[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


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html

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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
                                 ------                                

     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

                              ----------                              
                                                                   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

                              ----------                              


                         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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \2\ Center for Science in the Public Interest, Outbreak Alert 
(Revised and updated--2006).
---------------------------------------------------------------------------
           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\
---------------------------------------------------------------------------
    \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. .
---------------------------------------------------------------------------
  --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\
---------------------------------------------------------------------------
    \5\ Centers for Disease Control (1997). ``Hepatitis A Associated 
with Consumption of Frozen Strawberries--Michigan, March 1997.'' MMWR. 
46(13): 288-295.
---------------------------------------------------------------------------
  --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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
  --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\
---------------------------------------------------------------------------
    \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
    RSS Feed for FDA News Releases [what's this?]
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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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