[Senate Hearing 106-366]
[From the U.S. Government Publishing Office]




                                                        S. Hrg. 106-366
 
     ``OVERLAP AND DUPLICATION IN THE FEDERAL FOOD SAFETY SYSTEM''

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


                                HEARING

                               before the

                  OVERSIGHT OF GOVERNMENT MANAGEMENT,
        RESTRUCTURING AND THE DISTRICT OF COLUMBIA SUBCOMMITTEE

                                 of the

                              COMMITTEE ON
                          GOVERNMENTAL AFFAIRS
                          UNITED STATES SENATE

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION



                               __________

                             AUGUST 4, 1999

                               __________

      Printed for the use of the Committee on Governmental Affairs


                      U.S. GOVERNMENT PRINTING OFFICE
61-665 CC                     WASHINGTON : 2000

_______________________________________________________________________
For sale by the Superintendent of Documents, Congressional Sales Office
         U.S. Government Printing Office, Washington, DC 20402




                   COMMITTEE ON GOVERNMENTAL AFFAIRS

                   FRED THOMPSON, Tennessee, Chairman
WILLIAM V. ROTH, Jr., Delaware       JOSEPH I. LIEBERMAN, Connecticut
TED STEVENS, Alaska                  CARL LEVIN, Michigan
SUSAN M. COLLINS, Maine              DANIEL K. AKAKA, Hawaii
GEORGE V. VOINOVICH, Ohio            RICHARD J. DURBIN, Illinois
PETE V. DOMENICI, New Mexico         ROBERT G. TORRICELLI, New Jersey
THAD COCHRAN, Mississippi            MAX CLELAND, Georgia
ARLEN SPECTER, Pennsylvania          JOHN EDWARDS, North Carolina
JUDD GREGG, New Hampshire
             Hannah S. Sistare, Staff Director and Counsel
      Joyce A. Rechtschaffen, Minority Staff Director and Counsel
                  Darla D. Cassell, Administrive Clerk

                                 ------                                

SUBCOMMITTEE ON OVERSIGHT OF GOVERNMENT MANAGEMENT, RESTRUCTURING, AND 
                        THE DISTRICT OF COLUMBIA

                  GEORGE V. VOINOVICH, Ohio, Chairman
WILLIAM V. ROTH, Jr., Delaware       RICHARD J. DURBIN, Illinois
JUDD GREGG, New Hampshire            ROBERT G. TORRICELLI, New Jersey
                  Kristine I. Simmons, Staff Director
   Marianne Clifford Upton, Minority Staff Director and Chief Counsel
                     Julie L. Vincent, Chief Clerk




                            C O N T E N T S

                                 ------                                
Opening statements:
                                                                   Page
    Senator Voinovich............................................     1
    Senator Durbin...............................................     2

                               WITNESSES
                       Wednesday, August 4, 1999

Jane E. Henney, M.D., Commissioner, Food and Drug Administration, 
  U.S. Department of Health and Human Services...................     9
Catherine E. Woteki, Ph.D., R.D., Under Secretary for Food 
  Safety, U.S. Department of Agriculture.........................    11
Lawrence J. Dyckman, Director, Food and Agriculture Issues, U.S. 
  General Accounting Office, accompanied by Keith Oleson, 
  Assistant Director, Food and Agriculture Issues, U.S. General 
  Accounting Office..............................................    13
Carol Tucker Foreman, Distinguished Fellow and Director, Food 
  Policy Institute, Consumer Federal of America..................    16
Nancy Donley, President, S.T.O.P., Safe Tables Our Priority......    25
Caroline Smith DeWaal, Director, Food Safety Programs, Center for 
  Science in the Public Interest.................................    28
Rhona Applebaum, Ph.D., Executive Vice President, for Scientific 
  and Regulatory Affairs, National Food Processors Association...    30
Stacey Zawel, Ph.D., Vice President for Scientific and Regulatory 
  Policy, Grocery Manufacturers of America.......................    31

                     Alphabetical List of Witnesses

Applebaum, Rhona:
    Testimony....................................................    30
    Prepared statement...........................................   119
DeWaal, Caroline Smith:
    Testimony....................................................    28
    Prepared statement...........................................    96
Donley, Nancy:
    Testimony....................................................    25
    Prepared statement...........................................    92
Dyckman, Lawrence J.:
    Testimony....................................................    13
    Prepared statement...........................................    68
Henney, Dr. Jane E.:
    Testimony....................................................     9
    Combined prepared statement with attachments.................    49
Foreman, Carol Tucker:
    Testimony....................................................    16
    Prepared statement...........................................    81
Woteki, Catherine E.:
    Testimony....................................................    11
    Combined prepared statement with attachments.................    49
Zawel, Stacey:
    Testimony....................................................    31
    Prepared statement...........................................   124

                                APPENDIX

Charts submitted by Senator Durbin...............................    41
Letter to Senator Durbin, from Donna E. Shalala, Secretary of 
  Health and Human Services; Dan Glickman, Secretary of 
  Agriculture; and Neal Lane, Assistant to the President for 
  Science and Technology.........................................   130
Sanford A. Miller, Ph.D., Professor and Dean, Graduate School of 
  Biomedical Sciences, University of Texas Health Science Center 
  at San Antonio, prepared statement.............................   131
Questions and responses from Catherine E. Woteki, Ph.D., R.D., 
  Under Secretary, Food Safety, Department of Agriculture........   135
Questions and responses from Caroline Smith DeWaal, Director, 
  Food Safety, Center for Science in the Public Interests, with 
  attachments A thru F...........................................   141
Questions and responses from Melinda K. Plaisier, Associate 
  Commissioner for Legislature, Department of Health & Human 
  Services.......................................................   161


     ``OVERLAP AND DUPLICATION IN THE FEDERAL FOOD SAFETY SYSTEM''

                              ----------                              


                       WEDNESDAY, AUGUST 4, 1999

                                     U.S. Senate,  
       Oversight of Government Management, Restructuring,  
                 and the District of Columbia Subcommittee,
                        of the Committee on Governmental Affairs,  
                                                    Washington, DC.
    The Subcommittee met, pursuant to notice, at 10:40 a.m., in 
room 342, Dirksen Senate Office Building, Hon. George 
Voinovich, Chairman of the Subcommittee, presiding.
    Present Senators Voinovich and Durbin.

             OPENING STATEMENT OF SENATOR VOINOVICH

    Senator Voinovich. The hearing will come to order.
    Good morning and thank you for coming. Today the 
Subcommittee on Oversight of Government Management, 
Restructuring and the District of Columbia, holds the second 
hearing on the issue of food safety entitled, ``Overlap and 
Duplication in the Federal Food Safety System.''
    The first hearing, which was held on July 1, examined 
Federal oversight of egg safety as a case study of the 
fragmentation and overlap in Federal food safety 
responsibilities. This hearing will not focus on a single food 
area, but rather it will examine the organization of all 
Federal food safety responsibilities.
    I must say that a recent event in my life has influenced my 
thoughts on this issue. Last week, my wife came down with food 
poisoning and I became very sick. She had a couple of days of 
tests in the hospital and during the incident I kept wondering 
how did she get it and how could it have been avoided. I 
suspect that the source of the problem was not on the farm but 
rather in the handling of the food at the retail level. I am 
not saying that Federal inspectors should run out to all these 
retail establishments and do something about it. That is a 
county responsibility in our State. Nevertheless, that 
experience that I had really brought home to me--when you have 
to call emergency medical services at 1:30 in the morning and 
you have a very sick wife, you really understand the problem--
much more so than someone that has not had that experience.
    We have over 35 different laws that govern food safety 
policy, some of which are over 100 years old. Currently 10 
different agencies, within four cabinet-level departments, as 
well as two independent agencies have some responsibility for 
food safety. The combined food safety budget is over $1 billion 
a year.
    The Subcommittee will examine this issue with two questions 
in mind. First, if the Federal Government were to create a food 
safety system from scratch, start out right from the beginning, 
would it resemble the current system that we have? And, second, 
is this the best and most logical organization for Federal food 
safety agencies?
    In addition, the Subcommittee will discuss S. 1281, the 
Safe Food Act of 1999, introduced by Senator Durbin that has 
been referred to our Committee.
    According to the General Accounting Office, whose work on 
this issue has spanned more than two decades and included 49 
reports, food safety is one of 33 program areas in the Federal 
Government in which there is substantial fragmentation and 
overlap. The longer I am here, I see what is going on in this 
area is going on all over the Federal Government.
    As I mentioned earlier, four Federal departments, 
Agriculture, Commerce, Health and Human Services, and Treasury, 
as well as the Environmental Protection Agency and the Federal 
Trade Commission, have a role in food safety. Depending upon 
the department or agency, the Federal Government has vastly 
different approaches to food safety. For example, the Food 
Safety and Inspection Services in the USDA conducts continuous 
inspections at meat, poultry and egg processing plants around 
the country. The Food and Drug Administration, which is in 
Health and Human Services, on the other hand, conducts 
inspections of food processing plants within its jurisdiction 
once every 10 years, on average.
    In addition, several analysts of Federal food safety policy 
argue that some of our efforts lack a scientific basis and 
should be focused on the most severe food-borne threats to 
human health, specifically micro-bio contamination.
    I view this issue primarily as one of government 
management, and am most interested in learning how and why 
there are 12 different agencies involved in the oversight of 
food safety and what we can do to improve the current system.
    I am here today to listen. I had not studied this issue in 
depth before learning of Senator Durbin's interest in this 
legislation. However, I do look forward to learning from our 
witnesses this morning whether there is any justification for 
the fragmentation which seems to exist and whether we can do 
better.
    I would now like to yield to the Ranking Minority Member of 
this Subcommittee, Senator Durbin.

              OPENING STATEMENT OF SENATOR DURBIN

    Senator Durbin. Chairman Voinovich, thank you for this 
hearing. I appreciate it very much and it is a topic which is 
near and dear to my heart and your family experience this last 
week, which you told me about just a few days ago, is repeated 
about 81 million times each year in the United States. And 
unfortunately, for 9,000 of those cases, it is fatal. Thank God 
it did not happen to your family nor has it happened to mine, 
but we will hear testimony today from a family where it has 
happened. It is a serious issue.
    And it is one that, frankly, Congress really has no excuse 
to avoid any longer. In 1977, this same Committee issued a 
report about fragmentation in the food safety jurisdiction of 
the Federal Government. Twenty-two years ago we were dealing 
with this and saying that we have to do something about it. 
And, sadly, we have done very little.
    I want to say at the outset that the people who are 
testifying today, Dr. Henney, Dr. Woteki, folks from the 
General Accounting Office, as well as Carol Tucker Foreman, I 
believe are all sincere professional individuals who really 
have the public interest in mind. But I have to say that some 
of the best medical professionals when they get into the 
Federal bureaucracy kind of lose sight of the goal here. It all 
becomes a turf battle, a jurisdictional dispute and the same 
thing happens on Capitol Hill. Committee chairmen, everybody 
has got a piece of the action. Nobody wants to give it up. You 
go downtown, the USDA is afraid they are going to lose their 
employees if this goes to a single food agency. The FDA has the 
same fear and so do many other agencies.
    And that competition has created gridlock and has created 
utter nonsense when it comes to the responsibility for food 
safety in America. We have on this table before you here some 
examples of the different jurisdiction for foods. And it is 
incredible to look at one pizza and decide that is the USDA's 
responsibility, another pizza is the FDA's and the list goes on 
and on.
    And if you are out--I am kind of picking on Italian foods 
today, I do not mean to--but if you go out to the food store, 
and you buy beef ravioli and cheese ravioli, you have just 
bought two products that have different jurisdictions under the 
Federal Government.
    Beef ravioli, Department of Agriculture, of course; cheese 
ravioli, why, of course, the Food and Drug Administration. You 
would not want the USDA to look at cheese ravioli, would you? 
Or you would not want the FDA to look at beef ravioli. And that 
just, I think, illustrates what has happened here.
    Let me use one that comes from a little lighter vein and 
perhaps will betray my age a little bit. Forgive this, it may 
not be the best graphic, but one of my favorite routines on 
Saturday Night Live was Father Guido Sarducci, who had a 
routine entitled, ``How Many Popes in the Pizza?'' Well, we 
decided to take a look after the GAO report to find out how 
many different Federal agencies are responsible for making sure 
that the pizza that comes to your table is safe. You will 
notice that EPA, Agriculture Marketing Service, FDA, Animal 
Plant Health Inspection Safety, the Grain Inspection Safety 
Agency, and the Food Safety Inspection Service, all have a hand 
in inspecting this pizza on its way to our tables. Six 
different Federal agencies. How many bureaucrats in the pizza, 
I would ask Father Sarducci. And that is what it boils down to.
    And what are we going to do about it? Frankly, we have not 
done enough. We have talked about it, we have studied it, we 
have issued all sorts of pious statements about how we have to 
get this under control and I am just not pleased with where we 
are today.
    First, let me tell you why this is important. We do have 
the safest food supply in the world but it can be a lot safer. 
We do have a good food safety inspection system but it can be 
less bureaucratic, it can be more efficient, it can be driven 
by science and not by politics. And I think that is what every 
consumer wants.
    In addition to that, we have to concede that we are 
entering into an era where food safety is a big ticket item, 
not just in terms of life and death for Americans, but also in 
terms of commerce. Do you know what is going on in Europe 
today? We are in pitched battle in Europe today about the 
safety of food. And as a result, we are finding many of our 
exports from the United States that are being excluded, the 
Europeans will not buy them. They say they are dangerous. And 
the reason?
    Frankly, there is no FDA or U.S. Department of Agriculture 
in the European Union that people trust. And, as a result, it 
takes nothing to panic the consumers in Europe away from 
products or toward products. It really argues, from my point of 
view, for us to have a science-based, coordinated, single 
agency effort here. We have to be able to defend the products 
that we sell to American families and the products we export 
around the world. And as long as you are dealing with six 
different agencies when it comes to pizza, you can see how we 
are fragmented and moving in so many different directions.
    So, from the viewpoint of the 21st Century and the demands 
consumers will have worldwide for trust in the food that they 
eat, I think this concept is long overdue.
    Let me show you a couple of other charts that illustrate 
some of the history of this.\1\ I will go through them very 
quickly. We have had a series of GAO study reports. I am happy 
that GAO is here today. This has been an ongoing effort by the 
GAO. That just shows 5 or 6 years. All of them concluding that 
a single food safety agency was the way to go to try to make 
some sense out of the nonsense of our current bureaucracy.
---------------------------------------------------------------------------
    \1\ The charts referred to appears in the Appendix on page 41.
---------------------------------------------------------------------------
    The Governmental Affairs Committee, as I said, in 1977 and 
since has said repeatedly that dividing responsibility for food 
safety is not smart and we should put it in a single agency. 
The different reports by Vice President Gore on the same 
thing--this is from the National Academy of Sciences--I am 
going to be referring to this throughout the day because the 
industry people for some reason jumped on this report in August 
1998 and said, proof positive, the White House is opposed to a 
single food safety agency. And, yet, if you will look through 
it, they talk about a single voice, a single unified agency, 
one official.
    I really wish the people who are here representing the 
business community would not be so frightened by the idea of 
some change. This change could be for the better. You could 
have more confidence when it comes to consumers buying your 
product and you could have better results when you try to 
export overseas. But there has been this wall of resistance 
from the private sector side which just does not make sense.
    We are more than happy to work with you. We are not trying 
to make your life any more difficult. We are trying to make it 
more sensible. If you make pizza and the USDA inspector shows 
up every day and the FDA inspector shows up every 3 years, 5 
years or 10 years, how does that help you as a businessperson 
to make your plans and to go about your business? And I hope 
the private sector will be a little more open-minded as we get 
into this.
    We have asked the former food officials who have been 
involved in this from FDA as well as different agencies, and 
Carol Tucker Foreman, of course, is quoted here, and we will 
hear from her in person. Dr. Kessler said it is ironic that the 
National Government deals with food safety issues in such a 
haphazard, inconsistent manner. And he goes on to say that we 
need a single agency with one mission and one consistent set of 
food safety goals. After the folks leave government they tell 
us this.
    Sometimes, while they are there, but after they leave 
government they look back and say, why did I not do something 
about this tangled mess of Federal agencies stumbling over one 
another with the responsibility for food safety?
    Well, I thank the Chairman for bringing this together today 
and a lot more will come out during the course of the hearing. 
I am looking forward to the testimony.
    Thank you.
    The prepared statement of Senator Durbin follows:
                  PREPARED STATEMENT OF SENATOR DURBIN
    Mr. Chairman, I would like to thank you for calling this hearing on 
an issue of importance to every American virtually every time they eat. 
I appreciate your willingness to follow up on our hearing regarding egg 
safety with this more comprehensive look at the fragmentation in our 
Nation's food safety system.
    This is not the first time this committee has studied the issue of 
food safety. Consider the following quote from a study produced by this 
committee in 1977:

        Divided responsibility between the Department of Agriculture 
        and the Food and Drug Administration for food regulation has 
        created a regulatory program which is often duplicative, 
        sometimes contradictory, undeniably costly, and unduly complex.

        The current jurisdiction overlap has resulted in redundant 
        inspections of the same plant, the shifting of responsibility 
        of particular food items at various stages of production, and 
        inconsistent food labeling policy. The recurrent problems of 
        overlap, duplication, and concurrent jurisdiction are addressed 
        by UDSA and FDA officials on an ad hoc case-by-case basis. 
        There is currently no systematic or rational overall approach 
        to Federal food regulation.

        Committee on Governmental Affairs, United States Senate Study 
        on Federal Regulation, Volume V, Regulatory Organization 
        December 21, 1977, p. xv.

    Mr. Chairman, today this subcommittee revisits this issue and I am 
sad to report that the findings, reported by the Committee on 
Governmental Affairs over 20 years ago, remain an accurate description 
of the Federal food safety system of today. But we can change this 
situation. We currently have before us the Safe Food Act of 1999 (S. 
1281)--a piece of legislation that can fundamentally set the course for 
a food safety system that is efficient, effective, based in science, 
and has the promise of maintaining the confidence of the consuming 
public.
    Make no mistake, our country has been blessed with one of the 
safest and most abundant food supplies in the world. However, we can do 
better. Foodborne illness is a significant problem. While food may 
never be completely free of risk, we must strive to make our food as 
safe as possible. Americans at every level--Federal, State, and local 
government, industry, and the consuming public--share this 
responsibility.
    The safety of our Nation's food supply is facing tremendous 
pressures with regard to emerging pathogens, an aging population with a 
growing number of people at high risk for foodborne illnesses, broader 
changes in food distribution patterns, an increasing volume of food 
imports, and changing consumption patterns.
    The General Accounting Office (GAO) estimates that as many as 81 
million people will suffer food poisoning this year and more than 9,000 
will die. Children and the elderly are especially vulnerable. In terms 
of medical costs and productivity losses, foodborne illness costs the 
Nation up to $37 billion annually. The situation is not likely to 
improve without decisive action. The Department of Health and Human 
Services predicts that foodborne illnesses and deaths will increase 10-
15 percent over the next decade.
    In 1997, a Princeton Research survey found that 44 percent of 
Americans believe the food supply in this country is less safe than it 
was 10 years ago. American consumers spend more than $617 billion 
annually on food, of which about $511 billion is spent on foods grown 
on U.S. farms. Our ability to assure the safety of our food and to 
react rapidly to potential threats to food safety is critical not only 
for public health, but also for the vitality of both domestic and rural 
economies and international trade.
    Consumer confidence is important--just look what's happening in 
Europe, where Belgium has become embroiled in a dioxin crisis. Days 
before the national elections, poultry, eggs, pork, beef, and dairy 
products were withdrawn from supermarket shelves. Butcher shops closed 
and livestock farms were quarantined. Since then, countries worldwide 
have restricted imports of eggs, chickens, and pork from the European 
Union. Public outrage in Belgium over the dioxin scandal led to a 
disastrous showing by the ruling party in the national and European 
elections on June 14, and the government was forced to resign. Food 
safety concerns and fears are global.
    Part of the controversy in Europe is the failure of government to 
win the confidence of the consumers. People lose confidence and panic 
unnecessarily when their government can't step up to its 
responsibilities. From ``mad cow'' disease to dioxin, we cannot afford 
to ignore these lessons regarding government's role in effectively and 
efficiently managing food safety. A credible Federal food safety system 
reassures consumers and makes our products more acceptable--here and 
abroad.
    Today, food moves through a global marketplace. This was not the 
case in the early 1900's when the first Federal food safety agencies 
were created. Throughout this century, Congress responded by adding 
layer upon layer--agency upon agency--to answer the pressing food 
safety needs of the day. That's how the Federal food safety system got 
to the point where it is today. And again as we face increasing 
pressures on food safety, the Federal Government must respond. But we 
must respond not only to these pressures but also to the very 
fragmented nature of the Federal food safety structure.
    Fragmentation of our food safety system is a burden that must be 
changed to protect the public health. Currently, there are at least 12 
different Federal agencies and 35 different laws governing food safety, 
and 28 House and Senate subcommittees with food safety oversight. With 
overlapping jurisdictions, Federal agencies often lack accountability 
on food safety-related issues.
    In a hearing last month, this subcommittee examined the way in 
which this fragmentation negatively affected the safety of the Nation's 
egg supply. Salmonella Enteritidis (SE) has been recognized as a cause 
of food-borne illness associated with mishandled or undercooked eggs 
since the mid-1980s. In 1997, SE may have caused about 300,000 
illnesses, resulting in 230 deaths. Just last month, an International 
House of Pancakes restaurant in Richmond, Virginia was closed after 92 
people contracted salmonella from eating eggs there. Seven people were 
hospitalized. Yet in over a decade since this problem first surfaced, 
the four Federal agencies with egg safety responsibility still have not 
implemented an effective comprehensive SE-prevention program.
    At last month's hearing, the General Accounting Office (GAO) 
released its report, U.S. Lacks a Consistent Farm-to-Table Approach to 
Egg Safety, which described the gaps, inconsistencies, and 
inefficiencies in the current egg safety system.
    The General Accounting Office has been unequivocal in its 
recommendation for consolidation of Federal food safety programs. GAO's 
April 1998 report states that ``[s]ince 1992, we have frequently 
reported on the fragmented and inconsistent organization of food safety 
responsibilities in the Federal Government.'' In a May 25, 1994, 
report, GAO stated that its ``estimony is based on over 60 reports and 
studies issued over the last 25 years by GAO, agency Inspectors 
General, and others.'' The Appendix to the 1994 GAO report listed: 49 
reports since 1977, 9 USDA Office of Inspector General reports since 
1986, 1 HHS Office of Inspector General report in 1991, and 15 reports 
and studies by Congress, scientific organizations, and others since 
1981.
    Again, earlier this year, GAO in its 21-volume report on government 
waste, pointed to the lack of coordination of the Federal food safety 
efforts as an example. ``So many cooks are spoiling the broth,'' said 
the GAO while highlighting the absurdity of having one Federal agency 
inspecting frozen meat pizza and another inspecting frozen cheese 
pizza. But GAO is not the only agency calling for consolidation.
    Last August, the National Academy of Sciences (NAS) released a 
report recommending the establishment of a ``unified and central 
framework for managing Federal food safety programs,'' arguing that it 
should be ``one that is headed by a single official and which has the 
responsibility and control of resources for all Federal food safety 
activities. . .'' That report further states, ``Many members of the 
committee are of the view that the most viable means of achieving these 
goals would be to create a single, unified agency headed by a single 
administrator. . .'' I agree with this conclusion; S. 1281--the Safe 
Food Act of 1999--will do just that.
    The administration has stepped forward on the issue of food 
safety--the President's Food Safety Initiatives and the President's 
Council on Food Safety have focused efforts to track and prevent 
microbial foodborne illnesses. I commend President Clinton and 
Secretaries Glickman and Shalala for their commitment to improving our 
Nation's food safety and inspection systems. I also acknowledge the 
long list of accomplishments by our agencies, represented today by Dr. 
Catherine Woteki, Under Secretary for Food Safety at the U.S. 
Department of Agriculture and Dr. Jane Henney, Commissioner of the Food 
and Drug Administration in the U.S. Department of Health and Human 
Services. I commend the dedication of the professionals in our Federal 
agencies who are committed to improving the safety of our food supply.
    This administration has produced many food safety successes through 
a dedicated focus to coordinate agencies' efforts. Some suggest that 
this recent commitment to enhanced coordination is all that is needed. 
But this isn't the first time that coordination has been suggested. 
Again I refer to the 1977 Senate Governmental Affairs Committee report 
which says, ``While we support the recent efforts of FDA and USDA to 
improve coordination between the agencies, periodic meetings will not 
be enough to overcome the problems outlined above.'' Coordination alone 
is not enough, as the NAS committee reports, ``[T]he structure should 
also have a firm foundation in statute and thus not be temporary and 
easily changed by political agendas or executive directives.'' We must 
not retreat from recent food safety advances that have been made. We 
must provide the means to sustain this progress.
    Dr. Sanford A. Miller, a former Director of the FDA Center for Food 
Safety and Applied Nutrition (1978 to 1987) who also served on the NAS 
study committee, was unfortunately unable to appear to testify today. 
His written statement is submitted for the record. Dr. Miller sums it 
up well in saying, ``Each agency operates under a different mandate, 
governed by different laws and answering to different constituencies 
and traditions. To ask them to voluntarily ignore this history is 
naive. There needs to be a permanent structure focused on food safety 
to meet the enduring needs of the American people.''
    Earlier this year in response to the NAS report, even the 
President's Council on Food Safety stated its support for the NAS 
recommendation calling for a new statute that establishes a unified 
framework for food safety programs with a single official with control 
over all Federal food safety resources.
    As directed by the President, the Council is currently developing a 
strategic plan. Three weeks ago, the council hosted a day-long meeting 
to gather public comment as part of that process. Food Chemical News 
reported that a ``number of participants suggested that a single food 
safety agency would solve many of the problems by improving 
coordination and resolving uneven funding across agencies that makes it 
difficult to target resources based on food safety risks.'' I encourage 
the Council to seriously consider those comments.
    An independent single food safety agency is needed to replace the 
current, fragmented system. The Safe Food Act of 1999 would combine the 
functions of USDA's Food Safety and Inspection Service, FDA's Center 
for Food Safety and Applied Nutrition and Center for Veterinary 
Medicine, the Department of Commerce's Seafood Inspection Program, and 
the food safety functions of other Federal agencies. This new, 
independent agency would be funded with the combined budgets from these 
consolidated agencies.
    With overlapping jurisdictions, Federal agencies many times lack 
accountability on food safety-related issues. There are simply too many 
cooks in the kitchen. A single, independent agency would help focus our 
policy and improve enforcement of food safety and inspection laws.
    It's time to move forward. Let us stop using multiple Federal 
agencies to inspect pizza. Instead let us ``deliver'' what makes 
sense--a single, independent food safety agency.
    A single, independent agency with uniform food safety standards and 
regulations based on food hazards would provide an easier framework for 
implementing U.S. standards in an international context. When our own 
agencies don't have uniform safety and inspection standards for all 
potentially hazardous foods, the establishment of uniform international 
standards is next to impossible.
    Research also could be better coordinated within a single agency 
than among multiple programs. Currently, Federal funding for food 
safety research is spread over at least 20 Federal agencies, and 
coordination among those agencies is ad hoc at best.
    New technologies to improve food safety could be approved more 
rapidly with one food safety agency. Currently, food safety 
technologies must go through multiple agencies for approval, often 
adding years of delay.
    In this era of limited budgets, it is our responsibility to 
modernize and streamline the food safety system. The U.S. simply cannot 
afford to continue operating multiple systems. This is not about more 
regulation, a super agency, or increased bureaucracy, it's about common 
sense and more effective marshaling of our existing Federal resources.
    With the incidence of food recalls on the rise, it is important to 
move beyond short-term solutions to major food safety problems. A 
single, independent food safety and inspection agency could more easily 
work toward long-term solutions to the frustrating and potentially 
life-threatening food safety issues we face .
    Some individuals have argued that we don't need a whole new 
government bureaucracy, that moving boxes around on an organizational 
chart won't make food safer, and that if the system isn't broken then 
it doesn't need to be fixed. But what they don't appreciate is that the 
current fragmented system makes it impossible to apply resources to the 
areas of greatest need. The current fragmented system makes it 
difficult for the agencies to be held accountable. For example, the 
current fragmented system places food safety efforts in conflict with 
the mission for agricultural market promotion. A system that determines 
which agency inspects which plant based on whether the plant produces 
an open-faced sandwich rather than a traditional one is one which, if 
not broken, is certainly illogical.
    A single, independent food safety agency will not have the burdens 
of our current fragmented system. Consolidation of food safety 
functions in a single, independent agency will preserve the expertise 
currently in our agencies in a manner that will promote more efficient 
and effective government. One agency instead of 12 or more handling 
food safety is a reduction in bureaucracy and red tape.
    Mr. Chairman, we have before this subcommittee a bill, S. 1281, 
which can bring the various agencies together to eliminate the overlap 
and confusion that have at times, unfortunately, characterized our food 
safety efforts. We need action, not simply reaction. Our current 
fragmented food safety structure is not the best that we are capable of 
having and it certainly is not the most logically designed system. 
Members of the Senate Governmental Affairs Committee of 1977 understood 
the problem, and they were correct when they reported, ``Responsibility 
for Federal food regulation, which is currently divided, should be 
assigned to a single agency.'' I hope we can finally achieve that goal.
    I welcome today's witnesses and the insights they will share, and I 
look forward to working with you toward a more effective and less 
fragmented food safety system.

    Senator Voinovich. Thank you, Senator Durbin.
    I would like to now introduce the first panel of witnesses. 
Representing the administration are Dr. Jane Henney, who is the 
Commissioner of the Food and Drug Administration, U.S. 
Department of Health and Human Services; and Dr. Catherine 
Woteki, Under Secretary of Food Safety, U.S. Department of 
Agriculture. Lawrence Dyckman is the Director of Food and 
Agricultural Issues at U.S. General Accounting Office, and he 
is accompanied by Keith Oleson, Assistant Director, Food and 
Agricultural Issues.
    And rounding out the panel is Carol Tucker Foreman, who is 
the Distinguished Fellow and Director of the Food Policy 
Institute at the Consumer Federation of America.
    We thank all of you for coming this morning. It is the 
custom of this Subcommittee to swear in all witnesses. 
Therefore, I would ask you to stand and raise your right hands, 
and I would also ask the witnesses that will be on the second 
panel to stand, and I will swear all of you in.
    [Witnesses sworn.]
    Senator Voinovich. We will now call on our first witness, 
Dr. Henney. We are anxious to hear what you have to say.

 TESTIMONY OF JANE E. HENNEY, M.D.,\1\ COMMISSIONER, FOOD AND 
   DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN 
                            SERVICES

    Dr. Henney. Thank you. Mr. Chairman, let me express on 
behalf of all of us on the panel we are very sorry to hear 
about your wife but glad that she has recovered well.
---------------------------------------------------------------------------
    \1\ The combined prepared statement of Dr. Henney and Ms. Woteki 
appears in the Appendix on page 49.
---------------------------------------------------------------------------
    Mr. Chairman, and Members of the Subcommittee, we are 
pleased to be here this morning to discuss one of the 
administration's highest priorities, protecting our Nation's 
food supply. I am Dr. Jane Henney, the Commissioner of Food and 
Drugs at FDA and I am joined by Dr. Cathy Woteki, Under 
Secretary for Food Safety at USDA.
    We appreciate your continued interest in ensuring the 
safety of our Nation's food supply and look forward to a full 
discussion of the issues you are raising today. Although the 
American food supply is among the safest in the world, too many 
cases of foodborne illness occur in the United States each 
year.
    Mr. Chairman, today Dr. Woteki and I will describe many of 
the achievements that have happened in the past several years 
but we will also look at the work that remains.
    Today's food safety challenges are very complex. First, 
Americans are eating a greater variety of foods, particularly 
seafood, poultry, fresh fruit, and vegetables that are 
available throughout the year. Second, Americans are eating 
more of their meals that are prepared away from home. Third, 
nearly a quarter of the U.S. population--the very young, the 
old, the immune-compromised--is at higher risk for foodborne 
illness. And perhaps the most important element in our changing 
world is the emergence of new and more virulent foodborne 
pathogens.
    Since 1942, the number of known foodborne pathogens has 
increased more than five-fold. Until the first decade of this 
century, the regulation of food safety was primarily the 
responsibility of State and local officials. The Pure Food and 
Drugs Act and the Meat Inspection Act were both passed by 
Congress in 1906. From the beginning, nearly 100 years ago, 
these laws focused on different areas of the food supply and 
each of them took a different approach to the food safety 
issues because of different problems that were present at that 
time.
    The Pure Food and Drugs Act placed the initial 
responsibility for producing safe and wholesome food squarely 
on the shoulders of the food industry. The Federal Government's 
job, in effect, was to police the industry. Unlike FDA's law, 
the USDA's Meat Inspection Act requires continual government 
inspections in the slaughterhouse. These laws form the 
foundation of the food safety system today.
    Under the current structure, FDA has jurisdiction over 78 
percent of the Nation's food supply--all domestic and imported 
foods except for meat, poultry and egg products. FDA has 
jurisdiction where food is produced, processed, packaged, 
stored or sold. The USDA's Food Safety and Inspections Service 
has regulatory and inspection responsibility for meat, poultry 
and egg products.
    And although the guiding statutes of the USDA and FDA 
approach food safety differently, today each agency relies on 
sound science and risk-based approaches to food safety. As our 
written testimony explains our efforts are strengthened by 
close working relationships with other Federal agencies such as 
the Centers for Disease Control and Prevention, the 
Environmental Protection Agency, and our State and local 
partners. Together we promote food safety and prevent foodborne 
illness and food hazards through coordinated and integrated 
activities.
    Food safety has been a high priority for this 
administration. This year for the third consecutive year, the 
administration has strongly supported the multi-agency effort 
to protect the health of the American public by improving the 
safety of the Nation's food supply. This process began with the 
May 1997 report to the President entitled, ``Food Safety: From 
Farm To Table,'' a national food safety initiative.
    This report contained recommendations that are both 
comprehensive and ambitious, and implementation of the report 
has depended upon a food safety system that is integrated and 
interdependent.
    The report has led to a very needed shift in our collective 
attention and resources toward the growing problem of microbial 
contamination of food. In just 2 years, the administration has 
undertaken the vast majority of the report's recommendations.
    Last August the President established the Council on Food 
Safety, whose goal is to make the food supply even safer 
through a seamless science-based food safety system supported 
by well coordinated surveillance, standards, inspection, 
enforcement, research, risk assessment, education, and 
strategic planning.
    Dr. Woteki will be discussing this strategic plan. I would 
like to just briefly highlight a few of the administration's 
food safety successes. One, in July 1995, HHS and USDA began a 
collaborative project called FoodNet under this initiative. It 
provides a strong network for responding to new and emerging 
foodborne illnesses, for monitoring the burden of foodborne 
illness, and identifying the source of specific foodborne 
diseases. PulseNet was developed by the CDC and it is now 
joined by a collaborative effort with HHS and USDA, as well as 
several States, that enables a national network of public 
health laboratories to perform DNA fingerprinting on bacteria 
that may be foodborne. PulseNet permits rapid and accurate 
detection of foodborne illness outbreaks.
    The National Antibiotic Resistance Monitoring Program was 
established in 1996 as a strong inter-agency cooperative 
initiative. There are more achievements than I can highlight in 
this short time. I want to leave time for Dr. Woteki to go 
through our strategic planning process and specifically some 
highlights of our successes in the area of research.
    Thank you.
    Senator Durbin [presiding]. Thank you very much. Dr. 
Woteki.

TESTIMONY OF CATHERINE E. WOTEKI,\1\ Ph.D., UNDER SECRETARY FOR 
          FOOD SAFETY, U.S. DEPARTMENT OF AGRICULTURE

    Ms. Woteki. Thank you very much.
---------------------------------------------------------------------------
    \1\ The combined prepared statement of Dr. Henney and Ms. Woteki 
appears in the Appendix on page 49.
---------------------------------------------------------------------------
    Mr. Chairman, sorry you have to leave. Senator Durbin, I am 
pleased to be here as well, and I would like to echo the 
comment that Dr. Henney made about the commitments that we have 
within the administration to work together at all levels of 
government to strengthen our national food safety system. I 
have also brought with me today a couple of charts, as well, 
and I would like to draw your attention to the one that is over 
here on the side.
    This is actually taken from the same report that you cited, 
that the National Academy of Sciences issued last year, in 
which they describe the attributes of an effective food safety 
system and this diagram tries to capture all of those elements.
    I think what is important is to focus on the center oval in 
that diagram. Really the important focus of our food safety 
system and any other effective food safety system is on public 
health and improving human well-being. In addition, this chart 
illustrates that there are many different key players in the 
food safety system: The private sector, government, as well as 
consumers. And that they have independent functions but they 
are also interdependent in many ways.
    They are all dependent on a science-based approach that 
depends on research and the provision of education and 
important information that each of these sectors needs in order 
to fulfill its roles and functions.
    I think the chart also illustrates the fact that these 
groups have to work together through partnerships in order to 
achieve that central focus and goal: Improving public health.
    Now, we believe, within the administration, that the 
activities that we have ongoing do meet these attributes of an 
effective food safety system. And, as Dr. Henney indicated in 
her testimony, we are trying to put our testimony together to 
actually highlight the accomplishments over the last several 
years with respect to furthering these attributes of an 
effective food safety system.
    I would like to point out a second chart that we have 
brought along with us. It illustrates the logo for the Fight 
Bac campaign, which has been a very effective food safety 
education program that also has been science-based and has also 
been the result of a very effective partnership among the 
private sector, consumer groups, Federal agencies, and other 
organizations.
    Now, before I continue where Dr. Henney left off, I would 
like to just briefly talk about the role of the Office of Food 
Safety within the Department of Agriculture because it is a new 
office that was created in the 1994 reorganization. We believe 
that the creation of this office has effectively laid to rest 
the complaints that have arisen in the past about the potential 
for conflict of interest within the department with respect to 
food safety. By separating the regulatory from the marketing 
functions, we believe that we have successfully put those 
complaints to rest.
    The legislation that authorized the reorganization requires 
that the Office of Food Safety be filled by an individual who 
has a specific and proven public health or food safety 
background. And these changes have very substantially enhanced 
USDA's public health focus and also, I believe, fortified food 
safety's presence within the department's broad mission.
    The Food Safety and Inspection Service does report to the 
Office of Food Safety. As you know, we have the responsibility 
for the inspection of meat, poultry and egg products sold in 
interstate commerce, and also for the inspection of imported 
products. The agency has approximately 7,000 Federal inspectors 
that are located in 6,000 plants and, subject to the 
authorizing legislation for the agency, conducts continuous 
inspections.
    This amounts to approximately 8 billion poultry, 135 
million livestock, as well as inspections that are conducted in 
processing plants.
    Now, our testimony focuses on five additional attributes 
that the academy report listed for an effective food safety 
system. And I would like to just briefly describe them now.
    The first is research. And since we have a science-based 
approach to food safety, we have continued to emphasize and 
even given more emphasis under the President's Food Safety 
initiative to the importance of R&D. And certainly through the 
appropriations, Congress has very substantially increased the 
amount of funding that is going to food safety research.
    We also believe that these R&D activities are paying off in 
the development of new technologies that can be implemented 
farm to table to improve food safety. Another attribute that 
the academy report describes is effective regulation. And in 
the case of both the Food and Drug Administration and the Food 
Safety and Inspection Service, we are implementing new science-
based, hazard analysis and critical control program approaches 
to improve food safety. So, we believe that we are making very 
substantial strides in effective regulation.
    There are also independent reviews conducted both of the 
seafood inspection as well as of the meat and poultry HACCP 
implementations that are demonstrating the effectiveness of 
those programs.
    New technologies are dependent on the science. And we are 
seeing the adoption of new technologies from steam 
pasteurization to anti-microbial rinses to the use of 
competitive exclusion products, to improve food safety, again, 
at the farm level as well as at the processing level.
    We are also working on education and information programs 
to improve the amount and quality of science-based information 
that is available to the public as well as to all who are 
responsible for food safety in that continuum from farm to 
table. I mentioned the Fight Bac campaign at the beginning of 
my remarks. Clearly, we are also taking other steps through 
consumer labeling approaches and other information provision 
approaches.
    Last, we recognize the importance of partnerships with 
State and local governments as well as other partners 
throughout the food system. Both FDA and FSIS historically have 
had very strong partnerships with the States. Two recent 
examples are the Seafood HACCP Alliance in which States worked 
closely with FDA and the industry in the development of that 
new program and USDA's continued work with the 25 States that 
operate inspection programs.
    Now, where do we go from here? Dr. Henney referred to the 
work of the President's Food Safety Council and of the Task 
Force that both Dr. Henney and I co-chair that is emphasizing 
the development of a strategic plan and budget to develop 
further improvements in our approaches to assure the public the 
safety of their food.
    Now, to draft the strategic plan, the Council established 
the Task Force that Dr. Henney and I co-chair. We have through 
that Task Force, developed a draft set of goals and objectives. 
We have shared them with stakeholders in a meeting that was 
held last month to solicit their views and opinions and we have 
scheduled a second public meeting for October 1999, in just a 
couple of months.
    We will be providing a copy of a draft plan to the public 
early in the year 2000 and our final report is due to the 
President in July of next year. Now, we firmly believe that a 
seamless, science-based food safety system is critical to 
ensuring the safety of our food supply and in protecting public 
health. How we get there should be carefully thought through 
with all of our partners and stakeholders. And I would like to 
assure you that we are approaching this effort very seriously 
and, we think, as expediently as we can and building in ample 
opportunities for consultation with stakeholders and partners. 
And we are considering the full range of options that are 
available to us and the recommendations of the academy.
    I very much thank you for the opportunity to appear before 
you and to discuss our food safety programs and we are 
certainly looking forward to working with you in the future.
    Senator Durbin. Thank you.
    I would like to thank you and Mr. Dyckman as well as Mr. 
Oleson, from the General Accounting Office, for the work that 
they have done on this issue. They have testified before and I 
welcome their return to the Subcommittee.
    Mr. Dyckman.

    TESTIMONY OF LAWRENCE J. DYCKMAN,\1\ DIRECTOR, FOOD AND 
AGRICULTURE ISSUES, U.S. GENERAL ACCOUNTING OFFICE; ACCOMPANIED 
   BY KEITH OLESON, ASSISTANT DIRECTOR, FOOD AND AGRICULTURE 
             ISSUES, U.S. GENERAL ACCOUNTING OFFICE

    Mr. Dyckman. It is always nice to be before this 
Subcommittee, Senator Durbin.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Dyckman appears in the Appendix 
on page 68.
---------------------------------------------------------------------------
    Much of what I have to say you have summarized so, if you 
will bear with me repeating your statements because I think we 
agree on many points. Millions of people become ill and 
thousands die each year from eating unsafe food. As we have 
stated in previous reports and testimonies, fundamental changes 
to the food safety system would minimize the risk of foodborne 
illnesses. These changes include moving to a uniform risk-based 
inspection system, administered by a single agency.
    My testimony today provides another view of our work on the 
problems resulting from the current fragmented food safety 
system and discusses our views on where in the Federal 
Government food safety responsibilities should reside.
    As the chart up there shows and as you have already 
described, the Federal food safety system is very complex.
    Senator Durbin. I want to give you credit, the GAO credit 
for inspiring our pizza. That was your chart that did that. 
[Laughter.]
    Mr. Dyckman. Yes. I actually liked your props a little 
better than ours. We do have a chart. There are 12 agencies 
involved with food safety. Thirty-five different laws ensuring 
the safety of cheese pizzas and meat pizzas, involves a half a 
dozen agencies.
    Currently, food safety laws not only assign specific food 
commodities to particular agencies but also provide agencies 
with different authorities and responsibilities that reflect 
significantly different regulatory approaches.
    The following samples from our prior work show some of the 
problems we found in reviewing the Nation's fragmented food 
safety system. Federal agencies are not using their inspection 
resources efficiently because the frequency of inspection is 
based on the agency's regulatory approach. Some foods and 
establishments may be receiving too much attention while others 
not enough. For example, USDA inspects meat and poultry plants, 
as we have said, at least daily; while FDA inspects firms that 
process foods with similar risks such as rabbit, venison, 
buffalo, and quail, on average, once a decade.
    Senator Durbin. Let me stop you, Mr. Dyckman, if I might 
for a moment. Going back to the illustration here of this 
cheese ravioli, the FDA responsibility, once in a decade they 
might come through the plant to look at this product?
    Mr. Dyckman. That is our understanding.
    Senator Durbin. And on the beef ravioli, a daily 
inspection?
    Mr. Dyckman. Yes.
    Additionally, responsibilities for the oversight of 
chemical residues in foods are fragmented among three Federal 
agencies: The FDA, USDA, and EPA. As a result, chemicals posing 
similar risks may be treated differently by the agencies 
because they operate under different laws and regulations. This 
permeates down to the State level as well. For instance, 
because States use different Federal agency methodologies for 
determining tolerance levels, fish considered safe to eat in 
one State, can swim to the waters of another State and thus are 
considered unsafe.
    Enforcement authorities granted to the agencies also differ 
significantly and obviously that is one of the underlying 
problems with this whole food safety mess or quagmire. For 
example, unlike FDA, USDA has authority to require food 
processors to register so that they can be inspected. USDA can 
also temporarily detain any suspect meat and poultry products.
    We have also done work on imported foods and found that 
regulation of that is inconsistent and unreliable. For meat and 
poultry imports, USDA, by statute, can and does shift most of 
the responsibility for ensuring product safety to the exporting 
country and that is where we think it should be. In contrast, 
FDA must rely primarily on widely discredited port-of-entry 
inspections which cover less than 2 percent of shipments 
entering the United States in 1997.
    Fragmented responsibilities also cause problems for the 
food industry because there has not always been a complete 
clear, unified communication about health risks associated with 
contaminated food products.
    So, how do we deal with all of these problems? Well, we 
believe the most effective solution is to consolidate food 
safety programs under a single agency with a uniform authority. 
It is not a new concept, it is not a difficult concept, and it 
is common sense. It was debated first in 1972 by the Congress 
with a proposed bill to transfer FDA's responsibilities, 
including its food safety activities to a new independent 
agency.
    We have discussed today that the National Academy of 
Sciences mirrored much of the recommendations in our prior work 
and concluded that the current fragmented Federal food safety 
structure is not well equipped to meet emerging challenges and 
recommended that the Congress establish by statute a unified 
and central framework for managing Federal food safety systems. 
And the important thing and one that I want to stress is they 
recommended a system that is headed by a single official, not 
by several officials.
    However, whether food safety responsibilities should be 
housed under an independent agency or an existing department is 
subject to debate. In this regard, I just want to point out 
that we reported recently on the experiences of four countries 
that have consolidated or in the process of consolidating their 
food safety responsibilities. Great Britain's and Ireland's 
efforts were responding to heightened public concerns about the 
safety of their food supplies and choose to consolidate 
responsibilities in the agencies that report to their ministers 
of health, because the public lost confidence in the 
agricultural ministries that had responsibilities for some food 
products.
    While Canada and Denmark were more concerned about program 
effectiveness, cost savings, efficiencies, and they have 
consolidated their activities in agencies that already had 
those responsibilities, basically the agencies that report to 
the ministers of Agriculture.
    But regardless of where a single agency is housed, what is 
most important in our opinion, is the adherence to four key 
principles. First, a clear commitment by the Federal Government 
to consumer protection. Second, a system that is founded on 
uniform laws that are risk-based. Third, adequate resources to 
carry out the system. Fourth, competent and aggressive 
administration of the laws by the responsible agency and 
effective oversight by the Congress.
    If I could just make one more point, Senator Durbin, the 
original question was if we were asked to redesign the food 
safety system, how would we do it? If we had to start from 
scratch, as we enter the 21st Century, we would never build the 
present bifurcated system. It would not make any sense. I do 
not think if you asked a 100 people to start from scratch would 
they come up with what we have now. People are working hard, 
with best intentions, they are doing a fairly good job at what 
they do. But it is not that well coordinated.
    It is not completely risk-based. Parts of it are, large 
parts of it are not. So, why should we be satisfied with it 
now? Why not transform it? Why not transform it into the type 
of system and into the type of activities that your legislation 
calls for?
    This completes our statement. And we would be happy to 
answer any questions.
    Senator Durbin. Thank you.
    Carol Tucker Foreman, thank you for being with us.

TESTIMONY OF CAROL TUCKER FOREMAN,\1\ DISTINGUISHED FELLOW AND 
DIRECTOR, FOOD POLICY INSTITUTE, CONSUMER FEDERATION OF AMERICA

    Ms. Foreman. Thank you, Senator Durbin.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Foreman appears in the Appendix 
on page 81.
---------------------------------------------------------------------------
    I am Carol Tucker Foreman. From 1977 to 1981 I served as 
Assistant Secretary for Food and Consumer Services at the 
Department of Agriculture with responsibility for meat, poultry 
and egg products inspection. I am here today to provide the 
perspective of one who has tried to make this system work for 
the American people but is now freed from the institutional 
imperative to defend the status quo.
    Unlike the government witnesses, I can answer your 
question. If the Federal Government were to create a food 
safety system from scratch, would it resemble the current 
system? Is this the best and most logical organization for 
Federal food safety agencies? I think you know my answer to 
both of those questions would be an emphatic, no.
    Two years ago Congress provided the National Academy of 
Sciences funds to examine the Nation's food safety system and 
recommend ways to improve it. In ensuring safe food from 
production to consumption the committee recommended that 
Congress create a unified and central framework for managing 
Federal food safety programs headed by a single Federal 
official who has both the authority and control of resources 
necessary to manage food safety efforts.
    The committee also pointed out that ad hoc efforts--and I 
include in that the President's Food Safety Council--will not 
suffice to bring about the vast cultural changes and 
collaborative efforts needed to create an integrated system.
    The problems with the present system are obvious. It does 
not produce an acceptable level of public health protection. 
Eighty-one million cases of foodborne illness and 9,000 deaths 
each year from food poisoning are not marks of success.
    Second, the present food safety system does not use human 
or public resources well. In fiscal year 1998, FDA and FSIS 
spent just shy of $1 billion for food safety. USDA with the 
responsibility for only meat, poultry and eggs, got $746 
million of that; FDA, with responsibility for all the other 
food products, got only $222 million. The fiscal year 1998 
budget paid for 7,200 USDA inspectors, while FDA had only 250.
    That disparity may explain why a Center for Science in the 
Public Interest analysis of CDC data showed that food products 
inspected by FDA were implicated in more foodborne illness 
outbreaks than foods inspected by USDA. The present system 
depletes the energies and demeans the talents of committed 
public servants who spend way too much of their time bumping 
each other and jockeying for advantage.
    The Commissioner of the Food and Drug Administration, the 
Under Secretary and the administrator of FSIS spend hours 
negotiating who is going to sign a letter, whose language is 
going to be used, who is going to get to sit at the table and 
where they will sit? What a waste of public funds and public 
talent.
    In March 1999, President Clinton's Council on Food Safety 
committed to examining a unified system. The Council has not 
done that. The strategic plan does not say a word about it. It 
is gone. What a shocking lack of leadership. The Commissioner, 
the Under Secretary, and the trade associations, will testify 
here today, are going to urge you to ignore all the facts that 
have been laid out by the General Accounting Office.
    Trade associations and the government will argue that 
tinkering around the edges and a little more cooperation will 
do the job.
    With all due respect, that has been tried before. Fixing 
the present system by tinkering and nibbling is like trying to 
teach a pig to sing. It will not work, and the pig does not 
like it.
    Our system is broke. If we are serious about protecting the 
public health we need to fix it. Consolidating food safety in 
one agency with one budget, one leader and, ultimately, one 
authorizing statute is the only way to do that.
    A multitude of independent bodies, Congressional 
committees, the GAO, the National Academy of Science, and 
virtually all the public officials who have led these agencies 
and been asked about it after they have left government give 
you the same response I have.
    Senator Durbin. If I might interrupt for a second? The 
reason why the staffer is looking so nervous, as she is, is 
because I have 2 minutes left to vote. And I want to give you a 
chance to conclude. Are you near the end here?
    Ms. Foreman. I am.
    Senator Durbin. OK, fine, thank you.
    Ms. Foreman. The change can be accomplished in a phased 
manner that ensures an orderly transition. Talented and 
committed public servants can make this work if you tell them 
to make it work. They cannot make the present system work.
    The American people deserve a better, more effective 
system, Congress can start down that road by passing the Safe 
Food Act, S. 1281.
    Thank you.
    Senator Durbin. Thank you.
    Thanks, everybody. I am going to call a recess here for a 
few minutes as I run off to vote. And you are welcome to snack, 
if you would like, and I will be right back.
    [Recess.]
    Senator Durbin. I apologize for leaving but it is beyond my 
control. And I, again, apologize to Carol Tucker Foreman for 
interrupting you. Perhaps it gave more dramatic impact to your 
closing. [Laughter.]
    Dr. Henney, when I use the term, virtual reality, what does 
that mean to you?
    Dr. Henney. I do not have a lot of psychiatric training, 
but I would say, what does it mean to you? [Laughter.]
    Senator Durbin. Perfect answer.
    My concept of virtual reality is this new technology where 
you put on this helmet and you feel like you are somewhere that 
you are not, that you are doing things that you are not doing. 
And that is why I was stunned when I received a letter, which I 
am going to make a part of the record--from two people I 
consider close friends and one I respect and do not know as 
well--Secretary Donna Shalala, Secretary Dan Glickman, and Neal 
Lane, Assistant to the President for Science and Technology.\1\
---------------------------------------------------------------------------
    \1\ The letter referred to appears in the Appendix on page 130.
---------------------------------------------------------------------------
    I wrote them a letter and asked them to respond to the 
National Academy of Sciences report, what the Food Safety 
Council had to say about fully integrating the food safety 
system in the United States. And I would like to read to you 
what they said as a group--I know these letters go through 85 
different iterations and 85 different offices:
    ``Under the direction of the President's Food Safety 
Council we are rapidly moving toward creation of a virtual 
national food safety agency that provides a single voice on 
food safety issues. These efforts have resulted in Federal food 
safety agencies working as one, complementing one's efforts. 
Clearly, however, more work lies ahead to enhance and improve 
our achievements.''
    I am still wrestling with this virtual food agency. I want 
to deal in the real world here of a single food agency rather 
than a virtual reality. And as I listen to Dr. Woteki and Dr. 
Henney, I admire your efforts because you not only have an 
important mission, in this respect, the safety of food, you 
have an almost impossible assignment, to try to juggle all 
these agencies into one operation.
    And it appears that the Food Safety Council is playing the 
role of a summit conference, bringing together all these 
different Federal agencies providing Esperanto texts and things 
so they can speak to one another and understand. And it strikes 
me that this memorandum of understanding which was issued in 
February of this year, between the Food Safety Inspection 
Service and the Food and Drug Administration is a lot like the 
Middle East peace accord. We finally have these two agencies 
willing to work.
    Can you step back for a second? Can you say, let me think 
not as someone in government, but as someone outside 
government, that the thing you are proudest of is you have 
everyone speaking to one another? That you have people talking 
to one another?
    It strikes me as impossible to defend to families across 
America that this is good government. It strikes me that you 
are doing the best you can with a terrible situation. How many 
different agencies dealing with one food product? Either beef 
ravioli should not be inspected every day or cheese ravioli 
should not be inspected once a decade. Something is wrong here. 
Somebody has got it wrong.
    What I am suggesting is could we get together and talk? 
Could we try to deal with one agency here? You know what 
happened with the egg situation. We had that at the last 
hearing. We said to these agencies, tell us, here is the 
question. What temperature should we keep eggs at to keep them 
safe?
    Now, I am not a scientist. Cooked a lot of eggs, but I am 
not a scientist. And we said, work on this. Come up with it. 
How many years did it take the FDA? Eight years to come up with 
the answer to that question. And then they handed it over to 
the USDA to do their part of the calculation.
    That is what is driving me crazy. And I think most of the 
people who watch this think, surely they are not defending 
this. This long lead time, this bureaucratic tangle that we 
have created when it comes to food safety inspection. I will 
repeat what I said at the outset. I really do trust both of 
you. I think you really do have the best of intentions in what 
you are trying to do and you have done your best. You are good 
professionals. But how--I mean step back for a second. Do you 
really think this is the most efficient way for us to inspect 
food in America?
    Dr. Henney.
    Dr. Henney. Well, Senator Durbin, you have raised a number 
of points. I think that we tried to outline in our testimony 
that where we come from on this is basically outlined for us in 
the laws and the jurisdiction that Congress provided to each of 
our agencies or the other agencies of government. I think when 
it comes to looking at ways in which we can make those function 
effectively, we have made, I would say, great strides in the 
last 3 to 4 years of getting this to be much better integrated, 
much better coordinated----
    Senator Durbin. Can we address that----
    Dr. Henney [continuing]. As it needs to be. But I think 
that to the issue of jurisdiction, at an operational level that 
is why we have some of these memorandums of understanding. Our 
jurisdiction is very clear to us. It is how we work out in the 
field that we have had to have many discussions between and 
among ourselves as to how we can do that.
    Senator Durbin. There was a TV show, and I cannot remember 
which one, and the fellow used to get up and say, the Devil 
made me do it. And I do not know how long ago that was. And I 
have heard so many witnesses say, Congress made me do it. Do 
not blame us. Do not blame us about all these different laws 
and 10 years and one daily inspection, Congress made us do 
that.
    And, you are right. Congress did make you do a lot of these 
things. Congress came up with these crazy ideas that do not 
mesh and do not make sense. I am talking about something 
fundamental--changing the law. And I cannot get over how 
professionals in this business are resisting efforts to change 
the law and get out of this crazy quilt of jurisdiction into 
something that makes sense.
    So, I applaud you for taking this mish-mash of law that we 
have handed you and trying to make something good of it. Thank 
you.
    But let us get beyond that discussion for a second. What 
should we do? What should the law say? As a medical 
professional, would it not make more sense to have one agency 
driven by science in a coordinated effort, a new law, a new way 
of looking at things?
    Dr. Henney. I think that the--I will come back to something 
that Dr. Woteki said. And that is what we are driving toward 
are the best public health outcomes. We are looking within the 
context of the strategic planning group that we have. One of 
the things that we are specifically looking at is the laws that 
undergird all of our operations, where we have gaps or possible 
overlap. And looking at the different models that might make us 
more effective.
    I think that we have much to be proud of. There is clearly 
much that we can do and each one of these models that is 
suggested, whether it is total independence, consolidation or 
better integration, all have both merits and draw backs. And 
that is something that we are undertaking this year to really 
clarify for ourselves and the thing that we have been charged 
with doing is making recommendations to the council and to the 
President about that matter.
    Senator Durbin. Dr. Woteki, if you had to draw up that 
model, with your goal public health and well-being, would it 
look like the current system?
    Ms. Woteki. No. It would not look like the current system.
    Senator Durbin. Why?
    Ms. Woteki. Well, we explained in our written testimony. 
There are historical roots as to why this system has evolved to 
what it is today and why there are the separation of 
responsibilities that there are. But I do think that the report 
that the academy made that you referred to in your opening 
remarks and that I did as well actually did give some very 
serious consideration to what structurally might be a better 
replacement for what we have. And they came up with four 
different approaches and said that those four might not be the 
whole constellation either.
    One of them is an independent agency, as you have proposed. 
But the other three would be a lead agency, nesting those 
responsibilities within one department, or the creation of a 
council. So, the academy report, itself, says that there are a 
variety of different means by which you could achieve that 
effective system and among the things, as Dr. Henney said, that 
we are doing is looking at that range of ideas in addition to 
some other ones that have come up through the public meetings 
that we have had. And, essentially are going to be working 
through the pros and cons.
    Senator Durbin. But do you not see that as you step back 
and look at your best efforts now and those of your 
predecessors that when the point that was made, and I think by 
Mr. Dyckman earlier, about imported food, it is just impossible 
for me to explain to people why your agency feels that the 
safest thing for American consumers is for us to inspect the 
plants in the country of origin and the Food and Drug 
Administration says, no, the safest way to deal with it is 
inspect the product as it arrives in the United States.
    And it is a totally different approach. Scientifically, 
should we not be able to coordinate those? I mean clearly the 
food products involved are so similar, you cannot say, well, it 
makes more sense in one area but not in others. Should we not 
be able to at least come to a common ground, a common solution 
as to what the best scientific answer is to that question?
    Ms. Woteki. Certainly the administration agrees that we 
have to have a better approach towards the safety of imported 
food. One of the things that for the Food Safety and Inspection 
Service has been very important has been the legislative 
authorities that permit that system of equivalency, that 
require us for imported meat and poultry products to make sure 
that the country exporting to us has an equivalent system and 
permits us to do those inspections overseas.
    FDA has been seeking similar authorities and perhaps Dr. 
Henney would like to expand on that.
    Senator Durbin. Sure, please.
    Dr. Henney. Thank you.
    I think that, yes, we have on many occasions over the 
course of the years sought additional authority in this area. I 
think that the President last month also called on us to, in 
the wake of no active legislation in this area, asked that we 
work closely with Customs to use any administrative tools at 
our disposal to look at how we could focus on the imported food 
issue in a stronger way. And we will be doing that. But this, 
again, is something where, as I think as Dr. Woteki points out, 
we would also need to be working with you and Congress about 
the needed statutory authorities that are really not present 
for us at the current date.
    Senator Durbin. Let me ask you this. One of the things that 
seems clear is that there is a lot of communication among the 
different Federal food safety inspection agencies. How many 
inter-agency coordination meetings on food safety are held each 
week?
    Does anybody know?
    Dr. Henney. Let me just give you a few examples. I know 
that we held the strategic planning meeting, the Task Force, 
weekly, and we would be doing that this afternoon. I think 
between the Center for Foods, which is the lead agency for food 
safety out of the FDA, and the FSIS service, the lead officials 
there meet on almost a weekly basis.
    We have strong interaction. I think, as we look at our 
other colleagues at CDC and EPA, in fact, we have a person from 
CDC who now has been located with us and we have sent a person 
down there. So, that there are, yes, there are many meetings 
weekly if not daily.
    Senator Durbin. That raises the obvious question. Would it 
not be better if we had fewer meetings and more enforcement? 
Would it not be better if we had one set of rules, 
scientifically based, that all of the agencies or a single 
agency was attempting to enforce? Would the consumers be better 
off if there was less time spent by people working in food 
safety at agencies trying to piece together all these different 
standards and all these different approaches?
    Mr. Dyckman, would you like to respond to that?
    Mr. Dyckman. Well, clearly, it would be better to have more 
enforcement. I guess from the efficiency standpoint regardless 
of whether this is food safety, aviation safety, environmental 
safety, I think that the track record will show that when you 
have an independent, unified agency that has responsibilities 
the better off you are. Now, of course, EPA is not perfect, but 
they do not have unified legislation. And we have done lots of 
audit reports on EPA and have recommended that. But at least 
all the environmental laws or most of them are housed at one 
agency, it is a lot easier to coordinate and communicate.
    I wanted to address one other point. If I may take the 
liberty. I attended one of the strategic planning meetings, the 
open meeting that the President's Food and Safety Council had a 
few weeks ago and one of their goals is to create a national 
and to the extent possible, a international seamless food 
safety system from farm to table. And I believe the meeting was 
to address how to organize or reorganize the Federal food 
safety system.
    And quite frankly, I was disappointed that I did not even 
see on the table the option of consolidating all Federal 
agencies. There were proposals to make it more seamless, to 
better coordinate. But as we have heard today there were four 
options in the National Academy of Science report including a 
single food safety agency. But that fourth option which is a 
consolidated, unified single agency was not addressed.
    Senator Durbin. If I could go back then. Let me ask, there 
was a suggestion, I believe it was in Dr. Woteki's testimony, 
that we are approaching this effort seriously and expeditiously 
and considering the full range of options. Does that include a 
single food agency?
    Ms. Woteki. Most definitely. We are considering all of the 
recommendations that were made by the academy report as well as 
the recommendations that are coming forward from these various 
meetings that we have had.
    Senator Durbin. Because Mr. Dyckman said it was not brought 
up.
    Mr. Dyckman. Yes. I attended part of that and John 
Nicholson, sitting behind me, attended the whole day and we 
discussed it when he came back. And while we have heard 
officials say that is one of the options at the working session 
to get public input, it was not offered up on the table as a 
possible option, and it really surprised us.
    Senator Durbin. Carol Tucker Foreman, you have been on the 
inside, on the outside, and you addressed what you would have 
to just characterize as the politics of this situation here. 
Why are we running into this resistance? Now, people who are 
recognized professionals in the field and have to know in their 
heart of hearts that this is not the way to run a railroad. Why 
then do we have an administration which prides itself on food 
safety and is unwilling to move forward with the concept of 
this independent single agency?
    Ms. Foreman. Could I say one other thing before I answer 
that?
    Senator Durbin. Sure, of course.
    Ms. Foreman. Not only is the unified agency not part of the 
discussion but at the public meeting a number of people 
suggested that it should be and at the end of the meeting the 
two Secretaries went out, met with the media and said, we do 
not want a single food safety agency. It would be disruptive. 
Boy, you bet it would. It would disrupt this nice little club. 
It would make people's lives change. And I think out of that 
would come better food safety.
    There is a wonderful guy at OMB years ago who said, in 
Washington where you stand depends upon where you sit and turf 
is the ultimate determiner of what your position is. These are 
people who are committed, but every statement that Dr. Henney 
made comes qualified with, we want to do these things but only 
with the structure that we have now.
    We want better health, we want better science, but only 
with the structure that we have now. You cannot change the 
structure. It is the iron law of Washington.
    Senator Durbin. Well, let me address one specific concern 
that is legitimate, that would have to be resolved here. And 
that is the difference in responsibility between a public 
health agency, like the Food and Drug Administration, and an 
agency like the U.S. Department of Agriculture, which combines 
many different things relative to agriculture. In addition to 
promoting products, they are inspecting products.
    Certainly FSIS has a health component to it, but it is a 
much different agency by mission. Is that part of the friction 
here? Is that part of the tension that we run into when we talk 
about a single agency?
    Ms. Foreman. I do not think so. First, let me point out 
that Congress, by creating the Under Secretary for Food Safety 
began to address the conflict between USDA's different 
missions. The Under Secretary for Food Safety has only one 
responsibility, to protect public health. FSIS does not have to 
balance safety and marketing. Incidentally, I might point out, 
this is the highest ranking food safety officer in the U.S. 
Government by act of Congress. You still have to compete within 
the department.
    On the other hand, FDA is required to accommodate the food 
industry, to encourage the food industry, and to encourage 
international trade. So, FDA has to balanced interests. If you 
want the best for food safety, the best for the American 
people, stop this virtual stuff, take these two agencies and 
put them together under a leader who does not have to go up the 
line to a Secretary.
    Senator Durbin. Dr. Henney, let us go right to that point.
    Is that one of your concerns that if you move this out of 
the FDA, that it would compromise what you consider to be a 
central responsibility when it comes to public health? That it 
might go to an agency, a new one, an existing one which does 
not share that same public health commitment?
    Dr. Henney. Senator Durbin, I have not foreclosed 
conclusions here. I think that if you look at the issue that we 
are both driving for, both the reorganization that was done at 
USDA and within our own organization, public health is the 
bottom line. We come from that at the FDA from a variety of 
standpoints. Our history is in public health, what we have 
always done is always geared at the public health. We are a 
science-based regulatory agency that has a very long and proud 
history in this regard and we are also advantaged, we believe, 
by our sister agencies within the health department such as CDC 
and NIH and the like.
    I think that the working relationship that we have with the 
Agriculture Department for the other commodities that they 
regulate and the recent accommodation that was made in terms of 
public health being under the purview of the Under Secretary 
did separate that issue that had been present before in terms 
of marketing and public health.
    But we feel proud, quite frankly, of the fact that our 
whole history has really been driven by this issue and will 
remain that.
    Senator Durbin. Well, Dr. Woteki, I would like you to have 
a chance to respond to this as well. This is something that is 
often--this is the bottom line here. The turf battle goes over 
a lot of different aspects but one of the most basic is whether 
or not your agency, the Department of Agriculture, for example, 
could even take on this responsibility if it were given the 
entire food safety responsibility, because of some of the 
internal conflicts which have been written about over the 
years.
    What are your thoughts on that?
    Ms. Woteki. Well, I think that the greatest gains we are 
going to make in the future with respect to food safety are 
going to be ones that are premised on prevention. Techniques 
that we can put into place at the farm level as well as during 
processing and through the retail and preparation areas.
    The greatest gains though I think are really going to come 
in the prevention on-farm as well as in the processing areas. 
And those are going to require an enormous amount of further 
scientific research to develop the new technologies that can be 
applied, that are going to be cost-effective, and that will 
continue to deliver to the American consumer a high quality and 
safer food product.
    Senator Durbin. But the basic bottom line--I am sorry.
    Ms. Woteki. So, our whole approach that has guided what the 
Department of Agriculture has been doing for meat and poultry 
and egg product inspection and also that is guiding now the 
President's food safety initiative is this farm to table 
approach with a heavy emphasis on R&D as well as the adoption 
of science-based approaches in our regulatory systems.
    Senator Durbin. I guess the bottom line question though, is 
can your agency promote a product as well as oversee it, 
inspect it and do it with credibility?
    Ms. Woteki. Well, I think you can look to our record of the 
last 5 years, since the reorganization. And the answer to that 
is, yes. We have implemented this new science-based HACCP 
approach in meat and poultry. We have seen a very high 
compliance rate in the industry and recent data from CDC has 
indicated that there is a dramatic decrease in salmonellosis 
that parallels the declines that we are seeing through our own 
performance testing on products. That has been done. There has 
been a high rate of industry compliance and it has been quite 
successful.
    Senator Durbin. Mr. Dyckman, you noted that several 
countries have started wrestling with this question on their 
own and have come to different conclusions on it, if I 
understood your testimony. It was a situation in England and 
Ireland that they move toward more of a public health 
orientation and if not, if I do not remember correctly, Canada 
and Denmark moved more toward the agricultural side of it.
    Could you explain, if you have it there or if you know, 
what drove those decisions? I know the mad cow outbreak and 
other things were issues in England.
    Mr. Dyckman. Well, it was obviously, distrust in England 
and Ireland for Federal regulators that dealt with food safety. 
And, so, they chose to place their responsibilities in a health 
oriented agency, that is under the Health Ministers. It was 
less of a concern for the other two countries. They were more 
concerned with economy and efficiency.
    If I might return to your question that you asked the other 
two witnesses. GAO places a lot of emphasis on integrity and 
accountability. Integrity composes many aspects and it includes 
many things. One of them is clearly an appearance of a conflict 
of interest and I think you alluded to that today.
    There are questions, legitimate questions about whether or 
not an agency that promotes an industry should also regulate 
parts of that industry, even if there is a firewall. And I 
think Agriculture has a firewall. But still there are 
questions. Questions to the extent that if we were to start 
from scratch, we would avoid the appearance of conflicting 
interests.
    Accountability is another important issue in government, 
not just in food safety but all aspects of government. The U.S. 
taxpayer has the right to demand answers from one official who 
could represent an issue or set of issues. We do not have that 
in food safety right now. It is spread across various agencies 
as we have discussed today. And that is why there is such an 
effort to coordinate.
    Now, obviously, even if you put all food safety 
responsibilities or many of them in one agency there still 
would be a need to coordinate but at least you would be able to 
go to one agency official, to have one person testifying today 
on food safety representing the administration and would be 
able to say ``yes,'' I can make that change or explain the 
reason for not making that change.
    You would not have to go to several different agencies.
    Senator Durbin. I think that is the bottom line and the 
reason why, obviously, I am pushing for the idea that I believe 
in. But I also have the highest respect for all who have 
testified today who may see things differently. And I repeat 
what I said at the outset, I believe you are all professionals.
    I think you are doing the very best in terms of food safety 
for this country. I just think we can do it better and I hope 
that perhaps your testimony today and this hearing will cause 
some within the administration to understand that what I have 
in mind is not disruptive but, in fact, will create a more 
efficient approach. And I thank the panel very much for your 
testimony.
    Dr. Henney. Thank you.
    Ms. Woteki. Thank you.
    Senator Durbin. The next panel that we have includes Nancy 
Donley of Chicago, President of Safe Tables Our Priority; 
Caroline Smith DeWaal, Director of the Food Safety Programs for 
The Center for Science in the Public Interest; Dr. Rhona 
Applebaum, Executive Vice President for Scientific and 
Regulatory Affairs of the National Food Processors Association; 
and Dr. Stacey Zawel, Vice President for Scientific and 
Regulatory Policy for the Grocery Manufacturers of America.
    So, Nancy, if you are prepared, if you would lead off and 
then we will allow the others to join in.
    Thank you for being here.

TESTIMONY OF NANCY DONLEY,\1\ PRESIDENT, S.T.O.P., SAFE TABLES 
                          OUR PRIORITY

    Ms. Donley. Thank you, Senator Durbin for inviting me here 
today and thank you for your years and ongoing many, many more, 
I hope, in leading such good efforts in food safety. It has not 
gone unnoticed. The American public thanks you for it.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Donley appears in the Appendix on 
page 92.
---------------------------------------------------------------------------
    I was invited to testify here today on a subject that has 
become the single most important issue in my life and that is 
food safety. Until July 18, 1993, food safety was a non-issue 
as far as I was concerned. I did what most of the public does, 
I assumed that the food we fed our families was safe. I assumed 
that our government had the situation of ensuring the safest 
food safety possible well in hand. I assumed that the food 
industry was governed under the strictest of regulations to 
produce food of the highest safety level possible. I assumed 
that companies violating food safety law were dealt with 
swiftly and harshly. I assumed that there was an entity 
ultimately responsible for protecting my family from unsafe 
food. I assumed wrong on all counts, dead wrong.
    On July 18, 1993, my only child, my 6-year old son, Alex, 
died a brutally painful death after eating E.coli, 0157:H7 
contaminated hamburger. Alex wanted to be a paramedic when he 
grew up so that he could help people. So, when he died, we 
wanted to donate Alex's organs to fulfill his wish in helping 
others. We were told we could not. The toxins produced by 
E.coli 0157:H7 had destroyed his internal organs and they had 
liquified portions of his brain.
    My son suffered horribly and I still suffer and grieve 
every day, 6 years later and I will for the rest of my life. 
And this happens to millions of people every single year.
    After Alex's death I joined S.T.O.P., Safe Tables Our 
Priority. S.T.O.P. is a national nonprofit foodborne illness 
victims organization that was founded in the wake of the Jack-
in-the-Box E.coli 0157:H7 epidemic in 1993 that killed 4 
children and sickened over 700. Our founders include parents of 
children who died or were seriously injured from eating 
contaminated meat.
    Since then our membership has expanded to include people 
impacted by many different foodborne pathogens from all food 
groups. Our mission is to prevent unnecessary illness and death 
from foodborne pathogens.
    When I learned that Alex had died because his hamburger was 
contaminated with cattle feces, I was determined to understand 
where the system had failed and it has been an incredibly eye-
opening experience for me. S.T.O.P.'s initial focus was on 
fixing the E.coli 0157:H7 problem, a problem then thought to be 
confined to beef. I learned that at the time of Alex's death 
meat inspection did not include any measures to address 
microbial contamination. So, I worked extensively during the 
rule making process for FSIS's pathogen, hazard analysis and 
critical control point regulation which mandated microbial 
testing for the first time in history.
    Also, during this time, E.coli 0157:H7 was declared an 
adulterant in ground beef and safe food handling labels were 
required for all raw meat and poultry products sold at retail.
    Things were definitely looking up in the hamburger disease 
fight as E.coli 0157:H7 was commonly referred to. But then we 
learned that E.coli 0157:H7 is not just a hamburger problem. 
The primary reservoir of 0157:H7 is found in cattle and the 
first incidence and outbreaks of E.coli poisoning were found in 
ground beef. But outbreaks have subsequently been linked to 
such diverse foods as lettuce, sprouts, cantaloupe and apple 
juice. Japan had a national epidemic that infected over 10,000 
people with contaminated radish sprouts being the suspected 
vehicle.
    Several months ago school children in Europe became sick 
from E.coli 0157:H7 contaminated goat cheese and E.coli 0157:H7 
outbreaks have been linked to contaminated drinking water and 
in my home State of Illinois, children became very sick after 
swimming in a contaminated reservoir.
    This single pathogen, which is why I went through this 
list, affects products that is regulated by the FDA, FSIS and 
EPA. So, while FSIS was dealing with the problem in meat, 
prevention strategies were not put in place for other products 
that could be affected by the same pathogen and that was 
because no one was looking at the overall big picture.
    There appears to be a dangerous tunnel vision occurring 
within the individual agencies where they focus only on their 
small world and do not see how happenings in other areas might 
be of relevance to their own.
    The invitation to this hearing contained the following 
questions: One, if the Federal Government were to create a food 
safety system from scratch, would it resemble the current 
system? And, two, is this the best and most logical 
organization for Federal food safety agencies?
    If the Federal Government were to create a food safety 
system from scratch I cannot imagine it creating the fragmented 
system that exists today. The reason that it is so hodge-podge 
is that it was never planned. It just evolved into what it is 
today. Food safety was not the concern historically that it is 
today. Rather quality and labeling issues were the driving 
forces.
    So, consolidating food safety activities into a single 
independent agency would elevate food safety, prevent 
duplication, and fill-in gaps that currently exist in our 
multiple-agency system. A single independent agency would be 
better prepared to handle emerging food safety issues. It would 
be more efficient, more effective, and more responsive.
    The current structures of agencies within even larger 
departments undermines the importance of food safety because 
these departments have such broad and diverse agendas, but food 
safety always gets very--very often can get overlooked or does 
not receive the attention it deserves.
    FSIS is a subset of the USDA, a huge department, whose 
responsibilities include everything from forestry to circus 
animals. It is even more complex with CFSAN, a subset of the 
FDA, which is a subset of HHS. When you are such a tiny piece 
of the pie you do not command much attention. And food safety 
deserves to be the entire pie.
    It is time to face the fact that the current system of 
multiple agencies regulating food safety is simply not working. 
Victims are falling through the cracks because of the lack of a 
single cohesive food safety program. Imagine what might have 
happened if a single food agency had been implemented 
immediately following the Jack-in-the-Box epidemic. A single 
independent entity responsible for all foods including meat 
would have looked at the animal reservoir pathogens in a larger 
context. While developing a program to address the animal 
pathogens in meat, it would have logically and simultaneously 
looked at the potential of animal waste contaminating other 
foods as well and developed prevention strategies.
    These produce-related foodborne illness outbreaks might 
have been avoided all together. Our organization has members 
who were victims of the juice and lettuce outbreaks who 
question why did not government anticipate such a problem 
occurring? They want to know who was in charge of the safety of 
the food that made their loved ones sick? The answer is, 
tragically, a dual one. There were too many in charge and yet 
no one in charge.
    We strongly support the implementation of a single 
independent food safety agency. The safety of the food we feed 
our families is of critical importance and deserves the 
uncompromised scrutiny and attention of an agency unencumbered 
with other conflicting responsibilities such as trade and 
marketing issues.
    Now, many industry associations support the status quo of 
the marketers.
    Senator Voinovich [presiding].
    Ms. Donley, your time is almost up.
    Ms. Donley. Oh, I am sorry.
    In conclusion, we oppose such an arrangement to have 
conflicting agendas within agency. So, I would just like to say 
that it is time to acknowledge that we are beyond fixing the 
current situation and we really hope that turf wars will be set 
aside and just focus on protecting the common people. That is 
what we count on government to do.
    Senator Voinovich. Thank you very much. Ms. DeWaal.

 TESTIMONY OF CAROLINE SMITH DeWAAL,\1\ DIRECTOR, FOOD SAFETY 
      PROGRAMS, CENTER FOR SCIENCE IN THE PUBLIC INTEREST

    Ms. DeWaal. Thank you very much and I want to thank Senator 
Durbin for his tremendous leadership and Senator Voinovich for 
your willingness to look at this question. I am Caroline Smith 
DeWaal. I am Director of Food Safety Programs for The Center 
for Science in the Public Interest.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. DeWaal appears in the Appendix on 
page 96.
---------------------------------------------------------------------------
    CSPI is a nonprofit organization based in Washington and we 
have been working for over 25 years to help improve the public 
health largely through our work on nutrition and food safety 
issues. We are supported by over a million subscribers to our 
Nutrition Action Health Letter. Food safety experts believe 
that contaminated food causes up to 81 million illnesses and 
9,000 deaths each year.
    While these estimates illuminate the magnitude of the 
problem, for many consumers these aggregate numbers mean less 
than the specific outbreaks and recalls, such as the Jack-in-
the-Box outbreak, the outbreak from Odwalla juice, the Hudson 
Food recall where millions of pounds of ground beef were 
recalled or the most recent Bil Mar outbreak linked to listeria 
in processed meat products.
    These well-publicized cases have awakened consumers to the 
fact that contaminated food is a greater risk than we thought. 
Food contamination problems are cropping up in such health 
foods as apple cider and alfalfa sprouts to such traditional 
favorites as hamburgers and hot dogs. It is hard to know any 
more what is safe to serve your kids or your aging parents.
    CSPI has been collecting data on foodborne illness 
outbreaks for several years. Today we are releasing an updated 
version of this data in a report called, Outbreak Alert: 
Closing the Gaps in Our Federal Food Safety Net. In this 
listing of over 350 outbreaks FDA regulated foods were 
identified in three out of four of the foodborne illness 
outbreaks.
    Yet, FDA receives roughly one out of every four dollars 
appropriated for food safety regulation. This disparity is only 
one of many created by our current system, which spreads 
responsibility for food safety among numerous Federal agencies.
    Senator Voinovich asked us to address the following 
questions. If the Federal Government were to create a food 
safety system from scratch, would it resemble the current 
system and is this the best and most logical organization for 
the Federal food safety agencies?
    The answer to both of those questions is a resounding, no. 
It makes no sense when food safety problems fall through the 
cracks of agency jurisdiction. It makes no sense when multiple 
Federal agencies fail to address glaring public health 
problems. It makes no sense to have a single food processing 
plant get two different, entirely different food safety 
inspections while other plants get no Federal inspection at 
all.
    It makes no sense that the widely touted HACCP program is 
markedly different at the Food and Drug Administration and at 
the Food Safety and Inspection Service. It makes no sense that 
new food safety technologies face multiple hurdles at various 
agencies before they can benefit consumers.
    It makes no sense that the United States inspects imported 
food differently depending on which regulatory agency is in 
charge. Quite simply, the current food safety system makes no 
sense for today's consumers.
    CSPI documented these problems last year for the National 
Academy of Sciences panel that wrote ``Ensuring Safe Food from 
Production to Consumption.'' This year we have documented even 
more problems.
    For example, for State laboratories there are no minimum 
testing requirements when they are checking food. They actually 
have to run different testing protocols depending on which 
agency they are running the test for. This means that 
contaminated food recalls and outbreak announcements can be 
delayed for several days while Federal agencies retest products 
to confirm the findings of the State laboratories.
    Another example is genetically modified plant species. 
These are subject to a mandatory review at our APHIS, our 
Animal and Plant Health Inspection Service, to ensure plant 
health and safety. But only a voluntary review at the Food and 
Drug Administration to ensure human health.
    The agencies want us to believe that they can coordinate 
their way out of these problems. It is true that the Clinton 
Administration has worked hard to address many pressing food 
safety problems. Despite their best efforts, however, 
coordination will never provide the whole solution. While a 
joint FDA-FSIS egg safety task force has been meeting for 
years, neither agency has proposed on-farm controls for 
Salmonella that infects eggs.
    In addition, a memorandum of understanding between FSIS and 
FDA on inspection issues failed to net any meaningful change 
because USDA is statutorily limited to conducting only meat and 
poultry inspections. These examples show that coordination 
cannot ultimately address many of the problems with the current 
system.
    In Vermont, where I grew up, there is a joke a city slicker 
who asks directions from an old Vermont farmer. The punch line 
is, you cannot get there from here. Today we all want the 
safest possible food supply. But like that old Yankee farmer, I 
am afraid that you cannot get there from here. That is why CSPI 
strongly supports the Safe Food Act of 1999.
    Thank you very much for your time and attention.
    Senator Voinovich. Thank you very much. Dr. Applebaum.

    TESTIMONY OF RHONA APPLEBAUM,\1\ Ph.D., EXECUTIVE VICE 
PRESIDENT FOR SCIENTIFIC AND REGULATORY AFFAIRS, NATIONAL FOOD 
                     PROCESSORS ASSOCIATION

    Ms. Applebaum. Thank you, Mr. Chairman.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Applebaum appears in the Appendix 
on page 119.
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    My name is Rhona Applebaum and I serve as the Executive 
Vice President for Scientific and Regulatory Affairs for the 
National Food Processors Association.
    NFPA appreciates this opportunity to offer comments on the 
organizational structure of our Nation's food safety system. 
Because our primary mission is food science and food safety, we 
have a very direct interest in providing input on this 
proposal.
    In the few minutes I have this morning, I will briefly 
address the effectiveness of our current food safety system and 
some of the challenges to public health that system faces as 
well as why we believe a single food safety agency is not 
necessary to meet those challenges.
    While NFPA does not endorse S. 1281, the Safe Food Act of 
1999, we commend its author, Senator Durbin, for his 
legislation's goal of enhancing food safety, an objective 
shared by the food industry.
    Our means to the end is where we differ. Our approach 
embraces a single food safety policy not a single food safety 
agency. If the Federal Government were to start from scratch to 
establish a food safety regulatory system would it resemble the 
current system? Probably not. But then numerous other 
government agencies, whose missions parallel and/or compete 
with one another might also look differently with the benefit 
of a clean slate.
    We should be mindful that our existing food safety system 
has evolved over many decades and enjoys the confidence of the 
overwhelming majority of the American public. In short, the 
system works and it continues to evolve toward an even more 
effective system in the future.
    Rather than focusing our efforts on creating a new agency, 
our energies would be of greater benefit if we focus on 
enhancing the strengths of the existing system. The current 
regulatory framework in the United States, with shared 
oversight of food safety by FDA, USDA, and several other 
agencies, has resulted in Americans enjoying one of the safest 
food supplies in the world.
    So, while there may be ways to improve the current system, 
it is not accurate to say categorically that the system is 
broken and needs to be replaced.
    There are two primary reasons why our current system works 
well. The first is that safety is the food industry's No. 1 
concern, our principal focus. Safety is job one, as the saying 
goes.
    Second, the current food safety system is largely based on 
sound science and a mutual commitment to food safety by both 
food companies and all agencies involved in their regulation. 
But can the system be improved? Absolutely.
    Our plea is to work together to enhance not demolish the 
existing framework. NFPA believes that it is unnecessary to 
have a single food agency to improve the system. Three goals 
should be considered when discussing improvements to our 
current system.
    These include, first, better coordination among various 
Federal, State and local government agencies. Second, a single 
scientifically based Federal food safety policy which ensures 
uniform and consistent food safety guidelines and requirements.
    Third, and of extreme importance, is that sound objective 
science must be the basis for any changes and improvements to 
our food safety system. This view is endorsed by both the 
National Academy of Sciences and the President's Council on 
Food Safety.
    Sound science must be the tool used in determining the 
allocation of resources in the food safety regulatory 
framework.
    Mr. Chairman, in closing, NFPA believes that incorporating 
better agency coordination and more consumer education along 
with increased surveillance and better agency resource 
allocation in terms of risk assessment to consumers will go a 
long way to enhance the safety of the U.S. food supply and work 
is underway to see these actions realized.
    NFPA recommends that Congress examine the recommendations 
of the National Academy of Sciences and the changes being 
designed and implemented by the President's Food Safety Council 
before considering such drastic measures as the creation of a 
whole new government bureaucracy.
    As stated in our written comments, our system is not so 
flawed that it needs to be razed. It simply needs an upgrade 
and some remodeling.
    Again, Mr. Chairman, I thank you for the opportunity to 
provide testimony to this Subcommittee and welcome any 
questions you or other Members may have.
    Thank you.
    Senator Voinovich. Thank you. Dr. Zawel.

    TESTIMONY OF STACEY ZAWEL,\1\ Ph.D., VICE PRESIDENT FOR 
  SCIENTIFIC AND REGULATORY POLICY, GROCERY MANUFACTURERS OF 
                            AMERICA

    Ms. Zawel. Thank you, Mr. Chairman and Senator Durbin for 
the opportunity to come before you today to talk about this 
very important issue. As you know, my name is Stacey Zawel, and 
I am Vice President of Scientific and Regulatory Policy for the 
Grocery Manufacturers of America.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Zawel appears in the Appendix on 
page 124.
---------------------------------------------------------------------------
    And like I said, I definitely welcome the opportunity to 
come to talk to you and recommend ways to refine but not 
replace our Nation's food safety system. If we were starting 
from the beginning and had the luxury of creating a food safety 
system from scratch, GMA would recommend that the system be 
based on four fundamental principles.
    First, regulatory controls would rest on science-based 
assessments of risk, not speculative hazards. Second, education 
about proper methods of food handling and preparation would be 
provided at all stages of the food chain.
    Third, adequate staffing and resources would be provided to 
administer this food safety system. And, fourth, industry and 
all sectors of government would pledge to work together in a 
coordinated manner to maximize food protection.
    But the fact of the matter is we are not starting from 
scratch. We already have a food safety system in place. Critics 
argue that it is fatally flawed by a lack of coordination among 
the responsible agencies and senseless duplicative effort. They 
are wrong. The existing system is a successful partnership 
among government, industry and consumers, the diversity of the 
regulatory players adds a breadth and a depth of experience 
that is crucial in addressing the multi-faceted nature of the 
food safety challenge.
    The President's Council on Food Safety, which includes 
Secretary Shalala and Secretary Glickman, is working on a 
strategic food safety plan that will focus on enhancing 
cooperation among the responsible Federal agencies. Planned 
measures include a unified food safety budget and a single 
research plan. In the face of this commitment to enhance 
coordination at the highest levels of government, it is simply 
ludicrous to suggest that the present food safety system must 
be entirely scrapped.
    We need to work with the successful system we have, giving 
the Council on Food Safety time to make the adjustments 
necessary to perfect it. Any other course would be enormously 
disruptive and very expensive.
    GMA believes, therefore, that the question we should be 
asking today is not necessarily how can we build a food safety 
system from scratch but how can we assist the Council on Food 
Safety in improving the one that we have?
    GMA would suggest a renewed focus on the four basic 
principles I discussed earlier. The first one being that the 
food safety system must be based on science. Especially as food 
production, processing and distribution increases in complexity 
and sophistication, we must rely upon scientific techniques to 
detect and address potential food safety hazards. We have to 
identify and fight the true causes of foodborne illness with 
the right scientific weapons and those weapons can only be 
developed and refined through laboratory research and practical 
testing.
    We are starting to achieve some of the benefits a science-
based approach can bring and every effort should be made to 
ensure that this direction continues. For example, new 
techniques to reduce bacterial contamination such as 
irradiation and certain chemical compounds are being developed 
that offer encouraging results.
    USDA's adoption of the hazard analysis critical control 
point systems approach, a process control originally developed 
and used voluntarily by the industry has the potential to 
transform the antiquated meat and poultry inspection system 
from one based on sight, smell and touch to one founded on 
science-based assessments of risk. Although implementation 
challenges abound this technique and others do show some 
promise.
    USDA, FDA, and other Federal agencies, working with the 
States and industry, must continue their focus on the science 
and research.
    The second one is education and proper handling must be 
promoted. The handling of foods at all stages of the farm to 
table production chain affect safety. And everyone has a 
responsibility for and must be educated with respect to the 
proper and safe methods for handling food products.
    Third, adequate resources are definitely needed and have to 
be properly employed. Without properly trained personnel, 
state-of-the-art equipment and the necessary funds an emphasis 
on science and research is meaningless. Although FDA has 
historically enjoyed respect throughout the world, the agency's 
reputation is being threatened by a depletion of resources for 
food safety.
    Similarly, although FSIS is better funded, the agency's 
labor-intensive is both costly and antiquated.
    Fourth, Federal food safety agencies must also work 
cooperatively. Coordination is a challenge in a food safety 
system that draws upon these multiple disciplines, expertise, 
and history of several executive agencies. But replacing the 
successful system we have with a single agency is not a magic 
bullet for enhancing food safety. Moving boxes around on the 
government's organizational chart simply will not make food any 
safer.
    And in conclusion, what I think we need to do is focus on 
the Council on Food Safety that has already created a 
coordinated food safety system, united by a single budget and a 
research plan that the proponents of S. 1281 are seeking. 
Before embarking upon an expensive, disruptive reorganization, 
we owe it to the American people to see if the Council's 
strategic plan and related activities can address any 
challenges that exist and move the country to a new level of 
food safety and protection.
    That concludes my remarks and thank you very much for the 
opportunity to testify today.
    Senator Voinovich. Thank you.
    My impression is that the problem today in the country is a 
lot more severe than it was, say, 25 or 30 years ago, in terms 
of more food being processed and more people buying pre-
packaged things and the rest of it.
    That is the first impression I have gotten from this 
testimony. Second, that the diseases that are out there are a 
little more rampant than they were in the past and are more 
diversified than what we have encountered in the past.
    When did the Council on Food Safety get organized? When 
were they brought together to talk about looking at this, do 
you know?
    Ms. Applebaum. Approximately a year ago.
    Senator Voinovich. A year ago. The President has been in 
office 7 years. Go back and look at the studies about this 
problem which is, by the way, like so many other problems in 
the Federal Government. Just unbelievable. GAO report after GAO 
report after GAO report says that this is something that should 
be done and everyone says they are going to do something about 
it, but it does not happen.
    From what I can see from listening to this testimony, this 
is all over the lot. Dr. Zawel, why is it that you think that 
it would be terribly disruptive and cause all kinds of problems 
and so forth? I agree with a lot of what you said. This should 
be done, and this should be done, and this should be done. But, 
you know something? It hasn't been done for a long time.
    I know from my experience in government that when you have 
people all over the lot, everybody has got to get coordinated. 
We have, frankly, Senator Durbin, too many committees looking 
at too many things, and you cannot coordinate. It is just mind-
boggling.
    Dr. Applebaum, why don't you think it makes sense to take 
this stuff, get it on the table, try to reorganize it and get 
one agency and start from scratch and get the job done and do 
it right?
    I would think that industry would welcome it. You have one 
group coming in, another group coming in. I was just talking to 
the Ohio director of agriculture, and they are trying to get 
the State organized because it is not as coordinated as it 
ought to be.
    I would like your comments.
    Ms. Zawel. Well, let me just reflect some of what I said in 
my statement which is that our, I guess, opposition to a single 
food safety agency does not, at the same time, reflect that we 
do not think there are problems with the current system. There 
are some real challenges and that the system has been 
developed, as Dr. Applebaum has said, through a long history of 
events, which has brought us to where we are today. And, so, I 
do not think that I will necessarily go to the mat and say, 
every single aspect of today's current system is definitely 
ideal. I think we definitely need increased coordination, and 
all the other things that we called for.
    What I think would be terribly disruptive is to just 
decimate everything that we have, build brand-new 
infrastructures and build brand-new agency with a single head. 
I do not know. I am truly not convinced that that, in and of 
itself, is going to result in all this food safety challenge 
just going away.
    Senator Voinovich. Well, one thought that I have had is 
that if you are going to do this, I am not sure you would 
create a whole new agency. I would probably determine what 
agency is most involved in this area, perhaps the Department of 
Agriculture, and say, they are the most into this and then try 
to figure out how FDA could be folded into that. I would not 
start with a brand-new infrastructure. I do not think that 
would make the most sense, and would try to work out some 
system of doing it that way.
    Ms. Zawel. I think that with respect to coordination, which 
I think is probably one of the biggest challenges that any 
infrastructure has and certainly this one where we have 
multiple agencies, it is a challenge to coordinate. But at the 
same time if you look at any one organization, whether it is 
Congress or whether it is one single company, there is always 
challenges to coordinate. There are always going to be turf 
battles. So, the key to necessarily decimating all the turf 
battles is well--which I think is one of the biggest issues 
that you guys have in recommending the agency and making it 
more effective. I am not sure that that key is one agency, in 
and of itself.
    Senator Voinovich. I would add that it depends on where 
these responsibilities are in an agency. I have been through 
this as governor, and we formed cabinet councils to coordinate, 
but the issues that we were coordinating had relative priority 
in those agencies.
    The issue is where does this particular matter fit into the 
overall structure of an agency, and is it way down in Health 
and Human Services, which has tremendous responsibility?
    You just wonder how much attention does this particular 
area get from that agency, and would it receive a lot more 
attention if it were, say, located in the Department of 
Agriculture?
    Any other comments, Dr. Applebaum?
    Ms. Applebaum. Yes, Mr. Chairman, if I could just make some 
comments in regards to your observation. There seems to be, I 
will use the term, an epidemic, if you will, that you relate to 
foodborne disease. In that regard there is heightened 
awareness. The public is more aware of the fact that there is 
illness that can be conveyed through the food. So, there is a 
heightened awareness and people are more aware of the fact that 
there could be a food-related issue associated with the 
disease.
    And there are also more virulent organisms that we have to 
be cognizant of. The organisms that we are dealing with today 
are not the same ones we dealt with 25 or 50 years ago. But we 
also must be cognizant of the fact that there are different 
practices that we are following as consumers.
    We are looking more and more towards less processed. We do 
not necessarily cook our food like we did in the past. There 
are differences in education that was done in the past than 
that done currently.
    So, there are a whole lot of factors involved in terms of 
what is being implicated and blamed on, if you will, the 
increases in illnesses. The food industry does not take even 
one illness with any type of frivolity or look at it in a 
trivial way. We are very much concerned with that and it is 
very important.
    I want to get back also to the second point that you raised 
with Dr. Zawel; that is, Do you not think that the best way to 
the end, the means to the end in this regard, is just to focus 
everything on one particular agency? Let us have one body, one 
entity, a body that we can go to and then we can get all these 
things fixed.
    I think we all share the common goal of enhancing and 
improving the safety of our food supply. That is first and 
foremost in NFPA's concern and the members that both Dr. Zawel 
and I represent. The difference here is that we feel the 
solution to this problem needs a plan first, and the plan we 
view is a single food safety policy. Put the policy in place. 
Then, in terms of whatever house it is in, that will come 
later.
    We are looking now in terms of the advancements that have 
been done to date related to the NAS report as well as the 
President's Food Safety Council. There have been advancements 
made; even though they have only been in place for a year, 
progress is being made.
    We are looking at this, I am looking at this, our 
association is looking at this in terms of the advancements 
being made. Our food supply is not perfect, but there are 
things that have to be done. Better coordination, better 
integration, having everything based on sound science. But do 
we pull back and stop the advancement when there is advancement 
being made only to retract and take another direction that has 
no justification? There is not any evidence as to whether or 
not a single food safety entity is the best means to the end.
    That is our basic difference in this regard. We would like 
a plan. We would like the plan based on a single food safety 
policy; then enact that policy. It is the policy that is going 
to ensure the safety of the food supply, not a single entity, 
not a single agency, in and of itself. Can there be 
consolidation? Absolutely. Can there be consolidation of 
current statutory authority? Absolutely.
    We have been working on that for quite a long time. But to 
just demolish a system that is working and working effectively 
and is the model that the rest of the world is looking towards 
in order to pattern themselves, we do not think makes a lot of 
sense.
    Senator Voinovich. Thank you.
    Yes, Ms. DeWaal.
    Ms. DeWaal. Thank you, Senator Voinovich.
    I want to introduce, to pick up on another line that you 
were talking about and that is the relationship with the State 
Governments. I went to a meeting of the Association of Food and 
Drug Officials and these are the State people who really spend 
a lot of time regulating food. And they spent a lot of time 
talking to me about their concerns about the current Federal 
system.
    The State lab example I have given you. They have four 
different testing protocols depending on which Federal agency 
they are preparing a food sample for.
    In the area of outbreak investigation, the State will 
initiate an outbreak investigation but until they know what 
food is implicated, who do you call? And there is no ghost 
busters here. There is no food busters. They cannot even call a 
Federal agency, regulatory agency until they know whether it is 
a USDA or an FDA regulated food.
    In the area of State inspection there was a lot of concern 
right now USDA and FDA are developing new systems. And I am 
really encouraged that they are doing that to work more closely 
with their State partners. So, if a State inspector goes into a 
food plant you will not have a Federal inspector go in the next 
day.
    Well, the way they are doing this is with little laptop 
computers that these State inspectors will carry around with 
them and they will link-in electronically with the Federal 
system.
    Well, what if we have a laptop which is the USDA laptop and 
a laptop which is the FDA laptop and then they still have got 
their State laptops. There has to be a better system.
    We have 50 States who work on food safety. Every State has 
food safety responsibilities. And they are trying to link up 
with these multiple Federal agencies and they are having a hard 
time.
    I just want to talk on the Department of Agriculture issue. 
I understand that it is very appealing to think that you could 
maybe house everything over at USDA. And I think there is a big 
trust issue, though. And when President Nixon thought about 
forming the Environmental Protection Agency there were 
environmental functions spread out all over the Federal 
Government. And many of them were at the Department of 
Agriculture. But he decided that they needed, first of all, to 
create a new infrastructure to get the right focus on 
environmental protection and we have seen real results from 
that.
    And, second, he did, he formed the structure first. We just 
heard from NFPA that they want the plan first and the structure 
second. Well, that is not what happened when President Nixon 
looked at it. He formed the structure first and then Congress 
passed the laws that developed the plan. The Clean Water Act, 
the Clean Air Act, and many other laws which that agency now 
enforces.
    So, and in Canada, today, they are looking at more 
gradually combining food safety functions but they formed the 
structure, an independent inspection agency first and now they 
are just getting around to changing the laws.
    So, I think those are some things that you should think 
about as you consider that. Forming a plan first may take us 10 
years. I am not sure that we can afford that.
    Senator Voinovich. Any other comments? I know that Senator 
Durbin has some questions.
    Ms. Donley. I would just like to, if I might, Senator 
Voinovich, to your point of I wrote down here that it sounded 
like you were suggesting perhaps to fold it into an existing 
agency or department. And then you mentioned a point that I 
brought up as well that there in HHS, for instance, you used 
the example that it is so huge, it has so many responsibilities 
that there is a lack of attention. And I say that that is also 
the case in USDA.
    But if we are really going to do something and really take 
it the next step I think we should take it completely and make 
the next step that, make the complete move. And give something 
that is going to give the public confidence. The public is 
concerned with what it views as a conflict of interest in 
agencies that have marketing responsibilities and trade 
responsibilities also being the regulators. And, therefore, 
that is why we really see the need for this agency to be 
independent.
    Senator Voinovich. Thank you.
    Senator Durbin. I would like to note that we have got a 
vote. The buzzer is coming up.
    Senator Durbin. That is good news for the panel. 
[Laughter.]
    Because I will try to wrap up very briefly.
    Senator Voinovich. Yes. Because I think after that we 
probably should adjourn.
    Senator Durbin. I will. I will just ask a few questions and 
then we can both leave to vote or you can leave early if you 
would like. It is your decision, Mr. Chairman.
    Thank you for your testimony. I appreciate all of you being 
here and Nancy Donley, an old friend, thank you for reminding 
us that this is a life and death issue because your family was 
touched by that tragedy. And I have never forgotten the first 
hand-written letter you sent me so many years ago which brought 
my attention to this issue.
    And I just want to say very briefly, I agree with you. I 
think that we really have to think about the agency and its 
responsibilities so the mission is clear and the people 
understand what that mission is.
    USDA, by virtue of numbers and responsibility, looks like 
the obvious place to turn. But it does have some conflicting 
responsibilities here, at least responsibilities that are not 
necessarily complementary to a regulatory attitude. And that is 
something that I would look at very carefully. As much as I 
like the USDA, I would have to look at that very carefully.
    FDA, a smaller part of the pie, one-fourth, I think when it 
comes to the employees involved in it, has a major part of 
their responsibility, as Caroline Smith DeWaal has said, with 
three out of the four of the outbreaks coming through foods 
that were inspected or should have been inspected by that 
agency. And they certainly do not receive the money they 
deserve for the important responsibilities that we send their 
way.
    I would like to say to the two witnesses that come from the 
private side, because I only have a couple of minutes here, 
rather than being discouraged or upset or angry or 
confrontational I am encouraged by what you had to say. I do 
not know if this is a conscious decision or maybe I am looking 
for that pony on Christmas morning, but I really sense that 
there is a change in attitude here and it is a good one and 
more open-mindedness about this. And I do not disagree at all 
with what you have said.
    I mean it is really a chicken and egg, I guess it is a good 
analogy here, as to whether we are going to start the structure 
and then bring policy or start with policy and then bring 
structure. My guess is we are going to end up at the same 
place, either way.
    Because once we sit down and try to explain to your 
manufacturers and processors why we have an inspection of one 
of these products every day and another one every 10 years, it 
is going to come together when we say there is only one way to 
decide this and that is science. Any other way is pure politics 
or commercialism. It has to be science. What is the 
scientifically defensible approach to this?
    We are trying to sell that to Europe now so our products 
have a chance. We are as inclined to hyperbolic rhetoric as 
anybody on this side and I plead guilty. But we are not trying 
to do anything drastic or demolish or disrupt.
    I really think that if this is going to be done sensibly 
that it is going to have to be a reasonable transition here. We 
are bringing together a lot of ideas, a lot of science, a lot 
of agencies, and a lot of players trying to make this thing 
work better for American families. If we do not do it carefully 
we could lose ground rather than gain ground.
    So, more than anyone here as the champion of this cause, I 
will tell you I am determined to make sure it is done right if 
it is ever done at all. And that is not an overnight, super 
agency, conceived and created by one piece of legislation. I do 
not think it will ever happen that way, nor should it.
    We should really think this thing through and make sure 
when it is done that the change is for the better.
    The last point I will make, and I will give you a couple of 
minutes to respond if you would like, is I met with an 
executive of a major company, and I will not go any further to 
identify him, last year for breakfast. And he said, what are 
you working on? And I said, food safety. And his company makes 
a lot of food products. He laughed at me. Why are you doing 
this? He said, we have the safest food supply in the world. 
Cannot you find something better to do with your time?
    And that kind of took me aback and I did not quarrel with 
him, I respect him very much. And I said, well, I think it is 
an important issue. It was not but weeks later that he got hit 
with a major, multi-million dollar problem in this company 
involving food safety. And he was on the phone to me talking 
about food safety.
    As confident as we are of the goodness of our food supply, 
as much as we want to see it continue to be good, we know that 
terrible things can happen and we want to do our best to avoid 
them. And that is really what I am about here.
    I do not think that there is strength in the diversity of 
regulatory players, as has been said here, in one of the 
testimonies. I really think we have too many different voices. 
This Tower of Babel mentality where these coordinating meetings 
are going on night and day to try to keep these agencies 
working together. Would it not make a lot more sense to bring 
them all under one roof, on a science-based, sound theory and 
approach on food safety?
    I hope it will.
    Senator Voinovich. I would like to make one point before we 
have to go vote on the agriculture bill.
    We talked about the needs and so forth. But one of the big 
areas that we need to be concerned about is exporting our 
products. We are seeing more and more artificial barriers put 
up to our products, saying they are not healthy or they are 
this or they are that. I think that we need to be a lot more 
authoritative and united in terms of the quality of our 
products in terms of how to deal in the world market place. 
Because they are going to find any excuse they can to keep us 
out of that market place today.
    So, it is just another ingredient that may not have been 
around 25 or 30 years ago.
    Senator Durbin. That is all I have.
    Senator Voinovich. Any comments?
    Senator Durbin. Rebuttal?
    Ms. Zawel. I would just conclude and say that I think that 
we have the same interests in mind in terms of assuring that we 
have the utmost safest food supply in the United States and 
obviously we would certainly encourage, as we have, 
multinational companies that we represent, that that same 
product is safe as it goes across the oceans. And, initially I 
think Senator Durbin, you had said that you wished the industry 
would stop resisting or Chairman Voinovich, I cannot remember 
which one. And, I think that that is not necessarily, and I 
hope you recognize, where we are at. We definitely want to work 
towards ensuring and enhancing the food supply as much as we 
possibly can further. But that we believe, with all due respect 
to Caroline, that the plans and the policies that change and 
affect that system to make it better are really what is key and 
not necessarily the structure.
    Senator Voinovich. I would like to finish with one remark. 
I have a lot of confidence in the food industry that wants to 
put out the best products it can. They want quality products. 
They know that if they have problems that it is going to hurt 
the business. I think that sometimes those of us in government 
forget that the private sector is doing everything it possibly 
can to make sure that there are healthy products out there. 
Because they understand how important it is to the safety of 
the public and also to their businesses.
    Thank you very much.
    The meeting is adjourned.
    [Whereupon, at 12:54 p.m., the Subcommittee was adjourned.]



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