[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).