[Senate Hearing 110-790]
[From the U.S. Government Publishing Office]
S. Hrg. 110-790
DEVELOPING A COMPREHENSIVE RESPONSE
TO FOOD SAFETY
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
ON
EXAMINING DEVELOPING A COMPREHENSIVE RESPONSE TO FOOD SAFETY PROBLEMS
__________
DECEMBER 4, 2007
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut MICHAEL B. ENZI, Wyoming,
TOM HARKIN, Iowa JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico RICHARD BURR, North Carolina
PATTY MURRAY, Washington JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island LISA MURKOWSKI, Alaska
HILLARY RODHAM CLINTON, New York ORRIN G. HATCH, Utah
BARACK OBAMA, Illinois PAT ROBERTS, Kansas
BERNARD SANDERS (I), Vermont WAYNE ALLARD, Colorado
SHERROD BROWN, Ohio TOM COBURN, M.D., Oklahoma
J. Michael Myers, Staff Director and Chief Counsel
Katherine Brunett McGuire, Minority Staff Director
(ii)
C O N T E N T S
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STATEMENTS
TUESDAY, DECEMBER 4, 2007
Page
Kennedy, Hon. Edward M., Chairman, Committee on Health,
Education, Labor, and Pensions, opening statement.............. 1
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming,
opening statement.............................................. 4
Harkin, Hon. Tom, a U.S. Senator from the State of Iowa,
statement...................................................... 6
Prepared statement........................................... 7
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina, statement............................................ 9
Allard, Hon. Wayne, a U.S. Senator from the State of Colorado,
statement...................................................... 9
Leavitt, Michael, Secretary, Department of Health and Human
Services, Washington, DC.; accompanied by Dr. David Acheson,
Deputy Commissioner, Food Safety............................... 10
Prepared statement........................................... 14
Murkowski, Hon. Lisa, a U.S. Senator from the State of Alaska,
statement...................................................... 22
Murray, Hon. Patty, a U.S. Senator from the State of Washington,
statement...................................................... 24
Roberts, Hon. Pat, a U.S. Senator from the State of Kansas,
statement...................................................... 26
Taylor, Michael R., Research Professor of Health Policy, The
George Washington University, Washington, DC................... 33
Prepared statement........................................... 36
Corby, J. Joseph, Director, New York Department of Agriculture &
Markets, Albany, NY............................................ 42
Prepared statement........................................... 44
Dooley, Cal, President & Chief Executive Officer, Grocery
Manufacturers Association, Washington, DC...................... 53
Prepared statement........................................... 54
DeWaal, Caroline Smith, Food Safety Director, Center for Science
in the Public Interest, Washington, DC.; accompanied by David
Plunkett, Senior Staff Attorney................................ 56
Prepared statement........................................... 57
Young, Paul, Ph.D., Senior Marketing Manager, Waters Corporation,
Newtownards, N. Ireland........................................ 62
Prepared statement........................................... 63
(iii)
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
American Frozen Food Institute (AFFI)........................ 31
Safe Food International--World Health Organization........... 75
Response by Michael Leavitt to questions of:
Senator Kennedy.......................................... 81
Senator Harkin........................................... 83
Senator Mikulski......................................... 85
Senator Bingaman......................................... 86
Senator Brown............................................ 87
Senator Enzi............................................. 88
Senator Burr............................................. 90
Senator Hatch............................................ 94
Senator Allard........................................... 95
Response by Michael R. Taylor to questions of:
Senator Kennedy.......................................... 96
Senator Harkin........................................... 100
Senator Enzi............................................. 100
Senator Burr............................................. 102
Senator Allard........................................... 103
Response by J. Joseph Corby to questions of:
Senator Kennedy.......................................... 103
Senator Enzi............................................. 104
Senator Burr............................................. 105
Senator Allard........................................... 106
Response by Cal Dooley to questions of:
Senator Kennedy.......................................... 106
Senator Enzi............................................. 108
Senator Burr............................................. 108
Senator Allard........................................... 109
Response by Caroline Smith DeWaal to questions of:
Senator Kennedy.......................................... 109
Senator Harkin........................................... 113
Senator Enzi............................................. 114
Senator Allard........................................... 115
Response by Paul Young to questions of:
Senator Kennedy.......................................... 117
Senator Enzi............................................. 118
Senator Allard........................................... 119
DEVELOPING A COMPREHENSIVE RESPONSE TO FOOD SAFETY
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TUESDAY, DECEMBER 4, 2007
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10:29 a.m., in
Room SD-430, Dirksen Senate Office Building, Hon. Edward M.
Kennedy, chairman of the committee, presiding.
Present: Senator Kennedy, Harkin, Murray, Enzi, Burr,
Murkowski, Roberts, and Allard.
Opening Statement of Senator Kennedy
The Chairman. We'll come to order.
The most basic duty of any government is to protect the
safety of the people it serves. A recent report to the FDA
Science Advisory Board raises troubling questions about the
Administration's ability to meet this basic responsibility with
regard to food safety and many other areas where American
families count on FDA to protect their health. Instead of
improving matters the White House is poised to make them worse
by threatening to veto the very bill that funds the FDA.
The report's conclusions cannot be more stark or more
shocking. FDA does not have the capacity to ensure the safety
of the food for the Nation. FDA's ability to provide its basic
food system inspection, enforcement, and rulemaking function is
seriously eroded, as is its ability to respond to the outbreaks
in a timely manner and to develop the new regulatory approaches
needed to prevent future problems.
Every time American families go to the grocery store, they
worry about the safety of the food that they buy. Every time
parents buy toys for their children, they worry if the paint is
contaminated or the materials are defective. They ought to be
able to count on the FDA and other health agencies to stand
guard for them to use the latest and best science to protect
them and to stop at nothing to detect dangerous products.
But the Advisory Committee report reveals that FDA's
promise to protect America's families is too often an empty one
because of the starvation budgets and absent leadership that
the FDA has endured in recent years. The plain truth is the FDA
doesn't have the money it needs to do the job it has to do. If
the problems revealed by the report were confined to food
safety they'd be disturbing enough, but the study shows that
the effectiveness of the entire agency has been eviscerated by
neglect.
The major findings of the report read like an indictment.
Finding No. 1, the FDA cannot fulfill its mission, the FDA
cannot fulfill its mission, because its scientific base has
eroded and its scientific organizational structure is weak. No.
2, the FDA cannot fulfill its mission because its scientific
workforce does not have sufficient capacity and capability. And
finding No. 3, the FDA cannot fulfill its mission because its
information technology infrastructure is inadequate.
I'm pleased that we are joined by Secretary Leavitt today.
I welcome him to our committee. And I hope he'll take this
opportunity to explain to the American people how FDA has been
allowed to reach this sorry state.
I also look forward to a thorough examination of how to
improve food safety. Even a brief review of recent food safety
concerns must ring alarm bells in every community. Salmonella
was found in domestic peanut butter. Botulism was found in
chili. An adulterant from China in pet foods led to illness and
deaths in cats and dogs.
An E. coli outbreak in spinach from California last summer
killed three and sickened more than 200 others. I don't have to
look far to see the threat from E. coli. On Cape Cod last month
we were told to boil our drinking water because it was
contaminated with these dangerous bacteria.
The Administration's food safety plan offers
recommendations on improving food safety. And I look forward to
hearing Secretary Leavitt's discussion of this proposal.
However many experts believe we ought to do far more and I look
forward to the views of our distinguished panel on the matter.
Both the European Union and the Japanese have more robust
food safety programs than we do. And we can learn from them.
Most significantly they have much stronger programs to police
imported food, combining inspections in the country of origin
and testing of imported foods. And we should be able to do at
least as well.
We need to give the FDA the tools it needs to identify food
safety problems more quickly and respond more effectively. Most
importantly we need to focus on preventing outbreaks in food. I
know the Secretary's proposal is going to talk about the issues
of prevention. And we'll have a discussion on these matters.
Each part of the food industry must have an effective plan
in place to prevent hazards in the food it makes and markets.
Preventive controls aren't new and they work. The FDA has had
regulations in effect since 1973 to require safety processing
for many canned foods. Because of these regulations, there are
now virtually no problems with botulism in these foods.
FDA issued regulations in 2001 to require safety processing
for juices after E. coli in apple juice killed or injured
children. Most manufacturers now pasteurize their juice, which
eliminates this contamination. And despite the effectiveness of
these regulations the Administration plan proposes to expand
this authority only with major limits. Under the proposal FDA
will be able to impose preventive controls only for foods that
have repeatedly been associated with serious adverse health
consequences or death.
Essentially this provision is a requirement that people be
injured or even killed before FDA can act. Such a requirement
undermines the basic goal of preventing illness. Every
manufacturer should be required to implement effective
preventive controls and we must give the FDA the authority to
enforce the requirement before people are injured, not make
them wait until the damage is done.
The HELP committee worked together this year to reauthorize
user fee programs that provide significant resources for FDA.
We need to be similarly creative to meet the agency's other
pressing needs. It is a privilege to work with Senator Enzi on
this hearing and I look forward to working with him and our
committee colleagues to develop a response to food safety.
Mr. Secretary, we welcome you. We have the extraordinary
circumstance where the head of the FDA asked the Science
Advisory Committee to give guidance with regards to what the
agency needs in terms of expertise and science advice. And they
made a series of recommendations on it and what can be done in
terms of safety.
So we want to give credit to the agency in trying to look
at itself about how it ought to improve itself. And for going
outside and asking the distinguished panel, who, I think, have
demonstrated with their recommendations a willingness to give
us the unvarnished situation, which I think the American people
are entitled to.
You have gone and traveled the world to look at food safety
and you've been kind enough to come and brief me. I'm sure you
have briefed others on the committee about what you have been
attempting to do. But you've landed in the hot spot right now.
Because, food safety must be of central concern to American
families and this advisory panel report raises issues of what
is needed by way of resources to give protection to the
American people through food safety. And we are confronted with
the President stating that he's going to veto the FDA funding
that would help address these very needs. All of these have
come together right now in terms of the public policy issue.
We have a clear, unbiased series of recommendations that
are about as fierce an indictment of a governmental agency as
I've seen in 45 years of being in the U.S. Senate, certainly
with regards to the HELP panel. I'm someone who's been deeply
committed to the FDA, as others have been on this panel. We've
worked very closely with Senator Enzi and Senator Burr, Senator
Harkin who's been a real leader, Senator Murray and my friend
Senator Hatch as well.
And now we have the clear recommendations of the
Appropriations Committee on what is necessary to move ahead.
The President's request for FDA was $467 million. Senate
Appropriations recommended $522 million. Not an overly dramatic
increase, but at least, a very important down payment to
address food safety. And now we're facing a President of the
United States who is saying he's going to veto the bill.
Every family in America that looks to this agency for their
food safety, that goes down to that market today has to ask,
What in the world is going on? We're going to give you a chance
to speak to that, Secretary Leavitt, but before we'll hear from
our friend, Senator Enzi.
Opening Statement of Senator Enzi
Senator Enzi. Thank you Mr. Chairman. My message will
probably be a bit more optimistic.
[Laughing.]
But I would like to thank the Chairman for working with me
and working with me in a very bipartisan manner, not just
recently but for a long time. And it was exactly a year ago
that this committee held a hearing on bagged spinach because
there was a national problem with it. It was contaminated with
E. coli, as the Chairman mentioned, and we wanted to evaluate
the local, State and Federal response.
Now I think the most amazing thing that came out of that
hearing was that we have three agencies that are involved in
isolating and determining there's a problem and then solving
the problem. And all of the testimony that we got was a
tremendous cooperation between three agencies. We never hear
about that with the Federal Government. But three agencies with
as few as 30 cases are able to determine that there's a problem
and get the product pulled off the market. And that's out of
thousands of daily reports of potential problems. To sort
through those things and come up with a solution is absolutely
amazing to me.
Of course, we also heard a lot about some up and coming
technologies to improve food safety and of course, I
particularly noticed that those were developed by innovative
small businesses. And it's important for us all to remember
that small businesses are the engine of the economy. They
represent more than 99 percent of the businesses in this
country and they employ millions of people. Small businesses
have a lot to contribute.
But we also have to keep in mind that their resources are
not the same as the big companies. We do have to hold big and
small companies to the same high food safety standards but we
have to recognize that one-size-doesn't-fit-all when it comes
to regulation. So there's plenty of work to be done on food
safety at all levels of business, government and consumers. And
today we're here to evaluate and assess two new reports about
import safety and food protection.
Food safety is an issue that affects all of us. It's not a
partisan issue. We all want the safest food supply possible.
It's our shared goal. A goal that requires cooperation and
teamwork through a very complicated process and we'll examine
that process today.
The United States does have one of the best food safety
systems in the world. I appreciated the Chairman's comments
about a couple of other countries. Again, there are some
limited areas where they're doing better and we ought to take a
look at those and see if that won't improve our system too. But
we do have the best food safety system in the world. There is
room for improvement and those improvements can take many
forms.
For example, we can address how food becomes contaminated
in the first place and make improvements in that. We can look
at the advances in processing and handling the food to prevent
future outbreaks. We can also improve the testing and
inspection capabilities. For far too long the number of
inspectors at FDA has been decreasing even as imports rose
exponentially and new food safety problems arose. And finally
we do have to consider whether new authorities are needed to
respond to those problems that are not detected and corrected.
I'm pleased the Administration takes these issues as
seriously as I do. There's a lot to like in Secretary Leavitt's
report and the FDA Food Protection Plan. However we need to
carefully review the recommendations in those reports before we
rush to action.
I like to say that if something's worth reacting to in
Congress, it's worth overreacting to. So food safety is
critical to every American. And it's up to us to make sure that
we take the time to get it right.
Senator Kennedy and I just spent 2\1/2\ years working on
fixing the drug safety system in this country. Half of all
Americans take a prescription drug daily. One hundred percent
of them eat.
I will be studying these reports and details as I work on a
comprehensive approach to improve the safety of the food we
eat. Of the 50 suggestions for food safety, many concentrate on
high priority areas, those most susceptible to problems. Other
recommendations would provide more transparency on which
companies and food products are safe and which are not. They
would establish best practices and provide some incentives--
kind of a mix of the carrot and the stick.
When Americans purchase a snack, eat at a restaurant or sit
down to dinner with their families, they should be able to
expect that the food they eat will not make them sick. We need
to restore that faith. And I'm working with my colleagues
across party lines to develop a comprehensive, effective
strategy to enhance food safety.
Senator Kennedy and I began that effort in May working with
Senator Durbin to establish standards for pet food and set up
early warning systems for any problems with pet foods to
improve communication systems about all food recalls and to
coordinate State and Federal activities on fresh and processed
produce. Finally our efforts led to the creation of a database
of instances of tainted food so that the FDA can better track
patterns of problems and target its limited resources to where
they're most needed.
We still have a ways to go. New programs, tools,
technologies and authority are important and needed. But they
mean nothing if they don't restore consumer confidence in our
food supply.
Again, I thank the Chairman for holding the hearing and for
the witnesses, particularly the Secretary agreeing to
participate and I look forward to hearing the testimony today.
Thank you Mr. Chairman.
The Chairman. Thank you very much. We've been joined by
Senator Harkin, Senator Burr, Senator Allard, and Senator
Murray. I'd like to hear from the Chairman of the Agriculture
Committee. That committee has interest in food safety and eggs,
poultry and meat, so I ask Senator Harkin to say a word, then
Senator Burr if you wanted to speak. I don't want to cut off
the others.
We'd like to get to the hearing, but I do think there's a
special set of circumstances when we have both a member of our
committee and someone who's involved in the issue of food
safety as much as Senator Harkin is. So, Tom, we'd be glad to
hear from you and then I'd be glad to have a word from our
other side here. And then we'll get on with the Secretary.
Statement of Senator Harkin
Senator Harkin. Thank you very much Mr. Chairman. I
appreciate the kindness. And thank you very much for you and
for Senator Enzi for holding this hearing.
I'll just ask that my statement be made a part of the
record and I'll just say a couple of things here. I know you
want to move on and I apologize in advance that I will not be
able to stay for the whole hearing.
We have a real crisis of confidence in America today in our
food safety system. Every day we're reading about all these
problems. First, we had the E. coli outbreaks last year that
the Chairman spoke about. One hundred and ninety-nine people
were sickened. There were 31 cases of hemolytic uremic
syndrome, a severe kidney disorder, 102 hospitalizations, 3
deaths. Since then we've had recalls involving pet food, peanut
butter, lettuce, ground beef, chicken pot pies, pizzas, etc. In
September, more than a million pounds of hamburger were
recalled and then just last month another million pounds of
ground beef were recalled.
Again, as this committee knows our food safety inspection
system started years ago with meat and then poultry and then
eggs. And that was under the jurisdiction of the Department of
Agriculture, where it remains today in the Food Safety and
Inspection Service. Later on with the establishment of the Food
and Drug Administration, other food products came under their
jurisdiction. So we have a split system now where the FDA has
everything except meat, poultry and egg products and therein
lies a problem.
With meat, poultry and egg products there are slaughter
plants, facilities, and processing facilities. We have an
inspection system that dates back to more than half a century.
It's been modified and updated. But there are basically narrow
channels through which these products go and inspections can be
conducted in a fairly good manner.
Now, since that time we have seen the blending of meat and
meat products, including meat from other countries that come
into this country to get blended. That's why we have a problem
with ground beef all the time. You don't have big problems with
cuts of meat. Most of the problems are with ground beef blended
together from different areas. So that's an area in which we
need to have better oversight and better inspections on the
part of the Department of Agriculture.
But then think about how our eating patterns have changed.
The challenges we face today are broader and more complex than
they ever have been. Our entire food supply domestic and
imported, I think, needs to be examined. Fifty years ago we
gave little thought to problems with fresh produce. That's one
of our big challenges today.
So we have changing production methods. We have changing
eating habits, of course, and different technologies. Now the
Food and Drug Administration's plan that the Chairman spoke
about, I'm encouraged by some of it, but I'm very concerned
that the plan falls well short of a truly comprehensive
strategy for ensuring the safety of our food.
The Department of Agriculture and the FDA either need to
work together more closely in a harmonized, integrated system
for the safety of our food supply both from farms here to
dinner plates in this country or from imported food coming into
this country. Again now with the Department of Agriculture, I
would say to my friends here, we have an equivalency standard
for meat, poultry and egg products when we import them from
other countries. In other words the slaughtering facilities,
the inspection facilities in other countries must be equivalent
to our own when it comes to meat, poultry and egg products.
But when it comes to fruits and vegetables and other foods,
we have no equivalency standard, none whatsoever. And so, we
don't know about all these products coming in from other
countries. I mean every once in a while we detect antibiotics
in food from China. Once in a while we detect pesticides in
food. But FDA, right now, inspects, and I could be corrected on
this, but I think I'm right. FDA inspects less than 5 percent
of the food coming into this country.
What kind of assurance is that to our public, when first we
don't have an equivalency standard and then we inspect less
than 5 percent of food coming into this country? Because of the
changing patterns and the huge increase of imported foods
coming in, the changing patterns and the changing farming
technologies in our country with produce--fruits, vegetables,
which we want our people to eat more of because we know it's
healthy--perhaps it's time to think about a different system of
inspection. Maybe it is time to think about a single food
inspection agency charged with responsibility of all food
inspections.
I know Senator Durbin has an amendment to the Farm bill
which we have on the floor. Maybe we'll get to it one of these
days. But his amendment would sunset the FDA and the FSIS at
the end of 2010 which means that the next Congress would have
to do something and come to grips with this issue.
I don't know. I'm not here to tout his amendment, but quite
frankly I think it has a lot of promise. I think that there's
some validity to that approach of saying we're going to sunset
it and we better come up with something that harmonizes and
integrates all of our food inspection for domestic and imported
foods. And maybe sun setting everything would force Congress to
finally do something which we haven't done yet.
And so I just say to my Chairman here I look forward to
working with you and with Senator Enzi, both in my capacity as
a member of the committee but also as my capacity as Chairman
of the Agriculture committee to get to a better system that
harmonizes, that has equivalency standards, that really does
give better assurance to our people that their food is indeed
safe. So I look forward to working with you, Mr. Chairman in
this endeavor.
[The prepared statement of Senator Harkin follows:]
Prepared Statement of Senator Harkin
I would like to thank Chairman Kennedy and Ranking Member
Enzi for holding this hearing on developing a comprehensive
response to food safety. As we all recognize, food safety is of
critical importance not only to our food and agriculture
sectors, but also to public health. The results of weak food
safety oversight are human victims of foodborne illness and
severe economic consequences to our Nation's food and
agriculture industry. These problems can be prevented by
strengthening the Federal Government's ability to ensure a safe
food supply.
Today, we have a real crisis of confidence in this country
when it comes to food safety. Over the last year, the American
public has been bombarded with repeated recalls and alerts with
regard to adulterated food. In September of last year, an
outbreak of E. coli caused by contaminated spinach sickened 199
people, including 31 cases of Hemolytic Uremic Syndrome--a
severe kidney disorder. There were 102 hospitalizations, and 3
deaths. Since then, we've seen recalls involving pet food,
peanut butter, lettuce, ground beef, chicken pot pies, and
pizzas. In September, more than a million pounds of hamburger
patties were recalled because of contamination with E. coli.
There have been 40 cases of foodborne illness related to that
recall. Just a little over a month ago, there was another
million-pound recall of ground beef.
Now, I am not saying that our food safety system is
entirely broken. After all, recalls are a normal and necessary
part of the system. There have been too many, however, and in
the past year, the authorities have been tardy in catching and
responding to food-contamination problems. Gaps and lapses in
the food safety system have human and economic costs.
As this committee knows, government food inspection got its
start early in the 20th century with the publication of Upton
Sinclair's exposes of horrific conditions in the meat packing
industry. Since Sinclair's day, meat and poultry have been the
subject of intense scrutiny. But the food safety challenges we
face, today, are broader and more complex. Today, our entire
food supply, domestic and imported, needs to be examined. Fifty
years ago, we gave little thought to the safety of fresh
produce, but that is one of our challenges today. It is time
for our laws and regulations to be changed to reflect changing
production methods, eating habits, and technologies.
The Food and Drug Administration (FDA) released a ``Food
Protection Plan,'' which it describes as ``an integrated
strategy for protecting the Nation's food supply.'' I am
encouraged by some of the recommendations and action items the
Plan addresses. But I am very concerned that the Plan falls
well short of a truly comprehensive strategy for assuring the
safety of our food. The Department of Agriculture (USDA) and
FDA must work closely together towards a harmonized, integrated
strategy for our entire food supply, from farm to fork instead
of fixing problems in a piecemeal fashion for a portion of our
food supply. There are very good reasons for the differences
between how USDA and FDA regulates the food supply. However,
most of those differences have more to do with history than
science. Congress, government agencies, consumers, and the food
and agriculture sector must work together to modernize our food
safety system with the best available science to prevent
further losses in consumer confidence, and most importantly, to
prevent the loss of human lives. This is an enormous
undertaking, but as a member of this committee and in my role
as Chairman of the Agriculture, Nutrition and Forestry
Committee, I am committed to working on this issue of critical
importance to consumers and to American agriculture.
The Chairman. Senator Burr, if you'd want to make a
comment.
Statement of Senator Burr
Senator Burr. Mr. Chairman, I'll be extremely brief because
as I heard your points that you got from the Scientific
Advisory Committee, I'm not so sure I found it a condemnation
of FDA as I did the American education system because we're
falling deficient in educating the talent that we need in the
future, especially as the pool of scientific brain power begins
to be attracted by more than just the Federal Government.
Everybody runs short of what they need. So I think we're going
to do as much good by making sure we fix education as we are by
orchestrating something that Congress believes the FDA should
or shouldn't do or creating a new agency.
Let me just implore my colleagues. Let's give the FDA a
chance. The Secretary asked for these comments. He got the
comments. I found him always to be one that acts when he's
presented with information that's valuable to the agencies. I
think he deserves a chance.
Unfortunately we can't point at food safety and just look
outside our borders and say there's our problem. Our problems
have been inside our borders before. And it means collaboration
between the Federal Government and private sector companies.
That collaboration has started. We've got to see whether it can
grow into a defense mechanism that truly is one that we can all
be proud of and more importantly, that we can trust the system.
And I look forward to hearing the Secretary.
The Chairman. Well, Senator Allard.
Statement of Senator Allard
Senator Allard. Mr. Chairman if I might just make a brief
comment here. As a veterinarian I've had the experience of
actually doing food inspections. I belong to a profession who a
good deal of those members are active in the FDA and the
Department of Agriculture on food quality. And I would just
have to say that my personal view is that I think we shouldn't
lose our perspective here.
The American food supply is the best quality and the safest
in the world and that's because we do a lot scientifically. We
do a lot diagnostically to recognize problems. And then we
adjust that using good science and as a result, we tend to
report problems that don't get reported in other countries. And
we have a good quality food supply here. I don't think we
should forget that perspective.
Now, do we have problems? Sure, we have some problems. But
I think we have to keep a proper perspective in this. And I
would agree with Senator Burr. A lot of this is educational.
You know, if you have E. coli in hamburger, just make sure your
hamburger is well cooked. That will take care of the E. coli
problem. You don't need to have books and books of rules and
regulations on E. coli.
The American public needs to understand that there's
different types of E. coli. There's E. coli that's normal in
your bowel. There's E. coli that causes disease. And they need
to understand that.
So, I see a big need for improving our educational effort.
We need to continue to look at diagnostic ways in which we can
monitor food to make sure it is safer. And we need to make sure
we have the proper balance of enforcement and proper education.
So I'm looking forward, Mr. Chairman, to the comments from
the Secretary to understand what the FDA is doing and how
they're managing this and how they're responding to these
reports. And so, this is a very timely hearing. And I want to
complement you, Mr. Chairman for holding this hearing and
working with Senator Enzi. I think you make a great team on
this committee. And this is an important issue, something I'm
interested in. Thank you.
The Chairman. Thank you very much. Mr. Secretary, we look
forward to your comments. You've heard from us. We want to hear
from you. Welcome.
STATEMENT OF HON. MICHAEL LEAVITT, SECRETARY, DEPARTMENT OF
HEALTH AND HUMAN SERVICES, WASHINGTON, DC.; ACCOMPANIED BY DR.
DAVID ACHESON, DEPUTY COMMISSIONER, FOOD SAFETY
Secretary Leavitt. Well, thank you, Senator. I'm going to
acknowledge that I'm here with David Acheson, who is the Deputy
Commissioner for Food Safety. I may call on him at various
points for technical advice.
May I just acknowledge that the American people have high
expectations of quality and safety and they ought to? And I
acknowledge that my wife and I, my children, my grandchildren
all eat from the same food supply you and other members of the
Senate do. We have a very serious personal interest in this
being well developed. I would like to also associate myself
with those who have acknowledged that our food supply is among
the safest in the world.
We have a good system. It is not adequate for the future.
And I believe that's what this hearing is about. It's about how
do we take what we have and there's an old saying in the hockey
world, ``you have to skate where the puck's going to be.'' How
do we create a system for the 21st century that will
accommodate the very basic changes that are beginning to change
our market?
Over the course of the last several months as you have
suggested, I've seen sea ports, I've seen freight hubs at
border crossings, wholesale, retail, processing of food, drugs.
I've inspected everything from tire irons to gingerbread
houses. I've had a chance to see a pretty good fraction of this
on 300 ports of entry for imports. I've been able to get a
sense of how big this is. And it's clear to me that we have
seen warning signs in the last several months that our current
system is not keeping up and we have to respond.
I'd like to also point out that this is not an issue that
we are facing uniquely in the United States. About a month ago
I had the Ministers of Health and Food from eight of the
largest industrial countries in the world come to the United
States including the European Union. Every one of them are
dealing with this issue in the same way we are. Why, because
something very basic has changed. We're now in a global
marketplace.
I had a meeting in a grocery store some weeks ago, a couple
of weeks ago. I met a man named Dan who was the produce
manager. Dan told me that he had been in the produce business
for some 30 years. I'd asked what has changed most. He said,
``it's what the customers want.'' They want to have fresh
strawberries in January. They want blooming sunflowers in
November. And we can give it to them. But we now operate in a
global market.
So, what's changing here? The reason we're seeing these
warning signs is because our system, while good, is not
adequate for the future and it does not allow us, at this
point, to respond to those needs. And we need to change it.
I think appropriately the President responded to those
warning signs and asked that a group of his Cabinet--he
appointed a working group. He appointed me as Chairman. I think
it's an important point.
I'd like to just read the list of the Departments in the
Federal Government that are involved in this because it, I
think, demonstrates that this isn't just about the FDA or the
Department of Agriculture. This is a government-wide, society-
wide task that requires a coordinated and collaborative
approach. HHS, the Department of State, there's a lot of
international relationships involved here. The Department of
Treasury, the Department of Justice, the Department of
Agriculture, the Department of Commerce, the Department of
Transportation, the Department of Homeland Security, the Office
of Management and Budget, the Trade Rep, the EPA, the Consumer
Product Consumer Commission, all of these have a very important
role in how we develop a 21st century system of import safety.
Now I hope we get a chance to talk about the report today
some. I'd like to just summarize it if I could. I recognize
that the time is somewhat limited. I'd like to give you my
impressions after having been in, I think, a fairly sizable
fraction--seeing a sizable fraction of the system firsthand.
First, it is so large we will never inspect ourselves to
safety. We simply have to change our strategy. Rather than try
to inspect everything that comes across our borders and stand
at the border and simply try to catch things as they come. We
need to begin building quality into the system every step of
the way.
Now, I met the manager of a lettuce processing plant out in
Texas. He said to me, ``our motto here is you need to know your
grower.'' I said, ``what do you mean?'' He said, ``I want to
know where that lettuce came from. I want to know who planted
it. I want to know what nutrients they put on it. I want to
know the quality of the water they used. I know when they
picked it. I want to know how it was treated after it was
picked. I want to know who shipped it. In other words I want to
see that quality was put into that product every step of the
way.'' That's the future, in my judgment, building quality in.
Now, we divided our task, given to the President to take an
overall look at this system, into two parts. The first is we
took all of those Departments and developed teams and made very
deep looks into every one of those departments and asked
questions that I think, you would have asked, Senator. What are
the authorities that you currently have? Are they adequate?
What are the changes that we need to be responding to? Do you
have the authority and the budgets that are necessary? What
kind of limitations do you have right now that need to be
overcome? What do you need to do the job?
I then fanned out and went, as I mentioned, I went to over
30 different places and saw, I think, the totality of this
system. The good news is that the themes that began to boil up
from our deep look into the government response and began to
match those that we found in the field. We came back with a
report. There are 50 specific recommendations within 14
different categories.
Now I won't take the time to go through all of them. Let me
just give you seven or eight brief headlines that I think will
populate our conversation. The first is the need for us to have
a stronger certification process. It's my view that products
need to be not just inspected, we need to assure that the
process that's being used to provide safety has been inspected
by somebody we trust.
Now in some cases that's an FDA inspector or a Department
of Agriculture inspector or someone from the Customs and Border
Protection. In other cases it might be an independent
certifying body. For example, many of us are familiar with the
Good Housekeeping seal of approval. When we see that seal we
feel confident because we can trust them. We see Underwriter
Laboratories. Those are independent inspections. When they're
on it we assume that they have looked through and we can have
confidence in it. There are other independent inspections that
if the government has accredited them we could use to expand
what the current system has.
Now there was a blue uniformed FDA agent who taught me this
lesson. He said, ``Mr. Secretary, our job is like finding the
needle in the haystack. Our first job is we've got to shrink
the haystack. We've got to use certification processes to
figure out who the bad actors are and who the good ones are so
that we can concentrate on where the trouble's going to be.''
His point, I think, that leads to the second point I wanted
to make in addition to certification. We need to promote good
importing practices. We need to make it harder for people to
get goods into this country if they don't follow the rules. And
we need to make it easier for those that do.
The third point is greater transparency. People deserve to
know who it is that imports safe products and those that don't.
We need to give people their names. Why is that important? Time
after time I've had members of the retail community say, ``I'm
telling my suppliers, before you can put something on my shelf,
I want to know it's safe because my reputation is at stake.''
We need to tell retailers and consumers who those people are so
that the marketplace has a chance to do its magic on this
problem as well.
Increase presence overseas. We need to have more U.S.
personnel in exporting areas or in ports so that we're able to
not only look at goods before they come, but we can use their
presence there to teach people how to meet our expectations. We
need to build this into our trade agreements. We need to have
physical inspections as well.
Stronger penalties, higher standards, better systems. We
did find places where our systems are deficient. They need to
be improved. For example, FDA inspectors over and over tell me
that we have five passwords on our system that I have to
remember because I can't get all of the information I need from
one screen.
I had members of the Customs and Border Patrol tell me we
have seven different passwords that we need to receive and
sometimes they can't get the information between them. There
are times that the FDA can't get the information that's
necessary from the Department of Agriculture. That's a problem
we need to respond to.
The President recently issued an Executive order requiring
all the Federal agents to come together to create interoperable
systems. We need to have faster response tools. And these are
happening.
I was in a grocery store in the Midwest. I asked them about
their recall. They told me some impressive stories about the
way our recall system works. I might add, the fact that we have
recalls doesn't entirely mean we've had a failure. It means the
system found something and we're responding.
We have systems in most major retail outlets in this
country that if a retail product is known to need to come off
the shelf, it can happen in a matter of hours. They can shut
the cash registers down where no more products can get out
until they can get the product off the shelf. They're now
moving to a point where they can use their value cards and the
various communications vehicles they have with their systems to
notify customers. One grocery store told me that they can now
identify a canned good or some kind of produce item that was
sold in a previous period and within literally, minutes,
contact as many as 2 million consumers who may have in fact
purchased that product.
So, just to summarize, a change in strategy, Mr. Chairman,
needs to occur. We can't just stand at the border and hope to
catch things as they come in. We have to build quality in every
step of the way. We need to have stronger certification
processes. We need to promote better import practices.
Reward those who follow the rules, punish those that don't.
We need to have transparency where consumers know who it is
that produces a safe product and who doesn't. We need to have
an increased presence overseas, enhanced standards, stronger
penalties. We need to have better interoperable systems and we
need to have faster tools of response.
Now you raised the point about budget. And I'd like to talk
a little bit about our response in the report. The report makes
very clear that this will require more resources. We chose not
to try to replicate the entire budget process because there are
12 different departments involved. And if we were to try to put
what the amount is in the report we would essentially be
replicating that process.
Every budget that we have put forward in the last 3 years
while I've been involved has asked for more resources. Our
current budget will as well. So there's no question that
building that system for the future will require investment.
Mr. Chairman, I look forward to having this discussion. I
hope it's robust and it's complete. As I mentioned, my wife and
I, my children, my grandchildren, all eat from the same food
supply that committee members do and the American people
deserve to have these expectations and we need to meet them.
Thank you.
[The prepared statement of Secretary Leavitt follows:]
Prepared Statement of Michael O. Leavitt
Chairman Kennedy and members of the committee, I am pleased to be
with you today to discuss the Action Plan for Import Safety. The Plan,
which I delivered to the President on November 6, puts us on the verge
of a major transformation in the way we view imported consumer products
and assure their safety. At the request of the President, I chaired the
interagency working group on import safety which included
representatives from 12 Departments and Agencies. The Plan was
developed following a careful examination of import product safety
issues, and it contains 14 broad recommendations and 50 short- and
long-term action steps that will enhance the safety of imports entering
the United States for the 21st Century. Today I want to cover some of
the key elements of the Action Plan and explain our strategy for
implementing them.
First, it is important to mention why this effort is so important
and the challenges involved. Today, Americans import approximately $2
trillion worth of goods from over 800,000 importers through 300 ports
of entry. The growth in the volume of imports over the last two decades
has been nothing less than astounding and it shows no signs of slowing.
The expansion of imports is driven by growth of trade in a global
economy. There are many benefits to consumers. A wide variety of fresh
fruits and vegetables, seafood, and a range of ethnic and other foods
from foreign countries are available year round in our grocery stores
in a way that our parents could not have imagined. International trade
provides Americans access to innovative products and productivity
enhancing technologies from other countries which add to our quality of
life.
Imported products are generally safe in the United States and
Americans enjoy one of the safest food supplies in the world. Yet, we
are all aware of recent incidents with unsafe toys and tainted pet
foods from China. In addition, there have been concerns about the
safety of imported drugs. These incidents of unsafe imports raise
legitimate concerns. However, we should not conclude that imports are
unsafe or that all products from China or other countries are to be
avoided. Instead, these incidents point to the need to revamp the way
we deal with import product safety. To put it another way, imports are
safe today but, due to the high volume of trade, we need to transform
the import system and change the way we verify product safety to meet
the challenges of a global economy.
This problem is not unique to the United States. I have raised
these issues with the ministers of health from eight of our closest
trade partners, and they all have the same concerns. The growth of the
global economy has created new challenges for ensuring the safety of
imported products. Some of these challenges are: the large and growing
volume of imported products; the large number of ports of entry and the
need to process imported products quickly at the ports; the increased
volume of imports from less developed countries; the complexity and
variety of products which carry increased risk; and, the need for
stronger safety and quality standards around the world. Further, as
global trade has grown, so has the value of trade and the opportunity
for unscrupulous businesses to short circuit safety standards or engage
in the sale of counterfeit products. Our 20th century approach to
ensuring import safety of attempting to screen products at the border
is a ``snapshot'' approach that will not work for the 21st century. The
Federal Government cannot, and should not, attempt to physically
inspect every product entering the United States This is like trying to
find the needle in the haystack. The Action Plan we are discussing
today addresses this challenge.
Now, let me turn to our Strategic Framework for enhancing import
safety and some key elements of the Action Plan. The organizing
principles fall into three major areas: prevention, intervention, and
response, and we have a number of recommendations and specific short-
and long-term action steps in each of these areas.
Our overall goals are to:
Promote a common vision of import safety with our trading
partners and foster a culture of collaboration;
Focus on risks over the product life cycle rather than a
snapshot at the border;
Increase accountability, enforcement and deterrence;
Build interoperable data systems and encourage data
sharing; and
Promote technological innovation and develop new tools to
enhance import safety.
The Action Plan covers all imported consumer goods that could pose
a potential safety threat to U.S. consumers--from toys and tires to
drugs, medical devices, dietary supplements, cosmetics, and all foods
for both humans and animals. The general thrust of the plan is to
broaden our focus from examining products as they enter the United
States to monitoring imported products throughout their life cycle from
production to consumption, paying particular attention to the critical
points of risk along the way where safety can be compromised and safety
standards are most needed.
Some of the highlights of the Action Plan are:
Creating new and strengthening existing standards. We will
work with international standard-setting organizations and foreign
government regulators around the world to develop international
standards that reflect the same level of protection maintained for
consumer products in the United States.
Verifying compliance with safety standards. We are
proposing a voluntary certification program whereby products could be
certified as meeting U.S. safety standards. This may involve
verification--for example, testing or inspection by third parties or by
domestic or foreign regulatory bodies. In addition, if HHS is provided
the necessary authority, importers of certain high risk products could
be required to certify that those products meet certain standards
before they are exported to the United States.
Encouraging Good Importer Practices. Import guidance
documents will be developed to encourage the adoption of best practices
to improve import safety.
Enhancing enforcement. While voluntary product recalls are
usually adequate to protect consumers, we are recommending authority
for mandatory recall for the FDA in certain instances.
Expediting consumer notification of product recalls. Track
and trace technologies will enable officials to pinpoint where the
problem occurred and intervene quickly. In addition, other technologies
such as integrated circuit cards, also known as Smart Cards, may allow
retailers to notify consumers of potential safety problems.
Exchanging import data. U.S. Customs and Border
Protection, the FDA, USDA and other agencies will increase coordination
with real-time sharing of product safety information to better inform
decisions about clearing or rejecting import shipments. In addition, we
are exploring ways to expand the sharing of key data with foreign
governments, consistent with applicable law, and gaining more access to
data existing in the private sector as well.
The 12 Departments and Agencies involved in the generation of the
Action Plan each have a role in the implementation of its
recommendations. We also anticipate involvement of private sector
stakeholders--retailers and manufacturers, importers, consumer groups,
and others. Many of the Action steps can be accomplished by
administrative changes, but some will require changes in the law and we
are looking forward to working with Congress to accomplish these.
fda food protection plan
Earlier this year, I directed the FDA Commissioner to develop and
submit to me a comprehensive plan for protecting the Nation's food
supply. This plan, the FDA Food Protection Plan, was released at the
same time that I submitted the Action Plan for Import Safety to the
President. It utilizes the same framework as the Action Plan:
Prevention, Intervention, and Response, and its action steps are
consistent with and complementary to the recommendations of the Action
Plan. One distinction is that the Food Protection Plan applies to
domestic food producers as well as all imported foods regulated by the
FDA. I would now like to provide an overview of the Food Protection
Plan.
Prevention
Prevention is the first essential step for an effective, proactive
food safety and defense plan. There are three key prevention steps: (1)
promote increased corporate responsibility to prevent foodborne
illnesses; (2) identify food vulnerabilities and assess risk; and (3)
expand the understanding and use of effective mitigation strategies.
The prevention steps are risk-based and will be implemented as
appropriate to particular segments of the industry.
First, to promote increased corporate responsibility, we must
strategically place greater emphasis on preventive measures for food
safety and food defense. These measures will promote improved food
protection capabilities throughout the food supply chain. This will
require close interaction with growers, manufacturers, distributors,
retailers and food service providers, and importers. FDA will continue
to work with industry and State and local governments to further
develop the tools and science needed to identify vulnerabilities and
determine the most effective approaches. With regard to imports, we
will work with foreign governments, which have a greater ability to
oversee manufacturers within their borders to ensure compliance with
U.S. safety standards.
New authorities will be needed to accomplish this first goal. For
example, the Food Protection Plan outlines new authorities to require
entities in the food supply chain to implement measures solely intended
to protect against intentional contamination of food by terrorists or
criminals at points of high vulnerability. We have also proposed
authority to issue regulations in certain circumstances requiring that
high-risk foods be prepared, packed, and held under a system of
preventive food safety controls.
Second, to identify food vulnerabilities and assess risk, we will
work with the food industry, consumer groups, and Federal, State,
local, and international partners to generate the additional data
needed to strengthen our understanding of food safety and food defense
risks and vulnerabilities. A comprehensive, risk-based approach will
maximize the effectiveness of its available resources by focusing on
food products that have the potential to pose the greatest risk to
human and animal health. By analyzing data collected throughout the
food product life cycle, we are better able to detect risks posed by
food products. We are also better able to recognize key junctures where
timely intervention can reduce or avoid those risks. Working with the
Centers for Disease Control and Prevention (CDC), FDA will also build
the capacity to attribute pathogens to specific foods and identify
where in the production life cycle the foods became contaminated. When
established and emerging risks are identified, assessed, and ranked, we
are able to more effectively allocate our available resources to manage
these risks.
Third, in order to expand the understanding and use of effective
mitigation strategies, we will initiate additional risk-driven research
about the sources, spread, and prevention of contamination. We will
also develop new mitigation tools and implement appropriate risk
management strategies. Building on risk assessments, we will initiate
basic research to enhance our understanding of sources of
contamination, modes of spreading, and how best to prevent
contamination. This information will inform FDA's efforts to promote
increased corporate responsibility to implement effective preventive
steps. Focusing on higher risk foods, we need to increase research and
leverage relationships with outside organizations in order to develop
new methods to detect contaminants in foods, and seek to facilitate new
technologies that enhance food safety.
Intervention
Because no plan will prevent 100 percent of food contamination,
targeted, risk-based interventions are needed to provide further
protection. The Food Protection Plan includes ways to focus on
inspections and sampling based on risk, enhance risk-based surveillance
and improve the detection of food system signals that indicate
contamination.
However, the universe of domestic and foreign food establishments
subject to FDA inspection is immense and continues to increase.
Therefore, legislation is needed to authorize FDA to accredit or
recognize and use highly qualified, independent third parties to
evaluate compliance with FDA requirements, thereby allowing the
Agency's resources to be more effectively allocated. Use of accredited
third parties would be voluntary and might offer more in-depth review
and possibly faster review times and expedited entry for imported goods
manufactured in facilities inspected by accredited third parties. FDA
would not be bound by these third-party inspections in determining
compliance with FDA requirements. However, use of accredited third
parties could be taken into consideration when setting inspection and
surveillance priorities.
To enhance the Agency's risk-based surveillance, we plan to focus
on improving our ability to target imported foods for inspection based
on risk through the use of advanced screening technology at the border
and enhanced information sharing agreements with key foreign countries.
Also, as part of the fiscal year 2008 budget, the Administration
proposed a new user fee requiring manufacturers and laboratories to pay
the full costs of re-inspections and associated follow up work when FDA
reinspects facilities due to failure to meet current Good Manufacturing
Practice (cGMP) or other FDA requirements. Where FDA identifies
violations during an inspection or issues a warning letter, FDA
conducts follow up inspections to verify a firm's corrective action.
The proposed fee ensures that facilities not complying with health and
safety standards bear the cost of reinspection.
Further, we recommend the option of moving the inspection of high-
risk products of concern ``upstream'' by entering into agreements with
the exporting country's regulatory authority for that entity (or an
FDA-recognized third party inspector) to certify each shipment or class
of shipments for compliance with FDA's standards prior to shipment. FDA
would apply this requirement to imported products that have been shown
to pose a threat to public health for U.S. consumers. While FDA would
retain the authority to verify the safety of imported products, this
approach shares the burden of ensuring the safety of food products with
the exporting country. For such a system to be effective, we will have
to establish an in-depth collaboration with the relevant foreign
government authority to ensure that the standards, processes, and
criteria by which the foreign authority or third party is certifying
products are consistent with FDA's. The Agency will also have to take
several steps to ensure a secure system that prevents counterfeiting of
the certificates and takes into consideration trans-shipment of
products as a way to avoid certification. FDA would use
nondiscriminatory, scientific, and risk-based criteria to determine the
focus of this proposed authority.
As noted earlier, improving the detection of food system
``signals'' that indicate contamination is an important component of
enhancing our intervention capabilities. We can better detect and more
quickly identify risk ``signals'' in the food supply chain by deploying
new rapid screening tools and methods to identify pathogens and other
contaminants and by enhancing our ability to ``map'' or trace adverse
events back to their causes by improving the Adverse Event and Consumer
Complaint Reporting System. This additional information will serve as a
supplemental warning indicator for trending emerging food protection
problems.
The recent pet food recalls showed us that we must continue to
focus our efforts on animal as well as human food. For example, to
provide the information necessary to allow for early detection of, and
intervention with, contaminated pet food, FDA will work with the
veterinary community, veterinary hospitals, and other private sources
to develop an early warning surveillance and notification system to
alert veterinarians and others about problems with the pet food supply.
Response
To improve our immediate response, we will work with stakeholders
to develop an action plan for implementing more effective trace-back
process improvements and technologies to more rapidly and precisely
track the origin and destination of contaminated foods, feed, and
ingredients. We will also increase collaboration with foreign, Federal,
State, and local partners to identify a contamination source, remove
contaminated products, and implement corrective actions.
Another key component of improving FDA's response is additional
authority for emergency responses. The Food Protection Plan recommends
requesting mandatory recall authority and enhanced access to food
records during emergencies. This recall authority would be used only
when the current voluntary recall process fails to promptly remove
foods that present a threat of serious harm to humans or animals.
Although FDA has the authority to seize adulterated or misbranded food,
this is not the most efficient option when the contaminated product has
already been distributed to hundreds or thousands of locations. And
while FDA has been able to accomplish most recalls through voluntary
actions by product manufacturers or distributors, there may be rare
instances in which a firm was unwilling to conduct a recall. In such
situations, FDA needs the ability to require a firm to conduct a recall
to ensure the prompt and complete removal from distribution channels of
food that presents a threat of serious harm to humans or animals. This
authority would be limited to foods that the Secretary has reason to
believe are adulterated and present a threat of serious adverse health
consequences or death. It would be imposed only if a firm refuses or
unduly delays a voluntary recall. An order to recall food could only be
issued by the HHS Secretary, Deputy Secretary, or Commissioner of Food
and Drugs, and would be accompanied by appropriate due process rights.
We are also seeking authority that would give the FDA more complete
and streamlined access to records necessary to identify the source or
cause of foodborne illness and take needed action during food-related
emergencies. Improved access to information concerning the safety and
security of food, including records related to an article of food or
related articles of food that may present a threat, will enhance FDA's
ability to identify problems, respond quickly and appropriately, and
protect public health. The requirement would not impose any new
recordkeeping burdens and would maintain the current statutory
exclusions for the records of farms and restaurants.
Currently, access to records under section 414 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act or the act) is limited to instances
where, for an article of food, FDA has a reasonable belief that the
food is adulterated and presents a threat of serious adverse health
consequences or death. FDA proposes to expand access to records of
related articles of food, such as food produced on the same
manufacturing line. FDA also proposes, in food-related emergencies, to
remove the adulteration requirement to allow its inspectors access to
records in emergency situations where FDA has a reasonable belief that
an article of food presents a threat of serious adverse health
consequences or death.
As we continue to move forward with the Food Protection Plan, we
will work with other Federal agencies, State, local, and foreign
governments as well as industry to develop the food science and tools
necessary to better understand the current risks of the food supply,
develop new detection technologies, and improve response systems to
rapidly react to food safety threats.
u.s.-china challenges
Now I want to turn to the issue of imported products from China. As
I have mentioned, although there have been some recent problems with
Chinese imports, we must not conclude that all products made in China
are dangerous. However, as noted below, we are currently taking a
number of steps to improve the flow of information on the risks of
imports from China and efforts will be made to increase the safety of
Chinese imports through certification of quality controls in goods
produced in China for export.
Let me provide some context for the discussion. China has a complex
product safety regulatory system that consists of the Ministry of
Agriculture which monitors food production and regulates farm inputs;
the General Administration of Quality Supervision, Inspection and
Quarantine [AQSIQ] which monitors processing and trade, the
Certification and Accreditation Administration, which regulates the
production certification, and the State Food and Drug Administration
[SFDA] which coordinates food and drug policies and investigates safety
mishaps. The Chinese system is challenged by rapid growth and
decentralization of power which has resulted in overlapping authorities
in some areas and gaps in regulatory control.
I have met with Chinese officials on several occasions to discuss
import regulatory issues and we are in the process of finalizing
negotiations on two binding Agreements that we expect to sign soon. One
will cover the safety of food and feed, and the second will cover the
safety of drugs and medical devices. These agreements outline the
processes and points of contact for both countries to follow when the
importing country rejects a shipment.
We expect that the provisions of the Action Plan will be
instrumental to improving the safety and bolstering consumer confidence
in Chinese imports.
conclusion
Implementing the Import Action Plan and the Food Protection Plan
will require resources, including reallocation of existing resources,
as well as trade-offs, to fund these priorities. We plan to coordinate
with Federal departments and agencies to carefully plan the
implementation and submit funding needs through the normal budget
process in February 2008 and in subsequent years. To the extent that
additional statutory authority is needed to implement the Import Action
Plan, we look forward to working with this committee on import product
safety legislation.
U.S. imports are large and growing rapidly. American consumers like
the variety and abundance of consumer goods and the competitive prices
that result from global trade.
The American people, however, have reasonable expectations that the
products they buy for their families will be safe. We can and must do
more to honor that trust.
The Action Plan will lead to both short- and long-term improvements
in the way we view and regulate imported consumer products and
implementing these recommendations will enable us to meet the
additional safety challenges of imports in the 21st century. We
appreciate the support of this committee and Congress as we move
forward with our recommendations.
Thank you for the opportunity to discuss this important topic. I
will be pleased to respond to your questions.
The Chairman. Well, thank you very much, Mr. Secretary. And
I was looking through your report earlier and it has the
features that you've mentioned here. I looked at it in terms of
prevention and what's happening, currently. The authority you
need to deal with the challenges that you're facing, and you've
reviewed those.
I'm concerned about the current situation. As I'm looking
down the road I wonder how we're going to be able to build in
the future if we haven't got the underpinnings we need out
there at the present time. The advisory committee has
questioned the whole scientific workforce and infrastructure,
the underpinnings, when it describes the agency not having
adequate investment in information technology and the use of
antiquated equipment out there at the FDA.
And having to bring in people who have retired in order to
repair equipment at the agency because it's so antiquated. And
that the total number of inspectors is down, and the
difficulties and challenges getting the kind of scientific
workforce the agency needs. I agree that we have educational
issues, and we have to work on those matters.
But the core factor about the agency and it being able to
function is money. Money doesn't solve everything, but it is an
indicator of a nation's priorities.
I think the commissioner of FDA is to be commended for
requesting a review about where the agency is and what it
needs. I mean, that's a bold request. It could have been done
in house. And I think if it had been done in house, a lot of
this would have been smoothed over. But, as it is, we have very
distinguished individuals on that advisory committee and they
have pointed out the extraordinary challenge that the agency is
facing.
How are we going to look at the future when you've got the
underpinnings that are crumbling now? It does seem to me we've
got the central challenge now, to be able to look down the road
at how we're going to coordinate different kinds of inspections
in the future.
We have to talk about the condition of the underpinnings,
which this report has put out and examined. And when you've got
these kinds of conclusions, we would expect to hear from you
that the FDA does not have the capacity now to ensure the
safety of the food of the Nation. We can't worry about where
we're going to be in 10 years when the report indicts the
current situation. The report says, ``does not.'' It doesn't
say, ``didn't have'' or ``will not.'' It says, ``does not have
the capacity to ensure the safety of food for the Nation.''
Now, there are a lot of good things that are happening at
the FDA, and some of them have been mentioned in the course of
this morning's hearing. But, when you have an FDA that does not
have the capacity to ensure the safety of food of the Nation,
and the report has specific findings about how the scientific
base is eroded, how scientific organizational structure is
weak, and about weaknesses in the workforce and in information
technology.
It would seem to me that we have to get that in shape to be
able to build the follow up that you have talked about in your
testimony. And we can get into some of those matters as well in
the time that I have left. But, I would think the American
people would want a sense of urgency from their person leading
the agency, a sense of urgency about how you're going to
respond to the effective indictment in the report. I think
that's what they're waiting to hear. And I want to give you an
opportunity to address it.
Secretary Leavitt. Well, thank you Senator. Well, I think
the response is right here.
The Chairman. That's not the current situation.
Secretary Leavitt. Oh, yes it is. It is very much the
current situation. We're implementing major parts of this.
This Friday I will leave for example, for China where I
will sign agreements that we've negotiated with the Chinese
that will move us a great step forward in being able to deal
with the challenges of importing from China and other parts of
the world. We're already in the process of developing a system
I've spoken of. We're implementing this strategy.
What we have now for the first time is, we've taken a
comprehensive look at the system. We have a clear plan to move
forward. We have an action plan that not only includes the FDA,
but includes 12 different departments and agencies of the
Federal Government and a comprehensive way to go about it.
And we're reaching out to the private sector. It will not
be government alone. It's going to require a coordinated
effort. The urgency, we could not be responding more urgently.
I'm spending a very high percentage of my time as it goes from
the other departments to make certain that this is driven
forward.
And we're looking forward to working with you in assuring
that the legislative authorities that are necessary to make
this work are in place.
The Chairman. Well, you might have that new, fancy system
on papers but, you have an FDA that has broken information
technology equipment today. You can get the most dramatic
system on paper and it ain't going to work, it ain't going to
work. And this advisory committee went to the core, to the
basics, about what that agency needs. What is going to be
necessary out there to do the job?
And what's in this report is nothing new. Many of us who've
been following this agency and have been out to the agency,
have seen this for ourselves. I haven't been out there for 2 or
3 years, but I've been out there. And at that time these same
points could be made as are made by this independent,
scientific report.
You can have all of these other actions that you're talking
about internationally. My time is expired, but I will try and
get back to question you about them. But if we don't deal with
what this scientific advisory board says now, we are betraying
the commitment that the agency has to the American people to
protect them and their food supply.
Senator Enzi.
Senator Enzi. Thank you Mr. Chairman. And I want to thank
the Secretary for his usual, very concise, well laid out
presentation. I'm always impressed with that and impressed with
the results that he gets from his agency.
I think it's important with all of these discussions that
we don't move people into a state of fear that we keep them in
a state of education or in the State of Wyoming, either one.
[Laughter.]
When I was first elected Mayor, one of my first visitors
was a food inspector. And from the discussion I had with him I
was under the impression that it was my job to go around to the
restaurants with him and to see what sorts of things he was
finding there. As an accountant I should have known that the
job of a person like that is to find the bad things and to find
as many of the bad things as possible because their job is
prevention. And I went with him and he did a good job. And I
didn't eat in a restaurant for several months.
There are a lot of things behind the scenes that are being
taken care of. They have to be found first and yes it does take
people and it takes knowledge and it takes training and it
takes money in order to be able to do that. And I have some
confidence that the agency will do that.
You mentioned that you're going to be going to China and
working on a Memorandum of Agreement with them on import
issues. I'm pleased that you're going to do that. What do you
hope will come out of those discussions? What sorts of things
can be covered by a Memorandum of Agreement?
Secretary Leavitt. We're sending a very clear and
unequivocal message to any country or any organization that
desires to import goods into the United States for American
consumers. If they want access to American consumers they need
to produce goods that are meeting the safety requirements of
the United States and the quality requirements of the United
States.
We want them to have access to our markets. We want to have
access to theirs, and we'll help them know what our standards
are and we'll help them know how to meet them. But this is a
very important step in our relationship with China as well as
other countries that we will negotiate subsequent agreements
with.
Senator Enzi. You mentioned the high risk products. Some of
the items in the food protection plan would focus on those
higher risk products. Our food supply is very diverse. How do
you propose to determine the relative risk?
Secretary Leavitt. Well there are certain things that are
perishable, for example. Food inspectors will tell you these
are always things they look at. But as you talk to inspectors
at the borders and as you talk to those people who are involved
they'll tell you there's a whole myriad of things they look at
to determine who's a risk.
For example, one wouldn't necessarily think about an
importer who routinely does not keep the rules. They view that
person to be a high risk and they want to focus more attention
on them. And potentially need to spend less of their time on
people who always keep the rules and in whom they have
confidence because of their own experience and because they
have chosen to have their products and their processes
certified. So they'd like to focus more of their attention on
people who are historically producing problems and less of
their attention on people who always keep the rules.
Senator Enzi. Thank you.
We all agree that the food and import safety are critical
issues and the Chairman has raised the comment about the
resources that have been needed to carry out the plans and I'm
sure all of us want to work with you and your Department to
make changes to the food safety system, but no one can expect a
blank check. So we need to figure out what this is going to
cost so we can set priorities and get started on fixing the
problems. What can you tell me about the kind of resources that
will be needed?
Secretary Leavitt. Well for the first time we have a master
plan that lays out in the future what we need to do in order to
accomplish a 21st century system. We now need to take the 2009,
2010, 2011, 2012, and 2013 budget and apply it to that master
plan and invest every year. Now last year the Administration
proposed more money in each of those categories. We'll
undoubtedly do the same in 2009 and we now need to then apply
those appropriations to this plan and the authorities that we
need Congress to provide us to make this plan work and then
drive forward.
Frankly, the advisory panel that the Senator has referenced
reached many of the same conclusions that we did in our very
comprehensive look at this system. This report clearly
manifests that more resources will be necessary. We did not
attempt to substitute this effort for the regular budget
process, but it makes very clear that additional sources will
be necessary to make this work.
Senator Enzi. Well, I thank you for the courage it took to
put a plan in writing. We've had a Government Performance and
Results Act in place for the Federal Government for I think
about 15 years and this is the sort of thing that we're hoping
will happen. Where people take a comprehensive view of what
they are doing as well as any outside groups that might be
taking a look at it and figure out what needs to be done. And I
know that that takes a lot of courage and I thank you for it.
The Chairman. Thank you very much.
Senator Murkowski.
Statement of Senator Murkowski
Senator Murkowski. Thank you, Mr. Chairman and thank you,
Secretary Leavitt.
I too, appreciate the efforts that have gone into this.
When you think about things that can rattle a family, rattle a
community, when the food that you have purchased at a grocery
store and brought home to feed your family makes them ill, it
is the most invasive, frightening thing that can happen to a
family. I shouldn't say most. It is a very invasive thing. It
is a very frightening thing that happens and I think people
look to the government and say, ``What are you doing about it?
What have you done to make sure that my family is safe?''
I want to ask you about the request in the plan for the
recall. The mandatory recall authority would be used only when
the current voluntary recall process fails to promptly remove
foods that present a threat of serious harm to humans or
animals. Tell me what that really means in application. If
you're a grocery store and selling spinach and somebody's
gotten sick, you're going to pull that off because you want
people, your customers, to keep coming back.
What has to happen before there is a step in and there's a
mandatory recall?
Secretary Leavitt. Senator, I'm going to confess to you
that it was a surprise to me to find out that the FDA didn't
have that authority. Now I assumed they did. This goes back a
couple of years when I discovered this. Why? Because there's no
indication that it's ever been a serious problem up to this
point.
When I talked to the FDA people about how it works, they
tell me that they say to the manufacturer or the processor,
``we think your food is unsafe and we're prepared to make
public notice that your food is unsafe and recommend that
people not buy it.'' And people routinely then recall their
product. There may be circumstances where they refuse to do
that.
Senator Murkowski. Have we had any who just refuse to take
it off?
Secretary Leavitt. I'll ask David Acheson to answer that
since he's involved every day in it.
Mr. Acheson. Yes, we've had several. In the last few years
it's been two or three issues particularly in the pet food
industry where companies have absolutely refused and we've had
to use the strategy that the Secretary's pointed out of
alerting the public through the media.
Senator Murkowski. Huh. I guess I assumed that there was
some authority in place as well.
Let me ask a question that is more local. We've had some
situations where there's been seafood, tainted seafood, that's
come from China and probably from other countries as well. And
for a market like the Alaska market where we rely on the
reputation of a good and a safe seafood market when we have the
news come out that this fish is tainted. Stay away from it.
Oftentimes the distinction may not be made as to where it's
coming from. And then the consumer just says, ``Well, the
safest thing to do is stay away from all fish including the
domestic product that we worked hard to build the reputation
for.'' How can we do a better job of making sure the consumer
is appropriately alerted while at the same time we don't hamper
or lose ground in promoting our own domestic products where we
know we've got a level of safety?
Secretary Leavitt. I'm going to ask David to comment on
this. But you referenced something that I think is an important
thing to acknowledge. Earlier we had some conversation about
lettuce. If there's one incident regarding lettuce then people
assume all lettuce is tainted and they quit eating it. If they
have a situation with fish then they assume fish is not good
and they quit eating fish. And that's a serious threat.
And frankly it's a big problem to those particular
industries. And for that reason those industries have begun to
say, ``We need to have standards that assure that everyone is
maintaining quality and building it into their product because
if there isn't, we all suffer.''
So in the case of lettuce, for example, the produce growers
got together and the processors and said, ``let's develop some
standards.'' They then came to the FDA and said, ``here are
standards that we think are extraordinarily high and would
protect us, as an industry, by making certain that a few bad
actors don't spoil the market for everyone.'' And FDA has now
begun the process of incorporating those standards. We think
there are other areas where that could and should occur.
For example in fish where a standard can be developed in
cooperation with the industry who very much wants what you've
suggested not to happen. And then use regulatory authority to
incorporate that process using certification to say once we
have a standard let's get people we trust to make certain that
every single processor is meeting that standard. And if they're
not, we're going to watch them more closely than those that do.
David, do you want to comment on that?
Mr. Acheson. I think one of the key elements that you're
getting at is the importance of communication.
Senator Murkowski. Yes.
Mr. Acheson. And making sure that consumers really
understand what's implicated in a food safety situation and get
that information to them quickly. And it's not just consumers.
We need to apply that down to the stores at the local retail
level. So if there is a recall product it's removed
expeditiously.
The corollary of that is that following a recall, as with
spinach, is to let consumers know that the product is back on
the market and that it's safe to consume again. So, again it
really boils down to communication and how to improve on that.
And a part of the food protection plan is focused on
communication around the response element.
Senator Murkowski. Communication by way of advertising?
Mr. Acheson. By all means. I mean I think part of this
strategy that we'll use at FDA is to use a new risk
communications advisory committee that we've established and
really address what are all the modes by which we can
communicate with people: media, TV, Internet. And as the
Secretary pointed out part of that communication is in a recall
situation of an individual store informing a consumer that the
product that they may have purchased is a recalled item.
So there's many, many modes of communication that we need
to look at because it's not a single one that's going to work.
Senator Murkowski. Thank you Mr. Chair.
The Chairman. Thank you very much.
Senator Murray.
Statement of Senator Murray
Senator Murray. Mr. Chairman, thank you so much for having
this hearing today. I heard your opening statement. I've got
several meetings going on but I wanted to come back to ask a
few questions.
I agree this is just absolutely a critical issue, a very
difficult issue. I came into Congress in 1992. And before I
even got my nameplate we had the E. coli issue with Jack in the
Box and I had three young kids in my State who lost their lives
as a result of that. And I know personally how important it is
that we assure our consumers, our families everywhere, that the
food they buy is safe. And we have a challenge doing that in
this country. And we have to continue to take steps forward.
It's fun to bash government. It's everybody's game, but the
fact is that government is who regulates food safety and it's
our agencies who oversee this and the consumers depend on us
and we've got to be doing the right thing. So I really, truly
appreciate your having this hearing.
Secretary Leavitt, thank you for being here today and thank
you to all of our panelists.
Secretary Leavitt, I've looked at the food safety plans
that the FDA has put forward and they contain some
recommendations for new legislative authorities by the FDA,
such as the ability to mandate food recalls. I think some of
those are positive steps, but I'm concerned that the plan
doesn't go far enough to ensure the public safety because a lot
of the recommendations involve voluntary approaches. I wanted
to ask you why you focused on voluntary approaches instead of
required compliance measures?
Secretary Leavitt. Our desire was to focus the energy of
whatever resources we have in the areas where there is most
risk and to be able to expand that by rewarding people who go
to the point of adopting standards and certifying them to
expand our reach. If we have more eyes we're able to, in
essence, reach more. We think we can get people to voluntarily
do that because of the advantages it gives them for example, on
imports and being able to get their products into the country
safely.
Senator Murray. What if somebody doesn't do it?
Secretary Leavitt. Then we need authority to be able to
police that.
Senator Murray. Which means you need additional resources
to be able----
Secretary Leavitt. Which means we need to be able to have
the authorities to use the resources that we have to enforce
it.
Senator Murray. Well, authority is one thing and resources
another. If you don't have enough inspectors and you don't have
enough ability to go out there and make sure that people are
voluntarily complying then, all the voluntary measures in the
world don't work. I mean we've certainly seen that over and
over again.
I know Senator Enzi asked about the resources as well, but
I know, we all know, we're in tight budget times, but I think
safety of our food is a really critical issue. And I wanted to
ask you what we can expect to see from the Administration in
the fiscal year 2009 budget request for this?
Secretary Leavitt. We'll be requesting more money to
support this plan, as we did in 2008. We're in the process of
developing that budget along with the Office of Management and
Budget. So, I'm not in the position to say the precise amount,
but I can tell you I have requested substantial additional
budget for the FDA and for the other parts of HHS that are
relevant to this matter, as I know other departments have.
I think it's again important to point out that when we
looked at the totality of the system there were 12 different
departments and agencies that were involved. This can't be just
the FDA budget. It's got to be the entire budget based on a
plan that coordinates all of it.
It also needs to coordinate what goes on in the private
sector. Now, retailers today are saying to their producers,
``if you want space on my shelf, you need to show me, to the
point that I have no question, about the quality and safety of
your goods because I'm putting my reputation on your good when
I put it on my shelf.'' And some of the most aggressive
inspection, some of the most aggressive oversight on food and
product safety is coming from those whose brand depend on it.
Senator Murray. Ok, I understand that. But did--can I go
back just a second?
Then I heard you say that we will see an increase in the
budget, when it comes from the President, to cover these
agencies.
Secretary Leavitt. Well what I'm able to tell you is that I
have proposed substantial additional resources from the HHS
level. History tells me I usually don't get as much as I ask
for, but I expect that there will be more in this budget.
Senator Murray. Thank you. Thank you very much, Mr.
Chairman.
The Chairman. Thank you very much.
Senator Roberts.
Statement of Senator Roberts
Senator Roberts. Thank you Mr. Chairman. First I'd like to
associate myself with the remarks by my friend and colleague
from Colorado, Senator Allard, who indicated that despite all
of the problems we have and the challenges we have, and as the
Secretary has indicated, the current system is not adequate for
the future, that we still have the safest food supply in the
history of the world and by the way, at the lowest cost.
I do not think that we have a full blown crisis in regards
to public confidence of our food supply. I hope that's not the
case. Having said that, I can certainly appreciate it because I
can remember very well going to the State of Washington at a
Trade Round between what I'll affectionately call the Tear Gas
Round. That was some years ago in the State of Washington, in
Seattle and that was just following the tragedy in regards to
Jack in the Box and that 100 percent loss for those families
involved.
I must tell you as Chairman of the House Agriculture
committee at that particular time we conducted an inquiry, not
an investigation into that, and found out it was a good idea to
cook the meat. And from that time on I think most Americans
decided that medium and well would be better served than rare.
I ordered a cheeseburger by the way. I would tell my
colleague, the Senator from Washington, the distinguished
Senator from Washington and I couldn't get a cheeseburger,
because of that situation and the turmoil and the trauma that
all of that caused. I finally signed a liability statement so
that I could get a cheeseburger. Now that's carrying this thing
entirely too far. By the way it tasted like shoe leather. I
didn't ever do that again.
I can remember too that, you know, pointing out the
problem. Congressman Dooley will be part of a panel coming up.
And I hope everybody pays attention to Cal because he does have
a tremendous experience in the Congress and in the private
sector in regards to what he has to say on some positive
measures that the private sector will implement or is trying to
implement in regards to food safety.
But we have a parts per trillion technology now, Mr.
Chairman. It's very difficult. There's a little bit of
something on everything. Parts per trillion.
And I can remember a case, again back in the House, and I
apologize for going back to those days when I was somebody. But
at any rate, this was a situation on an additive in regards to
peanuts and there was an effort, an amendment on the floor of
the House to terminate the use of that additive. And we figured
out finally as we extrapolated what happened in regards to the
test to determine whether it was safety or not that a person
would have to eat 600 pounds of peanuts a day for that to
become a problem. There were some people in the House at that
time that I recommended eat 600 pounds of peanuts a day, but we
didn't get into any names.
And I'm not trying to be glib. I'm not trying to be
sarcastic. I'm just trying to point out that we do have a parts
per trillion technology that enables you to do a tremendous job
in terms of enforcement, if in fact, you can go beyond what we
have now and have the resources to do it and I applaud your
efforts.
What I would like to ask is this. As we review this issue
it seems there may be some things we can look to that may serve
as a model. That we might consider. And my druthers are this,
or my prejudice is this, because I think it would work.
It seems part of the solution would lie with getting the
entire food supply chain, the entire food supply chain, to act
on their own to the benefit of food safety. For the entire food
chain to be the owners of prevention-based interventions built
on some form of accountability, primarily based on traceability
and then your enforcement capability. All this accomplished
under some form of government certification and oversight than
in the worst case scenario you can act.
And it's my understanding that today there are prevention-
based interventions. And I'm really talking to the agriculture
side, but it can apply to the FDA as well, that exceed minimum
government requirements that exist today which can accomplish a
safer food supply. But there's very little incentive for them
to be implemented by our current system.
How can we incentivize them other than being punitive for
them to do that? Obviously it would be in their best interest.
And I would imagine that Mr. Dooley, who is sitting patiently
here with his arms crossed, would speak to that. But could you
respond to that in regards to incentivizing the private food
system to go beyond the government standard in their own best
interest?
Secretary Leavitt. Dave, would you like to comment on that?
Mr. Acheson. Yes, happy to. I think probably the easiest
example to give to you is one in relation to imports. As the
Secretary has pointed out, the current system is based on
inspection at the port of entry. And the vision that we're
moving forward is this whole part of life cycle process.
If, in that process, we understand the preventive controls
that work in foreign manufacturers and we know through our risk
assessments that they're implementing those preventive
controls. Then I think a significant incentive would be that
those products would be less likely to be inspected at the port
of entry because we know already that they're being
manufactured under a system using preventive controls. If
they're going beyond what we do, so much the better, but at
least to the minimum of what we expect for FDA.
So I think in that context through working with our
stakeholders, working with foreign governments, the private
sector, we can provide information about what are those
preventive controls. Where are the risks? What are the
concerns? And essentially help drive the system. Pushing the
resources where we need to, to the areas of greatest risk and
thereby providing incentives to industry to adopt those
preventive measures.
Senator Roberts. Mr. Chairman, my time is up. I didn't know
if the Secretary wanted to add anything or not.
Secretary Leavitt. Well, I would simply say that if we
assume that government will own the entire system, it will not
be as good a system as one government organizes that
incorporates all of the aspects of government, both State,
local and the private sector. And the remarkable incentives
that are there for those who desire to have products that are
delivered to consumers on a safe and effective basis.
I mentioned, I think you were here, but perhaps not, the
circumstance with lettuce a couple of years ago where the
lettuce producers said, ``anytime a bad actor performs in a way
that taints us all, we all lose.'' And so let's get together
and harness our capacity to hold everyone to a standard. And if
we do, the market improves. And we can then use government as a
means to discipline those who do not meet that standard in
addition to what the market does, then we'll get to the point
that we're building quality into the product as opposed to
standing at the border hoping to catch a few that try to cheat.
Senator Roberts. Mr. Chairman, I don't want to open up an
old wound, but I also remember the case of Alar and apples. It
cost the apple industry $600 million one year. We had people in
a school lunch program throwing away apples. It wasn't Mom and
apple pie anymore.
It was quite a few years ago and that was a shelf
preserver, but the consumer did not want to buy the apple that
did not have the shelf preserver because it didn't look that
good. Now there's some question as to whether Alar was proper
or not, but the industry suffered $600 million. And at that
particular time they would have done anything, anything, in
terms of public information through the FDA, through
themselves, but they just didn't have the wherewithal to do it.
And so we really went through a very difficult time which
is why I think it is so important that you are having this
hearing Mr. Chairman and why you have asked for additional
funding and knowing that we have to go beyond what we have now.
Thank you, sir.
The Chairman. Thank you.
Senator Allard.
Senator Allard. Thank you Mr. Chairman. And Mr. Secretary,
you know as Governor, I think that your health department and
the various county departments are extensions of State
government and I think most States organize like this because
they have uniform rules and regulations. They put out to the
States and the States adopt them, have the authority to close
down a business if they wanted to do it.
And so we get to the issue well, is it more appropriate at
the Federal level? Is it more appropriate at the local level as
far as enforcement is concerned? And having been in an
enforcement process myself, I mean, if you go in and you close
down a business, they're out of business if it's a grocery
store.
And so what happens, you know if you saw a bad can on the
shelf that was distended indicating there was gas production
then you took it off immediately. And the owner usually did
that because they understood that you had the power to close
down their business if they didn't because it was a human
health issue. I'm talking about human health. So it's a human
health issue.
So if you look at this I think you will find that there's
adequate enforcement and a lot of enforcement that happens
through the State Health Departments as well as the local
health departments work as an extension of the State health. At
least that's what happens in my State, in Colorado. And I think
that happens in most States.
From my personal experience, if we have a problem at a
local level with a retailer, he's going to respond. Not only
for public relations purposes, because he realizes that the
local health department inspector has pretty good control over
getting something off the shelf that's going to be an immediate
public health problem. And as soon as it gets recognized, if
necessary, you go to the judge, and you can go to the judge and
get a quick court order, locally and get it done.
My question is that with these various issues that have
been brought up in the last year and particularly the spinach
and the salmonella in the peanut butter and the E. coli in the
spinach. With the recommendations that you're now dealing with
that's come out of the working group, how would you handle this
situation differently in the last year? Would there have been a
change in the way you've managed those situations which you're
talking about with new recommendations from the working group
and yourself and what we now do? Is there going to be any
change there?
Secretary Leavitt. I will ask David to respond from a food
regulator standpoint. But let me make this point as a
policymaker. Consumers will punish harshly and rapidly those
that don't produce safe and quality products. There are times
when government is necessary to go further and to use different
authorities to do that.
I think you've asked a very important question about the
circumstances that occurred recently. I think it's important to
acknowledge we cannot eliminate all risk from society. There
will always be circumstances that occur where something goes
wrong and something that isn't as safe as our expectations, as
we aspire it to be. That's why we have this system--to catch
those moments and to make certain that they do not become
public health problems.
David.
Mr. Acheson. I think one point that probably won't change a
great deal is our ability to respond. When we have an outbreak
in spinach we get on it quickly and we respond. And I'd like to
find ways to improve that but substantially that system is
working.
What will change is to try to prevent it ever happening in
the first place. What we've got to do is maintain that rapid
response when we need it. But really figure out how to prevent
the problem from ever happening in the first place through
targeted risk-based prevention and intervention strategies.
Senator Allard. I do agree with Secretary Leavitt's
comments. You're not going to have it completely risk-free. We
do things in public health that reduce the risk. For example in
handling foods on a butcher table we go out and do swabs on the
butcher table and if the bacteria count is too high it
indicates there's improper sanitation. If it's at a low it
indicates that they're using proper sanitation, but you never
completely get rid of the bacteria.
But it's safe bacteria that we test for. It's E. coli, as a
matter of fact, that we test for. It's not the hazardous E.
coli that causes human disease, but we look for the safe. And
so, you know if the E. coli count is too high it indicates
there's improper sanitation, but there's always that risk that
some move forward.
So there's also an important educational element here that
the food preparer needs to know that if you're dealing with
salmonella you don't take eggs and mayonnaise and put them in a
potato sack and let it sit in the sun. You know, I don't care
how rigorous your inspection is, that's going to be a problem.
Same thing with raw meats, I mean, if you've got raw hamburger
that's ground and you don't cook it properly you run a high
risk of eating the pathogenic, the one that causes disease, E.
coli. If you cook it thoroughly the risk isn't there.
So, there's a big educational effort there and in the
working group's recommendations did they say anything about
educating food preparers so that they would be more aware of
that? I don't think people are as aware of that as at some
other past time in our history. It seems like that is one area
where we're falling down is the educational side.
Thank you, Mr. Chairman.
The Chairman. Thank you Mr. Secretary. I just want to
mention one last point here with regard to the FDA Science
Advisory Board and I'll submit some other questions.
The Chairman. This is what they pointed out with regard to
resources. In the recent Executive order announcing the
interagency working group on import safety, President Bush
stated that the current system must be fixed ``within available
resources.''
Now this is what they conclude. This is the FDA Science
Advisory Board. ``We can state unequivocally that the system
cannot be fixed within available resources.'' That's what they
say. That's the Advisory committee.
They've just made the finding that the system is broken.
We're talking about what's going to happen off in the future
and they say, ``we can state unequivocally that the system
cannot be fixed within available resources. Infrastructure
improvements to enhance existing laboratories, equipment and
personnel will require additional $10 million for CFSAN, $40
million for ORA. These estimates do not include funds required
to modernize the assessment of animal-derived products'' and
all the rest.
So, this is the Science Advisory Board talking about the
existing system here. We're concerned. We've heard your
testimony about the future, what's necessary for that. They're
talking about today. What is the here and now that is
threatening the agency's ability to provide safety.
Now what are you going to do about it? The American people
are watching. You're the man. They want to know whether you
have a sense of urgency to make sure there's going to be
adequate resources. Not this proposal here. It isn't dealing
with FDA science and technology. Your proposal does not deal
with it.
So we want to know what you're going to do about their
conclusions that the agency is in trouble and needs help. And
you're the man. This is the time. What's your response? Are you
going to get them additional help and assistance so that they
can do the job to protect the American food supply?
Secretary Leavitt. Senator, I am the man and here is the
plan.
[Laughter.]
It is a road map for continual improvement starting today.
We're implementing parts of this now. You referenced the
Executive order that indicated that this would need to be
implemented within available resources.
Now the working group went back to the President when we
made our report and said, ``we do not find that possible.'' And
the report itself says this will require additional resources.
And I believe you will see additional resources in the
President's budget and in future Presidents' budget to
implement this very comprehensive plan.
The Chairman. Ok. Thank you very much.
Secretary Leavitt. Thank you.
The Chairman. I appreciate it. We'll move on to our next
panel.
Our witnesses are Michael Taylor, a former USDA and FDA
food safety official now at George Washington University.
Paul Young of the Waters Corporation, a Massachusetts
Company. Dr. Young was a food safety inspector in Great
Britain, with expertise on the EU and Japan.
Cal Dooley, a former Congressman from California, family
farmer, is the president of the Grocery Manufacturers
Association.
Caroline Smith DeWaal. Is that pronounced correctly?
Ms. DeWaal. Yes.
The Chairman. Thank you. Is the Director of Food Safety,
the Center for Science in the Public Interest. She is a lawyer
and has laryngitis today. So Mr. Plunkett will deliver her
testimony, but she's here and going to help us with some
questions.
And Joe Corby, the Director of Food Safety, New York State,
37 years experience in food safety.
Senator Enzi. Mr. Chairman.
The Chairman. Yes?
Senator Enzi. While they're getting seated there I'd also
ask unanimous consent to include a statement from an outside
group, the American Frozen Food Institute.
The Chairman. It will be so included.
Senator Enzi. Thank you.
[The information previously referred to follows:]
Prepared Statement of the American Frozen Food Institute (AFFI)
Chairman Kennedy, Ranking Member Enzi and members of the committee,
thank you for the opportunity to submit this statement for the record.
We appreciate your commitment to food safety and commend the committee
for holding this important hearing.
The American Frozen Food Institute (AFFI) is the national trade
association that promotes and represents the interests of all segments
of the frozen food industry. AFFI fosters industry development and
growth, advocates on behalf of the industry before legislative and
regulatory entities, and provides additional value-added services for
its members and for the benefit of consumers. AFFI members manufacture
and distribute frozen foods throughout the United States and globally
and are committed to ensuring that these products are produced in
accordance with strict standards of safety and quality.
u.s. food and drug administration funding
Americans spend more than $1 trillion on food--nearly half of it in
restaurants, schools and other places outside the home. Consumers have
a reasonable expectation that the food products they buy are safe.
While much is being done to ensure the safety of these products,
safeguards must be continually updated to meet the changing demands of
a global economy.
The combined efforts of the food industry and government agencies
are credited with making the U.S. food supply among the safest in the
world. Recent food safety incidents, however, have spurred debate about
whether our regulatory agencies have adequate resources to do their
jobs as effectively as possible, and whether the current Federal food
safety laws have kept pace with the significant advancements in food
production, processing and trade.
While it is impossible to eliminate all potential food safety
risks, we can work smarter to reduce risk. It requires the creation of
new and innovative ways to protect American consumers and continual
improvement in managing the safety of our imports, in addition to our
domestic production. Approximately $2 trillion of imported products
entered the U.S. economy last year and expert's project this amount
will triple by the year 2015. Meanwhile, the major U.S.-food regulatory
agencies continue operating at budget levels well below amounts needed
to keep up with the influx of imports.
Food safety always has been and continues to be a top priority for
AFFI and its more than 500 member companies. This year, the Institute
joined the Coalition for a Stronger FDA in its efforts to build public
support for increased funding for the U.S. Food and Drug Administration
(FDA).
The Coalition for a Stronger FDA is comprised of consumer and
public health advocates, food and medical industry representatives, and
more than 50 patient groups working to ensure FDA remains well-
positioned to protect Americans. Funding for FDA is critical,
especially because the agency will be called on to address an
increasing array of domestic and international issues in the coming
years--including revolutionary food and medical advancements. The
Coalition is undertaking a multi-year effort to ensure FDA has
sufficient resources to protect patients and consumers, and to maintain
and build public confidence and trust in the agency.
The frozen food industry will continue to work with government
leaders, as well as others within the business community and the
general public to ensure government agencies with oversight over food
safety have the necessary resources to fulfill their responsibilities.
The work that the dedicated men and women of these agencies,
particularly FDA, do every day directly affects the lives of every
American--from public health to nutrition assistance, both at home and
abroad. Failure to adequately invest in these programs will have
serious long-term consequences for our country and its consumers.
Although the U.S. food industry has a tremendous track record of
supplying the world with safe, high quality food, we certainly
recognize the necessary and complementary role that FDA and other
regulatory agencies play. These entities ensure public health through
the establishment of food safety standards and by carrying out
necessary testing, inspections and scientific research.
In the wake of recent, highly publicized food safety concerns,
significant budget increases will allow agencies such as FDA to help
reassure consumers, speed innovation in food safety and medical
technology, and ensure the U.S. remains competitive in foreign markets.
A $115 million increase in the food budget, for example, would allow
FDA to hire more food inspectors, speed approvals for safe new food
technologies and products, and provide leadership in protecting the
food supply from intentional threats.
The proposed increase in funding that AFFI and the Coalition for a
Stronger FDA seek will assist FDA in developing new strategies and
continuing important work in the areas of regulatory enforcement,
monitoring and inspection, international harmonization, science-based
oversight, foreign food safety assessments and technical assistance,
and trade. These efforts are intended to enable the agency to remain an
effective force in resolving international issues bearing on the
safety, quality, and labeling of foods and other products.
This budget increase also will allow FDA to hire the next
generation of highly qualified scientists and other career agency
personnel who will be the future recipients of critical institutional
knowledge on a wide range of food safety issues. Without these funds,
the agency will face a critical shortage of expertise in the future.
food safety systems
Although the food industry has developed and implemented
sophisticated food safety assurance methods, Federal and State
regulatory officials have traditionally depended on spot-checks of
conditions and random sampling of final products to monitor compliance
with applicable regulations. This approach has tended to be reactive
rather than preventive with limited ability to address the many
challenges with which an industry as dynamic as the food industry is
increasingly faced.
Among the most important challenges in recent years has been the
increasing number of new food pathogens. There was also increasing
public health concern about chemical contamination of food products.
Other key challenges confronting the industry and regulatory agencies
over the years has been the increasing size of the food industry,
diversity of products and processes, amount of domestic food
manufactured, and the number and kinds of foods imported. At the time,
FDA and State and local agencies had similar levels of resources to
ensure food safety.
The food industry has effectively and, for the most part,
voluntarily employed the Hazard Analysis and Critical Control Point
(HACCP) system to identify and address potential hazards in food
processing. But HACCP is a dynamic system tailored to the unique
conditions in each individual processing facility. A foundation of
complementary preventive control programs is necessary for HACCP to be
effective. For example, the Current Good Manufacturing Practices
(CGMPs) are fundamental building blocks that can be applied generally
to all food facilities. By strengthening the preventive controls, food
safety can also be enhanced.
AFFI has been working with FDA and a coalition of more than 60 food
companies and trade associations to modernize CGMPs regulations for
foods. These building blocks include employee training, allergen
management, environmental monitoring, sanitation practices, and other
critical tools.
For more than 25 years, CGMPs have formed the basis for safety
assurance programs in food manufacturing facilities, and they have been
very effective. Given today's food safety concerns and the development
of new technologies for addressing such concerns, AFFI supports FDA's
efforts to modernize food CGMPs and ensure their application in all
processing facilities. In so doing, we have urged the agency to build
on and enhance the existing regulations, which should continue to serve
as foundational, prerequisite conditions for producing safe food
products.
conclusion
In today's global economy, continued and enhanced cooperation
between industry and government is critical to ensure the safety of the
U.S. food supply. The regulatory agencies, especially FDA, need
adequate resources now, and in the future, to carry out their mission
and mount the challenges of a continually growing global marketplace.
Working with FDA, the food industry needs to employ preventive control
programs that take advantage of modern technology.
Once again, thank you for the opportunity to submit this statement
for the record. We look forward to working with members of the
committee on this and other issues of relevance to the frozen food
industry.
The Chairman. OK. Mr. Taylor.
STATEMENT OF MICHAEL R. TAYLOR, RESEARCH PROFESSOR OF HEALTH
POLICY, THE GEORGE WASHINGTON UNIVERSITY, WASHINGTON, DC.
Mr. Taylor. Mr. Chairman, Senator Enzi and members of the
committee I do appreciate greatly this opportunity to testify
today on strategies to improve food safety and on the FDA's
Food Protection Plan.
Earlier this year the Government Accountability Office
declared the Federal Government's Food Safety Program at high
risk of failure due to its outdated laws, fragmented structure
and inefficient use of resources. This conclusion came after a
decade of recommendations from GAO and the National Academy of
Sciences to modernize the system, legislatively and
organizationally so that it can be effective in preventing food
safety problems instead of simply reacting to problems after
the fact.
The consequences of not acting on the GAO and NAS
recommendations are clear. We've heard about them today. They
include an unacceptably high burden of preventable foodborne
illness, a chronic inability to keep up with the food safety
challenges of today's global food system and declining public
confidence in the safety of the American food supplies.
So Mr. Chairman, it is time, at last, to begin the reform
process. It won't be easy. I can assure you of that. We're
talking about a food safety system that has evolved over many
decades without a coherent plan or strategy and that now
includes some 20 components of FDA, USDA, EPA and CDC, 3,000
State and local agencies and a myriad of obsolete laws.
The needed modernization of this complex system will take
time to design and implement and should be pursued with due
deliberation and care. But it must be pursued starting now. And
I believe the right starting point is the Food and Drug
Administration.
Among all of our agencies involved in food safety, FDA has
long been looked to as the natural focal point for food safety
leadership in the United States and internationally. It
oversees 80 percent of the U.S. food supply including an even
greater share of imported food and is the steward of a long
tradition of effective, science-based regulation to protect
public health. As we now know however, FDA's ability to provide
the needed food safety leadership is badly constrained, not
only by obsolete statues that focus more on reaction than
prevention, but also by plainly inadequate resources and an
internally fragmented and ineffectual organizational structure.
I believe all of these problems must be addressed for FDA to be
successful in an increasingly complex globalized food system.
Now as we embark on a comprehensive modernization process
we need to get the basic policy principles right. And I think
you will find good agreement among experts on the following
five principles around which resources and institutions should
be mobilized.
First, you must treat food safety as a farm-to-table
systemwide problem. This simply recognizes that hazards can be
created and minimized at many points across the system and we
should take advantage of all opportunities to reduce risk.
Second, we must make prevention of food safety problems the
central focus of the system, as we've been hearing today
because this is the only way. Preventing problems is the only
way to protect public health and maintain public confidence.
Third and very critically, we have to recognize again as
we've heard here today that the primary duty for prevention
falls on the food industry. The food industry, after all, not
government produces food and only the industry can make it
safe.
Equally important however, we must focus, this is the
fourth principle. We must focus FDA's program on setting and
enforcing standards that make the food industry accountable for
prevention. I believe ensuring accountability for prevention by
setting and enforcing standards is the unique and most
essential government role on food safety.
Fifth and finally, we do have to strengthen FDA's mandate
for providing national leadership on food safety. And we've got
to bolster the agency's tools for managing the science and
risk-based regulatory program and of course the FDA Science
Board report certainly underscores this need to bolster FDA's
science tools. This includes the ability to exercise--national
leadership includes working with State and local governments
and the industry to build a modern, nationally integrated
system that harnesses the best science and that makes good use
of all of its resources.
Mr. Chairman I'm glad to say that FDA's food protection
plan embraces many of these principles at least conceptually,
including the need for a farm-to-table approach, focus on
prevention and industry responsibility for prevention and it
contains many specific ideas that are worthy of adoption. I do
applaud the Secretary and the FDA staff for the effort and
thought that I know went into developing the plan.
The plan falls critically short however on implementation
of what I consider the most fundamental policy change required
to make the FDA's program effective which is as I've indicated,
establishing clear and comprehensive industry accountability
for prevention and doing this with respect to both domestic and
imported food. Rather than establish that accountability the
FDA plan relies almost entirely on voluntary approaches to
implementing preventive controls in the food industry. In fact
under the plan as the Chairman indicated in his opening
remarks, FDA would be able to require preventive controls only
if it could establish through rulemaking, that a particular
food has been associated with repeated, serious, adverse health
consequences or death.
This standard is actually more restrictive of FDA's ability
to act preventively than the authority FDA has been able to use
under current law to require preventive controls for seafood
and juice. Moreover, requiring FDA to prove that such serious
harm has already occurred treats preventive process control as
a tool for reacting to problems rather than systematically and
comprehensively building prevention into the system.
Mr. Chairman, we should not be afraid to regulate in the
name of food safety. We know that preventive process control is
the standard of care that many leading and responsible
companies have developed themselves and are already observing.
It should be the standard of care for everyone in the business
of producing and marketing food to American consumers. In my
view we would neither accomplish our public health goal nor
have a system that is credible in the eyes of the public if we
make the basic commonsense preventive control optional and
leave FDA in the role of encouraging progress rather than being
a credible source of standards and accountability for doing
food safety right.
Of course we have to be smart about regulation. Old
fashioned command and control regulation can impose unnecessary
cost and stifle innovation. The food industry itself has
historically been the source of much valuable innovation to
improve food safety. Regulations should foster that innovation,
not stifle it.
To that end modern effective regulation is clear in setting
performance standards for companies and flexible in how
companies can achieve the standard. It's not a one-size-fits-
all approach and we should work to assist small businesses. But
the public rightfully looks to government to set and enforce
standards to achieve goals like food safety that people can't
achieve solely on their own.
In sum Mr. Chairman, I hope this committee and Congress
will move forward in concert with the many stakeholders in the
food safety system to modernize FDA's food safety authorities
in accord with the five principles I've outlined today. I hope
Congress will work also to solve the serious resource and
organizational problems that are obstacles to FDA's success.
And we've heard about that today and I won't elaborate. But the
resources of FDA's food program have eroded down to a level
where they really are unable to take leadership and take
initiative.
Mr. Chairman we need to get FDA's food safety policies
right and we need to then back them up with the resources and
organizational structure to do the job. Thank you again for
this opportunity to testify. I look forward to questions.
[The prepared statement of Mr. Taylor follows:]
Prepared Statement of Michael R. Taylor *
Mr. Chairman, Senator Enzi, members of the committee, I appreciate
this opportunity to testify on strategies to improve food safety and on
the Food and Drug Administration's recently issued Food Protection
Plan.
introduction
This hearing is timely and important. For over a decade, the
Government Accountability Office (GAO) and expert committees of the
National Academy of Sciences (NAS) have been documenting fundamental
problems in the Nation's food safety system--a system that has evolved
over many years without a coherent plan or strategy and that now
includes some 20 components of FDA, USDA, EPA, and CDC, and 3,000 State
and local agencies.
Among all these agencies, FDA has long been looked to as the
natural focal point for food safety leadership in the United States and
internationally. It oversees 80 percent of the U.S. food supply
(including an even greater share of imported food) and is the steward
of a long tradition of effective, science-based regulation to protect
public health.
Unfortunately, FDA's current ability to provide food safety
leadership, or even meet its basic food safety responsibilities, is
badly constrained by:
Obsolete statutes that date back to the 1930's and focus
more on reacting to problems than preventing them;
Inadequate resources that are dwindling in the face of an
increasingly complex, global food supply; and an
Internally fragmented and ineffectual organizational
structure that makes FDA incapable today of providing effective food
safety leadership.
Certainly, FDA could be doing more with its present tools to
address some of today's pressing food safety problems. I believe,
however, that FDA will continue to fall short of what the public needs
and expects from this critical public health institution until Congress
provides a modern statutory mandate, an adequate and stable resource
base, and an institutional structure capable of national and
international leadership on food safety.
And that is why it is so timely and important for this committee to
be focusing on how to improve FDA's food safety program. Getting food
safety right at FDA is essential to the public's health, to the
confidence people want to have in the food they feed themselves and
their families, and to the economic success of the food system. This
committee's leadership will be essential to achieving these outcomes.
In my testimony today, I will not linger over the litany of what's
wrong with the FDA program. I will instead focus on what I believe are
the core policy elements of a successful strategy for improving food
safety, and I will assess the new FDA Food Protection Plan in light of
those elements.
In general, I find that the FDA plan contains many of the policy
ideas that experts agree are important to ensuring food safety--and
thus provides a platform on which to build. It falls critically short,
however, on clearly and properly defining the complementary but
distinct food safety roles of the food industry and the government. As
a result, the FDA plan does not include actions and recommendations
that I think are vital to FDA's success.
I note also that the administration's plan is silent on FDA's
resource and organizational problems, but I will focus in this
testimony on the core policies that should underlie FDA's food safety
strategy and program.
core policy elements of a successful food safety strategy
The following are the five core policy elements that I consider
essential to a successful FDA food safety strategy.
1. Treat food safety as a farm-to-table, system-wide problem.
For most of the 20th century, food safety regulators focused
largely on basic sanitation in processing plants, chemical contaminants
in food, and the safety of chemical additives. It was possible then for
FDA to focus on a relatively narrow set of establishments, commodities,
and decision processes through which those concerns could be addressed.
Over the last 20 years, however, the problem of foodborne illness
caused by microbial pathogens has emerged as a central food safety
concern and one that requires a broader, ``farm-to-table'' approach to
ensuring food safety.
A farm-to-table approach is required due to the simple reality that
dangerous bacteria and other pathogens can enter the food chain at
almost any point, from production on the farm through processing,
retail sale, and final preparation for consumption; they can grow; and
they can be killed. Thus, whether someone gets sick depends not on any
one contamination event but on a wide range of events and behaviors
that occur across the entire farm-to-table food system and that, in
combination, determine the likelihood dangerous levels of an organism
will be present at the point of consumption.
This expanded understanding of food safety makes everyone--from
farmers to consumers, as well as government food safety agencies--
actors in the food safety system. It creates the opportunity and need
for integrated action to minimize food safety risks at points all
across the farm-to-table system--wherever pathogens can enter the food
and grow or be reduced. FDA's food safety program must recognize and
act on this reality, as recommended repeatedly by GAO and NAS.
2. Make prevention of food safety problems the central focus of the
system.
Prevention is the core principle of public health and should be the
central focus of the food safety system. Prevention of problems is
certainly what consumers expect of the system, and it's the core
principle that drives modern approaches to food safety. Most notably,
HACCP (Hazard Analysis and Critical Control Points) is a system of
preventive process control that was developed originally by the food
industry as a method for anticipating and preventing food safety
hazards in particular food production and processing operations.
FDA has adopted HACCP as a regulatory requirement for seafood and
juice, but prevention is not an explicit part of its statutory mandate.
In fact, FDA's food safety legal authorities are designed primarily for
reacting to and correcting problems after they occur, not for
preventing them. In an on-going outbreak of foodborne illness, swift
reaction and containment measures are important and can reduce the
number of illnesses associated with that outbreak, but, to protect
public health and meet public expectations for food safety, preventive
measures such as HAACP need to be built in to the system so that the
risk of food safety problems occurring in the first place is minimized
to the greatest extent reasonably possible.
FDA currently pursues prevention of this kind only on a selective
and ad hoc basis. A comprehensive, systematic approach to prevention
should be a core principle and central focus of the food safety system.
3. Recognize that the primary duty for prevention falls on the food
industry.
This may be the most crucial point to emphasize in getting roles
and relationships between government and industry right. The
unavoidable reality is that government does not make food, and
government cannot make it safe. That's the food industry's job, and
making food safe--doing everything reasonably possible to prevent food
safety problems--is the most fundamental duty food producers and
processors owe to America's consumers.
Many of our Nation's leading food processors and retailers take
this duty very seriously, and they make extensive efforts to fulfill
it. They know food safety doesn't just happen; it's the result of a
plan. So they impose safety specifications on their suppliers to be
sure their raw materials and ingredients are safe; they implement HACCP
and other preventive control measures within their processing plants;
and they test their finished products to verify that their control
systems are working. In fact, over the years, much of the food safety
innovation in the United States has come from companies that take food
safety seriously and have plans for achieving it.
The problem is that many of the Nation's 44,000 food manufacturers
and processors, 114,000 food retailers, and 935,000 restaurants do not
have effective food safety plans. And, at the farm level, systematic
planning for prevention of food safety problems is in its relative
infancy. This must change.
Any business involved in producing, processing, and marketing food
must have a plan for making it safe, based on modern preventive
controls. This does not mean a one-size-fits-all approach. It does not
mean HACCP per se for every commercial participant in the food system.
But it does mean that anyone producing food for today's marketplace
should know how they are going to make it safe and should do that
consistently, every day.
4. Focus FDA on setting and enforcing standards that make the food
industry accountable for prevention.
While the food industry is inherently responsible for making food
safe by acting preventively, FDA's job as a public health regulatory
agency is to set and enforce standards that make the industry publicly
accountable for prevention, in accordance with a defined standard of
care. Setting standards for prevention means defining the
responsibility of food producers, processors and retailers to have and
implement food safety plans based on modern preventive controls. It
also means establishing performance standards that define the level of
protection, or food safety performance, that is to be achieved through
preventive controls, such as the levels of chemical residues or
microbial contaminants that are deemed acceptable.
Standards protect food safety only if companies comply with them,
and it is FDA's job to ensure compliance through inspection and
enforcement. For many leading companies, compliance is not an issue: if
the government sets a food safety standard, they will organize their
systems to comply. In fact, many will go beyond what the government
requires in response to the demands of their customers expressed in the
marketplace. The food industry is, however, highly diverse, with some
companies lacking the market incentive or an internal culture that
ensures they meet high food safety standards. That's why government
standards and government enforcement are needed, and it's why they are
in the interest of both consumers and those in the industry who take
their food safety job seriously and do it well.
Government regulation of food safety is essential, but it has to be
smart regulation. We have learned that old fashioned ``command and
control'' regulation - in which the government specifies not only the
outcome to be achieved but how industry must achieve it--can impose
unnecessary costs and stifle innovation. Instead, modern regulation is
clear in setting performance standards for companies and flexible in
how companies can achieve the standard. Thus, as a regulatory tool,
HAACP sets a standard of care for implementing preventive process
control but is inherently flexible in allowing companies to tailor
their preventive controls to the particular hazards and circumstances
in their operations. Performance standards for microbial contamination
say what level and incidence are acceptable, but they do not dictate
the interventions needed to achieve them.
In a food safety system based on holding the industry accountable
for prevention, regulators have a duty not only to avoid stifling
innovation but to affirmatively encourage it. This means among other
things ensuring that regulatory review of new food safety technologies
is done promptly and with an appreciation of the food safety benefits
of technological innovation.
5. Strengthen FDA's mandate and tools for providing national leadership
on food safety and managing a science- and risk-based
regulatory program.
While FDA's core role on food safety is to set and enforce
standards, it will be effective in this role only if it operates from a
position of strength as the Nation's leading science-based, public
health regulatory agency. To this end, FDA should have a clear mandate
to drive research aimed at understanding food safety problems and
solutions and setting science-based standards. It should work closely
with CDC, other Federal food safety agencies, and State and local
agencies to build an integrated, national system of food safety
protection. And it should provide scientific and policy leadership to
develop workable approaches to risk-based priority setting and resource
allocation across the food safety system.
assessment of the fda food protection plan
The five core policy elements outlined above reflect current
thinking about the attributes of a modern, effective food safety
system, as that thinking has evolved through the work of NAS, GAO and
other experts. The language of the FDA Food Protection Plan is largely
consistent with these ideas. It speaks of addressing risks of food
``from production to consumption''; it makes prevention and corporate
responsibility for prevention central themes of the plan; and it calls
for risk-based approaches to inspection and better use of information
to improve food safety. For this reason, the plan is a useful basis for
discussion.
The shortcomings of the plan lie in the specific actions it
proposes--and fails to propose--to implement these broad ideas. While
many of the proposed actions are worth pursuing, they do not add up to
an effective FDA strategy to improve food safety. In general, they fall
short of the action that is needed to establish the food industry's
farm-to-table accountability for prevention. To illustrate this key
point, I will review the FDA plan in light of the five core policy
elements discussed above.
1. Treat food safety as a farm-to-table, system-wide problem.
While stressing the importance of a farm-to-table approach to food
safety, the FDA plan proposes no specific actions to improve food
safety on the farm or at retail, beyond what it is currently doing.
At the farm level, the plan calls for FDA to meet with food
industry representatives to strengthen ``voluntary'' prevention efforts
and for FDA to develop guidelines for industry development of voluntary
``food protection plans'' for produce and other foods, but FDA has been
meeting with the industry about produce safety for the last decade, and
in 1998 issued non-binding ``good agricultural practice'' guidelines to
address the microbial safety of fresh fruit and vegetables.
Early this year, an industry trade group, the United Fresh Produce
Association concluded that the voluntary approach was insufficient and
called for FDA to establish mandatory, enforceable, on-farm standards
for safe produce production, but the FDA plan is silent on this idea.
And, while the plan calls generally for strengthening FDA's ability to
assess and prioritize risks and identify preventive strategies, it
contains no specific proposals for driving the research and analysis
needed to establish enforceable food safety performance standards on
the farm.
On retail food safety, the plan makes several references to the
need for dialogue with the States and localities, which play the
frontline role on food safety in the Nation's grocery stores and
restaurants. Such dialogue is important, but is has been ongoing for
many years and has resulted in important collaboration through FDA's
development and the adoption by many States of the Food Code, which is
a model ordinance for regulating food safety at retail. In addition,
FDA and the States collaborate on an innovative program to foster
improvement in State and local food safety regulatory programs, based
on uniform national standards. The FDA Food Protection Plan does not
include ideas for improving these core FDA retail food safety programs
or recommend any other specific actions to improve retail food safety.
While the FDA plan lacks concrete proposals for new actions to
address food safety risks on U.S. farms or at retail, it does call for
a number of actions to improve FDA oversight of food imports, including
more affirmative efforts to work with foreign governments on food
safety, develop knowledge needed to target high-risk imports, and
improve FDA's ability to detect problems at the port of entry. These
ideas are positive, but, as discussed below, the report does not
address the accountability of importers for ensuring that the food they
import was produced in accordance with U.S. standards.
2. Make prevention of food safety problems the central focus of the
system.
The FDA plan gives great prominence to the concept of prevention,
which would be an important and positive shift in emphasis in FDA's
food safety program, but the plan's approach is to work collaboratively
with the industry to foster voluntary adoption of preventive control
plans. Such voluntary efforts can contribute to progress in the near
term to the extent those not currently following recognized ``best
practices'' are willing to emulate leading companies that are already
implementing state-of-the-art preventive control plans. Such voluntary
efforts will not, however, solve the food safety problems posed by
companies that lack market incentives or are otherwise unwilling or
unable to bring their food safety practices up to modern standards.
Furthermore, voluntary approaches do not provide clear public
accountability for prevention.
Even more fundamentally, the FDA plan does not address the agency's
lack of a statutory mandate to make prevention the central focus of its
program. While prevention is clearly the necessary strategy for the
future, the basic food safety provisions of the Federal Food, Drug, and
Cosmetic Act on which FDA relies to regulate microbial pathogens were
enacted in 1938 and are silent on prevention. They consist instead of
adulteration and enforcement provisions designed for reaction to
problems and correction of them after the fact. To make prevention the
central focus of its program, FDA should be calling for a new
prevention mandate from Congress and the legal tools to back it up.
3. Recognize that the primary duty for prevention falls on the food
industry.
Again, the FDA plan calls prominently for promotion of ``increased
corporate responsibility to prevent foodborne illness,'' which is a
conceptual step forward, but the proposed implementation of this
central concept falls far short.
In fact, rather than recognizing that all those involved in the
food business have a prevention duty for which they should be publicly
accountable, the FDA plan actually places the burden on FDA to
determine case-by-case when preventive controls should be required.
Moreover, it calls on Congress to limit FDA's power to require
preventive controls to cases in which it can establish through
rulemaking that a particular food has been associated with ``repeated,
serious adverse health consequences or death.''
Placing the burden on FDA in this fashion is the opposite of a true
prevention strategy. It treats preventive process control as a tool for
reacting to problems after they occur rather than a tool for
systematically and comprehensively building prevention into the system.
And the stringent standard for requiring preventive controls that the
FDA plan recommends is a step backward from the legal authority that
FDA has under current law and has used already to require HACCP for
seafood and juice. It is far from clear whether the Office of
Management and Budget would have cleared, or the courts would have
sustained, FDA's seafood and juice HACCP rules had they been subject to
the standard recommended in the FDA plan.
The plan's lack of follow through on the principle of industry
responsibility for prevention is evident also in its import proposals.
These proposals focus on what FDA will do to work with foreign
governments and to better detect problems at ports of entry, but they
do not call for any new accountability on the part of importers to
ensure that problems have been prevented up the supply chain to the
point of production in the exporting country. FDA will never have
enough resources to police and ensure the safety of imports without
harnessing the expertise and efforts of the private sector and making a
U.S.-based entity legally accountable for ensuring prevention is
``built in'' for imports, just as it should be for domestically
produced food.
4. Focus FDA on setting and enforcing standards that make the food
industry accountable for prevention.
Other than the provisions for requiring preventive controls on a
case-by-case, reactive basis, the FDA plan does not address the need
for setting and enforcing standards that make the food industry
accountable for prevention. As noted earlier, the plan focuses on
encouraging voluntary adoption of preventive controls.
The closest the plan comes to standards and enforcement is in its
second core element of ``intervention,'' where the plan calls for
``targeted, risk-based interventions to ensure that the preventive
measures called for are implemented correctly.'' The three ``key
intervention steps'' do not, however, directly address prevention at
all, nor do they involve any measure that would create accountability
for prevention. The three proposed ``interventions'' are instead tools
for detecting problems after the fact, including risk-based inspection,
sampling, and surveillance and improved detection of food system
``signals'' that indicate contamination. These are all worthy
approaches to better targeting the use of scarce resources, but they
are more about detection and correction of problems than prevention.
The best way to ensure that necessary preventive measures are
implemented is to hold companies directly accountable for prevention in
accordance with a defined standard of care.
5. Strengthen FDA's mandate and tools for providing national leadership
on food safety and managing a science- and risk-based
regulatory program.
The FDA plan clearly envisions a food safety leadership role for
FDA in relation to the food industry and State and local government,
which is positive. The call for closer collaboration with State and
local food safety agencies is especially important to building an
effective, national food safety program and making good use of all
available public resources. On the industry side, however, the proposed
FDA leadership role in encouraging voluntary adoption of preventive
controls may actually blur rather than strengthen responsibility and
accountability for prevention.
The plan's call for FDA leadership on food safety research and on
developing the tools for a science- and risk-based approach to setting
priorities and allocating resources is an important strength. The plan
also recognizes the need for FDA to take the lead in developing the
tools and capacity for knowledge generation and information management
to improve food safety, such as enhancement of FDA's Emergency
Operations Network Incident Management System, more effective traceback
systems, and improved sharing of information across the system. Better
collection and use of information is obviously essential to our efforts
to improve food safety.
recommendations for improving on the fda food protection plan
FDA's plan has its clear strengths and weaknesses. On policy, the
plan's major strength is that it embraces the concept of industry
responsibility for prevention and calls for strengthening FDA's
capacities in important ways. The plan's major policy weakness is that
it fails to call for the statutory modernization and policy change that
is needed to implement the prevention concept in a really substantial
way and thus leaves FDA still relying too heavily on reaction. The plan
does not address at all FDA's problems of dwindling resources and an
ineffectual organizational structure for food safety.
With these points in mind, I offer the following major
recommendations to augment FDA's Food Protection Plan and equip FDA for
success on food safety.
Modernize FDA's Statutory Mandate
Congress should modernize FDA's food safety mandate to, among other
things:
Explicitly make prevention of foodborne illness FDA's
primary food safety mission;
Establish by law a duty for all those in the food business
to implement preventive controls appropriate to their particular
operation, subject to FDA's implementing regulations and guidance;
Direct FDA to establish and enforce performance standards
that make companies accountable for implementing effective prevention
measures;
Make importers legally accountable for assuring that
foreign producers and processors shipping products to the United States
are meeting U.S. standards;
Provide leadership in building an integrated, national
food safety system that is science- and risk-based and makes efficient
use of available resources to improve food safety.
Provide FDA an Adequate and Stable Resource Base
FDA's resources for food safety have been eroding for years as the
agency's food safety challenge gets larger. The total operating budget
for FDA's Center for Food Safety and Applied Nutrition--the resources
available to take action after the staff and rent are paid--is down to
around $25 million, which is a paltry sum for an organization charged
with driving food safety progress across 80 percent of the American
food supply, while also regulating dietary supplements and food
labeling, ensuring the safety of infant formula and food additives, and
attempting to provide food safety leadership internationally. An agency
with all these responsibilities that can't conduct or commission
research, adequately equip its staff, or travel simply can't do its
job.
Despite this well-documented resource reality, and despite the fact
that the FDA plan includes 38 actions to strengthen FDA's food safety
program, the plan is silent on resources. Presumably, the President's
2009 budget proposal will include the resources needed to implement the
plan.
Congress, however, has a responsibility to act. In addition to
meeting FDA's immediate needs through the 2008 and 2009 budget
processes, Congress should undertake a serious study of how to
establish an adequate and stable funding base for FDA's food safety
program for the long-term. Just as it is fair to hold the food industry
accountable for doing its food safety job, it is fair to hold FDA
accountable for the leadership and effective action we expect from that
agency, but only if it has an adequate and predictable resource base.
Congress should explore a range of resource options, including:
Requiring FDA to prepare for Congress a 5-year financial
plan and an annual ``professional judgment'' budget sufficient to
implement a modernized statutory mandate.
Establishing by law a statutory inspection mandate, with
consequences built in for failure to meet it, to serve as an anchor for
appropriated resources.
Authorizing FDA to collect establishment registration fees
and import fees to provide a steady base of resources for the food
safety program.
Unify and Elevate the Organizational Elements of the FDA Food Safety
Program
The third key ingredient for the success of any agency--after an
appropriate statutory mandate and adequate resources--is an
organizational framework suitable for its purpose. For food safety, FDA
needs a framework that enables it to provide national leadership on
food safety and run a coherent, well-planned program that makes the
best use of available resources to improve food safety. For several
reasons, FDA lacks such a framework.
First, within FDA, the food program has historically taken a back
seat to the drug and medical device programs in the competition for
management attention and resources. This is due in part to the intense
interest that drug and device companies, health professionals, and
patients all have in FDA's ``gatekeeper'' role for therapeutic products
and is reflected in the fact that most FDA commissioners come from a
biomedical or health care background. This strong tilt toward drugs and
devices was exacerbated by the drug and device user fee laws, which
have further focused FDA management attention, accountability, and
resources on the therapeutic side of the agency. History has taught
that the job of providing effective national leadership simultaneously
on both therapeutic products and food safety is too big a job for any
one person.
Second, FDA's organizational structure for food safety is
fragmented and lacks a clear focal point for leadership. CFSAN
ostensibly has the lead on food safety at FDA, but CFSAN actually
shares food safety jurisdiction with the Center for Veterinary
Medicine, which regulates pet food and animal drug and feed additive
residues in human food, and with the Office of Regulatory Affairs,
which manages the majority of FDA's food safety resources through its
field force of inspectors, compliance officers and laboratory
personnel. The recent establishment in the Office of the Commissioner
of an Assistant Commissioner for Food Protection, who serves as a
spokesperson and coordinator but lacks budget or line authority for
programs, further clouds responsibility and accountability for food
safety within FDA.
Finally, food safety leadership at FDA rests at least two
bureaucratic layers removed from the Secretary of Health and Human
Services. As decisionmaking in the executive branch continues to be
centralized at higher and higher levels, with OMB having enormous
influence on regulatory policy, the full time leader of the Nation's
premier food safety program needs to have the greater clout in the
system that comes from being presidentially appointed and reporting
directly to the Secretary.
The FDA Food Protection Plan did not address these structural
obstacles to the success of the food safety program. Congress should
address them by unifying the food-related components of FDA into a
single organization and elevating that organization within HHS under
the leadership of a presidentially appointed official reporting
directly to the Secretary.
conclusion
Thank you again, Mr. Chairman, for the opportunity to testify on
these important issues. I look forward to answering your questions and
the questions of your colleagues on the committee.
*Mr. Taylor is Research Professor of Health Policy at The George
Washington University School of Public Health and Health Services and
chair of the Food Safety Research Consortium. He served formerly as
Administrator of USDA's Food Safety and Inspection Service (1994-96)
and as Deputy Commissioner for Policy of the Food and Drug
Administration (1991-94).
The Chairman. Thank you very much.
Mr. Corby.
STATEMENT OF J. JOSEPH CORBY, DIRECTOR, NEW YORK DEPARTMENT OF
AGRICULTURE & MARKETS, ALBANY, NY
Mr. Corby. I wish to offer my sincere thanks to you,
Senator Kennedy, Senator Enzi and this committee for providing
me the opportunity to testify today and to discuss the role of
State and local government in our country's food safety system.
I've spent my entire working career of over 37 years as a
State food safety regulator for New York's Department of
Agriculture and Markets beginning as a food inspector in 1970.
During this time I've witnessed many changes in the manner in
which food protection programs have been conducted within the
country and have also seen the consequences when these programs
become weakened or ineffective. I continue to remain optimistic
about FDA as a partner in our efforts with food safety. Many of
the innovative food safety programs in existence today in New
York State, including our work with imported foods, are there
because we established a close working relationship with FDA's
New York district. A relationship that recognizes each others
strengths and weaknesses and one that promotes efforts for
working together rather than on our own.
We certainly do not agree with FDA on all food safety
matters. And we realize there is some bureaucratic obstacles to
our achieving success together. But we have always remained
close working partners on many issues and have a mutual respect
for one another.
My written testimony provided to the committee suggested
that this country is looking for leadership in the arena of
food safety and FDA must be more aggressive in developing
strategies that will ensure consumers they continue to have the
safest food supply in the world. I strongly believe the success
of FDA and other food safety agencies at the Federal level
depends on a large extent on effective coordination and
collaboration with food safety regulators and health officials
at the State and local level. There are more than 3,000 State
and local agencies involved in food safety and we've long been
on the front line in conducting foodborne illness surveillance,
investigating and containing illness outbreaks, conducting food
safety inspections at grower level, at processors and packers,
at warehouses, food processing plants and retail establishments
in taking regulatory action to remove unsafe products from the
market.
State and local food safety officials are much closer to
consumers than Federal agencies and under direct pressure to
respond to food safety concerns in their communities even when
the problems originate elsewhere. One need only ask themselves
who would they call when sickness associated with food strikes
them or a member of their family. In almost every circumstance
they would call the local health department or the State health
department or the State Department of Agriculture, seldom do
they call FDA. Furthermore when the news media discovers
recalled food products still on grocery store shelves months
after a recall was announced by a Federal agency they will
contact local or State food safety officials and demand to know
why.
To many of us in State and local food safety programs, it
appears that Federal policymakers do not have a clear
understanding of the food safety roles of State and local
agencies and the issues we face. The need for Federal-State
partnership in collaboration is well recognized and often
voiced. But absent some affirmative effort, Federal food safety
reform is unlikely to address the roles and the needs of State
and local agencies that are critical to achieve real progress.
This would be so unfortunate in today's world where food
safety and a defense of our food supply have become very much
linked together. We must build a system that contains the
elements of early detection, rapid response and quick recovery.
This cannot be done in my view without the active participation
of State and local government resources.
I have provided the committee with a survey summary of
State food protection programs conducted by the Association of
Food and Drug Professionals. This survey which was conducted
several years ago illustrates a very clear picture of the
enormity of food safety work that is performed at the State and
local level. What the survey reveals more than anything else
however, is that the safety of our food supply is not a Federal
matter only, but an issue to be dealt with by government at all
levels in a comprehensive and coordinated fashion.
AFDO and its State members have voiced for years the need
for a fully integrated food safety system in this country. With
the implementation of the new action plan set forth by FDA, the
ability and willingness of State and local agencies is to share
their resources and authorities and a sincere desire of FDA to
work with their State and local partners to restore consumer
confidence, we can build a seamless food safety system once and
for all.
Thank you and I look forward to your questions.
[The prepared statement of Mr. Corby follows:]
Prepared Statement of J. Joseph Corby
I wish to offer my sincere thanks to Senator Kennedy, Senator Enzi,
and this committee for providing me the opportunity to testify before
you and to discuss the role of State and local government in our
country's food safety system. I have spent my entire working career of
over 37 years as a State food safety regulator for the New York State
Department of Agriculture & Markets (NYSDAM) beginning as a Food
Inspector in 1970. I have witnessed many changes in the manner in which
food protection programs are conducted within the country and have also
seen the misfortunes of many, especially children, when these programs
become weakened and ineffective. I have interviewed victims of
foodborne illnesses and listened in great horror to the tragic tales of
mothers whose children had succumbed to an illness that was hidden
within their hamburger, vegetable salad, or apple cider. In recent
years, I began to wonder what food would we next learn could make us
sick and what emerging pathogen would now cause such danger and concern
for us. It seems to me that this Nation is screaming out for leadership
and demanding that its government build a seamless food safety system
that will restore their confidence in the food supply and in us. This,
in my view, is the challenge before us today.
The success of the Food and Drug Administration (FDA) and other
food safety agencies at the Federal level depends to a large extent on
effective coordination and collaboration with food safety regulators
and health officials at the State and local level. The more than 3,000
State and local agencies involved in food safety have long been on the
frontline in conducting foodborne illness surveillance; investigating
and containing illness outbreaks; conducting food safety inspections at
the processing, warehousing and retail area; and taking regulatory
action to remove unsafe products from the market. State and local food
safety officials are much closer to consumers than Federal agencies and
under direct pressure to respond to food safety concerns in their
communities, even when the problems originate elsewhere. One need only
ask themselves who they or their doctor would call when sickness
associated with food strikes them or a member of their family. In
almost every circumstance, they call the local health department or the
State health or agriculture department. Seldom do they call the FDA.
Furthermore, when the media finds recalled food products still on store
shelves months after a recall is announced by the FDA, the media will
contact local or State food safety officials and demand to know why.
To many of us in State and local food safety programs, it appears
that Federal policymakers do not have a clear understanding of the food
safety roles of State and local agencies and the issues we face. The
need for Federal-State-local ``partnership'' and ``collaboration'' is
well recognized and often voiced, but, absent some affirmative effort.
Federal food safety reform is unlikely to address the roles and needs
of State and local agencies with the specificity required to achieve
real progress. This is an important concern because, like many elements
of the public health system, State and local food safety agencies
operate under disparate and sometimes outdated statutory authorities,
face the challenge of working within a complex web of local, State and
Federal agencies having complementary and sometimes overlapping roles,
and are usually under funded.
Notwithstanding budgetary concerns within the States, there remains
a skillful, knowledgeable, and in many aspects untapped resource for
the FDA to collaborate with on matters of food safety and food defense.
In 2001, the Association of Food & Drug Officials (AFDO), the primary
organization that represents government food safety regulators,
conducted a survey of State food protection programs to quantify the
amount of food safety work performed there. The survey represented all
50 States, with at least one administrator from every State responding.
The results clearly demonstrated how huge a role the States play in the
overall food safety efforts that exist in this country. Appendix B on
the last page of this document summarizes the AFDO survey.
What is most alarming about this data is that the majority of this
work identified at the State level may not be accepted or even
acknowledged by Federal agencies. This is true despite the fact that
nearly 50 percent of the food inspections claimed to be performed by
the FDA annually are actually performed by State agencies under
contractual agreement. While there may be a number of reasons for this
(such as equivalency issues and differences in authorities and laws),
in my opinion we do a great disservice to consumers by not better
coordinating our overall food safety efforts in this country.
Another unfortunate matter is the fact that over 320,000 food
samples collected and analyzed by State food safety programs are, for
the most part, ignored by Federal agencies. Again, this may be a result
of the FDA's concern for equivalency or how samples are collected and
processed by State officials, but it seems very unwise to ignore such a
huge amount of important information relating to domestic and foreign-
produced foods. Why the FDA does not better utilize this data and
recognize its relevance to the protection of public health has remained
a mystery to State food safety program managers for some time.
I have had the great fortune of working for an agency that has had
the courage to meet food safety challenges very aggressively and the
willingness to explore innovative strategies to better deal with these
challenges. NYSDAM has gained its national reputation in food
protection because we recognize the value in resource integration,
partnering with Federal agencies, and pursuing a course that recognizes
that there is but one food supply to be protected regardless of the
number of government agencies involved.
There are certain components of New York State's food protection
program that I believe forge innovative, ``cutting edge'' partnerships
with the FDA and serve as models for other States. Our ``Integrated
Food Safety System'' is a partnership program with the FDA's New York
District, and perhaps most noteworthy is our Imported Food Initiative
agreement we have with that district's Upstate and Downstate Import
Operations.
The purpose of the Integrated Food Safety Partnership is to
establish an agreement that coordinates the food protection efforts of
NYSDAM's Division of Food Safety and Inspection and the FDA's New York
District Office. This agreement reduces consumer risk, eliminates
duplication, defines regulatory roles and improves channels of
communication. All manufacturing food establishments and food storage
facilities licensed or inspected by NYSDAM are covered by this
agreement and it serves as a pilot to demonstrate the effectiveness of
integrating the Federal/State responsibility for the food manufacturing
and storage industries. The partnership includes data and information
sharing, training, recalls, and enforcement strategies. It allows the
FDA and NYSDAM to share each other's resources and authorities. We
could have never implemented this partnership program without mutual
respect and the recognition that we both play critical roles in
protecting New York citizens.
Our Import Initiative pilot is the project of which I am most proud
because it is most timely and truly effective in dealing with the
overwhelming burden of imported foods. It is very clear that the number
of goods imported into this country has increased dramatically, and the
majority of these imports are foods (See Figure 1). The FDA's ability
to handle the enormous surge of imported products, however, is
increasingly limited; in fact it is estimated that less than 1 percent
of imported products are physically examined (See Figure 2). As a
result, the FDA is contracting out more and more domestic inspections
to State agencies in order to focus more resources to imported
products. Unfortunately, they cannot meet this huge demand, yet little
has been done to allow State agencies to play a greater role in the
surveillance and inspection of these foods. Imports have essentially
remained a role of the Federal Government through the efforts of U.S.
Customs and Border Protection [CBP], the U.S. Department of Agriculture
(USDA) and the FDA. The Import Initiative, however, allows the FDA and
NYSDAM to work more collaboratively on imported food oversight.
This cooperative effort is essential because approximately 33
percent of the imports coming into this country enter through New York
State. Because of our diverse population, many of these products remain
in New York and are marketed domestically here. These domestic
channels--which include food warehouses, processing plants, and
retailers--are the areas for which State and local food safety
regulators are primarily responsible. To summarize, one can conclude
that any imported food that makes its way through the scrutiny of the
Federal Government becomes primarily the responsibility of State and
local government regulators.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Note that although large volumes of imported food enter the United
States via ports of entry in New York State, food of import origin
offered for sale at New York wholesale/retail establishments can, and
does, enter the United States via any of the 400+ ports of entry
scattered throughout the country. NYSDAM's surveillance of foods of
import origin at the wholesale/retail level not only protects consumers
in New York State, but also provides valuable information to the FDA
regarding how the national import program is working. Subsequent joint
investigations of violative food product will enable the FDA to
determine why the violative food was not detected and detained and take
affirmative steps to do so in the future.
A good illustration of the dilemma for State agencies with imported
foods is depicted in Figure 3 below. This chart is a 5-year summary of
food recalls coordinated by NYSDAM. With a field staff of a little over
100 Food Inspectors, we are averaging over 350 food recalls a year.
This number is greater than the number of recalls coordinated by the
FDA and USDA annually. Of the 1,786 food recalls coordinated in New
York since 2002, 1,304 of these (or 73 percent) involved foods of
foreign origin. Of that amount, 1,030 (or 79 percent) were categorized
as Class I or Class II (health impacted).
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Rather than ignore the matter or simply forward all of our concerns
to the FDA, we decided to be more aggressive in our response. A vision
for integrating FDA and NYSDAM resources was developed into a project
that would allow NYSDAM to collaborate with FDA in the following three
basic areas:
1. Develop a Better Understanding of Laws and Authorities for Each
Agency
The FDA's strongest enforcement tool with imported food is the
``Import Alert'' (formerly known as ``Automatic Detention''), which
authorizes FDA detention without physical examination when suspect
foods, which ``appear'' to be in violation, are presented for entry
into this country. NYSDAM's strongest enforcement authority tool is the
``Food Seizure'' which prohibits the commercial movement of food
anywhere within the State. Merging and utilizing, where appropriate,
these authorities have produced influential impact on controlling
violative food imports.
2. Sharing of Resources
NYSDAM has ample resources in domestic channels, and the FDA has
focused resources at New York border entry points. Working jointly on
foods of import origin in New York State at both points is optimal and
allows the FDA to make better decisions on products to detain for
examination at the border.
3. Sharing of Intelligence and Information
NYSDAM shares inspection and sampling information relating to foods
of import origin in domestic commerce with the FDA. Where possible, we
also provide import entry numbers for adulterated imported foods so the
FDA can determine which of the 400 border entry points was involved and
the mechanism of distribution. The FDA provides immediate notice to
NYSDAM of imported food concerns so that State inspectors can take
prompt action in domestic channels.
As a result of this imported food initiative, a number of very
successful investigations have been conducted. Several of these are
worth noting as follows:
1. When a young female child died from choking on an imported gel
candy product, NYSDAM received information from the FDA that 18 other
children from around the world had met similar fates due to this type
of product. We further learned that an ingredient in this food
(``konjak'') prevented the candy from dissolving once placed in ones
mouth. This information was sufficient for New York and other States to
take immediate action against this product. In New York we coordinated
around 54 recalls and supervised the destruction of over 60 tons of
this product. It would have taken FDA approximately 8 months to outlaw
the use of this ingredient in these products. The States, on the other
hand, were able to respond quickly, and I have no doubt that our
actions saved children's lives.
2. An infant's sole source of food and nutrition is oftentimes the
infant formula provided to them. Without receiving the required
nutrition from these products, they can become ill and even die. A
scandal existed several years ago with Chinese manufactured infant
formula where manufacturers there were producing products absent a
number of required nutrients, causing the deaths of a number of Chinese
infants. The FDA advised NYSDAM that no entries for this imported
infant formula had been listed for the country. Nevertheless, we sent
Inspectors into Chinese-American neighborhoods, where we found this
product. We utilized our food seizure authority, sampled and tested the
product, and supervised its destruction following acknowledgement from
our Food Lab that the product failed to have much of any nutritional
value. A press release was issued through the Chinese media in New York
City cautioning anyone who may have purchased the product. Here as
well, I believe infant lives were saved.
3. In this country a manufacturer of a Grade A pasteurized dairy
product such as fluid milk or cream, yogurt or ice cream can not ship
their products out of State or country without verification that their
milk suppliers (dairy farmers) and manufacturing facility have received
and passed a food safety inspection. Unfortunately, a number of
imported Grade A dairy products are allowed to enter this country for
marketing without the same requirement being met. States, in most
cases, have approved source requirements for foods sold in their States
and are able to take action against these foreign dairy firms, which do
not have inspection verification. The FDA provides information to
NYSDAM of where these products are shipped in New York, and we dispatch
an inspector to the warehouse location. Products from foreign firms
that are not inspection-verified are either exported back to the
country of origin or removed from sale here and destroyed.
Our imported food initiative with the FDA has been so successful
that we have expanded the program and are now collaborating with other
Federal agencies involved with imported foods. These include U.S.
Customs & Border Protection (CBP), USDA's Food Safety and Inspection
Service Import Liaison, USDA's Smuggling & Interdiction Trade
Commission (SITC), and the Department of Homeland Security (DHS). Our
collaborative efforts with these agencies have allowed us to take the
following actions:
1. Removal of illegally imported or smuggled raw poultry from China
(avian Influenza concern).
2. Removal of illegally imported or smuggled meats from BSE
designated countries (BSE concern).
3. Surveillance activities for the illegal distribution and
marketing of African ``bush meat'' (Endangered species/potential human
virus concern).
Figure 4 below quantifies our imported food activity we typically
conduct.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The other very important element of our initiative has been the
development of educational programs for importers, import food
distributors, and retail food stores to assist them in protecting
themselves from receiving adulterated or misbranded imported foods.
These programs are especially useful to small businesses. In October of
this year we held a program for the Chinese American business community
and have another similar program planned for January with Russian
American businesses.
Our goals for this coming year is to train two additional FTE's to
perform the inspection and investigational work associated with
imported foods. We also hope to develop additional training courses for
small businesses and other industry officials that distribute and sell
imported foods. These courses will be designed to offer basic
assistance of what food safety concerns exist with imported food
products so that these firms can set specifications with foreign
manufacturers to assure violative products are not delivered into the
country. Distributors will further be trained in food labeling matters
so they can easily detect violative concerns such as illegal food
additives, illegal food colors, and undeclared food allergens and
sulfating agents.
We believe our import initiative has contributed to the adoption by
the Federal and State regulatory agencies of the best available
practices for controlling food safety and defense hazards associated
with imported foods. The program leverages current Federal and State
food safety activities to more effectively protect consumers, and it
provides a degree of innovation.
This kind of idea is not new, however. A program funded by the FDA
beginning in 1998 called the ``National Food Safety System'' (NFSS) was
intended to integrate the food safety resources of government at all
levels. A primary objective of that project was to improve food safety
through a collaborative effort of Federal, State and local government
agencies. It was believed then that a fully integrated, seamless and
science-based system would build consumer confidence and address all of
our food safety challenges. It would be foolish to ignore some of the
progress already in place, which resulted from the activities of the
National Food Safety System (NFSS) project. The following are examples
of significant NFSS accomplishments that have been achieved since the
inception of this project in 1998:
eLEXNET.--A secure electronic data sharing system for food
safety laboratory data.
ISO Accreditation.--An internationally recognized
laboratory accreditation program aimed at assuring uniform
methodologies for Federal, State and local laboratories.
Directory of Laboratory Capabilities.--A compilation that
identifies Federal, State and local laboratory capabilities in
preparation for emergency needs.
AFDO Recall Workgroup.--An effort involving State and
Federal (FDA and FSIS) officials to streamline and better coordinate
recalls for increased effectiveness in removal of contaminated product
from the marketplace.
Validation of Laboratory Methodologies.--A joint Federal/
State effort to standardize and develop national rapid detection
methods.
Foodborne Illness Outbreak Coordination Guidelines.--
Developed to provide uniform investigational procedures and
information-sharing protocols.
ORA-U.--Development of a comprehensive national training
and certification system to better facilitate uniform food safety
activities among all Federal, State and local field inspectors.
Uniform Criteria Workgroup.--Development of uniform
national regulatory standards.
Integrated Food Safety Partnership.--A pilot program that
integrates the food safety functions of a State and the FDA. A pilot of
this partnership, as described above, is currently in its early stages
of application.
The goals of the NFSS project were to establish a system that would
better utilize and leverage all the committed food safety resources at
all levels of government, build uniformity and consistency with
inspectional, analytical, enforcement and surveillance activities,
increase the level of consumer confidence by improving food safety, and
encourage the implementation of ONE food safety system. The projected
roles for Federal and State agencies envisioned in this seamless food
safety system were identified as follows:
The Federal Government would provide oversight in the following
areas:
Training
Certification
Risk Assessment
Program Evaluation
Imported Foods
Research
Science
Standards
Lab Practices
Additives
Packaging
Funding
State and local government agencies would share field resources in
the following areas:
Inspections
Investigations
Complaints
Sampling
Analysis
Compliance
Enforcement
Clearly, if we are to have a comprehensive, uniform, seamless and
risk-based food safety system for the Nation, a development strategy
that only examines the Federal component cannot be utilized. If it
were, then any attempt to correct the deficiencies in the current
system or to provide strategic plans for developing a truly effective
national food safety system is destined to fail.
The FDA Food Protection Plan and Action Plan for Import Safety are
the latest efforts by the agency in setting strategies for protecting
the Nation's food supply. These plans have great promise and both rely
very heavily on working collaboratively with stakeholders including
State and local agencies. The Action Plan for Import Safety speaks
specifically for considering cooperative agreements with States. The
Food Protection Plan uses less specific, more general language such as
``collaboration with'' and ``working closely with'' States in several
areas of the document. In my opinion, FDA should strive to work more
strategically with the States on a variety of functions including food
safety inspections, food product surveillance, and imported food
evaluations. In order to accomplish this, FDA would need to do the
following:
1. Accelerate the Manufactured Food Regulatory Program Standards
process so more States can participate and demonstrate their
equivalency to the FDA. The FDA can then share inspection work plans
with State agencies to avoid duplication of efforts.
2. The FDA must begin to accept State food laboratory analysis of
foods so they can better work with the States on sampling assignments
and the sharing of surveillance data. Work performed here should
include both imported and domestic products.
3. The FDA must improve their presence in foreign countries. By
gaining confidence with State and local governments handling most of
the domestic burden, FDA should be able to achieve this goal. A number
of States are performing inspection verification for foreign dairy
manufacturers of Grade A products. FDA should be performing these
inspections.
4. A number of States are leading the way in mandatory requirements
for vegetable growers and packers. California, Florida, and Virginia
have all introduced mandatory programs for specific commodities in
their States. The FDA should model these programs so they become
nationally accepted.
5. There is a huge need to improve our response efforts with food
recalls. Recent national recalls for peanut butter, spinach, and chili
sauce were confusing and ineffective. North Carolina employed an
Incident Command System [ICS] utilizing State and local government
officials from a multitude of agencies for the chili sauce recall. They
performed more recall audit checks in North Carolina than the rest of
the country combined. They also found a large number of these botulism-
tainted products in children's camps and other non-traditional food
venues ready for sale or service. The FDA needs to review their
response efforts with recalls and establish a formalized strategy with
State and local government to better deal with recalls.
6. The FDA needs to be granted recall and record review authority
by Congress to properly function as a regulatory public health agency.
While the country debates how to best protect our food and what
agency and how many will lead this effort, the fact remains clear that
whatever strategy is used the States and local agencies must be
recognized for the critical role they play.
Developing a new, comprehensive regulatory structure at the Federal
level will be an enormous task. It must include elements that address
human and animal health and nutrition, controls for foodborne
pathogens, surveillance of potential hazards, monitoring foodborne
illnesses, research and consumer education. Additionally, food safety
must now be part of any national security strategy.
Given the scope of the matter and the newfound critical importance
of food safety and security, it is difficult to argue against the
strategies outlined in FDA's Food Protection Plan and Action Plan for
Import Safety. What must not be overlooked, however, is the fact that
most of the food safety and food defense activities that occur in this
country occur at the State and local levels. The idea that food safety
or food defense is somehow only a Federal Government responsibility is
grossly inaccurate and misguided. There is great need for leadership,
however, and the FDA, assuming full implementation of these plans,
seems well suited.
Thank you for the privilege to present my views on these very
important matters.
______
Appendix B. AFDO National Survey--Survey Summary
Food Safety Regulatory Activities Conducted by Local and State
Government Agencies in Year 2001 \1\
------------------------------------------------------------------------------------------------------------------------------------------------
Inspections:
Food processing/repacking facilities..................... 56,644
Dairy plants............................................. 7,562
Manufactured milk plants................................. 5,956
Dairy farms.............................................. 159,483
Retail food service establishments....................... 1,178,348
Institutional food service establishments................ 51,290
Retail food stores....................................... 516,033
Intrastate wholesale meat processors..................... 418,844
Custom exempt meat plants................................ 12,310
Small animal slaughter houses............................ 24,395
Feed manufacturers and distributors...................... 19,904
BSE inspections.......................................... 3,475
Rendering plants......................................... 605
Food transportation vehicles............................. 9,481
Food salvage operations.................................. 2,067
Farm productions (GAPS).................................. 311
Food warehouses.......................................... 20,624
Other.................................................... 15,525
------------
Total.................................................. 2,500,857
Investigations:
Foodborne illness outbreaks.............................. 3,075
Tracebacks (not recalls)................................. 154
Consumer complaints...................................... 46,019
Shellfish growing areas.................................. 20,870
Commecial fishing areas.................................. 5,251
Farm pesticide residue................................... 472
Chemical residue in meat, milk, fish, and eggs........... 7,855
Disasters and/or emergency response...................... 2,816
Animal health matters (food safety related).............. 204
Other.................................................... 3,199
------------
Total.................................................. 89,915
Do high risk establishments receive more inspections per
year than lower risk establishments?
Yes...................................................... 69
No....................................................... 15
Number of licensed/permitted establishments................ 755,123
Number of unlicensed/not permitted establishments.......... 60,910
Number of FTEs (field)..................................... 3,685
Number of FTEs (administrative and support)................ 873
Entry Level Requirements:
High school.............................................. 17
Two-year college degree.................................. 10
Four-year college degree................................. 65
Other.................................................... 29
Do you require continuing education for inspectors or
investigators?
Yes...................................................... 55
No....................................................... 32
Do you require field inspectors or investigators to be
registered?
Yes...................................................... 26
No....................................................... 52
Do you require field inspectors or investigators to be
commissioned?
Yes...................................................... 20
No....................................................... 57
Enforcement Activities:
Embargo/seizure.......................................... 13,910
Stop sale................................................ 31,546
Health Advisories........................................ 90
Monetary penalties....................................... 9,878
License/permit revocation................................ 2,899
Injunctions.............................................. 74
Criminal prosecutions.................................... 4,048
Warning letters.......................................... 36,346
Informal hearings........................................ 1,102
Food recalls............................................. 660
Other.................................................... 28,537
------------
Total.................................................. 128,430
Laboratory Capabilities:
Food chemistry........................................... 52
Microbiology............................................. 63
Pesticide residue........................................ 43
Number of samples analyzed:
Food chemistry........................................... 59,991
Microbiology............................................. 252,307
Pesticide residue........................................ 15,767
------------
Total.................................................. 328,065
------------------------------------------------------------------------
\1\ Association of Food and Drug Officials. State Food Safety Resource
Survey, 2001.
The Chairman. Thank you very much. Congressman, glad to
have you here.
STATEMENT OF HON. CAL DOOLEY, PRESIDENT & CHIEF EXECUTIVE
OFFICER, GROCERY MANUFACTURERS ASSOCIATION, WASHINGTON, DC.
Mr. Dooley. Thank you. Thank you, Mr. Chairman. I'm
delighted to be here and I commend you for holding this
hearing.
You know Americans enjoy the safest food supply in the
world, but the food companies I represent recognize that steps
must be taken to make our food supply even safer. Ensuring the
safety of our products is the single most important goal of the
food industry. And our industry devotes enormous resources to
ensure that our products are safe.
As we've heard earlier this morning increasing imports and
changing consumer preferences pose new challenges for food
companies and for the FDA. To address those challenges we need
to modernize our food safety system. At GMA, our industry has
adopted a wide variety of preventative controls to confront the
causes of contamination at the source. We believe that the
prevention of contamination through the adoption of
preventative controls should continue to be the foundation of
our Nation's food safety strategies.
To improve the safety of imported foods we believe that
Congress should mandate by statute that every food importer
implement a supplier quality assurance program based upon FDA
guidance and subject to FDA review. Under this proposal food
companies would have to document that their foreign suppliers
were implementing good manufacturing practices and other
preventative controls. We also believe that Congress should
expand FDA's ability to develop the capacity of foreign
governments to detect threats and to harmonize food safety
standards.
FDA should also be given the authority to certify the
safety of high-risk imports, now subject to automatic detention
and permitted to credit third party inspectors, auditors and
labs to assist in these efforts. To improve our ability to
detect threats at the border we believe that FDA must be given
more resources to hire inspectors and to train other Federal
and State officials to inspect imported foods. But we also
believe that Congress must help focus FDA's inspections on
those imports posing the greatest risks to human health by
creating a voluntary program to expedite food imports posing
little or no risk.
To improve the safety of food produced in the United States
we believe that Congress should permit FDA to mandate that
fruits and vegetables be produced according to good agriculture
practices. Rising consumption of fruits and vegetables
represent and reflect the good news that more Americans are
making healthier food choices, but also create new food safety
challenges that should be addressed through strong produce
safety standards that can be tailored to reflect differences
among crops.
Congress should also direct FDA to modernize preventative
controls for packaged food products to reflect scientific
advances. But we object to prescriptive mandatory approaches.
Especially in light of the resource constraints at FDA that
will undermine the scientific advances in the foundations of
seeing the advances that could be incorporated through the
private sector. Finally we support granting FDA the authority
to issue a mandatory recall if a company has refused to conduct
a voluntary recall and there is a significant risk to human
health.
Let me close by saying a few words about resources. A FDA
Science Board concluded yesterday Congress and Administration
have simply failed to provide the agency with adequate
resources. As a result the agency lacks the scientific capacity
to fulfill its mission. Providing FDA adequate resources to
help defend the public from foodborne illness should be as
fundamental as defending the public from other threats foreign
and domestic.
Our companies do not depend upon FDA inspections to ensure
the safety of their products and they should not be asked to
pay a fee because Congress and the Administration has failed to
perform its most basic function, protecting the public. What's
more, taxing food imports or food facilities--as some have
proposed--to finance this basic function of government would
inevitably fall more heavily on some countries, some companies
and some consumers. And it would not employ a risk-based
allocation of those fees.
We can look to the simple fact that 33 percent of the
imports of food products coming into the United States are
coming from Canada. A country that has systems that are very
similar to ours in their food safety. And if you imposed an
import fee you would see in fact a disproportionate share of
that cost being funded by Canada.
I urge you to give FDA the resources and the additional
authority needed to meet the challenges posed by rising food
imports and changing consumer preferences. And just my last
statement I want to make it clear, Mr. Chairman and the other
members of the committee that I have been most pleased by the
constructive dialogue that we have had with CSPI and Mike
Taylor and many other groups on this. And we are committed to
working with you to ensure that we can collectively find a
system that really can meet the needs of consumers.
[The prepared statement of Mr. Dooley follows:]
Prepared Statement of the Hon. Cal Dooley
Good morning. I am Cal Dooley, President and CEO of the Grocery
Manufacturers Association.
Americans enjoy the safest food supply in the world, but food and
beverage companies recognize that steps must be taken to make our food
supply even safer. Ensuring the safety of our products--and thereby
maintaining the confidence of consumers--is the single most important
goal of the food and beverage industry. Product safety is the
foundation of consumer trust, and our industry devotes enormous
resources to ensure that our products are safe.
Steadily increasing food imports and changing consumer preferences
pose new challenges for food and beverage companies and for the Food
and Drug Administration. In recent years, we have experienced dramatic
changes in the volume and variety of food imports. The percent of food
imported into the United States increased by nearly 40 percent between
1995 and 2005 to 15 percent of the U.S. food supply. In particular,
roughly 60 percent of the fruits and vegetables and roughly 80 percent
of seafood now consumed in the United States are imported.
To address the challenges posed by rising imports and changing
consumer choices, food and beverage companies and Federal and State
agencies have placed continually greater emphasis on the prevention of
food contamination. By constantly identifying and addressing the
sources of contamination throughout each product's life cycle, we
continually reduce the risk of food-borne illness to consumers. We
believe that the prevention of contamination--through the adoption of
preventive controls--should continue to be the foundation of our
Nation's food safety strategies.
As you seek to modernize food safety legislation, we urge you to
focus on programs and policies that will prevent food contamination and
to consider the following recommendations. Many of these
recommendations were included in Commitment to Consumers: the Four
Pillars of Imported Food Safety, a comprehensive food safety proposal
released this fall by the Grocery Manufacturers Association.
One, we urge you to require that every food importer of record
institute a foreign supplier quality assurance program that assures
that all imported ingredients and products meet FDA food safety and
quality requirements. To assist companies in developing these supplier
quality programs, we propose that FDA issue guidance on key elements--
including, as appropriate, audits, testing, good manufacturing
practices, food defense programs, good agricultural practices, and
other preventive controls. Requiring food importers to ensure the
safety of their supply chains--and giving FDA the authority to oversee
industry's implementation of these programs--would significantly reduce
the likelihood of contamination.
Two, we further urge you to expand FDA's ability to build the
capacity of foreign governments to prevent and detect threats to food
safety. In particular, FDA should be directed to work with foreign
governments to expand training, accelerate the development of
laboratories, ensure the compliance of exports with U.S. regulations,
and harmonize food safety requirements among countries. FDA should also
be given the authority to detain food imports if inspections of foreign
facilities are warranted but are unduly delayed or refused, as proposed
by FDA in the agency's Food Protection Plan.
Three, we urge you to enhance FDA's ability to target those imports
that pose the greatest risk to consumers. In particular, we urge you to
create a voluntary program to permit expedited entry of foods that pose
no meaningful risk. By permitting food importers who demonstrate the
existence of a secure supply chain and who meet FDA's standards and
conditions to receive expedited entry, FDA could focus more scrutiny on
those imports that are more likely to pose a risk to public health. A
risk-based approach to food inspections, combined with enhanced
training of FDA and other Federal and State inspectors, would
significantly improve our ability to detect contaminated food. In
addition, FDA should build upon existing efforts to ensure the safety
of imported foods from countries or companies with a history of
problems by working with those foreign governments and food companies
to certify the safety of such products before they are offered for
import into the United States. Increasing our ability to scrutinize and
oversee imports based on risk would greatly enhance our ability to
detect threats to public health without crippling commerce or violating
our trade commitments.
Fourth, we urge you to take steps to continually improve the safety
of food produced in the United States. In particular, we urge you to
provide FDA authority to mandate that produce be produced following
good agricultural practices. Rising consumption of fruits and
vegetables, including ready-to-eat foods, reflects growing consumer
demand for healthier food choices but also creates new food safety
challenges that should be addressed through strong and enforceable
produce safety standards which can be tailored to reflect differences
among commodities. Similarly, we support modernizing preventative
controls for packaged food products to reflect scientific advances and
thereby strengthen the foundational elements of our food safety system.
We also support proposals to require facility registrations once every
2 years, as suggested in FDA's Food Protection Plan, and we support
increased frequency of facility inspections, provided that such
inspections are based upon a scientific assessment of risk and upon
history of compliance.
Fifth, we urge you to give FDA the authority to order a mandatory
recall when a company has refused to conduct a voluntary recall and
there is a significant risk to public health. Specifically, where the
responsible party refuses to voluntarily recall a product for which
there is a reasonable probability that the food will cause serious
adverse health consequences or death, the Secretary should be permitted
to order the company to conduct a recall.
We believe the adoption of these and other recommendations
identified in our Four Pillars proposal will, in combination, ensure
that Americans continue to enjoy the safest food supply in the world.
By focusing our efforts on prevention, by using limited FDA resources
wisely, by leveraging the expertise and resources of the food industry,
and by working in partnership with the Food and Drug Administration, we
believe Congress can help us meet the challenges posed by rising
imports and changing consumer preferences.
Our industry has made substantial investments in food safety and
has increased and will continue to increase our investments to address
the challenges posed by rising imports and changing consumer
preferences. We believe that Congress must also make significant new
investments in food safety. That's why we have joined forces with
groups like the Center for Science in the Public Interest to advocate
for major increases in FDA appropriations. We also think foreign
governments and suppliers should upgrade their food safety systems to
ensure that foods exported to the United States meet our high
standards. Although we support giving FDA more resources and more
authority, we strongly oppose proposals to tax food companies or impose
other fees on the food industry.
The benefits of a safer food supply accrue to the public generally,
much like the benefits of a strong national defense. A user fee is
appropriate when the benefits of the government service flow to an
individual (such as recreation fees, public transportation, or postage
stamps) or to a particular business (such as harbor maintenance fees,
accelerated review of prescription drugs, or bankruptcy filing fees).
But, the benefits of inspections, effective science-based standards,
and research and enforcement flow to all Americans, not simply to food
companies. What's more, such taxes or fees will fall unequally on some
companies--and, ultimately, on some consumers--and could violate our
trade commitments, inviting reciprocal taxes and fees on U.S. food
exports.
The food industry is eager to work with Congress to craft
modernized food safety legislation that makes the prevention of
contamination the foundation of our food safety system and which builds
upon a public-private partnership between the food industry and the
Food and Drug Administration.
The Chairman. Thank you very much.
Ms. DeWaal.
STATEMENT OF CAROLINE SMITH DEWAAL, FOOD SAFETY DIRECTOR,
CENTER FOR SCIENCE IN THE PUBLIC INTEREST, WASHINGTON, DC.;
ACCOMPANIED BY DAVID PLUNKETT, SENIOR STAFF ATTORNEY
Ms. DeWaal. Thank you very much. This is not a tragedy for
my children, but it definitely is because it is such an
important day. David Plunkett, senior staff attorney will give
my remarks and then I'll preserve my voice for questions if
there are any.
The Chairman. Ok.
Mr. Plunkett. Thank you Mr. Chairman and Senator Enzi for
calling this hearing for giving us an opportunity to testify on
behalf of consumers.
Late last week science advisors to the FDA released a
report indicating that the agency is in dire need of a modern
mission and sufficient resources to make its food safety
program credible. Given the numerous foodborne illness
outbreaks and recalls over the last 18 months from spinach,
lettuce, peanut butter, pet food, canned chili and others
together with these expert evaluations, the timing is excellent
to put forward fundamental reform of FDA's food program on
Congress' agenda for next year.
While FDA's food protection plan clearly signals the end of
the Administration's willingness to make changes in order to
restore credibility to FDA's program, Congress must go beyond
the limited reforms contained in the plan. CSPI recently
released a white paper, building a modern food safety system
for FDA-regulated foods, that's included in our testimony, that
lays out the principles of comprehensive food safety reform.
Congress passed several important food safety reforms when it
passed the Bioterrorism Act in 2002. Unfortunately, those
reforms were not effective enough to ensure discovery of an
intentionally contaminated ingredient that would ship to the
United States--incorporated widely in pet food. The next
disaster might be worse affecting humans as well as their pets.
In the Food Protection Plan the legislative authority
proposed by FDA is too narrowly targeted to effectively address
today's food safety challenges. Congress can learn from the
past and adopt comprehensive food safety reform.
The heart of any effective reform effort lies in
prevention. Congress should require every food plant regulated
by FDA to have food safety plans that demonstrate the companies
are aware of potential hazards and are taking steps to avoid
them. This would mean the companies that rely on ingredients
would have to exercise due diligence to ensure those products
have not been tampered with or otherwise arrived contaminated
whether they are from domestic or imported sources. Food safety
plans help ensure safe production and should be a prerequisite
for all food processors both domestic and foreign. Under a
modern statute these plans would also form the basis for food
safety audits and inspections done by the Federal Government.
The gaps in FDA's food protection plan are numerous. It
puts the burden on FDA to determine risk before requiring
process control programs. It does not provide adequate
inspection authority. It fails to require certification of
foreign facilities. It exempts farms. And it does not provide
for traceability.
The plan would do little to address the problems with
contaminated spinach, lettuce and peanut butter that led to so
many illnesses and hospitalizations or even melamine-tainted
wheat gluten that resulted in the massive recall of pet food.
It simply does not go far enough to address the very real
problems with a food supply that U.S. consumers have
experienced over the last 18 months, problems that have
resulted in a 16 percent decline in consumer confidence.
U.S.-food safety laws are antiquated and were never
designed to deal with modern issues such as escalating imports,
bioterrorism, or tainted produce. The recent outbreaks serve as
a reminder that much is needed to protect the food supply.
Congress needs to enact a food safety program that puts public
health at the forefront of food safety in America.
On behalf of the 900,000 consumers, represented by CSPI, we
urge Congress to go beyond the incremental changes proposed in
the food protection plan and adopt comprehensive reforms to
modernize food safety laws in the United States.
[The prepared statement of Ms. DeWaal follows:]
Prepared Statement of Caroline Smith DeWaal
My name is Caroline Smith DeWaal, and I am the director of food
safety for the Center for Science in the Public Interest (CSPI). CSPI
is a non-profit health advocacy and education organization focused on
food safety, nutrition, and alcohol issues. CSPI is supported
principally by the 900,000 subscribers to its Nutrition Action
HealthLetter and by foundation grants. We accept no government or
industry funding.
Thank you for the opportunity to address this committee and comment
on the Food and Drug Administration's (FDA) Food Protection Plan.
Before getting to FDA's new plan, I would like to provide some
background. In the 2002 Public Health Security and Bioterrorism
Preparedness and Response Act (``Bioterrorism Act''), Congress passed
new authorities designed to increase FDA's ability to prevent
intentionally contaminated food from reaching U.S. consumers. These new
authorities included mandatory registration of domestic and import food
facilities, prior notice for import food shipments, enhanced
recordkeeping and administrative detention. Despite mounting evidence
at that time that FDA's legal authorities were inadequate to address
the threat, Congress chose in 2002 to apply a targeted approach, adding
these few additional authorities, instead of tackling the more
difficult job of enhancing FDA's overall mission to ensure food safety
and food protection. Unfortunately, that approach failed to prevent the
many food outbreaks and recalls of the last year, including one
involving a toxic substance intentionally applied to a food ingredient
regulated by FDA.
Since September 2006, nationwide outbreaks of foodborne illnesses
and subsequent recalls have exposed glaring holes in the safety net
guarding U.S. consumers from contaminated food. Spinach contaminated
with a deadly strain of E. coli; peanut butter with Salmonella; canned
chili with Clostridium botulinum; pet food with toxic chemicals--these
were not isolated events. FDA-regulated foods are responsible for many
outbreaks each year as documented in CSPI's Outbreak Alert database.\1\
But each of these tragedies in 2006-2007 demonstrated a distinct gap in
FDA's system for regulating the food supply that underscores the need
for farm-to-table reform.
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\1\ Center for Science in the Public Interest, Outbreak Alert!
Database, 2007 at http://www.cspinet.org/foodsafety/outbreak/
pathogen.php.
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Today FDA's ability to protect the food supply is being questioned
by consumers and Congress alike. Overall consumer confidence in FDA has
plummeted. A Harris Poll has documented that those who thought FDA was
doing an ``excellent'' or ``good'' job went from 61 percent in 2000 to
36 percent in 2006. In addition, over the last year, consumers' overall
confidence in the safety of foods has fallen dramatically. The Food
Marketing Institute reported a 16 percent decline in consumer
confidence in the safety of food they purchase at grocery stores,
according to its annual survey. USA Today reported in July that 83
percent of shoppers were concerned about food from China, and 61
percent about food from Mexico.\2\ And based on many supermarket
conversations, these concerns have affected purchasing behavior as
well.
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\2\ Elizabeth Weise, Buying Only U.S. Food is a Tall Order, USA
Today, July 10, 2007, available at http://www.usatoday.com/news/health/
2007-07-10-american-goods_N.htm.
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This loss of consumer confidence has palpable effects on food
suppliers as well. After the spinach scare of 2006, spinach farmers
reported losing $350 million, and had still not recovered when a second
leafy green outbreak occurred in August of this year.\3\ But these
outbreaks were entirely predictable--and preventable--if FDA had the
resources to look beyond the next crisis and the authorities to compel
the food industry to take steps to prevent problems before they occur.
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\3\ Elizabeth Weise & Julie Schmit, Spinach Recall: 5 Faces. 5
Agonizing Deaths. 1 Year Later., USA Today, Sept. 20, 2007, available
at http://www.usatoday.com/money/industries/food/2007-09-20-spinach-
main_N.htm.
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CSPI applauds FDA for putting forward its Food Protection Plan and
for finally signaling to Congress the need to give FDA additional
authorities. But Congress should recognize that this plan outlines only
a few incremental steps that are not sufficient to prevent the food
safety problems consumers experienced just last year. Reforming our
outdated food safety laws could have tremendous public health benefits,
as each year 76 million Americans experience foodborne illnesses that
hospitalize 325,000 and result in 5,000 deaths.\4\ It is time for
Congress to institute real solutions--not stop-gap measures that will
fall short in a few years time.
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\4\ Paul S. Mead, et al., Food-Related Illness and Death in the
United States, 5 Emerging Infection Diseases 607, Sept.-Oct. 1999.
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FDA's Food Protection Plan calls for several authorities that CSPI
has long advocated, like mandatory recalls, and proposes changes to
address shortcomings in the implementation of the Bioterrorism Act's
food facility registration program. But its shortcomings are numerous:
It is not enough to ask for new authority to mandate
recalls but fail to ask for authority to require traceability standards
and impose civil penalties so that recalls are effective.
It is not enough to require strict food security plans but
fail to require food safety plans that would protect the public from
the inadvertent contamination of food that annually sickens and kills
so many Americans.
It is not enough to identify a need for the full life-
cycle approach to food safety but fail to ask for authority to
implement programs on the farm or in the country of origin.
In sum, the Food Protection Plan underscores the need for reform,
but Congress must take stronger action if it is to ensure the safety of
the food supply and protect Americans from preventable illnesses and
deaths.
100-year-old food safety laws create confusion and inefficiency
Today, our Federal food safety system functions under two distinct
statutory frameworks: one in operation at the U.S. Department of
Agriculture (USDA) and another at FDA. USDA has responsibility for the
safety of meat, poultry and certain egg products, covering about 20
percent of the food supply. Its statute provides for carcass-by-carcass
inspection in all meat and poultry slaughter plants and daily
inspection in meat and poultry processing plants using government-
funded inspectors. The Federal Food, Drug and Cosmetic Act and the
Public Health Service Act give FDA responsibility for regulating the
safety of the remaining 80 percent of the food supply, but the statutes
are reactive, giving the agency authority to act principally when food
is found to be ``adulterated'' or ``misbranded.'' Plants that produce
products regulated by both agencies see a stark disparity between the
programs, as when a frozen pepperoni pizza processing line regulated by
USDA is subject to daily inspections, while a frozen cheese pizza line
in the same plant is inspected by FDA about once every 10 years.
The disparity carries over into the programs that are responsible
for ensuring the safety of imported foods--a key concern driving
delivery of FDA's Food Protection Plan. While USDA has a fairly
intensive program for ensuring the safety of imported meat and poultry
products, FDA's program is anything but comprehensive. Unlike USDA, FDA
does not evaluate national programs to determine equivalence or visit
foreign countries to verify compliance with food safety procedures.\5\
Instead the agency relies on border inspections, but has the capacity
to inspect only 1 percent of food at the U.S. border. Although imports
of FDA-regulated foods have more than doubled in the last 7 years--from
4 million shipments in 2000 to approximately 9 million shipments in
2006--the rate of inspections has remained woefully low.\6\ Of these 9
million shipments, only 0.2 percent were analyzed in a laboratory as
part of its inspection process.\7\
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\5\ FDA's Import Program System Information Web site does not
delineate an audit system for imported product and directs users to
cross-reference the U.S. Customs Office for additional requirements.
FDA Office of Reg. Affairs, Import Program System Information, (Sept.
21, 2004), at http://www.fda.gov/ora/import/ora_import_system.html.
\6\ Alexei Barrionuevo, Food Imports Often Escape Scrutiny, N.Y.
Times, May 1, 2007, at http:
//www.nytimes.com/2007/05/01/business/01food.html.
\7\ Id.
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As with domestic food safety programs, import programs sometimes
overlap, but resources are not shared. For example, USDA and FDA
inspect food imports at 18 ports, but they do not share inspection
resources at these locations. In fact, according to the Government
Accountability Office, some USDA-approved import inspection facilities
store FDA-regulated products, and although USDA maintains a daily
presence at these facilities, FDA products can languish at the port
waiting for FDA inspectors.\8\ When it comes to authority and
resources, FDA remains the neglected stepchild of our food safety
system.
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\8\ Gen. Acct. Off. Rep. No. GAO-07-449T, Federal Oversight of Food
Safety: High-Risk Designation Can Bring Needed Attention to Fragmented
System, (Statement of David M. Walker, Comptroller General of the
United States) (Feb. 8, 2007).
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emerging hazards and intentional threats to the food supply
One of the most-widely discussed food safety catastrophes this year
began in March when pet food manufacturers recalled more than 100
brands of cat and dog food after receiving complaints of cats and dogs
developing sudden kidney failure from eating pet food. For weeks after,
new brands were pulled from shelves as processors tracked the tainted
ingredient--wheat gluten.
FDA investigations revealed that the pet foods that sickened so
many pets were contaminated with melamine and cyanuric acid, two
industrial chemicals. These toxins were found in wheat gluten imported
from China and used in many pet food and animal feed products
manufactured in the United States. Chinese wheat gluten producers are
believed to have intentionally contaminated the product with melamine
to give the appearance of increased protein content. According to an
investigation by The New York Times, cutting grain products with
melamine to fool protein tests is common practice among producers in
China, yet the contaminated wheat gluten passed across our borders
without being found or stopped by FDA.\9\
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\9\ David Barboza & Alexei Barrionuevo, Filler in Animal Feed Is
Open Secret in China, N.Y. Times, April 30, 2007, at http://
www.nytimes.com/2007/04/30/business/worldbusiness/30food.html.
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Tracing the pet food back through its supply chain, FDA eventually
identified the Chinese company that shipped the adulterated wheat
gluten into the United States. According to reports, however, the
company was little more than two rooms adjoining a warehouse in
China.\10\ Clearly the registration of importers, even coupled with
prior notice, was not sufficient to prevent the importation of this
purposefully contaminated product. FDA needs much stronger authorities.
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\10\ David Barboza, Clues to Pet Food Recall Traced to Chinese
City, Int'l Herald Tribune, April 11, 2007, at http://www.iht.com/
articles/2007/04/11/asia/gluten.php.
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In 2004, Tommy G. Thompson, the former Secretary of Health and
Human Services, expressed deep concern, saying that he was ``shocked''
that terrorists had not struck the Nation's food supply ``because it is
so easy to do,'' and that he ``worried every single night'' about food
safety.\11\ We share his concern, and hope that Congress treats the pet
food contamination incident earlier this year as a ``wake up call.'' It
could have been much worse if instead of melamine, a more potent
chemical was applied to a food ingredient widely used in the human food
supply. The United States should adopt modern systems that prevent or
promote early discovery of such problems, rather than relying on FDA's
limited ability to respond to food safety emergencies.
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\11\ Tommy Thompson Resigns From HHS, The Wash. Post, Dec. 3, 2004.
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shortfalls in resources and authorities at fda
Imports are not the only food safety challenge facing FDA.
Outbreaks linked to fresh spinach and lettuce and processed peanut
butter and canned chili in 2006 and 2007 are just the latest symptom of
an agency that is overwhelmed by responsibility, but lacking the staff
and resources to function effectively. Current FDA funding shortfalls
have reached a critical level and budget cuts have left the agency with
fewer inspectors, even as the workload continues to increase. Since
1972, domestic inspections conducted by FDA declined 81 percent.\12\
Just since 2003, the number of FDA field staff dropped by 12 percent,
and between 2003 and 2006, there was a 47 percent drop in Federal
inspections.\13\ These declines in inspectors and inspections can be
traced to an ongoing funding shortfall in the food safety program
estimated in the hundreds of millions of dollars.\14\
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\12\ House Comm. On Gov't Reform, Fact Sheet: Weaknesses in FDA's
Food Safety System, (October 30, 2006), 2, available at http://
oversight.house.gov/documents/20061101115143-67937.pdf.
\13\ Andrew Bridges & Seth Borenstein, AP Investigation: Food
Safety Inspections Lanquish, Associated Press, February 29, 2007,
available at http://abcnews.go.com/Health/wireStory?id=2905819.
\14\ Last year, one FDA budget official estimated a funding
shortfall in the food safety program of $135 million, which he
described as equivalent to a 24 percent budget cut. House Comm. on
Gov't Reform, supra at 2.
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The Peter Pan peanut butter outbreak and recall shows the
consequences of this gap in inspection capacity and the inadequacy of
FDA's Food Protection Plan. Last winter, the Centers for Disease
Control and Prevention determined that Salmonella-contaminated peanut
butter was responsible for causing illness in over 600 people in 47
States. This outbreak could likely have been prevented with a more
robust inspection program at FDA.
In 2005, FDA inspected the ConAgra facility where the peanut butter
was produced because of complaints about conditions at the plant. The
inspectors learned from plant managers that the company had destroyed
some product due to ``microbial problems'' in 2004, but the managers
did not disclose the problem was Salmonella contamination.\15\ When
FDA's oral request for documents from the plant went unanswered, FDA
did not follow up until 2007 when the agency conducted inspections of
the plant during the outbreak investigation.\16\ This is unacceptable
both to Congress and to consumers.
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\15\ The plant manager stated the FDA would have to submit a
written request if it wanted more information on the incident. See,
Joseph S. Enoch, FDA Failed to Follow Up on 2004 Peanut Butter
Contamination, ConsumerAffairs.com, Oct. 19, 2007, at http://
www.consumer
affairs.com/news04/2007/10/peanut_butter_recall17.html.
\16\ Marion Burros, Who's Watching What We Eat, N.Y. Times, May 16,
2007, at http://www.nytimes.com/2007/05/16/dining/16fda.html.
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The legal structure of the current system tilts Federal food safety
resources toward USDA. While USDA regulates the 20 percent of the food
supply known to cause 27 percent of attributed outbreaks, its food
safety appropriations are double that given to FDA.\17\ This is due
primarily to the legal requirements that the meat and poultry products
regulated by USDA must be approved before sale, while foods regulated
by FDA do not require pre-market approval.\18\ USDA employs more than
7,600 \19\ inspectors who are stationed in 6,282 establishments to
carry out its inspection mandate.\20\ FDA, meanwhile, has fewer than
2,000 inspectors who are spread over 210,000 domestic food processors
and warehouses.\21\
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\17\ Center for Science in the Public Interest, Outbreak Alert!,
Dec. 2006, 2, at http://www.cspinet.org/foodsafety/outbreak_alert.pdf.
\18\ The differences between USDA and FDA regulatory authorities
are detailed in ``Overseeing the U.S. Food Supply: Steps Should be
Taken to Reduce Overlapping Inspections and Activities,'' Gen Acct Off
Rep. No. GAO-05-549T (May 17, 2005).
\19\ USDA, Farm Bill Forum Comment Summary and Background: Food
Safety, (undated) at http://www.usda.gov/documents/FOOD_SAFETY.doc.
\20\ USDA, FY 2008 Budget Summary and Annual Performance Plan, 59,
available at http://www.obpa.usda.gov/budsum/fy08budsum.pdf.
\21\ FDA, Food Protection Plan, (Nov. 2007) 6.
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Unfortunately, the Food Protection Plan does not address these
problems, and could in fact add new ones. The requirement that foods
only come under process control programs if they have been linked to
``repeated, serious adverse health consequences or death'' could
potentially block needed action on foods like peanut butter and
spinach, where outbreaks are rare. By putting the burden on FDA rather
than the food industry, this standard could stop FDA from taking
necessary action to address problems by requiring preventive control
systems.
In summary, FDA's Food Protection Plan falls short of the
transformative reforms that are needed to remedy the shortfalls in
resources and antiquated authorities at FDA. Congress should implement
comprehensive reform of FDA's statutory mandate in order to better
protect the American public.\22\
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\22\ While food safety problems have garnered the most attention,
many other parts of the agency's responsibilities are not getting
adequate attention--issues such as obesity, the safety of dietary
supplements, and appropriate oversight of new technologies. In cases
like the Castleberry botulism recall, inspectors are literally taken
off other tasks to meet emergency needs.
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cspi's principles for modernizing fda's food safety mandate
The timing is excellent to put fundamental reform of FDA's food
program on the agenda of Congress over the next 12 months. A Sense of
Congress included in the recently enacted Food and Drug Administration
Amendments Act states Congress's readiness to adopt a modern regulatory
oversight program and fund it adequately to fulfill its mission.
Additionally, the emergence of coalitions of traditionally estranged
consumer and industry organizations, like the Coalition for a Stronger
FDA and the FDA Alliance, gives Congress a unique opportunity to appeal
to many constituencies as it rebuilds the agency.
While the Food Protection Plan clearly signals the Administration's
willingness to make changes in order to restore consumer confidence,
Congress must enact more comprehensive reform than those contained in
the Food Protection Plan. CSPI's recently released white paper,
``Building a Modern Food Safety System: For FDA Regulated Foods,'' lays
out the principles of comprehensive food safety reform. To meet the
need for prevention, intervention and response, Congress should require
food safety process control programs for all food processors that meet
performance standards established by FDA. Regular risk-based
inspections by FDA would ensure that food facilities are following good
safety practices and meeting the safety standards set by the FDA. Under
CSPI's principles, the registration program for importers would be
joined to a certification process to ensure foreign producers are
meeting the same standards as their U.S. competitors. A strong research
component is also necessary, as is a requirement that FDA build a
strong on-farm safety program. Finally, CSPI urges Congress to give FDA
five new enforcement authorities: (1) mandatory recall, (2) effective
and mandatory traceability, (3) detention authority, (4) civil and
criminal penalties, and (5) whistleblower protection.
The legislative authority sought by FDA is too narrowly targeted to
encompass the principles that are critically important to comprehensive
food safety reform. The heart of any effective reform effort lies in
prevention, not response. Congress should require every food plant
regulated by FDA to have food safety plans, like HACCP,\23\ that
demonstrate the companies are aware of potential hazards and are taking
steps to avoid them. This is already a requirement for all meat and
poultry plants, and it should be a prerequisite for all food processors
that want to sell food in the United States. This provides the basis
for establishing the industry's fundamental responsibility for ensuring
food safety.
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\23\ Hazard Analysis and Critical Control Points.
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The gaps in the FDA's Food Protection Plan are both numerous and
dangerous: it puts the burden on FDA to determine risk before requiring
process control programs; it does not provide adequate inspection
authority; it fails to require certifications of foreign facilities; it
exempts farms; and it does not provide for traceability. The plan would
do little to address the problems with spinach, lettuce, peanut butter,
or even melamine-tainted wheat gluten. It simply does not go far enough
to address the very real concerns with the food supply that U.S.
consumers have faced over the last 18 months.
U.S. food safety laws are more than a century old and were not
designed to deal with modern issues such as escalating imports,
bioterrorism, or tainted produce. The heightened awareness of terrorism
over recent years has demonstrated the need for enhanced national
security, and the recent outbreaks serve as a reminder that much more
must be done to protect the food supply. Congress needs to enact a food
safety program that puts public health at the forefront of food safety
in America. On behalf of the 900,000 consumers represented by CSPI, I
urge Congress to go beyond the incremental changes proposed in the Food
Protection Plan and adopt comprehensive reforms to modernize food
safety laws in the United States.
The Chairman. Thank you very much.
Dr. Young.
STATEMENT OF PAUL YOUNG, Ph.D., SENIOR MARKETING MANAGER,
WATERS CORPORATION, NEWTOWNARDS, N. IRELAND
Mr. Young. Mr. Chairman, Senator Enzi, members of the
committee, I'd like to thank you very much for giving me the
opportunity to testify today. I consider it a great honor and
particularly, Mr. Chairman, as you have already pointed out
that Waters Corporation is based in your own constituency of
Massachusetts. Despite taking my position, my current position,
with Waters in March of this year, I am still currently based
in Ireland where I have worked for more than 25 years as a
scientist involved in the regulation of food safety of food
destined for the European market.
Effective food safety control within a country requires not
only a comprehensive set of standards but also significant
collaboration. That involves collaboration between governments
and producers, but also needs to involve the processors, the
importers, the exporters. Indeed we in Waters acknowledge that
we also have an important role to play in delivering purposeful
innovations that address the needs of the scientist's tasks
with monitoring the compliance with food safety regulations.
Regulation of food safety standards of imported food
present yet another set of challenges. In an ideal world all
countries would apply and enforce the same set of standards for
food production. Indeed this is the goal of the Codex
Alimentarius Commission. Unfortunately however, the Codex
standards are not regarded as being comprehensive enough and as
a result individual countries or regions have independently
developed their own specific standards for imported food.
Faced with known harmonized country specific regulations,
producers in exporting countries tend to focus on producing
food under schemes designed to meet the requirements of the
intended recipient country. For example, one producer may
entirely focus on producing food under conditions that meet the
demands of the Japanese import regulations that we heard the
Congressman talk of earlier.
Japan relies very heavily on imports for more than 60
percent of all of the food consumed in the country. Faced with
a high level of food contamination the Japanese recently
revised their food standards and simultaneously placed the onus
on importers to ensure that imported food meets these new
standards. Compliance is monitored through an import testing
program in which approximately 10 percent of all of the food
consignments undergo laboratory analysis.
The European Union has adopted a more comprehensive farm-
to-table approach as we've heard mention of earlier. This
applies to all domestic production. As a prerequisite for
accepting imported food the EU demands that the exporting
country demonstrate equivalence with EU regulations. In this
way the EU approves countries and establishments for listed
commodities. These approvals are subject to satisfactory
inspection audits, carried out by the EU Commission.
In addition to regular inspection visits, compliance is
monitored through an import testing program. With non-compliant
findings being communicated through a rapid alert system to all
EU member states. The member states can then use this
information for recall if that action is required, but also to
stimulate increased vigilance. Faced with these differing
standards exporters will endeavor to meet the demands of their
chosen export markets.
However, difficulties are likely to arise when new
standards are ambiguous or are not clearly defined and
enforced. In the past I have read a seafood export action plan
that clearly stated that if product was found to be
noncompliant with EU standards than it could be sold into
markets where the regulations were less stringent. This may
sound shocking but different countries assess risk in different
ways and the EU applies the precautionary principle as is their
right under the SPS, the Sanitary and Phytosanitary Agreement.
But the application of this in other countries may be neither
uniform nor clearly stated.
In short, ensuring food safety requires collaboration
between all interested stakeholders. This includes governments,
producers, processors, and technology leaders. We've heard that
word collaboration quite a lot today, but I also believe
there's a serious risk that voluntary compliance may be
interpreted as being optional and regarded as representing less
stringent regulations.
Regulation alone cannot ensure that the food supply is
safe. This must be backed up by a well-resourced and robust
monitoring program. In this regard technology leaders such as
Waters also have responsibility to take part in these
discussions to ensure that our innovations are purposeful and
adequately address the challenge at hand. Ensuring food safety
is about protecting consumers first and foremost. But it also
plays a key role in maintaining consumer confidence and thereby
protecting the interests of our producers and their integrity
of their export markets.
Thank you once again for the opportunity to be here today.
And I will be happy to field any questions the committee might
have.
[The prepared statement of Dr. Young follows:]
Prepared Statement of Paul B. Young
about waters corporation
For 50 years, Waters has developed innovative analytical science
solutions to support scientists around the globe who focus on meeting
the stringent laboratory demands for food safety regulation and
analysis.
Waters Corp., a publicly traded corporation (NYSE:WAT)
headquartered in Milford, MA, holds worldwide leading positions in
three complementary analytical technologies--liquid chromatography,
mass spectrometry, and thermal analysis. Specifically, the company
designs, manufactures, sells and services ultra performance liquid
chromatography (UPLC), high performance liquid chromatography (HPLC),
chromatography columns and chemistry products, mass spectrometry (MS)
systems, thermal analysis and rheometry instruments.
In addition to providing solutions in food safety, Waters creates
business advantages for laboratory-dependent organizations by
delivering sustainable scientific innovation to enable advancement in
healthcare delivery, environmental management, and water quality.
Waters products are used by pharmaceutical, life science, biochemical,
industrial, academic and government organizations working in research
and development, quality assurance and other laboratory applications.
Waters Corp. employs approximately 4,700 employees worldwide,
operating in 27 countries.
summary of statement
The global trade in food is increasing significantly, such that
governments no longer have direct control over the production standards
employed for much of the food consumed by their citizens. While
governments do have a responsibility to promote and permit
international trade, they also have a responsibility to protect the
health of their citizens from the presence of potentially harmful
contaminants in the food supply.
The Codex Alimentarius Commission was set up in 1963 by the Food
and Agriculture Organisation (FAO) and the World Health Organisation
(WHO) with the aim of developing harmonized food standards and
guidelines. Codex therefore acts as a central point of reference with
respect to food standards; however, it is generally believed that the
current Codex standards lack sufficient scope to be either universal or
comprehensive. Also, the implementation/enforcement of standards varies
significantly from one country to another.
As a consequence, governments have been compelled to develop
mechanisms to ensure that imported food and feed does not pose a hazard
to the health of humans or animals.
These systems prove to be most effective when they involve
collaboration of numerous bodies and organisations. This includes
collaboration between governments and collaboration between regulatory
authorities, producer organisations and technology providers (such as
Waters Corporation) working together, ensuring that solutions are
effective, robust and cost effective.
FDA currently regulates domestic food production, but has little
control over the production standards employed for imported food. The
European Union (EU) concluded that relying on voluntary compliance did
not afford adequate assurances of protection and adopted an approach of
licensing third countries and the individual food producing
establishments therein. This involves frequent inspection audits of
each country, examining the food safety regulations and the
implementation of those regulations, to ensure that food destined for
the EU is produced under rules that afford equivalent guarantees to
those afforded by EU regulations. Compliance with these requirements is
monitored through the implementation of an import testing programme,
which includes, documentary checks (ensuring that food comes from an EU
approved establishment), physical checks and laboratory examination.
Non-
compliance can result in withdrawal of permission to export to the EU.
In response to complaints from consumer organisations in 2002
regarding the presence of contaminants in imported food, the Japanese
Government reviewed and revised The Food Safety Basic Law and the
standards set for food safety. Initially the Japanese Government did
not adopt a policy of third country approval/licensing, but rather
placed the onus on the importers to ensure that imported food was
compliant with the new Japanese food safety standards. Additionally,
the new regulations imposed a mandatory requirement on importers to
have new food imports tested to demonstrate that it met the standards.
Compliance with these standards is assured by a high level of
laboratory testing for a very wide array of chemical contaminants,
which is carried out by the Japanese Government during importation.
More than 10 percent of all Japanese food import consignments undergo
laboratory testing. Subsequently the Japanese Government has begun
licensing foreign establishments for some high-risk commodities.
Faced with the differing import requirements of each country/
region, exporting producers tend to focus on meeting the demands of
their chosen market. In the absence of exacting and robustly enforced
import requirements, the United States (U.S.) faces a real risk of
receiving product deemed unsuitable for markets with more stringent
controls.
background on international food safety standards
Article 20 of the General Agreement on Tariffs and Trade (GATT)
allows governments to act on trade in order to protect human, animal or
plant life or health, provided they do not discriminate or use this as
disguised protectionism.
The Agreement on the Application of Sanitary and Phytosanitary
Measures (SPS) permits governments to set their own standards, but
requires them to apply measures only to the extent required to protect
human health. It does not permit Member Governments to discriminate by
applying different requirements to different countries where the same
or similar conditions prevail, unless there is sufficient scientific
justification for doing so. It is indeed a basic precept of this
agreement that there should be a sound scientific basis for food safety
regulations. However, it does permit application of the precautionary
principle when risks can not be quantified.
The Agreement on Technical Barriers to Trade (TBT) seeks to ensure
that technical regulations and standards and analytical procedures for
assessing conformity with technical regulations and standards do not
create unnecessary obstacles to trade.
Both the SPS and TBT Agreements acknowledge the importance of
harmonizing standards internationally to minimize or eliminate the risk
of sanitary, phytosanitary and other technical standards becoming
barriers to trade.
The General Principles of the Codex Alimentarius states:
The publication of the Codex Alimentarius is intended to
guide and promote the elaboration and establishment of
definitions and requirements for foods to assist in their
harmonization and in doing so to facilitate international
trade.
codex and the ethics of international trade
Codex Alimentarius Commission also encourages food traders to adopt
voluntarily ethical practices as an important way of protecting
consumers' health and promoting fair practices in the food trade. To
this end, the Commission has published the Code of Ethics for
International Trade in Food. A principal objective of this code is to
stop exporting countries and exporters from dumping poor-quality or
unsafe food onto international markets.
national food safety standards
Harmonization of food safety standards may indeed be a very worthy
cause, however, it is generally accepted that Codex standards currently
lack sufficient scope to be comprehensive. Neither does Codex address
substances for which acceptable daily intakes (ADI) have not been
established. These include (but are not limited to) residues of
nitrofuran group of compounds and the antibiotic chloramphenicol.
Disputes over the presence of these substances in food have caused the
largest disruptions to international food trade, resulting from
contamination, in recent years. As a consequence, many countries have
developed a complete set of independent food safety regulations (albeit
ensuring conformity with Codex standards whenever possible).
Given the significant growth in global food trade in recent years,
many countries are currently in the process of revising (or in many
cases completely overhauling) their food safety legislation with regard
to both domestic production and importation.
the european union system
In 2002, the European Union made major changes to the way food
safety legislation is developed and implemented, when it passed Council
Regulation 178/2002 into European law. This regulation established The
European Food Safety Authority, an independent body with responsibility
for risk analysis, but devoid of risk management responsibility. This
ensured that risks would be evaluated independently from the effect any
legislation may have on trade, or on the management of the risk
(testing). It also ensured that the requirements of the SPS agreement
would be met in establishing a scientific basis for the legislation.
This regulation also established the Rapid Alert System for Food
and Feed (RASFF), whereby when violative food contaminants are detected
either at market or at a Border Inspection Port (BIP) information
relating to the product, the nature of the violation, the country of
origin and the notifying country is published on a weekly basis, shared
among the relevant competent authorities within the EU member states
for action if necessary (recalls, increased vigilance, etc.) and
simultaneously put into the public domain. Additionally, this
legislation put in place an absolute requirement for traceability at
all stages, from production, through processing, distribution and
retailing.
In the same year, legislation was introduced which specified the
criteria which must be applied when validating the analytical
techniques used for detection of chemical contaminants in food. The EU
Commission has chosen not to prescribe analytical techniques, instead
allowing regulatory laboratories to develop their own methods utilizing
the latest advances and technological innovations to improve
sensitivity, throughput and cost effectiveness. This is considered a
significant factor in allowing laboratories in EU member states to
respond rapidly to food safety issues and to keep pace with scientific
advances. However, in Commission Decision 2002/657 validation criteria
were laid down to ensure that laboratories demonstrate that analytical
techniques are fit for purpose and suitably robust when detecting
contaminants at the level of interest. The EU Commission demands that
violative results be confirmed using an unequivocal, confirmatory
technique and lays down the identification criteria that must be met in
this decision. The use of a confirmatory technique is required to
ensure that producers are not unfairly disadvantaged from the reporting
of ``false positive results'' that can occur when screening tests are
employed. This legislation also mandated that regulatory laboratories
must be accredited under the international standard ISO 17025, ensuring
that all laboratories are working to acceptable standards.
The European Union ensures the safety of domestic food production
through the implementation of a comprehensive raft of food safety
legislation, regulating the use of veterinary drugs in product of
animal origin (POAO) and of pesticides in both POAO and non-POAO.
Compliance with this legislation is monitored through a comprehensive
testing programme the level of testing of which is based on a
percentage of annual production. These testing programmes are funded
from a levy imposed on producers (for example, a levy per head of
animals slaughtered in the case of POAO). The EU Commission has fixed
the minimum levels of this levy depending on the species.
It is noteworthy that for substances where the risk is established,
but not quantified, the EU applies the precautionary principle. A
significant number of contaminants are known to be carcinogenic and/or
genotoxic, however the risk has not been quantified and they are seldom
likely to generate acute conditions which can serve as signals of
frequent violation. In these cases the EU has imposed a complete ban on
their presence and requires laboratory analysis to demonstrate
compliance.
how the eu treats imports
Accepting that global trade in food is increasing year on year and
that EU is probably the largest single market in the world, the EU
Commission does not adopt the view that trading partners will
automatically become food safety partners. Instead the EU makes the
latter a precondition to becoming the former.
The EU Commission maintains lists of approved countries and
establishments within those countries, which are approved by
commodities. Therefore, as an example, China must be named on an
approved list for the export of seafood before any product will be
permitted entry into the EU. Additionally, individual establishments
within China are maintained on an approved list for the export of
seafood and only those establishments are permitted to export product
to EU. This system is similar to that operated by the USDA for meat and
poultry, but in 2004 the EU extended this to make provision for not
just POAO, but for any foods which may constitute a risk (Council
Regulation 882/2004).
A requirement for remaining on these lists includes the annual
submission of details of control programmes which are in place
regulating the safety of food produced for the EU including the results
of regulatory monitoring. The underlying premise is that third
countries must be able to offer assurances that food exported to EU is
produced under a series of controls that offer at least the same
guarantees of safety as is offered by European regulations. There must
be a legal basis for enforcement of these regulations. Therefore,
although the EU can not enforce its legislation on third countries, it
does demand equivalence.
An additional prerequisite for remaining on these approved lists
involves permitting regular inspection of competent authorities,
production, processing, traceability and the laboratories involved in
regulatory monitoring (including checking the efficacy of methods of
analysis employed). The aim of these inspections is verification of the
assurances given and the inspections are carried out by the staff of
the Food and Veterinary Office (FVO) with the assistance of scientific
``national experts.'' If a significant number of noncompliances are
observed during an inspection mission, it can (and does) result in an
establishment, or entire country being de-listed and therefore
forfeiting the ability to export a given commodity to the EU.
In 2001, a World Health Organisation (WHO) committee examining
coordination and harmonization of food safety control systems concluded
that whilst it is not possible to test our way to safe food, a robust
monitoring system is vital to ensure compliance with regulation
controlling food production. The EU Commission has determined that no
consignment from a third country should be permitted to enter the EU
without being subject to veterinary checks and that fixed percentages
must undergo physical checks (Commission Decision 97/78). In practice,
based upon assurances offered by third countries, a derogation
regarding the level of these physical checks may be negotiated on a
country-by-country basis.
A mechanism for recovery of costs associated with carrying out the
import monitoring has been described in Council Regulation 882/2004.
This legislation lays down minimum charges per consignment that must be
applied, but makes provision for recovery of the full economic cost of
inspection and any laboratory analysis. The importer or their agent is
responsible for these charges. A significant level of violation
detected during this import monitoring may result in 100 percent of
product undergoing laboratory analysis before it is permitted to enter
the EU. If the violation is deemed to constitute a significant risk
then it may result in the country being de-listed for that commodity.
the japanese system
Japan is one of the least self-sufficient developed countries in
the world, importing more than 60 percent of its food. Therefore, Japan
has traditionally relied heavily upon the regulatory systems in the
exporting countries for ensuring food safety. However, in 2002 a number
of consumer organisations carried out surveys that found high
concentrations of certain agricultural chemicals were present in
imported crops. Many of the detected chemicals were banned from use in
domestic Japanese production. This prompted a complete overhaul of the
Food Safety Basic Law (the main statutory instrument regulating food
safety in Japan). Central to this was the establishment of the Food
Safety Commission, an independent body with responsibility for risk
analysis. Additionally, the Specifications for Food and Food Additives
was revised to include many more chemicals than had been previously
addressed. This creation of the so-called Japanese Positive List
(listing 799 agricultural chemicals) was prompted by the fact that the
licensing of agricultural chemicals differs from one country to
another. Prior to the creation of the positive list, when chemicals not
licensed in Japan were identified in imported food, each violation was
dealt with on a case-by-case basis. The maximum residue levels (MRLs)
in the positive list are based on internationally accepted values where
available, but a uniform limit of 10 parts per billion (ppb) is applied
for substances for which safe levels had not been established.
It is worth noting that Japan does not demand equivalence in terms
of analytical testing, since domestic produce is not tested for the
full range of chemicals detailed in the positive list, but accepts that
local legislation effectively controls the use of unlicensed chemicals.
In addition, the change in Japanese legislation did not make provision
for maintenance of approved lists of countries and establishments, for
the purposes of import. Instead, the onus for ensuring compliance was
placed on the importer combined with heavy penalties for violation.
When violations are detected, subsequent consignments must undergo
voluntary testing in Japanese laboratories, paid for by the importer,
before the consignment can be released. If the violation rate exceeds 5
percent of consignments from an establishment (or country) then a
complete ban on importation may result.
For substances not permitted to be present at any concentration
(so-called Not Detect or ND), the challenge is ensuring that all
laboratories are capable of offering the same assurances. EU does this
by specifying a minimum required performance level (MRPL) that
laboratories must demonstrate. Japan has adopted a different approach
in prescribing methods that must be used by Japanese regulatory
laboratories. It appears to be generally accepted by the Japanese
scientists that this author has spoken to, that this is too restrictive
and limits the ability of the laboratories to employ recent
technological advances, such as Ultra Performance Liquid Chromatography
(UPLC, developed by Waters Corporation) to increase throughput and
improve cost effectiveness.
Although the Japanese government does not maintain approved lists
for all commodities, when recurrent violations are detected, Japanese
scientists may be dispatched to the offending country to offer
technical assistance in a bid to correct the problem. The Japanese
Government has subsequently introduced approved lists, but only for
spinach imports. However, there is speculation that this may be
extended to other foods.
differences between the eu, japan
Whilst Japanese legislation appears similar to EU regulations,
there are fundamental differences in the implementation. Whereas, EU
demands equivalence in terms of legislation and levels of monitoring,
Japan places the onus for compliance on the importer and ensures
compliance through a very high level of import monitoring. The result
is that Japanese importers will typically demand certification of
compliance with Japanese regulations prior to dispatch.
Despite this high level of testing of produce destined for Japan,
the Japanese authorities ensure compliance by carrying out laboratory
analysis for a very large number of contaminants at import (around 10
percent of all imported food consignments undergo laboratory analysis)
and publish the results of violations detected. It is interesting to
note that a frequently used level of testing is designed to detect a 1
percent violation rate with reasonable efficacy (that is to say, if 1
consignment out of every 100 is violative for a particular substance
then there is a 95 percent chance that violations will be detected),
yet the dramatic changes in Japanese legislation were prompted by the
discovery of a 0.4 percent violation rate across all commodities and
chemical contaminants. It should also be noted that even a 10 percent
inspection rate does not in itself constitute a significant level of
protection. Rather, it serves as a monitoring tool to ensure
compliance.
export food safety testing
It might be reasonable to assume that such a high level of interest
in food safety from a number of very large food importers would itself
create a harmonized set of standards resulting in the food safety
equivalent of ``herd immunity.'' In some instances, this may be the
case. For example, the Thai Department of Fisheries has submitted a
list of recommended establishments to the U.S. FDA which is very
similar to the approved list maintained by the EU, but it is noted that
use of these establishments by U.S. importers is voluntary and that
some recent FDA refusals (October 2007) came from establishments not on
the recommended list.
It is also noted that whilst only 4 countries appear to have
submitted lists of recommended establishments for seafood to the United
States, 95 have done so to the EU (where it is mandatory). One assumes
that this arises because the standards are not harmonized
internationally and the requirements are very different from one market
to another. Therefore, in practice, exporting countries tend to focus
on separate schemes depending on the intended recipient. This is borne
out by the observation that many establishments on the FDA refusals
list are not on approved lists for the EU and therefore would not be
permitted to export to the European Union. This should not be
interpreted as an indication that they are necessarily producing
substandard goods, but rather that they may be focused on markets not
requiring advanced approval.
conclusion
It is clear that any food safety system which relies on voluntary
compliance will be inherently risky, since even the very stringent
systems employed by both the EU and Japan continue to give rise to a
significant number of cases of violative food contamination (as
published by each authority). Countries without unequivocal regulations
governing the production of imported food run the risk of inviting the
delivery of sub-standard products. This author has examined a seafood
export action plan which clearly stated that seafood found to be in
violation of EU regulations could be sold into markets where the
regulations were less stringent. In the absence of comprehensive,
internationally applied standards, imported food safety can only be
ensured through the application of unambiguous legislation in
combination with a robust enforcement and monitoring programme.
The Chairman. Well, thank you very much. Tell me, Dr.
Young, the point that I gather that you're making is that the
food safety, certainly in the EU, I imagine in Japan as well,
is more stringent, more restrictive than we have currently in
the United States. Is that so?
Mr. Young. It would be my opinion that the regulations in
Japan and Europe are quite different but the one thing that
they do share in common is a very strict enforcement and they
are very well-
defined. They have very well-defined standards. So the
exporters are aware of the standards that they must meet.
The Chairman. Well, if they do not meet the standards in
terms of the EU, I think you mentioned that those food
products, some of those can be sold to other countries?
Mr. Young. The particular action plan that I was referring
to was a document that I read a few years ago. And yes, it was
clearly stated in the document that if food did not meet the EU
standards then it could be sold into markets where the
regulations were less stringent. And essentially what that
means is that if their rules are not clearly stated that this
is what we demand. This is the quality of product we demand.
These are the standards that you must meet. Then essentially
that product could be deemed to be compliant with those rules
and regulations.
The Chairman. Well, in a practical effect as some of that
is sold in the United States. Is that correct?
Mr. Young. I beg your pardon, sir?
The Chairman. Some of those food products are sold in the
United States. They don't meet the European standard and they
can be sold here in the United States.
Mr. Young. That could be the case.
The Chairman. Well, is it the case? I mean you're an
expert. I've got a limited period of time. It is the case,
isn't it?
Mr. Young. It probably is the case. I can't say for certain
that those products were sold but one thing I can state is that
products that are destined for Europe are tested before they're
shipped to Europe. And I cannot say that the products destined
for the United States undergo the same level of testing.
The Chairman. Ms. DeWaal do you know that to be the case,
or not?
Ms. DeWaal. I think, Senator, that a number of States have
actually proven this. They have tested seafood products that
FDA is not testing and they have found illegal antibiotic
residues. So in fact we think and FDA actually, after the
melamine incident, FDA actually had to ban certain seafood
products that, Senator, they had known for 7 years that these
products were coming in with illegal pesticide residues. Excuse
me, antibiotic residues. And they didn't ban them until after
the melamine incident.
The Chairman. You know, Mr. Taylor as I understand, the EU
acted in 2002 to change the food safety system, establish the
system that focuses on risk that provides for a rapid response
when unsafe food is found. There is an absolute requirement to
be able to trace all food to its source to retail and they have
comprehensive testing on all foods. And countries that import
to the EU must be pre-
approved, on lists of approved countries, from approved
suppliers in those countries, and even the foods are approved
to import.
Is that your understanding?
Mr. Taylor. Yes, Mr. Chairman. I think the traceability
requirement in particular illustrates a commitment----
The Chairman. Do we have that type of system----
Mr. Taylor. We do not.
The Chairman [continuing]. Here in the United States?
Mr. Taylor. Not implemented, that sort of farm-to-table
traceability and accountability system here.
The Chairman. And do you, just professionally, think that
provides a greater degree of safety?
Mr. Taylor. I think traceability, being able to know where
a product came from and the conditions in which it was
produced, from farm to table is fundamentally important.
The Chairman. What about Japan?
Mr. Taylor. Well, again, the Japanese as Mr. Young
indicated have much more clearly defined standards for imports
and higher degrees of inspection and testing than we do.
There's no question about it.
The Chairman. Don't you think a lot of Americans that might
be watching this hearing could be saying, ``Well, why does
Japan and why do the Europeans have stronger protective systems
than the United States?''
Mr. Taylor. I think it would be a fair question to ask. It
is not as though we haven't known for a decade that our system
can be improved in fundamental ways. GAO and the National
Academy of Science have been telling us this for a decade. And
so it is time to act to build this sort of systemwide
prevention into our system.
The Chairman. How much additional burden, Congressman
Dooley, would this type of system put on the food industry?
Mr. Dooley. Well, I think what we're suggesting, Senator
Kennedy, is that we really have to define that public, private
partnership that would be most effective in achieving that
objective. And what we have proposed is that we would mandate
that every importer on record, of every importer of food or
food ingredient product in the United States would have to have
a supplier quality assurance program. That would ensure that
you would have in fact, the food safety audits that would be in
place. That would ensure that those companies we're resourcing
for have good management practices in place, sanitary practices
in place. That we would develop these set of guidance with FDA,
that you would then have the private sector being vested with a
primary responsibility of preventing these occurrences.
And one of the reasons why we think this is the most
appropriate alternative is that we have 190,000 different
companies that are registered under the Bioterrorism Act that
would be eligible to import food products into the United
States today. And we do not think that if you go down a
regulatory approach where you'd have FDA vested with that
responsibility that you're ever going to have that capacity and
the resources to certify those.
And so what we are suggesting is, we work in cooperation
with FDA. That they help us set the standards and the guidance
where the private sector then mandates to have the plans in
place to ensure that we could have systems that would allow for
greater traceability and greater confidence that we are having
the food supplier require the audits are in place.
The Chairman. Senator Enzi.
Senator Enzi. Thank you Mr. Chairman.
Dr. Young, you note that the European Union found that
relying on voluntary compliance was insufficient and that you
instead licensed other countries and individual foreign
establishments. The FDA Food Protection Plan proposes third
party certification but not country certification. And I'm
thinking particularly of China where the compliance is so
varied.
You have some firms who definitely meet standards and
others who have no intention of doing so. Could you elaborate a
little bit on that role of certifying entire countries? Does
that country certification have the unintended consequence of
keeping good actors in non-certified counties from doing
business in European Union, or in the United States.
Mr. Young. Yes, Senator. You're quite right. The business
of certifying countries in addition to certifying particular
establishments from the European Union point of view is of
vital importance. The reason for that is the European Union
believes that compliance will not be achieved unless the
government is involved, unless there is government regulation.
I have acted as an EU inspector, involved in audits of
third countries and the very first steps that are involved are
inspecting the legislation to make sure that's there's a legal
framework for taking action because the European Union believes
that without that legal framework there will not be an
effective system of control.
Does that answer your question?
Senator Enzi. That helps quite a bit. I'll have a follow up
on that, probably in writing if you'd be so kind as to answer
some more detailed questions that we don't have time to cover
here.
Mr. Dooley, requiring importers to ensure the safety of
their supply chains does make a lot of sense to me. And your
larger members can easily travel to other countries and inspect
the factories or have a long-term presence in those facilities.
Big companies can have staff that are dedicated to those
issues. What would a small business do?
Mr. Dooley. Well we think it's important that whether it's
a small company or a large company that is engaged in
international commerce and is sourcing products from outside
the United States that they also have a responsibility to
comply with putting in place the best practices which are going
to ensure that we are mitigating and preventing food safety
outbreaks. You know, you see today a lot of small and mid-size
companies are resourcing products. They have the ability to
contract with intermediaries that can, in fact, provide some of
the food safety quality audits that would need to be put in
place that have the contractual arrangements that would allow
them to also comply with this suggestion that we are making
that you have a mandatory supplier quality audit in place if
you're going to be importing a product into the United States.
And if I could just briefly make one comment on your prior
question on this whole issue of certification and equivalency,
in theory that sounds like a very sound and fairly reasonable
and simple approach. But I just want to caution people. We have
been trying to negotiate with Canada an equivalency agreement
on fish processing that they have similar standards in place
that would meet ours. We have been trying to do that for 10
years and we have not been able to achieve that with Canada
alone which would be a similar industrialized country as the
United States.
So I think we have to be very cautious about going down a
path in terms of thinking that this equivalency and the
certification of a country and their standards being similar to
ours is going to be easily obtained.
Senator Enzi. Thank you. And I'll have some follow up
questions on that as well in writing.
Mr. Corby, why do you think you're able to detect problems
at a much higher rate than the FDA or the USDA?
Mr. Corby. Well, for one thing I think because of our
resources. And we have quite a few inspectors. And we do a
great deal of surveillance. And we do a great number of
inspections.
Plus we're closer to the consumer in that we do the retail
inspections, the restaurants, the grocery stores and we're the
first ones to be contacted when there's an illness. So I think
it's because we're alert of these problems probably firsthand.
Senator Enzi. Thank you. And again I'll have some follow up
questions on that and some for Ms. DeWaal as well, but since
your voice is going I'll let you do that in writing.
The Chairman. Thank you.
Senator Allard.
Senator Allard. Thank you Mr. Chairman. I'd like to start
out with Dr. Young. We have different problems in, I mean, your
uniformity issues that you're talking about in certification
and assessment in different countries and in different
companies, there's a lot of difference depending on what part
of the world you're in and diseases that you might be dealing
with that could affect the food supply.
How does a country like England for example or Ireland, set
up a uniform assistance of assessing that or do you get very
specific for each country and you look at those diseases from
that country and you set up regulation just for that country or
do you have a general set of rules? And then if you do this how
do you reconcile that with trade agreements between the various
countries?
Mr. Young. Senator, the first thing I have to say is that
my area of expertise is chemical contaminates, not microbial
contamination and the way that the EU handles that level of
chemical contaminate control is through a uniform set of
conditions. The EU will draft legislation which can be based
either as a regulation which does not need to be transposed
into domestic law or it can set up these commission decisions
which do need to be transposed.
So when the EU deems that it's important and it's important
that everyone works to the same standards they will draft a
regulation and that's of course across the entire European
community. And those regulations then need to be also
transposed into the domestic law of the exporting countries to
ensure that the standards are the same. This is all with regard
to chemical contaminates. And that includes not only the range
of contaminates that need to be monitored which will be
adjusted based on the commodity on a risk-based analysis but
also includes things like the level of testing, the level of
monitoring that need to be carried out to ensure that there is
compliance with the local regulations.
Senator Allard. We have certain countries that recognize
products as being hazardous and other ones don't, based on good
scientific knowledge. For example, in Colorado or in the United
States, the scientific literature and what we generally
recognize here is that certain hormones to stimulate growth
development in cattle are not harmful. Yet there are European
countries, or Europe, I think, recognizes those as harmful.
How do you reconcile that and the scientific literature
indicates, in the United States, that it's not harmful and in a
European country they apparently feel it is or is it purely a
trade issue?
[Laughter.]
Mr. Young. That's a very difficult question to answer, sir.
Is it a trade issue? Perhaps there's an element of trade
associated with it, but, the argument I believe the European
Union takes on that particular subject is that they adopt a
precautionary principle. And that's to say that they are not
sure whether the science is verified and therefore they will
adopt a precautionary approach. And they will therefore ban
those substances.
Senator Allard. So the World Trade Organization in these
trade agreements allow you to take a precautionary approach so
that if anybody makes an allegation as far as you're concerned
from a protectoral standpoint whether you can prove that it's
safe or not then you apply that standard just on the allegation
itself whether you have the scientific body to support the rule
or regulation.
Mr. Young. Well certainly the Sanity and Phytosanitary
agreement make provisions for the precautionary principle. I
still believe that there's a need to prove that there's a
reasonable basis for those precautions and whether or not
Europe has done that with regards to hormones I'm not sure.
Senator Allard. Thank you. Mr. Coby. Is it Coby?
Mr. Corby. Corby.
Senator Allard. Yes, Corby.
Mr. Corby. Yup.
Senator Allard. In the State of New York you have authority
to shut down a business if it creates a public health problem,
don't you?
Mr. Corby. Yes, we do.
Senator Allard. Yes. I think that's true in most States,
isn't it?
Mr. Corby. Yes, it is. Most all of the establishments are
either licensed or permitted by State or locals.
Senator Allard. Right.
Mr. Corby. And we can revoke the license, yes.
Senator Allard. You----
Mr. Corby. And we also have the seizure authority which
allows us to stop a product that we believe may be adulterated
in its track.
Senator Allard [continuing]. You have inspected grocery
stores I assume?
Mr. Corby. Yes.
Senator Allard. Have you ever looked at the bulletin board
on a grocery store? I have, at least in Colorado. They'll have
a bulletin board up there that's maybe 2 feet square or 2 3
and it's plastered with permits and----
Mr. Corby. Oh, yes.
Senator Allard [continuing]. All sorts of licenses and what
not.
Mr. Corby. Yes.
Senator Allard. And you wonder how in the world they can
comply with all that, don't you from time to time?
Mr. Corby. Yes.
Senator Allard. They do. But, I think we need to be careful
on how much we force on a small business like that, you going
to do that inspection.
Mr. Corby. Well, there's a lot of things going on at the
State and local level where they now will post inspection
reports on a Web site or are required to post it at the front
door.
Senator Allard. Yes. And so it quickly becomes available
to----
Mr. Corby. Yes.
Senator Allard [continuing]. The public if they're
interested in one. And they'll do an evaluation on the store
and how they're doing. And those reports are all made public I
assume.
Mr. Corby. Yes, they are.
Senator Allard. So they really have strong enforcement----
Mr. Corby. We do.
Senator Allard [continuing]. Rules as far as that's
concerned, yes.
Mr. Chairman, thank you.
The Chairman. Thank you very much. We'll submit to leave
the record open and submit some questions.
I think it's been an enormously interesting and valuable
hearing today. We've had a good explanation on the issues of
food safety today.
The Advisory committee report is a clear call for action
and our committee is determined to answer that call. I look
forward to working with all of our colleagues to see that we
develop a comprehensive approach to the challenges that the FDA
faces both in food safety and in these other areas. This has
been very, very valuable, very useful and we are very grateful
to all of our witnesses and we will be submitting that we leave
the record open for a week. We're going to be submitting some
additional questions and calling upon you as we try to fashion
and shape a legislative approach to ensure greater protection
for American families.
Thank you very, very much. And the committee stands in
recess.
[Additional material follows.]
ADDITIONAL MATERIAL
Prepared Statement of Safe Food International--World Health
Organization
preamble
Foodbome illnesses are prevalent in all parts of the world,
resulting in millions of deaths each year. In developed countries, such
as Australia and the United States, about one in three persons
experience some type of foodborne illness every year, which can range
from mild to fatal. In the developing world, the World Health
Organization (WHO) estimates that contaminated food contributes to 1.5
billion annual episodes of diarrhea in children below the age of five
and at least 1.8 million deaths. Food also can carry traces of
hazardous chemicals, like pesticides or heavy metals, that cause
neurological and hormonal damage as well as cancer. From production to
consumption, it is the responsibility of national governments, the food
industry, and consumers themselves to ensure that food is safe.
However, governments have the pivotal role of providing a framework for
establishing effective food safety programs.
united nations food safety resolutions and other actions
While the need to ensure safe food was recognized when WHO was
established more than 50 years ago, more recently the International
Conference on Nutrition (Rome, 1992)--cosponsored by WHO and the Food
and Agriculture Organization of the United Nations (FAO)--declared that
access to nutritionally adequate and safe food is an individual right
of all consumers. They specifically urged governments to ``establish
measures to protect the consumer from unsafe, low quality, adulterated,
misbranded, or contaminated foods.''
In 1993, the FAO held a Technical Consultation on the Integration
of Consumer Interest in Food Control. The consultation, with inputs
from organizations representing consumers' interests, identified the
following issues as critical consumer concerns: nutritional quality;
safety standards; labeling; environmental contaminants; food
irradiation; and the application of modern biotechnology to food
production and processing. It also identified barriers to consumer
input in food control, particularly in developing countries.
The 53rd WHO World Health Assembly (Geneva, 2000) adopted a food
safety resolution calling on its 192 Member States: ``to integrate food
safety as one of their essential public health and public nutrition
functions and to provide adequate resources to establish and strengthen
their food safety programs in close collaboration with their applied
nutrition and epidemiological surveillance programs.'' The WHO World
Health Assembly in a separate resolution adopted in 2002 also
recognized the urgent need to protect food from threats of intentional
contamination with biological and chemical agents and radiological
materials.
In 2002, the United Nations in cooperation with consumer
organizations drafted and eventually adopted guidelines for consumer
protection that urges governments to ``give priority to areas of
essential concern for the health of the consumer, such as food, water,
and pharmaceuticals. . . . Governments should maintain, develop or
improve food safety measures, including, inter alia, safety criteria,
food standards and dietary requirements and effective monitoring,
inspection and evaluation mechanisms.''
These international resolutions attest to the growing urgency of
food safety. As food is increasingly traded globally, food safety has
become a global public health issue. Dialogue between the United
Nations' specialized agencies and groups representing consumers'
interests is vital to improving national programs and protecting all
consumers. Valuable contributions have been made by the long-standing
involvement of international consumer organizations like Consumers
International and the growing involvement of the International
Association of Consumer Food Organizations in the work of the Codex
Alimentarius Commission and its subsidiary bodies that deal with health
and safety issues.
formation of safe food international
In 2003, the Center for Science in the Public Interest (CSPI) *
started the Safe Food International project with support from the WHO,
FAO, and consumer organizations in many parts of the world to promote
stronger national food safety programs, to reduce food-related deaths
and illness, and to deter the use of food as a target of intentional
contamination.
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* CSPI represents over 900,000 consumers in the United States and
Canada and was also the founding organization for the International
Association of Consumer Food Organizations.
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Safe Food International was established on the principle that,
while food-safety hazards vary from region to region, consumers in all
parts of the world are critically concerned about the safety of the
food they eat. As food production changes from local systems to
international ones, consumers are demanding that food safety programs
at home and abroad ensure that the food marketed to their families is
safe to eat. National food-safety programs are usually funded by taxes
paid by consumers, who depend on those programs to protect their
health. However, in most countries, consumer and non-governmental
public-health organizations have no formal role in the development of
food-safety policies.
Consumer organizations can be instrumental in promoting effective
national food safety systems. Encouraging greater coordination among
interested groups, allocating additional resources to consumer
representation, and providing more opportunities for consumer
participation would be beneficial in many countries.
development of the guidelines
Safe Food International developed these Guidelines in
consultation with consumer organizations in both developed and
developing countries, based on WHO and FAO reports describing the
elements of effective national food safety programs and CSPI's
experience as a leading food safety advocate. Consumer organizations
and national governments can use these Guidelines to strengthen their
national food-safety programs and guard against any potential hazards
in the food supply, including intentional contamination (food
bioterrorism). Ultimately, the Safe Food International Guidelines
assist both consumer organizations and governments in focusing on the
basic requirements for national food safety programs in their
countries.
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These Guidelines may be translated, quoted, and reproduced
by bona fide consumer organizations to promote the development of sound
national food safety programs. Reference to Safe Food International
would be appreciated. For further information, please contact Safe Food
International, 1875 Connecticut Avenue, NW, Suite 300, Washington, DC.
20009, (202) 777-8364, or by email at [email protected]. To find the
Guidelines and other related materials, please see the Safe Food
International Web site, at www.safefoodinternational.org.
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With the cosponsorship of WHO and FAO, Safe Food International has
convened an international conference that developed these Guidelines in
consultation with the following consumer organizations: Union for the
Protection of Consumer Rights (Armenia); Test-Achats (Belgium); Ligue
pour la Defense du Consommateur (Benin); ProTeste (Brazil); Federation
of Consumers in Bulgaria; Mouvement National des Consommateurs
(Cameroon); Center for Science in the Public Interest (U.S. and
Canada); Ontario Public Health Association (Canada); Union des
Consommateurs (Canada); Organizacion de Consumidores y Usuarios
(Chile); Pesticide Eco-Alternatives Center (China); EcoWomen (China);
China Consumers' Association; Estonian Consumers Association;
Federation of Consumer Organizations (India); Consumer Coordination
Council (India); Voluntary Organization in the Interest of Consumer
Education (India); Consumers Korea (Republic of Korea); Consumers
Lebanon; Consumers Association of Penang (Malaysia); Pro Public
(Nepal); Consumers' Institute (New Zealand); Asociacion Peruana de
Consumidores y Usuarios (Peru); Polish Consumer Association;
Association Senegalaise pour la Defense de 1'Environnement et des
Consommateurs (Senegal); National Consumer Forum (Seychelles);
Consumers Union (United States); Consumer Education Trust (Uganda);
Which? (United Kingdom); Centro de Estudios, Analisis y Documentacion
del Uruguay (Uruguay); Consumidores y Usuarios Asociados (Uruguay);
International Association of Consumer Food Organizations; Consumers
International.
Financial support for Safe Food International was provided by the
NTI Foundation's Global Health and Security Initiative; the Center for
Animal Health and Food Safety; the Philancon Fund; and the Center for
Communications, Health and the Environment. The Canadian International
Development Agency and the FAO provided travel funding to conference
delegates from developing countries.
Guidelines to Promote National Food Safety Systems
The Guidelines cover eight essential elements for an effective food
safety program: Food Laws and Regulations; Foodborne Disease
Surveillance and Investigation Systems; Food Control Management;
Inspection Services; Recall and Tracking Systems; Food Monitoring
Laboratories; Information, Education, Communication, and Training;
Funding and Affordability of the National Food Safety Program.
1. food laws and regulations
Each country must have effective, comprehensive food legislation to
give its government the authority to ensure a safe food supply. Some
countries have not developed specific laws to assure food safety--or
they have developed such laws only recently. In other countries, food
safety laws were drafted decades ago. Frequently, they do not address
emerging hazards, like harmful bacteria, viruses, mycotoxins,
pesticides, and prions, or new innovations, such as genetically
modified plants and irradiation. Consumer organizations should be
vigilant in identifying ways in which their national laws should be
implemented, strengthened and modernized.
A modern national food law contains several essential elements.
First, it should provide a framework for an integrated and coordinated
food safety system. It should give food safety authorities effective
tools to respond promptly to hazards in the food supply, especially
during emergencies, and to remove hazardous food from the market in a
timely fashion. Finally, it should promote the use of preventative food
safety systems.
Food safety legislation should:
Be developed with the participation of all stakeholders,
and in particular consumer organizations.
Articulate a high level of health protection, for example,
food should be ``safe for human consumption.''
Contain clear definitions to increase consistency and
legal security.
Be based on scientific advice that is high quality,
transparent, independent, and at a minimum, in line with standards,
guidelines and other recommendations of the Codex Alimentarius
Commission.
Ensure the food authority and food producers and
processors give consumers accurate information about food products,
including labeling on all matters relevant to their health and safety.=
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= Governments should follow appropriate Codex guidelines for the
use of Halal claims in food labeling.
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Include mechanisms to facilitate traceback and recall of
contaminated food.
Put primary responsibility for producing safe food on
producers and processors.
Be regularly monitored and evaluated to ensure all
stakeholders' requirements are being met.
Apply to food aid, including during times of food security
emergencies.
National legislation should require establishment of standards or
other relevant management options for disease-causing organisms;
naturally occurring contaminants such as aflatoxin; pesticide residues;
and environmental contaminants, such as lead and methylmercury. It
should enable monitoring and enforcement of these standards effectively
and efficiently. The aim of such management options should generally be
a continuous improvement of the national food safety situation.
Legislation should also establish requirements for labeling
relevant to food safety and risk management addressing issues such as:
ingredients in descending order by weight; presence of allergens; date
marking; and instructions for safe use and storage. The labeling of
food produced by genetically modified organisms is currently being
discussed by the Codex Committee on Food Labeling.
All substances intentionally added to food and all new food
technologies that may change the safety or nutritional qualities of
food should be shown to be safe and suitable for their intended
purposes. Food legislation should establish pre-market approval
procedures for food additives, artificial food components and
ingredients, foods derived from modern biotechnology, food processing
technologies such as irradiation, and residues of food animal drugs and
pesticides to ensure safety and nutritional adequacy of the food supply
for consumers. These procedures should establish the safe conditions of
use through labeling instructions and maximum residue limits or maximum
levels.
Food legislation should require that feed for food-producing
animals, including feed additives, and drugs for food-producing animals
are safe for both humans and animals, including possible antimicrobial
resistance. Feed for ruminants (cows, sheep, goats and others) grown
for food should not contain ruminant tissues or by-products.
2. foodborne disease surveillance and investigation systems
A foodborne-disease surveillance system tracks information on
illnesses, gathers information to identify outbreaks (two or more
illnesses linked to a single hazard), links outbreaks to food sources,
and traces the food identified in the outbreak back to its origins.
The first evidence of contamination of food will likely be found
through the surveillance system. An effective surveillance system is
one that identifies foodborne-illness outbreaks while there is still
time to remove the contaminated food from the market and prevent
illnesses. This is especially true for incidents involving food that
has been intentionally contaminated.
Many countries have surveillance systems that rely on
investigations of illnesses that are reported to medical officials. In
some countries, sophisticated surveillance systems are designed to
deliver a high degree of certainty before specific foods are linked to
an outbreak. Such food attribution information is important to both
risk managers and the public. However, some countries use systems that
were developed to address food industry concerns that the wrong food
might be blamed for causing a food-borne illness outbreak. Those
systems can be too slow to operate effectively in an emergency.
To help risk managers issue more timely food recalls and to address
the threat of intentional contamination, countries should review their
surveillance systems with respect to their capacity to recognize
emergencies rapidly.
1. A national food control system should establish links between
the symptomatic foodborne-illness surveillance system and the food-
monitoring system (see section 6 below).
2. Countries should establish or strengthen early warning systems
to allow rapid detection of contamination incidents to ensure prompt
public alerts.
3. Countries should ensure that their surveillance systems include
data on the symptoms and effects of chronic exposure to foodborne
contamination.
4. Identifying diseases in animals may provide a quicker indication
of a problem in the food supply than waiting for human diseases to
occur. Linking the veterinary health sector to the surveillance network
might provide earlier warning of a problem in the food supply.
The public should have the right to information emerging from the
surveillance systems, including all data to support:
Annual foodborne disease incidence trends.
Identification of susceptible population groups.
Identification of hazardous foods.
Results of routine sampling and analysis of food products.
Identification and tracing of causes of foodborne disease
from the farm to the kitchen.
Early alerts for outbreaks and food contamination.
3. food control management
Many countries currently have more than one food safety agency,
some with conflicting or overlapping responsibilities. An integrated
national food control authority should address the entire food chain
from farm-to-table and should have the mandate to move resources to
high-priority areas.
The national legislation should define the food-control management
structure. Core responsibilities of that system include establishing
regulatory measures, monitoring system performance, facilitating
continuous improvement, and providing overall guidance.
National legislation should define an integrated or coherent food
safety system including designation of a lead food safety authority
that should be empowered to:
Develop and implement an integrated national food-control
strategy.
Set standards and regulations.
Approve new food ingredients and food safety technologies.
Participate in international food-control activities.
Develop emergency response activities.
Carry out risk analysis.
Monitor enforcement activity and performance.
Implement effective mechanisms for involving stakeholders,
including Consumer organizations, at different steps of the
decisionmaking process.
Develop and promote food safety training curricula and
programs.
Sufficient resources should be provided to the authority to carry
out its mandate.
Risk analysis plays an important role for a national food control
system. Risk analysis comprises of three stages: risk assessment, risk
management and risk communication. Risk analysis involves identifying
risks, weighing their likelihood and their impact, and establishing
systems to manage and minimize risks. Risk management is the term given
to the legal, regulatory, educational, and voluntary actions used to
control risks. Risk assessment is a scientifically based process
consisting of the following steps: Hazard identification, hazard
characterization, exposure assessment, and risk characterization. Risk
assessment should always be carried out openly and transparently and
ideally by independent scientific committees which are open to public
scrutiny. While formal risk assessments can be highly beneficial, they
can also be very time-consuming and expensive, beyond the reach of many
governments. It is also essential that risk assessments answer the
right questions and are explicit about any judgments or assumptions
that have been made.
Where the science is uncertain or inconclusive, but there is
evidence of a potential risk, it is important that a precautionary
approach is adopted by risk managers. Failure to take action
sufficiently early to protect the public can have devastating
consequences.
Risk assessment is therefore an important aspect of risk management
decisions, but not the only one. Other factors may also need to be
taken into account by risk managers when determining the approach that
has to be taken. Public involvement throughout the risk analysis
process is essential in order to understand what these broader factors
may be (including for example ethical, environmental or broader social
aspects) which can affect people's willingness to accept a particular
risk. It is essential that consumers are involved in determining an
acceptable level of risk.
Risk communication is essential and has to be a two-way process
between risk managers, risk assessors, consumers and their
representatives, and other stakeholders.
Risk-management decisions should be based on the best available
evidence and proceed within a timeframe that can minimize consumer
harm. Risk managers can be informed by risk assessments conducted
either in their own country or assessments done for international
organizations, like the WHO. In order to respond to food safety
emergencies, the government should establish a national food safety
emergency coordination body. An effective emergency response system
must be tailored to the circumstances and should include links to law
enforcement and intelligence agencies, food-recall systems, risk
assessment specialists, and the food industry, as well as the more
traditional sectors of health care providers, laboratories, and
emergency services. These systems should be tested to ensure that the
communication and response systems work effectively.
4. inspection services
Sound food safety legislation and policies are meaningless unless
they are effectively enforced. Inspection services form the core of the
food safety system, giving government regulators, customers, and
consumers regular information regarding conditions throughout the food
chain and on farms that can impact the safety of the food supply. In
addition, inspectors give the government in-house expertise that can be
used to conduct investigations and respond to food safety emergencies.
Food premises should be inspected as a matter of principle before
they sell to the public to ensure that they meet hygiene requirements.
Food inspection must ensure that all foods are produced, handled,
processed, packed, stored, and distributed in compliance with
legislation and regulations. Food inspection and regulation should
extend from the farm to restaurants, street vendors, and other retail
venues. There should be a sufficient number of inspectors to allow an
adequate frequency of inspections. These inspections should be based on
the risks posed by different foods and the history of problems in a
particular sector of the food supply.
The food inspector is a key functionary who has day-to-day contact
with the food industry, trade groups, and often the public. The
inspector must therefore be honest and well-trained, independent, and
be in a position to avoid external influence, including potential
conflicts of interests. Training of food inspectors is an important
component of an efficient food-control system. As national programs
improve with the introduction of systems focused on controlling and
preventing food safety problems (so-called Hazard Analysis and Critical
Control Point (HACCP) systems) and the adoption of new technologies to
improve food safety, retraining should be conducted to ensure that
inspectors are providing optimal services.
Traditional inspection functions include responding to non-
compliance with food laws, handling consumer complaints, and advising
the food sector. In a modern food safety system, inspection functions
include the following:
Inspecting premises and processes.
Evaluating HACCP plans.
Sampling food during harvest, processing, storage,
transport, or sale.
Recognizing spoiled and hazardous food, food that is
otherwise unfit for human consumption, or food that is deceptively sold
to consumers.
Recognizing, collecting, and transmitting evidence.
Encouraging the use of voluntary quality assurance
systems.
Conducting inspection, sampling, and certification of food
for import/export purposes.
Conducting risk-based audits of food establishments with
HACCP or other safety assurance programs.
Recommending formal action, including prosecution, where
food safety lapses could endanger public health.
Information on food inspection results, such as hygiene scores,
should be made available to the public through, for example, web-based
systems, media and other communication channels.
5. recall and tracking systems
Recall and tracking systems are vital to consumers and other actors
throughout the food chain when food that does not comply with national
standards, including contaminated food, inadvertently reaches any part
of the food chain, including the consumer. The national food safety
system should have comprehensive procedures covering the prompt removal
of contaminated and mislabeled food products from the domestic market.
Recalled products that are deemed to be unsafe should be properly
disposed of and not exported to other countries.
Recalling contaminated food can be triggered by the food industry,
consumer organizations, or the food control authorities. Tracking
systems are used to trace the route of contaminated food or sick
animals that may enter the food supply. Outbreak investigations often
use tracking systems to trace back food linked to an outbreak to the
farm or factory that produced it.
Tracking or traceback systems may also be required in order to give
additional reassurances of safety, for example, to enable post-market
monitoring of any unintended health effect. They are also important to
ensure liability and compensation.
Tracking systems generally start with the food producers. In the
case of live animals, it may include animal identification systems
using ear tags and other devices. Processed foods should be clearly
marked with a lot number and the time and date of production. Produce,
grains and other plant-based foods should be labeled in a manner that
clearly indicates the place of origin (country and State or province
and preferably the farm or packing house). In all cases, packaged food
purchased by the consumer should be marked to allow identification.
Recall systems should be a coordinated effort between the national
government and the individual firm(s). If the government requests a
recall, firms should have an affirmative duty to recover recalled
products and to destroy or dispose of them properly. National laws
should include penalties for companies that fail to comply with recall
requests from national governments.
6. food monitoring laboratories
Laboratories are an essential component of an effective food
control system. They allow regulators, producers, and consumers to
examine food for chemical and microbiological hazards that are not
apparent through routine physical examination. Laboratory analysis can
be critical to:
Identifying contaminated foods.
Identifying the source of an outbreak of food poisoning.
Allowing regulators to bring enforcement action against
adulterated and unsafe food.
Confirming the safety of domestic food products as well as
exports and imports.
Allowing for dietary exposure assessments.
Allowing consumer organizations and food processors to
monitor and analyze the food quality at the user end.
Assist in the regulatory decisionmaking process and
evaluate the effectiveness of risk management interventions.
Effective food-control programs are able to monitor the quality and
safety of the Nation's food supply. It is government's responsibility
to ensure that mechanisms are put in place to make sure food is safe
before it is marketed. A range of analytical capabilities are required
for detecting a large variety of food contaminants, such as pesticides,
pathogenic bacteria, pathogenic prions, foodborne viruses, parasites,
radionuclides, environmental chemicals, and biotoxins. In addition,
capabilities to test for spoilage and compliance with all other
official food-control standards are needed.
The food-control management authority should establish quality
assurance (proficiency) criteria for the operation of laboratories and
should monitor their performance.
7. information, education, communication, and training
Communication among food safety, agriculture and other relevant
authorities, consumers and consumer organizations, and the food
industry should be a vital and continuous function of a national food
safety program. Communication with the public and the food industry in
emergency situations, such as disease outbreaks or contaminated food
alerts, is an increasingly important component of the national food
safety system. Consumers should always be promptly, accurately and
fully informed about any disease outbreak, contaminated food incident,
or food recall through a sound alert system and traceability using
effective and practical communication methods. Communication must be a
two-way process to ensure that authorities are aware of and take
account of consumer concerns and perceptions.
Wherever possible, risks should be explained in the context of the
overall diet. Where it is not possible to give consumers clear
information or advice about a risk, efforts should be made to explain
as clearly as possible what is and is not known and what steps are
being taken to address uncertainties.
Informing the public and the food industry about trends in food and
foodborne diseases is an important role of government authorities.
National governments should ensure communication during emergency
situations by establishing industry alert and agriculture alert
systems. Through the network of food safety regulators (INFOSAN), WHO,
and in cooperation with FAO, operates an electronic information system
to keep regulators informed of the emerging food safety issues,
including emergency situations.
Giving consumers' advice regarding how to avoid foodborne illness
is an educational function of the national food safety program.
Education programs should begin in childhood using both formal and
informal methods. Programs should also target high-risk groups and/or
their caregivers. High-risk consumers include infants and young
children, pregnant women, the elderly and immune-compromised
individuals.
On-going training in specific skills, such as communication, and
technical capacity building for inspectors, laboratory personnel,
scientists, consumer organizations, and the food industry is critical
to ensure that existing inspection programs are prepared to handle
emerging hazards and to integrate new technologies to reduce hazards.
8. funding and affordability of the national food safety programs
National food safety programs must be funded sufficiently and
transparently to conduct regular inspections of food-processing
facilities and imports, to conduct laboratory tests of both domestic
and imported food, to set standards and do risk analysis, as well as
many other functions. The nature of the funding must not compromise
their integrity and independence. Funds must be utilized efficiently to
maximize public health protection and with accountability to the
public.
Governments have the primary responsibility for ensuring the safety
of domestic, imported, and exported food, and should provide core
funding for such activities. However, support for building the
capacities of such systems in the poorest countries should be the focus
of bilateral and multilateral assistance, as appropriate.
Many countries fund food safety programs using cost-recovery
systems. Cost-
recovery options include a tax and/or specific fees for licensing,
inspection activity, food sampling and analysis, and food safety
training. However, those systems should not unfairly impact the poorest
consumers and public health organizations.
Food safety programs must be structured to protect and promote
public health and be affordable and accessible to small farmers and
producers. This is important for preserving the diversity and quality
of the food supply. Costly regulatory measures can put small farmers
and producers out of business. Consolidation of the food industry can
make food more vulnerable to large-scale contamination.
Response to Questions of Senators Kennedy, Harkin, Mikulski, Bingaman,
Brown, Enzi, Burr and Hatch by Michael Levitt
questions of senator kennedy
Question 1. There's a lot of real value in the Food Protection
Plan. One thing that concerns me, however, is that the plan proposes
allowing the agency to require process controls for a food, but only
after the food is associated with repeated instances of serious adverse
health consequences or death. Why should the FDA have to wait for
children or the elderly to die or be seriously injured by a food before
companies making it are required to make it safely?
Answer 1. An overarching strategy of the Import Safety Action Plan
and the Food Protection Plan is to target Agency resources to achieve
maximum risk reduction. FDA will primarily focus on promoting the use
of risk-based, preventive systems that companies can voluntarily apply
at all levels of food production and processing, when appropriate.
Potentially high-hazard food categories may require additional
control measures. To address the potential need for additional control
measures for high-hazard food categories, HHS has requested explicit
authority to issue regulations requiring specific types of foods
(associated with repeated instances of serious health problems or death
to humans or animals from unintentional contamination) be prepared,
packed, and held under a system of preventive food safety controls.
Such authority would strengthen the FDA's ability to require
manufacturers to implement risk-based HACCP or equivalent processes to
reduce foodborne illness from high-risk foods. The criteria that the
food be ``associated with repeated instances of serious health problems
or death to humans or animals for unintentional contamination''
provides a clear and straightforward definition of high-risk foods or
categories of food of greatest Agency concern. The identification of
high-risk foods eligible for this provision can be made based on
existing data and knowledge so FDA would not have to wait for further
deaths or serious injury before these provisions could be implemented.
By targeting recognized high-risk foods, but not limiting the overall
preventative approaches to high-risk foods, we hope to achieve the
greatest public health impact with the resources available.
Question 2. One recommendation in the Plan is that FDA should
certify third parties to conduct food safety inspections. There may be
real value in such a program, but we authorized such a program for
medical devices in 2002 and very few device companies have taken
advantage of it. What do you think will make food companies participate
in a third party inspection program? What sort of resources will the
FDA need to review and act on all the information that these
inspections might generate?
Answer 2. One lesson learned from our experience with other third
party inspection programs is that industry participation depends on
appropriate incentives. Accordingly, we intend to seek input from
stakeholders to best understand how to maximize participation in a
third party inspection program for food. This will assist in estimating
the resource requirements to review and act on the information that may
flow from third party inspections.
Question 3. How much additional money do you think the FDA needs to
carry out the Food Protection Plan?
Answer 3. The activities recommended in the Import Safety Action
Plan involve 12 different Departments and agencies and we are currently
working on the implementation plans for the 14 broad recommendations
and the 50 action steps. The requests for additional resources will be
coordinated through the budget process for the affected Departments and
agencies and result in requests for additional funding over a number of
years. The President's fiscal year 2009 budget request will soon be
presented to Congress and will include the first installment of funds
to carry out these activities.
Question 4. A significant impediment to the FDA doing a better job
on food safety is its serious lack of adequate resources, as recently
documented by the FDA Science Board Report. The Food Action Plan
proposed two modest user-fee programs, on export certificates and re-
inspections. How much money will each of these user-fees generate?
Answer 4. For fiscal year 2008, the proposed food and feed export
certificate user-fee program was estimated to collect $3.7 million, and
the proposed user-fee for re-inspections was estimated at $23.3 million
including foods and medical products-related activities.
Question 5. Why does the Food Protection Plan propose requirements
related to intentional contamination based on a risk assessment while
allowing requirements for unintentional contamination based on repeated
actual incidents of serious harm to consumers?
Answer 5. When FDA conducts a food risk assessment, we take the
following variables into account:
the possibility that consuming a particular food will
result in a foodborne illness due to contamination of the product,
which depends on such factors as the number of microbes present or the
level of a chemical or toxin present, the susceptibility of the person
to the contaminating agent, and whether the food was properly handled
and cooked;
the severity of that illness, should it occur;
the point in the production cycle where contamination is
most likely to occur; and
the likelihood of contamination and steps taken during the
production cycle to reduce the possibility of contamination.
Both the proposal to require additional preventive controls for
high-risk foods (unintentional contamination) and the proposal to
require preventive controls against intentional adulteration
(intentional contamination) take this type of risk assessment into
account. For the foods or food categories covered by the unintentional
contamination proposal, FDA can identify these foods as ``high-risk''
based on the known possibility of these foods causing illness, known
instances of illness severity, and known data and experience around
where the contamination is most likely to occur. The required
preventive controls would then focus on known process control systems
to reduce the possibility of contamination. The intentional
contamination proposals take into account the same risk factors based
on risk assessment modeling and best professional judgment in the
absence of data and experience with these types of events in the United
States. Therefore vulnerability assessments are required to suggest
reasonable and appropriate mitigation measures given the number of
uncertainties, and the fact that such attacks have not actually
happened, around such events.
Question 6. What is the rationale for protecting from liability
companies that comply with requirements related to intentional
contamination of food?
Answer 6. This proposed authority would require companies to follow
FDA requirements to prevent the intentional contamination of food.
Recognizing that these requirements would be intended to help prevent
the actions of third parties who may have ill intent and over whom the
companies have no control, HHS determined that it would be appropriate
to pair this proposal with an affirmative defense that would be of use
if a third party were able to circumvent those required actions as
fully implemented by the company. This does not provide full liability
protection, but does allow a firm, if charged with negligence in a
lawsuit, to have the benefit of an affirmative defense that it had
fully complied with the relevant FDA requirements.
questions of senator harkin
Question 1. I support mandatory recall authority for both USDA's
Food Safety and Inspection Service (FSIS) and for FDA. However, I know
that recall authority comes with a cost. How much would it cost to
implement such authority and is FDA planning on requesting more funding
for it in its fiscal year 2009 budget?
Answer 1. FDA is seeking mandatory recall authority to be used only
when the current process of voluntary recalls fails to promptly remove
foods that present a threat of serious harm to people or animals. While
FDA has been able to accomplish most recalls through voluntary actions
by product manufacturers or distributors, there have been rare
instances in which a firm was unwilling to conduct a recall. In such
situations, FDA needs the ability to require a firm to conduct a recall
to ensure the prompt and complete removal from distribution channels of
food that presents a threat of serious harm to people or animals. In
these rare situations this may result in a more efficient use of
available FDA resources. The Administration is completing its work on
the President's fiscal year 2009 budget request and will present the
budget request to the Congress in February.
Question 2. In the submitted witness testimony for the hearing, we
have read that statutes need to be significantly changed to modernize
our food safety system. Do you agree? If so, does FDA have a
legislative proposal?
Answer 2. The Import Safety Action Plan and the Food Protection
Plan identify several legislative changes that would enable
implementation of certain action steps and strengthen FDA's ability to
continue to protect Americans from foodborne illnesses. Some of these
are discussed in my written testimony. I look forward to working with
you and other Members of Congress on these authorities.
Question 3. In the FDA Food Protection Plan, FDA places a renewed
emphasis on the threat of an intentional contamination of food. Please
describe FDA's relationship with intelligence officials and any ongoing
collaboration the agency has with Federal Government intelligence
agencies.
Answer 3. In July 2005, the Department of Homeland Security (DHS),
the U.S. Department of Agriculture (USDA), the Food and Drug
Administration (FDA), and the Federal Bureau of Investigation (FBI)
announced a new collaboration with private industry and the States in a
joint initiative, the Strategic Partnership Program Agroterrorism
(SPPA) Initiative. The SPPA Initiative is a true partnership program,
where an industry member, trade association or State may volunteer to
participate in this vulnerability assessment program utilizing the
``CARVER + Shock'' method. The desired results of the SPPA Initiative
include sharing:
unclassified reports that detail generally identified
vulnerabilities, possible mitigation strategies, and warnings and
indicators of an attack. The unclassified reports will be distributed
to all site participants;
classified reports that outline sector-wide
vulnerabilities and lessons learned to effectively and appropriately
prioritize national assets and resources. The classified reports will
be distributed to DHS, USDA, FDA, and FBI;
the ``CARVER + Shock'' assessment tool, and adapting it,
if necessary, to the unique production, processing, retail,
warehousing, and transportation system for each sub-sector;
lessons learned;
assessment templates for each ``system'' by sub-sector
that can be exported to other sites to identify vulnerabilities that
incorporate existing tools;
sector-specific investigative templates and field guides
for the food and agriculture/intelligence sector; and
research and development initiatives related to the food
and agriculture sector.
DHS has established the Homeland Infrastructure Threat and Risk
Assessment Center (HITRAC), where intelligence analysts and
infrastructure specialists work to identify the threat to critical
infrastructures, vulnerabilities and interdependencies, and the overall
risk inherent in any potential attack against critical infrastructure.
The HITRAC has worked closely with the food and agriculture sector to
ensure that the most complete, actionable, accurate information
regarding private sector assets is disseminated expeditiously to key
stakeholders.
The Commissioner of FDA has designated the Office of Criminal
Investigations (OCI) as the Agency's lead point of contact for liaison
with the intelligence communities. OCI has several initiatives in place
to fulfill their mission. Below is a sample and description of those
initiatives.
OCI has a counter-terrorism section located at OCI Headquarters
with the capability and background to analyze information from law
enforcement and intelligence community sources so that they can assist
in terrorism-related threat assessments involving FDA regulated
products and respond to assist the FBI in counter-terrorism cases where
an FDA regulated product is involved. OCI special agents are assigned
and serve on several interagency terrorism-related task forces
including the FBI Joint Terrorism Task Forces (JTTF), U.S. Attorneys'
Office Anti-Terrorism Task Forces, and select Regional Task Forces
around the country.
OCI's counter-terrorism efforts include daily contacts and
interactions with the Central Intelligence Agency (CIA), the National
Counterterrorism Center (NCTC), the Federal Bureau of Investigation
(FBI), the Department of Homeland Security (DHS), the Defense
Intelligence Agency (DIA), Customs and Border Protection (CBP), and the
FDA-Prior Notice Center (PNC). In addition, OCI maintains relationships
with domestic and foreign law enforcement agencies to receive and act
on any information regarding threats to FDA-regulated products or
incidents of actual product tampering. OCI also actively participates
in the SPPA Initiative.
Shortly after the September 11, 2001 attacks, the OCI counter-
terrorism section organized an ``Agriculture Intelligence'' working
group, referred to as ``AgInt,'' to address threats to U.S. agriculture
from ``farm-to-fork.'' These monthly meetings include representatives
from FDA (OCI, CFSAN, CVM, Import Ops, and PNC), the U.S. Department of
Agriculture-USDA's Animal Plant Health Inspection Service (APHIS); Food
Safety Inspection Service (FSIS); Agricultural Research Service (ARS);
and the Office of the Inspector General (OIG), the FBI, the National
Counter-Terrorism Center (NCTC), the CIA, the Department of Defense
(DOD) and the Department of Homeland Security (DHS). These meetings are
held at OCI Headquarters.
OCI's counter-terrorism efforts successfully established and
strengthened relationships between Federal, State and local law
enforcement, and the food and agricultural industry.
Question 4. Coordination across departments of the Federal
Government is critical to ensuring the safety of our food supply. Does
FDA currently use USDA resources (financial or personnel) for its food
safety programs? Should this type of activity be encouraged to promote
collaboration between the two agencies?
I agree wholeheartedly with you about the importance of
coordination and a closer collaboration within the Administration is a
key element of the Import Safety Action Plan. The import community,
U.S. Customs and Border Protection and other agencies will exchange
real-time product and compliance data on each import transaction to
better inform decisions to clear or detain import shipments. We also
will pursue information sharing agreements with foreign regulatory
entities.
With regard to the relationship between the FDA and USDA, these
agencies work closely together on food safety and food defense
programs. This has been particularly evident in efforts to track cases
of BSE in domestic cattle. FDA and USDA coordinate food safety research
needs to address gaps and to avoid duplication. Another example of
coordination with USDA is the Food Emergency Response Network (FERN).
FDA has worked in close collaboration with USDA's Food Safety and
Inspection Service to include a substantial number of laboratories
capable of analyzing foods for agents of concern. FERN is a network of
Federal, State, and local laboratories capable of testing food samples
for microbiological, chemical, and radiological threat agents. This
partnership provides essential analytical expertise and surge capacity
in case of emergencies. In addition, the FDA, USDA, and other
Departments will collaborate to improve the rapid response to interdict
unsafe imports, and to use electronic track and trace technologies,
where feasible.
questions of senator mikulski
Question 1. In your testimony at the Senate HELP hearing on
December 4, 2007, you noted that the FDA ``plans to develop
international standards that reflect the same level of protection
maintained for consumer products in the United States.'' I applaud this
initiative and some of the suggestions you have made to Congress as a
first step, such as authorizing FDA to accredit third parties for food
inspections abroad. However, making sure that imported foods meet the
same safety standards of U.S. foods from handling to packaging, and
processing is a tall order. How do you plan to implement this standard?
Answer 1. We have always required that imported foods meet the same
safety standards as domestically produced products. However, the Import
Safety Action Plan and the Food Protection Plan call for the
implementation of export certificate programs for certain imported
products and the development of third party certification programs to
evaluate compliance with FDA requirements. In addition, we will
continue to harmonize international standards through our participation
in the Codex Alimentarious Commission and make import safety a key
principle in our diplomatic relationships and trade negotiations with
foreign countries. Together, these steps will help to elevate the
standards of imported goods. Ultimately, however, import safety is a
responsibility that must be shared by the public and private sector
stakeholders involved in the imported products supply chain.
Question 2. What regulations will you establish to determine
whether a food product imported from another country meets the same
safety standards as those required of foods in the United States?
Answer 2. The Federal, Food, Drug and Cosmetic Act requires all
food products distributed in the United States--whether produced
domestically or abroad--to meet the same standards. In the Import
Safety Action Plan and the Food Protection Plan we are proposing
additional measures to supplement current authorities that would
enhance FDA's ability to determine whether a food product imported from
another country meets the same safety standards as those required of
foods in the United States. In addition, stronger penalties and
enforcement actions will be required to ensure accountability.
Specifically, we propose to:
Accredit Highly Qualified Third Parties for Voluntary Food
Inspections;
Refuse admission of food, if FDA's efforts to conduct a
foreign inspection are unduly delayed, limited or denied at a facility
where the product was manufactured, processed, packed or held; and
Require electronic import certificates for shipments of
designated high-risk products.
Question 3. What plans do you have to provide foreign producers
with incentives to upgrade their food safety systems?
Answer 3. Under the current system, foreign producers and exporters
already have a number of incentives for ensuring that their food
products comply with U.S. safety requirements. First and foremost,
foreign producers do not wish to run the risk of their product being
refused entry into this country. In certain cases, after problems are
encountered, future shipments are under more scrutiny through issuance
of an import alert and, under FDA policies, may not be allowed to enter
U.S. commerce unless the producer/exporter is able to establish that
the products are in compliance, such as by satisfactory test results.
Producers/exporters can suffer severe losses when their products are
found not in compliance with FDA food safety requirements. For foods
having a good record of compliance, on the other hand, FDA sets a
higher ``may proceed'' rate so that the products are not held on entry
into the United States for examination and possible testing. This
higher ``may proceed'' rate enables food products to enter U.S.
commerce faster.
The Import Safety Action Plan recommends a number of additional
steps to enhance foreign food safety systems. The certification
programs which verify compliance of foreign producers with U.S.
standards and the third party inspection programs will provide
incentives to strengthen foreign food programs. In addition, we will
step up collaboration and information sharing with foreign governments
and regulatory bodies, develop good import practice guidances, best
practices for track and trace technologies, and continue to work on
food safety priorities through our diplomatic relationships and provide
technical assistance to foreign regulatory entities. Finally, as we
have done with China, we are entering into formal agreements with
foreign governments.
Question 4. What do you do right now if you find imported food that
was handled under unsanitary conditions or has not been subject to
controls that meet the U.S. level of protection?
Answer 4. FDA can refuse admission of food offered for import if it
appears that the food has been manufactured, processed, or packed under
unsanitary conditions or is adulterated or misbranded. FDA gives notice
to the owner/consignee stating the reason FDA believes the product is
subject to refusal and explaining their right to provide evidence
regarding the product's admissibility. If FDA ultimately concludes that
a violation appears to exist, the product will be refused admission
into the United States, and the importer is required to either export
or destroy the product.
If FDA finds a problem with a product or range of products from a
particular producer, shipper, or importer, FDA can issue an import
alert or import bulletin to signal FDA field staff to pay special
attention to those products. For example, FDA may issue an import alert
for ``detention without physical examination'' explaining that FDA
staff may initiate refusal of admission of a product as soon as it is
offered for import without first examining it and taking a sample. An
import alert for detention without physical examination is based on
information, such as the past history of the company or product,
sufficient to support refusal of future shipments of the product.
Question 5. How do you compare imported foods to those from the
United States to determine if they meet the same level of food safety?
Answer 5. All imported products that are regulated by FDA are
required to meet the same standards as domestic goods. Imported foods
must be pure, wholesome, safe to eat, and produced under sanitary
conditions.
FDA performs routine surveillance inspections of imported foods to
check for compliance with U.S. requirements. While FDA is not able to
physically inspect a large percentage of food entries, we
electronically screen all import entries using an automated system,
which helps our field inspectors determine which products pose the
greatest risk and therefore should be physically examined.
FDA also performs laboratory analysis on a sampling of products
offered for import into the United States and performs periodic filer
evaluations to ensure that the import data being provided to FDA is
accurate. Certain violations relating to imported food may lead to
civil or criminal charges.
questions of senator bingaman
I was pleased FDA's Food Protection Plan discusses the importance
of using risk-based technology to help FDA screen for potentially
unsafe imports while facilitating the importation of safe products. For
some time, I have helped fund the screening system called PREDICT
(Predictive Risk-based Evaluation and Dynamic Import Compliance
Tracking), which is under development for FDA by New Mexico State
University. The concepts behind the PREDICT were proven in 2004 and
successfully piloted this year as a part of FDA's import screening
system.
Question 1. What is FDA's timetable and budget to fully implement
the PREDICT system?
Answer 1. A pilot test of the PREDICT prototype system was
conducted by FDA during the summer of 2007. The prototype system is
currently limited to seafood and the pilot test was limited to seafood
imported through a small number of ports in southern California. FDA
has recently begun an expansion of the prototype to include all food
products. Should this be successful, our plan is then to include other
FDA-regulated commodities. The plan is to test the food prototype
during fiscal year 2008 as it evolves, using the same few California
ports, with feedback from the users. Considerable work must be done by
subject-matter experts to develop the extensive risk-based criteria
which will be required. Open-source intelligence activities must be
expanded. A prototype integration of the PREDICT user screens into
FDA's enterprise-wide import system will be developed. Technical
requirements must be developed in order to ensure the final prototype
represents a model which, when expanded to full production, will fully
conform to applicable information technology standards. FDA estimates
that completion of the prototype system will be accomplished during the
first quarter of fiscal year 2009, and that deployment of a production
version nationwide could begin thereafter within 6 to 9 months.
Question 2. What is FDA's estimate over the next 5 years of the
amount of funding needed to bring PREDICT to full operational
capability?
Answer 2. We have provided $1.0 million in fiscal year 2008 for
this purpose and we intend to continue to support this important
program. FDA is working to deploy these funds and will be able to
determine estimates for future funding as we move forward.
questions of senator brown
Question 1. How can we shift our focus at FDA to prevention in food
safety rather than in responding to problems after they've already come
about?
Answer 1. This is a key point and one of the underpinnings of the
Import Safety Action Plan and the Food Protection Plan. These call for
risk-based prevention steps, which will move forward concurrently.
1. Promote Increased Corporate Responsibility to Prevent Foodborne
Illnesses.--FDA designed its plan for the full life cycle of food--from
production to consumption, whether it be domestic or imported. The
prevention elements of the plan emphasize the importance for FDA and
corporations to work collaboratively to prevent food problems from
occurring. Promoting increased corporate responsibility is key in
shifting FDA's food protection effort to a proactive rather than a
reactive one. The FDA will seek partnerships with industry to enhance
consumer confidence. FDA will continue to work with industry in (a)
developing food protection plans that address safety and defense
vulnerabilities, (b) implementing prevention steps, and (c) developing
contingency plans to improve response to an outbreak of foodborne
illness.
The FDA will primarily focus on promoting the use of risk-based,
preventive systems that companies can apply at all levels of food
production and processing, when appropriate. Voluntary approaches may
be as basic as following good manufacturing practices to ensure proper
equipment sanitation and employee safety training. Potentially high-
hazard food categories may require additional control measures. FDA
will work with industry, consumer, and Federal, State, local, and
international partners to help model and promote preventive controls
based on best industry practices.
FDA plans to acquire additional data to develop a better
understanding of foreign country practices for food and feed. This may
include the examination of best practices around the food safety
control systems of other countries as well as increased understanding
of the difficulties faced in implementing food protection measures. FDA
will also seek to share U.S. food safety and defense best practices
with foreign governments and provide technical assistance, when
possible, to those countries exporting food products to the United
States so they can enhance their regulatory systems. As part of its
review of foreign systems and products, the Agency will analyze food
import trend data and integrate it into a risk-based approach that
focuses inspection resources on those imports that pose the greatest
risk. This approach will also focus foreign inspections on high-risk
firms. In the near term, a special emphasis will be placed on firms
located in countries where imports into the United States have been
refused repeatedly and import violations have threatened the health of
U.S. consumers.
2. Identify Food Vulnerabilities and Assess Risks.--FDA actions
will include gathering data for risk assessments and to conduct risk
evaluations of commodity-agent combinations and relative risk ranking
of commodities. A comprehensive, risk-based approach allows the FDA to
maximize the effectiveness of its available resources by focusing on
food products that have the potential to pose the greatest risk to
human and animal health.
By analyzing data collected throughout the food product life cycle,
we are better able to detect risks posed by food products. We are also
better able to recognize key junctures where timely intervention can
reduce or avoid those risks. Working with CDC, FDA will also build the
capacity to attribute pathogens to specific foods and identify where in
the production life cycle the foods became contaminated.
3. Expand the Understanding and Use of Effective Mitigation
Measures.--Building on risk assessments, FDA will initiate basic
research to enhance our understanding of sources of contamination,
modes of spreading, and how best to prevent contamination. This
information in turn will inform FDA's efforts above to promote
increased corporate responsibility to implement effective preventive
steps.
Focusing on higher risk foods, FDA, working with other agencies,
will undertake basic research and leverage relationships with outside
organizations. The FDA will also research, evaluate, and develop new
methods to detect contaminants in foods, and seek to facilitate new
technologies that enhance food safety.
Question 2. Last week, a draft report was released indicating that
the FDA doesn't have the resources it needs to ensure the safety of our
foods. What are you going to do to ensure that FDA has the funding it
needs to do its job?
Answer 2. The activities recommended in the Import Safety Action
Plan involve 12 different Departments and agencies and we are currently
working on the implementation plans for the 14 broad recommendations
and the 50 action steps. The requests for additional resources will be
coordinated through the budget process for the affected Departments and
agencies and result in requests for additional funding over a number of
years. The President's fiscal year 2009 budget request will soon be
presented to Congress and will include the first installment of funds
to carry out these activities.
Question 3. Right now, the Food Safety Plan advocates a voluntary
certification program where products are certified as meeting U.S.
safety standards. Do you think these programs should really be
voluntary? Wouldn't they be more effective if they were mandated?
Answer 3. Voluntary certification programs are useful in helping
FDA focus its resources on the areas of highest risk and will allow us
to leverage the resources of reliable third parties. FDA will be able
to facilitate the entry of products from certified firms while focusing
its own resources on non-certified firms or firms for which FDA has
reason to believe there are safety or security concerns. Such programs
would be audited by FDA, and FDA would retain its authority to inspect
those establishments, as appropriate.
Mandatory certification can play an important role as well. For
this reason, we recommend authority to require import certificates in
certain circumstances. Mandatory programs require more time and
resources to establish, but may be appropriate when the risks
associated with a particular product, region, country, or producer are
higher. Requiring mandatory certification for all products would be
very resource intensive and could hinder trade unnecessarily.
questions of senator enzi
Question 1. You indicate in your testimony that building
interoperable data systems and encouraging data sharing is important to
import safety. Can you tell me more about what is required to achieve
this interoperability? What sort of new legislative authority would you
need?
Answer 1. FDA plans to enhance its information technology (IT)
systems related to both domestic and imported foods. Many of these
improvements will be implemented in the next 2 years; a few will extend
beyond 2010. The enhancements described below do not require new
legislative authority. The Mission Accomplishment and Regulatory
Compliance Services (MARCS) program manages the integration,
reengineering, and enhancing the legacy systems that support field
activities. These systems include OASIS and other components which
support import processing. Improvements range from replacing the
current process that screens import entries; giving investigators
faster access to product information via views of Center databases;
improving sample collection/tracking on both desktop and mobile
platforms; to developing a broker information center to allow Customs
Brokers to quickly exchange information with import reviewers.
In addition to MARCS, FDA is working on a number of related
projects that will improve import safety in the next 2 to 3 years.
These include:
Working closely with CBP to ensure that its planned
Automated Commercial Environment, a component of International Trade
Data System, will provide the functionality long sought by FDA.
Developing a standard way of finding, creating, and
updating the information about facilities/enterprises FDA regulates.
Enhancing FDA's Decision Support System to boost
performance and expand its ability to rapidly access information.
Ongoing data cleanup and upgrade of internal system
interfaces to synchronize and validate data across centers and ensure
rapid access to correct information.
Substantially improving in the IT infrastructure that
helps staff exchange data among field offices and between the field and
Headquarters.
Expanding of the Electronic Exchange Network that
facilitates data sharing among public health partners and collaboration
among food safety experts.
FDA's Unified Registration and Listing System (FURLS)
integration of the registration and listing systems currently
maintained in the individual Centers.
Developing a Product Quality System to encompass an
electronic mechanism for manufacturers' registration and product
listings, and capture inspection data from compliance reviews.
Implementing FDA's Information and Computer Technologies
plan for the 21st (ICT21) century to ensure that FDA has the
infrastructure needed to support these IT initiatives and move towards
the Bioinformatics era.
Question 2. Third party inspection and review programs have a
somewhat mixed track record. One common criticism is that companies
don't use these programs because they would have to pay to be inspected
more frequently, when they could just use the less-frequent and
``free'' government program instead. How do we ensure that third party
review is sufficiently rigorous that it actually protects the public
health, but isn't such a high standard that it deters people from using
the program?
Answer 2. We have confidence in FDA's third party inspection
programs. FDA trains, accredits, and oversees the work of third party
inspectors to ensure that their inspections are as rigorous as if FDA
employees had conducted them. Moreover, FDA also maintains the right to
inspect at any time. While it is true that many firms have not taken
advantage of this option in the past with respect to the medical device
third party inspection program, FDA is working to increase
participation and we are pleased that FDA included needed improvements.
In the international context, these types of inspections can play an
important role. Because other countries also accept third party
inspections, firms may be able to have one inspection that satisfies
the requirements of several regulatory bodies. This will help to
streamline the movement of imports.
Question 3. I have some concerns about the proposed user-fee for
re-inspections. I firmly believe that FDA needs more resources and more
inspectors. However, if an inspector knows that FDA gets more money if
he or she has to come back, I wonder if that creates a perverse
incentive to find violations and fail companies. How do we guard
against this potential conflict of interest?
Answer 3. FDA's decision to re-inspect a facility or initiate
regulatory action after a violative inspection is informed by the
applicable Federal statute (i.e., Federal Food, Drug, and Cosmetic Act
and Public Health Service Act), regulations, and agency policies and
procedures. Neither the decision to take a regulatory action nor the
decision to re-inspect a facility rests with the FDA Investigator. An
FDA Investigator inspects regulated industry based on previously
established Agency policies and procedures. The FDA Investigator's role
is to inspect FDA-regulated industry in accordance with the
requirements of our statute, regulations, and established Agency
policies and procedures and to prepare a written account of any
findings that appear to the Investigator to be out of compliance with
the Agency's laws or regulations. Once the Investigator has written the
inspection report explaining the inspectional findings, including the
evidence necessary to support the observations, the report is further
evaluated by other FDA personnel within the chain of command. The first
line supervisor will review the report for accuracy and assurance that
the observations are based on facts and supported by the evidence
collected. The matter may then be referred to a District Compliance
Office for review and evaluation to determine if the Agency should
consider regulatory action. Depending on the specific FDA commodity and
the governing Center within FDA, the regulatory action may also require
review by other FDA offices to ensure that the action is consistent
with various requirements, policies, procedures, and practices. If an
action is taken, the determination whether a re-inspection is warranted
is also weighed carefully to ensure that the decision is consistent
with Agency policies and procedures. We believe that any perceived
conflict of interest regarding our current proposal for user-fees for
re-inspections is addressed by the current evaluation process FDA
utilizes. Moreover, the proposed re-inspection fee only covers the
actual costs of the inspection. There is no net revenue gain to FDA
from conducting re-inspections.
Question 4. Track and trace technologies are going to be an
important part of our food safety system at some point, as you suggest.
We heard a lot about Radio-Frequency Identification (RFID, a track and
trace technology) at last year's hearing, but it seemed that the
conclusion was that this technology isn't ready for prime time, at
least at the unit-of-sale package level. What do we need to do to get
to a point where track and trace is a reality?
Answer 4. Over the years, FDA has monitored industry efforts to
develop and promote RFID track and trace technology in the context of
prescription drugs. Section 505D of the Federal Food Drug and Cosmetic
Act, as amended by the Food and Drug Administration Amendments Act,
gives the agency the authority to develop standards for the
identification, validation, authentication and tracking and tracing of
prescription drugs, and to develop a standardized numerical identifier
to be applied to prescription drugs. Recognized standards will be
useful to help promote the use of this technology, which the standards
must address.
For foods, however, it is not clear that RFID is the best, or only,
technology appropriate for effective trace-back. HHS plans to work with
stakeholders to develop an action plan for implementing more effective
trace-back process improvements and technologies to more rapidly and
precisely track the origin and destination of contaminated foods, feed,
and ingredients. In so doing, it will be critical to identify best
practices for the use of track and trace technologies to facilitate
their adoption by industry.
Question 5. In all three of the focus areas--prevention,
intervention and response--there is a clear need for new science and
technologies. What do you believe is the role of FDA's Critical Path
initiative and the new Reagan Udall Foundation for the FDA in
developing these new tools?
Answer 5. Both the Import Safety Action Plan and the Food
Protection Plan emphasize the need for new scientific and technology
developments to ensure the safety of FDA regulated food products, both
domestic and imported. These goals are also at the heart of the
Critical Path Initiative, and activities under way under this
Initiative directly support the achievement of these goals. For
example, developing and implementing standards for data being collected
and managed by FDA and progress the Agency is making to move into a
wholly electronic environment will help the Centers identify and track
problems, improving our ability to intervene and respond. Improving
manufacturing approaches (one of the Critical Path's 6 key topics),
such as building quality into manufacturing and packaging processes,
will help ensure that products are manufactured, packaged, and stored
safely.
The recently enacted FDA Amendments Act of 2007 provides for the
creation of the Reagan Udall Foundation. The Foundation is charged with
advancing the mission of the FDA to modernize medical, veterinary,
food, food ingredient, and cosmetic product development, accelerating
innovation, and enhancing product safety. The statute specifically
directs the Foundation to take into account the FDA's Critical Path
reports and priorities. Thus, developing new science and technology for
product safety in all three areas--prevention, intervention and
response--should be within the Foundation's mission.
Question 6. I agree that we need to do a better job of
communicating about product recalls. One thing I've been thinking about
a lot is retail food safety. Big chains hear about recalls, smaller
ones often don't. I've been looking at the reverse-911 system that was
used in southern California during the recent wildfires to tell
residents to evacuate. I feel like there's a role for a system like
that for communications up and down the supply chain during a recall.
What do you think?
Answer 6. Although companies generally comply with voluntary
recalls, the Import Safety Action Plan includes a recommendation to
seek authority for mandatory recalls when voluntary recalls are
ineffective. Also, we are recommending cooperative agreements between
Federal and State inspection entities and greater information sharing,
the initiatives on track and trace technologies, and the proposal to
develop a best practices model for expediting consumer notification of
recalls. Together, these steps will significantly enhance the
effectiveness of recall communications.
In addition, FDA conducts recall effectiveness checks to determine
whether a recall is progressing satisfactorily, with the number of
checks dependent on the degree of the hazard. For example, during the
recent Castleberry's Chili recall in July 2007, FDA conducted more than
3,700 recall effectiveness checks. FDA will continue to explore new
opportunities for optimizing recall communications to ensure our recall
messages reach all of the necessary recipients.
questions of senator burr
Question 1. From my perspective, the largest gap in the FDA Food
Protection Plan was the lack of discussion about FDA resources. The
data comparing the resources of the FDA to that of the USDA is
startling and very troubling, especially given that the FDA regulates
80 percent of the U.S. food supply. Are you requesting that OMB include
more money for FDA food protection activities in the ``2009 budget,''
if so, how much?
Answer 1. The activities recommended in the Import Safety Action
Plan involve 12 different Departments and agencies and we are currently
working on the implementation plans for the 14 broad recommendations
and the 50 action steps. The requests for additional resources will be
coordinated through the budget process for the affected Departments and
agencies and result in requests for additional funding over a number of
years. The President's fiscal year 2009 budget request will soon be
presented to Congress and will include the first installment of funds
to carry out these activities.
Question 2. Several witnesses will testify that the FDA Food
Protection Plan limits the ability of the FDA to act in important food
safety areas due to the proposed requirement that foods only come under
process control programs if they have been linked to ``repeated,
serious adverse health consequences or death.'' Peanut butter and
spinach could probably not reach that level, but I think everyone
agrees that the processing plants for both food products need control
programs. Do you agree that the ``repeated, serious adverse health
consequences or death'' bar may be too high?
Answer 2. This is an important point. The proposed authority to
require additional prevention controls for high-risk foods
(unintentional contamination) is focused on those foods or categories
of foods of greatest concern because of their known serious public
health impact. Such authority would strengthen the FDA's ability to
require manufacturers to implement risk-based HACCP or equivalent
processes to reduce foodborne illness from these high-risk foods. It is
appropriate to target prevention efforts where they can have the
greatest public health impact.
However, we are not ignoring other foods that do not fall into this
category. HHS and FDA will work to consider safety and defense risks
associated with foods through their whole life cycle whether
domestically produced or imported. This includes the following actions:
Meet with States and consumer groups to solicit their
input on implementing preventive approaches to protect the food supply.
Meet with food industry representatives to strengthen
science-based voluntary prevention efforts, including developing best
business practices and food safety guidelines.
Develop written food protection guidelines for industry
to: (a) develop food protection plans for produce and other food
products and (b) implement other measures to promote corporate
responsibility.
Issue a final regulation requiring measures to prevent
salmonella in shell eggs and resulting illnesses.
Meet with foreign governments to share results of domestic
prevention efforts and develop approaches for improving food safety at
the source.
Provide foreign countries with technical assistance so
that they can enhance their regulatory systems.
Analyze food import trend data and integrate it into a
risk-based approach that focuses inspection resources on those imports
that pose the greatest risk.
Focus foreign inspections on high-risk firms and products.
Improve FDA's presence overseas.
Question 3. Mr. Corby will testify about the unique and successful
partnership the State of New York has developed with the FDA. Does the
FDA have plans to replicate that partnership with other States?
Answer 3. Yes. FDA has posted the New York Department of
Agriculture and Markets partnership agreement on the FDA Partnership
Internet site and has made it available to all FDA Districts and the
States. To the extent resources are available and States are willing to
enter into these agreements, FDA has encouraged its District Offices to
develop the appropriate partnerships to enhance the working
relationships with the States within their districts.
Question 4. Mr. Corby's written testimony mentions North Carolina's
use of an Incident Command System for the chili sauce recall. Due to
that system, NC performed more recall audit checks than the rest of the
country combined. Do HHS and FDA have any intention of pushing more
States to adopt Incident Command Systems?
Answer 4. North Carolina demonstrated that its State
infrastructure, the Incident Command System (ICS), functioned
exceptionally well during a national recall. FDA has been working on
the use of an Incident Command System process and recommended that
basic ICS training include ICS-100 (Introduction to Incident Command
System), ICS-200 (ICS for Single Resources and Initial Action
Incidents), ICS-700 (National Incident Management System (NIMS), An
Introduction), and ICS-800 (National Response Plan (NRP), An
Introduction) on-line training courses for FDA staff who may be called
upon to respond and manage emergency incidents.
In 2007 and 2008, the FDA's Office of Crisis Management/Office of
Emergency Operations and the Office of Regulatory Affairs began a
series of ICS training classes to be held across the country in
National Incident Management System (NIMS), ICS 300 (Intermediate ICS
for Expanding Incidents) and ICS 400 (Advanced ICS). The target
audiences for these classes are both FDA and State officials with a
goal of integrating response operations across Federal, State, and
local jurisdictions.
Question 5. I'm pleased the FDA Food Protection Plan includes
strategies to protect the food supply from intentional contamination--
known as food defense. In my view, it doesn't matter if food is
contaminated unintentionally or intentionally--we should be prepared
for both. As you know, the human health and economic consequences of a
deliberate attack on our agriculture and food system could be massive.
And we know from intelligence sources that some folks are interested in
acquiring the ability to do so. Mr. Secretary, how are you working with
DHS and USDA to ensure a coordinated approach to protecting the
agriculture and food system from biological, chemical, or radiological
contamination?
Answer 5. The National Strategy for Homeland Security and the
Homeland Security Act of 2002 served to mobilize and organize our
Nation to secure the homeland from terrorist attacks. The homeland
security goals to prepare for, and respond to, such events are set
forth in Homeland Security Presidential Directives (HSPDs) 5, 7, 8 and
9. HSPD-5 ensures that all levels of government responding to an
incident of national significance have the capability to work
efficiently and effectively together using a common national domestic
incident management approach, and HSPD-8 provides guidance on how to
prepare for such a response, including prevention activities. HSPD-7
focuses on issues concerning protection of all national critical
infrastructures and key resources, the majority of which are owned and
operated by the private sector. HSPD-9 represents a major step toward
establishing a comprehensive national policy to defend the food and
agriculture system against ``terrorist attacks, major disasters and
other emergencies.''
Significant progress in the Food and Agriculture Sector, one of the
identified Critical Infrastructures, on homeland security goals can
only be accomplished through a partnership effort between all levels of
government and those who own the Critical Infrastructure. The Food and
Agriculture Sector Coordinating Council (SCC) was formed as part of the
private sector response. The SCC is a self-governing body representing
the food and agriculture industry. It provides a forum for the private
sector to discuss infrastructure protection issues among themselves and
to communicate with the government through the Government Coordinating
Council (GCC). The GCC, with representation from Federal, State, Tribal
and local governments, is the public sector component of the food and
agriculture public-private partnership framework. The objective of the
GCC is to provide effective coordination of food and agriculture
security strategies and activities, policy, and communication across
government and between the government and the Sector to support the
Nation's homeland security mission. The GCC conducts monthly conference
calls to discuss infrastructure protection issues. Also, monthly calls
are held between the leadership for the GCC and SCC to discuss
infrastructure protection issues. The Food and Agriculture Sector holds
a joint face-to-face GCC/SCC meeting each quarter to discuss issues of
concern. Finally, the Food and Agriculture Sector is also populating an
electronic notification system with contact information for the GCC and
SCC members so that we can convene a meeting of the sector members on
short notice.
In July 2005, the Department of Homeland Security (DHS), the U.S.
Department of Agriculture (USDA), the Food and Drug Administration
(FDA), and the Federal Bureau of Investigation (FBI) announced a new
collaboration with private industry and the States in a joint
initiative, the SPPA Initiative. The SPPA Initiative is a true
partnership program, where an industry member, trade association or
State may volunteer to participate in this vulnerability assessment
program utilizing the ``CARVER + Shock'' method. The desired results of
the SPPA Initiative include sharing:
Unclassified reports that detail generally identified
vulnerabilities, possible mitigation strategies, and warnings and
indicators of an attack. The unclassified reports will be distributed
to all site participants.
Classified Reports that outline sector-wide
vulnerabilities and lessons learned to effectively and appropriately
prioritize national assets and resources. The classified reports will
be distributed to DHS, USDA, FDA, and FBI.
The ``CARVER + Shock'' assessment tool, and adapt, if
necessary, to its unique production, processing, retail, warehousing,
and transportation system for each sub-sector.
Lessons learned.
Assessment templates for each ``system'' by sub-sector
that can be exported to other sites to identify vulnerabilities that
incorporate existing tools.
Sector-specific investigative templates and field guides
for the food and agriculture/intelligence sector.
R&D initiatives related to the food and agriculture
sector.
Conducting face-to-face CARVER + Shock evaluations is resource-
intensive and limiting in terms of the number of evaluations that can
reasonably be conducted in any given timeframe. Therefore, the FDA has
sponsored the development and delivery of a CARVER + Shock software
tool that can be downloaded for free. In developing this software, FDA
worked closely with USDA and beta tested the software with DHS in order
to ensure maximum applicability. By having an on-line, free to use,
CARVER + Shock software that produces results equivalent to those of a
face-to-face session, any member of the food processing industry now
has the ability to conduct a vulnerability assessment of their
facilities and processes in a confidential manner. This CARVER + Shock
software tool went live on our Web site in late June 2007 and has
already been downloaded more than 2,000 times. The software tool is
expected to be used by State and local food security agencies,
industrial providers and any other parties interested in food defense.
The tool is designed for use throughout the food processing industry.
In addition, FDA in cooperation with the Centers for Disease
Control and Prevention, USDA, and State and local organizations
representing food, public health, and agriculture interests announced a
new food defense awareness initiative, ALERT. The ALERT initiative is
designed to provide a uniform and consistent approach to food defense
awareness at any point in the food supply chain, from farm to retail
establishment. ALERT identifies five key points that industry and
businesses can use to decrease the risk of intentional food
contamination. The five key points are as follows:
A--How do you ASSURE that supplies and ingredients you use are from
safe and secure sources?
L--How do you LOOK after security of the products and ingredients
in your facility?
E--What do you know about your EMPLOYEES and people coming in and
out of your facility?
R--Could you provide REPORTS about the security of your products
while under your control?
T--What do you do and who do you notify if you have a THREAT of
issue at your facility, including suspicious behavior?
We have prepared ALERT materials in several languages (English,
Spanish, Chinese, Korean, and Vietnamese) and offer training on our Web
site that is suitable for State, local, and industry stakeholders.
These are just a few of the many activities we have undertaken to
protect against vulnerabilities and to coordinate and share information
with our food defense partners.
Question 6. In November, FDA awarded grants to three Food Emergency
Response Network (FERN) labs to improve the ability to detect
radioactive material in food resulting from deliberate or accidental
contamination. How will these new radiological screening and analysis
capabilities fit into the overall food defense surveillance strategy
supported by FERN?
Answer 6. The new radiological screening and analytical
capabilities are targeted toward enhancing detection of radiological
contamination and strengthening the Nation's overall capability to
rapidly detect and respond to deliberate attacks on the food supply.
These enhanced capabilities further expand the FDA's advancement of
the integrated strategy for protecting the Nation's food supply by
their direct application in the three core elements of prevention,
intervention, and response as outlined in the agency's Food Protection
Plan. Laboratories with the established radiological capabilities will
be involved in food defense surveillance testing and will bolster the
FDA's emergency response efforts by increasing the capacity for testing
of foods for radioactive contamination, whether intentional or
accidental.
Question 7. Do you perceive the user-fee outlined in Chairman
Dingell's bill to be a tax or a user-fee?
Answer 7. We would note that a user-fee relating to imports would
need to be consistent with U.S. obligations under treaty. While
deferring to the United States Trade Representative (USTR) in this
area, we understand that under Article VIII of the General Agreement on
Tariff and Trade (GATT), fees--other than import duties and other taxes
covered by another GATT provision--must be limited in amount to
approximate the cost of services rendered and must not represent an
indirect protection to domestic products or a taxation of imports for
fiscal purposes.
Question 8. Do we need mandatory, enforceable, on-farm standards
for safe produce production (as suggested by Mr. Taylor) or voluntary
food protection plans as outlined by the FDA Food Protection Plan?
Answer 8. We believe that the development of written food
protection guidelines to facilitate industry food protection plans for
produce is an important step to ensuring produce safety. These
guidelines would make a significant contribution to shifting the focus
of produce safety from response to prevention, would call attention to
corporate responsibility, and likely could be implemented significantly
faster than a mandatory approach. In addition, FDA continues to explore
additional actions it might take to improve produce safety. In 2007,
FDA held two public hearings on produce safety which included the
solicitation of all our stakeholders on ways to improve the safety of
fresh produce. More specifically, FDA requested comments on what new
Federal actions, if any, are needed to enhance the safety of fresh
produce. FDA will continue to work with industry, consumer, and
Federal, State, local, and international partners to comprehensively
review food supply vulnerabilities and develop and implement risk
reduction methods.
questions of senator hatch
Question 1. You have proposed a role for accredited third parties
to evaluate compliance with FDA requirements. Ever since the Medicare
program began, third parties have evaluated whether hospitals comply
with Medicare requirements. Very little inspection is done by Federal
workers. Can food safety follow the Medicare model?
Answer 1. The Import Safety Action Plan and the Food Protection
Plan acknowledge that the ever-increasing volume of imported products
and the complexity of food safety issues associated with them require
an approach other than an exclusive reliance on examinations and
analyses performed when products reach U.S. ports of entry. We have
called for ``pushing out the borders'' by incorporating information
about how the product was produced and the food safety controls and
checks that were in place during its production into the import entry
decision making process. This information can come from the processor,
the government of the country in which it was produced, or reliable
third-party, nongovernmental organizations. Such work is already done
by these entities and information about those efforts could be used to
inform the FDA entry review process. If the information that is
obtained is sufficient to conclude that the risk of product
adulteration or misbranding is significantly reduced, then the need for
FDA examination or testing may be similarly reduced. That could enable
FDA to shift those resources to riskier products, for which there is
little or no information about its life cycle. FDA is working to
develop these kinds of systems to improve the efficiency and
effectiveness of U.S. control over imported foods. FDA does not
envision that these systems will take the place of sampling and
examination at the port of entry, but does envision that they will be
an important component of the overall entry control system. Of course,
third party information, whether it is derived from a governmental or
nongovernmental source, is only as valuable as the accuracy and
integrity of the information. For that reason, the Import Safety Action
Plan and the Food Protection Plan both acknowledge the need for
auditing and/or accreditation systems for third party certifiers.
A third party inspection system for food safety could have many
similarities with the Medicare hospital model. However, one major third
party in the United States is responsible for hospital inspections
whereas we envision multiple third parties will be necessary to conduct
food establishment inspections worldwide.
Question 2. What is the role of accredited third parties in other
countries?
Answer 2. Official accreditation is the procedure by which a
government agency having jurisdiction formally recognizes the
competence of an inspection and/or certification body to provide
inspection and certification services on its behalf. Depending on the
program, an officially accredited third party may either: (1) carry out
inspections and tests directly on the agency's behalf to ensure that a
product is in conformance with requirements; or, (2) certify an entity
(e.g., conformity assessment service/inspection service/laboratory) to
carry out services according to specified criteria.
The role of accredited third parties is to ensure that products
meet requirements. This is the case whether accredited third parties
carry out their work in other countries with respect to imported food,
or whether they carry out their work domestically on domestically-
produced food. This is also the case whether such third parties
accomplish their objectives through direct product inspection and/or
testing, or whether they accomplish the objective indirectly, e.g.,
certifying another body to actually inspect and/or test the product.
For example, Australia permits the utilization of accredited foreign
third parties to ensure that quality management systems are in place
for a specific food producing firm/establishment to ensure that
Australia's food safety requirements are met. Food produced by such
firms/establishments is permitted to enter Australia at its lowest rate
of inspection.
Question 3. What are the advantages and disadvantages of seeking
agreements with other countries to recognize the same accredited third
parties?
Answer 3. The principal advantage of having an agreement with
another country which recognizes the same accredited third parties is
the potential for enhancing information sharing. Since regulatory
requirements for a food normally differ between countries, it would not
be expected that an agreement with a country to mutually recognize an
accredited body would result in accepting the other's country data for
regulatory purposes. However, having in place an agreement to recognize
the same accredited third party should increase confidence in the data
gathered by the third party for either country and should enhance data
sharing. This data sharing could provide significant industry as well
as consumer health benefits and could result in better targeting of
scarce resources.
There do not appear to be obvious disadvantages for two countries
seeking an arrangement to recognize the same third party. Presumably
the accredited third party treats each country as a separate and unique
client. If confidentiality and conflict of interest requirements differ
between the two countries, these two areas could become difficult
obstacles to overcome, but would not necessarily be disadvantages.
Question 4. Could mutual recognition of accredited third parties
speed harmonization of standards across countries?
Answer 4. Harmonization of standards can refer both to specific
national standards for food products and to standards for assessing
conformance by assessment bodies such as third party certifiers. It
would not be expected that mutual recognition of accredited third
parties would result in any harmonization of specific product
standards. However, the mutual recognition of an accredited third party
by two or more countries using an agreed upon specific set of criteria
could speed the use of the criteria as an assessment standard,
particularly if those countries were influential in world trade
discussions.
questions of senator allard
Question 1. Can you describe how the recommendations by the working
group, and FDA, would have avoided and/or more quickly addressed the
issues that arose in relation to our domestic food supply over the past
year? Please address, specifically those dealing with E. coli
contaminated spinach and salmonella contaminated peanut butter?
In your opinion did the current system effectively address these
issues in a timely manner?
What did your agency learn from these situations, and how were
these concerns taken into account when making the recommendations that
you have discussed today?
Answer 1. The investigation into the E. coli outbreak linked to
bagged fresh spinach in 2006 determined that a number of the Good
Agricultural Practices recommended by FDA were not being followed on or
near the field implicated as the source of the contaminated spinach. As
part of the Food Protection Plan announced by FDA in November, FDA will
strive to ensure that Good Agricultural Practices are being implemented
on produce farms in the United States and on farms in other countries
that export produce to the United States.
FDA responded immediately to the outbreak upon learning that fresh
bagged spinach had been implicated as the vehicle in the outbreak. FDA
was told of the link to fresh bagged spinach late in the day on
September 13, 2006. FDA and the California Department of Health
Services had staff in the packing house on September 14, and FDA issued
a warning to the public the same day. Your response to the outbreak
could not have been any faster.
Similarly, FDA was informed that peanut butter had been implicated
in the Salmonella Tennessee outbreak on February 13, 2007. FDA
contacted ConAgra, the manufacturer, that same evening. FDA and the
Georgia Department of Agriculture had staff in the manufacturing plant
the next day, and FDA issued a press release alerting consumers not to
eat peanut butter under the brands Peter Pan and Great Value.
Subsequent press alerts were issued as greater knowledge of the scope
of the contamination was determined over the course of the
investigation.
FDA's response was timely and communications were consistent with
the information we had about the scope of the problem. While we worked
to ensure timely and coordinated communications with stakeholders, we
are seeking to enhance communications and outreach with industry, State
and local government partners. The Food Protection Plan has a component
focused on improving communications.
Consistent with the Food Protection Plan's three main themes of
Prevention, Intervention and Response, we are seeking to build safety
into the production of produce and manufactured foods, verify
prevention and intervene when risks are identified, and respond rapidly
and appropriately when outbreaks occur.
Question 2. In your opinion what can be done to further educate the
public, private sector and interested government agencies on food
safety, recalls, etc.''
Answer 2. We currently engage in a large portfolio of activities
related to educating the various stakeholder groups, many of these in
partnership with other Federal agencies. There are additional
activities that we could engage in to further educate the stakeholders
listed above regarding food safety and recalls. To reach the broadest
population of stakeholders, TV and alternative mass media campaigns
need to be considered. Curriculum for elementary, middle, and high
schools relative to food safety could also be considered. In some
cases, the information provided to the children will serve to educate
their parents. We are exploring a reinvigoration and associated
marketing campaign of our branded Web site, www.foodsafety.gov, shared
among USDA, CDC and FDA, where stakeholders can find food safety
information and information on recalls. Routine public safety
announcements and radio spots could be increased in frequency and
content. In short, we need to use the media and our schools more
broadly for food safety and recall educational purposes.
With regard to recalls, the recalling firm has the primary
responsibility to effectively and rapidly remove problem products from
the marketplace. FDA carefully monitors, advises or provides direction
in the recall efforts, and often undertakes additional steps to enhance
recall effectiveness by issuing press releases, posting information on
the FDA Web site, disseminating information to our State regulatory
partners, and by making Agency experts available for inquiries from
media, industry, or consumers. We recently began posting photographs of
recalled food items on the FDA Web site for significant recalls to
enhance the public's ability to accurately identify the problem
products. For the most significant ones, FDA establishes dedicated
pages on the FDA Web site where all the most current information
relative to a recall can be found. In addition, consumers and
businesses can now subscribe to a Listserve available on FDA's Web site
(http://www.fda.gov/opacom/7alerts.html) that will automatically
provide information via e-mail on recalls, market withdrawals and
safety alerts. This Web site also allows the public and private sectors
to query the system for information on specific recalls. We plan to
assess existing FDA consumer materials to determine if additional
resources on where to find recall information is required for the
consumer. We will continue to engage consumer groups for input on
optimizing recall communications.
There are, however, additional activities FDA can pursue to ensure
even greater public awareness of food-related recalls and we are
exploring other options.
Response to Questions of Senators Kennedy, Harkin, Enzi, Burr and
Allard by Michael R. Taylor
questions of senator kennedy
Question 1. There's a lot of real value in the Food Protection
Plan, however, one thing that concerns me is that the plan proposes
allowing the agency to require process controls for a food, but only
after the food is associated with repeated instances of serious adverse
health consequences or death. Why should the FDA have to wait for
children or the elderly to die or be seriously injured by a food before
companies making it are required to make it safely?
Answer 1. FDA should not have to wait until people are hurt before
requiring that food producers and processors implement commonsense
preventive-process controls. We should instead be taking a public
health approach to food safety, which means focusing on preventing
problems that can make people sick rather than merely reacting to
problems after people are hurt. And the fact is that many companies
already implement modern process control procedures to prevent food
safety problems. My recommendation is that Congress should mandate
preventive process control, flexibly adapted to a company's particular
circumstances, as the proper standard of care for all food companies.
Question 2. A significant impediment to the FDA doing a better job
on food safety is its serious lack of adequate resources. I believe the
President should propose a substantial increase in FDA's budget and the
Congress should increase appropriated funds to the FDA. Assuming that
won't happen, or that increases won't be sufficient, I'd like you to
comment on some ways to leverage FDA resources:
a third party program for inspection and laboratory
testing;
fees on the food industry, such as an annual registration
fee;
enhanced collaborations with States and localities.
Answer 2. I agree with the Chairman that, ideally, FDA's public
health regulatory programs should be fully and adequately financed with
appropriated funds. If that doesn't happen, however, I think all three
of the suggested ideas have promise as ways to leverage or enhance FDA
resources.
Many food companies already undergo third-party audits to verify
they are operating state-of-the art preventive process control systems
in response to the demands of their commercial customers, such as
restaurant and grocery chains. Such audits could be a useful surrogate
for FDA inspections if the auditors could be accredited by FDA or some
other credible body to verify their independence and qualifications and
if records of their audits were readily available to FDA. FDA could
then focus its resources on companies that are not subject to such
audits. I see somewhat less potential for leveraging private laboratory
capacity. The network of commercial laboratories that already exists
plays a useful role in performing testing to support the industry's
process control needs, and efforts should continue to ensure that such
labs are properly accredited and reliable. FDA should be able to
consider data from demonstrably reliable private labs in the course of
its regulatory decisionmaking. Such private testing capacity can never
substitute, however, for FDA having substantial, first-tier lab
capacity in-house for the testing needed to support its inspection and
enforcement activities.
With respect to fees on the food industry, I think a well-
structured annual registration fee system may be the most equitable way
to generate a significant base of resources for FDA's food safety
program. The very large number of domestic and foreign food
establishments under FDA's jurisdiction would make it possible to raise
significant sums while keeping the per establishment fees very modest,
and this would avoid any sense that the agency was dependent on or
beholden to any small group of companies for its resources. It would be
important to make clear that, in its use of its food safety resources,
FDA is properly accountable to the public and the Congress, not the
food industry.
Finally, enhanced collaborations with State and local agencies
should be an important element of a modernized national food safety
system, regardless of concerns about resources, but I also agree that
through more active partnerships with States and localities, FDA can
achieve much more to improve food safety than it ever could on its own.
There are over 3,000 State and local agencies, including health and
agriculture departments, local sanitarians, and public health
laboratories, working on some aspect of food safety. In addition to
their traditional role as the front-line regulators and inspectors of
retail food establishments and investigators of food-borne disease
outbreaks, State and local agencies can play an important role in the
enhanced food safety oversight that is needed on the farm. In the end,
we need an integrated, national food safety system that takes full
advantage of the expertise and resources available at all levels of
government.
Question 3. You raised concerns about relying on voluntary efforts
by the industry. Could you please expound on the problems with a
voluntary approach to food safety?
Answer 3. First, I recognize and respect the fact that many leading
companies are making efforts to implement modern, state-of-the-art food
safety procedures that go well beyond any government requirement.
Indeed, historically, and still today, much of the on-the-ground
innovation in food safety has come from the food industry, including
HAACP (Hazard Analysis and Critical Control Points), which represents a
standard of care for preventive process control that is widely accepted
among food safety experts and practitioners. Companies that implement
these procedures know that it is in their best business interest to do
so in light of the nature of the markets in which they operate and the
demands of their customers. Many companies also are committed to food
safety because it is the right thing to do.
Unfortunately, some companies operate in markets that are driven by
low cost rather than high quality or high safety standards, and not all
companies have the same level of internal corporate commitment to food
safety. That is why we need regulation: to ensure that all participants
in the commercial market for food observe a well-defined standard of
care for food safety that meets reasonable public expectations. Efforts
by government to ``encourage'' voluntary improvement in food safety
practices by companies that are not otherwise committed to them for
business or other reasons can easily be ignored and can have at best a
transitory effect. In a voluntary system, when the government efforts
at encouragement flag, marketplace and business reality take over, and
there is no mechanism in place for holding companies accountable for
observing a standard of care based on prevention of food safety
problems. The government is left in a reactive mode, able to seek
correction only after a problem has been found with food in the
marketplace or after someone has gotten sick. The public--and companies
that already follow proper food safety procedures--expect and deserve
better.
Question 4. You argue that every food company should have a plan to
prevent food safety problems. Some would argue that such an approach is
not risk-based, is over-regulatory, and will require companies to spend
money for little gain in food safety. How would you respond to these
concerns?
Answer 4. This is an important point: modern preventive process
control is inherently risk-based and flexible in the sense that it
involves companies tailoring their preventive controls to the
particular hazards that are likely to arise in their operations and to
their own production or manufacturing system. Some plants are
inherently low-risk and can have very simple food safety plans, while
others may require more robust plans to deal with more significant
potential hazards. I also think that, in crafting a legislative mandate
in this area, Congress should recognize the need for flexibility in
implementing a comprehensive requirement for food safety plans based on
preventive controls. Small businesses should be given technical
assistance and more time to comply; all firms should get clear guidance
to facilitate the implementation of plans that add to the level of food
safety assurance without being unduly burdensome. The point is not to a
have a plan that exists just to satisfy a regulatory requirement but
rather to have a plan that helps a company have confidence--and be able
to assure customers--that proper steps have been taken to make the food
safe.
Question 5. What can the HELP Committee, which is an authorizing
committee and not the Appropriations Committee, do to increase the
frequency with which food facilities are inspected?
Answer 5. One of the critical policy issues in considering reform
of the food safety system is the role of inspection and the nature and
frequency of inspection sufficient to be effective. This is very much
an issue for the HELP Committee. In my view, inspection should be seen
as part of an overall program to ensure a high level of compliance with
food safety standards. Some minimum frequency of inspection is no doubt
needed for this purpose, and one thing Congress could do is mandate a
minimum frequency, while also recognizing that some food establishments
pose a higher risk of non-compliance than others--and thus merit more
frequent inspection--based on the inherent nature of their operations
and their own performance over time. By establishing through
authorizing legislation a modern, risk-based inspection mandate that
includes measures of performance for FDA in terms of frequency of
inspection and levels of compliance with food safety standards,
Congress will have given the Appropriations Committees a benchmark
against which to consider necessary funding levels.
Question 6. You talked about food safety from farm-to-table. Ms.
Smith DeWaal talked about food safety on farms, and Mr. Dooley
mentioned good agricultural practices for produce. Traditionally, the
FDA doesn't play a huge role on farms or at retail establishments. Do
you have some suggestions about how we could enhance FDA's role there
without raising the obvious sensitivities? What role can the States
play?
Answer 6. A true public health, preventive approach to food safety
has to consider the full spectrum of the food system, from farm-to-
table, because risks and opportunities to reduce risk exist all across
that system. Both the production (on-farm) and retail ends of the
spectrum present unique challenges for any food safety regulatory
strategy, however, that are quite different from those that arise in
food processing establishments. And I agree that these differences and
some of the special sensitivities that exist, especially on the farm,
need to be considered, and I think State and local agencies have
important roles to play, both on the farm and at retail.
One of the challenges on the farm is that there are so many
independent farming operations of enormous diversity in terms of the
products they produce, the conditions under which they produce them,
and, especially, their size. Moreover, historically, while animal
producers have been subject to regulation with respect to their use of
pesticides and animal drugs, they have been left largely out of the
food safety system's efforts to reduce the burden of foodborne illness
associated with pathogenic microorganisms. This is despite the fact
that the basic concepts of preventive process control that can reduce
risks in processing plants can be applied on the farm. Preventive
controls on the farm need to be pursued, however, by recognizing the
diversity of operations and working with agricultural producers to
craft approaches that are flexible and adaptable to diverse conditions.
It may be appropriate, for example, to focus the scope of any
regulatory requirements on the farm where they can do the most good for
food safety by exempting certain commodities, such as grains, and
possibly small producers. The fact is that a large percentage of the
Nation's supply of fresh produce that is vulnerable to dangerous
contamination is produced by a relatively small number of large
producers. In addition, government oversight on the farm should take
full advantage of State and local agencies for inspection and other on-
farm activities. In my view, standards should be set nationally, while
on-farm verification that standards are being met could be done
principally by State and local inspectors or accredited third-party
inspectors.
At retail, State and local agencies already take the lead in
inspection under a longstanding collaboration with FDA, which
recommends through its model Food Code science-based standards and
procedures for preventing food safety problems. At their discretion,
States and localities adopt and enforce Food Code provisions or other
standards and thus play the front-line role on retail food safety. This
should continue. It is neither feasible nor desirable to have Federal
inspectors inspecting every grocery store and restaurant in the
country. Instead, the focus should be on strengthening the State and
local roles by creating greater Federal incentives for adoption of the
Food Code and greater Federal support for State and local compliance
programs through technical assistance, training, and investment in
local laboratory capacity.
Question 7. You testified about how important increased resources
are for the FDA. How much does the FDA currently have for inspections?
How much does it need? Do you have a sense of what the agency could do
with another $10 million? Another $100 million?
Answer 7. FDA's total field budget for the food program in fiscal
year 2007 was about $300, which supported a total field workforce of
about 1,900, including inspectors and the laboratory personnel and
compliance officers needed to test products and build cases based on
the work of the inspectors. This workforce has to cover nearly 50,000
domestic processing establishments and nearly three times that number
overseas, which account for millions of import shipments annually. FDA
inspects most domestic plants rarely if at all, tries but fails to
inspect all ``high risk'' seafood plants annually, visually inspects
less than 1 percent of import shipments, and actually tests less than a
fifth of those. I recite these facts to illustrate my view that a $10
million increase would be insignificant in relation to the challenges
FDA faces and that even a $100 million increase, by itself, would not
solve FDA's funding problem over the long haul.
I personally think that the budget for FDA's field force needs to
double in real terms in order to keep up with the growing complexity of
food safety problems and the flood of imports. But, to be effective,
FDA's field force needs more than additional resources: it needs to be
deployed in support of a new preventive strategy--one that empowers
FDA's field force to hold companies accountable for implementing having
appropriate preventive controls, rather than FDA being in the business
of simply detecting and correcting problems. At any realistic funding
level, FDA will never have enough inspectors to adequately protect food
safety if they are working in their present, largely reactive mode.
Question 8. I understand FDA now inspects food facilities on
average every 10 years. I think it's unlikely that appropriated money
will increase enough, or that a user fee program could raise enough
money, to allow FDA to inspect every food facility annually or even
every 2 years. So there might be some value in a third party inspection
program, if companies were to participate in it. Would you support such
a program? Under what conditions?
Answer 8. I think a third-party inspection or ``audit'' program can
add value to the food safety system by providing a credible,
independent source of verification that a company has in place the
right preventive controls and that the controls are working properly.
Government inspection resources could then be deployed more toward
companies that are not subject to such third-party inspections. To be
relied on for any governmental purpose, however, at least the following
conditions should apply: (1) the auditing firms must be accredited and
the auditors certified as meeting prescribed standards of training and
experience, (2) the records of their audits must be readily accessible
to FDA; (3) adverse findings that suggest unsafe product might be in
the market must be reported promptly to FDA; and (4) FDA would retain
the discretion to inspect plants that had been subject to a third-party
audit.
Question 9. Given finite resources and the many millions of
imported food shipments from thousands of foreign sources, how can FDA
provide sufficient oversight to assure American consumers that imported
foods are safe?
Answer 9. As with domestically-produced food, Congress needs to
provide FDA with a modern mandate for oversight of imports that is
commensurate with the globalization of the food supply. Specifically,
Congress should make the U.S.-based importer or other responsible
entity accountable for ensuring that the imported food has been
produced in accordance with U.S.-food safety standards, including
applicable preventive process controls. This approach calls upon
importers to manage their supply chains responsibly and, as a condition
of entry of food into the United States, be able to document that
imported food was produced under conditions that make it safe. Though
this approach relies on the food industry meeting its food safety
responsibilities, it requires meaningful government oversight to be
effective and credible. Some of this could come by enhancing FDA's
authority and resources to inspect overseas and to work with foreign
governments to leverage their food safety oversight capacity. In
addition, imports may be particularly amenable to third-party audits as
a complement to government inspection. Importers with well-documented
systems for ensuring the safety of their products that are verified
regularly by independent, credible auditors could be given fast track
entry into the United States.
questions of senator harkin
Question 1. I agree with your emphasis on prevention of food-borne
illness as presented in your testimony. However, to focus on
prevention, we must act in a coordinated manner across all government
agencies that play a role in ensuring the safety of our Nation's food
supply.
Please describe the steps that FDA, USDA, and other agencies with
responsibility over food safety can take to coordinate programs and,
more importantly, integrate their missions, in order to focus on
prevention, intervention, and response as called for in the FDA Food
Protection Plan.
Answer 1. The Federal Government's many food safety agencies cannot
effectively coordinate their programs, integrate their missions, and be
more preventive under the current structure of the system, which is
prescribed by law. Certainly, there has been coordination in certain
focused areas, such as among CDC, FDA and USDA's Food Safety and
Inspection Service on food-borne illness surveillance and outbreak
investigations. With respect to integrating their core food safety
programs, however, the agencies are hamstrung. This is most evident in
the case of FSIS, which gets two-thirds of Federal food safety
resources to carry out a statutorily required but obsolete form of
inspection in the Nation's meat and poultry plants. FSIS is required by
law to use nearly all of its resources for this purpose, rather than
for collaborating with FDA on integrated preventive strategies, and
FSIS is even precluded by law from working with FDA on the farm to
address pathogens such as E. coli O157:H7 and Salmonella, which often
originate on the farm but then affect meat and poultry and FDA-
regulated products, such as fresh produce. The only substantial and
lasting solution to the lack of integrated effort across the Nation's
food safety system is legislative change. Congress should modernize the
food safety laws to make prevention the central responsibility and to
create a unified organizational structure with clear accountability for
mounting integrated, prevention-oriented efforts to reduce foodborne
illness.
questions of senator enzi
Question 1. You talk about performance standards, and I think this
makes a lot of sense. One thing I worry about, though, is a
proliferation of dozens or even hundreds of performance standards and
how businesses, especially small businesses, can stay on top of it. We
don't want to take all the innovation and flexibility out of the
system. How do we make sure we have the standards we need, without
getting too far down in the weeds?
Answer 1. Performance standards should focus on significant hazards
where an objective measure of performance can make a clear contribution
to food safety. The number of such hazards in any operation is
typically small and thus any given business should have a fairly small
number of standards to keep up with. In addition, proper performance
standards are inherently flexible and should promote innovation. For
example, rather than telling a company the exact time and temperature
it should achieve in cooking a ready-to-eat food (a so-called ``command
and control'' approach), it should specify the amount of pathogen kill
required to produce a safe food and leave it to the innovation of the
company to adopt the cooking process that works best for its products
in its operation. In this way, the government sets the food safety
goal, on behalf of the public, and the company is free to choose how
best to achieve the standard.
Question 2. You object to the standard in the Food Protection Plan
for FDA imposing preventive controls of a food associated with
``repeated serious adverse health consequences or death.'' Other than
the use of the word ``repeated'' isn't that basically the standard for
a Class I recall? We have to set priorities somehow--why isn't this
standard good enough? What should the standard be?
Answer 2. My most fundamental objection to the approach in the FDA
Food Protection Plan is that it relies on FDA rulemaking to establish
requirements for preventive process control on a case-by-case basis. I
think we need a comprehensive, congressionally mandated shift to
preventive controls, with FDA charged to implement the mandate in a
reasonable, flexible way, including possibly exempting some categories
of companies from the requirement. In short, based on all that the food
industry and the food safety agencies have learned about the value of
preventive controls, Congress should shift the presumption from one
that says such controls are not required to one that says they are.
While I do not think that the requirement of preventive controls
should be left to case-by-case FDA rulemaking, if it is, the standard
should be one that focuses on prevention, not the intensity of
reaction. The classification of a recall as Class I determines not
whether a product should be withdrawn but simply the intensiveness of
the efforts a company must make to pull adulterated product from the
market and confirm the effectiveness of the recall. It is appropriate
that the most intensive efforts be reserved for cases in which there
may be serious adverse health consequences. Products are also subject
to a recall, however, if they ``may cause temporary or medically
reversible adverse health consequences.'' Somewhat less intensive
efforts may be justified to complete the recall of such products from
the market, but we should still be seeking to prevent products posing
such risks from entering the market in the first place through
preventive controls. Otherwise, we would be failing to address the
great majority of foodborne illness cases through preventive controls,
which I believe would be bad for public health and public confidence in
the food supply. This is why the Class I standard for intensity of
reaction in a recall situation is not a good model for deciding when
preventive controls are needed.
Finally, I would note, as I did in my testimony, that the standard
proposed in the Food Protection Plan is actually more restrictive of
FDA's authority to require preventive controls than current law. Under
current law, FDA has mandated HAACP (Hazard Analysis and Critical
Control Points) based on the law's food adulteration provisions and the
general authority the law gives FDA to issue regulations for ``the
efficient enforcement of the Act.'' Under this standard, FDA can issue
preventive control regulations based on a showing that they will guard
against a reasonable possibility of injury to consumers. The last thing
Congress should do is make the standard for preventive controls more
restrictive at a time when many in industry, as well as the expert
community, are calling for a shift to prevention as the key to an
effective, credible food safety system.
Question 3. You suggest unifying the food-related components of FDA
into a single organization within HHS. I'm intrigued by this idea, as I
think it avoids some of the pitfalls of ``single food agency''
proposals, but I think it falls short on dealing with the fact that
there are still 20 different agencies that have a piece of food safety.
Do you believe a new organization split off from FDA would be better
off in terms of making sense out of the fragmented jurisdiction? Why?
Answer 3. I agree that bringing together all of the agencies that
have a piece of food safety is the ideal solution and should remain a
goal. I am convinced, however, that the right first step is to focus on
FDA and on building within HHS a model food safety organization with
the modern legislative mandate and other tools required to provide real
leadership on food safety nationally and internationally. At some later
time, if circumstances permit, the food safety functions of USDA could
be folded into a fully unified Federal food safety agency.
The new organization within HHS would be better off in its ability
to lead on food safety because, first, the four major components of FDA
with food safety responsibilities would be unified into a cohesive unit
with accountable leadership, and second, the food safety function in
HHS would be elevated within the department, thus enhancing the ability
of the food safety leader to be heard and be impactful in the executive
branch and in the world. Right now, the food function at FDA is
fragmented and submerged. That has to change for FDA and HHS to be
effective on food safety.
questions of senator burr
Question 1. How can the current FDA retail food safety program be
improved? What other actions can be taken to improve retail food
safety?
Answer 1. The key for FDA on retail is to build on and enhance its
partnership with the States and localities. Congress should recognize
in law the critical role of State and local agencies on retail food
safety, and it should provide FDA with the mandate and the resources to
foster wider adoption and effective implementation of the Food Code.
There is also much opportunity for FDA to leverage State and local
interest in retail food safety by providing training and other
technical assistance.
Question 2. Since you do not think FDA should be in charge of
determining when preventive controls should be required, what does the
new statutory prevention mandate for the FDA look like? What will the
rules be for industry, both domestic and international, to follow?
Answer 2. I think that Congress should establish by law the
principle (or presumption) that all those who produce and sell food
should have in place the basic preventive controls to make it safe.
This should be in the form of a flexible mandate that recognizes the
diversity of the food system from farm to retail and that authorizes
FDA to tailor the requirement to the circumstances of particular
sectors. The basic elements for both domestic and international
producers include demonstrated adherence to basic sanitation
procedures, awareness of the potential hazards in their operations, and
effective measures in place and working to minimize those hazards in
accordance with applicable food safety performance standards. This is
mostly common sense and good management of a food operation and should
be implemented with reasonableness so that the system is making a real
contribution to food safety, not just satisfying a legal mandate.
Question 3. Please explain in more detail your vision of FDA
reorganization and what type of food safety position you want to be
created.
Answer 3. I think FDA should be divided into two agencies. One
would manage FDA's drug, medical device and biologics functions. The
other would manage all of FDA's food-related functions and would
include the current Center for Food Safety and Applied Nutrition,
Center for Veterinary Medicine, the food-related field resources from
the Office of Regulatory Affairs, and the National Center for
Toxicological Research. The unification of these components in a single
agency would put all of the food safety resources and expertise under
one official, who could then be held accountable for the success of the
overall program. It is particularly important that the field force at
FDA become an integral part of the public health-oriented prevention
effort on food safety, with clear accountability to the food safety
leader. This bifurcated FDA should take advantage of synergies and
shared services to the extent possible.
In addition to being unified, the food function should be elevated
within HHS by making the leader of the food safety agency a
presidential appointment, with a 7-year term, and reporting directly to
the Secretary. The food safety leadership position should be
accountable to the Secretary, the President and the Congress but be
seen as a professional position that requires continuity to be
successful.
Question 4. What do you think about the Grocery Manufacturers
Association's idea of expedited entry of foods that meet FDA's
standards and conditions for expedited entry?
Answer 4. I support the idea of expedited entry as an incentive for
importers to more carefully manage their supply chains and to provide
an extra measure of assurance that their products have been produced in
accordance with U.S. standards.
Question 5. I noticed you used to run the USDA Food Safety and
Inspection Service in the 1990s. I'm interested in your perspective on
the best way for us to ensure any food safety and defense legislation
we enact reflects a comprehensive ``farm-to-fork'' strategy. We cannot
forget the farm portion of this equation--for both produce and animal
agriculture. What is your advice to us in this regard?
Answer 5. The food safety challenges at the farm level are diverse
and difficult. Approaches that work in processing plants may not work
well on the farm. Nevertheless, production agriculture is properly just
as much a part of the food safety system as any processor or retailer,
and ways need to be found to set and enforce standards for preventive
controls or other interventions on the farm where they can make a real
contribution to food safety. One example is the fresh produce sector.
Another is the control of pathogens in animal production. The
implementation of any new standards on the farm should be done in
partnership with State and local agencies, including agriculture
departments, that have working relationships with the farm sectors in
their communities.
questions of senator allard
Question 1. It is my understanding that during recent issues with
the domestic food supply, including issues with spinach and peanut
butter, the industry was willing and cooperative in working with FDA to
institute a recall. How would additional enforcement authority have
changed this scenario?
Answer 1. Most recalls are conducted voluntarily, and any mandatory
recall authority should be structured so that it does not undercut
incentives for companies to cooperate on voluntary recalls. FDA and
USDA should, however, have authority to mandate a recall when a company
does not cooperate or when a mandatory recall is the best way to
protect public health in an emergency situation. I do not know enough
about the details of the spinach and peanut butter cases to comment on
them specifically.
Question 2. In your opinion what can be done to further educate the
public, private sector and interested government agencies on food
safety, recalls, etc.''
Answer 2. I think the basics of food safety and how consumers can
protect themselves should be built into every elementary school
curriculum. With regard to broader public and industry education, no
agency has a clear mandate or significant resources for this purpose.
Without those tools, there is little the agencies can do. I think the
collaborative efforts on food safety education going on between
government and industry through the Partnership for Food Safety
Education have the right idea but lack the resources to achieve the
scale and reach needed to make a difference.
Question 3. Do you think that further education should play a role
in addressing food safety? Do you have a single suggestion to further
education and the distribution of informative resources regarding food
safety?
Answer 3. I think food safety education has a critical role to
play. Consumers have the right to expect that everyone involved in
producing and marketing food has done everything reasonably possible to
make it safe, but consumers still need to know and observe safe food
handling practices. I think educating kids from a young age as part of
their elementary education is the place to start.
Response to Questions of Senators Kennedy, Enzi, Burr, and Allard
by J. Joseph Corby
questions of senator kennedy
Question 1. A significant impediment to the FDA doing a better job
on food safety is its serious lack of adequate resources. I believe the
President should propose a substantial increase in FDA's budget and the
Congress should increase appropriated funds to the FDA. Assuming that
won't happen, or that increases won't be sufficient, I'd like you to
comment on some ways to leverage FDA resources:
a third party program for inspection and laboratory
testing,
fees on the food industry, such as an annual registration
fee, and
enhanced collaborations with States and localities.
Answer 1. Even if there were a substantial increase in resources
and funding for FDA, the majority of food safety efforts in this
country would still be performed by the States and local government
agencies. What FDA must do, and do now, is adopt strategies for
incorporating State and local government food safety efforts into a
national food safety and defense plan. This is something FDA has
recognized for years, but has failed to accomplish. FDA must leverage
third parties and government entities for inspection and lab testing in
order to meet today's food safety demands.
Third party inspection and lab testing at foreign manufacturing
plants is a logical step for assisting FDA with imported products.
State and local governments can very capably handle much of the
domestic inspection and lab testing that is needed. FDA should not be
eliminated from domestic food safety work, but a more collaborative and
coordinated effort could be established with State and local agencies
in a more strategic fashion. The Manufactured Foods Regulatory Program
Standards [MFRPS], when fully implemented, will ensure State and local
agencies are performing at a nationally recognized performance
standard.
Most States and local agencies do assess fees to food
establishments by way of licenses or permits. These can be used as an
administrative enforcement mechanism, allowing State and local agencies
to revoke a license or permit for firms that fail to follow food safety
standards. Registration fees, on the other hand, are generally employed
for raising income and do not carry the administrative clout a license
or permit has. These fees, whether a license, permit, or registration,
can provide necessary funding for government agencies to carry out
needed food safety control functions.
Enhanced collaboration with State and local government agencies by
FDA will never be accomplished until FDA begins to accept State and
local inspection results and laboratory analytical work. Although FDA
encourages States to enter their lab results into a data system called
Elexnet, they do not use those laboratory results to initiate
enforcement action. Some State laboratories, including New York's, are
part of FDA's Food Emergency Response Network [FERN] and FDA will
accept the test results of those laboratories for specific, FERN-
related activities. However, the routine analytical work on foods
performed by these same food labs is not accepted. If FDA were to
accept analytical work from State and local government labs and act on
that data, there would be an immediate impact on food safety. New
York's recalls of imported foods is one example. A total of 1,469
recalls of imported products from 61 countries were coordinated by New
York officials since 2002, and that information, including relevant lab
analysis, was shared with FDA. FDA Import alerts were only issued on
these products after FDA collected an additional sample of the recalled
product for their own individual testing. To date, FDA has issued only
13 import alerts from the 1,469 imported food recalls coordinated by
New York State.
Question 2. Mr. Taylor talked about food safety from farm-to-table.
Ms. Smith DeWaal talked about food safety on farms, and Mr. Dooley
mentioned good agricultural practices for produce. Traditionally, the
FDA doesn't play a huge role on farms or at retail establishments. Do
you have some suggestions about how we could enhance FDA's role there
without raising the obvious sensitivities? What role can the States
play?
Answer 2. States are already active at the producer level and FDA
must begin to leverage this work. State officials in California have
mandated a better practices program for leafy vegetable growers. State
officials in Florida and Virginia are active in mandating similar
efforts for tomato producers. Many other States, including New York,
have developed their own Good Agricultural Practices [GAPs]
certification programs and have made them available to fruit and
vegetable growers. These GAPs certifications are conducted annually by
States and have been used effectively by fruit and vegetable growers to
enhance their markets. The private sector also has a number of GAPs
certification entities.
Question 3. Mr. Corby, you describe how the FDA won't use test
results or other information generated by the States. It makes sense to
me that there could be considerable gains in efficiency if FDA were to
accept such information. Would New York State, and, if you can answer,
other States, be willing to work with the FDA to address any concerns
it may have about information generated by the States, to make this
happen?
Answer 3. The considerable gains you mention could be accomplished
immediately. Consider that more than half of the inspections of food
establishments reported annually by FDA were inspections performed by
States under contract with FDA. Why FDA will not accept all the other
inspections performed by the States in other food firms remains a
mystery to State food safety program managers. Also, food firms that
FDA may inspect once every 5 years or more are inspected annually by
the States and, in many cases, multiple times each year. All of the
States would likely be willing to work with FDA to develop a strategic
inspection plan that would coordinate efforts and avoid duplication.
Not all the collaborative efforts that could be accomplished would
require additional funding. FDA should, however, consider a better
funding system for the States than is currently utilized. USDA/FSIS is
budgeted funds specifically for working with the States. FDA needs a
similar line item in their budget for this purpose.
questions of senator enzi
Question 1. I like your idea of one food system. However, I don't
think one food agency is the way to one food system. How do we get to
one food safety system?
Answer 1. I believe a ``single food safety policy'' is what is
needed. Whether there is one agency or a multitude of agencies at the
Federal level, the States and local agencies will still perform the
bulk of the work. In the later part of 1990, an effort called the
National Food Safety System [NFSS] was put together and a number of
collaborative Federal/State efforts were developed which are still in
existence today. An alliance of food safety stakeholders should be
organized to identify foundations for re-establishing an integrated
food safety system for this country. There is currently an effort to do
this through George Washington University, the Association of Food &
Drug Officials [AFDO], and other organizations.
Question 2. How can we ensure that Federal food safety efforts
effectively leverage State and local activities? Your State has done so
through partnership agreements, but it seems that these have to be
executed State by State. Is there any way to do it more efficiently,
perhaps on a regional scale?
Answer 2. For inspection purposes, the Manufactured Food Regulatory
Program Standards [MFRPS] is a great place to begin. Once State and
local agencies verify that they meet the recognized program standards,
FDA should begin to offer these States more inspection contract work.
This added contract funding will provide States the motivation for
complying with the MFRPS and thereby qualify for additional funds, to
enhance the States' food safety programs. Most States will likely be
very anxious to participate.
An effort to leverage laboratory analytical work conducted by
States and local agencies is currently underway by FDA. This is a
critical piece for FDA and may require lab certification and methods
verification, all of which is currently supported by the States.
It is true that most collaborative Federal/State efforts today are
produced on a State-by-State basis. There are, however, a number of
successful existing partnership models that could be promoted and
applied nationally or regionally. Two of the more popular ones are the
Integrated Food Safety Partnership (model for State and FDA District)
and the Import Collaborative Project (New York and Texas). These
agreements are designed to produce a seamless system that is crucial
for enhancing a food safety program.
Question 3. When you share information with FDA, where does it go?
Do you think it just gets archived into a big database, or do you
believe this vital intelligence is acted upon?
Answer 3. We share information with the FDA District Office in
Jamaica, New York or the Upstate Import Office in Buffalo, New York.
This data and information can be transmitted from there to any FDA
office or Center. Unfortunately, the majority of this data is not
utilized.
questions of senator burr
Question 1. How many States have similar food safety partnerships
and/or import initiatives with the FDA offices in their States?
Answer 1. Texas has recently begun an imported food program modeled
after what New York has been doing, while Michigan and Oregon have
asked for our assistance in developing import programs there.
Question 2. What have been the biggest hurdles in working with the
FDA on those initiatives?
Answer 2. The biggest hurdle has been the laboratory issue. As
mentioned above, New York coordinated 1,469 food recalls of imported
foods from 61 countries, providing FDA with the analytical evidence
that the products were adulterated. FDA would only issue import alerts
after they had completed their own lab testing. More frustrating was
the fact that only 13 import alerts were accomplished for the 1,469
recalls because of FDA's lack of resources.
Question 3. I have heard about a new initiative, called FoodSHIELD,
which the Association of Food and Drug Officials is supporting along
with the DHS National Center for Food Protection and Defense and USDA.
I understand this system is supposed to support Federal, State, and
local government agencies, labs, and emergency responders in defending
the food supply through web-based tools. What are the benefits of
FoodSHIELD, and how can we support this innovative approach? In
addition, what is the status of the FoodSHIELD databases that will
profile the infrastructure responsible for protecting and defending the
food supply?
Answer 3. FoodSHIELD is a sophisticated web-based platform that
facilitates communication, coordination, education and training among
the diverse communities that make up the Nation's food and agriculture
sectors. It is sponsored by the National Center for Food Protection and
Defense [NCFPD] in partnership with the Association of Food & Drug
Officials. Two major components of FoodSHIELD are ``LABDIR,'' a
database that captures the national lab infrastructure, and
``Food&AgDIR,'' the counterpart for Federal, State, and local food
safety and defense programs. A few of the benefits of FoodSHIELD are as
follows:
Provides contact information for food protection and
defense individuals across the Nation at the Federal, State, and local
government levels;
Profiles all agencies responsible for food protection and
defense efforts from ``farm to fork'';
Illustrates the enormity of food protection and defense
efforts accomplished at the State and local levels by providing
specific data on inspections and investigations conducted at that
level;
Collects information from food laboratories relative to
accreditation, analytes, equipment, and expertise;
Allows agencies to gauge their program performance against
others through the use of Query tools;
Allows individuals to quickly obtain emergency contact
information for State and local governments; and
Expansion of FoodSHIELD will include similar available
information from industry.
There are currently about 28 States actively participating in
FoodSHIELD and AFDO is obtaining commitments from the remaining States
to get involved as well. Congress's support of FoodSHIELD would be most
welcomed.
questions of senator allard
Question 1. In your opinion what can be done to further educate the
public, private sector and interested government agencies on food
safety, recalls, etc.''
Answer 1. We need a comprehensive education and risk communication
system. Education should be a partnership between government, industry,
and academia to provide consumers with instant food safety information
concerning recalled products and illness issues. There have been a
number of real successes associated with the formation of stakeholder
alliances that were established to promote food safety education or to
advance HACCP principles within a specific food industry (ie., Seafood
HACCP Alliance). Stakeholders need to coordinate their education
programs and messages, and this could be accomplished through a
stakeholder's alliance. Product recalls must become better coordinated
as well. State and local governments are much closer to industry and
consumers than Federal agencies, and they can better provide
information to small businesses, non-English speaking entities, and
specialized food establishments such as food banks, food pantries, and
institutions.
Question 2. Do you think that further education should play a role
in addressing food safety? Do you have a single suggestion to further
education and the distribution of informative resources regarding food
safety?
Answer 2. Yes, education plays a very important role. Small
businesses are in greatest need of education and State and local
regulatory agencies have begun to target these establishments through
food safety education requirements that include management
certification and recertification. There is also food safety programs
provided to small businesses specifically designed to assist them in
gaining compliance with State requirements. We do this in New York and
find that 75 percent of the firms provided specific educational
guidance will gain compliance and pass their next inspection. We
believe that education has become an effective enforcement and
compliance tool. Multi-language materials and ethnic-specific
programming is best coordinated at the State or local level for the
reason mentioned in Question 1.
Response to Questions of Senators Kennedy, Enzi, Burr and Allard
by the Hon. Cal Dooley
questions of senator kennedy
Question 1. There's a lot of real value in the Food Protection
Plan, however, one thing that concerns me is that the plan proposes
allowing the agency to require process controls for a food, but only
after the food is associated with repeated instances of serious adverse
health consequences or death. Why should the FDA have to wait for
children or the elderly to die or be seriously injured by a food before
companies making it are required to make it safely?
Answer 1. The responsibility to produce safe food must, in the
first instance, rest with the food industry. Food companies are in the
best position to understand and evaluate the potential risks associated
with the production of different types of foods and to evaluate the
preventive controls that might reasonably address those risks. The
Secretary should thus have limited authority to require specific
preventive controls when there is a risk of severe health consequences.
The effectiveness and ongoing necessity of controls required under such
emergency circumstances should be periodically reviewed by FDA.
Question 2. A significant impediment to the FDA doing a better job
on food safety is its serious lack of adequate resources. I believe the
President should propose a substantial increase in FDA's budget and the
Congress should increase appropriated funds to the FDA. Assuming that
won't happen, or that increases won't be sufficient, I'd like you to
comment on some ways to leverage FDA resources:
a third party program for inspection and laboratory
testing;
fees on the food industry, such as an annual registration
fee; and
enhanced collaborations with States and localities.
Answer 2. Greater consideration of how third party inspectors,
auditors and laboratories can effectively supplement existing FDA
resources should be the focus of the committee's deliberations, and
greater collaboration between local, State and Federal agencies should
be encouraged. However, food imports and facilities should not be taxed
to provide benefits that accrue to the public, such as the cost of
science and inspections. Fees are appropriate when the benefit of a fee
flows to the food industry. The benefits of science and inspections
flow to the public generally, not to the food industry.
Question 3. I understand that many in the food industry are
implementing process controls to assure the safety of the foods they
make, and they also expect their suppliers to have such controls in
place. These sorts of voluntary programs are of course beneficial, but
they don't help for those who don't voluntarily comply. Shouldn't every
company have a plan to make its food safe, as Mr. Taylor and Ms. Smith
DeWaal have testified?
Answer 3. Food companies are subject to a longstanding legal
requirement to produce food that is not adulterated. All food companies
are now required by regulation to implement a variety of preventive
controls. What's more, food companies routinely identify and evaluate
food safety hazards, implement additional preventive controls, and
employ systems to ensure the effectiveness of preventive controls. FDA
has ample current authority to intervene with food companies that do
not adhere to these existing legal requirements.
Question 4. What can the HELP Committee, which is an authorizing
committee and not the Appropriations Committee, do to increase the
frequency with which food facilities are inspected?
Answer 4. Thanks to the leadership of Senator Kennedy, FDA food-
related spending for fiscal year 2008 enjoyed an increase. What's more,
Secretary Leavitt has pledged to seek a substantial increase for FDA
food-related spending in the fiscal year 2009 budget request. We are
eager to work with Senator Kennedy, other members of the HELP
Committee, and with our partners in the Alliance for a Stronger FDA to
ensure that appropriators recognize the critical importance of funding
for FDA food-related activities. FDA should partner with other Federal
agencies and with State and local officials to maximize the
effectiveness and reach of various food facility inspections so that,
using a risk-based system, facilities can be inspected at an
appropriate frequency.
Question 5. Mr. Taylor talked about food safety from farm to table.
Ms. Smith DeWaal talked about food safety on farms, and you mentioned
good agricultural practices for produce. Traditionally, the FDA doesn't
play a huge role on farms or at retail establishments. Do you have some
suggestions about how we could enhance FDA's role there without raising
the obvious sensitivities? What role can the States play?
Answer 5. We support the creation of scientifically based and
enforceable produce safety standards. Although produce safety standards
should be set nationally, FDA should be directed to partner with those
State agencies designated by each governor (State agriculture
commissioners, for example) to facilitate compliance and to ensure that
unique local conditions are properly addressed.
Question 6. You testified against user fees. I believe that an
inadequately resourced FDA is a liability for the food industry, and
also for consumers and the public health. Do you agree, and if not, why
not? If you do agree, and we assume for the sake of argument that FDA
does not receive adequate increased appropriations, doesn't it become
imperative for the food industry to support some form of user fees?
Answer 6. FDA is an essential and important partner for the food
industry and needs additional resources to fulfill its mission of
ensuring food safety. As I noted earlier, we are confident that
Congress and the Administration share our desire to increase FDA
spending and we oppose taxes or fee on food imports or facilities. As
you know, a user fee is appropriate when the benefits of the government
service flow to an individual or to a particular business. In this
case, the benefits of inspections, science-based standards, and
enforcement activities flow to all Americans, not simply to food
companies. What's more, food taxes or fees will fall unequally on some
companies and some consumers. Increasing food taxes at a time when food
prices are rising faster than inflation (due, in large measure, to the
expansion of the Federal ethanol mandate) would negatively impact many
Americans. The potential difficulties in obtaining sufficient
appropriated funds should not be an excuse to impose a new tax on the
food industry.
questions of senator enzi
Question 1. You support mandatory recall, but only when a company
has refused to conduct a voluntary recall. What about where the company
is conducting the recall, but dragging their feet about it? Should FDA
be able to order them to conduct the recall on a certain timetable?
Answer 1. Yes. Foods that present the risk of serious adverse
health consequences or death should be removed from the marketplace as
fast as possible. We think that the recall system will work best when
companies have the initial opportunity to conduct a recall. FDA should
have the authority to order a recall if a company declines to undertake
one and to monitor the effectiveness of recalls and to be able to
intervene if a recall is undertaken but not implemented effectively.
Question 2. Prior to this year, no one would have thought that pet
food was risky, but then there was a huge problem with melamine
contamination. We can definitely do better on food safety, but we will
someday be taken by surprise. How do you determine which products pose
``no meaningful risk?''
Answer 2. Theoretically, any food can present a meaningful risk
with respect to intentional contamination. But the vast majority of
foodborne illness is due to inadequate controls over naturally
occurring hazards, not to intentional contamination. By knowing the
hazards associated with specific products, by using good food-borne
illness attribution data, and by understanding the processes used in
production of a food and the controls applied in addressing the
hazards, it is possible to determine which products pose the greatest
risk to consumers.
Question 3. FDA is woefully underfunded and understaffed. I am
concerned that even with sufficient funds, there might not be
sufficient personnel to fill the jobs, given the technical expertise
required. You support capacity-building abroad, which is great, but
what about capacity building here at home?
Answer 3. As a member of the Alliance for a Stronger FDA, we
strongly support greater funding for FDA. In particular, we have urged
Congress and the Administration to double FDA spending over 5 years.
questions of senator burr
Question 1. Mr. Taylor believes that the FDA should be given a new
statutory prevention mandate that, through regulation, will outline
specific standards the food industry needs to meet. It sounds like you
agree with him. Is that correct?
Answer 1. We support making the prevention of contamination the
primary focus of FDA's food-related activities. GMA believes the focus
of our food safety efforts should be on the prevention of
contamination. By constantly identifying and addressing the sources of
contamination throughout each product's life cycle, we continually
reduce the risk of food-borne illness to consumers. All food companies
are now required by regulation to implement a variety of preventive
controls. In addition, food companies routinely implement additional
preventive controls to address additional risks posed by specific
products.
Question 2. The drug and device industries pay FDA user fees for a
set of FDA performance goals agreed to by industry and the FDA. If
Congress changes FDA's statute on food safety and requires the FDA to
be much more aggressive on the prevention side, I could envision a
similar user fee and performance goal agreement being worked out
between FDA and the food industry. Would you still consider that to be
a tax?
Answer 2. Yes. FDA is an important and essential partner of the
food industry, and we work with FDA to continually identify and prevent
risks to public health. Expanding FDA's ability to develop science-
based standards and new preventive controls benefits all consumers, not
simply food companies. The performance goals in the drug and device
context are fundamentally different from those that might be
implemented on the food side. Drug and device companies are principal
beneficiaries of the additional FDA staffing that the user fees provide
while the public would be the principal beneficiaries of any fees
imposed on the food side.
questions of senator allard
Question 1. In your opinion what can be done to further educate the
public, private sector and interested government agencies on food
safety, recalls, etc.''
Answer 1. Greater resources for FDA as well as greater
collaboration between Federal, State, and local agencies are critically
needed to improve food safety education.
Question 2. Do you think that further education should play a role
in addressing food safety? Do you have a single suggestion to further
education and the distribution of informative resources regarding food
safety?
Answer 2. Public education is among the most effective tools
available to address the threat of food-borne illness. Public agencies
and the private sector are investing significant resources in efforts
to promote food safety education. This begins with food safety
education in elementary schools, but it requires reinforcement in later
years as well. We need to be more innovative in how we approach this,
with messages being delivered through print, broadcast, and electronic
media.
Response to Questions of Senators Kennedy, Harkin, Enzi and Allard by
Caroline Smith DeWaal
questions of senator kennedy
Question 1. There's a lot of real value in the Food Action Plan,
however, one thing that concerns me is that the plan proposes allowing
the agency to require process controls for a food, but only after the
food is associated with repeated instances of serious adverse health
consequences or death. Why should the FDA have to wait for children or
the elderly to die or be seriously injured by a food before companies
making it are required to make it safely?
Answer 1. Process controls should be applied to all food production
and not limited only to those foods with a history of causing
``repeated instances of serious health problems or death to humans or
animals,'' as called for in the Food Protection Plan. CSPI endorses
legislation that would require all food establishments to implement
process controls that meet performance standards designed to protect
the public from foodborne illnesses.
I am especially concerned about the standard set forth in the Food
Protection Plan, as neither peanut butter nor spinach production would
be subject to process controls. Yet our experience of the last 2 years
has shown that these products could clearly benefit from such a system.
A single outbreak of Salmonella in Tennessee in peanut butter sickened
628 people in 47 States in 2007 and a single outbreak of E. coli
0157:H7 on spinach caused 205 illnesses and killed three in 2006. The
peanut butter outbreak was linked to unsanitary conditions and a leaky
roof, while the spinach outbreak was linked to inadequate controls to
stop contamination from a nearby pasture. In both cases, simple process
controls implemented and regularly monitored in the plant or on the
farm may have prevented the outbreak. However, the standard in the Food
Protection Plan could conceivably require FDA to wait for multiple or
``repeated'' instances of serious health problems or death before
requiring process controls. Prior to the 2007 outbreak, peanut butter
had been related to only three outbreaks since 1990 and prior to 2006,
spinach to only two.\1\
Requiring a history of repeated outbreaks is also inconsistent with
other instances where Congress has imposed safety requirements on the
food industry based on the prospect of harm, rather than the proof of
harm. For example, the Bioterrorism Act's traceability requirement at
21 U.S.C. 350c(b) is based on the need to identify whether a food
``presents a threat of serious adverse health consequences or death to
humans and pets'' and uses a ``reasonable belief '' standard to trigger
its record access provisions. 21 U.S.C. 350c(a).
It is likely a reactive standard will prove inadequate for
preventing outbreaks and FDA would have to return to Congress for
authority to require process controls based on more proactive criteria.
Question 2. A significant impediment to the FDA doing a better job
on food safety is its serious lack of adequate resources. I believe the
President should propose a substantial increase in FDA's budget and the
Congress should increase appropriated funds to the FDA. Assuming that
won't happen, or that increases won't be sufficient, I'd like you to
comment on some ways to leverage FDA resources:
a third party program for inspection and laboratory
testing;
fees on the food industry, such as an annual registration
fee; and
enhanced collaborations with States and localities.
Answer 2. The solution to inadequate resources at FDA is for the
President to propose and Congress to enact a budget adequate to support
FDA's responsibilities. Inadequate resources impose a significant risk
to public safety.\2\ The Coalition for a Stronger FDA estimated FDA
needs for fiscal year 2008 at several hundred million dollars \3\ above
fiscal year 2007 funding just to carry out its current food safety
mission. The FDA Science Board identifies a need for an additional $390
million at CFSAN and ORA to implement a new food import system,
modernize and implement safety standards for fresh produce, and improve
laboratories.\4\ This does not include funds needed for CVM to
modernize FDA's regulation of animal-derived products.\5\ The Action
Plan for Import Safety also highlights the need for additional
resources to implement its recommendations.\6\
The FDA's Food Protection Plan attempts to sidestep the growing
evidence of an agency that is underfunded by proposing leveraging third
party inspections, imposing new fees and doing a better job of
collaborating with State and local agencies. Fees proposed in the plan
would raise about $26 million, which only offsets the costs of carrying
out re-inspections of plants that fail an initial inspection and an
export certificate program.
Each bulleted proposal above has merits, but none provides a
panacea for FDA's budget problems. And each will require start up costs
to ensure that activities done using other entities have the requisite
reliability, including training, accrediting, compensating and auditing
the external government or third party inspectors to ensure plants meet
Federal standards.
Often these proposals are submitted as an alternative to increasing
the funding for FDA. However, using third parties requires additional
funding for certification and for State implementation. In fact, State
and Federal agencies need compensation to conduct additional
inspections, just as FDA would. Third party certification also would
divert resources from FDA inspection to training, accrediting and
auditing the third party organizations. Enhancing collaboration with
State and local governments should be done. But it should be funded--
otherwise FDA will have to divert scarce resources from their already
anemic inspection program to an aggressive oversight program.
CSPI supports funding food safety through the annual appropriation
process, but if direct revenue sources must be found, then applying a
general fee on foreign and domestic registrations under the
Bioterrorism Act could generate significant funds. We prefer this
approach to a fee-for-service system for food inspections, where
inspectors may believe that they are working for the companies rather
than the public. More than 332,000 food establishments have registered
with FDA under the Bioterrorism Act. A registration fee of $1,000 could
generate $332 million for food safety activities. CSPI would be happy
to provide additional analysis of this concept.
Question 3. Could you please your concerns, if any, with a
voluntary approach to food safety?
Answer 3. Much of the current FDA food safety program is voluntary.
FDA lacks authority to require producers to recall tainted products,
and instead relies on a voluntary system to take unsafe food off the
market. FDA's infrequent inspections mean that food safety is largely
managed through an industry honor system for food processors. Farmers
are not required to follow the agency's good agricultural practices.
These voluntary systems are failing to protect the public and industry
as evidenced by the fact that outbreaks linked to FDA-regulated
products are much more common then those linked to meat and poultry
regulated by USDA. In fact, food regulated by FDA account for 66
percent of all outbreaks of foodborne illness reported between 1990 and
2005 \7\--more than twice the number of outbreaks attributed to food
regulated by USDA.
Voluntary programs implemented through marketing orders
administered by USDA suffer additional defects. The programs are
controlled by the growers or processors who are subject to economic
pressures and who can terminate the order by majority vote if
compliance becomes too burdensome. Since the standards are set by the
industry, they may not represent good science and are frequently
developed without balanced input from the public health community or
from the consumers they are intended to protect. This often results in
programs that implement the least burdensome standards possible because
the focus is more on minimizing the impact on processors or producers
than on protecting consumers. The public is also at risk since
participants may vote to end the marketing order at any time and thus
terminate whatever protections it provides with little notice to
consumers.
FDA's reliance on voluntary compliance with guidelines, education,
and awareness proved ineffective in preventing foodborne illness from
fresh produce. In 2006, CSPI called on FDA to enact a mandatory
program, pointing out that the most important benefit of a mandatory
program is that it would assure that both domestic and foreign growers
and processors implement good agricultural practices. While many of the
best growers and processors use HACCP-like systems and adhere to good
agricultural practices, compliance is clearly not universal.\8\ It was
estimated that California spinach growers lost approximately $350
million in sales because of consumer reaction to the 2006 outbreak.\9\
Voluntary government guidelines like the ones called for in the
Four Pillars recommendations from GMA may be useful in helping industry
identify its responsibilities, but cannot substitute for enforceable
standards. In a voluntary system one bad actor can negate the efforts
of responsible growers and food processors.\10\
Question 4. You argued that every food company should have a plan
to prevent food safety problems. Some would argue that such an approach
is not risk-based, is over-regulatory, and will require companies to
spend money for little gain in food safety. How would you respond to
these concerns?
Answer 4. If a company wants to prepare food and sell it to the
public, it has the responsibility to show that it has evaluated food
safety hazards associated with the products and processes, and has
implemented systems that will eliminate or control those hazards.
Otherwise all the risk of production is being borne by the consumer of
the product, and consumers are in fact being used as the ``canaries in
the coal mine.'' This is not acceptable, and many responsible companies
have already implemented food safety plans throughout their productions
systems.
These food safety plans should form the basis for government
inspection and provide the road map for evaluating systems failures
whenever an outbreak or recall occurs. Risk should certainly be used to
determine inspection frequency, but it should not be the factor that
determines what foods are subject to process controls.
Congress should enact food safety reform that places the primary
responsibility for food safety on food establishments and gives the
government sufficient authority to monitor and enforce this
responsibility.\11\ Written HAACP or HAACP-like plans are required of
all meat, poultry, seafood and juice manufacturers, and have proven
effective in helping to control hazards in those products. These plans
are also widely used by many individual companies where they are not
currently required today. Process control plans can be incorporated
into food production systems at all levels. Inspections and audits of
the plans would ensure all food establishments are meeting safety
standards--such as limits on the incidence or levels of contamination.
Monitoring and enforcement of safety standards is a key element of
inspection in a successful food safety program.
The European Union has demonstrated that requiring process controls
on all food establishments can be done without imposing too high a
premium on individual companies. In the alternative, failing to
implement process controls broadly will result in repeated instances of
outbreaks imposing costs on the public and industry for healthcare
services, litigation and lost confidence. These costs can be
substantial. The Peter Pan peanut butter outbreak cost ConAgra more
than $140 million, including $55 million in lost sales.\12\ Meanwhile
foodborne illnesses from all sources impose a cost on consumers of
billions of dollars annually.\13\
Question 5. What can the HELP Committee, which is an authorizing
committee and not the Appropriations Committee, do to increase the
frequency with which food facilities are inspected?
Answer 5. The problems with inadequate inspections of food are not
limited to a lack of funding. The United States lacks a modern food
safety oversight system, like those currently in use in the European
Union and many other countries around the world. The failure to
modernize our system is having real impacts--consumers worry that we
have a ``third world'' food supply, and other countries are reluctant
to import poorly regulated food products.
The HELP Committee should develop and pass a modern food safety
mandate for FDA-regulated food. It should contain the following
elements:
1. A National Food Safety Program that incorporates:
Update registration of food establishments and foreign
food establishments.\14\
Process controls (including on-farm process controls) to
reduce the adulteration of food products.
Performance standards enforced by inspections.
Importer accountability supported by certification of
foreign countries' food safety systems and exporters.
Federal and State cooperation.
Mandatory traceback.
A resource plan that describes funding needed to implement
the national program.
2. Research and Education
Public health assessment system.
Public education and advisory system.
Research.
3. Enforcement
Food detention, seizure and condemnation.
Notification and mandatory recall.
Civil and criminal penalties.
Citizen civil actions.
Whistleblower protections.
Administration and enforcement.
4. Appropriations adequate to carry out these authorities
Question 6. Mr. Taylor talked about food safety from farm-to-table.
You talked about food safety on farms, and Mr. Dooley mentioned good
agricultural practices for produce. Traditionally, the FDA doesn't play
a huge role on farms or at retail establishments. Do you have some
suggestions about how we could enhance FDA's role there without raising
the obvious sensitivities? What role can the States play?
Answer 6. The Fresh Produce Safety Act introduced by Senator Harkin
offers a good starting point for improving safety on the farm. The bill
establishes a national program for issuing good manufacturing practices
for processors and good agricultural practices on the farm. Processors
and growers would have to have written safety plans and keep records
that can be inspected by the FDA. This is a good model for improving
FDA oversight of on-farm safety.
Question 7. 1 understand FDA now inspects food facilities on
average every 10 years. I think it's unlikely that appropriated money
will increase enough, or that a user fee program could raise enough
money, to allow FDA to inspect every food facility annually or even
every 2 years. So there might be some value in a third party inspection
program, if companies were to participate in it. Would you support such
a program? Under what conditions?
Answer 7. As I noted above, FDA's Food Protection Plan attempts to
sidestep the growing evidence of an agency that is underfunded by
proposing leveraging third party inspections as a way of better
allocating existing resources. The proposal has merits, but is not a
panacea for FDA's budget problems. It will require start up costs to
ensure that activities done using States or private entities have the
requisite reliability. Mandating the use of third parties would also
divert scarce agency resources from FDA inspection to training,
accrediting and auditing the third party organizations. Therefore, the
use of third parties should be seen as an alternative use of additional
resources, not a substitute for new resources.
With respect to States acting in place of FDA inspection, that
system is already in place. Many inspections of FDA-regulated
facilities are already conducted by State inspectors. For example, of
17,730 FDA inspections conducted in 2006, more than half (9,164) were
State contract or State partnership inspections.\15\ The problem with
this approach is that State inspection programs are not consistently
funded, and are often the victim of cuts when the State is facing a
budget shortfall. Therefore, FDA needs the ability to monitor State
inspections year-to-year, and step up Federal oversight whenever State
inspections are cut. Otherwise, the programs will be highly variable
and therefore less valuable in protecting consumers.
With respect to third parties acting in place of FDA, this concept
is controversial among many consumer organizations, who worry about the
privatization of this important government service. At CSPI, we believe
that there is a role for third party inspectors, so long as they have
the same interests as the buying public in assuring the safety of the
product. Thus, third party inspectors paid for by a retailer would be
more trustworthy than one paid for by the company being inspected. It
is also critical that these private entities are certified by FDA
regularly, and that their inspections are regularly audited by FDA.
The concept of ``nested audits'' is very useful in this context.
One country I have visited used this very effectively in its seafood
inspection program. Seafood companies each utilize a HACCP-based safety
assurance program. This program is audited by a private auditor
certified by the government. The plants are then regularly inspected by
the government agency, with the inspection frequency based on the
plant's performance during previous inspections. The agency can audit
the work of the private auditor at the same time that it looks at the
plant during the inspection. The government program is also subject to
audit by countries that import fisheries products, which in this case
included the governments of the European Union, Japan, and the United
States. This type of ``nested audit'' provides a high degree of
certainty that the audits are high quality, and that the standards for
the audits are constantly being updated to meet international
standards. It encompasses the concept of continuous improvement for all
levels of the program.
Question 8. What can you tell us about the food safety approaches
of the European Union or other countries, including both domestically
produced food and imported food, with a focus on how those approaches
compare to that of the United States?
Answer 8. The European Union (EU) has a much more modern system
than the United States. Many of the national systems were modernized
after the BSE (``mad cow'') crisis in Europe, with a move toward
unifying food safety responsibility under a single agency in many
countries. In addition, the national programs must implement standards
adopted by the European Commission. The EU has also centralized risk
assessment under the European Food Safety Authority, which has the
ability to independently evaluate risks and communicate to consumers
and the national governments, though it has no regulatory (risk
management) responsibilities.
The lessons learned in the EU can help guide our efforts to
modernize food law in the United States. The EU's starting concept is
that ``food policy must be built around high food safety standards,
which serve to protect, and promote, the health of the consumer.'' \16\
The European Commission's White Paper on Food Safety identified the
following principles\17\:
Food safety policy must be based on a comprehensive,
integrated approach that covers the food chain from ``farm-to-fork.''
Stakeholders' roles in the food chain must be clearly
defined.
1. Food manufacturers and food operators have the primary
responsibility for food safety;
2. Competent authorities monitor and enforce this
responsibility; and
3. Consumers are responsible for proper storage, handling and
cooking of food.
Feed, food and their ingredients must be traceable through
records kept by operators.
The system needs to be flexible and reviewed to adapt to
emerging risks and recognize new developments, while having a
transparent approach to developing new policies.
Risk analysis (which encompasses risk assessment, risk
management and risk communication) should be the foundation for food
safety policy.
The science applied must meet the highest standards of
independence, excellence and transparency. Where appropriate the
precautionary principle should be applied in risk management decisions.
There are additional sources of information to guide the committee
as well. CSPI, working with the World Health Organization and the Food
and Agricultural Organization of the United Nations, formed the Safe
Food International project. In 2004, Safe Food International published
guidelines in consultation with consumer organizations in developed and
developing countries to assist both consumer organizations and national
governments in focusing on the basic requirements for national food
safety programs in their countries. I have attached a copy of the
Guidelines.
[Editor's Note: Due to the high cost of printing, previously
published materials are not reprinted. For the Guidelines, please see
http://www.safefoodinternational.org/
guidelines_for_consumer_organizations
.pdf.]
questions of senator harkin
Question 1. I agree with your emphasis on prevention of foodborne
illness as presented in your testimony. However, to focus on
prevention, we must act in a coordinated manner across all government
agencies that play a role in ensuring the safety of our Nation's food
supply.
Please describe the steps that FDA, USDA, and other agencies with
responsibility over food safety can take to coordinate programs and,
more importantly, integrate their missions, in order to focus on
prevention, intervention, and response as called for in the FDA Food
Protection Plan.
Answer 1. FDA and USDA have had almost 100 years to coordinate
their programs and integrate missions without making much progress. We
still have USDA and FDA personnel inspecting imports side-by-side, and
food plants that are subject to dual regulation. It would be a mistake
to attempt to patch this system one more time by establishing an
interagency authority or attempting to legislate cooperation between
two separate food regulators.
We believe the best approach would be to form a unified food safety
administration in the United States, a step already taken in many other
countries. The agency should be given a modern mandate, should be
staffed from the existing food programs at FDA and USDA, and should use
a budget that combines the resources of both these existing agencies.
This approach has already been proposed by Senator Richard Durbin in
the Safe Food Act of 2007, in response to a report of the National
Academy of Sciences.
The United States can learn from experiences in many other
countries that have already created a single authority to manage food
safety. In 2005, GAO reviewed programs in seven countries that have
consolidated food safety activities under one agency and reported that
officials and stakeholders consistently stated that doing so ``led to
significant qualitative improvements in food safety operations that
enhance effectiveness or efficiency.'' \18\ Among the advantages cited
in the report are ``reduced overlap in inspections, more targeted
inspections based on food safety risk, more consistent or timely
enforcement of food safety laws and regulations, and greater clarity in
responsibilities.'' \19\
Short of this, Congress could require both agencies with regulatory
responsibility over the food supply to take responsibility for the
entire food supply and provide them each with authority to act whenever
they see a problem. This would permit inspectors to work across
jurisdictions. This would address the problems that exist with imported
foods where USDA and FDA jurisdictions sometimes overlap, but resources
are not shared. If Congress is not willing to truly modernize food
safety systems, it should consider some new ``outside-of-the-box''
approaches to improve the workings of the current system.
questions of senator enzi
Question 1. Like many of us, you are concerned about FDA getting
the resources needed to implement the Food Protection Plan. Do you have
any sense of what level of funding it would take to turn things around?
Your testimony indicated hundreds of millions of dollars, but can you
be more specific?
Answer 1. The FDA Alliance estimates FDA needs for fiscal year 2008
are $140 million above fiscal year 2007 funding levels, recommending a
budget of $597 million for food safety programs.\20\ The Coalition for
a Stronger FDA last year began recommending an increase of $115 million
for food safety programs at FDA but more recently raised its estimate
to $250 million.\21\ The FDA Science Board identifies an additional
$390 million needed to implement a new food import system, modernize
safety standards for fresh produce and upgrade existing laboratories.
This does not include funds needed for CVM to modernize FDA's
regulation of animal-derived products.\22\ Based on these
recommendations, anything short of $100 million in the fiscal year 2009
budget will not be adequate to see real improvement in FDA's food
program and the actual need is more in the range of $200 to $400
million.
Question 2. You represent consumers. How do we get them--and by
``them'' I mean all of us, since we are all consumers--to be better
players in food safety? We could change many things, and send consumers
much safer food, but they could still contaminate it at home. Other
panelists talked about the farm end of the ``farm-to-fork'' continuum--
what about the fork end?
Answer 2. Educating consumers about safe food handling is a
critical part of the food safety continuum. And it is not something
that is done just once. Every year new scientific information is
available, and consumers need to be reminded of the previous
recommendations for keeping their food safe. CSPI joins with several of
the government agencies that offer regular advice to the public on how
to keep their food safe. We publish food safety advice in our Nutrition
Action Health letter as well as on our Web site and in our media
interviews. In fact, for over 5 years, the National Press Club invited
me to hold a press conference right before Thanksgiving to remind
consumers about safe handling, cooking and storage of holiday meals in
their home kitchen.
Another important approach is the use of safe handling labels on
meat, poultry, eggs, and other raw food products that reminds consumers
of the basic handling messages for consuming these products, as well as
warning labels on unavoidable unsafe products, like raw shellfish
harvested from certain regions, unless treated to control the hazards.
In considering legislation, Congress should include a public
education program, including labeling of raw and unsafe food products,
and education of health professionals. Information provided to health
professionals would improve diagnosis and treatment of foodborne
illness. The Administration should be required to issue health
advisories about foods that pose a threat to the public. However, this
is not a substitute for improving the overall safety of the food
consumers buy.
Another issue to consider in legislation is the importance of
managing risks in the restaurant and retail food sector. More than
twice as many food-borne illness outbreaks occur from food prepared
outside the home. Restaurants and food establishments accounted for 46
percent of reported outbreaks between 1998 and 2004, according to data
compiled by CSPI from CDC and State health department reports,\23\
while home prepared foods accounted for 20 percent of outbreaks.
Question 3. Given the number and incredible variety of FDA-
regulated foods, do you think pre-market approval of foods by FDA is
advisable or even possible?
Answer 3. FDA has oversight of more than 136,000 registered
domestic food facilities and there are approximately 189,000 registered
foreign food facilities.\24\ For comparison, USDA, which conducts pre-
market inspections, has responsibility for just 6,282 plants
nationally.\25\ Pre-market approval for FDA-regulated foods would be
costly and is not needed. Instead, Congress should enact laws to
require food facilities to have in place industry specific food safety
process control plans that are designed to meet federally established
performance standards for safety. The plans should be subject to
regular auditing by FDA during inspections, or using nested audits.
The concept of ``nested audits'' is very useful in understanding
how FDA might improve oversight. One country I have visited used this
very effectively in its seafood inspection program. Seafood companies
each utilize a HACCP-based safety assurance program. This program is
audited by a private auditor certified by the government. The plants
are then regularly inspected by the government agency, with the
inspection frequency based on the plant's performance during previous
inspections. The agency can audit the work of the private auditor at
the same time that it looks at the plant during the inspection. The
government program is also subject to audit by countries that import
fisheries products, which in this case included the governments of the
European Union, Japan, and the United States. This type of ``nested
audit'' provides a high degree of certainty that the audits are high
quality, and that the standards for the audits are constantly being
updated to meet international standards. It encompasses the concept of
continuous improvement for all levels of the program.
questions of senator allard
Question 1. In your opinion what can be done to further educate the
public, private sector and interested government agencies on food
safety, recalls, etc.
Answer 1. Educating consumers about safe food handling is a
critical part of the food safety continuum. And it is not something
that is done just once. Every year, new scientific information is
available, and consumers need to be reminded of the previous
recommendations for keeping their food safe.
CSPI joins with several of the government agencies that offer
regular advice to the public on how to keep their food safe. We publish
food safety advice in our Nutrition Action Healthletter as well as on
our Web site and in our media interviews. In fact, for over 5 years, as
a public service, the National Press Club invited me to hold a press
conference right before Thanksgiving to remind consumers about safe
handling, cooking and storage of holiday meals in their home kitchen.
Another important approach is the use of safe handling labels on
meat, poultry, eggs, and other raw food products that reminds consumers
of the basic handling messages for consuming these products, as well as
warning labels on unavoidably unsafe products, like raw shellfish
harvested from certain regions, unless they are treated to control the
hazards.
In considering legislation, Congress should include a public
education program, including labeling of raw and unsafe food products,
and education of health professionals. Information provided to health
professionals would improve diagnosis and treatment of foodborne
illness. The Administration should be required to issue health
advisories about foods that pose a threat to the public. However, this
is not a substitute for improving the overall safety of the food
consumers buy.
Another issue to consider in legislation is the importance of
managing risks in the restaurant and retail food sector. More than
twice as many food-borne illness outbreaks occur from food prepared
outside the home. Restaurants and food establishments accounted for 46
percent of reported outbreaks between 1998 and 2004, according to data
compiled by CSPI from CDC and State health department reports,\26\
while home prepared foods accounted for 20 percent of outbreaks.
Question 2. Do you think that further education should play a role
in addressing food safety? Do you have a single suggestion to further
education and the distribution of informative resources regarding food
safety?
Answer 2. The biggest single impact for food safety education would
be through proactive programs in the schools. Early education on safe
food handling is essential to breaking down bad habits in the home--
like failing to take precautions like hand washing or properly cooking
food. Food safety information can easily be added to the science
curriculum at almost every level, explaining not only what consumers
should do, but why it is effective. School-based curriculums have many
crossover effects to the general public. Educating children helps to
impact their parents' behavior. Educating teenagers before they begin
working in restaurants can avoid many mistakes.
FDA has posted information specifically targeted for students and
educators at http://www.cfsan.fda.gov/dms/educate.html. Additionally,
the National Science Teachers and FDA have collaborated on a food
safety curriculum with materials and training available to help science
teachers teach about food safety posted at http:
//www.foodsafety.gov/fsg/teach.html. These are good efforts that
should be sustained and expanded but they have not and cannot close the
loop on food safety.
The home should be the final defense and not the front line in
preventing foodborne disease. Our goal should be to provide safe and
wholesome food to consumers, using preventive control programs at all
levels. Private and public programs can then effectively arm consumers
with information on how to recognize and avoid foodborne disease
through safe food handling techniques.
References
1. Center for Science in the Public Interest, Outbreak Alert
Database, http://www.cspinet.org/foodsafety/outbreak/pathogen.php. (The
Outbreak Alert Database is maintained by the Center for Science in the
Public Interest (CSPI). CSPI uses CDC data and other highly reliable
sources to track food-borne illness outbreaks by food source. Its
database contains over 5,000 outbreaks with both food and hazard
identified spanning 1990 to 2005. A peer-reviewed article describing
the database was recently published in Food Protection Trends. Caroline
Smith DeWaal et al., Foods Associated with Food-borne Illness Outbreaks
from 1990 through 2003, 26 Food Protection Trends 466, (2006).)
2. FDA Science Board, FDA Science and Mission at Risk 2 (Nov.
2007).
3. FDA Science Board, supra at 56; Leslie Pray & Sally Robinson,
Nat'l Academies of Science, Challenges for the FDA: The Future of Drug
Safety, 18 n.5 (2007).
4. FDA Science Board. supra at 53.
5. Id.
6. Interagency Working Group on Import Safety, Action Plan for
Import Safety, Nov. 2007, 16.
7. Center for Science in the Public Interest, Outbreak Alert!, Dec.
2007, p. 5.
8. Center for Science in the Public Interest, Citizen Petition,
(Nov. 15, 2006) available at http://www.cspinet.org/new/pdf/
fda_produce_petition.pdf.
9. Elizabeth Weise & Julie Schmit, Spinach Recall: 5 Faces. 5
Agonizing Deaths. 1 Year Later, USA Today, Sept. 20, 2007, available at
http://www.usatoday.com/money/industries/food/2007-09-20-
spinachmain_N.htm.
10. See Renae Merle, After Last Year's E. Coli Outbreak, Produce
Testing Diverged at the Border, Wash. Post, Oct. 12, 2007 (``Noting
that the [voluntary Leafy Green Marketing Agreement] program touts 99
percent of producers have signed up, [State Sen. Dean] Florez adds,
``It only takes 1 percent to poison an entire Nation.'').
11. Compare Commission of the European Communities, White Paper on
Food Safety, Jan. 12, 2000. 8. (. . . feed manufacturers, farmers and
food operators have the primary responsibility for food safety;
competent authorities monitor and enforce this responsibility through
the operation of national surveillance and control systems . . .)
12. Mike Hughlett, E. coli Outbreak Kills Meat Company: Huge Costs
Seen in Fixing Problems, The Chicago Trib., para.19-11, Oct. 6, 2007,
http://www.chicago
tribune.com/features/lifestyle/health/
chisat_toppsoct06,1,4231570.story.
13. Ike Wilson, Local Farmers React to Proposed Food Safety Law,
The Frederick News-Post Online, para.8, Oct. 5, 2007, http://
www.fredericknewspost.com.
14. Food facility registration passed in the Bioterrorism Act of
2002.
15. FDA, FY 2008 Congressional Justification for Food and Drug
Administration: Food, at 29, http://www.fda.gov/oms/ofm/budget/2008/1-
BudgetNarrative
CFSAN.pdf.
16. Comm. of the European Communities, White Paper on Food Safety,
Jan. 12, 2000, 6. The White Paper on Food Safety provides the basis for
establishing the European Union's food safety program.
17. Id. at 8-9.
18. Gov. Acct. Off. Rpt. No. GAO-05-212, Food Safety: Experiences
of Seven Countries in Consolidating Their Food Safety Systems, Feb.
2005, 4.
19. Id.
20. The shortfall in funding for FDA is described by Frank Claunts
with the Office of Management at the Food and Drug Administration in a
briefing ``FDA: Financial Realities'' in 2006. The charts from that
briefing are available in the FDA Alliance release ``Improve Consumer
Health & Safety: Increase FDA Funding'' at http//www.strengthenfda.org/
FDA_Alliance_Booklet_Complete.pdf.
21. FDA Science Board supra at 56.
22. FDA Science Board, supra at 53.
23. Outbreak Alert Database, supra. See also, Sonja J. Olsen et
al., Surveillance for Foodborne Disease Outbreaks--United States, 1993-
1997, MMWR Surveillance Summaries available at http://www.cdc.gov/mmwr/
preview/mmwrhtml/ss4901
al.htm for additional tables on the number of foodborne disease
outbreaks by year and place where food was eaten.
24. FDA, Food Protection Plan, Nov. 2007, 6.
25. USDA, FY 2008 Budget Summary and Background, 59, at http://
www.obpa.usda.gov/budsum/fy08budsum.pdf.
26. Outbreak Alert Database, supra.
Response to Questions of Senators Kennedy, Enzi, and Allard
by Paul Young, Ph.D.
questions of senator kennedy
Question 1. You raised concerns about relying on voluntary efforts
by the industry. Could you please expound on the problems with a
voluntary approach to food safety?
Answer 1. Unsurprisingly, it is more expensive to produce food
which is free of contaminants than otherwise. Pesticides and veterinary
drugs are often used in crop and animal production, respectively,
specifically to increase production gains. For example, it is well-
documented that prophylactic use of antibiotics in animal production
will not only prevent disease from occurring in the animals, but will
also act as a growth promoter significantly improving feed conversion
(i.e., more growth for the same amount of animal feed consumed). There
is therefore a significant financial incentive for producers to use
these chemicals to reduce costs and increasing profit margins.
FDA currently operates a voluntary approval scheme listing foreign
producer establishments that importers are recommended to use when
sourcing seafood for import into the United States. Due to the
voluntary nature of this scheme, only four countries have submitted
lists of establishments (Canada, Japan, New Zealand and Thailand),
whereas 95 have done so to the European Union where approval is
mandatory. Additionally, FDA recommends that ``Importers may consider
purchasing from processors that are on such lists, and documenting that
they are doing so, as one way of meeting their affirmative steps
responsibility . Despite this recommendation for voluntary action, many
of the seafood import consignments refused entry by FDA during October
2007 originated from processing establishments not cited on the
approved lists (even where those lists exist).
Clearly, the current voluntary approach carries little weight and
given the price competitive nature of food production, a voluntary
system does little to remove the incentive to use agricultural
chemicals inappropriately.
It should also be noted that unlike pathogen contamination where
acute disease conditions in consumers can act as indicators or
``signals'' of contamination, many of these agricultural chemicals,
whilst being both genotoxic and carcinogenic may not give rise to acute
conditions and left undetected could result in long-term effects.
Question 2. Mr. Taylor talked about food safety from farm-to-table.
Ms. Smith DeWaal talked about food safety on farms, and Mr. Dooley
mentioned good agricultural practices for produce. Traditionally, the
FDA doesn't play a huge role on farms or at retail establishments. Do
you have some suggestions about how we could enhance FDA's role there
without raising the obvious sensitivities? What role can the States
play? Do the authorities in the European Union and Japan have
regulatory authority on farms and at retail?
Answer 2. As part of its farm-to-table approach, the European Union
introduced legislation in 2004 (Regulation (EC) No. 852/2004) which
requires all food business operators to implement and maintain a Hazard
Analysis and Critical Control Point programme (HACCP). Whilst it is
accepted that HACCP implementation is not yet feasible for primary
production (although this is scheduled for review), it recommends that
primary producers should implement these procedures as far as possible
and additionally details specific hygiene measures and recordkeeping
required by producers involved in both animal rearing and plant
production. All of this inevitably increases the record-keeping burden
of farmers and in Europe many farmers are increasingly turning to
dedicated IT solutions, some of which can be managed from the field. I
understand that Japanese authorities also strictly control the
distribution of pesticides and veterinary drugs and enforce regulations
mandating farmers to keep records regarding their use and withdrawal.
Question 3. You testified that Japan tests 10 percent of its
imported food. Do you believe it is practical for the United States to
test 10 percent of its imported food, and if not, is there a practical
alternative?
Answer 3. Testing per se does not make the food safe, but serves to
demonstrate compliance with required standards of production, thereby
building consumer confidence. With regard to the practicality of 10
percent testing in the United States, FAO figures for the top 20
agricultural import commodities indicate that Japan imports
significantly more than the United States, by volume. This would
indicate that a 10 percent level of testing is achievable.
However, the figure of 10 percent cited in my testimony relates to
the level of food imports undergoing laboratory analysis in Japan. The
equivalent figure for the United States is currently quoted at around
0.2 percent. A shift to 10 percent testing would represent a 50-fold
increase in the current level of laboratory analysis in the United
States. Whilst employing the latest technological advances, such as the
recent innovations from Waters, will help both in terms of cost
effectiveness and throughput, clearly this would still require
additional resources. Europe, for example, makes provision to allow
testing to keep pace with import levels by funding imported food
testing from a levy imposed on the importers, legislating to allow
governments to recover up to the full cost of sampling and analysis.
questions of senator enzi
Question 1. You mention in your testimony a seafood export action
plan whereby shipments in violation of the EU regulations could be sold
into less stringent markets. Since a number of countries are
overhauling their food safety systems, how do we get it right here at
home while maintaining harmonization with other countries?
Answer 1. Situations like this arise because effective global
harmonization of standards does not yet exist and because when import
requirements are not either clearly stated or robustly enforced, they
may be interpreted as being optional. When developing standards for
U.S. domestic production, one must also bear in mind that the United
States is the world's largest exporter of agricultural commodities and
as you suggest, it is highly desirable to have standards acknowledged
as offering equivalence with the requirements of export markets as
described within the WTO SPS agreement. Implementing standards in line
with the recommendations of Codex Alimentarius Commission will help,
where these Codex standards exist. Otherwise, equivalence can only be
assured through a comprehensive understanding of food safety
requirements of each country or market. It is for precisely this reason
that we in Waters Corporation are actively involved in discussions
regarding food safety legislation with regulators in many countries, in
order to facilitate this exchange of information.
Question 2. The EU and Japan have a food risk analysis body
separate from the risk management side. I worry that these two sides
would be too isolated from each other--I think risk assessment and risk
management are iterative. You need those two functions to work together
and learn from one another. Can you comment on how effective or not
effective this separation is?
Answer 2. I can see both sides of this argument. I completely agree
that close cooperation between risk assessment and management is
absolutely essential, particularly with regard to ensuring effective
and timely intervention. Indeed, exchange of scientific information is
also key to ensuring that control measures are both necessary and
appropriate. On the other hand, one vital role of food safety
regulation involves maintaining consumer confidence. There is a risk,
if both functions are covered by one organization that, either in
reality or in the public's perception, the practicalities of risk
management may influence the risk assessment and subsequent control
measures. This separation ensures that regulations are based on science
and the scale of control measures are appropriate to effectively manage
the risk and are not dictated by the availability of resources. From my
experience working in risk management in the UK, this system of
separation works well, but only because of the very close collaboration
and interaction that exists between both sides.
Question 3. We heard a lot about Radio-Frequency Identification
(RFID) at last year's hearing, but it seemed that the conclusion was
that this isn't ready for prime time, at least at the unit-of-sale
package level. How is the EU implementing the requirement for full
traceability?
Answer 3. Certainly, RFID is receiving a lot of attention for the
traceability advantages it offers. However, food production is a very
price conscious environment and reports indicate that early adopters of
RFID appear to be struggling to justify the relatively high cost
associated with this technology, which would agree with your assessment
that it may not yet be appropriate for food traceability. There is a
requirement for traceability in EU food law which it defines as ``the
ability to trace and follow a food, feed, food-producing animal or
substance intended to be, or expected to be incorporated into a food or
feed, through all stages of production, processing and distribution.''
The EU has published guidelines which require food business operators
to document the names and addresses of the supplier and customer in
each case, as well as the nature of the product and date of delivery.
In addition to the general requirements, sector-specific legislation
applies to certain categories of food products (fruit and vegetables,
beef, fish, honey, olive oil) so that consumers can identify their
origin and authenticity. In the case of animals, producers must now
``tag'' every one with details of their origin and, when animals are
taken for slaughter, stamp them with the traceability code of the
abattoir. The tools used (ear tags, passports, bar codes) may vary from
one country to another but must carry the same information.
Question 4. Whenever people talk about international standards, ISO
comes up for discussion. I think they do a lot of great things, but
when it comes to food safety, is ISO good enough?
Answer 4. There is no doubt that ISO standards play an important
role in food safety. For example, the accreditation standard ISO 17025
is widely accepted as being highly desirable for laboratories involved
in food safety analysis. However, ISO standards regarding safe food
production are still evolving (such as the recent standards ISO
22000:2005 on hazard control and ISO 22005:2007 on traceability) and
have yet to find widespread application. Many producers therefore
choose to implement the Hazard Analysis and Critical Control Point
(HACCP) recommendations to demonstrate due diligence. In Europe there
is a legislative requirement for all food business operators to
implement a HACCP programme. Indeed, some of the evolving ISO standards
seek to standardize the implementation of HACCP.
questions of senator allard
Question 1. In your opinion what can be done to further educate the
public, private sector and interested government agencies on food
safety, recalls, etc.''
Answer 1. This would appear to require considerable collaboration
involving all interested parties. In a European survey, when asked who
consumers most trust to inform them of a serious food risk, public
authorities came fourth (behind consumer groups, physicians and
scientists). Key elements appear to lie in maintaining the trust of the
consumers and in providing them with accurate, easily understood
information. In food recalls that I have been involved with in the
past, the relevant agencies issued photographs of affected product,
making it easy for consumers to establish whether they need to take
action or not. I understand that this is currently being piloted by FDA
and the consumer feedback should be most interesting.
Effective training for scientists involved in food safety analysis
is also vital in ensuring that methods of analysis are appropriate and
offer satisfactory assurances of product compliance. This necessity
extends beyond U.S. borders, since imported food safety inevitably
relies, to a large extent, on assurances provided by laboratories in
those exporting countries. Waters Corporation has had discussions with
a number of U.S. executive agencies who are regularly approached by
scientists from foreign laboratories requesting training. It has been
suggested that the establishment of a food safety institute capable of
offering specialized scientific training to both domestic and foreign
scientists would be of great benefit.
Question 2. Do you think that further education should play a role
in addressing food safety? Do you have a single suggestion to further
education and the distribution of informative resources regarding food
safety?
Answer 2. In addition to the frequently discussed risk assessment
and risk management strategies, risk communication also plays an
extremely important role in food safety control. If consumers are
presented only with the bald facts of potential hazards associated with
a particular foodstuff, without the balanced view of the potential
health benefits to be gained from wholesome product, it is likely to
initiate complete avoidance which will, not only, damage the business
of the vast majority of responsible producers but may also limit the
source of valuable nutrients for the consumers. In a recent European
survey 53 percent of people surveyed claimed to have changed their
eating habits as a result of hearing about a food hazard, with 16
percent stating that this change was permanent. The challenge then lies
in building confidence for consumers that they are being both
adequately protected and informed. If pressed to make a single
suggestion regarding dissemination of information, it would be to
create a single central repository for information relating to all
aspects of food safety, ensuring that the message is consistent,
comprehensive and, above all, easily understood by consumers.
[Whereupon, at 12:38 p.m. the hearing was adjourned.]