[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

                               __________

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                                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

                              ----------                              

                               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

                              ----------                              


                       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.
---------------------------------------------------------------------------
    \1\ Center for Science in the Public Interest, Outbreak Alert! 
Database, 2007 at http://www.cspinet.org/foodsafety/outbreak/
pathogen.php.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \4\ Paul S. Mead, et al., Food-Related Illness and Death in the 
United States, 5 Emerging Infection Diseases 607, Sept.-Oct. 1999.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \11\ Tommy Thompson Resigns From HHS, The Wash. Post, Dec. 3, 2004.
---------------------------------------------------------------------------
             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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
      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.
---------------------------------------------------------------------------
    \23\ Hazard Analysis and Critical Control Points.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    * 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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
     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.
---------------------------------------------------------------------------
    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.=
---------------------------------------------------------------------------
    = Governments should follow appropriate Codex guidelines for the 
use of Halal claims in food labeling.
---------------------------------------------------------------------------
     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.]

                                    

      
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