[Senate Hearing 110-294]
[From the U.S. Government Publishing Office]
S. Hrg. 110-294
FOOD SAFETY
=======================================================================
HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARING
MARCH 12, 2007--VERONA, WISCONSIN
__________
Printed for the use of the Committee on Appropriations
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COMMITTEE ON APPROPRIATIONS
ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont TED STEVENS, Alaska
TOM HARKIN, Iowa ARLEN SPECTER, Pennsylvania
BARBARA A. MIKULSKI, Maryland PETE V. DOMENICI, New Mexico
HERB KOHL, Wisconsin CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington MITCH McCONNELL, Kentucky
BYRON L. DORGAN, North Dakota RICHARD C. SHELBY, Alabama
DIANNE FEINSTEIN, California JUDD GREGG, New Hampshire
RICHARD J. DURBIN, Illinois ROBERT F. BENNETT, Utah
TIM JOHNSON, South Dakota LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island SAM BROWNBACK, Kansas
FRANK R. LAUTENBERG, New Jersey WAYNE ALLARD, Colorado
BEN NELSON, Nebraska LAMAR ALEXANDER, Tennessee
Charles Kieffer, Staff Director
Bruce Evans, Minority Staff Director
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Subcommittee on Agriculture, Rural Development, Food and Drug
Administration and Related Agencies
HERB KOHL, Wisconsin, Chairman
TOM HARKIN, Iowa ROBERT F. BENNETT, Utah
BYRON L. DORGAN, North Dakota THAD COCHRAN, Mississippi
DIANNE FEINSTEIN, California ARLEN SPECTER, Pennsylvania
RICHARD J. DURBIN, Illinois CHRISTOPHER S. BOND, Missouri
TIM JOHNSON, South Dakota MITCH McCONNELL, Kentucky
BEN NELSON, Nebraska LARRY CRAIG, Idaho
JACK REED, Rhode Island SAM BROWNBACK, Kansas
ROBERT C. BYRD, West Virginia
(ex officio)
Professional Staff
Galen Fountain
Jessica Arden Frederick
Dianne Preece
Fitzhugh Elder IV (Minority)
Stacy McBride (Minority)
Graham Harper (Minority)
Brad Fuller (Minority)
Administrative Support
Renan Snowden
C O N T E N T S
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Page
Statement of Senator Herb Kohl................................... 1
Statement of Dr. Patricia Verduin, Sr., Vice President,
Scientific and Regulatory Affairs, Grocery Manufacturers and
Food Products Association...................................... 3
Prepared Statement of........................................ 5
Statement of Thomas E. Stenzel, President and CEO, United Fresh
Produce Association............................................ 7
Prepared Statement of........................................ 10
Statement of Caroline Smith DeWaal, Director, Program on Food
Safety, Center for Science in the Public Interest.............. 14
Prepared Statement of........................................ 16
History of Produce Outbreaks in the United States................ 16
Fall 2006 Produce Outbreaks...................................... 17
Consumer Confidence.............................................. 18
FDA's Budget Problems............................................ 19
CSPI Proposal.................................................... 19
Safe Food Act.................................................... 21
Statement of Michael W. Pariza, Director, Food Research
Institute, Madison, Wisconsin.................................. 22
Prepared Statement of........................................ 25
Statement of Hon. Andrew C. von Eschenbach, Commissioner, Food
and Drug Administration, Department of Health and Human
Services....................................................... 32
Prepared Statement of........................................ 34
Guidance for Industry............................................ 37
Guide to Minimize Microbial Food Safety Hazards of Fresh-cut
Fruits and Vegetables.......................................... 37
Scope and Use.................................................... 38
Definitions...................................................... 39
Personnel........................................................ 40
Building and Equipment........................................... 44
Sanitation Operations............................................ 47
Production and Process Controls.................................. 51
Documentation and Records........................................ 56
Traceback and Recall............................................. 57
How the FDA Works to Keep Produce Safe........................... 62
FDA Fact--Fresh-cut Fruits and Vegetables Draft Final Guidance... 69
FDA News--FDA Issues Final Guidance for Sale Production of Fresh-
cut Fruits and vegetables...................................... 69
Statement of Robert Brackett, Director, Food and Drug
Administration, Center for Food Safety and Applied Nutrition... 71
HACCP Approach................................................... 72
Imported Fruits and Vegetables................................... 73
Guidance Implementation.......................................... 74
Grant Program for Research....................................... 75
Mandatory Regulations............................................ 76
Rapid Response Teams............................................. 77
Research......................................................... 78
Prepared Statement of the Wisconsin Department of Agriculture,
Trade and Consumer Protection.................................. 84
FOOD SAFETY
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MONDAY, MARCH 12, 2007
U.S. Senate, Subcommittee on Agriculture, Rural
Development, Food and Drug Administration, and
Related Agencies, Committee on Appropriations,
Verona, WI.
The subcommittee met at 9:10 a.m., at West Madison
Agricultural Research Center, Hon. Herb Kohl (chairman)
presiding.
Present: Senator Kohl.
statement of senator herb kohl
Senator Kohl. It's a privilege to be with you and we do
appreciate very much your taking the time, folks, to come to
this hearing on food safety. I know everybody has busy
schedules and I believe our topic demands some thoughtful
attention and that's exactly what we're going to give it today.
We're also happy to have such a good gathering here this
morning.
I especially want to thank our witnesses. Some of you
traveled all the way from Washington. We appreciate that very
much. Others have traveled all the way across town. Whether you
came 1,000 miles or 5, nevertheless, the important thing is to
make progress on the thing that we care about very much and
that's food safety.
As the chairman of the Senate subcommittee that funds our
primary food agencies, both the FDA and the USDA, I think we
have not just an opportunity but also an obligation to turn
comments and ideas into meaningful actions and accomplishments.
We certainly have enough scientific and intellectual heft in
this room to make a difference.
By way of introduction, our panels will include the
Commissioner of the Food and Drug Administration, Dr. Andrew
von Eschenbach, the Director of the FDA Center for Food Safety
and Applied Nutrition, Dr. Bob Brackett. Dr. Brackett, I'm
happy to say, is returning to his home roots. He is a Wisconsin
native and a UW graduate.
We also have with us Dr. Pat Verduin, the Senior Vice
President of Scientific and Regulatory Affairs for the Grocery
Manufacturers and Food Products Association; Mr. Tom Stenzel,
President and CEO of the United Fresh Produce Association,
which represents growers, shippers and packers for fresh
vegetables and produce; Ms. Caroline Smith DeWaal from the
Center for Science in the Public Interest, a group representing
consumers and finally; Dr. Michael Pariza, the Director of the
Food Research Institute, which is located right here in
Madison.
Before we get underway, I'd also like to thank West Madison
Agriculture Research Center, especially Mr. Thomas Wright, for
letting us use this great facility and for working with us to
set up this hearing. We really appreciate that very much.
We're having this food safety hearing here in Wisconsin
because this is one of the many places where folks have gotten
sick from contaminated foods. In fact, more people got sick in
Wisconsin during last September's E. coli spinach outbreak than
in any other State.
We're going to go through briefly some food safety numbers
because I think they speak clearly and simply about the
challenges that we face. Between 1998 and 2004, outbreaks in
produce have almost doubled. Since 1990, there have been almost
650 outbreaks caused by produce and over 30,000 people have
gotten sick.
The past 6 months have been particularly troublesome. In
September, 200 people got sick, including 49 in Wisconsin, and
three died from E. coli in spinach. Also in September, almost
200 people got salmonella from tomatoes. In late November and
early December, we had two separate E. coli outbreaks from
lettuce and 71 people were afflicted in the Northeast and 81 in
Minnesota, Iowa and Wisconsin.
A few weeks ago, FDA recalled cantaloupes because of
salmonella and we are still in the middle of the peanut butter
recall, as you know, because of salmonella, which was first
detected in August of 2006.
Against that backdrop, we find another set of numbers that
I believe are equally troubling, if not more so. In 2003, there
were 870 food inspectors at the FDA. By 2006, that number had
dropped to 640. So the FDA lost 230 inspectors in less than 4
years and food inspections dropped nearly in half during that
time. Safety tests for food produced in the United States have
dropped by nearly 75 percent, and even though some 20 to 30
percent of our fruits and vegetables are imported, less than 1
percent are inspected by the FDA.
These are some sobering numbers and as the morning
progresses, I'm sure they will be contrasted against more
optimistic statistics. We will hear, probably several times
today, that overall food safety in our country is high. That's
good for us, good for our country and that's very important.
Part of the credit belongs to mature meat and poultry
inspection systems that have evolved over decades.
But today we're not here to talk about meat and poultry;
we're here to talk about preventing food-borne illness from
fruits and vegetable contamination. We're here today to talk
about things specifically within FDA's jurisdiction and our
question, plain and simple, is can it be better?
I suspect our panelists will say yes and so the next
question to each and every one of our panelists is how? What
are the specific steps we can take this week, this month, this
year, next year and so on? We need to have a sustained
commitment and we need to keep on pushing and that's the role
that I and others intend to take.
There are, without a doubt, some complex factors involved.
We have growing imports of fruits and vegetables, as I pointed
out. Produce is moving further and faster than it was a decade
or two ago. We don't have inspectors in every processing plant.
We have growing consumption and lots of fruits and vegetables,
as we know, are eaten raw. Some of these trends have been very
good for consumers, but when it comes to safety, it means that
we have yet a bigger hill to climb.
Logic tells us that this hill will be easier to climb if
there is collaboration, cooperation and coordination. So we
begin this hearing from a mindset of collaboration, cooperation
and coordination.
We have with us a representative of growers, a
representative of food companies, a representative from a
consumer group, a highly knowledgeable food safety scientist,
and two of the top government food safety officials. These
people are in charge of the process from farm to table. I know
and we all know that there is no silver bullet, but we have
enough brainpower and political power in this room to make a
difference and to come up with something meaningful, something
real, something that will prove to Americans that we are
serious.
The patience of the American people is not unlimited and
neither is mine so I hope that we will seize this opportunity
to make a difference.
With this statement, I'd like to turn now to our first
panel for their statements. Dr. Verduin, Mr. Stenzel, Ms.
Smith-DeWaal and Dr. Pariza, we look forward to what you have
to say and I'm hoping that you can start this off with your
thoughts on these questions, the questions that I raised a
moment ago. Is produce in our country safe? Can it be safer?
And how can we do that? Dr. Verduin.
STATEMENT OF DR. PATRICIA VERDUIN, SR., VICE PRESIDENT,
SCIENTIFIC AND REGULATORY AFFAIRS, GROCERY
MANUFACTURERS AND FOOD PRODUCTS ASSOCIATION
Dr. Verduin. Thank you. Thank you for the opportunity to
appear before the committee and discuss our current food safety
system. The Grocery Manufacturers and Food Products Association
represent the world's leading food, beverage and consumer
products company. We promote sound public policy that serves to
protect the safety and security of the food supply through
scientific excellence.
Mr. Chairman, few issues are more critical to the public
health than ensuring the safety of the food supply. Food safety
is the number one priority for the food industry and without
it, really nothing else we do is possible. The entire food
industry, from field to fork, is committed to efforts that
prevent, detect and resolve food outbreaks. The American food
supply is safe, nutritious and wholesome. The American food
safety system, which includes combined efforts from the entire
food industry and the government, is the most rigorous and
respected in the world.
However, the recent outbreaks remind us that while zero
risk in our food safety system is always the goal, given the
reality and nature of food itself and those who handle it, our
food supply will never be totally risk free. At the same time,
we must never lose sight of the tremendous obligation we have
to provide consumers with the safest food supply possible.
The food industry takes recent outbreaks seriously. These
outbreaks had a ripple effect that was felt throughout the
entire industry. Many food products use spinach as a key
ingredient in processed foods such as soups, dips and frozen
products. These products were perfectly safe to eat given the
processing steps that would have destroyed any pathogens.
Unfortunately, busy consumers aren't always able to make that
distinction and simply choose not to eat any products that
contain these ingredients.
This poses an additional risk to overall health. The
Federal Government's Food Pyramid is urging consumers to
increase their consumption of fresh fruits and vegetables.
Outbreaks such as these can cause a consumer to do the exact
opposite. In addition to the unfortunate implications these
outbreaks have for public health, they immeasurably damage the
consumer's confidence in our country's food safety system.
Many dedicated people over several generations have worked
collectively to gain this trust. It would be truly unfortunate
to lose this hard-earned and well-deserved confidence of the
consumers in the food supply.
To reduce foodborne pathogens, a multi-faceted approach
from farm to fork is prudent, using the well-proven HACCP
approach. The commodities represented in these recent outbreaks
are eaten raw and they present specific challenges that will
not be addressed in a single kill step. The solution will most
likely involve an integrated food safety program that works
collectively to reduce the risks of pathogenic contamination.
Good agricultural practices, GAPs, must be used to reduce the
pathogen load created during growing, harvesting and
transportation of these commodities.
While many commodities have GAPs developed, they do not
contain validated metrics and procedures to minimize the risk
of pathogen contamination. These GAPs should also address
packinghouses or the processing plants. Establishing commodity-
specific interventions within these plants is critical to the
ultimate safety of these products. A single program will most
likely not be appropriate due to the wide variation in produce
type, farming programs, handling operations, et cetera.
Stakeholders are attempting to define the best practices to
apply to these GAPs but it is critical that these are science-
based, achievable and allow the industry to meet market demand
while minimizing risks to consumers.
Another essential tool is the surveillance system,
comprised of PulseNet, OutbreakNet, and FoodNet. The system
consists of a network of public health laboratory government
agencies, including CDC, FDA, and FSIS. Through the network, we
are able to more rapidly identify specific strains of pathogens
and isolate their origins. We must ensure this surveillance
system is fully supported and even expanded.
To ensure proper implementation of any food safety program,
regulatory oversight with effective training and inspection is
necessary. There must be a means to ensure compliance to
existing and/or enhanced GAPs. While there is a role for
industry mandated standards and auditing, some level of
regulatory oversight will be needed for credibility in the eyes
of consumers.
At this time, such an inspection system for the farm does
not exist at the Federal level. This dictates the need for a
combined and collaborative effort among the Federal and State
authorities. We also need a consensus around the control points
on the farm and the packing house and then determine how to
evaluate their effectiveness. Again, appropriate resourcing is
required.
We would like to express some final thoughts on future
needs. Currently, there is no one intervention that will
eliminate the naturally occurring risks of fresh produce. GMA
petitioned the FDA over 6 years ago, to approve irradiation as
an appropriate intervention to apply to various ready-to-eat
products. GMA is working with FDA to get that irradiation
approved, especially for produce, so that the industry can
embrace the technology and gain consumer acceptance.
This is only one possible tool. There may be other
technologies currently in development that we can consider fast
tracking. The science to support the new food safety programs
and technologies to control pathogens for fresh produce is
lacking. Such knowledge and technology gaps must be filled so
new interventions can be properly verified and validated. We
believe the land grant university system offers the perfect
vehicle for these efforts and money should be dedicated toward
this research as well as toward the extension programs that
provide outreach to farmers.
At the end of the day, many of the steps that must be taken
to enhance our food safety system will require appropriate
funding. Congress must be prepared to adequately fund the
agencies that play a critical role in the food safety supply
and funding for the FDA is especially critical. GMA believes
very strongly that FDA's steady decrease in staffing needs to
change. That's why as part of the Coalition for a Stronger FDA,
we support significant increases to the FDA food programs,
starting with the increase of $115 million in fiscal year 2008.
We recognize this is over 10 times the administration's request
of $10 million but we believe the time has come.
prepared statement
Mr. Chairman, no one has a greater stake in the credibility
of the food safety system than our member companies. GMA is
committed to working with all stakeholders to improve food
safety and particularly the safety of fresh produce. Thank you
very much for the opportunity to testify and I'll look forward
to the rest of my colleagues' testimony.
[The statement follows:]
Prepared Statement of Dr. Patricia Verduin
Mr. Chairman and Members of the Committee: Thank you for the
opportunity to appear before the committee today to discuss our current
food safety system as it pertains specifically to fresh produce. The
Grocery Manufacturers/Food Products Association (GMA/FPA) represents
the world's leading food, beverage and consumer products companies. We
promote sound public policy and champion initiatives that serve to
protect the safety and security of the food supply through scientific
excellence.
Mr. Chairman, few issues are more critical to public health than
ensuring the safety of the food supply. Food safety is the number one
priority of the food industry. Without it, nothing else we do is
possible. The entire food industry--from field to fork--is committed to
and continues to work very closely with Federal and State authorities
to prevent, detect and resolve food outbreaks, as well as communicate
clearly and concisely with the public in the event of an outbreak.
The American food supply is safe, nutritious and wholesome, and the
American system of food safety protection--which includes the combined
efforts of the entire food industry and the government--is among the
most rigorous and respected in the world. Over the last 10 years, the
number of food related illnesses and deaths associated with these
illnesses have experienced a steady decline. This is due to improved
food handling, technological advances and the vastly improved speed &
ability of food companies and government regulators to identify the
source and cause of foodborne outbreaks.
However, the recent foodborne illness outbreaks remind us that
while zero risk in our food safety system is always the goal that both
industry and government strive for, the reality and nature of food
itself and the human dimension of the food safety system, our food
supply will never be totally risk free. At the same time, all of us in
industry and government must never lose sight of the tremendous
responsibility and obligation we have to provide consumers with the
safest food supply possible.
The food industry takes very seriously the recent foodborne illness
outbreaks involving spinach and cut lettuce and all of the public
concern they have generated. While our friends in the fresh produce
sector were more directly impacted by these incidents, make no mistake,
these outbreaks had a ripple effect that was felt throughout the food
industry. In addition to spinach itself, many of our food products use
spinach as a key ingredient in processed foods such as soups, dips and
a broad range of frozen products such as frozen enchiladas or ravioli.
Frozen and canned spinach and many spinach-containing products were
perfectly safe to eat given the kill steps involved in their processing
that would have destroyed any potential pathogens. Unfortunately, in
such situations, busy consumers aren't always able to make that
distinction and instead simply choose not to eat any products
containing ingredients that were involved in an outbreak. As this case
demonstrates, outbreaks involving fresh produce can also have a very
negative impact on consumers from a diet and nutrition standpoint.
Ironically, as the Federal Government through MyPyramid is urging
consumers to increase their consumption of fruits and vegetables,
outbreaks such as these can cause a consumer to do the exact opposite.
These outbreaks clearly indicate the need for a focused effort to
reduce the risk to consumers. In addition to the obvious implications
foodborne illness outbreaks have for public health, they could also do
almost immeasurable damage to consumer confidence in our country's food
safety system. Even when we take into consideration the recent
outbreaks, the U.S. food supply is arguably one of the safest in the
world. We have achieved this enviable position not by luck or accident,
but through the commitment of the food and agricultural industries and
generations of dedicated public servants at the Federal, State and
local levels who work for our food safety regulatory agencies. It would
be truly unfortunate for us to lose the hard earned and well-deserved
confidence of consumers in our food safety system, especially when
there are clear steps that can be taken by both industry and government
to greatly minimize the risk of future outbreaks.
To reduce foodborne pathogens, a multifaceted approach from farm to
fork is prudent using the well-proven HACCP approach. The commodities
represented in these recent outbreaks are eaten ``raw'', presenting
specific challenges that will not be addressed with a single ``kill
step''. The solution will most likely involve an integrated food safety
program that works to collectively but significantly reduce the risk of
pathogenic contamination. Unlike canning where one step in the process
is responsible for preserving safety, produce safety will most likely
have multiple food safety control points.
Good agricultural practices (GAPs) is the first step in this chain
and must be used to reduce the pathogen load created during growing,
harvesting and transportation of these commodity products. While most
commodities have GAPs developed, they contain appropriate metrics and
validated procedures to minimize the risk of pathogen contamination.
These GAPs should also address the second step in the chain which is
the packing house and/or processing plant. Establishing commodity-
specific and appropriate interventions within these plants is critical
to the ultimate safety of the product consumed. We understand that a
single program will most likely not be appropriate due to the wide
variation in produce type, farming programs, handling operations, and
other variables. Various concerned stakeholders are attempting to
define the best standards to apply to GAPs. These stakeholders include
not only growers and industry, but also Federal and State authorities.
It is critical that these standards be science-based, achievable and
allow farmers, processors and retailers to meet the market demand while
minimizing risk to the consumer.
Another essential tool we have at our disposal is our current
surveillance system comprised of PulseNet, OutbreakNet and FoodNet.
This system consists of a network of public health laboratories,
epidemiologists and government agencies including CDC, FDA and FSIS.
Through this network, we were able to more rapidly identify the
specific strains of the recent foodborne illnesses in question and
isolate their origins, thereby minimizing impact on public health and
the marketplace. We must ensure that this surveillance system is fully
supported and, where appropriate, expanded. Each outbreak identified
begins at the local level, and CDC requires adequate funding to ensure
State and local jurisdictions have the resources to do the surveillance
and investigations needed.
To ensure proper implementation of any food safety program,
regulatory oversight with effective training and inspection is
necessary. There must be a means to ensure compliance to existing and/
or enhanced GAPs. While there is a role for industry-mandated
standards, requirements and auditing, some level of regulatory
oversight will be needed for credibility in the eyes of the consumers.
This oversight and ability to enforce has been in place in processing
establishments amenable to Federal and State authority. At this time,
such an inspection system for farms does not exist at the Federal
level. This dictates the need for a combined and collaborative effort
among Federal and State programs. We need to ensure that different
standards are not being applied by different States or regions. We need
consensus on what the control points are on the farm and in the packing
houses and then determine how to appropriately evaluate their
implementation and effectiveness. Again, as this integrated system is
developed, appropriate resourcing at both the State and Federal levels
is essential. Programs on paper do not effect change, people and
activities dedicated to this effort are the essential component.
The final step to consider is consumer behavior. Outreach to the
consumer is a critical component of food safety. American families
continue to spend less and less time in the kitchen preparing food and
opt for convenience. Therefore it is equally important that substantive
outreach programs be continued and enhanced to emphasize the importance
of proper food handling by consumers.
We would also like to express some final thoughts on future needs .
. .
Currently, there is no one intervention that will eliminate the
naturally occurring risk of fresh produce. GMA/FPA petitioned FDA over
6 years ago to approve irradiation as an appropriate intervention to be
applied to various ready-to-eat food products. GMA/FPA is still working
closely with FDA to get irradiation approved, especially for produce,
so that industry can begin to embrace this technology and work with
Federal and State agencies in a consolidated and focused outreach
program to gain consumer acceptance and reduce the risk of foodborne
disease. This represents only one tool in the toolbox. There may be
other technologies that are currently in development to consider fast-
tracking evaluation and approval.
The science to support new food safety programs and technologies is
lacking in a number of areas, in particular what is most critical and
effective to control pathogens on fresh produce. To really minimize the
risk of future foodborne disease outbreaks and improve consumer
confidence, such knowledge and technology gaps must be filled so that
new interventions or operating programs can be properly verified and
validated. We believe that the land-grant university system offers a
perfect vehicle for these efforts and monies should be dedicated toward
this research as well as toward the extension programs that provide
outreach and training to growers and their workers.
At the end of the day, many of the steps that must be taken to
enhance the safety of our food safety system will require appropriate
funding. Congress must be prepared to adequately fund FDA, USDA and the
other agencies that are playing critical roles in protecting our food
supply.
Mr. Chairman, no one has a greater stake in the credibility of the
food safety system than our member companies. GMA/FPA is committed to
working with all stakeholders to improve food safety as is evidenced by
the leadership we provided in determining effective pathogen lethality
in juices to meet FDA performance standards associated with its HACCP
regulation and the development of a new risk-based inspection program
by FSIS.
Thank you again Mr. Chairman for the opportunity to testify. I
would be pleased to respond to questions that you and the other members
of the subcommittee may have.
Senator Kohl. Thank you. That was a very good statement.
Mr. Stenzel.
STATEMENT OF THOMAS E. STENZEL, PRESIDENT AND CEO,
UNITED FRESH PRODUCE ASSOCIATION
Mr. Stenzel. Thank you, Mr. Chairman. Good morning. Let me
begin by repeating something that you've heard before and
you're going to hear again. Food safety is our industry's top
priority. The spinach outbreak last fall was a tragic
occurrence and one that struck very hard here in Wisconsin. So
many people were affected and it's a testament to the Wisconsin
Division of Public Health that the outbreak was identified here
first and communicated to the CDC.
On behalf of our industry, our hearts go out to those who
became seriously ill or lost a loved one. We can never forget
the real human impact when something goes wrong in our food
safety system. That's what drives food safety to be a process
of continuous improvement, not a static achievement. We are on
a continuum, constantly striving toward perfection while
understanding scientifically that perfection or zero risk is
simply not possible.
When the spinach outbreak occurred, our entire industry
immediately pulled all spinach from shelves nationwide and
cooperated fully with the FDA in tracking this problem back to
its source. In fact, we now know that the only contaminated
product came from one small farm, packaged in one processing
plant on one production shift. That's out of more than 300,000
acres of lettuce, spinach and leafy greens grown in that
California region known as the Salad Bowl of the World.
But while the source of this outbreak was indeed narrow,
our entire industry will learn its lessons, joining together to
study ways to reduce all common risk factors and better assure
day-to-day compliance with best practices throughout the
industry.
Today, an important initiative is underway within our
California industry to adopt stringent food safety measurement
criteria, which can be enforced and verified. These science-
based standards require careful selection of growing fields
based on farm history and proximity to animal operations,
monitoring of irrigation water and other water sources that can
come in contact with crops, prohibition of raw manure with the
use of only certified, safe fertilizers, good employee hygiene
in fields and handling and of course, strong food safety
controls in all processing plants.
But while there is much our industry can and must do, we
must also count on the Government to do its job. Today, the
Department of Health and Human Services shares a critical
public health challenge to increase consumption of fresh
produce. The 2005 U.S. Dietary Guidelines call on Americans to
literally double our consumption of fruits and vegetables. But
I feel that if we do not ensure public confidence in a strong,
credible and comprehensive food safety system, we put that goal
at risk.
We believe consumers must be able to shop in any grocery
store or order fresh produce in any restaurant with confidence
that their selection is a safe and healthy choice. Now, I am
personally confident in my produce choices today. I know how
hard our industry is working, from field to table, on food
safety. But no matter how hard our industry works, public
confidence will also ultimately depend on Government as the
final health and regulatory authority to determine proper food
safety standards and ensure that they are being met.
Let me review three key principles we believe are critical
to food safety. First, we believe produce safety standards must
be consistent for an individual commodity grown anywhere in the
United States or imported into this country. Consumers must
have the confidence that safety standards are met, no matter
where the commodity is grown.
Second, we believe achieving consistent produce safety
standards across the industry requires strong Federal
Government oversight and responsibility in order to be most
credible to consumers and equitable to producers. We believe
the FDA must determine appropriate, nationwide safety standards
in an open and transparent process, with full input from the
States, industry, academia, consumers and all stakeholders.
As science tells us that there is no such thing as zero
risk, the public must be able to trust in an independent,
objective government body as the ultimate arbiter of what is
safe and is not. Industry can't make that call alone.
Finally, we believe produce safety standards must allow for
commodity specific food safety practices based on the best
available science. In a highly diverse industry that is more
aptly described as hundreds of different commodity industries,
one size clearly does not fit all.
With our colleagues from FDA here today, let me address
several action steps we believe to be necessary. First, we
support FDA's broad, good agricultural practices, which are
applicable to all producers at farm level. FDA's GAPs guidance
continues to provide an effective roadmap for producers, and
cooperative agreements with USDA and the States would assure
more effective education, monitoring and compliance with these
and future guidelines.
Second, we support FDA's approach to developing
enforceable, science-based commodity-specific GAPs where there
is a demonstrated need based upon outbreak history or specific
risk factors. Resources must be focused on the greatest areas
of need.
Finally, we support specific, enforceable standards for
fresh-cut, ready-to-eat produce and have encouraged FDA to take
the important step of completing its draft guide to minimize
microbial food safety hazards for fresh-cut fruits and
vegetables. We anticipate some discussion of that later from
our FDA panel and I'd just like to say, congratulations to FDA
for very timely work in moving forward with this particular
guidance document.
Let me conclude with just a couple comments about
appropriation priorities in this hearing. We believe the most
important issue on the table today is whether FDA is adequately
funded, has sufficient staff with scientific training and
experience in our sector of the food industry, has research
dollars available to address key questions, has strong working
agreements with the States to support as needed and has the
commitment of the President and the Congress.
PREPARED STATEMENT
As a Nation committed to reducing food-borne disease, we
all share the important task to adequately fund, staff and
support the FDA in carrying out its mission. We as an industry
must do all we can to prevent illnesses from ever occurring and
we will. At the same time, we pledge our support for government
efforts to provide a stronger food safety regulatory framework
that assures the public that all appropriate safety standards
are in place and are being met. Thank you.
[The statement follows:]
Prepared Statement of Thomas E. Stenzel
Good morning. My name is Tom Stenzel and I am President and CEO of
the United Fresh Produce Association. Our organization represents more
than 1,200 growers, packers, shippers, fresh-cut processors,
distributors and marketers of fresh fruits and vegetables accounting
for the vast majority of produce sold in the United States. We bring
together companies across the produce supply chain from farm to retail,
including all produce commodities, both raw agricultural products and
fresh ready-to-eat fruits and vegetables, and from all regions of
production.
I mention these characteristics because our organization's views on
food safety are shaped by this broad and diverse membership across the
entire produce industry, not any one sector or region. Within our
industry, there are always diverse and strongly held views on each
issue we face. Our association attempts to develop the best overall
industry policies and practices to serve the American consumer.
Let me begin by repeating something you've heard many times before,
and will hear many times in the future. Food safety is our industry's
top priority. The men and women who grow, pack, prepare and deliver
fresh produce are committed to providing consumers with safe and
wholesome foods.
The spinach outbreak last fall was a tragic occurrence, and one
that struck hard here in Wisconsin. So many people were affected, and
it is a testament to the Wisconsin Division of Public Health that the
outbreak was identified here first and communicated to the Centers for
Disease Control. On behalf of our entire industry, let me say our
hearts go out to those who became seriously ill or lost a loved one. We
can never forget the real human impact when something goes wrong in our
food safety system.
That is what drives food safety to be a process of continuous
improvement, not a static achievement. We are on a continuum,
constantly striving toward perfection, while understanding
scientifically that perfection--or zero risk--is not possible. Our
overall safety record is good in providing American consumers over a
billion servings of fresh produce every day. But, our industry cannot
rest when even rare breakdowns in food safety systems can cause such
human impact as that felt here in Wisconsin last fall.
Let me allay any concerns that our industry has just now begun to
address food safety. In fact, our association published the first Food
Safety Guidelines for the Fresh-Cut Produce Industry 15 years ago in
1992, and we are now on our 4th edition. We developed the first
industry guidelines in the mid 1990s to minimize on-farm
microbiological food safety risks for fruit and vegetables, and worked
closely with the U.S. Food and Administration to publish Federal
guidelines soon thereafter. Put simply, food safety has been at the
forefront of our mission to serve the American public for many years.
When a tragedy such as the E. coli O157:H7 outbreak occurs, we are
committed to learning all lessons possible and incorporating that
knowledge into continuous process improvement.
I want to address two main points today. First, I want to talk
specifically about what our industry has done to address this outbreak,
and what we are doing now to improve food safety practices from field
to table. Second, I want to share with you our association's views on
the most appropriate produce safety regulatory framework to protect
public health.
When the spinach outbreak occurred, our entire industry immediately
pulled all spinach from shelves nationwide, and cooperated fully with
FDA in tracking this problem back to its source. That total industry
wide shutdown was an unprecedented response, but FDA felt it necessary
until they were certain any contaminated product was removed from the
market.
In fact, we now know that the only contaminated product came from
one 50-acre farm, packaged in one processing plant, and only on one
production shift. That's out of more than 300,000 acres of lettuce,
spinach and leafy greens grown in the region where this product was
grown, and dozens of processing plants around the country. But, when
faced with an immediate public health question, we agreed with FDA to
err on the side of caution.
Once we learned of the outbreak, our industry also immediately
began a comprehensive reevaluation of spinach production, handling and
processing to make sure we were taking all appropriate steps to assure
safety. This included not only the company directly involved in the
outbreak, but companies throughout the spinach growing and processing
sector. While the source of the outbreak itself proved to be narrow,
the entire industry joined together to make sure we collectively are
addressing all the common risk factors that can be associated with
fresh leafy greens grown outside in nature and consumed without
cooking.
This effort has led to an important initiative spearheaded by the
leafy greens industry to adopt stringent food safety measurement
criteria which can be implemented and verified across this sector of
the industry. The California Department of Food and Agriculture has
recently adopted a Leafy Greens Marketing Agreement which will serve as
a means of setting rigorous measurements of safety for leafy greens
from this major production region. We also believe similar standards
must apply nationally and internationally, and I will address this
issue specifically in a moment.
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.
Under the Leafy Greens Agreement, growers will be audited by the
California Department of Food and Agriculture to ensure that they are
complying with these standards. And, they 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 a step like this toward self-regulation for a private
industry sector is not an easy task. 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. I want to publicly
recognize those growers, shippers and processors of leafy greens who
have made this commitment.
Stepping out now to a national multi-commodity perspective, I can
tell you that many other sectors of our industry are pursuing similar
efforts to define, implement and verify best practices from field to
table.
For example, the Florida tomato industry is at the forefront of
developing good agricultural practices for their sector of the
industry, and exploring various means to assure compliance across
multiple growing regions outside of the State as well. Just two weeks
ago, the tomato industry convened a meeting of some 75 scientists in
government, academia and industry to discuss new tomato research
initiatives to further reduce risk.
In an effort similar to the leafy greens and tomato good
agricultural practices we've discussed, our organization and others
have co-published GAP guidance documents for the melon industry, and
work is underway on green onions and herbs.
And, of course, many other regional groups are implementing similar
efforts. Last month, I met with hundreds of growers in New Jersey where
a new food safety task force put together by their Department of
Agriculture is looking at specific GAPs and training programs for their
growers. And another good example is the Georgia Fruit and Vegetable
Growers Association, which has its own GAPs training program to help
small growers in that State better understand and apply best practices.
All these efforts represent industry led initiatives to further
reduce risk and ensure the safest possible produce for the public.
It is within the context of all of these industry driven efforts
that I turn now to discuss what we believe to be the most appropriate
regulatory framework for fresh produce safety. While there is much our
industry can and must do, we also have to recognize the important role
of the Federal Government.
Today, our country faces a critical public health challenge to
increase our consumption of fresh produce. The 2005 U.S. Dietary
Guidelines call on Americans to literally double our consumption of
fruits and vegetables. And now, our Nation is faced with an obesity
crisis that threatens the long-term health of our children unless we
radically change eating habits and help them learn to make healthier
choices for a lifetime.
I am here today because I fear that if we do not ensure public
confidence in a strong, credible and comprehensive food safety
regulatory framework, we are putting that goal at risk. It is simply
unacceptable for Americans to fear consuming those very fresh fruits
and vegetables that are essential to their good health.
Our industry can have but one goal in food safety and it starts
with the consumer. We believe consumers must be able to shop in any
grocery store, or order fresh produce in any restaurant, with complete
confidence that their produce selection is a safe and healthy choice.
Fear has no place in the produce department. Whatever low risk that
might be present must be viewed as an acceptable risk, based on strong
government assurance that proper food safety systems are in place, and
that the benefits of consumption far outweigh the low risk.
Now, I personally am confident in my produce choices today. I know
many of the people who are growing and processing fresh produce, and I
trust them to be doing their very best to market safe products. I know
a lot about these many industry efforts across the country to develop
best agricultural practices and implement strong standards and
controls. And I know how hard our own team is working to make sure
every corner of our industry is focused on food safety.
But, no matter how hard our industry works, public confidence also
ultimately depends upon government as the final health and regulatory
authority to determine proper food safety standards and ensure that
they are being met.
Let me review three key principles we believe to be critical for
our Nation's food safety regulatory framework.
Consistent Produce Food Safety Standards
First, we believe produce safety standards must be consistent for
an individual produce commodity grown anywhere in the United States, or
imported into this country. Consumers must have the confidence that
safety standards are met no matter where the commodity is grown or
processed. Because of the variation in our industry's growing and
harvesting practices in different climates and regions, flexibility is
very appropriate and necessary. For example, some production areas use
deep wells for irrigation while others use river water supplied from
dams. Some farms use sprinkler irrigation, others use a drip system
laid along the ground, and still others use water in the furrows
between rows of produce. But the common factor must be that all uses of
water for irrigation must meet safety standards that protect the
product. That must be true whether the produce is grown in California,
Florida, Wisconsin or Mexico.
We strongly applaud industry groups in different States and regions
that are working to enhance local practices. Their work demonstrates
the industry's commitment to do all we can to enhance safe growing and
handling practices. But to build consumer trust, strong scientific
standards we're developing for one region can only be successful if
applied consistently across the industry.
Federal Oversight and Responsibility
Second, we believe achieving consistent produce safety standards
across the industry requires strong Federal Government oversight and
responsibility in order to be most credible to consumers and equitable
to producers.
We believe that the U.S. Food and Drug Administration, which is the
public health agency charged by law with ensuring the safety of the
Nation's produce supply, must determine appropriate nationwide safety
standards in an open and transparent process, with full input from the
States, industry, academia, consumers and all stakeholders. We are
strong advocates for food safety standards based on sound science and a
clear consensus of expert stakeholders.
But in a situation where science tells us there can be no zero
risk, and there is no cooking step for our product, the public must be
able to trust in an independent, objective government body as the
ultimate arbiter of what is safe enough. In the future, we must be able
to stand side-by-side with government to reassure the public that
together, we have done everything necessary to implement and comply
with strong mandatory government standards to protect public health.
Let me say a word here specifically about USDA's role in helping
our industry enhance safety. USDA is a strong ally and offers a number
of means to assist the produce industry in safely growing, handling and
processing fresh produce. First, as a diverse agricultural industry,
marketing orders have been an extremely useful means of setting quality
standards, conducting research and promoting specific commodity groups.
These orders fall under the Agricultural Marketing Service of USDA, and
are increasingly being looked at as a potential means to stimulate good
food safety practices as well. Growers of a commodity can come together
and vote to require specific practices that then become mandatory for
all growers of that commodity.
In addition, USDA through AMS offers several auditing programs that
assist the industry in measuring good agricultural practices, good
handling practices, and HACCP programs in processing plants. These are
good education and training programs, as well as a means to measure
individual operators' understanding and implementation of food safety
practices.
We believe these programs can be very helpful, and are an important
element in enhancing food safety systems. Yet, while these programs are
an important means for specific sectors of the industry to enhance
performance, long-term public trust requires that FDA set the most
appropriate regulatory safety standards. That is simply a call that
industry cannot make alone.
And, FDA must have the ultimate responsibility to ensure that
industry is complying with these standards. That does not mean that FDA
has to hire 5,000 new inspectors to visit every farm in America and
travel around the world. But it does mean that FDA must have
relationships with other governments, USDA, and State agriculture and
regulatory officials to ensure that compliance is taking place.
Cooperative agreements between FDA and the States have been extremely
effective in providing oversight of food safety standards.
Our analysis is that FDA has the regulatory authority today to
promulgate any needed rules and regulations, issue guidance that
compels industry action, enter into agreements with States to support
field investigations, and generally set all necessary standards to
protect the public health.
Commodity-Specific Scientific Approach
Finally, we believe produce safety standards must allow for
commodity-specific food safety practices based on the best available
science. In a highly diverse industry that is more aptly described as
hundreds of different commodity industries, one size clearly does not
fit all.
For example, the food safety requirements of products grown close
to the ground in contact with soil are far different from those grown
on trees. And, the large majority of produce commodities have never
been linked to a foodborne disease. Every produce commodity is
different, and our food safety regulatory approach must contain needed
scientific flexibility to address specific commodities differently
based on their unique production and handling practices.
This will be an extremely important point in looking at produce
safety. Government and industry alike must be careful that broad
strokes do not result in requirements that should not apply to specific
commodities, and do nothing to enhance safety. Taking a general
approach would be far too easy to add regulatory costs and burdens to
sectors where those requirements are unneeded, without doing anything
to enhance safety where most critical.
We support the approach currently taken by FDA to establish broad
Good Agricultural Practices (GAPs) applicable to all producers at farm
level. FDA's 1998 GAPs guidance continues to provide an effective
roadmap for producers, and cooperative agreements with USDA and States
can assure compliance with these guidelines based on today's science
and as they are modified by FDA in the future to reflect increasing
knowledge.
We also support FDA's scientific approach to develop commodity-
specific GAPs where there is a demonstrated need. This must be a
scientific process, looking at outbreak history and potential risk
factors to ensure that resources are not diluted trying to address
hundreds of commodities that have never been linked to illnesses. These
principles are embodied in commodity specific guidance documents that
are being developed for tomatoes, melons, leafy greens and green
onions, as well as FDA's already published guidance document for fresh
sprouts.
Finally, we support FDA's approach to address specific standards
for fresh-cut processing, as contained in the agency's proposed Guide
to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and
Vegetables. We strongly support HACCP food safety programs in all
fresh-cut processing plants. Although research has not yet identified a
kill step such as pasteurization for fresh-cut ready-to-eat produce, we
must apply strict processing controls to minimize any risk that might
be introduced from incoming raw agricultural product or at the
processing level.
Together, these three principles I've discussed help define a food
safety regulatory policy that we believe will most help our industry
enhance produce safety, concurrent with establishing the highest level
of public trust in fresh produce. We strongly support a U.S. regulatory
framework for the fresh produce industry that incorporates these
principles.
Let me conclude with a few comments about appropriations
priorities. We believe one of the most important issues at this hearing
is whether FDA is adequately funded, has sufficient staff with
scientific training and experience in our sector of the food industry,
has research dollars available to address key questions, has strong
working agreements with the States to provide support as needed, and
has the commitment of the President and full support of Congress.
Now that's a big commitment, but we believe it is essential to have
a strong and effective Federal regulatory framework for the produce
industry. As a Nation committed to reducing foodborne disease, we all
share the important task to adequately fund, staff and support the FDA
in carrying out its mission.
Finally, let me address the subject of research. Our industry is
doing everything we know today to reduce the risk of foodborne disease,
but there are many scientific questions literally begging for research.
We need better understanding of ways to reduce E. coli O157:H7 in
cattle; we need better ways to prevent potential contamination from
pathogens that might be present at field level; and we need to develop
more 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.
We ask for the committee's support in boosting produce safety
research as a vital part of reducing risk in the future. Specifically,
we support an additional appropriation for fiscal year 2008 of $10
million for USDA's Agricultural Research Service, $10 million for the
USDA Cooperative State Research, Education and Extension Service, and
$6.5 million for the FDA Center for Food Safety and Applied Nutrition,
for produce safety research. We also ask the committee for its support
as we discuss significantly greater research needs in the 2007 Farm
Bill.
In conclusion, let me return to the important role fresh fruits and
vegetables play in public health. Of course any reasonable person in
the food industry would want to produce only the safest possible
product. But for us, somehow it seems even more important because of
the healthfulness of fresh produce.
With that public health imperative, we simply cannot allow fears of
food safety to become linked with fresh produce.
We as an industry must do all we can to prevent illnesses from ever
occurring, and we will. To those who became ill from last year's
outbreak or have loved ones who did, we pledge to do our very best to
prevent this from happening in the future.
At the same time, we pledge to support government efforts to
provide a strong food safety regulatory framework that assures the
public that appropriate safety standards are in place and are being met
by the industry.
Together, we can help consumers enjoy an ever increasing array of
safe, healthy and nutritious fresh fruits and vegetables.
Senator Kohl. That's very good, Mr. Stenzel. Thank you very
much. Ms. DeWaal.
STATEMENT OF CAROLINE SMITH DE WAAL, DIRECTOR, PROGRAM
ON FOOD SAFETY, CENTER FOR SCIENCE IN THE
PUBLIC INTEREST
Ms. DeWaal. Thank you, Senator. This is an important
hearing. It's an important hearing both for the citizens of
Wisconsin but also the citizens of the United States. So I
appreciate the fact that you're having it.
The Center for Science in the Public Interest is a consumer
organization. We represent over 900,000 consumers, both in the
United States and Canada. The Centers for Disease Control and
Prevention estimates that 76 million consumers get ill each
year from something they ate and 5,000 die.
According to CSPI's database, we have a 5,000 outbreak
database spanning 15 years, fruits and vegetables and the
dishes with salads prepared from them cause 13 percent of food-
borne illness outbreaks and 21 percent of associated illnesses.
Food-borne illnesses from produce surpass those of all other
single food categories, including beef, chicken, and seafood.
Produce sickens more people each year than these categories.
The average size of the outbreaks is larger in produce than in
any other food category.
The bottom line here is that consumers want to eat fresh
vegetables and fruits and we love the convenience that the
industry has brought forward with these bagged products and
ready-to-eat products that allow us to have salads on the table
in just a few minutes. But consumer confidence in these bagged
products has certainly declined since the fall. The spinach
outbreak had as many fatalities as the Jack-in-the Box
hamburger outbreak in 1992, and it may well prove to be the
tipping point for consumer confidence unless the industry and
the government act quickly to provide solutions to the risks.
In my written testimony, we do have data supporting this
with a Rutgers University study of consumer confidence. Many
consumers were confused about whether canned or frozen products
were impacted. Also, they were never really sure when the
recall or the warning ended and whether it also extended to
other bagged greens for a large percentage of consumers.
For us, though, last fall's produce outbreaks were just the
latest symptom of an agency, FDA, that is overwhelmed by
responsibility but lacks the staff and resources to function
effectively. In fact, since 1972, inspections conducted by FDA
have declined 81 percent and just in the last 3 years there was
a 47 percent drop in Federal inspections. FDA's food program is
facing a critical shortfall, around $135 million, just for a
current functioning budget and overall, this means that
consumer confidence in FDA has really plummeted. A Harris poll
has documented that those who thought FDA was doing an
excellent or good job dropped dramatically since just 2000.
Sixty-one percent of consumers rated the government as doing an
excellent or good job in 2000 and only 36 percent believed that
in 2006.
Equally important is the fact that the Federal agency's
food safety expenditures are widely disproportionate to the
risks between the foods that they regulate. The U.S. Department
of Agriculture regulates 20 percent of the food supply, meat
and poultry, and these products caused about 32 percent of the
outbreaks, yet its food safety appropriations have doubled that
given to the Food and Drug Administration. The Bush
administration's 2008 budget proposal gives USDA around $270
million in new appropriations. The FDA, which regulates 80
percent of the food supply, including produce, was only given a
$10.6 million increase.
Senator, this is a food safety budget that defies logic and
we really hope that you can help to correct this inequity. CSPI
has petitioned FDA to take action right away. Fresh fruits and
vegetables are the center of a healthy diet so it is critical
that immediate steps are taken. CSPI has petitioned the FDA to
require all fresh fruit and vegetable producers and processors
to develop written plans to identify where contamination is
likely to occur and how to prevent it. We believe the farmers
themselves hold the key to the solution. These plans should
apply first to high-risk products, such as leafy green
vegetables and more gradually to other areas.
Specifically, we're asking for a three-pronged approach.
The FDA should require all growers and processors to have
written food safety plans designed by the farmers themselves.
The FDA should develop standardized criteria for farmers to use
for such items as the use of manure, water quality and worker
sanitation. Worker sanitation, by the way, is critically
important to protecting food safety. Finally, the written plan
should be audited at least once per growing season by FDA, the
States and the buyers and FDA should review these audits.
Senator, you asked us very specifically to talk about
specific steps that could be taken this year. We think you
could help out dramatically by equalizing the budget, the food
safety budgets that are already in the President's budget for
2008, between USDA and FDA. The money is there. It needs to be
more equitably distributed and in addition, we urge you to get
FDA to understand that consumers can't fix this problem. We
can't tell them to wash it to eliminate it. We could urge them
to cook it. Cooking it would destroy the hazard but who wants
cooked salad? I certainly don't and I know most consumers don't
want to go that level. People ask me, do we need chlorine?
Should we wash it in chlorine? We hope not. We hope that we're
not going to get to that point. But voluntary standards don't
work. They've been tried. We have a history of outbreaks and
it's not working. It definitely won't work with imports as well
and a lot of our produce is coming from foreign countries.
PREPARED STATEMENT
So the guidance documents FDA has put out are not enough
and if you could urge them and demand that they put in place
the same systems that Mr. Stenzel has been asking for and we're
asking for. We're all at the same place on this. Thank you.
[The statement follows.]
Prepared Statement of Caroline Smith DeWaal
My name is Caroline Smith DeWaal, and I am director of food safety
for the Center for Science in the Public Interest (CSPI). CSPI is a
nonprofit health advocacy and education organization focused on food
safety, nutrition, and alcohol issues. CSPI is supported principally by
the 900,000 subscribers to its Nutrition Action HealthLetter and by
foundation grants. We accept no government or industry funding.
The Center for Disease Control and Prevention (CDC) estimates that
76 million Americans get sick and 5,000 die from foodborne hazards each
year in the United States. Many health-conscious Americans consume
fresh produce as part of a balanced diet, but in the last decade,
produce is too frequently the cause of major outbreaks, resulting in
deaths, illnesses, both mild and severe, and great market
disruptions.\1\
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\1\ Center for Science in the Public Interest, Outbreak Alert
(Revised and updated--2006). This database of foodborne illness
outbreaks is maintained by CSPI. It contains 15 years of data, from
1990-2004. Outbreaks are classified by both food vehicle and disease-
causing agent. Food is classified by which agency regulates the
product. During the years 1990-2004, there were 3,323 foodborne illness
outbreaks from FDA-regulated foods (e.g. seafood, produce, eggs, milk);
USDA regulated-foods (e.g. beef, poultry, pork) caused 1,344 outbreaks.
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According to CSPI's database of 5,000 foodborne illness outbreaks
spanning 15 years, fruits and vegetables caused 13 percent (639) of
these outbreaks with nearly 21 percent (31,496) of the associated
illnesses. Norovirus, Salmonella and E. coli O157:H7 illnesses have
been traced to a wide variety of produce, including lettuce, salads,
melons, sprouts, tomatoes, and many fruit- and vegetable-containing
dishes.\2\ In fact, foodborne illnesses from these produce outbreaks
surpassed those from all other foods, including beef, chicken and
seafood. Equally troubling is that the average size of these outbreaks
is larger than outbreaks from other foods, thus affecting more people.
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\2\ Center for Science in the Public Interest, Outbreak Alert
(Revised and updated--2006).
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history of produce outbreaks in the united states.
Produce outbreaks in the United States have been documented from
both imported produce and domestically grown produce. Imported fruits
and vegetables have caused numerous large and sometimes deadly
outbreaks. Here are several examples:
--Both in 1996 and 1997, thousands of people became ill in both the
United States and Canada from a parasite, Cyclospora, on
raspberries grown in Guatemala.\3\ Cyclospora infects the small
intestine and typically causes watery diarrhea, loss of
appetite, substantial loss of weight, and persistent fatigue.
If untreated, illness may last for a month or longer, and may
follow a remitting-relapsing course.\4\
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\3\ J Hoffman et al (1996). ``Update: Outbreaks of Cyclospora
cayetanensis Infection--United States and Canada, 1996.'' July 19,
1996. MMWR 45(28): 611-612.
\4\ CDC Division of Parasitic Diseases (2004). Fact Sheet:
Cyclospora Infection--Information for Healthcare Providers. April 19,
2004. March 5, 2007. .
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--In 1997, over 256 cases of Hepatitis A were associated with the
consumption of frozen strawberries. The strawberries were
harvested in Mexico and processed and frozen in southern
California before they were distributed by U.S. Department of
Agriculture (USDA) to school lunch programs in several States,
including Michigan, Wisconsin, Louisiana, Maine and Arizona.\5\
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\5\ Centers for Disease Control (1997). ``Hepatitis A Associated
with Consumption of Frozen Strawberries--Michigan, March 1997.'' MMWR.
46(13): 288-295.
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--Three multistate outbreaks of Salmonella serotype Poona infections
associated with eating cantaloupe imported from Mexico occurred
in the spring of consecutive years during 2000-2002. FDA
conducted traceback investigations and determined that the
cantaloupes were from farms in Mexico. FDA conducted on-farm
investigations in Mexico and found many possible sources of
contamination, included irrigation of fields with water
contaminated with sewage; processing (cleaning and cooling)
with Salmonella-contaminated water; poor hygienic practices of
workers who harvest and process the cantaloupe; pests in
packing facilities; and inadequate cleaning and sanitizing of
equipment that came in contact with the cantaloupe.\6\
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\6\ SM Anderson et al. (2002) ``Multistate Outbreaks of Salmonella
serotype Poona Infections Association with Eating Cantaloupe from
Mexico--United States and Canada, 2000-2002.'' November 22, 2002. MMWR,
51(46);1044-1047.
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--In 2003, a major Hepatitis A outbreak linked to raw green onions
used in restaurant salsa sickened 555 people in Pennsylvania,
killing three of them. Preliminary traceback by FDA indicated
that green onions supplied to the restaurant were grown in
Mexico under conditions where contamination with human waste
was likely. Other onions from this area were linked to
outbreaks in Georgia, Tennessee, and North Carolina that
occurred earlier in the fall.\7\
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\7\ V Dato et al. (2003) ``Hepatitis A Outbreak Associated with
Green Onions at a Restaurant--Monaca, Pennsylvania, 2003.'' MMWR,
52(47): 1155-1157.
---------------------------------------------------------------------------
But problems with domestic produce are also widespread:
--In February 2004, following fourteen outbreaks linked to lettuce
and tomatoes, FDA sent a letter to firms that grow, pack, or
ship fresh lettuce and/or fresh tomatoes reminding them to
review their current operations in light of the agency's
guidance.\8\ FDA sent another letter specifically to California
lettuce firms in November 2005 expressing concern over
continuing outbreaks of foodborne illness and outlining actions
the industry should take in order to ensure lettuce safety.\9\
---------------------------------------------------------------------------
\8\ FDA, CFSAN (2004). Letter to Firms that Grow, Pack, or Ship
Fresh Lettuce and Fresh Tomatoes. Feb. 5, 2004. March 5, 2007. .
\9\ FDA, CFSAN (2005). Letter to California Firms that Grow, Pack,
Process, or Ship Fresh and Fresh-cut Lettuce. November 4, 2005. March
5, 2007. .
---------------------------------------------------------------------------
--At a June 2004 public meeting to discuss the proposed Produce
Action Plan, Dr. Robert Gravani of Cornell University's Food
Science Department reported that a Good Agricultural Practices
Survey of Farm Workers in New York State showed that
approximately 30 percent of producers were unaware of Good
Agricultural Practices (GAPs) for their particular crop. The
numbers show the need for a mandatory regulatory program for
fresh produce and the same should go for fresh-cut produce.
--A qualitative study examining food safety practices used by Iowa
produce growers was conducted by researchers from Iowa State
University. Observational and in-depth interview techniques
were used to assess current food safety practices at each
operation. Producers were conscious of product safety, but
levels of awareness about risk varied. Areas that needed
improvement included improved hand washing facilities and
practices; provision of employee training; and the development
of cleaning and sanitizing protocols for both products and food
contact surfaces.\10\.
---------------------------------------------------------------------------
\10\ J Ellis, et al. (2005). ``Assessing On-farm Food Handling
Practices of Iowa-grown Produce and Eggs in Regard to Food Safety.''
Food Protection Trends, 25(10): 758-61.
---------------------------------------------------------------------------
fall 2006 produce outbreaks
The 2006 spinach outbreak hit Wisconsin the hardest. The State had
49 confirmed cases, 24 hospitalizations, nine individuals with
Hemolytic Uremic Syndrome (HUS) resulting from their E. coli poisoning,
and one death.\11\
---------------------------------------------------------------------------
\11\ Wisconsin Department of Health and Family Services. ``Disease
Outbreaks and Investigation.'' 2006. October 3, 2006. March 5, 2007.
.
---------------------------------------------------------------------------
On September 5, 2006, the Wisconsin Department of Health and Family
Services was notified of several cases of E. coli O157:H7 in the State.
Two days later the State health department contacted the Centers for
Disease Control and Prevention (CDC) and the Wisconsin State Laboratory
about this suspected outbreak. On September 8, the Wisconsin State
Laboratory ``DNA fingerprinted'' the specific E. coli strain and posted
the information for the CDC and other State laboratories. This posting
allowed the CDC to match the genetic fingerprint of the Wisconsin E.
coli O157:H7 to victims of an outbreak in Oregon and the multi-State
outbreak investigation of E. coli began. Investigations by the CDC, the
Wisconsin health department, and the Oregon health department
identified fresh spinach as the likely culprit.\12\ On September 14,
the FDA issued a warning for consumers to avoid eating fresh
spinach.\13\ But the warning came after much of the produce was
distributed and consumed. Overall, during August and September, E. coli
O157:H7 in fresh spinach sickened 204 people in 26 States, killing at
least three.
---------------------------------------------------------------------------
\12\ Wisconsin Department of Health and Family Services. ``Disease
Outbreaks and Investigation.'' 2006. October 3, 2006. March 5, 2007.
\13\ States Food and Drug Administration. (September 14, 2006). FDA
Statement on Foodborne E. coli O157:H7 Outbreak in Spinach. Press
Release. September 14, 2006. March 5, 2007.
---------------------------------------------------------------------------
While many produce outbreaks occurred prior to 2006, this outbreak
provided the smoking gun that sourced the cause all the way to the
farm. FDA traced the exact strain of the E. coli bacteria to a
California spinach farm, finding it in nearby manure piles, in a creek
and even in a wild pig.\14\ These findings definitively proved that the
E. coli contamination that sickened so many people started right on the
farm.
---------------------------------------------------------------------------
\14\ ProMED-mail. E. coli O157, spinach--USA (multistate)(20).
ProMED-mail 2006; 27 October: 20061027.3067. February 23, 2007.
---------------------------------------------------------------------------
This spinach outbreak was the first of a series of produce
outbreaks that swept the Nation in the closing months of 2006. In late
September, Salmonella found in tomatoes sickened restaurant patrons
throughout the Nation. This time 183 people fell ill in 21 States. E.
coli O157:H7 appeared in produce once more before the year's end when
shredded iceberg lettuce at Taco Bell and Taco John Restaurants
sickened 152 individuals.
Rapid investigations and the quick release of information to
consumers are important to lessen the public health impact. In
September, FDA's nationwide consumer notification to avoid spinach
likely reduced the illness and death toll, and its continual updates
meant that many additional consumers heard the news.\15\ Thorough \16\
investigations are also essential to prevent reoccurrences of
outbreaks. But it is time to do more. Consumers want FDA to put in
place a regulatory system that will prevent these outbreaks from
occurring.
---------------------------------------------------------------------------
\15\ United States Food and Drug Administration. (September 14,
2006). FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach.
Press Release. September 14, 2006. March 5, 2007.
\16\ United States Food and Drug Administration. Spinach and E.
coli. November 15, 2006. March 5, 2007.
---------------------------------------------------------------------------
consumer confidence
Consumers want to eat fresh vegetables and fruits and we love the
convenience of bagged salads that allow us to have a salad on the table
in few minutes. But consumer confidence in the safety of these bagged
products has certainly declined since the fall. The spinach outbreak
had as many fatalities as Jack in the Box hamburger outbreak of 1992.
It may prove to be a tipping point for consumer confidence unless the
industry and the government act quickly to provide solutions to the
risks that are now so evident.
In November 2006, the Food Policy Institute at Rutgers University
conducted a telephone survey of 1,200 adults to see if consumers had
heard about the FDA advisories and the subsequent recalls of spinach
and to understand how the outbreaks would affect their future
consumption of fresh spinach.\17\ The majority of Americans knew about
the recall (87 percent) and most learned of it from television reports
(71 percent). Many Americans were unsure which spinach products were
affected; only 68 percent knew that, in addition to bagged fresh
spinach, bulk spinach was also recalled. Twenty-two percent incorrectly
identified frozen spinach as recalled. The survey also documented that
public notice is sometimes not enough to warn people off a high-risk
food item. In fact, more than one-in-eight Americans (13 percent) who
were aware of the recall continued to consume fresh spinach during the
recall.
---------------------------------------------------------------------------
\17\ Cutie, Cara Ph.D., et al, Public Response to the Contaminated
Spinach Recall of 2006. Food Policy Institute, Rutgers University.
(February 5, 2007).
---------------------------------------------------------------------------
Many consumers were confused about when the recall ended; at the
time of the survey in November 2006, 6 weeks after the FDA's initial
warning, 45 percent were unsure if the spinach recall had ended. Many
consumers surveyed were also avoiding other fresh greens: 18 percent
had stopped buying other bagged produce. At the time of the survey 44
percent of consumers resumed eating fresh spinach and 20 percent said
they ``definitely will eat spinach in the future.'' Five percent of
Americans who ate spinach before the recall said they ``definitely will
not eat spinach in the future.'' Nearly one in five reported (19
percent) that they will now avoid spinach grown in particular areas of
the country and 15 percent said they would avoid specific brands of
spinach.
fda's budget problems
Last fall's produce outbreaks are just the latest symptom of an
agency that is overwhelmed by responsibility, but lacks the staff and
resources to function effectively. The agency responds to crisis after
crisis rather than preventing them. Current FDA funding shortfalls have
reached a critical level and budget cuts have left the agency with
fewer inspectors, even as their workload continues to increase. In
fact, since 1972 inspections conducted by the FDA declined 81 percent.
Since 2003, the number of FDA field staff dropped by 12 percent and
between 2003 and 2006, there was a 47 percent drop in Federal
inspections.\18\
---------------------------------------------------------------------------
\18\ Waxman, Henry. Fact Sheet: Weaknesses in FDA's Food Safety
System. Representative Henry Waxman. (October 30, 2006); Andrew
Bridges, Seth Borenstein, ``AP Investigation: Food Safety Inspections
Lanquish,'' Associated Press, February 29, 2007.
---------------------------------------------------------------------------
FDA's food program has a current funding shortfall of $135 million,
which an FDA budget official described as equivalent to a 24 percent
budget cut. This means that many other parts of the agency's
responsibilities are just not getting attention--things like obesity,
dietary supplements, and appropriate oversight of new technologies.
Overall consumer confidence in FDA has plummeted. A Harris Poll has
documented that those who thought FDA was doing an ``excellent'' or
``good'' job went from 61 percent in 2000 who to 36 percent in 2006.
Equally important is the fact that the Federal agencies' food
safety expenditures are disproportionate to the risk posed by the foods
they regulate. USDA regulates 20 percent of the food supply, which
causes 32 percent of outbreaks, yet its food safety appropriations are
double that given to FDA.\19\ This means that while USDA has the
resources to inspect meat and poultry plants daily, the FDA inspects
food facilities it regulates on average just once every 5 to 10 years.
---------------------------------------------------------------------------
\19\ Center for Science in the Public Interest, Outbreak Alert
(Revised and updated--2006).
---------------------------------------------------------------------------
The Bush Administration's 2008 budget proposal brings no relief to
the ailing agency. The recent budget proposal gives USDA $270 million
in new money for food safety and security. The FDA, on the other hand,
regulates 80 percent of the food supply, including produce, but will
only get $10.6 million in new food safety money. It is a food safety
budget that defies logic.
cspi proposal
Fresh fruits and vegetables are at the center of a healthy diet, so
it is critical that immediate steps are taken to improve their safety.
CSPI has petitioned the FDA to take action to require that all fruit
and vegetable producers and processors develop written plans to
identify where contamination is likely to occur and how to address it.
This approach is appropriate for both large and small growers and
processors. It targets resources to critical areas and reduces risk by
using prevention. These plans should apply first to the highest-risk
products--such as leafy green vegetables that have been repeatedly
linked to illness outbreaks and more gradually to other segments of the
industry.
Specifically, CSPI proposes a three-prong approach to improve the
safety of fresh fruits and vegetables:
--First, FDA should require all growers and processors to keep a
written food safety plan, designed by the farmer to address the
specific environmental conditions on the farm.
--Second, FDA should develop standardized criteria for use by the
farmers for such items as water quality, manure use and
management, and worker sanitation.
--Finally, the written plans should be audited at least once per
growing season by FDA, the States, or the buyers, and FDA
should review these audits.
FDA's standards should include the following areas:
Manure.--The grower must manage the application of manure to ensure
that it does not contribute to the contamination of crops, including
limitations on the crops where and the times when it may be applied.
The use of raw manure on produce during the growing season should be
prohibited as currently required under USDA's Organic Certification
Program.\20\ Composting of manure intended for use on food crops should
be monitored and records should be maintained to ensure effective
controls are used to destroy pathogens. Domestic animals should be
excluded from fields and orchards during the growing and harvesting
season, and growing areas should have wildlife deterrents. Farmers and
producers should ensure that animal waste from adjacent fields,
pastures, or waste storage facilities do not contaminate growing areas.
Manure treatment and storage sites close to fresh produce fields
increase the risk of contamination; livestock producers should be
required to move or otherwise control these sites.
---------------------------------------------------------------------------
\20\ National Organic Program. 5 CFR pt.205.203(c).
---------------------------------------------------------------------------
Water.--Growers and producers should ensure that the water supply
used for irrigation and in food processing plants is suitable for its
intended use. The internationally agreed-upon Codex Code of Hygienic
Practice for Fresh Fruits and Vegetables Processors says that growers
should assess the microbial and chemical quality of the water used in
primary production.\21\ Vegetable processors should use only potable
water in processing or for cleaning or sanitizing the facility and
equipment. Facilities should have an environmental monitoring program
that includes sampling for pathogens to detect areas of harborage and
to verify the effectiveness of cleaning and sanitizing programs in
preventing cross-contamination. Sanitizers used for washing vegetables
should be approved by FDA and continuously monitored by the facility to
ensure they remain at effective levels in the wash water. If effective
sampling programs can be developed, water used for washing produce
should be monitored for the presence of pathogens at a rate adequate to
ensure highly contaminated batches are identified and eliminated.
---------------------------------------------------------------------------
\21\ United Nations Codex Alimentarius Commission (2003). Codex
Code of Hygienic Practice for Fresh Fruits and Vegetables. Section
3.2.1.1. March 5, 2007. . See also: Beuchat LR (1998). ``Surface
decontamination of fruits and vegetables eaten raw: A review.'' Food
Safety Issues. World Health Organization.
---------------------------------------------------------------------------
Hygiene.--Growers and processors should ensure that employees have
close access to bathrooms and that handwashing facilities are visible
to supervisors. Employees with direct and indirect access to the
production areas should be trained in preventive controls that will
help to eliminate or minimize contamination of produce.
Sanitation.--Processors should establish mandatory sanitation
standard operating procedures, including cleaning procedures for
equipment, storage areas, air systems, and water storage areas.
Facilities should be designed to facilitate maintenance and good
sanitation practices so that contamination may be controlled throughout
receiving, cooling, processing, packing, and storage operations. There
should be limited access to the facility and to its processing areas;
adequate space for operations; adequate drainage of processing and wash
water; food contact surfaces that are easy to clean and maintain; and
areas and structures designed to protect the product and equipment from
contamination.
Traceback.--Processors should mark packaging to ensure easy
traceback when fruits and vegetables are implicated in an outbreak.
Package markings should be specific enough to extend all the way back
to the farm/farms of origin. The ability to identify the source of a
product is a critical component of food safety programs intended to
prevent the occurrence of microbial contamination. Information gained
from a traceback investigation can help limit the impact of an outbreak
of foodborne illness and help to identify and eliminate conditions that
may have contributed to product contamination.
Written food safety plans would help farmers to focus on hazards
associated with their products and the steps taken to address those
hazards. These plans are the essential first step in preventing a
reoccurrence of the outbreaks from last fall. The plans should be
reviewed during random third party and State auditing based on
consistent standards. Seasonal audits would allow FDA to monitor that
the regulations are being fully implemented and enforced. If States or
third party auditors are relied on, FDA should periodically conduct on-
sight audit reviews to ensure that auditors provide consistently
reliable services. Whenever auditors inform FDA or if the agency finds
violations, it should bring enforcement actions, including product
seizure and criminal sanctions.
Foodborne illness outbreaks related to fresh produce are a major
public health problem. Prevention, early detection, and control
measures must be in place at every step of fresh produce production to
help minimize food safety risks. Voluntary guidelines are not an
effective public health response to address the food safety problems
related to fruits and vegetables. And while FDA can likely cobble
together the authority it needs to regulate on the farm from existing
statutes, there is no clear mandate from Congress that ensures food
safety oversight all the way from the farm to the table. Food safety is
critically important to consumers' health and to the health of the
industries that produce food; yet, it is governed by laws that are 100
years old. It is time to modernize food safety.
safe food act
While we believe that FDA has authority to implement these
improvements under both the Federal Food, Drug and Cosmetic Act and the
Public Health Service Act, neither of these laws give the agency clear
authority from farm-to-table when it comes to food safety. The FFDCA
sets up a reactive structure, in which the agency is truly empowered
only when food is found to be adulterated or misbranded. This is very
different from the Federal Meat Inspection Act, for example, that
requires government inspectors to approve every meat product before it
can be sold.
In order to bring these disparate food safety laws together, on
February 15, 2007, Senator Richard Durbin and Representative Rosa
DeLauro introduced The Safe Food Act to streamline food safety at the
Federal level. This bill creates a strong, science-based Food Safety
Administration, ending the current tug-of-war between agencies.
The Safe Food Act would create a system of risk-based inspection,
``determined by the type of food handled and the type of processing to
which the food is subjected.'' \22\ Food establishments would receive a
rating (1-5) to determine the number and the time between inspections,
based on public health considerations and strong scientific evidence.
The risk-based inspection program would continue the ``carcass-by-
carcass'' inspections at slaughterhouses and perform daily inspections
of other high-risk products. All food processors would be inspected at
least annually, with many inspected much more often. This system of
risk-based inspection would allow for the best use of department
resources while still ensuring the safety of the entire ``farm-to-
fork'' process.
---------------------------------------------------------------------------
\22\ DeLauro, Rosa L. Summary: The Safe Food Act of 2005, H.R. 1507
Congresswoman Rosa L. DeLauro's Website. March 5, 2007.
---------------------------------------------------------------------------
The Safe Food Act addresses imported foods as well. The FDA
currently inspects only about 1 percent of food entering the United
States, due to its limited resources and does little to evaluate
foreign food safety systems or inspect foreign plants.\23\ The Safe
Food Act gives the Food Safety Administration the authority to evaluate
and certify a country's food safety program to ensure that it is ``at
least equivalent to the food safety program in the United States.''
\24\ Food coming from uncertified countries or plants will not have an
``open visa'' to enter the United States without inspection or
regulation as they do today, while food that are properly certified
would move quickly.
---------------------------------------------------------------------------
\23\ General Accounting Office (GAO), Food Safety. Overview of Food
Safety and Inspection Service and Food and Drug Administration
Expenditures (GAO/T-RCED-00-300T). (September 20, 2000) (statement of
Lawrence J. Dyckman, Director, Food and Agriculture Issues, Resources,
Community, and Economic Development Division, GAO). March 5, 2007.
\24\ United States. Congress. House of Representatives. 110th
Congress, 1st Session. H.R. 1148, The Safe Food Act of 2007.
[introduced in the House of Representatives 16 February 2007]. 110th
Congress. Congressional Bills, GPO Access. March 5, 2007.
---------------------------------------------------------------------------
When food safety problems do occur, it is vital that the Food
Safety Authority has sufficient tools to respond in an emergency.
According to the World Health Organization ``tracing systems and market
recalls are thus critical in responding to food contamination, whether
deliberate or inadvertent.'' \25\ Today, however, the USDA and the FDA
rely on voluntary company tracking and recall systems. The Safe Food
Act mandates the establishment of a national system for ``tracing food
and food producing animals from point of origin to retail sale.'' \26\
---------------------------------------------------------------------------
\25\ Food Safety Dep't, World Health Org., Terrorist Threats to
Food: Guidance for Establishing and Strengthening Prevention and
Response Systems, Food Safety Issues 4 (2002). March 5, 2007.
\26\ United States. Congress. House of Representatives. 110th
Congress, 1st Session. H.R. 1148, The Safe Food Act of 2007.
[introduced in the House of Representatives 16 February 2007]. 110th
Congress. Congressional Bills, GPO Access. March 5, 2007.
---------------------------------------------------------------------------
The Safe Food Act works to prevent foodborne illness and
bioterrorism without grand schemes or an inflated budget. Instead, it
ensures a strong national program, outbreak surveillance, and
effective, honest public communication. The food industry is the first
line of defense, but recent outbreaks demonstrate that effective
industry programs require government monitoring and oversight.
Senator Kohl. That's great, very good. Dr. Pariza.
STATEMENT OF MICHAEL W. PARIZA, DIRECTOR, FOOD RESEARCH
INSTITUTE, MADISON, WISCONSIN
Dr. Pariza. Thank you. I really appreciate the opportunity
to speak here this morning and I want to begin by commending
you, Senator Kohl, for holding this extraordinary meeting here
in Badger Capitol, where we know that the most important reason
for having a belt line is to transport excited sports fans from
all over the State to Kohl Center.
Seriously, Senator Kohl, it is almost impossible to fully
express our gratitude to you for your unfailing dedication and
support, both public and personal, to the State of Wisconsin
and to the University and we really feel that you exemplify the
highest principles of public service.
We are here this morning to consider a serious issue, the
apparent increase in food-borne illness associated particularly
with fresh produce. I say apparent because we are not really
sure how much is due to a true increase as opposed to increased
awareness and reporting. Of course, either way, it's important
news and we know that important news can be both good and bad.
The good news is that the public and Congress are focusing
on food related issues that are true risks rather than
distractions like the Carcinogen of the Week headlines that
used to occupy an inordinate amount of FDA's energy and
resources. I am pleased to say that we were able to work with
former Congressman Scott Klug to revise the so-called Delaney
clause to bring it in line with current scientific
understanding.
This revision permitted resources to be re-directed to
food-borne illness, which is a real issue that we can actually
address with the tools of science. We can really reduce the
risks, the economic loss, the morbidity and the mortality
caused by food-borne pathogens and toxins.
There is bad news, too. There are critical gaps in our
knowledge base. The limiting factor is lack of research funds
rather than lack of good ideas. Perhaps even worse is the
realization that our regulatory agencies, in particular, the
FDA lack of resources to apply to what we already do know and
of course, we've heard that from other panelists.
On the morning of September 11, 2001, Americans got a wake-
up call that continues to reverberate. Funds were quickly
allocated to, among other things, food security, which was
certainly appropriate. UW Madison is a major partner in the
Department of Homeland Security's National Center for Food
Protection and Defense, which is currently headquartered at the
University of Minnesota. However, funds that had previously
been allocated for traditional food safety research and
regulatory activities were also redirected to the defense
against food bioterrorism and that trend should be reversed.
The prospect of food bioterrorism is very scary and could have
catastrophic consequences but in fighting this demon, we should
not lose sight of the more mundane and very real risks of food-
borne illness in more familiar corners.
You've asked whether the current system is working or
broken. The answer, in my opinion, is yes and yes. One might
argue that the system works, at least sort of because food-
borne illness, when it happens, particularly on a large scale,
is still news. If the system were completely broken, food-borne
illness would be commonplace and that certainly is not the
case.
The safety of fresh produce is very important and the focus
of this hearing. Illnesses and deaths associated with fruits,
vegetables and herbs are unacceptable. Of course, fresh produce
is not the only type of food that can harbor risks, like
pathogens, so it is important that funds are not simply
redirected to fresh produce safety from other important areas.
We need an overall increase, in other words, is what I'm
getting at here.
UW Madison's Food Safety Program is designed to enhance the
safety of all foods consumed in the United States. We've found
that knowledge coming from one area can often be applied to
other areas. At the risk of sounding immodest, I should tell
you that a substantial amount of the information used by the
processed food industry and its regulators to ensure safe food
was discovered or developed at FRI. Especially noteworthy
examples of research by FRI faculty and staff that affect
virtually every consumer included the development of the
methodologies that are used worldwide to ensure that processed
cheese spreads are safe and methods for producing
microbiologically safe low-nitrite bacon.
You may have noticed holes in the plastic wrap around fresh
mushrooms. Those holes are there because FRI researchers
discovered that allowing air to enter freely into the package
eliminates the threat of botulism from that product.
FRI faculty and staff isolated the toxins that produce
staphylococcal food poisoning, known euphemistically as the
two-bucket disease. They also developed the reagents needed to
detect these toxins and used them to save a small cheese
company in Green Bay, Wisconsin from bankruptcy. Today you know
that company as Schreiber Foods.
More recently FRI personnel studied the transmission on
farms of E. coli O157:H7, which you've heard a lot about. No
one ever wants E. coli because it causes bloody diarrhea and it
can be fatal, especially for children. This critically
important work led to a simple solution. Keep manure out of the
water that cows drink. Now that may sound obvious but imagine
how difficult it is to implement on a large dairy farm. One
needs knowledgeable, dedicated individuals and capital
investment into the required equipment. This research was
initiated to enhance our understanding of the ecology of E.
coli O1578:H7 and reduce the risk of that pathogen in ground
beef. But the discoveries from the project have wider impact
that includes reducing the contamination of fresh produce from
farm runoff and the use of manure as fertilizer.
Other current FRI research is aimed at helping the State
and national dairy and meat processing industries develop safe
formulations, reduce mold toxins in grain, eliminate thin
layers of microbial pathogens from food processing equipment,
control acrylamide formation in fried potato products, and
understand botulinum toxin. The last, incidentally led to the
development paradoxically of botulinum.
Yes, that's right. The first Botox ever approved by FDA for
human drug use was purified right here in Madison at the Food
Research Institute.
Wisconsin Alumni Research Foundation known as WARF, has
patented discoveries made at FRI involving conjugated linoleic
acid, which is now the sixth most financially successful
technology in WARF history and it earns more than $1.5 million
annually from the royalty income book, which goes back to the
university-supported research.
FRI faculty and staff also collaborate with the broader UW
Madison community, for example, the College of Engineering.
Projects include using nano-technology to develop novel sensors
for detecting microbial pathogens and toxins, and procedures
for disposing of the food that was intentionally contaminated
with a biological agent. We are discussing other major
collaborative efforts to utilize our collective expertise in
food safety, risk analysis, risk perception and applied
economics to study the spread of microbial contamination from
farm fields to consumers in the fresh produce industry.
The ultimate goal of this project is to assess the
effectiveness of potential risk reduction measures and identify
cost effective strategies for improving the safety of fresh
produce.
I've discussed how the current National Food Safety Program
sort of works. The system is also sort of broken. To be clear,
the system needs repair, not a major overhaul and in this
regard, you can help us with one big matter, the need for
increased funding requires that you direct it to food safety
research and regulatory activity without, of course,
compromising the equally important, complimentary efforts aimed
at preventing food bioterrorism.
With regard to fresh produce, we need improvements in pre-
harvest practices and post-harvest intervention. These are
particularly crucial. The term pre-harvest encompasses all that
happens while a crop is growing in the field or orchard. By
contrast, post-harvest encompasses what happens between the
harvest of a crop and the transport to a supermarket and may
include washing, cutting and packaging.
In this country, the most important pathogens associated
with fresh produce are enteric pathogens, particularly E. coli
O1578:H7 and salmonella. These microorganisms are commonly
found in the intestines of mammals and birds and they find
their way into fresh produce because of fecal contamination.
Birds fly over orchards, rodents run between crop rows,
cows graze near fields and so forth. You can reduce the impact
through improved fencing and cover, and cultivation that
minimizes contamination from runoff, but we would have to grow
all of our crops in sterile greenhouses to ensure the complete
absence of contamination and this is where so much additional
research is helping us.
PREPARED STATEMENT
I'm running way over time so I'm just going to bring it to
the end. In summary, the U.S. food safety system is not really
broken but it is also not working as well as it could and a
critical missing component is sufficient funding for research
and regulatory activities. Thank you.
[The statement follows:]
Prepared Statement of Michael W. Pariza
Good morning. I'm Mike Pariza, Director of the UW-Madison Food
Research Institute (FRI) and Wisconsin Distinguished Professor of Food
Microbiology and Toxicology. I appreciate the opportunity to speak this
morning and will begin by commending Senator Kohl for holding this
extraordinary meeting here in Badger Capital, where we know that the
most important reason for having a beltline is to transport excited
basketball fans from all over the State to the streets that go to the
Kohl Center.
Seriously, Senator Kohl, it is almost impossible to fully express
our gratitude for your unfailing dedication and support, both public
and personal, to the State of Wisconsin and UW-Madison. You exemplify
the highest principles of public service.
We are here this morning to consider a serious issue: the apparent
increase in foodborne illness, associated particularly with fresh
produce. I say ``apparent'' because we are not really sure how much is
due to a true increase, as opposed to increased awareness and
reporting. Of course either way it's important news, and as we know
important news can be both good and bad.
The good news is that the public and Congress are focusing on food-
related issues that are true risks, rather than distractions like the
``carcinogen-of-the-week'' headlines that used to occupy an inordinate
amount of FDA's energy and resources. I'm pleased to say that we were
able to work with former Congressman Scott Klug to revise the so-called
``Delaney Clause'' and bring it in line with current scientific
understanding. This revision permitted resources to be redirected to
foodborne illness, which is a real issue that we can actually address
with the tools of science. We really can reduce the risks, the economic
loss, the morbidity and mortality caused by foodborne pathogens and
toxins.
But there is bad news too. There are critical gaps in our knowledge
base. The limiting factor is lack of research funds rather than lack of
good ideas. Perhaps even worse is the realization that our regulatory
agencies, in particular FDA, lack the resources to apply what we
already do know.
On the morning of September 11, 2001 Americans got a wake-up call
that continues to reverberate. Funds were quickly allocated to among
other things food security, which was certainly appropriate. UW-Madison
is a major partner in DHS's National Center for Food Protection and
Defense, which is currently headquartered at the University of
Minnesota.
However, funds that had previously been allocated for traditional
food safety research and regulatory activities were also redirected to
defense against food bioterrorism, and that trend should be reversed.
The prospect of food bioterrorism is very scary and could have
catastrophic consequences, but in fighting this demon we should not
lose sight of the more mundane but very real risks of foodborne illness
from more familiar corners.
You've asked whether the current system is working or broken. The
answer, in my opinion, is yes and yes. One might argue that the system
works, at least ``sort of,'' because foodborne illness, when it happens
particularly on a large scale, is still news. If the system were
completely broken foodborne illness would be commonplace, and it
certainly is not that.
The safety of fresh produce is very important and the focus of this
hearing. Illnesses and deaths associated with fruits, vegetables and
herbs are unacceptable. Of course fresh produce is not the only type of
food that can harbor risks from microbial pathogens, so it is important
that funds are not simply redirected to fresh produce safety from other
important areas.
UW-Madison's food safety program is designed to enhance the safety
of all foods consumed in the United States. We've found that knowledge
gained from one area can often be applied to other areas. At risk of
sounding immodest, I should tell you that a substantial amount of the
information used by the processed food industry and its regulators to
ensure safe food was discovered or developed at FRI. Especially
noteworthy examples of research by FRI faculty and staff that affect
virtually every consumer include the development of the methodologies
that are used worldwide to ensure that processed cheese spreads are
safe, and methods for producing microbiologically safe low-nitrite
bacon. You may have noticed holes in the plastic wrap around fresh
mushrooms; those holes are there because FRI researchers discovered
that allowing air to enter freely into the package eliminates the
threat of botulism from the product.
FRI faculty and staff isolated the toxins that produce
staphylococcal food poisoning, known euphemistically as ``the two
bucket disease.'' They also developed the reagents needed to detect
these toxins, and used them to save a small cheese company in Green Bay
Wisconsin from bankruptcy. Today you know that company as Schreiber
Foods.
More recently FRI personnel studied the transmission, on farms, of
Escherichia coli O157:H7, also know as hemorrhagic E. coli because it
causes bloody diarrhea that can be fatal, especially for children. This
critically important work led to a simple solution: keep manure out of
the water that cows' drink. That may sound obvious but imagine how
difficult it is to implement on a large dairy farm. One needs
knowledgeable dedicated individuals, and capital investment in the
required equipment. This research was initiated to enhance our
understanding of the ecology of coli O157:H7 and reduce the risk of the
pathogen in ground beef, but the discoveries from the project have
wider impact that include reducing the contamination of fresh produce
from farm runoff and the use of manure as fertilizer.
Other current FRI research is aimed at helping the State and
national dairy and meat processing industries develop safe
formulations, reduce mold toxins in grain, eliminate thin layers of
microbial pathogens (called biofilms) from food processing equipment,
control acrylamide formation in fried potato products, and understand
botulinum toxin which led, paradoxically, to the development of
botulinum toxin as a drug. Yes, that's right, the first BOTOX ever
approved by FDA for human drug use was purified right here in Madison
at FRI. The Wisconsin Alumni Research Foundation (WARF) has patented
discoveries made at FRI involving conjugated linoleic acid (CLA). CLA
is now the 6 most financially successful technology in WARF history,
and earns more than $1.5 million annually in royalty income, the bulk
of which goes to support research at UW-Madison.
FRI faculty and staff also collaborate with the broader UW-Madison
community, for example the College of Engineering. Projects include
using nanotechnology to develop of novel sensors for detecting
microbial pathogens and toxins, and procedures for disposing of food
that was intentionally contaminated with a biological agent. We are
discussing a major collaborative effort to utilize our collective
expertise in food safety, risk analysis, risk perception, and applied
economics to study the spread of microbial contamination from the farm
fields to consumers in the fresh produce industry. The ultimate goal of
this project is to assess the effectiveness of potential risk-reduction
measures, and identify cost-effective strategies for improving the
safety of fresh produce.
I've discussed how the current national food safety system ``sort
of'' works. But the system is also ``sort of'' broken. To be clear, the
system needs repair, not a major overhaul. In this regard you can help
us with one big matter: the need for increased funding directed to food
safety research and regulatory activity, without of course compromising
the equally important complementary efforts aimed at preventing food
bioterrorism.
With regard to fresh produce, the need for improvements in pre-
harvest practices and post-harvest intervention is crucial. The term
``pre-harvest'' encompasses all that happens while a crop is growing in
a field or orchard. By contrast ``post-harvest'' encompasses what
happens between the harvest of a crop and its transport to a
supermarket, and may include washing, cutting and packaging.
In this country the most important pathogens associated with fresh
produce are enteric pathogens, particularly E. coli O157:H7 and
Salmonella. These microorganisms are commonly found in the intestines
of mammals and birds, and they find their way onto fresh produce
because of fecal contamination--birds fly over orchards, rodents run
between the crop rows, cows graze near fields planted with food crops,
and so forth. You can reduce the impact through improved fencing and
cover, and cultivation practices that minimize contamination from
runoff. However we would have to grow all our crops in sterile
greenhouses to ensure the complete absence of contamination.
Accordingly, there is great need for improved pathogen surveillance
tools and detection methodologies. Typically one is dealing with small
levels of pathogen contamination against a much larger backdrop of
harmless, mundane bacteria that are commonly found in soil. Quickly
identifying the pathogens and differentiating them from their harmless
relatives is no easy task, and we don't have optimal tools for this
yet.
Post-harvest intervention focuses on treating fresh produce so that
the inevitable pathogens are destroyed while at the same time
protecting the fresh quality that consumers want.
Traditional post-harvest methods for killing pathogens and
preserving vegetables and fruit, for example canning, are not the
solution because no matter how safe canned vegetables are they don't
taste fresh. Rinsing fresh produce helps but effectiveness is limited
because pathogens can sometimes hide within the cellular structures of
the plant, where the rinse cannot penetrate. Other methods, for example
irradiation and the use of high-pressure pasteurization, appear to work
very well in many applications. However both of these are expensive,
and in the case of irradiation unfairly maligned. Accordingly there is
urgent need for novel processing and disinfection methodologies that
are effective and economically viable across a wide range of products
and applications.
Post-harvest intervention is an area that truly needs more
research. We will not solve the problem of fresh produce safety until
we master post-harvest intervention.
Finally, education is critically important to maintaining a safe
food supply. While there is a lot we do not yet know, it is equally
true that there is a lot about food safety that we do know, and that is
where educational programs focused on food and food safety at research
universities like UW-Madison come in. Some of our former students go
into the private sector where they often make crucially important
contributions. An example is the late Dr. Howard Bauman, who received
his Ph.D. at UW-Madison under the direction of Professor Mike Foster,
FRI's last Director and one of the principals involved in moving the
Food Research Institute from the University of Chicago to UW-Madison in
the 1960s. Dr. Bauman spent his career at the Pillsbury Company, where
he invented a procedure called HACCP, the acronym for Hazard Analysis
Critical Control Point. HACCP is a method used to identify and control
the vulnerable steps in a process where contamination may occur. It has
become the backbone for food safety analysis worldwide and is mandated
by USDA. If you operate a food plant in the United States, you must
have a HACCP plan. HACCP is also applied to agricultural practices, to
identify and control the most vulnerable areas for pathogen
contamination.
We're also very proud that some of our food safety program
graduates choose careers in the public sector, for example Dr. Brackett
who you will hear from next, and Dr. Don Burr who is in the audience.
Both Dr. Bracket and Dr. Burr manage key programs to help ensure that
our food remains safe and secure.
In summary, the U.S. food safety system is not really broken, but
it is also not working as well as it could. A critical missing
component is sufficient funding for research and regulatory activities.
Senator Kohl. Thank you very much, Dr. Pariza. A couple
questions, Dr. Verduin. In your statement, you talked about the
need for regulatory oversight but you noted the differences in
commodities, farm programs, etcetera. Are there basic
standards, in your opinion, that could be implemented for all
commodities as a Federal baseline?
Dr. Verduin. Yes. I believe there are. I believe there are
some basic farm practices and standards relative to water
irrigation systems, manure--certain standards that would apply
to all farms and commodities. Then what we would believe would
happen is, depending upon the commodity, as Mr. Stenzel said,
you would then get down to much more specific standards
relative to that commodity's practices, how it is cut, how it
is harvested. So we believe there are overarching guidelines
that can be established that are science-based and specific.
Let me just comment on science-based. There is a lot of
stuff that we don't know. There are a lot of things that are
going to be built into these standards initially that may prove
out to be ineffective, that are our best guess or our best
judgment on all the expertise, and that's okay for a time, but
we also need the science to support and put in those things
that really do matter and strengthen them as much as possible.
So we would like guidelines put in place, over all
commodities, with underpinnings for specific commodities and
then we would like, at the same time, research being done to
make sure those guidelines represent the best science and the
best interventions and the best limits to date.
Senator Kohl. Okay. Do you think that the FDA currently has
the ability to make these improvements within their authorities
and their funding levels?
Dr. Verduin. We believe they have the authority to make
these improvements. We believe they have the authority to make
these guidelines and to also work with the States. They have
the authority to work collaboratively and to get into
cooperative agreements with the States.
Having said that, and I know you're going to hear this
again, they need the money to do it and we also believe that
Congress expressly asking them to do it is also important.
Senator Kohl. Good. Could you talk a little bit about
irradiation? We keep hearing about it. In your opinion, is it
safe? Would it work on everything? And what other technologies
do you think are on the horizon? Do we need to do more
research?
Dr. Verduin. I think irradiation is a tool in the toolbox.
I think it is a potential--obviously, we know that the science
is there that supports the fact that it kills pathogens. On
fresh produce, we know that it's applicable to certain types of
produce and not to others, not from a safety perspective but
from a quality of product eaten perspective, how consumers
perceive the product. Is it crispy at the end of the day? So we
know that the science works. We know that it is one tool that
we can potentially apply to certain products. We believe that
that tool should be allowed to be used.
Having said that, it's not the only tool. There is modified
atmosphere packaging, there are sanitizers that we could use
that also need to be further investigated and further
researched at hopefully the land grant universities like the
University of Wisconsin and should we continue to pursue these
and continue to make them available to farmers and to
processors.
Senator Kohl. Thank you. Mr. Stenzel, what economic effects
have the recent outbreaks had on your members?
Mr. Stenzel. Well, Senator, clearly there has been a huge
economic impact. I hesitate to even answer the question,
though, in equating economic impact with the human impact of
the food-borne illness itself. So please don't misjudge that.
In looking at the impact of the spinach outbreak in
particular on our industry, as I stated in my testimony, this
proved to be a very narrow outbreak, one company and one
particular bag produced in one processing plant on one day. But
the impact was across the entire industry. It's one of the
reasons why I think you have seen an unusual phenomenon occur.
CSPI and the industry is sitting side by side and asking the
FDA to do the same thing, and that is because our industry has
had such impact from this loss of consumer confidence, across
many people who did not cause the outbreak, and that's
something that we've come to grips with, that we either have to
restore public confidence in our overall food safety system or
else our industry may not be able to fulfill that public health
challenge of increasing consumption of fruits and vegetables.
Senator Kohl. Thank you. You said that the FDA does not
need to go out and hire 5,000 new inspectors in your statement
or to be on every farm and in every plant. I certainly agree
that's not feasible nor would it be responsible, but do you
think FDA has all of the people it needs, both in the field as
well as at the FDA?
Mr. Stenzel. As Dr. Verduin stated in response to your
question to her, I do believe it is a resource question for
FDA. It is not a question of authority. It's not a question of
intent. We have the greatest respect for the scientists in the
Center for Food Safety and Applied Nutrition but they simply
don't seem to have the resources to tackle this job as quickly
and as effectively as we think they could, despite best
efforts.
Now when you look at the inspection force, I know that
there has been a drop in that area as well. That's something
that needs to be tackled at the same time, but I think it is a
little bit of a different issue than simply the scientific
staff within the center itself that need even more resources at
that Federal level in addition to the Office of Regulatory
Affairs.
When it comes to on farm inspections, we see a great
potential for Federal/State cooperation. Every State has its
own department of agriculture, departments of health and they
really have their boots on the ground, if you will, in order to
be able to go to do some of the farm inspections that we're
talking about. But it needs to be still under FDA's authority
and FDA's direction as to what they should be looking for.
Senator Kohl. Mr. Stenzel, tracing back to a source after
the outbreak is obviously important in order to see what went
wrong and learn lessons to prevent future incidents. But I'm
sure you'd agree it's even more critical to detect an outbreak
early when something does go wrong, in order to keep more
people from getting sick. How can we better detect food-borne
disease quickly to prevent further spread of the illness?
Mr. Stenzel. Well, Senator, that's absolutely a top
priority, I think, for everyone in the public health community,
certainly within the industry as well. When an outbreak occurs,
and it doesn't matter what product it is, whether it is fresh
produce or a packaged, processed product, that product is being
consumed and we only learn about it after the fact. In our
case, we were 3, 4, 5 weeks after the product had been consumed
in that spinach outbreak, so early detection is something that
is extremely important to minimize the likelihood of additional
people becoming ill.
Dr. Pariza mentioned that clearly, in terms of the
importance of that early detection process. Let me give you one
example of something that you'll hear more about and that's
shelf life and the amount of time the product is being
consumed. In the spinach outbreak in particular, 25 to 30
percent of the people who became ill consumed the product after
the use by date that was stamped on the back. We've simply got
to do a better job also of teaching people that that's not a
wise practice, either. So we've got to look at the total supply
chains and make sure that we have the strongest public health
detection systems in place as well.
Senator Kohl. Thank you very much. Ms. DeWaal, it seems
like many of the standards that you talk about regarding
hygiene, sanitation, et cetera, wouldn't require a significant
test. You could simply walk onto a farm or processing plant and
see if the standards were, in fact, being met. But they would
require FDA or State inspectors to show up much more often. Do
you agree with that?
Ms. DeWaal. Yes. The model that we're working off of is one
that actually has been tried in the meat area and with quite a
bit of success. It's one where the plants themselves design the
safety systems but it's got to meet certain hazards. We know
the use of manure around produce can be a hazard. It's already
regulated with respect to organic but it's not regulated for
general produce. We know that water quality is vital,
critically important. We know that farm worker hygiene and the
ability to wash your hands is very important to the safety of
these products. About 40 percent of the produce outbreaks in
our database come from norovirus, which is transmitted from an
infected human onto the food.
So there are things that we know and that you could go onto
a farm and say, let me see your records of manure use or
composting records. You could actually see the hygiene
facilities sitting right there. You could see if the hand
washing sinks are visible. These kinds of things don't take
fancy tests. Tests can be very important, especially in
processing, to check the water to ensure that you don't have a
highly contaminated batch of lettuce or spinach coming in, for
example, but tests in the field, I think, will not be the key
here. It is good old-fashioned inspection, which is someone
going on the farm.
Let me talk for one minute about the issue of who should
inspect. Do we need 5,000? Do we need an army of inspectors
like we have over in the meat area, for meat and poultry
inspection? I think that we could do with less if we utilize
not only the States but also the buyers. The buyers have every
bit of interest in ensuring the safety of those products and so
if you have auditing that is done, both at the State level or
at the level of the Wal-Marts or the Costcos who are going to
be buying the products, that auditing system could be
consistent and it could be something that FDA could double-
check.
It's critical though, that this also be capable of being
enforced. If FDA has a problem on a farm, that they can walk in
on the basis of a State audit or a third-party, independent
audit and take enforcement action.
So we have to work on it. It's not the good, old-fashioned
USDA inspectors like we have in meat who can take action right
away. It's a new model but I think it's one that could be very
effective.
Senator Kohl. Very good. You stated that the average size
of an outbreak of food-borne illness from produce is larger
than it is from other foods. Why is this so?
Ms. DeWaal. In our database, the average size of a produce
outbreak is about 49 people. This is over a span of 15 years
and this is almost double the size of outbreaks from beef or
chicken and four or five times that of seafood. So it's really
distinctive.
Part of what's going on is I think for a long time, produce
was the last thing they suspected when they saw a salmonella or
an E. coli outbreak, they thought it was chicken or beef long
before they suspected the produce. Although produce is consumed
very quickly--so you buy the lettuce, you eat it very quickly,
sometimes compared to the meat or poultry, so the outbreaks
simply take longer to identify and the food source takes longer
to identify and to trace back. Oftentimes, FDA doesn't even
recall the product because they say the product is all gone by
the time they know enough to recall it.
So that's what we've observed and I think the public health
departments are getting better at identifying produce but the
trend is still there.
Senator Kohl. Thank you very much. Dr. Pariza, you
mentioned several discoveries by the talented faculty and staff
at FRI. Can you talk a little bit about how, for example, in
the mushroom packaging you mentioned, you get from the question
to the answer? How long would research like that take when you
are trying to answer a specific question?
Dr. Pariza. Yes, thank you very much. That particular
finding, actually I don't know how long it took exactly but I'm
sure it didn't take very long. That's because when you have an
awful lot of information already about an item and about what
was happening inside of the package. So that was not a very--
that particular finding, we were able to apply previous
information very quickly to come to a solution. I guess that it
probably didn't take more than a few months at the most. So
there is a range of how long things might take and it's really
dependent on the nature of the question.
Senator Kohl. In your opinion, Dr. Pariza, if there were a
pool of funding that FDA dedicated to new food safety research
to answer some of the questions that you mentioned in your
statement, how long would it take, in your opinion, to yield us
some real results?
Dr. Pariza. Well, yeah, I think some results could come
fairly quickly. Other results might take longer. I could
imagine certain things with regard to better applying an
understanding, for example, of how E. coli is transmitted on
farms, could be applied fairly quickly if you have the
resources. There may be other things, like trying to develop
better tests, that could take quite a bit more time. I do have
to say that I believe testing is extremely important because an
inspector can't see a pathogen. You really have to have tools
to do this; you have to be able to detect the pathogens on
produce in order to have meaningful impact on all of this.
Senator Kohl. Very good. Well, I think you all are a great
panel and you're a great resource of information and
suggestions and recommendations. I'm going to use your
expertise so that in this hearing, listening to you talk and
having the opportunity, as we do today, to have the top dogs
from Washington here, Dr. von Eschenbach and Dr. Brackett. I'm
sure you feel that this is an unusual opportunity we have to
not only have them in our presence but to talk to them a little
bit.
So after they make their statements, instead of maybe me
questioning them or making a suggestion or making a request,
I'd like to give you all an opportunity to pose one or two
questions to Dr. Brackett or Dr. von Eschenbach to get the kind
of answers that you'd like to get right here on the ground, as
well as myself, from people who you can hope will make a
difference. So we'll do that after they make their statement.
Thank you so much.
First of all, I'd like to thank you both again for taking
the time and putting forth the effort to be here with us today.
As the panel that we've just heard have aptly illustrated,
FDA's food safety programs deserve some very specific attention
and I'm grateful that you are here today to give it and give us
your attention.
I've scheduled you to appear as the second panel so you
could have the benefit of hearing the witnesses before you, who
I'm sure you would agree have done an outstanding job and I
hope you consider that a blessing rather than a curse. It's a
blessing because now you have a chance to make some real
replies and illustrate how the FDA, under your leadership, can
make progress on these important topics.
There are some who suggest that the FDA's food systems are
not up to the task. Some might have called those systems
somewhat broken and I want those critics to be convinced
otherwise. I suggest that we need to convince them not just
with words--both myself and yourself--but with deeds and
accomplishments and I, of course, want to work with you in the
years to come to do exactly that.
I said before and I want to repeat, outbreaks of food-borne
illness caused by produce have doubled since 1998. During this
time, the FDA's food budget has suffered. The number of people
getting sick is going up but the number of inspections and food
safety tests are going down. So too, are the number of food
inspectors and overall staff at the FDA's Center for Food
Safety. As we know, imports have risen dramatically over the
years but the agency is only able to inspect less than 1
percent of imported product.
I know the arguments and we all understand the arguments. I
know that your ability to ask for additional funding is
limited, that you have to support the President's budget
request. I don't envy your position. However, the job of the
FDA is to protect the public as I'm sure we would agree and not
just a budget request.
We all know that more needs to be done. We've talked about
this multiple times. I know that you are truly committed to
protecting the public and of course, it's my job to help you to
do just that. I want to help you put more people on the ground
in the right place, people who not only react when an outbreak
occurs but more importantly, people who are in place to prevent
more outbreaks. I want to help you accomplish the research to
be more efficient, to have faster tests, to enhance the FDA's
capacity for preventing contamination as well as to trace as
quickly as possible when contamination does occur.
We all understand these things cost money and you cannot do
them all by yourself. But there are things that we can do,
things that we can do now. We can require farmers and
processors to implement and maintain good safety practices.
You've been asked to do so by two of the witnesses that we have
here today and I know that you are considering this. I hope
that you will speak to some of these ideas today and respond to
what you've already heard. We're looking forward to your
statements and thank you again for being here. Dr. von
Eschenbach, we'd like to hear from you first.
STATEMENT OF HON. ANDREW C. VON ESCHENBACH,
COMMISSIONER, FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. von Eschenbach. Thank you very much, Mr. Chairman. Let
me begin by thanking the entire subcommittee that you chair for
the tremendous support that has been provided to the Food and
Drug Administration. I know this staff is here as well and is
testimony to the tremendous support that you have provided to
us. I want to thank you personally for your national
leadership, not only in the support of the food component of
FDA but for the tremendous leadership you've provided
addressing many of the challenges we face with regard, for
example, to your vision of generic drugs. I think your
leadership is manifested here today and it's a great
opportunity for us to be in Wisconsin and specifically to be
accompanied by one of Wisconsin's finest, Dr. Brackett, and I
think the fact that he is born and bred in Wisconsin and now
leads the Center for Food Safety and Applied Nutrition is again
testimony to the important role that we recognize is being
played here in this conference room.
You take great pride in this State's contributions to the
American food supply and clearly, you are unsurpassed with
regard to contributions of cheese and cranberries, so feeding
the American people is an important part of Wisconsin's
commitment. We're blessed in this country to be unsurpassed
with regard to our food, both in terms of its nutrition and
with regard to the choices that are provided to us and in fact,
with regard to food safety. But the world is changing around us
and we've noted, for example, as has been pointed out, an
increase in the consumption of fresh fruits and vegetables. We
noticed important changes in production and rapidly moving from
farm to table. And that has provided new challenges to us.
So it is also fitting to be here in Wisconsin, where, as
has been pointed out, the Wisconsin Department of Health and
Family Services was the first to detect the outbreak of E. coli
and to fingerprint that particular pathogen so we were able to
determine that it was not just a sporadic illness but in fact,
a food outbreak.
We must, as you have pointed out, Mr. Chairman, together
and collectively recognize that no matter how nutritious, no
matter how safe, no matter how good our food is in this
country, we must do better and FDA is committed to working with
you and others because even one death is one death too many.
You have my written testimony, Mr. Chairman, which I'll
submit for the record and the Food and Drug Administration has
provided a number of materials for this particular hearing that
I would also like to have included. One of them describes the
steps that occur in the anatomy of an outbreak so that there is
an opportunity to understand the sequential events that all
typically result in FDA intervening in a food outbreak, taking
appropriate steps, as we did with regard to both the recent
outbreak of E. coli and salmonella.
We've also provided an edition of FDA Consumer and in this
recent edition, it defines the specific steps that FDA is
taking to continue to enhance the safety of produce, especially
fresh produce. We will be providing also in the handout and the
materials, a new FDA Guidance that we are announcing today for
the safety of fresh produce.
You asked us, Mr. Chairman, how we can make it better. FDA
will commit to you and to the American people, our ongoing
effort toward a multi-step, multi-disciplinary campaign to
improve food safety. It is a part of an overarching continuous
quality improvement of products initiative so that food, along
with drugs, devices and biologics, will all be enhanced with
regard to not just their effectiveness but their safety, by
focusing on the life cycle of the product, from production to
consumption and the FDA's important role and multiple steps
with multiple partners in that continuum.
With regard to food, it will be an effort from farm to
fork. A few of the initiatives that we believe are important to
address food safety are to look at the protection that can be
provided by enhanced detection and enhanced remedies. One
particular initiative that I think should be significant into
this effort is our current Office of Regulatory Affairs
reorganization that we have currently proposed to Congress.
Within that reorganization, we will provide opportunities to
significantly enhance the efficiency of our field operations to
be able to provide a shift from laboratory efforts that are
centralized to laboratory opportunities that we can take into
the field and also enhance the number of trained investigators
that will be available to that field force.
We will also be enhancing our ability to coordinate our
food safety efforts by greater integration of our food defense
efforts. We have a focus in that regard, across that continuum,
on risk management and risk mitigation strategies. Some of
those opportunities will allow us to enhance greater
cooperation with State laboratories, particularly through the
CFSAN Network and especially with regard to our interactions
with academia, including a very significant opportunity we've
had with the University of Wisconsin, to address many issues
with regard to the protection of our food supply.
We will continue our efforts with regard to coordination
with other Federal agencies. We have currently an effort that
was fully supported by Secretary Johanns and Secretary Leavitt
that will be announced that will bring USDA and the Department
of Health and Human Services to a much closer level of
integration around food safety.
This past week, Julie Gerberding, head of the Centers for
Disease Control and Prevention and I have announced the
commitment to a joint leadership task force between FDA and CDC
that will be specifically focused on enhancing our data
integration networks as well as our enhanced communications
strategies. So as we go from diligence to outbreak, the
relationship between the CDC and the FDA will be much more
seamless and much more efficient.
We will also be increasing our efforts with regard to
enhancing the safety, the science of safety, particularly with
focused research efforts not only in CFSAN but also in our
National Center for Toxicological Research and our Center for
Veterinary Medicine, all of which will be able to provide an
opportunity for us to focus on the science that is necessary to
understand the anatomy of an outbreak.
PREPARED STATEMENT
In particular today, we are pleased to announce a further
effort to enhance our collaboration with industry by
approaching an initiative of building quality in to the
production process. I'd like to this opportunity with your
permission, Mr. Chairman, to turn the microphone over to Dr.
Brackett to give you specific reference to that new initiative
of collaboration with industry.
[The statement follows:]
Prepared Statement of Dr. Andrew C. von Eschenbach
Good morning, Chairman Kohl. Thank you for the opportunity to
appear today to discuss food safety and the safety of fresh produce. I
appreciate your commitment to the work of FDA and I commend you for
your special interest in the safety of America's food supply.
Appearing with me today is Dr. Robert Brackett, Director of FDA's
Center for Food Safety and Applied Nutrition. We appreciate the
opportunity to discuss FDA's current processes as well as planned
improvements for food safety, particularly the safety of fresh produce.
In the past decade, fresh produce consumption has increased, and
fresh-cut produce \1\ represents a particularly fast-growing segment of
the fresh produce market. These foods are an important part of a
healthy and nutritious diet, and Americans expect them to be safe. The
2006 outbreaks of Escherichia coli (E. coli) O157:H7 infection linked
to fresh spinach and lettuce emphasize the need for continued efforts
to protect the public health from foodborne illnesses associated with
fresh produce. We at FDA are committed to doing everything we can to
help ensure that these and all other FDA-regulated foods are safe.
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\1\ Fresh-cut is defined as fruits and vegetables that have been
minimally processed and altered in form, by peeling, slicing, chopping,
shredding, coring, or trimming, with or without washing or other
treatment, prior to being packaged for use by the consumer or a retail
establishment. Minimally processed fruits and vegetables have not
undergone steps designed to kill pathogens that may be present.
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Therefore, FDA has requested an increase of $10.6 million for food
safety activities in fiscal year 2008. This increase will bring the
total FDA investment for food safety to $391 million in fiscal year
2008. This investment will help FDA reduce risk across the lifecycle of
produce production. FDA will use these resources to develop better
methods to detect and attribute foodborne illness outbreaks related to
produce, increase sampling and traceback, develop and update guidance
to prevent and reduce outbreaks, obtain additional expertise in the
production and processing of fresh produce, and enhance our response to
foodborne outbreaks.
Fresh vegetables and fruits pose particular food safety challenges.
Because most produce is grown in an outdoor environment, it is
vulnerable to contamination from pathogens that may be present in the
soil, in agricultural or processing water, and in manure used as
fertilizer, or due to the presence of animals in or near fields or
packing areas. It is also vulnerable to contamination due to inadequate
worker health and hygiene protections, environmental conditions,
production safeguards, and sanitation of equipment and facilities. The
fact that produce is often consumed raw or with only minimal
processing, without any type of intervention that would reduce or
eliminate pathogens prior to consumption, contributes to its potential
as a source of foodborne illness. Consequently, controlling the way
fresh produce is grown, harvested, and moved from field to fork is
crucial to minimizing the risk of microbial contamination.
For the past 100 years, FDA has established and maintained the gold
standard for food safety. Americans have one of the safest food
supplies in the world. But the production, distribution, and
importation of foods, the public's consumption practices, and our
ability to track and identify foodborne pathogens have changed
significantly, and FDA must respond to those changes. Fresh produce
serves as a good example of the changes we are witnessing. Consumption
of fresh produce--especially items like spinach and lettuce implicated
in recent outbreaks of foodborne illness--has increased significantly
since 1999. According to USDA, per capita consumption of leafy green
lettuce and spinach grew by 59 percent and 130 percent respectively,
between 1999 and 2006.
Therefore, reducing the risk of foodborne illness requires strong
science capable of identifying both the sources of risk and effective
control measures. We are using molecular technology to improve our
ability to identify foodborne illnesses and their causes by tracking
the fingerprints of the suspected contaminants. We must address some of
these risks as food is produced and other risks as food is processed
and distributed. We must also enhance our ability to detect and contain
outbreaks. Reducing the risk of foodborne illness also requires
effective partnerships with other parties interested in food safety.
Finally, reducing the risks of foodborne illness also requires FDA to
strategically deploy inspection resources in a manner that addresses
the greatest risks to the food supply. FDA has focused its food safety
efforts in three key areas, and I elaborate on these here.
Strengthening the Scientific Basis for FDA's Program to Improve Food
Safety
Strengthening the scientific basis for FDA's program to improve
food safety is key to improving FDA's effectiveness at protecting
public health. For the past decade, FDA has worked closely with USDA's
Agricultural Research Service (ARS) and Cooperative State Research,
Education, and Extension Service (CSREES) to coordinate and mutually
support our respective research efforts related to produce safety. This
relationship allows FDA to augment its research resources and gain
access to facilities and expertise we do not have. In this spirit, we
collaborated with ARS and CSREES to look for sources of E. coli O157:H7
in California's Salinas Valley, to analyze water samples from the
Salinas watershed for E. coli O157:H7, and to relate the location of
bacteria to geographical, seasonal, or rainfall variation. FDA will use
the information obtained from this study to inform produce growers
about strategies to prevent pre-harvest microbial contamination.
We strengthen the scientific basis for our program by collaborating
and learning with others, such as participating in many scientific and
technical meetings on food safety. Last month we participated in a
forum sponsored by the Western Institute for Food Safety and Security
to share information on assessing industry approaches to address the
safety of lettuce and leafy greens on the farm and at packing, cooling,
and processing facilities. In February 2007, the FDA-affiliated Joint
Institute for Food Safety and Applied Nutrition and the University of
Florida sponsored a workshop to improve understanding of how tomatoes
become contaminated with Salmonella and other pathogens. In May 2007,
FDA, the National Center for Food Safety and Technology, and the
University of Georgia's Center for Food Safety will co-sponsor a
workshop on microbial testing to reach a consensus on the role of
microbial testing to ensure the safety of produce.
To seek additional input from the public, we are holding two public
hearings (March 20 in California and April 13 in Maryland) concerning
the safety of fresh produce. We will share information about recent
outbreaks of foodborne illness related to fresh produce and solicit
comments, data, and other scientific information about current
agricultural and manufacturing practices, risk factors for
contamination, and possible measures by FDA to enhance the safety of
fresh produce.
Enhancing Effective Partnerships
To succeed in our science-based efforts to promote food safety, we
need to enhance our collaborations with stakeholders interested in food
safety, particularly with respect to fresh produce. Fresh produce is
produced on tens of thousands of farms, and contamination at one step
in the growing and processing chain can be amplified at the next step.
FDA has worked with the public and private sector to encourage industry
to follow the recommendations and standards contained in FDA guidances.
After enlisting the help of the scientific community and the industry,
FDA published the ``Guide to Minimize Microbial Food Safety Hazards for
Fresh Fruits and Vegetables.'' This guide, published in 1998,
recommends good agricultural practices and good manufacturing practices
that growers, packers, and shippers can take to address common risk
factors in their operations. We have worked with the domestic and
foreign fresh produce industry since the release of this Guide to
promote its recommendations and to advance the scientific knowledge to
enhance the safety of fresh produce.
The example of fresh sprouts illustrates how successful these
efforts can be. In 1999, there were 390 reported illnesses associated
with eating contaminated fresh sprouts. FDA published two guidance
documents for sprouts that year. We believe that the subsequent decline
in sprout-associated illnesses was in large part due to industry
adhering to recommendations in those guidances through our outreach and
inspection efforts. In 2004, only 33 illnesses were reported associated
with fresh sprouts, and in 2005 and 2006 there were none.
FDA's efforts in this area are ongoing. I am pleased to report that
this morning FDA issuing a draft final version of its ``Guide to
Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and
Vegetables'' (the Fresh-cut Guide). This guidance is intended for all
fresh-cut produce firms, including, among others, fresh-cut spinach and
lettuce/leafy greens, to enhance the safety of fresh-cut produce by
minimizing the microbial food safety hazards. In addition, FDA worked
with the Delegation of the United States to the international Codex
Alimentarius Commission to request, at the earliest possible date, an
expert consultation on the microbiological safety of fresh produce to
support the development of commodity-specific annexes to the hygienic
code. In August 2006, FDA launched its ``Lettuce and Leafy Greens
Initiative,'' which assesses practices and conditions at select farms
and facilities in California, in collaboration with California's
Department of Health Services and its Department of Food and
Agriculture. We will continue to work with Federal, State, local and
international food safety partners and with industry to develop
guidance, conduct research, develop educational outreach materials, and
initiate other commodity- or region-specific programs to enhance the
safety of fresh produce.
Improving Risk-Based Targeting of Inspection Resources
FDA is significantly improving its ability to target its inspection
resources at the greatest risks to public health. However, inspections
cannot and will not identify every potential contaminant. Improving the
processes and operations of all participants in the food production and
distribution process offers the greatest protection for American
consumers, and inspections are only one component of this activity. To
make best use of available resources, FDA uses a targeted, risk-based
approach to inspections. FDA conducted 17 percent more import field
exams in 2006 than in 2003. In addition, the FDA/USDA Food Emergency
Response Network increased its laboratory participation to 134
laboratories in fiscal year 2007, compared to 30 participating
laboratories in March 2004 (near FERN's inception), integrating the
Nation's food testing capability for microbiological, chemical and
radiological threat agents.
FDA's ability to reallocate resources based on risk was tested when
peanut butter was recently implicated in an outbreak of Salmonella
Tennessee. FDA issued a warning to consumers within 24 hours of
receiving notification by CDC, and swiftly deployed inspectors to the
plant. ConAgra recalled the products and ceased production in the
implicated processing plant. FDA is working to identify the root source
of the contamination in order to prevent similar foodborne illness
outbreaks from recurring.
Conclusion
FDA is working hard to ensure the safety of food, in collaboration
with its Federal, State, local, and international food safety partners,
and with industry and all its other stakeholders. The American food
supply continues to be among the safest in the world. We have made
progress, and we will continue to strive to reduce the incidence of
foodborne illness.
Thank you for the opportunity to discuss FDA's continuing efforts
to improve the safety of fresh produce. I am happy to answer any
questions.
______
Guidance for Industry
guide to minimize microbial food safety hazards of fresh-cut fruits and
vegetables
introduction
The Federal Government provides advice on healthful eating,
including consuming a diet rich in a variety of fruits and vegetables,
through the Dietary Guidelines for Americans and the related MyPyramid
food guidance system (Ref. 1, 2). In response, per capita consumption
data show that Americans are eating more fresh produce (Ref. 3). With
$12 billion in annual sales in the past few years (Ref. 4), the fresh-
cut sector of the produce industry is its fastest growing segment. As
the fresh-cut produce market continues to grow, the processors of such
produce are faced with the challenge of processing an increasing
variety and volume of products in a manner that ensures the safety of
this produce. From 1996 to 2006, seventy-two foodborne illness
outbreaks were associated with the consumption of fresh produce. Of
these produce related outbreaks, 25 percent (18 outbreaks) implicated
fresh-cut produce (Ref. 5). Many factors may play a role in the
incidence and reporting of foodborne illness outbreaks that implicate
fresh produce, such as an aging population that is susceptible to
foodborne illness, an increase in global trade, a more complex supply
chain, improved surveillance and detection of foodborne illness,
improvements in epidemiological investigation, and increasingly better
methods to identify pathogens (Refs. 6 thru 12).\1\
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\1\ This guidance has been prepared by the Center for Food Safety
and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.
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Processing fresh produce into fresh-cut products increases the risk
of bacterial growth and contamination by breaking the natural exterior
barrier of the produce (Ref. 6). The release of plant cellular fluids
when produce is chopped or shredded provides a nutritive medium in
which pathogens, if present, can survive or grow (Ref. 6). Thus, if
pathogens are present when the surface integrity of the fruit or
vegetable is broken, pathogen growth can occur and contamination may
spread. The processing of fresh produce without proper sanitation
procedures in the processing environment increases the potential for
contamination by pathogens (see Appendix B, ``Foodborne Pathogens
Associated with Fresh Fruits and Vegetables.''). In addition, the
degree of handling and product mixing common to many fresh-cut
processing operations can provide opportunities for contamination and
for spreading contamination through a large volume of product. The
potential for pathogens to survive or grow is increased by the high
moisture and nutrient content of fresh-cut fruits and vegetables, the
absence of a lethal process (e.g., heat) during production to eliminate
pathogens, and the potential for temperature abuse during processing,
storage, transport, and retail display (Ref. 6). Importantly, however,
fresh-cut produce processing has the capability to reduce the risk of
contamination by placing the preparation of fresh-cut produce in a
controlled, sanitary facility.
This guidance is intended for all fresh-cut produce processing
firms, both domestic firms and firms importing or offering fresh-cut
product for import into the United States, to enhance the safety of
fresh-cut produce by minimizing the microbial food safety hazards. This
guidance does not set binding requirements or identify all possible
preventive measures to minimize microbial food safety hazards. We
recommend that each fresh-cut produce processor assess the
recommendations in this guidance and then tailor its food safety
practices to the processor's particular operation. Alternative
approaches that minimize microbial food safety hazards may be used so
long as they are consistent with applicable laws and regulations.
This guidance primarily addresses microbiological hazards and
appropriate control measures for such hazards. However, some chapters
in the guidance discuss physical and chemical hazards.
FDA's guidance documents, including this document, do not establish
legally enforceable responsibilities. Instead, guidance documents
describe the Agency's current thinking on a topic and should be viewed
only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance
means that something is suggested or recommended, but not required.
scope and use
Fresh-cut Produce.--This guidance covers fresh-cut fruits and
vegetables that have been minimally processed (e.g., no lethal kill
step), and altered in form, by peeling, slicing, chopping, shredding,
coring, or trimming, with or without washing or other treatment, prior
to being packaged for use by the consumer or a retail establishment.
Examples of fresh-cut products are shredded lettuce, sliced tomatoes,
salad mixes (raw vegetable salads), peeled baby carrots, broccoli
florets, cauliflower florets, cut celery stalks, shredded cabbage, cut
melon, sliced pineapple, and sectioned grapefruit.\2\ Fresh-cut produce
does not require additional preparation, processing, or cooking before
consumption, with the possible exception of washing \3\ or the addition
of salad dressing, seasoning, or other accompaniments. As the fresh-cut
produce market continues to evolve, the scope of this guidance may need
to be modified to address new or novel types of products.
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\2\ Fresh sprouts are raw agricultural commodities and thus, their
production is not governed by 21 CFR Part 110. FDA does, however,
recommend that sprouting firms employ current good manufacturing
practices. Also, FDA has published specific guidance for the production
of sprouts. We recommend that producers of sprouts refer to this
guidance, ``Reducing Microbial Food Safety Hazards for Sprouted Seeds''
(Ref. 13) and ``Guidance for Industry: Sampling and Microbial Testing
of Spent Irrigation Water During Sprout Production'' (Ref. 14).
\3\ For information regarding re-washing of fresh-cut produce, go
to http://www.dhs.ca.gov/
fdb/, click on ``Food Safety Program'' and scroll down to the Produce
section to obtain a link to the Recommendations from Fresh-cut Produce
Re-wash Panel, April 4, 2006.
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Fresh-cut Produce and Current Good Manufacturing Practice
Requirements for Foods (CGMPs) (21 CFR Part 110).--FDA's regulations
\4\ in 21 CFR Part 110 establish CGMPs in manufacturing, packing, or
holding human food. However, raw agricultural commodities (RACs), as
defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act
(the Act), are not subject to the CGMP requirements by virtue of the
exclusion in 21 CFR 110.19. Section 201(r) defines a raw agricultural
commodity as any food ``in its raw or natural state . . .'' Fresh-cut
fruits and vegetables are not RACs because they are no longer ``in
[their] raw or natural state'' and instead have become ``processed
food'' as that term is defined in the Act. Section 201(gg) of the Act
defines a ``processed food'' as ``any food other than a raw
agricultural commodity and includes any raw agricultural commodity that
has been subject to processing, such as canning, cooking, freezing,
dehydrating, or milling.'' Under 21 CFR 110.3, the definitions in
section 201 of the Act apply to Part 110. Thus, fresh-cut fruits and
vegetables are appropriately considered ``processed foods'' and are
subject to the CGMPs in Part 110. The conclusion that fresh-cut produce
are not RACs is consistent with the preamble to the proposed revisions
to the CGMP regulation (44 FR 33238 at 33239, June 8, 1979), which
states, when discussing the exclusion for RACs, that such products may
be excluded because ``food from those commodities is . . . brought into
compliance with the Act at the later stages of manufacturing,
processing, packing, or holding.'' The CGMPs establish food safety
practices applicable to processors who manufacture, process, pack, or
hold processed food. FDA believes that the recommendations in this
guidance complement the CGMPs by suggesting more specific food safety
practices for processors of fresh-cut produce.
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\4\ A copy of the CGMPs in 21 CFR Part 110 may be accessed on the
internet at http://www.gpoaccess.gov/cfr/index.html.
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Fresh-cut Produce and HACCP Systems.--A Hazard Analysis and
Critical Control Point (HACCP) system is a prevention-based food safety
system designed to prevent, reduce to acceptable levels, or eliminate
the microbial, chemical, and physical hazards associated with food
production (Ref. 6). One strength of HACCP is its proactive approach to
prevent food contamination rather than trying to identify and control
contamination after it has occurred.
Although HACCP is not currently required for the processing of
fresh-cut produce, the United Fresh Produce Association recommends use
of HACCP principles, and according to the association, many segments of
the fresh-cut produce industry have adopted HACCP principles.\5\
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\5\ United Fresh Produce Association: http://www.unitedfresh.org/.
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FDA encourages fresh-cut produce processors to take a proactive
role in minimizing microbial food safety hazards potentially associated
with fresh-cut produce. We recommend that fresh-cut processors consider
a preventive control program to build safety into the processing
operations for fresh-cut fruits and vegetables. Awareness of the common
risk factors discussed in this guidance and implementation of
preventive controls determined by a firm to be appropriate to its
individual operations will enhance the safety of fresh-cut fruits and
vegetables. FDA also recommends that processors encourage the adoption
of safe practices (See Chapter IV) by their partners throughout the
supply chain, including produce growers, packers, distributors,
transporters, importers, exporters, retailers, food service operators,
and consumers, to ensure that the processor's efforts will be enhanced.
This guidance begins with a discussion of primary production and
harvesting of fresh produce in Chapter IV and continues with
recommendations for fresh-cut processing in four areas--(1) personnel
health and hygiene, (2) training, (3) building and equipment, and (4)
sanitation operations. Following this discussion, the guidance covers
fresh-cut produce production and processing controls from product
specification to storage and transport. The final chapters provide
recommendations on recordkeeping and on recalls and tracebacks.
definitions
The following definitions apply to this guidance.
Adequate Quality Water.--The determination of adequate quality
water is based on its use, where adequate quality water for one purpose
is not necessarily adequate for another purpose. (1) Where the water
does not become a component of the fresh-cut produce, adequate quality
refers to water that is safe and sanitary, at suitable temperatures,
and under pressure as needed for all uses; and (2) where the water is
used in a manner such that it may become a component of the fresh-cut
produce (e.g., when such water contacts components, fresh-cut produce,
or any contact surface), adequate quality water refers to water that
complies with applicable Federal, State, and local requirements.
Fresh Fruits and Vegetables.--Fresh produce that is likely to be
sold to consumers in an unprocessed (i.e., raw) form. Fresh produce may
be intact, such as whole strawberries, carrots, radishes, or tomatoes,
or cut from roots or stems during harvesting, such as celery, broccoli,
lettuce, or cauliflower.
Fresh-cut Fruits and Vegetables or Fresh-cut Produce.--Fresh fruits
and vegetables for human consumption that have been minimally processed
and altered in form by peeling, slicing, chopping, shredding, coring,
or trimming, with or without washing, prior to being packaged for use
by the consumer or a retail establishment (e.g., pre-cut, packaged,
ready-to-eat salad mixes). Fresh-cut produce does not require
additional preparation, processing, or cooking before consumption, with
the possible exception of washing or the addition of salad dressing,
seasoning or other accompaniments.
Food Hazard.--A biological, chemical, or physical agent that is
reasonably likely to cause human illness or injury in the absence of
its control.
Pathogen.--A microorganism capable of causing human illness or
injury.
Processing Water.--Water that is used for post-harvest handling of
produce, such as washing, cooling, waxing, or product transport.
Standard Operating Procedures (SOPs).--Procedures established by an
operator for the day-to-day activities involved in the production of
safe and wholesome food.
Sanitation Standard Operating Procedures (SSOPs).--Procedures
established by an operator for the day-to-day sanitation activities
involved in the production of safe and wholesome food.
IV. Primary Production and Harvesting of Fresh Fruits and Vegetables
In general, anything that comes into contact with fresh produce has
the potential to contaminate it. Fresh produce may become contaminated
at any point along the farm-to-table continuum. The major source of
microbial contamination of fresh produce is indirect or direct contact
with animal or human feces. Once fresh produce has been contaminated,
removing or killing the microbial pathogens is very difficult.
Prevention of microbial contamination at all steps in the farm-to-table
continuum is preferable to treatment to eliminate contamination after
it has occurred.
On the farm, potential contamination avenues include contact with
untreated manure used as a soil amendment, contaminated water, infected
workers, or conditions in the field or packing facility such as unclean
containers and tools used in harvesting and packing, and the presence
of animals. In transport, conditions such as unclean floors and walls
of the transport vehicle and unclean containers can contribute to
contamination with pathogens. Thus, it is important that fresh-cut
produce processors be aware of the conditions under which their fresh
produce is grown, harvested, packed, and transported. Furthermore,
knowing your suppliers and what they are doing to minimize risk of
contamination is prudent.
To reduce potential contamination, FDA's 1998 ``Guide to Minimize
Microbial Food Safety Hazards for Fresh Fruits and Vegetables'' (GAPs
Guide) (Ref. 15) provides recommendations for growers, packers, and
shippers to use good agricultural and good manufacturing practices in
those areas over which they have control to prevent or minimize
microbial food safety hazards in fresh produce. Potential sources of
contamination identified in the GAPs Guide are biosolids and manure,
water, field workers, equipment, and containers.
We recommend the following practices to ensure that incoming fresh
produce is safe and suitable for processing into fresh-cut product:
--Becoming aware of practices used by your suppliers (i.e., growers,
packers, coolers, transporters, etc.)
--Evaluating the practices of your suppliers by a knowledgeable food
safety expert
--Accepting produce from suppliers who use GAPs, GMPs or other
appropriate practice from the farm to the processing facility
--Using a mechanism to verify the use of food safety practices by
your suppliers (e.g., letter of certification or guarantee from
a supplier)
personnel
This section provides recommendations regarding personnel of an
establishment that processes fresh-cut produce. The recommendations
address two major areas: worker health and hygiene, and training.
Worker Health and Hygiene
Workers can carry microbial pathogens on their skin, in their hair,
on their hands, and in their digestive systems or respiratory tracts.
Unless workers understand and follow basic food protection principles,
they may unintentionally contaminate fresh produce and fresh-cut
produce, food contact surfaces, water supplies, or other workers, and
thereby, create the opportunity to transmit foodborne illness. Basic
food protection practices related to worker health and hygiene fall
into two categories, disease control and cleanliness.
Disease Control
FDA recommends that employees with direct access (such as
processing, storage, and transport workers) and indirect access (such
as equipment operators, buyers, and pest control operators) to the
production areas of fresh-cut fruits and vegetables follow good
hygienic practices for maintaining personal health and hygiene in order
to protect the product from contamination.
FDA recommends the following practices to prevent food, food
contact surfaces, and food packaging materials from becoming
contaminated with microbial pathogens from an employee with an
infectious illness or wound:
--Establishing a company policy that requires employees to report any
active case of illness to supervisors before beginning work
--Training supervisors to know the typical signs and symptoms of
infectious disease
We recommend that firms train employees to report to their
supervisor any information about personal health status or
activities relating to diseases transmitted through food. Such
information would include reporting an active case of illness.
FDA recommends that supervisors be trained to recognize the
symptoms of active infectious disease; these symptoms are
vomiting, nausea, diarrhea, and abdominal cramps. We recommend
that employees with these symptoms be excluded from any
operations which may be expected to result in contamination of
fresh or fresh-cut produce or food contact surfaces, including
equipment and utensils, until the medical condition is
resolved.
--Covering cuts and wounds with a suitable water proof dressing
when workers with such injuries are permitted to continue
working.
We recommend that firms maintain an adequate supply of bandages
that provide protection from any wound. A wound containing pus
(such as an open and draining boil or other infected wound)
that is located on a part of the body that could contact fresh
produce or fresh-cut produce, processing equipment, or tools,
presents a risk of contaminating fresh-cut produce. When a
worker in the processing area needs a bandage, we recommend
that the firm consider using a bandage that is detectable by a
metal detector if there is a metal detector in the processing
line. Using detectable bandages will allow the facility to
detect when a bandage has fallen into the processing line so
that corrective action can be taken. We also recommend that a
worker with a wound that cannot be covered to prevent contact
with fresh produce or fresh-cut produce, processing equipment,
or tools not work with any aspect of fresh produce or fresh-cut
produce, processing equipment or tools until the wound has
healed.
Cleanliness
FDA recommends that employees use the following food protection
practices to prevent fresh or fresh-cut produce or food contact
surfaces including equipment or utensils from becoming contaminated as
a result of poor employee hygiene or inappropriate employee conduct:
--Maintaining adequate personal cleanliness
--Washing hands frequently and effectively and sanitizing hands if
needed
FDA recommends that employees wash their hands before beginning
work and after engaging in any activity that may contaminate
their hands. FDA's recommendations regarding when employees
should wash their hands are reflected in the following list:
Before beginning work, especially if the employee has direct
contact with fresh produce
Before putting on a new pair of disposable or non-disposable
gloves and after removing the gloves
After touching human body parts or anything other than food or
food contact surfaces
After using the toilet; after coughing, sneezing, or using a
handkerchief or tissue
After using tobacco, eating, or drinking
After engaging in any activity that may contaminate hands, such
as handling garbage, cleaning chemicals, or incoming produce
before it has been washed
After caring for or touching animals
Before returning to a workstation
--Washing and sanitizing non-disposable gloves before starting work,
and as needed
--Changing disposable gloves whenever contamination is a possibility
Improperly used gloves may become a vehicle for spreading
pathogens. The use of gloves does not lessen the need for, or
importance of, hand-washing and other proper hygiene practices.
We recommend that if gloves are used in a facility, the firm
develop guidelines for their safe use, sanitation, and
changing.
--Wearing appropriate attire on the job
FDA recommends that employees wear clean clothes and any
additional outer items (e.g., hairnets and beard covers, lab
coats, aprons, and appropriate footwear) that will help protect
fresh and fresh-cut produce from inadvertent contamination
during processing.
--Not engaging in certain activities where food may be exposed or
utensils are washed
FDA recommends that employees in food processing areas not engage
in activities that could contaminate food, such as eating,
using tobacco, chewing gum, or spitting.
Training
Training every employee about the CGMPs and preventive controls
will help to eliminate or minimize contamination of fresh-cut produce.
We recommend that education and training programs be designed to help
employees understand what is expected of them and why what is expected
is important. We also recommend that company expectations for proper
employee hygiene and food protection techniques be clearly communicated
to new employees before starting employment and reaffirmed during
periodic training programs. There are many materials available to firms
to support employee training. We recommend that firms consider whether
the language of the training and training materials is appropriate for
the employees. Useful materials and information may be found at the
USDA/FDA Foodborne Illness and Education Information Center (http://
www.nal.usda.gov/foodborne/index.html), the Fight BAC! campaign of the
Partnership for Food Safety Education (http://www.fightbac.org/
main.cfm), and Government Food Safety Information (http://
www.foodsafety.gov/).
Training employees before they begin work with fresh or fresh-cut
produce, at regular intervals, and at a minimum annually provides
employees with important information about food safety best practices
and company policies. We recommend that firms consider teaching, in the
same training session, only a small number of employees at or near
their workstation, if the environment permits it, for short periods of
time, such as 10-15 minutes per session. The sessions could cover only
one topic at a time and could be targeted to specific food safety
concerns of that workstation. For example, washing station employees
could be trained about appropriate antimicrobial chemical usage, and
packaging station employees could be trained about proper handling and
cleanliness of boxes and totes. We recommend refresher or follow-up
training to reinforce the initial training. Training a few employees at
a time can be an effective way to provide refresher training with the
least disruption to work.
A firm may wish to post signs and pictorial representations of good
practices covered in training as an additional way to reinforce
training. We recommend that signs be multilingual and posted in areas
close to where the practice is performed. We also recommend that the
training provided to employees be documented so there is a record of
the training topics covered and which employees completed it.
A well-designed training program provides information to help
employees apply CGMPs while on the job. We recommend that a fresh-cut
produce firm's training program for employees (including temporary,
seasonal, and full time employees) include training on the CGMPs for
production, maintenance, quality assurance, and quality control with an
emphasis on worker health and hygiene; employee roles and
responsibilities; and sanitation principles and sanitary practices.
Training for Worker Health and Hygiene
We recommend that employees be trained to follow good personal
hygiene practices, including the use of proper hand washing techniques,
wearing clean clothes and any additional outer coverings (e.g.,
hairnets and beard covers, disposable gloves, aprons), and appropriate
conduct on the job. FDA also recommends that employees be trained on
how, when, and to whom to report illness. Hand washing training is
particularly important. We recommend that employees be trained about
how, when, and why they must properly wash their hands and exposed
portions of their arms. We also recommend that employees be taught to
wash and sanitize their hands before entering areas where fresh or
fresh-cut produce is present.
Figure 1 is an example of an aid that could be used to train
employees on the proper technique to use in washing hands:
----------------------------------------------------------------
How to Wash Your Hands
Use soap and warm running water, wet hands, apply soap, vigorously
rub hands up to elbows for 20 seconds, rinse hands, turn off running
water with a paper towel not bare hands, dry hands with a paper towel
or air dry. Do not share towels, soap combined with scrubbing helps
dislodge and remove dirt and germs.
Figure 1.--Example of a Training Aid on How to Wash your Hands
----------------------------------------------------------------
Training on Employee Roles and Responsibilities
We recommend that employees be trained consistent with the level of
complexity of their jobs and that additional training be provided as
needed to ensure current knowledge of equipment and process technology.
One goal of a training program is to help workers understand the
importance of the tasks for which they are responsible, particularly
those tasks that are important to minimizing microbial food safety
hazards (such as monitoring the disinfectant level in wash water). We
recommend that employees be trained about how to perform these tasks;
to be aware of the microbial food safety hazards associated with them;
to understand the procedures for monitoring conditions such as the
disinfectant level, pH, and the temperature of the wash water, and any
associated recordkeeping that the firm chooses to implement; to know
the actions that are needed to minimize contamination of the product;
and to consult with their supervisors if the established limits (such
as the appropriate level of disinfectant in the wash water) are not
met.
We recommend that personnel responsible for maintaining equipment
that may have an impact on food safety be trained to understand the
importance of their role in the production of safe food. Equipment
maintenance jobs that may have an impact on food safety include
changing water filters, maintaining refrigeration units, treating
processing water, and calibrating equipment. We recommend that
employees be trained to identify deficiencies that could affect product
safety, to take the appropriate corrective actions (e.g., in-house
repairs, contract repairs), and to be able to understand how indirect
cross-contamination may occur when proper equipment controls are not
maintained.
Training on Sanitation Principles and Sanitary Practices
We recommend that employees with cleaning and sanitation duties be
trained to understand the principles and methods required for effective
cleaning and sanitation, especially as those methods relate to food
safety. We recommend that supervisors be trained to identify and
promote good sanitary practices.
We also recommend that employees be trained in the proper use of
sanitizing agents (sanitizers) and foot foam, foot baths, or spray
systems, in proper cleaning and sanitizing steps of the equipment and
facility, in proper use of equipment in the production environment,
such as hoses and tools, and in the proper use, handling, and storage
of chemicals used in sanitation.
Figure 2 is an example of an aid that could be used to train
employees on the proper use of sanitizers:
----------------------------------------------------------------
Use Sanitizers Properly for Food Safety
Hand sanitizing stations
After hand washing, sanitize your clean hands with a sanitizer
solution
Allow hand to air dry
Wash hands and sanitize gloves (disposable or reusable) before
wearing
Re-sanitiZe your hands after touching non-food contacts surfaces
Foot sanitizer
When entering any area where fresh produce or fresh-cut produce is
present, walk through a foot sanitizer unit
Sanitizer Maintenance
Monitor and change hand and food sanitizer solutions as needed to
maintain effective sanitizer strength, pre manufacturer's
recommendation
Figure 2.--Example of a Training Aid on Proper Use of Sanitizers
----------------------------------------------------------------
Equipment (whether fixed or free standing), fixtures, floors,
walls, and other structures in a processing facility can become a
source of microbial contamination if not adequately maintained in
sanitary condition. The high humidity and structural niches in a fresh-
cut produce processing facility encourage microbial build-up. To
prevent fresh-cut produce from becoming contaminated by equipment or
other structures in the facility, we recommend that employees be
trained on proper cleaning and sanitizing steps within the processing
areas.
Figure 3 is an example of an aid that could be used to train
employees on the cleaning and maintenance of processing equipment and
facilities:
----------------------------------------------------------------
Cleaning and Sanitizing Steps
Remove heavy debris from floors with brooms or shovels and dry
clean processing equipment, if neededSec.
Pre-rinse the equipment with adequate quality water
Clean remaining debris from floor
Rinse floor and drains with adequate quality water using a low
pressure hose
Use dedicated brushes to scrub floor and drains with an effective
cleaner, applying adequate quality water as needed
Foam and scrub the equipment with an effective cleaner and scrub
using dedicated brushes
Thoroughly rinse the equipment, floors, and drains with adequate
quality water using a low pressure hose
Remove excess water from floors
Sanitize (according to manufacturer directions) the equipment and
floors
Figure 3.--An Example of a Training Aid on Cleaning and Sanitizing
Steps Within Processing Areas
----------------------------------------------------------------
In addition to using sanitizers \1\ appropriately and cleaning and
sanitizing the equipment and facility regularly, proper use of
equipment, such as hoses, can also reduce the risk of contamination of
fresh and fresh-cut produce. For example, keeping hose nozzles off the
floor can help prevent nozzles and employee hands from becoming a
source of contamination. We recommend that sections of hose that touch
the floor or other unclean surface not make contact with fresh produce,
food-contact surfaces, or packaging materials. A retractable hose
suspended from the ceiling may help to prevent such contamination. In
addition, allowing hose ends to sit in standing water or to be
submerged in water tanks could allow back siphonage of water, thereby
contaminating the water distribution system.
---------------------------------------------------------------------------
\1\ Work from top down for cleaning and sanitizing activities. Some
equipment may need to be disassembled before cleaning and sanitizing
followed by reassembly.
---------------------------------------------------------------------------
Further, we recommend that employees be trained to avoid use of
high-pressure water hoses to clean floors, walls, and equipment in the
processing and packaging areas during production or after production
equipment has been cleaned. This practice will help prevent aerosols
from contacting processing equipment and food-contact surfaces,
product, or packaging materials. Therefore, we recommend that employees
be trained on the proper use of cleaning equipment.
building and equipment
FDA recommends that the processing facility and its structures
(such as walls, ceilings, floors, windows, doors, vents, and drains) be
designed to be easy to clean and maintain and to protect the product
from microbial, physical, and chemical contamination. For example,
designing food contact surfaces to be smooth, nonabsorbent, smoothly
bonded, without niches, and sealed would make these surfaces easier to
clean and thus, would prevent the harborage of microbial pathogens.
Building
Both direct contamination and cross-contamination of produce can be
minimized by giving proper attention to physical design, emphasizing
proper product flow, using appropriate construction materials, managing
facility traffic, and ensuring proper airflow. We recommend that
facilities and staging areas be designed to facilitate maintenance and
good sanitation practices so that contamination may be controlled
throughout receiving, cooling, processing, packing, and storage
operations. We also recommend that buildings, fixtures, and equipment
be maintained in a condition that will protect fresh-cut produce from
potential microbial, chemical, and physical contamination.
External/Internal Structures
In general, we recommend limiting access to the facility and to its
processing areas, providing adequate space for operations, ensuring
adequate drainage of processing and wash water, installing food contact
surfaces that are easy to clean and maintain, and designing areas and
structures to protect the product and equipment from contamination.
In addition, we recommend the following practices:
--Adequately screening open windows, vents, fans, and similar
features to prevent pest (insect, bird, rodent, reptile) entry
--Closing all exterior doors and entrances when not in use and
ensuring an adequate seal when exterior doors and entrances are
closed
--Properly constructing all walls, ceilings, windows, doors, floors,
and overheads (e.g., pipes, air vents, and lights) and
maintaining them in good condition (e.g., no cracks, rust,
breakage, missing parts, or dips allowing puddles to form) so
that they do not harbor pests or pathogens
--Designing properly sloping floors to drains (\1/4\ inch per foot),
and sealing and keeping them in good repair so as to provide
adequate drainage
--Designing floor drains to prevent the accumulation of water in or
around the drains and making drains accessible for cleaning
--Fitting floor drains with seals and grates capable of preventing
pest entry
--Using floor flumes with caution due to the potential for water
aerosol contamination of the room air and nearby equipment
surfaces
We recommend against the use of a floor flume transfer from the
produce cooling and packing operation into or across an area
housing fresh-cut produce operations.
--Constructing trench drains for automatic flushing
--Using under-floor drains in fresh-cut produce processing areas
--Designing collection areas for waste stream water to prevent
product and equipment contamination
--Designing pipelines to avoid pipe and wall condensation from
becoming a source of contamination
Where overhead condensate cannot be prevented, we recommend that
catch pans be utilized, and be cleaned and sanitized on a
regular basis.
--Avoiding wood construction materials wherever possible
If wooden equipment is used (including pallets), we recommend
that the equipment be in good condition and well maintained so
it is not a source of physical or microbial contamination. Non-
wooden construction materials, such as plastic or stainless
steel, are preferable for use in processing areas because they
reduce the risk of microbial harborage and cross-contamination
of final product.
--Using protective guards for light fixtures to prevent broken glass
from falling into product
Facility Layout
We recommend that a fresh-cut fruit or vegetable processing
facility be designed so that incoming raw products never cross paths
with or are commingled with finished fresh-cut produce products.
Similarly, we recommend maintaining separate raw incoming product, in
process, and finished product areas so as to prevent the potential for
microbial cross-contamination. Adequate food safety controls, operating
practices, and facility design can reduce the potential for
contamination by using location and/or flow of humans, product,
equipment, and air.
We recommend the following practices that use location to reduce
the potential for contamination:
--Having rest rooms that open into a location other than a processing
area
--Locating the door to the outside in an area other than into a
processing area
--Having a microbiology lab that opens into an area other than into a
processing area
--Storing in-process and raw produce materials in different rooms
--Establishing dedicated cold rooms for raw product and processed
product
--Locating hand washing and sanitizing facilities to facilitate
regular and appropriate use by employees
--Locating a disinfectant foot foam, foot bath, or foot spray at all
entrances and exits to all production and finished product
storage areas.
We recommend the following practices that use flow of personnel,
product, equipment, or air to reduce the potential for contamination:
--Having short direct routes for both product and personnel flow
--Designing the plant for one direction of personnel traffic,
product, and air flow
--Designing product areas to have traffic patterns that separate raw
and finished product using either linear product flow (raw to
finished product) or by physical partition (Figure 7 in
Appendix E is an example of product and personnel flow patterns
in a fresh-cut processing plant.)
--Using an air filtration system for central air distribution and
airflow that is counter to product flow, so that filtered air
moves with a positive pressure from the cleanest areas (e.g.,
from packaging and finished product storage) toward less clean
areas (e.g., the receiving area)
We also recommend that air intake for the facility be located to
minimize contamination of the intake air by:
--Keeping the number of entrances and exits to the processing areas
to a minimum
--Restricting the movement of lift trucks, bins, totes, maintenance
tools, cleaning implements, clothing, and people from receiving
and storage zones to processing and packaging areas
Color coding bins, totes, clothing, cleaning implements,
maintenance tools, and other items (e.g., blue aprons for
receiving zones and red aprons for processing and packaging
areas) may help achieve separation of traffic and thereby,
minimize cross-contamination.
Equipment Design, Construction, and Maintenance
We recommend that the processing equipment be designed and
constructed to be easy to clean and maintain and to avoid microbial
contamination of the fresh-cut product.
Equipment Design and Construction
We recommend the following to facilitate cleaning and to help
ensure that fresh-cut produce is not contaminated during the processing
operation:
--Using smooth, non-absorbent, sealed, and easily cleanable food
contact surfaces that are sloped to drain freely and made of
durable, non-corrosive, nontoxic materials
Food contact surfaces include items such as knives, conveyors,
belts, chutes, product totes, gloves, tools including shovels
and racks, cutting boards, tables, dryers and spinner baskets,
and packing scales. We recommend that all food contact surfaces
be smoothly bonded (e.g., free of pits, folds, cracks,
crevices, open seams, cotter pins, exposed threads, and piano
hinges) to avoid harboring pathogens. Where two food contact
surfaces meet, we recommend use of a cover over the juncture to
prevent food debris from collecting in the crevice and creating
an area that is difficult to clean.
--Locating catwalks with open grating so they do not pass over areas
of exposed fresh or fresh-cut produce or food-contact surfaces
--Designing equipment in the processing area to prevent water
collection
We suggest cautious use of hollow structures, such as catwalk
framework, table legs, conveyor rollers, and racks, because
they may collect water and debris, and thus, harbor pathogens.
--Elevating food-contact surfaces sufficiently above the floor (with
accessibility for cleaning) to prevent contamination from floor
splashes
--Installing stationary equipment away from floor drains to allow
accessibility to drains for cleaning and to prevent
contamination of the equipment
Equipment Maintenance
Establishing a preventive maintenance program helps to ensure that
all equipment functions as intended. Equipment failure requiring
maintenance activities during production may increase the risk of
microbial contamination, particularly from L. monocytogenes (Ref. 16).
Preventive maintenance includes periodic examination and maintenance of
equipment such as valves, gaskets, o-rings, pumps, screens, filters,
and heat exchanger plates. We recommend that a firm develop appropriate
plans of action in case important equipment, such as refrigeration
equipment, disinfectant delivery systems, power systems, or alarm
systems, malfunctions. We also recommend the following practices:
--Performing maintenance and calibration of equipment by
appropriately trained personnel
We recommend that maintenance personnel who work in the
processing or packaging areas comply with the hygiene
requirements for production employees.
--Installing, calibrating, and maintaining temperature measuring or
recording devices as necessary to ensure accuracy
--Frequently sharpening knives, if used, including retractable
knives, and disinfecting before use
We recommend that knives be replaced if damaged or if they cannot
otherwise be maintained in a sanitary condition.
--Frequently inspecting cutting blades and belts during processing
operations for damage, product residue build up, or cleaning
needs
We recommend that blades be removed and cleaned separately, and
remaining equipment parts disassembled (if possible) and
cleaned on a regular basis.
--Operating metal detectors in accordance with the manufacturer's
instructions and checking for proper functioning at least daily
to ensure effective detection of metal and removal of affected
product
We recommend that procedures be in place, such as a the use of
metal detectors during packaging operations, to minimize the
possibility that metal ends up in finished product packages.
--Calibrating safety control devices that are essential for
maintaining the proper level and activity of wash water
disinfectant, at a frequency recommended by the manufacturer
and documenting this activity on the instrument calibration
forms/logs
--Examining air filters for both intake air and compressed air and
changing at least as often as the manufacturer specifies, or
more frequently if a problem is indicated, such as evidence of
filter fouling or perforation
sanitation operations
Pathogenic microorganisms may be found on floors, in drains, and on
the surfaces of sorting, grading, processing, and packaging equipment.
Without appropriate sanitation practices, these surfaces may be a
source of microbial contamination.
Sanitation Program
We recommend the use of a comprehensive sanitation program
developed by a trained employee such as a certified sanitarian to avoid
microbial contamination of the product in a fresh-cut processing
facility.
We recommend that fresh-cut processors consider using the following
practices for their sanitation program:
--Establishing sanitation standard operating procedures (SSOPs),
including a cleaning and sanitizing procedure with a regular
schedule for all equipment, storage areas, fresh and fresh-cut
produce production areas, air systems, and water storage areas
An example of such a schedule is included in Figure 4. When
visual inspection or environmental monitoring results for
equipment or the facility reveal dirt, food residues, or other
debris, we recommend a more frequent cleaning and sanitizing
schedule relative to what is shown in Figure 4.
FIGURE 4.--AN EXAMPLE OF A PROCESSING PLANT ENVIRONMENTAL SANITATION MASTER SCHEDULE \6\ \7\
----------------------------------------------------------------------------------------------------------------
Cleaning/
Area Sanitation Method Tools Cleaning Materials Frequency
----------------------------------------------------------------------------------------------------------------
Walls........................... Foam, brush, rinse Soft nylon brush Chlorine- Once/Month Walls
and High Pressure Quaternary adjacent to
Hose (when ammonium processing
appropriate). (``quat'')-based equipment should
cleaner. be cleaned daily
Ceiling......................... Foam, brush, rinse Nylon brush, high Chlorine-quat- Once/Month
pressure machine. based cleaner.
Floors.......................... Wash, rinse....... Hard bristle broom Chlorine-quat-or Daily
(not straw), iodine based
floor scrubbers, cleaner.
low pressure hose.
Doors........................... Foam, scrub, rinse Scouring pad, Chlorine-quat- Once/Week
cloth. based cleaner.
Plastic curtains................ Foam, rinse....... Foam and Rinse.... Chlorine-quat- Once/Week
based cleaner.
Overhead pipes, electrical Foam, brush....... Brush, bucket, Chlorine-quat- Once/Month
conduits, structural beams. high water based cleaner.
pressure machine.
Hoist, overhead light fixtures.. Wipe, clean....... Cleaning pad...... Water, light Once/Quarter
detergent.
Refrigeration coils............. Rinse, sanitize... High pressure hose Water, sanitize Once/Quarter
with quat.
Chillers........................ Scouring.......... Scouring pad...... Acid cleaner...... As Needed/Audit
Air distribution filters........ Soak.............. Plastic bins...... Chlorine-alkaline Once/Quarter
detergent.
Drains, trench.................. Clean, flood, Soft Nylon brush, Chlorine-alkaline Daily
rinse. 50 gallon detergent, quat
container. or iodine based
sanitizer.
Grids........................... Brush, rinse...... Nylon brush, high Chlorine-alkaline Daily
water pressure detergent.
machine.
Waste, dumpster areas........... Foam, brush, rinse Nylon brush, high Heavy duty Daily
water pressure chlorine-based
machine. cleaner.
Employee break rooms/bathrooms.. Wash, rinse....... Nylon brush, Chlorine-based Frequently
sanitary brushes. soap or quat. throughout the
day
Maintenance areas............... Scrub, rinse...... Nylon brush....... Degreasing agent.. Once/Month
----------------------------------------------------------------------------------------------------------------
\6\ Used with permission from the United Fresh Produce Association (UFPA), Food Safety Guidelines for the Fresh-
cut Produce Industry, 4th Edition, 2001.
\7\ Also, as noted previously in section V.B.3., we recommend that employees be trained to avoid use of high-
pressure water hoses to clean floors, walls, and equipment in the processing and packaging areas during
production or after production equipment has been cleaned. This practice will help prevent aerosols from
contacting processing equipment and food-contact surfaces, product, or packaging materials.
--Including as part of the sanitation schedule the name of the
employee (and alternate when primary employee is absent)
responsible for the activity, the equipment to be cleaned and
how to disassemble it, the frequency of cleaning, procedures
for cleaning (including type and concentration of cleaning
compound and sanitizer), time and temperature requirements,
cleaning solution flow rate (pressure) if applicable, and the
name of an employee responsible for verifying the program
effectiveness by inspection
--Cleaning the condenser unit, drip pans, and hoses of refrigerators
--Keeping cold storage as dry as possible
--After cleaning and sanitizing, visually inspecting the area cleaned
for product residue and conducting routine microbiological
tests (conventional or rapid microbiological methods, such as
total count or bioluminescence) to verify effectiveness of the
cleaning and sanitizing program
--When reassembling sanitized equipment, placing the equipment parts
on a sanitary mat and not on the floor
--Cleaning and sanitizing all processing equipment, facility
utilities (e.g., air system, water system), and food-contact
surfaces after maintenance work and prior to use in production
--Cleaning and sanitizing processing equipment and food-contact
surfaces between the processing of different commodities, if
appropriate based on risk
--Avoiding cleaning and sanitizing equipment during processing
operations to prevent contamination
--Minimizing splashing during the cleaning of floor drains by using
an appropriate brush, such as a \1/4\ inch smaller brush than
the diameter of the drain opening, or a splash guard
For cleaning drains, we recommend using dedicated utensils (color
coded and used for cleaning drains only) to minimize the
potential for contamination. We also recommend that floor
drains not be cleaned during processing operations and that the
person who cleaned drains not clean fresh-cut produce food
contact surfaces without changing outer garments, and washing
and sanitizing his or her hands.
--Regularly inspecting tools for cutting, slicing, and shredding for
damage that could impair cleaning and sanitizing them
We recommend replacing a tool if it cannot be fixed so that it
can be adequately cleaned.
Cleaning and Sanitizing Chemicals
Cleaning and sanitizing chemicals may be toxic, and should be
stored in dry, secure, and ventilated areas away from facility traffic
and processing operations. They should be handled by employees trained
in the use of such chemicals.
We recommend the following practices in using cleaning and
sanitizing chemicals:
--Using adequate quality water for cleaning and sanitizing at
temperatures appropriate for the chemicals used
--Using toxic chemicals for cleaning operations in accordance with
the manufacturer's instructions and in accordance with relevant
Federal, State, and local government regulations
--Clearly labeling toxic chemicals
--Storing toxic chemicals and pesticides in a manner that protects
against contamination of food, food-contact surfaces, and food-
packaging materials and in accordance with relevant Federal,
State, and local government regulations
--Monitoring the effectiveness of cleaning and sanitizing chemicals
by visual inspection and environmental testing (especially
grooves and niches) for microbial growth
Pest Control
We recommend a pest control program be implemented throughout the
entire processing facility to eliminate pests (such as rodents, birds,
reptiles, and insects) that may harbor or be a vector for a variety of
pathogens. As part of the plant's pest control program, consider
frequent monitoring of affected and treated areas to assess accurately
the effectiveness of the program. Some helpful physical and chemical
controls are recommended below.
--Using window screens, screen doors, and weather stripping for all
doors, and air fans at all doorways
--Keeping all exterior doors closed when not in use
--Removing waste products to, and storing waste products in, a
location outside the facility
--Removing old, unused equipment from the facility
--Maintaining the exterior grounds surrounding the facility in a
manner that will control pest harborage
--Properly storing ingredients, finished product, and food packaging
--Cleaning up spills and produce debris in a timely manner
--Using pesticides, traps, bait, and chemicals that are acceptable
for use in a food processing facility and that will not
contaminate foods, food ingredients, or food packaging
Chemical controls should be applied by a licensed pest control
operator or according to local regulations.
--Maintaining a map to identify by numbered locations all rodent
traps and bait boxes used both inside and outside the
processing facility.
Sanitary Facilities and Controls
Employee Changing Facilities and Toilets
We recommend that changing facilities and restrooms be adequate and
located in proximity to processing areas, but not so close that they
could be a source of contamination. We recommend that restrooms not
open directly into processing areas and doors be equipped with self-
closing mechanisms or have a maze-type entrance/exit.
Hand Washing Facilities
FDA recommends the following practices for employee hand washing
facilities:
--Providing a sink, hot and cold running water of adequate quality,
effective hand cleaning preparations (e.g., liquid soap),
sanitary hand drying devices (such as disposable paper towels),
and a waste container
--Installing water control devices (such as knee, foot, or elbow
faucet controls) that will protect against contamination of
clean hands
--Posting signs that show proper hand washing procedures
We recommend that these signs be posted near the facility
entrance, in restrooms, near all hand washing stations, and
wherever employees may handle produce, food packaging
materials, or food-contact surfaces. We further recommend that
these signs be multilingual where some of the workers in the
facility are not native English speakers or pictorial where
literacy is a concern.
Air Quality
Air inside a processing plant can be a vehicle for contamination of
food by mold, yeast, dust, or pathogens if not properly controlled.
Where fresh and fresh-cut fruits and vegetables are exposed to open
air, we recommend that air quality be monitored to ensure that it is of
suitable quality.
We also recommend that fresh-cut processors consider the following
to maintain appropriate air quality:
--Using positive, negative, and ambient air pressure differentials to
direct potential airborne contaminants away from microbially
sensitive areas. For example, negative air pressures in raw
product areas, microbiology laboratories, and rest rooms may
help to keep air from those areas from flowing into the
processing areas. Similarly, positive air pressure can be
maintained in areas such as the processing and packaging area.
--If air filtering equipment is used in a fresh-cut processing
facility, filters should be performing at manufacturer
specified levels of performance.
--Filtering compressed air (such as oxygen (O2), nitrogen
(N2), and carbon dioxide (CO2) used in
modified atmospheric packaging) when such air contacts fresh
produce using a 0.3 micron filter (with an efficiency of
approximately 75 percent)
Water Supply
Water can be a carrier of microorganisms including pathogens.
Adequate quality water is critical in a fresh-cut processing facility
because of the absence of a step lethal to pathogens (kill step) in
processing the product as well as the presence of factors such as the
high degree of product handling, the damage to product during cutting,
shredding, etc., and the potential for temperature abuse in processing
and storage. We recommend that the water supply in a food processing
plant be sufficient for the operations intended and be derived from an
adequate source. We recommend that water for operations in the
processing facility, such as cleaning and sanitizing the facility and
equipment as well as preparing the product for processing, processing
the product, and manufacturing ice, be of adequate quality. Where water
does not become a component of the fresh-cut produce, we recommend that
water be safe and sanitary, at suitable temperatures, and under
pressure as needed for all uses. For water that is used in a manner
such that the water may become a component of the fresh-cut produce
(such as when such water contacts components, fresh-cut produce, or any
contact surface), we recommend that water comply with applicable
Federal, State, and local requirements.
See Section VIII.C., which provides our recommendations for
maintaining water quality used from preparation for processing through
processing operations.
We recommend the following practices regarding the water used in a
processing facility:
--Complying with applicable Federal, State, and local requirements
for water that contacts fresh-cut produce or food-contact
surfaces, including water used to make ice
We recommend that processors protect sources of water and ice
from contamination and that ice be manufactured, transported,
and stored under sanitary conditions.
--Testing well water, if used, at the site of the well and at the
point in the plant most distant from the well on a regular
basis to ensure compliance with Federal, State, and local
requirements
--Maintaining and inspecting on a routine basis any water charcoal
filtering system to prevent it from becoming a source of
microbial or physical contamination of water
--Reviewing on a periodic basis water systems to ensure that no
cross-connections exist between systems carrying water that is
of adequate quality and systems carrying water that is not.
--Ensuring that the volume, temperature, and pressure of water is
adequate for all operational and clean up demands
Environmental Monitoring
FDA recommends an environmental monitoring program designed to
detect areas of pathogen harborage and to verify the effectiveness of
cleaning and sanitizing programs in preventing cross-contamination. We
recommend the following practices:
--Performing environmental sampling on both food contact and non-food
contact surfaces (e.g., drains)
--Determining the appropriate target pathogen, test locations, and
frequency of sampling.
We recommend that the appropriate target pathogen be the most
resistant microorganism of public health significance that is
likely to occur in fresh-cut produce.
--Focusing environmental monitoring on an indicator organism, such as
Listeria spp., which indicates microbial contamination but is
nonpathogenic and more easily detectable than a target
pathogen, such as L. monocytogenes
--Establishing a plan for action in the event that a microbiological
test indicates the presence of a target pathogen or indicator
organism
--Documenting corrective actions and follow-up for all positive
microbial test results
production and process controls
To minimize the potential for the growth of microorganisms and for
the contamination of fresh-cut produce, FDA recommends that control
measures be in place to prepare, process, package, and store the
product.
Product Specifications
We recommend that food processors consider developing
specifications and controls for all ingredients and components
(including raw fruits and vegetables, packaging materials, and gases)
that are necessary for production of safe finished product.
Specifications provide standards by which a food processor can assess
the acceptability of ingredients and components and thus, minimize
microbial, chemical, and physical hazards. We recommend, for example,
that the fresh-cut processor know as much as possible about the
production practices and conditions for the firm's incoming product.
The ``Guide to Minimize Microbial Food Safety Hazards in Fresh Fruits
and Vegetables'' (Ref. 15) provides useful guidance when reviewing
primary production practices.
Receipt and Inspection of Ingredients
Opportunities for contamination of fresh produce occur from the
field to the processing facility. Loading, transporting, and unloading
produce may introduce contaminants. Damaged produce, soil, debris, and
pests may all arrive with the produce when it is delivered to the
facility. To help ensure the quality of incoming fresh produce, we
recommend that the processor carefully inspect the produce upon receipt
at the processing facility. We also recommend the following practices:
--Transporting the produce from the field to the processing, packing,
or cooling facility as soon as practical after harvest
--Inspecting delivery vehicles carrying fresh produce and other
components of the finished product, e.g., cartons, packaging
materials, for cleanliness
--Visually inspecting incoming fresh produce for damage, filth, and
infestation according to a predetermined sampling plan and
rejecting products that do not meet established specifications
--Removing all damaged, moldy, or decomposed product and extraneous
matter (such as metal or other foreign material) from in-coming
raw ingredients to a designated area
--Retaining information about all incoming ingredients, such as the
identity of the grower or supplier, date of harvest, the field,
and linking the information on the incoming product with the
operation's production records (e.g., when processed, date,
shift) for finished product
This information will be useful in the event a traceback is
conducted. See section X in this guide for more information on
tracebacks.
Specific Processing Steps
Preparation for Processing
Appropriate preprocessing of incoming produce can help minimize
microbial, chemical, and physical hazards. We recommend that fresh-cut
produce processors consider the following activities to help minimize
microbial, chemical, and physical hazards in in-coming produce:
--Inspecting fresh produce throughout the processing stream for field
contaminants that may not have been noticed during the incoming
produce inspection
--Removing from the processing stream damaged or decomposed produce,
extraneous matter, and produce that appears to be contaminated
by animal feces, fuel, machine grease, or oil
--Removing as much dirt as possible from incoming produce
We recommend, when appropriate, washing incoming RACs prior to
further processing (such as cutting or chopping) to reduce the
overall potential for microbial contamination from the surface
of intact fruits and vegetables.
Processing Water
Water is used extensively in almost all aspects of processing
fresh-cut fruits and vegetables, including during cooling, washing, and
conveying of produce. Although water may be a useful tool for reducing
potential contamination, it may also introduce or spread contaminants.
When used for washing, cooling, rinsing, or conveying food, we
recommend that water comply with applicable Federal, State, and local
requirements.
In a fresh-cut processing operation, water quality changes as the
water is used and, thus, maintaining the quality of processing water
should be considered. Reusing processing water may present a risk of
new or increased number of microbial populations, including human
pathogens.
We recommend the following practices:
--Where water is reused in a series of processes, arranging water
flow to be counter to the movement of produce through different
operations, with the result that as produce is further
processed, it is exposed to the cleanest water
--Monitoring and treating processing water for level of disinfectant
chemical to ensure the water is maintained in a condition
suitable for the application (e.g., washing, cooling, or
transporting) and does not become a source of microbial
contamination
--Routinely inspecting and maintaining equipment designed to assist
in maintaining water quality, such as chlorine injectors,
filtration systems, and backflow devices, to ensure efficient
operation
We recommend that ice used on fresh or fresh-cut produce be
included in routine water quality testing.
Maintaining Water Quality
When used appropriately with adequate quality water, antimicrobial
chemicals help minimize the potential for microbial contamination of
processing water and subsequent cross contamination of the product. The
effectiveness of an antimicrobial agent, as well as the amount that
should be used, depends on the treatment conditions, such as water
temperature, acidity [pH], water hardness, contact time, amount and
rate of product throughput, type of product, water to product ratio,
amount of organic material, and the resistance of pathogens to the
particular antimicrobial agent. For example, the antimicrobial activity
of a chlorine-based disinfectant depends on the amount of hypochlorous
acid (also called ``free chlorine'') present in the water. The amount
of hypochlorous acid in the water depends upon the pH of the water, the
amount of organic material in the water, and, to some extent, the
temperature of the water. If the amount of hypochlorous acid is not
maintained when the amount of organic material increases, the
antimicrobial agent may lose effectiveness in maintaining water
quality. If a fresh-cut processor uses a chlorine containing compound
as a disinfectant, we recommend that the processor monitor the
processing water for free chlorine or hypochlorous acid concentrations.
As another example, the measurement of Oxidation-Reduction Potential
(ORP) is used as an indicator of the activity of any antimicrobial
agent that is an oxidizer and as a measure of the agent's effectiveness
during processing. Variables that affect antimicrobial activity during
processing directly affect the ORP value and may also be used to
determine the effectiveness of these oxidizers such as hypoorous acid,
hypobromous acid, chlorine dioxide, ozone, and peroxides.
We recommend that fresh-cut processors consider options for
maintaining the quality of water most appropriate for their individual
operations. Producers may wish to contact a local agricultural
extension agent, their chemical supplier, or a food safety consultant
for help in deciding what water treatment chemicals to use. In
addition, processors may refer to 21 CFR 173.315, ``Chemicals used in
washing or to assist in the peeling of fruits and vegetables,'' for
additional information about chemicals approved for use in wash water.
We recommend that fresh-cut processors also consider the following
regarding water quality maintenance:
--Following the manufacturer's directions for correct mixing of
antimicrobial agents to obtain effective concentrations and to
minimize safety hazards
Manufacturers' suggested or allowable levels of antimicrobial
chemicals in wash water should not be exceeded.
--Monitoring disinfectant levels frequently in water used for various
processing operations to ensure appropriate concentrations are
maintained
Test strips or test kits may be useful for monitoring some
disinfectant levels.
--Minimizing the build up of organic material in wash water
For some operations, filtering recirculating water or using a net
to scoop plant material or other debris from tanks may help
reduce the build up of organic material.
--Following contact between produce and processing water containing
antimicrobial chemicals with a clean water rinse of adequate
quality to remove any treatment residues where appropriate and
consistent with the manufacturer's directions
Washing Fresh Produce
Prior to arriving at the processing facility, RACs may be washed in
the field or in a place such as a cooling facility. RACs may also go
directly from the field to the processing facility to be washed after
receipt. Regardless of where the initial washing of the produce takes
place, washing produce can reduce the overall potential for microbial
food safety hazards because most microbial contamination is on the
surface of the produce. If pathogens are not removed, inactivated, or
otherwise controlled at this initial stage, they can potentially spread
the contamination to additional produce during processing. Washing RACs
before any processing of the produce occurs may reduce potential
surface contamination. However, washing, even with disinfectants, can
only reduce, not eliminate, pathogens, if present. Washing has little
or no effect on pathogens that have been internalized in the produce.
A number of post harvest processes, such as hydrocooling, use of
dump tanks, and flume transport utilize a high degree of water-to-
produce contact. We recommend that fresh-cut processors use practices
to maximize the cleaning potential during these processes and to
minimize the potential for cross-contamination.
We recommend the following practices:
--Using a series of washes, if appropriate
For some operations, a series of washes may be more effective
than a single wash. An initial wash treatment may be used to
remove the bulk of field soil from produce followed by an
additional wash or washes containing an antimicrobial chemical.
--Using appropriate wash methods
Vigorous washing of produce not easily bruised or injured
increases the likelihood of pathogen removal. Different methods
may be used to wash different types of produce, including
submersion, spray, or both. Regardless of the method used,
maintaining the quality of the wash water (see section 2.a.
above) is important in order to minimize the potential for
contamination.
--Maintaining the efficacy of wash treatments
--Using wash water of an appropriate temperature
Produce is susceptible to infiltration of wash water if warm
produce is placed in water that is cooler than the produce.
Such infiltration occurs when the temperature difference
creates a pressure differential causing air spaces inside the
fruit or vegetable to contract, thereby allowing water to be
pulled into the fruit or vegetable. If pathogens are present in
the cooling/wash water, they may infiltrate the produce, and
subsequent washing will not reduce levels of these pathogens
(Refs. 6, 14). Therefore, water used for washing or cooling
produce should contain sufficient levels of disinfectant to
reduce the potential for pathogens to persist in such water.
When it is not practical to reduce the temperature differential
between the wash/cooling water and the produce, it is
especially important that processors follow practices to
minimize pathogens in the water or on the surface of produce.
Such practices may include using antimicrobial chemicals in the
wash water or using spray type wash treatments instead of
submerging produce. Alternatively, produce may be cooled by
means other than hydrocooling and then washed with water that
is warmer than the produce.
Precooling and Cold Storage
Sanitary cold storage of RACs and fresh-cut produce is important to
reduce the risk of microbial contamination and potential for subsequent
growth. However, most current temperature recommendations for both
whole and fresh produce are based on temperatures that maintain quality
attributes.\8\ Although we recognize that more research needs to be
done to identify the types of whole and fresh-cut produce that will
support the growth of human pathogens and the temperatures at which
this pathogen growth will occur, certain practices can reduce the
potential for pathogen growth and contamination during precooling and
cold storage. We recommend the following practices to reduce this risk:
---------------------------------------------------------------------------
\8\ An exception is Chapter 1 of the FDA Food Code (2005), which
defines potentially hazardous food (PHF) and identifies specific fresh
produce (among other foods) that is considered PHF and therefore
requires refrigeration at 41:F. Cut melons are considered a PHF. See
website at http://www.cfsan.fda.gov/dms/foodcode.html.
---------------------------------------------------------------------------
--Holding RACs and fresh-cut produce at appropriate cold storage
temperatures to reduce the potential for microbial growth
--Preventing condensate and defrost water from evaporator-type
cooling systems (e.g., vacuum cooling, cold storage) from
dripping onto fresh and fresh-cut produce
--Designing and maintaining forced air cooling to avoid contaminating
fresh produce
In most instances, vacuum cooling or use of fans poses the lowest
risk of microbial contamination
--Holding cut melons and any other fresh-cut product determined to
need temperature control for safety at 41 F ( 5 C)
--Locating temperature monitoring devices in the warm area of the
refrigerator unit (e.g., near the door) and calibrating them on
a regular basis
--Inspecting all refrigeration units on a regular basis and keeping
them in good operating condition
--Storing similar commodities together (unprocessed product next to
unprocessed product and finished product next to finished
product) to avoid cross-contamination
--Using an appropriate inventory system to ensure first in first out
(FIFO) use and FIFO shipment of raw materials and finished
products
Washing Fresh-cut Produce: Post-processing Controls
Final washing of fresh produce after cutting, slicing, shredding,
and similar fresh-cut processes helps remove some of the cellular
fluids that could serve as nutrients for microbial growth. Monitoring
the quality of water used in such operations and replacing it at an
appropriate frequency as indicated by such monitoring may help prevent
the build up of organic material in the water and reduce or prevent
cross-contamination of processed produce. We have the following
additional recommendations for use after the final wash of processed
produce:
--Where appropriate for the product, removing as much excess water as
possible from processed produce through draining methods such
as spin drying
--Keeping containers used to hold produce (e.g., spin baskets) from
direct contact with the floor and away from containers that
have had direct contact with the floor (e.g., in cold storage)
Packaging
Anything that touches fresh-cut produce has the potential to
contaminate it, including the materials used in packaging the finished
product.
We recommend the following practices:
--Maintaining an effective system to prevent the use of contaminated,
damaged, or defective cartons and totes in order to prevent
microbial contamination of the fresh-cut produce during packing
operations
--Overseeing incoming materials and gases used in packaging to
confirm that they are not damaged or defective and are in
appropriate working order
--Rejecting packaging materials that are damaged or contaminated
--Determining the appropriate gas mixtures for products
--Using containers and cartons for their intended purpose only. For
example, we recommend against using a carton designated for
holding fresh-cut produce to hold tools.
--Storing packaging containers and other packaging materials in a
manner so as to protect them from contamination, such as away
from pests, dirt, cleaning chemicals, and water condensation
from overhead equipment and structures
--Maintaining a program to identify and correct situations where
damage to containers may potentially occur
--Labeling all finished fresh-cut produce products with recommended
storage instructions (e.g., ``Keep Refrigerated'') or storage
temperature to inform all persons handling the product of the
recommended storage conditions
Modified Atmosphere Packaging (MAP)
Some packaging controls used for fresh-cut produce affect the
environment within the package by reducing the levels of oxygen. Low
oxygen levels help maintain the quality of fresh produce and extend
shelf-life by slowing respiration and senescence in plant tissues.
Oxygen can be reduced passively by using gas permeable films in
packaging that result in the natural development of the desired
atmosphere; the desired atmosphere is a consequence of the products'
respiration as gas diffuses through the film (Ref. 6). Oxygen can also
be reduced actively by displacing the mixture of gases in a package
with a gas mixture that has a low concentration of oxygen (1-5
percent). Microorganisms respond differently to the surrounding gases
depending on their tolerance. While reduced oxygen and elevated carbon
dioxide retard the growth of spoilage microorganisms such as
Pseudomonas spp., the same gas conditions may provide growth
opportunities for pathogenic microorganisms. At extremely low oxygen
levels (< 1 percent), anaerobic respiration can occur, resulting in
tissue destruction that affects product quality and creating the
potential for growth of foodborne pathogens such as Clostridium
botulinum (Ref. 6). It is generally believed, however, that fresh-cut
produce will spoil before the toxin becomes a concern (Ref. 6). Non-
pathogenic aerobic and facultative microorganisms are present at the
time of packaging and persist after packaging.
MAP is only effective in extending shelf-life if used in
conjunction with good refrigeration. Elevated temperatures can promote
the growth of spoilage organisms and pathogens that may be present.
Thus, we recommend that food processors using MAP adhere to strict
temperature controls and appropriate shelf-life parameters. Because
refrigeration temperatures may not be maintained during distribution of
the products or while they are held by retailers or consumers, we also
recommend that controls be in place to either prevent increases in
temperature, as feasible, or to alert the processor, retailer, or
consumer that the product may not be safe to consume. Processors may
wish to consider providing product handling guidelines on temperature
control and washing to the distributor, retailer, and consumer. Another
potential source of contamination of fresh cut produce packed in MAP
occurs when the gases, equipment, or packaging materials are not
properly maintained. As with any type of packaging, we recommend that
controls be put in place to ensure that the process of packaging the
product and the packaging materials themselves do not cause the product
to become contaminated.
Shelf-life
Fresh-cut fruits and vegetables can cause illness due to
contamination with a variety of microorganisms because these products
do not undergo any processing to ensure the total elimination of
microorganisms that might be present. Some packaging and storage
techniques for fresh-cut produce (e.g., MAP, refrigerated storage) may
slow the rate of physical deterioration by slowing respiration of the
produce. However, if packaging and storage are not properly controlled,
pathogens may grow to levels that could render the product unsafe for
human consumption. The rate of respiration of fresh produce is
inversely related to product shelf-life, which means that a higher
respiration rate decreases shelf-life (Ref. 6). Fresh fruits and
vegetables that have been cut or otherwise physically altered will have
increased respiration, and thus, a shorter shelf-life. To address the
risks of increased respiration, we recommend the following practices:
--Communicating (through product labeling) that the consumer should
refrigerate the product to prevent product spoilage and the
potential for growth of pathogens
--Ensuring that any ``use by'' date on the product package is
validated by studies of the product with respect to
microbiological safety
We recommend that records of these data and studies be maintained
to document the reliability of the ``use by'' labeling.
Transportation and Storage
We recommend that finished fresh-cut product be stored and
transported under conditions that will protect the food against
physical, chemical, and microbiological contamination. We recommend, if
feasible, that raw whole produce not be stored with finished product
and finished product be transported in clean, sanitary vehicles. We
also recommend the following practices:
--Keeping finished products refrigerated at temperatures appropriate
for the product during storage, transportation, and display for
sale to minimize the potential for growth of microbial
pathogens
--Equipping refrigerated transportation vehicles and storage rooms
with accurate temperature measuring devices, preferably
including a temperature recording function
If a recording temperature device is not used, we recommend that
a min/max thermometer, i.e., a thermometer that shows the range
of temperatures attained over a set time period, be used.
--Shipping fresh-cut produce products on a FIFO basis to minimize
storage time
--Ensuring that the equipment in refrigeration vehicles is designed
to circulate cold air uniformly throughout the vehicle while
taking the load layout into consideration
--Placing fresh-cut produce products in storage facilities and
transportation vehicles in a manner that allows for proper air
circulation
--Transporting and storing fresh-cut produce products in vehicles and
containers that are dedicated to carrying food products and
have been treated by a process that is effective in destroying
vegetative cells of microorganisms of public health
significance
--Inspecting transportation vehicles and containers for debris, soil,
and off-odors prior to loading to increase their suitability
for transporting fresh-cut produce
--Loading and unloading fresh-cut produce in a manner that minimizes
the potential for damage and for microbial contamination
documentation and records
We recommend as a general practice that food processors maintain
records sufficient to reflect important product information and
practices. Such documentation can be helpful to the processor in
several ways. First, such records help ensure consistency of processing
operations and end-product quality and safety. They are more reliable
than human memory, and they are a useful tool to identify operational
areas where inconsistencies occur and further employee training may be
needed. Second, maintaining adequate documentation and records of
processing operations is important if a traceback investigation of
product is ever needed. We recommend that records be retained at the
processing plant for at least six months after the date that the
products were prepared unless a longer retention time is required under
a relevant law or regulation. Records are most useful when they begin
by including the date and time, name of person(s) who completed the
record, and the activity or production station being recorded.
Records that may be kept for most food processing operations
include the following:
--Water quality and supply records
--Water treatment and monitoring records
--Employee training records
--Temperature control records
--Equipment monitoring and maintenance records
--Calibration records
--Sanitation records
--Product processing batch records
--Corrective action records
--Pest control records
--Distribution records
--Inspection records (e.g., incoming product, facility, production
area)
--Microbiological contamination records (e.g., food contact surfaces,
equipment)
traceback and recall
Traceback is the process of tracking food items, such as fresh-cut
produce, back to their source (growers, packers, processor, field and
when harvested). The ability to identify the source of a product can
serve as an important complement to food safety programs intended to
prevent the occurrence of microbial contamination. Information gained
from a traceback investigation may also be useful in limiting the
impact of an outbreak of foodborne illness and in identifying and
eliminating conditions that may have resulted in the produce becoming
contaminated. We recommend that fresh-cut processors establish and
maintain written traceback procedures to respond to food safety hazard
problems when they arise.
We also recommend that fresh-cut processors establish and maintain
a current written contingency plan for use in initiating and carrying
out a recall. Having procedures in place will enable the recall of any
lot of product that may have been implicated in an outbreak or that
tested positive for a pathogen and help provide detailed information to
assist the investigation of any foodborne illness associated with the
product. Recall procedures usually include the name of the contact
persons responsible at all times; the roles and responsibilities for
the coordination of a recall; the methods to identify (e.g., use of lot
codes), locate, and control recalled products; requirements to
investigate other possibly affected products which could subsequently
be included in the recall; and procedures for monitoring the
effectiveness of the recall.
Because a recall may extend to more than one lot of product, we
recommend that processors develop a coding system to help identify
incoming product sources, individual production lots and to whom each
lot is distributed. Use of package and date codes can help link product
packages with production times, equipment, and raw ingredient sources
and may facilitate recovery of products during a recall.
In the event of a firm-initiated recall, if a firm believes its
product is adulterated or otherwise violates the Act, we request that
the firm immediately notify the appropriate FDA district office in the
State where the processing facility is located. District office
locations are provided in 21 CFR 5.115. (See Appendix A for information
to include in the notification.)
Produce growers and packers, fresh-cut produce processors, and
shippers are encouraged to work with their partners in growing,
transporting, distributing, packing, and processing, and with retail
sectors to develop technologies that allow identification of fresh-cut
produce from the grower to your operation, to the retailer, and to the
consumer.
additional information
The following are additional resources for information on how to
handle food products safely.
On the web
FDA/Center for Food Safety and Applied Nutrition www.cfsan.fda.gov
Fight Bac!TM www.fightbac.com
Gateway to Government Food Safety Information www.foodsafety.gov
USDA/FDA Foodborne Illness Education Information Center
www.nal.usda.gov/fnic/foodborne
Centers for Disease Control and Prevention (CDC) www.cdc.gov
USDA/Food Safety and Inspections Service (FSIS) www.fsis.usda.gov
NACMCF HACCP guidelines http://www.cfsan.fda.gov/comm/nacmcfp.html
Other resources
Ednet: a monthly electronic newsletter for food safety educators. To
subscribe, send an email message to [email protected]
with the message, ``Subscribe EDNET-L first name last name.''
Foodsafe: An online electronic discussion group. Go to
www.nal.usda.gov/fnic/foodborne to join.
FDA's Outreach and Information Center: 1.888.SAFEFOOD
Code of Hygienic Practices for Fresh Fruits and Vegetables (CAC/RCP
53-2003)
General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 4-2003)
references
(1) U.S. Department of Health and Human Services and U.S.
Department of Agriculture, Dietary Guidelines for Americans 2005,
January 2005. See website at http://www.health.gov/dietaryguidelines/
(accessed 2/27/07).
(2) U.S. Department of Agriculture, ``MyPyramid,'' April 2005. See
website at http://www.mypyramid.gov/(accessed 2/27/07).
(3) U.S. Department of Agriculture, Economic Research Service, U.S.
per Capita Food Consumption of Fruits and Vegetables, 2005. See web
site at http://www.ers.usda.gov/Data/FoodConsumption/(accessed 2/27/07)
(4) Produce Marketing Association, ``Fresh-cut Produce Industry''
fact sheet, 2006. See web site at http://www.pma.com/. Click on
``Member Resources'', ``Information Resource Center'', and then ``Fact
Sheets'' (membership required; accessed 2/9/07)
(5) U.S. Food and Drug Administration (FDA), 1996-2006 Produce
Outbreaks (unpublished data).
(6) Institute of Food Technologists and FDA. ``Analysis and
Evaluation of Preventative Control Measures for the Control and
Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut
Produce.'' September 2001. See web site at http://www.cfsan.fda.gov/
comm/ift3-toc.html (accessed 2/27/09)
(7) Mead, P.S., Slutsker, L., Dietz, C., et al. 2000. Food-Related
Illness and Death in the United States. Journal of Environmental
Health. 62(March): 9-18.
(8) Allos, B.M., Moore, M.R., Griffin, P.M., and Tauxe, R.V. 2004.
Surveillance for Sporadic Foodborne Disease in the 21st Century: The
FoodNet Perspective. Clinical Infectious Disease. 38(Suppl 3): S115-
120.
(9) Lampel, K.A., Orlandi, P.A., and Kornegay, L. 2000. Improved
Template Preparations for PCR-Based Assays for Detection of Food-Borne
Bacterial Pathogens. Applied and Environmental Microbiology. 66(10):
4539-4542.
(10) Sivapalasingam, S., Friedman, C.R., Cohen, L., and Tauxe, R.V.
2004. Fresh Produce: A Growing Cause of Outbreaks of Foodborne Illness
in the United States, 1973 through 1997. Journal of Food Protection.
67(10): 2342-2353.
(11) Tauxe, R.V. 2002. Emerging Foodborne Pathogens. International
Journal of Food Microbiology. 78 (2002) 31-41.
(12) Trevejo, R.T, Courtney, J.G., Starr, M., Vugia, D.J. 2003.
Epidemiology of Salmonellosis in California, 1990-1999: Morbidity,
Mortality, and Hospitalization Costs. American Journal of Epidemiology.
2003:157:48-57.
(13) FDA, ``Reducing Microbial Food Safety Hazards for Sprouted
Seeds,'' 1998. See web site at: http://www.cfsan.fda.gov/dms/
guidance.html#prod (accessed 2/28/07)
(14) FDA, ``Sampling and Microbial Testing of Spent Irrigation
Water During Sprout Production,'' 1999. See web site at: http://
www.cfsan.fda.gov/dms/guidance.html#prod (accessed 2/28/07).
(15) FDA, ``Guide to Minimize Microbial Food Safety Hazards in
Fresh Fruits and Vegetables,'' October 1998. See web site at: http://
www.foodsafety.gov/dms/guidance.html#prod (accessed 2/28/07).
(16) Department of Health and Human Services and the United States
Department of Agriculture. Quantitative Assessment of Relative Risk to
Public Health from Foodborne Listeria monocytogenes Among Selected
Categories of Ready-to-eat Foods. September 2003. See web site at:
http://www.cfsan.fda.gov/dms/lmr2-toc.html (accessed 2/28/07).
(17) FDA, Center for Food Safety and Applied Nutrition, ``Foodborne
Pathogenic Microorganisms and Natural Toxins Handbook (Bad Bug Book),''
January 2001. See website at: http://www.cfsan.fda.gov/mow/intro.html
(accessed 2/28/07).
(18) FDA and the Centers for Disease Control and Prevention,
``Reducing the Risk of Listeria monocytogenes, FDA/CDC 2003 Update of
the Listeria Action Plan,'' November 2003. See web site at: http://
www.foodsafety.gov/dms/lmr2plan.html (accessed 2/28/07).
appendix a
Notifying FDA of a Recall
In the event of a firm-initiated recall, if a firm believes its
product is adulterated or otherwise violates the Act, we request that
the firm immediately notify the appropriate FDA district office and
that the notification include:
--the identity of the product involved (i.e., an adequate description
of the type of food to include brand name and specific variety,
date of releasing the food, the lot or code number or other
identifier of the implicated product, the quantity and how the
food is packaged);
--the reason for the recall and the date and circumstances under
which the product deficiency or possible deficiency was
discovered;
--an evaluation of the risk associated with the product;
--the total amount of implicated product units processed and the time
span of processing;
--the total amount of product in inventory and the total amount of
product distributed;
--the distribution information including the number of direct
accounts and, where necessary, the identity of the direct
accounts;
--a copy of the firm's recall communication, if any has issued, or
the proposed communication if none has issued;
--the proposed strategy for conducting the recall; and
--the name and telephone number of the firm official who should be
contacted concerning the recall
For further FDA guidance on recalls, see 21 CFR sections 7.40-7.59.
appendix b
Foodborne Pathogens Associated with Fresh Fruits and Vegetables
The U.S. Public Health Service has identified a number of
microorganisms associated with foodborne illness that are notable
either because of the severity or because of the prevalence of the
illness they cause. Foodborne microbial pathogens associated with the
consumption of fresh fruits and vegetables include Cyclospora
cayetanensis, Escherichia coli O157:H7, hepatitis A virus, Listeria
monocytogenes, Norovirus, Salmonella spp., and Shigella spp.\9\
---------------------------------------------------------------------------
\9\ More information about these and other microbiological
pathogens can be found in FDA's Bad Bug Book (http://vm.cfsan.fda.gov/
mow/intro.html). See Ref. 17.
---------------------------------------------------------------------------
Cyclospora.--Infections (cyclosporiasis) are caused by the
protozoan Cyclospora cayetanensis. The infections are spread by
ingestion of food or water contaminated with infected stool. Direct
person-to-person transmission is unlikely because excreted oocysts
require days to weeks under favorable environmental conditions to
become infectious (i.e., sporulate). The natural host for this parasite
has not been identified; however, contaminated water used for
irrigation and pesticide application and poor worker hygiene have been
suggested as the most likely routes of contamination. The infection
(cyclosporiasis) is commonly characterized by watery diarrhea, loss of
appetite, weight loss, abdominal bloating and cramping, low-grade
fever, nausea, vomiting, and fatigue. Relapses and asymptomatic
infections can occur. Outbreaks of cyclosporiasis have been linked to
fresh raspberries, mesclun lettuce, and basil or basil-containing
products. (For more information: www.cfsan.fda.gov/mow/intro.html)
E. coli O157:H7.--Is a bacterium and one of the enterovirulent
strains of Escherichia coli. Most E. coli strains are nonpathogenic,
found in the intestines of all animals, including humans, and function
by suppressing harmful bacterial growth. However, there are a minority
of strains such as serotype O157:H7 that may cause human illness. E.
coli O157:H7 is a life-threatening bacterium that produces large
quantities of potent toxins that can cause severe damage to the lining
of the intestines. Human illness associated with E. coli O157:H7
infection may include nonbloody diarrhea, hemorrhagic colitis,
hemolytic uremic syndrome (HUS), or thrombotic thrombocytopenic purpura
(TTP). Hemorrhagic colitis progresses from abdominal cramps to
nonbloody diarrhea to bloody diarrhea. HUS largely affects young
children and is the leading cause of acute renal failure in children.
TTP is a rare syndrome of E. coli O157:H7 infection, which largely
affects adults and resembles HUS histology. E. coli O157:H7 outbreaks
have been associated with meat (especially undercooked or raw
hamburger), fresh produce, raw milk, unpasteurized apple juice,
coleslaw, and contaminated water (For more information:
www.cfsan.fda.gov/mow/intro.html).
Hepatitis A Virus.--May cause a serious, and sometimes fatal,
disease. Hepatitis attributed to hepatitis A virus is characterized by
sudden onset of fever, malaise, nausea, anorexia, and abdominal
discomfort, followed in several days by jaundice. Hepatitis A virus is
excreted in fecal material and is transmitted by the fecal-oral route,
which include consumption of contaminated food. The most common food
sources of Hepatitis A are shellfish and salads, but it may also be
transmitted through drinking water. (For more information:
www.cfsan.fda.gov/mow/intro.html)
Listeria Monocytogenes.--Is a bacterium \10\ that causes
listeriosis, a serious disease in pregnant women, the elderly, and
those with weakened immune systems. L. monocytogenes is widespread in
the environment (i.e., in soil, water, and decaying vegetation) and has
been isolated from domestic animals, humans, raw produce, food
processing environments (particularly cool damp areas), and home
refrigerators. Outbreaks of listeriosis in the United States have been
associated with the consumption of hot dogs, deli or luncheon meats,
pate, salami, Mexican-style soft cheeses and butter made with raw milk,
and raw vegetables (Ref. 16). (For more information: www.cfsan.fda.gov/
mow/intro.html)
---------------------------------------------------------------------------
\10\ For additional information, FDA, the Centers for Disease
Control and Prevention, and the U.S. Department of Agriculture (USDA)
have developed a Listeria Action Plan (Ref. 18) and a Listeria risk
assessment (Ref. 16).11 Used with permission from UFPA, Food Safety
Guidelines for the Fresh-cut Produce Industry, 4th Edition, 2001.
---------------------------------------------------------------------------
Noroviruses.--Are a group of related, single-stranded RNA,
nonenveloped viruses that cause acute gastroenteritis in humans.
Norovirus was recently approved as the official genus name for the
group of viruses provisionally described as ``Norwalk-like viruses.''
Norovirus is transmitted by the fecal-oral route most commonly via
contaminated water or contaminated foods. Shellfish and salad
ingredients are the foods most often implicated in norovirus outbreaks.
(For more information: www.cfsan.fda.gov/mow/chap34.html and http://
www.cdc.gov/ncidod/dvrd/revb/gastro/norovirus.htm)
Salmonella.--Is the second most common cause of foodborne illness
(salmonellosis) in the United States and is responsible for millions of
cases of illness each year. Typical symptoms of salmonellosis are
nausea, vomiting, abdominal cramps, fever, mild diarrhea, and headache;
these symptoms usually last 6-48 hours. Salmonella outbreaks have been
associated with the consumption of raw and undercooked eggs,
undercooked poultry and meat, dairy products made with unpasteurized
milk, shrimp, fresh produce, and unpasteurized fruit juice. (For more
information: www.cfsan.fda.gov/mow/intro.html)
Shigella spp.--Humans are a natural reservoir for Shigella spp. The
primary means of transmission of the shigella organism is by the fecal-
oral route. Most cases of infection by shigella (shigellosis) are
attributed to the ingestion of food or water contaminated with fecal
matter. Contamination has often been associated with poor personal
hygiene of food workers. Typical symptoms include abdominal pain,
cramps, diarrhea, fever, vomiting, and blood, pus, or mucus in stools.
Shigellosis outbreaks have been associated with shredded lettuce,
potato salad, green onions, parsley, cheese, seafood, and poultry (Ref.
19). (For more information: www.cfsan.fda.gov/mow/intro.html)
appendix c
Pathogens Often Transmitted by Food that Has Been Contaminated by
Infected Employees
A wide range of communicable diseases may be transmitted by
infected employees to consumers through contaminated food or food
utensils. We recommend that fresh-cut produce firms establish an
ongoing program to identify employees who present a risk of
transmitting foodborne pathogens to fresh produce or to other
employees. Below is a list of the most common pathogens that may be
transmitted through food and their associated symptoms.
------------------------------------------------------------------------
Pathogen Symptoms
------------------------------------------------------------------------
Hepatitis A virus......................... fever, jaundice
Salmonella typhi.......................... fever
Shigella species.......................... diarrhea, fever, vomiting
Norwalk and Norwalk-like viruses.......... diarrhea, fever, vomiting
Staphylococcus aureus..................... diarrhea, vomiting
------------------------------------------------------------------------
Diarrhea, fever, and vomiting are also symptoms of several other
pathogens that could be transmitted by food contaminated by infected
employees.
Please refer to this CDC web site for further information on
foodborne diseases, pathogens, and toxins: http://www.cdc.gov/
foodsafety/disease.htm.
appendix d
potential sources of microbial contamination
Ingredients
--Raw produce
--Fresh-cut produce
Packaging materials
--Containers, films, lids, trays
Processing aids
--Compressed air
--Untreated or inadequately treated wash water
--Ice
--Reused processing water
Facility environment
--Ceilings, overhead structures, catwalks
--Rubber seals around doors (especially coolers)
--Drains
--Walls
--Standing water
--PWet insulation in walls or around pipes and cooling units
--Condensate
--Vacuum cleaner contents
--Hand washing areas (sinks) and restrooms
Food contact surfaces
--Fibrous or porous type conveyor belts
--Filling or packaging equipment
--Equipment cleaning tools
--Slicers, dicers, shredders, blenders,
--Belts, peelers, collators
--Containers, bins, tubs, or baskets
--Hands, gloves, and outerwear
--Ice makers
--Utensils
Nonfood-contact surfaces
--In-floor weighing equipment
--Hollow rollers for conveyors
--Trash cans and other such ancillary items
--Visible bearings within equipment
--Condensate drip pans
--Maintenance tools (wrenches, screw drivers, etc.)
--On/off switches
--Cracked hoses
--Equipment framework
--Wet rusting or hollow framework
--Poorly maintained compressed air filters
--Motor housing
--Forklifts, hand trucks, trolleys, racks
--Vacuum cleaners and floor scrubbers
examples of scenarios that may cause microbial contamination of the
product
1. A processing line is moved or modified significantly.
2. Used equipment is brought in from storage or another plant and
installed into the process flow.
3. An equipment breakdown occurs.
4. Construction or major modifications are made to a fresh-cut
produce processing area (e.g., replacing refrigeration units or floors,
replacing or building walls, modifications to sewer lines).
5. An employee unfamiliar with the operation and microbial controls
has been hired or assigned to work or clean equipment in the processing
areas.
6. Personnel who handle fresh produce and fresh-cut produce touch
surfaces or equipment that are likely to be contaminated (e.g., floor,
trash cans) and do not change gloves or follow other recommended
procedures before handling product.
6. Periods of heavy production make it difficult to change
processing water or clean food contact surfaces at the facility as
scheduled.
7. A drain backs up.
8. Product is caught or hung up on equipment for an extended period
and is not removed during equipment clean-up. Microorganisms may grow
in stagnant product and can be a major source of contamination during
production. FDA recommends that equipment be modified to eliminate
areas where product stops moving along or through a processing line and
cannot be readily removed during cleaning.
9. There are frequent product changes on a packaging line which
necessitate changing packaging film, labels, forming pockets or molds,
line speeds, etc.
10. Personnel are used interchangeably for handling unprocessed
produce and finished fresh-cut product.
11. There is increased production requiring wet cleaning of down
lines in the same room as lines running product.
12. Equipment parts, tubs, screens, etc. are cleaned on the floor.
13. Waste bins in the processing areas are not properly maintained,
cleaned, and sanitized. Personnel handling product may come into
contact with these items and thenpara.ntaminate product and/or product
contact surfaces.
appendix e
an example of product/personnel flow patterns in a fresh-cut processing
plant \11\Sec.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
______
How the FDA Works to Keep Produce Safe
The contamination of fresh spinach with the bacteria Escherichia
coli (E. coil) O157:H7 during the fall of 2006 led to one of the
largest and deadliest outbreaks of foodborne illness in recent years.
---------------------------------------------------------------------------
\11\ Used with permission from UFPA, Food Safety Guidelines for
there Fresh-cut Produce Industry, 4th Edition, 2001.
---------------------------------------------------------------------------
Most of the illnesses due to E. coil occurred from August 26, 2006,
to Sept. 16, 2006. Illnesses from spinach were confirmed in 26 States,
and one case was confirmed in Ontario, Canada. In all, nearly 205 cases
of illness were recorded during the outbreak, including 31 involving a
type of kidney failure called hemolytic uremic syndrome (HUS). More
than 100 people were hospitalized, and three deaths were recorded,
including a 2-year-old boy in Idaho.``One foodborne illness is too
many,'' says Robert Brackett, Ph.D., director of the Food and Drug
Administration's Center for Food Safety and Applied Nutrition (CFSAN).
``We've seen that there is no such thing as a small error when it comes
to produce safety. Even what may be perceived as a small error can have
disastrous consequences.''
Fresh produce is especially vulnerable to contamination--because
it's grown in a natural environment. It may be grown in a field or
orchard, and it is often consumed raw, without cooking or other
treatments that could destroy bacteria and other pathogens.
The FDA works with many partners to prevent contamination, but it's
impossible to eliminate all problems through prevention. ``When there
is a problem, we want to catch it early and contain it through
efficient outbreak response,'' says David Acheson, M.D., director of
food safety and security in the CFSAN. ``In this case, the FDA mounted
a collaborative effort with public health authorities throughout the
country to identify the source of the problem and prevent its spread.''
The CFSAN has the lead responsibility for ensuring food safety,
regulating everything except meat, poultry, and processed egg products,
which are regulated by the U.S. Department of Agriculture (USDA). The
Centers for Disease Control and Prevention (CDC) has a complementary
role, serving as the lead Federal agency for conducting disease
surveillance and outbreak investigations. Surveillance systems
coordinated by the CDC, in collaboration with the States, provide an
essential early-information network to detect dangers in the food
supply.
Detecting an Outbreak
When a patient is diagnosed with E. coli O157:H7, a sample of the
bacterial strain is sent to a participating PulseNet lab, says
Christopher Braden, M.D., chief of outbreak response and surveillance
at the CDC. PulseNet is a national network of public health
laboratories that perform genetic fingerprinting on foodborne bacteria
that result in human illness. Scientists use a process called pulsed-
field gel electrophoresis (PFGE), a technique that subtypes bacteria.
``After the bacterial strain is subtyped or ``DNA fingerprinted''
at a lab, the fingerprint is then uploaded electronically to the
national PulseNet database where it can be compared with other patterns
in other States,'' Braden says. ``This gives us the capability to
rapidly detect a cluster of infections with the same pattern occurring
in multiple States. The strength of this system is its ability to
identify patterns even if the affected people are geographically far
apart.''
Epidemiologists in Wisconsin were the first to alert CDC officials
about a small cluster of E. coli O157:H7 infections on Sept. 8, 2006.
At that time, the source of the problem was unknown. Wisconsin posted
the bacterial strain to PulseNet to alert the entire network. PulseNet
confirmed that E. coli strains from infected patients in Wisconsin had
matching PFGE patterns and identified the same patterns in other
States. ``Once a cluster of cases with the same DNA pattern is
identified, epidemiologists interview patients to determine whether
cases of illness are linked to a food source or what other exposures
they have in common,'' Braden says.
Oregon's State health department also had noted a small cluster of
cases and began interviewing patients. On September 13, 2006, Wisconsin
and Oregon health officials both notified the CDC that eating fresh
spinach was reported. Most of those interviewed reported eating
prepackaged raw spinach that came from a bag. That same day, the CDC
Director's Emergency Operations Center notified the FDA's Emergency
Operations Center (EOC) of the possible association of prepackaged raw
spinach to the illnesses. The FDA's EOC is the agency's focal point for
coordinating and managing all emergencies involving products regulated
by the FDA.
Alerting the Public
After learning from the CDC that fresh spinach was confirmed as the
source of the outbreak, the FDA immediately took action to prevent
further illness by alerting the public. On Sept. 14, 2006, the FDA and
the CDC held a conference call with the States and issued a public
alert, advising consumers not to eat bagged spinach at that time.
Neither frozen nor canned spinach was implicated in the outbreak.
Those who had become ill reported eating various brands of bagged
spinach, processed by Natural Selection Foods LLC of San Juan Bautista,
Calif. One week after Wisconsin officials notified the CDC, Natural
Selections, which bags spinach under several brand names, announced a
voluntary recall. The company recalled all spinach products with a date
code of October 1 or earlier. Five more companies issued recalls
between September 15 and September 22. ``These secondary recalls
occurred because Natural Selections had shipped spinach to other
companies that repackaged it,'' Acheson says.
The companies that issued secondary recalls were RLB Food
Distributors, L.P., of West Caldwell, N.J. River Ranch Fresh Foods LLC
of Salinas, Calif.; Kenter Canyon Farms Inc. of Sun Valley, Calif.;
Triple B Corp., doing business as S.T. Produce of Seattle; and Pacific
Coast Fruit Co. of Portland, Ore.
On September 16, the FDA expanded its warning and advised consumers
not to eat any fresh spinach or fresh spinach-containing products. ``We
expanded the advisory when we learned that bagged spinach was sometimes
sold in an un-bagged form at the retail level,'' Brackett says. The FDA
advised retailers and food service operators that they should not sell
raw spinach or blends that may contain raw spinach.
``We were also concerned about fresh spinach products that could
still be in consumers' refrigerators,'' Brackett says. ``At that point,
the priority was to prevent further illnesses. We wanted to get the
word out and get fresh spinach off the shelves while we conducted an
investigation to narrow down the source. The number of illnesses was
increasing daily, which was alarming. And the reach was nationwide. We
also knew that there were a significant number of severe illnesses and
hospitalizations.''
E. coli O157:H7 causes diarrhea, often with bloody stools. Though
most people recover in a week, some are more vulnerable, especially
very young children and older people. Of the 95 cases that had been
reported by Sept. 15 2006, almost half had been hospitalized, and 15
percent had NUS, a condition that can cause kidney damage and death.
The FDA's advice to not eat any fresh spinach remained in effect
until Sept. 22, 2006, Brackett says, when the FDA became confident that
the source of the tainted spinach was restricted to three California
counties. On that day, the FDA advised the public that fresh spinach
implicated in the outbreak was grown in Monterey, San Benito, and Santa
Clara Counties. At the same time, the FDA said that spinach grown
elsewhere was not implicated in the outbreak and could be consumed.
The Trace-Back Investigation
From the first indications that fresh spinach was the culprit in
the fall 2006 outbreak, investigators from the FDA, the CDC, and the
States worked together to trace the implicated spinach back from
consumption to the fields. The fact that illnesses were reported in
multiple States suggested that contamination likely happened early in
the distribution chain.
``Traceability to the farm is absolutely critical,'' says Jeff
Farrar, D.V.M., Ph.D., chief of the Food and Drug Branch in the
California Department of Health Services (CDHS). ``We have seen many
processors in the past who believed they had state-of-the-art
traceability systems and when outbreaks occur, they realize their
systems are not nearly as good as they thought.''
On September 14, 2006, Erica Pomeroy, an investigator in the San
Francisco District of the FDA's Office of Regulatory Affairs, was
already in the Salinas Valley with James Sigl, a senior investigator
with the CDHS. The Salinas Valley is in the central coast region of
California, about 55 miles south of San Jose and 20 miles northeast of
Monterey.
``We were there conducting an assessment of a grower when we got a
call that we needed to go to Natural Selections to start an
investigation,'' Pomeroy says. They were in the area as part of the
FDA's Lettuce Safety Initiative, which calls for assessments of growing
and harvesting practices in major growing areas of leafy greens during
September and October--months when outbreaks have occurred in the past.
It took Pomeroy and Sigl about 45 minutes to drive to Natural
Selections, where they reviewed the spinach washing and packaging
process and collected documents from the company to determine which
fields should be investigated.
Serving as team leaders for the investigation, they set up a
command center at a hotel near the Salinas Valley. They were soon
joined by other members of the California Food Emergency Response Team
(CaIFERT), a collaboration between the FDA's Pacific Region and the
CDHS. CaIFERT includes a diverse team of investigators, food
scientists, environmental scientists, microbiologists, and chemists.
``Having the right people with the right skills available on site
is critical to any successful investigation,'' says Barbara Cassens,
the FDA's San Francisco district director. ``By training the CaIFERT
staff together and offering them an opportunity to develop a working
relationship prior to an emergency, we were able to move quickly in
this outbreak response.''
Pomeroy says the command center served as a place where they could
have computer access and convene to share information, review findings,
and plan strategies. ``By focusing on fields associated with certain
production lots, we were able to narrow the search to nine different
ranches in the area,'' Pomeroy says. We interviewed harvesters and
growers about growing practices, irrigation practices, and their
workers. We collected samples in and around the suspect fields from
every possible source of contamination--water, soil, and domestic and
wild animal feces.'' Labs of the FDA, the CDHS, and the USDA were able
to process about 900 samples in a relatively short time.
And while investigators were conducting investigations on the farm
level, other experts continued to analyze data collected in spinach
questionnaires of people who had gotten ill. ``The FDA collaborated
with CDC to design a spinach questionnaire, a tool used to elicit a
detailed history of spinach consumption from people who became ill,''
says Karl Klontz, M.D., a medical officer in the CFSAN. ``We worked
with CDC to analyze data collected using information such as brand
name, date of purchase, Universal Product Code (UPC) code, and lot
numbers.''
A Break in the Case
On September 20, 2006, a big break came when New Mexico's public
health laboratory announced that it had isolated the outbreak's strain
of E. coli O157:H7 from an open package of spinach that came from the
refrigerator of a patient who had become ill. ``The package of spinach
that tested positive was Dole baby spinach best if used by August 30,''
Klontz says. This was a tremendous help in tracing back to the fields.
Later, the strain implicated in the outbreak also was isolated from
open packages of fresh spinach consumed by ill people in several other
States, including Utah, Pennsylvania, Colorado, Ohio, and Wisconsin.
In the end, the focus of the trace-back investigation narrowed to
four fields on four different ranches. On September 29, 2006, the FDA
announced that all spinach implicated in the outbreak traced back to
Natural Selection Foods.
Possible Routes of Contamination
The investigation into how the spinach may have become contaminated
included sample collection in facilities and a review of animal
management practices, processing practices, and water use. Richard
Gelting, Ph.D., an environmental engineer from the CDC's National
Center for Environmental Health, was deployed to California at the
FDA's request to join in the investigation of possible environmental
sources of contamination. He investigated irrigation well structure,
ground water movement, and water management practices in the implicated
farm regions.
On Oct. 12, 2006, the FDA and the State of California announced
test results. The field investigation, discovered the same strain of E.
coli O157:H7 involved in the illnesses in environmental samples
collected at one of four implicated ranches that supplied spinach to
Natural Selection. The samples included water from a stream and cattle
feces taken from pasture areas on the ranch outside the crop fields.
The E. coli O157:H7 isolates from these samples were matched to the
outbreak strain by their PFGE patterns. Wild pig feces collected by
investigators on the ranch were also found to contain this same strain
of E. coli O157:H7.
``One unusual finding on the ranch was a high population of wild
pigs,'' says Farrar. ``But we haven't determined conclusively that wild
pigs were the source of the contamination. Finding an exact-matching E.
coli strain on an implicated farm is a first in California, and it
directly reflects the CALFERT approach. But we still don't know how the
pathogen came into contact with the spinach.''
Fencing around the cow pastures nearby appears to keep the cows
from going into the spinach fields. But Gerald Wiscomb, an expert on
the team from the USDA's Wildlife Services, observed during his
behavioral studies that pigs go into the crop fields on the ranch.
``There are many possibilities,'' Pomeroy says. ``It could be that the
pigs rooted around the cow feces, contaminating themselves, and then
later defecated in the spinach fields.'' Another possibility is that
surface contamination from pig and cow feces in the pasture areas got
into the ground water.
More research is needed to better understand how E. coli O157:H7 is
introduced into the environment, says Farrar. ``We need a better
understanding of how the organism survives, whether it grows in certain
conditions, exactly how it comes into contact with ready-to-eat
products, and how ifs affected by current processing practices,'' he
says.
History of Outbreaks in the Salinas Valley
Produce-related outbreaks have been a continuing problem in recent
years. Since 1995, there have been 20 outbreaks involving leafy greens,
most traced to California. Many, but not all, were traced to the
Salinas Valley. But there aren't definitive answers as to why many of
these outbreaks are linked to the Salinas Valley, according to experts.
``Some have speculated that the reason other areas have not been
implicated is simply because of the difference in the volume of
production,'' Farrar says. ``The Salinas Valley produces much more
leafy greens than any other area in the country so we may be more
likely to see outbreaks from this area. Others believe there are one or
more unidentified geographic, topographic, or environmental risk
factors unique to Salinas Valley that result in systemic contamination
with E. coli O157:H7.''
In a recent multiagency investigation project, the CDHS discovered
many E. coli O157:H7 positive findings in agricultural ditch water in
many area locations. This is the runoff water originating in the hills
surrounding the Salinas Valley. Although none of these isolates have
matched any known outbreak strains, these findings have resulted in a
grant from the USDA's Agricultural Research Service to the University
of California at Davis (UC-Davis) and the CDHS to look further into
environmental sources of contamination in this area.
Industry and FDA Action
In 2004 and 2005, the FDA wrote to industry to express both the
agency's concerns with continuing outbreaks and its expectations for
industry to improve produce safety. One letter to the lettuce and
tomato industries in February 2004 encouraged industry to review
practices in light of the FDA's Good Agricultural Practices (GAPs) and
Good Manufacturing Practices (GMPs) guidance. Another letter, sent in
November 2005, reiterated this concern and focused on fresh-cut lettuce
and other leafy greens.
After the most recent spinach outbreak, the FDA and the State of
California asked the produce industry to develop a comprehensive plan
to minimize the risk of another outbreak due to E. coli in spinach
grown in California.
The Grower-Shipper Association of Central California, the Produce
Marketing Association, the United Fresh Produce Association, and the
Western Growers Association pledged their commitment and submitted a
draft plan to the FDA.
Implementation of this plan is voluntary, but the FDA and the State
of California may institute regulatory requirements if it is determined
that they are needed.
The Public Health Service Act authorizes the FDA to make and
enforce regulations to prevent the introduction, transmission, or
spread of communicable disease. And the Federal Food, Drug, and
Cosmetic Act provides a broad statutory framework for Federal
regulation to prevent adulterated foods from entering commerce, and to
ensure that human food will not be hazardous to health.
Farrar says that industry also has proposed the creation of a
statutorily based ``Marketing Order and Marketing Agreement'' on the
State level for growers and processors as a possible avenue. ``We are
familiarizing ourselves with this proposal for mandatory and uniform
standards for leafy greens industry in California that would be
administered under the California Department of Agriculture's statutory
authority,'' he says.
The FDA and the State of California have reiterated previous
concerns and advised firms to review their operations in light of the
FDA's guidance for minimizing microbial food safety hazards, as well as
other available information regarding the reduction or elimination of
pathogens on fresh produce.
Charles Sweat, chief operating officer of Natural Selection Foods,
announced that his company will require a number of measures be taken
by growers that supply their company with the fresh-cut produce that
they pack. These measures include working with growers from seed to
harvest, inspecting the seed, irrigation water, soil, plant tissues,
and wildlife. The company also indicated that sanitation protocols for
farm equipment and packaging supplies will be enhanced and monitored,
and that a ``firewall'' will be set up to test all the freshly
harvested greens before they enter the production stream.
``Clearly things have to change throughout the leafy greens
industry and the changes need to occur quickly,'' Farrar says. ``We
have relayed to industry that the solution must include specific,
measurable, enforceable on-farm food safety practices that are based on
the best science that's available now.''
According to PAP guidelines, areas that should be considered to
minimize the potential for microbial contamination of produce include:
--agricultural water used for irrigation or crop protection sprays
--wild and domestic animals
--worker health and hygiene
--the production environment, which includes the use of manure,
previous land use, and use of adjacent land
--post-harvest water used to wash or cool produce
--sanitation of facilities and equipment.
The Produce Safety Plan
The FDA instituted a Produce Safety Action Plan in 2004. The action
plan builds on previous guidance and addresses microbial food safety
hazards and good agricultural and management practices common to
growing, harvesting, washing, sorting, packing, and transporting of
most fruits and vegetables sold to consumers in an unprocessed or raw
(minimally processed) form.
The plan contains four objectives: preventing contamination of
fresh produce with pathogens; minimizing the public health impact when
contamination of fresh produce occurs; improving communications with
producers, preparers, and consumers of fresh produce; and facilitating
and supporting research relevant to fresh produce.
``A significant change is that we've gone from a broader-scope
guidance in the past to more commodity specific guidance,'' says Nega
Beru, Ph.D., director of the CFSAN's Office of Plant and Dairy Foods.
``Certain commodities account for most of the foodborne outbreaks
associated with produce.''
As part of the plan, the FDA has provided technical assistance to
help industry develop food safety guidance for five commodity groups:
cantaloupes, lettuce and leafy greens, tomatoes, green onions, and
herbs. The guidelines for cantaloupes, tomatoes, and lettuce have been
finalized and are available. With FDA assistance, industry work on
guidances for herbs and green onions is ongoing.
In March 2006, the agency released draft guidance for the fresh-cut
produce industry. The agency is working to finalize its ``Draft
Guidance to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits
and Vegetables.'' The Lettuce Safety Initiative, developed in August
2006, supports the produce safety plan and covers lettuce and other
leafy greens, including spinach.
In August 2006, the FDA met with Virginia officials to discuss
outbreaks associated with tomatoes produced on the Eastern shore of
Virginia. The FDA worked with the Florida Tomato Exchange and the
University of Florida's Institute of Food and Agricultural Sciences to
arrange a forum, held in November 2006, to discuss improving tomato
safety. Also in November 2006, the FDA announced results of an
investigation by State and CDC investigators which found that consuming
tomatoes in restaurants was the cause of illnesses of Salmonella
Typhimurium. Twenty-one States reported 186 cases of illness to the
CDC.
``Produce safety is the number one priority in CFSAN right now,''
Brackett says. ``Our role is to serve as a leader in providing
direction for industry and to apply the best science-based approaches
toward building an even safer food supply. As a result of effective
collaboration with our public health partners, the American food supply
continues to be among the safest in the world. But we also know that we
must continue to work on reducing the incidence of foodborne illness to
the lowest level possible.''
e. coli outbreaks at taco bell and at taco john's
On December 14, 2006, the Centers for Disease Control and
Prevention (CDC) announced that the Escherichia coli (E. coli) O157:H7
outbreak linked to Taco Bell Restaurants in northeastern States
appeared to be over. Based on a number of factors, shredded iceberg
lettuce is considered overall to be the single most likely source of
the outbreak at this time. The FDA announced that it continues to
narrow its investigation by focusing efforts on finding the sources of
shredded iceberg lettuce served at the restaurants.
The peak of the outbreak occurred from the last week of November
until the beginning of December. A total of 71 cases in five States
were reported to the CDC Delaware (two cases), New Jersey (33 cases),
New York (22 cases), Pennsylvania (13 cases), and South Carolina (one
case--this person ate at a Taco Bell in Pennsylvania). Fifty-three
hospitalizations and eight cases of hemolytic uremic syndrome (HUS)
have been reported. HUS can cause permanent kidney damage and death.
FDA investigators reviewed Taco Bell's records in order to trace
the distribution channels of the iceberg lettuce and identify the farm
or farms where the lettuce was grown, as well as all the firms and
facilities that handled the product. This outbreak has been traced to
California's Central Valley.
In January 2007, the agency also announced that it had moved closer
to identifying the source of illness for an outbreak of E. coli O157:H7
at Taco John's Restaurants in Iowa and Minnesota. The FDA and the State
of California, working with State health officials in Minnesota, Iowa,
and Wisconsin, have DNA-matched the strain of E. coli O157:H7 bacteria
associated with the outbreak with two environmental samples gathered
from dairy farms near a lettuce-growing area in California's Central
Valley. The outbreak sickened 81 people in November and December 2006.
Illnesses were reported in Minnesota (33), Iowa (47), and Wisconsin
(one). Twenty-six people were hospitalized, and two suffered from HUS.
No deaths have been associated with the outbreak.
produce safety tips
In light of recent contaminated produce outbreaks, the FDA is
emphasizing advice to consumers on how to reduce the risk of foodborne
illnesses from fresh produce.
Buying
Purchase produce that is not bruised or damaged.
When selecting fresh-cut produce--such as half a watermelon or
bagged mixed salad greens--choose only those items that have been
refrigerated or surrounded by ice.
Bag fresh fruits and vegetables separately from meat, poultry, and
seafood products when packing them to take home from the market.
Storage
Strawberries, lettuce, herbs, mushrooms, and other perishable
fruits and vegetables can best be maintained by storing in a clean
refrigerator at a temperature of 40 degrees F or below. If you're not
sure whether an item should be refrigerated to maintain quality, ask
your grocer.
All produce that is purchased pre-cut or peeled should be
refrigerated within two hours to maintain both quality and safety.
Keep refrigerators set at 40 degrees F or below. Use a refrigerator
thermometer to check!
Preparation
Many pre-cut, bagged produce items like lettuce are pre-washed. If
so, it will be stated on the packaging. This pre-washed, bagged produce
can be used without further washing.
As an extra measure of caution, you can wash the produce again just
before you use it. Pre-cut or pre washed produce in open bags should be
washed before using.
Begin with clean hands. Wash your hands for 20 seconds with warm
water and soap before and after preparing fresh produce.
Cut away any damaged or bruised areas on fresh fruits and
vegetables before preparing or eating. Produce that looks rotten should
be discarded.
All unpacked fruits and vegetables, as well as those packaged and
not marked pre-washed, should be thoroughly washed before eating. This
suggestion includes produce grown conventionally or organically at
home, or produce that is purchased from a grocery store or farmer's
market. Wash fruits and vegetables under running water just before
eating, cutting, or cooking.
Even if you plan to peel the produce before eating, it is still
important to wash it first.
Washing fruits and vegetables with soap or detergent or using
commercial produce washes is not recommended.
Scrub firm produce, such as melons and cucumbers, with a clean
produce brush.
Drying produce with a clean cloth towel or paper towel may further
reduce bacteria that may be present.
Separation
Keep fruits and vegetables that will be eaten raw separate from
other foods, such as raw meat, poultry, or seafood, and from kitchen
utensils used for those products.
Wash cutting boards, dishes, utensils, and countertops with hot
water and soap between the preparation of raw meat, poultry, and
seafood products and the preparation of produce that will not be
cooked.
For added protection, kitchen sanitizers can be used on cutting
boards and countertops periodically. Try a solution of one teaspoon of
chlorine bleach to one quart of water.
If you use plastic or other nonporous cutting boards, run them
through the dishwasher after use.
For More Information
Safe Handling of Raw Produce and Fresh-Squeezed Fruit and Vegetable
Juices
FDA Issues Final Guidance For Safe Production of Fresh-Cut Fruits
And Vegetables (Press Release, March 12, 2007)
The FDA page on E. coli Outbreaks
The CDC page on E.coli Outbreaks vvww.fightbac.org
--www.foodsafety.gov
______
FDA Fact--Fresh-cut Fruits and Vegetables Draft Final Guidance
The Food and Drug Administration announces the availability of the
draft final fresh-cut guidance, entitled ``Guide to Minimize Microbial
Food Safety Hazards of Fresh-cut Fruits and Vegetables'' (the Guide).
The purpose of the Guide is to minimize the potential for microbial
contamination during the processing of fresh-cut produce by providing
recommendations to fresh-cut processors.
Fresh-cut produce is produce that is minimally processed (no lethal
kill step) and altered in form by peeling, slicing, chopping,
shredding, coring or trimming with or without washing or other
treatment prior to being packaged for use by the consumer or a retail
establishment. Examples of fresh-cut products are shredded lettuce,
sliced tomatoes, salad mixes (raw vegetable salads), peeled baby
carrots, broccoli florets, cut melons and sectioned grapefruit.
The fresh-cut produce sector is the fastest growing sector of the
produce industry. As the fresh-cut sector grows, a larger volume and
greater variety of fresh-cut products have become available. From 1996
to 2006, 26 percent of all outbreaks associated with fresh produce
implicated fresh-cut produce.
If pathogens are present, the processing of fresh-cut produce by
peeling, slicing, shredding, coring, or trimming may increase the risk
of bacterial contamination and growth by breaking the natural exterior
barrier of the produce thereby supplying nutrients for pathogens to
grow. In addition, the high degree of handling common in fresh-cut
operations may increase the risk of cross-contamination if adequate
controls (e.g., adequate levels of free chlorine in a dump tank) are
not in place.
The Guide is a continuation of existing programs such as the good
agricultural practices (GAPs) program and covers the processing of
fresh produce into fresh-cut produce, the next link in the supply
chain. In FDA's 2004 Produce Safety Action (PSAP), the issuance of the
Guide was identified as an action that could help achieve the PSAP's
first objective, to prevent contamination from occurring.
The Guide complements FDA's Current Good Manufacturing Practice
regulations for food (21 CFR 110) and provides a framework for
identifying and implementing appropriate measures to minimize the risk
of microbial contamination during the processing of fresh-cut produce.
Specifically, it discusses the production and harvesting of fresh
produce and provides recommendations for fresh-cut processing in the
following areas: (1) personnel health and hygiene, (2) training, (3)
building and equipment, (4) sanitation operations, and (5) fresh-cut
produce production and processing controls from product specification
to packaging, storage and transport. The Guide also provides
recommendations on recordkeeping and on recalls and tracebacks.
In the Guide, FDA recommends that processors encourage the adoption
of safe practices by their partners throughout the supply chain,
including produce growers, packers, distributors, transporters,
importers, exporters, retailers, food service operators, and consumers.
The Guide also recommends that fresh-cut processors consider a
preventive control program such as the Hazard Analysis and Critical
Control Points (HACCP) system to build safety into their processing
operations. HACCP is a system designed to prevent, eliminate, or reduce
to acceptable levels the microbial, chemical, and physical hazards
associated with food production.
FDA will hold two public hearings concerning the safety of fresh
produce including fresh-cut produce on March 20, 2007, in Oakland, CA
and April 13, 2007, in College Park, MD (Wiley Building).
______
FDA News--FDA Issues Final Guidance for Sale Production of Fresh-cut
Fruits and vegetables
The Food and Drug Administration (FDA) today published a draft
final guidance advising processors of fresh-cut produce how to minimize
microbial food safety hazards common to the processing of most fresh-
cut fruits and vegetables, which are often sold to consumers in a
readyto-eat form.
The document--``Guide to Minimize Microbial Food Safety Hazards of
Fresh-cut Fruits and Vegetables''--suggests that fresh-cut processors
consider a state-of-the-art food safety program such as the Hazard
Analysis and Critical Control Points (HACCP) system, which is designed
to prevent, eliminate, or reduce to acceptable levels the microbial,
chemical, and physical hazards associated with food production.
The guidance complements FDA's regulations of manufacturing
practices and incorporates comments received in response to its draft
issued in March 2006. The current version will not be final until the
White House Office of Management and Budget completes an authorization
step required by the Paperwork Reduction Act, and the agency announces
that the guidance is final.
``Ensuring the safety of the American food supply is one of this
Agency's top priorities,'' said Andrew C. von Eschenbach, MD,
Commissioner of Food and Drugs. `` Americans are eating more fresh-cut
produce, which we encourage as part of a healthy diet. But fresh cut-
produce is one area in which we see food borne illness occur. Offering
clearer guidance to industry should aid in the reduction of health
hazards that may be introduced or increased during the fresh-cut
produce production process.''
Dr. von Eschenbach will testify before a hearing by the
Agriculture, Rural Development, and Related Agencies Subcommittee of
the Senate Committee on Appropriations, which will address the
processes in place and improvements being made regarding food safety,
specifically the safety of fresh produce and vegetables. The hearing
will take place in Madison, Wisconsin, on March 12, 2007.
Processing produce into fresh-cut product increases the risk of
bacterial contamination and growth by breaking the natural exterior
barrier of the produce by peeling, slicing, coring, or trimming the
produce with or without washing or other treatment before the produce
is packaged for consumers. Examples of fresh-cut products are shredded
lettuce, sliced tomatoes, salad mixes (raw vegetable salads), peeled
baby carrots, broccoli florets, cauliflower florets, cut celery stalks,
shredded cabbage, cut melons, sliced pineapple, and sectioned
grapefruit.
Consumers can reduce their risk of illness from fresh-cut produce
by following safe handling practices such as refrigerating the product
after purchase; using only clean hands, utensils or dishes in preparing
the product; and discarding the product when the ``use by'' date has
expired.
The Guide complements FDA's Current Good Manufacturing Practice
regulations for food (21 CFR 110) and provides a framework for
identifying and implementing appropriate measures to minimize the risk
of microbial contamination during the processing of fresh-cut produce.
Specifically, it discusses the production and harvesting of fresh
produce and provides recommendations for fresh-cut processing in the
following areas: (1) personnel health and hygiene, (2) training, (3)
building and equipment, (4) sanitation operations, and (5) fresh-cut
produce production and processing controls from product specification
to packaging, storage and transport. The Guide also provides
recommendations on recordkeeping and on recalls and tracebacks.
The Guide also recommends that processors encourage the adoption of
safe practices by their partners throughout the supply chain, including
produce growers, packers, distributors, transporters, importers,
exporters, retailers, food service operators, and consumers. These
practices include:
--Establishing a company policy that employees report any active case
of illness to supervisors before beginning work and training;
--Training supervisors to recognize typical signs/symptoms of
infectious disease; maintain the proper first aid to protect
and cover any wound; and not allow an employee to work with any
aspect of fresh or fresh-cut produce, processing equipment or
tools until the wound has healed and/or the infectious disease
has been treated.
FDA believes awareness of the common risk factors discussed in this
guidance and implementation of preventive controls determined by a firm
to be appropriate to its individual operations will enhance the safety
of fresh-cut fruits and vegetables. More information on safe handling
practices of produce can be found at http://www.fightbac.org/.
Written comments on the Guide are acceptable at any time and should
be sent to FDA's Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Comments on the Guide-specific to issues involving the Paperwork
Reduction Act should be faxed within 30 days of the publishing date of
the Federal Register notice to the Office of Information and Regulatory
Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.
The Guide is accessible on the FDA Website at: http://
www.cfsan.fda.gov/guidance.html
Additional Information about the Guidance
Fact Sheet: ``Fresh-Cut Fruits and Vegetables Draft Final
Guidance''
Federal Register Notice (March 13, 2007) [PDF, 67KB]
Dr. von Eschenbach's Statement before the Agriculture, Rural
Development, and Related Agencies Subcommittee of the Senate Committee
on Appropriations
Relevant Food Safety Information: ``How the FDA Works to Keep
Produce Safe''
www.foodsafety.gov
Alert: Food Defense Awareness Program
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Senator Kohl. Dr. Brackett.
STATEMENT OF ROBERT BRACKETT, DIRECTOR, FOOD AND DRUG
ADMINISTRATION, CENTER FOR FOOD SAFETY AND
APPLIED NUTRITION
Dr. Brackett. Thank you, Senator Kohl and thank you, Dr.
von Eschenbach. I am pleased this morning to announce that as
we speak, a new important tool in produce safety is being
announced at this time and posted and that is something that
Mr. Stenzel alluded to during his testimony, which is a
guidance to minimize microbial safety of fresh fruits and
vegetables. This is a document that was first published in
draft in March 2006 and specifically addresses the cut-fresh
growth produce industry and focusing on, as was mentioned by
some of the panelists, a complement to the more general Good
Agricultural Practices that we've published that really focuses
and provides much more focused guidance on that particular
industry.
It addresses such things as personal health and hygiene,
which is important, as Ms. DeWaal mentioned, the building and
equipment and the best practices that can be used there,
sanitary operations and what controls could be used in the
fresh produce industry, fresh-cut produce industry and perhaps
some recommendations for records, which the industry might use.
Many of the recommendations are based on similar principles of
what we call HACCP in other industries so we're encouraged that
this is going to be something that the industry can use in a
great way.
Also, I want to re-emphasize that we are anxious to have
consumers regain confidence to complete their diets with more
fresh fruits and vegetables and we're hoping that this is one
way that we can again, encourage consumers to be more healthful
in their diets.
Senator Kohl. Thank you very much. Consistent with what I
said just a few minutes ago, what I'd like to do at this time
is to give the first panel an opportunity to make a suggestion,
comments, get some answers directly from the source. Who would
like to stand up first and get shot down?
Senator Kohl. Mr. Stenzel, go ahead.
HACCP APPROACH
Mr. Stenzel. Thank you, Senator. This is quite an
opportunity. I commend you and I appreciate your participation
in this as well. Dr. Brackett, could you give us a sense of--
we're looking at a number of regulatory options in the produce
industry and you have so much experience beyond produce as
well--the seafood HACCP approach and how that has worked in the
seafood industry and then also, a second issue, closer to
produce, the Sprout Guidance document that FDA published a
number of years back, both of which we believe have been very
effective in addressing risks in the food supply. So your
perspective on those and applicability in produce?
Dr. Brackett. Well, thank you. I think what you've listed
are two different models that we've used in food safety, both
of which are actually considering with respect to produce. The
first was seafood HACCP has specific points during the
production of seafood at which the manufacturers are required
to take interventions to make sure that the product is not
contaminated or not made less safe, a good example of which
would be is proper refrigeration as they catch them on the boat
so that when it gets to the dock, there hasn't been any
microbial contamination. That is in the form of a regulation
and that's something that we have used. It has worked in other
industries, including meats and poultry, quite well.
Now, the second one had to do with sprouts. Sprouts was an
example of something where we had unacceptable numbers, a lot
of illnesses associated with particularly alfalfa sprouts and
when our researchers went and looked to find out where this was
occurring, we found the specific points in sprout production
and that allowed us to write some guidance that would tell the
manufacturer, if you do these certain things, specifically
testing at certain points, you can really reduce the risk that
you have. We have had good adoption of those guidelines and in
fact, the sprout illnesses have dropped to the point where they
were none reported in the last few years after points where
there were hundreds before that.
So both of those mechanisms can work but I think the
important part is to have a good understanding of the science
underlying the advice so that you can actually tailor it.
IMPORTED FRUITS AND VEGETABLES
Senator Kohl. Ms. DeWaal.
Ms. DeWaal. Thank you. One of the challenges in this issue
is that so much of our produce is imported from other countries
and one of our great concerns is that the use of guidance may
be somewhat effective for our domestic industry and have
absolutely no impact on the people growing in foreign
countries. In fact, we've had a large number of outbreaks from
imported produce, both fruits and vegetables. How will your
latest guidance help in preventing outbreaks associated with
imported fruits and vegetables?
Dr. von Eschenbach. I'm going to ask Dr. Brackett to speak
specifically to the science but I do want to comment on the
more global issue of our relationship outside of our borders.
Our Office of International Foods is very actively engaged in
multi-lateral discussions. I personally have committed to
continue to enhance that so that we work to disseminate these
good agricultural practices into those areas and into those
regions so that we're able to enhance the ability of them to be
creating and bringing into this country, quality products. We
have, as part of an integration with the Food Defense Program,
the ability for prior notice so that as imports are coming into
this country, they are already recognized and know the source
from which they're coming so we can identify those sources
according to areas of risk and therefore, direct our inspection
efforts to those areas in which we do have concerns that have
the quality of production, whereas those other areas in which
we have very close collaborative interactions and working
relationships that are assured of quality at the site of
production, we could then mitigate those kinds of efforts in
terms of our import strategies. So we are protecting the
border, we're working outside of our borders to enhance their
practices and then using the kinds of guidance that are being
developed here as a foundation for that kind of sharing of
vital information.
Dr. Brackett. One of the first things in the foundational
sort of ways that we deal with this, because we have different
regs for importing products versus our domestics. We have some
different tools, is to really engage both the industry and the
governments at the other half of the exporting countries and
telling them what our expectations are, which is we expect the
products that they send us are as absolutely safe as what we
get in this country or we will take assertive action and I'll
get to that in a moment.
But part of one of the requests we get is, they will say,
well, this is fine. What would you like us to do? And that's
where documents such as the guidance documents or some of the
other good agricultural practices is very important, because we
will go to them and tell the governments, this is what our
expectations are. We also, of course, have an educational role
and this we do through partners like the Joint Institute for
Food Safety and Nutrition at the University of Maryland, which
actually has a program that goes out to producing countries to
educate their governments, local governments as well as their
industry, in application of good agricultural practices and now
with the fresh-cut guidance.
Having said that too, we've worked directly with the
governments and I see us doing more of this in the future, in
such programs as we have with Mexico. We have an MOU with
Mexico under the Federal Recognition Program, that basically
tells them how we expect cantaloupe to be produced because
we've had salmonella outbreaks with cantaloupe and in those
cases where a particular farm or a particular company is not
meeting our expectations, we need to go down there and audit
these. They are removed from our list of companies that can
import into this country and so that's been important.
In the past, many of the outbreaks that you alluded to,
such as raspberries from Guatemala, we work very closely with
the country and with the industry but we never were able to get
rid of that parasite, which was a spore and in fact, so through
our import alerts, we basically stopped shipment in this
country and that's one of the most powerful tools we have with
those countries, is if they are not living up to our
expectations, they simply can't ship to us.
GUIDANCE IMPLEMENTATION
Senator Kohl. Dr. Verduin.
Dr. Verduin. I have a two-part question. Number one is, you
have this new guidance, which I congratulate you on, but, do
you see a regulatory framework that helps make sure that
guidance gets implemented throughout the industry? That's
number one and then number two, is what do you see the role of
industry and I think Ms. DeWaal--she commented on that--hard
data. Do you see that helping FDA at all and is there a way
that you think if the auditing practices and the testing that
the customers of fresh produce require get implemented, and get
incorporated into the data that you--will use that data to
regulate the industry, the growers?
Dr. Brackett. I'll answer the second part first. I think
that any kind of data that we get from the industry is
absolutely helpful to us. It helps us make real life sort of
decisions, practical decisions on where the outbreaks are
actually occurring and why they are occurring. Many of the data
that CSPI has provided for us has helped us sort of target
where the outbreaks are happening and as was mentioned, in
upcoming sources of infection are the viral, particularly with
norovirus and in many cases, that is a people-person problem
where someone is actually touching the product, either in the
field or in many cases, in the point of preparation, such as
restaurants. It's important for us not to forget that that part
happens. It does happen. It can be a farm to table approach and
so we have to focus resources appropriately on that.
With respect to how we're going to implement the guidance,
I think that's--one of the things we're going to do is look at
the industry and we hope that will work with trade associations
to make sure that these are implemented. But we'll go look
again, as we did with our Leafy Greens Initiative last summer
in the Salinas Valley to actually assess if they are being
implemented.
One of the other things that we'll be doing is having
several public meetings, one of which is going to be on March
20 in Oakland, California. Another one, is April 15 in
Washington, to get the best knowledge that we can both from the
industry as well as the scientific community, as to what the
best regulatory approach is, given this industry, as diverse as
it is and as important as it is to public health.
Dr. von Eschenbach. If I could just add to that somewhat, I
think the chairman has pointed out very well, the importance of
collaboration and cooperation and clearly, we've heard this
morning, not just the concern that the industry has on the
impact on public health but it's also true to point out that
there are great motivations on the part of the industry from
both a legal perspective, an economic perspective, in addition
to the commitment to public health.
I view that the opportunities to go from the continuum of
statute to regulation to guidance is that there are really
tremendous opportunities given that spirit of cooperation and
collaboration, to really enhance the guidance mechanism and
guidance opportunity. It allows us to continue to adapt to the
rapidly changing environment, new science, new insight to what
our best practices are. I think, in your testimony, you pointed
out many times, we need to learn and understand and the
guidance gives us the flexibility to continue that rapid
learning process and changing process, which doesn't
necessarily encourage statute or from a regulatory point of
view.
As Dr. Brackett has pointed out, if it is not working, then
we need to move to a more stringent type, a much longer and
laborious type of process like regulation or statute. But I
think guidance has really given us an opportunity for
flexibility and the ability to integrate, coordinate and adapt
knowledge of your understanding and when you refine it, it's
really going to be an efficient plan.
Ms. DeWaal. Thank you.
GRANT PROGRAM FOR RESEARCH
Senator Kohl. Dr. Pariza.
Dr. Pariza. Thank you. One of the most successful and
really economically successful as well programs that we've had
in this country in the way of the research has been through the
National Institutes of Health, where investigators put in
research proposals in areas that they think are important. They
are peer-reviewed and then scored and ultimately, you find out
who is funded and not funded based on that scoring. FDA used to
participate in this 25 or 30 years ago. FDA was a participant
that had funding, which was allocated for this and so if you
submitted a proposal to NIH in some area that related to FDA's
program, and it was approved, the FDA would fund it. What I'm
wondering is if you were able to provide FDA with some
sufficient new funding, would they be interested in maybe
reinitiating this program?
Dr. Brackett. Well, that's an interesting question and I'll
let Dr. von Eschenbach too, answer this as well but since he
has much more experience in NIH than I do but one of the
important questions of mine with funding would be research, and
we certainly have had a program like that, is in this
particular case, we think that we need some very focused, very
applied research and that's something that some organizations
are better at than others. And I think one of things we want to
make sure is that whatever research document, whoever funds it,
that it is targeted so that it really answers somebody's
critical questions, whatever the method.
Dr. von Eschenbach. I feel, having spent 4 years as
Director of the National Cancer Institute and having had the
perspective of NIH, I believe it is extremely important for
there to be a very solid core of research within the Food and
Drug Administration, independent of the research that occurs at
the National Institutes of Health and in academia. But I don't
believe that the FDA should stand apart. We need to create much
more collaboration and interactions with those other sources of
research that are very, perhaps basic and developmental as
FDA's core research effort is much more applied.
This is going to be particularly important as we go forward
with regard to CFSAN, as we look not just at food safety and
food defense, but even more important, at the issue of
nutrition and the important role that fruit must play in
promoting our health. So I see the importance of the
integration but I don't believe that the FDA needs to duplicate
the research structure that currently exists at NIH with regard
to investigator initiated, hypothesis-driven research. I think
we can complement that and we must have a very strong research
base with a continuum that moves much more to the applied.
MANDATORY REGULATIONS
Senator Kohl. Several members of our first panel talked
about the need for FDA to publish mandatory regulations for
produce instead of what we have now, voluntary guidance. You
could do this with no money, and setting a minimum safety
standard seems to be a simple and a good idea. I know the FDA
has resisted that effort thus far. Could you comment on that?
Dr. von Eschenbach. Mr. Chairman, as I indicated in my
follow-on question, I believe the sense, as we look at our
options, it isn't a matter of resisting regulation as much as
it is trying to fully utilize the opportunities that guidance
has provided to us in terms of flexibility, in terms of the
abilities which we could rapidly, more rapidly implement them
instead of the regulatory process itself. So I believe, as Dr.
Brackett has pointed out, for example, even in the sprouts
experience, how effective those guidances can be in eradicating
and eliminating threats to our food supply. So I would, at this
point, use the opportunity to fully utilize the guidance
mechanism and the guidance process as opposed to regulation.
We'd certainly accept regulatory processes--an issue of
focusing on guidance.
Senator Kohl. Well, we have mandatory regulations in the
meat industry and the poultry industry in respect to safety and
inspection and we understand our produce is not exactly the
same by any means. But the public has come to accept and expect
that the meat and the poultry, mandatory safety processes will
occur.
So maybe, Dr. Brackett, why is produce so different that
you might suggest that we cannot even begin to approach it in
this way? Several members of the panel believe that we should
at least make that attempt and that some of the things that we
can do with respect to requiring certain sanitation procedures
on the farm to occur should be universal and should be subject
to mandatory kinds of rules and regulations. What is your
thought and your comment?
Dr. Brackett. Well, I think that in order for any kind of
regulation to be successful, it has got to answer the question
or solve the problem that it is intended to ask. I think a big
difference between meat and poultry and where produce is, is
simply the state of scientific knowledge at this time. One of
the things that people immediately want us to do is to
implement actions on the farm level or anywhere else, just
because they think they might have something mandatory. But we
want to make sure that whatever we tell the industry actually
works so that this doesn't cause any undue economic burden on
them, to make sure that if it doesn't solve the problems, so
that the illnesses continue, which is one of the things we are
concerned about. We are in a stage now, in a phase where I
think the scientific knowledge is going to increase
dramatically in the next few years and we hope to apply that to
any kind of regulatory strategy but especially regulations that
are much more difficult to change down the line.
RAPID RESPONSE TEAMS
Senator Kohl. I have to ask about a rapid response team
approach. I know you're trying to focus and target resources
and we all agree that trying to blanket the country with 5,000
additional inspectors just is not feasible. But I believe and
others have suggested that one way to improve where we are
right now is to create five or six rapid response, FDA Rapid
Response Teams and put them around the country in strategic
locations. The purpose would be to respond to an outbreak at
the very inception so that it does not spread. And when they
are not doing that, they could do things like sample, inspect,
and do other work however you direct them. Each of these teams
might have five or six or seven people, depending on your
wisdom and judgment as applied members. This would be a more
economical way and I think that the right people out in the
field can contain outbreaks when they do occur. Do you have
some response to that thought, which I know you've heard before
and we've discussed it. Dr. von Eschenbach.
Dr. von Eschenbach. Well, Mr. Chairman, as a matter of
fact, I'm greatly appreciative for the kind of guidance that
you've given us with regard to the importance of a rapid
response team and in fact, we're looking at that issue and your
suggestion. One of the things that Dr. Brackett can comment on
is the lessons learned in the spinach outbreak and in fact, by
virtue of having close collaboration between our Office of
Regulatory Affairs, CFSAN and the States, particularly in this
case, the State of California, because they had initiated this
concept of a rapid response team around the issue of addressing
problems with regard to lettuce, that enabled us to really
effectively be able to intervene in the spinach outbreak and
one of the lessons learned is the importance of having these
rapid response teams ready to be deployed and on the ground. So
expansion of that program and creating more rapid response
teams is certainly now an important part of our strategic
agenda going forward. I think it is an important lesson learned
and your direction in that regard has been very well taken. Do
you want to comment?
Senator Kohl. Dr. Brackett.
Dr. Brackett. The team that Dr. von Eschenbach was
referring to was called CALFERT and this is a team that we put
together with the State of California, both agriculture and
their public health officials, and the term CALFERT is another
acronym meaning California Food Emergency Response Team. They
were meant to work as a team. They were trained together on
farm investigations, on food breakout breaks, as a group. So
that whenever an outbreak occurred, they were able to quickly
go into action and go investigate and so that team sort of has
the--been the model for how things should be done. An important
component of that, again, is to have the flexibility to be out
there and to respond quickly, which is the point that you made.
But the other part was, what do they do when there is not an
outbreak? And they were the same group, for instance, when we
had our Leafy Greens Initiative, to go out to the farms in
California in August to make sure that the good agricultural
practices were being enforced or adopted and to look at the
level of education that was needed among the farmers. This was
the group that was actually doing that.
When the spinach outbreak occurred, they were in the field
doing that, so they were the ones that were immediately able to
respond to that. That's probably one of the reasons why we were
able to identify this outbreak to the level that it was,
something we had never been able to do before. So it's a very
good model.
RESEARCH
Senator Kohl. Dr. Brackett, are there other promising areas
of research that are going on right now within your area of
responsibility?
Dr. Brackett. There are many different types of research
that are going on, not only within our own agency but within
USDA and the private sector.
This includes, as Dr. Pariza mentioned, better detection
methods. One of the things that help in a response is if you
are able to identify the organism and trace it back in a much
faster way. That helps the public health as well. Being able to
look at some of the new technologies such as irradiation, such
as high pressure, many other food technologies. People haven't
even thought about how that could be applied to products where
consumers want them fresh, a more fresh-like taste in
something, not unlike salads. That's another area of interest
that we have.
But another part that people sometimes forget about is the
research that is on consumer behavior and why people make the
choices they do, what they are hearing to make sure that when
we have a message, which was a very important lesson learned in
the spinach outbreak, to make sure that we communicate clearly
and often with the consumer so that they can know what the true
risk is and what it isn't. We want to make sure that when the
consumers come out of one of these outbreaks, they are
confident again, and that takes some consumer behavior
research. So that's one that is often forgotten about.
Senator Kohl. Let me just talk about imported produce. Of
the produce we're eating now, 20 to 30 percent of the total is
imported and the importation inspection system is--I won't say
it's non-existent, but it really is small. It's really amazing,
if you think about it, why we don't have more outbreaks when so
much of what comes in from foreign countries is not inspected
and it winds up in our stores and it winds up in our stomachs
without any real inspection taking place. What can we look
forward to? What might be the state of the art in that whole
system 5 years from now, 10 years from now? Is there any hope
that we can bring to the American people in some reasonable
period of time, some kind of an inspection system on imported
produce that will give them some sense of safety? Dr. von
Eschenbach.
Dr. von Eschenbach. At least at the outset, the short term,
Mr. Chairman. What we are approaching this from is the
perspective of risk management and risk mitigation. I already
alluded to the ability to have prior notice, for example, and
then to be looking at how we are building quality in before
that product ever even comes to our shores. Tools that we will
enable to do that are more sophisticated information
technologies that would enable us to manage that data, manage
that information, would be an important part of the
developmental process and an important part of our effort.
Detection methodologies that we could use, that we would be
able to deploy in the field, so to speak or at the point of
inspection would be opportunities for enhanced safety and those
are very important research questions. Someone, I think it was
Dr. Pariza, alluded to, for example, what role nano-technology
has, what role some molecular technologies might play in being
able to sample and test at the point of contact, especially
when you're dealing with perishable items that need to move
very rapidly. So I can see a continuum with regard to further
research that are on very disparate ends of the spectrum, from
very fundamental, basic, to really technologies that we have to
manage risk. I don't know if Bob has a specific plan in terms
of what he sees as research opportunities and importance but I
see it as just a part of the continuum.
Dr. Brackett. Yes, I think whatever the research results
that we, or the rules that we get, we would absolutely want to
export to our trading partners to make sure that they are using
the same things. And I think it is important to realize that we
are in a growing global economy where we are going to be
trading back and forth and we want to make sure that,
especially in the area of fresh produce, that the expectations
and the standards that are being used are international, not
just our own. So one of the things we've done in terms of
trying to promote this is introduced produce safety as one of
the items that will be addressed in the Codex Elementarious
discussions on international food standards of fresh produce. I
think just for us to have standards and not have the
expectation that every other country will have those same high
standards, I think would be self-defeating for us.
So that's one important area that is a little more long-
term but the other part again, is to continue our
collaborations with groups such as CFSAN and make sure that
they are out and doing the education that is needed with the
trading partners, to make sure that we support whenever there
is an action taken by the FDA for a product that is coming to
this country, that we get back with that country and know why
their product is being held at the border so that they can
correct the action. They want to correct it and we want to have
safe food.
Then the adoption of technologies at the border so as Dr.
von Eschenbach mentioned, we could really address the highest
risk products as quick as we can and not wait until they get
into the consumers' mouths before we find out there was a
problem.
Senator Kohl. Does the panel have any other follow-up
thoughts or questions you want to ask? Ms. DeWaal.
Ms. DeWaal. I always have more questions.
The thing that concerns me a bit is the issue again, going
o back to imports, which I think you covered very, very well.
But we still have no mechanism to enforce those standards on
importers, to the extent that they are using simply guidance as
your approach suggests. There is no mandatory requirement for
our domestic industry, who is now calling for one, and there is
simply no way to enforce those standards for importers. So I
guess, Dr. von Eschenbach, I'm wondering if you would consider
the issue of how you will enforce, not after the outbreak
happens but before the outbreak happens, the standards that you
are proposing. Because under USDA, they approve the country
before they import, they approve individual meat plants before
they import, and they inspect 20 percent of imported meat and
poultry products. Do you need a system like that? And without
such a system, how can you enforce guidance documents that
aren't even mandatory for our own country?
Dr. Brackett. Sure. I think the biggest tool we have as far
as our experience at the border, is to be able to stop products
if we know that there has been a problem in the past. Now, that
pre-supposes that we have identified a problem in the past, but
again, one of the challenges that we have with any kind of
requirements is being able to make sure that what we tell them
to do is, in fact, making a difference in that country. One of
the areas of research that is critical to understand in this
is, for instance, the survival and growth of E. coli O157, the
same in the soils in Salinas Valley as it is in Montello,
Wisconsin as it is in Oaxaca, Mexico. And without that
understanding, what we have as standards in this country may
not at all apply in that country. We have to make sure that
we're much more focused.
Dr. von Eschenbach. I think the point that Dr. Brackett is
making and why I wanted him to make it is to make it clear that
it isn't as if the borders are totally letting just about
anything comes in. We do have standards, we do have prior
notice, we do have the ability to interdict and stop something
from coming into the United States when we have concerns.
The issue, I believe, this again goes back to the point
that the chairman made, is that this is a problem that I
believe we will solve best by our ability to work
collaboratively and cooperatively from the level of the farm
all the way through to the point that the product gets on
someone's table. In a variety of places along the way, we have
opportunities to continue to enhance that process and that
system, clearly building quality in at the very beginning, is
the way to ensure everything downstream being approved and the
guidances that we're creating and the relationships that we're
creating, both within this country with producers as well as
what we're creating outside of this country, I think, will lead
us to that kind of an outcome, as the science and as we're
evolving and developing the knowledge that we need, not to just
do the right thing but due to the right plans. So I don't see
it at this point as being our failure is simply we don't have
the power to do something like that. I think the focus is much
more on creating the systems and the opportunities to do more,
not just simply creating a regulation. I don't see that as the
solution to the problem by itself.
Dr. Brackett. A couple things that I neglected to say are
when we look at products at the border, it's not the produce
standards that we're looking at. In many cases, we apply
appearance standards where if the product looks like it's been
mishandled, we can lock it at that point without even having to
do microbiological testing. But microbiological testing is
going to be important and in fact, we have changed the way that
we've done testing, which actually led to some of the recalls
that you mentioned in cantaloupe--not because anyone had gotten
ill but because our ability to detect it at a much, much lower
level was much better and it had gotten to that point and in
fact, some of the new techniques that we use--we're actually
bringing investigators in from the industry from Mexico into
the United States to teach them actually how we're doing it so
they can get it before it even is sent out.
Senator Kohl. I'd like to ask you, gentlemen, how important
is it to get back to the former level of inspectors and to
increase the number of inspections? Dr. Brackett, would you
like to respond to that?
Dr. Brackett. Sure. I think what--one of the difficulties
in answering that directly because the food system is changing
and the way we do business and the technology is changing.
Rather than just getting back to a certain number, what we
really have to do is back to the point where each individual
investigator is actually having a bigger impact than they might
have had in the past. So we need to be flexible enough and
nimble enough in this agency to be able to respond to changing
technology and societal changes in products they eat so that we
can apply those inspections at the right point and it makes a
difference.
Dr. von Eschenbach. One of the other strategies, Mr.
Chairman, that we want to pursue is to amplify the impact of
respecting field force, for example, much more collaboration
and interaction with the States and enhancing the number of
inspections that are done by State officials so that we're
creating, if you will and multiply that, that will enhance our
ability to continually expand this network of protection and
interdiction. So we've talked about not just the number of
investigators but we've talked about the kind of investigators,
the different skill sets that now we need to develop within
that field force, the creation of teams of inspectors and these
rapid response teams, for example, is one dimension of that, to
multiply their impact by giving them more modern tools of
science and technology with which to work and by having them
work collaboratively and cooperatively with others who are
engaged in the same effort, including industry. All which
results in a rapidly enhanced inspection process within this
country, not just simply a matter of counting the number of
inspectors or the number of inspections and then also having
that entire platform be based on a risk management strategy,
whether it is a HACCP model or a modifications of a HACCP model
but for us to begin to understand where to focus those
inspections, both by product because certain products carry
with them inherent risks that don't exist in another product
and today, of course, we recognize the inherent risks of fresh-
cut produce and fresh-cut vegetables going from soil to table.
And also as we talked about on multiple times throughout
this hearing, not just in terms of products but source. There
will be differences and risk depending upon the source of that
product and not just the source in terms of the soil or not or
what process it's going through but even in terms of whether
it's coming from one country or another country, etcetera.
So I hope that what the audience and what the subcommittee
will appreciate is that the FDA, in addition to being
collaborative and cooperative, is really taking a strategic
approach to the issue of protecting our food, both its safety
and protecting it from intentional contamination and doing that
in the context of a real overarching strategy that is multi-
factorial.
Senator Kohl. I'm going to ask the question to you, Dr.
Brackett, you work with the amount of money that you get every
day and you make it go as far as you can. How constrained are
you by your budget from doing the things that you really,
really believe need to be done?
Dr. Brackett. Well, I think anytime you ask someone,
especially a former researcher about what could be done, the
sky is the limit. But I think we can--we address the things
that need to be done today. Where I think we are more
constrained is, as has been mentioned before, in the generation
of new knowledge, in some cases, where we either don't have the
capacity, internally, to do that and it's appropriate to have
that funding go either through us or as it has done in the
past, or some other direction to make sure that those actions,
those projects, those research proposals, would be done to the
outside, to make sure. So even if we had a whole boatload of
money dumped on us right now, that wouldn't necessarily get us
to where we want to be unless that was applied and managed the
right way to people that could actually give us the answers
that we want to get.
Senator Kohl. Any other questions from the panel, from the
audience? Some ideas, some thoughts, anything on your mind,
folks?
Ms. DeWaal. Can I just ask one last question on the issue
of raw manure and the fact that in the organic industry, USDA
has very specific requirements for the application of raw
manure for products labeled organic? Why aren't those applied
to our agriculture and isn't farm worker sanitation such a
basic issue of not only human rights but also food safety that
those--don't we know enough already that farm workers should be
washing their hands before they touch the food? Aren't there
things we know already that could really make a difference in
protecting fruits and vegetables from making us sick?
Dr. Brackett. Yeah, there are a lot of things and we've had
these cultural practices and their good manufacturing practices
in the plants ever since we've had those documents out. We
could apply a mandatory, for instance, hand washing, much as
you would in a restaurant. In many cases, actually they are
under those jurisdictions in local health departments where
they have to do that on the farm anyway, through local health.
So that's actually being done. A bigger challenge is how do you
get these people to actually do it without having someone stand
there and watch? And that again, is a communications problem
that we have to--and a cultural problem in many cases, that we
have to address.
With respect to the organic, yes, there are specifications
for raw manure on organic and that, I think, was done
specifically because people had the impression that if it was
organic, that it would be using raw manure and so really, it
was a way to assure the consumers that they did have standards
for that, where the conventionally grown products have not
traditionally used raw manure and in those cases where you have
chemical applications or if you have compost and manure, the
assurance was that the organic product was as safe as a
conventionally grown product.
Senator Kohl. Are you comfortable with that answer?
Ms. DeWaal. No. Senator, with all due respect, I believe
that they know that there are certain minimum standards for the
use of manure, for farm worker hygiene, for water quality that
they know enough about to implement standards.
Senator Kohl. What did you say with respect to organic?
Ms. DeWaal. There are specific standards for organic. If
you want to label a product organic, they can't apply raw
manure within a certain amount of time of planting or
harvesting these products. There are some requirements also for
composting. These are already in place for the organic industry
and are not applied to traditionally grown. I mean, I'm from a
dairy State just like Wisconsin. I'm from Vermont. Farmers all
over that State apply raw manure to the land. It's used all the
time and it's an appropriate use of manure but it's got to be
done within some restrictions based on what's going to be grown
on that land. So I'm not comfortable yet that we're getting a
straight answer. I'm sorry.
Dr. Brackett. Do you want me to respond to that? No, you're
quite right. People should be washing their hands, people
should not be using raw manure on produce, there's no question
about that. In many cases, in local application, this is
already applied. In our investigations, though, we haven't seen
where raw--I'm sure it does happen, just like people disobey
the speed limit--but we haven't seen an overall use in the raw
manure across the industry. The application usually is with
compost and in some cases, grazed with what they call green
manure, which is not animal waste, which is really treated to
kill the pathogens that are there. Now, in some cases, for
instance, with the new marketing agreement in California, there
are some standards there being proposed of some network for the
people in that State to produce that would actually have
testing of the compost and manure to make sure that it didn't
have organisms.
Now, there is still some debate on whether the metrics that
are being used are right ones but at least they're making a
good attempt to try to, in their own industry, adopt those. We
have to make sure they are science based before we really apply
those in a stronger way, though.
Mr. Stenzel. Sir, if I could jump into this?
Senator Kohl. Yeah, go ahead.
Mr. Stenzel. Discussing this a little bit, oddly enough,
Dr. Brackett identifies one of the reasons that we are so
interested in a uniform, national approach. The commercial
production of spinach and lettuce and leafy greens, which is
dominantly focused in that area of California, is now holding
itself to the standards of not using raw manure and yet we hear
in Vermont that perhaps some of the product that is being grown
just for local markets may not have the same standards. So we
do need to move toward a national, uniform approach.
That can be achieved in a number of ways but I think that's
one of the things that the commercial vegetable industry is
increasingly concerned about, that we want to make sure that
the same standards are equitably applied to growers across the
country.
Senator Kohl. All right. Well, I think this has been a
great hearing, very illuminating and certainly have brought
many of the most important questions to the table and gotten
responses from you. I think we all understand and agree that we
can and must do better. We will do better, working together,
finding ways that we can collaborate and move the process
forward to make our produce safer. Again, we need greater
levels of confidence from the public. This is our goal. And I
think there have been several ideas that I think have come
forth today that I particularly feel might be productive and
useful. So on behalf of all of us, I want to thank you, you
guys for coming out today and giving us the benefit of your
knowledge and your authority and your ideas and things that you
would like to get done. I think you would agree, you learned a
lot from this panel. These are experts who are also people who
work on the ground and are ready and comfortable and
knowledgeable about what's happening and as such, I think
you've got to give information and thought to this hearing. So
we thank you for being here and I thank you guys for coming and
we thank you all for being here.
ADDITIONAL SUBMITTED STATEMENT
The Wisconsin Department of Agriculture, Trade and Consumer
Protection has submitted a statement that will be placed into
the hearing.
[The statement follows:]
Prepared Statement of the Wisconsin Department of Agriculture, Trade
and Consumer Protection
Dear Honorable Subcommittee Members: As Secretary of the Wisconsin
Department of Agriculture, Trade and Consumer Protection (DATCP), I
would like to enter these comments into the record of the March 12,
2007 hearing, held by the Senate Subcommittee on Agriculture
Appropriations.
Recently there have been several high profile food illness
outbreaks. Two of the most devastating outbreaks involved E. coli in
bagged spinach and E. coli contamination of Taco Bell products. These
incidents have put the spotlight on the Nation's food safety system.
Much discussion has centered on how USDA and FDA can improve their
inspection activities and put forth a more unified surveillance system.
Lost in the discussion however is the important role the States
play in surveillance, inspection, regulation and enforcement, and
outbreak response.
States are the backbone of our Nation's food safety system,
providing a network of inspectors who are on the job in a variety of
food-related venues. Over 80 percent of the food safety regulatory work
done in this country is performed by employees of State or local
government.
This regulatory work is comprised of activities that respond to
incidents where food is contaminated as well as activities that seek to
prevent significant food safety problems (e.g., routine facility
inspections). Whether food becomes contaminated by accident, intent, or
act of nature, States are in the frontlines protecting the public.
The Association of Food and Drug Officials (AFDO) conducted a
survey of State activities in 2001 that showed State and local
governments performed:
--More than 2.5 million inspections of food establishments
--More than 3,000 food borne illness investigations
--Investigation of over 46,000 consumer complaints
--Response to over 2,800 emergencies or disasters involving food
products
--More than 128,000 emergencies or disasters involving food products
embargos, seizures and stop sales; injunctions; criminal
prosecutions; warning letters; informal hearings; and food
recalls; and collection and analyses of over 328,000 food
samples, including more than 252,000 microbiological samples.
The Department of Agriculture, Trade and Consumer Protection
(DATCP) serves in the frontlines ensuring food safety in Wisconsin. Our
Division of Food Safety is responsible for the safety and wholesomeness
of the State's food supply, from the point of production through
processing, packaging, distribution, and retail sale. The division also
protects consumers from fraud and the misbranding of food products.
The division licenses and inspects more than 14,000 dairy farms,
370 dairy plants, 192 certified laboratories, 3,400 bulk milk tankers
and more than 6,800 other food processing businesses, meat slaughter
and processing plants, food warehouses, grocery stores and other food
businesses. Food and meat inspectors regularly inspect processing
facilities and sample food and meat products.
Also, State food laboratories play a crucial role in surveillance
activities, and they play the primary role in responding to outbreaks
by bringing expertise to bear in an emergency. Take the E. coli spinach
outbreak in September, 2006: Our DATCP food laboratory was the second
laboratory in the Nation to isolate and identify the disease causing E.
coli in spinach. Our effort was critical to the national response to
this illness.
A study by the Scripps-Howard News Service indicates that Wisconsin
has the Nation's best record in diagnosing the causes of food illness
(The Detroit News, November 24, 2006). This excellent record is the
result of a strong public health and food safety system in Wisconsin.
The factors that contribute to this strong system are evident in a
review of the chronology of the events in the State response to the E.
coli spinach outbreak:
September 5, 2006--Wisconsin's Division of Public Health (DPH) is
notified of several E. coli cases in the State.
September 7, 2006--Wisconsin notifies the U.S. Centers for Disease
Control (CDC).
September 8, 2006--Wisconsin's State Laboratory of Hygiene posts
the ``DNA fingerprint'' of the causative organism to a national data
base. State public health professionals believe the evidence points to
bagged spinach as the source of illness.
September 14, 2006--Based upon data provided by Wisconsin and other
States the U.S. FDA and the USDA issue a national alert, warning people
not to eat bagged spinach.
September 25, 2006--Wisconsin's State Department of Agriculture
Laboratory, having worked through the weekend, detects and confirms the
presence of E. coli O157 in spinach samples collected from patients by
local health sanitarians.
September 26, 2006--The State Agriculture Laboratory provides the
E. coli O157 cultures isolated from food to the State Laboratory of
Hygiene for further comparison testing.
September 27, 2006--The State Laboratory of Hygiene confirms the
strain isolated from food has an identical ``DNA fingerprint'' to the
strain isolated from clinical samples.
States are clearly indispensable partners to USDA and FDA--
especially since FDA food safety inspections dropped 47 percent between
2003 and 2006, according to a database analysis of Federal records by
the Associated Press. The analysis also shows there are 12 percent
fewer FDA employees in field offices who concentrate on food issues.
In fact, response efforts begin and may end at the State level.
States have inspection and surveillance systems in place; the State
systems employ highly skilled professionals such as epidemiologists,
food inspectors, public health sanitarians, and laboratory chemists and
microbiologists who work within the system on a daily basis.
As seen in the bagged spinach E. coli outbreak, the States are
often the first responders in a food emergency. The Federal Government
acted as a facilitator for the national response, and offered technical
support to the States when needed. The better the response at the State
level, the quicker the response will be at the national level.
That's why strengthening our Nation's food safety system, means
strengthening the State-Federal partnership by:
--Providing more financial support to on-going cooperative agreements
with the States for food surveillance and inspection
activities.
--Providing additional financial support to the USDA-AMS
Microbiological Program (MDP), and assuring that this important
program that strengthens Agriculture Laboratories on the
frontline of outbreak response continues to be funded in future
years.
Eight select State Agriculture Laboratories are the backbone of
the MDP. Using sophisticated techniques and technology, the
primary role of MDP is to provide surveillance data by testing
produce for the presence of disease causing organisms, such as
E. coli, Salmonella, and Listeria.
Techniques and technologies developed or fine tuned by the state
labs within MDP were utilized in Wisconsin's response to the
bagged spinach outbreak. However, MDP funding for fiscal year
2007 and beyond is in serious jeopardy, potentially costing
DATCP $170,000.
--Similarly, in fiscal year 2006, USDA's Food Safety and Inspection
Service (FSIS) failed to provide full 50 percent funding for
our State Meat and Poultry Inspection program for the first
time in 38 years. The fiscal year 2006 short fall was
approximately $170,000. If funding remains at this diminished
level, we anticipate the State will be under funded by $570,000
in fiscal year 2007.
Wisconsin's meat safety and inspection program--and the consumers
and 360 small processors who depend on it--need USDS-FSIS to
provide at least 50 percent of the program's funding needs.
State meat inspection programs are a bargain for the Federal
Government, which pays only half of the costs. If a State drops
its meat inspection program, the Federal Government by law
would need to take it over--and assume 100 percent of the
costs.
--Providing additional financial support to the Food Emergency
Response Network (FERN), and assuring that those funds are
allocated to support all the labs within the network.
As we review our Nation's food safety system, it is essential that
we also look to the States for ideas that work. The Wisconsin system
works because there is a high degree of collaboration throughout the
system; there is a great deal of expertise and dedication throughout
the system; there is an independent inspection and surveillance
infrastructure in place that provides routine inspection and testing
activities. What we're doing here in Wisconsin is a great example of
what can be done across America to protect our food supply.
Thank you for coming to Wisconsin and for considering these
comments. Please keep these thoughts in mind as you work to strengthen
our national food safety system.
CONCLUSION OF HEARING
Senator Kohl. This hearing is recessed.
[Whereupon, at 11:10 a.m., Monday, March 12, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
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