[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
HOW DO WE FIX OUR AILING FOOD SAFETY SYSTEM?
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
MARCH 11, 2009
__________
Serial No. 111-12
Printed for the use of the Committee on Energy and Commerce
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JAN SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
HILDA L. SOLIS, California JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas TIM MURPHY, Pennsylvania
JAY INSLEE, Washington MICHAEL C. BURGESS, Texas
TAMMY BALDWIN, Wisconsin MARSHA BLACKBURN, Tennessee
MIKE ROSS, Arkansas PHIL GINGREY, Georgia
ANTHONY D. WEINER, New York STEVE SCALISE, Louisiana
JIM MATHESON, Utah PARKER GRIFFITH, Alabama
G.K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
(ii)
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan NATHAN DEAL, Georgia,
BART GORDON, Tennessee Ranking Member
ANNA G. ESHOO, California RALPH M. HALL, Texas
ELIOT L. ENGEL, New York BARBARA CUBIN, Wyoming
GENE GREEN, Texas HEATHER WILSON, New Mexico
DIANA DeGETTE, Colorado JOHN B. SHADEGG, Arizona
LOIS CAPPS, California STEVE BUYER, Indiana
JAN SCHAKOWSKY, Illinois JOSEPH R. PITTS, Pennsylvania
TAMMY BALDWIN, Wisconsin MARY BONO MACK, California
MIKE ROSS, Arkansas MIKE FERGUSON, New Jersey
ANTHONY D. WEINER, New York MIKE ROGERS, Michigan
JIM MATHESON, Utah SUE WILKINS MYRICK, North Carolina
JANE HARMAN, California JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas TIM MURPHY, Pennsylvania
JOHN BARROW, Georgia MICHAEL C. BURGESS, Texas
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
C O N T E N T S
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Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Prepared statement........................................... 3
Hon. Nathan Deal, a Representative in Congress from the State of
Georgia, opening statement..................................... 7
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 7
Prepared statement........................................... 10
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 12
Hon. Donna M. Christensen, a Representative in Congress from the
Virgin Islands, opening statement.............................. 13
Hon. Phil Gingrey, a Representative in Congress from Georgia,
opening statement.............................................. 13
Hon. John P. Sarbanes, a Representative in Congress from
Maryland, opening statement.................................... 14
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 14
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 15
Hon. John Barrow, a Representative in Congress from the State of
Georgia, opening statement..................................... 17
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 18
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 19
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, opening statement..................................... 19
Hon. Betty Sutton, a Representative in Congress from the State of
Ohio, opening statement........................................ 20
Hon. Gene Green, a Representative in Congress from the State of
Texas, prepared statement...................................... 21
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, prepared statement............................. 24
Hon. Eliot L. Engel, a Representative in Congress from the State
of New York, opening statement................................. 26
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 26
Witnesses
Caroline Smith Dewaal, Food Safety Director, Center for Science
in the Public Interest......................................... 27
Prepared statement........................................... 30
William Hubbard, Advisor, Alliance for a Stronger FDA, Former
Associate Commissioner for Policy and Planning, Food and Drug
Administration................................................. 39
Prepared statement........................................... 41
Martin Cole, Ph.D., Research Professor of Biology and Director,
National Center for Food Safety and Technology, Illinois
Institute of Technology........................................ 56
Prepared statement........................................... 59
Thomas E. Stenzel, President and CEO, United Fresh Produce
Association.................................................... 70
Prepared statement........................................... 73
Jim Lugg, Consultant, Chiquita Brands, Former Executive Vice
President, Food Safety and Quality, Fresh Express.............. 89
Prepared statement........................................... 91
Submitted Material
Article entitled, ``Food Problems Elude Private Inspectors,'' New
York Times, March 5, 2009, submitted by Ms. Eshoo.............. 119
HOW DO WE FIX OUR AILING FOOD SAFETY SYSTEM?
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WEDNESDAY, MARCH 11, 2009
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:10 a.m., in
Room 2123 of the Rayburn House Office Building, Hon. Frank
Pallone Jr. (chairman) presiding.
Members present: Representatives Pallone, Dingell, Eshoo,
Engel, Green, DeGette, Schakowsky, Gonzalez, Barrow,
Christensen, Castor, Sarbanes, Space, Sutton, Waxman (ex
officio), Stupak, Deal, Shimkus, Buyer, Pitts, Murphy,
Blackburn, Gingrey, and Barton (ex officio).
Staff present: Phil Barnett, Staff Director; Karen Nelson,
Deputy Staff Director for Health; Karen Lightfoot,
Communications Director; Rachel Sher, Counsel; Steve Cha,
Professional Staff Member; Virgil Miller, Legislative
Assistant; Jennifer Berenholz, Deputy Clerk; Lindsay Vidal,
Press Assistant; Alli Corr, Special Assistant; Alvin Banks,
Special Assistant; Caitlin Sanders, Staff Assistant; Clay
Alspach, Counsel; Ryan Long, Counsel; and Chad Grant,
Legislative Analyst.
OPENING STATEMENT OF HON. FRANK PALLONE, JR.
Mr. Pallone. The subcommittee is called to order. Today the
subcommittee is meeting to discuss the topic of food safety.
Unfortunately, news of unsafe food products has continued to
make front-page headlines. The outbreak of E. coli in spinach a
few years ago, the outbreak of salmonella in peppers this past
summer, and the most recent outbreak of salmonella in peanut
butter all emphasize that now is the time for us to act. Nine
people have died as a result of this most recent peanut butter
outbreak, and hundreds more have gotten sick. And millions of
dollars have been lost in sales due to products being recalled.
Food safety, or perhaps more accurately the lack thereof,
continues to be one of my top priorities. In every Congress for
the last 12 years, I have introduced food safety legislation
that aims to bolster the FDA's enforcement and regulatory
authority over the food industry.
This year, I have collaborated with my colleagues Mr.
Dingell and Mr. Stupak to introduce a comprehensive FDA reform
bill. Many of the food provisions within the FDA Globalization
Act built upon concepts and provisions I have put forth in my
previous bills, and they emphasize prevention and shifting the
responsibility of safe food from the FDA to the manufacturers.
What it all comes down to is that it is not the
government's duty to make food safe. The companies, in my
opinion, should be responsible for the products they make and
must be held accountable for that responsibility. It is their
job to make their food safe and to implement a plan that will
ensure that they achieve that goal.
It is the government's job, on the other hand, to set
standards for food safety and hold the food industry
accountable for meeting those standards through regulatory and
enforcement authorities. We must empower the FDA with those
authorities so that the agency can effectively prevent problems
from ever occurring rather than simply reacting when something
bad has happened. And we must also require manufacturers to put
in place the food safety plans to ensure that their products
and production lines are safe.
But there are other mechanisms aside from food safety plans
that companies can implement to ensure the safety of their
products. And we will hear testimony this morning from industry
experts on the various safety mechanisms companies can
implement in order to product their product lines and keep our
Nation's food supply safe.
We will also hear about some of the regulatory authorities
that the FDA needs in order to ensure that companies are
actually implementing and following these preventative
mechanisms.
And finally we will hear from witnesses about the
enforcement tools the FDA needs to fulfill its mission of
protecting the public health and protecting Americans from
harmful products both in the United States and abroad.
I am looking forward to the discussion today and the
information we will glean. We do want to pass food safety
legislation rather quickly this year if we can, and so
obviously today's hearing will be very helpful in that regard.
And I do want to mention--I don't see him--but Congressman
Stupak has done an excellent job in the O&I Subcommittee in
bringing attention to this issue over the last, actually over
the last 3 years. He and I and Congressman Dingell have this
legislation, but he has repeatedly had hearings addressing some
of the concerns that have led to the legislation.
[The prepared statement of Mr. Pallone follows:]
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Mr. Pallone. And I now recognize my colleague, Mr. Deal.
OPENING STATEMENT OF HON. NATHAN DEAL
Mr. Deal. I want to thank the Chairman Pallone for holding
this hearing as we evaluate concepts that we as policymakers
should consider in approaching reform of the Nation's food
supply as a food safety issue at the Food and Drug
Administration. I appreciate the timeliness of this hearing,
particularly since my home state of Georgia has itself been
under a lot of attention as a consequence of a rogue peanut
processing operation in the state, as you indicated,
contributed to nine deaths and several hundred Americans being
sickened all across our country.
But let me be clear. I support giving FDA the resources it
needs to ensure our Nation's food supply remains safe and
reliable for American dinner tables across the country. I
believe a modernized approach to risk identification and
prevention, particularly through hazard analysis and critical
control point plans and similar prevention-minded procedures is
a realistic and evidence-based solution to mitigating the
hazards in the Nation's food supply chain.
We must focus on pursuing reforms with public safety
protection as a top priority. However, we must do so diligently
and methodically to ensure our actions do not cripple small
businesses in the food industry across the country.
Our Nation's food supply needs a great deal of improvement
in terms of the safeguards and fallback measures expected of a
21st century food supply chain in the United States.
Recognizing the need for a risk-based approach to food safety
reform, I have joined Representatives Jim Costa and Adam Putnam
in cosponsoring H.R. 1332, The Safe Food Enforcement Assessment
Standards and Targeting Act of 2009, Safe FEAST Act as it is
referred to. This act takes an aggressive yet realistic effort
to improve food safety by granting FDA enhanced statutory
authority to do its job as well as require implementation of
safety measures to prevent food-borne problems before they even
manifest themselves.
It is my hope that any legislation that we pass out of this
committee is similar to the provisions contained in H.R. 1332.
I look forward to continuing to work with my colleagues on both
sides of the aisle as we look at concepts that are aimed to
improve the safety of America's food supply. Thank you for
holding this hearing today. I look forward to the testimony of
our witnesses, and I welcome them to this hearing today. Thank
you. I yield back my time.
Mr. Pallone. Thank you, Mr. Deal. Next is Chairman Waxman.
I forgot to mention the work that you did on your previous
committee on government oversight on the food safety issues as
well. Thank you.
OPENING STATEMENT OF HON. HENRY A. WAXMAN
Mr. Waxman. Thank you very much, Mr. Chairman. America does
not need another deadly outbreak to understand that our food
safety system is in desperate straits. We have ample proof of
that. This is a bad situation not just for the American public
but for the food industry itself. We must act now to address
the problem, and this hearing today is the first step on that
legislative path.
Today we will hear about some of the major concepts that
our witnesses believe must be included in a model food safety
bill. The FDA Globalization Act of 2009 provides an ideal
starting point, and I commend Chairman Emeritus Dingell,
Chairman Pallone, Chairman Stupak for their work on this bill.
Using this bill as a foundation, this committee will work with
the President's FDA to implement some commonsense food safety
measures that are long overdue.
As we move forward, we will also draw upon the work of
Chairman Stupak and Ranking Member Walden who lead our
subcommittee on Oversight and Investigations. It is clear we
need to give FDA some basic authorities that will enable it to
do its job.
As the Oversight and Investigation hearing illustrated, FDA
does not have the authority to routinely access records
documenting the steps that manufacturers take to assure safety.
FDA also lacks modern and flexible enforcement tools like
administrative civil monetary penalties. It is our job to get
FDA the resources and authorities it needs to get the job done
and to do it well.
But with over 300,000 registered food facilities throughout
the U.S. and abroad, it is clear we can't rely on FDA alone to
prevent food-borne illness outbreaks. Manufacturers must
implement preventive systems to stop outbreaks before they
occur, and we need to hold them accountable when they fail.
Dr. Stephen Sundlof, FDA's director of food safety and
applied nutrition, agreed at our hearing last month that each
company in the chain of manufacturing has an obligation to
ensure that the ingredients they are using as well as their
final products are safe for Americans to consume.
Related to this, I would like to announce now that next
Thursday, on March 19, we will hold another investigative
hearing that focuses on the companies that purchased these
tainted peanuts and why their food safety systems failed to
prevent these deaths and illnesses.
We have a challenging job ahead of us, but we also have
many reasons to be optimistic. In his budget, President Obama
called for over $1 billion for FDA's efforts to increase and
improve inspections, domestic surveillance, laboratory
capacity, and domestic response to prevent and control food-
borne illnesses.
I also know that President Obama is committed to naming an
FDA commissioner soon, and I look forward to his announcement.
The food safety crisis calls for strong leadership at that
agency, and we need it now.
Let me say a few words about the notion of a so-called
single food agency. A lot of good points have been made about
the need to improve our fragmented system and ensure that food
safety is given appropriate attention by our regulatory
agencies, but reorganizing large federal bureaucracies takes a
great deal of time. And this is time we do not have when it
comes to food safety. We have to act now. We have to
concentrate the additional resources we can get at this point
on the job at hand.
Our first goal should be to address the problems that
plague this program where it currently sits. After we finish
that job, we can consider whether a reorganization is
necessary, and if so, how to go about it.
I look forward to hearing from our witnesses about what
steps we can take to begin this process. Thank you, Mr.
Chairman. Yield back my time.
[The prepared statement of Mr. Waxman follows:]
[GRAPHIC] [TIFF OMITTED] T7100A.005
[GRAPHIC] [TIFF OMITTED] T7100A.006
Mr. Pallone. Thank you, Chairman Waxman. Our ranking member
of the full committee, Mr. Barton.
OPENING STATEMENT OF HON. JOE BARTON
Mr. Barton. Thank you, Chairman Pallone and Chairman
Waxman. As we all know, there are differences between the
political parties in Congress, but there are also many
similarities. On food safety, there is no daylight between
Henry Waxman and Joe Barton, between the Republican minority
and the Democratic majority. We both agree it is important. We
both agree we need to take a look at the problem in a serious
fashion, and we both agree that if necessary we need to work
together to move legislation to fix that problem.
This committee in the last Congress through the Oversight
and Investigation Subcommittee held nine hearings on food
safety, and just this past month, as has already been
mentioned, we held another hearing on the most recent food
safety outbreak, the peanut butter salmonella outbreak.
This committee and the various subcommittees have been
active on food safety and we are going to continue to be
active. The food safety debate in the past few years has
centered on funding additional money for the Food and Drug
Administration. Unfortunately, in my opinion, instead of asking
the appropriators to give the FDA additional funding, some have
wanted to raise the additional money through a pay-to-play fee
on food companies.
Last Congress, Nathan Deal of Georgia, ranking member on
this subcommittee, and myself wrote the appropriators and asked
them to give the FDA additional funds through the appropriation
process. The appropriators responded positively, increased the
appropriation for the FDA by $150 million in last year's
supplemental appropriation bill.
We are the authorizing committee, and it is our job to give
the FDA the authority to have the tools that it needs to make
sure that our food is safe to eat. We must then get industry,
consumers, the Food and Drug Administration, and the Congress
together to strengthen the food safety system.
Last week, I cosponsored the bipartisan Safe Food
Enforcement Assessment Standards and Targeting Act. That takes
up a page just the name of the thing. Which was introduced by
Congressman Costa, Congressman Putnam, Congressman Deal, among
others, because I think that it is the right approach to food
safety. It takes a risk-based, prevention-based approach to
fixing the problem.
We need to focus on preventing food problems before they
occur. One way the legislation I just enunciated does that is
by requiring that companies create and properly execute food
safety plans. Experts say that if the peanut corporation of
America had had one, the salmonella outbreak never would have
happened in the first place. The Costa Putnam bill also take a
risk-based approach to food safety. It requires the FDA to
focus the resources on high-risk facilities first where we get
the most bang for our regulatory buck.
Mr. Chairman, this is an issue that unites consumers and
producers. Consumers want to be confident the food they eat is
safe. Producers rely on that confidence because without it,
their brand means nothing. In fact, it is a negative. There
seems to also be a bipartisan and a bicameral support for
moving food safety legislation.
Again I say that on the Republican side, we stand united
with our friends on the Democrat majority side. We want to
outline the problems in hearings like the one we are having
today. And if we need a legislative solution, we are prepared
to cooperate in preparing that solution. Thank you, Chairman
Pallone, again for holding this hearing.
Mr. Pallone. Thank you. Next is the gentleman from Texas,
Mr. Gonzalez. Thank you. The gentlewoman from the Virgin
Islands, Ms. Christensen.
OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN
Ms. Christensen. Thank you, Mr. Chairman. Mr. Chairman,
when the Subcommittee on Oversight met last month to take
testimony on the salmonella outbreak, Chairman Pallone, you
promised that you would hold this hearing. So I want to thank
you and Ranking Member Deal for following up so quickly.
In listening to the tragic stories of the families who were
here that day and hearing the callousness of the peanut
corporation executives from the emails that the subcommittee
had uncovered, it was clear that there were gaping holes in the
food safety system, which needed to be closed.
In reviewing the testimony, several themes emerge with
which I agree. One, the health and well being of the American
public could not wait any longer for solutions to address our
broken food safety system. Two, that the system must be
completely overhauled in a manner that prioritizes
coordination, resources, prevention, surveillance,
accountability, transparence, and response and that empowers
the FDA. And third, that we paid the price for our Nation's
broken food system, and we paid in human lives and health,
direct and indirect economic costs in the way that citizens
both here and abroad view products coming from the U.S.
So I look forward to the testimony of our outstanding panel
and to working to make bills like H.R. 759 law. Thank you, Mr.
Chairman.
Mr. Pallone. Thank you. Mr. Gingrey.
OPENING STATEMENT OF HON. PHIL GINGREY
Mr. Gingrey. Thank you, Mr. Chairman. Mr. Chairman, public
health officials estimate that each year 76 million people
become sick, 325,000 are hospitalized, and 5,000 die from food-
borne illnesses caused by contamination. And of course, the
most recent of these incidents in my home state of Georgia
sickened more than 677 people in 45 states and caused at least
nine deaths due, in part, to a breakdown at FDA Oversight.
We therefore have an important oversight and legislative
role in ensuring confidence in the safety of our food supply.
And I do commend the chairman for holding these hearings. While
I am pleased to see this committee engaged on such a critical
issue as food safety, we must avoid sending mixed signals.
If we are trying to build a consensus that the FDA is
overworked and lax on food safety oversight, adding things like
tobacco to FDA's responsibilities, I hope, will not take away
from the very thing we are advocating here today. People
understand the dangers of tobacco. There is no safe cigarette,
but what they don't understand and they don't expect is a
spinach salad or a scoop of peanut butter to kill them or their
loved ones.
So, Mr. Chairman, I hope that these hearings will help us
reach a greater understanding of the breakdowns in the current
system as well as the appropriate solutions to safeguard the
health and the welfare of all Americans. And I do look forward
to working with you in a bipartisan way. And I thank you, Mr.
Chairman. I yield back.
Mr. Pallone. Thank you. The gentleman from Maryland, Mr.
Sarbanes.
OPENING STATEMENT OF HON. JOHN P. SARBANES
Mr. Sarbanes. Thank you, Mr. Chairman, for holding the
hearing and for the work you have been doing on food safety and
also want to salute Chairman Stupak, Chairman Waxman for their
work as well as so many others who have been part of this
effort.
There are so many obvious negative consequences to not
having good oversight of our food supply. Among them, of
course, are when there is a severe contamination, which can
lead to harm and to death, and we have seen that recently once
again.
A little less obvious is the low level contamination that
can be broadly distributed across the food supply, but it is
also certainly the province of those who are supposed to guard
our food safety.
The third that I am particularly intrigued with, and I have
read some of the testimony and look forward to the witnesses
today, is the effect that occurs when there is an outbreak and
a crisis and alarm in the public that then causes people to
turn away from healthy food, which, of course, undermines our
overall objective of getting people to eat right in this
country. So we have got to make sure we protect the food supply
so that we can advance our overall goal.
I look forward to the hearing today. Thank you. I yield
back.
Mr. Pallone. Thank you. Mr. Pitts.
OPENING STATEMENT OF HON. JOSEPH R. PITTS
Mr. Pitts. Thank you, Mr. Chairman. Like to thank you for
convening this hearing on a topic that we read about in the
newspapers every day, food safety. The ongoing salmonella
outbreak linked to the consumption of products containing
peanut ingredients from a single firm, Peanut Corporation of
America, is only the latest in a string of high profile food
safety related incidents.
The U.S. food supply is widely regarded as among the safest
in the world. Nonetheless, as we have just heard, public health
officials estimate that each year 76 million people become
sick, 325,000 are hospitalized, and 5,000 people die from food-
borne illnesses caused by contamination from any one of a
number of microbial pathogens.
Recent scares about spinach and peppers and peanut butter
and other products, both imported and domestic, have lead to
public confusion about which products are safe and whether the
food items they have in their refrigerators and pantries could
be contaminated.
These instances have also lead to a lack of confidence
among many Americans in the government's ability to keep them
and their families safe from food-borne illnesses. Our
constituents must have confidence that when they go to their
local grocery store or convenience store, the food they buy is
safe and it has met the highest standards and safeguards of our
food safety system.
The U.S. food safety system, which includes as many as 15
different federal agencies collectively administering at least
30 different laws related to food safety must be modernized to
meet the conditions of the 21st century.
I look forward to hearing from our witnesses today,
specifically on the role FDA plays in food safety on what must
be done to prevent or mitigate future food-borne illnesses and
outbreaks, what changes must be made to FDA's current
practices, and whether FDA's current resources are adequate to
accomplish these goals.
And I would like to thank all of our witnesses for
testifying today. I look forward to your statements. I yield
back my time.
Mr. Pallone. Thank you, Chairman Dingell, and thank you for
introducing this bill and all your efforts on this issue.
OPENING STATEMENT OF HON. JOHN D. DINGELL
Mr. Dingell. Thank you, Mr. Chairman, and thank you for
holding today's hearing on the adequacy of our food safety
system.
I want to say that this is a most timely and necessary
hearing because we have before us one of the finest messes in
history. Everybody is busily blaming Food and Drug for the
inadequacy of the protection of American consumers. The blame
for that lies right here in the Congress and downtown in the
executive branch because of the failure of the agencies in the
federal government and this Congress to see to it that FDA has,
first of all, a good and adequate basic fundamental statute on
which they may work, and our failure to see to it that they
have an adequate and reliable revenue stream to enable them to
do what has to be done.
Food safety is long a concern of mine, and today's hearing
is very timely and necessary. You have mentioned, and it has
been mentioned already, that we have a fine piece of
legislation before this committee, which I will mention later.
We do, and its enactment could do much to resolve the problems
at Food and Drug.
There are not only problems with regard to food, but there
are problems with regard to pharmaceuticals and devices. And
there are severe problems in an uncooperative food processing
industry that has done everything it can to obfuscate the
matters and to see to it that we don't get legislation.
As you know, Mr. Stupak and his sister subcommittee has had
some fine hearings, and he has brought folks in here to explain
what is going on out there and to have Food and Drug tell us
whether we have the resources. And we have had hell's own time
prying the truth out of them.
We have a major problem on our hands relating to the safety
of the food supply. It is killing Americans. The government
accountability offices recognize this when they designated
federal oversight of food safety as a high risk area for the
first time in 2007. The Congress has done nothing about this
except to talk and to come forward with a lot of wondrous plans
like setting up a single agency to administer the business.
Now, we have given them some more money, and that has been
useful, but we have a lot more that has to be done. FDA is
responsible for 80 percent of the food supply in the United
States, but it is receiving only 24 percent of the
expenditures. And I repeat, as a result of this, people are
getting sick and dying.
Every year, 76 million people contract a food-borne illness
in the United States. About 325,000 of these require
hospitalization, and about 5,000 die according to the Center
for Disease Control. So we have that on our backs and upon our
hands.
More specifically, in the last two years, we can cite just
a few events which have occurred. Melamine in infant formula
and in milk products coming in from China. Nothing done to stop
it. Tainted peppers from Mexico, harmful seafood and harmful
fish from China, E. coli in spinach. That is just a little, and
every year we get new information about the Food and Drug's
inability to protect the American people.
Unfortunately the theme of a failed food supply system has
not receded. We currently find ourselves in the middle of what
is possibly the largest food recall in history, and it is
costing billions of dollars to consumers and to innocent food
processors because Food and Drug could not and did not do its
job. And we have had hearings, by the way, on that which read
like a joke book.
We currently find ourselves with FDA wrestling with a food-
borne illness outbreak associated with salmonella which has
been found in peanut products produced by the Peanut
Corporation of America, PCA. And because of the outright
negligence of this company, more than 2,100 products from ice
cream to dog food have been recalled. And by the Department of
Agriculture can investigate and can inspect dog food
manufacturers every year. Food and Drug can't do the same thing
for food processors for human beings.
Because of the outright negligence of this company then,
more than 680 people in 46 states have been sickened, and so
far, we know of nine who have died from these events. And I
think we can assume, given the way things have been going, that
this is not yet over.
What we have found in this instance and in many others is
that FDA funding is woefully inadequate and their authorities
are outdated. They have proven to be incapable of protecting
our food supply. I commend the President for recognizing the
inadequacy of FDA's resources and for proposing increased
funding for food safety activities in his budget package.
However, my experience in the Congress has shown me that
the only way to adequately address the problem of resources is
by ensuring a steady predictable revenue stream for FDA. I
propose to do this by establish a registration fee for
manufacturers so that we can look and see what is coming into
this company.
And I would note to you because of Food and Drug's
inability to address this problem that we are finding
controlled substances are coming into this country right
alongside of other commodities uninspected by Food and Drug or
anybody else.
This is the only way we can make sure that Food and Drug is
able to carry out its responsibilities. In addition to the
shortage of resources, we must address the issue of
authorities. It is shameful that FDA does not have authority to
mandate recalls, to require manufacturers to identify and
develop plans to mitigate hazards before they occur rather than
after people are sick and die. And to identify safety questions
by having full access to safety records without delay and to
appropriately trace the ability and not only their own ability,
but the origin of tainted products.
Mr. Chairman, you and I, along with Chairman Stupak, have
an appropriate safety solution to our food problems, H.R. 759,
and I urge and invite our colleagues to join us in this
particular undertaking. As a result of the failure to have Food
and Drug given the authority it needs and the resources,
people, I repeat, are dying.
The Congress is working to address a mess left behind by
another industry that has been left to self-regulate. I refer
to the banks and the securities industry. And there, they are
destituting people all across the United States in all kinds of
ways from their 401(k)s to their retirements to their saving
account and to their hopes of the future and their homes and
their mortgages.
I look forward to our witnesses' testimony today. I
apologize for taking so much time, but I hope that this process
will shake some folks up so that we will get some progress that
we need in making the American people safe. I thank you, and I
commend you, Mr. Chairman.
Mr. Pallone. Thank you. The gentleman from Illinois, Mr.
Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman, and I will be brief.
I want to thank the Chairman Emeritus. He is passionate about
this. I see my friend Bart Stupak here, and I got to serve on
ONI, had numerous of these hearings. We know the need, and we
know we need to move rapidly.
I have always been supportive of a risk-based approach in
making sure that the money that is needed goes to where it is
needed. And I think we need to focus on that. There are a lot
of preventive aspects that we can do like irradiation in a lot
of those areas that doesn't affect food quality. I think we
identified that, and we ought to help and incentivize movement
in that direction. And funding is always going to be an issue.
Make sure we fund appropriately so the money is going to where
it is needed.
That is why I am excited about being back on this
committee. Mr. Chairman, I think serving with Bart has helped
me get up to speed on this issue, and I look forward to being
helpful. I yield back.
Mr. Pallone. Thank you. The gentleman from Georgia, Mr.
Barrow.
OPENING STATEMENT OF HON. JOHN BARROW
Mr. Barrow. Thank you, Mr. Chairman, and thank you for
keeping your promise to stay on this issue until we get
something done about it. I can add nothing to the comprehensive
statement of the Chairman Emeritus. But as befits my diminutive
stature in the picture, I will focus on something smaller.
I know that colleagues of mine are working on more
comprehensive legislation from subjects like increasing the
resources and increasing the amount of FDA inspections to
creating a system of traceability to creating mandatory recall
authority. There are a whole bunch of major elements that need
to be put in place.
I want to focus on something that I think ought to be a
part of any comprehensive bill or can stand alone as a genuine
contribution to this. And that is a measure to increase the
effectiveness of both the sampling and the testing that is done
of food. What we need in this country is a system that doesn't
give manufacturers the option of knowing what they need to know
and when they need to know it, but requires them to know what
they need to know when they need to know it, and that provides
real-time information, reporting that information at the very
same time to an effective regulator of the public interest so
that the public knows what we need to know when we need to know
it.
I think that would go a long way toward cleaning up what is
broken in this system, but we cannot continue to rely on a
system that is essentially the honor system that allows folks
to use the American people as a population of lab rats to test
the food on them first to find out what is wrong with it. That
won't work. We have to be proactive about it, and that is what
I hope the witnesses will be able to share with us about today.
Thank you, Mr. Chairman. I yield back.
Mr. Pallone. Thank you. The gentlewoman from Tennessee,
Mrs. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN
Mrs. Blackburn. Thank you, Mr. Chairman, and welcome to our
witnesses. We are ready to hear from you today, and I have just
a couple of thoughts to add to the comments that have been
made. The hearings on food safety are not new. I will also say
that as we have worked through this process over the last
several years, one of the things that we have repeatedly asked
you all for is clarification on your internal communications.
How you communicate with one agency, one division knowing what
work is being done in another one. It seems as if you
continually have stumbles that do harm to the work that you are
trying to do.
Also, best practices. You seem reticent to talk about best
practices and how you address some of the problems that face
you all with food safety and with other parts. We know that you
have to change the way you deal with quality control, that that
is something for the suppliers as well as for you all
internally. And we know that you need a reformed review system,
that you also need some organizational changes to take place.
Now, with the Chairman Emeritus in his remarks, which we
all agree with much of that. I will differ on one point. I
think before you start spending more money, what you need to do
is show how you are going to reorganize and how you are going
to address the problems that are before us.
And thank you, and I yield back.
Mr. Pallone. Thank you. The gentlewoman from Colorado, Ms.
DeGette.
OPENING STATEMENT OF HON. DIANA DEGETTE
Ms. DeGette. Thank you very much, Mr. Chairman, and I want
to thank my compadre, Bart Stupak, for all the work we have
been doing in ONI over the last 10 years on these food safety
issues. I think that the bill that the chairman and the
Chairman Emeritus and Mr. Stupak introduced is excellent,
especially since it includes several issues I have been working
on for many years, which is mandatory recall authority for the
FDA and also traceability because we had the ability to do
mandatory recall right now.
Most people think we have it, and if we had had it, perhaps
some of those people in this latest peanut butter outbreak
would not have died because the FDA would have been able to
recall that peanut butter sooner.
Two things I will say. The first thing is I think we need
to improve the traceability provisions in the bill, and I look
forward to working with the chairman on that. The technology
exists, and there is no reason we shouldn't be doing it.
The second thing is, as well as more resources, we need to
give the FDA more authority to obtain the information that they
need through subpoena authority and other kinds of authority.
And finally, I agree completely with Chairman Waxman when
he says that we need to do all of this now, and then after we
do it, we need to look at structural changes in the way we
oversee our food safety in this country. Congresswoman DeLauro
and I have worked for many years on a unity food safety agency,
but that will take time. And time is certainly something we
don't have right now, given what is happening with all these
outbreaks. Thank you, Mr. Chairman.
Mr. Pallone. Thank you. The gentlewoman from Florida, Ms.
Castor.
OPENING STATEMENT OF HON. KATHY CASTOR
Ms. Castor. Thank you, Mr. Chairman, and I want to thank my
colleague, Mr. Stupak, as well. Food safety is vital to the
health of all Americans. And many of you know, the Government
Accountability Office keeps a very short list of major
government problems that require significant reform. It is
called the high risk series, and it includes notorious
governmental failures such as the Financial Regulatory System,
maintenance of our roads and bridges. Food safety also is on
this high-risk list, and reform is vital.
Let me give you one example. Tomatoes from my home state of
Florida last year were blamed for a nationwide salmonella
outbreak that was eventually traced to jalapeno and Serrano
peppers from Mexico. In the meantime, the FDA's warning not to
consume tomatoes from Florida cost tomato producers at least
$100 million. All of the time and effort spent warning
consumers about Florida tomatoes only served to delay the
solution to the real problem and allow more Americans to get
sick.
We have to address a lack of resources, the labyrinth
regulatory regime, the lack of federal authority. The problems
facing the food safety and oversight are legion, and they are
difficult, but they are not insurmountable. So I look forward
to the witnesses' thoughtful recommendations today. Thank you.
Mr. Pallone. Thank you. The gentleman from Ohio, Mr. Space.
Mr. Space. Thank you, Mr. Chairman. In yielding back, I
would just like to thank you and Chairman Stupak and Chairman
Dingell for your good work in this area. I look forward to the
testimony.
Mr. Pallone. Thank you. The gentlewoman from Ohio, Ms.
Sutton.
OPENING STATEMENT OF HON. BETTY SUTTON
Ms. Sutton. Thank you, Mr. Chairman, for having this
hearing and, you know, it was only a month ago today that under
the tremendous leadership of Chairman Stupak that we had a
hearing in the Oversight Subcommittee on the recent salmonella
outbreak associated with peanut products. And at that hearing,
I told the tragic story of an elderly woman from my district
who died of salmonella poisoning.
Sadly, Mr. Chairman, since then, another elderly woman from
northeast Ohio by the name of Nellie Napier has died from
salmonella. In fact, her death was announced that day. There
have been over 99 cases of salmonella reported in Ohio and 680
nationwide.
Now, I know, Mr. Chairman, that you and others have long
been working to fix our broken food safety system, and I thank
you. I thank Chairman Waxman and Chairman Emeritus Dingell and
Ms. DeGette and others.
The bottom line, Mr. Chairman, is that Congress needs to
act quickly and comprehensively to address the food safety in
our country. It is clear that the FDA does not have the current
authority or capacity to properly oversee the safety of our
food supply. That is why I reintroduced the Protect Consumers
Act, to give FDA mandatory recall authority. It is a very
simple measure. Certainly should be part of a comprehensive
overhaul, but frankly I would love to see it moved quickly in
its own right if we cannot move the comprehensive bill as
quickly as we would like.
We cannot sit back and let any more people become ill from
food they eat. I look forward to hearing from our panelists
today and working with my colleagues to fix our broken food
system, and I yield back.
Mr. Pallone. Thank you. The gentleman from New York, Mr.
Engel.
Mr. Engel. Mr. Chairman, I would like unanimous consent to
have Mr. Green's remarks entered into the record.
Mr. Pallone. Without objection, so ordered.
[The prepared statement of Mr. Green follows:]
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OPENING STATEMENT OF HON. ELIOT L. ENGEL
Mr. Engel. Thank you, Mr. Chairman. Thank you for holding
this important hearing today. If there is any good that may
come of the Peanut Corporation of America salmonella crisis, it
is now more clearly than ever that our food safety system is
broken and in need of critical reforms.
An AP poll last year found that 46 percent of people were
scared that they would get sick from tainted food, and there is
a reason for this fear: U.S. food-borne illnesses result in 76
million illnesses, hundreds of thousands of hospitalizations,
and up to 5,000 deaths each year.
As one of our witnesses astutely pointed out in his
testimony, our Nation is sustaining deaths equivalent to those
that perished in the World Trade Center attack in New York
every six months. When you think about it in those terms, it
just takes your breath away. And yet, we have set up the FDA to
fail here. We expect the FDA to ensure the safety of our
Nation's food supply, but we haven't given it the resources or
authority to get the job done.
Sure there are many food companies and facilities that are
employing best practices to preserve their own food products,
but unfortunately it is those that don't that cause crippling
problems for our public health and economy. This is why it is
so important to grant FDA the ability to mandate clear
preventative controls, strong traceability, and mandatory
recalls within their food safety authority.
Mr. Chairman, the costs are clear. I look forward to
working with you on a comprehensive food safety reform bill
this year. I yield back.
Mr. Pallone. Thank you. Gentlewoman from California, Ms.
Eshoo.
OPENING STATEMENT OF HON. ANNA G. ESHOO
Ms. Eshoo. Thank you, Mr. Chairman, for holding this very
important hearing on the issue of food safety, which is so
needed. The American people should be able to trust their
government to protect them from food-borne illnesses, and right
now, to put it mildly, we are not even doing an adequate job.
When people are dying or becoming seriously ill as a result
of what they ingest in the United States of America that has
always had the highest standards, we are really in trouble. And
it is an area that most frankly the Congress has neglected for
a long time.
So I think that now is the time to address it because the
FDA really should be the world's premier food inspection
authority. It is an issue that affects everyone. Doesn't matter
whether you are rich or poor, where you live in the country,
whether you are a youngster or an oldster, God help you if you
have ingested something that has not been reviewed.
And we live in a global economy, and we have things pouring
into our country, and unless it is inspected, then our citizens
are placed at risk. I have cosponsored legislation that
Congresswoman DeLauro has offered. I think it is a very good
bill. I think that there are good ideas, both in this committee
and from outside the committee. I think that the system has to
obviously be modernized, and I really think that we should
separate our food from the FDA.
I think we should have a food safety administration. I, for
one, am a little tired of running the FDA on user fees. I think
we are doing it on the cheap, and as long as we do that, we are
going to be plagued with the problems that we are here to
discuss today.
So I look forward to working with all of my colleagues on
this issue. I don't think anyone has a corner on the market of
wisdom on it, but I do think that the committee should take
into consideration all of the bills that are being introduced
on this because there are very good ideas that are contained in
each one.
So thanks again, Mr. Chairman, and to the witnesses that
are going to testify today, thank you. We know that you will be
instructive. We will learn from you, and hopefully we will pay
close attention to you. Thank you.
Mr. Pallone. Thank you. I think that concludes opening
statements by the members. So we will now turn to our panel. I
want to welcome you, and I ask you to come forward. We only
have one panel today, but they are distinguished. And they are
actually quite--let them sit down first.
I will start on my left with Ms. Caroline Smith DeWaal, who
is the food safety director for the Center for Science in the
Public Interest, and she has been dealing and calling attention
and been a watchdog on this issue for a number of years. Many
of your ideas have been incorporated in my bill and then into
the larger bill sponsored by Mr. Dingell and Mr. Stupak and
myself.
Mr. William Hubbard, who is former associate commissioner
for policy and planning at the Food and Drug Administration and
an advisor for the Alliance for a Stronger FDA. Good to see you
again.
Dr. Martin Cole, who is research professor of biology and
director of the National Center for Food Safety and Technology
at the Illinois Institute of Technology.
Mr. Thomas Stenzel who is president and CEO of United Fresh
Produce Association.
And finally Jim Lugg who is former executive vice-
president, Food Safety and Quality, Fresh Express, and
consultant for Chiquita Brands. Thank you all for being here,
and we have 5-minute opening statements, and we will start with
Ms. DeWaal.
STATEMENTS OF CAROLINE SMITH DEWAAL, FOOD SAFETY DIRECTOR,
CENTER FOR SCIENCE IN THE PUBLIC INTEREST; WILLIAM HUBBARD,
ADVISOR, ALLIANCE FOR A STRONGER FDA, FORMER ASSOCIATE
COMMISSIONER FOR POLICY AND PLANNING, FOOD AND DRUG
ADMINISTRATION; MARTIN COLE, PH.D., RESEARCH PROFESSOR OF
BIOLOGY AND DIRECTOR, NATIONAL CENTER FOR FOOD SAFETY AND
TECHNOLOGY, ILLINOIS INSTITUTE OF TECHNOLOGY; THOMAS E.
STENZEL, PRESIDENT AND CEO, UNITED FRESH PRODUCE ASSOCIATION;
AND JIM LUGG, CONSULTANT, CHIQUITA BRANDS, FORMER EXECUTIVE
VICE PRESIDENT, FOOD SAFETY AND QUALITY, FRESH EXPRESS
STATEMENT OF CAROLINE SMITH DEWAAL
Ms. DeWaal. Thank you very much, Chairman Pallone and also
Chairman Deal for having this hearing. I do want to recognize
just the tremendous food safety leadership that is in this room
from you, Chairman Pallone, to former Chairman Dingell, Mr.
Stupak, and Representatives DeGette and Eshoo. You have all
been tremendous leaders, and we are thankful to be hopefully at
this point of having legislation poised to really address these
problems.
I am the director of food safety for the Center for Science
in the Public Interest. And we represent over 900,000 consumers
both in the U.S. and Canada. We are focused on food safety,
nutrition and even alcohol issues. Pretty much anything you put
in your mouth we worry about.
The impact of the Peanut Corporation of America outbreak
and recall are still reverberating through the food supply. It
has caused nearly 700 confirmed illnesses and nine deaths and
the recall of over 3,200 separate products. Despite its size
and scope, this event is neither rare nor unexpected. Congress
has held nearly 20 hearings in the last two years focused on
similar failures of FDA's food program linked to everything
from spinach tainted with E. coli, pet food containing an
intentionally added melamine, which sickened and killed many,
many animals, and even a previous peanut butter salmonella
outbreak, which was thoroughly investigated in this committee.
These events are causing steep declines in consumer
confidence, both in the overall safety of the food supply and
in FDA's ability to protect the public. Nearly half of those
questioned by Consumers Union in November said their confidence
in food safety had declined.
Also last fall, a poll conducted by Ipsos-McClatchy
reported that 28 percent of those polled believe food safety
had gotten worse, and 46 gave food safety controls a failing
grade. In July 2008, in the midst of the salmonella outbreak
linked first to tomatoes and then to peppers, an Associated
Press-Ipsos poll found that 46 percent of people were worried
that they might get sick from eating tainted products. Clearly
it is time for Congress to take action to fundamentally reform
and fully fund our food safety system.
I will now outline a couple of the essential elements that
CSPI thinks need to be in any legislation moving forward to
begin the process of reforming FDA's food safety program.
The heart of any effective reform effort lies in
prevention, not response. Legislation should include at least
the following three components for preventing food safety
problems at food processors. First, Congress should require
every food plant regulated by FDA to have a food safety plan
detailing that it has analyzed its operations, identified
potential hazards, and is taking steps to minimize or prevent
contamination. These requirements are already in place for all
meat and poultry processors today but not in plants regulated
by FDA.
Legislation should set risk-based inspection frequencies
for food plants and establish clear auditing parameters when
states are conducting inspections on behalf of the federal
government.
And finally specific authority should allow the agency to
set testing frequencies and require food processors to report
adverse reports to government inspectors. Without these checks
on the plants, companies can follow the practices of PCA, which
instead of fixing its salmonella problems, it fixed the tests.
Consumer concerns extend up and down the food chain from
the farm to the table. So legislation also needs to provide on-
farm food safety plans that will give farmers tools to manage
risks like raw manure, unsafe water, and worker hygiene.
Imported foods also pose special challenges as they enter
the U.S. from all over the world including many countries where
they are essentially unregulated. CSPI supports the use of
certification systems operated by foreign governments and some
third parties if they are subject to appropriate oversight by
FDA. Certifiers of imported product can give FDA boots on the
ground and greatly increase the agency's capacity to enforce
our food safety requirements among the foreign facilities from
175 different countries that export to the U.S.
President Barack Obama has promised a government that
works. These new authorities, together with increased funding
will certainly help FDA improve. But to deal with the root of
the problem, Congress and the Obama administration will need to
go beyond making a few improvements. Structural reforms are
also essential.
FDA is responsible for 80 percent of the food supply, and
yet the commissioner's attention is frequently on drugs,
medical devices, and cosmetics, animal feed, many other issues
that FDA regulates. Food issues frequently unfortunately fall
to the bottom of the pile. Today there is no single expert in
charge of the policies budget and enforcement staff and no
credible voice communicating to the public and the industry
what needs to be done to prevent outbreaks.
It is time to elevate food monitoring functions within the
Department of Health and Human Services. With both the public
and the regulated industries clamoring for change, we are very
happy to be here today and to have the tremendous leadership on
this committee. Thank you.
[The prepared statement of Ms. DeWaal follows:]
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Mr. Pallone. Thank you. Mr. Hubbard.
STATEMENT OF WILLIAM HUBBARD
Mr. Hubbard. Thank you, Mr. Chairman. I have a written
statement for the record. I will just make a few brief remarks
if I may.
As you know, the public is confused and even frightened by
what is going on. Imagine a fully loaded 737 crashing every
other week. That is the type of toll we are talking about here,
but yet we continue to tolerate the intolerable. And the public
health costs have been mentioned by many of the members today,
and they are very real.
Suffering out there is very real, and also I don't think we
should disregard economy costs that companies and the health
care system are being burdened by food-borne disease outbreaks
that are largely preventable. So we are allowing things to
happen that we can stop, and I would like to make two main
points about the problem.
First is the issue of FDA resources. I believe I have a
slide if we could put it up, and I think really in a way it
captures the problem that FDA has gone through. Do we have that
slide? When I came to the FDA in the 1970s, there were 70,000
food processors in the United States. FDA had the resources to
inspect 35,000 times a year, which meant everybody could get a
visit every other year. There were very few imports at the
time.
[Slide.]
As you can see from this slide, we are now doing about
6,000 or 7,000 a year, but if you plotted the increase in the
industry, that has gone from the 70,000 domestic firms at that
period to 150,000 today and another 216,000 farm firms. So we
have gone from inspecting about 50 percent of the food supply
at any time to five percent of the domestic processors and
about two percent of all processors. And that has largely been
a function of resources. FDA's budget has been cut and cut and
cut for 30 years, and we simply need to find a way to reverse
that.
And you can also plot, as those numbers go the direction
they go, recalls have gone up. FDA's adverse findings when they
do do inspections have gone up, and you have a general lack of
overall quality in many of these firms.
I will say, however, as I say in my testimony, I think the
food supply is generally safe. We have gaps though that are
willing to cause the problem. Unless everybody does it right,
no one can get it right.
And then the other main point I wanted to make is
authorities. FDA has authorities dated to 1906. It is
essentially a relic of the 19th century. It doesn't work. It
requires an inspector to perhaps catch a problem the day he
happens to get there if he gets there at all. FDA needs the
kind of preventive controls many of you have mentioned and Ms.
DeWaal mentioned, in which they can require a firm to examine
how they make their food and control hazards so the food never
gets contaminated to begin with.
And those are practices that the leading food firms use
now, so we are not talking about imposing on the food industry
some strange new regulatory regime. We are talking about
adopting industry-developed preventive control technology that
has been proven to work.
And then lastly there are some other provisions that I
think are very important. Trace back has been mentioned. We saw
with the tomatoes last year and the spinach earlier how these
outbreaks drag on for weeks or even months because FDA doesn't
have adequate trace back authority.
They need access to the records of these firms so they know
where the food has come from and where it is going. They need
mandatory recall authority. Clearly some firms simply stall for
a few days, and during those few days while FDA is begging them
to do a recall, the food is moving and being consumed.
And we also need to accredit these labs that are doing a
lot of the work because you need to know you have a high level
of quality in the laboratories.
There are some other things in my testimony; however, in
the interest of time, I will stop there. But I certainly do
urge you to act this year on food safety legislation.
[The prepared statement of Mr. Hubbard follows:]
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Mr. Pallone. Thank you. Dr. Cole.
STATEMENT OF MARTIN COLE
Mr. Cole. Chairman Pallone, Ranking Member Deal, good
morning. I guess what I would like to try and do, I have
written testimony. I would like to make a few remarks to try
and help this committee wrestle with the complexities of the
food safety systems and what approaches they should take.
I really do applaud the important work and the urgency and
the opening remarks that have been made this morning. Certainly
we have seen, I think we are all acknowledging, the complexity
of the supply chain. The food business is global now. Go to the
supermarket, the products can be from anywhere in the world.
Global sourcing of ingredients.
Look at consumer trends now. You know we want people to eat
healthy food. There is a trend toward more natural, fresher
products, less preserved, more convenient products, longer
shelf life. All of those, as a food microbiologist, they go
against traditionally what you would like to see in the
marketplace. So we want food to be healthy, but we want it to
be safe.
And we certainly need to, I think as the opening remarks
have mentioned, we have new issues, and we need a new approach,
OK. We need to have a modern food safety system here in the
U.S. I think really in simple terms, I look at that in terms of
four main components to a modern food safety system.
First of all, risk-based preventative measures. You need
programs to monitor progress. That can be trend analysis. That
can be testing, inspection, even Epidemiology, but you need
programs to be able to monitor progress.
You need appropriate government oversight. Without
government oversight, you get the issues that we have in peanut
butter and salmonella.
And then lastly you need a strong research program because
things are changing so fast. If you don't have a world class
research program, you can't deal with issues proactively and
deal with them swiftly.
Dealing with microorganisms--and I am a microbiologist by
trade--dealing with microorganisms is even more complicated
because they are alive, OK. So bacteria have the ability to
grow and survive and adapt throughout the food chain. So when
we are designing food safety systems, we need to be cognizant
of the ability of bacteria to change and to grow and adapt. So
that adds another complexity with what we are dealing with.
Now, in response to these issues, I mean this is not just a
U.S. issue. Internationally, the food safety community has
responded by developing new tools, risk-based tools, to try and
ensure the safety of the food supply. And it now possible
through modeling and risk assessment to be able to link the
level of hazard or the prevalence of a hazard in the food
supply to the likely illness that it is likely to cause. And
that has allowed us to develop new risk management frameworks
that will provide for scientific underpinning to the develop or
risk-management options, the science behind the frequency of
inspections, et cetera. So these new developments we need to be
using.
It is ironic that, you know, in the U.S. much of these
developments have been led by U.S. scientists, and yet we need
to start walking the talk here. So we have done a good job, I
think, in tracking sporadic cases of food-borne illness through
new tools, food safety net, Wholesfield, del electrophoresis
fingerprinting if you like, of organisms. But we are really
falling behind in the prevention side, and that is really where
we need to up our game.
A quick word about oversight testing and inspection. I
think the short answer is you can't test and inspect safety
into food. OK you need that oversight because without that, you
get the PCA issue. But testing alone, think of the issue with
salmonella where a very low infective dose can give you an
illness. It is like looking for a needle in a haystack. The
statistics of sampling are such that you can't test safety into
food.
Think also of the volume of foods that are coming into the
U.S. now. What is it? Over 60 percent of fresh produce, fruit
and vegetables, coming to the U.S. from overseas, over 80
percent of seafood coming from overseas. You know we need to be
practical about the percentage of foods we can realistically
inspect. We need the inspection there as a deterrent, but we
need to be smart about where we use those resources. And we
need to use them where the highest risks are.
Now, in industry, there are two main tools for really
applying and implementing risk-based measures, and as was
mentioned before, these are standards tools that have been
adopted through Codex. The two main tools are good
manufacturing practice, or GMP, and hazard analysis critical
control point, or HACCP. And you can think of GMP as like the
building blocks, the standard operating procedures for sanitary
design, equipment, people, labeling, recall procedures, et
cetera.
Many of the recall issues that we see from FDA actually, if
you look at whether GMP would deal with them or whether HACCP
would, many of them actually would deal with GMP, and it is an
oversight issue that we have. So we need to think about where
we should be using GMP and also where we should be using HACCP.
HACCP is a more systematic approach identifying, evaluating
the food safety hazards. It is usually more quantitative in
nature, usually defining a critical control point in the food
chain that you must control to reduce, eliminate, and prevent
hazards. Typically in a value chain, you would be looking at a
performance standard for HACCP as well.
Now, I also have one slide to share with the committee this
morning. I could take that. I think it is a good lead in to
some other testimony relating to fresh produce. You can go to
slide three please. That is great. So really I think it kind of
illustrates a good lead in to the next witness. If you look at
the complexity of the supply chain for fresh produce, you can't
pasteurize lettuce, OK. You would have lettuce soup if you were
to do that.
OK, so there isn't one kill step in the chain. So you have
to take a through chain approach. You have to take good
agricultural practice. You have to look at what you are doing
in terms of washing of the produce, and you have to look at
what you are doing in terms of the distribution.
So I just wanted to share with you this is a complex
business. There is research going on at the moment between
industry and government to really try and come up with the risk
management options that would build some robustness into the
value chain for fresh produce. This is a category of food we
want people to eat more of, OK. Hugely impactful in terms of
nutrition, and yet we need to build more robustness in terms of
safety.
My final comment, Mr. Chairman, is around research. You
know the U.S., I think, should be really at the forefront of
research in terms of the safety and health of food. It is such
an important driver of public health, but also very important
in terms of trade for the U.S. With that, thank you very much.
[The prepared statement of Mr. Cole follows:]
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Mr. Pallone. Thank you, Dr. Cole. Mr. Stenzel.
STATEMENT OF THOMAS STENZEL
Mr. Stenzel. Thank you very much, Mr. Chairman. I don't
have a slide, but I will thank Dr. Cole for sharing on behalf
of the fresh produce industry. And I will affiliate myself with
his remarks.
In my written testimony, I have provided a number of
specific policy provisions that I will call to the committee's
attention, but I would like to spend just a few minutes this
morning talking a bit more personally about some of these
issues.
First, I would encourage all of you to eat more fresh
fruits and vegetables. At a time when Congress is debating
health care reform, all public health authorities agree that
one of the most important things we can do to improve health is
to eat more fruits and vegetables. But achieving that goal is
dependent upon the main issue that we are talking about today,
and that is the critical challenge to modernize and reform food
safety law.
Now, I personally am confident in my produce choices today.
We consume over a billion servings of fresh produce every day
in the United States, over five million bags of salad every
day. And out of the hundreds of different produce items in the
supermarket, a very small number, only five, have been related
to any type of food-borne disease in recent years in quantity.
But we also know that we have issues. Consumers know it,
and consumers are fearful of fresh produce at the moment. And
that is something we have to address. Now, our industry has
been working in this area for many, many years, but the spinach
crisis almost three years ago now was a watershed moment for
us.
Remember the unprecedented national response. We pulled
spinach off of the shelves of every grocery store in America
for weeks. In fact, we now know the only contaminated product
came from one farm through one processing plant on one day's
production, even one afternoon shift. It wasn't even the whole
day. There has been no contamination from that processing plant
or from spinach in the last two and a half years. And yet
today, spinach consumption is still down in the United States,
one of the healthiest vegetables that we should all be
consuming.
Following that outbreak, we undertook a mission. First, to
look at a comprehensive reevaluation of all our leafy greens
production. Mr. Lugg will talk about that, and his leadership
in that area of our industry has been tremendous. We looked at
every possible step and have adopted the most rigorous good
agricultural practices with strong compliance measures and
audits, some conducted by the California Department of Food and
Agriculture, but also other states and private sector auditors.
But our industry also had to address the broader question
of federal regulation. In January of 2007, our board of
directors adopted a series of policy principles for mandatory
federal oversight of our business. Let me explain the three
principles briefly.
First, we believe produce safety standards must allow for
commodity specific food safety practices based on the best
available science. In a highly diverse industry that is more
aptly described as hundreds of little industries, one size
clearly does not fit all. For example, food safety requirements
applicable to products grown close to the ground would be very
different from food safety practices for fruit grown on trees.
Secondly, we believe produce safety standards must be
consistent for any individual commodity wherever it was grown
or processed anywhere in the United States or imported into the
country. Consumers must have confidence that the same safety
standards were applied no matter whether the produce is grown
in California, New Jersey, or Mexico.
Finally we believe achieving consistent produce safety
standards across the industry does require strong federal
government oversight and responsibility. That is going to take
credibility for consumers, and it is also going to create
equity for producers across all of our industry. The FDA must
determine the most appropriate nationwide safety standards in
an open and transparent process with full input from the
states, industry, academia, consumer groups, and all
stakeholders.
Most of my testimony this morning has been about
prevention. Preventive controls are where it is at. That is
what we have to do. As Dr. Cole said, we are not going to test
food safety into our products. But I do have to take just one
moment to talk about outbreak investigations as well.
When I testified before the ONI subcommittee last summer in
the midst of the jalapeno outbreak, I raised several issues
that were critical, and I think the peanut paste fiasco of the
last several months continues to reinforce those. It is clear
that no one is in charge of these outbreak investigations.
There is no chain of command. There is no command and control
procedure, and American consumers and industry alike are left
to be whipsawed back and forth from momentary change to change.
Crisis planning is not done in advance. It seems to be
learned on the job. The government's failure to use industry
expertise, at least in our case, to help reduce and end the
outbreak last summer was a tragedy.
Now, let me say that this needs to be transparent. It has
to be supported by consumer groups, and it has to be a squeaky
clean system. But there is expertise in industry that can help
reduce, moderate, and end outbreaks even in the tragic
situations when they occur. And we have to find a way for CDC
and FDA to take advantage of that expertise.
Finally risk communication is critical. The principle of
timely and rapid communication with the press and public cannot
be underestimated. But it is also critical that any risk
communication expert would advise precision and care in
communicating exactly what needs to be said and not
speculating. One single office at FDA needs to have the
authority and accountability for public communications with one
single officer designated as the media spokesperson.
Let me conclude. There is a public health imperative that
we consume more fresh produce. We as an industry are doing
everything we possibly can to make sure that we are delivering
safe and healthy products. But because science tells us there
is no such thing as zero risk, government must also be able to
assure the public that our food safety systems are based on the
best available science and are enforced by strong and
appropriate oversight. Thank you.
[The prepared statement of Mr. Stenzel follows:]
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Mr. Pallone. Thank you, Mr. Stenzel. Mr. Lugg.
STATEMENT OF JIM LUGG
Mr. Lugg. Thank you, Mr. Chairman and members of the
subcommittee. My name is Jim Lugg. I am former executive vice-
president of food safety and quality at Fresh Express and today
a consultant to Chiquita Brands International.
The strategy or food safety plan is a requirement for any
company that is in the food business. And it must be a solid
one, and it must be adhered to. Regular reviews of that food
safety plan are required so that we are constantly updating it
for new risks that we have become aware of.
In our business in Fresh Express, we have to look at really
three areas. One is the production area. Second is harvesting,
and third is processing. Each of those areas are unique unto
themselves and require specialized plans. But these reviews
that we do of these three areas are what help us identify risks
and prevent contamination from occurring.
More importantly, I think the overall lesson we have
learned from these plans are that we have to do a very good job
at focusing on preventive efforts. That means that in our case
we have really four things that we look at: where are we
planting the crop, what is the environment surrounding the crop
along with its creatures, third, what kind of water will we use
to irrigate with and then process it with, and finally, all
along that supply chain we have the worker issue, worker
hygiene.
But again I stress the fact that even though we have a
robust plan and we have been doing fresh cut lettuce since
1978, we constantly must update that plan so as we can identify
new risks that we didn't realize because of new science or
whatever the case may be.
But I can point out a simple case that you can all identify
with, I think. If we have a lot of lettuce that we are ready to
harvest and one of our people can identify what seems to be an
animal incursion into that field of product, we have two
choices. If we can clearly identify where the incursion
occurred, we can avoid harvesting that product. If we can't
clearly identify that risk, we abandon the field completely.
But I emphasize that this issue of risk evaluation is a
never ending process in the food industry. And that is true
whether it is fresh, whether it is frozen, or whether it is
canned. Almost without fail, these risk evaluation lead to more
effective preventive steps, and that is the bottom line.
And I also would emphasize that these food safety plans, at
least at our company where we handle a number of different
vegetables, are not transferable. Lettuce is different from
tomato, so they must be commodity specific.
And then I want to go on and just mention that in our
company when we do identify a risk, we focus intently on how to
manage that risk and how to evaluate whether our management
practices are safe. This requires a lot of record keeping, what
has been measured, when it was measured, and all those sorts of
details. But the important point I want to make is that once
the risks are identified, the preventive process controls must
be put in place and then measured for their effectiveness.
I also want to conclude actually by saying that we have a
lot of tools that we can use to measure our effectiveness such
as third party audits, testing, inspections, and so forth. And
these tools are very effective in helping us evaluate how well
we are doing.
But the one thing I just want to give you a simple example
of in closing is an acre of spinach has more or less three
million plants in it. The typical practice for sampling a
spinach field to measure, see if a pathogen is present, is to
collect something less than 100 plants from that acre of three
million plants. You can calculate for yourself how challenging
the odds are of finding a pathogen in that sort of a regime.
Finally and just to summarize, I believe the FDA should
insist on every food company having a very current food safety
plan. Secondly, the FDA should satisfy itself that regular risk
evaluations are being done. Third, FDA should have access to
preventive action steps that have been taken to manage the
risk. And finally, my message is it is all about prevention.
Thank you.
[The prepared statement of Mr. Lugg follows:]
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Mr. Pallone. Thank you, Mr. Lugg, and thanks to all the
panel. We will have 5 minutes questions from each member who
desires, and I will start with myself.
I wanted to ask Dr. Cole. You explained the difference
between the hazard analysis and critical control points or
HACCP and good manufacturing processes. But I am not sure I
understand how that relates to many of the bills that are now--
you know, they are calling them preventive safety plans which
you flashed up in your chart or preventive controls.
Just describe to me a little better maybe the differences
between the HACCP and many of the bills, the language in the
bills preventive safety plans or preventive controls if you
could a little better. I know you flashed one of those up, but
I don't necessarily understand the difference.
I understand that the GMPs are like the basic fundamentals
but----
Mr. Cole. Yes, I think the best way to think about it is
the term preventative food safety plan is a broad term which
could include a whole range of different preventative measures.
The way that those preventative measures could be implemented
within industry and then inspected are things like GMP which is
the, as you said, are the basic kind of building blocks. You
can't do HACCP unless you have the building blocks in place,
unless you have the basic sanitary conditions in place.
Mr. Pallone. But then these preventative control systems
can vary widely. So if that is the case, is it sufficient to
just require that all manufacturers or producers simply have a
food safety plan in place, or do we have to--if it has to be a
need for FDA to have ability to be more specific than that?
Mr. Cole. I think the trick there is, because even with the
additional resources, there is always going to be finite kind
of resources we can bring to bear on a public health burden. So
we have to be smart about the way that we apply these tools.
And so we have to use either GMP or HACCP or both appropriately
to the hazard that we are trying to control and the risk that
we are trying to manage.
So, you know, let us take a fresh produce example. I think
the comments from one of the testimonies here relating the
products--is it product specific. If we were to look at the
safety of potatoes, OK. Potatoes usually end up being cooked
and prepared, and we are not really that concerned about the
safety of potatoes.
Mr. Pallone. So it is going to vary from product to
product?
Mr. Cole. It is going to vary depending on the level of
risk that we are trying to control, yes.
Mr. Pallone. Now, let me go to Ms. DeWaal then. I mean you
can comment on this as well, but if there was a system of
mandatory preventive controls in place prior to the PCA
outbreak, would that have helped to prevent it from ever
occurring in the first place? And if you want to comment on
what Dr. Cole mentioned.
Ms. DeWaal. Well, thank you, and I do agree with Dr. Cole
that the preventive control plan covers your underlying GMPs,
sanitation plans, as well as your HACCP plan if you have one,
and your testing.
The key element for the PCA recall and outbreak is that the
company, because of the absence of a plan and the records to
support that plan, they were not compelled during the
inspections to actually show what they knew to the inspectors,
which meant that when the State of Georgia went in and did
inspections, they were just doing a spot check. Conditions on
that day were what they could inspect. If a bill passes that
contains this kind of requirement, when an inspector arrives,
they will not only to get to inspect the plants and the
products that are there, they will be able to go back and look
through the records. And hopefully in that case, they would
have found and acted on the causative salmonella test result
findings that PCA had.
Mr. Pallone. Because they basically have a plan in place
about what they have to check for is what you are saying?
Ms. DeWaal. That is right. It gives the inspectors the
access to the information on food safety that the plant itself
maintains, which today FDA doesn't have it and the states don't
have it.
Mr. Pallone. Well, just give me a little more. Maybe, Mr.
Stenzel, you know, talk about how a plan might be different,
you know, like tomatoes versus spinach. And are there certain
things that you would require, you know, for both versus things
that would be different?
Mr. Stenzel. There are. You are seeing the full chain here
in this panel discussion. We actually start at the farm level
with good agricultural practices, which are kind of the GMPs of
the farm level I might say. That is the basics that all farms
should be following. There are also then commodity specific
standards and practices that we believe are appropriate, we
have called for FDA to implement. Particularly for those
products that have been associated with a pathogen in the past,
even rarely. So for tomatoes, there would be different sets of
standards and practices, commodity-specific guidelines.
Today that exists. The industry has worked hard in
different sectors, tomato industry, the leafy greens. In fact,
we have done a pretty good job, but we need FDA to be the
holder of that standard so that it is applied across the
industry and is not left just to individuals to follow it on
our own.
Mr. Pallone. OK, thank you. Mr. Deal.
Mr. Deal. I think there seems to be general agreement that
a food safety plan needs to be in place, and they will vary
depending on what level of production you are in. Mr. Lugg,
though, if we do make these plans mandatory and FDA comes in to
inspect, in your opinion, what records should be disclosed to
the FDA inspector in terms of those safety plans?
Mr. Lugg. We would really like to have happen is when the
plans are being developed, we would like to have FDA input
along with our own so that the plan has all of the steps that
the FDA would like to see included in it so that when the
inspector arrives, he has been a part of that architecture, and
he can easily see what he wants to see.
Mr. Deal. So he would, by having access to the plan, know
what they have done from a preventive standpoint?
Mr. Lugg. Exactly. I think the owner of the food needs to
own the food safety plan, but certainly there are very good
advisors within CFSAN, for example, that can assist in making
that plan even better.
Mr. Deal. Let us go to the next step on this in a logical
sequence, and any of you that would like to respond, please do
so. The next logical step is what do you do with regard to
laboratory testing? Now, I would imagine that many firms have
internal labs that do internal testing, and they would, of
course, I presume, maintain records of their own internal
testing. Others would rely on external labs to provide testing
and test results back for them. The one big question that I
still have is to what extent do we require those lab tests to
be disclosed to FDA?
And the reason I have some concern about it is that you may
have tests being done for a variety of different reasons. One
might be someone who is going to process a product, but they
want to find out what the status of the raw product is. Let us
say peanuts for example. In its raw stage, they may get a
result that may have some salmonella contamination.
But if they are intending to follow through with the kill
cycle, then obviously that should eliminate that particular
problem. My concern is that I don't think we ought to
necessarily overburden FDA with every lab report given under
every circumstance and for every purpose.
So how do we differentiate what lab report should be
disclosed? And do you have any thoughts on that?
Mr. Hubbard. I will take a shot at that if I may. The FDA's
concern is that if you require these lab tests to be routinely
submitted, people may just stop doing them.
Mr. Deal. That is right.
Mr. Hubbard. Firms often do them as part of their quality
control process at the end to make sure that their systems are
working. I think the state of Georgia was considering
legislation that would require notification. But the theory is
if you require it and the firm just stops doing the lab
testing, you have not improved things.
Mr. Deal. Right.
Mr. Hubbard. But it would be important if FDA finds a
connected problem, say, in a PCA example, is in their
inspection and says to them do you have any laboratory findings
that would help us understand if you are the source of the
problem. And if they say yes, then, of course, FDA should be
able to access those records.
Mr. Deal. So you are saying then that should be a part of
the maintain records subject to inspection when the FDA
inspector comes in, not that the lab, upon receiving a negative
or positive, as the case may be, report that the lab has to
directly report at that point to FDA.
Mr. Hubbard. I understand that that is the FDA position,
yes.
Mr. Deal. OK. All right, anybody else want to comment on
that? Ms. DeWaal.
Ms. DeWaal. Thank you. I just want to note that today most
of the bills that you are looking at do have some lab
reporting, but the different bills are different in their
strengths. And we really want to get, first of all, this access
that Mr. Hubbard is talking about. Any time an inspection is
done, the inspectors should be able to see the full range of
what the plant is looking at.
But there are times, for example, where, if testing is
compulsory for an industry or where there is some kind of
public health alert, that you might want to compel some kind of
reporting to the agency. So I think you need to leave the door
open in some of those circumstances for testing direct
reporting. But the reporting really should go from the plant to
the agency, not necessarily from the lab.
Mr. Deal. Dr. Cole.
Mr. Cole. Yes, I think that is a pretty good answer. Again
it comes back to based on risk. So if we are looking at the
testing results as part of an ongoing food safety plan, I think
the agency should have access to those records as part of that.
They should have access as to what follow-up actions were taken
as a result of those results. And then for certain products,
you might want to make it compulsory that a positive
salmonella, for example, is a notified situation. If I am
making infant formula, for example, and I get a positive
salmonella, that should be a notifiable instance, and that
should go directly to the agency.
So again unfortunately the devil is in the detail with the
risk, managing the risk versus the resources.
Mr. Deal. Well, just a quick comment. That is where we need
your help, in fleshing out the devil because we can get the
broad principles. I think it is the fleshing out of that I
would appreciate hearing from you if you have any further
thoughts about how we do that. Thank you, Mr. Chairman.
Mr. Pallone. Thank you, Mr. Deal. Mr. Gonzalez is next.
Mr. Gonzalez. Thank you very much, Mr. Chairman. First
question, and I need to get the pronunciation. Is it Ms.
DeWaal? Is that correct?
Ms. DeWaal. DeWaal, that is correct.
Mr. Gonzalez. DeWaal. Thank you. We have DeWaals in San
Antonio that came from Minnesota, but they spell their name a
little different, but it is DeWaal.
Page three of your written testimony, ``the absence of
federal inspection, inadequate state inspection have let
problems at PCA fester.'' No matter how much we, I guess,
empower the FDA, it is just going to be overwhelming. We are
never going to have all of the assets and resources truly
because of just the expanse of the issues. And we are going to
have to form partnerships obviously with state authorities and,
of course, private enterprise.
With the Peanut Corporation of America, my understanding is
that they had an operation in Texas. You are probably very
familiar. It may have been Georgia-based, but we had peanut
butter, a lot of it obviously out of the state of Texas.
Mr. Deal. Virginia-based.
Mr. Gonzalez. It is Virginia-based? Well, then we are a
subsidiary and happy to have been a subsidiary. But the
question comes down to is that they did have private testing.
And I am just wondering. I don't know what we have out there
now as far as certification of the labs that are actually
hired. The question always is that the closeness of the
relationship generally will lead to whatever conclusion the
person that is requesting the testing.
Do you have concerns about that particular aspect going
forward?
Ms. DeWaal. Yes, I think it is critically important that
the legislation should contain a lab accreditation provision.
Now, that won't apply to every in-house lab that a company may
have. But lab accreditation will raise the confidence that both
inspectors at the state level, federal level, can have in the
results of those tests.
But getting to your question on the complexity and how will
FDA actually manage its job, I mean they have a huge job of
regulating both the domestic industry and the imports. And the
reality is the agency has been starved for resources. There are
certainly management structures that could work that would
allow for FDA to have very consistent programs working with the
states to do inspection, but I don't believe those programs
have been designed at the agency.
And unfortunately the public is really losing confidence in
the ability of this agency to do those tasks. So it is
important to get the funding in place, to get the new
legislation and these new authorities in place where there is
common agreement on so much of this.
But I am not sure that even with those elements we are
going to be able to restore consumer confidence in the
functioning of this agency. So I was very glad today to hear
Chairman Waxman say that the question of structure, which was
also raised by Representative Eshoo, would be one that they
would leave open for further consideration because it is very
important that consumers trust the agency to manage this huge
responsibility.
Mr. Gonzalez. And I think the authors of the bills
recognize that, and we are going to be moving forward, and
hopefully we will do as complete a job as possible under the
circumstances and the competing bills.
This is going to be to Mr. Stenzel and Mr. Lugg. And that
is what really establishes accountability? In my view, it is
liability. Not that this may have an application, one concern I
have is that the FDA is, in essence, not just the floor of the
standard of care but represents the standard, which we all
agree today is totally inadequate in form and in practice.
And yet many people will look to that as what would govern
the behavior of individuals out there in this particular chain
as we say from the farm to the retailer. Do you all have any
views on the liability of individuals out there and how
important that aspect in this whole, what I say, the
accountability established by liability?
Mr. Stenzel. Mr. Gonzalez, you raise an important point. I
think the chairman mentioned it in the beginning. It is the
responsibility of food companies and food purveyors to ensure
that we have safe foods. It is government's responsibility, we
believe, to make sure that there is a system of oversight and
integrity and set the standards that we have to comply with.
But ultimately that liability on the individual food company is
a pretty darn important motivator. Look at PCA, you know, for
the example of when you do something wrong, I think they were
called a rogue operator, Mr. Deal, look at what that penalty is
going to be.
I would also like to comment on your earlier question if I
may about partnerships particularly on farm. This is very
important. We don't anticipate a reality of FDA hiring 3,000
inspectors to go across farms in the United States or abroad.
The partnership there we would recommend is with USDA who knows
agriculture in the United States, knows it abroad as well, in
partnership with state departments of agriculture.
FDA needs to set the public health standard. That is for
the integrity and confidence. But then in terms of actual
outreach education auditing on farm, a strong partnership with
Agriculture would make sense.
Mr. Gonzalez. And Mr. Lugg, I apologize but my time is up.
And I yield back to the chairman.
Mr. Pallone. Thank you. The gentleman from Illinois, Mr.
Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman. I want to start with
Mr. Lugg, and like the comments that were just addressed by my
colleague from Texas, I understand that the heavy hand of a
liability process will also punish the bad actors, and it is in
the best interest of everyone to have a safe and efficient
operation.
Mr. Lugg, is it safe to say that sometimes the inspections
conducted by you all are maybe more specific than you might get
from an FDA inspection?
Mr. Lugg. Yes, our inspections particularly with respect to
good agricultural practices in the field are very detailed.
Mr. Shimkus. Can you give us an example----
Mr. Lugg. Sure.
Mr. Shimkus [continuing]. Of something that you may have
spotted that FDA may not have?
Mr. Lugg. Yes, in the agricultural production sector, which
the FDA really doesn't spend a lot of time with, we have our
own staff that will go and select a piece of ground that we are
going to plant on, and that piece of ground is chosen based on
the environment that surrounds it, and the quality of the water
that we could use to irrigate with. That is something that the
FDA wouldn't normally be concerned with.
Now, we have a new group in California called the leafy
greens marketing agreement, and they do get concerned with the
good agricultural practices. But the FDA folks generally come
into our manufacturing facilities.
Mr. Shimkus. And I think, Mr. Stenzel, I think that is kind
of your point you were making as far as having USDA deal kind
of with the agricultural end of this process. I think a lot of
us, depending upon the, you know, what your life experiences
are. I used to be in the active military, and we feared the
inspector general coming down. And the inspector general would
have--we knew the list, right. We knew the standards, and by
golly, by knowing they were coming down, it made us clean up.
Really we want to be careful. I mean we really want to go after
the bad actors.
I mean we want to go after the people who would take a
report, falsify the records, inspect them, and nail them versus
those who have a proven track record of having--or, I think you
testified once before or when we were doing the Oversight
Investigation, if you talk about leafy greens. And if the
processing facility has irradiation and salmonella is--you may
want to inspect to make sure that the irradiation machine is
working. But if that is killing salmonella, then you have
addressed that need versus maybe the multitude of other things
that you might have to do.
Ms. DeWaal, I have talked about this because I really want
to focus, and I have talked about the risk-based approach. And
that talked about the food safety plan, but then identifying
for particular crops. I mean you can have a generic system, but
you do have to identify for the specific crop. But what about
the debate of the inspection regime? If you have a successful
manufacturing facility, has good manufacturing process, has a
food safety plan, has historically been graded at 100 percent,
A plus, super duper, five star quality. Do you think it is a
good use of our resources to be in there twice a year versus--
my issue is if they are a good actor, we ought to incentivize
them. And we ought to take the time for the second
investigation and go after the bad actors. Could you comment on
that?
Ms. DeWaal. Certainly. The question of trying to create a
risk-based inspection system but one that also gives the agency
the flexibility to identify the best performers and spend less
time and less resource there is one that we have really spent a
lot of time looking at. I wish we were dealing with legislation
that required six-month inspections. Most of the bills actually
are looking at, you know, maybe one year, maybe two years,
maybe four years, depending on the type of facility. So there
is a broad range of inspection.
But there is one bill that actually provides strict
inspection, a risk-based inspection system, but then gives a
lot of flexibility to FDA to set alternative inspection
frequencies when plants show that they deserve it. And that
type of language is contained in Representative DeLauro's bill,
the Food Safety Modernization Act.
So the bills range from very general language also to very
specific language. Her bill has more frequent inspection
frequencies, and maybe, I don't know how the committee would
feel about the affordability of some of the inspection
frequencies in the bill. But it is a very good model to look at
it because it really defines what is risk-based inspection for
the agency and then sets these alternative inspection
frequencies based on criteria.
Mr. Pallone. Thank you. Ms. Christensen.
Ms. Christensen. Thank you, Mr. Chairman, and I want to
thank the panelists for their testimonies and particular for
their recommendations.
Some of you have recommended a separate agency, and I will
ask. Anyone can answer or all can answer. For those who think
we should have a separate agency or for those who don't, do you
think it would be just as effective to have just a specific
office under FDA with a single head? Would that equate well
enough for you?
Ms. DeWaal. I think I will start this answer. You all are
welcome to join in. We have looked at the question of a single
agency ranging from a unified agency with all of meat and
poultry inspection combined with all of FDA inspection to one
that is more narrow.
The approach that we are looking at right now is one which
just separates out the food functions at FDA under a separate
food standards administration, similar to what they have done
in many European countries and in other developed countries
around the world.
The food standards agency would be headed by a food safety
expert, and we don't have that in place today at FDA. There is
no line authority for food safety. The policy issues are
handled at CFSAN, the Center for Food Safety and Applied
Nutrition. The inspection force is managed by the Office of
Regulatory Affairs. The budget comes out of the commissioner's
office.
There is really no line authority here, and really there is
no risk communicator. When something bad happens, I mean who is
going to be on the call? Right now, we hear from CFSAN. We hear
from ORA and CDC. So I think there is a structural problem that
needs to be addressed at FDA. It is possible that you could
have a deputy commissioner for food issues, for example, that
might play that role, but it is very important to us that you
have someone with direct line authority to the secretary of
agriculture.
Just looking at the sister food safety agency for a moment,
at the U.S. Department of Agriculture, they did about 10 years
ago pass a law that required food safety to be headed by an
undersecretary of food safety, and that person does have direct
line authority to the secretary of agriculture.
So our concern about some kind of deputy commissioner model
is that you would still have everything going through the
commissioner who has just an incredibly large job for consumer
protection today.
Mr. Hubbard. I will give it a shot too. I have spent some
time over the years thinking about that. It may be necessary to
do that at some point, but if we could wave a magic wand right
now and create a single food agency, tomorrow nothing would be
any different because you would still have an under-resourced,
under-authorized agency that couldn't solve these problems. So
I think you are doing the right way which is fix the underlying
problem. Then go back and see if the structure can work with
that and be effective. And if it is not, then I think the next
step would be to look at a single agency.
Mr. Stenzel. If I may, I think I am going to agree with
Caroline on this, that I do think that there is a fundamental
problem in the lack of direct food authority within the agency
at this point. So I would urge you to think about at least that
narrow issue in the current food safety legislation.
Whether is the equivalent of undersecretary of FSIS at USDA
I think is a good one. We have to untangle food authority from
everything else within FDA.
Ms. Christensen. Thank you. I came from the Committee on
Homeland Security, and, of course, there as well, food security
is also a major concern. And the way the system is today, I
don't have any degree of comfort that if the terrorists wanted
to do something to our food system that they would have any
problem. I was noting that then Secretary Tommy Thompson had
raised that concern, and he remarked that he couldn't
understand why terrorists had not attacked our food supply
because it was so easy to do.
But your recommendations talks about preventing
contamination at the production, at the storage and
transportation lines. Do you feel that the recommendations that
you are giving us around the food safety system now are
adequate also for protecting from an attack either from a
homegrown or outside terrorist?
Mr. Hubbard. Well, the principles are the same because you
would analyze the risk and how easy it would be, say, to
introduce a microbial agent into food and then have it, you
know, be shipped around to a lot of different places and injure
a lot of different people. So you still would be looking at
well, how accessible is my facility? Might be as simple as
making sure there is a security guard every night and the doors
are locked. And of course, in other areas, it might need to be
more sophisticated than that.
Mr. Pallone. Mr. Gingrey.
Mr. Gingrey. Thank you, Mr. Chairman. A couple of weeks ago
when we were having a hearing about the salmonella outbreak,
unfortunately from the processing plant in my home state of
Georgia down in southwest Georgia. The testimony told us that
the labs, these private labs that the processing plant
contracted with to check for salmonella, apparently there were
several positive results, and then finally one negative. And
you know the rest of that story.
But the question I want to ask of the entire panel is what
came up during that hearing. The fact that the labs were not
required, maybe even prohibited, as I understood it, from
sending that positive information to anybody else except from
whence it came, from who they were contracted with to do the
laboratory testing, and it just seemed to me that it would be
fairly easy to get that information to the FDA. Computers allow
us to do that.
I would like to ask the entire panel in fact what your
thoughts are in regard to these positive results from the
private labs actually being required to submit those to the
FDA. And we will start from my left, your right.
Ms. DeWaal. Thank you. The facts situation that was
outlined in that committee hearing was just tragic, and I think
the committee did a tremendous service to get those facts out.
The mandatory requirement for labs to report would--it looks
like an appealing solution because they are the ones doing the
test. But we have real concerns that if you don't couple any
mandatory testing reporting with a requirement to test, then
the result will be, as Mr. Hubbard said, that companies just
won't test.
So you need to have in the legislation the ability for FDA
to say for peanut processors, you might have to test for this
pathogen or that indicator organism, and then determine when
those test results would be appropriate. I do think that there
are some pathogens--botulism is an example--where mandatory
reporting by a lab might be appropriate.
But I think the legislation should be clear that FDA has
the authority to require companies to test. They should be able
to test their test records when they inspect the plants, and
that means anybody, the Agricultural Department of Georgia or
the FDA. And then on certain pathogen combinations that, in
fact, it would be open to mandatory testing either by the plant
or by the lab.
Mr. Hubbard. Mr. Deal touched upon that earlier. Certainly
it would be important if FDA went to a facility like PCA and
was doing an inspection and identified PCA as a source of a
problem, that they should be able to say as part of their
inspection process have you done any lab testing? And if the
answer is yes, could we see that so we could see what you knew
and when you knew it?
But to require all labs to automatically send information
to the FDA could actually cause people to stop doing the
testing, which would not be an outcome that I think most people
would want. I think Ms. DeWaal sort of----
Mr. Gingrey. But as Ms. DeWaal said, FDA certainly could
require in certain commodities at----
Mr. Hubbard. In certain commodities.
Mr. Gingrey [continuing]. Certain steps in the process----
Mr. Hubbard. Yes.
Mr. Gingrey [continuing]. That the testing be done for
particular pathogens, and that could be a requirement.
Mr. Hubbard. And that might be necessary in some cases.
That is right.
Mr. Cole. I would agree with those comments. I think this
is a situation where given, you know, this is not the first
outbreak we have had with peanut butter. We had one two years
ago. There have been outbreaks overseas. I think we should be
viewing this product as a high-risk product. We should have a
requirement to test and a requirement to report those tests. I
think also we need to have preventative controls in place to
prevent contamination. Once salmonella is in that product, it
is very resistant, oK, to heat processing et cetera. So we need
suppliers or companies buying that product too should have, you
know, really done a better job in supplier assurance of that
product rather than just looking at test results as well.
Mr. Stenzel. I think we share a pretty common view on the
panel, particularly the access to those test records is the
most critical aspect. I share the same concern in terms of
required every single test to be automatically forwarded to
FDA. I am not sure that that is the most effective answer for a
company that deliberately retested and retested until they
found something they wanted.
That is criminal behavior, and no matter what standard we
would put in place, I am not sure we are going to prevent
someone who does that. They would not send the results----
Mr. Gingrey. Yes, agreed. In that situation, it wouldn't
have made a difference.
Mr. Stenzel. But the access to the records I think is
absolutely critical.
Mr. Gingrey. Thank you, Mr. Stenzel. Mr. Lugg? Your
microphone is not on.
Mr. Lugg. I am sorry. Because we are in the fresh business,
and the difficulty we have in collecting a representative
sample, we rely so heavily on prevention that we just have a
lot of lab results from our agricultural fields. We do have a
program of what we call intelligent testing, and we do share
those results routinely with researchers and our California
Department of Public Health.
As far as a requirement to furnish test results, I think
that might discourage people from actually getting tests done
and might in the end result in not the result that you would
like.
Mr. Pallone. We have to move on. Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman. I want to elaborate on
some of the points Mr. Gonzalez raised. We have learned at
numerous hearings the foods program at FDA has been starved for
resources over the years and, Mr. Hubbard, in your testimony,
you state there are currently 150,000 registered facilities in
the U.S. And the charts you provided us today on the plummeting
numbers of inspections in the U.S. paint a stark picture of the
effects of this loss of resources, and that has a real impact
on food safety.
But the problem doesn't stop there. We are all acutely
aware of the fact that we now have an increasingly globalized
food market. We import foods from all over the world,
apparently more than 200,000 registered foreign food
facilities. How much does each inspection cost? Do you have any
kind of estimate you can give?
Mr. Hubbard. Domestic inspection or HACCP inspection can be
around $3,000 and regular sanitation GMP inspection can be
around $2,000. So they are not cheap.
Mr. Waxman. Well, if we are talking about having FDA
inspect over 360,000 facilities with some regularity, that is
an overwhelming task in terms of the workload, and it will
obviously cost a great deal.
I have heard many suggest that the answers to extend FDA's
workforce by supplementing it with private inspectors working
on behalf of FDA, but I want to raise some concerns about that.
There was a recent article in ``The New York Times'' that
raised problems with these private inspectors. They say that
food company being inspected often hires and pays for its own
private inspector creating a conflict of interest, how those
private inspectors frequently did not catch the problems at
plants, whose products later sickened consumers.
And some of those companies who later were found to have
contaminated products were even given excellent or superior or
ratings. That was the case with both PCA peanut outbreak and
with the children's snack Veggie Booty in 2007.
So in some ways, I am even more concerned about the notion
of relying on private inspectors in foreign countries.
Obviously the primary reason domestic companies want to import
from other countries is that these products are less expensive.
And the reason they are less expensive is usually that they are
not produced under strong food safety protection. So relying on
third parties in those countries raises some serious questions.
My fundamental concern with a third-party system for
imported foods governed by FDA is that it still puts a huge
burden and responsibility on FDA. I think that a company
benefiting from the importation of cheaper products and
ingredients should have a duty to check up on these foreign
companies and be held accountable when there are failures.
Indeed, some companies are already doing very thorough
inspections of their foreign suppliers on their own. Do you
agree that a company should have a responsibility to check on
its own suppliers? And if we are forced to rely on third-party
private inspectors, what sort of protections do you think can
be put into place to address some of these concerns?
Mr. Hubbard. Yes, Mr. Chairman. You have touched upon a
very important issue, and it may be your single hardest policy
choice in this debate because you are absolutely right. The
third-party system has not proven itself to be working properly
now. It clearly is not working. FDA does believe that there are
ways of beefing up that system----
Mr. Waxman. Don't pay attention to that.
Mr. Hubbard [continuing]. With prohibitions against
conflict of interest, with better training, with FDA audits
behind them. The fundamental dilemma is you can never have
enough inspectors to go to 316,000 facilities of FDA
inspectors. But on the other hand, these third-party folks need
to be under a very serious regimen of oversight, and I do think
that your question about having the importers, the U.S.
importer bear more responsibility for the quality of the
product they are buying from, say, China is an important piece
of it.
And, in fact, the major food companies are beginning to
acknowledge that they need to do that, that they need to know
who they are buying from and what their quality is. And if they
don't know that, they should not be buying from that foreign
firm.
Ms. DeWaal. Thank you.
Mr. Waxman. Do you want to add anything to that?
Ms. DeWaal. I do. The concept you have laid out in terms of
having the company take more responsibility works well when you
are dealing with ingredients. But, sir, it doesn't work so well
when you are dealing with whole foods. There are a lot of foods
that come in a port of entry and go directly into retail. And
who is going to be that importer of record becomes a real issue
because it is defined today in regulations. But it could give
rise to some fly-by-night situations.
Mr. Waxman. Well, we have to look at these concepts
carefully because we can't afford all the inspectors that we
think we are going to need, and I don't know that we can rely
on all those third-party inspectors either to feel that we are
being protected.
I see my time has expired, and other members are waiting
for their turn. So I will yield back the time I have overdone.
Mr. Pallone. Thank you, Chairman Waxman. I am going to ask
Mr. Sarbanes to ask questions, and then that will be it before
the votes. We have three votes, a 15, a 5, and a 5. So we will
ask you to stay so we can continue with questions. So we will
do Mr. Sarbanes, and then we will come back for the rest of the
members.
Mr. Sarbanes. Thank you very much, Mr. Chairman. Thank you
all for your testimony. I was particularly interested in the
discussion about consumer confidence and how difficult it is
going to be to restore consumer confidence. And I take it that,
if I am hearing the discussion properly, even with the best
food safety regime in place, there is still going to be
outbreaks, right? So if you link your bid to boost consumer
confidence to the notion that you would prevent outbreaks, that
is sort of a dead-end aspiration.
So it really comes then, I would imagine, the thing that is
going to bolster consumer confidence the most effectively is a
rapid response when there is--because that is the high profile
incidences, right, that occur? Otherwise it is like oxygen. You
are not going to notice it, right, if things are working well.
So it is when there is an outbreak that you have a rapid
response, that you have the traceability opportunities and so
forth. And you show the public that you can quickly isolate it,
you know, within hours, within days, whatever is feasible to do
with a good safety regime. And then they come away from the
experience saying, you know, the cop is on the beat. This is
being handled, and, you know, we are protected.
And I would just like to get your reaction to that. And
maybe there is other leverage points to help with this consumer
confidence question, but it seems to me that is probably one of
the most obvious. Yes, Ms. DeWaal.
Ms. DeWaal. Thank you. You are right that we are always
going to have outbreaks. The issue is how many and how big are
they. The bills that you are considering address both ends. If
we can prevent the problems from occurring, then the number of
outbreaks will be reduced. If we can increase the traceability,
the ability to find the contaminated product, then we are going
to reduce the size of those outbreaks.
So I think there are components that address both of those
issues, but I think they are both essential.
Mr. Sarbanes. Any other comments? Yes?
Mr. Hubbard. I would like to make the point, Mr. Sarbanes,
most of my career at the FDA, Roper and Washington Post and
Harris polls showed FDA with the second highest consumer
confidence in the entire--among all civilian agencies, next to
the National Park Service. But since, 2000, that has reversed.
Mr. Sarbanes. Um-hum.
Mr. Hubbard. It used to be around 70 percent confidence
level. Now it is around 30 percent. That is a tremendous
reversal that I think reflects the kind of concern you are
talking about because when FDA can't find the source of these
things quickly and then stamp them out, get the food out of the
commerce, then I think the public just feels their government
is not serving them well.
So the speed at which outbreaks can be responded to and
stopped is absolutely important. But that will require more
than FDA.
Mr. Sarbanes. Right.
Mr. Hubbard. You have the CDC component, and then the state
health departments are a big piece of that.
Mr. Sarbanes. Let me ask a question about the deterrent
effect because you all have alluded to this. And I am just
curious now where the number of inspections relative to the
number of facilities and so forth is so low. I mean is there an
operative deterrent effect at the current time, or not really?
Mr. Hubbard. I actually tracked that a few years back. As
the inspections went down, the recalls went up. And the adverse
findings from the FDA inspections that did get done went up. So
in other words, as inspectors disappeared, the vigilance in the
firms disappeared with them.
Mr. Sarbanes. Right.
Mr. Hubbard. So I think the fact that they think FDA might
come helps, and the fact that, you know, FDA won't come now is
clearly not helpful.
Mr. Sarbanes. Well, and I imagine there is a sort of
tipping point that you have to get past to create an effective
deterrent in this process. I have no further questions. Thank
you, Mr. Chairman. I yield back.
Mr. Pallone. Thank you. So we are going to break. We have
three votes. Should be back in about half an hour, but we will
come right back and finish with the rest of the members.
Committee stands in recess.
[Recess.]
Mr. Pallone. If I could ask the panel to take their seats
again, and thank you. And our next member for questions is the
gentlewoman from Florida, Ms. Castor.
Ms. Castor. Thank you, Mr. Chairman. To the panel, just as
folks all across the country would be surprised that FDA does
not have mandatory recall authority, I think they would also be
quite surprised that the FDA does not have the authority to
fine bad actors.
Has this always been the case? Compare that to other
agencies that have that authority to institute civil monetary
penalties and then if you would provide a recommendation on
what you think an FDA reform food safety bill should contain.
Mr. Hubbard. I will give that a shot if I may. If you line
up the various authorities of agencies all across government,
the newer agencies tend to have a much broader range of
authorities, such as civil money penalty and subpoena
authority.
FDA is one of the oldest agencies, and it was created in
1906. And at the time, it was believed that the way to enforce
the law is to put the owner in jail if he sold a bad food. But,
you know, you are not going to put the Kraft CEO in jail
because one of his firms made a little mistake. And to enjoin
the company that is making the food, which is a good thing, and
seize the food if it was considered adulterated.
But it did not give FDA these more modern tools that
provide them more leverage. So, for instance, civil money
penalties, the industry won't like, but it is a nice
intermediate tool to say OK, tomorrow it is going to cost you
$1,000. And if you don't fix it, it might cost you $2,000. And
finally they will fix it.
And those kind of flexible tools have been shown to be very
helpful for FDA in other contexts such as medical devices where
it does have that authority.
So I absolutely encourage you to look at the modern toolbox
that regulatory agencies have and consider giving FDA those
tools as well.
Ms. DeWaal. We strongly agree. There are a whole set of
tools, including things like even citizen sue provisions which
are used in statutes that have been developed in the last 20 or
30 years. FDA doesn't have any of this capacity. So I think the
bill should include updating both the criminal penalty section
but also giving this new authority for civil monetary
penalties, traceability, and mandatory recall. Thank you.
Mr. Stenzel. Honestly, Ms. Castor, I really don't have the
experience to answer the question historically or related to
other agencies. I do think some of the civil penalty areas can
make sense in this area as well.
Ms. Castor. Anyone else? Are any states that you know of,
have they adopted their own civil penalties under their state
inspection regulatory authority? Do you know? OK, thank you
very much, and I will yield back.
Mr. Pallone. Thank you. The gentlewoman from Ohio, Ms.
Sutton.
Ms. Sutton. Thank you, Mr. Chairman, and thank you for the
witnesses for waiting for us. A couple of things very quickly.
Mr. Lugg, you made an observation that has been made here in
the past in our oversight hearing in which when discussing the
concept of required reporting of test results to the FDA, you
indicated that that may result in the failure to test and have
an opposite effect.
But I have to tell you that after we heard that sort of
proffered at the last hearing, I received a lot of feedback,
and it was certainly running through my mind, from my
constituents who all well, we will fix that. We will just make
them test. And so I mean I just have to tell you that in the
realm of America, people are like that seems ridiculous to this
congresswoman and to the people at least who I heard back from.
So I think we can correct that problem if we need to by
mandating the test. And I just appreciate having the
opportunity though to address that. The other questions that I
have, a lot of you have talked about imports and the complex
sort of questions that it creates in ensuring the safety of the
process and the food that results on our dinner tables.
Ms. DeWaal and I think, Dr. Cole, you also addressed this
issue. And, Dr. Cole, I think, if I am not mistaken--let us see
if I can find it--you explained the way that this works under
the WTO. And I think that that is really, really helpful
because I am not sure that people out and about really
understand our limitations on ensuring the safety of imports
into this country. That in many ways--and perhaps this is a
simplification, and I certainly ask you to explain in more
detail--but in summary, when I read your statement about this,
in essence we rely on the standards of other countries. Is that
sort of an accurate assessment, or would you like to expand on
that?
Mr. Cole. I think through WTO, appropriate level of
protection is defined by the member, in this case a country,
and the regulations are set up to provide a shield, not a
sword. So if a country can decide that it is going to have a
more stringent standard than the default CODEX standard, it
needs to have evidence that its own safety system can meet that
standard as well. That is kind of how it works in a nutshell.
So there are frameworks there from CODEX that we can borrow
from. There are default criteria that we can use. It doesn't
stop us setting our own standard, but we need to be able to
show actually that we are meeting that standard for our own
public health benefit, if you know what I mean.
Ms. Sutton. But with respect to the WTO and as things
currently exist, you mentioned that the idea of what is
considered ``reasonable'' differs from country to country, and
acceptable risk is culturally defined.
And I think that those are important things for the
American people to understand when we talk about certainly
another subject that is related to this, and that is the way
our trade system is working and what kind of exposures we have
as a result of some of the policies that we follow. So I
appreciate that assessment.
Now, there are so many things that I would to explore more.
But, Ms. DeWaal, as you noted in your testimony and we have
heard some conversation here today about, the ability to access
records from food manufacturers is now currently found in the
Bioterrorism Act of 2002. And, of course, the FDA cannot demand
access to food company's records unless they believe that an
article of food is adulterated and presents a threat of serious
adverse health consequences or death to humans or animals.
And if you could just take this moment to explain how the
limitations of working under that framework have resulted in
adverse results.
Ms. DeWaal. Thank you for the question. Probably one of the
best examples of the failing of records access when it was
needed by FDA was in an inspection of another peanut butter
processor. That company, and it was disclosed actually in this
committee's investigations, that company found that they had an
inspection going on, and the inspector wanted to see the
salmonella testing records. But the company itself said well,
you have to submit the request in writing. FDA never circled
back with that written request, and the company never disclosed
those records. Another major multistate recall resulted from
peanut butter linked to that company.
It is clear that FDA does not have the record access that
it needs under the Bioterrorism Act. So I think it is essential
that in any legislation that should emerge from this process
that that be fixed. And records access should be tied into this
food safety plant. It should be broad. It should go to testing.
It should go to processing records and corrective actions.
Thank you.
Mr. Pallone. Thank you. Ms. Eshoo.
Ms. Eshoo. Thanks again, Mr. Chairman, and thank you to the
witnesses for your patience and waiting and for the testimony
that you have given.
I wanted to highlight something that appeared in the ``New
York Times'' last week, and Chairman Waxman made reference to
it. But I want to read this, and with your permission, Mr.
Chairman, I would like to place the full article in the record
of the hearing.
Mr. Pallone. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Ms. Eshoo. Thank you. The story starts out ``when food
industry giants like Kellogg want to ensure that American
consumers are being protected from contaminated products, they
rely on private inspectors like Eugene A. Hatfield. So last
spring, Mr. Hatfield headed to the Peanut Corporation of
America plant in southwest Georgia to make sure its chopped
nuts, paste, and peanut butter were safe to use in things as
diverse as granola bars and ice cream. The peanut company
though knew in advance that Mr. Hatfield was coming.
He had less than a day to check the entire plant, which
processed several million pounds of peanuts a month. Mr.
Hatfield, 66, an expert in fresh produce, was not aware that
peanuts were readily susceptible to salmonella, which he was
not required to test for anyway. And while he was inspecting
the plant to reassure Kellogg and other food companies of its
suitability as a supplier, the Peanut Corporation was paying
for his efforts.''
You can tell where I am going with this. Now, here is a
quote. ``The overall food safety level of this facility was
considered to be SUPERIOR''--that is in capital letters--``he
concluded in his March 27, 2008 report for his employer, the
American Institute of Baking, which performs audits for major
food companies. A copy of the audit was obtained by the ``New
York Times.''
Now, it seems to me we have a big problem here. We know,
according to your testimony, what it costs to do inspections.
It is not cheap, but it seems to me that outside of national
security, there are two major functions the government has--and
I have always kept this with me, from local government to the
Congress--public health and public safety.
And this issue bears both responsibilities. We are now not
only talking about preventing. We are talking about life and
death in our system, the American system, that should be the
gold standard of the world. So for the record, what I would
like to know is do you think that this third-party, these
private inspectors are really the best way to go? I mean it
said in this article that the contributions of third-party
audits to food safety are the same as the contribution of mail
order diploma mills to education.
Why don't we start over here? I heard your comments
earlier. Why don't we start over here with Mr. Lugg?
Mr. Lugg. Thank you for the question. That is a very good
subject that you raise, and that is----
Ms. Eshoo. I know it is, but I want to know what you think
of these private inspectors. Do you think they should be
retained? Do you think they have a place in the system? Do you
think that we can reform it so that private inspectors have to
exercise more responsibility? Tell me what you think
representing you--who are you representing?
Mr. Lugg. Chiquita Brands----
Ms. Eshoo. Chiquita.
Mr. Lugg [continuing]. International.
Ms. Eshoo. Right.
Mr. Lugg. Our philosophy has been from day one we cannot
rely on third-party inspectors.
Ms. Eshoo. Um-hum.
Mr. Lugg. We do believe that there should be in place a
system for licensing third-party inspectors, and they should be
regularly brought in to keep their licenses in force. And----
Ms. Eshoo. So they are not paid by the very people that
they are inspecting? Is that what you are saying?
Mr. Lugg. Whoever pays, I didn't address the payment issue.
Ms. Eshoo. I see.
Mr. Lugg. But I just am----
Ms. Eshoo. Well, how is what you just said, how does it
differ from what we have today?
Mr. Lugg. Well, we are very concerned that standards are
different depending on the audit firms that do the audit.
Ms. Eshoo. I see.
Mr. Lugg. And if we always go back to the CODEX
Almuntarius, which is a fundamental document and auditors are
licensed based on their knowledge and so forth of how to
conduct inspections, there should be an improvement in the
third-party audit, regardless of who pays for it.
Ms. Eshoo. Good. Mr. Stenzel.
Mr. Stenzel. Congresswoman, I would say that private
inspectors are an essential and important part of our food
safety system today.
Ms. Eshoo. But what I just read----
Mr. Stenzel. Because we have one example where it didn't
work----
Ms. Eshoo. But this is--so you think it is the only one?
Mr. Stenzel. I didn't say it is the only one, nor that it
is the end of the solution. But private inspection is one way
that private sector companies do audit each other, and that is
an important part. No one is more concerned than Kellogg in
that story that the people they hired to do inspections didn't
do an adequate job.
Ms. Eshoo. But where is the safety valve in this, in what
you are saying?
Mr. Stenzel. But here is where I think is important when we
get to this legislation. Should FDA incorporate third-party
private inspectors? And if that becomes the case, then there
has to be much more rigorous certification of inspectors.
Ms. Eshoo. So you are acknowledging that there are holes in
what the system does now?
Mr. Stenzel. Absolutely.
Ms. Eshoo. Good. All right. Well, at least you are doing
that. I am glad. And, Mr. Chairman, I think that when we do a
bill, we have to pay a lot of attention to this area. And I
think that it is important to have a stand-alone NHHS.
I worry a great deal that what Congress is going to fall
back on is what we have done with so many other areas of FDA
and fund it through some kind of user fee. And I don't think
that is the way to approach this. I think we are skating on
very, very thin ice.
I also think that Congress should be taking a look at an
overlapping term for the FDA commissioner so that it is never
politicized. I think it should be a six-year term and not be
subject to the whims of politics that we have seen. That hasn't
come up today, but I think there is a lot of work to be done
relative to the FDA.
And if we come up with all kinds of reforms but we don't
fund what needs to be funded, we are going to be right back
here with these good people hearing testimony all over again.
So thank you. I was glad to return from the floor. I did want
to ask the questions, and I thank the witnesses and the
chairman. This is a big issue for us in the country.
Mr. Pallone. Thank you. Ms. DeGette.
Ms. DeGette. Thank you very much, Mr. Chairman. Mr.
Stenzel, I wanted to ask you. With produce in particular, the
industry now has the ability to trace produce not just from the
field but from the exact part of the field it was planted all
the way to the end wherever it is, the grocery store or the
restaurant. Correct?
Mr. Stenzel. That possibility exists. It is certainly not
in place across the whole industry.
Ms. DeGette. But it is done in parts of the industry?
Mr. Stenzel. In some cases, yes.
Ms. DeGette. Some companies have instituted voluntary
traceability within their companies, correct?
Mr. Stenzel. Absolutely. Many companies are doing that.
Ms. DeGette. And, in fact, California has enacted standards
that involve traceability, correct?
Mr. Stenzel. Yes, ma'am.
Ms. DeGette. And so I guess I am wondering what your
industry's view would be if we enacted traceability laws as
part of comprehensive food safety legislation?
Mr. Stenzel. I would comment on the whole area.
Traceability is an essential part of food safety. I think it is
something that we have to look at. I would first ask in the
Bioterrorism Act in the one up, one down, I am not aware of any
case where FDA has ever cited a company for failure to produce
records in an adequate time. So a lot of what we talk about in
produce traceability, even last summer's episode was chasing
the wrong commodity.
Ms. DeGette. Right.
Mr. Stenzel. Not the fact they couldn't trace the tomatoes.
Ms. DeGette. Right. Well, we need to fix the one up one
down too.
Mr. Stenzel. Right.
Ms. DeGette. I think everybody agrees with that. But if we
did fix that, we could do traceability.
Mr. Stenzel. On traceability for produce, about 18 months
ago, our industry launched an industry-wide initiative to
handle bulk produce. If it is in a bag or if it is in a
package, you have a UPC code, and it is much more easily
tracked. But for bulk produce in cartons----
Ms. DeGette. I hope you don't mind if I interrupt you.
Mr. Stenzel. Please.
Ms. DeGette. I only have 5 minutes, and the question I
asked you was does your industry support traceability?
Mr. Stenzel. We are doing everything we can to implement
traceability across the----
Ms. DeGette. And would you support it as part of a
comprehensive----
Mr. Stenzel. Certainly as part of comprehensive food
safety.
Ms. DeGette [continuing]. Legislation. Thank you very much.
And, Mr. Lugg, what is your view on traceability? Would you be
supportive as well?
Mr. Lugg. We certainly are 100 percent supportive, and if
you look at any of our packaged salads, you can trace them
immediately.
Ms. DeGette. Now, Mr. Hubbard, I want to ask you a question
about traceability because, as you know, we have discussed this
in my legislation. And I have also talked about it with Ms.
DeWaal. So you might actually have some input too.
What my traceability legislation says is that the FDA shall
develop guidelines for each different industry. Do we have the
technology to do that in the different parts of the food
industry?
Mr. Hubbard. I think we do, and in fact, I think the tomato
folks showed some of that technology to you last summer. And
clearly there is bar code and radio frequency identification
technology and others that allow you to track a product all the
way back to its origin. And the Defense Department is using it
for everything from tanks to nuts and bolts. And so it is
becoming widely used anyway. And I would hope that that might
be one avenue for a solution here.
Ms. DeGette. This is an issue we started talking about some
years ago. And people in the industry didn't think that they
could do it. And so they opposed it, but now I call it the
salsa fiasco of last year where first we thought it was
tomatoes, then jalapenos. And it took months and months. It not
only hurt the consumers, it devastated the tomato industry. I
think people are now realizing not just the health benefits but
the commercial benefits.
Ms. DeWaal, I wanted to ask you a question. I think you
talked about this before, and I just wanted to put a little
fine point on it. With the peanut problems we have had this
year, it seems to me that the types of records production, you
would both need to have mandatory inspections of some kind in
every industry. And you would also have to have mandatory
production of those documents because if you just had mandatory
production of the documents without the mandatory inspections,
then people might not do the inspections. Is that what you were
saying?
Ms. DeWaal. That is correct. The inspections are an
essential part of the enforcement program. This is to prevent
outbreaks from occurring. The records production should be part
of that, and also mandatory testing for certain pathogens that
might be linked to those products. So all of this goes into a
preventive approach.
Ms. DeGette. Right, because you don't want people to get
sick in the first place if possible. I just have one last
question for all the witnesses if you can just answer yes or
no. Would you support mandatory recall authority for the FDA as
part of comprehensive food safety legislation?
Ms. DeWaal. Yes.
Mr. Hubbard. Yes.
Mr. Cole. Yes.
Mr. Stenzel. Yes.
Mr. Lugg. And yes.
Ms. DeGette. Thank you very much, Mr. Chairman.
Mr. Pallone. Thank you. Mr. Stupak.
Mr. Stupak. Thank you, Mr. Chairman, and thanks for
allowing me to sit in even though I am not part of the
subcommittee. You know my interest in this and in our
legislation. The hearing focused today a lot on inspection
fees, certifications, even brought up the 6-year term for the
FDA commissioner. But no matter what we do in this field,
whether it is inspection fees or whatever we are doing, we
still have to change the culture of the FDA.
You can have all the laws and all the money in the world,
but if we don't have a culture at the FDA that is willing to be
aggressive in this area, we are still going to have food-borne
illnesses. For instance, we talked a lot about the tomato
industry. The tomato industry and members of our Committee on
Oversight Investigations repeatedly told the FDA because of the
time of the outbreak, the only place that tomatoes could have
possibly affected it were from south Florida. South Florida has
a very good trace back and certification of their product. So
it couldn't have come from the United States.
But what did the FDA do? They still--and if you go to their
Web site today--still insist it is tomatoes. They have killed
the tomato industry. Last year, $125 million they lost because
the FDA wouldn't listen to anybody. And we find out it is
jalapenos out of Mexico. But go to Web site, the tomato
industry is still being associated with this outbreak. So I
think we need leadership at the FDA, and we haven't had that.
Mr. Hubbard, you said that we can never make food 100
percent safe, and I guess I would tend to agree with you
somewhat. And then you said that there are gaps in our food
safety system. What are those gaps?
Mr. Hubbard. Well, principally, it is that the system
relies upon this infrequent inspection process and forces FDA
to pay got-you or state inspectors, instead of putting the
burden on the producer to demonstrate at all times that they
are producing a safe food. That is the paradigm shift that
needs to occur.
Mr. Stupak. OK, let me ask you this. Our committee's
research has found that more than 10 years ago, recommendations
to develop a national food protection training center have been
repeated made, yet no action has been taken to date.
More than 8 years ago, the Department of Health and Human
Services office of inspector general concluded that an
effective food safety system depends on the collective effort
and coordination among federal, state, and local levels on
government. Yet that same report noted the FDA provides limited
training for state food protection professionals, and that
states themselves cannot afford the cost of such training.
Nearly 2 years ago, the FDA issued program standards, which
requires states to have training plans that ensure all
inspectors receive training required to adequately perform
their work assignments. Still only a few states have done it.
So let me ask do we need a national food protection training
center to train state and local inspectors to federal
standards, and maybe even these private inspectors we have
heard so much about today?
Mr. Hubbard. I think we do, and in fact, I would urge you
to consider in your legislation authorizing or mandating that
FDA creates such a thing. I think the Georgia example showed
that states were not perhaps up to snuff, and these third-party
inspectors, as several members have raised, clearly are not up
to snuff either. So that sort of a training academy would, in
my view, raise standards for everyone.
Mr. Stupak. OK, there is some limited training, I know,
through University of Maryland, but it is very limited. You
don't have to go through it, so we are almost looking like a
college curriculum. That is being developed through some
legislation. That is why I wanted to ask you that question.
But let me ask you this, and if you know this. What is the
current practice? Like take the PCA, Peanut Corporation of
America. Georgia and Texas state inspectors inspected it. What
happened to those reports? Do they go to the FDA and sit on a
shelf or in someone's computer program? Is there an internal
audit about what is being done in these inspections?
We heard about Mr. Hatfield from Ms. Eshoo about never
inspecting or gave a superior rating. The one in Texas received
a very good rating. Is there an internal audit conducted by the
FDA then of these reports that come in? Or do they just sit
until something happens? Do you know?
Mr. Hubbard. Well, there is the paper process that says how
it should work, and there is a way it apparently really works.
What should have happened in that case is that state inspector
should have been trained to an FDA standard, which I gathered
didn't happen.
Mr. Stupak. Right.
Mr. Hubbard. Then they should have presented the FDA with
the findings, but, of course as you know, the state inspector
didn't find any problems. So, you know, I suppose you could
argue there was nothing for FDA to follow up on.
Mr. Stupak. But wouldn't the FDA at least have some
standards like especially since you had the 97 ConAgra peanut
butter outbreak? Wouldn't they at least inspect for salmonella?
Mr. Hubbard. They did do guidance after that ConAgra
example, and the way it works is the FDA actually commissions
state officials. So when they go in, they carry two badges, the
Georgia badge and the FDA badge. And they are supposed to do
the equivalent of an FDA inspection, but that apparently did
not happen in this case.
Mr. Stupak. Correct, because a true FDA inspection takes a
little bit of time. I think you indicated $2,000 up to $5,000
for an inspection and more than 8 hours.
Mr. Hubbard. Yes, on average, an FDA inspection of that
nature would take a day to a day and a half, whereas state
inspections are often done in a couple of hours.
Mr. Stupak. So even if these inspectors are trained,
certified, everything, you still need an internal audit of what
they are doing, or someone at the FDA looking at this to make
sure it is being done properly, do we not?
Mr. Hubbard. I think you are right.
Mr. Stupak. OK, was there ever internal audits like that of
state inspectors on foods? Do you know in your time there?
Mr. Hubbard. You know, I am sorry. I don't know, but I
would hope so.
Mr. Stupak. Well, I think that is one of the questions in
our follow up period that we are having next week is, you know,
were there internal audits and what was going on with these
things? One more if I may, Mr. Chairman.
Mr. Lugg, you indicated that I think your first priority,
you said, when you come to work on food is you select the land
and then you watch the water and that. Is that in this country
or other countries too? Chiquita bananas come from all over,
right? Costa Rica, everywhere?
Mr. Lugg. Yes, our company operates in approximately 70
countries around the world, but particularly in the Fresh
Express packaged salads, whether the product is coming from
Guatemala, which we have to get our snow peas from in winter
months, or down in Chile where get in the winter months. We
send our own inspecting staff down to locate the land, and then
we use special, global, geospacial technology to make sure that
those lots are actually being harvested when they say they
were.
Mr. Stupak. OK, what about the chemicals that they use
during the process? Is that all approved by your company?
Mr. Lugg. Those are chemicals that we approve, and then
there are samples taken to make sure that they are within the
residue limits.
Mr. Stupak. Thank you, Mr. Chairman.
Mr. Pallone. Thank you, Mr. Stupak. Let me thank the whole
panel. I mean we are done with our questions, but, you know, we
really do appreciate your input not only today but throughout
the process. Mr. Stupak has had hearings and hearings in the
full Government Reform Committee with Mr. Waxman. We do intend
to move a bill. You know, I this subcommittee, probably our
next hearing will be a legislative hearing on legislation that
we would move. We are still waiting for the new FDA. I mean
there isn't a commissioner. So we would still like to get that
input. But, you know, it is our intention to move fairly
quickly.
So thank you very much. We appreciate all your input.
Without objection, this meeting of the subcommittee is
adjourned.
[Whereupon, at 1:25 p.m., the subcommittee was adjourned.]
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