resources
and current regulatory authority to impose an animal health quarantine,
and granting this authority to FDA is unnecessary. As pointed out in
the full Committee markup this provision would extend to retailers and
there is no indication in the bill as to how the quarantine would be
removed once put into place. As written this provision creates
confusion between the roles of USDA and FDA and needs to be thought
through carefully so there are not any unintended consequences created
by this bill. Again, specifically exempting livestock and poultry in
these new regulations would eliminate duplication into current USDA
authority.
We appreciate the Energy and Commerce Committee working with the
livestock groups to address some of the duplicative and unnecessary
regulatory authority this bill grants the FDA. We look forward to
working with both the Energy and Commerce and Agriculture Committees to
add clarifying language to ensure there is not any confusion as to
Congress' intent of this bill.
While I have this opportunity to address the Committee on food
safety, I would like to discuss several topics that are being linked to
the food safety debates. First is the misconception that an animal
identification system is a necessary component for food safety. Animal
identification programs are tools to help monitor and trace disease in
the event of an animal health emergency. Animal identification systems
do not enhance food safety, nor were they ever intended to. In
addition, animal identification systems do not prevent animal disease;
they are only a tool to help trace and contain them. Producers
currently utilize animal identification for herd management, genetic
improvement and as a positive tool for their operations' marketing
program.
Another topic that is receiving a lot of interest from the media
and activist groups is the use of antibiotics in the beef industry.
Animal health and well-being are top priorities for cattle producers
across the country. Without healthy animals, we do not have healthy
food for American families, so we judiciously utilize important tools
like vaccines, antimicrobials, and other drugs to control disease,
treat disease, and provide a higher quality of life for our cattle
while keeping the food supply safe. Additionally, all products approved
by FDA for use in food producing animals must first pass significant
human food safety benchmarks. It is also important to recognize that
animal drugs go through a rigorous, science-based testing process
before they are approved for use. FDA, USDA, veterinarians, animal
health companies, producer organizations, and other stakeholders have
implemented several layers of human health protections. The issue of
antimicrobial resistance is very concerning to cattle producers. To
date extensive international research on the topic of antimicrobial
resistance shows no link between antimicrobial use in livestock and
antimicrobial resistance in humans. NCBA producers and The Beef
Checkoff proactively work to increase our knowledge of antimicrobial
resistance in both animals and humans. We encourage and advocate for
judicious use of all medications. In fact, NCBA producer-made policy
supports the Producer Guidelines for Judicious Use of Antimicrobials
which have been in place since 1987. In addition, NCBA participates in
the Codex Alimentarius Task Force on Antimicrobial Resistance.
Antimicrobial resistance is not a black and white issue. It is a
multi-faceted and extremely complex issue that cannot be solely focused
on the use of drugs in animal agriculture. Unfortunately, animal
agriculture has been a primary target in this fight, with little or no
consideration given by the public to the use, misuse, and mishandling
of human drugs by the general population. To ensure that the issue of
antimicrobial resistance is properly addressed, it is imperative that
we gather accurate, appropriate, and complete data to identify any
problems and all contributing factors. To date, only limited data
exists. These data need to be gathered and scientifically evaluated
without bias or a pre-determined agenda before any further action is
taken by Congress.
Cattle producers have a long history of proactively providing
solutions to issues when science-based evidence shows there is an issue
that needs to be addressed. Again, to date there is no scientific
evidence linking the judicious use of antimicrobials in the beef
industry to antimicrobial resistance in humans. The international
scientific community continues to actively research and discuss this
issue. It is important that we have strong conclusive science-based
information before any legislative actions are taken that could impact
the health of our animals and food supply.
In closing, I would like state again, that the U.S. has the safest
food supply in the world, which is an achievement worth noting. The
beef industry will continue to dedicate time and resources to address
food safety issues to ensure the U.S. maintains the safest food supply
in the world. It is imperative for our government to use sound science
when evaluating the effectiveness of our food safety systems, and to
realize the differences between FDA's and USDA's regulatory authority
of food safety. Science-based intervention and management strategies
coupled with safe food handling techniques, will help our industry
maintain its goal of providing a safe, high-quality product for the
consumer. Everyone plays an important role in food safety and our
industry will continue our research and educational outreach efforts to
consumers.
I appreciate the opportunity to testify today about the beef
industry's role in food safety and some of our areas of concern with
H.R. 2749. Cattle producers are concerned that unnecessary duplication
of USDA's regulatory authorities will undermine our common goal of
creating a more effective and efficient food safety system. We are
happy to provide additional information and look forward to working
with both the Energy and Commerce and Agriculture Committees to clarify
some of the provisions so there is not any misunderstanding of
Congressional intent.
The Chairman. Thank you, Dr. Ives, for your statement.
Mr. Peppler, welcome to the Committee.
STATEMENT OF KENT PEPPLER, PRESIDENT, ROCKY
MOUNTAIN FARMERS UNION, MEAD, CO; ON BEHALF OF
NATIONAL FARMERS UNION
Mr. Peppler. Good morning, Mr. Chairman, and Members of the
Committee. My name is Kent Peppler. I am President of Rocky
Mountain Farmers Union, which represents family farmers and
ranchers in Colorado, Wyoming, and New Mexico. I am here today
on behalf of Rocky Mountain Farmers Union and National Farmers
Union, and I am also a fourth generation farmer in northern
Colorado and we have also fed cattle and sheep and hogs in the
past.
As a farmer, it is my best interest to maintain the
confidence of American consumers that the food on our supper
table is safe. About 3 weeks ago, USDA announced that JBS Swift
Beef Company, based in my neighborhood in Greeley, Colorado,
was voluntarily recalling approximately 380,000 pounds of
assorted beef products that may have been contaminated with E.
coli. Unfortunately, USDA has wasted time, attention, and
efforts on this recall by focusing on the origin of the cattle.
This reminds me of the story of the guy who loses his wallet on
the east side of the street and decides to look for it on the
west side of the street because the light is better.
I urge you not to get distracted in this debate by those
who argue that it is the farmers who are the problem. Farmers
are the first line of defense in addressing food safety issues,
and I would argue that we have done a heck of a job. You don't
see headlines of food contaminated when it's going straight
from the farm to the consumer. The headlines we have been
seeing too often lately typically appear with the logos of big
corporate vertically integrated ag processors. Placing
unnecessary, onerous, costly and burdensome regulations on
farmers will not yield the results we all need and want in this
issue. The lack of outreach to the independent farm production
sector by those in Congress, who are intent on moving food
safety legislation forward, is problematic.
Provisions that adversely impact independent family farmers
and ranchers will be counterproductive in improving the safety
of our food. A punitive or one-size-fits-all approach for
traceability, penalties or other efforts seeking to improve
food safety will not yield successful results. Specifically,
small and mid-size operations that focus on sustainable and
organic production methods are concerned with potentially
excessive burden and expense associated with legislative
efforts on food safety. Congressional leaders must do a better
job in reaching out to our producer community. You might be
surprised with what you find, common sense solutions and ideas
for achieving better food safety that those inside the beltway
hadn't considered. NFU's policy supports two key components for
improving food safety: One, creating a new regulatory body,
single food agency to oversee the entire U.S. food system
including imports, and two, providing the regulator with
mandatory recall authority.
My written testimony details additional policy suggestions.
Concerns we have with the Food Safety Modernization Act of
2009, include the following: Traceability requirements have
been improved by allowing producers to maintain records either
electronically or on hard copies for 6 months; however, the
focus of improving food safety should not be misdirected on
independent farmers and ranchers. Registration fees are
woefully deficient in recognizing the difference between small
processors and large corporate multi-national processors. The
legislation needs to recognize the uniqueness of small
processing facilities and exempt those from any fees, so as not
to discourage those facilities from participating in an already
consolidated and concentrated food processing system.
Unintentional barriers to producers interested in
transitioning into organic production methods: Requirements or
encouragement of producers to eliminate certain environmental
practices under the guise of safer food production. The FDA has
no background, knowledge, or expertise of real world
environmental practices by farmers, and I strongly urge this
Subcommittee, and others who understand the benefits of
environmental practices like buffer strips, to engage your
colleagues to articulate the consequences of pursuing this
misdirected path.
Farmers are the first link of the food safety chain and can
be a valuable resource as Congress determines what policies
will yield the greatest results. As an organization that
represents independent family farmers and ranchers, RMU and NFU
are eager to provide an on-farm real-world perspective to the
food safety debate.
[The prepared statement of Mr. Peppler follows:]
Prepared Statement of Kent Peppler, President, Rocky Mountain Farmers
Union, Mead, CO; on Behalf of National Farmers Union
Good morning, Mr. Chairman and Members of the Committee. My name is
Kent Peppler, I serve as the President of Rocky Mountain Farmers Union,
which represents family farmers and ranchers in Colorado, Wyoming and
New Mexico. I am a fourth generation farmer from Mead, Colo., my
operation consists of 500 acres of corn, wheat, alfalfa hay and barley.
In the past my family raised sugar beets and sunflowers; we also fed
cattle, sheep and hogs. I am here today on behalf of Rocky Mountain
Farmers Union and National Farmers Union (NFU)--a nationwide
organization representing more than 250,000 farm, ranch and rural
residents.
There is no question that doing more to protect our food supply is
necessary. The solutions to achieving this goal are as diverse as the
perspectives of impacted communities. America's farmers and ranchers
are the best in the world at what they do; it is in our best interests
to maintain the confidence of American consumers that the food on their
supper table is safe.
Many in agriculture would agree that food safety concerns could be
addressed at minimum by adequate and appropriate enforcement of
existing regulations. A vast array of regulations and laws exist today,
yet the Federal agencies tasked with enforcing those laws are not given
adequate resources to accomplish the job. I must also note that
existing regulations, even when enforced, have not yielded appropriate
protections for consumers--as demonstrated by the recent cookie dough
and peanut butter outbreaks. The failure to inspect and regulate food
processing facilities is a concern held by producers across the
country. However, adding additional mandates from Congress, without
equipping the agencies to do the job, will yield the same failed
results we are experiencing today.
The complexities of our modern food supply system have outpaced the
ability of regulators to sufficiently address supply safety controls.
Last summer, during the Salmonella saintpaul outbreak, Rocky Mountain
Farmers Union called on consumers to demand more local and seasonal
food production rather than rely upon the status quo of food
distribution. In response to other recent food safety outbreaks, some
have suggested the solution is nationwide marketing orders. Our members
have worked to prevent such regulations being imposed on family farmers
because of evidence from the Food and Drug Administration (FDA) that
demonstrates E. coli O157:H7 outbreaks have been associated with
products coming from processing facilities, not the farm. Efforts to
establish a nationwide set of mandatory food safety marketing orders
for all produce farms is the wrong approach to addressing food safety
concerns.
A growing concern with the direction of legislative food safety
action is the impact on farmers' environmental practices. Attached to
my testimony is a July 13, 2009 article published in the San Francisco
Chronicle titled, ``Crops, Ponds Destroyed in Quest for Food Safety.''
If producers are required to eliminate environmentally beneficial
practices based upon no evidence the revised production practices will
yield safer food, the consequences will be severe. The FDA has no
background, knowledge or expertise of real-world environmental
practices by farmers and I strongly urge this Subcommittee and others
who understand the benefits of environmentally beneficial practices
like buffer strips, wildlife habitat and water quality protection to
engage your colleagues to articulate the consequences of pursuing this
misdirected path.
Three weeks ago yesterday, the U.S. Department of Agriculture's
(USDA) Food Safety and Inspection Service (FSIS) announced that JBS
Swift Beef Company, based in my neighborhood of Greeley, Colo., was
voluntarily recalling approximately 380,000 pounds of assorted beef
products that may have been contaminated with E. coli 0157:H7. While
not the largest beef recall our nation has faced, it serves as an
unwelcome reminder that the time to act on food safety is now.
Unfortunately, time, attention and focus have been wasted by USDA on
this recall by focusing on the origin of the cattle. It reminds me of
the story of the guy who loses his wallet on the east side of the
street, and decides to look for it on the west side because the light
is better. Consumers and producers would be better served if
slaughterhouses are no longer allowed to self-regulate and the entire
regulatory system is updated to reflect the complexities of today's
modern food supply.
NFU's policy has called on Congress to create a new regulatory body
to oversee the U.S. food system. In order to be successful, such a
system must be adequately funded to carry out its mission. This will
require the Federal Government to make food safety a fiscal priority
and not demand user fees or registration fees to cover the entire cost
of providing safe food to American consumers.
Our members also support the creation of a single food agency to
regulate the food supply as a whole, including increasing amounts of
imported foods. The agency should be granted authority for issuing a
mandatory recall in the event of a food safety outbreak. With the
recent voluntary beef recall in my state, we know the meat was
processed approximately 65 days prior to the voluntary recall and
distributed to at least 13 states and international markets. The
inability to issue a mandatory recall perpetuates both consumer fear
and depressed product sales. Mandatory recall authority should also
include a requirement for timely notification at points of sale to
minimize distribution of product to consumers. Reduced product sales
lead to lower market prices received by producers and can last for
weeks or months, devastating producers' income. Mandatory recall
authority could mitigate the economic impact on producers while at the
same time containing consumer fear.
Any food safety legislation must recognize implications for farmers
and their ability to continue to provide an affordable, safe and
abundant food supply. Farmers are the first link of the food safety
chain and can be a valuable resource as Congress determines what
policies will yield the greatest results. As an organization that
represents independent family farmers and ranchers, RMFU and NFU are
eager to provide an ``on-the-farm,'' real-world perspective as the food
safety debate proceeds. An aggressive outreach and education effort
must be made to producers regarding food safety measures that can be
implemented on the farm. An affiliate of NFU, the Community Alliance
with Family Farmers based in Davis, Calif., has been developing an
educational outreach campaigned, geared toward producers, to mitigate
food safety concerns on the farm. Their efforts should be replicated
across the country and would require no legislative action.
We are concerned with the lack of outreach to the independent farm
production sector by those in Congress who are intent on moving food
safety legislation forward. Provisions that adversely impact
independent family farmers and ranchers will be counterproductive in
improving the safety of our food. A punitive or one-size-fits-all
approach for traceability, penalties or other efforts seeking to
improve food safety will not yield successful results. Specifically,
small and mid-sized operations focused on sustainable and organic
production methods are concerned with potential excessive burden and
expense associated with legislative efforts on food safety. While the
language in the Food Safety Enhancement Act of 2009 (H.R. 2749) to
account for organic production methods and size are needed, more must
to be done to address these concerns. Congress must ensure new food
safety legislation does not prescribe a separate set of standards that
would unintentionally discourage producers from transitioning to
organic production methods. I encourage this Subcommittee to reach out
to all food producers, including small scale and organic producers, to
ensure legislative efforts do not disproportionately burden these good
actors.
Traceability
H.R. 2749 includes language to establish a higher standard of
traceability of food in order to quickly identify and contain the
source of an outbreak. While working through the Energy and Commerce
Committee process, the bill was improved to provide an accommodation
for producers that sell directly to grocery stores, restaurants or
consumers. The modified section allows producers to maintain records
either electronically or in hard copy format for a 6 month period. This
section was also improved by requiring a cost/benefit analysis, public
hearings, a pilot project and information gathering effort prior to
publishing regulations.
Imports
According to an April 2009 Congressional Research Service report,
the FDA physically inspects approximately one percent of all imported
food items with 450 inspectors covering more than 300 ports of entry.
According to USDA's Economic Research Service, the value of agriculture
imports went from approximately $37 billion in 1998 to $80 billion in
2008. Combined with frequent headlines of tainted imports such as pet
food ingredients, baby formula, shrimp--our food safety efforts cannot
continue to fail to acknowledge the increasing amount of food entering
our country from places around the globe that either have no food
safety standards or standards in name only.
Registration Fees
As currently drafted, H.R. 2749 does not appropriately recognize
the differentiation between small and large processors. To require all
food facilities, regardless of size, pay an annual registration fee of
$500 demonstrates a deficiency in the legislation. Congress should
recognize the uniqueness of small processing facilities and exempt such
facilities from this fee so as not to discourage small-scale processors
from participating in an already consolidated and concentrated food
processing system.
Additional Policy Suggestions
In order to maintain the high quality of our food supply, NFU
supports the following standards for production, processing and
transportation of food products:
Vigorous action by U.S. regulatory agencies to prevent the
introduction of bovine spongiform encephalopathy (BSE) into
U.S. livestock and livestock products;
A moratorium on mechanical de-boning until the process can
be improved to ensure that no undesired portions of the carcass
are present in the final product;
Labeling of irradiated products and further research on its
long-term effects on human health;
Opposition to the transportation of food in containers that
have carried incompatible substances;
Protecting our nation's food supply and the rigorous
inspection of all imported food, fiber, Milk Protein
Concentrate (MPC), animal products and by-products to ensure
they meet our nation's sanitary and phyto-sanitary standards
including safe pesticide levels. USDA inspection stamps/seals
should be placed only on the individual items inspected;
Permitting states to implement food safety regulations more
stringent than comparable Federal regulations where states deem
consumer health and safety to be at risk or when individual
agricultural producers strive to set a higher bar for the
safety of food products destined for specialty or export
markets; and
Labeling the use of all additives, such as carbon monoxide
injected in meat and seafood or packaging for appearance or
shelf-life purposes.
Labeling
Thorough and accurate food labels are an important tool that help
consumers make informed decisions and allows producers to differentiate
their products. We support mandatory labeling for food products to
include all ingredients, additives and processes such as:
Carbon Monoxide;
Artificial growth hormones;
Products derived from cloned animals;
Irradiation;
The identity of the parent company; and
Country-of-origin.
Agri-Terrorism
With increased attention and focus on potential agri-terrorism
attacks on our nation's food chain, rural America must be educated,
prepared and vigilant of all potential circumstances. National Farmers
Union supports:
The Department of Homeland Security (DHS) and USDA
immediately developing mechanisms to combat agro-terrorism with
full funding provided by DHS. Such mechanisms should ensure the
safety of the consumer and agricultural industry;
Increased cooperation between USDA, DHS, Department of
Health and Human Services (HHS) and the Federal Emergency
Management Agency (FEMA) to establish, expand and continue to
determine vulnerabilities within the agricultural and food
industries;
Establishing a USDA public awareness and education campaign
for producers;
Providing Federal guidance and funding to states and
localities to develop and implement plans for agricultural
disease prevention, recovery and response, based upon already
established state animal response activities; and
A requirement of representatives of Federal, state and
county agencies to notify landowners prior to non-emergency
access of their private property. Representatives and vehicles
used for access should also display appropriate agency signage
and identification.
I thank you for the opportunity to testify today and look forward
to responding to any questions Committee Members may have.
Attachment
San Francisco Chronicle
Crops, ponds destroyed in quest for food safety
Carolyn Lochhead, Chronicle Washington Bureau
Monday, July 13, 2009
(07-13) 04:00 PDT Washington--Dick Peixoto planted hedges of fennel
and flowering cilantro around his organic vegetable fields in the
Pajaro Valley near Watsonville to harbor beneficial insects, an
alternative to pesticides.
He has since ripped out such plants in the name of food safety,
because his big customers demand sterile buffers around his crops. No
vegetation. No water. No wildlife of any kind. ``I was driving by a
field where a squirrel fed off the end of the field, and so 30 feet in
we had to destroy the crop,'' he said. ``On one field where a deer
walked through, didn't eat anything, just walked through and you could
see the tracks, we had to take out 30 feet on each side of the tracks
and annihilate the crop.''
In the verdant farmland surrounding Monterey Bay, a national marine
sanctuary and one of the world's biological jewels, scorched-earth
strategies are being imposed on hundreds of thousands of acres in the
quest for an antiseptic field of greens. And the scheme is about to go
national.
Invisible to a public that sees only the headlines of the latest
food-safety scare--spinach, peppers and now cookie dough--ponds are
being poisoned and bulldozed. Vegetation harboring pollinators and
filtering storm runoff is being cleared. Fences and poison baits line
wildlife corridors. Birds, frogs, mice and deer--and anything that
shelters them--are caught in a raging battle in the Salinas Valley
against E. coli O157:H7, a lethal, foodborne bacteria.
In pending legislation and in proposed Federal regulations, the
push for food safety butts up against the movement toward biologically
diverse farming methods, while evidence suggests that industrial
agriculture may be the bigger culprit.
`Foolhardy' approach
``Sanitizing American agriculture, aside from being impossible, is
foolhardy,'' said UC Berkeley food guru Michael Pollan, who most
recently made his case for smaller-scale farming in the documentary
film ``Food, Inc.'' ``You have to think about what's the logical end
point of looking at food this way. It's food grown indoors
hydroponically.''
Scientists do not know how the killer E. coli pathogen, which
dwells mainly in the guts of cattle, made its way to a spinach field
near San Juan Bautista (San Benito County) in 2006, leaving four people
dead, 35 with acute kidney failure and 103 hospitalized. The deadly bug
first appeared in hamburger meat in the early 1980s and migrated to
certain kinds of produce, mainly lettuce and other leafy greens that
are cut, mixed and bagged for the convenience of supermarket shoppers.
Hundreds of thousands of the bug can fit on the head of a pin; as few
as ten can lodge in a salad and end in lifelong disability, including
organ failure.
Going national
For many giant food retailers, the choice between a dead pond and a
dead child is no choice at all. Industry has paid more than $100
million in court settlements and verdicts in spinach and lettuce
lawsuits, a fraction of the lost sales involved.
Galvanized by the spinach disaster, large growers instituted a
quasi-governmental program of new protocols for growing greens safely,
called the ``leafy greens marketing agreement.'' A proposal was
submitted last month in Washington to take these rules nationwide. A
food safety bill sponsored by Rep. Henry Waxman, D-Los Angeles, passed
this month in the House Energy and Commerce Committee. It would give
new powers to the Food and Drug Administration to regulate all farms
and produce in an attempt to fix the problem. The bill would require
consideration of farm diversity and environmental rules, but would
leave much to the FDA.
An Amish farmer in Ohio who uses horses to plow his fields could
find himself caught in a net aimed 2,000 miles away at a feral pig in
San Benito County. While he may pick, pack and sell his greens in 1 day
because he does not refrigerate, the bagged lettuce trucked from
Salinas with a 17 day shelf life may be considered safer.
The leafy-green agreement is based on available science, but it is
just a jumping-off point. Large produce buyers have compiled secret
``super metrics'' that go much further. Farmers must follow them if
they expect to sell their crops. These can include vast bare-dirt
buffers, elimination of wildlife, and strict rules on water sources. To
enforce these rules, retail buyers have sent forth armies of food-
safety auditors, many of them trained in indoor processing plants, to
inspect fields.
Keeping children out
``They're used to working inside the factory walls,'' said Ken
Kimes, owner of New Natives farms in Aptos (Santa Cruz County) and a
board member of the Community Alliance With Family Farmers, a
California group. ``If they're not prepared for the farm landscape, it
can come as quite a shock to them. Some of this stuff that they want,
you just can't actually do.'' Auditors have told Kimes that no children
younger than 5 can be allowed on his farm for fear of diapers. He has
been asked to issue identification badges to all visitors.
Not only do the rules conflict with organic and environmental
standards; many are simply unscientific. Surprisingly little is known
about how E. coli is transmitted from cow to table.
Reducing E. coli
Scientists have created a vaccine to reduce E. coli in livestock,
and a White House working group announced plans Tuesday to boost safety
standards for eggs and meat. This month, the group is expected to issue
draft guidelines for reducing E. coli contamination in leafy greens,
tomatoes and melons.
Some science suggests that removing vegetation near field crops
could make food less safe. Vegetation and wetlands are a landscape's
lungs and kidneys, filtering out not just fertilizers, sediments and
pesticides, but also pathogens. UC Davis scientists found that
vegetation buffers can remove as much as 98 percent of E. coli from
surface water. UC Davis advisers warn that some rodents prefer cleared
areas.
Produce buyers compete to demand the most Draconian standards, said
Jo Ann Baumgartner, head of the Wild Farm Alliance in Watsonville, so
that they can sell their products as the ``safest.''
State agencies responsible for California's water, air and wildlife
have been unable to find out from buyers what they are demanding.
They do know that trees have been bulldozed along the riparian
corridors of the Salinas Valley, while poison-filled tubes targeting
rodents dot lettuce fields. Dying rodents have led to deaths of owls
and hawks that naturally control rodents.
Unscientific approach
``It's all based on panic and fear, and the science is not there,''
said Dr. Andy Gordus, an environmental scientist with the California
Department of Fish and Game. Preliminary results released in April from
a 2 year study by the state wildlife agency, UC Davis and the U.S.
Department of Agriculture found that less than \1/2\ of 1 percent of
866 wild animals tested positive for E. coli O157:H7 in Central
California. Frogs are unrelated to E. coli, but their remains in bags
of mechanically harvested greens are unsightly, Gordus said, so ``the
industry has been using food safety as a premise to eliminate frogs.''
Farmers are told that ponds used to recycle irrigation water are
unsafe. So they bulldoze the ponds and pump more groundwater, opening
more of the aquifer to saltwater intrusion, said Jill Wilson, an
environmental scientist at the Central Coast Regional Water Quality
Control Board in San Luis Obispo.
Wilson said demands for 450 foot dirt buffers remove the agency's
chief means of preventing pollution from entering streams and rivers.
Jovita Pajarillo, associate director of the water division in the San
Francisco office of the Environmental Protection Agency, said removal
of vegetative buffers threatens Arroyo Seco, one of the last remaining
stretches of habitat for steelhead trout.
Turning down clients
``It's been a problem for us trying to balance the organic growing
methods with the food safety requirements,'' Peixoto said. ``At some
point, we can't really meet their criteria. We just tell them that's
all we can do, and we have to turn down that customer.'' Large
retailers did not respond to requests for comment. Food trade groups in
Washington suggested calling other trade groups, which didn't comment.
Chiquita/Fresh Express, a large Salinas produce handler, told the
advocacy group Food and Water Watch that the company has ``developed
extensive additional guidelines for the procurement of leafy greens and
other produce, but we consider such guidelines to be our confidential
and proprietary information.''
Seattle trial lawyer Bill Marler, who represented many of the
plaintiffs in the 2006 E. coli outbreak in spinach, said, ``If we want
to have bagged spinach and lettuce available 24/7, 12 months of the
year, it comes with costs.''
Still, he said, the industry rules won't stop lawsuits or eliminate
the risk of processed greens cut in fields, mingled in large baths, put
in bags that must be chilled from packing plant to kitchen, and shipped
thousands of miles away.
``In 16 years of handling nearly every major foodborne illness
outbreak in America, I can tell you I've never had a case where it's
been linked to a farmers' market,'' Marler said. ``Could it happen?
Absolutely. But the big problem has been the mass-produced product.
What you're seeing is this rub between trying to make it as clean as
possible so they don't poison anybody, but still not wanting to come to
the reality that it may be the industrialized process that's making it
all so risky.''
Some major recent outbreaks of foodborne illness
The Food and Drug Administration lists 40 foodborne pathogens.
Among the more common: E. coli O157:H7, Salmonella, Listeria,
Campylobacter, botulism and hepatitis A.
June 2009: E. coli O157:H7 found in Nestle Toll House refrigerated
cookie dough manufactured in Danville, Va., resulted in the recall of
3.6 million packages. Seventy-two people in 30 states were sickened. No
traces found on equipment or workers; investigators are looking at
flour and other ingredients.
October 2008: Salmonella found in peanut butter from a Peanut Corp.
of America plant in Georgia. Nine people died, and an estimated 22,500
were sickened. Criminal negligence was alleged after the product tested
positive and was shipped.
June 2008: Salmonella saintpaul traced to serrano peppers grown in
Mexico. More than 1,000 people were sickened in 41 states, with 203
reported hospitalizations and at least one death. Tomatoes were
suspected, devastating growers.
April 2007: E. coli O157:H7 found in beef, sickening 14 people.
United Food Group recalled 5.7 million pounds of meat.
December 2006: E. coli O157:H7 traced to Taco Bell restaurants in
New Jersey and Long Island, N.Y. Green onions suspected, then lettuce.
Thirty-nine people were sickened, some with acute kidney failure.
September 2006: E. coli O157:H7 found in Dole bagged spinach
processed at Earthbound Farms in San Juan Bautista (San Benito County).
The outbreak killed four people, sent 103 to hospitals, and devastated
the spinach industry.
E-mail Carolyn Lochhead at [email protected].
http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/07/13/MN0218DVJ8.DTL
This article appeared on page A-1 of the San Francisco Chronicle
The Chairman. Thank you very much, Mr. Peppler.
Mr. Reinhard, welcome to the Committee.
STATEMENT OF ROBERT G. REINHARD, DIRECTOR OF FOOD SAFETY AND
REGULATORY AFFAIRS, SARA LEE
CORPORATION; CO-CHAIRMAN, TECHNICAL AND
REGULATORY COMMITTEE, NATIONAL TURKEY
FEDERATION, DOWNERS GROVE, IL
Mr. Reinhard. Good morning, Chairman Peterson, Congressman
Goodlatte, and the Members of the House Agriculture Committee.
My name is Bob Reinhard, and I will be testifying on behalf of
the National Turkey Federation. In the interest of time, I will
abbreviate my opening comments to a few short remarks and ask
that my entire testimony be accepted for the record.
The National Turkey Federation is a nonprofit trade
association representing nearly 100 percent of the U.S. turkey
industry. We greatly appreciate the opportunity to provide
comments today.
Federal inspection of turkey and other meat and poultry
products by the USDA Food Safety Inspection Service has
undergone major changes in the last 13 years. The collaborative
efforts of the industry and FSIS have resulted in major
accomplishments related to food safety and pathogen reduction.
Both government and industry have shown they are capable of
implementing scientific food safety programs and that a modern
science-based inspection service, within the framework of the
existing statutes, can be effective.
However, work remains to be done on all sides and there
should be a role for Congress to play in this process. Yet, we
believe the mindset and commitment that has been established by
both the regulators and the regulated has created a foundation
for continuous improvement of meat and poultry inspection.
On March 14, 2009, President Obama announced the creation
of the Food Safety Working Group to focus on food safety based
on the need to improve the existing food safety system. The
Food Safety Working Group is chaired by the Secretaries of the
Department of Health and Human Services and the Department of
Agriculture. The purpose of the Food Safety Working Group is to
provide information to the President on how the food safety
system can be modified for the 21st century, a system fostering
coordination on food safety issues throughout all government,
and to work to ensure the existing food safety laws are
enforced.
In the last week, the Food Safety Working Group announced
several new initiatives founded on three core principles:
prevention, strengthening surveillance, and improving response
and recovery. The National Turkey Federation supports and
believes in these same principles. The use of scientific data
analysis is particularly critical in making informed decisions
towards the improvement of our food safety system. To that end
the agencies need to continue to strive to have more specific
information about attribution, as well as work together to
share data, not only with each other, but more broadly with the
regulated industry and other interested parties.
HACCP is a science-based food safety system, first
implemented in 1998, that clearly has enhanced food safety and
public health. HACCP implementation was not always pretty and
might not have been so successful without the extensive
meetings and consultations between FSIS, industry, and
consumers during implementation, along with the effective
oversight of this Committee. We bring this up to only caution
that any changes to the existing laws and regulations should be
done so carefully and all due diligence should be exercised.
Given the nature of this hearing it would not be
appropriate to close without discussing H.R. 2749, the Food
Safety Enhancement Act of 2009, recently passed by the Energy
and Commerce Committee. One thing of note in the bill is the
exemption in section 5 regarding products that are inspected
under the Meat and Poultry Inspection Acts and the farms
raising these products. We applaud the efforts of Chairman
Waxman, Ranking Member Barton and the entire Energy and
Commerce Committee to include this exemption, and we would
encourage Congress to preserve and, if possible, strengthen
this exemption as the bill moves through the legislative
process.
The opportunity for Congress to pass significant food
safety legislation rarely comes along. It is NTF's position
that with an opportunity that is presented, legislation should
give USDA and FDA additional tools to collaborate with
industry, consumers, academia and all other stakeholders to
prevent food safety problems from occurring in the first place.
Before adding new regulations we strongly encourage this
Committee and all Members of Congress to consider whether
those--whether that legislation provides measurable public
health outcomes.
In closing, it should be reiterated that the U.S. meat and
poultry supply is one of the safest in the world; however, the
turkey industry recognizes changes could be made to further
enhance confidence to the consuming public. As the food safety
reform debate moves to the forefront in the Congressional
agenda, any changes that are enacted should ensure demonstrable
improvements in food safety and public health.
Mr. Chairman and other Members of the Committee, again, let
me thank you for allowing the National Turkey Federation the
opportunity to provide testimony today. The number one goal of
the U.S. turkey industry is to provide safe, wholesome
nutritious quality products at an affordable cost to our
customers. Thank you very much, and I will be happy to answer
questions.
[The prepared statement of Mr. Reinhard follows:]
Prepared Statement of Robert G. Reinhard, Director of Food Safety and
Regulatory Affairs, Sara Lee Corporation; Co-Chairman, Technical and
Regulatory Committee, National Turkey Federation, Downers Grove, IL
Good morning Chairman Peterson, Ranking Member Lucas, and Members
of the House Agriculture Committee. My name is Bob Reinhard and I am
the Director of Food Safety and Regulatory Affairs for Sara Lee
Corporation. Today I will be testifying on behalf of the National
Turkey Federation, as Co-Chairman of the federation's Technical and
Regulatory Committee, which oversees all scientific and technical food
safety activities for the federation. The National Turkey Federation is
a nonprofit, U.S. trade association located in Washington, D.C.,
representing the entire turkey industry, including local farmers,
processors, marketers, retailers and industry allied services.
Currently, NTF represents nearly 100 percent of the U.S. turkey
industry and we greatly appreciate the opportunity to provide comments
today.
The U.S. turkey industry raises more than 260 million turkeys,
which after processing represents approximately 6 billion pounds of
safe, wholesome, nutritious protein products for domestic and
international consumers. Food safety is NTF's number-one priority and
federation members' future success is directly linked to customer
confidence in the safety of the food supply and turkey products. Since
the inception of the National Turkey Federation in 1940, science-based
food safety has been an industry priority and over the years the
membership has agreed food safety is an issue on which they would
cooperate, share best practices, and developing science-based, state-
of-the-art food safety interventions from the farm to the consumer.
Federal inspection of turkey and other meat and poultry products by
the USDA Food Safety Inspection Service (FSIS) has undergone major
changes in the last 13 years, and the collaborative efforts of industry
and FSIS have resulted in some major accomplishments related to food
safety and pathogen reduction. Both the government and industry have
shown they are capable of implementing scientific food safety programs
and that a modern, science-based inspection system within the framework
of the existing inspection statutes can be effective. However, work
remains to be done on all sides, as we will discuss momentarily, and
there should be a role for Congress to play in this process. Yet, we
believe that the mindset and commitment that has been established by
both the regulators and the regulated has created a foundation for the
continuing improvement of the meat and poultry inspection.
Going back more than a decade, it was a coalition from the food
industry that included the National Turkey Federation, which petitioned
the USDA's FSIS for a preventive, science-based food safety system and
in 1996 FSIS promulgated the Pathogen Reduction/Hazard Analysis
Critical Control Point (HACCP) requirements. With this ``HACCP rule,''
which was implemented by industry in 1998, certain naturally occurring
pathogens in raw meat and poultry products were identified as potential
food safety hazards and if those hazards were likely to occur, process
controls to eliminate or control those hazards were implemented at the
production facility. Further, a processing establishment was also
required to have programs for ensuring they maintain the highest
sanitary conditions in their facility, known as Sanitation Standard
Operating Procedures (SSOPs). We feel these programs have been highly
successful, but again recognize that further progress is and can be
accomplished.
On March 14, 2009, President Obama announced the creation of a Food
Safety Working Group (FSWG) to focus on food safety based on the need
to improve the existing food safety systems. The FSWG is chaired by the
Secretaries of the Department of Health and Human Services and the
Department of Agriculture. The purpose of the FSWG is to provide
information to the President on how the food safety system can be
modified for the 21st century, assist in fostering coordination on food
safety issues throughout all of government, and to work to ensure that
existing food safety laws are enforced.
In the last week, the FSWG announced several new initiatives,
founded on three core principles: prevention, strengthening
surveillance, and improving response and recovery.
Examples fostering these principals, which were shared by the
Secretaries included:
Preventing harm to consumers;
Food safety inspection and enforcement dependent on data and
analysis; and
Outbreaks identified quickly and stopped.
Industry supports and believes in these same principles. The use of
scientific data analysis is particularly critical in making informed
decision towards the improvement of our public health system. To that
end, the agencies need to continue to strive to have more specific
information on attribution, as well as work together to share data, not
only with each other but more broadly with the regulated industry and
with other interested parties.
The industry is confident and optimistic that the White House FSWG,
the Secretary of Agriculture, and the Secretary of Health and Human
Services will continue to take a leadership and preventive role on food
safety issues and work to break down barriers in working across
different government agencies. The FSWG should monitor implementation
of their recommendations, as well as ensure coordination of food safety
policies between the different parties overseeing the implementation of
recommended measures.
At this point, it is very important to note, HACCP and SSOPs have
yielded significant and measurable successes, as shown by USDA FSIS
pathogen testing data. Specifically, on an annual basis, the Office of
Public Health and Science analyzes more than 125,000 products and
conducts more than 650,000 combined analyses on these meat and poultry
products and in the processing environment in federally inspected
establishment. These FSIS analyses include testing for chemical and
biological food safety hazards, including pathogens of public health
concern like Listeria monocytogenes and Salmonella. Using this
scientific quantitative data as a benchmark, since turn of the century
(2000 to 2007) we have seen a 74 percent reduction in the incidence of
Listeria monocytogenes in ready-to-eat meat and poultry products.
Additionally, since an initial baseline study by FSIS in 1996 on
Salmonella prevalence on raw turkey carcasses, we have seen a 64
percent reduction in this pathogen's presence. However, we need better
attribution data to confirm what our best instincts tell us--that these
food safety improvements have a correlation to the decline in foodborne
illness. The development of attribution information will be of critical
importance as we continue to make improvements in food safety.
We share this information to show that we are not in need of re-
building a system, but in need of enhancing a system that is already
working. Everyone wants to do better, but we need to build on our
successes and use data with attribution information to drive the
changes that will lead to improvements in public health.
Modernization
HACCP is a science-based proven food safety system that has
enhanced the safety of the meat and poultry products produced in the
United States. And since initial implementation in 1998, there have
been ongoing efforts to improve the way regulatory oversight is
executed and how a processing establishment performance is measured.
During HACCP's implementation period in 1998, FSIS hosted numerous
public meetings across the country and provided countless supporting
documents to assist the regulated entities in achieving compliance with
the new requirements. The process was phased-in based on plant size,
with specific focus on small and very small establishments. Today, all
federally inspected meat and poultry establishments have implemented a
hazard analysis and preventive control system.
We bring this up to only caution that any such changes to the
existing laws and regulations should be done carefully and all due
diligence should be exercised. Any changes to the existing statue
should be done with a scalpel, not an axe, to ensure that the current
level of inspection is not compromised.
When the current food safety statutes were passed, no one
envisioned HACCP, yet the law proved flexible enough to accommodate it.
As science and technology improves, it is highly plausible that the
food safety inspection process would and should be improved as well.
Changes to FSIS and FDA statutory authority should not be so
prescriptive that they stifle innovation and prevent industry, the
Secretary of Agriculture, or the Secretary of Health and Human Services
from making science-based improvements with definable public health
outcomes that are deemed appropriate. Currently, as reiterated by the
White House FSWG, FSIS has embarked on further refining its inspection
process using science, risk and other appropriate data. The agency has
been moving to utilize public health risk in determining how to best
utilize their inspection resources. In today's economic environment, it
is prudent that the government and industry focus more of their limited
resources toward processes to prevent food safety concerns and that we
focus specifically on interventions that have a measurable outcome
related to public health. This clearly is the way of the future. FSIS'
efforts offer instructive lessons for anyone interested in food safety.
All food safety systems should be designed to manage and reduce risk to
the food supply. Congress may want to consider giving FSIS expanded
authority to allocate inspection resources according to risk so that
inspectors are focused most closely on those tasks that will have the
biggest impact on food safety. For example, federally inspected
establishments could be allowed to share bird-by-bird inspection duties
in a joint effort, working with and under the close supervision of FSIS
employees to assure the safety of poultry caresses. Such a system would
permit inspection resources to be shifted to inspection processes that
have a higher risk related to food safety and a measurable public
health outcome.
Current Legislation
Given the nature of this hearing, it would not be appropriate to
close without discussing H.R. 2749, the ``Food Safety Enhancement Act
of 2009'' recently passed by the Energy and Commerce Committee.
One thing of note is the exemption in Section 5 regarding products
that are inspected under the Meat and Poultry Inspection Acts and the
farms raising these products. We applaud these exemptions and the
efforts of Chairman Waxman, Ranking Member Barton and the entire Energy
and Commerce Committee to include this exemption, and we would
encourage Congress to preserve and, if appropriate, strengthen the
exemption as the bill moves through the legislative process.
The opportunity for Congress to pass significant food safety
legislation rarely comes along. It is NTF's position that with an
opportunity like what is presented; legislation should give USDA and
FDA additional tools to collaborate with industry, consumers, academia
and all other stakeholders to prevent food safety problems from
occurring in the first place. Before adding new regulations, we
strongly encourage this Committee and all Members of Congress consider
whether legislation provides measurable public health outcomes.
In closing, it should be reiterated that the U.S. meat and poultry
supply is one of the safest in the world. However, the turkey industry
recognizes changes could and should be made to further enhance
confidence in the consuming public. As the food safety reform debate
moves to the forefront of the Congressional agenda, any changes that
are enacted should ensure demonstrable improvements in food safety and
that a measurable public health outcome is achieved.
Mr. Chairman and other Members of the Committee, again, let me
thank you for allowing the National Turkey Federation the opportunity
to provide this testimony today. The number one goal of the U.S. turkey
industry is to provide safe, wholesome, nutritious, quality products at
an affordable cost to our customers. Thank you very much and I will be
happy to answer any questions.
The Chairman. Thank you very much, Mr. Reinhard, for your
testimony.
Mr. Maravell, welcome to the Committee.
STATEMENT OF NICHOLAS C. MARAVELL, OWNER AND OPERATOR, NICK'S
ORGANIC FARM, LLC, POTOMAC, MD
Mr. Maravell. Thank you, Chairman Peterson and Members of
the Committee. I am Nicholas Maravell, an organic farmer for
the past 30 years. I appreciate the opportunity to provide
testimony on H.R. 2749 especially with regard to organic,
sustainable, and family-sized operations and on-farm value-
added processing. I own and operate Nick's Organic Farm located
in Montgomery and Frederick Counties, Maryland. I have 170
acres in production. We raise grass fed Angus beef, pastured
chickens and turkeys, free range eggs. We sell various types of
mixed hays. We produce field corn, soybeans, barley, rye grain,
and hairy vetch. We grow fresh vegetable soybeans.
We operate a diversified and integrated farm, raising
several types of crops and types of animals together. As an
ecologically-based operation, we rely on crop and animal
diversity and longer and more varied crop rotations to build a
farming system that stands up to the test in good times and in
bad, while maintaining or improving the quality of our soil and
our environment. We are not highly concentrated in one product.
Our diversity allows us to design a system where the parts work
well together. Our marketing strategy must complement our
production diversity. Given our small size and our varied
product mix we must add value on the farm to be economically
viable.
We do this by making the products organic, by selling about
90 percent directly to the final user and by on-farm
processing. We process our own organic chicken and turkeys,
pack our eggs and vegetable soybeans, condition organic seed,
and grind our grains into poultry feed. In most cases, we are
only one step down from the final consumer. This direct
personal marketing relationship allows us to develop trust with
our customers based on full accountability and traceability.
The customer has no doubt where to find accurate information
about our operation or products.
What concerns me most about this bill is that could be
perilously close to making our nation's food safety more
difficult to achieve in the long run. While the Food Safety
Enhancement Act of 2009 will have some positive impacts it will
also have unanticipated consequences. In my opinion, as a
farmer, this legislation needs more refinement before going
forward. Over the last 30 years I have seen tremendous growth
and vitality in small and diversified farms, in on-farm value-
added processing, and in decentralized direct to consumer
marketing channels. None of these growth areas have been
associated with major food safety issues. These innovations and
alternatives to the mainstream food system have already
implemented transparency and connection between the producer
and the consumer. As long as they provide safe food these
approaches should be given incentives, not barriers, to
continue their growth by adding new entrepreneurs and expanding
existing operations.
As a certified organic grower and on-farm processor, I
already meet the major concerns raised in this bill. To have to
meet them again would be cost and time prohibitive. I have
attached an analysis of the food safety aspects of the organic
certification program.
To the extent that this bill does not recognize and
encourage diversity in our food system; to the extent this bill
economically favors further industry consolidation and
centralization, because smaller more diverse operations cannot
efficiently meet the added regulatory costs, restrictions and
burdens; then our food supply becomes more susceptible to large
shocks whether from unintended contamination or from
bioterrorism.
Another concern with this bill is its one-size-fits-all
solution to food safety. The flat $500 registration fee is an
example. For modest family-sized operations that may conduct
only minimal and occasional processing, the cost and ensuing
paperwork are very burdensome. Estimates indicate the vast
majority of fees to be generated under this bill would come
from facilities with gross sales of under a million dollars.
And yet the vast volume of food with potential safety
weaknesses is concentrated in operations generating more than
$1 million in sales. If true, then smaller operators are being
asked to disproportionately pay for the monitoring of larger
operations. This is fundamentally unfair, I repeat,
fundamentally unfair.
I have specific recommendations in my written testimony on,
one, a revised fee structure; two, taking into account fees
already paid and data already collected; three, the need to
make explicit all of the exemptions that would apply to farms;
four, the need to specify explicit coordination with the USDA
Secretary in certain sections; and, five, additional language
for safety standards to ensure small scale diversified and
organic producers would be able to continue their practices in
a safe economical and responsible manner.
[The prepared statement of Mr. Maravell follows:]
Prepared Statement of Nicholas C. Maravell, Owner and Operator, Nick's
Organic Farm, LLC, Potomac, MD
Mr. Peterson, Mr. Lucas, and Members of the Committee, I am Nick
Maravell, an organic farmer for the past 30 years.
I appreciate the opportunity to provide testimony on H.R. 2749
regarding food safety to an Agriculture Committee.
I own and operate Nick's Organic Farm, located in Montgomery and
Frederick Counties, Maryland. I have 170 acres in production.
I am a strong supporter of food safety, and in all my years of
organic production and on-farm processing, I have never had a food
safety issue or problem arise. I would like to offer a few observations
and recommendations which I believe should shape the House Member's
thinking regarding changes to the food safety policy contained in H.R.
2749, especially with regard to organic, sustainable, and family sized
operations and on-farm value added processing.
We raise grass fed Angus beef, pastured chickens and turkeys, and
free range eggs. We grow and sell various types of mixed hays, and we
maintain different types of pastures. We produce field corn, soybeans,
barley, rye grain, and hairy vetch. We grow fresh edible vegetable
soybeans.
We operate a diversified and integrated farm, raising several types
of crops and types of animals together. As an ecologically based
operation, we rely on crop and animal diversity, and longer and more
varied crop rotations, to build a farming system that stands up to the
test in good times and bad, while maintaining or improving the quality
of our soil and environment. We are not highly concentrated in one
product, such as beef or dairy, or in two or three main cash crops. Our
diversity allows us to design a system where the parts work well
together and require little re-direction once the system is
established.
Our marketing strategy must complement our production diversity.
Given our small size and our varied product mix, we must add value on-
farm to be economically viable. We do this by making the products
organic, by selling about 90% directly to the final user, either a
consumer or another farm, and by on-farm processing. We process our own
organic chickens and turkeys, pack our eggs and vegetable soybeans,
condition organic seed, and grind our grains into poultry feed. Our
beef is processed off the farm under USDA inspection. In most cases, we
are only one step down from the final consumer. This direct personal
marketing relationship allows us to develop trust with our customers
through accountability and traceability. The customer has no doubt
about where to find accurate information about our operation or
products.
Observations on Food Safety Provisions in H.R. 2749
What concerns me most about this bill is that it could be
perilously close to making our nation's food safety more difficult to
achieve in the long run. While the Food Safety Enhancement Act of 2009
will have some positive impacts on the safety of our nation's food
supply, it will also have some unintended consequences. In my opinion
as a farmer, this legislation needs more refinement before going
forward. I do not make this statement lightly or out of self-interest,
but out of deep concern for the ultimate safety and security of our
country's food supply.
Over the last 30 years, I have seen tremendous growth and vitality
in small and diversified farms, in on-farm value added processing, and
in decentralized direct to consumer marketing channels. Growth of
farmers markets, community supported agriculture (CSAs), the Buy Local
and Slow Food movements, and the expansion of organic and sustainable
food and farming practices have given the consumer many choices. None
of the growth areas, especially those direct-to-consumer areas, have
been associated with major food safety issues. Part of the reason for
this safety record has to do with the approaches they take to
producing, processing, and marketing food. These approaches represent
innovations and alternatives to the mainstream food chain because, at
the core, they have already implemented transparency and connection
between the producer and the final consumer. As long as they provide
safe food, these approaches should be given incentives, not barriers,
to continue their growth by adding new entrepreneurs and expanding
existing operations.
To the extent that this bill does not recognize and encourage the
diversity in our food system, to the extent this bill economically
favors further industry consolidation and centralization because
smaller more diverse operations can not efficiently meet the added
regulatory costs and burdens, then our food supply becomes more
susceptible to large shocks--whether from unintended contamination or
from bioterrorism.
In my case, as a certified organic grower and on-farm processor, I
already meet the major concerns raised in this bill. To have to meet
them again through an additional program would be cost and time
prohibitive. I have attached a detailed analysis prepared by the
Organic Trade Association which shows the food safety aspects of the
USDA organic certification program that are already in place.
Fees and Registration
Another of my concerns with this bill is that it proposes to
legislate a ``one size fits all'' solution to food safety. The flat
$500 registration fee structure is one good example of this approach.
For larger corporate facilities, this fee may be insignificant. For
modest family sized operations that may conduct only minimal and
occasional processing, the cost and the ensuing paperwork are very
burdensome. Estimates indicate the vast majority of fees to be
generated under this bill would come from facilities with gross sales
of under $1 million, and yet the vast volume of food with potential
safety weaknesses is concentrated in operations generating more than $1
million in sales. If the Committee can determine that this situation is
true, then smaller operators are being asked to disproportionately pay
for the monitoring of larger operations. This is fundamentally unfair.
I repeat, fundamentally unfair. My recommendation is to charge no
registration fees for operations with sales less that $500,000, to
charge a $250 fee for facilities with sales between $500,000 and
$1million, and to charge appropriately scaled fees for facilities with
sales of over $1 million.
In my case, I already pay modest fees and am already registered for
most aspects of my food production and on-farm processing operations
with the Maryland Agriculture and Maryland Health Departments and with
the Federal level through my USDA organic certification program. Again,
treating all operations as ``one size fits all'' ignores other state
and Federal programs already in place and leads to potentially
unnecessary costs and paperwork burden. I recommend the Secretary of
HHS, with explicit coordination with the USDA Secretary, be directed to
take into account fees already paid and data already collected to
accomplish the purposes of registration and data collection wherever
feasible.
Exemptions
In an attempt to make policy appropriate to the type and scale of
food production and processing activity, the bill provides for some
exemptions, particularly for farms that meet certain conditions and for
livestock programs administered by USDA. I know the exemption
provisions rely on the definitions of ``facility'' contained in the
Bioterrorism Act of 2002 and regulations at 21 CFR 1.226 and 227. I
also know that, in at least one instance, a Federal court has
interpreted the definition of food to apply to livestock, creating a
fuzzy line between USDA and FDA program jurisdiction. I am not sure
what aspects of my farm production and on-farm processing will be
exempt from Sec. 414--Maintenance and Inspection of Records (including
Tracing System for Food); Sec. 415--Registration of Food Facilities;
Sec. 418--Hazard Analysis and Risk-Based Preventative Controls; Sec.
418A--Food Safety Plan (and associated compliance with Sec. 419--
Performance Standards). I recommend that the language of this bill make
all the exemptions explicit so that farmers and processors know what
exactly to expect. I further recommend that this bill state explicitly
that the definition of ``food'' in the Food, Drug, and Cosmetic Act
(FDCA) does not apply to livestock. This latter recommendation is made
notwithstanding the jurisdictional division already contained in the
FDCA and this bill regarding USDA's livestock inspection programs.
Explicit Coordination With USDA
As a farmer, I am concerned that the bill does not seem to utilize
the expertise of other agencies, especially the USDA. Vast new
authority is given to the Secretary of HHS regarding areas in which
USDA has relevant expertise:
Sec. 403 (i)--Quarantine of Geographic Location
Sec. 414(c)--Tracing System for Food
Sec. 419A--Safety Standards for Produce and Certain other Raw
Agricultural Commodities
I recommend that the bill specify that the Secretary of HHS
explicitly coordinate policy in these areas with the Secretary of USDA.
Safety Standards
I strongly endorse the language in 419A(b)(7), (8) and (9) which
permits flexibility, coordination, and could prevent duplicative
efforts by (i) recognizing the special impacts on small-scale and
diversified farms, wildlife habitat, and organic production methods,
(ii) allowing coordination for education and training with other
entities that have experience working directly with farmers, and (iii)
allowing the HHS Secretary to recognize other publicly available
procedures and practices to implement safety standards. I would
recommend adding the words ``direct farmer to consumer distribution
channels'' to the impacts listed in paragraph (7). If combined with
explicit coordination with the USDA Secretary, these provisions would
help ensure small scale, diversified and organic producers would be
able to continue their practices in a safe, economical, and responsible
manner.
Attachment
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The Chairman. Thank you very much, Mr. Maravell. We
appreciate your being with us.
Mr. McDonald, welcome to the Committee.
STATEMENT OF DREW McDONALD, VICE PRESIDENT, NATIONAL QUALITY
SYSTEMS, TAYLOR FARMS, SALINAS, CA
Mr. McDonald. Good morning, Chairman Peterson, Mr.
Goodlatte, and Members of the Committee. My name is Drew
McDonald, and I am Vice President of the National Quality
Systems for Taylor Farms in Salinas, California. Thank you for
allowing me the opportunity to testify today.
We are the world largest salad and fresh cut vegetable
processor, with ten processing plants operating in seven states
and Mexico. Taylor's valued network of local, independent
family-run farms who supply produce to extend across more than
a dozen states as well as from outside the United States, in
Canada, Chile, and Mexico. We provide fresh healthy products to
a hundred million Americans, to provide enjoyment and promote
healthy lifestyles. We are also active in the major produce
trade organizations, including United Fresh Produce, Western
Growers, and Produce Marketing Association.
I want to start out by saying that the fresh produce
industry has been at the forefront of developing comprehensive
food safety programs for many years. The industry has worked
side by side with Federal Government regulators and scientists
as well as academia to develop best practices and extensive
commodity-specific guidelines for various produce items. My
written statement outlines a number of challenges that are
important for the Committee to consider.
Today I would like to focus on three areas of great
concern. First of all, audit cost and consistency. One of our
greatest challenges is agreed-upon standards for food safety
audits. Without a government-endorsed standard the produce
industry faces multiple, redundant audits, which in most cases
are not interchangeably acceptable to different buyers. In
addition, many producers are financially challenged to comply
with these requirements, and perhaps most importantly, it's not
clear that the increased cost of these audits result in better
compliance or safer food.
Next, under the topic of accountability and transparency,
over the last few years regulatory requirements have spurred
industry improvements in the areas of prevention and traceback.
The primary focus has been on prevention of foodborne disease
and experts agree this is the most important investment. The
key to this has been stronger industry-government
collaboration. One very good example of this is the California
Leafy Greens Marketing Agreement. This was implemented
following the spinach outbreak a few years back. It provides an
excellent model that achieves a HACCP-like risk-based approach.
It enforces measurable food safety mitigation steps from
growing to processing.
Under the program produce handlers are audited by USDA
trained inspectors to ensure that they are complying with the
standards. It is a model approach that involved industry
coordination with FDA, CDC, CDFA, and university food safety
experts. It is not an easy, task but it is a critical in
preventive measures and provides assurance to the public that
our industry is doing everything we can to make our products
safe.
Now, concerning the current Congressional efforts on food
safety, the fresh produce industry has been a leading proponent
of strong, credible food safety standards. In fact as you know,
the industry has developed a set of policy principles that call
for mandatory, science based, and commodity specific standards.
We are pleased that the consensus in Congress has grown in
support of these principles. In particular, the Food Safety
Enhancement Act, passed by the House Energy and Commerce
Committee, addressed a number of critical issues related to
produce, but there are still several issues that Congress needs
to consider which will provide a strong foundation for the
legislation.
Regarding finished product testing, as someone who deals
with testing on a regular basis, I continue to be concerned
with the concept of trying to test our way to a safe product.
Testing has very process specific implications and the
Committee-passed bill contains language on testing that, if
implemented, will not improve food safety, but will generate
confusion and ultimately costs that do not correspond to
enhanced food safety.
Scientists and FDA continue to recommend a HACCP approach
with finished product testing as a prudent validation that the
process and associated HACCP plan is working. Taylor Farms--we
utilize the HACCP plan throughout all our plants and it
includes various testing points along the way. The goal must
always be on preventing food safety issues during the process
rather than trying to detect them after the process. As such,
the Federal Government should not rely on testing as a
cornerstone for the improvement of safety in our food supply.
Concerning traceback and outbreak investigation, as
discussed earlier, efforts to date have focused on prevention.
What we have not done enough of is spend time on how to
investigate and manage an outbreak when it does occur. FDA and
its stakeholders must figure out how we can better address a
foodborne illness outbreak to protect both public health and
maintain consumer confidence.
Regarding the geographic quarantine, based on recent
outbreaks and actions by FDA, we would have serious
reservations about the impact that the quarantine power would
have on a particular commodity sector or region, and how that
impact would do little to actually enhance food safety.
In conclusion, it's in everyone's interest to maintain a
safe supply of healthy fruits and vegetables, and starting with
the fresh produce industry, we must continue to take
responsibility to do all we can. We must provide safe food.
Each time any fruit or vegetable is implicated in a foodborne
illness outbreak, industry suffers from lost consumer
confidence in our industry as a whole and consumer health
suffers due to a reduction in the consumption of healthy fresh
produce. In the long run this is simply not sustainable and
certainly not acceptable. A Federal food safety system must be
elevated that maintains the confidence in eating healthy fresh
fruits and vegetables, and, yet, can deal with the rare
problems without destroying public confidence.
Thank you again for the opportunity to participate in this
hearing, and I look forward to your questions.
[The prepared statement of Mr. McDonald follows:]
Prepared Statement of Drew McDonald, Vice President, National Quality
Systems, Taylor Farms, Salinas, CA
Introduction and History of Taylor Farms
Good morning Chairman Peterson, Ranking Member Lucas and Members of
the Committee. My name is Drew McDonald and I am Vice President of
National Quality Systems for Taylor Farms Salinas California. We are
the world's largest salad and fresh cut vegetable processor with ten
processing plants operating in six states and Mexico. Taylor's valued
network of independent, family-run farms who supply produce to us
extend across more than nine states including California, Arizona,
Oregon, Washington, Colorado, New Mexico, Michigan, New Jersey, Florida
as well as other countries such as Canada, Chile, and Mexico. We
provide fresh healthy products to 100 million Americans each week to
provide enjoyment and promote healthy lifestyles.
We are active in the major produce trade organizations including
serving on the board of directors for United Fresh Produce Association,
Western Growers, and Produce Marketing Association. These organizations
have help lead industry efforts to bring safe, healthy, affordable and
great-tasting fruits and vegetables to the public.
Taylor Farm Food Safety Investment
Taylor Farms is committed to the development of processes and
systems that promote the prevention of product failure. It is our
belief that it is both impossible and impractical to inspect quality
into a product. As such, we employ a three-stage approach to assure
product performance. We start with a development process that clearly
defines the requirements of the product. The product is then integrated
into our established quality systems where each key step of the process
is carefully monitored and controlled. Finally, the product is
subjected to a rigorous hazard analysis and incorporated into our
company wide HACCP program to insure food safety. Before any product is
processed for commercial distribution, quality control points and food
safety critical control points have been thoroughly documented and
shown to be effective. Subsequent periodic audits and verification of
key finished product attributes are conducted to assure the on-going
adequacy of the procedures and systems. Together, these programs assure
that the products packaged and distributed by Taylor Farms meet our
exacting standards for quality, customer performance and food safety
day in and day out.
Over the last few years we have invested over $100 million in new,
state-of-the-art processing facilities. The Taylor Farms' facilities,
operations and work practices have been developed according to Good
Manufacturing Practices. These FDA regulations cover the design,
maintenance and sanitary operation of our facilities, equipment,
processes, storage areas and distribution practices. Each of these
areas is audited and results documented on a daily basis by Taylor
Farms' staff. These daily audits include both visual inspections as
well as random microbiological sampling of equipment surfaces. On a
monthly basis, environmental samples are taken throughout the facility
to verify the effectiveness of our overall sanitation program.
Additionally, Taylor Farms commissions audits by accredited independent
auditors to insure a fresh look at our sanitary practices.
What are Some of our Food Safety Challenges
First and foremost, the fresh produce industry has been at the
forefront of developing comprehensive food safety programs for many
years. In fact the first Food Safety Guidelines for the Fresh-Cut
Produce Industry were published in 1992, and recently updated by FDA in
February 2008. The industry also developed Good Agricultural Practices
(GAPs) in the mid-1990s to minimize on-farm microbiological food safety
risks for fruit and vegetables, and worked closely with FDA as the
agency published its overarching GAPs document in 1998. More recently,
the industry has worked with scientists from government, academia and
industry to develop extensive commodity-specific food safety guidelines
for tomatoes, melons, sprouts, and leafy greens, and have implemented
strong compliance systems based on state inspections and audits by
government personnel. Put simply, food safety has been at the forefront
of our industry's commitment to serve the American public for many
years.
Despite this ongoing industry commitment, there continue to be
significant challenges associated with preventive control practices
along with how the government responds to outbreaks once they occur.
Below are few of examples of challenges we continue to see related to
food safety.
Audit Consistency and Cost--One of our greatest challenges today is
the lack of a consistent and agreed-upon standard for food safety
audits. Without that government endorsed standard, different customers
demand different food safety audits which are burdensome to our
company. Today, the produce industry faces multiple, redundant audits,
which in most cases are not interchangeably acceptable to different
buyers. Most buyers will only accept the results and certification of
certain certification bodies, thus leading to a proliferation of
different audits for different buyers. In some cases, the same auditor
will visit a facility multiple times to perform different audits to
verify compliance with different and potentially conflicting standards.
In addition, inconsistencies in audit standards among the different
certification bodies have created frustration and confusion, have
unnecessarily increased operational costs, and may create an obstacle
to training in food safety practices. To date, every effort to create a
harmonized set of produce food safety audit standards has only added
another set of standards to the list. If third-party certification
programs are to be successful, there must be a system in place that
requires buying companies to recognize and approve the results of these
audits without requiring their own duplicative audits to recognize the
same results.
In addition, produce industry food safety certification programs
range in cost (auditor/certification fees alone) from a few hundred
dollars per audit (generally by the not-for-profit organizations) to
tens of thousands of dollars (generally by the more complex
certification bodies like SQF or ISO). Yet, we do not have evidence
that the increased costs of some audits result in better evidence of
compliance with standards or better evidence of safer food. The
tremendous range in audit fees can have a significant impact on the
ability of particularly small businesses to participate. If exorbitant
audit fees were required, we fear that many producers would be
financially challenged to comply with these requirements.
Need for Improved Accountability and Transparency--The produce
industry has a decades-long history of implementing food safety
improvements to prevent both deliberate and unintentional contamination
of produce as it makes it way from the field to the retail store or
restaurant. We have a commercial interest in ensuring that only safe
wholesome fresh fruits and vegetables are delivered to our customers'
tables. As a result, industry is driven to constantly improve and
refine its own food safety programs and food safety defense
capabilities.
In addition, there are legal requirements, such as the Perishable
Agricultural Commodities Act, the Bioterrorism Act, and new
governmental mandates that call for industry action including the FDA
Produce Safety Action Plan and the more recent Food Protection Plan.
These Federal actions have spurred industry improvements in the areas
of prevention and trace back; each integral parts of comprehensive food
safety programs. These efforts, conducted in cooperation and
consultation with FDA, DHS, USDA, state departments of health and
agriculture and food safety experts, have also resulted in greater
awareness of potential vulnerabilities, the creation of more effective
prevention programs, and the ability to respond more quickly to
outbreaks of foodborne illness.
Yet, as I look at all of the work that has gone into industry
driven initiatives along with our collaborations with the government, I
am left with an observation that our priority has been almost
exclusively on prevention of foodborne disease from the farm up through
the distribution chain. This is a good thing as both the industry and
FDA agree that the most important investment in food safety is on
prevention. Accordingly, the industry has implemented best agricultural
practices for tomatoes, leafy greens, and other products to prevent
contamination, and devoted extensive resources to auditing systems to
measure compliance against these standards. However, we also need to
focus on the management of outbreaks after they occur. As the industry
and government work towards enhancing food safety, what we have not
done, is spend a commensurate amount of time on how best to investigate
and manage an outbreak when it does occur. It is time for government,
industry and all stakeholders to figure out how we can better fight a
foodborne disease outbreak to both protect public health and minimize
damage to consumer confidence and industry profitability. Let me
provide some examples.
In recent experiences with outbreaks and during the investigations,
it has become clear that no one is in charge, leaving local, state, and
Federal officials vying for leadership; various agencies pursuing
different priorities; and well-meaning individuals reacting
independently to events rather than as part of a coordinated
investigation moving forward in a logical and expeditious direction.
Local and state governments are usually first to discover illnesses,
and are free to draw their own conclusions and issue press releases at
any time. But how can CDC or FDA stand by when a state seems to be
``more protective'' of its citizens? Yet, not just today's experience
but past history shows us that premature mistakes have consequences.
When local officials first blamed strawberries for a cyclospora
outbreak in the mid 1990s, their advice may have actually pushed
consumers to eat more raspberries that were eventually found to be the
cause.
The government's failure to use industry's expertise in outbreak
investigations is one of the most important problems we have today.
There is an abundance of knowledge in the industry about specific
commodities, growing regions and handling practices, and specific
distribution systems that can be used to protect public health in an
outbreak. FDA and CDC should also welcome outside expertise not just
from industry, but also from academia, from USDA experts who certainly
better understand produce distribution systems, and even from the
states themselves.
Finally, every health or safety regulatory decision requires an
assessment of risks and benefits. Agencies make risk management
decisions every day that attempt to balance risks and benefits broadly
to society, whether in automobile design, toy manufacturing, airline
safety, or even FDA approval of food additives. Yet in the case of
foodborne disease, FDA and CDC seem ill-prepared to grapple with any
risk management approach other than ``all or nothing.'' In the cases
such as spinach in 2006 and then tomatoes/peppers from last summer, it
seems that internal agency decisions on when to warn the public, how
broadly to make a warning, and what specifically to advise, are based
as much on fear of being second-guessed rather than careful risk
analysis. That inevitably leads one toward extreme measures--in effect
banning all spinach, tomatoes or peppers--in the quest for zero risk of
immediate illness. But, is such a consumer message truly without risk,
when it needlessly scares the public away from a healthy food that may
help prevent disease? We simply must develop risk management systems
that can distinguish those producers or distributors who can assure the
safety of their produce in the marketplace from those who cannot.
Stronger Industry/Government Collaboration--No company can take
food safety for granted because when an outbreak occurs it impacts the
industry as a whole, and we all suffer. It is incumbent upon us as an
industry to do all we can to prevent these outbreaks and to ensure that
our products are safe every bite, every time. That is why we should
support strong industry and government collaboration to prevent
outbreaks from occurring. One example that we think is very important
is the California Leafy Greens Marketing Agreement.
The California Leafy Greens Marketing Agreement serves as a means
of setting rigorous measurements of safety for leafy greens from this
major production region. These science-based standards include careful
attention to site selection for growing fields based on farm history
and proximity to animal operations, appropriate standards for
irrigation water and other water sources that can come in contact with
crops, prohibition of raw manure with use of only certified safe
fertilizers, good employee hygiene in fields and handling, and of
course, strong food safety controls in all processing plants. The
program is based on GAPs and essentially serves as a standard risk
assessment similar to HACCP. Hazards in the growing and harvest
operations have been identified and specific control points have been
established. Under the Leafy Greens Agreement, produce handlers are
required to ensure that their product is meeting these standards. They
are audited by the California Department of Food and Agriculture to
ensure that they are complying with these standards. It should be noted
that not only are the auditors CDFA employees but they are USDA trained
and the process by which they audit is USDA-certified. And, the produce
suppliers will face penalties if found not to be in compliance, with
the ultimate consequence of not being allowed to sell product if they
cannot do so safely. Taking this risk-based process approach involved
industry coordination with FDA, CDC, CDFA and university food safety
experts was not an easy task for the private industry sector. But we
believe this is a critical step in continuing to assure the public that
our industry is doing everything we can to make our products safe.
Food Safety Research--In recent years, Federal funding for food
safety research has been woefully inadequate, with little to no
research focused directly on mitigating risk factors associated with
potential field contamination of fresh produce, or to developing
effective microbial reduction and elimination techniques after harvest
and in processing. While there's no obvious silver bullet around the
corner, developing a ``kill step'' akin to pasteurization while still
protecting the natural texture and flavor of our product would be a
critical advancement in preventing even rare future illness outbreaks.
As a nation, we need Congress to fund scientific research to help
prevent future outbreaks. Specific produce safety research at FDA that
is field oriented and implemented to find practical solutions is
critically important, and we urge Congress to include a robust research
agenda when considering reforming our nation's food safety laws.
We believe that boosting produce safety research is a vital part of
reducing risk in the future but we are not waiting for the government
to act. Taylor Farms contributed $2 million to the creation of the
Center for Produce Safety at the University of California at Davis.
This is a public-private partnership that funds applied research
directed at the most acute needs of the produce industry's food safety
agenda. The food safety regulatory body not only needs to be able to
address food safety today but also food safety in the future. This
means they need be able to understand the economic and market impacts
of food safety, have the means to develop meaning advances in food
safety while supporting the industry in commercializing these advances.
They must also be a vocal national and international advocate of the
safety of the U.S. food supply. Any enhancement of the U.S. regulatory
scheme must be driven by a central focus to insure that the U.S. food
supply remains the preeminent example of safety and wholesomeness.
Current Legislation Before Congress
Over the past several years, you know that the fresh produce
industry has been a leading proponent of strong, credible food safety
standards. In fact, the industry has developed a set of policy
principles that call for mandatory, science-based and commodity-
specific standards. We are pleased that the consensus in Congress has
grown in support of these principles, which have largely been
incorporated into all major food safety legislative vehicles before the
House and Senate.
Let me now turn specifically to the Food Safety Enhancement Act of
2009 which the House Energy and Commerce Committee passed in June.
During the debate on this legislation, the Committee addressed a number
of critical issues including commodity specific produce standards,
flexibility for industry to utilize best practices/innovation in
traceability programs, and allowing individual experience for fresh
produce processors in developing HACCP based food safety programs.
However, there are several issues that Congress needs to continue to
consider which will provide a strong foundation for this legislative
proposal.
Finished Product Testing--The Committee-passed bill contains
language on testing that, if implemented, will not improve food safety
but will generate confusion and costs. First, the bill requires that
companies include a description of the facilities' environmental and
product testing programs. Second, the Secretary would be required to
conduct a pilot project and a study to evaluate the feasibility,
benefits and costs of collecting finished product testing results from
Category 1 facilities that are required to comply with Good
Manufacturing regulations. After completion of the study, the Secretary
could require the submission of finished product test results of
Category 1 facilities that must comply with Good Manufacturing
regulations.
As someone who deals with testing on a regular basis, I continue to
be concerned that one cannot test their way to a safe product. A 1985
National Academy of Science report came to that conclusion when they
recommended HACCP as an alternative to product acceptance testing.
Since then, scientists and FDA have recommended finished product
testing as a prudent validation that the process and associated HACCP
plan is working; neither recommended it as a routine measure of lot
safety.
Taylor Farms employs and rigorously maintains a HACCP program for
all of our products at all of our facilities. As part of this program,
Taylor Farms periodically verifies compliance with and the validity of
our Critical Control Points and Pre-Requisite Programs by sampling for
indicator microorganisms. It is Taylor Farms' belief that HACCP
provides greater security of control over product safety than is
possible with traditional product testing. The Taylor Farms' HACCP
program was independently developed along the guidelines established by
the National Advisory Committee on Microbiological Criteria. This plan
is periodically re-evaluated and validated for changes and/or newly
available information. All HACCP documentation is maintained at the
production site for a period of 365 days after the end of shelf life of
the product. When FDA inspects us, which is at least once per year per
plant, these programs are review. The Taylor Farms' position on HACCP
and finished product testing is consistent with the recommendations of
the Joint FAO/WHO Codex Alimentarius Commission, the USDA and the U.S.
Food and Drug Administration.
Companies with good food safety plans may decide to do finished
product testing for this purpose but, again, this doesn't improve food
safety, just verifies the plan is working, and punishes good companies
for their surveillance when a positive is found. The bill requires
rigorous food safety plans, but I believe the inclusion of finished
product testing runs counter to the rest of the bill and will actually
discourage testing. Where to test, when to test, what to test, and what
to test for, are very much product and process specific questions.
There is no blanket answer other than to say do not expect testing in
and of itself to distinguish safe food products from unsafe food
products. In some instances testing of raw materials may provide more
insight into the safety process than finished product testing.
The goal must always focus on preventing food safety issues during
the process rather than trying to detect them after the process. From
this perspective one might say that finished product lot testing has
little to no benefit in an ongoing food safety program. Even the most
rigorous microbiological testing programs as outlined by the
International Commission on Microbiological Specifications for Foods
can only ensure the detection of contamination 95% percent of the time
when that adulterant has contaminated over 5% of the lot in question.
Traceback on recent foodborne illness outbreaks consistently tell us
that contamination levels far lower than 5% are involved, suggesting
that finished product testing would have absolutely no impact on the
rate of future foodborne illness outbreaks. Congress or the Federal
Government should not rely on testing as a cornerstone for the
improvement of our food supply's safety.
Funding of Food Safety Requirements--Food safety is a public health
issue affecting our entire society and accordingly the cost of any
increased Federal regulatory oversight should be borne by U.S. general
revenues. Public funding will have the advantage of making consistent
funding available for food safety oversight and not be subject to the
same inconsistent production that the produce industry faces. The
funding structure for the Committee-passed bill uses a both
appropriations and mandatory fee-based structure. While the fee
structure is more reasonable than where it started, fee increases are
pegged to inflation and FDA compensation shortages. The appropriations
funding is not. One can envision that, very quickly, facility fees will
become the funding vehicle for food safety, shifting fruit and
vegetable production in favor of larger, more complex farming
operations and away from many smaller operations. This shift could work
against product diversity and support for local agriculture, and act as
a barrier to entry for smaller operations that today already contribute
substantially to the safe and wholesome supply of fruits and
vegetables.
Geographic Quarantine--This section gives FDA the power to restrict
the movement of food from states or regions if it believes that the
type of food presents an imminent threat of serious adverse health
consequences or death. While the bill demands that the commissioner or
deputy commissioner may take this action only when a food may cause
serious adverse health impacts, that evidentiary standard applies only
to the particular food. As written, the bill provides no evidentiary
finding that comparable food within that region or state carries that a
risk of adverse health impacts. Based on recent outbreaks and actions
taken by FDA, we would have serious reservations about the intent of
this provision and the impact it could have on particular commodity
sectors or regions. In particular tomatoes would have qualified under
this scenario last summer and thus the entire domestic tomato industry
would have been under a nation-wide quarantine. What is more, the bill
elsewhere allows FDA to stop distribution of product based on a
reasonable belief that it may cause serious adverse health effects,
which makes the quarantine language unnecessary. The produce industry
supports reasoned action based on science and evidence but we must
object to quarantining all growers based on nothing more than
conjecture.
In addition, FDA currently, has a number of actions available to
them such as a Public Health Advisory, Import Alert, Detention without
Examination that would allow them to alert the public, if that is
necessary. For instance, last year's Public Health Advisory press
release from FDA recommended consumers not eat tomatoes was strong
enough guidance for consumers to stop eating tomatoes while the entire
distribution chain to stop moving tomatoes throughout the country.
Similar actions occurred in the 2006 spinach outbreak. As discussed
above, the bill's mandatory and emergency recalls provisions along with
administrative detention authority empower FDA to stop movement of a
food product quickly and efficiently. Further, with the new mandate
that food companies must incorporate traceability systems, one would
conclude that effective traceback/tracefoward system will be
implemented to render the need for a Geographic Quarantine Authority
unnecessary.
Finally, by providing FDA with the ability to ``quarantine'' a
particular food in a geographic region would be extremely harmful to a
multitude of the innocent producers, handlers, distributors, and
packers of a particular commodity under this authority and could have a
long-term impact on consumer confidence of that region's ability to
produce or process safe food. Again, we would cite the tomato situation
from last summer and what that could have done for the tomato industry
of this country had this been in effect.
Need for Improved Accountability, Transparency, and Industry
Partnership--I have already described the need for improved
accountability and transparency by FDA during its foodborne illness
outbreak responses and recovery activities, and the need for FDA to use
industry's expertise in outbreak investigations. None of these is
addressed in the Committee-passed bill.
Conclusion
It is in everyone's interest to maintain a safe supply of healthy
fruits and vegetables and starting with the fresh produce industry we
must continue to take responsibility to do all we can on our own. Each
time any fruit or vegetable is implicated in a foodborne illness
outbreak, industry suffers from lost consumer confidence in our
industry as a whole and consumer health suffers due to a reduction in
the consumption of healthy produce. In the long run, this simply is not
sustainable and certainly not acceptable. As has been mentioned today
from my industry colleagues, stakeholders should continue developing
commodity specific best practices and marketing agreements such as the
LGMA and self-imposed regulation is an important positive step.
Industry action is our most important defense. At the same time a
Federal food safety system must also be elevated that maintains the
confidence in eating healthy fresh fruits and vegetables; can deal with
the rare problems without destroying public confidence; and doesn't
kill the industry or sweep all products into the same bucket. Given the
ongoing discussions on health care reform the benefits of fresh produce
to the American diet cannot be stressed enough. How many lives can be
extended with increased consumption? Imagine how regular consumption of
fresh fruits and vegetables can extend quality of life in old age? What
if fruits or vegetables are removed from the diet out of fear the
consequences will be the cost to society?
Thank you again for the opportunity to participate in this hearing
and look forward to answering your questions.
The Chairman. Thank you very much, Mr. McDonald.
We thank all of the witnesses for their testimony. I would
like to announce that we are going to try something new here as
of today, because of some--I keep getting tons of questions
every time we have been doing things, based on who gets here,
and concerns about where you are on the list and whether you
got counted on time or not.
So, from now on, or at least for the time being, we are
going to recognize Members by seniority, and we will see how
that works for a while.
Mr. Kratovil. In reverse order.
The Chairman. You know, I am up for maybe every once in a
while reversing the order. I am not opposed to that; I am just
trying to make it a little more predictable.
But anyway, Ms. Tucker-Foreman, I was struck--you made a
statement that has been made to me by Mr. Dingell that he did
not want FDA on the farm, and he did not want to get into our
jurisdiction. But having read this bill, there is no way for me
to come to any conclusion but the way the bill is in the
current form; despite their efforts to try to clarify this,
they are clearly, in my opinion, going to be on the farm.
And Dr. Ives, sitting next to you, I think if I heard you
correctly, you came to that conclusion, and others brought this
up.
So--you are sitting next to each other, so let's try to get
to the bottom of this. Why do you think I am wrong? You know,
it just--it is kind of like what we have been involved in here
with the SEC and the CFTC, where these folks that want to take
the CFTC that never caused any problem at all--that didn't have
any collapses in this financial crisis--and give them to the
SEC, which screwed everything up.
Now, I would not say that FSIS is perfect or that the work
that we have done is perfect, but I would argue it is a heck of
a lot better than what FDA has been doing. So, where we are
coming from here is, we want to be helpful to make FDA more
productive, but we think if it gets--if it muddles up the
situation, we are actually going to be worse off.
I am going to be meeting with Mr. Dingell and Mr. Waxman
tomorrow to propose some language to them to clarify this, and
we will see whether we can do that.
But would you support further efforts to clarify that?
Ms. Tucker-Foreman. Mr. Chairman, I would not support ever
giving FDA any of the authority that USDA currently has to
inspect and regulate meat and poultry, the safety of meat and
poultry products.
I think their system of HACCP-plus-inspection works
reasonably well.
You know that there are other things we want there. FDA has
had some authority for on-farm activities as long as I can
remember. If they think, for example, that drugs, animal drugs,
are being misused, they can go on the farm. There is a reason
and they have some expertise at FDA to have them involved in
produce safety.
The Agricultural Marketing Services and the Leafy Greens
Agreement are completely voluntary. If somebody doesn't want to
follow the rules, the only penalty is they don't get to use the
label anymore. David Shipman, the acting Administrator of the
agency, was before this Committee a month ago saying FDA is the
food safety agency and FDA ought to have the primary
responsibility for assuring the safety of produce on-farm. And
they do have the expertise; they developed draft guidance
documents, two of them now over the past several years to do
this.
I don't think anybody anticipates that FDA is going to have
a flock of personnel out on farms. They have spoken about
working with state agencies to enforce these regulations when
they get them, and I think that is entirely appropriate.
The Chairman. Well, thank you.
What I am going to suggest to them is to clarify this in
terms of livestock and grain. The food and vegetable people
acknowledge there is a place for FDA, and they actually, as
part of what we are going to suggest, in making sure that we
get that in the legislation. It is a combination of clarifying
it for grain farms, livestock farms, and then having the
regulation that the food and vegetable people want brought into
the legislation in a way that they think is workable. So that
is what we are going to try to achieve.
And, I just hope that people will work with us and the
Committee will, because if they don't fix this, I am thinking
about having a markup and reporting this bill unfavorably if we
don't get this resolved.
I don't see any reason why we can't get this resolved. Mr.
Dingell seems to want to work with us on this, and we will try
to do that.
But, from my reading of this at the present time, in terms
of livestock and grain farms, I think there is a potential
problem; and we would like to get it clarified.
Ms. Tucker-Foreman. I certainly thought the language was
dispositive in maintaining current jurisdiction and exempting
anything that is regulated by the Federal Meat and Poultry
Inspection Acts.
So I am curious to know what the problems are.
The Chairman. Well, we can visit about that.
Ms. Tucker-Foreman. Okay. Thank you.
The Chairman. But my time has expired.
The gentleman from Virginia, Mr. Goodlatte.
Mr. Goodlatte. Thank you, Mr. Chairman. I would like to
follow up on that with the entire panel.
I think everybody agrees that there are some things that
can and should be done here to improve food safety. A lot of
things are being done, and it is important that the public know
that we have, based upon the statistics on foodborne illness,
the safest food supply in the world. But there are always going
to be ways you can improve on that and help to avoid more of
the families that we are seeing here today. So I don't think
there is anybody who would disagree that we can do more.
My question to each and every one of you is--and we will
start with you, Mr. Wooten--do you support the bill that was
reported out of the Energy and Commerce Committee, the Waxman
bill, in its current form? Not how you would like it to be, not
with some changes you would like to see; do you support it or
oppose it in its current form?
Mr. Wooten. In its current form, we really have some
reservations about supporting it. There are questions that we
feel need to be resolved before American Farm Bureau could
support this bill.
Mr. Goodlatte. In its current form then, I take it you
would oppose it.
Mr. Boyle?
Mr. Boyle. Mr. Goodlatte, we have expressed concerns to the
Committee, prior to the markup, about a number of the
provisions, not so much because of how they would apply to the
companies we represent, who are regulated under FSIS
authorities, but because of the precedent that they may
establish that may one day apply to the companies that we
represent.
And I articulated my concerns in both my written and oral
testimony. They concern the very prescriptive nature of the
HACCP authority that is in that bill, the availability of civil
penalties that FDA could apply to food companies under its
regulations, mandatory recall.
The user fee precedent is extremely troubling.
Mr. Goodlatte. I am going to cut you off because I don't
have very much time. I have to go all the way down the line,
and I have some other questions I want to ask, too.
So in your current form, do you support it or oppose it?
Mr. Boyle. We have not taken a position in favor or
opposition, but we do have concerns about the precedent.
Mr. Goodlatte. Ms. Tucker-Foreman?
Ms. Tucker-Foreman. The ten organizations I am here
representing support the passage of the bill.
Mr. Goodlatte. Dr. Ives?
Dr. Ives. NCBA does not support the current bill.
Mr. Goodlatte. Mr. Peppler?
Mr. Peppler. National Farmers Union has not taken a
position on the bill. And as it is right now, we have some
severe reservations on it.
Mr. Goodlatte. So you would not support it in its current
form?
Mr. Peppler. Probably not.
Mr. Goodlatte. Mr. Reinhard?
Mr. Reinhard. The National Turkey Federation has concerns
with the bill as it exists and thinks it could be strengthened,
but we have not taken an official position to support or oppose
the bill.
Mr. Goodlatte. But you would not support it in its current
form?
Mr. Reinhard. We would like to work with the Committee and
Congress.
Mr. Goodlatte. I am not taking that away from you at all. I
know that is a concern each and every one of you has. But you
don't support it the way it is right now?
Mr. Reinhard. That is correct.
Mr. Goodlatte. Mr. Maravell?
Mr. Maravell. I can speak just for myself, so this is easy.
I have severe reservations about the bill, and I could not
support it as is. And I have communicated some of those
reservations with my fellow farmers, and tried to communicate
those with the Committee and Committee staff as well.
Mr. Goodlatte. Mr. McDonald?
Mr. McDonald. There has definitely been great improvement
in it, but at this point we are not in a position to support
it.
Mr. Goodlatte. Okay. All right. Thank you very much.
Let me ask Mr. Wooten, representing the Farm Bureau, is it
appropriate for the Food and Drug Administration to establish
mandatory food production practices on the farm? And if so,
what resources and expertise does the FDA need in order to set
and enforce such standards?
Mr. Wooten. Well, the FDA obviously is not equipped at this
point to look at agricultural practices. We certainly think
they ought to work, as one of the witnesses said, closer with
those folks that are on the ground, the state agencies, in some
type of partnership with the state agencies and, where
appropriate, the private industry to make it work.
Mr. Goodlatte. In your testimony about record-keeping, you
expressed concerns about the lack of confidentiality
protections in H.R. 2749. What sorts of information are farmers
typically worried about being disclosed?
Mr. Wooten. It would be difficult. I mean, the types of
information that may be disclosed would be production methods,
some costs, types of products used. I mean, there would be some
real questions there.
Mr. Goodlatte. Okay.
Dr. Ives, I am concerned about the Waxman proposal for FDA
to establish mandatory on-farm production practices.
Is it fair to say that there is a great deal of variety
among cow/calf operations? Is it possible for the FDA to write
a one-size-fits-all standard for cattlemen?
Dr. Ives. No. You are exactly right, there is a tremendous
amount of diversity within our organization, all the way from
the cow/calf through the stocker phases into the feed yard. And
there is absolutely no way one size will fit all.
Mr. Goodlatte. Mr. Chairman, if I might, I have one more
question I would like to ask to Mr. Peppler.
In your testimony, you refer to a lack of resources
hampering the effectiveness of our Federal food safety system.
To the best of your knowledge, has the FDA or the USDA been
receiving less funding than they have requested for food safety
activities?
Mr. Peppler. Could you repeat it again, sir?
Mr. Goodlatte. Sure.
The question is, you refer to a lack of resources hampering
the effectiveness of our Federal food safety system; and I am
wondering if you can help us quantify that.
To your knowledge, has the FDA or the USDA been receiving
less funding than they have requested for food safety
activities?
Mr. Peppler. I can't answer that. But I am working off the
statistic that on the imported food we are only inspecting one
percent of it.
Mr. Goodlatte. I saw a chart that was put up by Mr. Boyle
that showed there were about 8,000 workers inspecting 6,300
facilities related to meat processing, and 1,800 inspectors,
less than a quarter, inspecting 136,000 nonmeat or other food
processing plants.
Would you say that the biggest disparity, the biggest
problem here, exists on the FDA side of not adequately
providing the number of inspectors that are needed for those
types of facilities?
Anybody else want to try that one?
Ms. Tucker-Foreman. If I could, sir, we certainly agree
that the FDA needs additional resources. And in the last year,
Congress has begun--in the last 2 years, Congress has begun to
give them additional resources.
The biggest problem is that FDA has no specific
responsibility to prevent foodborne illness, and they do have
an arrangement under law where they have to provide services to
meet the user fees that are collected under the drug and device
laws.
So part of the reason they don't have the resources is that
Congress has set up a system that has sucked the resources out
of FDA. But until they have a responsibility to prevent, I
don't know that just resources will fix the problem.
Mr. Goodlatte. Well, I agree that resources alone will not
fix the problem. But if you have one inspector responsible for
60 or 70 food processing facilities, it is awfully hard for
them to either play a role in food prevention or inspection.
So it is certainly a key ingredient. And, you and I could
probably agree on some other things that could be done as well.
Where you and I would disagree is whether that FDA
inspector of any kind would be in any way fit to go onto farms
and set up systems that would in any way be effective at
preventing food illness.
I yield back, Mr. Chairman.
Mr. Holden [presiding.] I thank the gentleman.
Mr. McDonald, there is a company in my home State of
Pennsylvania, Hanson Technologies, that has developed
technology that can test the wash water of produce for
Salmonella and E. coli at the processing level. Their
technology has the ability to perform screening of the entire
produce lot, without culturing, in 2 hours or less after sample
collection, which is the fastest, most comprehensive testing
available.
And, Mr. McDonald, in your testimony you seem to disagree
with final product testing. But do you think that the produce
processing industry would benefit from being able to rapidly
test for common pathogens? And do you think they should be
required to do so in order to verify that their food safety
plans are working?
Mr. McDonald. Thank you for the question, Mr. Holden.
I actually have pretty intimate knowledge of their process.
We have a research facility that we set up with them, and spent
more than a month; and I am actually on their advisory board as
a technical--in a technical capacity.
And it is a great concept. It is essentially using a
biotracer to identify in a very rapid manner.
It is not as simple as a finished product test. In fact,
what it really is testing is the water, the wash water, which I
agree with to some extent; technically, it is in the right
direction. It is a great example, though, where the technology
is not quite ready yet for prime time, so to speak.
So we absolutely are looking at those kinds of approaches.
Is it the answer that is going to solve it? Any finished
product testing, again, it is going to tell you what happened
already; and it may have some preventative components, but
really what you have to do is go to the process before that.
Mr. Holden. Thank you.
I have one more question for members of the panel. I think
Mr. Peppler might have referred to this in his testimony.
Some recommended food safety practices on the farm may be
in direct contradiction with good conservation practices. For
example, removing wildlife habitat from around farm fields to
reduce the possibility of animal contact with produce might be
encouraged for food safety purposes, but runs directly counter
to environmental conservation principles.
I am just wondering if anyone on the panel has any opinion
about that.
Ms. Tucker-Foreman. If I could, sir, there has been some
criticism of that in the media just this week.
The complaints that are being made about the sterile
borders around fields are steps that have been taken solely in
response to private contractual obligations; that is, if you
want to sell to a particular company, the farmer says you got--
the company says you have to take these steps to make sure that
your field is sterile.
We favor a science-based system there. And in fact, one of
the requirements in H.R. 2749 is that the FDA establish
science-based requirements. That they take into consideration
the environmental impact, and that they consult with the USDA
in the development of these activities. So this is something we
have been extremely sensitive to, because none of us has any
interest at all in encouraging practices that would take away
important wetlands or wildlife habitat.
But what is happening right now is happening as a result of
private contracts. If FDA set standards, it might encourage a
change in those private contracts.
Mr. Holden. Anyone else? Mr. Peppler or anyone?
Go ahead, sir.
Mr. Maravell. Okay. Thank you, sir.
With regard to organic and various types of sustainable
production, we have to have a diversity of habitat in our
production system, which would include both wildlife and, for
insects, beneficial insects.
So our system is based upon bringing in natural elements
that keep pathogens and destructive pests in balance. And if we
have to take away those purposefully kept wildlife habitat
areas, it would decrease--I mean, we would have to find another
way to control pathogens and pests.
Mr. Holden. Mr. Peppler, were you trying to respond?
Mr. Peppler. Yes, sir.
I believe in my written testimony there is a copy of an
article that talks about exactly what you are talking about,
concerning a farmer in California that had a private marketing
order and was forced to destroy his environmental buffers
around his field.
So, definitely, that would be a concern.
Mr. Holden. Thank you.
Mr. McDonald. May I? Is the time up?
Mr. Holden. Briefly.
Mr. McDonald. Just very briefly, I agree with Ms. Tucker-
Foreman and the other comments.
I will say, having been involved in the Leafy Greens
Marketing Agreement, this issue did come up very much in the
beginning and quite aggressively. And a lot of it was left,
because of misinterpretation of the standards, the marketing
agreement went above and beyond that to kind of address it.
It is probably a small percentage at this point. It is
something that needs to be addressed, but there is no reason
that they can't be--they shouldn't contradict each other.
Environmental policy and food safety buffer zones, these kinds
of things, should not be in conflict.
Mr. Holden. Thank you.
The gentleman from Kansas, Mr. Moran.
Mr. Moran. Mr. Chairman, thank you. I yield my time to the
gentleman from Texas, Mr. Conaway, who believed he had arrived
prior to me, and was entitled to my time.
Mr. Conaway. I did point that out to him. I hope that the
Chairman will be open to some conversation about his unilateral
decision to alter the Committee rules, because it is nice to be
able to get here, on time, and sit through the witnesses and
listen, and not have some ranking------
Mr. Moran. Reclaiming my time------
Mr. Conaway. Ms. Foreman, in all seriousness, thank you for
bringing three examples of heartbreaking stories of where the
system either didn't work or couldn't have worked, showing how
important it is for us to get this right and setting a backdrop
for us to have this conversation. If we have disagreements as
to how we get to where we want to get to, it is not because we
are callous and heartless and insensitive to the heartbreaks
that these three families have suffered as a result of these
tragedies, but it will be legitimate differences of opinion
between informed individuals where we might wind up.
I am concerned, as some of the others have testified, that
particularly when you use the word ``anticipate'' having a
legion of FDA folks running around--legislation doesn't really
allow you to write in anticipations. I am worried about the
unintended consequences this legislation may have by having FDA
reach into the farm prior to conversion of farm products into
food, that would be detrimental to the system and the overall
regulatory impact that has.
I was curious, Mr. McDonald, you mentioned there weren't
any audit standards for the industry to comply with; and yet
later on in your conversation, you said the industry had in
fact come up with some standards in other areas. And I am
curious as to why the processors, the growers, the producers of
a particular product that wanted to have an audit system in
place so that the buyers could use it and rely on it, wouldn't
come up with a voluntary set of standards that the collective
group could agree to, and then have that rolled out, as opposed
to each company that buys setting up its own standards.
Is it not a possibility for something like that to occur,
where the industry itself could self-regulate the process?
Mr. McDonald. Yes. Thank you for the question. It is
absolutely possible. And that is the example I gave in the
Leafy Greens Marketing Agreement.
There is a perfect example where actually not only
industry, but industry and government came together, along with
academia, to develop standards. Essentially, they took the FDA
guides, existing guides, that are very good, and came up with
specific metrics that everyone agrees upon, and then using
government auditors to actually inspect against.
Mr. Conaway. Okay. You had mentioned that there were
multiple audits available and that some of the audits--and
maybe I misunderstood------
Mr. McDonald. Yes. So the first part of it is, there is a
redundancy, and numerous amounts of audits that are driven
mainly by kind of the buying community, because there isn't an
FDA standard approach.
So it is two extremes. You have no standard as far as the
government, something that is not very clearly measurable; and
then you have a proliferation of third-party audits that are
driven by the buying community.
Mr. Conaway. I guess that is the group I am focusing on.
Why wouldn't that group, along with the growers and the folks
that have to comply with those audits, why wouldn't you work
through a process so that everybody gets it as close to as
workable as you can? And I trust that system far more than I
trust FDA coming up with those audit standards.
Mr. McDonald. Exactly. And the Leafy Greens Marketing
Agreement is that scenario.
Mr. Conaway. Okay.
Mr. McDonald. It still takes time to get everyone convinced
of it.
Mr. Conaway. Even though there is the economic reason why
it is clearly better. Okay.
Mr. McDonald. Absolutely. Yes.
Mr. Conaway. Thank you, Mr. Chairman. I yield back. And I
appreciate--yield back to the gentleman from Kansas my minute
and a half.
Mr. Moran. Mr. Chairman, I yield back the balance of my
time.
Mr. Holden. The chair thanks the gentleman and recognizes
the gentleman from North Carolina, Mr. McIntyre.
Mr. McIntyre. Thank you, Mr. Chairman.
And I want to say to Larry Wooten thank you for your
leadership, your commitment to agriculture, and your service to
our nation's farmers and ranchers through your work with the
Farm Bureau.
Some of you may not realize, but Larry Wooten grew up on a
small farm in Pender County in the Congressional district in
southeastern North Carolina that I have the opportunity and
privilege to represent.
And thank you personally and professionally for the
commitment I know you have and the service you give. I wanted
to ask you a question.
On page six of your testimony, you discuss your concerns
about the bill that the Energy and Commerce Committee has put
forward as it relates to FDA authority to come onto a farm and
search production records. Specifically, the bill would remove
language in the Bioterrorism Act that requires FDA to have a,
``reasonable belief'' that a product is harmful to public
health before they can inspect a farmer's production records.
As you know, I have had serious concerns about the FDA
coming on the farm. That has been a battle cry that many of us
have had in North Carolina in our concerns, as well as
nationwide, about the FDA coming onto the farm.
Would you please elaborate on what your concerns are about
the FDA coming on the farm, and this specific provision that
would remove that requirement?
Mr. Wooten. Well, obviously those of us in North Carolina,
we are working, particularly tobacco producers, are working
with FDA on FDA coming on the farm dealing with tobacco, as
well you know, Congressman McIntyre.
We just think that this bill says explicitly that FDA can
come on the farm. There is explicit record-keeping. We have
just got real concerns about a Federal bureaucracy that can
come to any farm in North Carolina or another state without a
reasonable reason for being there.
Mr. McIntyre. Let me ask you this. I know our time is
limited.
Last summer, the FDA falsely advised consumers against
consuming raw tomatoes--all of us in this room will probably
remember that--when tomatoes were never part of the food safety
incident in question.
Could you elaborate on this situation and the hardship it
caused producers? And would you support some type of indemnity
initiative for producers who have been negatively impacted by
mistaken determinations by the FDA?
Mr. Wooten. No question about it, that was a terrible
thing. It caused terrible financial hardship on many producers
not only in our state, but around the country. And myself, as
well as American Farm Bureau, we have in policy to support
indemnification back to producers where agencies of
government--whether it be FDA, CDC or whatever other agency of
government--makes erroneous accusations that hurt farmers, that
there needs to be an indemnification program there.
Mr. McIntyre. Thank you.
Mr. Maravell, in order to comply with the new food safety
rules, producers such as you would have to keep significant
records on production and handling practices that must be
available to FDA inspectors on demand. We know that failure to
produce accurate records may result in serious monetary fines,
even if those record-keeping errors do not directly endanger
food safety at all.
As a producer, are you concerned about your ability to
comply with these potential regulations and civil penalties?
Mr. Maravell. Yes, I am. Let me just state that as an
organic producer, we already have a close relationship with the
USDA program. And I don't want to overstate this, but after one
of my inspections, because we are inspected annually, one of my
employees said, ``You don't really need a farm to be certified,
all you if need is a file cabinet.'' Because we have--and I
have multiple file cabinets; we have tremendous documentation.
If documentation on my production practices were to have an
inadvertent mistake, I am not subject to a fine unless it
produces an adverse effect and I violated the law somehow--I
mean, if I put something in the wrong file, put the wrong
number on something, if there is no harm.
So let me just say that, yes, I am very concerned about
this. And I am also concerned about not understanding what
aspects--because I run a diversified operation, I don't know
what aspects of my program are going to be subject to the new
provisions in this bill. And so I am a little concerned that
FDA comes in and requires information on demand, and I may not
have it in the format that they want it, because I have the
information, but I have it fed into a different program. And my
program has a very good safety record.
And I don't know--as the Chairman was referring to--I have
grain storage facilities, I have feed grinding facilities. Does
that automatically put me under new types of record-keeping? I
already provide all that information to my certifier. My
certifier is already accredited by USDA under the organic
program.
So, yes, I am very concerned. I spend a lot of time putting
all of this information together.
I would like to make one point about that, however. This is
a voluntary program. I don't have to be an organic farmer. I
choose to be an organic farmer, and so I am willing to make
that extra effort to be in an organic program. And it is a
program that is a public-private partnership. It is a program
where we have private certifiers, as well as my certifier
happens to be public, the Maryland Department of Agriculture,
working together with the Federal Government. And our record-
keeping responsibilities are appropriate to the size, scale,
and scope of operation and the type of production methods that
we use. So I feel comfortable with the record-keeping that I am
currently engaged in.
If I have to do this all over again, I feel very
uncomfortable, because I feel as if I already have the
information, I just don't have it the way they want it, or I
can't get it fast enough or something like that.
Mr. McIntyre. Thank you.
Thank you, Mr. Chairman.
The Chairman [presiding.] I thank the gentleman.
The gentleman from Texas, Mr. Neugebauer.
Mr. Neugebauer. Thank you.
One of the things, as I looked at the proposed legislation
and listened to the testimony that we had today, it occurs to
me that even in this bill everything is looking back. In other
words, it is based on, if an event happens, we can go and
identify where that source was, and that then, hopefully, we
mitigate something after it has happened.
The question I have is, if we implement this legislation as
it is, how significant of an increase in food safety are we
actually going to have in relation to the cost? And when I talk
about cost, I am not trying to put a value on anybody's life. I
mean, anytime we lose anybody for any reason it is a tragedy.
But what I wonder is, sometimes in government we try to
throw a bunch of government at a problem, and what we find in
the end is, we just threw a bunch of government at the problem
and we really didn't basically improve what we were actually
trying to accomplish.
Everyone in the food business or in the agriculture
business has a huge vested interest in getting this right. And
as I heard--and I appreciate Mr. Goodlatte asking that
question--how many of you supported this bill. But, the most
important question I have today is, is this bill going to make
a significant difference, or do we--are we still not where we
need to be? Do we need to take more time if we are going to
have a comprehensive food safety program in this country--have
more hearings and make sure that we are actually addressing the
problems where they are? Because in any system there are
sometimes gaps.
And so the best policy to me is filling the gaps, not just
throwing another blanket over the problem.
So just in the remaining time, just kind of to get a
feedback, does this bill do it or do we need more study and
more work to make sure we are filling the gaps?
Mr. Wooten?
Ms. Tucker-Foreman. Is that to me, sir? I didn't know if
you were addressing that to me.
Mr. Neugebauer. To the panel. Anybody who wants to jump in.
Mr. Boyle. I will take a shot at a response, not so much
specifically about the bill, but about your overarching concern
and question: Do the government standards really result in a
demonstrable improvement in public health? And in terms of two
of the strictest standards with which my members deal, E. coli
and Listeria, there has been some demonstrable improvement in
foodborne illness data associated with those two pathogenic
bacteria.
We also have invested a lot of money on reducing the
incidence of Salmonella in our beef, pork and chicken products
and turkey products. There have been significant reductions
over the last 10 years, Congressman, between 60 and 70 percent
in each one of those product categories. Yet, the incidence of
illness associated with Salmonella has increased about 14
percent over the last 8 years.
So we have reduced the presence in our products, but yet we
haven't had a positive impact, a positive public health impact.
And that is a legitimate area of inquiry for the Congress and
for the regulators.
You impose costs, but you have to be able to demonstrate
benefits, too. And that is a concern that we have in the
industry.
It is also an area where we could make better regulatory
and legislative decisions if we had more specific food
attribution data from the CDC. They can estimate how many
Salmonella illnesses occur a year, but they can't tell you
which food products are associated with those numbers of
illnesses. Therefore, you can't target your resources to the
products that are causing the incidence of those illnesses.
Mr. Maravell. Congressman, as a farmer, everybody knows the
saying, ``If it ain't broke, don't fix it.'' I guess my feeling
and my reaction in reading this bill is that if there are
science-based and identified high-risk areas, we should
investigate how to go after those and solve those.
My concern is that, in 30 years, I have never--as an
organic producer, I have never had a food safety issue arise.
Food safety is always on my mind. And as a small operator, I am
responsible for the growing, the harvesting, the slaughter, the
packaging, the processing, and the marketing. If I detect
anything in that which I feel is faulty from a food safety
perspective, I can make the decision like that to change it. I
don't need to go through a corporate committee or an outside
consulting study. You know, I can effect it and do it right
away.
And I probably shouldn't say this, but I am probably more
concerned about food safety than most of my customers are. I
have to constantly--I have personal contact with my customers,
and I must say that you need to always remind your customers of
proper food handling characteristics. And we do things that go
beyond what we would be required to do, because if there ever
were a food safety issue, the customer isn't going to be
wondering what they did, they are going to be wondering what I
did. And so that is why we have to be extra vigilant.
But getting back to your question, if there is legitimate
scientifically-based areas, or problem identified in certain
production practices, then we should definitely investigate
those areas and go after those areas.
In my case, I am not aware of any in the types of products
that I produce; and so I feel that this is a broad-brush
approach, where we should be focusing mainly on those areas
where we can get the biggest bang for the increased expenditure
of funds and increasing the authority of the FDA.
Mr. Reinhard. I would just like to reiterate that the
National Turkey Federation, as Mr. Boyle said and others have
said, really does believe in the principles of preventive-based
food safety systems. And certainly when you are looking at
where you are going to put resources, how you are going to go
about dealing with those issues that occur, preventive is where
everyone wants us to be. And to drive consumer confidence, it
is most important that the preventive-based methods be what we
focus on.
Anything after product is produced is after the fact. And
it didn't really achieve what is the desire of everyone in this
room.
Mr. Wooten. At American Farm Bureau, we have looked at all
these bills dealing with food safety; and our preference to
this one would be the Putnam-Costa bill, H.R. 1332, because it
engages the industry in helping figure out more of these
solutions.
The Chairman. I thank the gentleman.
The gentleman from Iowa, the Subcommittee Chairman, Mr.
Boswell.
Mr. Boswell. Thank you, Mr. Chairman, and thank you for
having this hearing today. And thank the panel. You have given
great testimony; and it is important to us.
To save time, I would like to associate my remarks, Mr.
Chairman, to what you have said and Mr. Goodlatte. I certainly
feel the same. I would like to point that out, before I ask--I
will have one question.
But last Monday I appeared before the Rules Committee to
deal with some of these issues. Antibiotics was the issue of
the day; and I want to say now, so it is in this record, that
there weren't others invited that had the opportunity to
represent farmers and ranchers and us.
And so I would like to ask, Mr. Chairman, to have the
testimony I gave there, in the interests of time, be entered
into our record here today.
The Chairman. Without objection, so ordered.
Mr. Boswell. Thank you very much. I appreciate that.
[The information refered to is located on p. 133.]
Mr. Boswell. And I just want to say that the discussion we
have just had--and I think Mr. Maravell made a good comment--
applies to all farmers and ranchers. We do not want to have
unsafe food. It is just as simple as that.
We are stewards of that. We take it seriously. And I think
every one of you would agree with that, and everybody that is
familiar with what goes on out on the farm or the ranch knows
that is a true statement. We do not want to send bad product
down the road. If we see something going on, we do something
about it.
And we don't want to waste money either. So, as Mr. Cardoza
said, who is a Member of the Committee--I am glad he was there
that day--that we are kind of tight-fisted when it comes to
spending money we don't need to spend. And on the antibiotic
issue, for example, we wouldn't do that if we didn't think it
was safe.
And we have science. We got into the discussion about the
Denmark situation--you will see that when you read the record--
and the science there and the science here. Let's just talk
about the science as we talk about other areas.
Maybe we ought to talk about energy or global climate
change. Who do you want to represent? I happen to think there
is global warming going on, and there is science to prove it.
Then you go over here, and there are scientists brought forward
that say, ``No, I don't think that is the case.''
Well, we have to have a lot of confidence in having an
excellent Secretary of Agriculture--and I've known him
personally for years and years--and a Department that is ready
to deal with this. And we have that. And we must do all we can,
working together, to be sure that these kinds of issues are
handled by the people that have the hands-on, the know-how, the
staff, the experience, the presentation made here this morning;
and it is something that is very, very important to us.
I do have one question. I will direct this, if I could, to
Ms. Tucker-Foreman. FSIS is mandated by law to have equivalent
standards with foreign countries for imports for beef, pork,
and chicken. Fact?
Ms. Tucker-Foreman. Absolutely.
Mr. Boswell. Why shouldn't the same standard apply to
seafood?
Ms. Tucker-Foreman. I couldn't agree with you more. We
think that the USDA system, which requires equivalency before a
country can send their products to the United States, is an
appropriate protection for American consumers.
We supported your efforts last year to move catfish
inspection to FSIS simply because FDA didn't have the resources
and wasn't applying any resources to enforcing it; and we got
continuous inspection for catfish.
Now the problem, sir, is that USDA began, before we had
huge amounts of international trade, and instituted this system
of prior certification. FDA had no such system. You now have
food coming in here from 100 countries. I think--I am trying to
remember, and I just can't, the number of foreign plants that
export to the U.S. And you can't go back at this point and say
that they have to stop exporting to the U.S. until they can go
back and be certified.
So we think there has to be some system that starts from
the point where we are that is not totally disruptive of trade,
but does a hell of a lot better job of protecting Americans
from unsafe imported food than we are having right now. Eighty-
four percent of our seafood is imported, and there have been
serious questions raised about the contamination with
pesticides and other chemicals.
And we join you in any support you can give for that.
Mr. Boswell. Thank you.
Because of the clock, I just want to make--if I could, Mr.
Chairman--one more comment.
I doubt--maybe there is, but I doubt there is anybody in
the room that has spent more time in Vietnam than I have--a
couple years to start with, and I was all over that country
because I was flying helicopters.
In my second tour, I was in the delta. And it is not to
brag, I could probably take you to any major city in Vietnam
without a map or navigation aid. I have seen the country.
I went back in December, as you know, you just mentioned,
and Mr. Goodlatte was along, and we went down just to have a
look. And what has caused me to want to make a comment about
this is what was in the CongressDaily today.
And people took exception. We don't want to start a trade
war, of course not, but we want safe food. We want safe food.
And we made comments--I made comments, their processing looked
pretty good, providing I don't know about the quality of the
water going through that processor, but it looked pretty good.
But the spawning and their growing places for those fish we
are talking about is putrid. I don't know what else to say. So
let's not have a trade war. Let's not worry about that. Let's
invite them to come and see how we do it. And maybe they would
like to invite our people to come over and see in detail how
they do it. That wouldn't be a bad idea. And maybe that would
be a good place to start.
But this statement from the other side of the rotunda about
this, I think maybe they ought to go have a look and see what
they think.
But I see no controls, no regulation of what is going into
those waters where those fish are spawned and raised. I think
it is something that we ought to be responsible to do. You
know, let's do it in a delicate way if we can, but I don't
think we should be ignoring it.
And I wanted that to be part of our record today.
Thank you, Mr. Chairman.
The Chairman. I thank the gentleman and thank him for his
leadership and tenacity on these issues.
The gentleman from Texas, Mr. Conaway.
Mr. Conaway. Mr. Chairman, the gentleman from Kansas has
already yielded me time.
The Chairman. He yielded it to you?
Mr. Conaway. He did. He was out of order.
The Chairman. I am finding more problems with my new
system.
Mr. Conaway. Exactly.
The Chairman. Mr. Fortenberry.
Mr. Conaway. I will yield to Mr. Fortenberry.
Mr. Fortenberry. So I get 10 minutes?
The Chairman. No.
We have a series of seven votes coming up. I will announce
at this point, we will continue as soon as those votes are over
with. And I might as well say at this point as well, too, that
we purposely put--we reversed the order, which is, I guess,
something you are not supposed to do, to put the Administration
witnesses after this panel so that the Members could have the
input from these folks and would set us up better to ask
questions of the Administration.
So that is kind of why we did what we did.
So Mr. Fortenberry?
Mr. Fortenberry. All right. Thank you, Mr. Chairman.
Mr. Boyle, thank you for your insightful comments about how
any new framework for addressing the essential issue as to how
we improve food safety has to look at how that framework
actually produces that benefit. I thought that was particularly
insightful.
But I would like to turn my attention to you, Mr. Maravell.
You have a degree and background in urban studies and you are
now a farmer?
Mr. Maravell. That is correct. Yes, I am a boy from New
York that went astray.
Mr. Fortenberry. Well, I congratulate you. Clearly, your
choice in life is an indication of what I think is a new
movement in society, and the way in which you are conducting
your operation as well.
And I thought you were very insightful, in addition to the
other comments, with this particular framework of your
language. You said these approaches--talking about farmers
markets, buying local, as well as community-supported
agriculture--represent innovations and alternatives to the
mainstream food chain. At the core, they have already
implemented transparency and connection between the producer
and the final consumer. As long as they provide safe food,
these approaches should be given incentives, not barriers.
I think, again, one of the growing opportunities in
agriculture is related to this broader philosophical movement
of a desire for a reconnection with the land between the urban
and the rural, between the family and the farm. And to the
degree that that actually is an assist in improving food
safety, it should be looked at through another paradigm,
perhaps.
We oftentimes follow into a logical, sequential decision-
making process here, where if you have a problem with food
safety, you tighten up the existing structure rather than
reexamine the paradigm. I think you are doing that, along with
a number of other people in their desire to clearly understand
where their food is coming from and to have a role not just in
consuming it, but being a part of its growth and processing.
So, with that said, I am getting a number of people who
have expressed concerns that this particular bill is going to
adversely impact--and you have laid out some specific ways,
such as the fee being necessarily unfair, the added burden of
record-keeping--but also the lack of clarity of jurisdiction,
who is defining what. I think those are important points to
make. And, it is important that we ensure, as this particular
bill goes forward, that we are not detracting from this new
growth area of farming for entrepreneurs and innovators who are
bringing new types of food production--which are really old
food production methodologies--back into the mainstream of
consumer products.
So is that a fair summary of what you suggested? The fee,
the record-keeping, added burden of record-keeping, as well as
the jurisdictional questions that remain as to what you are
going to actually have to do with the variety of platforms of
food that you grow?
People are writing, and they are concerned that they are
growing their own food, is this going to impact them? ``I am an
organic producer, how is this going to impact me? Is this going
to basically shut down--because of increased barriers, again--
this new entrepreneurial option that is growing because of
consumer demand out there?''
Mr. Maravell. Let me comment on that a little bit.
People often ask me, where are the new farmers going to
come from, because the average age of the farmer is getting
older in America. And I tell them they are going to come from
the cities. And I am an example of that, but also I see that
happening all the time, people transitioning from the cities
into agriculture on the urban fringe.
Last weekend I had a lot of customers show up, and what we
try to do is, we try to talk to each customer about what we do,
how we do it, and understand what their concerns are. We get a
tremendous reception, because the customers very rarely have an
opportunity to talk to the owner or the producer of the food
that they eat. And they have a lot of questions. They can't
figure all of this stuff out. And indeed, some of them are
saying, Well, have you seen on the Internet--and there is a lot
of misinformation going on on the Internet--that Congress is
going to make it so you can't produce organic food anymore and
things like this?
There are some legitimate concerns about being able to
communicate effectively with the consumer to say that, yes, we
are going to encourage multiple models for delivering food to
the American public. And that diversity will ultimately build
the strength of our food system and make our food system more
secure.
And as long as the efforts of this bill can continue along
those lines, recognizing the diversity of our agriculture and
the diversity of models for delivering our food to our people,
and not provide barriers so that people will say--I don't want
to go far afield here, but people thinking about entering into
the profession of agriculture who are currently perhaps, like I
was, a city boy, way back when--don't feel that the barriers
are insurmountable.
I am now considering adding additional enterprises to my
operation to make it more diverse. The first thing I come up
against are regulatory barriers. I don't have knowledge
barriers, I don't have production-based barriers. I have a
customer base that would support my going into new enterprises.
They are already buying my products. They buy other types
of products I produce. And the first thing I run into--and it
is not just food safety; I am going to run into planning and
zoning, I am going to run into farmland preservation. I mean, I
have to consult with so many different places just because I
would want to start a small dairy herd, for example, or I would
want to put some of my grains into a baked product.
Mr. Fortenberry. I am about to run out of time, so I am
going to cut you off. Thank you for your insights. Thank you
for your work.
I think, again, as we look at how to strengthen
opportunities and widen the horizons, for not only new
producers that are coming in, but alternative delivery
systems--you are on the leading edge of that--that forms
another chapter of our very important overall agricultural
production system.
So that is one end of it, ensuring that--and we certainly
want to clamp down rumors that people aren't going to be able
to grow organically, but at the same time ensure that this bill
is not putting up artificial barriers to what is already
achieving, at least to the degree that we can know it, safe
delivery of a food system. And along with the other comments
that were made, particularly by Mr. Boyle, if we implement
something new, make sure that the implementation actually
corresponds with the benefits.
So thank you all.
Thank you, Mr. Chairman.
The Chairman. I thank the gentleman.
And we are going to recess for these votes. My guess is we
will be back about 12:30. So we will recess the Committee until
the end of the series of votes.
[Recess.]
Mr. Costa [presiding.] The House Agriculture Committee will
now return to order after our recess.
I hope those of you have had an opportunity to get some
lunch. We had a series of seven votes; and, absent any
procedural votes, we should be able to finish this panel and
then move to the second panel.
I have a list of Members here who I will follow the order
based upon when they arrive, and some Members may not be able
to return because of other committee hearings or other
scheduled meetings. But the Chairman asked me to begin the
hearing again, and we will do that. I know my Republican
colleagues will join us soon, those that can make it.
But let me make a couple observations here. Chairman
Peterson and I have been working, along with Members of this
Committee, on food safety issues for, in a number of cases,
many, many years. Comprehensive food safety policy is job
number one as it relates to farmers, ranchers, and dairymen and
the panoply of agriculture in America.
As I am fond of saying, common sense tells you that farmers
are, first and foremost, consumers. They eat the food they
grow, as do their families and their neighbors. Second, they
have an economic interest in the event that there is an issue
on food safety regarding pathogens that impact the food line in
which illness or more horrific deaths may result.
So when that happens, clearly, it is something that we all
ought to guard against to ensure that we produce the safest
food in the world. And, obviously, anytime there are illnesses
as a result of food contamination, as we witnessed in the
situation with the peanut butter earlier, the market is
devastated. It is impacted.
Let me talk about the issues that are of most concern, that
Chairman Peterson and I and others have been talking about with
members of this panel. Certainly the Energy and Commerce
Committee with Chairmen Waxman and Dingell are offering to
continue to work with us, and we thank them for their efforts
to reach out, because there are overlapping issues that both
Committees have in concern.
The Food Safety Enhancement Act that has been introduced, I
believe, makes several important steps in the right direction.
But I do think I speak for many other Members of this Committee
on a bipartisan level that there are concerns. There are
concerns about the legislation that has come from the Energy
and Commerce Committee.
It is a fact that the United States Department of
Agriculture has more knowledge and experience on on-farm
practices than does the Food and Drug Administration. I don't
believe it is contrary to the mission of the FDA--the
Department that is in contradiction with efforts they focus on
food production and processing and packing, critical steps on
the food chain, that they are contrary to ensuring an important
role in maintaining the safety of that food.
I know my constituents, in what is one of the most robust
agricultural regions in the country, producing over half the
nation's fruits and vegetables, want to ensure that safety is
job number one. They are playing an active role in continuing
to raise the bar to ensure that that food safety happens in
terms of production, distribution patterns, traceability, all
the critical issues that are important in ensuring and
improving food safety in America.
We noticed last year, last summer, to take as an example,
the tomato industry as proof that the Food and Drug
Administration can make mistakes. Far-reaching provisions like
the emergency recall that is in this current legislation,
without due process, I find troubling.
I think the bill also contains provisions that deal with
geographic quarantines, which is an authority that already the
United States Department of Agriculture has for animals, which
in some instances is duplicative for products that don't--are
impacted when the Food and Drug Administration gives recall
authority or administrative detention.
There are not provisions in the current legislation that
require or shore up accountability for the FDA should they make
another error, as occurred in the tomato example last July. So
while there are a number of important provisions, we need to
work together and Chairman Dingell and Chairman Peterson have
spoken about reaching out to one another in that effort.
Fees are another critical question. How do you provide
fees? There is an appropriate role to ensure that we do our
part, whether it be specialty crops or others, but we know that
the Food and Drug Administration's budget is short and, because
of the budget issues, fees that can be adjusted yearly without
any sort of accountability I find troubling, especially for
small farms.
There are other issues, including trade, finished product
testing, and others which I think need to be addressed in this
legislation.
Finally, I think we can all agree that, at the end of the
day, we want to try to improve food safety in America. We want
to deal with qualitative analysis that ensures that American
food and fiber is the best it can be when we look at the world
markets that we compete in. We want to ensure that the
partnership that exists between American farmers and ranchers
and dairymen, the partnership that exists between them and
consumers is improved. Because, at the end of the day, of
course, the consumers are the people that we produce the food
and fiber for.
The qualitative analysis is critical here as we weigh the
issues of risk assessment and risk management, and we will be
working with Chairman Dingell and Members of the Energy and
Commerce Committee to try to iron out these differences that I
wanted to highlight here this afternoon.
With that said, I want to begin on the list here as I see
the Members who are next in line based upon the time that they
came in here.
Mr. Boswell, you have asked to yield your 5 minutes to Mr.
Kissell?
Mr. Boswell. Yes.
Mr. Costa. Mr. Kissell.
Mr. Kissell. Thank you, Mr. Chairman.
Seniority tends to work a little quicker when there are
maybe a few chairs empty.
Mr. Costa. Take advantage of it.
Mr. Kissell. I appreciate the panel staying here through
our votes.
Our special guests today, Robin and Jeff and Mr. Almer and
our guests from Chicago, whose name I did not get written down,
thank you all for being here today; and we especially think of
you as we go through this process, because this is the ultimate
example of what can happen and what we are here today for.
Once again, my thanks to the panel. I especially want to
thank Mr. Wooten for being here today. Being from North
Carolina myself, I want to associate myself with what Mr.
McIntyre said earlier about the great job that you do for us in
North Carolina. Mr. Wooten, we think in North Carolina that we
have a food safety program that is as good as anybody's in the
nation and is recognized nationally and internationally. I am
wondering just what thoughts might you have about what we do
right in North Carolina, that you would want to share with the
panel and the Committee, that we ought to take into
consideration as we look at this legislation.
Mr. Wooten. Well, thank you, Congressman Kissell; and we
must be doing some things right.
I saw yesterday that the head of the Food and Drug Division
of North Carolina, Mr. Reardon, offered his resignation and is
coming to Washington to work with FDA. So, apparently, that
news was announced yesterday.
But, you have to realize for it to be a good working
relationship it has got to be a partnership that one--as I said
earlier in my testimony, we think FDA may have some oversight,
but it needs to be in conjunction and cooperation with those
state agencies. And I know that is already in the bill, those
state agencies that have jurisdiction, that are close to the
ground.
Where we have had problems in the states, whether it be
North Carolina or other states, the local folks are on the
ground first. And I think, where appropriate, to be effective
you have to engage the private sector working with state
agencies and Federal agencies to get to the bottom of the
problem as quickly as you can for the benefit of the consumers
out there and the producers. For farmers, this is devastating.
When these type of things happen, it is devastating to those
producers, financially and otherwise. So it is important that
we get on it quickly.
Mr. Kissell. And, Mr. Wooten, also, in North Carolina we
have the opportunity for the occasional hurricane or tropical
storm, that it creates a situation where the different agencies
have to work together. And what do you think we can learn from
that in terms of being able to respond to an emergency in terms
of a problem with our food system?
Mr. Wooten. Well, I think you have to have almost an
emergency response team similar to, as you said, what happens
when you have natural disasters. Any problem with the food
supply in the country is certainly a disaster. It certainly
calls for a national concern. And, we are going to have to have
that emergency response mentality to get on it, involving all
agencies.
Mr. Kissell. One last question. And, once again--I
appreciate all the panel, and I know all my questions have gone
to Mr. Wooten, but, once again, I am very proud of what has
taken place in North Carolina. But last year when we had
problems in North Carolina, along with so many other people,
the tomatoes and peppers, I believe, what was the impact on our
farmers and what do you think needs to be a way that, when
farmers have a situation that crops are pulled, what
compensation should they get?
Mr. Wooten. Well, as I said, we believe, and I said in the
testimony, we believe that an indemnification program--when
mistakes are made by agencies of government, whether it is FDA,
CDC, whatever agency of government, that farmers need to be
indemnified for the losses when those mistakes are made.
Mr. Kissell. Once again, thank you, panel. Thank you, Mr.
Chairman. I yield back my time.
Mr. Costa. I thank the gentleman.
I have a number of questions.
First, to the panel, and you need not opine if you don't
have some quick examples to provide us. But I think it is
important, as I said in my opening comments, to understand
where there are duplicative functions that exist in food safety
legislation and that are being proposed in the legislation.
Because, given the importance to improve food safety, I don't
think anyone should--I would think that no one would believe
that we want to have duplicative efforts as it relates to food
safety.
Anyone care to comment?
Ms. Tucker-Foreman. Mr. Costa, under existing law, FDA is
the only agency that has responsibility for the safety of
commodities raised on the farm. USDA has a number of agencies
that are involved with those commodities, but they are service
agencies. I am sure you are going to hear that from the
Agricultural Marketing Service. Their purpose is not safety. It
is what the title of the agency says, ``Marketing.''
Sometimes they come together, and it is very important for
AMS and FDA to be cooperative. And if I could give you an
example that is old, but I think it is still good. When I was
at USDA, they had a problem of sulfur residues in hogs, and it
was being picked up by the meat inspectors, and people were
being penalized for it. Farmers couldn't bring their hogs to
the slaughterhouse for a period of time after that happened.
And farmers were saying, but we followed the rules. We
withdrew when we were supposed, to and we worked with--in this
case APHIS, FDA, and FSIS got together; and FSIS has no on-farm
authority. FDA knew if they went on the farm, it would be
viewed as they were looking for a violation of the law. So we
got together with APHIS and got them to go and try to find out
why this was happening.
Mr. Costa. But, Ms. Tucker-Foreman, you would say that
either today in existing law with the Federal law, or in
conjunction or cooperation with state law as in California as
in the proposed legislation, there are no duplicative efforts
that either exist or could be created as a result of this
legislation?
Ms. Tucker-Foreman. Agricultural Marketing Service------
Mr. Costa. I am not talking about the Marketing Service.
You made that statement. That is clear.
We have food safety as it relates to herbicides,
pesticides. We have food safety as required by monitoring with
USDA inspectors and meat plants. That has nothing to do with--
----
Ms. Tucker-Foreman. I thought I was specific to crop
commodities. The FSIS has no on-farm authority. FSIS's
authority begins at the slaughterhouse door. It has no on-farm
capacity at all.
Mr. Costa. But I am taking the interpretation of my
question, being to go beyond on-farm.
Ms. Tucker-Foreman. I am sorry. I thought you were
specifically asking about on-farm authorities, Mr. Costa. I may
have misunderstood your question.
Mr. Costa. I was talking about in terms of the full gamut
of our efforts to provide food safety.
Ms. Tucker-Foreman. I think there is not a lot of overlap
now. There is very little with FDA and FSIS, and they have
worked cooperatively for years together. So I don't know that
this law creates a problem there. I can't find it in this
proposed law.
Mr. Maravell. Congressman Costa, this is Nick Maravell. I
am an organic producer, and I look at the registration and
information reporting requirements in this bill, and I provide
all of that information both to state agencies and to my
certifier, which is the Maryland Department of Agriculture,
which is certified by the U.S. Department of Agriculture or
accredited by the U.S. Department of Agriculture.
So the location of my facility--because I do on-farm
processing, the location of my production areas, the exact
types of crops that I produce, the exact types of animals that
I produce, all my emergency contact information, a complete--I
maintain a complete list of all of my customers with their
addresses and telephone numbers in case there is a problem in
terms of having to do a recall.
All of this information I keep, some of which I have to
submit to my state agencies or to my organic certification, my
certifier. So I am keeping maybe not in the exact format that
this bill might require in terms of electronic, although some
of mine is in electronic form, but it may not meet the
compatibility with the Federal system. So I maintain all of
this information and a lot more information because of my
organic certification.
I pay a fee also for my organic certification as well, and
this information that I submit is submitted annually. I am
inspected annually.
Mr. Costa. Bottom line?
Mr. Maravell. The bottom line is that I would have to find
out what the new formats were from FDA and to provide yet an
additional report and additional fees for information that I am
already submitting. That is my opinion. And that is with regard
to the registration area. I am not sure if you have specific
other areas that you are also referring to, Congressman.
Mr. Costa. Ms. Tucker-Foreman, I want to move on, but go
ahead.
Ms. Tucker-Foreman. I will pass and let you go. Thank you.
Mr. Costa. Dr. Ives and Mr. Reinhard, in your testimony you
talked about the concern of livestock being defined as food and
that the bills that have been proposed were meant to exempt
livestock as food. Can you explain why that is needed and what
the pending legislation--what areas that you have concerns on
in terms of why it is needed and why the pending legislation
doesn't go far enough, as it relates to those issues you
outlined in your testimony?
Dr. Ives. I will speak for NCBA. With regard to the
definition of food, we feel very firmly that livestock are not
food until the point they get to the packing plant, and that by
not having that further defined that would give the FDA
potential ability to come on the farm and potentially place
regulations on-farm that right now would be duplicative of what
is going on right now with USDA.
Mr. Reinhard. Related to livestock specifically for Federal
inspection under the meat or poultry act, it does read that
they are exempted by the existing bill that came out of Energy
and Commerce. The concern is how that is interpreted and how
that language should go. Because at some point in time
determination has to be made when that product is turned into a
food to fall under the Federal Meat Inspection Act or the
Poultry Products Inspection Act. So Congress being able to
strengthen that and to deal with the other part that my
colleagues have testified on the fruits and vegetables and that
side of the business where the bill does specifically talk
about on-farm could be improved.
Mr. Costa. Thank you.
Mr. Wooten, I mentioned earlier about the problems last
year associated with the efforts when the FDA, I think, falsely
advised consumers against consuming raw tomatoes when they were
never actually a part of the food safety in question. I am
wondering if you could talk about the hardships that has caused
producers, and if one should consider some sort of an
indemnification effort when there are false claims such as that
that have obviously been a mistake that was made.
Mr. Wooten. Yes, sir. As I said earlier, there were
millions of dollars lost by producers in this effort. We have
some farmers--I know one farmer who is still paying back a loan
today that he incurred because he couldn't sell his tomatoes.
So it just devastated many producers not only in the State of
North Carolina but around the country.
As I said earlier, we at American Farm Bureau and our
organizations all across the country very much believe that an
indemnification program is needed as we consider this
legislation, in terms of mistakes that are made by government
agencies that wrongly cause financial hardship on producers.
Mr. Costa. Mr. Boswell, for questions or comments.
Mr. Boswell. Thank you, Mr. Chairman.
Just a couple of things to wrap up for me to Ms. Tucker-
Foreman.
Again, all of you, thank you. I am sorry we had that long
interruption there, but we don't really control that.
Do you think that the FDA has the data necessary to rate
products based on risk?
Ms. Tucker-Foreman. I just want to be sure I understood. Do
I think FDA today has the data------
Mr. Boswell. The data necessary to do this.
Ms. Tucker-Foreman. Not completely, no. And the legislation
directs them to do studies to determine what pathogens are the
greatest risk and to also assess food products.
Mr. Boswell. Thank you.
And just to move on then, Dr Ives------
Mr. McDonald. Mr. Chairman, may I answer on that as well?
Mr. Costa. You may.
Mr. McDonald. I agree completely with what was just said.
And specifically for us, as we have seen in the last few years,
it seems that the category for establishing risks--categorizing
it is based on outbreaks.
And I would just like to give an example of a customer call
that I had recently regarding onions up in Canada related to an
outbreak in a small chain up there. And this customer called
and said, oh, I see that onions were implicated; so now that is
a risk item, correct? And I said, well, not necessarily. If we
go by the kind of method that FDA has used, then yes. But we
are just going to keep adding to a list. The list will just
keep growing with any subsequent outbreak, and that is not
necessarily what risk is about as far as categorizing it.
What we really want to do and what I answered to my
customer, I said, what we want to look at is that not onions
are the risk but maybe certain practices associated with that
product. I think, at this point, FDA does not have that
information or enough of it.
Thank you.
Mr. Boswell. Thank you.
Dr. Ives, a question, if FDA considers livestock as food,
what impact would H.R. 2749 have on cattle and ranching
operations, in your opinion?
Dr. Ives. Well, it is difficult to say, because it depends
on what regulations would come down from their ability to then
regulate what we do. Currently, we have both APHIS as well as
the state agencies that regulate the movement of cattle across
the United States. It is not so much of an issue within state
but of course the international--we do get a lot of Mexican-
origin steers as well as Canadian cattle, and we are just
concerned that there is going to be an abundance of regulation
that could come down from their ability to regulate.
Mr. Boswell. Thank you, Mr. Chairman. I yield back.
Mr. Costa. Before I dismiss this panel and begin with the
second panel, I want to focus in on something that in the years
that I have served in the California State Legislature, and now
in Congress, that I always think is the crucible, the bottom
line, in terms of ensuring that we have the highest food
efficacy and safety standards that science and technology will
allow us to have. In that discussion, obviously, the science
and the technology today is different than it was 30 years ago
or 50 years ago, and it all comes down to, in my view, the
issue between risk assessment and risk management.
And, Ms. Tucker-Foreman, with your experience and
background, let me ask you first a question. When we are
measuring risk assessment versus risk management, when we are
trying to do a qualitative analysis in terms of what government
can do, whether it be at a Federal or state level, in terms of
the dollars available, the best bang for the buck to minimize
risk for the best safety standards we can achieve, I think
there is a threshold question here. Do you think it is possible
to achieve zero risk?
Ms. Tucker-Foreman. Absolutely not.
Mr. Costa. Do you think that there is a perception
oftentimes out there that somehow, just as we would wake up in
the morning and get into our car and go to work or travel
wherever, that there is some risk associated with that
exercise?
Ms. Tucker-Foreman. I should--I do. I should qualify my
statement. I think there are some foods where, in fact, there
should be a zero risk. I think all of us understand that------
Mr. Costa. What foods may they be?
Ms. Tucker-Foreman. Foods that have been cooked to a
temperature that kills the pathogens in them and not been
exposed to situations where they could get into the food after
that.
Mr. Costa. I think that is a good example. I am glad you
raised that.
Where does the responsibility then lie if, in fact, the
consumer is made aware that the food has to be cooked to a
certain level to eliminate those pathogens?
You know, I tend to like my beef medium rare, pink and
juicy. Maybe that is borderline as it relates to the pathogens.
But just as a person would get into a car, if they operate that
car in a way that they are driving it too fast, or they are
driving it recklessly or they are driving it under the
influence, great harm can result in what would be the ill-
advised practices of operating that vehicle just as cooking the
food that you just described, would it not?
Ms. Tucker-Foreman. Let me respond first by saying I heard
the phrase several times this morning ``we have the safest food
in the world,'' and I think that we take pride in this country
in having a safe food supply.
With regard to meat and poultry products, I think there is
a very high standard there, because every item of meat and
poultry comes to you with an endorsement that says USDA
inspected and approved. It is the only product I know that says
to you your government has checked this for safety. They don't
check every car for safety before it goes out. And so, there is
a very high standard with regard to meat and poultry products
because they carry that seal, and I think USDA------
Mr. Costa. But whose responsibility is it--getting back to
the point, though, if the consumer is made aware that they need
to cook that food at a certain temperature for a certain length
of time and they don't follow those--I mean, is that any
different than a person that gets in a car and drives 120 miles
an hour?
Ms. Tucker-Foreman. It is because the law says that USDA
shall not affix the seal of inspection to an unsafe product and
that product------
Mr. Costa. But it depends how the product is operated. If a
person drives a vehicle at 120 miles an hour in an urban
setting, and the vehicles are inspected, and there are laws
that say you shouldn't drive faster than 35 or 60 or whatever--
----
Ms. Tucker-Foreman. I hope there is a policeman there to
catch them, which is why we have inspectors.
Mr. Costa. Right. I agree. But who is responsible? The
person operating the car, the person cooking the food, or the
person that produced the food, or the person that manufactured
the car?
Ms. Tucker-Foreman. I think, under the meat inspection law,
the food is not supposed to be contaminated with E. coli
O157:H7, even if it is a raw product.
Now, for most pathogens, Salmonella, for example, USDA
doesn't set a standard in a raw product. For E. coli, there is.
But this is not going to be a very fruitful conversation.
Let me suggest that my organization for a long time has been
active in something called Partnership for Food Safety
Education. We think it is important that all consumers practice
self-defense, and we urge people to cook their meat not until
it is no longer pink but until their ground beef is 160
degrees. So just as a matter of self-protection, you need to
cook your food and handle it carefully.
Mr. Costa. You are probably correct. We may have to agree
to disagree on this point.
Ms. Tucker-Foreman. I think so.
Mr. Costa. But I thank you for your response.
I want to thank all of the members for their response. You
have been patient. I hope you did get a lunch during our vote
break. If you didn't, you can get one now, unless you would
like to sit around and hear the second panel.
So we will take your testimony. Members may have further
questions that they would like to ask of this panel. We will
ask the Members to submit the questions as expeditiously as
possible, and there are 10 days in which panel members will
have to respond to questions posed by Members of the Committee,
and of course that will be part of the record. So thank you for
your patience and your testimony.
Let us begin with the next panel. All right, if we can
remove those folks and please find your seats so we can begin
with the second panel.
We have Mr. Jerold Mande, Deputy Under Secretary for Food
and Safety with the United States Department of Agriculture.
In addition to that, we have Ms. Cindy Smith, acting Under
Secretary for Marketing and Regulatory Programs with the United
States Department of Agriculture. It is my understanding that
Ms. Smith will be available for questions and that she will not
present testimony.
And then we will have Mr. Taylor, Senior Advisor to the
Commissioner for the U.S. Food and Drug Administration, who
will opine on behalf of the FDA.
So we will have two of our panel members out of the three
who will make their 5 minute presentations at this time.
Mr. Mande, can we please begin with you.
STATEMENT OF JEROLD R. MANDE, DEPUTY UNDER
SECRETARY FOR FOOD SAFETY; AND CINDY SMITH, ACTING UNDER
SECRETARY FOR MARKETING AND REGULATORY PROGRAMS AND
ADMINISTRATOR, APHIS, U.S. DEPARTMENT OF AGRICULTURE,
WASHINGTON, D.C.
Mr. Mande. Mr. Costa, Mr. Goodlatte, Members of the
Committee, thank you for inviting me to appear before you today
as you review current issues in food safety. Food safety is an
important topic, and we welcome your interest.
My name is Jerold Mande, and I am the new Deputy Under
Secretary for Food Safety at USDA. With me is Cindy Smith,
USDA's acting Under Secretary for Marketing and Regulatory
Programs, who will be available to answer any questions you
might have on USDA's current activities and authorities on the
farm.
Since this is my first time before your Committee, I want
to briefly introduce myself. My career has been devoted to
public service and public health. Before coming to USDA, I
worked in positions affecting public health and food safety
policy at Yale University School of Medicine, the White House,
the U.S. Department of Labor, Food and Drug Administration, and
the U.S. Congress.
This really is an important time for food safety. I am
proud to be joining the team at USDA and to be responsible for
the Food Safety and Inspection Service, which is the public
health-focused inspection agency in the Department.
President Barack Obama, Agriculture Secretary Tom Vilsack,
and Health and Human Services Secretary Kathleen Sebelius have
made food safety reform a top priority; and they are to be
commended for taking on this difficult and challenging issue.
Members of this Committee have also demonstrated their
dedication to improving the food safety system. I think that we
all agree that we need the tools in place to achieve a virtual,
single food safety system through cooperation and
collaboration, and we cannot let this unique window of
opportunity pass us by.
Just last week, the President's Food Safety Working Group
released its Key Findings, which identified three core
principles: first is prioritizing prevention; second,
strengthening surveillance and enforcement; and third,
improving response and recovery. The Key Findings highlight
steps that USDA and FDA will take in the near future to improve
food safety by preventing Salmonella, E. coli O157:H7, and
building a national traceback and response system.
Let me tell you what we will be doing at USDA. The most
important conclusion reached by the Working Group is the
critical importance of prevention.
FSIS is moving aggressively to implement sensible measures
designed to prevent outbreaks of foodborne illness. FSIS will
develop or update performance standards to reduce the
prevalence of Salmonella and Campylobacter in turkeys and young
chickens. Performance standards demonstrate the plant's process
control by measuring the presence of the pathogen in product.
By revising current performance standards and setting new ones,
FSIS will ensure food safety improvements in the products it
regulates.
By the end of July, we will also take steps to further
combat E. coli O157:H7 in beef. For example, FSIS will provide
our inspection program personnel with streamlined, consolidated
instructions to inspect, sample, and act to reduce E. coli
O157:H7 in beef. At the same time, we will begin sampling of a
new beef component, one not previously sampled. That component
called ``bench trim'' is comprised of pieces left over from
steaks and other cuts that are then used to make ground beef.
These actions to combat E. coli O157:H7 build on a series
of previous steps FSIS has taken to ensure our meat is safe. We
have started with the most common beef cuts that are used to
make ground beef and added additional cuts step by step when
the evidence supported it. We will continue to do that.
We have carefully reviewed the current food safety bills
before Congress. In particular, we have studied H.R. 2749, the
Food Safety Enhancement Act, which I recognize is of great
interest to this Committee. We have concluded that this bill
will not change FSIS's and FDA's current food safety
jurisdictions. I know that has been a key concern of yours, so
let me state that again: H.R. 2749 would not, in our opinion,
alter the current jurisdictions of FDA or FSIS.
The President's Working Group also examined the laws that
are the foundation of our system. We need 21st century laws to
run a 21st century food safety system. With this in mind, USDA
will be seeking to modernize its food safety statutes to
address emerging threats to the food supply, new scientific
understanding of those threats, and new technologies to combat
those threats.
We seek the support and help of this Committee to find ways
to modernize our current laws. We are developing concepts
stemming from the legislative principles of the Working Group
on priorities that we think should be addressed to modernize
the statutes for the 21st century. I look forward to meeting
with each of you in the near future to discuss our ideas.
My USDA colleagues and I are committed to on all-out effort
to stop foodborne pathogens from reaching grocery store shelves
and the dinner tables of American families. An effective food
safety system is critical for all Americans, from farmers to
processors to consumers.
Mr. Costa, Mr. Goodlatte, and Members of this Committee, I
want to thank you for allowing me the opportunity to be here to
discuss current food safety system enhancements; and I look
forward to your questions.
[The prepared statement of Mr. Mande follows:]
Prepared Statement of Jerold R. Mande, Deputy Under Secretary for Food
Safety, U.S. Department of Agriculture, Washington, D.C.
Chairman Peterson, Ranking Member Lucas, and Members of the
Committee, thank you for inviting me to appear before you today at this
hearing to review the current issues in food safety.
First of all, I would like to introduce myself to the Committee. My
name is Jerold Mande, and I am the new Deputy Under Secretary for Food
Safety at USDA as of last week. Before coming to USDA, I was the
Associate Director for Public Policy at the Yale Cancer Center, where I
developed a national model to increase support for cancer prevention
and control, including diet, exercise, and obesity. Prior to Yale, I
served on the White House staff as a health policy adviser specializing
in key food safety, tobacco control, and cancer initiatives. Among the
food safety initiatives were the expansion of FoodNet and PulseNet. I
was also Deputy Assistant Secretary for Occupational Health at the U.S.
Department of Labor, and I was Senior Advisor and Executive Assistant
to the Commissioner of the Food and Drug Administration (FDA), where I
led the design of the Nutrition Facts food label. I began my career
right here in Congress where I was first hired to work on food safety
legislation. Having the opportunity to serve as Deputy Under Secretary
for Food Safety returns me to the topic that originally attracted me to
public service and I continue to remain passionate about food safety
issues. I look forward to working with the Committee in the coming
months and years.
Food safety is a priority for this Administration and the USDA's
Food Safety and Inspection Service (FSIS). I commend President Barack
Obama and Secretary Tom Vilsack for taking on this difficult issue and
making review of the current state of our food safety system a top
priority. I also appreciate this Committee's work to support FSIS and
to explore ways to improve the nation's food safety system.
I would like to begin my testimony today with a description of the
mission and a brief overview of FSIS and then I will move on to discuss
the President's Food Safety Working Group and the important
recommendations it has proposed to improve food safety.
Mission and Overview of FSIS
FSIS is the public health-focused inspection agency within the U.S.
Department of Agriculture. It is responsible for ensuring that the
nation's commercial supply of meat, poultry, and processed egg products
is safe, secure, wholesome, and accurately labeled and packaged,
whether those products are domestic or imported. We administer and
enforce the Federal Meat Inspection Act, the Poultry Products
Inspection Act, the Egg Products Inspection Act, portions of the
Agricultural Marketing Act, the Humane Methods of Slaughter Act, and
the regulations that implement these laws.
FSIS Workforce
Our statutes require us to be present for all slaughter operations
and to inspect each carcass, and we inspect each processing
establishment at least once per shift. Inspection program personnel
perform approximately nine million food safety and 1.5 million food
defense verification procedures annually at these plants. In Fiscal
Year (FY) 2008, FSIS personnel inspected about 50 billion pounds of
livestock carcasses, about 59 billion pounds of poultry carcasses, and
about 4.3 billion pounds of processed egg products. Additionally, FSIS
personnel inspected 3.3 billion pounds of imported meat and poultry
products at our borders.
In addition to in-plant personnel in federally-inspected
establishments, FSIS employs a number of other field personnel, such as
laboratory technicians and investigators. Program investigators conduct
surveillance, investigations, and other activities at food warehouses,
distribution centers, retail stores, and other businesses operating in
commerce that store, handle, distribute, transport, and sell meat,
poultry, and processed egg products to the consuming public. These in-
commerce businesses do not operate under grants of inspection and are
not inspected on a daily basis by FSIS. However, the agency verifies
that FSIS-regulated products moving in consumer distribution channels
continue to be safe and wholesome.
All products that FSIS inspection program personnel find to be not
adulterated receive the USDA mark of inspection. This is one of our
most powerful tools in protecting the public health. Denying the mark
of inspection means that the product cannot legally be shipped in
commerce and sold to the consuming public.
Data-Driven Science-Based Policies
Since 2000, FSIS has required that all meat and poultry plants
operate under the Hazard Analysis and Critical Control Point (HACCP)
system. Under HACCP, plants are responsible for identifying the hazards
presented by the products they produce and the processes they
implement, and for determining how to prevent, eliminate, or control
the occurrence of those hazards. Our responsibility is to verify that
plants are following their own food safety or HACCP plans. The HACCP
system is designed to both prevent problems from occurring and
facilitate the rapid identification and correction of problems before
they occur.
In late 2001, FSIS began to employ food safety assessments (FSAs),
further strengthening the public health protection provided by FSIS'
program. These FSAs, carried out by highly trained scientific
personnel, thoroughly assess the design of the plant's food safety
plan, looking closely at whether the establishment has fully assessed
the relevant hazards, and they verify that the establishment has put in
place controls or preventive measures that are effective. These
intensive reviews, now done on a routine basis, are valuable not only
for what they accomplish but also because they provide data that the
agency analyzes and uses to determine whether changes or refinements in
agency policy are necessary. FSIS has committed to conducting routine
FSAs in every plant every 4 years, and more frequently as needed.
Our policies at FSIS are rooted in science and based on data.
Through science-based initiatives and efforts to continue to strengthen
our infrastructure, FSIS works to prevent adulterated food from
reaching the consumer. In 2008, FSIS personnel tested about 21,300
ready-to-eat product and environmental samples using risk-based
criteria for Listeria monocytogenes and approximately 49,000 raw
product samples for E. coli O157:H7 in ground beef and Salmonella in
raw meat and poultry.
Recalls
Recalls are the last weapon that FSIS uses to combat foodborne
illness and protect public health. The purpose of a recall is to remove
meat or poultry from commerce as quickly as possible when FSIS has
reason to believe it is adulterated or misbranded. The agency issues
information about a recall as quickly as possible to the public,
stakeholders and public health partners through press releases which
are also posted on FSIS' website at www.fsis.usda.gov. FSIS also posts
lists of retail stores that received product if the product presents a
significant (Class I) public health risk.
Imports
Finally, FSIS ensures the safety of imported meat, poultry, and
processed egg products through a three-part approach. First, FSIS
establishes the initial equivalence of the meat, poultry, or processed
egg inspection system of a country that wishes to export to the United
States. Equivalence is the foundation for FSIS' system of import
safety. Second, we verify continuing equivalence of the foreign system
through annual audits. Finally, FSIS import inspectors perform re-
inspection of all shipments of meat, poultry, and processed egg
products at the border, including statistically-based random sampling
that is intended to verify the effectiveness of the foreign inspection
system.
The country-to-country approach to food safety that FSIS applies is
an efficient and effective means to ensure the safety of the products
that FSIS regulates and illustrates that our trading partners'
governments have appropriately invested in and exercised control of
their food safety infrastructure. The equivalence principle recognizes
that an exporting country can employ different sanitary measures than
the U.S. to address food safety hazards if the country can objectively
demonstrate that its safety measures achieve the same level of public
health protection as the measures used by the United States for its
meat, poultry, and processed egg products.
Food Safety Working Group
The Obama Administration has already begun to act on food safety.
President Obama announced the formation of the Food Safety Working
Group in March and called on Agriculture Secretary Vilsack and Health
and Human Services Secretary Kathleen Sebelius to co-chair the Working
Group. While FSIS and FDA have a major role in the Working Group, input
from other agencies and stakeholders is critically important. At a
Listening Session hosted by the White House on May 13, representatives
from industry, consumer advocacy groups, state governmental agencies,
and even members of your own staffs participated in breakout sessions
to discuss important food safety priorities. The members of the Working
Group value all the comments heard that day and are dedicated to
bringing all stakeholders into the picture. The public can post their
comments on the interactive website, www.foodsafetyworkinggroup.gov.
Summaries of the Listening Day breakout sessions are also available on
the same website.
Just last week, the Key Findings of the Working Group, which
incorporated some of the comments from the Listening Day, was released
and identified three core principles: (1) prioritizing prevention; (2)
strengthening surveillance and enforcement; and (3) improving response
and recovery. The Key Findings highlights steps that FSIS, FDA, and
other Federal agencies will take in the near future to improve food
safety by preventing Salmonella contamination, reducing the threat of
E. coli O157:H7, and building a national traceback and response system.
Focus on Prevention
The most important conclusion reached by the Working Group is the
critical importance of prevention. Too often in the past, the food
safety system has focused on reacting to problems rather than
preventing them from occurring. The Working Group recommends a shift to
prioritizing prevention and moving aggressively to implement sensible
measures designed to prevent outbreaks of foodborne illness.
FSIS fully supports the Working Group's recommendation to focus on
preventing foodborne illnesses from occurring. In fact, FSIS has
already begun moving in the direction of prevention by increasing its
focus on risk. As stated previously, the agency has already implemented
HACCP for meat and poultry products. In addition, FSIS has used
performance standards for some foodborne pathogens to reduce the
occurrence of those pathogens in meat and poultry products. The agency
is conducting baseline studies that will provide the data necessary to
establish new and up-dated performance standards for the foods that
FSIS regulates.
FSIS will continue to develop and implement other preventative
measures. The Key Findings highlighted two recommendations that will
work to prevent the prevalence of two common foodborne pathogens in
meat and poultry products. FSIS is moving forward to implement these
recommendations. First, FSIS will develop a performance standard for
use in reducing the prevalence of Salmonella in turkeys and will revise
the current Salmonella performance standard for young chickens. In
addition, FSIS will develop performance standards for Campylobacter for
both turkeys and young chickens. Performance standards demonstrate the
plant's process control by measuring the presence of the pathogen in
product. By revising current performance standards and setting new
ones, FSIS will ensure food safety improvements in the products it
regulates. The agency will also enhance its Salmonella verification
program with the goal of having 90 percent of poultry establishments
meeting the new standards by the end of 2010. FSIS will also provide
our inspection program personnel with streamlined, consolidated
instructions to inspect, sample, and act to reduce E. coli O157:H7 in
beef. At the same time, we will begin sampling of a beef component not
previously sampled. That component, called ``bench trim,'' are the
pieces left over from steaks and other cuts that are then used to make
ground beef. These actions build on a series of previous steps FSIS has
taken to ensure our meat is safe. We have started with the most common
beef cuts that are used to make ground beef, and added additional cuts
step-by-step when the evidence supports it. We will continue to do
that.
Strengthening Surveillance and Enforcement and Improving Response and
Recovery
FSIS is just as committed to the other two core principles
identified by the Working Group. The agency will be implementing
regulatory and administrative actions over the next 2 years to
strengthen its surveillance, inspection, and enforcement activities and
to improve outbreak response and recovery such as enhancing the
national surveillance networks for foodborne diseases like FoodNet and
PulseNet and improving coordination and communication with food safety
and public health partners in an outbreak.
To strengthen its surveillance through inspection, FSIS has been
working on a number of actions related to data integration and
analysis. The most significant initiative is the development of a
Public Health Information System (PHIS), which will integrate the
agency's data systems to allow FSIS to quickly and accurately identify
trends, including vulnerabilities in establishments' food safety
systems, and thus allow us to more efficiently and effectively protect
public health. It will be a truly remarkable new tool that will
revolutionize how our inspection program personnel work by dramatically
increasing the value of their observations in the field.
The Key Findings identified the following other recommendations for
FSIS. First, within 3 months, FSIS will work with other Federal
agencies to create a new incident command system to address outbreaks
of foodborne illness. This approach will link all relevant agencies, as
well as state and local governments, more effectively, facilitating
communication and decision-making in an emergency. Second, FSIS, FDA,
and the Centers for Disease Control & Prevention will work with state
and local agencies to update their emergency operations procedures to
be consistent with the new ``Guidelines for Foodborne Disease Outbreak
Response'' to be issued by the Council to Improve Foodborne Outbreak
Response this month. Implementation of these guidelines will lead to
quicker response, better communication, and better coordination by all
Federal, state, and local agencies. Third, FSIS will improve
collaboration with states by increasing the capacity of its successful
public health epidemiology liaison program to state public health
departments and expanding outreach within 6 to twelve months. Finally,
the website www.foodsafety.gov will be enhanced to better communicate
information to the public and include an improved individual alert
system allowing consumers to receive food safety information, such as
notification of recalls. Agencies will also use social media to expand
public communications. The first stage of this process will be
completed in 90 days.
Modernizing Food Safety Laws
The Working Group was charged with examining the whole picture of
the U.S. food safety system and emphasizes the need to upgrade our food
safety laws for the 21st century. The current system is hamstrung by
outdated laws, some of which were enacted over 50 years ago. While the
meat and poultry acts have been amended many times, they do not allow
us to address the significant risks facing our food supply as
effectively and efficiently as possible. These laws should be
modernized to allow for improved flexibility and coordination and to
enable USDA to move quickly to address the emerging threats to the food
supply.
We seek the support and commitment of this Committee to find ways
to modernize the current laws. We are developing concepts, stemming
from the legislative principles of the Working Group, on priorities we
think should be addressed to modernize our statutes for the 21st
century. I look forward to meeting with you in the near future to
discuss our ideas. There are currently bills before Congress to address
FDA's authorities, such as H.R. 2749, the Food Safety Enhancement Act
of 2009, but we must also modernize FSIS' statutory authorities to
create a national food safety system. There are many valuable
provisions in H.R. 2749 and we would like to see similar legislation
for FSIS. There has been unprecedented cooperation and collaboration
between USDA and HHS on the Food Safety Working Group.
In the future, once Congress passes a bill and it is enacted into
law, the cooperation and collaboration will continue as FSIS will work
closely with Congress and FDA to implement the new legislation. We
think that this modernization will be facilitated if we gather ideas
from the public and our workforce through listening sessions and other
means. For example, this hearing, as well as the one held by the
Subcommittee on Livestock, Dairy, and Poultry in April, is very useful
to gauge the input from Congress.
Not only will the modernization of FSIS' authorizing statutes
improve public health outcomes, but, in conjunction with modernization
of the Federal Food, Drug, and Cosmetic Act, it will be an opportunity
to better coordinate food safety laws and regulations across the
Federal Government.
Next Steps
Mr. Chairman and Members of the Committee, I am proud to be joining
the team at USDA and to have the opportunity to oversee the Food Safety
and Inspection Service. It is an exciting time for food safety in this
country. President Barack Obama, Secretary Tom Vilsack, and Secretary
Kathleen Sebelius have clearly expressed a willingness to tackle food
safety, and they are to be commended again for taking on this difficult
and challenging issue. Members of Congress have also demonstrated their
dedication to improving the food safety system. We cannot let this
window of opportunity pass us by.
High profile outbreaks in everything from FSIS-inspected ground
beef to FDA-inspected peanut products and cookie dough cause American
consumers to lose confidence in the safety of their food supply. For
its part, FSIS is ready to continue this dialogue and will remain
committed to improving its preventative public health infrastructure in
an all out effort to stop foodborne pathogens from reaching grocery
store shelves and the dinner tables of American families.
Chairman Peterson, Ranking Member Lucas, and Members of the
Committee, thank you again for allowing me the opportunity to be here
today to discuss our current food safety system and future
enhancements. I look forward to your questions.
Mr. Costa. Thank you, and we look forward to asking the
questions.
Next is Mr. Taylor, Senior Advisor to the Commissioner of
the U.S. Department of Food and Drug Administration.
Mr. Taylor.
STATEMENT OF MICHAEL R. TAYLOR, J.D., SENIOR ADVISOR TO THE
COMMISSIONER, U.S. FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES,
ROCKVILLE, MD
Mr. Taylor. Good afternoon, Mr. Costa, Mr. Goodlatte. I am
Mike Taylor, Senior Advisor to the Commissioner at the Food and
Drug Administration; and I want to thank you for the chance to
be here and particularly to join my colleagues at USDA.
Just last week, I started work as Senior Advisor to the
Commissioner. It really is an exciting time to be back at the
Food and Drug Administration, where I happened to work twice
before in my career. I look forward especially this time to
working closely with USDA and all of our food safety partners,
especially Congress, as we move forward to modernize the
nation's food safety system.
As you know, I also had the honor from 1994 to 1996 to
serve as Administrator of the USDA's Food Safety and Inspection
Service and to appear before this Committee in that capacity,
so it is a pleasure to be back before you as well.
Mr. Chairman, I greatly value my experience at USDA, both
because of the opportunity that I had then to work with the
dedicated people at FSIS on important improvements in the
inspection program, but also because of what I learned about
how the major elements of the nation's food safety system work
together. There is, in fact, a long history of collaboration
between FDA and various components of USDA to manage and
prevent food safety problems, and both agencies, in fact, have
a long history of working with the agricultural sector.
I am especially delighted to be coming back into government
at a time when the President, as Mr. Mande indicated, has not
only made food safety a high priority, but has called for even
greater collaboration among the food safety agencies. We at FDA
embrace that charge enthusiastically, because we know that the
vision of a modern, science-based and prevention-oriented food
safety system simply demands that we all work together.
As you also know, FDA is the Federal agency that is
responsible for most of the food supply except for the meat,
poultry, and processed egg products, which are overseen by our
partners at USDA. Ensuring the safety of FDA-regulated products
is really central. It is a vital part of FDA's public health
mission; and, importantly, our work on such topics as animal
drug approvals, animal drug residues, and animal feed supports
USDA's mission in turn in ensuring the safety of meat, poultry,
and processed egg products.
As Mr. Mande indicated, the President's Food Safety Working
Group recently issued its Key Findings, which we at FDA of
course embrace fully and Mr. Mande has outlined: prioritizing
prevention, strengthening surveillance and enforcement, and
improving response and recovery.
The Working Group noted the need to modernize the food
safety statutes to provide key tools that both FDA and USDA
need to keep food safe. At FDA, the new statutory tools that we
need, broadly speaking, include enhanced ability to require
science-based preventive controls for food safety at food
facilities; enhanced ability to establish and enforce
performance standards that ensure the proper implementation of
preventive controls; better tools to foster compliance with
science-based standards, including enhanced inspection and
access to basic food safety records; and, finally, new tools to
strengthen FDA's ability to oversee food imports.
H.R. 2749, the bill we are focusing on today, addresses all
of these authorities. But I also note, Mr. Costa, the bill that
you introduced with many of your colleagues on this Committee,
H.R. 1332, the Safe Food Enforcement, Assessment, Standards,
and Targeting Act of 2009, also addresses many of these points,
as does the bill introduced by Chairwoman Rosa DeLauro of the
Appropriations Subcommittee that oversees the budgets of our
two agencies. These bills are really important to note because
they illustrate the broad agreement that exists today on the
general direction of food safety reform toward risk-based
preventive controls to reduce foodborne illness, which is a
public health goal that, as evident from this hearing today, we
all share. That is a common objective for all of us.
Now, for FDA, one of the most important elements of the
legislation that is before the Congress that has come out of
Energy and Commerce is that it provides a mandate for FDA to
achieve specified frequencies of inspection. The legislation
also provides a funding source to help FDA fulfill its new
responsibilities. A greater investment in inspection is
critical to ensuring high rates of compliance with preventive
control standards and other food safety performance standards
that will help drive improvement in food safety and drive
reduced rates of foodborne illness. FDA thus supports the
bill's inspection frequencies for domestic facilities.
However, food imports present a significant resource
challenge. FDA plans to increase inspection of foreign food
facilities, but we are concerned that the bill's foreign
inspection mandate may not result in the best use of FDA's
resources in light of the approximately 200,000 registered
foreign facilities, and the high cost of overseas inspections.
We believe we can achieve cost-effective oversight of
imports by working with foreign governments, increasing
targeted risk-based foreign inspections by FDA, strengthening
importer accountability for the safety of the food they import,
and supporting strong third-party inspections. We think it will
take a mix of these initiatives to provide the oversight of
imports that we need.
Before closing my oral statement, I just want to say that I
look forward to the discussion that we started earlier in this
hearing, and I hope we will continue now with the scope and the
impact of this legislation on the farm. I think that is an
important discussion to have, and I hope that we can allay some
of the concerns that I have heard expressed about the scope and
impact of the bill.
There are three points that I will just touch on briefly
and we can hopefully go into a little bit more.
First of all, there is nothing new about FDA's presence on
the farm. We have already mentioned FDA's role with animal
drugs, animal feed regulated by FDA, feed additives, and
produce. FDA has a long history of being present on farms with
respect to produce and shell egg safety. Most recently, FDA
issued a new rule to address shell egg safety.
The second point is that there is a history of
collaboration with USDA with respect to on-farm matters in
cooperation with the agriculture sector in ways that have
yielded real benefit, both for food safety, for public health,
and for the agricultural sector. And we could talk about the
collaboration between FDA, APHIS, and FSIS on BSE control and
prevention, which has been a real success story that has been
very collaborative; the whole issue of animal drug and tissue
residues, which again FDA set certain standards. FSIS inspects.
We investigate when there are problems. There is a very
cooperative relationship that has ensured high compliance with
the standards to limit animal drug residues in meat and poultry
products.
I could go on. Dairy regulation--I mentioned eggs--there
are a number of examples of this sort of cooperation; most
recently, produce. With good agricultural practice and
guidance, we will be coming out with some more of those soon.
The final point that I just want to flag and I know you
will want to probe is that the bill that, as it has emerged
through the process so far, has actually done a very good job
of being very judicious about the way the bill would reach the
farm.
First of all, farms continue to be exempted from the
registration requirement and the requirements that come with
that including the fee concern I heard expressed earlier. Farms
are exempt from registration and from the fee. That applies
only to facilities as defined in the Act. Farmers are exempted
from the comprehensive preventive control requirement that
applies to all food facilities. That does not apply to farms.
Those authorities that FDA would be given to address food
safety problems that do arise on the farms, such as potentially
with produce, are authorities that require FDA to meet a
certain risk threshold to do rule making, to devise anything
but one-size-fits-all controls that really address the
particular hazard. I think that is very much in keeping with
the science-based approach that FDA believes is important for
food safety.
There are other ways in which the authorities that FDA has
to pursue traceability, to potentially require record-keeping,
these all require not only that FDA meet some test of its being
risk-based, really serving a food safety purpose, but will
require FDA to consult with USDA, which we would do anyway, and
would require us to engage the community through rule-making.
So, we have a bill here that has gone a long way towards
addressing some of the concerns here, and I look forward to
further discussion of that. Thank you.
[The prepared statement of Mr. Taylor follows:]
Prepared Statement of Michael R. Taylor, J.D., Senior Advisor to the
Commissioner, U.S. Food and Drug Administration, Department of Health
and Human Services, Rockville, MD
Introduction
Good morning, Chairman Peterson and Members of the Committee. I am
Mike Taylor, Senior Advisor to the Commissioner, at the Food and Drug
Administration (FDA or the agency), which is part of the Department of
Health and Human Services (HHS). Thank you for the opportunity to
appear before you today to review current issues in food safety,
especially pending food safety legislation. I am pleased to be here
with my colleagues at the U.S. Department of Agriculture (USDA).
Last week I was appointed as a Senior Advisor to the Commissioner
of Food and Drugs. I am happy to be back at FDA to continue my work in
the food safety arena. When I served as FDA's Deputy Commissioner for
Policy from 1991 to 1994, I was involved in the issuance of regulations
to address seafood safety and to implement nutrition labeling
requirements. From 1994 to 1996, I served at USDA as the Administrator
of the Food Safety and Inspection Service and as Acting Under Secretary
for Food Safety. While at USDA, I led the development of new safety
requirements for meat and poultry. Since 2000, my food safety work has
been in the academic and research arenas. It is an exciting time to be
back at FDA, and I look forward to working closely with USDA and all of
our food safety partners, including Congress, as we move forward to
modernize the nation's food safety system.
By way of background, FDA is the Federal agency that is responsible
for most of the food supply except for meat, poultry, and processed egg
products, which are overseen by our partners at USDA. Ensuring that
FDA-regulated products are safe and secure is a vital part of FDA's
mission, and FDA's work on animal drug approvals, animal drug residues,
animal feed, and other issues also supports USDA's vital food safety
responsibilities with respect to meat, poultry, and processed egg
products.
Food safety is a core public health issue. Every year, millions of
our friends and neighbors in the United States suffer from foodborne
illness, hundreds of thousands are hospitalized, and thousands die.
Public health has been defined by the Institute of Medicine as
``fulfilling society's interest in assuring the conditions in which
people can be healthy.'' A precondition for health is having access to
safe food.
President Obama has made a personal commitment to improving food
safety. On July 7, 2009, the Food Safety Working Group, which he
established, issued its key findings on how to upgrade the food safety
system for the 21st century. The Working Group recommends a new public-
health focused approach to food safety based on three core principles:
prioritizing prevention, strengthening surveillance and enforcement,
and improving response and recovery.
The Working Group noted the need to modernize the food safety
statutes to provide key tools for FDA, the Food Safety and Inspection
Service at USDA, and other components of the Federal Government to keep
food safe. Some of the necessary legislative authorities highlighted in
the findings include:
the ability to require sanitation and preventive controls at
food facilities, based on a scientific hazard analysis;
the ability to access basic food safety records at
facilities;
the ability to use resources flexibly to target food at the
highest risk and achieve the maximum gain for public health;
the ability to establish performance standards to measure
the implementation of proper food safety procedures; and
the ability to require mandatory recalls.
A food safety bill recently passed by the Committee on Energy and
Commerce in the House of Representatives, H.R. 2749, the ``Food Safety
Enhancement Act of 2009,'' addresses all of the above authorities and
includes many of the other key recommendations of the Working Group.
This legislation's primary sponsors include Chairman Henry Waxman of
the Committee on Energy and Commerce, Chairman Emeritus John Dingell,
Chairman Frank Pallone of the Health Subcommittee, and Chairman Bart
Stupak of the Subcommittee on Oversight and Investigations.
Another comprehensive food safety bill is H.R. 1332, the ``Safe
Food Enforcement, Assessment, Standards, and Targeting Act of 2009'' or
``SAFE FEAST Act.'' Its sponsors include many Members of this
Committee, including Representative Jim Costa, Chairman Collin
Peterson, and Subcommittee Chairmen Dennis Cardoza, Leonard Boswell,
Joe Baca, and David Scott, as well as other Members. H.R. 1332 also
includes many of the authorities identified as important by the Working
Group, such as preventive controls and mandatory recall authority.
The Chairwoman of the House Appropriations Committee's Subcommittee
on Agriculture, Rural Development, FDA and Related Agencies,
Representative Rosa DeLauro, also has introduced legislation, H.R. 875,
the ``Food Safety Modernization Act of 2009,'' which provides
comprehensive reform to the food safety statutes.
These bills illustrate that there is broad agreement on the general
direction of food safety reform toward an improvement of risk-based
preventive controls to reduce foodborne illness, a public health goal
we all share. These legislative initiatives share the core principles
identified by the Working Group: prioritizing prevention, strengthening
surveillance and enforcement, and improving response and recovery.
A coalition of consumer groups is fighting for improvements in the
food safety system so that more families do not have to suffer tragic
consequences from foodborne disease. Major sectors in the food industry
also support and are advocating for fundamental change.
But even with the President's support . . . even with the full
efforts of HHS and USDA and other Federal, state, local, tribal, and
territorial food safety partners . . . and even with the backing of
consumer groups and industry, our efforts will fall short unless
Congress modernizes food safety laws to deal with the challenges of the
21st century.
Food Safety Legislation
From FDA's perspective, there are three key questions to ask about
food safety legislation:
First, does the legislation support a new system focused on
prevention?
Second, does the legislation provide FDA the legal tools
necessary to match its existing and new food safety
responsibilities?
Third, does the legislation provide or anticipate resources
for the agency to match its responsibilities?
As H.R. 2749 was recently passed by the Committee on Energy and
Commerce, I will focus on that bill for a discussion of these
questions. I will address each of these three questions in turn and
highlight a few of the many important new authorities in this bill.
Does the legislation support a new food safety system focused on
prevention?
The legislation would indeed transform our nation's approach to
food safety from responding to outbreaks to preventing them. It would
do so by requiring and then holding companies accountable for
understanding the risks to the food supply under their control and then
implementing effective measures to prevent contamination.
FDA is eager to further the development of this modern system.
Working with USDA, industry, consumers, states, localities, and other
key partners, we will establish basic standards for preventive
controls. We will then join with states and localities to create an
integrated national system of inspection, verification, and
enforcement.
Key relevant provisions in the legislation include section 102,
which requires facilities to conduct hazard analyses and implement
preventive controls. It also requires companies to have a comprehensive
food safety plan. Section 104 requires adherence to science-based
safety standards issued by the Secretary for fresh produce and certain
other raw agricultural commodities to prevent contamination. Section
112 improves FDA's ability to share key information on food safety
between levels of government. These, and other provisions, are critical
to modernizing our nation's food safety system.
Does the legislation provide FDA the legal tools necessary to match
its existing and new responsibilities?
In a new food safety system, FDA has the fundamental responsibility
of overseeing and verifying the implementation of preventive measures
by hundreds of thousands of companies. The agency also retains the
existing critical role of protecting the public during an outbreak. FDA
needs new legal authorities to be able to succeed in these roles and
protect the public health. This legislation would provide these
critical tools.
The legislation recognizes the importance of modernizing FDA's
efforts to protect the safety of the food supply. Under sections 102,
103, and 104, the failure to comply with preventive controls, the food
safety plan requirement, performance standards, or safety standards for
produce would result in the food being deemed adulterated. An
adulterated food is subject to seizure, condemnation, and forfeiture,
and also may be refused admission when offered for import into the
United States. Section 132 makes the agency's administrative detention
authority more useful by expanding the circumstances under which the
agency can detain a food, thereby preventing its movement or
distribution while the agency takes appropriate regulatory action.
Section 134 increases the criminal penalties for certain ``knowing''
violations, including distributing violative food, and section 135
provides the agency with civil penalties when a person violates the
Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act). Together,
these authorities underscore the responsibilities of firms to only
market safe food and give the agency essential tools to enforce these
requirements to protect American consumers.
The bill also recognizes the importance of providing FDA with
improved access to information. Section 101 requires facilities to
register annually, deems products of non-registered facilities
misbranded and consequently prohibits their sale, and allows FDA to
modify the food categories that firms provide during registration.
These measures will help ensure that the agency has accurate
information about who is making food for American consumers.
Section 204 will provide FDA with important information about
commercial importers and require that they comply with good importer
practices as a condition of maintaining the registration. This section
also prohibits importing a product without being properly registered,
and deems a product misbranded if it is imported by an unregistered
broker or importer.
The requirements in this section of the bill represent significant
enhancements to FDA's authorities with respect to imported products. At
present, importers and brokers are not required to register with FDA.
These changes will reduce risks to consumers from potentially harmful
products by requiring importers to take appropriate steps to protect
product safety, and by allowing FDA to take action against importers
who do not implement appropriate measures to ensure the safety of the
products they import--similar to FDA's ability to target domestic
producers and facilities that have not taken these measures.
Section 106 provides FDA with explicit authority to access food
records during routine inspections, thereby addressing one of the most
significant gaps in FDA's existing authority. The authority provided in
this provision is essential to enable FDA to identify problems and
require corrections before people become ill. It also enables the
agency to verify during routine inspections that firms are maintaining
required records.
Although FDA has routine records access for certain other FDA-
regulated products, and USDA has routine records access for USDA-
regulated products, FDA does not have explicit authority for routine
access to records for the vast majority of foods under its
jurisdiction. This provision provides FDA with access to critical
information to identify problems before an emergency occurs. Under
current limited authority, FDA generally only has access to required
records during an emergency situation involving serious threats to
health or life. Records access and record-keeping by all persons in the
distribution chain are the key mechanisms of providing regulators with
information on plant operations, product safety, and product
distribution. Such information is necessary to verify compliance and
identify problems.
The requirement in section 107 to implement a product tracing
system for food will also provide FDA with enhanced information that
will help the agency trace foods more quickly during an outbreak. The
current requirement to keep records for the immediate previous source
and immediate subsequent recipient (one up/one back) requires the
agency to go to each point in the distribution chain during an outbreak
to trace the source and distribution of the contaminated product, which
is not a sufficiently expedient process when trying to prevent more
people from becoming ill. The ability to trace the path of any food,
including tomatoes, other fresh produce, and peanut butter, back
through every point in the supply chain to the source, or forward
through the supply chain to the retailer or food service establishment
is crucial for limiting foodborne illness during an outbreak, for
preventing future outbreaks, and for reducing the impact on the
segments of the industry whose products were not associated with the
illnesses.
Does the legislation provide or anticipate resources for the agency
to match its new responsibilities?
One of the most important elements of the legislation is that it
provides FDA, for the first time, a mandate to achieve specified
frequencies of inspection. The legislation also provides a funding
source to help FDA fulfill its new responsibilities. A greater
investment in inspection is critical to ensuring high rates of
compliance with the preventive control standards and other food safety
performance standards that will help drive improvement in food safety
and reduced rates of foodborne illness.
Section 105 proposes a rigorous inspection schedule for food
facilities, ranging from at least every 6 to 12 months for high-risk
processing facilities, every 18 months to 3 years for low-risk
processing facilities and food labelers and packers, to at least every
5 years for warehouses. These requirements start 18 months after
enactment. To meet these requirements, section 105 allows the agency to
use inspections conducted by inspectors from recognized state, local,
and other Federal agencies, and foreign government officials.
FDA supports the bill's inspection goals for domestic food
facilities. We also welcome the challenge and opportunity provided by
the bill to develop and apply the most modern approaches to inspection,
including wider use of microbial testing, to verify that companies are
meeting their prevention responsibilities and to achieve our public
health goals.
We also appreciate the flexibility the bill provides to adjust
inspection frequencies based on solid information about where we can
achieve the greatest public health benefit through wise use of our
finite resources. This flexibility would allow for more frequent
inspection of foods, facilities, and processes that we find to be high
risk and possibly less frequent inspection of facilities that we can
have confidence, based on evidence, pose low risk.
Food imports present a significant resource challenge. It is
important that food imports meet the same requirements as domestic
products, and we are pleased that the bill provides FDA with new tools
to help achieve this, including the requirement that importers observe
good importer practices and authorization to require certification of
compliance for imported food under certain circumstances. FDA plans to
increase inspection of foreign food facilities, but we are concerned
that the bill's foreign inspection mandate may not result in the best
use of FDA's resources, in light of the approximately 200,000
registered foreign facilities and the high cost of overseas
inspections. We think we can achieve cost-effective oversight of
imports by working with foreign governments, using the bill's new tools
for import oversight, supporting strong third-party inspections, and
increasing targeted, risk-based foreign inspections.
The bill authorizes three fees that are also requested in the
President's FY 2010 budget. For example, section 101 provides for a
registration fee. This fee is of critical importance to enable the
agency to increase its inspection coverage of the approximately 378,000
registered facilities and to enhance its other food safety activities.
Section 108 provides for a reinspection fee for a food facility that
commits a violation that requires additional inspections by FDA. This
will help cover the costs of reinspecting FDA-regulated facilities that
fail to meet Current Good Manufacturing Practices (CGMPs) or other FDA
requirements. Section 203 authorizes the Secretary to charge and
collect a fee for the issuance of export certificates for food and
animal feed which would facilitate trade. This fee will help cover the
cost of this program, which is necessary for firms to do business with
countries that require such certificates.
We are committed to working with Congress to ensure that FDA has
sufficient resources, including fees, to carry out its inspection
mandate.
Conclusion
This is a historic moment for food safety in the United States--a
moment for FDA and its sister agencies in the Federal Government to
rise to the challenge of the 21st century. Success means fewer
hospitalizations and deaths, fewer economically devastating recalls,
and greater health for the American people. As Secretary Sebelius
recently noted at a Food Safety Working Group listening session, ``with
the leadership and commitment by our President and so many Members of
Congress, and this renewed partnership across HHS, USDA, and our sister
Federal agencies, I know that this is the time when we will finally
make real progress and strengthen our nation's food safety system.''
The legislation is a major step in the right direction toward
achieving the recommendations of the President's Food Safety Working
Group. I look forward to working with you to address both the issues
raised here today and any other matters of concern.
Thank you again for the opportunity to discuss FDA's perspective on
pending food safety legislation. I would be happy to answer any
questions.
Mr. Costa. All right. I think you hit at the heart of a
number of our questions, but let me first go back to Mr. Mande.
In your oral testimony, I thought you mentioned that the
goal was to move toward a single food safety agency.
Mr. Mande. No, I said sort of a single food safety system,
a seamless system.
Mr. Costa. A seamless system but not a single agency; is
that correct?
Mr. Mande. What I said was a single system so that
producers and the public can look at one food safety approach.
Mr. Costa. So it is not the Administration's intent, then,
with this collaborative effort that you have spoken of, that
you have participated in to produce this report, to, in fact,
produce a plan that would create a single food agency.
Mr. Mande. That recommendation is not in the President's
Working Group report.
Mr. Costa. All right.
Mr. Taylor, you hit the nail on the head as it relates to
many of the concerns related to the certain proposed
legislation. Are you saying or am I to take from your last
comments that the FDA does not believe that it is necessary to
have the authority to inspect farms, from our grain farms in
the Midwest to our vegetable farms, where a great deal of
specialty crops are raised, to our livestock?
Mr. Taylor. No, sir, that is not what I am saying, Mr.
Costa. In fact, FDA has long had the authority under the
current Federal Food, Drug, and Cosmetic Act to inspect farms,
inspect anywhere--anyplace where food is produced or held. It
is authority that traditionally has not been exercised very
much, but it is authority that is important. Because when there
is a problem that arises and--for example, when we have
problems with a produce situation, it is essential that FDA be
able to get back to the farm, the source of production, so that
we can know what the source is, contain the problem for the
benefit of the public health.
Mr. Costa. So is it the intention of the agency, then, to
promulgate rules and regulations for on-farm food safety
practices and then to begin conducting inspections to see if
those on-farm safety practices are being followed?
Mr. Taylor. The bill will give FDA the authority to
establish on-farm safety practices with respect to produce, and
they require the agency to, on a risk basis where we believe it
would make a meaningful difference in improving the safety of
the product, to establish regulations with respect to
particular commodities or classes of commodities.
And then the question is, how do we ensure compliance with
those standards? And this is where I think we would envision
working closely with state agencies, devising a way to ensure
there is adequate oversight to verify compliance.
Mr. Costa. So it is the intention then for the agency to
promulgate rules and regulations that will provide for on-farm
inspections, and then I would assume with the fees the Food and
Drug Administration would intend to send those inspectors to
those farms to determine whether or not those rules are being
followed?
Mr. Taylor. Well, again, the first step is setting
standards; and there are a number of ways that we would go
about seeking to ensure compliance.
One role, one function of the standards would be to say to
the commercial sector, the purchasers, that these are the
standards that products are required to meet; and we would
expect, as is often the case with these standards, the private
sector would do a lot of the enforcement, if you will------
Mr. Costa. So have you taken the time to envision how many
new inspectors the Food and Drug Administration would need to
provide these on-farm inspections?
Mr. Taylor. Again, the scope of the on-farm inspection
activities can't be mapped out at this stage because we haven't
decided what commodities will be subject to the new standard.
Mr. Costa. Do you think in determining risk assessment and
risk management that that is the best way to address these
issues of safety?
Mr. Taylor. Yes. That in effect is what the bill calls upon
us to do, is to identify where the risks are and to establish
appropriate controls and standards to minimize those on the
basis of science, on the basis of where we can demonstrate this
for the benefit of food safety.
Mr. Costa. In addition to the legislation that we have been
discussing, there has been talk about FDA's authority to have
quarantine in geographical regions, the ability to provide that
quarantine for various products. Some products do move, as
animals do. Shouldn't the goal be to move away from, it seems
to me, a negative or a reinforcement or a punishment to a
geographic region in the use of this quarantine?
Mr. Taylor. Well, again, what we want to be doing is
preventing problems and not having to deal with situations that
might arise where some sort of a reaction to a problem is
needed. As I read the quarantine provision, though, that is a
provision that is aimed at a very unusual situation where there
is an imminent risk of very significant harm to the public
health.
Mr. Costa. But don't you think if you have a significant
traceback program that people have confidence in that a
quarantine is not necessary?
Mr. Taylor. Quarantine simply addresses what you do if you
do traceback to a situation where the only way that you can
protect the ag sector and the public is to contain the food
that you believe is at most risk.
Mr. Costa. But if you can traceback--we had an example last
year where Members of the Committee, not this Committee, I
believe the Committee that has jurisdiction of the bill, went
on farm; and they looked at tomatoes grown in various stores
that were being sold and traced it back to five different farms
within a period of a half an hour to a 5 hour period. Why would
you want to put a quarantine over a region when you have the
ability to trace the individual farms in which that product
came from?
Mr. Taylor. That is a very important point. One of the
values of traceback would be to target where the problem is.
Quarantine is going to be a very unusual remedy. I mean, in the
ordinary case if you traceback and you know the scope of the
problem and you can take care of the problem there is no need
for quarantine. That would be a very unusual remedy where there
was no other alternative way to contain a problem.
Mr. Costa. My time has expired; and I think the gentleman
from Kansas is next, Mr. Moran.
Mr. Moran. Mr. Chairman, thank you very much.
The on-farm performance standards that are being considered
in this legislation, a couple of questions. What is the
conclusion or the basis that FDA would be the better regulator
than USDA in regard to those performance standards? And are
those performance standards going to be compatible with what we
can expect from foreign producers of agriculture products who
import into the United States?
Under current law, meat and poultry, we have some assurance
that those meat and poultry products that are coming in are
produced under similar standards. It seems to me that we are
once again creating a significant competitive disadvantage,
increasing costs for production of agriculture in the United
States in a sector of our economy that continues to compete
with foreign producers.
Mr. Taylor. Let me address that second question first.
Any standards we set domestically for domestic producers
would have to be met by foreign producers. That is an absolute
basic principle. We can't have a separate standard for domestic
producers.
Mr. Moran. And our ability to ensure that those standards
are being met would be what?
Mr. Taylor. Well, if this law were passed, it would be this
combination of new authorities and tools that we would have to
oversee and ensure compliance with those standards. So it would
include working with foreign governments to step up what they
do. It would include for the first time FDA clearly having
legal authority to inspect foreign facilities and to prevent
food coming in if companies overseas have prevented us from
inspecting.
We need to look at strengthening, very fundamentally, the
importer's duty to manage that supply chain. That is another
important part of the puzzle. And third-party certifications
done in a rigorous accredited sort of way are all elements of
doing this.
When you have 200,000 overseas facilities, it is very clear
that there is not one sort of simple way to provide the level
of assurance that we need. And I agree with you completely. We
need that. We have to look at putting together a set of
elements to produce that result.
Mr. Moran. Would the U.S. be able to enforce those
performance standards in foreign countries?
Mr. Taylor. We would do the enforceability at the point of
entry. I mean, one of the elements of this bill is to require
the importer to maintain good importer practices, which
includes documentation of the controls that are in place
overseas and the fact that those products have met our
standards, so we have direct authority over the importer.
Plus, the bill would give FDA extraterritorial jurisdiction
over violations of the Act so that again we can begin to
address those problems upstream. I think that one of the
strengths of the bill is that it addresses FDA's need for
strengthened legal tools to oversee imports.
Mr. Moran. Are there scientific standards that are accepted
globally in regard to food safety?
Mr. Taylor. For some commodities and some hazards, yes, and
for some, no. I think in the case of produce this issue of how
you set specific, quantitative standards to try to give
benchmarks for controlling pathogens, that is a work in
progress. We have more work to do with the scientific
community, with USDA, with the agricultural community.
We have Good Agricultural Practices, sort of broad
guidances and standards; and the industry itself has started to
develop specific quantitative metrics for what would be the
microbial quality of the water used in irrigation. And we need
to move in that direction to use these science-based criteria
so we can have objective benchmarks for safety. But that is a
work in progress that this bill would really compel FDA to
pursue; and, hopefully, we would invest in the science that
makes that possible.
Mr. Moran. We have been trying for a long time to utilize
scientific-based standards in regard to, for example, meat
export, our battles with Japan and Korea and others to accept
meat products from the United States. It seems to me it has
been very difficult to reach a conclusion, and particularly
when there is a competitive advantage or disadvantage based
upon that scientific standard.
Mr. Taylor. Right. These are difficult issues, and there
are always going to be disputes, and there is a long way to go
to harmonize standards internationally. But that is a worthy
goal.
Mr. Moran. Then my question about USDA versus FDA. The FDA,
it seems to me, doesn't have the tools, the personnel, the
county FSA offices that USDA has. Is there a reason that FDA
makes more sense than USDA?
Mr. Taylor. Well, Congress in its wisdom gave FDA its
jurisdiction decades ago that FDA has been exercising and
working with the agricultural community, working with USDA on
developing guidances. I think there is actually a lot of
expertise at FDA on this subject. But FDA would not work in
isolation. I think no one could work in isolation on this
topic. We have to work with others.
Mr. Moran. Let me ask a different question on a different
topic of today's hearing. The prevention and pro-growth
antibiotics, it seems to me--in fact, as I understand it, the
President announced his support for the ban in recent days.
What has happened scientifically? What study has arrived that
says this is the new standard? Are we basing this belief on
some--it seems to me that almost in a very short period of time
we have changed our theory about the use of antibiotics; and my
question is, what is the scientific basis for that change?
Mr. Taylor. Well, actually, the scientific consensus on
this issue, that we have a public health concern with
nontherapeutic, nontreatment uses of antibiotics, that
consensus has emerged over the last several years. The World
Health Organization, our Institutes of Medicine, the National
Academy of Sciences here have made this finding before. So in
terms of scientific ground breaking, we really didn't break new
scientific ground.
FDA expressed its public health judgment really in line
with the judgment of scientific bodies, consensus bodies, that
this nontherapeutic, growth-promotion, feed-efficiency use
presents a public health concern and is not a judicious use of
antibiotics from a public health standpoint. So there is really
not new scientific ground being broken, particularly.
Mr. Moran. Was there consultation with, for example, Ms.
Smith at USDA before reaching this conclusion?
Mr. Taylor. Well, I have to take a little bit of a pass on
exactly the details of what happened before I started a week
ago last Monday, but this is--FDA has been part of an
interagency task force on antibiotics. CDC is involved. I know
there has been involvement of USDA in that process, and we can
brief you happily on all the details of that.
But, no, the FDA definitely doesn't work in isolation on
this issue. The Center for Veterinary Medicine is very engaged
with the whole animal production industry and with colleagues
at USDA.
Mr. Moran. Mr. Chairman, thank you for the time. I have not
seen Mr. Boswell's, the gentleman from Iowa, testimony before
the House Rules Committee, but I feel very comfortable in at
least commending him for his leadership on this topic of
antibiotics, and I appreciate his involvement in this
discussion.
I yield back. My time has expired.
The Chairman [presiding.] I thank the gentleman.
I think you folks, I guess, heard the testimony of the
previous panel where the livestock, poultry people, and the
grain people are concerned that the language that is in the
current bill that was marked up by the Energy and Commerce
Committee is not sufficient to take care of their concerns. How
do you interpret the situation, all three of you? Their
concerns, do you think they are valid enough?
Mr. Taylor. I did hear a number of concerns expressed
about--for example, from the standpoint of the gentleman who
runs the organic farm business, that he had the impression that
he would be required to register and pay a fee. Well, that is
just not the case.
I think there are a number of concerns about the reach of
this that really go way beyond what the bill would actually do.
Because, again as I indicated earlier, I think the bill has
been very judicious about putting boundaries around the scope
of this authority and exempting farms very broadly from the
core requirements of registration and preventive controls. So I
would like to think that we can dialogue to allay those
concerns and answer those questions. And, it is still a work in
progress, of course; but, we have come a long way to produce a
pretty well-bounded bill.
The Chairman. Do you two have any comments?
Mr. Mande. I would add that, as I said in my testimony, we
have looked at the bill, and we don't think it changes the
jurisdiction between FDA and the Department of Agriculture. I
think the one thought I'd add is I did hear some from the panel
maybe a higher comfort level with some of the work that USDA
has done over the years. And, while this legislation doesn't
change that, I think what we are witnessing, and have seen a
trend toward this, is growing cooperation between our two
agencies.
So I suspect that, as we have done in the past and will do
more of, there will be the expertise and the experience that we
have we will be sharing with FDA; and hopefully that will
assure that they benefit from the experiences we have had in
the past in carrying out new authority should Congress provide
those to them.
Mr. Taylor. Mr. Chairman, I can't help but note that your
USDA witness once worked at FDA and your FDA witness once
worked at USDA. So I think we have a good line of
communication.
The Chairman. Well, that could be, but we haven't convinced
everybody.
One of the concerns I guess the language in there where it
says you guys are to consult with each. What it is, it says you
``may'' consult. Why couldn't that say you ``shall'' consult?
Mr. Taylor. You know, the President says we shall consult,
so we shall consult. I------
The Chairman. Would it be a problem if we made that change?
Mr. Taylor. I--we are going to consult. So, if it is the
wisdom of the Congress how you want to admonish us to do what
we intend to do, we have to consult. We cannot implement these
provisions without consulting.
The Chairman. The FDA, on a livestock farm or a grain farm,
you have no intention of changing what you are doing and going
out there------
Mr. Taylor. No. I think that is the point. For the vast
majority of grain farmers, ranchers, they are not going to see
this bill making--changing their practices. We are required
under this bill to target what we do on the farm to those
circumstances where we can identify risks that can be reduced
through some appropriate intervention.
The Chairman. One of the concerns is that there was
apparently some court someplace, some judge that declared that
live cattle was food. Now, I don't know how you eat a live cow,
but that has created some concern. Do you know anything about
that?
Mr. Taylor. I am aware from my old food law days that there
is such a court case. So, I mean, FDA doesn't--it regulates
what those cattle eat, the animal feed. It regulates the drugs
that are administered to them. And it is important that those
regimes stay in place. They provide protections for farmers as
well as consumers. But, again------
The Chairman. What problem would it cause if we clarified
this to make it clear that this does not apply to livestock and
grain farms?
Mr. Taylor. I think the important thing is in terms of the
preventive control mandate and those new authorities. That is
one question. One thing you don't want to do is take away
existing authorities that FDA has had for years and has used
successfully to deal with issues. Don't get in the way of FDA's
ability, for example, I would suggest, to deal with BSE in the
way it has done that, working with APHIS and FSIS.
So I think real care needs to be exercised to not
inadvertently trim away necessary authorities to deal with
matters that, again, are important both to consumers and to the
agricultural sector.
The Chairman. All right. I thank the panel.
The gentleman from Iowa, Mr. Boswell.
Mr. Boswell. Thank you.
Mr. Moran, I didn't follow all your questions, because I
let this thing interrupt me. I apologize for that. So I may
have to ask you to help me out here a little bit.
Back to summarize that conversation, I guess I would direct
this question to Ms. Smith. Did the FDA, in fact, consult with
USDA before changing their policy?
Ms. Smith. Before changing the policy on the------
Mr. Boswell. On the use of antibiotics for feed efficiency
and growth promotion.
Ms. Smith. I am not personally familiar with what the level
of collaboration was. I know we have very recently been working
with FDA on this issue.
Mr. Boswell. You are not sure they did or did not?
Ms. Smith. I am not sure at what point in the process we
were collaborating. I would be happy to go back and check with
those that were more directly involved.
Mr. Boswell. Is it normal operating procedure for decisions
of this magnitude to be cleared through OMB's interagency
process?
Ms. Smith. Yes, it is.
Mr. Boswell. I would like to know if that happened or not.
Ms. Smith. Okay.
Mr. Boswell. Do you know?
Mr. Taylor. The testimony that was delivered Monday was
cleared through OMB.
Mr. Boswell. It was cleared.
Mr. Taylor. Yes.
Mr. Boswell. Well, I think some fence mending is going to
have to take place around here. Because that total process was
very offensive. It was like you deliberately tried to blindside
some of us on this Committee, and we really don't appreciate
that. But we have to go forward. We have to work together, and
we need to do that. So I would suggest that we may have to have
some continuing discussion about this. We may need to call the
Secretary and visit with him. I don't know. But I was stunned.
When I went over there Monday and found that out cold
turkey, if you will, it didn't seem like that is the way you
ought to be doing business here. So if that is not the way you
should be doing business, it creates doubt in your sincerity or
whether you are disingenuous or not, or just what in the heck
is going on.
This has a lot of potential impact on farmers and ranchers,
and you know that. And I think with all the experience you tell
us you have had--and I am glad for that--that you also know
that those of us who do farming and ranching we, of all people,
want the food to be safe. You heard some of that said this
morning from the first panel. And I don't mean just the organic
farmer but from all the farmers. And I have to wonder if you
really get that. I am concerned about it.
So I think we just have to take a hard look at this, Mr.
Chairman, and see what we need to do. But I didn't hear any
recommendation. Maybe I missed it, but I think your question
was from ``may'' to ``shall'' and we probably ought to do that.
I think that would be a wise thing for industry and for the
country and for the whole process.
So, with that, I am going to yield back. But I think you
better come visit with us.
Mr. Taylor. If I may------
Mr. Boswell. No, I think I am done. Thank you.
The Chairman. I will give you a chance to say what you want
to say, and then we are going to wrap this up.
Mr. Taylor. First of all, the statement Monday about FDA's
position on the public health issue here is one thing, that the
question of what the solution is to what is a difficult problem
for everybody including--certainly, we understand the
agricultural sector--I mean, what is the right solution and how
does the community come together to address what is a long-
standing concern of the scientific and public health community?
How do we address that?
And, that is the question that I hope we can have dialogue
on, and also I am sure that the folks involved in the decision
and the statement that was made would be delighted to come and
brief, and would welcome the chance to come and brief and have
that communication.
The Chairman. All right. Mr. Boswell.
Mr. Boswell. There may be another question. Ms. Smith,
could you discuss APHIS's current quarantine authority and how
it is used?
Ms. Smith. Sure, I would be happy to.
The Animal and Plant Health Inspection Service has
authority under two different areas, under the Plant Protection
Act and under the Animal Protection Act. We have the authority
to quarantine, which means we can prohibit or restrict the
importation--exportation or interstate movement, and in the
case of animals, depopulate those as well for plant and animal
pest and disease purposes. We take the action under the
authorities to maintain U.S. agricultural health and to protect
exports, export opportunities for U.S. producers, as well as to
work to protect human health in concert with other Federal
agencies as well.
In the case of livestock, we will quarantine animals to
stop the spread of disease or depopulate the animals if other
options such as testing quarantine will not mitigate the
disease spread, or there is an imminent threat to public or
animal health risk.
In the case of plants, APHIS will quarantine an area to
prevent the movement of plants and plant products such as
firewood to prevent the further spread of a plant pest. We
generally work in cooperation with states, because they
typically will leverage an intrastate authority.
The Chairman. All right. I thank the gentleman.
If there are no further questions, under the rules, the
record of today's hearing will remain open for 10 calendar days
to receive additional material and supplementary written
responses from the witnesses to any question posed by a Member
to the panel.
This hearing of the House Committee on Agriculture is
adjourned.
[Whereupon, at 2:38 p.m., the Committee was adjourned.]
[Material submitted for inclusion in the record follows:]
Supplmental Material Submitted by Hon. Leonard L. Boswell, a
Representative in Congress from Iowa
Testimony for the Record of Hon. Leonard L. Boswell, Before the House
Committee on Rules, H.R. 1549, the Preservation of Antibiotics
for Medical Treatment Act of 2009
H-313, the Capitol, July 13, 2009, 2:30 p.m.
Chairwoman Slaughter, Ranking Member Drier and Members of the Rules
Committee, I would like to thank you for allowing me the opportunity to
testify here today. I have spent most of my life involved in animal
agriculture and have seen first-hand the responsible use of
antibiotics.
I understand the issues that affect the livestock, dairy and
poultry industries having spent most of my youth working in livestock
production and today I still have a hand in managing a cow/calf
operation on my farm in Lamoni, Iowa. Once I retired from 20 years in
the Army I moved back to Iowa to begin farming. I sat down with my
local veterinarian to discuss the use of antibiotics to treat sick
animals and prevent future illness. From my experience with producers
and veterinarians, the thoughtful use of antibiotics is not the
exception, it's the rule.
During the 110th Congress, it was my privilege to serve as Chairman
of the Agriculture Subcommittee on Livestock, Dairy and Poultry. On
September 25th of last year, we held a hearing to review the advances
in animal health within the livestock industry. We were specifically
looking at how antibiotics are used on America's livestock farms. Our
witnesses included veterinarians from USDA's Animal Health and Plant
Inspection Service and FDA's Center for Veterinary Medicine (CVM),
producers, veterinary practitioners and academics from across the
country. We believe that we heard from a good cross-section of the
users of the animal health products, the doctors responsible for the
use of antibiotics and the experts studying the resistance trends from
use of antibiotics in animals.
As the Subcommittee Members listened to the witnesses, it became
very clear that America's livestock, dairy and poultry producers have a
responsibility to safeguard animal health and public health. A
responsibility they take very seriously. They are committed to using
antibiotics responsibly and have developed responsible-use guidelines
for each of their respective industries. They didn't develop these
guidelines because Congress told them to do so; they developed the
guidelines because it was the right thing to do for their animals and
their consumers.
I think that the perspectives the witnesses shared at our hearing
last year are important to the discussion here today about H.R. 1549,
the Preservation of Antibiotics for Medical Treatment Act of 2009. I
would like to take a few moments to take what we learned from that
hearing in terms of what H.R. 1549 would do to the livestock industry.
H.R. 1549 would remove seven classes of antibiotics from the market
unless sponsors can demonstrate that they are safe and effective. Our
witnesses clearly outlined the rigorous approval process that animal
antibiotics must go through to gain approval already. All antibiotics
used to keep animals healthy have passed the in-depth FDA process, and
have been shown to be safe and effective and have undergone review for
their potential to cause increased antibiotic resistance. H.R. 1549
would require antibiotic sponsors to prove again what has already been
proven during their initial FDA approval. This FDA process is a
stringent, science-based regulatory review takes years and millions of
dollars. Requiring another step undermines the FDA's process of
reviewing the human health impacts of individual animal drugs based on
science and risk assessment.
Our witnesses also shared with us that not many antibiotics are
currently available for use in livestock. H.R. 1549 overlooks the
legitimate veterinary need to preserve these antibiotic classes for use
in food animals to ensure that healthy animals enter the food chain.
There are few new antibiotics anticipated for approval by FDA, so if
H.R. 1549 is enacted and products are removed from the market place,
America's livestock producers will be left with few, if any, medicines
to prevent and control animal disease. H.R. 1549 will result in more
sick animals and it is my fear that it will leave us with a potentially
less safe food supply.
In the mid-1990's the European Union made a decision to phase out
the use of antibiotics as growth promoters. Denmark, which had a pork
industry roughly equivalent to the size of the pork herd in Iowa (which
is the largest pork producing state in the country), instituted a full
voluntary ban in 1998 which became mandatory in 2000. Many proponents
of restricting the use of certain animal antibiotics as a model often
point to this ban instituted in Denmark, citing a drop in total tons of
antibiotics used in pork production in that country. When you ban the
use of a product, it is self-evident that usage rates would drop.
Citing this obvious consequence as a rationale for restrictions in
other countries borders on the illogical. Interestingly, what the
proponents never seem to discuss are the other effects of that ban. I
would like to call your attention to the testimony received in my
Subcommittee where these effects were discussed in detail. Some of our
witnesses had even visited Denmark and seen first-hand the downturn in
swine health in that country.
After the ban became fully implemented in 1999, Danish pork
producers saw an immediate increase in post-weaning diarrhea and an
increase in piglet mortality, which has had long lasting effects on the
Danish pig industry. The increase in piglet deaths and the overall
impact on animal well-being might be acceptable if it resulted in
improvements to public health, but such improvements have not
materialized. And while overall use of antibiotics in Denmark declined,
there has been a marked increase in the therapeutic use of
antibiotics--those used to treat and control diseases. Today, the use
of therapeutic antibiotics in Danish pigs now surpasses what was used
to prevent disease and promote growth prior to the ban in 1999 and
continues to rise each year. I think the Danish pork industry can now
attest to the validity of the age-old cliche: ``an ounce of prevention
is worth a pound of cure!''
As for costs, a 2009 Iowa State University study estimated that the
effect of a ban in the United States similar to Denmark's would raise
the cost of production by $6 per pig in the first year after such a
prohibition; 10 years after the ban, the cumulative cost to the U.S.
pork industry would exceed $1 billion.
A recent study by Dr. Scott Hurd, associate professor at Iowa State
University's College of Veterinary Medicine and former U.S. Department
of Agriculture Deputy Under Secretary for Food Safety, demonstrated
that when pigs have been sick during their life, those pigs will have a
greater presence of food-safety pathogens on their carcasses. This is a
serious implication that must be considered when looking at the costs
and benefits of antibiotic use in livestock.
In all discussions on antibiotic use in food animal production, we
need to be clear what the issue really is. H.R. 1549 is confusing the
problem of antibiotic resistance in general with the faulty proposition
that blames human resistance issues on antibiotic use in animals. Most
informed scientists and public health professions acknowledge that the
problem of antibiotic resistance in humans is overwhelmingly an issue
related to human drug use.
A 2006 report from the Institute of Food Technologists, an
international scientific society, said ``eliminating antibiotic drugs
from food animal production may have little positive effect on
resistant bacteria that threaten human health.'' In fact, eliminating
animal antibiotics may be detrimental to public health.
As our witnesses outlined for my Subcommittee, antibiotic-resistant
bacteria develop from many factors, including human use of antibiotics
and routine household use of disinfectants such as antibacterial soap.
According to a paper published in 2001 in the Journal of the American
Veterinary Medical Association, people and their pets on a per-pound
basis use ten times the amount of antibiotics that are used in food
animal production. More than 95 percent of the antibiotics used for
animals are devoted to treating them for disease conditions, not as
growth promoters as many claim.
Protecting human health and providing safe food are paramount
concerns of America's livestock producers. That is why we test for
antibiotics residue as part of our food safety programs. The FDA
establishes withdrawal times or withholding periods which are times
after drug treatment when milk and eggs are not to be used for food,
and during which animals are not to be slaughtered.
If I may speak specifically to H.R. 1549, \2/3\ of the bill has
been enacted into law and should be allowed to work before removing
products from market. Provisions requiring more USDA research into the
causes of and solutions to antibiotic resistance were passed as part of
the farm bill in 2008. The Animal Drug User Fee Amendments of 2008
require FDA to collect antibiotic sales data from companies and make a
summary of that data public. The provisions were designed to provide
better information to researchers conducting risk assessments and
should be allowed to yield information before products are removed from
the market. Congress has already taken action, and we should see the
results from our action before we start removing antibiotics from the
market.
Risk assessments are an important tool in approving antibiotics and
ensuring that they are not harming public health. Voluntary risk
assessments have been done by sponsors, and FDA is now requiring
specific risk assessments for new and existing antibiotic products. Dr.
Randy Singer, a veterinarian and epidemiologist working at the
University of Minnesota, testified last September about a risk
assessment in which he participated. His team assessed the risk of the
agricultural use of the macrolide family of antibiotics poses to human
health. The research hypothesis was that since macrolide-antibiotics
are also used in human medicine, the use of macrolide antibiotics in
animal agriculture could compromise the efficacy of these antibiotics
in human medicine and potentially increase the number of macrolide-
resistant bacterial infections in people. The team developed a risk
assessment model following the format of FDA's guidance document #152.
Dr. Singer and his team of researchers found that all macrolide
antibiotic uses in animal agriculture in the U.S. posed a very low risk
to human health. The highest risk was associated with macrolide-
resistant Campylobacter infections acquired from poultry, but this risk
was still estimated to be less than 1 in l0 million and would thus meet
the standard of ``reasonable certainty of no harm'' employed by FDA-
CVM.
Dr. Singer also shared with us that animal illness likely plays a
critical role in reducing the chances of contamination during
processing. He participated with a team that developed a mathematical
model relating animal illness to human illness. In this model, there
was a large increase in human illness associated with small increases
in animal illness. This suggested to the group that agricultural
management strategies that fail to employ the judicious use of
antibiotics may have significant negative impacts on human health.
While I accept that there are those who will always believe that
antibiotics administered in feed at low doses over several weeks raise
hypothetical concerns about their potential to increase rates of
resistance, in my opinion the evidence is undeniable that these
applications improve animal health. Antibiotic uses in animals
therefore have human health benefits. This goes back to our livestock
producers' moral obligation to care for their animals and protect
public health.
If policy decisions are going to be made regarding antibiotic use,
we need to use the proper tool for making those decisions; risk
assessments are the most appropriate tool, as Dr. Singer described to
my Subcommittee. Decisions made without considering the results of
scientific risk assessments will result in unintended consequences,
including increased animal death and disease and increased risks to
public health as we saw in the Denmark example.
As your witnesses today discuss a topic that is important to the
livestock producers in not just my district and home state but yours as
well, I sincerely hope that you consider what my Subcommittee learned
last Congress. H.R. 1549 will have detrimental effects, not only on our
farmers who feed the world safe and wholesome meat and meat products,
but also on public health.
Again I would like to thank you for allowing me the opportunity to
testify before you today. I hope as a farmer and user of antibiotics I
have offered you some insight into the livestock industry's
perspective. In the United States we are very blessed to have the
safest, most plentiful, and most affordable food supply in the world.
As policy makers we must take a hard look at how our decisions affect
human health and our ability to feed ourselves and the world.
I'd be happy to answer any questions. Thank you.
______
Submitted Statement of National Council of Farmer Cooperatives
Chairman Peterson, Ranking Member Lucas and Members of the
Committee, on behalf of the more than two million farmers and ranchers
who belong to one or more farmer cooperatives, the National Council of
Farmer Cooperatives (NCFC) thanks you for your continued leadership on
issues affecting U.S. agriculture. NCFC appreciates this opportunity to
submit its views regarding food safety, in particular H.R. 2749, the
Food Safety Enhancement Act of 2009, and respectfully requests this
statement be made part of the official hearing record.
Since 1929, NCFC has been the voice of America's farmer
cooperatives. Our members are regional and national farmer
cooperatives, which are in turn composed of nearly 3,000 local farmer
cooperatives across the country. NCFC members also include 26 state and
regional councils of cooperatives.
We believe farmer cooperatives offer the best opportunity for
America to realize the farmer-focused ideal of American agricultural
policy. Farmer cooperatives allow individual farmers the ability to own
and lead organizations that are essential for continued competitiveness
in both the domestic and international markets.
America's farmer-owned cooperatives provide a comprehensive array
of services for their members. These diverse organizations handle,
process and market virtually every type of agricultural commodity
produced. They also provide farmers with access to infrastructure
necessary to manufacture, distribute and sell a variety of farm inputs.
Additionally, they provide credit and related financial services,
including export financing. Earnings from these activities are returned
to their farmer members on a patronage basis, helping to improve their
income from the marketplace.
America's farmer cooperatives have a large stake in producing,
handling, and processing our nation's food supply, and take pride in
providing the most safe, abundant, and affordable food in the world.
NCFC supports science-based, risk-based enhancements to our nation's
food safety system, but some of the policies put forward in H.R. 2749
are overly burdensome, duplicative, and may not actually result in a
safer food supply. We appreciate the many changes that have already
been incorporated into the bill, and the work that the Members of the
Energy and Commerce Committee have done to make it more feasible for
agriculture--but we continue to have the following concerns with the
bill.
NCFC is opposed to the inclusion of a facility registration fee in
the Food Safety Enhancement Act. The bill currently requires all
facilities to register with the Food and Drug Administration (FDA)
annually and pay an annual registration fee of $500 per domestic or
foreign facility, not to exceed $175,000 per company per year. For
farmer cooperatives, any facility registration fee is a direct tax on
cooperative members; we are opposed to such a tax.
This registration fee is particularly onerous and burdensome for
small- and medium-sized producers and cooperatives. One illustrative
example comes from the National Grape Cooperative Association, Inc.,
which grows grapes and processes Welch's grape juice and other grape
products. Along with the Concord grapes that made their cooperative
into a well-known national brand, many of National Grape's members also
grow smaller acreages of a white grape variety, the Niagara grape,
which is used to make white grape juice products. One of the challenges
of harvesting and processing any white grape variety is color
retention--avoiding the darkening and browning of the juice that starts
with oxidation as soon as the grapes are harvested. In order to control
this oxidation and retain the desirable light color of the Niagara
juice, the industry has always had to depend upon the addition of small
quantities of potassium metabisulfite (PM) to the grapes in the field
during harvesting. PM is one of the most widely used food
preservatives, has been used for many years, and is classified as
GRAS--Generally Recognized as Safe--by the FDA.
As part the Bioterrorism Act of 2002, ``food facilities'' were
required to register with the FDA. In reviewing the wording of this new
registration requirement, National Grape found that the FDA defined
food facilities in their regulations as any ``domestic or foreign
facilities that manufacture, process, pack, or hold food for human or
animal consumption.'' This left the cooperative wondering whether some
of their members' farms might be considered ``food processing''
facilities.
National Grape requested a ruling from the FDA at that time on
whether their members' application of PM to their grapes in the field
during harvest meant that their farms could be considered to be food
``processing'' facilities under the new regulations. The FDA warned
that the farms could be considered food facilities under a strict
interpretation of the regulations and recommended that everyone
involved should register as such.
While this registration was not onerous--there were no big expenses
to the cooperative or its members--the bill passed out of the Energy
and Commerce Committee includes a $500 annual registration fee for all
facilities. The 600 grower members of National Grape are now facing a
$500 per farm annual registration fee that has the potential to add
$300,000 annually to their cost of doing business at a time when the
costs associated with labor, fuel, and other inputs are also
increasing.
This is one example of the ill effects of what a registration fee
could mean for cooperatives. There are many other cooperatives, small
and large, which would be severely impacted by a registration fee. We
appreciate that the registration fee has been reduced as the bill has
progressed through the drafting process. But any registration fee is
unacceptable--particularly for cooperatives, where that fee is a direct
hit on cooperative members--and we urge Congress to remove any
registration or user fees from the bill.
Another concern with the bill is the new authority granted to FDA
to access confidential food safety records. The bill dramatically
expands FDA's access to facility records and expressly encompasses
farms in the records access requirement. The bill deletes the current
limitation in the Bioterrorism Act that FDA first must have a
``reasonable belief'' that a product is adulterated and presents a
threat of serious adverse health consequences or death to humans or
animals--inspectors would not need to have any indication that a food/
feed safety issue may exist as a precondition to accessing or
photocopying records. FDA should only have access to records that
directly bear upon product safety, and the bill must provide
protections against unauthorized disclosure by FDA of proprietary or
confidential business information to which the agency gains access when
reviewing the contents of written food/feed safety plans and other
records.
We also are concerned with the mandatory recall and quarantine
authority granted in H.R. 2749. The bill gives FDA mandatory recall
authority as well as new authority to quarantine products within a
geographic area. The bill should provide an opportunity for affected
facilities to voluntarily recall products before FDA issues a mandatory
recall. And because FDA is given recall authority, product quarantine
is redundant and unnecessary, and could harm producers who are caught
up in a geographic quarantine but are not part of the problem. Also
concerning is that the bill lacks any kind of indemnification for
producers who may be wrongly harmed in a regional quarantine.
Additionally, the Food Safety Enhancement Act of 2009 requires FDA
to develop and implement regulations setting standards for safe
growing, harvesting and holding of raw agricultural commodities if they
are required to minimize the risk of ``serious adverse health
consequences or death to humans or animals.'' The bill also cites
``manure, water quality and employee hygiene, sanitation and animal
control and temperature controls'' that FDA determines to be
``reasonably necessary.'' NCFC strongly urges that any standards set by
FDA must be commodity-specific and risk-based. Also, FDA is not the
expert agency to set standards for issues like manure and water
quality--the setting of those standards should be deferred to the U.S.
Department of Agriculture. NCFC is also concerned that the bill muddies
the jurisdiction between USDA and FDA in the regulation of meat, and
hopes Congress will strengthen the livestock exemption in the bill by
clarifying that livestock is not ``food'' and thereby is exempt from
these new FDA authorities.
One final area of concern is product traceability. The bill
currently requires FDA to establish a product-tracing system that far
exceeds the current one-up-one-back system required by the Bioterrorism
Act. Many commodities are already traceable and many others are in
various stages of developing a commodity-specific traceback system. Any
federally-mandated traceback program must take into account the
feasibility and costs associated with implementing such a program. In
addition, any new Federal program must also take into account the work
that is currently under way and systems that are already in place.
Again, America's farmer cooperatives have a large stake in
producing, handling, and processing our nation's food supply, and take
pride in providing the most safe, abundant, and affordable food in the
world. We appreciate the Committees' attention to this critically
important issue and urge the Committee to continue to push for
agriculture's interest as this debate moves forward. NCFC looks forward
to working with the Committee on food safety legislation that makes
science-based, risk-based enhancements to our nation's food safety
system.
______
Submitted Questions
Submitted Questions by Hon. Eric J.J. Massa, a Representative in
Congress from New York *
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* There was no response from the witnesses by the time this hearing
went to press.
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Question 1. H.R. 2749 gives the Secretary wide discretion to set
packing standards. What is the likelihood that these ``standards''
would include mandatory disinfectant wash water. Such a standard,
requiring a highly chlorinated wash water for instance, would put many
of my farming constituents who are engaged in direct sales out of
business. These farmers would be put out of business not only because
of the cost of such a standard, but a mandatory disinfectant wash would
adversely affect the ``freshness'' of their product:, not to mention
the environment and those people engaged in washing the produce.
Answer.
Question 2. Specifically, how do the food safety standards in HR
2749 take into account the specific variations and unique needs of
different commodities, geographic locations and production methods,
etc.? Agriculture is not a one size fits all industry.
Answer.