[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]




         HEARING TO REVIEW RECENT RECALLS IN THE MEAT INDUSTRY

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

                                HEARING

                               BEFORE THE

                            SUBCOMMITTEE ON
                     LIVESTOCK, DAIRY, AND POULTRY

                                 OF THE

                        COMMITTEE ON AGRICULTURE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                      WEDNESDAY, NOVEMBER 7, 2007

                               __________

                           Serial No. 110-35


          Printed for the use of the Committee on Agriculture
                         agriculture.house.gov





                  U.S. GOVERNMENT PRINTING OFFICE
50-509                    WASHINGTON : 2009
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing 
Office  Internet: bookstore.gov Phone: toll free (866) 512-1800 
Fax: (202) 512-2104  Mail: Stop IDCC, Washington, DC 20402-0001









                        COMMITTEE ON AGRICULTURE

                COLLIN C. PETERSON, Minnesota, Chairman

TIM HOLDEN, Pennsylvania,            BOB GOODLATTE, Virginia, Ranking 
    Vice Chairman                    Minority Member
MIKE McINTYRE, North Carolina        TERRY EVERETT, Alabama
BOB ETHERIDGE, North Carolina        FRANK D. LUCAS, Oklahoma
LEONARD L. BOSWELL, Iowa             JERRY MORAN, Kansas
JOE BACA, California                 ROBIN HAYES, North Carolina
DENNIS A. CARDOZA, California        TIMOTHY V. JOHNSON, Illinois
DAVID SCOTT, Georgia                 SAM GRAVES, Missouri
JIM MARSHALL, Georgia                JO BONNER, Alabama
STEPHANIE HERSETH SANDLIN, South     MIKE ROGERS, Alabama
Dakota                               STEVE KING, Iowa
HENRY CUELLAR, Texas                 MARILYN N. MUSGRAVE, Colorado
JIM COSTA, California                RANDY NEUGEBAUER, Texas
JOHN T. SALAZAR, Colorado            CHARLES W. BOUSTANY, Jr., 
BRAD ELLSWORTH, Indiana              Louisiana
NANCY E. BOYDA, Kansas               JOHN R. ``RANDY'' KUHL, Jr., New 
ZACHARY T. SPACE, Ohio               York
TIMOTHY J. WALZ, Minnesota           VIRGINIA FOXX, North Carolina
KIRSTEN E. GILLIBRAND, New York      K. MICHAEL CONAWAY, Texas
STEVE KAGEN, Wisconsin               JEFF FORTENBERRY, Nebraska
EARL POMEROY, North Dakota           JEAN SCHMIDT, Ohio
LINCOLN DAVIS, Tennessee             ADRIAN SMITH, Nebraska
JOHN BARROW, Georgia                 TIM WALBERG, Michigan
NICK LAMPSON, Texas
JOE DONNELLY, Indiana
TIM MAHONEY, Florida

                                 ______

                           Professional Staff
                    Robert L. Larew, Chief of Staff
                     Andrew W. Baker, Chief Counsel
                 April Slayton, Communications Director
           William E. O'Conner, Jr., Minority Staff Director

                                 ______

             Subcommittee on Livestock, Dairy, and Poultry

                   LEONARD L. BOSWELL, Iowa, Chairman

KIRSTEN E. GILLIBRAND, New York      ROBIN HAYES, North Carolina,
STEVE KAGEN, Wisconsin                    Ranking Minority Member
TIM HOLDEN, Pennsylvania             MIKE ROGERS, Alabama
JOE BACA, California                 STEVE KING, Iowa
DENNIS A. CARDOZA, California        VIRGINIA FOXX, North Carolina
NICK LAMPSON, Texas                  K. MICHAEL CONAWAY, Texas
JOE DONNELLY, Indiana                JEAN SCHMIDT, Ohio
JIM COSTA, California                ADRIAN SMITH, Nebraska
TIM MAHONEY, Florida                 TIM WALBERG, Michigan

              Chandler Goule, Subcommittee Staff Director

                                  (ii)




















                             C O N T E N T S

                              ----------                              
                                                                   Page
Boswell, Hon. Leonard L., a Representative in Congress from Iowa, 
  opening statement..............................................     1
    Prepared statement...........................................     2
Goodlatte, Hon. Bob, a Representative in Congress from Virginia, 
  opening statement..............................................    23
Fossella, Jr., Hon. Vito J., a Representative in Congress from 
  New York, prepared statement...................................     6
Hayes, Hon. Robin, a Representative in Congress from North 
  Carolina, opening statement....................................    16
    Prepared statement...........................................    16
Lampson, Hon. Nick, a Representative in Congress from Texas, 
  prepared statement.............................................     5
Peterson, Hon. Collin C., a Representative in Congress from 
  Minnesota, opening statement...................................     3
    Prepared statement...........................................     4
Smith, Hon. Adrian, a Representative in Congress from Nebraska, 
  prepared statement.............................................     5

                                Witness

Raymond, Dr. Richard, Under Secretary for Food Safety, Food 
  Safety and Inspection Service, U.S. Department of Agriculture, 
  Washington, D.C................................................     6
    Prepared statement...........................................     9
    Responses to submitted questions.............................    41

 
         HEARING TO REVIEW RECENT RECALLS IN THE MEAT INDUSTRY

                              ----------                              


                      WEDNESDAY, NOVEMBER 7, 2007

                  House of Representatives,
     Subcommittee on Livestock, Dairy, and Poultry,
                                  Committee on Agriculture,
                                                   Washington, D.C.
    The Subcommittee met, pursuant to call, at 2:10 p.m., in 
Room 1300 of the Longworth House Office Building, Hon. Leonard 
L. Boswell [Chairman of the Subcommittee] presiding.
    Members present: Representatives Boswell, Gillibrand, 
Kagen, Holden, Lampson, Costa, Peterson (ex officio), Hayes, 
Rogers, Conaway, Smith, and Goodlatte (ex officio).
    Staff present: Adam Durand, Nathan Fretz, Alejandra 
Gonzalez-Arias, Scott Kuschmider, Rob Larew, John Riley, April 
Slayton, Kristin Sosanie, John Goldberg, Alise Kowalski, Pam 
Miller, Stephanie Myers, Pete Thomson, and Jamie Weyer.

OPENING STATEMENT OF HON. LEONARD L. BOSWELL, A REPRESENTATIVE 
                     IN CONGRESS FROM IOWA

    The Chairman. The hearing of the Subcommittee on Livestock, 
Dairy, and Poultry to review recent recalls of the meat 
industry will come to order. And we will begin with some 
opening statements, and when the Ranking Member comes back, we 
will stop where we are at and let him get his statement in. And 
so I think we will just go ahead and proceed now, and so I will 
make mine, and then we will probably recognize Chairman 
Peterson for his.
    So I do want to thank everybody for joining, to discuss a 
very serious subject for American consumers and the meat 
industry. We have seen an increase in the number of illnesses 
and recalls related to foodborne pathogens this year and E. 
coli O157:H7, which I will leave the numbers off in the future, 
E. coli, which has been responsible for the majority of these 
cases.
    Last month, when I discussed with Chairman Peterson that we 
wanted to hold a hearing on the meat recalls, the big story was 
the Topps recall, which has been linked to 32 illnesses and 
involved more than 21 million pounds of ground beef products. 
Since then, additional details have come to light in that case 
that have raised some questions about how and when recalls 
occur. We have also seen several more large recalls and E. coli 
since the Topps case, and there are many questions that need to 
be asked about why we are seeing these increases and what USDA 
is doing in response. This is an issue that affects every state 
and every district. Iowa has had 42 illnesses from E. coli, and 
just last Friday, Kayla Boner, an eighth-grader from my 
district, died after testing positive for E. coli.
    Today I am pleased to welcome Dr. Richard Raymond, USDA's 
Under Secretary for Food Safety, who has been on the job for 
about 16 months. He brings the experience as the former 
President of the Association of State and Territorial Health 
Officials and a state public health official in Iowa's neighbor 
to the west, Nebraska. As he brings his expertise as a public 
health official to the Under Secretary's office in the USDA, I 
hope that he will be able to help us understand how these 
illness outbreaks in multiple states are tracked and 
investigated and what we can do better to bring together 
information and make more informed decisions about recalls when 
human illnesses are involved.
    This hearing is an important step in the exchange of 
information. We are here today to listen to Dr. Raymond and to 
collectively come to conclusions about why we are seeing more 
recalls, what has caused the increase in E. coli contamination, 
and how are we working to come to a reasonable solution. This 
is not a witch hunt or a time to point fingers, but an 
opportunity to talk about what we can do as a team to solve 
problems. There will be some difficult questions today, but the 
answers will help each of us make better decisions on how to 
provide the necessary resources for FSIS.
    I hope this hearing will be an opportunity for Members of 
the Committee to learn about the important role FSIS has in 
protecting food safety and to discuss where we are and what we 
can do to reduce E. coli and other pathogens in the meat, 
poultry, and egg products that we serve our families. Mr. Under 
Secretary, thank you for being here today, and we look forward 
to your testimony.
    [The prepared statement of Mr. Boswell follows:]

  Prepared Statement of Hon. Leonard L. Boswell, a Representative in 
                           Congress From Iowa
    Good afternoon, I would like to thank everyone for joining us today 
to discuss a very serious subject for American consumers and the meat 
industry. We've seen an increase in the number of illnesses and recalls 
related to foodborne pathogens this year, and E. coli O157:H7, which 
has been responsible for the majority of these cases.
    Last month, when I discussed with Chairman Peterson that I wanted 
to hold a hearing on meat recalls, the big story was the Topps recall, 
which has been linked to 32 illnesses and involved more than 21 million 
pounds of ground beef products. Since then, additional details have 
come to light in that case that have raised more questions about how 
and when recalls occur. We've also seen several more large recalls for 
E. coli since the Topps case, and there are many questions that need to 
be asked about why we are seeing these increases and what USDA is doing 
in response.
    This is an issue that affects every state and every district. Iowa 
has had 42 illnesses from E. coli and just last Friday, Kayla Boner, an 
8th grader from my district, died after testing positive for E. coli.
    Today, I am pleased to welcome Dr. Richard Raymond, USDA's Under 
Secretary for Food Safety who has been on the job for about 16 months 
now, and he brings experience as the former President of the 
Association of State and Territorial Health Officials and a state 
public health official in Iowa's neighbor to the west, Nebraska. As he 
brings this expertise as a public health official to the Under 
Secretary's office at USDA, I hope that he will be able to help us 
understand how these illness outbreaks in multiple states are tracked 
and investigated and what we can do better to bring together 
information and make more informed decisions about recalls when human 
illnesses are involved.
    This hearing is an important step in the exchange of information. 
We are hear today to listen to Dr. Raymond and to collectively come to 
conclusions about why we are seeing more recalls, what has caused the 
increase in E. coli contamination, and how are we working to come to 
reasonable solutions. This is not a witch hunt or a time to point 
fingers, but an opportunity to talk about what we can do as a team to 
solve problems. There will be some difficult questions today, but the 
answers will help each of us make better decisions in how to provide 
the necessary resources for FSIS.
    I hope this hearing will be an opportunity for Members of the 
Committee to learn more about the important role FSIS has in protecting 
food safety and to discuss where we are and what we can do to reduce E. 
coli and other pathogens in the meat, poultry and egg products that we 
serve our families. Mr. Under Secretary, thank you for being here 
today, and I look forward to your testimony.
    At this time I would like to recognize my Ranking Member and good 
friend Robin Hayes from North Carolina for any opening remarks he would 
like to make.

    The Chairman. At this time I would like to recognize 
Chairman Peterson for any opening remarks that he might wish to 
make.

OPENING STATEMENT OF HON. COLLIN C. PETERSON, A REPRESENTATIVE 
                   IN CONGRESS FROM MINNESOTA

    Mr. Peterson. Thank you, Chairman Boswell, for calling this 
much-needed hearing. I am sure this Committee will have a lot 
of questions for Dr. Raymond this afternoon, and I thank him 
for being with us here today.
    Today's hearing is very important for consumers of meat and 
poultry products, given the high number of recalls and 
illnesses related to foodborne pathogens this year and this 
past month in particular. We have seen close to 20 recalls 
related to E. coli in beef in 2007, with seven recalls in the 
last 30 days alone. To put that in perspective, there were 
eight recalls for all of 2006. I hope Dr. Raymond can shed some 
light on what has changed, if anything, regarding the nation's 
meat and poultry supply and why we have seen these increases. 
Our hearing today will consider not just the chronology of the 
Topps beef recall that took place in September, but also the 
events surrounding the recall that illustrate many important 
issues regarding inspection, testing, foreign equivalency, 
cooperation between FSIS and other agencies, and the timely 
public notification of these issues.
    As Dr. Raymond has suggested, the Topps case is a wake-up 
call, and we need vigorous review of our inspection practices 
and procedures. In the case of Topps, FSIS said that the 
company was commingling meat from one day to the next. This 
makes it nearly impossible to immediately pinpoint the 
origination of E. coli. Also, the overall design of the plant's 
food safety system was in question. Was Topps following its 
HAACP plan? Why didn't inspectors, present every day in 
production, not know that problems existed?
    If FSIS cannot identify a problem that would result in a 
recall of a full year of product, I have concerns about whether 
inspectors have the necessary training and management to get 
the job done correctly. Why were there 18 days between the time 
USDA confirmed E. coli from an open Topps package in a 
consumer's home and the time that it issued the first product 
recall? And why did it take so long to connect the contaminated 
product in the Topps case with severe illnesses in Canada, 
where the product had originated?
    In reviewing the increase in recalls today, we should also 
examine the coordination of efforts between our government 
agencies, domestically and internationally, in responding to 
outbreaks and informing the public. Specifically, how does USDA 
collaborate in a timely fashion with the Food and Drug 
Administration, the Centers for Disease Control and Prevention, 
foreign food safety agencies or other public health entities at 
the state and local levels? Certainly, in the Topps case, and 
in the case of the Totino's pizza recall recently, the 
initiative to act and establish conclusive links between 
illnesses and tainted products was taken at the state level and 
not the Federal level. Was this the result of lack of 
communication between Federal and state agencies? We need to 
know.
    Consumers should have unquestioned confidence in the food 
that they are buying. The public depends on our agencies to 
cooperate, share information, and be diligent and comprehensive 
in informing the public about health risks. To respond in the 
manner that was undertaken in the Topps case only reinforces 
many of the criticisms of the structure of our food safety 
system. The massive meat recalls in 1997 and 2002 brought about 
significant changes in USDA policies and inspections.
    As a Committee with primary jurisdiction over the 
inspection of domestic and imported livestock, poultry, and 
meat products, I hope that this Subcommittee can get some good 
answers today about the tools, training, data, and oversight 
surrounding these recalls, what FSIS is doing to correct its 
procedures, to fill in the gaps where necessary, and where we 
can all move forward to continue to enjoy the safest and most 
abundant food supply in the world.
    Again, I thank the Chairman for his leadership on this 
issue, and we look forward to the testimony of Dr. Raymond and 
questions of the Committee, and I yield back the balance of my 
time.
    [The prepared statement of Mr. Peterson follows:]

  Prepared Statement of Hon. Collin C. Peterson, a Representative in 
                        Congress From Minnesota
    Thank you, Chairman Boswell, for calling this much-needed hearing. 
I am sure this Committee will have a lot of questions for Dr. Raymond 
this afternoon. I thank him for appearing today.
    Today's hearing is very important for consumers of meat and poultry 
products given the high number of recalls and illnesses related to 
foodborne pathogens this year, and this past month in particular. We 
have seen close to 20 recalls related to E. coli in beef in 2007, with 
seven recalls in the last 30 days alone. To put that in perspective, 
there were eight recalls for all of 2006. I hope Dr. Raymond can shed 
some light on what has changed, if anything, regarding the nation's 
meat and poultry supply, and why we have seen these increases.
    Our hearing today will consider not just the chronology of the 
Topps beef recall that took place in September, but also the events 
surrounding the recall that illustrate many important issues regarding 
inspection, testing, foreign equivalency, cooperation between FSIS and 
other agencies, and timely public notification. As Dr. Raymond has 
suggested, the Topps case is a ``wake-up call'' and we need rigorous 
review of our inspection practices and procedures.
    In the case of Topps, FSIS said that the company was co-mingling 
meat from one day to the next, making it nearly impossible to 
immediately pinpoint the origination of the E. coli, and the overall 
design of the plant's food safety system was in question. Was Topps 
following its HAACP plan? Why didn't inspectors, present every day of 
production, not know that problems existed?
    If FSIS cannot identify a problem that would result in a recall of 
a full year of product, I have concerns about whether inspectors have 
the necessary training and management to get the job done correctly. 
Why were there 18 days in between the time USDA confirmed E. coli from 
an opened Topps package in a consumer's home and the time it issued the 
first product recall? And why did it take so long to connect the 
contaminated product in the Topps case with severe illnesses in Canada, 
where the product had originated?
    In reviewing the increase in recalls today, we should also examine 
the coordination of efforts between our government agencies 
domestically and internationally in responding to outbreaks and 
informing the public. Specifically, how does USDA collaborate in a 
timely fashion with the Food and Drug Administration, the Centers for 
Disease Control and Prevention, foreign food safety agencies, or other 
public health entities at the state and local levels? Certainly in the 
Topps case and in the case of the Totino's pizza recall, the initiative 
to act and establish conclusive links between illnesses and tainted 
products was taken at the state level, and not the Federal level. Was 
this the result of a lack of communication between Federal and state 
agencies?
    Consumers should have unquestioned confidence in the food they are 
buying. The public depends on our agencies to cooperate, share 
information, and be diligent and comprehensive in informing the public 
about health risks. To respond in the manner that was undertaken in the 
Topps case only reinforces many of the criticisms of the structure of 
our food safety system.
    The massive meat recalls in 1997 and 2002 brought about significant 
changes in USDA policies and inspections. As the Committee with primary 
jurisdiction over the inspection of domestic and imported livestock, 
poultry and meat products, I hope this Subcommittee can get some good 
answers today about the tools, training, data and oversight surrounding 
these recalls, what FSIS is doing to correct its procedures, to fill in 
the gaps where necessary, and where we can all move forward to continue 
to enjoy the safest and most abundant food supply in the world. I thank 
the Chairman and I yield back my time.

    The Chairman. Thank you, Chairman Peterson. Mr. Hayes is 
not back, but we will recognize him when he does come.
    I would ask that all other Members submit their statements 
for the record.
    [The prepared statements of Messers. Lampson, Smith, and 
Fossella follow:]

 Prepared Statement of Hon. Nick Lampson, a Representative in Congress 
                               From Texas
    Mr. Chairman, I want to thank you for holding this important 
hearing to review the recent recalls in the meat industry. This issue 
is one that affects every rancher, every packer, every retailer--and 
every American.
    Rates for the recall of meat have skyrocketed this year, leading 
not only to increased illnesses and death, but also to a decrease in 
consumer confidence. So far this year I have received nearly four 
hundred letters from constituents demanding a change in the system. 
They are worried about their health and the health of their children, 
as am I. And they are concerned that we are not doing enough. USDA's 
Food Safety and Inspection Service (FSIS) is meant to provide a stop-
gap so that tainted meat does not reach the marketplace. But clearly, 
there is a gap in FSIS's ability to prevent this. Contaminated meat 
should be prevented from ever reaching store shelves.
    Together with the USDA, we must explore steps that we can take--
including stepped up inspections, an improved recall system, and better 
education of consumers--to ensure that our food supply remains the 
safest in the world. I thank Dr. Raymond for joining us to discuss this 
vital issue, and I am glad that we are here today to initiate a serious 
and frank discussion of the issues facing FSIS as they work to monitor 
and protect our nation's supply of meat, poultry and eggs.
                                 ______
                                 
 Prepared Statement of Hon. Adrian Smith, a Representative in Congress 
                             From Nebraska
    Good afternoon and thank you, Mr. Chairman.
    The meat industry is important to Nebraska's economy. The 81 meat 
packing plants (excluding poultry processing) in the state employ 
20,000 Nebraskans and ship $10.5 billion worth of product each year--
more than any other state. Producing a safe and quality product that 
consumers can trust is vital to the beef industry.
    America's food supply is the safest in the world. Yet we 
continually strive to improve our industry's procedures and 
technologies. Relative to the vast amount of safe and wholesome product 
produced each year, recalls are rare, but they remind us that we must 
remain vigilant and that continued advances in food safety research are 
needed.
    I am pleased that scientists at the USDA Meat Animal Research 
Center in Nebraska's Third District are developing testing and 
intervention strategies for E. coli O157:H7, and are preparing training 
materials on proper sampling and inspection. An additional, and 
important avenue of their research is the investigation of pre-harvest 
food safety techniques, which could further enhance food safety.
    Each recall event is an opportunity to learn more about how we can 
protect our food supply. That is why we are here today. I want to thank 
our witness for testifying, and the Committee and the Chairman for 
holding this hearing. I look forward to working with you in the future.
                                 ______
                                 
   Prepared Statement of Vito J. Fossella, Jr., a Representative in 
                         Congress From New York
    Today's hearing provides an important opportunity for Congress to 
examine the health-related impacts on individuals impacted by the 
resent massive beef recall by the Topps Meat Company. As we have all 
read in various news publications over the last few months, our 
nation's beef supply, specifically that distributed by the Topps Meat 
Company, was responsible for the sickness of over 30 individuals, some 
with E. coli poisoning, all across the United States, and putting 
millions of other American's at great risk.
    I would like to thank Chairman Boswell and Ranking Member Hayes for 
the opportunity to submit this testimony for the hearing this morning. 
I would also like to thank each of the panelists who have agreed to 
testify before the Subcommittee this morning.
    I come before you today with great concern for two of my 
constituents; a 12 year old girl and a 19 year old boy, both of Staten 
Island. The 12 year old girl was hospitalized for nearly a week due to 
E. coli poisoning from hamburger purchased from Waldbaum's convenience 
store on Staten Island. The hamburger, manufactured at Topps Meat Co., 
contained the E. coli bacteria and forced the little girl into the 
intensive care unit at Staten Island University Hospital. 
Unfortunately, this problem is not isolated. We also learned that Topps 
Meat Co. expanded its initial recall of 332,000 pounds of ground beef 
to over 21.7 million pounds. These two instances highlight a possible 
pattern and warrant a full and comprehensive examination by the Federal 
Government.
    I believe the safety of our nation's food supply is one the highest 
priorities Congress must adhere to. I personally have three young 
children and being a parent, I want to know that the food supply my 
family and all American's are consuming is safe from harm. It is my 
firm belief that parents should feel safe when purchasing food at their 
local grocery store, yet I come to this hearing today wondering if they 
can be assured of just that. I ask you this one question today--how can 
you assure parents and all American's that the food they are purchasing 
for their families is safe?
    I respectfully request a full and comprehensive examination of the 
current food inspection processes be held on the safety of our nation's 
food supply and the plants where it is manufactured.
    I look forward to working with this Subcommittee, the Department of 
Agriculture and manufacturers from across the spectrum to pursue the 
kind of reforms that will direct the focus on what matters most and 
that is the safety of all American's. Again, I would like to thank the 
Chairman and Ranking Member for this opportunity today and I look 
forward to hearing the testimony of our panelists today.

    The Chairman. At this time I think we will go ahead and ask 
our witness to make his opening comments. And we would like to 
welcome Dr. Richard Raymond, Under Secretary for Food Safety, 
U.S. Department of Agriculture. Please share what you have to 
share with us. Please begin.

  STATEMENT OF DR. RICHARD RAYMOND, UNDER SECRETARY FOR FOOD 
               SAFETY, FOOD SAFETY AND INSPECTION
            SERVICE, U.S. DEPARTMENT OF AGRICULTURE,
                        WASHINGTON, D.C.

    Dr. Raymond. Thank you. Good afternoon, Mr. Chairman, 
Congressman Hayes, Members of the Subcommittee, and Chairman 
Peterson. I am Dr. Richard Raymond, the Under Secretary for 
Food Safety at the United States Department of Agriculture, and 
I appreciate the opportunity to appear before you today to 
discuss the Food Safety and Inspection Service's ongoing 
efforts to protect the public's health.
    But I want to begin today by addressing some concerns that 
have been expressed by Members of Congress regarding comments 
made by me about risk-based inspection and processing and its 
relation to the recall by Topps Meat Company. I apologize for 
making any previous references to RBI and Congress in the 
context of this recall. I have no basis upon which I could say 
that RBI would have prevented this recall. There is certainly 
no correlation between the recall and any Congressional 
actions, and I hope the Subcommittee will accept my apology.
    I also want to notify the Subcommittee that, based on the 
challenges posed to food safety by E. coli O157:H7 and what we 
have learned from the recent recalls, I do believe that we need 
to take additional time to strengthen our system and our data 
collection capabilities before moving forward with risk-based 
inspection and processing. We welcome the Office of the 
Inspector General's report, expected by the end of the year, 
which is examining the data used in the development and design 
of risk-based inspection and processing, and we will use that 
report to further focus our efforts.
    In my testimony today, I will focus on the rise in the 
number of recalls of FSIS-inspected products related to E. coli 
O157:H7 and highlight some of the steps that the agency is 
taking to drive down the incidence of E. coli O157:H7. Since 
January 2007 there have been 19 recalls, as of today, related 
to E. coli O157 in beef this year. Nine of those have been 
associated with human illnesses. As Chairman Peterson noted, in 
2006 there were only eight E. coli O157:H7-related recalls, and 
none of those were related to human illness. In 2005, there 
were only five E. coli O157:H7-related recalls.
    This year's experience has made clear why we cannot be 
satisfied with the progress that we have made. We need to do 
more to strengthen our policies and our programs. As the 
increased number of recalls demonstrates, the challenges to 
public health are constantly evolving, and FSIS must evolve and 
change with them. We are undertaking new, ongoing, and soon-to-
be upcoming actions to protect public health against the risk 
of E. coli O157:H7, including expanded testing and more rapid 
recalls.
    In June 2007, FSIS identified an increased number of E. 
coli O157:H7-positive tests in beef, as well as a larger number 
of recalls and illnesses caused by this pathogen than in recent 
years. As a result, FSIS increased the number of tests of 
ground beef for E. coli O157:H7 by more than 75 percent, from a 
base level of about 1,100 tests per month to 1,943 in July. 
Even though the agency saw nothing unusual in the positive 
sample rate in July, it continued an increased sampling 
schedule for most raw ground beef establishments of at least 
once per month, or approximately 1,350 samples scheduled per 
month.
    Earlier this year, the FSIS also began trim testing in the 
establishments. Trim is the primary component in ground beef, 
in addition to testing ground beef itself. Based on preliminary 
data from the agency's beef trim baseline done last year, which 
showed that we were more likely to find positive in trim than 
ground beef, FSIS began trim testing in March of 2007, not 
waiting for the final analysis of the baseline. By testing 
earlier in the production chain, FSIS minimizes the likelihood 
that this contaminated source material could be used in ground 
beef production that is available to consumers.
    FSIS has also recently announced a new initiative to test 
additional components of ground beef, including head, cheek, 
and weasand meat. FSIS will be requiring countries whose beef 
is exported to the United States to conduct the same trim and 
beef component sampling or an equivalent measure, and the 
agency will begin doing verification sampling of trim to 
supplement the agency's ground product sampling at ports of 
entry. We will begin analyzing imported and domestic product 
test results to determine whether we need to make further 
changes to FSIS policies and programs. We have already made 
progress in getting recalls done more rapidly.
    As a result of lessons learned from the Topps Meat Company 
recall, FSIS now takes into account a broader, more complete 
range of evidence when evaluating whether to seek a recall or 
whether to take regulatory action. This gives the agency a 
credible approach to more rapidly taking action when certain 
types of evidence are available. In two recent cases, FSIS 
acted upon epidemiological evidence that linked illness to 
opened, FSIS-inspected product found in consumers' freezers, 
where previously, by policy, we believed the agency needed a 
test result from an intact or unopened package because of the 
possibility of cross-contamination. More than 1 million pounds 
of ground beef were recently recalled as a result of this 
change in our recall procedures.
    We have implemented a number of key initiatives targeted to 
federally-inspected plants that produce raw beef products. The 
FSIS notified the beef industry that as of November all beef 
plants will be expected to verify that they are effectively 
controlling E. coli O157:H7 during slaughter and processing. 
The agency also provided the agency specific examples of 
minimum controls that would meet the minimum criteria for a 
well-controlled process. Identifying which establishments 
achieve the minimum criteria and which establishments do not 
will provide FSIS with the critical information on 
establishments with vulnerabilities.
    FSIS inspection personnel began specialized training during 
the week of October 29, after which they will be equipped to 
complete a checklist describing the control measures and 
interventions used by raw beef suppliers and processors to 
control E. coli O157:H7. These checklists will be completed by 
November 30 and will be updated quarterly to help the agency 
more quickly identify potentially significant changes in 
production controls and to ensure that the plant takes 
corrective action. FSIS has accelerated its plans to review 
suppliers and processors based on this new checklist in 
response to concerns about the increased positives of E. coli 
O157:H7. Implementation for this survey was originally 
scheduled for April 2008. FSIS will analyze the checklist data 
and use it to adjust programs or policies as needed, such as 
where the agency needs to conduct targeted verification testing 
and how to prioritize food safety assessments in plants.
    The FSIS has determined that these steps were needed to 
ensure that inspection program personnel in the industry fully 
understand the nature of the challenge presented by E. coli 
O157:H7. These steps are laid out in much more detail in my 
written testimony and posted on the FSIS website and include 
actions such as scheduling food safety assessments upon 
notification of any Federal, or state positive test result for 
E. coli O157:H7 in raw ground beef, increased follow-up testing 
in plants that have had positive E. coli O157:H7 test results 
and suppliers of positive product, and also routine targeted E. 
coli O157:H7 testing.
    In short, the agency is ensuring that suppliers, 
processors, and FSIS inspection personnel will be able to 
identify an emerging problem as early as possible to prevent 
contaminated product from entering commerce. Agency actions 
must be based on protecting public health, and I want to 
emphasize how important this is to me personally. As I have 
often said, I did not move to Washington to oversee recalls. I 
came to Washington to help prevent foodborne illness. Even one 
illness is one too many, and with the actions we have announced 
and undertaken, I believe that we are on the right track.
    In conclusion, we will continue to engage the scientific 
community, consumers, public health experts, Congress, our own 
employees, and all other interested parties in an effort to 
identify science-based solutions to public health issues, to 
ensure positive public health outcomes. We all know that we can 
save lives with sensible science-based policies, and together I 
believe we will do just that.
    Mr. Chairman, I thank you again for providing me with the 
opportunity to address the Subcommittee and to submit testimony 
regarding the steps that FSIS is taking to remain a world 
leader in food safety and public health. I look forward to 
working with you to continue to improve our food safety system.
    [The prepared statement of Dr. Raymond follows:]

Prepared Statement of Richard Raymond, Under Secretary for Food Safety, 
  Food Safety and Inspection Service, U.S. Department of Agriculture, 
                            Washington, D.C.
    Good morning, Mr. Chairman, Congressman Hayes, and other Members of 
the Subcommittee. I am Dr. Richard Raymond, Under Secretary for Food 
Safety. I appreciate the opportunity to appear before you today to 
discuss the Food Safety and Inspection Service's (FSIS) ongoing efforts 
to protect public health.
    I want to begin by addressing concerns expressed by Members of 
Congress regarding my comments about risk-based inspection (RBI) in 
processing and its relation to the recall by Topps Meat Company. I 
apologize for making any reference to RBI and Congress in the context 
of this recall. I have no basis upon which I could say RBI would have 
prevented this recall. There is certainly no correlation between the 
recall and Congressional actions. I hope the Subcommittee will accept 
my apology.
    I also want to notify the Subcommittee that based on the challenges 
posed to food safety by E. coli O157:H7 and what we have learned from 
recent recalls, I believe that we need to take additional time to 
strengthen our system and our data collection capabilities before 
moving forward with RBI in processing.
    We welcome the Office of the Inspector General's report, expected 
by the end of the year, which is examining the data used in the 
development and design of risk-based inspection in processing. We will 
use that report to further focus our efforts.
    In my testimony today, I want to start by briefly describing FSIS' 
food safety responsibilities. I will then focus on the rise in the 
number of recalls of FSIS-inspected products, especially related to E. 
coli O157:H7, and highlight some of the steps the agency is taking to 
drive down the incidence of E. coli O157:H7. I will also explain FSIS' 
role during recalls, specifically during the Topps recall.
FSIS' Mission
    As Under Secretary for Food Safety, I oversee FSIS. FSIS' mission 
is to ensure that meat, poultry, and processed egg products distributed 
in commerce for use as human food are safe, secure, wholesome, and 
accurately labeled. FSIS is charged with administering and enforcing 
the Federal Meat Inspection Act, the Poultry Products Inspection Act, 
the Egg Products Inspection Act, portions of the Agricultural Marketing 
Act, and the regulations that implement these laws. FSIS also ensures 
compliance with the Humane Methods of Slaughter Act, which requires 
that all livestock be handled and slaughtered in a humane manner. The 
agency is responsible for determining equivalence to Federal standards 
at the state level and among our foreign trading partners.
    Our front-line personnel form the backbone of FSIS' public health 
infrastructure in establishments, laboratories and import houses 
throughout the country. In FY 2007, the agency had approximately 7,600 
full-time in-plant and other front-line personnel protecting the public 
health in 6,000 federally-inspected establishments nationwide where 
FSIS inspection program personnel performed antemortem and postmortem 
inspection procedures to ensure public health requirements were met in 
the processing of over 44 billion pounds of livestock carcasses, almost 
57 billion pounds of poultry carcasses, and about 3.5 billion pounds of 
liquid egg products. Approximately 60 cents of every food dollar in the 
United States is spent on foods that FSIS inspects.
    In FY 2007, FSIS inspection program personnel conducted more than 
nine million procedures to verify that establishments met food safety 
and wholesomeness requirements. The amount of FSIS-regulated meat and 
poultry imports has remained approximately the same over the past 5 
years, hovering around 4 billion pounds of meat and poultry from 29 of 
the 33 eligible countries. In addition, about 6 million pounds of egg 
products from Canada were presented for import re-inspection at U.S. 
ports and borders during the past year. FSIS also has Program 
Investigators nationwide who conduct food safety, food defense, and 
outbreak investigations and enforcement.
Recent Recalls
    Since January 2007, there have been 19 recalls related to E. coli 
O157:H7 in beef this year. Nine of those have been associated with 
human illnesses. In 2006, there were eight E. coli O157:H7 related 
recalls, none of which were related to human illnesses. In 2005 there 
were only five E. coli O157:H7-related recalls. This year's experience 
has made clear why we cannot be satisfied with the progress that we 
have made. We need to do more to strengthen our policies and programs.
    As the increased number of recalls demonstrates, the challenges to 
public health are constantly evolving, and FSIS must evolve with them. 
Public health is a lot like riding a bicycle. If we're not moving 
forward, then we're falling down, and in public health there is no such 
thing as training wheels. We can't and won't let ourselves, our 
partners, or our nation's food safety system stagnate.
    We are undertaking new, ongoing and upcoming actions to protect 
public health against the risk of E. coli O157:H7, including expanded 
testing and more rapid recalls. In June 2007, FSIS identified an 
increased number of E. coli O157:H7 positive tests in beef, as well as 
a larger number of recalls and illnesses caused by this pathogen than 
in recent years. As a result, FSIS increased the number of tests of 
ground beef for E. coli O157:H7 by more than 75 percent (from our base 
level of 1,100 to 1,943) in July. Even though the agency saw nothing 
unusual in the positive sample rate in July, it has continued an 
increased sampling schedule for most raw ground beef establishments 
once per month (i.e., approximately 1,350 samples scheduled per month).
    Earlier this year, FSIS began trim testing, the primary component 
in ground beef, in addition to ground beef itself. FSIS has also 
recently announced a new initiative to test additional components of 
ground beef. By testing earlier in the production chain, FSIS minimizes 
the likelihood that this contaminated source material could be used in 
ground beef that is available to consumers. FSIS is also requiring 
countries whose beef is imported to the United States to conduct the 
same trim and beef component sampling or an equivalent measure, and the 
agency will begin doing verification sampling of trim to supplement the 
agency's ground product sampling at ports of entry. We will be 
analyzing imported and domestic product test results to determine 
whether we need to make further changes to FSIS policies and programs.
    We have already made progress in getting recalls done more rapidly. 
As a result of the lessons learned from the Topps Meat company recall, 
FSIS now takes into account a broader, more complete range of evidence 
when evaluating whether to seek a recall or whether to take regulatory 
action. This gives the agency a credible approach to more rapidly 
taking action when certain types of evidence are available. In two 
recent cases, FSIS acted upon epidemiological evidence that linked 
illness to opened, FSIS-inspected product found in consumers' freezers, 
where previously, we believed the agency needed a test result from an 
intact or unopened package because of the possibility of cross-
contamination. More than 1 million pounds of ground beef were recently 
recalled as a result of this change in our recall procedures.
    We are examining our training and staffing patterns to ensure that 
inspection program personnel and supervisors are doing their jobs 
correctly, that they are held accountable, and that they have 
appropriate workloads and supervision.
    We have implemented a number of key initiatives targeted to 
federally-inspected plants that produce raw beef products. FSIS 
determined that these steps were needed to ensure that inspection 
program personnel and the industry fully understand the nature of the 
challenge presented by E. coli O157:H7. The agency is ensuring that 
suppliers, processors, and FSIS inspection personnel, will be able to 
identify an emerging problem as early as possible to prevent 
contaminated product from entering commerce.
    Since September 28, 2007, FSIS inspection program personnel have 
been sending E. coli O157:H7 samples to FSIS labs for testing, 
irrespective of the company's test results. Previously, the agency did 
not submit a sample to the lab if the company destroyed E. coli 
O157:H7-positive product or diverted it to cooking. While this practice 
of not submitting samples did not pose a human health risk, our new 
approach will allow us to increase the number of pulsed-field gel 
electrophoresis (PFGE), or DNA fingerprint patterns entered into 
PulseNet. PulseNet is the CDC's national molecular sub-typing network 
for foodborne disease surveillance and has searchable databases of all 
PFGE patterns from patients and food products in the United States.
    On October 12, 2007, FSIS issued a notice instructing its District 
Offices to have Enforcement Investigation Analysis Officers schedule a 
food safety assessment upon notification of any Federal or state 
positive test result of E. coli O157:H7 in raw ground beef or ready-to-
eat (RTE) meat and poultry products. The same action will be taken for 
positive sample results of Listeria monocytogenes or Salmonella in RTE 
products.
    On October 12, 2007, FSIS also issued a notice instructing 
inspection program personnel to collect multiple follow-up samples of 
beef products in plants that have had a positive E. coli O157:H7 
sample. Previously, FSIS collected only one follow-up sample following 
a positive test result. FSIS implemented this policy because analysis 
of E. coli O157:H7 sample data from 2000 through 2005 showed that 
plants are more likely to have a second positive sample if they have 
had a positive sample within the preceding 120 days. Suppliers of E. 
coli O157:H7-positive beef products will also be subject to this 
increased follow-up testing. Increased follow-up testing will provide 
the agency with a statistically-based level of confidence regarding the 
likely presence of E. coli O157:H7 in FSIS-regulated product.
    FSIS notified the beef industry that, as of November, all beef 
plants will be expected to verify that they are effectively controlling 
E. coli O157:H7 during slaughter and processing. The agency also 
provided the industry specific examples of minimum controls that would 
meet the minimum criteria for a ``well-controlled'' process. 
Identifying which establishments achieve the minimum criteria, and 
which establishments do not, will provide FSIS the critical information 
on establishments with vulnerabilities.
    FSIS inspection personnel began specialized training during the 
week of October 29, after which they will be equipped to complete a 
checklist describing the control measures and interventions used by raw 
beef suppliers and processors to control E. coli O157:H7. These 
checklists will be completed by November 30, and will be updated 
quarterly to help the agency more quickly identify potentially 
significant changes in production controls and ensure the plant takes 
corrective action. FSIS will analyze the checklist data and use it to 
adjust programs or policies as needed, such as where the agency needs 
to conduct targeted verification testing and how to prioritize food 
safety assessments.
    To supplement current hazard analysis surveillance activities, FSIS 
is developing and will implement in November, a process to assign 
specially trained investigators to evaluate corporate practices to 
control E. coli O157:H7. These investigators will identify the 
corporations whose controls are insufficient and may pose a threat to 
public health. This will help us identify the best practices at the 
establishments, generally, and within corporations. Once those best 
practices are identified, we can encourage better controls across-the-
board, rather than on an establishment-by-establishment basis.
    By January 2008, the agency will begin using a newly developed test 
that will detect lower levels of E. coli O157:H7 contamination.
    Also in January 2008, FSIS will begin routine targeted sampling for 
E. coli O157:H7 at slaughter and processing facilities. Currently, all 
plants have an equal chance of being tested. Under this new 
verification testing program, FSIS will test larger-volume operations 
and those with recent positive tests more frequently than in the past. 
Data from the checklists that will be generated by inspection personnel 
in November will also be used to determine testing frequency for 
establishments. The results of these checklists, in turn, could lead to 
new FSIS policies, directives, and regulations.
    In Fiscal Year 2008, when FSIS conducts audits of countries 
exporting raw beef products to the United States, the agency will place 
special emphasis on E. coli O157:H7 control measures.
    It is critical that all of our food safety partners are informed 
and have the opportunity to share their ideas about the larger impact 
of FSIS' policies and regulatory actions on the food safety system. 
This way, we all work together to create the most effective food safety 
policies possible, in order to keep moving forward. Communication and 
trust is integral to that effort.
    In September, FSIS participated in an E. coli O157:H7 workshop in 
Chicago, sponsored by the North American Meat Processors Association. 
This workshop focused on small-volume beef processors that specialize 
in producing ground beef and mechanically-tenderized steaks and roasts.
    Beginning in October and continuing into November, FSIS will 
conduct outreach and training sessions around the country for small and 
very small processors of raw beef products, other stakeholders, and 
FSIS inspection program personnel. This training will focus on FSIS' 
new E. coli O157:H7 policies, as well as on lessons learned from the 
recent recalls associated with E. coli O157:H7. It will ensure that 
small and very small plants can effectively implement these measures to 
protect public health.
    On October 17, FSIS, along with the Food and Drug Administration 
(FDA) and CDC, hosted a public meeting in Washington, D.C., regarding 
pathogenic E. coli organisms other than E. coli O157:H7. We expect that 
as a result of this meeting, we will be able to ensure that any future 
steps we take to reduce the prevalence of pathogenic non-O157:H7 E. 
coli will be better understood by all of our food safety partners.
    On October 18, agency officials held a conference call with all 15 
District Offices to fully explain the new policies to combat E. coli 
O157:H7 and to discuss implementation and how activities by inspection 
program personnel in plants will be monitored through agency management 
controls.
    Agency actions must be based on protecting public health. I want to 
emphasize how important this is to me, personally. As I have often 
said, I did not move to Washington to oversee recalls; I came to 
Washington to prevent foodborne illnesses. Even one illness is too 
many. With the actions we have announced and undertaken, I believe we 
are on the right track.
FSIS' Responsibilities Related to Recalls
    As stated in FSIS Directive 8080.1, Revision 4, the purpose of a 
recall is to remove product from commerce as quickly as possible when 
FSIS has reason to believe it is adulterated or misbranded. FSIS may 
become aware of misbranded or adulterated product in commerce in 
several ways. For example, FSIS may be alerted to a potential recall 
situation by: (1) the company that manufactures or distributes the 
product; (2) test results from FSIS sampling programs; (3) observations 
or information gathered by FSIS inspection program personnel in the 
course of their routine duties; (4) consumer complaints; or (5) 
epidemiological or laboratory data submitted by state or local health 
departments, other USDA agencies, or other Federal agencies, such as 
the U.S. Department of Heath and Human Services' (HHS) Food and Drug 
Administration (FDA), the Centers for Disease Control and Prevention 
(CDC), and the Department of Defense.
    FSIS' Recall Management Staff coordinates and convenes the recall 
committee, which makes recommendations for all recalls of FSIS-
inspected meat and poultry products. When a company conducts a recall, 
which can and does occur 24 hours a day and 7 days a week, FSIS 
notifies the public through a press release, which is posted on FSIS' 
website along with a photo of the product, when practicable. The agency 
also issues recall information as quickly as possible through list-
serves, e-mails, and faxes sent directly to stakeholders, including 
Members of Congress; news media; Federal, state, and local public 
health partners; and constituents. We have begun translating more of 
the recall releases into Spanish. Individuals can also subscribe to 
receive automatic e-mail notification of recall updates, including 
press releases, directly from FSIS' website.
    The USDA Meat and Poultry Hotline (1-888-MPHotline or 1-888-674-
6854) is staffed by food safety specialists who speak English and 
Spanish and can be reached from 10 a.m. to 4 p.m. Eastern Time, Monday 
through Friday. Recorded messages are available 24 hours a day on the 
Hotline, and during most recalls, FSIS records a message to inform the 
public of pertinent recall information.
    AskKaren, FSIS' virtual representative, is available 24/7 to answer 
questions from the public about safe food preparation and handling. 
AskKaren includes information about recalls, including FSIS' role 
during recalls, how recalls are conducted, and how FSIS notifies the 
public during recalls. AskKaren also shows consumers where they can 
find information on specific recalls of FSIS-regulated products.
    After the recall occurs, FSIS conducts effectiveness checks to 
ensure that consignees have received notice of the recall and are 
making reasonable efforts to retrieve and destroy the recalled product 
or return it to the recalling firm. Upon compliance, the recalling firm 
is officially notified by letter that the recall is completed, and no 
further action is expected.
    In certain cases where FSIS has had good evidence that no 
adulterated product remains in commerce, meaning there is nothing to 
recall, but believes consumers may still have product in their homes, 
the agency has issued public health alerts, which may contain all of 
the pertinent information found in a recall press release (i.e., 
company name and contact information, pounds of product implicated, 
epidemiological information, product labels, product production dates). 
In these cases, the agency feels it is imperative to notify consumers 
of the potentially contaminated products that may still be in their 
homes--for example, product that may be in their freezers.
    To protect public health, FSIS has also issued public health alerts 
when the agency has had evidence to implicate certain types of products 
in causing foodborne illness but is not able to definitively link the 
products to a specific establishment.
    We also rely on our Federal, state and local public health partners 
in government, as well as consumer and industry representatives, to 
share this information with the public. Since public health alerts are 
very widely used in the public health community to warn consumers of 
potential health concerns (i.e., heat advisories, potential side 
effects of vaccinations, etc.), public health alerts are likely to get 
widespread local news media coverage, because it is framed as a public 
health issue instead of a business issue.
    In order to improve voluntary recalls of meat and poultry products, 
FSIS published a proposed rule on March 7, 2006, which would allow FSIS 
to make available to the public lists of retail establishments that 
have likely received the products that are subject to the recall. The 
agency held a public meeting on the proposed rule on April 24, 2006, 
and the public comment period ended on June 11, 2006. The agency has 
reviewed the public comments and is currently revising the final rule.
    FSIS issued this proposal because it concluded that making retail 
information available to the public will help consumers to better 
identify the recalled product. This valuable new information should 
help consumers to better protect themselves and their families.
    Experience has shown that during a public health emergency, early, 
detailed, accurate and consistent information is one of our greatest 
tools to prevent panic, illnesses, and a collapse in consumer 
confidence. By working closely with our partners at all levels of 
government and industry, and among consumers, we can ensure that people 
have the information they need to keep themselves and their families 
safe.
Topps Meat Company Recall
    The Topps recall of frozen ground beef products showed us that we 
needed to strengthen our policies and programs. I will outline the 
timeline of the actions that the agency took, beginning with a report 
of a human illness, which is where we often start our active 
investigations.
    This case was somewhat different because it began with an illness 
reported directly to USDA by a consumer, rather than a public health 
partner. On August 31, 2007, our Consumer Complaint Monitoring System 
received a report of a possible E. coli O157:H7-related illness 
concerning a consumer in Florida.
    According to agency protocols, that very same day, it was logged 
into our system and FSIS field investigators collected leftover product 
from that patient's freezer in Florida. Also that same day, this 
product was sent to our regulatory lab in Athens, Georgia, for testing.
    On September 7, 2007, the agency reported a positive E. coli 
O157:H7 test result from the product left over from that patient's 
freezer. At this point, we were not able to take recall action based on 
this initial test. Although we knew we were dealing with the O157:H7 
strain, we wanted to conduct further testing to characterize this 
pathogen and determine definitively that it was linked to the Florida 
patient's illness.
    The next line of testing was initiated, in the form of a pulsed-
field gel electrophoresis or PFGE test. This is the so-called DNA 
fingerprint of a pathogen. It is a secondary test done to characterize 
the pathogen more completely. The test was initiated on September 7, 
and, as usual, this test took several days to complete.
    Meanwhile, on September 8, 2007, regulatory lab in Athens, Georgia, 
had received an intact box of product from the Topps plant. Our 
protocol calls for 13 sub-samples to be tested. We treat each of them 
as an individual sample, and from this same product that had presumably 
caused the Florida patient's illness, we received 13 negative test 
results.
    On September 14, 2007, we finally received the result of our PFGE 
fingerprint testing. By that time, the Florida Department of Health 
officials had uploaded their PFGE test results from the patient and CDC 
PulseNet, and CDC's PulseNet database managers confirmed that the PFGE 
patterns were indistinguishable. We then had information that linked 
the patient to the exposure, and in this case, again, it was leftover, 
opened product from the patient's freezer.
    In accordance with our past protocol, the agency did not 
immediately convene the recall committee. On September 20, 2007, FSIS 
learned of two additional illnesses in New York State. At that point, 
we were told that the illnesses were associated with Topps product, but 
the PFGE test results were not yet complete.
    On September 22, 2007, we did get a report that the PFGE test 
results were complete in New York State, and that PFGE fingerprinting 
had linked these two illnesses with the products associated, but they 
differed from the E. coli O157:H7 fingerprint from the Florida case.
    In other words, we had discovered three different PFGE patterns 
related to three different products from the same establishment, which 
caused three different illnesses.
    Our investigators worked to solidify the link between the 
processing plant and attempted to explain the three different E. coli 
O157:H7 fingerprints. On September 24, 2007, New York State alerted 
FSIS to the fact that its state officials had already tested an 
unopened box of hamburger patties that they obtained in a supermarket, 
and that this box also tested positive for E. coli O157:H7. The next 
morning, September 25, FSIS reconvened its recall committee and that 
day, the Topps Meat Company issued its recall of 331,582 pounds of 
frozen ground beef products because of possible contamination with E. 
coli O157:H7. The product recalled was from three specific production 
dates in the plant and three separate PFGE patterns were linked to 
patients and ground beef products for those dates.
    Also on September 24, 2007, FSIS began a food safety assessment, a 
thorough scientific review of the plant, in response to the illnesses 
associated with the consumption of Topps ground beef patties. The food 
safety assessment indicated that controls were insufficient to 
eliminate or reduce E. coli O157:H7 in the raw ground beef products.
    On September 26, 2007, FSIS suspended inspection at the plant based 
on the September 25 recall; reported human illnesses; and the agency's 
food safety assessment of the establishment, which found inadequate raw 
ground process controls and sanitation concerns. FSIS began reviewing 
Topps' suppliers, and on September 29, Topps expanded its original 
recall to include a total of approximately 21.7 million pounds of 
frozen ground beef products. The recall was expanded based on 
additional positive product testing reported by the New York Health 
Department, reported illnesses, and findings from the food safety 
assessment.
    On October 4, 2007, FSIS took regulatory action (a Notice of 
Intended Enforcement) due to concerns about inadequate process controls 
for the plant's raw ``not ground'' operations. That same day, FSIS 
publicly outlined the timeline of the Topps recall, the preliminary 
findings from its investigation of the Topps recall, actions already 
taken by the agency and further steps to reduce E. coli O157:H7.
    On October 5, 2007, Topps announced it was going out of business.
    As the result of the Topps Meat Company recall investigation, FSIS 
delisted Ranchers Beef, Ltd., on October 20, 2007. No product from that 
firm has been eligible to come into the United States since that date.
    As announced on October 26, 2007, a joint investigation between the 
Canadian Food Inspection Agency (CFIA) and FSIS has identified a likely 
source of the multi-state outbreak of E. coli O157:H7 infections linked 
to the Topps Meat Company.
    On October 25, 2007, the CFIA provided FSIS with PFGE patterns, or 
DNA fingerprints, from tests of beef trim from a Canadian firm, 
Ranchers Beef, Ltd. (Canadian establishment number 630). This firm 
provided trim to the Topps Meat Company. While the firm, which had been 
located in Balzac, Alberta, ceased operations on August 15, 2007, some 
product remained in storage and was collected and tested by CFIA as 
part of the joint investigation of the Topps recall and as part of 
CFIA's own investigation into 45 illnesses in Canada from E. coli 
O157:H7.
    This piece of information, with the assistance from our food safety 
partners in Canada, helped us to determine a likely source of 
contaminated product which led to the September 29 Topps Meat Company 
expanded recall. We have a long history of cooperation and 
collaboration with CFIA.
    On October 26, 2007, PulseNet provided verification to FSIS that 
this PFGE pattern indistinguishable from those of the patients who were 
ill and from positive tests conducted by the New York Department of 
Health on product (both intact packages and open packages from 
patients' homes) that was later recalled by the Topps Meat Company on 
September 29. PulseNet is the CDC's searchable database of all PFGE 
patterns from patients and food products in the United States.
    As of October 26, 2007, CDC reported 40 illnesses under 
investigation in eight states, with 21 known hospitalizations. The 
latest onset of illness is September 24, 2007. This summer was the 
first time this rare PFGE pattern had been seen in North America. 
Thirty-one of the 40 illnesses were indistinguishable from this rare 
PFGE pattern. Investigations continue in order to find the source of 
the other two PFGE patterns linked to Topps.
    FSIS notified industry on October 26 to hold all boneless beef 
manufacturing trim from Ranchers Beef, Ltd., or raw products produced 
in whole or in part from these products until the joint investigation 
is completed. The agency, on that same day, issued a notice to 
inspection program personnel in the field to retain these products.
    As I announced on November 3, 2007, FSIS immediately began an audit 
of the Canadian food safety system that will focus on Ranchers Beef, 
Ltd. and will include other similar establishments that export beef to 
the U.S.
    FSIS has instituted additional import requirements for meat and 
poultry products from Canada. Effective this week, FSIS will increase 
testing for Salmonella, Listeria monocytogenes and E. coli O157:H7 and 
will require that shipments be held until testing is complete and 
products are confirmed negative for these pathogens. In addition, 
Canadian meat and poultry products will receive increased levels of re-
inspection by FSIS to confirm they are eligible to enter commerce when 
presented at the U.S. border.
    The audit and stepped up actions at the border are being conducted 
because of concerns about testing practices at Ranchers Beef, Ltd., 
that were discovered as part of the ongoing investigation. FSIS will 
review the preliminary findings of this audit to determine whether 
there is need to continue these additional interim requirements.
    These measures are being taken to further ensure the equivalency of 
the system already in place. We continue to work together with our food 
safety partners both domestically and internationally to ensure 
imported meat and poultry products are produced under food regulatory 
systems equivalent to those in the United States, and provide the same 
level of protection against food hazards as is achieved domestically.
    On November 2, 2007, FSIS Administrator Alfred Almanza and an 
additional senior FSIS food safety official met with their counterparts 
at the CFIA to inform them of increased testing and re-inspection 
requirements.
Conclusion
    We will continue to engage the scientific community, consumers, 
public health experts, Congress, our own employees and all interested 
parties in an effort to identify science-based solutions to public 
health issues to ensure positive public health outcomes. We all know 
that we can save lives with sensible science-based policies and 
together we'll do just that.
    Mr. Chairman, thank you again for providing me with the opportunity 
to address the Subcommittee and submit testimony regarding the steps 
that FSIS is taking to remain a world leader in food safety and public 
health. I look forward to working with you to improve our food safety 
system.

    The Chairman. Well, thank you, Mr. Secretary, and we do 
recognize the lengthy statement you have prepared, at 20 some 
pages, and we think that review is quite thorough, and we 
appreciate that, that you have taken the time to prepare that 
for us; and you called attention to it, your website.
    At this time I would like to recognize Ranking Member Hayes 
for any opening comments that he might make.

  OPENING STATEMENT OF HON. ROBIN HAYES, A REPRESENTATIVE IN 
                  CONGRESS FROM NORTH CAROLINA

    Mr. Hayes. Thank you, Mr. Chairman and Chairman Peterson. 
This is a very valuable hearing, very necessary. We are here 
for one purpose and one purpose alone, to ensure that we do 
have the highest standards of food safety. Very appropriate 
that we are here today.
    We have the safest food system anywhere in the world. I 
will submit my prepared statement for the record, but again, I 
would reemphasize that we are here to examine and confirm that 
our processes and procedures are effective and accurate and 
ensure the safety that connects consumer, processor, and 
producer. So, Dr. Raymond, thank you for your commitment to 
medicine and the general health of everybody, and, Mr. 
Chairman, thank you for doing this.
    [The prepared statement of Mr. Hayes follows:]

 Prepared Statement of Hon. Robin Hayes, a Representative in Congress 
                          From North Carolina
    Thank you, Mr. Chairman, for holding this hearing relating to the 
safety of our food supply. I cannot stress enough how important this 
topic is to all of our constituents. It is always worrisome when 
Federal regulators request that food or consumer products must be 
recalled for safety reasons, and tragic when a contaminant in our food 
supply results in even a single case of foodborne illness.
    In recent years, our food safety system has undergone dramatic 
changes which have resulted in improvements across the board. Industry 
has made improvements in their internal systems; new technologies have 
been introduced which have mitigated the risk of contamination with 
foodborne pathogens; and our regulatory agencies have implemented some 
fairly progressive enhancements in their inspection systems.
    Despite these laudable efforts, the magnitude of the recent recall 
of ground beef has received a great deal of press attention which I 
fear has left the public with the impression that our food safety 
system is failing them.
    As of today, there have been 19 recalls of beef products resulting 
from contamination with E. coli O157:H7. This compares with eight 
recalls in 2006, five in 2005, and six in 2004. Fourteen of these 
recalls have occurred since the beginning of June when the Food Safety 
and Inspection Service began observing an increasing prevalence of E. 
coli O157:H7.
    Today, I would like to hear from the Under Secretary about what 
research is being conducted to determine the cause or causes of the 
increasing prevalence of E. coli O157:H7? What actions have the agency 
and industry taken to mitigate this risk? What can consumers do to 
further minimize the risk of foodborne illness?
    Mr. Chairman, thank you again for holding this hearing. I yield 
back.

    The Chairman. You bet. We appreciate your comments and, for 
other Members, if they want, the chair requests they submit 
their opening statements for the record so that we can get on 
with our process.
    At this time I am going to vary the system a little bit, 
with the concurrence of my Ranking Member, and recognize Mr. 
Peterson for the questions he might have, because of his 
schedule. Mr. Peterson?
    Mr. Hayes. I concur.
    The Chairman. Thank you.
    Mr. Peterson. Well, thank you very much, Mr. Chairman, and 
thank you and Mr. Hayes for your leadership and, again, for 
this hearing. Dr. Raymond, how much does it cost FSIS to take 
samples on an annual basis.
    Dr. Raymond. Mr. Chairman, I don't have that number 
available, but I certainly will make it available to you from 
my staff.
    Mr. Peterson. Okay. Also, can you tell me how much it costs 
FSIS to take each individual sample?
    Dr. Raymond. How much per test? Dr. Goldman tells me it is 
just a little over $100 for each test that we do, and our 
budget is about $45 million per year for our testing program--
$15 million, I am sorry.
    Mr. Peterson. Fifteen million dollars. If you can give me 
the breakdown on how many samples you are taking and so forth.
    Dr. Raymond. Absolutely.
    Mr. Peterson. Yes. How often does FSIS take samples at each 
plant?
    Dr. Raymond. Currently it is about once per month. We will 
be changing that in January, when we begin a more targeted 
sampling that will be based on the plant's history and 
production volume.
    Mr. Peterson. And how often do the plants themselves take 
their own samples?
    Dr. Raymond. That varies plant by plant. Some do not take 
samples at all, and others take samples as often as every 15 
minutes.
    Mr. Peterson. And why is that?
    Dr. Raymond. That is a corporate decision.
    Mr. Peterson. And you don't have any problem with that; 
that there is such a wide disparity?
    Dr. Raymond. A lot of that is dependent upon the volume the 
plant produces and also, obviously, cost-effectiveness. We do 
not mandate the plants do testing, so, no, I have no problem 
with it.
    Mr. Peterson. Do we know how much it costs the plants to do 
these samples?
    Dr. Raymond. I do not.
    Mr. Peterson. Is there any way to find that out?
    Dr. Raymond. Yes, there is, and we will get that for you, 
too.
    Mr. Peterson. Good. How many Notices of Intent to Delist 
were issued to Canada during your last audit?
    Dr. Raymond. Six.
    Mr. Peterson. Six? Do you treat Canada the same as you do 
all other countries that import meat products to the United 
States, even though, according to the FSIS audit report, it 
appears that they have inadequate systems in place? According 
to your own audit report, I guess.
    Dr. Raymond. Our audit report found some deficiencies which 
were corrected quickly, promptly, by the Canadian system and by 
the plants that were involved. This is not unusual, when we do 
our annual audits, to find a plant or two or more that have 
deficiencies. It is not unusual to either delist a plant or 
send a Notice of Intent to Delist. It is the same as sometimes 
happens with us when we are audited by our international 
partners.
    Mr. Peterson. So the problems that you found have been 
solved?
    Dr. Raymond. Yes, they have.
    Mr. Peterson. Do we know how the problem occurred with the 
Canadian meat that came in that caused the E. coli problem in 
Topps?
    Dr. Raymond. Yes, sir, we do.
    Mr. Peterson. So that has been tracked down? But you are 
satisfied with what the Canadians are--well, apparently you 
aren't, because now you are holding the trucks at the border 
until they can certify that the test results are okay. Is that, 
I understand, how you are doing things?
    Dr. Raymond. Yes, sir, that is correct. I have asked our 
inspection personnel at the import houses to do that as a 
matter of caution, until we can complete an audit of this 
particular plant and its products. We want to make sure that 
none of that product is still coming across the border, and 
also to make sure that that was an isolated incident and has 
not been repeated in any other slaughter plants in the Canadian 
system.
    Mr. Peterson. Thank you. In responding to my letter asking 
questions about the public health alert issued by FSIS on 
August 30, on the second page it suggests that in certain cases 
when FSIS has evidence that all product in question may still 
be in people's refrigerators or freezers, FSIS has issued 
public health alerts that include information similar to what 
would be found in a recall press release. But later on the same 
page it says that the agency has not previously issued a public 
health alert similar to the one issued August 30. Can you 
clarify for the Committee how the agency determines if a 
product may be in consumers' freezers and why a recall was not 
necessary in this case?
    Dr. Raymond. Yes, sir. I will do my best. In this 
particular case, the product involved was 1 pound packages of 
fresh, raw ground beef with a very limited sell-by/use-by date. 
By the time that we were made aware of the investigation that 
had been going on in the Northwest, and they had identified 
these eight to ten cases that were linked epidemiologically, 
the sell-by/use-by dates had long since gone by. We sent some 
of our investigators from OPEER and the field office into some 
of the retail outlets and found no product remaining on the 
shelves or in the coolers of these particular stores. At the 
same time, this particular company was also surveying their 
list of consignees, and they all said that there was no product 
left on their shelves. It had all been sold or destroyed or 
returned to be cooked by those use-by dates, and, again, our 
investigators confirmed that finding. So we felt that probably, 
because they were small, 1 pound packages, they probably had 
pretty much been consumed. But we realized there may be some in 
someone's freezer or some in someone's refrigerator that hadn't 
been used by the consume-by date, and we felt the public needed 
to be aware of that, especially since there had been illnesses. 
And that is why we did issue the public health alert, so the 
public would be aware that if they bought this particular 
product and still had it in their refrigerators or freezers 
they should either destroy it or return it.
    Mr. Peterson. Mr. Chairman, I have one last follow-up. In 
response to my September 14 letter, we asked, prior to issuing 
the public health alert on August 30, did the FSIS recall 
committee at any point request that Interstate Meat 
Distributors conduct a recall of the product named? Your answer 
was, yes, you did, but then FSIS changed your answer because of 
new information. Can you explain what kind of information you 
received and what was involved in that decision process?
    Dr. Raymond. Yes, sir, I can. It was the same day that we 
had requested that the company consider a recall. They informed 
us that they had done this survey of the people they sell to, 
and that there was no product left on the shelves. It was 
actually that very same day, that very same hour, that we made 
that request that our folks in the field reported back that 
they had found no product on the shelves. That is why we 
changed from asking them to do a recall to doing the public 
health alert.
    Mr. Peterson. Has FSIS ever changed their position in 
asking for a recall before this occurrence? Has that ever 
happened?
    Dr. Raymond. Not that I am aware of, sir.
    Mr. Peterson. Yes. All right. Thank you. Thank you, Mr. 
Chairman.
    The Chairman. Thank you. We have a vote request, or a vote 
call, going on, but I think I will start the questions just for 
the couple here, and then we will break and go do our vote. 
But, Dr. Raymond, in 2004, six out of 48 recalls were 
associated with E. coli, but in 2007, 16 out of 40 have been 
due to E. coli. Can you explain why we have seen this increase? 
What is your evaluation?
    Dr. Raymond. I think there are several factors, Mr. 
Chairman, and I will admit that these are my feelings and 
beliefs, and I don't have science. But, for instance, I 
mentioned in my opening remarks there have been a couple 
recalls that we have done since Topps that we would not have 
done a year ago because of open product in patients' freezers, 
and I do believe that that is a reason to do a recall, so there 
are two of them that would not have occurred in the past. That 
is one example. We do a much better job with our outbreak 
investigations than we have in the past, partly because of a 
system called PulseNet that is cosponsored by FDA, the USDA, 
and the CDC, and this allows PFGE patterns, the fingerprint of 
the E. coli O157, to be submitted to CDC and put into a common 
computer system, and it is a system that also includes E. coli 
from our plant product testing. And we can now link what 
ordinarily might have been isolated instances of illnesses, and 
we can link them into clusters, and we can better identify the 
source. Each year, we get better with that. The other theories 
that I have, and we are doing some research on most of these, 
and there are probably other ones that we will find out at a 
meeting that we are conducting this fall with top food 
scientists, industry, and consumers to see what they all think 
about the rises. Some factors that may enter into this is the 
inclement weather that we saw this year in the Southwest, with 
severe drought, and severe moisture in the Midwest, where a lot 
of cattle are on the hoof. Weather changes like that do stress 
cattle and do cause higher E. coli levels. We have seen 
elevated corn prices because of biofuel use, and feeders are 
changing what they feed cattle because of costs, and when you 
change what you feed cattle, you do change the contents of 
their intestines. And we are doing research at the Animal 
Research Center in Clay Center, Nebraska, under the ARS of USDA 
to determine different feeding patterns. And hopefully we will 
actually find some feed patterns that will lower E. coli, but 
we need to find out if the patterns we have seen now have 
increased it. We have also seen an increase in turn-over of 
skilled employees at some of our plants, and when you have a 
turn-over of skilled employees and get less skill, you are more 
apt to see some human errors also. Again, theory, not proof. 
There are probably other factors that we are looking into. I do 
not believe it is because the industry has gotten careless or 
sloppy. I do not believe it is because our inspectors have 
become less diligent. I do believe there has been a change in 
the ecology of the bug. It also may be that this particular 
pathogen has changed, has morphed. We know that bacteria 
develop resistance to antibiotics. There is no reason to 
believe that E. coli O157 might not develop resistance to some 
of the antimicrobial treatments that we have been using in the 
plants for the last 10 years. Those are all things we need to 
find out. I think it is further upstream than in the plants. I 
think it is starting with the animals' environment.
    The Chairman. Well, I appreciate what you have said about 
the theory, and are you taking steps to put science to some of 
that, to ensure that your theory is correct?
    Dr. Raymond. I don't know that it will ensure my theories 
are correct, but we are certainly taking steps to find out if 
they are correct or not. We are also doing other research to 
look into the causes for the increase, yes, sir.
    The Chairman. Okay. With that, I think we will stop now and 
go take care of this voting, and we will return as quick as we 
can. We have two votes, and then we will be back. I think the 
second vote is a 5 minute, so we hope to be back shortly.
    [Recess.]
    The Chairman. I think we will continue with my questions. I 
have a couple minutes left, and by that time I think Mr. Hayes 
will be back, and we will continue on. Doctor, you may have 
answered this question. I think you did, part of it, in that 
first address, but I guess I was thinking about during 
operations centers and things in my own background. It seemed 
like we need something like this going on. And I am just 
wondering if FSIS, the CDC, state Departments of Health, and 
FDA are working together and how that is going on? I think you 
touched on it. Would you just elaborate a little bit, if that 
is happening, and how it is happening?
    Dr. Raymond. Absolutely. Be glad to. When there is a 
foodborne illness, it is usually identified by a healthcare 
practitioner, based on a culture. Once that culture is back, 
depending on state laws, it is usually mandatory, particularly 
for E. coli O157, that the result will be reported to the state 
and/or local health department. It is the state or local health 
departments that do the epidemiological work to start with, to 
try to figure out the source of the infection and to link it to 
others within that state. At the same time, when they get the 
PFGE, they will forward that to the CDC, so the CDC can help 
coordinate interstate investigations and bring them together. 
FDA and USDA will get involved early on in situations like 
that, oftentimes before a product is identified, so that we are 
made aware of it, so we can work with them. Although, we do not 
ordinarily do any of the investigative work. Our work is to 
work with the plants on recalls, et cetera, although, we 
coordinate very closely. Sometimes we will be made aware of an 
infection by the consumer hotline directly. A patient can call 
in to us and say, ``I think I have a foodborne illness, or I 
have a foodborne illness. My doctor just told me it is E. coli 
O157,'' and we will be made aware of it that way, by other 
channels. But usually it starts out with state and local and 
then it goes up the Federal ladder. I hope that is what you 
were looking for.
    The Chairman. It is, and I appreciate that. I am going to 
now ask Mr. Hayes to go right in with the questions he might 
have, and we will go through a 5 minute process with different 
Members as they arrive and so on. And we will probably have 
more than one round, so I will be back to you in a little bit. 
So, Mr. Hayes.
    Mr. Hayes. Thank you, Mr. Chairman, and you answered my 
question about the round. I do have several questions. Dr. 
Raymond, again, thank you for being here. When requesting a 
meat recall, you rely on the cooperation of the industry to 
carry out the request. Some observers fear that if legislation 
granting mandatory recall authority is enacted, cooperation 
between the agency and industry would disappear, and some 
recall orders would be litigated under the company's right to 
due process. FSIS will certainly have to create a formalized 
review process if recall authority became mandatory. Will you 
support mandatory recall authority for meat, poultry, and egg 
products?
    Dr. Raymond. No, we do not support it, sir. We think our 
system works very well.
    Mr. Hayes. Okay. There were 14 recalls related to 
contamination with E. coli, and you know the numbers, since the 
beginning of June, three of which were announced last week 
alone. Is this indicative of a problem with our Food Safety and 
Inspection Service?
    Dr. Raymond. No, I do not believe it is a problem with the 
program itself.
    Mr. Hayes. Okay. I will come back to that in just a minute. 
This past June, FSIS observed an upward trend in E. coli 
prevalence. When were you made aware of these data, and what 
actions did you personally undertake to determine the cause? 
You sort of touched on that before, but if you could hone in on 
it a little more?
    Dr. Raymond. I believe, to the best of my recollection, I 
was probably made aware of the increase in product sampling 
that was coming back positive probably in April or May. It was 
a very slight increase, but some of our scientists didn't know 
if it was a blip or if it was the start of a trend, but they 
wanted me to be aware of it at that time. Because it was a very 
small increase, I did not ask them to do anything different 
with it but just to keep me posted and keep an eye on it. It 
was in the next couple months that trend continued, and we 
began to see some increase in recalls due to illnesses. It was 
in June that we sat down and initiated some of those policies, 
the first and most simplest being nearly doubling the testing 
in July to try to see how big this problem might be.
    Mr. Hayes. E. coli is a naturally occurring bacteria that 
is out there all the time. That is my understanding. I want to 
make sure we affirm that. Correct?
    Dr. Raymond. Yes, it is, sir.
    Mr. Hayes. All right. Is it your view that you need new 
legal authority to address current food safety challenges, or 
are you able to do so within your existing rule-making 
capabilities? How are you adapting that to the Topps recall?
    Dr. Raymond. I believe we have all the legal authorities 
that we need to do our job, and we obviously can use rule 
making at times. We can also use notices and directives when 
that is permissible under the HAACP regs, et cetera.
    Mr. Hayes. Dr. Raymond, there has been a lot of trouble 
with other imported ingredients outside of your agency's 
jurisdiction? What do you do at FSIS that sets you apart with 
regard to meat on equivalency?
    Dr. Raymond. Sir, there is quite a bit, and I will try to 
highlight it very quickly. If a country asks for permission to 
export a meat or poultry product to this country, we will audit 
that country's system first. We will take a look at the 
paperwork, make sure they have the legal authorities, 
regulatory authorities, make sure they have the Federal 
inspectors, et cetera, like we do. If the paper audit appears 
favorable, we will do an in-country audit, where we will 
actually inspect the plants, laboratories, headquarters, et 
cetera. If their whole food safety system is found to be 
equivalent to ours for a particular product, they may be asking 
for poultry, they may be asking for beef or pork, they may be 
asking for all, it is determined equivalent for that particular 
species. We will work with our sister agency, APHIS, the Animal 
and Plant Health Inspection Service, to make sure they have no 
problems with product coming in from that country that might 
endanger our animals of the same species. For instance, in 
Brazil they can only ship cooked beef, because of hoof-and-
mouth disease. After we made the equivalence determination, 
that it is equivalent, we then go through a formal rule-making 
process, which, as you know, could be quite lengthy. We will 
write a proposed rule which will go through clearance. It will 
get printed in the Federal Register, 60 to 90 days for public 
comment, and then we have to address those comments. We then 
write a final rule, go back through clearance, and then 
eventually get it printed in the Federal Register. We have done 
that for 33 countries, 29 of them currently are shipping 
product to this country. Once we have determined equivalence 
and they are allowed to ship, we then do annual audits, in-
country, to make sure they are maintaining that equivalence, 
or, if we have changed any equivalency issues, that they have 
adjusted. And then the third thing that we do to assure that 
this product is safe is we also re-inspect nearly every 
shipment that comes into this country, and ten percent of the 
boxes or loads are opened up and visually inspected for 
content. The boxes are examined for being intact and not 
damaged or tampered with, and about five percent of product 
that comes into this country, meat and poultry products, will 
be microbiologically tested for pathogens and/or residues.
    Mr. Hayes. Thank you, Dr. Raymond, for your concise 
answers, and Mr. Chairman, I will yield and wait for the second 
round.
    The Chairman. Okay, well, thank you, Mr. Hayes. At this 
time I noticed that we have been joined by Ranking Member of 
the full Committee, Mr. Goodlatte, and I would like to 
recognize him for any remarks he might like to make.

 OPENING STATEMENT OF HON. BOB GOODLATTE, A REPRESENTATIVE IN 
                     CONGRESS FROM VIRGINIA

    Mr. Goodlatte. Well, Mr. Chairman, thank you very much. I 
regret I wasn't able to be here when the hearing started, but I 
want to thank you for calling this hearing. This is a very 
important issue. In fact, I would say, of all the issues this 
Committee is responsible for, I don't believe that there is 
anything more important than assuring the safety of our 
nation's food supply.
    While the media attention to recent recalls of meat and 
poultry products has led some of our colleagues to question the 
effectiveness of current food safety law and regulation, I 
would suggest that, prior to assigning blame, we should first 
seek to understand what if anything may be wrong with the 
system. More importantly, we have to determine why the 
prevalence of E. coli is an increasing trend. It is my 
understanding that this past summer managers within the Food 
Safety and Inspection Service began to observe trends in their 
microbiological test results, indicating increased prevalence 
of E. coli O157:H7. I suspect that the agency has been working 
diligently to determine the cause, and I look forward to a 
discussion of their actions and working theories.
    The most important aspect of this hearing is to determine 
how the agency, from the Under Secretary down to the line 
inspectors in the plant, responded to this information and what 
lessons can be learned from their subsequent actions. Working 
to ensure food safety requires constant vigilance and a 
capacity to incessantly review and improve the safety process 
and procedures. In the event that mishaps do occur, and it 
would be unrealistic to believe that they won't, every effort 
must be made to identify the source of the problem, take 
corrective action, and incorporate increased vigilance and 
preventive efforts into daily operations.
    Again, Mr. Chairman, thank you for holding this hearing. I 
yield back at this time, and at a later time I will ask some 
questions of the witness.
    The Chairman. Well, thank you, Mr. Goodlatte. At this time 
the Chair recognizes the gentleman from California, Mr. Costa, 
for 5 minutes.
    Mr. Costa. Thank you very much, Mr. Chairman, for your time 
and the efforts of Members of the Committee to deal with this 
very important issue.
    I would like to start today by reflecting, as I think a 
number of Members have, that when you look at the size of the 
production of the American beef industry, that produces over 25 
billion pounds of high-quality beef each year, 36 billion 
pounds of poultry, and 21 billion pounds of pork, that it is a 
remarkable accomplishment. Due in fact, that we have the high 
level of standards that we do. Certainly, detection of E. coli, 
Listeria, and Salmonella and any other pathogens in our food 
supply is a concern to all of our consuming public. We should 
do everything we possibly can from the administrative effort as 
well as what makes good public policy here in Washington.
    Dr. Raymond, I want to ask you a number of questions, and 
if time doesn't allow I will submit them for your written 
testimony response. But I want to first of all talk about the 
issue of risk management versus risk assessment. You spoke, in 
your closing comments in your opening statement about that one 
illness is one too many, to paraphrase your comment. And I 
agree. One death is one too many.
    We provide a framework of policy for food safety in 
America. We do the same as it relates to automobile safety. 
When we are talking about risk assessment versus risk 
management, we have to try to do our very best, but I want to 
get an understanding from you, given the pathogens that exist 
within the food system, whether or not the notion that somehow 
you create an expectation level that we can create zero risks. 
I mean, we have over 40,000 deaths with people who get into 
their car every day and drive throughout the year: 40,000 
Americans that lose their lives throughout the year being in an 
automobile, yet we try to provide auto safety. The deaths that 
we have, or the illnesses, by comparison, relative on food 
safety, is far safer to get up in the morning and to have your 
breakfast or to have a nice dinner. What is the expectation 
level that you think is realistic that we can provide for the 
American consuming public as it relates to our beef and the 
other meat products that we consume?
    Dr. Raymond. I thank you for the question, Congressman. We 
obviously are in no position to tell the American public that 
raw meat and poultry are declared pathogen free. We don't have 
the science to make that kind of a statement, so we do need to 
work with the American public to make sure they know how to 
properly handle, prepare, and cook meat and poultry products. 
In relation to ground beef, for the last 3 years, our product 
testing, our sampling of product in the plants, was positive at 
a consistent rate of 0.17 percent.
    Mr. Costa. Repeat that number?
    Dr. Raymond. 0.17 percent. That is pretty good. To put it 
in perspective, out of about 12,000 tests that were drawn, 20 
were positive. That is really good. But that is such a virulent 
pathogen, that is 20 times product would have gone out into 
commerce if we had not tested it and detained it, and that 
could have made a lot of people really ill.
    Mr. Costa. Understandable, but in terms of a comparative 
analysis, as I was attempting to do a moment ago with 
automobile----
    Dr. Raymond. Right.
    Mr. Costa.--safety, if we could attain that level of safety 
for American drivers, it would be phenomenal.
    Dr. Raymond. It would be, sir, and, but with all due 
respect, I just need to point out that the testing percentage 
for this year has gone up considerably, and that is my concern, 
is that we are not at that 0.17 level any more.
    Mr. Costa. Well, let me get to that point, because I have a 
number of questions. The meat industry, have they been 
cooperative in this effort to deal with E. coli O157, in your 
opinion?
    Dr. Raymond. They are extremely cooperative.
    Mr. Costa. What are the most significant ways in which the 
pathogen can be reduced or eliminated in the harvesting or 
processing and the operations, in your opinion now?
    Dr. Raymond. The most significant way would be to eliminate 
it from the intestine of the cow, and that would be with either 
vaccines or bacteriophages that are being developed and 
hopefully will be able to be used soon.
    Mr. Costa. Has the implementation of the new regulatory 
process, in your opinion, helped make meat products safer for 
consumers?
    Dr. Raymond. If you are referring to HAACP, yes.
    Mr. Costa. Yes.
    Dr. Raymond. Yes, that is what we have seen, and we have 
seen an 80 percent drop in product testing, and we have seen a 
32 percent drop in foodborne illness.
    Mr. Costa. Are we going to reach out on an international 
level to provide that same standard?
    Dr. Raymond. HAACP is an internationally-recognized----
    Mr. Costa. But I mean, in the alliance, to provide the 
technical and the regulatory support, is it there?
    Dr. Raymond. Yes, it is.
    Mr. Costa. Okay. I have a number of other questions, Mr. 
Chairman, but my time has expired, and I will submit them for 
the record. I want to thank you again for this hearing.
    The Chairman. Thank you. Mr. Goodlatte, do you have any 
questions?
    Mr. Goodlatte. Yes, thank you, Mr. Chairman. Dr. Raymond, 
in response to the Topps recall, senior managers with FSIS 
indicate that they would be evaluating the training records of 
the in-plant inspectors to determine if there were any 
inadequacies in the instructions related to HAACP compliance 
inspections. Can you update the Committee on the agency's 
findings?
    Dr. Raymond. Ken, are we done? Okay. Dr. Peterson, who is 
the Assistant Administrator for the Office of Field Ops., says 
we would be happy to submit this for the record, the detailed 
report, that it is part of the revised training that is being 
developed right now to address those issues.
    Mr. Goodlatte. All right. Two recalls in the past few weeks 
have occurred because ready-to-eat products such as frozen pot 
pies and frozen pizzas were linked to foodborne illness 
outbreaks. It is my understanding that all tests of intact 
product have come back negative for the adulterant. Under your 
policy, if a ready-to-eat product was a common food source in a 
foodborne illness outbreak, but you could not verify the 
presence of the pathogen in any intact packages of the product, 
would USDA request the company to recall it?
    Dr. Raymond. If the epidemiological evidence linked to the 
product, yes, we absolutely would request them to do a recall. 
And we have on many occasions.
    Mr. Goodlatte. And have you ever had them not comply with 
those voluntary recall requests?
    Dr. Raymond. No, we have not.
    Mr. Goodlatte. Very good. What role does trace-forward play 
in recalls?
    Dr. Raymond. If I understand the question, trace-forward is 
just what we do when we ask for a recall, and a company does 
the recall. Our inspectors, part of our workforce, go into the 
stores to make sure it has been removed from the shelves, if 
that is the question. And obviously once we have done that we 
either find that the recall is done and the product has been 
removed, or, if it hasn't been removed, we readdress the issue.
    Mr. Goodlatte. Do you have cooperation in that regard? Does 
your trace-forward program indicate companies are removing the 
product from the shelves when requested to do so?
    Dr. Raymond. With very rare exceptions, and the exceptions 
are when it is maybe perhaps massive, and all the stores didn't 
get the message at the same time. But, yes, it has been 
extremely successful.
    Mr. Goodlatte. What are the weakest links in your ability 
to track the products through commerce?
    Dr. Raymond. Well, I think actually the weakest link is 
knowing who bought it. I think we have good, strong links in 
linking it to the retail stores and to the restaurants, but it 
is the who bought it and what did they do with it is where we 
need to get better at. We also need to identify the retail 
stores when we do recalls, so the consumers that have it in 
their refrigerators or on their shelves will know, ``I bought 
it at X supermarket on this date, and that is the supermarket 
where they say it was sold at.'' I think that will strengthen 
that link between the retail store and the consumer.
    Mr. Goodlatte. So the increasing use of technology by the 
distributors and the retailers in getting the message to that 
end-user is something that can be enhanced?
    Dr. Raymond. That can be enhanced, but the recalls can also 
be enhanced by identifying retail stores.
    Mr. Goodlatte. Very good. Thank you, Mr. Chairman.
    The Chairman. Thank you, Mr. Goodlatte. At this time we 
would like to recognize Mr. Lampson for questions he might 
have. Five minutes.
    Mr. Lampson. Thank you. It seems that a lot of illnesses 
occur due to cross-contamination and improper cooking methods. 
What steps has the USDA taken to better educate consumers when 
it comes to safe food preparation?
    Dr. Raymond. We have a very, very active consumer education 
program. We work with our food safety education partners, which 
includes both consumer organizations and industry, quite 
closely. They help us a lot. They actually provide some of the 
funding for what we do and what they do. We have the Clean, 
Separate, Cook, and Chill campaign that is widely recognized 
throughout the country. We just within the last year instituted 
the new Be Food Safe campaign with our food safety education 
partners. We have made pamphlets, brochures, things that are 
available to use in newspapers, or in media, available to our 
state and local health partners in food safety. They can use 
our materials, and they can put their own logo on so that they 
get some recognition. I feel that people out in rural America 
will listen to their local health official more than they will 
listen to me, speaking from D.C. So far we have had 7,000 
requests for that information, those packets, those brochures. 
We obviously have public service announcements on a regular 
basis. We do film clips for PSAs, for events like Thanksgiving 
and Super Bowl, where people gather in large numbers and 
sometimes don't practice safe food handling, because they leave 
things out after Thanksgiving dinner, watch the football game, 
or whatever. We try to address those. We try to do a lot of our 
communications multi-lingually. We try to involve personalities 
when we can that might get the public's attention, again, more 
than me. It has been very successful, and it is a big part of 
what we do. It didn't used to be. We used to be the regulatory 
agency. Now we try to put the ``and'' in Food Safety and 
Inspection Service.
    Mr. Lampson. The State of New York has a policy of issuing 
a consumer warning when an outbreak is suspected so that 
citizens can take some kind of proper precaution. Would it be 
possible for the USDA to issue a consumer warning as an 
investigation is taking place so that consumers can take 
precautions when preparing meat, in order to reduce possible 
illnesses?
    Dr. Raymond. Congressman, I don't think that would be 
helpful. It probably would cause concern and perhaps less trust 
than they currently have in the system if we put out a warning 
and then, 2 days later, said, ``False alarm. You don't need to 
worry.'' As soon as we have a link to a product that we know is 
solid, we will do the recall or the public health alert, 
whichever is most appropriate. To your previous question, a 
couple other things we do have. We have the AskKaren hotline, 
which is a 24 hour line people can call in and ask food safety 
questions. It is a virtual line, that they will get an answer. 
And then we also have the M&P hotline, so when people are 
preparing Thanksgiving dinner and they wonder, can you cook a 
frozen turkey, or how long, we do have those information 
sources also available for public education. They are widely 
utilized.
    Mr. Lampson. The next one, currently when adulterated 
products are discovered, the FDA and FSIS have the ability to 
request a voluntary recall or to seize and detain products. The 
President yesterday announced a proposal to give the FDA 
mandatory recall authority when a company refuses a voluntary 
recall. What implications would giving this authority to FSIS 
have?
    Dr. Raymond. I do not believe it would improve what we do 
at all, because I think we do a really good job with recalls at 
this point in time. Once the product is recognized, and the 
illness is attributed to a product, we have no problem with 
industry. They have always complied with our requests for 
voluntary recalls.
    Mr. Lampson. Then is this unnecessary?
    Dr. Raymond. I believe it is totally unnecessary and might 
be bothersome, because I don't want to take a system that 
really works well and run the risk that it will work less well.
    Mr. Lampson. According to news reports, New York and 
Florida were both investigating an outbreak that apparently 
FSIS was not informed as to the state of their investigations 
or test results. Can you discuss what procedures are in place 
to facilitate communication between various agencies, including 
state Departments of Health, the CDC, FDA, and FSIS?
    Dr. Raymond. Certainly. The states have laws that require 
reporting of certain illnesses. They do vary state by state, 
but most of the common foodborne pathogens are mandatory 
reporting by the state. If a healthcare provider detects a 
foodborne pathogen in an ill patient, that will be reported to 
the state Health Department in most states. State Health 
Departments work closely with their local health departments. 
Each state is different, but someone will go do an 
epidemiological investigation on that illness, and sometimes 
even the state Departments of Agriculture will get involved if 
there are samples to be taken from retail stores, et cetera. So 
multiple local partners and state partners get involved first. 
They report their findings to the CDC, and the CDC will then 
coordinate a broader epidemiological investigation that 
involves more than one state border. They will try to tie these 
isolated incidents together with PulseNet and say, ``We have an 
outbreak.'' At some point in time, the investigation will begin 
to point a finger at a product, hopefully, but not always. Most 
outbreaks do not have attribution. They do not point a finger 
at meat or poultry or produce. When they do, that is when we 
get involved, or the FDA gets involved, and sometimes we get 
involved jointly, because it may be the pizza that has been 
mentioned here, or the pot pies. Those pot pies have wheat, and 
they sometimes have dairy products. They certainly have produce 
in them, as do the pizzas. It takes a great deal of work 
together to determine whether it is a product we regulate or a 
product they regulate.
    Mr. Lampson. Thank you very much, Dr. Raymond. I yield back 
my time, Mr. Chairman. My time has expired.
    The Chairman. Thank you. The Chair recognizes Mr. Rogers 
for 5 minutes.
    Mr. Rogers. Thank you, Mr. Chairman. I want to go back and 
follow up on the questioning that Mr. Costa was talking about 
risk-based assessments or inspections. You were talking about 
the contamination level this year was higher than last year's 
baseline level of .17.
    Dr. Raymond. Yes, sir.
    Mr. Rogers. How are you establishing that baseline for 
inspection?
    Dr. Raymond. We do about 12,000 ground beef samples per 
year in plants that produce ground beef. That is our baseline, 
and we have been doing this for quite a few years. We saw an 80 
percent drop from 2003 to 2004 and maintained at that 0.17, and 
this year. I could look up the exact number we have done so 
far, but the percentage positive is about 0.22 percent.
    Mr. Rogers. In these 12,000 samples, is there some risk-
based criteria that you apply to those samples to discern which 
ones you are going to test and which ones you are not?
    Dr. Raymond. No, sir, there is not at this time, but we are 
taking corrective actions to put some targeting to the way we 
sample currently. A small plant is just as likely to get 
sampled as a large plant, and that just doesn't make sense to 
me. The agency has developed a system that will be implemented 
in January that will do more targeted sampling. The larger 
plants will get more sampling, just because more people can be 
exposed. Sampling will be based on the plant's past history. If 
they have had positive samples in the recent past, they are 
going to get more sampling, be they big or small, et cetera, et 
cetera.
    Mr. Rogers. Are those the only two criteria that you are 
going to be looking at----
    Dr. Raymond. No.
    Mr. Rogers.--the volume and their history?
    Dr. Raymond. No, sir.
    Mr. Rogers. What other criteria might be applicable?
    Dr. Raymond. What other criteria besides volume and past 
samples? Plant performance on PBIS, our own inspection service, 
non-compliance reports that indicate the plant is doing less 
than a stellar job in enforcing their policies, consumer 
complaints that may be related to the plant can do that. If our 
inspection force sees a lack of process control, carry-over 
from one day to the next of a work product without a way to 
isolate that, things that create risk will create increased 
testing.
    Mr. Rogers. You said that this year's rate of contamination 
was higher. What is it this year compared----
    Dr. Raymond. It is about 0.22.
    Mr. Rogers. That is about a 50 percent increase in what you 
had last year?
    Dr. Raymond. About a 33 percent, I believe, sir.
    Mr. Rogers. Okay. It is my understanding that some meat 
imports are further packed or processed in USDA-inspected 
facilities. Is this packaging and processing carried out under 
continuous inspections by USDA?
    Dr. Raymond. Slaughter is carried out under continuous 
inspection processing, and packing is under daily inspection.
    Mr. Rogers. Okay. The last thing I want to know, is there 
any statutory authority that you need from this body to be able 
to better do your job?
    Dr. Raymond. No, sir, I do not believe so.
    Mr. Rogers. Thank you. That is all I have, Mr. Chairman.
    The Chairman. Thank you. The Chair recognizes Mr. Kagen for 
5 minutes.
    Mr. Kagen. Thank you very much, Mr. Chairman, for holding 
this very important hearing today. Thank you, Dr. Raymond, for 
all you have done and the people that work with you. I very 
much applaud your efforts. It is very difficult to chase down 
bacteria. It is difficult to chase down where the E. coli came 
from, but, in your experience, would you make a determination 
or a close ``guestimate'' as to whether or not a consumer 
should make in part their decision on where they are going to 
purchase their meat products based upon where the meat was 
butchered? Is it, for example, safer for a consumer to purchase 
a meat product that is produced and butchered locally as 
opposed to some distant place, where it might be under a mass 
production facility?
    Dr. Raymond. Congressman Kagen, my job and the agency's job 
is to make certain the meat product or the poultry product that 
you or your spouse or someone else purchases at a retail store 
is safe to eat, and it should not make any difference whether 
it is a small plant, a large plant, a local plant, or even an 
international plant.
    Mr. Kagen. But in your experience or from the body of 
evidence that you have had an opportunity to review, is it more 
likely to find E. coli, Salmonella, or Listeria at a smaller 
production plant or a larger plant?
    Dr. Raymond. In my experience, it is across the board. We 
have some large plants that do not perform well in Salmonella 
sets, we have some very small plants that perform extremely 
well, and some that do not.
    Mr. Kagen. And what is the process whereby you or your 
staff will determine the sampling techniques? Will you sample 
each run of slaughtering process on a daily basis or is it 
intermittent? What is the method you use to sample the product?
    Dr. Raymond. It depends on what the product is, sir, and 
what the sampling is. For instance, for Salmonella on poultry 
we will do a set of carcass washes or rinses, 53 consecutive 
work days, and we will do that. And if this plant comes in 
below a certain level of positive carcasses, they may not get 
another sample set for 2 years. If they come in above a certain 
level, set, they will get another sample set started 
immediately upon termination of the certain set.
    Mr. Kagen. You bring up an interesting question, that is, 
the threshold limit. What is your threshold limit of safety for 
toxic E. coli?
    Dr. Raymond. Zero.
    Mr. Kagen. Zero. So if you have a sample that comes up with 
E. coli, toxic variety, can you trace that back to the ranch or 
the production facility?
    Dr. Raymond. We try to trace it back as far as we can into 
the slaughterhouse that provided the product that may have been 
ground into ground beef. That is where we would like to get to. 
That is where the problem has occurred, and that is where we 
need to take steps to keep it from happening again.
    Mr. Kagen. You mentioned also in an earlier question that 
the system works fairly well. Is that correct?
    Dr. Raymond. I believe it does, sir.
    Mr. Kagen. And yet the sampling rate for imported foods is 
\1/10\ of 1 percent of the product that comes in. Yet, we have 
had some foods that have been contaminated and some human 
illnesses have resulted from that. So would you say that there 
are some improvements that need to be made, and if so, where 
are these improvements to be made?
    Dr. Raymond. Congressman, with all due respect, about 3 or 
4 years ago the amount of product that was sampled for 
pathogens that was meat or poultry under our inspection was 
about 0.2 or 0.3 percent. The last couple years, it has been 
four percent of all product that comes into this country, meat 
and poultry, has been sampled for pathogens and/or residues.
    Mr. Kagen. And has that resulted in a number of catches, so 
to speak?
    Dr. Raymond. Actually, we have seen very few catches. We 
have not had issue with the product coming across the border to 
any great degree.
    Mr. Kagen. Very good. On another subject, in the remaining 
time that I have, you have a number of education programs for 
consumers----
    Dr. Raymond. Yes, sir.
    Mr. Kagen.--on purchasing and preparation of foods. Is 
there a program that you would like to highlight at this time?
    Dr. Raymond. The Be Food Safe campaign that we launched 
about a year ago is showing to be extremely popular with our 
food safety partners, the local and state health officials, the 
epidemiologists, et cetera. They are using this extensively in 
their local campaigns, and that is where I think we really need 
to get is local rather than coming from inside the beltway.
    Mr. Kagen. Very good. Thank you much, and I yield back my 
time.
    The Chairman. Thank you. The Chair recognizes Mr. Conaway 
for 5 minutes.
    Mr. Conaway. Thank you, Mr. Chairman. Dr. Raymond, on the 
12,000 samples, I missed what Mr. Costa said on billions of 
pounds of ground beef. Is that a statistically valid sample 
across everything that is going to be produced in a year? I 
mean, how did you determine that 12,000 samples are enough to 
do what you need to do?
    Dr. Raymond. I didn't personally determine that. Our 
scientists do those numbers, and I have a great deal of 
confidence in them that it is statistically significant. We are 
trying to make it more statistically significant by doing more 
targeting, starting in January.
    Mr. Conaway. I recall recently that Cargill recalled a 
million pounds of ground beef on their own. Maybe I am making 
that up, but do companies, I would assume the responsible 
companies are doing their own inspections, their own testing? 
Is that an unusual circumstance to have a company recall its 
own product without having intervention? There was nobody else 
involved, as I understand it. Is that unusual?
    Dr. Raymond. Well, first of all, let me, so that everybody 
is on the same page, when the companies do their own testing 
they generally hold and test, test and hold. And if they have a 
positive product they either destroy that product or they cook 
that product. They do not send it out as raw ground beef. If a 
company is testing product and just goes ahead and sends it out 
and it comes back positive, they are going to voluntarily 
withdraw that product. It is the same when we test product. 
Some of it is held, and some of it is ground into commerce. I 
would like to go into the one you are talking about.
    Mr. Conaway. Sure.
    Dr. Raymond. I believe that you are talking about the most 
recent Cargill one. This gives an example of one of the reasons 
we have 19 recalls, and one of the reasons that is not all bad. 
Two recalls ago, a company that we tested the product, tested 
positive. It was a very small company. They produced 50 pounds 
of ground beef that day, and they voluntarily recalled it. It 
had all been sold to restaurants. None of it had been served to 
customers yet, so there were no illnesses involved. Our 
investigation into that particular product linked it back to a 
Cargill plant. At the Cargill plant, we went through their 
records with them, and they realized a limited time where that 
product could have been produced, and they recalled about a 
million pounds of product. So there were actually two recalls 
based on one sample test, which shows, I believe, that we are 
doing our job. Because it was our sample that caught the 
positive, and not just in the 50 pounds, but perhaps a wider 
net when they pulled the million pounds back. I believe we have 
prevented illnesses with what we do.
    Mr. Conaway. One last question. On the things that you look 
for, the pathogens that you look for, the consumer is 
ultimately the last line of defense with proper handling and 
cooking. Are there pathogens that you are concerned about that 
are not controlled by proper cooking, at the end of the day?
    Dr. Raymond. The one thing we do worry about is Listeria 
monocytogenes, which is in ready-to-eat products. It is 
products that you should not have to expect to cook at home: it 
is beef jerky; it is cooked hams; it is issues like that, that 
the pathogens should be cooked out of those products, but 
unfortunately there are environmental issues. Sometimes the 
product is properly cooked but then contaminated by the 
environment. Or, as in the botulinum recall, we found out there 
was an error in the cooking process in that particular plant, 
so, yes, those you can't cook out at home.
    Mr. Conaway. Okay. But the raw meats that you buy at the 
store and you bring home, if you properly cook the chicken, 
beef, or turkey, to the ultimate temperatures, that would 
handle all these pathogens?
    Dr. Raymond. The temperatures that we recommend for cooking 
will kill all of those pathogens that that temperature is for, 
yes.
    Mr. Conaway. Okay. So the consumer can ultimately protect 
themselves, no matter what you do, from these issues?
    Dr. Raymond. Yes, sir.
    Mr. Conaway. Okay. You bet. Thank you for sharing.
    The Chairman. Thank you, Mr. Conaway. The chair recognizes 
Mrs. Gillibrand for 5 minutes.
    Mrs. Gillibrand. Thank you, Mr. Chairman, for holding this 
important hearing, and thank you, sir, for being here. I just 
want to return to the issue of the risk-based inspection system 
and the baseline of 12,000 samples. Is that something that you 
are going to change, the baseline number of samples? Will it 
increase or decrease? And you talked about changing some of the 
criteria and targeting. Can you talk a little bit more about 
what you will change?
    Dr. Raymond. Yes, and thank you for the question, because 
it gives me an opportunity to go back to one of the recent 
questions that I didn't answer quite correctly. The 12,000 
samples that we use for ground beef is verification testing. It 
is not statistically significant, but it is verification that 
the plant's passive plans and other procedures are in place. 
The trim testing is statistically significant. I want to make 
that clarification. And we do about 6,000 samples per year. We 
have started in March, and we will do about 6,000 samples per 
year on trim, in addition to the 12,000 in ground beef.
    Mrs. Gillibrand. And which criteria for testing will you 
change?
    Dr. Raymond. There will be multiple criteria changed. Right 
now the sampling is just routine and random for the ground 
beef, and what we will change is to look at a plant's record. 
We will be looking at their past history of testing. We will be 
looking at their systems, and processes that are in place. We 
will be taking a look at our own inspection workforce. We will 
take a look at previous positives, and those will all go into 
the thought process as to who to target with more intense 
testing.
    Mrs. Gillibrand. And then will you report back to Congress, 
or how will you publish your changes in systems?
    Dr. Raymond. We will always respond to any request from 
Congress, of course, for information relating to our Food 
Safety and Inspection Service.
    Mrs. Gillibrand. So when you formulate your new system, 
will you make sure you advise us on what you are now doing, 
going forward?
    Dr. Raymond. Absolutely.
    Mrs. Gillibrand. Okay. I also heard from my colleague, Dr. 
Kagen, that there are now vaccines for cows for E. coli that 
gives them immunity to it. Is that something you are looking at 
or that will be discussed?
    Dr. Raymond. The vaccine has been developed but has not 
been approved yet, at this time in the United States. That is 
not something that we have any control over. It is the USDA 
that is looking at that, and, yes, we are very interested, and 
we follow that very closely.
    Mrs. Gillibrand. Is that something that would be 
preventive? What is your understanding of the effectiveness of 
that course of action?
    Dr. Raymond. Well, as a physician I believe strongly in 
vaccines. They prevent millions of illnesses a year in this 
world, tens of thousands of illnesses in this country. We have 
eradicated smallpox, for instance. Can we eradicate E. coli 
O157? Doubtful. And it won't be perfect, because when we are 
talking cattle, we are talking two different age groups. If you 
are talking just cattle that will be slaughtered for steaks and 
other cuts like that, under 30 months, the vaccine probably 
will be wonderful. But if a farmer has to give it to a dairy 
cow for 13 years, who is going to pay for the vaccine before 
the dairy cow gets ground up into our ground beef? Those are 
issues that need----
    Mrs. Gillibrand. To be addressed.
    Dr. Raymond. Yes.
    Mrs. Gillibrand. Thank you. Just one last question. Can you 
talk a little bit about the recall for the Topps products, 
because it was something we heard a lot about in New York. I 
would like your comments on what happened and whether, under 
your new risk-based inspection system, there would be any 
difference, whether it would have been caught.
    Dr. Raymond. I cannot say with any degree of certainty that 
it would have been caught under a risk-based inspection system. 
What I can say is that under a risk-based inspection system, 
after the incident happened at Topps, they definitely would 
have moved to the right and received more intensified, longer 
inspection, because of the points that would have been scored 
against them for their demonstration of the inability to 
control risk in their plant. Because they were making a high-
risk product and because they were making a high volume of the 
high-risk product, all those factors would have entered in. I 
am very confident they would have gone to the upper tier of 
inspection for subsequent grinding if they had stayed open.
    Mrs. Gillibrand. Thank you. Thank you, Mr. Chairman.
    The Chairman. Thank you, Mrs. Gillibrand. I appreciate the 
questions. We will go another round for those that would like. 
I kind of triggered something. You said 30 month, and we are 
not going into the 30 month Canada situation, but there are 
some concerns about that. I just want you to know that. But, 
having said that, what is the FSIS role in regard to the 
shipment of meat from a foreign country?
    Dr. Raymond. Well, our role, Mr. Chairman, in the shipment 
of meat from a foreign country; first, starts with determining 
if that country has an equivalent food safety system to ours. 
Second, it is annual audits to make sure they are maintaining 
that equivalency and performing the way we want them to 
perform, to be allowed to export. Third, it is re-inspection of 
that product as it comes across the border. And last, it is 
opening ten percent of those boxes and visually inspecting that 
product and doing the microbiological testing that we have 
already talked about, and the residue testing. At that point, I 
think our responsibility ends, and it goes into the rest of the 
product that we inspect on a regular, daily basis.
    The Chairman. It has come to light that some of the meat 
that was contaminated with E. coli came from Canada. Could you 
tell it why did it take so long for FSIS to receive this 
information?
    Dr. Raymond. Yes, sir. The Topps recall, I believe, was on 
September 25. It got expanded on September 29, I believe, after 
we had done the food safety assessment. It was not too long 
after that, and I don't know if I want to call it a sister 
company, but J&B meats had some link with Topps, not 100 
percent corporate, but there were some linkages there. And J&B 
meats became a plant of interest to us. We did have one patient 
became ill from a product that linked to J&B meats by an open 
box in their freezer, another one that would ordinarily not 
have been recalled under the past conditions. When we took a 
look at J&B meats and the Topps meats for those two products 
that were linked to human illnesses, we found three common 
sources of three common suppliers for those days, and we 
immediately focused our attention on those three suppliers of 
record, one Canadian and two domestic. It didn't mean any of 
them had produced product that was contaminated, but the three 
plants that produced to those two processing plants, and we 
notified the Canadian Government of our interest in the plant 
in Canada. At that same time we delisted that plant until we 
could be certain that they were not a producer of record of the 
contaminated product. The Canadian Food Inspection Agency went 
and inspected that plant, which had gone into receivership and 
was no longer producing but had product being held in their 
warehouses during their legal processes. They sampled product 
from that date that we had linked, and that product came back 
positive for E. coli O157 with the matching fingerprint, the 
PFGE that I talked about. It matched the fingerprint of the E. 
coli O157. It was present in at least 31 of the patients in our 
outbreak and also matched the fingerprint of the one down at 
J&B meats. And that is how we made the link, usually we are not 
successful in our trace-backs. I really don't think this took 
actually very long at all. We were just happy to be successful.
    The Chairman. I appreciate that. I am told that each time a 
lot or a batch is changed out at the grinders', they are 
supposed to be torn down and go through the cleaning process 
and the equipment. How often does this happen, and is it 
something inspectors look for?
    Dr. Raymond. Our inspectors obviously are tasked with a lot 
of activities, and a lot of them, of course, are the plants' 
procedures for the good hygiene within the plant and the 
physical environment. Yes, it is one they look for. I think the 
frequency is going to vary upon the plant, the size, the 
product, so I can't give you a definitive answer as to how 
frequently that does occur.
    The Chairman. Having visited a plant and even worked there 
many, many years ago, I am just concerned at the pace they have 
to do that, what they do when they change products, and clean 
the equipment, to make sure it is ready to go with the new 
grinding that will take place. So I appreciate that you are 
watching for it. What happens if the grinder is found not to be 
doing it?
    Dr. Raymond. If it is in their HAACP plans and is one of 
their critical control points, we could actually pull the 
inspection workforce if we wanted to. Most likely what would 
happen, a non-compliance report would be written up, and they 
would be expected to take corrective actions immediately.
    The Chairman. I appreciate that. At this time I recognize 
Mr. Schmidt--Mr. Smith. You have joined us. Would you like to 
have a question or two? We will recognize you for 5 minutes.
    Mr. Smith. Thank you, Mr. Chairman. Thank you, Dr. Raymond. 
My greetings from Nebraska.
    Dr. Raymond. Great. Thanks.
    Mr. Smith. You mentioned in response to an earlier question 
that the best way to improve food safety with respect to E. 
coli is to eliminate it from the animal's digestive tract. How 
much of an impact could the pre-harvest measures impact the 
incidence of foodborne illness, and when do you expect that 
some of the pre-harvest tools will be available to the 
industry?
    Dr. Raymond. Congressman Smith, I really can't speculate as 
to when those pre-harvest things that we have talked about, the 
phages, and the process that those things have to go through 
for clearance. I don't want to give you a date that I can't 
back up scientifically.
    Mr. Smith. Sure. I appreciate that, but I appreciate your 
acknowledging the possibilities that are out there. Also, we 
know that the industry is evolving somewhat, and we know that 
there are some niche markets out there in the meat industry. At 
the same time that brings about smaller operators, which I 
think is great value-added opportunity in agriculture. Could 
you describe the programs that are in place, or could be in 
place, that will ensure that future processors and small 
businesses are not negatively impacted by positive findings 
when they test raw materials?
    Dr. Raymond. Yes, sir. Thank you for the question. One of 
the things that we have done right, very well, in the last 
couple years, that I am very proud of, is our outreach to small 
and very small plants. We conducted several listening sessions 
across the country late in the summer of 2005. What we found 
was it was apparent that small, very small plants did not 
really have robust HAACP plans and really had not engaged with 
HAACP. They really had not received the training, education, 
and support that they needed to get those HAACP plans done so 
that we could say their product was just as safe as a larger 
plant. And we developed an outreach program based on that. We 
worked with our international HAACP alliance for a 2 day 
conference. They worked with us and developed this outreach 
plan. We have a new person that is in charge of that particular 
program, not a new hire, but a new position, totally in charge 
of that. And that is what this person does, day in and day out, 
both that and training for our workforce of specialists in the 
area. We conduct many sessions per month for small and very 
small plant outreach across the country, attended by plant 
management and also by our own employees so they are hearing 
the same thing at the same time and they are getting a 
consistent message. We have worked with the technical center in 
Omaha to provide one consistent message for their questions. We 
weren't doing a very good job in that area. We have a website 
specifically for small, and very small plants, frequently asked 
questions. I think we actually have a new brochure we just 
started producing just a few weeks ago that goes to the small, 
very small plant operators with updates to help them. They 
don't have the resources to scan the Web and everything else 
that the large companies do, so we are trying to help them stay 
intact and up front with their policies.
    Mr. Smith. Okay. Thank you. Thank you, Mr. Chairman.
    The Chairman. And I apologize to you, Mr. Smith, for 
calling you Mr. Schmidt.
    Mr. Smith. Close enough. I didn't even realize it.
    The Chairman. Oh, well, then, I am sorry I brought it up 
then. At this time the Chair recognizes Mr. Hayes for second 
round, 5 minutes.
    Mr. Hayes. Thank you, Mr. Chairman, and Dr. Raymond, again, 
thank you for your concise answers. We have talked a lot about 
sampling, and we have talked about testing. We have talked 
about tracing and recalls, all of which are important parts of 
our food safety program. Would you spend a couple minutes 
talking about the prevention policies that the Department has 
in place? By prevention, I mean from the time the animal leaves 
the farm until he ends up on the shelf. I think it would be 
helpful, particularly given the nature of the situation we are 
dealing with, to reinforce how stringent your policies are in 
terms of how the animals are handled, processed, and packaged. 
So, if you would walk us through that, I think it would be 
helpful and kind of complete this picture.
    Dr. Raymond. I will sure try to do that, Congressman Hayes. 
First of all, handling. Humane handling, of course, there is a 
law about humane handling, and that is one of the things that 
we do make certain happens in all plants that we are 
responsible for. Humane handling does decrease the risk of 
contamination with fecal contents. Our Agriculture Research 
Center is also doing research into the holding pens and how can 
we reduce contamination within the holding pens? We know, when 
the cattle leave the feed lot, there is a certain amount of 
carcass contamination. We know, when the carcass is pulled, 
there is a whole lot more, just in the shipping and 
transporting. We need to figure out how to reduce that. But 
that said, once the animal is knocked down and we go to the 
hide pull, there are certain measures that plants are taking 
there to try to reduce scatter and splatter when the hides are 
pulled off these animals. That is where the greatest risk of 
contamination comes from. It is really not intestinal spillage. 
It is contamination from the hide, during the hide pull. There 
are rinses. There are antimicrobial rinses. There are different 
temperatures that have been developed by the Agriculture 
Research Center, out in Clay Center, Nebraska. Many of these 
companies are following that advice, their practices that help 
reduce the amount of fecal contamination. Obviously the 
inspection by our workforce, looking for any signs of feces or 
fecal contamination on the floor, on the walls, and the hides 
on the carcasses. Some plants have actually very sophisticated 
machinery that the carcass goes through that would detect 
almost microscopic amounts of fecal contamination on the 
carcass and will stop the line instantly until that carcass is 
removed, derailed, and retreated. Obviously, testing is 
important and needs to comply to HAACP plans. They are probably 
the most important thing. I mean, the rinses and the chemicals 
are all nice, but the HAACP plans that the plants have all put 
into place have been required since the year 2000, and that is 
when we really saw E. coli begin to decrease as a foodborne 
illness as a result of those HAACP plans. That is the most 
important factor, I believe, in getting E. coli numbers down, 
preventing it from getting onto your dinner plate or my dinner 
plate.
    Mr. Hayes. What I just heard you say is that you have very 
stringent and strict processes and procedures that are 
consistently followed from large plants to small plants, east, 
west, north, south, so that the same, consistent behavior and 
procedures will result in the best and safest meat possible. 
And I think that is pretty clearly what you said. Did I repeat 
you correctly?
    Dr. Raymond. The one thing I just want to clarify is that 
the procedure is not exactly the same from plant to plant. The 
plants do develop their own HAACP plans, and then they must 
follow their HAACP plans. Variation is allowed. One thing the 
industry has done that has been very proactive is they declared 
public health not to be a competitive nature. They share best 
practices in most of the industry, and not a practice for a 
plant that is slaughtering 365 head an hour, because the same 
practices don't apply to the small, custom, exempt slaughterer. 
So they are not exactly the same, but they are very stringent 
procedures, and they must follow them.
    Mr. Hayes. But you make sure that the appropriate procedure 
is used for the expected outcome, which is safe food.
    Dr. Raymond. Yes, sir.
    Mr. Hayes. And is your research department and other 
individuals within your department, are they always monitoring 
and looking to see if the antimicrobial, which I can't say very 
well, and the other chemicals and processes are the most 
effective? They are appropriate for strains and mutations of E. 
coli and other bacteria that are developing, so you stay on top 
of that both in research and application? Is that a fair 
statement?
    Dr. Raymond. Yes, sir. And, again, just for a point of 
clarification is the Agriculture Research Service, which is 
another branch of the USDA, but it is the USDA that is actively 
doing this research, along with a lot of other universities, 
land-grant institutions, and the industry itself are also doing 
research.
    Mr. Hayes. Well, thank you again, Dr. Raymond. I think you 
have done an excellent job. Mr. Chairman, I think you have with 
this hearing made it very clear that food safety is crucial. 
Monitored continuously, anything can be done and we have 
proven, but day in and day out we are on the case.
    The Chairman. I appreciate you saying that. It is exactly 
right. Second round, Mr. Kagen, for 5 minutes.
    Mr. Kagen. Thank you, Mr. Chairman. Dr. Raymond, you had 
indicated earlier in questioning that the safe level of 
exposure to E. coli O157 is 0, and if that is the case, I am 
confused about why it took so long with regard to the Topps 
case for your agency to work and get the job done. I will quote 
David Goldman. ``Let me be clear from the beginning. At this 
point we weren't able to take action based on the initial 
test.'' Well, if a test came up positive, and the safe level is 
0, why wasn't that the time to act?
    Dr. Raymond. Congressman Kagen, at that time the policy of 
the agency was that we would not take a product that had been 
opened. We would test it, but even if the test came back 
positive we would not feel we had a strong enough link to do a 
recall or to seize and detain if we were forced to seize and 
detain. That is why a recall was not done at that time. That 
policy has changed. I did not agree with that policy, 
especially if it is a frozen product. The reasoning behind this 
is the product may have been contaminated by the person in the 
home. I will use an example. If someone had just changed a 
baby's diapers, and, you know as a physician, we all have E. 
coli. We just don't have O157:H7 fortunately. But if you get a 
culture back on a product in the refrigerator, and it has E. 
coli in it, and you haven't got down any further than that, 
that could be easily contaminated from a person.
    Mr. Kagen. So as a result of the Topps situation, the 
policy has changed?
    Dr. Raymond. Yes, it has.
    Mr. Kagen. And, in your view, it has changed for the 
better?
    Dr. Raymond. Absolutely.
    Mr. Kagen. Okay. And with regard to this issue, in New 
Jersey, at a Topps facility, the USDA noted that there were 
some safety violations. Can you state for the record what those 
violations were?
    Dr. Raymond. First of all, they were not doing any testing 
for E. coli. In the past, they had been, and they had stopped 
that.
    Mr. Kagen. How long had they stopped testing?
    Dr. Raymond. We had done a food safety assessment in that 
plant in 2005, and their food safety assessment at that time, 
which is a very detailed inspection investigation, they had 
done very well. They showed well on that, and they were 
testing, I believe, monthly at that time, and the last year 
they were not.
    Mr. Kagen. And I am certain you are pursuing the reasons 
why, perhaps top personnel, a technologist, moved on, and no 
one replaced him or her?
    Dr. Raymond. It changed ownership, sir.
    Mr. Kagen. Okay, so a different owner had a different style 
of practice, but it wasn't in keeping with the good health of 
the consumer?
    Dr. Raymond. That is the assumption I would make, yes.
    Mr. Kagen. Okay. The final question I have has to do with 
the visual inspections that inspectors do on meat packaging, 
and also on meats when they are being cooked. In my lifetime of 
experience when I am cooking meat, I look at it to see if it is 
well cooked, and, unfortunately, it is my understanding that if 
meat has been preserved with carbon monoxide that I have lost 
my ability to visually determine if the meat is fully cooked. 
Is that a fair statement?
    Dr. Raymond. We do not recommend visual observation to see 
if meat is fully cooked. We recommend everyone use a food 
thermometer, sir.
    Mr. Kagen. Well, excuse me. I have never used a 
thermometer. In my medical practice I have, but not when I am 
preparing food for the family. I daresay that most people don't 
measure the temperature of their hamburger meat or their steaks 
when they are cooking it. They use their visual eyes, so if you 
will just go along with me in assume that most people in 
America don't use a thermometer when cooking meat, and most 
people in Canada probably don't, or maybe Central America, 
South America. If we can't use our eye, and we don't have a 
thermometer in the kitchen, how do we judge if we are cooking 
it thoroughly? And again I am coming after the issue of carbon 
monoxide treatment of pinking up the meat.
    Dr. Raymond. I will go along with you.
    Mr. Kagen. Well, let me just make it easy for you, okay? Do 
you routinely use a thermometer to cook your hamburger?
    Dr. Raymond. Yes, sir, I do.
    Mr. Kagen. I am flabbergasted. I daresay you are probably 
the only one in the room.
    Dr. Raymond. I think that the row right behind me had 
better be using a food thermometer, because none of us can 
afford to have a foodborne illness with E. coli O157 and say we 
didn't use a thermometer. I think the choir is behind me on 
this one, but I will agree with you, that I am in the minority. 
You are in the majority, and I need to get myself in the 
majority, and you in the minority, through our consumer 
education. But back to your question, carbon monoxide maintains 
the healthy, pink color of the meat because it doesn't interact 
with the oxygen. Cooking, it will not maintain that pink when 
it cooks. I mean, it has nothing to do with the color of the 
meat when it is being cooked. It has to do with the color of 
the meat when it is sitting in your refrigerator.
    Mr. Kagen. So if I cook it to the temperature of 160 
degrees Fahrenheit, the carbon monoxide in the meat will change 
color and look fully cooked. Is that correct? Is that your 
expert testimony?
    Dr. Raymond. Yes. Yes, sir, to the best of my 
understanding.
    Mr. Kagen. Thank you very much for your answers, and thank 
you, Mr. Chairman.
    The Chairman. Well, that brings us to the close of 
questions. I did have one last one that I would like to ask 
you, Mr. Secretary. You mentioned that as of this month all 
beef plants will have to verify they are controlling E. coli 
during slaughter and processing. Can you tell me how they will 
be expected to do this, what your oversight will be?
    Dr. Raymond. Yes, there is about a 47 page survey that our 
inspectors have received special training on. They will be 
doing their surveys of the plants, all these different 
processes and steps to see if they are using them or not using 
them. That report will be looked at at the district level by 
supervisors and other staff, and they will take a look at these 
plants. If a plant does not have the proper steps in place they 
will probably get a food safety assessment sooner than later, 
and they will have to verify or justify why they do not have 
these processes in place. If they have something better, that 
is fine, but if they don't have something better, we will work 
with them to get those processes in place. What we are really 
trying to do is get a baseline. We do not know for sure how 
many plants have adopted our 2002 guidelines and how many have 
not. What we have found is, Topps was not using it, but they 
had been 2 years before, and we do feel that was a large part 
of the problem with the Topps plant. I want to know if that was 
an isolated incident or if this is something a little bit more 
pervasive. If it is a little bit more pervasive we will have to 
take a look at future policies, maybe rules and regulations in 
fact, to make some of these things regulatory rather than 
suggested.
    The Chairman. I appreciate that. Now we focused a lot on 
beef and E. coli. Is this just a problem for beef, or does this 
also have a relevance to pork, and are there processes that are 
different?
    Dr. Raymond. This is beef. We are doing this in the 1,500 
plants that slaughter and/or process beef. That is where our 
issue with E. coli has been this year, not with pork.
    The Chairman. Not any evidence with pork?
    Dr. Raymond. No.
    The Chairman. Well, I appreciate that. Does FSIS certify 
that a plant's HAACP plan is effective for ensuring food 
safety? Do you have any kind of a certification process?
    Dr. Raymond. We don't certify the plants, sir. We make sure 
they follow their plans.
    The Chairman. They make their plan, and you check that they 
are following their own plan?
    Dr. Raymond. That is correct.
    The Chairman. Well, I appreciate what you have had to say. 
Before we adjourn, does the Ranking Member have any remarks you 
would like to make in closing?
    Mr. Hayes. Good hearing, Mr. Chairman. Thank you.
    The Chairman. Okay. Well, I want to thank you, Mr. 
Secretary, for coming and sharing with us today. I think we are 
on the same concern, that we want our producers to do the very 
best they can. We want to protect them. I make no apologies 
that I am one of those and want them to have every opportunity 
to stay in their business and can grow their business. Of 
course we all have to base this on consumer protection and 
making sure that consumer gets what they think they are getting 
and are getting it safely. And so some of the comments you have 
made today were encouraging. I appreciate the things that you 
are concerned about and what innovations you are setting into 
motion. We thank you for doing that, and we will probably keep 
a continuing dialogue with you about how that is going and wish 
you continued success in doing so. So with that, I want to 
thank you for the time you spent with us today. In closing and 
adjournment, under the rules of the Committee, the record of 
today's hearing will remain open for 10 days to receive 
additional material and supplementary written responses from 
the witness to any questions posed by Members of the panel. The 
hearing of the Subcommittee of Livestock, Dairy, and Poultry is 
hereby adjourned.
    [Whereupon, at 4:00 p.m., the Subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
 Questions Submitted to Dr. Richard Raymond, Under Secretary for Food 
    Safety, Food Safety and Inspection Service, U.S. Department of 
                     Agriculture, Washington, D.C.
Canada
    Question 1. During FSIS' audit of Canada's meat, poultry and egg 
products inspection system (May 1-June 6, 2007), CFIA delisted one 
establishment and issued Notices of Intent to Delist to an additional 
six establishments (out of 24 total establishments visited) for 
deficiencies in their Hazard Analysis and Critical Control Point 
(HACCP) systems, sanitation standard operating procedures (SSOP), and/
or sanitation performance standards (SPS). Further, according to FSIS' 
audit report, auditors found numerous deficiencies at the Canadian 
plants, including:

   ``In 20 of 21 establishments, CFIA was not enforcing all of 
        the U.S. regulatory requirements, which are equivalent to 
        Canadian requirements.'' (p. 7)

   ``Seventeen of the 20 slaughter and/or processing 
        establishments (including cold storage) audited had 
        deficiencies in the implementation, maintenance, corrective 
        actions, and/or record-keeping requirements of the SSOP. These 
        deficiencies resulted in both potential and direct product 
        contamination.'' (p. 11)

   ``Nineteen of the 20 slaughter and/or processing 
        establishments (including the cold storage) audited had 
        deficiencies in SPS.'' (p. 11)

   ``Three of the nine slaughter establishments had 
        deficiencies in the generic E. coli testing program.'' (p, 14)

   ``There was no Canadian method for Salmonella analysis of 
        meat and poultry products that had been deemed equivalent by 
        the U.S.'' (p. 16)

   ``Some inspection personnel were not well-trained in the 
        performance of their inspection tasks.'' (p. 16)

    Based on these findings, how did FSIS conclude that the Canadian 
inspection system is equivalent to the U.S. system?
    Answer. When conducting audits, the program auditors of the FSIS 
Office of International Affairs' International Audit Staff usually 
identifies some issues and deficiencies that have not been adequately 
addressed by the Central Competent Authority (CCA) in each of the 
countries that export meat, poultry, and processed egg products to the 
United States. Each of these issues and deficiencies must be evaluated 
as they relate to the entire inspection system, and FSIS considers all 
of these issues and deficiencies when the agency is determining whether 
or not the system is equivalent. The CCA is expected to recognize the 
concerns raised by the auditors and to address and correct them in a 
timely manner, in the same way that the management of a domestic 
establishment is expected to address concerns and deficiencies raised 
by FSIS inspection personnel.
    The deficiencies identified during FSIS' May 1-June 6, 2007, audit 
of Canada's meat, poultry, and processed egg products inspection 
system, taken as a whole, were not of such a nature, extent, and degree 
that the system was deemed not equivalent to that in the United States. 
For example, even though the methods that Canada was using to test meat 
and poultry products for Salmonella species were not the same as those 
employed by FSIS and had not been submitted to FSIS for equivalence 
determination, they were nonetheless methods considered adequate by 
other recognized authorities, such as the Association of Official 
Analytical Chemists.
    The finding that some inspection personnel ``were not well-trained 
in the performance of their inspection tasks'' referred, for the most 
part, to a minority of front-line inspectors who did not adequately 
understand the need for conducting hands-on pre-operational sanitation 
inspection each time the task arose in Canada's computer-generated 
task-assignment program. According to one of the auditors who 
participated in the May-June 2007 audit of Canada, the CCA had already 
initiated a program to increase the field inspectors' awareness and 
understanding of the duties in question.
    As part of FSIS' implementation of additional requirements for 
imported meat and poultry products from Canada, the agency increased 
reinspection and testing for Salmonella, Listeria monocytogenes, and E. 
coli O157:H7 at import houses beginning on November 9, 2007. Normal 
levels of testing for Listeria monocytogenes and Salmonella in ready-
to-eat product resumed on November 28, 2007 after the increased testing 
revealed no problems with Canadian products exported to the United 
States.

    Question 2. On November 3, FSIS announced that it would immediately 
conduct a follow-up audit of the Canadian food safety system that will 
include beef exporting establishments similar to Ranchers Beef, Ltd. 
What has that audit team found?

    Answer. Regarding the Canadian Food Inspection Agency's (CFIA) E. 
coli O157:H7 controls:

   CFIA has a monitoring program for testing all federally 
        registered ground beef establishments for E. coli O157:H7. This 
        includes establishments certified to export ground beef to the 
        United States.

   CFIA is using E. coli O157:H7 laboratory testing methods 
        (MFLP 80 and MFLP 90) that have not been deemed equivalent by 
        FSIS. This was a finding identified during FSIS' May-June 2007 
        audit. These two methods were submitted to FSIS on November 8, 
        2007, for equivalence approval.

   At the time, CFIA did not have an E. coli O157:H7 program 
        for testing beef trimmings produced for the domestic or the 
        export market. FSIS has required that CFIA have such a program, 
        as is the case for all of our trading partners. It began on 
        January 20, 2008.

    Regarding a review of beef slaughter establishments similar to 
Rancher's Beef in start-up and operations:

   Three establishments have been identified as being similar 
        to Rancher's Beef, i.e., opened for the purpose of handling an 
        abundance of cattle that were not eligible to be exported to 
        the United States due to USDA's Animal and Plant Health 
        Inspection Service's (APHIS) restrictions on importation of 
        cattle more than 30 months of age.

   Audits of these three establishments were conducted on Nov. 
        9 and Nov. 13, 2007.

   Two of these establishments were audited on site and the 
        third had a records audit of controls and testing for E. coli 
        O157:H7 in raw beef products and raw beef manufacturing trim 
        intended for export to the United States for use as raw ground 
        beef.

   The two establishments that were audited on site identified 
        E. coli O157:H7 as a hazard in the HACCP plan, were testing 
        lots of product for E. coli O157:H7, were not re-testing 
        positive (or presumptive positive) lots, and were using an 
        intervention (lactic acid application to carcasses) in 
        slaughter.

   CFIA was not performing verification testing for E. coli 
        O157:H7 in either of these establishments, but was receiving 
        copies of lab reports from establishment E. coli O157:H7 
        testing.

   In the establishment in which the records audit was 
        performed, no issues arose regarding food safety programs or 
        monitoring documentation.

    Question 3. As part of FSIS' institution of additional requirements 
for imported meat and poultry products from Canada, the agency will 
increase testing for Salmonella, Listeria monocytogenes, and E. coli 
O157:H7 at import houses.
    If a sample of Canadian product taken by FSIS during re-inspection 
comes back positive for E. coli O157:H7, will the Canadian firm that 
produced the product be subject to follow-up sampling by the Canadian 
Food Inspection Agency (CFIA), pursuant to FSIS Notices 17-07 and 62-
07?
    Answer. Yes.

    Question 4. Will the same supplier be subject to an audit by CFIA 
that is equivalent to a food safety assessment, pursuant to FSIS Notice 
64-07?
    Answer. Yes.

    Question 5. Finally, will the Canadian firm be put in to Systems 
Tracking E. coli O157:H7-Positive Suppliers database, pursuant to FSIS 
Notice 66-07?
    Answer. Yes.
Outbreak Investigation Coordination
    Question 6. It appears that states are conducting outbreak 
investigations in silos, rather than communicating with each other or 
the Federal Government. For example, on November 1, FSIS issued a 
recall release for 3.3 million pounds of frozen meat pizza that had 
been linked to a foodborne illness outbreak spanning ten states and 
that included 21 reported illnesses. The Tennessee Department of Health 
had conducted a case control study and determined that meat pizza was 
the common thread in the patients, yet, according to FSIS officials, 
FSIS only learned about the outbreak 6 days prior to the recall.
    Is it typical that FSIS is made aware of potential foodborne 
illness outbreaks only after a state concludes its investigation?
    Answer. Working closely with state public health agencies is a key 
priority for FSIS. The point at which state public health agencies 
contact FSIS varies from state to state. Many states inform FSIS very 
early in an investigation, while others wait until they're ready for 
Federal agency food trace-back and/or recall actions. Generally 
speaking, FSIS is notified when a state begins to suspect FSIS-
regulated product is associated with illness. FSIS has been forging 
better relationships with its public health partners and has made 
significant improvements. In pursuit of doing still better so we can 
learn about outbreaks earlier and improve public health, FSIS will host 
a meeting and tabletop exercise focused on ``Better Communications, 
Better Public Health Outcomes: Strategies for Improved Coordination 
During Foodborne Outbreaks'' in early 2008.

    Question 7. Was it CDC that first notified FSIS about the outbreak 
related to frozen meat pizza?
    Answer. Yes. The Centers for Disease Control and Prevention (CDC) 
alerted FSIS about the outbreak related to frozen meat pizzas. In many 
situations, states report details on outbreak investigations to FSIS if 
and when they suspect FSIS-regulated product is associated with 
illness. In some instances, states provide CDC with their initial 
report. CDC will, in turn, report details on an outbreak investigation 
to FSIS if a FSIS-regulated food product is suspected or confirmed to 
have caused the outbreak. The latter occurred during the outbreak 
associated with frozen meat pizzas.

    Question 8. How can FSIS and the Federal Government improve 
communication between state health departments and the Federal 
Government?
    Answer. FSIS works to continually improve communications with state 
health departments. FSIS Public Health and Epidemiology Liaisons make 
routine contact with state public health officials and has made big 
strides toward achieving this goal. FSIS is a member of the Council to 
Improve Foodborne Outbreak Response (CIFOR). The Council's goal is to 
improve foodborne disease surveillance, outbreak detection, 
investigation, and reporting at the local, state, and Federal levels. 
CIFOR was created to help develop model programs and processes that 
will facilitate the investigation and control of foodborne disease 
outbreaks. FSIS is also a partner in OutbreakNet, a network of public 
health epidemiologists at the local, state, and Federal levels who 
investigate foodborne disease outbreaks. FSIS helps improve 
communications between state health departments and Federal agencies 
through participation in these activities. FSIS will host a meeting and 
tabletop exercise focused on ``Better Communications, Better Public 
Health Outcomes: Strategies for Improved Coordination During Foodborne 
Outbreaks'' in early 2008. The meeting will include CDC, the Food and 
Drug Administration, state and local public health agencies, and 
industry and consumer organizations.

    Question 9. Is there any agreement under which states are compelled 
to report foodborne illness outbreaks or E. coli illnesses to the CDC 
or FSIS?
    Answer. FSIS is not aware of any agreements that compel or require 
states to report outbreaks. However, CDC and FSIS strongly encourage 
states to report foodborne outbreaks. It is important to note that the 
lead responsibility for outbreak and illness investigation is held by 
state and local public health agencies. CDC and FSIS assist states in 
their investigations. FoodNet (which is centrally managed by CDC and 
cosponsored by FDA and USDA, and involves the participation of ten 
state health departments), includes performance standards for outbreak 
reporting. The performance standards for outbreak reporting are set as 
goals, not requirements. Regarding the reporting of E. coli O157:H7 
illnesses, laboratory-confirmed infections caused by E. coli O157:H7 
were added in 1994 to CDC's Nationally Notifiable Disease List.

    Question 10. FSIS issued a public health alert on October 9, 
followed by a recall 2 days later, for pot pies that were linked to an 
outbreak of salmonellosis. In fact, according to the CDC, there were 
238 illnesses with matching genetic fingerprints identified in 34 
states between January 1 and October 19, 2007. When was FSIS first 
notified about this outbreak?
    Answer. On July 31, 2007, CDC informed FSIS of its investigation of 
a cluster of 78 cases identified by molecular subtyping using single 
enzyme pulsed-field gel electrophoresis analysis. At that time, the 
cluster was not considered an outbreak because it was unclear whether 
or not a common source of infection was the underlying cause of the 
rise in cases.

    Question 11. Was there any coordination of the outbreak 
investigations, or were investigations conducted independently by the 
states?
    Answer. The investigation was centrally coordinated by CDC. States 
investigated illnesses identified in their respective states and 
provided details on each case to CDC.

    Question 12a. After 10 months of the outbreak, what led FSIS to 
initially issue a public health alert, and then, only 2 days later, 
issue a recall for an ``undetermined amount'' of products?
    Answer. The CDC began to assist states and centrally coordinate the 
multi-state investigation in late July 2007. State public health 
investigators had investigated illnesses in states prior to CDC's 
involvement. Despite considerable investigative effort by CDC and state 
public health agencies, the food vehicle remained elusive until October 
4, 2007, when pot pies were identified by a state as a suspect food 
vehicle. The multi-state epidemiologic case control study led by CDC 
implicated pot pies as the likely food vehicle on October 8, 2007. The 
findings of the study were presented to FSIS on October 8, 2007, and 
investigative findings at the manufacturing plant led to the issuance 
of the public health alert by FSIS and the subsequent recall of pot 
pies.

    Question 12b. What changed in 2 days?
    Answer. On October 3, 2007, the CDC launched a multi-state case 
control study with detailed questions on chicken and egg consumption. 
Based on additional information provided by the Minnesota Department of 
Health, CDC added questions to the study on October 5, 2007, focusing 
on frozen chicken and turkey pot pie product consumption. CDC notified 
FSIS on October 5, 2007, that states had identified an FSIS-regulated 
product as the potential source of contamination.
    After discussions with CDC and the states throughout the weekend, 
on October 8, 2007, FSIS personnel began to gather additional 
information at the establishment where these frozen pot pie products 
were produced. The company voluntarily ceased operation of their pot 
pie line on October 8, 2007.
    On October 9, 2007, FSIS issued a public health alert that Banquet 
brand and generic store brand frozen not-ready-to-eat pot pie products 
with ``P-9'' printed on the side of the package might have been the 
potential source of reported illnesses caused by Salmonella. This 
determination was based on epidemiological evidence collected by the 
CDC and state public health departments.
    On October 10, 2007, FSIS sent a team of specially-trained 
Enforcement, Investigation, and Analysis Officers (EIAOs) to conduct a 
food safety assessment at the establishment.
    On October 11, 2007, based on the findings of FSIS' food safety 
assessment, ConAgra Foods voluntarily recalled an undetermined amount 
of all varieties of frozen pot pie products in commerce that might have 
been linked to an outbreak of salmonellosis.
Inspection
    Question 13. In a staff briefing following the Topps recall in New 
Jersey, FSIS officials explained that they had found that in a recent 
analysis, inspector in the plant had only completed four out of 20 
HACCP 02 procedures. In addition, officials explained that it's not 
clear when inspectors complete a procedure, exactly which verifications 
took place. For instance, FSIS management personnel had no way of 
determining whether the inspectors that had completed a HACCP 02 
procedure had actually verified that the plant had Certificates of 
Analysis from their beef suppliers.
    Has FSIS considered making changes to the Performance-Based 
Inspection System in order to allow inspectors to specify exactly which 
verifications they conduct during a shift?
    Answer. FSIS is currently making a change to its inspection 
methodology that will be one key component of the Public Health 
Information System (PHIS). As part of the data collection for PHIS, 
FSIS inspection personnel will be expected to document which set of 
factors were considered in arriving at a determination of regulatory 
compliance or noncompliance. Full deployment is scheduled for late FY 
2009. In the meantime, FSIS is developing plant-specific Performance-
Based Inspection System schedules and other reports that a district 
analyst in each district office will routinely prepare and provide to 
the front-line supervisor. The front-line supervisor will use this 
information to manage the appropriate implementation of inspection 
activities in each establishment under his or her purview.

    Question 14. Has FSIS determined the reason that the inspector at 
the Topps plant only completed four of 20 HACCP 02 procedures leading 
up to the recall? If so, please explain the reason.
    Answer. Performance-Based Inspection System (PBIS) data revealed 
that the procedure 03B02 was scheduled 20 times and not performed 16 
times during the summer of 2007. In three instances an unscheduled 
HACCP 03B01 was performed on the same day instead of the scheduled 
HACCP 03B02 procedure (HACCP 03B02 procedures take longer to perform 
then HACCP 03B01 procedures). Once in July, and two additional times in 
September, the CSI performed an unscheduled 03B02 procedure on 
individual days when that procedure was not scheduled. Although the 
03B01 scheduled procedures were performed at a high rate of 80 percent, 
the scheduled 03B02s were performed at a lower than expected rate.
    There are two HACCP procedures: an ``01'' procedure and an ``02'' 
procedure, for verifying that an establishment is meeting the 
regulatory requirements of 9 CFR Part 417, which are the HACCP 
regulations. The 03B is the raw, ground process and so the 03B01 is a 
HACCP ``01'' procedure performed for a raw ground process and the 03B02 
procedures is a HACCP ``02'' procedure for the raw, ground process.
    The HACCP 01 procedure is for verifying, at random, one or more of 
the HACCP regulatory requirements. There are five regulatory 
requirements--monitoring, verification, corrective actions, record-
keeping, and reassessment. The inspector is to use a random process for 
selecting the regulatory requirements to be verified.
    The HACCP 02 procedure is for verifying all applicable regulatory 
requirements (monitoring, verification, record-keeping, corrective 
actions, and reassessment) at all of the CCPs in the HACCP plan for a 
specific production.
    Since the HACCP 01 procedure focuses on only one aspect of the 
HACCP system at a time and allows the inspector to select the specific 
aspect of the HACCP system he/she will verify, it is less likely to 
uncover a systemic problem with the system. Because the HACCP 02 
procedure is performed on a specific production lot, it is possible 
that on the occasions the procedure was performed everything had been 
properly executed. The HACCP 02 procedures are scheduled often enough 
to ensure that if there are systemic problems with the company's 
execution of its HACCP and prerequisite programs, such noncompliance 
would be discovered. That is why it is important to perform the 
scheduled procedures often enough to ensure that over time, these 
problems can be uncovered through these and other verification 
activities, such as agency sampling programs.
    FSIS generally expects that scheduled procedures will be conducted 
as scheduled, but we realize there also needs to be some flexibility to 
allow substitution of other procedures when the conditions in the plant 
warrant this. The district analyst reports referenced in the response 
to Question 13 and Question 16 will provide better, more routine, data 
to front-line supervisors to enable them to make timely corrections in 
work activity by the assigned CSI.
    As discussed in the briefings, FSIS believes that inspection 
personnel at this and other establishments did not fully understand the 
verification expectations regarding Certificates of Analysis and 
Letters of Guarantee. The agency issued training in association with 
FSIS Notice 65-07 that addressed this incomplete understanding of the 
verification expectations.

    Question 15. Is it common at other grinding establishments that 
HACCP 02 procedures are performed at such a low rate?
    Answer. The low rate of scheduled 02 procedures performed at this 
plant during this time period is not common. Although the 03B01 
scheduled procedures were performed at an acceptable rate of 
approximately 80 percent, the scheduled 03B02s were performed at a 
lower than expected rate. In addition, the unscheduled 03B02 procedures 
were performed at a higher than expected rate. FSIS generally expects 
that scheduled procedures will be conducted as assigned. The district 
analyst reports referenced in the response to Question 13 and Question 
16 will provide better, more routine, data to frontline supervisors to 
enable them to make timely corrections in work activity by the assigned 
CSI.
    Eighty percent completion exceeds the AssuranceNet performance 
measure for HACCP scheduled procedures. That performance measure was 
based on the annualized output of approximately 2,500 inspector 
assignments conducting nine million food safety procedures.

    Question 16. Are District Managers or other FSIS personnel 
responsible for reviewing inspectors' assignments and recognizing when 
assigned tasks are not being completed? What does FSIS personnel 
responsible for supervising inspectors do when assigned tasks are not 
being completed?
    Answer. Yes. FSIS currently has management control data that is 
routinely viewed by the district and field supervisors that indicate 
whether minimum performance rates of certain assigned tasks (such as 
various quality procedures including finished product standards in 
poultry or labeling) are being conducted. The management control 
identifies the performance rate at the district and the circuit level, 
but not down to the plant level. Currently, FSIS is working with the 
districts and an external contractor to identify which specific 
analytical tools and reports are needed by the district office 
management team to identify issues specific to an assignment and 
individual plant. This assessment will include a detailed analysis of 
the types of software tools and reports used to track procedures 
performed below the front-line supervisor level and is expected to be 
completed by the end of February 2008. The district and field 
supervisors will then have uniform reports that they will use to 
provide improved supervisory oversight of the execution of in-plant 
inspection activities.
    However, it should be noted that not all tasks are equal in 
priority. Public health tasks take precedence.

    Question 17. Why does FSIS not require an establishment to notify 
the agency when the establishment changes its HACCP plan?
    Answer. Establishments are required by regulation (417.2(d)) to 
sign and date their HACCP plans whenever the plans are modified. 
Although FSIS regulations do not require direct notification of FSIS, 
inspectors are tasked with reviewing the establishments' plans, and are 
then informed by the dates and signatures that the plans have been 
modified. Instituting a requirement that establishments notify FSIS 
would require notice and comment rulemaking under the Administrative 
Procedures Act.
    Inspectors are expected to be in the establishment daily making 
observations. In addition, weekly, inspectors meet with plant 
management to discuss the week's inspection findings and concerns. At 
this time, FSIS considers these actions to be sufficient for FSIS 
inspection program personnel to be informed about changes made to the 
HACCP plan. Moreover, when the HACCP plan is substantively modified to 
require a reassessment, the plant is obligated by the current 
regulations to ensure that the changes are validated and that on-going 
verification demonstrates that the food safety system is working as 
intended. Should FSIS determine that its current procedures are 
insufficient, FSIS will consider rulemaking to mandate such 
notification. Meanwhile, in the public health information system under 
development to replace the current PBIS process for scheduling 
inspection verification procedures, FSIS is designing the replacement 
system to cause the in-plant inspection personnel to document the 
process controls in place in the establishment and then, on a regular 
basis, capture when changes are made to the system on file, as well as 
to capture how the system was changed. By focusing the in-plant 
inspection personnel on knowing what the current design is of the food 
safety system, FSIS believes that inspection program personnel will 
become more attune to subtle changes in the establishment's food safety 
system.

    Question 18. Does USDA-FSIS approve companies' HACCP plans or 
review them to ensure that they include adequate procedures to prevent 
likely hazards from occurring? Does FSIS approve any changes to 
companies' HACCP plans?
    Answer. The HACCP regulations were written to provide industry with 
the flexibility and responsibility to identify food safety hazards 
specific to their process and a method specific to their process for 
preventing the identified hazards. FSIS determines implementation 
compliance through verification activities by in-plant personnel and 
through assessment of the plant's HACCP plan design by individuals 
trained in analysis of food safety systems. If the HACCP plan is deemed 
inadequate, the agency uses due process to advise the establishment of 
its finding. The establishment is typically provided an opportunity to 
comply with HACCP regulations before FSIS effects a suspension of 
inspection personnel because of an inadequate food safety system.

    Question 19. What has FSIS found following the E. coli O157:H7 
control reassessments at beef establishments and the subsequent 
``Responses to the Reassessment'' document that inspectors submitted 
pursuant to Notice 65-07?
    Answer. FSIS is in the final stages of analyzing the data. Thus, 
the information provided below is preliminary. The agency will be 
pleased to provide a briefing when the information is complete.
    As of January 11, 2008, 96.2 percent of establishments reassessed 
their HACCP Plans. Of those who reassessed, 32.6 percent changed their 
HACCP Plans, 14.7 percent changed their SSOP Plans, and 35.0 percent 
changed their prerequisite programs as a result of the reassessment.
    FSIS has received a variety of reasons why beef establishments 
responded the way they did to Notice 65-07, depending on whether or not 
the establishment changed its HACCP Plan, Sanitation Standard Operating 
Procedures Plan, or prerequisite plan or program. Among the reasons for 
changing HACCP plans, for example, were: adding or modifying one or 
more critical control points; no longer using table beef trim in ground 
beef; requesting Certificates of Analysis from beef suppliers; testing 
bench beef trimmings that are used in products; increasing the 
frequency of sampling and testing; increasing the testing of the water 
supply; having stopped grinding beef; and having changed the raw-not-
ground plan by stopping the tenderization of raw intact meat from the 
processing plan.

    Question 20. How many plants was the inspector assigned to Topps 
responsible for inspecting at the time of this recall? Was the workload 
for that inspector similar, heavier or lighter than other inspectors 
responsible for similar kinds of facilities? Approximately how many 
hours per day did the inspector spend in the Topps facility?
    Answer. Overall, the average number of plants on assignments with 
similar facilities was 3.47 plants per assignment. The Topps assignment 
was changed from four plants to five plants, which lasted for 
approximately 1 year. The assignment was changed again to three plants 
just before the recall occurred. These adjustments were due, in part, 
to plants moving into the Elizabeth, New Jersey, area and more 
recently, the opening of a new plant in that geographic area.
    Inspection program personnel who have been assigned to Topps have 
spent, on average, 1\1/2\ to 2 hours per day at Topps as part of their 
normal 8 hour shift. The plants in the Topps assignment are in a 
metropolitan area and are within proximity of each other, so there is 
little travel time involved in the workday.

    Question 21. When there is a shortage of inspectors in a given 
area, how does USDA ensure that each plant is visited by an inspector 
each day?
    Answer. FSIS has relief inspection personnel whose job is to fill a 
position when there is a vacancy or personnel are on previously 
scheduled leave. Further, FSIS' general structure of assignments is 
such that, if an unforeseen staffing shortage occurs (e.g. due to sick 
leave or short-term training), the work in the vacant assignment can be 
distributed to other assignments nearby on a short-term basis. In the 
latter situations, inspection personnel prioritize their work activity.

    Question 22. When an inspector is assigned to more than one 
processing plant, how many hours is the inspector expected to spend in 
each plant? How many hours is an inspector assigned to a single 
processing plant expected to spend in the plant?
    Answer. FSIS is obligated to provide inspection coverage. 
Inspection assignments are determined through a work measurement 
process that takes into consideration factors such as administrative 
time, within-the-plant travel based on the square footage of the 
facility, and the time required to accomplish the necessary food safety 
and other consumer protection tasks per plant. These tasks were 
studied, timed, and annualized to determine the staff year associated 
with the task being performed in an establishment. The amount of time 
an inspector assigned to more than one processing plant spends in each 
plant is dependent, in part, on the complexity of activities that occur 
in each plant. For example, if the work measurement determines a single 
processing plant to have a workload that constitutes a full workload 
for one person, the inspector would spend all day at that one 
assignment. This exceptional situation typically only occurs in remote 
areas where there are no other plants within commuting distance. 
Geographical and logistical reasons also affect inspector assignments; 
adding travel time between distantly situated plants may or may not be 
an acceptable trade-off, given the situation.

    Question 23. When FSIS takes samples for E. coli O157:H7 and finds 
positive samples, are those routinely sent for PFGE analysis and are 
those PFGE patterns routinely entered into PulseNet?
    Answer. All E. coli O157:H7 isolates from FSIS' sampling program 
are sent to the FSIS Lab in Athens, Georgia, for pulsed-field gel 
electrophoresis analysis and subsequent uploading into the PulseNet 
database.

    Question 24. Does USDA receive test results for samples taken by 
companies who have their own microbiological testing programs? If yes, 
are positive samples sent for PFGE analysis? Are those PFGE patterns 
routinely entered into PulseNet?
    Answer. FSIS inspectors review the test results for samples taken 
by companies who have their own microbiological testing programs. It is 
FSIS' understanding that most company testing does not include a 
culture confirmation component, which would result in an isolate that 
could be subjected to pulsed-field gel electrophoresis (PFGE) analysis. 
Even if a PFGE analysis were conducted, private laboratories are not 
part of the PulseNet Network.
    PulseNet is a national network of public health and food regulatory 
agency laboratories coordinated by CDC. The network consists of: state 
health departments, local health departments, and Federal agencies 
(CDC, USDA FSIS, and FDA).

                                  
