[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]



 
   FOOD AND COSMETIC PROVISIONS OF THE FOOD AND DRUG ADMINISTRATION 
             GLOBALIZATION ACT DISCUSSION DRAFT LEGISLATION

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


                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                             APRIL 24, 2008

                               __________

                           Serial No. 110-108


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov


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                    COMMITTEE ON ENERGY AND COMMERCE

    JOHN D. DINGELL, Michigan, 
             Chairman
HENRY A. WAXMAN, California
EDWARD J. MARKEY, Massachusetts
RICK BOUCHER, Virginia
EDOLPHUS TOWNS, New York
FRANK PALLONE, Jr., New Jersey
BART GORDON, Tennessee
BOBBY L. RUSH, Illinois
ANNA G. ESHOO, California
BART STUPAK, Michigan
ELIOT L. ENGEL, New York
ALBERT R. WYNN, Maryland
GENE GREEN, Texas
DIANA DeGETTE, Colorado
    Vice Chair
LOIS CAPPS, California
MIKE DOYLE, Pennsylvania
JANE HARMAN, California
TOM ALLEN, Maine
JAN SCHAKOWSKY, Illinois
HILDA L. SOLIS, California
CHARLES A. GONZALEZ, Texas
JAY INSLEE, Washington
TAMMY BALDWIN, Wisconsin
MIKE ROSS, Arkansas
DARLENE HOOLEY, Oregon
ANTHONY D. WEINER, New York
JIM MATHESON, Utah
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana               JOE BARTON, Texas
                                         Ranking Member
                                     RALPH M. HALL, Texas
                                     FRED UPTON, Michigan
                                     CLIFF STEARNS, Florida
                                     NATHAN DEAL, Georgia
                                     ED WHITFIELD, Kentucky
                                     BARBARA CUBIN, Wyoming
                                     JOHN SHIMKUS, Illinois
                                     HEATHER WILSON, New Mexico
                                     JOHN B. SHADEGG, Arizona
                                     CHARLES W. ``CHIP'' PICKERING, 
                                         Mississippi
                                     VITO FOSSELLA, New York
                                     STEVE BUYER, Indiana
                                     GEORGE RADANOVICH, California
                                     JOSEPH R. PITTS, Pennsylvania
                                     MARY BONO, California
                                     GREG WALDEN, Oregon
                                     LEE TERRY, Nebraska
                                     MIKE FERGUSON, New Jersey
                                     MIKE ROGERS, Michigan
                                     SUE WILKINS MYRICK, North Carolina
                                     JOHN SULLIVAN, Oklahoma
                                     TIM MURPHY, Pennsylvania
                                     MICHAEL C. BURGESS, Texas
                                     MARSHA BLACKBURN, Tennessee
_________________________________________________________________

                           Professional Staff

 Dennis B. Fitzgibbons, Chief of 
               Staff
Gregg A. Rothschild, Chief Counsel
   Sharon E. Davis, Chief Clerk
  David Cavicke, Minority Staff 
             Director

                                  (ii)
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
HENRY A. WAXMAN, California          NATHAN DEAL, Georgia,
EDOLPHUS TOWNS, New York                 Ranking Member
BART GORDON, Tennessee               RALPH M. HALL, Texas
ANNA G. ESHOO, California            BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    HEATHER WILSON, New Mexico
    Vice Chairman                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine                     MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin             MIKE ROGERS, Michigan
ELIOT L. ENGEL, New York             SUE WILKINS MYRICK, North Carolina
JAN SCHAKOWSKY, Illinois             JOHN SULLIVAN, Oklahoma
HILDA L. SOLIS, California           TIM MURPHY, Pennsylvania
MIKE ROSS, Arkansas                  MICHAEL C. BURGESS, Texas
DARLENE HOOLEY, Oregon               MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          JOE BARTON, Texas (ex officio)
JIM MATHESON, Utah
JOHN D. DINGELL, Michigan (ex 
    officio)
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
 Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     1
Hon. Nathan Deal, a Representative in Congress from the State of 
  Georgia, opening statement.....................................     3
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     4
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, opening statement.......................................     5
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................     6
Hon. Steve Buyer, a Representative in Congress from the State of 
  Indiana, opening statement.....................................     8
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................     9
    Prepared statement...........................................    11
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................    15
Hon. Tammy Baldwin, a Representative in Congress from the State 
  of Wisconsin, opening statement................................    16
Hon. Edolphus Towns, a Representative in Congress from the State 
  of New York, prepared statement................................    18
Hon. Darlene Hooley, a Representative in Congress from the State 
  of Oregon, opening statement...................................    20
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, prepared statement..............................   109

                               Witnesses

Stephen Sundlof, D.V.M., Ph.D., Director, Center for Food Safety 
  and Applied Nutrition, Food and Drug Administration............    21
    Prepared statement...........................................    25
Michael R. Taylor, research professor of health policy, 
  Department of Health Policy, School of Public Health and Health 
  Services, George Washington University.........................    57
    Prepared statement...........................................    59
Michael Ambrosio, vice president of food safety and quality 
  assurance, Wakefern Food Corporation...........................    66
    Prepared statement \1\.......................................
James Lovett, corporate senior vice president, Covance 
  Laboratories...................................................    68
    Prepared statement...........................................    69
Calvin Dooley, president and CEO, Grocery Manufacturers 
  Association....................................................    73
    Prepared statement...........................................    75
Caroline Smith DeWaal, food safety director, Center for Science 
  in the Public Interest.........................................    82
    Prepared statement...........................................    84

                           Submitted Material

Discussion Draft.................................................   111
Food Marketing Institute, FMI, Recall Authority..................   180
Article entitled ``Food Safety: The Supermarket Perspective,'' by 
  FMI............................................................   111

----------
\1\ Mr. Ambrosio did not submit a prepared statement for the 
  record in time for printing.
.................................................................


   FOOD AND COSMETIC PROVISIONS OF THE FOOD AND DRUG ADMINISTRATION 
             GLOBALIZATION ACT DISCUSSION DRAFT LEGISLATION

                              ----------                              


                        THURSDAY, APRIL 24, 2008

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:12 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. Frank 
Pallone, Jr. [chairman of the subcommittee] presiding.
    Members present: Representatives Pallone, Towns, Green, 
DeGette, Baldwin, Hooley, Matheson, Dingell [ex officio], Deal, 
Buyer, Pitts, Myrick, Murphy and Barton [ex officio].
    Staff present: Jeanne Ireland, Jack Maniko, Virgil Miller, 
Ryan Long, Nandan Kenkeremath, Melissa Sidman, Chad Grant, Brin 
Frazier, and Lauren Bloomberg.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. I call the meeting to order.
    Today we are having a hearing in the subcommittee on the 
Food and Drug Administration Globalization Act, and I will 
recognize myself initially for an opening statement.
    The draft of this legislation was released by Chairman 
Dingell, Mr. Stupak, and myself and it builds upon H.R. 3610 
introduced by Chairman Dingell, as well as H.R. 3115 introduced 
by Mr. Stupak, H.R. 3484 introduced by Ms. DeGette, and my 
bill, H.R. 3624. This draft also incorporates findings from the 
Subcommittee on Oversight and Investigation of the full 
committee, the report released by the FDA Science Board's 
Subcommittee on Science and Technology, the Administration's 
Food Protection Plan and Import Safety Plan, and input from key 
stakeholders in the field. This draft is significantly 
different from the bill we discussed last fall on food safety. 
the Committee staff worked very hard to incorporate all the 
comments and feedback we received during and since the last 
hearing, and as a result we have before us today a more 
expansive discussion document. Due to its length and density of 
information, we have decided to hold at least two hearings so 
that we have enough time to devote to each issue, and today we 
will focus on the food-related provisions only.
    Something must be done to strengthen and improve the 
regulation and safety of our food supply. Too often, consumers 
hear on the news about a food product recall and too often we 
read about people getting sick after consuming everyday foods 
like spinach and peanut butter. These instances are taking an 
enormous toll on consumer confidence in food items. In 2007, 
consumer confidence in the safety of food purchased in 
supermarkets reached its lowest level since 1989. A public 
opinion poll conducted by the Trust for America's Health last 
year found that 67 percent of Americans are worried about food 
safety. Meanwhile, consumer confidence in the FDA itself is 
plummeting. A Harris poll conducted in 2006 indicated that only 
36 percent of Americans believe the FDA is doing a good job, 
and that is down from 61 percent in 2000.
    And this is not just about consumer confidence. However, 
these instances truly endanger the American people. Each year 
76 million Americans get sick due to unsafe food products. 
Every year 325,000 individuals will be hospitalized and 5,000 
will even die from foodborne hazards. It is estimated that the 
medical costs and lost productivity due to foodborne illnesses 
cost us $44 billion annually, and these illnesses are 
completely preventable, in my opinion.
    All of this raises questions about our current food safety 
laws, many of which were enacted in the 1900s. Obviously, laws 
that were written in the early 20th century are no longer 
current, particularly as the food industry becomes increasingly 
more global. And rather than continuing to simply react to 
outbreak after outbreak of contaminated products, it is about 
time that we put in place a stronger and more thorough system 
to prevent contaminated food products from reaching store 
shelves. We must work with players at every stage of food 
production from producers to processors to manufacturers to 
retailers, as well as government entities and the scientific 
community in order to ensure the full and active participation 
required to protect our food supply.
    In the United States today, there are 44,000 food 
manufacturers and processors and 114,000 food retailers. If you 
factor in international facilities, that number increases 
dramatically. And yet the FDA, the agency that is tasked with 
overseeing 80 percent of the food supply, has had to face 
eroding budget resources year after year. Not surprisingly, 
this has forced the FDA to cut resources. Since 2003, the 
number of FDA field staff dropped by 12 percent, and between 
2003 and 2006, federal inspections dropped by 47 percent. As I 
understand it, there is widespread acknowledgement that the FDA 
is woefully underfunded. The FDA Science Board itself issued a 
report in which they deem the agency as powerless to improve 
and will be unable to complete its tasks without a significant 
increase in funding, and it is up to us in Congress to ensure 
that this agency gets the funding levels it needs to protect 
the American people.
    Now, the draft before us will generate revenue, adding to 
the funding the FDA receives through the appropriations process 
by requiring all food facilities to register on an annual basis 
with the FDA and pay a registration fee. This will benefit the 
agency in two ways. First, the FDA will have an up-to-date list 
of all food facilities, both domestically and abroad, and 
second, it will generate the resources necessary to allow the 
FDA to conduct inspections of food facilities and other safety-
related activities, tasks they cannot currently perform. The 
draft will also require each and every one of these facilities 
to have a comprehensive food safety plan that is available to 
the FDA, particularly during on-site inspections, and these 
safety plans are an important tool for preventing food safety 
problems from occurring and quickly and appropriately 
addressing incidents of contamination should something slip 
through the cracks. The draft also creates incentives for 
companies to be in compliance with food safety standards while 
establishing strong penalties for bad actors.
    We will hear testimony this morning from industry experts 
on how the provisions related to food safety in this discussion 
draft could improve the safety of our Nation's food supply and 
what areas within this draft still need to be explored in 
greater detail.
    I want to thank all the witnesses. I want to especially 
welcome Mike Ambrosio, who is from my home State of New Jersey, 
and also Cal Dooley, who of course is a former Member of 
Congress and a friend.
    Mr. Pallone. I now recognize my colleague, Mr. Deal, for 
his opening statement.

  OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Deal. Thank you, Mr. Chairman. I want to thank you for 
providing the subcommittee with the opportunity to evaluate 
this discussion draft addressing food, drug, cosmetic and 
device safety.
    I think it goes without saying that a bill that is this 
comprehensive in nature would make very fundamental changes in 
the way the FDA regulates all of these items. Obviously, with 
legislation which includes these kinds of sweeping changes, we 
must take adequate care to evaluate the bill's impact. Looking 
at the different components of this legislation separately I 
think helps to facilitate that goal, and I want to thank you 
for affording this opportunity.
    Like I mentioned at our hearing on food safety last 
September, I think we have all heard from constituents in our 
districts about their concerns over the safety of this Nation's 
food supply and the products that we are importing into this 
country. Now more than ever, however, we are also starting to 
hear about the burden being faced by American families on 
account of rising food prices. As we move forward in this 
arena, I think we are going to have to carefully balance our 
desire to secure the Nation's food supply without unnecessarily 
increasing food prices. As we work to ensure American families 
can have confidence in the food products they consume, I think 
it is critical for this committee to wrestle with the most 
cost-effective way to achieve this. Spending more money does 
not necessarily result in safer food products.
    Moreover, as we discussed at length last year during the 
reauthorization of the Prescription Drug User Fee Act, PDUFA, 
we seem to be moving toward a total reliance upon the regulated 
industry to fund the regulating agency. My limited 
understanding of some of the fee structures in this bill makes 
this seem more true, not less. There are many who are already 
uncomfortable with the FDA's dependence on funds from the 
prescription drug industry, and now it seems that we are moving 
the food industry in the same direction. These food safety 
issues are certainly important ones that we should be 
addressing, and I look forward to the testimony of our 
witnesses about this draft and steps that Congress should be 
taking to secure our food supply.
    I thank you for the time, and I yield back to the Chairman.
    Mr. Pallone. Thank you, Mr. Deal.
    I recognize our vice chair, Mr. Green, for an opening 
statement.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman, for holding the hearing 
today on the discussion draft of the Food and Drug 
Administration Globalization Act.
    Over the past year there have been several high-profile 
food contamination incidents in the United States. These 
outbreaks also led the GAO to our food safety program, High 
Risk, and the FDA's own Science Board to say the FDA does not 
have the capacity to ensure the safety of food for the Nation. 
Mr. Stupak and the Subcommittee on Oversight and Investigation 
had a series of hearings on the state of food safety which 
found the FDA simply didn't have the money, technology, or 
manpower to fulfill its mission. The findings of this 
committee, the GAO, and the Science Board are alarming, to say 
the least, and most certainly indicate the FDA needs more 
resources to protect our food supply. I wholeheartedly support 
legislation that would improve the ability of the FDA to 
protect our food supply, and I commend the chairman of our full 
committee for the dedication to improving food safety.
    I do have concerns regarding the port-of-entry provisions 
in the discussion draft. I appreciate the fact that the 
Committee did make some changes regarding the provision from 
H.R. 3610, but I still have some concerns with the section on 
the port-of-entry provisions in the draft. I have the honor of 
representing Houston, and the Port of Houston is vital to our 
economy and provides thousands of jobs in our district as well 
as southeast Texas. The port is the largest port in the United 
States in terms of foreign tonnage and a large portion of that 
is related to our energy industry, but the port imported 
606,000 tons of imported food products in 2007.
    The discussion draft has a provision that would allow 
foreign and domestic food facilities to voluntarily seek 
certification from the FDA, and the FDA would have a list of 
certified companies. After 5 years, uncertified foreign food 
facilities would only be allowed to enter the United States at 
a port of entry which has an FDA lab. The Port of Houston does 
not have an FDA lab. In fact, there is no FDA lab in the entire 
State of Texas, even though we share the longest border with 
Mexico. I have yet to understand why Texas, with the level of 
trade and the southern border with Mexico, does not have an FDA 
lab. In fact, there are over 300 ports of entry in the United 
States and only 13 ports actually have FDA labs. The FDA lab 
for the State of Texas actually is in southern Arkansas. Again, 
I don't know how much food is imported into Arkansas since it 
is not near a border or a port.
    With regard to the discussion draft, we don't know if 
foreign food facilities will actually register with the FDA 
because their registration is voluntary. If these companies 
choose not to register and go to these 13 ports with labs, I 
question whether the FDA can handle the actual certifying of 
all these facilities and if the FDA labs at the 13 ports will 
be able to handle an increased number of imports from 
unregistered food facilities. Therefore, I respectfully request 
the chairman of the Committee work with me to address the 
concerns regarding the port-of-entry provision. I don't think 
we should pick winners and losers based on a decision that was 
made decades ago and not based in reality, of where the food 
products are actually imported today.
    With that, I look forward to working with you, Mr. Chairman 
and staff, and I yield back my time.
    Mr. Pallone. Thank you, Mr. Green.
    Next I recognize the ranking member of the full committee, 
Mr. Barton, for an opening statement.

   OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Barton. Thank you, Mr. Chairman. We appreciate the 
regular order on this bill. Having a legislative hearing on it 
I think is a good start.
    I must say, as we have discussed the issue of food safety 
this year, Chairman Dingell and myself and a number of members 
on both sides of the aisle have numerous times said that we 
hope we could work together on this issue. I am very 
disappointed that the drafting of these bills so far, 
Republicans have not been allowed any input. It does not bode 
well for moving legislation if we are given drafts that we were 
not allowed to have input into or expected to accept them as 
is. Having said that, the fact that you are having a 
legislative hearing is a good step and we hope that we may have 
some input into the process.
    I would say the bill before us needs some improvements. I 
would start with some basic principles. The bill is replete 
with user fees. If you look at the price of food and how much 
it has gone up just in the last 6 months to a year, I think we 
should tread lightly on imposing additional costs on our food 
industry because ultimately the consumers pay those costs. 
Yesterday's Washington Post had a front page story about hunger 
in the world and, as food prices are exploding, how it is going 
to be more and more difficult to deal with just some of the 
basic food commodities.
    I also have a problem with the restriction of ports of 
entry, as my good friend from Texas, Mr. Green, just pointed 
out. We don't have an FDA laboratory in Texas yet we do have a 
number of very active ports and it would seem somewhat over-
micromanagement to restrict the imports basically to places 
that have these laboratories already in place. So I think that 
is something that we need to work on.
    Overall, I could go through three or four more pages of my 
opening statement but suffice it to say, I take Chairman 
Dingell at his word when he says that that is an important 
issue to him and he would like to move legislation. My 
preference on the minority side is to be cooperative, but in 
order for us to be cooperative, we have got to be allowed to be 
cooperative, and the draft bill before us we had absolutely no 
input into, therefore, we have no ownership of, therefore we 
tend to look at somewhat skeptically.
    With that, Mr. Chairman, I yield back.
    Mr. Pallone. Thank you, Mr. Barton.
    I next recognize the chairman of the full committee and 
thank him for all his work in putting together this bill and 
making it a priority. Mr. Dingell.

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Dingell. Mr. Chairman, first, this is a very important 
hearing that we are conducting today. Second, I want to commend 
you for the hearing but also for your leadership in this very 
important matter and for the way that we have worked together 
on a number of other important matters this year. So far this 
committee has been vigorously investigating whether the Food 
and Drug Administration has the resources and the authorities 
that it needs to protect the public health.
    I want to say that, as everyone will note, we are not 
considering introduced legislation today but rather a staff 
draft which will enable us to gather information about the 
feelings and concerns of our people and about industries' 
concerns about the situation that we confront. With the 
assistance of Mr. Stupak and Mr. Shimkus, we have had seven 
hearings to report and to investigate on tainted foods, with 
causes ranging from intentional adulteration to poor 
manufacturing processes. We found that there are enormous 
amounts of foods and other commodities coming in which the Food 
and Drug Administration cannot even begin to investigate. The 
consequences of this have been severe risk, danger, and hurt to 
our people.
    I want to observe that from what we are going to learn at 
these hearings, it is my intention to work with you, Mr. 
Chairman, and other members of this committee, first, to meet 
the concerns of the members, second, to perfect the 
legislation, and third, to see to it that legislation is 
introduced upon which we may commence moving with great speed 
and vigor in the full committee, and I want to observe that we 
have in this committee this year and last year been working 
very closely together across the aisle. My colleagues on the 
Republican side have made enormous contributions to the public 
interest and I am proud of the way that we have worked together 
in these matters. It is my intention that we shall continue to 
do so on this legislation.
    We have found in our investigations, and this has been 
confirmed by FDA's own Science Board, that FDA lacks the 
resources and the authorities to adequately oversee the 
Nation's food supply in the 21st century. I would note that 
they have similar inability in the areas of prescription 
pharmaceuticals and other areas of the concerns of that agency.
    Now, it must be observed the agency has been less than 
forthcoming about its funding needs. It is evident to almost 
everyone else, however, from the experts to our constituents 
and people who are being sickened and killed by the 
inadequacies of that agency, that the agency is starved for 
resources and that it cannot meet its basic responsibilities. 
The discussion draft that we are considering today will focus 
on our efforts to seek real legislative concerns to what is in 
fact a public health crisis.
    First, the discussion draft aims to increase the resources 
that the FDA needs to do its job. As the FDA Science Board 
found as a result of years of chronic underfunding, and I note 
this did not start this week, FDA does not have the capability 
to ensure the safety of the food for the Nation. The Science 
Board goes on to call the rate at which FDA inspects food 
facilities appallingly low and notes that FDA has been forced 
not to increase food inspections but to cut them by 78 percent 
over the past 35 years, at precisely the same time that food 
importation has increased exponentially. FDA estimates that at 
most it inspects domestic food manufacturers once every 10 
years. Once every 10 years. The Department of Agriculture can 
inspect dog food manufacturers more often than Food and Drug 
can inspect the producers and makers of foods for our people, a 
curious and indefensible situation. For foreign food 
facilities, the situation is even worse. At its current rate of 
inspection, FDA would need more than 2,000 years to visit every 
plant. This system must change.
    Second, because we can't just inspect our way out of the 
problem, the draft provides FDA with resources and authorities 
to prevent food safety problems before they occur. Building on 
legislation introduced by you, Mr. Chairman, we ask those who 
supply Americans their food to ensure the safety of their 
product, and when prevention fails, FDA must have strong 
enforcement tools including authority to order recalls, as our 
colleague, Ms. DeGette, and others have suggested. Many are 
reaping the benefits of globalization but we must make sure 
that all parts of the food chain here bear some responsibility 
as well.
    Finally, the draft provides a range of incentives for good 
acts in the global system. Many companies with reputations to 
protect are on the cutting edge of food safety. In the absence 
of effective FDA oversight, they are using their purchasing 
power to urge improvements in safety from their suppliers. 
Those who do this must be rewarded and we must work to assist 
them so that they can build preventive and protective measures 
into their products. At the same time, we must ferret out the 
bad actors who seek to game the regulatory system and pass off 
contaminated products as safe for consumption, as we have 
learned from tragic events caused in the not too distant past. 
E. coli contaminated spinach and pet foods spiked with melamine 
and lack of regulatory diligence have led to the deaths of 
people and pets, and these are only a couple of small examples 
of what is going on.
    Mr. Chairman, food, drug, device, and cosmetic safety are 
not partisan issues and it is our intention that they cannot be 
so. I look forward to working with all my colleagues on the 
Committee, especially our ranking member, Mr. Barton, and my 
Republican colleagues and also other members, as we have 
previously worked together on legislation important to the 
American people, such as the Consumer Product Safety 
Modernization Act, the National Institutes of Health 
Reauthorization, and I hope that we can work together to craft 
good, sensible legislation that provides the necessary 
resources and authority for the Food and Drug Administration to 
fulfill its critical mission to protect the American people. 
And I want my colleagues here in the Committee to know that it 
is my intention to work with them to see that their concerns, 
whatever they might be, are addressed and that we can come 
forward with a bill that will be supported by the Committee 
with great enthusiasm.
    Mr. Chairman, I thank you for your courtesy.
    Mr. Pallone. Thank you, Chairman Dingell.
    Next, the gentleman from Indiana, Mr. Buyer, is recognized 
for an opening statement.

  OPENING STATEMENT OF HON. STEVE BUYER, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF INDIANA

    Mr. Buyer. Thank you, Mr. Chairman, and I will pick up 
right where Chairman Dingell left off.
    We are really going to get serious about focusing on the 
safety and efficacy of the food, drug, and medical devices. I 
have received numerous assurances from Chairman Dingell of his 
willingness to work with me on legislation that Jim Matheson 
and I have been drafting. That bill has now been introduced, 
and I think Chairman Dingell and others are very concerned 
about the safety of not only the food but also the access of 
America's drug supply.
    Our delivery systems have changed dramatically with the 
globalization of food and the drug markets, and we no longer 
have the luxury of monitoring only the operations within our 
borders. We now have the challenge of ensuring the safety of 
facilities in areas of the world where criminal interests are 
high and the regulatory systems are very weak. Over the past 
year I have focused on the safety of drugs coming into our 
country and completely diverting our highly regulated drug 
supply chain, and I understand next week we will turn our 
attention to the drug and device sections of the discussion 
draft before us. I look forward to working with you, Chairman 
Dingell, and Chairman Pallone, and what I am asking is on 
behalf of Jim Matheson and I, that when you offer this 
discussion draft that you take what Jim Matheson, Gene Green, 
Mike Rogers, and I have introduced. It is H.R. 5839, and what 
we have done, Chairman Pallone, is, we have built off of the 
good work that Chairman Dingell had done when he created the 
paper pedigree back in 1988, and so much has advanced since 
1988 with regard to technology and we need to take advantage of 
that and move from the paper pedigree, Chairman Dingell, that 
you created that can be easily adulterated, and move into the 
electronic pedigree, and Jim Matheson and I have worked hard 
with all industries in the supply chain and worked to do the 
very best, and I think what would be very prudent, what I am 
asking both chairmen of the full committee and the 
subcommittee, that this be considered next week for hearing so 
we can receive input.
    Chairman Dingell, you understand it was very complex when 
you laid out this framework. It hasn't gotten any simpler and 
it is a very difficult subject to explain to someone who knows 
nothing about it. It takes a lot of time and investment, and I 
think it would be very prudent for us to incorporate that in 
our hearing next week and I would ask for your indulgence and 
consideration.
    With that, I yield back.
    Mr. Pallone. I am going to ask the subcommittee's 
indulgence because of his time constraints and being on the 
same subject as Mr. Buyer if we could ask--I will ask unanimous 
consent to let Mr. Matheson go out of order. So ordered.
    The gentleman from Utah is recognized.
    Mr. Matheson. Actually, Mr. Chairman, if I could waive my 
opening statement and use that during my question time, that is 
what I would like to do.
    Thank you very much, Mr. Chairman.
    Mr. Pallone. Thank you.
    Ms. DeGette.

 OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Ms. DeGette. Thank you very much, Mr. Chairman. I ask 
unanimous consent to put my full statement in the record.
    I want to commend you and Chairman Dingell as well as 
Chairman Stupak and Ranking Member Barton for the way the 
Committee has conducted itself with regards to food safety over 
the last year. This is a really complex issue and it is one 
that demands a thoughtful and reasoned response, and that is 
why we have had all the number of hearings we have had in the 
Oversight and Investigation Subcommittee. Now we have the draft 
legislation and the hearing today and so I think it is really 
wonderful the process we are using.
    I also want to thank Chairman Dingell and his staff for 
incorporating the provisions of my legislation granting the FDA 
mandatory recall authority in the case of an outbreak. I often 
talk to my constituents about the fact that when there is 
tainted food on the shelves, the FDA has absolutely no 
authority to order a mandatory recall, and I think that a 
mandatory recall can give us two good results. The first one is 
obviously that if you have a recalcitrant producer who will not 
voluntarily recall products, then you can mandatorily recall 
it, but in addition, I think the threat of a potential 
mandatory recall actually will put pressure on food 
manufacturers and distributors to make the food safe in the 
first place, because in truth, while mandatory recall is 
important, we want to have the food safe before it is recalled 
to begin with, and so I think that that is an important 
provision of this bill. It was kind of an edgy leap to put it 
in there and I think it is important that that be part of any 
strong food safety legislation.
    The second thing I would like to discuss which is not in 
the draft legislation and I think also would be very effective 
is legislation I have introduced, H.R. 3485, the TRACE Act, and 
what that does is, it sets up a food traceability system. We 
all remember the outbreak of E. coli in spinach a couple of 
years ago and there was a voluntary recall, but it took weeks 
and weeks to discover the source of the problem. In the 
meantime, spinach producers all around the country with 
perfectly fine facilities and good produce lost tremendous 
profits. What we learned in our hearings in the Oversight and 
Investigation Subcommittee is that in fact we have the ability 
to trace food. In fact, some of the organic food producers and 
other small family producers do have traceability systems. And 
if consumers could walk into a store and see a lot number or 
some kind of a number where we could trace that food back to 
the source, we would have an ability then to make sure that our 
food products, we could find where the problem was, we could 
identify it, and then we could do the recall or whatever we 
needed to do right away.
    So I am hoping I can work with you, Mr. Chairman, and the 
rest of the Committee to include the provisions of that 
legislation as well in any final bill that we introduce. Thank 
you very much.
    [The prepared statement of Ms. DeGette follows:]
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    Mr. Pallone. Thank you.
    I recognize Mr. Murphy of Pennsylvania for an opening 
statement.

   OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Murphy. Thank you, Mr. Chairman.
    This Congress we have had six Oversight and Investigation 
hearings regarding food safety, and this is the second hearing 
in this subcommittee looking at potential legislative remedies 
for food safety. I think these hearings have given us 
substantial evidence of the need to increase the safety of our 
food supply when you look at some of the things that have 
occurred, such as 76 million people who contracted foodborne 
illness in the United States each year and about 325,000 
require some hospitalization; about 5,000 die, according to a 
2007 GAO study. In the first 2 months of this year alone, the 
Department of Agriculture has issued 5 recalls on top of 58 in 
2007 and 34 the previous year. This number increases 
substantially when you factor in FDA recalls, and of course, we 
just experienced the largest beef recall in U.S. history of 143 
million pounds, including 50 million pounds that have been sent 
to federal nutrition programs, including school lunch programs. 
We continue to have problems ensuring the safety of food 
imports. In July of last year, California issued a recall of 
imported Chinese ginger after discovering it had been treated 
with a dangerous pesticide. With a shaky track record on 
products ranging from tires to toothpaste, I think we can all 
agree allowing imported Chinese food with lax oversight is a 
substantial problem.
    Although America is an envy of other nations in terms of 
what we have in food and farm safety, the question remains, how 
do we remedy the problem with our food supply without unduly 
taxing the near 300,000 food facilities in this country? I have 
serious concerns about the legislation before us today, but it 
begins the process of finding a legislative solution and I 
welcome the debate.
    I have toured many facilities in my district and I know the 
tight profit margins many of them operate under. Registrations 
and the additional regulations could severely impact these 
local businesses. Let us also keep in mind the expense to them 
and the expense passed on to consumers with food. U.S. food 
prices rose 4 percent in 2007, and in 2008, it is expected to 
be even worse. Eggs cost 25 percent more in February than they 
did a year ago. Milk and dairy products are up 13 percent. 
Poultry is 7 percent higher, according to the USDA. Flour used 
to make bread was selling at $16 a hundredweight last summer 
and it is up to the 40s and expected to go to some $60.
    Keep in mind also these overlap with our energy issues. The 
grain needed to fill a 25-gallon tank with ethanol would, 
according to Lester Brown, feed one person for a year, and 
filling that tank every two weeks would feed 26 people. So any 
impact we have upon cost of U.S. food supplies and other food 
supplies are affected around the world.
    Keeping all these challenges in mind, I look forward to 
working on a bill that addresses the weaknesses of our food 
inspection network without unduly burdening small businesses, 
and most importantly, without unduly burdening every family and 
the cost of their grocery basket.
    I look forward to the testimony of today's witnesses, and I 
yield back.
    Mr. Pallone. Thank you.
    Next is the gentlewoman from Wisconsin, Ms. Baldwin, 
recognized for an opening statement.

 OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF WISCONSIN

    Ms. Baldwin. Thank you, Mr. Chairman, and thank you very 
much for holding this important hearing. I want to commend you 
and Chairman Dingell and Chairman Stupak for putting forward 
this discussion draft that addresses the very serious challenge 
we face with respect to food and drug safety.
    The fact that our Nation faces a very serious food safety 
concern is not in question. We all know about many of the 
incidents that have been related by previous speakers--tainted 
spinach, peanut butter, and just recently in March of 2008 we 
had salmonella-tainted cantaloupe in several states, including 
my home State of Wisconsin, that caused several people to fall 
ill.
    But there are questions that do need to be asked and they 
include, what additional authorities does the FDA need to 
ensure the safety of our food supply? Does the FDA have 
sufficient resources to carry out appropriate food safety 
measures? What steps can we take to prevent food contamination 
incidents before they occur? And in an increasingly 
interconnected world, how do we ensure that food coming in from 
other countries is safe? And I think that the Dingell-Pallone-
Stupak discussion draft addresses these questions in a 
thoughtful and constructive manner. I strongly agree that the 
FDA is in critical need of increased resources to ensure the 
safety of our Nation's food supply. We must take steps to make 
sure that this need for resources is met, and I support the 
draft provisions that provide those much-needed resources.
    I am also pleased that the discussion draft includes a 
provision that would allow the FDA to partner with accredited 
third-party laboratories to perform testing. This partnership 
will expand the FDA's laboratory testing capacity and will 
result in more food being tested. This is a smart way to 
harness the abilities of the private sector and a smart way to 
expand the FDA's food safety efforts without draining the 
already very scarce resources of the FDA.
    Lastly, Mr. Chairman, I would like to extend a special 
welcome and thank you to James Lovett, who is one of our 
witnesses today. Mr. Lovett is testifying on behalf of Covance, 
a company that has more than 60 years of food testing 
experience, among other things that they do, and it has a very 
large and impressive facility in my home district and hometown 
of Madison, Wisconsin. I am pleased that they will be able to 
communicate with us today and share their unique perspective in 
this debate and the role that they play in ensuring the safety 
of our Nation's food, and I look forward to today's discussion.
    Thank you again, Mr. Chairman, for holding this hearing.
    Mr. Pallone. Thank you.
    Next for an opening statement, the gentleman from New York, 
Mr. Towns.
    Mr. Towns. Thank you very much, Mr. Chairman. I would like 
to place my opening statement in the record.
    [The prepared statement of Mr. Towns follows:]
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    Mr. Pallone. Thank you.
    The gentlewoman from Oregon, Ms. Hooley.

 OPENING STATEMENT OF HON. DARLENE HOOLEY, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Ms. Hooley. Thank you, Mr. Chair. Thank you for holding 
this hearing and for providing this discussion draft of the 
Food and Drug Administration Globalization Act legislation.
    Mr. Chair, I think it is safe to say that everyone in this 
room and, for that matter, everyone listening to or watching 
this hearing, wants our food system to be safe and safer than 
it currently is. It is clear to me that the first order of 
business is to increase the resources available to the FDA. As 
this committee has pointed out on a number of occasions, FDA's 
own Science Board refused to address the role of science in the 
agency's work without first addressing the historic lack of 
resources for the agency as a whole. I do, however, have some 
issues with the user fees as set up by this legislation, which 
I will get to in a minute.
    I am also pleased that the bill tries to direct the FDA and 
the food industry to prevent problems before they occur. That 
makes sense from the point of view of the consumer who does not 
want to get sick to prove anyone's point, as well as from the 
point of view of the industry that does not want to go bankrupt 
facing a major product recall.
    The third item in this bill that I am pleased about is the 
attempt to provide flexible authorities for the enforcement of 
food safety standards. That is going to help improve industry 
standards and ensure compliance without the need for 
overbearing enforcement provisions.
    I do, however, have a few concerns about the discussion 
draft that I think need to be addressed. Let me sum them up. 
This bill as it currently stands would competitively 
disadvantage small food producers and processors, leave Oregon 
in the position of having zero ports of entry for imported 
foodstuffs and inadvertently increase energy usage to get out 
food. But let me emphasize the issue is so important and your 
work on it to date is so laudable that I want to work hard to 
resolve these issues and arrive at a bill that I can support 
and that we can pass out of committee.
    First, if we must go the road of user fees, then the fees 
must be on a sliding scale, or processors below a certain size 
should be exempt altogether from the fee. Two thousand dollars 
is cost-prohibitive for many of my small food processors. Many 
people in Oregon are turning toward local food producers and 
processors to get the freshest, best food while using the least 
amount of energy to get it. The way this user fee is set up 
puts those producers at a disadvantage. I also believe that 
registration of these facilities may already be required by 
other federal legislation, for example, the Bioterrorism Act of 
2002, and I wonder about duplicating efforts.
    Second, I have concerns about the country of origin 
labeling provisions. I want to thank you for changing the COOL 
provisions from unworkable to workable. We are almost there but 
not quite. We need to work on the definition of processed food 
since it varies from the Bureau of Customs and what is proposed 
in the Farm Bill. We also need to clarify who is responsible 
for listing ingredients on whose Web site and is the ingredient 
listed per the time of year it is available or is it tied to a 
particular package. There are lots of details to be worked out 
and I look forward to working with them and with you and your 
staff.
    Third, I am extremely concerned about the provisions that 
limit eventually the importation of food only through ports 
with an FDA or FDA-certified inspection and testing facility. 
Oregon does not have one, not even at the Port of Portland, 
which would mean that all of our food importation business 
would be sent to California or Washington. That means the loss 
of business to Oregon ports but it also means in this time of 
ever-increasing gas prices that the cost of food will include 
the increased use of gas to get that food from California and 
Washington to Oregon. I thought we were supposed to be 
encouraging the decrease of energy, not passing a policy that 
requires the unnecessary increased use of gas.
    Lastly, I am very concerned that these policies combined, 
the registration fees, the importation requirements, the 
labeling requirements, will work against my small food 
producers. In Oregon, folks pride themselves on innovation, and 
I would not want the pursuit of food safety to be the death 
knell for locally produced, locally consumed fresh foods. I 
have more details from the food safety division of the Oregon 
Department of Agriculture that I would submit for the record.
    I look forward to working with you, Mr. Chair, and my 
colleagues to resolve these concerns. Thank you.
    Mr. Pallone. Thank you, and I believe that concludes the 
Members' opening statements so we will now turn to our 
witnesses, and I would ask the first panel, which is the FDA 
representatives, to come forward please.
    Thank you for being here today. On our first panel, we have 
Dr. Stephen Sundlof, who is director of the Center for Food 
Safety and Applied Nutrition at the FDA, and accompanying him 
is Dr. Steven Solomon, who is deputy director of the Office of 
Regional Operations in FDA's Office of Regulatory Affairs.
    Let me mention that we have 5-minute opening statements. Is 
just one of you going to speak? OK. So a 5-minute opening 
statement is from the witness, and that becomes part of the 
hearing record. The witness may in the discretion of the 
Committee submit additional brief and pertinent statements in 
writing for inclusion in the record, and I would now recognize 
Dr. Sundlof.

 STATEMENT OF STEPHEN SUNDLOF, D.V.M., PH.D., DIRECTOR, CENTER 
     FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG 
                         ADMINISTRATION

    Dr. Sundlof. Good morning and thank you, Chairman Pallone 
and members of the Subcommittee. I am Stephen Sundlof, director 
of the Center for Food Safety and Applied Nutrition at the Food 
and Drug Administration, and I appreciate the opportunity to 
discuss our legislative proposals as well as proposals 
developed by you and your colleague on the Committee to enhance 
FDA's ability to carry out its important public health mission.
    Food can become contaminated at many different steps along 
the path from farm to fork. In recent years, FDA has done a 
great deal to prevent both deliberate and unintentional 
contamination of food at each of these steps. However, changes 
in consumer preferences, changes in industry practices, and the 
rising volume of imports have posed challenges that require us 
to adapt our current food protection strategies.
    To address these challenges, last November, Secretary of 
Health and Human Services Michael Leavitt presented to the 
President an Action Plan for Import Safety which reflects the 
input of 12 departments and agencies and provides 
recommendations to enhance the safety of imported products. In 
conjunction with the Action Plan, FDA released a Food 
Protection Plan which provides a framework to identify 
potential hazards and counter them before they can do harm. 
Together these plans provide an updated and comprehensive 
approach to ensure that the U.S. food supply remains one of the 
safest in the world. The plans encompass three core elements: 
prevention, intervention, and response. The prevention element 
means promoting increased corporate responsibility so that food 
problems do not occur in the first place. The intervention 
element focuses on risk-based inspections, sampling, and 
surveillance at all points in the food supply chain. The 
response element bolsters FDA's emergency response efforts by 
allowing for increased speed and efficiency.
    Consistent with the goals of the Action Plan, in December, 
HHS and the People's Republic of China signed a Memorandum of 
Agreement to enhance the safety of food and animal feed 
products exported from China to the United States. The 
Memorandum of Agreement establishes a bilateral mechanism to 
provide greater information to ensure products from China meet 
U.S. standards for quality and safety. The key terms of the 
agreement include enhanced registration and certification 
requirements, greater information sharing, faster access to 
production facilities, and the implementation of key benchmarks 
to evaluate progress. The first formal bilateral meeting under 
the Memorandum of Agreement was held in Beijing last month.
    FDA has also made a commitment to station inspections and 
other agency representatives in China to increase our ability 
to carry out foreign inspections and to facilitate cooperation 
between FDA and its counterpart regulatory authorities. FDA is 
considering endeavors similar to this in other countries.
    In the plans we identified several new legislative 
authorities needed to help us fully implement them. For 
example, FDA is requesting the authority to require entities in 
the food supply chain to implement measures solely intended to 
protect against intentional adulteration of the food supply by 
terrorists or criminals.
    We are also requiring explicit authority to issue 
regulations requiring preventive food safety controls for high-
risk foods. Such authority would strengthen FDA's ability to 
require manufacturers to implement a risk-based Hazardous 
Analysis and Critical Control Point, or HACCP, or equivalent 
process to reduce foodborne illnesses from these foods.
    Some of the other legislative proposals include authorizing 
FDA to accredit and use highly qualified independent third 
parties to evaluate compliance for voluntary inspections, 
allowing the FDA to move the inspection of high-risk products 
of concern upstream by requiring the exporting country's 
regulatory authority or a third-party inspector to certify each 
shipment for compliance with FDA's standards prior to shipment, 
giving FDA authority to issue mandatory recalls if a voluntary 
recall is not effective, authorizing the FDA to refuse 
admission of imported food if inspection access has been 
delayed, limited or denied, and giving FDA enhanced access to 
food records during emergencies
    We commend the members of this committee and their staff 
for developing the discussion draft entitled ``The Food and 
Drug Administration Globalization Act of 2008.'' We recognize 
and appreciate the Committee's efforts to include new 
authorities requested by the Administration in support of the 
Action Plan for Import Safety and the Food Protection Plan.
    We are in the process of reviewing the discussion draft in 
detail, and we look forward to working with you on this 
legislation. At this time, however, we can make some general 
comments that guided the development of the Action Plan for 
Import Safety and which we believe should also guide the 
development of product safety legislation.
    First, any legislation should allow FDA to set requirements 
and priorities based on a strong scientific risk assessment. 
Given the breadth and scope of the food products imported into 
the United States, FDA cannot rely on inspections as its 
primary means of ensuring food safety. Any legislation should 
build on the framework in the plans to build in safety measure 
to address risks throughout the product's life cycle and focus 
efforts on preventing problems first and then use risk-based 
interventions to ensure preventive approaches are effective 
coupled with a rapid response as soon as contaminated food or 
feed is detected or when there is harm to people or animals.
    The Federal Government should be striving to address food 
safety concerns while minimizing the potential effects on the 
increasing costs of food. While the Administration is 
supportive of user fee programs in which regulated industries 
provide funding for additional performance and efforts or 
programs designed to recoup the costs of enforcement actions 
such as reinspections, the Administration will carefully review 
any proposed user fee to ensure that it is being assessed 
against identifiable recipients for special benefits derived 
from federal activities beyond those received by the public.
    Any legislation should be carefully designed to avoid 
creating real or perceived barriers. Any legislation should 
empower robust, voluntary private sector efforts already 
underway.
    With these in mind, we believe that the proposed 
legislation should be more closely targeted and prioritized 
according to risk. Several of the legislative sections are not 
exclusively targeting high-risk products. Some of these 
requirements would require such substantial resources that they 
would not be feasible. Further, such resources could detract 
from more important food safety and food defense priorities.
    In addition, the legislation should more explicitly 
incorporate the Administration's strategy of leveraging efforts 
underway by certifying bodies and foreign nations. Finally, 
several provisions of this bill may need to be reviewed in 
light of U.S. agreement obligations, and we are reaching out to 
the United States Trade Representative for further insight on 
these.
    Thank you again for the opportunity to discuss FDA's 
legislative proposals as well as the proposals developed by the 
Committee. We look forward to working with you to obtain 
passage of the requested legislative authorities identified in 
the Food Protection Plan and the Action Plan for Import Safety, 
and I would be happy to answer any questions at this time.
    Thank you, Mr. Chairman.
    [The prepared statement of Dr. Sundlof follows:]
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    Mr. Pallone. Thank you, Dr. Sundlof.
    I will recognize myself for 5 minutes for questions. I have 
two questions. I am going to try to get in one about the 
funding and one about your authority, so just bear with me so 
we can get both of those in.
    The draft legislation incorporates some of the suggestions 
your agency made in its recently released Food Protection Plan, 
and those are strong concepts and things the FDA should be 
doing to protect the American people. But we know for a fact 
that the FDA is underfunded. Commissioner von Eschenbach even 
recently stated in an interview that you have requested more 
than the 2.95 percent overall increase for the FDA that was 
proposed by the Administration, and former FDA Commissioner and 
CMS Administrator Mark McClellan stated, and I quote, ``The 
President's fiscal 2009 budget barely gives FDA enough funds to 
operate at last year's level and does little to make up for the 
steady loss of staffing that the agency has endured for the 
past decade.''
    So my first question, in your professional judgment, how 
much money does the FDA need to carry out the tasks laid out in 
your plan and also in this bill?
    Dr. Sundlof. Thank you, Mr. Chairman. Well, first of all, a 
lot of it has to do with the authorities that we are going to 
be given. If we do acquire some of these authorities, it will 
make a big difference on the amount of revenues and resources 
that we are going to need. For instance, if we have the 
authority to recognize third-party inspectors, then we would 
expect that the number of inspections that would be required by 
FDA, we would be relying on those third parties to do a lot of 
the inspection work for us. That doesn't mean that there aren't 
costs associated with that. We would have to certify those 
third parties to make sure that they are inspecting in 
accordance with our regulations. But it is very difficult at 
this point to say exactly how much additional revenues we will 
be needing until we have a clearer picture of what new 
authorities that we have already declared we need in order to--
--
    Mr. Pallone. Well, do you want to make a distinction 
between your plan versus this bill? I mean, I know this bill 
you are just seeing in the last few days, but do you want to 
talk about the cost of additional money under your plan at 
least?
    Dr. Sundlof. Well, under our plan, again, we would have--it 
depends again on the amount of inspection that is going to be 
required. Under this particular plan, the Globalization Act, it 
would basically require that every food manufacturer in the 
world that exports to the United States would have to be 
inspected at a fairly regular frequency, either 2 or 4 years.
    Mr. Pallone. Do you have cost estimates for your plan 
anywhere in the agency at this point you could give us?
    Dr. Sundlof. We don't have cost estimates at this time. The 
plan that we were talking about said that we would take a 
tiered approach, that we would have more frequent inspections 
for those high-risk plants and fewer inspections for plants 
that----
    Mr. Pallone. Well, let me just ask you this because I want 
to get to the second question. If you can at some point--I am 
sure at some point you are going to put some kind of cost on 
your plan--get back to us because obviously the amount of 
funding is a big issue here in terms of how we pay for it.
    In your testimony, you mentioned three core elements that 
are vital to ensuring a safe food supply including concepts 
like prevention, intervention, and response and, while 
prevention is very important to me and is a central theme in my 
bill on food safety, I don't think we should be just reacting 
to instances of contaminated food but instead we should make 
sure things--we should make sure those instances never happen 
in the first place. And yet at the same time, in your testimony 
you are only asking for authorities in specific areas such as 
the power to protect against the intentional adulteration of 
food and for high-risk foods. However, the recent outbreaks 
have not been intentional nor have they solely affected high-
risk products, and yet Americans are still dying from foodborne 
illnesses. So my question is, does the FDA currently have the 
authority to protect the American people from low-risk, non-
intentional outbreaks, and if not, what authorities do you need 
to do so, to provide those protections?
    Dr. Sundlof. Thank you, Mr. Chairman. We do have the 
authority to protect the public against both high and low risk. 
What we are requesting in the Food Protection Plan and Import 
Safety Action Plan is the authority to explicitly require that 
companies that have higher-risk foods that they are producing 
have plans in place, written plans in place that we can audit 
against to make sure that they are following a preventive 
program so that contaminated food does not get to the public. 
Now, for lower-risk plants, we would encourage those low-risk 
plants to also have similar preventive measures in place. We 
think that in order to make the maximum use of our resources, 
that we should be targeting those firms that produce high-risk 
products.
    Mr. Pallone. So essentially you have the authority, in your 
opinion, for both right now but you are focusing on high risk?
    Dr. Sundlof. We are focusing on, we would like to have 
explicit authority to require firms that produce high-risk 
foods to have plans in place and documented so that we can 
inspect against those particular plans. Right now that 
authority is explicit for seafood and I believe at least 
seafood and other high-risk products there is no explicit 
authority for that.
    Mr. Pallone. Thank you.
    The gentleman from Georgia.
    Mr. Deal. Thank you.
    Dr. Sundlof, one of the concerns that you have already 
heard expressed from members here in opening statements and one 
that my State would have a concern about too is the lack of FDA 
inspection facilities adjacent to our ports of entry. Would you 
briefly address that concern and how would you propose to deal 
with the concern about having inspection facilities available 
at ports of entry?
    Dr. Sundlof. Yes, so laboratory facilities at ports of 
entry.
    Mr. Deal. Yes.
    Dr. Sundlof. Well, I can just say that depending upon what 
kind of food is imported into the United States, it may not 
make a difference whether or not there is a laboratory there 
because that laboratory may not be doing the types of analysis 
that we would require. For instance, if it was seafood and the 
particular laboratory was only looking at things like pesticide 
residues, it wouldn't--there would be no effect on having a 
laboratory right there. We believe that with the rapid 
transportation that is available today that products can be 
shipped from the port of entry to any of our laboratories 
within 24 hours, and that really doesn't represent a problem 
for us.
    Mr. Deal. Well, obviously, as you have already heard, 
States are very concerned about their own competitiveness in 
terms of what may be mandated for inspections that will dictate 
laboratory analysis. I think that is one of those concerns that 
all of us are going to have to be very aware of in terms of 
anything legislatively mandated in that regard. My State, for 
example, as I understand, does not have a laboratory except in 
Atlanta, Georgia, which is very much inland from our ports. So 
that will be a concern that you are going to continue to hear, 
I think, and something that as a practical matter all of us 
both at the legislative level and at the enforcement level need 
to look at very carefully and have a more thorough 
understanding.
    In that regard, could you expound just a little bit about 
the existing agreements with other countries in terms of, you 
indicated that the authority to rely on the exporting country 
to certify safety is an important element in this whole 
process. How successful do you think that currently is? What 
needs to be done? If we need to beef up that end of it, what 
needs to be done there?
    Dr. Sundlof. Thank you. Currently the only agreement that 
we have underway is with China and we have just begun that 
process, and we have identified certain high-risk foods, 
seafood being one of them, that we would require that the 
Chinese government certify to our standards that those products 
were safe before they ever left the port. We are considering 
similar agreements with other countries for which we have 
concerns about their ability to ensure that the food is safe. 
What we have asked for in the Import Safety Action Plan is the 
explicit authority to require certification from other 
countries as a condition of them being able to export to the 
United States.
    Mr. Deal. Obviously that could potentially impact trade 
agreements and other matters, and you indicated that 
consultation with the U.S. Trade Representative Office was one 
of the areas that needs to take place, and I agree with that. 
Would you, after you and your staff have consulted with USTR, 
would you be willing to come up and brief us staff-wise and 
members who are interested on what those kind of trade 
implications might be and areas of concern that we should be 
aware of in that regard?
    Dr. Sundlof. Certainly.
    Mr. Deal. I think that would be very helpful for us to have 
a pretty detailed understanding of the interaction between all 
of these things as it relates to what we are trying to 
legislatively achieve here.
    Thank you, and I would yield back my time.
    Mr. Pallone. Thank you, Mr. Deal.
    Recognize Chairman Dingell for 5 minutes for questions.
    Mr. Dingell. Mr. Chairman, I thank you for your courtesy.
    These questions to the Food and Drug Administration. The 
Science Board estimated that over the past 35 years your 
inspection capability has fallen 78 percent because of cuts in 
funding. In addition, they estimated that you inspect food 
manufacturers once every 10 years. They also estimated that you 
made only 96 overseas food inspections last year out of a 
potential for 180,000 or more facilities that needed 
inspection. Are these statements true?
    Dr. Sundlof. I believe they are, sir.
    Mr. Dingell. All right. Now, let us look at your situation. 
You have the unfortunate situation that you have received huge 
cuts so your ability has declined enormously over that period 
of time. You now do not know what the additional burdens 
imposed on you by this bill will do. I am asking you at this 
time to submit to us in writing at your earliest convenience a 
statement of what you need to carry out your current 
responsibilities, and second, what you will need under this 
bill to carry out the responsibilities imposed upon you. Can 
you give me a quick and dirty answer as to what you will need 
to bring yourself current with your present responsibilities 
under law in terms of inspecting food-producing establishments? 
How much?
    Dr. Sundlof. I don't have a number for you.
    Mr. Dingell. Then we will send you a letter and I will 
expect that you will give us a response.
    Mr. Chairman, I ask unanimous consent that the record 
remain open for that to be inserted.
    Mr. Pallone. Without objection, so ordered.
    Mr. Dingell. Now, tell us, please, about what the 
additional responsibilities will be as asked about by our very 
able chairman.
    Dr. Sundlof. Well, the additional responsibilities both in 
the Food Protection Plan and the Import Safety Action Plan and 
in the bill that we are discussing today is going to be that we 
will take on a new role and that is as a certifying body, that 
we will certify other, whether it is a foreign government, 
whether it is a State agency, or whether it is a private 
industry, private sector industry, to inspect to our standards.
    Mr. Dingell. In order to enable us to make a proper 
appraisal, we will also include that question and you give us a 
more detailed and thoughtful answer on that.
    Now, I would like to address risk-based systems and 
information and structure. According to the Science Board, FDA 
lacks information science capability and information 
infrastructure to fulfill its regulatory mandate. They found 
that there is insufficient capability in modeling risk 
assessment and analysis. Are you familiar with that statement?
    Dr. Sundlof. I am familiar with the statement, sir.
    Mr. Dingell. The report goes on to state FDA IT 
infrastructure is obsolete, unstable, lacks sufficient controls 
to ensure continuity of operations or to provide effective 
disaster recovery services, and they go on to observe that, 
given the lack of dependable IT infrastructure, an eroding 
science base, and a dwindling workforce, they raise questions 
about whether FDA can effectively model risk to evaluate food 
shipments entering the interstate commerce currently. Are you 
familiar with that?
    Dr. Sundlof. Yes, sir, I am.
    Mr. Dingell. Do you agree with that or disagree with it, 
yes or no?
    Dr. Sundlof. Well, I don't completely agree with that. We 
have put a lot of emphasis in fact when we announced----
    Mr. Dingell. Just simply, because our time is limited, do 
you agree or disagree?
    Dr. Sundlof. I disagree with the entirety of the statement, 
not with the--let me restate that. I don't disagree with the 
entirety of the statement. There are certain statements within 
that that I do disagree with.
    Mr. Dingell. Now, you have down there two different systems 
of handling your data and information, do you not?
    Dr. Sundlof. I am not sure what you are referring to.
    Mr. Dingell. Please submit the answer to that for the 
record. I believe you do.
    Now, Commissioner von Eschenbach stated before the National 
Press Club in February of 2008 that he will continue to make 
his staff available day or night to work with Congress on food 
safety legislation. Tell me when the Administration will have 
its comments to us regarding the discussion draft.
    Dr. Sundlof. I don't have a time frame. I know that we are 
working----
    Mr. Dingell. I would like it at your earliest convenience.
    Mr. Chairman, just one more question.
    You state in your testimony that any legislation should 
empower robust, voluntary, private sector efforts and that such 
is already underway. Is that correct?
    Dr. Sundlof. That is correct.
    Mr. Dingell. My time is expired, but I want you to submit 
to us a clear statement of what that means and what you are in 
fact doing to give us these robust voluntary private sector 
efforts that are already underway.
    Mr. Chairman, I thank you for your courtesy.
    Mr. Pallone. Thank you, Chairman Dingell.
    Ranking Member Barton is recognized for questions, 5 
minutes.
    Mr. Barton. Thank you, Chairman Pallone. I have been 
watching the hearing on my television set as I was in a series 
of private meetings so I somewhat kept up with the hearing 
although I haven't been here in person.
    Dr. Sundlof, has the FDA taken any kind of an official 
position on the bill that is the subject of this hearing today?
    Dr. Sundlof. No, the Department has not taken an official 
position.
    Mr. Barton. If you read your testimony, one could interpret 
that the FDA would prefer, instead of a strict regulatory 
approach, more of a risk-based approach. Is that a fair 
statement?
    Dr. Sundlof. Yes, it is a fair statement that we would 
prefer to use our resources to apply to the highest risk areas 
rather than a broad, across-the-board inspection program.
    Mr. Barton. Do you see a possibility, since this is a 
discussion draft, to have a meeting somewhere in the middle 
between the approach in the bill before us and the approach 
where you have limited assets and you apply those more risk-
based approaches? Is there a possibility to meld those two 
together?
    Dr. Sundlof. I would certainly hope so.
    Mr. Barton. I would too. Would you care to comment on the 
use of third parties for certain functions as opposed to having 
everything be done directly by paid employees of the FDA?
    Dr. Sundlof. Well, sir, I think it is impractical, 
especially when we are talking about foreign inspections, to 
think that the FDA could possibly cover 150 different countries 
and somewhere between 140,000 and 180,000 different 
manufacturers. First of all, it would require that we had 
agreements with all those foreign governments to go in and 
inspect but the reality of that situation is that if everybody 
took that approach, then every country would be inspecting 
every other country and it would be a continuous string of 
inspections that would go on and I don't see how a company 
could actually produce food under those conditions because they 
would be constantly inspected by every country. So we believe, 
and I think it is consistent with the proposed legislation, 
that we rely on either foreign governments to certify according 
to our standards or third party independent folks to certify to 
our standards and that we would have an auditing function to 
make sure that they are in compliance with our standards.
    Mr. Barton. Is it fair to say that the approach you just 
outlined, if I understand correctly, is used right now on the 
drug side? Don't you have that same approach for inspecting 
drugs and drug ingredients?
    Dr. Sundlof. We do with a few countries under mutual 
recognition agreements, not all countries but more and more. We 
are looking to other countries if we believe they are 
equivalent to our system, and utilizing the information that 
they gather from their inspections.
    Mr. Barton. But there would be a precedent on the drug side 
in some countries?
    Dr. Sundlof. Yes.
    Mr. Barton. All right. What is your view of the proposal 
that all food imports have to come into certain ports that 
already have an FDA laboratory?
    Dr. Sundlof. Well, again, our food laboratories are 
scattered throughout the United States, not always associated 
with ports of entry, and that different types of testing and 
sampling occur in various parts of the United States. So even 
if the import did come to a port where there was a laboratory, 
there is no guarantee that that laboratory could actually run 
the analysis that we would want and so we would still have to 
ship that sample to another laboratory in the United States 
that specialized in that particular testing. So at least from 
my view is that it doesn't gain us very much, requiring that 
the particular port have a laboratory.
    Mr. Barton. My time is about to expire. My last question, 
if I understand the bill correctly, it also restricts the 
ability of the FDA to reorganize or relocate any of these food 
inspection laboratories. In the 21st century, do you think that 
is good public policy to put that kind of a restriction into 
law?
    Dr. Sundlof. Mr. Chairman, I think that we always want to 
preserve our flexibility in the FDA to put our resources where 
we think they will serve in the best interest of the public.
    Mr. Barton. Thank you, Chairman Pallone.
    Mr. Pallone. Thank you, Mr. Barton.
    Next is our vice chair, Mr. Green, recognized for 
questions.
    Mr. Green. Thank you, Mr. Chairman, and I think some of the 
questions I have may have been answered, but Doctor, you heard 
my opening statement. I have the Port of Houston and we don't 
have a lab. In fact, we don't have one in the State of Texas, 
even though we have the biggest land port I guess in the world, 
in Laredo and Nuevo Laredo, Texas, for goods including 
foodstuffs. Do you happen to know what the lab in Arkansas's 
specialty is? Is it really food testing or is it something else 
the FDA may be doing?
    Dr. Sundlof. I am going to ask Dr. Solomon to respond to 
that.
    Dr. Solomon. They do do food in the Arkansas lab, among 
other areas, but food testing is one of their areas.
    Mr. Green. And I don't know who put the lab there but I can 
imagine if it was a Member of Congress, somebody from southern 
Arkansas many decades ago, and I understand how that works and 
that is why if the bill makes some changes, it should recognize 
that there are ports that have a great deal of foodstuff coming 
in, and I know you can oversight stuff and I know the bill 
hopefully will call for alternative certification at 
independent labs that are certified and would not pick winners 
and losers in a bill based on the 13 lab locations.
    The FDA's use of voluntary registration or certification 
before they regulate food and drugs, and are these labs able to 
handle the current workload or with this increased workload 
that you would have? Now, I have to admit, I have been on the 
docks at the Port of Houston and had FDA inspectors there with 
me, so we have inspectors on the docks.
    Dr. Sundlof. Again, I am going to ask Dr. Solomon to 
respond to that.
    Dr. Solomon. We are always looking at our laboratories and 
other activities to see their capacity, their capability, their 
timeliness of doing work, and we are continually evaluating how 
we can improve that because testing is one component of trying 
to get assurances about the safety of food, so we are handling 
our current workload. We understand that there is more work 
that needs to be done and we are looking to obtain additional 
efficiencies by trying to improve the laboratory capabilities, 
capacity, and their timeliness.
    Mr. Green. And the last thing is, I know this bill provides 
additional funds for the expansion, and would the FDA, with 
these funds, intend to add more labs and particularly locations 
that have a great deal of imports that you would need, and 
would you consider locating them in areas that have that high 
food import or trade levels?
    Dr. Sundlof. Right now I don't believe that we have made 
any kind of decisions about increasing laboratory capability. 
One of the things we are considering is recognizing independent 
laboratories and accrediting those laboratories to conduct 
analysis that would supplement the work that is currently done 
in the FDA laboratories.
    Mr. Green. And I know the cost issue, if it costs so much 
to do at an independent lab, that it would be maybe cheaper to 
actually establish an FDA lab in a location if you have enough 
business to do it.
    Dr. Sundlof. It is certainly something that we would 
consider.
    Mr. Green. Thank you, Mr. Chairman. I yield back.
    Mr. Pallone. Thank you, Mr. Green.
    The gentleman from Indiana, Mr. Buyer, for questions.
    Mr. Buyer. Thank you.
    To either of you, do you think it is important to have a 
non-delegation clause when it comes to the authority to issue a 
mandatory recall?
    Dr. Sundlof. I am sorry, sir. Could you repeat the 
question?
    Mr. Buyer. Do you believe it is important to have a non-
delegation clause when it comes to the authority to issue 
mandatory recall?
    Dr. Sundlof. OK. Thank you. Let me just say that in 
virtually every situation where we have asked for a recall, we 
have gotten compliance from the regulated industry. So it would 
be a very rare event if we asked for a voluntary recall and we 
were denied that recall. And in those extraordinary 
circumstances, I don't have concerns that that delegation would 
be given to the Commissioner or even the Secretary because I 
believe these would be fairly extraordinary circumstances.
    Mr. Buyer. Why is it an important issue for you?
    Dr. Sundlof. Why is it an important issue? It is an 
important issue because we believe that there could be 
circumstances where the public's health was at risk and where 
we were not given--our request for voluntary recall was denied 
and we would never want to find ourselves in that situation, 
where we couldn't go out and ensure that we could remove any 
potentially risky food products from the marketplace.
    Mr. Buyer. Regarding your risk-based approach to, I don't 
care whether the issues are in drugs or here in food, when you 
set forth the model or the paradigm to do that, there are 
acceptable levels of risk that you have to take. So when you 
articulate to us that you prefer risk-based approaches, can you 
elaborate a little bit further on why that is the preferable 
approach?
    Dr. Sundlof. It is the preferable approach because we want 
to make sure that with--the universe of food out there is 
obviously vast. We have limited resources and we want to use 
those resources as judiciously as we can to target those 
products that we believe have the greatest potential to cause 
harm to public health. So it is purely from the standpoint that 
we first of all want to have systems that we can identify what 
is a high-risk food, why is it high risk, and then make sure 
that we are paying adequate attention to those high-risk foods 
to ensure that they are safe and not ignoring the lower-risk 
products because we are finding that some of the products that 
we thought were low risk in the past actually turned out to be 
higher risk than we thought. We are really targeting our 
efforts to make sure that we are addressing the food that has 
the highest potential to cause harm to the public health.
    Mr. Buyer. When you come to judgment, do you have 
interagency cooperation or interdepartmental cooperation with 
the Department of Homeland Security?
    Dr. Sundlof. We do have frequent interactions with the 
Department of Homeland Security and we do discuss these issues.
    Mr. Buyer. When you say ``and we do discuss these issues,'' 
so with regard to interfacing of targeting systems in your 
risk-based approach with regard to countries, localities, 
territories, companies that are on certain lists, is that what 
we are talking about?
    Dr. Sundlof. With Homeland Security, we have come up with a 
risk paradigm to identify which products have the greatest 
potential for causing a catastrophe should the food become 
adulterated intentionally, and I think Dr. Solomon has some 
more information on that.
    Dr. Solomon. The prior notice submission for food entries 
were located with Customs and Border Protection and Homeland 
Security at the National Targeting Center and our staffs along 
with USDA work side by side in looking at the assessment of 
entries coming in and particularly from a concern about 
bioterrorism concerns making those assessments jointly and 
sharing information so that co-location is very valuable to us. 
Other examples on Homeland Security relate to the pet food 
contamination, when we worked to stop product coming in from 
China, the wheat gluten and the rice protein concentrate, 
Customs and Border Protection and Homeland Security went out 
and did a nationwide blitz to see was there any evidence of 
this product, this contaminant coming in from any other 
country. So we focused on the initial product and Homeland 
Security focused on the rest of the border issues.
    Mr. Buyer. Thank you very much.
    Mr. Pallone. Thank you.
    The gentlewoman from Wisconsin, Ms. Baldwin, for questions.
    Ms. Baldwin. Thank you, Mr. Chairman.
    Dr. Sundlof, you have already addressed a couple of 
questions relating to the third-party system that is being 
proposed in this discussion draft to enhance and augment FDA's 
food testing capabilities. As I understand it, FDA currently 
works with independent testers like Covance, who will be 
represented in the next panel. So I wonder, from your 
experience with independent testers, do you agree that they do 
sound, independent scientific testing, and also, can you speak 
to what sort of accreditation process you would envision FDA 
undertaking to ensure that the testing done by third parties is 
rigorous and in accordance with the highest scientific 
standards?
    Dr. Sundlof. Thank you. We currently do rely on independent 
third-party laboratories when, for instance, we have an import 
alert against a product coming into the United States. We 
require that those importing firms have their product tested 
upon entry to the United States and that they pay for that 
their through an independent third-party laboratory and then we 
review the results of that so we do have some good 
relationships. We do rely on them right now. In terms of 
accrediting, there are certain laboratory accreditation 
standards that I believe we would be relying on in officially 
accrediting. Right now we don't accredit. We would like to 
accredit. We rely on the testing results of certain 
laboratories that we have confidence in but we want to take 
that to the next step and actually be able to accredit them. 
There would be--there are very good accreditation standards in 
place and we would most likely rely on what is already out 
there.
    Ms. Baldwin. What sort of accreditation processes are in 
place that you don't currently use but you might?
    Dr. Sundlof. I think there are some ISO standards. I think 
there are other standards. I am not familiar with all of them 
right now.
    Ms. Baldwin. The other question I have is, sort of trying 
to move FDA from basically being in a reaction mode for food 
safety issues and looking at what actions the FDA should be 
taking to prevent food contamination, food safety incidents 
before they even occur, and what could the FDA be doing right 
now to prevent future food safety threats? What additional 
authorities do you think the FDA needs to be more proactive and 
preventive, and what are your comments on the draft 
legislation's provisions that seek to enable FDA to act more 
proactively by requiring foreign and domestic food facilities 
to have safety plans in place to identify and mitigate hazards?
    Dr. Sundlof. Thank you. What we asked for in our Food 
Protection Plan and Import Safety Action Plan is somewhat 
similar to what is in the proposed legislation. Under both of 
those plans, we would require two things. First, for 
intentional contamination, we would want our high-risk food 
areas to have certain preventive measures documented and in 
place that we could inspect against so that is a preventive 
measure. The other one that we asked for is for high-risk food 
production facilities, that they would have HACCP-like plans in 
place that we again could--mandatory--that we could inspect 
against to ensure that they were--that they did have effective 
preventative programs in place.
    Ms. Baldwin. Thank you.
    Mr. Pallone. The gentleman from Pennsylvania, Mr. Pitts, is 
recognized for questions.
    Mr. Pitts. Thank you, Mr. Chairman.
    Dr. Sundlof, do you think requiring the labeling of the 
country of origin of every ingredient in a product will improve 
the safety of that product, and if so, why?
    Dr. Sundlof. The safety of the products that come into the 
United States from other countries should be as safe as the 
domestically produced products. We are asking for these new 
authorities to help ensure that but I don't want people to feel 
that relying on a country of origin label is going to give them 
information about the safety of that particular product. It 
should meet the United States' standards.
    Mr. Pitts. And what is your primary concern about 
supporting the country of origin labeling?
    Dr. Sundlof. I don't have--I don't think I have a position 
on whether or not to support or not support country of origin 
labeling, only that it should not be viewed--if there is 
country of origin labeling, that it should be viewed as a way 
for consumers to make judgments on the safety of the product. 
We don't believe that country of origin labeling in any way 
should be associated with the safety of foods imported from 
other countries.
    Mr. Pitts. What is it related to then?
    Dr. Sundlof. Well, it would be something other than that 
and again, we have not taken a position on anything else. From 
the point of view of the FDA, that is the thing that we are 
concerned about the most is that food that is imported conform 
to the same standards as domestically produced food and 
therefore country of origin labeling does not provide any 
additional information.
    Mr. Pitts. Are you concerned about possible confusion with 
a requirement for labeling to the public and the concern about 
the difficulties of a manufacturer to comply and the cost for 
changing ingredients? For instance, if you have a product with 
22 ingredients, and one of them is from Brazil, and, let's say 
Brazil has a drought. The company may gave to go to Argentina 
for that particular ingredient. Are you concerned about the 
constantly changing label, the requirements?
    Dr. Sundlof. Again, since the FDA has not asked and the 
Administration has not asked for country of origin labeling, 
that is not something that we even consider at this point.
    Mr. Pitts. Do you think it would be a mistake if food 
safety legislation tried to undo what many food manufacturers 
have already put in place in regards to food safety and replace 
it with a system that relies on inspections of all facilities 
and testing of all food shipments?
    Dr. Sundlof. Certainly we don't believe that inspection or 
sampling and testing of all food shipments is a feasible 
approach, considering that we receive somewhere on the order of 
almost 10 million import entries per year, at least at this 
time, not even feasible to try and test our way into safety.
    Mr. Pitts. If we are going to have the safest food supply 
system possible, don't we have to rely or put more onus on the 
manufacturers to prevent food safety issues?
    Dr. Sundlof. Yes, absolutely, and that is one of the 
principles of both the Import Safety Action Plan and the Food 
Protection Plan is to put especially the prevention 
responsibility on the suppliers, manufacturers that are----
    Mr. Pitts. Do most corporate food manufacturers have safety 
systems in place to prevent both intentional and unintentional 
food contamination?
    Dr. Sundlof. Many of them have excellent systems in place, 
not all of them.
    Mr. Pitts. Would you say most of them?
    Dr. Sundlof. I don't have a figure on that. It becomes a 
matter of, you may have many, many small companies that produce 
a small percentage of the food versus large companies that 
produce a much larger--a few large companies that produce 
larger percentage but we are aware of many good plans already 
in place.
    Mr. Pitts. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you.
    Next is the gentleman from Utah, Mr. Matheson, recognized 
for questions.
    Mr. Matheson. Well, thank you, Mr. Chairman. Mr. Chairman, 
I would like to work with you on another issue, which is not 
currently included in the discussion draft before us but I 
think it is an issue that is very much within the purview of 
the FDA and food safety and I think it should be included in 
legislation that we move here in the House. This is a problem 
that stems from the lead content of certain ceramic or 
decorative food ware such as plates.
    In my home State of Utah, and I am sure in districts 
throughout the country, consumers are unaware that lead is 
component of glazes and can leach out of ceramic ware if the 
glaze is improperly fired or worn down from daily use. Children 
are at particular risk of lead exposure and this risk is 
compounded when we are talking about food containers because 
kids frequently consume acidic juices that leach lead from 
ceramics. Now, this issue recently hit home for me. A young 
mother in Utah who was breastfeeding her baby used ceramics 
plates to heat her food in the microwave. Her infant became 
very sick and ultimately her doctors discovered that the baby 
was suffering from lead poisoning because of the plates used in 
the food preparation for her mother. This mother was completely 
unaware of the potential health risk posed by certain ceramic 
ware products, as I suspect many, if not everyone in this room, 
as well would be aware of that risk.
    Mr. Chairman, I brought with me a brief video clip of news 
coverage which I think will give my colleagues on the Committee 
as well as our panel a better snapshot of this issue just as 
brief background. In November of 2007, over 400 people lined up 
at the Salt Lake Country Government Center to have bags and 
tubs filled with dishes along with toys and jewelry tested for 
lead levels. Once they found out that this is a problem, the 
public has responded with great concern. You will see lines of 
people in the video, which showcases the magnitude of interest 
in the problem. This runs for less than a minute but it helps 
highlight the story of this mother and her baby. Could we run 
the video?
    Mr. Pallone. And I will mention the gentleman actually has 
an additional 3 minutes from what it is up there, because you 
had 8.
    [Video shown.]
    Mr. Matheson. Well, as I said, I wanted to give a brief 
clip just to show how I found out about the issue and show how 
compelling it is when you see Chloe and her mom, who were 
subjected to this.
    Dr. Sundlof, what I wanted to ask you, first of all, I 
first want to just confirm, are you aware of the cases of lead 
poisoning among children that have been traced to ceramic 
dishes?
    Dr. Sundlof. No, sir. The last one that we are aware of in 
which ceramic ware was involved, and we don't know if that was 
actually the cause of the increased blood lead levels in a 
child, was in 2004, and that was, I believe, in New York and 
there was a ceramic plate that was imported from France. That 
child did have elevated levels of lead in the blood but it is 
not clear as to whether the plate was the source or not. We do 
have standards. The FDA does have standards for lead in ceramic 
ware and we test at the borders for that.
    Mr. Matheson. What percentage of plates coming in do you 
test?
    Dr. Sundlof. I will ask Dr. Solomon for input.
    Dr. Solomon. We actually do several different tests. One is 
a quick swab test, because the issue with lead----
    Mr. Matheson. Just how many do you test though? I guess 
that is what I am interested in. I mean, I can't believe it is 
many of the plates coming in. Is it a small percentage that 
actually get tested?
    Dr. Solomon. We would have to get back to you for the 
record.
    Mr. Matheson. I understand there is a Memorandum of 
Understanding that the FDA has signed with the state 
administration of entry, exit, inspection and quarantine in 
China, and in that Memorandum of Understanding, you established 
a certification system that ceramic ware made in China that is 
imported to the United States would carry an inspection stamp. 
On the box it has a CCIB stamp for the Chinese organization. It 
also carries an FDA stamp. So when consumers go and buy these 
plates, and I have seen them in the stores in Utah, there is an 
FDA stamp on the box, but that stamp doesn't necessarily 
provide any information to the consumer about lead content. 
What protections does that stamp indicate to consumers when 
they see the stamp on a ceramic plate that is being sold in the 
United States?
    Dr. Sundlof. This may not be the authoritative answer and I 
will get back to you if it is not, but what I believe that 
means is, we have assurances from the Chinese government that 
ceramic ware that is exported to the United States will meet 
our standards for lead. That doesn't mean that they don't have 
any lead in them but they will meet the low levels of leachable 
lead that we have established.
    Mr. Matheson. See, what I think is, consumers, when they 
see an FDA label on a box, assume it is safe. That would be 
what I would assume. I think that is what most people would 
assume. And I think most consumers have no idea that lead 
exists in ceramic ware at all. Wouldn't it be more useful at 
least to have a label on the box that mentions that this 
product may contain lead? I mean, I have got a plate right 
here. I can't tell that it has lead but it has been tested. It 
has all kinds of lead in it. I have a plate right here that was 
sold by another company where they have stamped on it that it 
lead-free so you have some manufacturers that will tell you 
that they don't have lead in their product but both of these 
that came from overseas are going to have that FDA label on the 
box and that doesn't give me as a consumer much information at 
all. So it seems to me it might be helpful if we could maybe at 
least inform consumers that there is lead in the product. Would 
FDA be open to something like that?
    Dr. Sundlof. Well, the way that we--rather than declaring 
something to be lead-free, we have established levels at which 
we don't believe that there is any harm to public health, that 
the levels of lead are extremely low that leach from these 
ceramic utensils. One of the other things that--what we are 
concerned about is the lead that can actually leach out of the 
plates. Many of the glazes do contain lead but if they are 
fired correctly in the process of manufacturing these plates, 
then that lead should be sealed there into the plate and not be 
available for ingestion.
    Mr. Matheson. I am not here to argue about the level that 
is safe or not safe. I would suggest that in the testing that 
was done for hundreds of people in Utah, the levels were all 
over the map. Some of them were well in excess of FDA's 
standards. And secondly, we don't know if the glaze has been 
fired correctly, and as a consumer, I can't tell you if the 
glaze is right on this plate. I have no idea if the glaze has 
been fired correctly. As a consumer, until I saw this story on 
the news back in Utah, I didn't know there was lead in this.
    So Mr. Chairman, I am very anxious to see if there 
something we can do in this bill to make sure consumers are 
better informed about the possibility of lead being in these 
plates so they can make their own decisions about using this 
type of plate to microwave food, and I appreciate you working 
with the Committee on this and I appreciate your indulgence 
with the extra time for questioning. I yield back my time.
    Mr. Pallone. Thank you, and we will certainly follow up on 
your request.
    Next is the gentlewoman from North Carolina, Ms. Myrick for 
questions.
    Ms. Myrick. Thank you, Mr. Chairman.
    I just have one question, Doctor. What would you say is the 
most cost-effective way in broad terms to improve food safety 
in this country without dramatically increasing the price of 
food, which is already very high right now and moving up?
    Dr. Sundlof. Well, if I look at all of the legislative 
authorities that we have requested in the Food Protection Plan 
and Import Safety Action Plan, I believe that third-party 
certification, where we can multiply our inspectorate by the 
use of independent third parties is the most effective way to 
improve the safety.
    Mr. Pallone. Thank you.
    The gentlewoman from Oregon, Ms. Hooley, for questions.
    Ms. Hooley. Thank you, Mr. Chair. I have a question for Dr. 
Sundlof. Actually I have lots, but I am going to try to narrow 
this down.
    You mentioned in your testimony that FDA recently signed a 
Memorandum of Understanding concerning food safety and facility 
registration with China. Were you aware, and this may be 
happening in other States as well, that Oregon Department of 
Agriculture has been working for the last couple of years with 
China on food processing facility inspection protocols? What is 
your opinion of the role of States in food safety?
    Dr. Sundlof. I was not aware of that, and I don't have a 
position on that. We can get back to you on that.
    Ms. Hooley. OK. That would be helpful.
    Several years ago, I was very involved in passing country 
of origin food labeling that actually made it through the House 
and the Senate and signed by the President and yet it has 
really never taken place. The question is, is that ever going 
to happen, number one. And number two, as we look at food 
processing and in talking to at least some of my food 
processors in my district, they were talking about, there are 
examples where they may get garlic that is a mixture of garlic 
from several companies that they put into whatever food they 
are making or they may have a bad year for broccoli one place 
and so you get it someplace else the next year. What do you 
think, and how do you do this if you are going to label that 
can or put it on a Web site? I mean, whose Web site, what do 
they have to list? Is it the final manufacturing where it is 
put in the can or put in the containers or whatever they put it 
in? Is that going to work, first of all? And will the public 
have more assurance that that will in fact make our food safer?
    Dr. Sundlof. Again, the FDA did not ask for country of 
origin labeling. I believe the U.S. Department of Agriculture 
does have that authority as well as the Treasury, I believe. We 
do not. We didn't ask for it. As you indicated, there are 
complications in trying to do that with the many ingredients 
that may make up a food and the fact that those sources of 
ingredients can change overnight. We certainly, as I said 
earlier, do not want or believe it is in the best interest of 
the public to be viewing country of origin labeling as a way of 
determining whether or not a product is safe because those 
products need to meet the U.S. safety standards just as 
domestically produced food.
    Ms. Hooley. Thank you very much.
    Mr. Pallone. Thank you, and I think that concludes our 
questions. Thank you very much for your input, and in those 
cases where we asked for follow-up questions, if you could get 
back to us in writing as quickly as possible. Thank you again. 
Thank you both.
    Dr. Sundlof. Thank you, Mr. Chairman.
    Mr. Pallone. And I would ask the next panel to come 
forward. I want to welcome our second panel, and let me 
introduce each of you. Starting on my left is Mr. Michael 
Taylor, who is research professor of health policy for the 
Department of Health Policy of the School of Public Health and 
Health Services of George Washington University. Next is Mr. 
Michael Ambrosio, who is vice president for food safety and 
quality assurance of the Wakefern Food Corporation in Elizabeth 
in my home State of New Jersey. And then we have Mr. James 
Lovett, who is a corporate senior vice president of Covance 
Laboratories. This says based in Princeton, New Jersey, but I 
know you mentioned--oh, OK. I know you mentioned Wisconsin as 
well. And then we have our colleague, the Honorable Cal Dooley, 
a former Congressman and president and CEO of the Grocery 
Manufacturers Association. Good to see you again, Cal. And 
finally is Ms. Caroline Smith DeWaal, who is the food safety 
director for the Center for Science in the Public Interest, who 
has been working on these issues for many years. Good to see 
you as well.
    As I mentioned, we have 5-minute opening statements from 
each of the witnesses. Those statements will be made part of 
the hearing record. Each witness may in the discretion of the 
Committee submit additional brief and pertinent statements in 
writing for inclusion in the record, and I will start again on 
my left with Mr. Michael Taylor, who is recognized for 5 
minutes. Thank you.

 STATEMENT OF MICHAEL R. TAYLOR, RESEARCH PROFESSOR OF HEALTH 
 POLICY, DEPARTMENT OF HEALTH POLICY, SCHOOL OF PUBLIC HEALTH 
       AND HEALTH SERVICES, GEORGE WASHINGTON UNIVERSITY

    Mr. Taylor. Thank you very much, Mr. Chairman, Ranking 
Member Deal and members of the Committee. I appreciate the 
opportunity to testify today on the discussion draft of the 
Food and Drug Administration Globalization Act. Last year, as I 
think we have already heard this morning, the Government 
Accountability Office declared the Federal Government's food 
safety program at high risk of failure due to its outdated 
laws, fragmented structure, and inefficient use of resources. 
This came after a decade of recommendations from GAO and the 
National Academy of Sciences to modernize the system 
legislative and organizationally so that it can be effective in 
preventing food safety problems instead of simply reacting to 
problems after the fact.
    So Mr. Chairman, I applaud the subcommittee for tackling 
this critical issue and for focusing first on the obsolete food 
safety laws under which the Food and Drug Administration 
operates. FDA's legal tools for addressing foodborne illness 
and the safety of imported foods were enacted in 1938. They may 
have been suitable for their time but they focus more on 
reacting to problems rather than preventing them and they are 
plainly inadequate to deal with today's globalized food supply.
    As we embark on modernizing these laws, I urge the 
subcommittee to be clear first on the basic policy principles 
that should guide reform, and I think you will find good 
agreement among experts on the following five principles, and 
in fact, we have heard most of them embraced in varying ways 
already this morning.
    First, it is critically important to treat food safety as a 
farm-to-table systemwide problem. This simply recognizes that 
hazards can be created and minimized at many points across the 
food system. Second, we must make prevention of food safety 
problems the central focus of the system because this is the 
only way to protect public health and maintain public 
confidence. Third, we must recognize that the primary duty for 
prevention falls on the food industry, as we have heard this 
morning. It is the industry, not government, that produces 
food, and only the industry can make it safe. Fourth, we must 
focus FDA on setting and enforcing standards that make the food 
industry accountable for prevention. Ensuring accountability by 
setting and enforcing standards is the unique and most 
essential government role on food safety. Fifth and finally, we 
must strengthen FDA's mandate for providing national leadership 
and international leadership on food safety and bolster the 
agency's tools for managing a science- and risk-based 
regulatory program. This includes a stronger research mandate 
and working with State and local governments to build a 
nationally integrated food safety system that makes good use of 
all its resources.
    Now, I think that the discussion draft that is on the table 
for discussion today embraces most of these principles to 
varying degrees. First and foremost, the discussion draft is, I 
believe, on the fundamentally right track in mandating safety 
plans and preventive controls for all food facilities, domestic 
and foreign. Importantly, it also recognizes in order for food 
safety plans and preventive controls to be effective in 
improving food safety and enhancing public confidence, the 
plans must be linked to food safety outcomes in the form of 
performance standards set and enforced by FDA. To me, this 
coupling of preventive controls with objective measures of 
performance is the most essential element of meaningful food 
safety reform.
    The discussion draft also addresses the important issue of 
food safety at the farm level with what I think is a very 
judicious approach to establishing standards for fresh produce 
and it includes some innovative ideas for enhancing oversight 
of imported foods. Overall, I think the discussion draft is the 
right starting point.
    As outlined in my written testimony, however, I do have 
questions about some provisions, such as the proposal for 
certification of food facilities. While I see its potential 
value for imports if done by credible third parties, I think we 
have to focus first on strengthening the accountability of 
importers themselves for ensuring the safety of the food they 
import, and further, I do not think that FDA should be in the 
business of certifying food facilities.
    In moving forward with this legislation, I hope the 
subcommittee will also consider measures to strengthen food 
safety oversight at the retail level in collaboration with 
State and local agencies and to give FDA the research mandate 
and resources it needs to restore its scientific leadership on 
food safety. Mr. Chairman, restoring FDA's capacity for 
leadership is critical to food safety and to public confidence 
in food safety. We need to get FDA's food safety policies right 
and then we need to back them up with the resources to do the 
job.
    Thank you again for the opportunity to testify, and I look 
forward to questions.
    [The prepared statement of Mr. Taylor follows:]

                   Statement of Michael R. Taylor \*\
---------------------------------------------------------------------------

    \*\ Mr. Taylor is Research Professor of Health Policy at The George 
Washington University School of Public Health and Health Services and 
chair of the Food Safety Research Consortium. He served formerly as 
Administrator of USDA's Food Safety and Inspection Service (1994-96) 
and as Deputy Commissioner for Policy of the Food and Drug 
Administration (1991-94).
---------------------------------------------------------------------------
    Mr. Chairman, Mr. Deal, members of the subcommittee, I 
appreciate this opportunity to testify on the food and cosmetic 
provisions of the Chairman'sFood and Drug Administration 
Globalization Act'' discussion draft.

                              Introduction

    I applaud the subcommittee for tackling the modernization 
of our food safety laws. For over a decade, the Government 
Accountability Office (GAO) and expert committees of the 
National Academy of Sciences (NAS) have been documenting 
fundamental problems in the nation's food safety system--a 
system that has evolved over many years without a coherent plan 
or strategy and that now includes some 20 components of FDA, 
USDA, EPA, and CDC, and 3,000 state and local agencies.
    Among all these agencies, FDA has long been looked to as 
the natural focal point for food safety leadership in the 
United States and internationally. It oversees 80% of the U.S. 
food supply (including an even greater share of imported food) 
and is the steward of a long tradition of effective, science-
based regulation to protect public health.
    Unfortunately, FDA's current ability to provide food safety 
leadership, or even meet its basic food safety 
responsibilities, is badly constrained by:
     Obsolete statutes that date back to the 1930s and 
focus more on reacting to problems than preventing them;
     Inadequate resources that are dwindling in the 
face of an increasingly complex, global food supply; and an
     Internally fragmented and ineffectual 
organizational structure that makes FDA incapable today of 
providing effective food safety leadership.
    Certainly, FDA could be doing more with its present tools 
to address some of today's pressing food safety problems. I 
believe, however, that FDA will continue to fall short of what 
the public needs and expects from this critical public health 
institution until Congress provides a modern statutory mandate, 
an adequate and stable resource base, and an institutional 
structure capable of national and international leadership on 
food safety.
    And that is why it is so timely and important for this 
subcommittee to be focusing on how to improve FDA's food safety 
program. Getting food safety right at FDA is essential to the 
public's health, to the confidence people want to have in the 
food they feed themselves and their families, and to the 
economic success of the food system. The subcommittee's 
leadership will be essential to achieving these outcomes.
    In my testimony today, I will outline what I believe are 
the core policy elements of a successful strategy for improving 
food safety, and I will comment on how these elements are 
addressed in the discussion draft of the ``Food and Drug 
Administration Globalization Act of 2008'' released on April 18 
by Chairman Dingell. I will also touch on the need to provide 
FDA an adequate and stable funding base for its food safety 
program and to unify and elevate the organizational elements of 
the program so that FDA can once again provide food safety 
leadership, nationally and internationally.
    In general, I find the discussion draft to be very much on 
the right track. It recognizes that food safety is a farm-to-
table and global challenge and that FDA's program must be based 
not only on reacting to problems but on enforcing the duty of 
the food industry to prevent them. The draft legislation's core 
requirement that companies have food safety plans--and that the 
plans be based on the concept of preventive process control and 
be designed to satisfy government-established performance 
standards--is central to any meaningful modernization of the 
food safety system. The draft also contains innovative 
provisions to address the safety of imported food.
    I will offer some suggestions for improving these and other 
provisions of the draft, and I will note some additional 
legislative needs I recommend the subcommittee consider.

       Core Policy Elements of a Successful Food Safety Strategy

    The following are the five core policy elements that I 
consider essential to a successful FDA food safety strategy.
    1. Treat food safety as a farm-to-table, system-wide 
problem.
    For most of the 20th century, food safety regulators 
focused largely on basic sanitation in processing plants, 
chemical contaminants in food, and the safety of chemical 
additives. It was possible then for FDA to focus on a 
relatively narrow set of establishments, commodities, and 
decision processes through which those concerns could be 
addressed. Over the last twenty years, however, the problem of 
foodborne illness caused by microbial pathogens has emerged as 
a central food safety concern and one that requires a broader, 
``farm-to-table'' approach to ensuring food safety.
    A farm-to-table approach is required due to the simple 
reality that dangerous bacteria and other pathogens can enter 
the food chain at almost any point, from production on the farm 
through processing, retail sale, and final preparation for 
consumption; they can grow; and they can be killed. Thus, 
whether someone gets sick depends not on any one contamination 
event but on a wide range of events and behaviors that occur 
across the entire farm-to-table food system and that, in 
combination, determine the likelihood dangerous levels of an 
organism will be present at the point of consumption.
    This expanded understanding of food safety makes everyone--
from farmers to consumers, as well as government food safety 
agencies--actors in the food safety system. It creates the 
opportunity and need for integrated action to minimize food 
safety risks at points all across the farm-to-table system--
wherever pathogens can enter the food and grow or be reduced. 
FDA's food safety program must recognize and act on this 
reality, as recommended repeatedly by GAO and NAS.
    This broader understanding of the food safety challenge--
and the need to act in a comprehensive, integrated way to meet 
it--applies with full force to the growing volume of food 
imports.
    2. Make prevention of food safety problems the central 
focus of the system.
    Prevention is the core principle of public health and 
should be the central focus of the food safety system. 
Prevention of problems is certainly what consumers expect of 
the system, and it's the core principle that drives modern 
approaches to food safety. Most notably, HACCP (Hazard Analysis 
and Critical Control Points) is a system of preventive process 
control that was developed originally by the food industry as a 
method for anticipating and preventing food safety hazards in 
particular food production and processing operations.
    FDA has adopted HACCP as a regulatory requirement for 
seafood and juice, but prevention is not an explicit part of 
its statutory mandate. In fact, FDA's food safety legal 
authorities are designed primarily for reacting to and 
correcting problems after they occur, not for preventing them. 
In an on-going outbreak of foodborne illness, swift reaction 
and containment measures are important and can reduce the 
number of illnesses associated with that outbreak, but, to 
protect public health and meet public expectations for food 
safety, preventive measures such as HAACP need to be built in 
to the system so that the risk of food safety problems 
occurring in the first place is minimized to the greatest 
extent reasonably possible.
    FDA currently pursues prevention of this kind only on a 
selective and ad hoc basis. A comprehensive, systematic 
approach to prevention should be a core principle and central 
focus of the food safety system.
    3. Recognize that the primary duty for prevention falls on 
the food industry.
    This may be the most crucial point to emphasize in getting 
roles and relationships between government and industry right. 
The unavoidable reality is that government does not make food, 
and government cannot make it safe. That's the food industry's 
job, and making food safe--doing everything reasonably possible 
to prevent food safety problems--is the most fundamental duty 
food producers and processors owe to America's consumers.
    Many of our Nation's leading food processors and retailers 
take this duty very seriously, and they make extensive efforts 
to fulfill it. They know food safety doesn't just happen; it's 
the result of a plan. So they impose safety specifications on 
their suppliers to be sure their raw materials and ingredients 
are safe, they implement HACCP and other preventive control 
measures within their processing plants, and they test their 
finished products to verify that their control systems are 
working. In fact, over the years, much of the food safety 
innovation in the United States has come from companies that 
take food safety seriously and have plans for achieving it.
    The problem is that many of the nation's 44,000 food 
manufacturers and processors, 114,000 food retailers, and 
935,000 restaurants do not have effective food safety plans. 
And, at the farm level, systematic planning for prevention of 
food safety problems is in its relative infancy. This must 
change.
    Any business involved in producing, processing, and 
marketing food must have a plan for making it safe, based on 
modern preventive controls. This does not mean a one-size-fits-
all approach. It does not mean HACCP per se for every 
commercial participant in the food system. But it does mean 
that anyone producing food for today's marketplace should know 
how they are going to make it safe and should do that 
consistently, every day.
    4. Focus FDA on setting and enforcing standards that make 
the food industry accountable for prevention.While the food 
industry is inherently responsible for making food safe by 
acting preventively, FDA's job as a public health regulatory 
agency is to set and enforce standards that make the industry 
publicly accountable for prevention, in accordance with a 
defined standard of care. Setting standards for prevention 
means defining the responsibility of food producers, processors 
and retailers to have and implement food safety plans based on 
modern preventive controls. It also means establishing 
performance standards that define the level of protection, or 
food safety performance, that is to be achieved through 
preventive controls, such as the levels of chemical residues or 
microbial contaminants that are deemed acceptable.
    Standards protect food safety, however, only if companies 
comply with them, and it is FDA's job to ensure compliance 
through inspection and enforcement. For many leading companies, 
compliance is not an issue: if the government sets a food 
safety standard, they will organize their systems to comply. In 
fact, many will go beyond what the government requires in 
response to the demands of their customers expressed in the 
marketplace. The food industry is, however, highly diverse, 
with some companies lacking the market incentive or an internal 
culture that ensures they meet high food safety standards. 
That's why government standards and government enforcement are 
needed, and it's why they are in the interest of both consumers 
and those in the industry who take their food safety job 
seriously and do it well.
    Government regulation of food safety is essential, but it 
has to be smart regulation. We have learned that old fashioned 
``command and control'' regulation--in which the government 
specifies not only the outcome to be achieved but how industry 
must achieve it--can impose unnecessary costs and stifle 
innovation. Instead, modern regulation is clear in setting 
performance standards for companies and flexible in how 
companies can achieve the standard. Thus, as a regulatory tool, 
HAACP sets a standard of care for implementing preventive 
process control but is inherently flexible in allowing 
companies to tailor their preventive controls to the particular 
hazards and circumstances in their operations. Performance 
standards for microbial contamination say what level and 
incidence are acceptable, but they do not dictate the 
interventions needed to achieve them.
    In a food safety system based on holding the industry 
accountable for prevention, regulators have a duty not only to 
avoid stifling innovation but to affirmatively encourage it. 
This means among other things ensuring that regulatory review 
of new food safety technologies is done promptly and with an 
appreciation of the food safety benefits of technological 
innovation.
    5. Strengthen FDA's mandate and tools for providing 
national leadership on food safety and managing a science- and 
risk-based regulatory program.While FDA's core role on food 
safety is to set and enforce standards, it will be effective in 
this role only if it operates from a position of strength as 
the nation's leading science-based, public health regulatory 
agency. To this end, FDA should have a clear mandate to drive 
research aimed at understanding food safety problems and 
solutions and setting science-based standards. It should work 
closely with CDC, other federal food safety agencies, and state 
and local agencies to build an integrated, national system of 
food safety protection. And it should provide scientific and 
policy leadership to develop workable approaches to risk-based 
priority setting and resource allocation across the food safety 
system.

                    Comments on the Discussion Draft

    The five core policy elements outlined above reflect 
current thinking about the attributes of a modern, effective 
food safety system, as that thinking has evolved through the 
work of NAS, GAO and other experts. I will organize my major 
comments and suggestions concerning the discussion draft around 
these five elements.
    1. Treat food safety as a farm-to-table, system-wide 
problem.
    As I understand section 102 of the discussion draft, it 
would apply the requirements for a food safety plan and 
preventive controls to all facilities that process or store 
food for the U.S. market, whether domestic or foreign. It thus 
strengthens and modernizes standards for food safety in these 
critical facilities and recognizes, properly, that U.S. food 
safety standards should apply to imported food just as they do 
to domestically-produced food.
    The discussion draft also takes an important step in 
section 103 toward bringing agricultural producers more fully 
into the food safety system by making the food safety plan and 
preventive control requirements applicable to the production of 
fresh produce, subject to FDA being able to spell out how 
producers can comply for specific types of produce. I agree 
that, within FDA's jurisdiction, produce deserves the highest 
priority in setting standards for on-farm prevention of food 
safety problems. I also agree that the measured approach taken 
in the discussion draft is appropriate, given the wide range of 
large- and small-scale growers involved and the relative 
inexperience of many in this sector with preventive process 
control.
    My only suggestion with regard to the produce provisions of 
the discussion draft is to include a clear directive to FDA to 
prioritize the types of produce that are most in need of 
preventive controls to ensure food safety and to move forward 
promptly with the needed regulations. In addition to produce, 
FDA has jurisdiction over on-farm food safety practices for 
eggs and has proposed regulations that would require preventive 
measures for egg safety. FDA should be directed to finalize 
those regulations.
    The subcommittee should also take note of the fact that 
animal production practices can be an important risk factor for 
produce safety, as well as the safety of meat and poultry 
products. In the case of produce, failure to prevent access of 
animals to fields where crops are grown or to manage manure in 
a way that prevents water- or air-borne transmission of 
pathogens increases the risk of contamination with E. coli 
O157:H7 and other dangerous bacteria. USDA and FDA both have 
roles to play in addressing animal production practices that 
affect food safety, but USDA has no authority to regulate on 
the farm for food safety purposes, and FDA's mandate and 
authority in this area are at best murky. Congress thus needs 
to take a comprehensive look at how to improve the government's 
ability, working in collaboration with the agricultural 
community, to strengthen food safety practices on the farm.
    While the discussion draft addresses the on-farm and 
processing segments of the farm-to-table spectrum, it does not 
address the critical retail sector, which includes both 
restaurants and grocery stores. State and local agencies play 
the frontline role in setting and enforcing standards at the 
retail level, and there is a long history of collaboration 
between these agencies and FDA, through the FDA's Food Code and 
other efforts, to help ensure that state and local oversight 
reflects up-to-date science and is reasonably consistent 
nationally. This collaboration needs to be strengthened through 
training, technical assistance, and federal incentives for 
state and local agencies to adopt updated standards for retail 
food safety and implement them effectively.
    2. Make prevention of food safety problems the central 
focus of the system.
    The central strength of the discussion draft is that it 
would direct and empower FDA to implement a food safety system 
that is based on the public health principle of prevention. 
That is what the food safety plan and process control 
requirements in section 102 are all about, and I hope the 
subcommittee and Congress will adopt this essential reform.
    3. Recognize that the primary duty for prevention falls on 
the food industry.
    The discussion draft embraces the key principle that the 
primary duty for prevention rests with the food industry by 
requiring in section 102 that the operators of all facilities 
have food safety plans based on preventive controls.
    The draft also reflects the modern understanding of the key 
elements of preventive process control for food safety, which 
include hazard analysis, validation of the specific controls 
selected to address the hazards, monitoring and verification 
that the controls are working as intended, proper 
recordkeeping, and procedures for correcting problems when they 
do occur. It is important that, in codifying the food 
industry's prevention duty, Congress spell out these basic 
principles.
    As section 102 recognizes, in-process and end-of-process 
testing can be important tools for verification that preventive 
controls are working properly. The nature of the company 
testing that is appropriate and useful for this purpose will 
vary substantially, however, based on the nature of the food 
and process involved. I believe the role of testing as a 
process control verification tool deserves serious discussion, 
with the goal of fostering such testing by companies when it 
can contribute to food safety, while preserving the flexibility 
for companies to adopt testing approaches that make sense in 
their particular operations.
    Section 107 calls specifically for end-of-process testing 
of food shipments to ensure compliance with applicable food 
safety standards, with the approach to testing depending on 
whether facilities are certified or not under the discussion 
draft's certification provision in section 106. I interpret 
section 107 as being intended, at least in part, to provide 
incentives for facilities to seek and gain certification. I 
have some concerns and suggestions concerning the draft's 
approach to certification, which I will note below. I see a 
need for discussion, however, of how section 107 testing 
relates to testing conducted under a food safety plan. Among 
other things, care needs to be take to ensure that the nation's 
testing infrastructure is not swamped with testing--such as for 
baked bread, dry cereals, and low-acid canned foods--that may 
not contribute to food safety.
    4. Focus FDA on setting and enforcing standards that make 
the food industry accountable for prevention.
    From a public health and consumer protection perspective, 
food safety plans and preventive controls are valuable only to 
the extent they are designed and implemented to achieve 
acceptable food safety outcomes. Section 102 of the discussion 
draft adopts this principle in two critically important ways: 
(1) it explicitly directs FDA to examine food safety plans to 
ensure they meet ``relevant regulatory and food safety 
standards,'' and (2) it authorizes FDA to establish by 
regulation and to enforce performance standards that define for 
specific hazards the level of food safety performance a 
facility must meet. These are essential elements of the needed 
modernization of FDA's food safety legal authority.
    I have one suggestion with regard to FDA's role in setting 
standards. I recommend FDA be given an affirmative directive to 
identify the most significant hazards in the food supply, 
prioritize hazards with respect to the need for performance 
standards to prevent food safety problems, and to implement a 
program to systematically develop and adopt standards for the 
highest priority hazards. Without a mandate to set priorities 
and act preventively, the crisis-of-the-day reality in which 
FDA operates will keep it mired in reaction, rather than 
leading on prevention.
    While I think the discussion draft is basically sound in 
authorizing FDA to set standards, I have some concerns and 
suggestions about how the draft approaches FDA's ability to 
hold companies accountable for meeting the standards. And 
standards benefit food safety only to the extent compliance is 
achieved. I'll touch here on the basic enforcement mechanism 
for food safety plans, preventive controls, and performance 
standards; the role of civil penalties; and the proposed 
certification program.
    I see no enforcement provision in the discussion draft for 
the requirement that facilities have food safety plans based on 
preventive controls and that they meet hazard-specific 
performance standards. I assume this is a drafting oversight. I 
recommend that the legislation make it a prohibited act for a 
facility to fail to have a food safety plan that complies with 
the new requirement or to ship a product that fails to meet a 
hazard-specific performance standard. Products that fail to 
meet a hazard-specific standard should also be deemed 
adulterated.
    I support the availability of civil penalties as a tool for 
holding companies accountable for prevention. The prevention 
value of food safety plans and preventive controls depends on 
their being implemented successfully on a continuing, daily 
basis. This will happen only if a facility's managers have in 
place not only a satisfactory written plan but the systems to 
ensure the plan is implemented properly. Many companies need no 
incentive from government to have such systems, but many do. 
For the shift to prevention to work in practice and be credible 
to the public, FDA needs accountability tools that provide 
incentives for these companies to work in this new way.
    Under current law, FDA's most commonly used remedies for 
dealing with food safety problems are voluntary recalls and 
judicial seizure actions. In both cases, FDA is able to act 
only against the food itself, rather than the behavior that 
gave rise to the food safety problem. FDA can also seek court-
ordered injunctions to control future behavior and criminal 
penalties to punish past conduct, but pursuing these remedies 
is extremely cumbersome and costly.
    Civil penalties provide FDA an efficient remedy for 
situations in which companies have failed to act preventively 
by having and successfully implementing a proper food safety 
plan. A civil penalty provision should be crafted carefully to 
recognize that the implementation of a food safety plan is 
never perfect and that the success of a plan lies not in 
preventing every problem, but in minimizing problems as much as 
reasonably possible and responding well to contain problems 
when they do occur.
    I think the discussion draft's approach to certification of 
food facilities in section 106 deserves careful consideration 
and thought. I see the value of certification in the import 
situation as a way to bolster the assurance that products 
offered for import to the United States have been produced 
under conditions that meet U.S. standards. I think this can 
help compensate for the reality that the United States cannot 
possibly provide the same level of inspection and compliance 
oversight in foreign facilities that it can provide in U.S. 
facilities. I think it is even more fundamentally important, 
however, to clarify and strengthen the duty and accountability 
of U.S.-based importers for ensuring the food they import meets 
U.S. food safety standards.
    I also see the potential value of certification for 
domestic facilities as an element for FDA to consider in 
guiding the risk-based allocation of its inspectional 
resources, which I think is critical to the long-run 
effectiveness and efficiency of the federal food safety 
program.
    I have a number of specific concerns and suggestions about 
the certification proposal in the discussion draft, of which I 
will mention two here.
    First, certification should be done only by independent 
third parties, which, in the case of imports, could include 
foreign governments. I do not think FDA should be the 
certifying party. FDA should accredit certifiers, but not grant 
certifications itself.
    I base this view largely on my experience at USDA, where 
the granting of the government stamp of approval creates a 
commonality of interest between the agency and the company and 
erodes the independence and objectivity of the agency in 
assessing the company's future problems and behavior. I'm also 
concerned that, if FDA is put in the certification business, 
that will become a dominant focus of the agency's food safety 
managers, rather than setting and enforcing food safety 
standards. This is a particular concern because certifications 
are based on a snapshot in time, while the preventive approach 
to food safety depends on the continuing successful 
implementation of food safety plans and compliance with 
performance standards.
    Second, the discussion draft is not clear on how 
``compliance with applicable requirements'' is to be determined 
for purposes of granting certification. Is it sufficient to 
have an adequate written plan? Does the plan's successful 
implementation have to be demonstrated in practice over time? 
Does compliance with applicable performance standards have to 
be demonstrated?
    5. Strengthen FDA's mandate and tools for providing 
national leadership on food safety and managing a science- and 
risk-based regulatory program.
    The discussion draft directs FDA to conduct research on 
testing methods, with a priority to be accorded development of 
methods to detect intentional contamination. This is good as 
far as it goes, but, as outlined earlier, I recommend that FDA 
be given a broader mandate to drive problem-solving food safety 
research; build a more integrated, national food safety system; 
and provide system-wide leadership for risk-based priority 
setting and resource allocation, as called for by GAO and NAS.

                        Resources and Structure

    Beyond a modernized statute, the other key ingredients for 
FDA's future success on food safety are adequate and stable 
resources and a unified and elevated organizational structure.
    Provide FDA an Adequate and Stable Resource Base
    FDA's resources for food safety have been eroding for years 
as the agency's food safety challenge gets larger. Staffing 
levels are declining, and the total operating budget for FDA's 
Center for Food Safety and Applied Nutrition--the resources 
available to take action after the staff and rent are paid--is 
down to around $25 million, which is a paltry sum for an 
organization charged with driving food safety progress across 
80% of the American food supply, while also regulating dietary 
supplements and food labeling, ensuring the safety of infant 
formula and food additives, and attempting to provide food 
safety leadership internationally. An agency with all these 
responsibilities that can't conduct or commission research, 
adequately equip its staff, or travel simply can't do its job.
    FDA needs an adequate and stable resource base for its food 
safety program. The discussion draft addresses this need 
primarily through annual facility registration fees. This is, 
obviously, a controversial topic. I am one of many who believe 
that public health and regulatory programs of the government 
should, ideally, be financed through normal appropriations 
rather than fees. The primary value at stake here, however, is 
that FDA must have an adequate and stable funding base. If 
appropriated funds are not realistically going to meet this 
need, registration fees are probably the least objectionable 
alternative, because they spread the cost widely and do not 
involve a direct quid pro quo between FDA and the industry.
    Unify and Elevate the Organizational Elements of the FDA 
Food Safety Program
    The third key ingredient for the success of any agency--
after an appropriate statutory mandate and adequate resources--
is an organizational framework suitable for its purpose. For 
food safety, FDA needs a framework that enables it to provide 
national leadership on food safety and run a coherent, well-
planned program that makes the best use of available resources 
to improve food safety. For several reasons, FDA lacks such a 
framework.
    First, within FDA, the food program has historically taken 
a back seat to the drug and medical device programs in the 
competition for management attention and resources. This is due 
in part to the intense interest that drug and device companies, 
health professionals, and patients all have in FDA's 
``gatekeeper'' role for therapeutic products and is reflected 
in the fact that most FDA commissioners come from a biomedical 
or health care background. This strong tilt toward drugs and 
devices was exacerbated by the drug and device user fee laws, 
which have further focused FDA management attention, 
accountability, and resources on the therapeutic side of the 
agency. History has taught that the job of providing effective 
national leadership simultaneously on both therapeutic products 
and food safety is too big a job for any one person.
    Second, FDA's organizational structure for food safety is 
fragmented and lacks a clear focal point for leadership. CFSAN 
ostensibly has the lead on food safety at FDA, but CFSAN 
actually shares food safety jurisdiction with the Center for 
Veterinary Medicine, which regulates pet food and animal drug 
and feed additive residues in human food, and with the Office 
of Regulatory Affairs, which manages the majority of FDA's food 
safety resources through its field force of inspectors, 
compliance officers and laboratory personnel. The recent 
appointment in the Office of the Commissioner of an Associate 
Commissioner for Food Safety does not solve the problem. This 
position lacks budget or line authority for programs and thus 
in some ways further clouds responsibility and accountability 
for food safety within FDA.
    Finally, food safety leadership at FDA rests at least two 
bureaucratic layers removed from the Secretary of Health and 
Human Services. As decisionmaking in the executive branch 
continues to be centralized at higher and higher levels, with 
OMB having enormous influence on regulatory policy, the full 
time leader of the nation's premier food safety program needs 
to have the greater clout in the system that comes from being 
presidentially appointed and reporting directly to the 
Secretary.
    I recognize that these organizational issues are beyond the 
scope of the discussion draft and that solving them requires 
careful thought and planning, but I hope that the subcommittee 
will see the need to tackle them as part of a continuing effort 
to equip FDA to do its food safety job. In my view, the 
solution lies in unifying the food-related components of FDA 
into a single organization and elevating that organization 
within HHS under the leadership of a presidentially appointed 
official reporting directly to the Secretary.

                               Conclusion

    Thank you again, Mr. Chairman, for the opportunity to 
testify on these important issues. I look forward to answering 
your questions and the questions of your colleagues on the 
Committee. And I would be happy to discuss with your staff 
further details on the discussion draft.

                              Major Points

     The discussion draft is on the fundamentally right track 
in mandating food safety plans and preventive process controls 
for all food facilities, domestic and foreign.
     The establishment and enforcement of performance 
standards is a key element of prevention oriented reform, as 
contemplated by the discussion draft.
     The process for setting and enforcing performance 
standards needs to be strengthened, including the judicious use 
of civil penalties as an incentive for compliance.
     The application of the food safety plan and preventive 
controls requirement to fresh produce is a positive and 
important step toward a ``farm-to-table'' food safety system, 
but the legislation should also address improving oversight at 
the retail level.
     Certification can be useful to bolster confidence in 
imports and guide risk-based resource allocation of domestic 
inspection resources, but FDA should accredit certifying 
bodies, not grant certifications itself.
     To ensure FDA's success, Congress needs to address not 
only its legislative authority but also FDA's resources and 
organizational structure.
                              ----------                              

    Mr. Pallone. Thank you, Mr. Taylor.
    Mr. Ambrosio.

 STATEMENT OF MICHAEL AMBROSIO, VICE PRESIDENT OF FOOD SAFETY 
        AND QUALITY ASSURANCE, WAKEFERN FOOD CORPORATION

    Mr. Ambrosio. Chairman Pallone and members of the Health 
Subcommittee, I am honored to appear before you today to 
present our views and suggestions on the Food and Drug 
Administration Globalization Act and legislation. I am Mike 
Ambrosio, vice president of quality assurance, Wakefern Food 
Corporation, and have been in charge of food safety programs at 
Wakefern for the past 28 years.
    Founded in 1946, Wakefern Food Corporation has grown from a 
small, struggling cooperative into a strong regional player 
with significant operations in the New York metro area. 
Headquartered in Keasbey, New Jersey, Wakefern, along with 
ShopRite stores, has become one of New Jersey's largest 
employers with approximately 32,000 associates in New Jersey 
and 47,000 overall.
    In 2007, retail sales totaled $10 billion. Wakefern 
operates 2.5 million square feet of warehouses and logistical 
distribution centers supplying over 200 stores in New Jersey, 
New York, Pennsylvania, Delaware, Connecticut, Massachusetts, 
and Rhode Island.
    The Wakefern organization is the Nation's largest retailer-
owned non-farm cooperative in the United States and is 
comprised of 44 members who independent own and operate 
supermarkets under the ShopRite banner.
    Mr. Chairman, I applaud you, your ranking member and the 
subcommittee for your efforts to improve food safety. We too 
believe that improvements will best be achieved through a 
three-tiered program that emphasizes prevention, intervention, 
and response. This morning I will present several of Wakefern's 
recommendations for revising the bill, but I ask that my entire 
statement be included for the record.
    Media coverage of recent outbreaks, recalls, and food 
safety scares have contributed to a decline in consumer 
confidence and reveal new challenges for ensuring the food 
supply is safe in an ever-changing marketplace. I am pleased to 
note that in 2008 with the Federal Government and the private 
sector working together to improve food safety, consumer 
confidence has rebounded.
    Our retail industry trade association, the Food Marketing 
Institute, working with Wakefern and its other members, has 
outlined a number of retail industry food safety efforts and 
goals in a report being released today. Mr. Chairman, I would 
like to submit this paper, the FMI Food Safety Paper: the 
Supermarket Perspective, for the record.
    Enhancing the safety of the food supply requires the active 
effort and strong support of suppliers, food wholesalers, and 
retailers, as well as government. This includes our commitment 
to train our own people, our efforts to implement best food 
safety practices, and our outreach to consumers. It is a farm-
to-table challenge that needs a farm-to-table solution. It is 
both a domestic and an international problem we must address 
together.
    Wakefern is committed to working with the supply community 
to constantly improve the safety of the food they manufacture, 
process, and to this end participate in the Safe Quality Food 
program, SQF.
    Within the domestic retail setting, training store managers 
and workers in food safety is an important tool. Currently 
Wakefern makes extensive use of the SuperSafeMark program.
    The final link is the supply chain is the consumer. 
Wakefern has long provided consumers with practical, science-
based guidance on the safe food handling at home through the 
Partnership for Food Safety Education. Our customers expect the 
foods they purchase to be safe, whether it is store produced, 
manufactured, or farm grown.
    As retailers, we have an obligation to make sure we are 
sourcing from suppliers who have food safety plans in place. 
Accredited third-party certification companies are objective, 
independent bodies that are highly qualified to evaluate 
manufacturing facilities and to test, if warranted, that the 
supplier meets or exceeds all federally mandated food safety 
standards.
    One such program is SQF, which is managed by FMI and 
recognized by the Global Food Safety Initiative, which also 
recognizes several other certification programs. Wakefern uses 
SQF because SQF is a well-documented, validated food safety 
management system. We are pleased to see that your bill 
recognizes this concept but we would ask that you work with us 
to ensure that accredited third-party programs do not become a 
substitute for FDA inspection and regulation. These programs 
are best used to supplement and leverage FDA resources since 
FDA will never have sufficient resources to inspect every 
facility. In recognition of rigorous infrastructure currently 
in place, we encourage Congress and FDA to examine how other 
countries are using certification as part of the overall risk 
assessment plan.
    We believe that the FDA should be given the authority to 
mandate a recall in those cases where a company responsible for 
adulterated food does not act properly to recall a food. We 
also believe that suppliers should be required to give 
retailers immediate notification when a recall action is taken.
    In addition, there are several other initiatives we would 
like to support: global sourcing safety, rapid testing, safety 
standards for produce. Here again, as a retailer, Wakefern will 
be using SQF in a vigorous appeals process. There are several 
other food safety initiatives that Wakefern supports but were 
not included in your draft: traceback systems and designating a 
lead food safety agency.
    Mr. Chairman, there are also proposals in the legislation 
that Wakefern would not support and we have asked our industry 
trade association to examine more closely. These are 
registration fees, user fees, and country of origin labeling.
    Mr. Chairman, thank you for the opportunity to testify. I 
remain available to the subcommittee for further discussion and 
information should you need it.
    Mr. Pallone. Thank you, Mr. Ambrosio.
    Mr. Lovett.

  STATEMENT OF JAMES LOVETT, CORPORATE SENIOR VICE PRESIDENT, 
                      COVANCE LABORATORIES

    Mr. Lovett. Thank you, Mr. Chairman and members of the 
subcommittee. I am James Lovett of Covance, one of the world's 
largest and most comprehensive contract research organizations. 
Headquartered in Princeton, New Jersey, Covance has operations 
in more than 20 countries and more than 8,700 employees, two-
thirds of whom are in the United States. We conduct research 
and development for new medicines and provide laboratory 
testing services to food and other industries. One of my 
responsibilities at Covance is our food testing business. I 
thank you for inviting me to participate in this discussion on 
food safety. We strongly support the subcommittee's efforts to 
advance food safety in our country and we also support the 
third-party testing provision in the draft discussion bill.
    Covance is a full-service laboratory to the food industry 
offering comprehensive testing services. Our facility in 
Madison, Wisconsin, is one of the largest food testing 
laboratories in the world. Our lab routinely analyzes more than 
50,000 samples per month. It operates 24 hours a day, 7 days a 
week. It serves not just industry customers but also State and 
federal labs including the FDA. I would like to thank 
Congresswoman Baldwin for her support of our Madison facility, 
and she has actually toured our facility there, and I would 
also like to note that we operate food testing laboratories in 
Battle Creek, Michigan, and Singapore that have similar 
capabilities.
    Let me turn to the current status of food safety testing at 
the FDA. You know, the sheer volume, variety and complexity of 
FDA-regulated imports coming into this country is stunning. FDA 
agrees in its Food Protection Plan that ``increases in the 
volume and complexity of imported foods have taxed the limits 
of FDA's approach to handling imports.'' So FDA has recommended 
a new approach that includes the use of highly qualified third 
parties.
    We agree with the vision of the FDA and of this 
subcommittee about the potential contribution of third-party 
testing labs. This will provide several benefits. First is 
faster implementation. This country currently has significant 
private laboratory capacity capable of ramping up quickly to 
meet any new testing requirements desired by Congress and the 
FDA. Second is efficient use of limited resources, as we noted 
earlier. It is not necessary for FDA to dramatically increase 
its own laboratory testing capabilities. The capability exists 
already in the private sector, and we can quickly meet new 
requirements. Third is access to state-of-the-art testing 
facilities. Covance and many other qualified laboratories 
maintain highly trained staff and state-of-the-art equipment 
with a high level of automation, ensuring rapid and high-volume 
sample throughput. And then fourth is the ability of the FDA to 
maintain adequate oversight and control. FDA has worked 
effectively with Covance and other labs for many years on a 
variety of issues. Authorizing FDA to accredit third parties 
builds on the success but it should entail very strict 
accrediting requirements.
    Let us face it. It is essential that the American public 
have a high level of confidence in their food safety and the 
testing of their food. Food testing laboratories, whether 
private or public, should be held to high standards. We have 
some suggestions for appropriate accreditation standards for 
consideration.
    First is FDA Good Laboratory Practices, or GLPs. FDA 
already has published GLPs for third-party laboratories for 
many years. We are not starting from scratch with third-party 
lab standards. FDA should continue to use this highly reliable 
standard which is respected across the globe.
    Second is the International Standards Organization, as was 
noted earlier, the ISO 17025 standard. ISO standards generally 
are used in manufacturing and the chemical and petroleum 
industries and in food processing and other areas. Requiring 
ISO certification, together with the FDA GLP program, would 
help ensure stringent recordkeeping requirements.
    Third is AOAC International official methods. The majority 
of testing methods actually used today for food testing have 
been fully validated and standardized by AOAC International. 
AOAC provides validation services for testing methods and AOAC 
official methods are considered the gold standard of test 
methods around the world. FDA laboratories themselves use an 
AOAC method when it is available, as does Covance.
    So in conclusion, Covance applauds the Committee for 
including provisions of its draft bill authorizing the FDA to 
accredit third-party labs. We believe there is an appropriate 
role for independent third parties to improve the safety of our 
food supply and this use of third parties will also permit FDA 
to quickly and easily alter resource requirements based on 
changing needs and circumstances.
    So I thank you for the opportunity to testify and I would 
be pleased to answer any questions.
    [The prepared statement of Mr. Lovett follows:]

                       Statement of James Lovett

                              Introduction

    Mr. Chairman and members of the subcommittee, I am James 
Lovett, Corporate Senior Vice President for Covance Inc., one 
of the world's largest and most comprehensive contract research 
companies, with global operations in more than 20 countries, 
and more than 8,700 employees worldwide (approximately two-
thirds in the United States). Our company conducts research and 
development for pharmaceutical companies and provides 
laboratory testing services to the chemical, agrochemical, and 
food industries. I am responsible for Covance's food testing 
business. We are pleased to have been invited as part of this 
discussion on food safety, and look forward to working with the 
Committee as this process continues.

                       Overview of Covance's Work

    Covance is a full service laboratory to the food industry, 
offering comprehensive testing services for both food safety 
and food nutrition. The food testing organization originally 
grew from a research branch of the University of Wisconsin over 
75 years ago. This testing facility in Madison, Wisconsin, is 
now one of the largest food testing laboratories in the world. 
The total Covance campus in Madison covers nearly one million 
square feet of laboratories and employs almost 2,000 scientists 
and technicians, and food testing is an important part of our 
operation. In addition to the Madison laboratory, Covance 
operates food testing laboratories in Battle Creek, Michigan, 
and in Singapore.
    The food testing laboratory in Madison can routinely 
analyze over 50,000 samples per month. It operates 24 hours a 
day, seven days a week. It provides rapid accurate test data to 
industry customers, as well as state and federal government 
agencies. The food safety testing programs employed at Covance 
cover testing protocols for chemical contamination, 
microbiological contamination, pathogen detection, and 
detection of other deleterious contaminants. The testing 
profile includes detection of the contamination, identification 
of the chemical or microbe, quantification of the 
contamination, and confirmation of all positive test data. Our 
laboratories in Michigan and Singapore feature similar 
capabilities. Covance has provided food testing support to FDA 
for many years on a wide variety of projects.

              Current Status of Food Safety Testing at FDA

    FDA regulates roughly 80 percent of the U.S. food supply, 
which is $417 billion worth of domestic food and $49 billion in 
imported food annually. \1\ FDA has oversight of more than 
136,000 registered domestic food facilities. Approximately 
189,000 registered foreign facilities manufacture, process, 
pack, or hold food consumed by Americans.
---------------------------------------------------------------------------
    \1\ FDA Food Protection Plan, Nov. 2007, p. 6.
---------------------------------------------------------------------------
    FDA plays a critically important role in ensuring the 
safety and public confidence in the food we eat. Foodborne 
illnesses are caused by more than 200 different foodborne 
pathogens of which we are currently aware. These include 
viruses, bacteria, parasites, and toxins, plus a vast number of 
potential chemical contaminants and metals.
    FDA's Food Protection Plan outlines many of the factors 
complicating its mission of protecting the safety of the U.S. 
food supply. Changes in demographics, convenience trends, and 
consumption patterns are converging in a way that poses new 
challenges for ensuring the safety of the foods we eat. In 
addition, the sheer volume, variety, and complexity of the FDA-
regulated products arriving at U.S. ports makes it nearly 
impossible for FDA to adequately oversee compliance with food 
safety standards and FDA regulations. According to FDA's 
report, over 300 U.S. ports receive products from the more than 
150 countries and territories with whom the U.S. trades. \2\
---------------------------------------------------------------------------
    \2\ Id., p. 8.
---------------------------------------------------------------------------
    FDA concedes in its plan that ``increases in the volume and 
complexity of imported foods have taxed the limits of FDA's 
approach to handling imports.'' \3\ In response, FDA has 
recommended a new approach for addressing potential safety 
issues with imported foods, including increased intervention in 
the form of targeted, risk-based inspections and testing. FDA's 
plan supports the concept of accrediting highly qualified third 
parties to assist with this effort. FDA acknowledges it lacks 
the resources to adequately perform this function on its own. 
Furthermore, it understands that using qualified third parties 
will allow this new approach to be implemented more quickly and 
efficiently than by simply increasing FDA's infrastructure and 
staff resources.
---------------------------------------------------------------------------
    \3\ 3 Id., p. 8.
---------------------------------------------------------------------------
    Covance believes that FDA is doing the best it can with the 
resources it has. However, the reality is that less than 1 
percent of U.S. food imports are tested. This does not compare 
favorably to the 25 percent that is tested in Canada or the 
even higher percent that is tested in Japan. We believe a risk-
based plan, as suggested by the FDA, offers the best general 
approach to improving food safety without having to test every 
last article of imported food. However, even under a risk-based 
approach, our nation should clearly be testing much more food 
than it currently does.
    Even where good processes are believed to be in place to 
assure food safety, testing is the only way to be confident 
that those processes are actually working to produce and ship 
food that is safe for consumption by the American public. If 
you think about it, all food is tested--either in a laboratory 
before a human eats it or by the consumer at the actual time of 
consumption. We believe it is only prudent to have a robust 
testing program to ensure that the ultimate test--what happens 
when a human being eats the food--consistently results in a 
passing grade.

        Benefits of a Third Party System to the American Public

    Covance applauds the Committee for including within its 
draft bill a provision authorizing FDA to accredit third party 
laboratories. Authorizing FDA to accredit third parties to 
assist in the efforts to institute a more rigorous, risk-based 
approach to food safety testing will provide the following 
benefits:
    (1) Faster Implementation of New Food Safety Objectives
    (2) Efficient Use of Limited Government Resources
    (3) Access to State-of-the-Art Testing Facilities
    (4) Ability of FDA to Maintain Adequate Oversight and 
Control

    (1) Faster Implementation--This country currently has 
significant private laboratory capacity capable of quickly 
ramping up to meet any new testing requirements desired by 
Congress or FDA. There is no need for FDA to do this alone--
with longer timelines to ramp up and higher cost to the U.S. 
taxpayer--when capable private laboratories can help.
    (2) Efficient Use of Limited Resources--It's not necessary 
for FDA to dramatically increase its laboratory testing 
capabilities. This capacity currently exists in the private 
sector and we would be able quickly meet any new testing 
requirements.
    (3) Access to State-of-the-Art Testing Facilities--Covance 
and many other highly qualified laboratories maintain ``state 
of the art'' equipment providing a high level of automation, 
ensuring very rapid and high volume sample through put. These 
sophisticated instruments provide the very highest level of 
sensitivity and selectivity, allowing our laboratories to 
provide extremely sensitive and precise test results. Our 
highly trained staff is able to report results faster than most 
other laboratories, including those currently operated by FDA.
    (4) Ability of FDA to Maintain Adequate Oversight and 
Control--FDA has worked with independent laboratories for many 
years in the human and animal drug approval process, the new 
cosmetic approval process, and in the submission of new food 
additives. In our experience, this process has worked well. 
Expanding some of the existing relationships by providing FDA 
with authority to accredit third parties to expand food testing 
capacity would rightfully entail very strict accrediting 
requirements. Only laboratories able to demonstrate the ability 
to comply with very strict standards established by FDA should 
receive accreditation. FDA should conduct compliance audits to 
ensure all accredited laboratories maintain these high 
standards. By placing control within the FDA for accreditation 
on the front end, while providing auditing authority to ensure 
third party laboratories maintain the required standards, FDA 
will have the tools it needs to maintain adequate oversight of 
this new authority.

       How a Comprehensive Third Party Testing System Would Work

    For a typical food shipment that FDA has determined must 
receive testing at a port-of-entry, we believe the process 
might work as follows:
     When a food shipment arrives at a U.S. port, FDA or the 
importer would determine whether it should be subject to 
testing under FDA's new risk-based testing requirements. If a 
shipment is chosen for testing, the food would be sampled 
according to a strict sampling plan determined by FDA to arrive 
at a ``statistically'' valid sample. These samples could be 
taken by third party, independent sampling companies, several 
of which already exist.
     Samples would then be transferred to the third party 
laboratory--with the collected samples maintained under a 
``chain of custody'' while they are transported.
     Samples would arrive at the laboratory and be ``logged 
in'' to the laboratory data system. At the same time, FDA and 
the private food company would be notified of sample arrival 
and given an estimate for data completion. Within hours of 
sample receipt, the laboratory could initiate testing.
     When test data is complete, results would be 
simultaneously transmitted to FDA and the food company. If any 
data show a presumptive positive for a pathogen or poisonous 
chemical, an investigation would be initiated immediately to 
confirm these results. Once again, notification would be sent 
simultaneously to FDA and the food company.
     The testing company would conduct the investigation to 
confirm the test data and final reports would be issued to FDA 
and the food company.

          FDA Accreditation and Oversight of Third Party Labs

    It is essential that the American public have a high level 
of confidence in accredited third party laboratories. 
Therefore, I would like to expand upon the FDA accreditation 
requirements that will be critical to an effective and 
efficient third party testing program.
    The data produced by the independent laboratories will be 
used to make critical decisions about the quality of the U.S. 
food supply. Therefore, FDA must require rigorous standards and 
accreditation requirements for third party laboratories. We 
fully support the provisions in the draft FDA Globalization Act 
which provide for the Secretary to accredit laboratories, 
monitor laboratory performance and conduct annual audits. I 
will discuss some of the requirements we would expect FDA to 
include within its accreditation standards. FDA might include 
other requirements as well.

                     FDA Good Laboratory Practices

    In order to become a qualified third party testing 
laboratory, FDA must provide for laboratory accreditation and 
certification, and the laboratory must be able to produce 
acceptable data in the proficiency testing program. FDA should 
standardize the test methods being used so that comparable 
procedures would be used by all testing facilities. FDA already 
has published Good Laboratory Practices (FDA GLP) for third 
party laboratories and this protocol has been followed by a 
multitude of laboratories in their data submission to FDA for 
many years. FDA should continue to use this highly reliable 
standard, which is respected across the globe.

       International Standards Organization (ISO) 17025 Standard

    Another standard FDA might require as part of the 
accreditation process is ISO--the International Standards 
Organization--a European-based organization with a mission to 
standardize practices in a number of industries. ISO standards 
are used in manufacturing, in the chemical and petroleum 
industries, and in food processing. ISO's published test 
methods are often similar to AOAC, which I will discuss in a 
moment. In particular, the ISO 17025 standard was developed for 
laboratories and requires comprehensive documentation of 
laboratory activities in the form of Standard Operation 
Procedures (SOP). The standard also requires a Quality Manual 
that describes overall business conduct. Companies are required 
to submit to an inspection for this accreditation, and must 
demonstrate acceptable testing performance in the form of an 
external sample evaluation program. Although not as 
comprehensive as the FDA GLP program, ISO 17025 is very 
effective in ensuring a laboratory keeps good records. 
Requiring ISO certification, together with the FDA GLP program, 
would be very effective in ensuring stringent recordkeeping 
requirements and the high standards for the measurement of the 
data quality.

                  AOAC International Official Methods

    The majority of the testing methods currently used today 
have been fully validated and standardized by AOAC 
International and these methods would provide a uniform 
framework for the industry. Founded in 1884, AOAC provides 
validation services for testing methods including laboratory 
evaluation, proficiency testing, and validation of test methods 
which are globally recognized. AOAC Official Methods are 
considered the ``gold standard'' of test methods around the 
world, and are recognized by regulatory agencies and courts of 
law. FDA laboratories themselves use an AOAC method when it is 
available, and these standards are already used extensively in 
the food and dietary supplement industries. This aligns the FDA 
and third party laboratories very well. We recommend FDA 
require use of AOAC methods whenever they are available. FDA 
might also be encouraged to establish priorities for 
development of additional AOAC methods to meet new testing 
needs as they are identified.

                           Sampling Protocol

    The draft bill indicated that the sampling and testing for 
a non-certified food company will be handled by an accredited 
testing laboratory. Currently a number of different models 
exist for conducting sampling. In order to ensure the efficacy 
of the test results, it is important that the sampling protocol 
be uniform and clearly established.

                               Conclusion

    In conclusion, Covance applauds the Committee for including 
provisions in its draft bill authorizing FDA to accredit third 
party laboratories. We believe there is an appropriate role for 
independent third party laboratories in improving the safety of 
the U.S. food supply. Proper oversight by FDA will guard 
against any perceived conflicts of interest. Use of third 
parties will also permit FDA to more quickly and easily alter 
resource requirements based upon changing circumstances and 
needs. Other benefits as discussed above include the following:
    (1) Faster Implementation of New Food Safety Objectives
    (2) Efficient Use of Limited Resources
    (3) Access To State-of-the-Art Testing Facilities
    (4) Ability of FDA to Maintain Adequate Oversight and 
Control
    I hope my testimony will prove useful as the Committee 
considers measures to enhance FDA's food safety testing 
capabilities. Thank you for the opportunity to testify and I 
would be pleased to answer any questions the Committee may 
have.
                              ----------                              

    Mr. Pallone. Thank you, Mr. Lovett.
    Congressman Dooley.

    STATEMENT OF CALVIN DOOLEY, PRESIDENT AND CEO, GROCERY 
                   MANUFACTURERS ASSOCIATION

    Mr. Dooley. Well, thank you, and I am delighted to be 
joining all of you today and I am testifying on behalf of the 
Grocery Manufacturers Association, the National Fisheries 
Institute, the Snack Food Association, the American Frozen Food 
Institute, and the American Bakers Association. We are all 
committed in representing our members to be partners with you 
and others to ensure that we can advance reforms that will 
enhance the safety of our food supply.
    In particular, as we move forward with considering what 
should be included in reforms, we have several measures.
    One, we urge you to give FDA the power to establish safety 
standards for fruits and vegetables. Two, we urge you to 
require that every food company has a food safety plan that is 
based upon food safety risk analysis, that documents 
appropriate food safety controls, and that is available for FDA 
to review. Three, we urge you to require every food importer to 
police their foreign suppliers and document for FDA review 
their food safety controls. And four, we urge you to give FDA 
new powers to address bad actors who have declined to recall 
contaminated food products posing a risk of severe health 
consequences. We are pleased that a bipartisan piece of 
legislation embodying these components was introduced just 
yesterday by Congressman Costa and Congressman Putnam.
    When we turn to the issue of the provisions that are in the 
discussion draft bill, we think there are many in there that 
are constructive but we do have some serious concerns about 
others. We have strong objections to the registration fees, the 
import fees, and other fees that will essentially result in $1 
billion in taxes on food products which will show up in 
increased costs at the grocery store shelves. You put this on 
top of the energy legislation that was passed by this committee 
that is also diverting 25 percent of our corn crop from food to 
fuel, you are further compounding the rapid escalation in food 
prices that we have never seen in recent times.
    We are also very concerned about some of the prescriptive 
and regulatory approaches that would allow FDA inspectors to 
second-guess food safety decisions from many of our member 
companies that are really embodying the latest in technology 
and science to ensure that they have the most effective systems 
in place. What you would be effectively doing would be 
something that is analogous to asking the DMV inspector to be 
questioning whether or not the engineer that was designing the 
brakes for the Ford auto were the best. This is not the route 
that we should be doing down.
    And when we come to the issue of the third-party 
certification, I think we have to be very concerned about 
basically having FDA give the authority and the power of 
effectively a government agency to pass judgment on whether or 
not suppliers or manufacturers are in compliance with FDA 
regulations. Again, if you turn this around, what we are going 
to be effectively doing is saying to any producer of food or an 
ingredient product, regardless of where they are in the world, 
could be France, could be Canada, could be Somalia, is that we 
are going to require them to be certified by a third-party 
entity that we have supposedly sanctioned to pass judgment on 
whether or not they are complying with our defined set of 
regulations and rules. What are we to expect is going to be the 
response to this? Do you not expect that Canada, that France, 
that the U.K., that China, that Japan will also put in place 
similar protocols that would require every exporter of a food 
product in this country to be accredited or certified by a 
group that they have sanctioned? I really ask the Committee to 
give serious consideration about going down a path that will 
inevitably invite a response that will have great harm on our 
ability to access international markets, which are so important 
to our industry.
    The food industry is willing, though, to accept that there 
are some needs for reform to ensure that we are allowing FDA to 
have the appropriate enforcement provisions when you have an 
instance of a need for a mandatory recall. You know, we support 
some of the provisions that include this for when you have a 
Class I need for a recall.
    The other provision I would like to touch on in closing is 
the provision that would allow for a $500,000 civil penalty to 
be assessed on a daily basis. Right now, what happens when you 
have a potential food safety problem that is occurring, is that 
there is a very collaborative interaction between the 
manufacturer and FDA and CDC, the Centers for Disease Control. 
If you put in place a threat of a $500,000 civil penalty, you 
are going to really undermine that collaboration, that 
discussion that really leads to the most efficient and quickest 
determination of what products pose a risk and getting them out 
of the market as quickly as possible. Our member companies do 
not need a threat of a civil penalty to ensure that they are 
deploying the best practices, and I would ask the Committee to 
give serious considerations whether or not that would in fact 
be an effective reform to enhance the safety of our food 
products.
    [The prepared statement of Mr. Dooley follows:]
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    Mr. Pallone. Thank you.
    Ms. DeWaal.

   STATEMENT OF CAROLINE SMITH DEWAAL, FOOD SAFETY DIRECTOR, 
           CENTER FOR SCIENCE IN THE PUBLIC INTEREST

    Ms. DeWaal. Thank you so much, Chairman Pallone, and on 
behalf of our over 900,000 consumer members of the Center for 
Science in the Public Interest, I want to thank you for your 
leadership on food safety, and Representative Deal, 
Representative Barton, Representative Dingell, the many members 
of this committee who have worked long and hard on this issue 
in the last 2 years.
    The impact of foodborne disease has been fully described in 
hearings already before this subcommittee, and with this 
hearing I see that your committee is really starting the job of 
solving the problems in our food safety system. But let us not 
forget the victims, some of whom have testified before this 
committee, victims like Ashley Armstrong, who at 3 years of age 
suffered acute kidney failure and months of dialysis after 
eating E. coli-tainted spinach. Her cost, the costs of her 
family were unspeakable. Hundreds of thousands of dollars in 
medical costs. Her parents spent months in the hospital. Or 
Mora Marshall, who at 86 years of age was hospitalized and will 
spend the rest of her life in nursing care from eating 
salmonella-tainted peanut butter. As the Committee moves 
forward to consider this legislation, these are a few of the 
victims I hope you remember and the illnesses that we must 
prevent as you search for ways to empower the FDA with the 
resources and the authority that it so sorely lacks today.
    It seems like every week another food warning sends 
consumers to their pantries to look for the source of a melon 
or the production code on a recently recalled can or jar of 
food. Food outbreaks and recalls in recent years have caused a 
dramatic loss in consumer confidence and many, many costs to 
the food industry as well.
    CSPI has long advocated that Congress take this step of 
creating a modern food safety system, and we believe after 
analyzing 16 years of outbreak data that this system we are 
operating under, and the proof is in the last few years, is 
fundamentally flawed. We need a new system. We have supported a 
unified food agency. We have brought forward many concepts and 
ideas to this committee and others but it is critically 
important that the new system be based on public health.
    While the FDA Globalization Act does not contain sweeping 
reform of the nature that we have proposed in the past, 
nonetheless, the improvements that it proposes are essential to 
address the gaps and weaknesses in FDA's current food safety 
programs. It builds upon the improvements of the Bioterrorism 
Act of 2002 but adds a fundamental new structure to FDA's food 
safety program. It contains numerous improvements. I will just 
mention a few: written process control plans utilizing 
performance standards that create a food safety foundation that 
has not before existed at FDA. It also contains a voluntary 
certification program for imported foods but one that has 
strong incentives to encourage food companies to seek 
certification and that is modeled on programs already in place 
in the retail sector and it also has important new enforcement 
authorities, things like mandatory recall and civil penalties 
that the FDA needs to do its job.
    In the spirit of the draft discussion, CSPI has offered a 
number of suggestions, the most important of which is the 
recommendation that you increase the inspection frequency in 
the bill. The inspection frequencies you have right now of 2 
years and 4 years are really not good enough and we would like 
to see those inspection frequencies increased to ensure that 
the food companies really know they have to comply.
    The FDA Globalization Act, though, really takes many ideas 
from many stakeholders, people like the Grocery Manufacturers 
of America, who put out their own plan; CSPI, who put out a 
white paper in the fall; and the Food and Drug Administration's 
``Food Protection Plans.'' It really very successfully weaves 
many of these ideas together.
    This hearing really demonstrates that there is widespread 
agreement among these entities and also the Committee here on 
the need to improve FDA's oversight of imports, their 
inspection capability and their enforcement tools. While each 
stakeholder may differ on the particulars, the FDA 
Globalization Act offers an unprecedented opportunity for 
Congress to pass strong food safety legislation that in fact 
represents the best ideas for improving the current system. 
Thank you.
    [The prepared statement of Ms. DeWaal follows:]
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    Mr. Pallone. Thank you, and I want to thank all the panel. 
We will start with questions and I will recognize myself 
initially for 5 minutes. I am trying to get one question in for 
Mr. Taylor and then one for Mr. Ambrosio.
    Mr. Taylor, you mentioned the need to strengthen the 
performance standards section in the discussion draft. We have 
gotten some questions on this provision in particular as there 
appears to be confusion as to what performance standards are 
and what they should be. Some even feel that it would be 
impossible to create performance standards for all foods and 
would like us to focus only on the top 10 contaminants and 
those most risky products. In your professional opinion, what 
should we be aiming for as we expand the performance standards 
section of the bill?
    Mr. Taylor. I think this is a really important question to 
ask and I think Cal Dooley's comments sort of pose the issue. I 
think I completely agree with Cal that what we are not talking 
about is standards where the government is going in and telling 
companies how to produce safe food and how to design the brakes 
in the car. That is the old-fashioned command and control 
approach to regulation, which is a failure. I ran the food 
safety agency as USDA which is based on that principle and I 
have seen it not working very well. When I use the term 
performance standards, I am referring to standards that address 
the outcome that is to be achieved. We have these in the 
current system today. We have pesticide tolerances, for 
example, that set a quantitative limit on the amount of a 
residue that can be present in food and companies then work to 
meet that outcome. They are not told how to do it. They work to 
achieve it. We also have standards with respect to microbial 
pathogens, which is what I think we are really focusing on here 
today and of course the recent work that FDA has done on 
Listeria trying to find a health-based level of Listeria that 
protects public health and that the companies can then work to 
meet that what I refer to as a food safety outcome that is an 
acceptable level of contamination so it is not about mandating 
how they do it, it is ensuring on behalf of the public that 
these food safety plans are actually designed to achieve an 
outcome that is acceptable to the public. The modern approach 
to regulation is performance standards, not command and control 
mandatory standards.
    I would also emphasize that there are many, many hazards in 
the food supply. I strongly believe that FDA ought to be 
directed to take a risk-based approach to focus on the most 
significant hazards in terms of impact on public health and 
figure out what are the selected commodity and pathogen-
specific hazards for which a new performance standard can 
actually help drive progress on food safety so it should be 
targeted and it should be done in a way that is not prescribing 
how the industry does it but defines on behalf of the public 
what is an acceptable outcome in these high-priority cases.
    Mr. Pallone. Thank you.
    Mr. Ambrosio, I would like to follow up on your comments on 
the concept of certification since your views on the matter 
seem to be different from Mr. Dooley's. My understanding is 
that many retailers including most of the largest like Wakefern 
but also Wegman's, Safeway, Giant, already now ask their 
suppliers to be certified for safety by a third-party entity. 
In fact, that under one particular certification system already 
being used by major retailers, 30,000 facilities were certified 
last year alone. Is it your sense that that is where the food 
industry is heading? Is it your view that certification can 
play an important role in helping to augment FDA oversight?
    Mr. Ambrosio. Thank you. Certification can play an 
important and vital role in this. The SQF model, which is 
recognized by the Global Food Safety Initiative, is an 
international standard that parallels with the British Retail 
Consortium and the IFS. When you look at it, it is really, 
without getting too technical, and I can give you information 
with regard to the technicality of the program, but it truly is 
an enhanced HACCP program when you look at it. There are a lot 
of good things that manufacturers do, but in this particular 
case, when you look at a certification body that oversees what 
processes are being performed at those manufacturing 
facilities, it truly gives you a sense that there is a good 
management system that is put in place. It really is walking 
the walk and talking the talk. I mean, essentially when you go 
in there, it is the manufacturing facility that develops these 
plans and they live by it. It has been proven, it is worldwide, 
it has been globally recognized for several years now. It 
started when the Alar situation happened on the West Coast. So 
when you look at it from a global perspective, it is 
recognized. It parallels Dutch HACCP. It parallels many other 
global food safety initiatives that are out there and it is 
recognized.
    Mr. Pallone. Well, you mentioned this particular one, the 
Safe Quality Food program. Do you want to just elaborate a 
little more on how that operates with you?
    Mr. Ambrosio. Well, SQF is a FMI-managed program and 
essentially it is what I had said, it is a managed program. It 
is a really enhanced way of looking at things. They look at it 
from the grower's level, if you want to look at produce, for 
that matter, and then they take it all the way to the 
processing end. There are different levels of SQF where you get 
into SQF 1000 and 2000 and both address the needs of what you 
are actually looking at. It is pretty much tailored to the 
specific discipline of the operation, so if you are looking at 
a manufacturer, there are disciplines within the body of that 
program that address that. If you are looking at a farmer, it 
gives you those disciplines with regards to the growing 
conditions, and if you are processing spinach, as we had the 
incident back in 2006, you will see that that will go right 
into the processing facility in which the spinach is 
manufactured.
    Mr. Pallone. OK. Thanks a lot.
    Mr. Deal.
    Mr. Deal. Thank you.
    Dr. Sundlof testified that he thought FDA should be given 
the authority to promulgate regulations to prevent intentional 
adulteration of food by terrorists or criminals. Do any of you 
oppose FDA being given that authority? I see no opposition.
    He also testified that FDA should have the authority to 
require that food facilities register with the FDA every 2 
years. Do any of you oppose giving that authority statutorily? 
I see none.
    He also testified that FDA cannot deny entry into the 
country of a food produced in a foreign facility where the 
facility operators hampered or denied FDA's ability to inspect 
that facility. He asked that we change the law to allow FDA to 
deny entry of foods produced in that facility. Do any of you 
oppose us changing the law in that regard? Yes, Ms. DeWaal?
    Ms. DeWaal. Mr. Deal, my apologies. Your second question 
slid by me. We actually support annual registration.
    Mr. Deal. So the 2 years is not often enough?
    Ms. DeWaal. Yes, but more to the point, all of these 
elements are--they are not opposed but they are not enough. 
They will not solve the problems we have seen with spinach, 
with peanut butter, with imported pet food and food 
ingredients. They will not solve those problems alone. But I 
don't oppose them per se.
    Mr. Deal. The foreign facility, I assume everybody would 
generally agree that if they have denied or hampered FDA's 
authority to inspect, that we should at least give FDA the 
authority to deny products from those facilities coming in. 
Anybody opposed to that proposal? OK.
    He also requested in his testimony that FDA have the 
authority to order a mandatory recall in the event that a 
company does not conduct its own voluntary recall, and I think 
the indication is that we haven't had that situation develop 
yet. Would any of you--and that that authority in FDA be non-
delegable below the Commissioner of FDA level. Would you all 
generally support that proposition? I believe I see agreement 
on that.
    OK. Let me move to some of the other issues that we maybe 
don't have quite as much agreement on. You know, I referenced 
PDUFA reauthorization in my opening statement, and when we have 
been dealing with user fees in the past, user fees have 
generally been considered to have benefit for the people who 
are paying the fees. In the case of pharmaceuticals, to speed 
up the process of the FDA review so presumably their product 
could get to market quicker. What benefit to the payor of these 
fees do you see in the proposal here? OK. Sort of what I 
thought. Let me ask you--oh, yes. OK. Yes, ma'am?
    Ms. DeWaal. I think one of the issues of cost that has to 
be looked at is the price of not having a program, and not 
having a program today, an effective food safety program, 
actually costs consumers not to mention the cost to the victims 
of these outbreaks, which can be quite large, but even if you 
have a mild case of illness and you are out of work for 2 days, 
that costs you, your employer. So there are significant 
societal costs here. In addition though, the industry itself 
has faced significant costs from the failure and lack of a 
system. The spinach industry has faced, I think in liability 
costs alone, it is $100 million, which is what Mr. Dooley and I 
have been lobbying for as a minimum of what FDA needs next year 
to do its job for food safety. So the liability costs, the 
costs to the industry here are huge--business interruption, 
which occurred for the entire spinach industry. So the fee 
issues are not--nobody likes them but we need systems in place 
that are effective as soon as possible.
    Mr. Deal. Well, I think all of us would agree that we would 
like to avoid these kind of bad situations developing. If any 
of us had confidence that we could write a statute that would 
do that, certainly we would do it. I don't think anybody thinks 
we have the ability to do that.
    Mr. Dooley?
    Mr. Dooley. Yes, if I can just respond, is that GMA and the 
related associations which I identified prior to my testimony, 
totally oppose the user fees that are currently being proposed 
or most of them that are being proposed in the draft. We would 
support perhaps a user fee that would be associated with an 
export certificate because that does provide a proprietary 
benefit. But again, when we look at this whole issue of public 
safety, this should be a public charge, much as your public 
safety on your streets and your communities of your 
neighborhoods, and that if you move down the path of charging a 
fee from the people who you are inspecting, you also have the 
potential to undermine the credibility and the integrity of 
this inspection service by having those who are being inspected 
basically funding it.
    Mr. Deal. And as you know, that is one of the concerns that 
we have had of becoming so dependent on those fees for what is 
supposed to be an objective analysis.
    Thank you all, and my time is expired.
    Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Mr. Deal.
    The gentlewoman from Wisconsin, Ms. Baldwin.
    Ms. Baldwin. Thank you, Mr. Chairman. I have been focusing 
a lot in opening statements and previous questioning on the 
discussion draft's third-party testing provision. I am going to 
continue to do that with just a couple of quick questions for 
Mr. Lovett.
    The discussion draft contemplates additional food testing 
over what is currently occurring, and I am wondering, looking 
forward to ultimate passage of a bill, implementation of a 
bill, what proportion of additional testing would you see 
third-party laboratories taking on versus FDA itself?
    Mr. Lovett. Thank you for your question, Congresswoman 
Baldwin. I think that third-party labs can take on substantial 
testing. It is not that there are a lot of empty labs sitting 
out there, just ready to start running tomorrow because 
obviously, our free enterprise system doesn't work that way. 
But companies like ourselves can ramp up laboratories very 
quickly. Just last year the Singapore laboratory that I 
mentioned, we took an empty building and 6 months later had an 
ISO 17025 certified laboratory running testing on food, and so, 
this is ramp-up that can happen very quickly and I think that 
in the absence of very substantial appropriations to allow the 
FDA to build the large number of labs that I think will 
ultimately be needed, the private sector can really make a big 
contribution here.
    Ms. Baldwin. You mentioned in your testimony that currently 
your company, Covance, works with the FDA, government at the 
federal level, State level, and private entities. Can you talk 
a little bit about the current partnership you have with FDA 
and then also explain to me how would the testing done by your 
company or a third party compare to the type of testing that is 
currently done by the FDA? Is it similar or is it different? 
Please elaborate.
    Mr. Lovett. Yes. Thank you again. I will take the second 
question first, if you don't mind. I think the testing is 
actually quite similar. You know, we both run AOAC methods when 
that is feasible or when they are available, and we run similar 
methods on other occasions. So I think the testing between a 
good government lab and a good private lab is basically the 
same.
    In terms of work we have done with the FDA, it has been 
myriad work over the years on a multiple of occasions. Often it 
is something where, for example, in the case of ephedra, when 
that first became a safety concern several years ago, there 
wasn't a good method to identify ephedra in food and it was 
actually Covance that was retained by the FDA to develop a 
liquid crystal mass spectrometer analysis--I am a lawyer, not a 
chemist--to identify ephedra in both supplements and food. 
These were then fully validated by the AOAC and the FDA and 
they were used together with data that we generated through our 
own testing to ultimately ban dietary supplements containing 
ephedra. Another example is acrylamide. When that became a 
concern, we were contracted by the FDA to conduct a large 
market basket survey to identify how much acrylamide there 
actually was in a whole series of different kinds of foods, and 
I think that is a good example where we were able to ramp up 
very quickly to do what was a very large volume of testing on 
short notice that would have been difficult for an existing 
government lab that is already very busy to take on.
    Ms. Baldwin. Thank you.
    Mr. Lovett. Thank you.
    Mr. Pallone. The gentleman from Pennsylvania, Mr. Pitts.
    Mr. Pitts. Thank you, Mr. Chairman.
    Mr. Dooley or anyone else who would like to respond, given 
all the new requirements, the import choke points, testing of 
every single import, what could we expect to happen to the 
price of food if this bill passes?
    Mr. Dooley. Well, inevitably there would be an increase in 
the cost or the price of production that would inevitably be 
passed on to consumers so you would see an increase, but it is 
hard to quantify just what the magnitude of that would be. We 
can quantify what the magnitude of the fees would be. I mean, 
you have in the legislation with the registration fees, that is 
$600 million. If you look at the $10,000 per importer fee, what 
does that mean to Mr. Ambrosio's stores that he has. If they 
are importing directly, maybe it is wine from France or cheese 
from Europe or someplace, are they going to be liable for a 
$10,000 fee, or that little boutique store that you might have 
on Main Street that is an importer directly, are they also 
going to be $10,000? We look at that as being another magnitude 
that could be as much as $400 million on top of that. And then 
if you go into the regulatory side of it, that inevitably is 
going to increase some prices. But the one thing I want to 
clarify is, is that there is a lot of our companies today are 
doing--have in place the best practices, and when it comes to 
the audit, what we are concerned with is, we have a proposal 
that would say that every private sector company that has a set 
of preventive controls in place and if you are importing you 
have a supplier quality assurance plan, that plan will 
inevitably include a third-party probably certification or 
audit. But that is going to be a private contractual 
arrangement that they will have with their supplier. Why we are 
so concerned and what we think will add additional costs here, 
if you have FDA sanctioning one audit that might be out there, 
is that you can create a restriction in the marketplace which 
will drive up the costs of audits that will also be passed on 
to that consumer, and you also have the threat of again 
imposing these on other countries and their companies that are 
manufacturing that they are going to have a new cost there that 
they are going to respond. And so I think we have to be very 
careful about going down this path of this certifying these 
third-party auditors.
    Mr. Pitts. Now, you mentioned ethanol, the ethanol mandate 
for gasoline has dramatically increased the cost of food. Can 
we estimate the increase in the cost of food for this bill in 
conjunction with the ethanol mandate?
    Mr. Dooley. You know, we haven't done the complete analysis 
on that. We have currently retained an economist that is doing 
some modeling to get some more precise figures in terms of the 
increased cost of food that is associated with the ethanol 
mandate. On this provision we haven't done that work yet.
    Mr. Pitts. Can you provide the Committee with the analysis 
when you----
    Mr. Dooley. We will do that.
    Mr. Pitts. Thank you.
    The draft calls for labeling packaged meat and poultry 
products when it has been packaged using minute levels of 
carbon monoxide. The rationale is that it may artificially keep 
the meat red longer and mislead consumers. Are there types of 
packaging that have the effect of preserving the redness of 
meat longer?
    Mr. Dooley. Yes, there are a number of different 
alternatives that processors can use that can provide for 
preserving the color as well as in preserving the quality of 
the product for an extended period of time and this is an 
example. When I mentioned in my testimony that we are very 
concerned about prescriptive controls being put in place, this 
is a classic example of Congress putting a prescriptive control 
on what type of technology can be used in the packaging of a 
meat product. They are requiring a separate label that will 
basically make this very difficult to be used in the 
marketplace, and the concern that we have is that you have--
when I was serving in Congress, of the 435 colleagues that I 
had there, none of them I think had a Ph.D. in food science, 
and yet you have Congress promulgating a provision that will 
impede the adoption and utilization of technology that has 
benefits to consumers.
    Mr. Pitts. Has there been any evidence that the use of 
carbon monoxide in meat packaging has any adverse health 
effects?
    Mr. Dooley. The scientific evidence overwhelmingly points 
out that this poses no health risk to consumers by its 
utilization.
    Mr. Pitts. OK. I just have one more question. The draft 
requires country of origin labeling for where the final product 
was produced along with a requirement to maintain a Web site 
with a list of all sourced ingredients. Can you comment on that 
provision in terms of your ability to do it and in terms of 
what it contributes to food safety, anyone? Go ahead, Mr. 
Dooley.
    Mr. Dooley. Well, first off, what the grocery manufacturers 
are absolutely committed to, it doesn't matter if that food 
product that you are manufacturing in the United States or if 
you are importing a food product or if you are importing 
ingredients from any country throughout the world that those 
have to be safe, and that this idea that we are going to be 
able to develop a Web site where we can put on every ingredient 
that is in a particular product, it is going to be problematic. 
I mean, you look at a pound of Folgers coffee on the grocery 
store shelf. It could have beans coming from 27 different 
countries. And if you look in the frozen food aisle, you might 
have a product that has mixed vegetables in it. Well, at 
different times of the year, that company is going to be 
sourcing those vegetables from different countries. So are we 
then to put on the Web site this product could contain 
vegetables that came from these 50 countries at some point 
during the year, and what is the value to the consumer by 
providing that information? We would say there is little to 
none and it will not provide any significant benefits in terms 
of--any benefit whatsoever in terms of food safety issues.
    Mr. Pitts. Thank you, Mr. Chairman.
    Mr. Pallone. I am going to go to a second round, in part 
because I think we expect Mr. Dingell to come back so I am 
going to ask some questions myself and then we will go back and 
forth again for those who would like to.
    Going back to Congressman Dooley again, in your testimony 
you emphasize that we need to implement a risk-based approach 
for the prevention of contamination, and in our conversations 
with industry experts, oftentimes though they sort of indicate 
that that is not an easy thing to do. Can you elaborate on this 
idea and explain how it would factor in safety mechanisms for 
what usually would be considered low-risk products like peanut 
butter which, as you know, was a recent cause of a salmonella 
outbreak?
    Mr. Dooley. Well, I think that--and Mr. Taylor probably can 
elaborate on this too, is that there are some products that are 
processed in a manner which they are inherently low risk. There 
are some products that are going to be more acidic that are 
going to be a lower risk. There are going to be some products 
which are fresh and are semi-processed that are going to be of 
higher risk, and we need to have a regulatory system and an 
inspection system that is developed where you are allocating 
more of your scarce resources if you are FDA on those products 
that pose the greatest risk. And I would even say when you look 
at the fee structure that you put in place, does it make any 
sense to charge a flat fee of $2,000 across the board or should 
that be a risk-based fee? Does it make any sense to have an 
arbitrary number of inspections saying a plant has to be 
inspected every 2 years regardless of the risk of that product 
that is being processed? Once again, you need to have a system 
which is identifying the inherent risk of a product to 
consumers to have a foodborne illness and then allocating your 
resources in a way that is going to make the biggest 
difference.
    Mr. Pallone. I still don't understand how you would propose 
to do this risk-based modeling. I mean, I have been having a 
problem with that in many areas, not just this one, but let me 
go back to----
    Mr. Dooley. If I can respond?
    Mr. Pallone. Sure.
    Mr. Dooley. What you are doing in effect if you are 
establishing some of the performance standards that Mr. Taylor 
referenced, you are in fact then identifying that there are 
some levels in some products that are going to need to have a 
performance standard because you have identified a risk. This 
is not that hard to do.
    Mr. Pallone. All right. Following up then, let me ask Ms. 
DeWaal because obviously this relates to both what Congressman 
Dooley and Mr. Taylor said, I mean, you heard Mr. Taylor's 
views on the performance standards and basically this is the 
same question. What would we look at in terms of performance 
standards, and given the difficulty, in my opinion, in 
structuring a risk-based model, how do you factor this all in?
    Ms. DeWaal. Thank you, Chairman Pallone. On this issue of 
risk-based whether it is performance standards or inspection 
frequency, one thing that we have seen over the last year is 
even the U.S. Department of Agriculture, which has a much more 
robust inspection system, has been unable to develop the data 
necessary to really catalog their facilities in terms of risk. 
It doesn't mean they are not going to continue to work on it 
but the bottom line is, they don't have that system in place 
today to do it. In terms of performance standards, the way the 
Globalization Act is structured right now allows for FDA to 
utilize performance standards where they see it is appropriate. 
It leaves discretion in the agency itself to use performance 
standards. The model of using performance standards to evaluate 
and measure how the process controls are working is an 
excellent model but again, I would agree with your assessment--
we are not there yet. We can't use it for every single food 
product, but we can use it more effectively than we do today.
    Mr. Pallone. Mr. Taylor?
    Mr. Taylor. I just might add a point to hopefully clarify 
and add to this. The provision in the bill that would call for 
standards for fresh produce is an example, I would argue, of 
taking a risk-based approach, taking the evidence that we got 
from the outbreak investigations that have shown that we do 
have a risk of contamination of fresh produce with certain 
bacteria and that there is a need to put in place standards to 
prevent that, and the standards would presumably be crafted 
scientifically to address a particular hazard, whether it is 
salmonella or E. coli, and be a way to measure the success of 
the efforts that were taken, so the risk-based approach is 
making the decision to focus efforts in terms of standard 
setting and then inspection on this particular set of 
commodities because they pose public health risks. I want to 
underscore, there was some suggestion that somehow the food 
industry in running its business would take a risk-based 
approach. Well, in a way that is true, but the food industry 
has a fundamental obligation which I think most companies take 
seriously to ensure that every food that they produce is safe. 
You can make any food unsafe if you allow contamination with 
pesticides or other chemicals and so there is that foundational 
duty that the companies have to be sure that the broad 
standards for safety in the food laws are met, but the risk-
based approach is really focused on how we target government 
efforts to get a public health benefit for the resources that 
are invested.
    Mr. Pallone. Mr. Pitts, do you want to ask any more 
questions?
    Mr. Pitts. I will ask another one.
    Mr. Pallone. You are recognized.
    Mr. Pitts. Thank you, Mr. Chairman.
    To anyone, according to the FDA Food Protection Plan, there 
are over 300 ports in the United States where food is imported 
into this country. The draft legislation would require a 
certification for food facilities or the importer would be 
limited to the ports in which there is an FDA lab in that 
metropolitan area. Given that some labs are not located at 
major ports, the number of ports where food could be imported 
could actually be lower than 13. Is it practical to say that we 
are going to have the number of ports available to import food 
to be less than 13, and not have a devastating effect on our 
food supply? Who would like to comment?
    Ms. DeWaal.
    Ms. DeWaal. Thank you so much. In terms of narrowing the 
number of ports of entry from 300 to 13, I think that the 
intention of the bill is not the way I read it plainly is to 
have a system where it is voluntary to get certified but there 
is a strong incentive. If companies want to continue to operate 
exactly as they do today, which is they can go to any port of 
entry they choose, they get certified, and it gives a time 
frame for allowing that certification to occur. It can't occur 
overnight because there aren't probably enough certifiers in 
place. The thing that certainly hit home for me as I listened 
to the FDA witness today was the fact that today they are not 
using their laboratories for the most part to check imported 
food. Very little imported food today is ever checked in a 
laboratory. I believe it is like two-tenths of 1 percent. So 
the new system will have to utilize laboratories, whether they 
are FDA laboratories or private laboratories, to do the testing 
that is needed for imports and that is not being done today.
    Mr. Pitts. Anyone else like to comment?
    Mr. Taylor.
    Mr. Taylor. Well, I think the certification issue is 
getting a lot of discussion before this legislation moves 
forward. I think it is a very interesting idea and I think it 
has significant questions around it. I would urge that we think 
about certification as an add-on, a way to supplement a system 
that is based fundamentally on the duty of the importer to be 
able to document how it was that food they are importing, they 
are importing into the United States, they should be able to 
document how it is that that food was produced in a way that 
meets U.S. standards. As I understand the proposal that the GMA 
put out last fall on imports, that is what they recommend, and 
the reason I think that is so important because that is the 
legally accountable entity here in the United States that FDA 
can hold responsible and can prevent their ability to bring 
imports into whatever port if that assurance is not provided. 
Then there is the question of how those companies meet that--
those importers, I should say, meet those duties and I think 
there are roles for third-party certification and a lot of 
different ways to sort of provide that assurance but I would 
build certification on top of a foundation of accountability 
for the importer to provide assurance that the product produced 
overseas is being produced in accordance with the same 
standards that we are able to enforce directly here in the 
United States.
    Mr. Pitts. Mr. Ambrosio?
    Mr. Ambrosio. We like testing, as retailers. However, that 
is not what I really look at from my standpoint governing where 
I have to govern. Testing only validates a process. I don't 
know how many items you would have to test in order for 
somebody to feel good about it. If you look at Salinas Valley 
and you look at lettuce in that valley over there, and I have 
been there several times, how many heads of lettuce do you have 
to test in order for somebody to feel good about it? It all 
goes back to the culture of those farmers and how they produce 
the item and how they harvest the item coming to port. So you 
can test and test and test but you might not see everything 
that you are testing. Testing only gives you a snapshot and it 
validates the program. In the case of the biggest outbreak we 
have ever had on produce, it was domestic, it wasn't imported. 
So I think we really have to look at what we are doing 
domestically first and then think about we can take the good 
practices that we have learned domestically and then give the 
importers more of an opportunity to enhance their growing 
manufacturing procedures.
    Mr. Pitts. Mr. Lovett?
    Mr. Lovett. If I could just build on what Mr. Ambrosio 
said, I totally agree that testing only validates an existing 
program and it is really the overall program that assures food 
safety. At the same time, that just begs the question of how 
much testing is needed to really validate the program, and I am 
not sure that two-tenths of 1 percent is enough. So I think 
even to go to 1 percent would be a fivefold increase, which 
would be very substantial. Without delving into all the details 
of certification as it relates to the question you first raised 
about linking ports of entry to the FDA labs, I think that 
leveraging the resources of private labs, which I think is 
going to be needed as a practical matter to increase the amount 
of testing at a rate that we are all going to probably want to 
see, means that you don't necessarily have to have that linkage 
to a particular port because there are private labs in all 
kinds of locations.
    Mr. Pitts. Thank you very much for your testimony. My time 
is up.
    Thank you, Mr. Chairman.
    Mr. Pallone. Thank you.
    Again, I am just going to ask a few more questions. We are 
waiting for Mr. Dingell. He should be here any minute.
    Let me go back to Mr. Dooley again. In your testimony, you 
state, and I quote, ``Congress should direct FDA to develop a 
plan to help build the scientific and regulatory capacity of 
major exporters to the United States.'' Do you want to develop 
that? I mean, I know you made that statement, but what do you 
expect to be done to follow up on that?
    Mr. Dooley. Well, I think this is where you really have to 
define that public-private partnership that can really help 
develop the capacity in many of the developing countries of the 
world to have the ability not only to establish the appropriate 
standards and protocols but also the ability to enforce those, 
and that is where I think, the potential. I don't want anyone 
to think that I am a critic of a standard for an audit. I 
think, though, those audits ought to be a private contractual 
arrangement between the retailer, the manufacturer, and 
potentially the companies that are providing those ingredients. 
So there is the ability to help build out a private sector 
infrastructure that could see the greater utilization of some 
of these audits that have higher standards that can be 
deployed, and in some instances could be sanctioned by those 
governments to become the standard for that particular country. 
So there is a lot of work here. I mean, we are all part--the 
CSPI and GMA and others are part of a coalition to increase the 
funding for FDA. You know, we want to double it over 5 years. 
We think there are opportunities to do it. We are not talking 
about that much money in the grand scheme of things and we want 
to be a partner with all of you in trying to achieve that.
    Mr. Pallone. Thank you.
    Mr. Dingell, Chairman Dingell is recognized for questions.
    Mr. Dingell. Mr. Chairman, thank you.
    I would like to welcome my old friend, Mr. Dooley, back and 
tell him how pleased we are to have him here. Just real 
quickly, Mr. Dooley, do you think our current system of 
regulation is working well? Yes or no.
    Mr. Dooley. Being a former Member of Congress, it is 
difficult to say yes or no.
    Mr. Dingell. Well, I only have 5 minutes and I have lost 15 
seconds of it already.
    Mr. Dooley. I think the system is working as well as we 
should expect. You know, we need to modernize FDA.
    Mr. Dingell. I note here that we have had 76 million 
illnesses, 325,000 hospitalizations, 5,000 deaths annually due 
to foodborne illnesses. Does that tell you things are working 
well?
    Mr. Dooley. You know, we would clearly state that there is 
room for improvement. We are committed to trying to implement 
the private sector reforms and the public reforms that can 
achieve that, and we also have to accept what are the sources 
of those foodborne illnesses.
    Mr. Dingell. Let us look at this now, Mr. Dooley, because 
you are one of our experts on this matter. As I understand it, 
when the food processing industry spends money, they then 
charge it back against the consumers, for example, when they 
buy produce, they charge that against the consumers. When they 
advertise the buildings and food processing machines, they 
charge that against the consumers. When they have wages and 
things of that kind, they charge that against the consumers, 
right?
    Mr. Dooley. We operate in a manner that is similar to any 
other private sector business, be it the auto industry or the 
food industry.
    Mr. Dingell. So you are here complaining, I note, about the 
fact that the food processing industry is going to be paying a 
$2,000 annual tax for each food facility and a $10,000 annual 
tax for each food importer to finance food objectives. That is 
a major objection of yours, is it not? But that is something 
that you are going to level against the consumers, isn't it? 
That is not being extracted from your pocket. That is coming 
out of the pocket of the consumers, isn't it?
    Mr. Dooley. It is a cost of doing business.
    Mr. Dingell. Cost of doing business, and you are going to 
happily assess that against the consuming public. So if the 
consuming public doesn't complain about that and the consuming 
public says this is a good idea, we are going to get safer 
food, your complaint is pretty much vanished because, lo and 
behold, the people who are going to have to pay the charge 
happen to like the idea and your folks aren't going to pay it. 
Now, what, given that circumstance, is your complaint?
    Mr. Dooley. I would say that I don't subscribe to your 
assessment that the consumer would have no problem with their 
food costs being increased, and I also would note that the 
Consumer Federation of America also objects to user fees.
    Mr. Dingell. Let us look at this thing. Your folks are 
afflicted by trial lawyers, who start lawsuits against your 
folks because you sell unsafe commodities and they collect big 
judgments, don't they?
    Mr. Dooley. Our folks are totally committed to producing 
the safest products.
    Mr. Dingell. But the trial lawyers extract large sums of 
money in most generous settlements paid for by your clients, 
don't they?
    Mr. Dooley. On the rare instance where we do have a food 
safety problem, trial lawyers oftentimes do find profit 
opportunities.
    Mr. Dingell. And your folks sit there in this very unhappy 
situation where you are seeing all this stuff coming in from 
China, dog food that is doctored, catfish, and other fishery 
products that are coming in that are coming from some of the 
most contaminated, polluted waters in the world. They are full 
of bacteria and microbes and all manner of nasty things, 
viruses, and as we look at it, the Chinese lace these very 
heavily with antibiotics. Now, I am not sure who they are 
protecting, the Chinese or us, but our people are getting a lot 
of antibiotics. Do you like that situation?
    Mr. Dooley. No, and we are pleased that the legislation 
that----
    Mr. Dingell. And your people are----
    Mr. Dooley [continuing]. Congressmen Costa and Putnam have 
introduced will put in place----
    Mr. Dingell. Let me finish.
    Mr. Dooley [continuing]. Standards that improve that.
    Mr. Dingell. Your people are selling this stuff to 
Americans. Your members are doing that. And frankly, I have the 
view that you need a little protection from that situation, 
don't you?
    Mr. Dooley. That is why we have advanced a set of proposals 
that would enhance the level of food safety.
    Mr. Dingell. So you need Food and Drug to have the money, 
the personnel to check these matters out, do you not?
    Mr. Dooley. That is why we are part of the Alliance for a 
Stronger FDA.
    Mr. Dingell. Yes or no is usually quite sufficient because 
my time is, regrettably, very limited and I want to hear from 
you but I have to hear the answers that I need to hear so we 
have a good record, so we understand what you are really 
standing for and what you are really telling us.
    Now, I was just taking a look here and I found that after 
the spinach outbreak in 2006, this comes from testimony which 
you may have heard already, spinach farmers reported losing 
$350 million, and have still not recovered when a second leafy 
green outbreak occurred in August 2007. Big lawsuits, spinach 
market killed, your people inconvenienced, lawsuits filed, fine 
mess, right?
    Mr. Dooley. But we have supported FDA being required to 
develop good agricultural practices for leafy greens and other 
produce.
    Mr. Dingell. OK. So then we find that Peter Pan, and I like 
their peanut butter, but all of a sudden they had an outbreak 
that cost ConAgra $140 million, including $55 million in lost 
sales. That has gone on forever. Now, it occurs to me that 
maybe if Food and Drug had a little better capacity to inspect 
these things, we could all feel a little bit safer. These 
things might not have occurred and all the other things that 
are happening with regard to foods and pharmaceuticals wouldn't 
be transpiring. Am I right?
    Mr. Dooley. No.
    Mr. Dingell. Now, I am kind of surprised to hear you say 
that you do not believe that a stronger food safety system 
would provide service to your industry.
    Mr. Dooley. No, what I was saying, if I can go beyond the 
no, is that ConAgra, as you stated, they realize when they have 
$140 million loss with this one outbreak----
    Mr. Dingell. Well, do you think----
    Mr. Dooley. --what more incentive do they need to have to 
put in place----
    Mr. Dingell. Let me ask----
    Mr. Dooley. --protocols to make sure that won't happen.
    Mr. Dingell. Let me ask a question here. Do you think that 
we need a stronger food safety system in service to your 
industry or not?
    Mr. Dooley. Yes.
    Mr. Dingell. Yes, you do agree? OK. Now, because you are 
goodhearted folks, make a fine living by putting food on 
Americans' dinner tables and the result of a good Food and Drug 
is that your people are protected, they don't get all these 
nasty lawsuits, they don't lose sales, they maintain customer 
confidence and a guy comes in and says well, I still want to 
get Peter Pan peanut butter because I think it is safe, but 
they lost $55 million on this deal and the spinach people are 
still not recovered. Now, what we have proposed in the 
discussion draft are fees. Fees are designed to improve the 
safety of the Nation's food supply and also to assure that you 
folks in your industry get safe foods in from places like China 
where they sell all manner of crap to the citizens of China, 
unsafe stuff, and if you have been to China, as I have a number 
of times, I think you have too, you will find that you are 
going to be damn careful of what you eat over there or you are 
going to come down with something real nasty, and what we want 
to do is see that this stuff that comes in is safe. I hope you 
are supportive of that. Are you?
    Mr. Dooley. Well, you are supporting--enhancing the food 
safety system. That is recognized by the work----
    Mr. Dingell. The thing I find most interesting, Mr. Dooley, 
is, almost every other Food and Drug-regulated industry--
pharmaceuticals, medical devices, animal drugs--they have all 
come forward and said this is a good idea, we want to have 
strong Food and Drug to protect our people against unsafe 
commodities, and yet comes my old friend Cal Dooley says we 
don't need any help, everything is fine while we are poisoning 
people with bad fish from China, while we are poisoning people 
with unsafe spinach and peanut butter that is causing huge 
outbreaks of gastric difficulty to our people. Don't you think 
that is a little backward approach?
    Mr. Dooley. I think that was a----
    Mr. Dingell. The food industry has had years of wonderful 
exemption from regulation. They just don't bother you. They get 
around to see your folks about every 10 years, look at the 
plant and say well, maybe this plant is OK, but the other 9 
years and three-quarters, there is nobody bothering you. And 
look at what has happened. People are getting sick, bad 
commodities are getting on the market, and my old friend Cal 
Dooley is coming in here and telling us that this industry does 
not need any help. You are protecting the American people.
    Mr. Dooley. Mr. Dingell----
    Mr. Dingell. I think we can take a poll in this room today 
and see how many people agree with you, or if we would walk up 
and down the street and ask Americans how good a job you are 
doing, I suspect they wouldn't be in agreement with you. What 
do you think about that?
    Mr. Dooley. Will you give me the courtesy of responding?
    Mr. Dingell. I find myself curious. You have never been 
able to produce the support that it takes in your industry to 
give Food and Drug the resources that it needs. Nobody else 
has. So finally we have a way of making Food and Drug be able 
to finance things of particular importance. Now, it is 
interesting to note on imports, less than 1 percent of the 
imports of food are inspected by Food and Drug. You have unsafe 
fish, you have unsafe vegetables, you have unsafe meats, you 
have all kinds of stuff coming in. You have unsafe 
pharmaceuticals coming in. You have counterfeits. You have 
adulterated, filthy foods, pharmaceuticals and things of that 
kind coming in from overseas and here comes my old friend Cal 
Dooley here to tell this poor Polish lawyer from Detroit we 
really don't need any help, we are doing just fine. How do you 
feel about that?
    Mr. Dooley. The industry and GMA back in September of last 
year advanced our four pillars for enhanced food safety. The 
basics and the components of those proposals is embodied in 
legislation that has been introduced by Congressman Costa and 
Congressman Putnam yesterday. It is a clear demonstration of 
this industry's commitment to enhance our food safety and 
further define the public-private partnership which can achieve 
those outcomes. We also make it very clear that, much like the 
medical device and the pharmaceutical industry, we will support 
user fees that provide a proprietary benefit to our members.
    Mr. Dingell. Let us address this. Since this industry all 
of a sudden became energized by the talk of introduction of 
legislation, they began doing all these things and yet unsafe 
foods are coming in from China. People are still getting sick 
from unsafe foods. Food and Drug doesn't have the resources to 
do the job and you are here this morning, or this afternoon 
now, telling us that you don't need any help and everything is 
fine.
    Mr. Dooley. Mr. Dingell, that is a clear misrepresentation 
of my statements. We have consistently stated that we are 
supportive of, and have been constructively engaged with, your 
staff, with Mr. Pallone's staff, with Republicans and 
Democratic members of this committee in offering our ideas and 
proposals on how we can enhance the food safety, both domestic 
as well as international.
    Mr. Dingell. Mr. Dooley, I have the greatest fondness for 
you, as you well know, but I didn't roll off the cabbage wagon 
yesterday, and I happen to know that your industry will go to 
any length to avoid legitimate regulation to protect the 
consumers. We are going to do that with your help, and I hope 
we will have your help, and we are going to do it without your 
help if we don't have your help. I will tell you, it will much 
easier for you and the industry to work with us than to work 
against us. I hope you will cooperate with us because the 
facts, Mr. Dooley, are not with you.
    Mr. Chairman, I thank you.
    Mr. Pallone. Thank you, Chairman Dingell.
    Mr. Pitts, did you want to add anything? You are done? All 
right.
    First of all, let me thank all the members of the panel. We 
really appreciate your time and your bearing with us, and as 
Mr. Dingell said, we really do want your help and your 
cooperation and your ideas as we move forward, so thank you 
again.
    Let me just say in closing, I want to remind the members 
that they may submit additional questions for the record to be 
answered by the relevant witnesses. The questions should be 
submitted to this committee clerk within the next 10 days so 
you will find out within the next 10 days if there are 
additional questions that we would like to have responses from 
in writing.
    Without objection, this meeting of the subcommittee is 
adjourned.
    [Whereupon, at 1:17 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                   Statement of Hon. Henry A. Waxman

    I want to thank Chairman Pallone for holding this very 
important hearing today. I also want to commend our colleagues, 
Chairman Dingell, Chairman Pallone and Chairman Stupak for 
their efforts in pulling together this very strong legislation 
to address the very serious and glaring gaps in FDA's 
authority.
    There are few issues that matter more to Americans than the 
safety of the foods they eat and the drugs and devices they 
rely upon each day to keep them healthy--or to save their 
lives.
    People want to have the very basic assurance that, when 
they sit down for a meal, the food they eat won't make them 
sick. That should just be a given in our country. Americans 
expect no less.
    Unfortunately, we now have far too much evidence that FDA 
has not been meeting these expectations.
    Tainted peanut butter, contaminated fresh produce, 
uninspected imports about which little is known. I could 
continue with this list, but I think we have become all too 
familiar with it. Sadly, Americans have practically become 
accustomed to hearing these stories in the newspapers and on 
the nightly news.
    So it is critical that we get FDA the authorities and 
resources it needs to fix this very disturbing and dangerous 
situation.
    This bill takes some significant steps in that direction.
    I strongly support the inclusion of a mandatory facility 
registration along with corresponding registration fees. The 
fees are minimal--just $2,000 per year per facility. This is a 
common-sense way to get FDA a desperately needed infusion of 
resources.
    We are asking FDA to take on a great deal of new 
responsibility here and each aspect of that responsibility 
demands resources if we want FDA to succeed. The registration 
fees will provide a critical portion of those dollars and I 
hope the food industry will get behind them. We all know that 
giving FDA authority without the necessary resources is 
tantamount to doing nothing at all.
    I also want to briefly address the third party 
certification program in the bill. As many of you know I've 
long been opposed to the concept of permitting third parties to 
fulfill what are essential FDA functions. But in the area of 
foods, where there are over 300,000 facilities around the 
world, I understand we are looking at a very different 
situation from the drug or device context.
    So I think that there is a case for considering the use of 
third parties to supplement FDA's oversight of the imported 
food supply and to enlist the states in helping us inspect the 
domestic food supply. But this third party system is far from 
an ideal system for protecting American consumers, and a far 
cry from having FDA itself doing this work.
    So if we create this kind of system, we have got to proceed 
with great caution. Ensuring that basic safeguards are in place 
is absolutely critical.
    FDA must be able to maintain careful controls over the use 
of these third parties. FDA's accreditation process needs to 
ensure that the certifying agents possess the skills, 
expertise, and training necessary to act as an effective FDA 
surrogate. The Agency should be required to issue regulations 
clearly setting forth who may or may not become accredited. 
Once a third party is certified, FDA needs to perform frequent 
spot checks of certifying agent's work to ensure that those 
third parties are fulfilling their responsibilities--and then 
have the flexibility to swiftly revoke an accreditation if FDA 
concludes failures have occurred.
    It is also critical that there be no conflicts of interest 
between the certifying agent and the facility.
    I look forward to working with Chairman Dingell, Pallone, 
and Stupak to make sure these protections are clear and 
effective. If this program does not have integrity, it will not 
succeed.
    We will need FDA to be our partner in bringing about the 
change envisioned in this legislation. We need strong 
leadership from the FDA and from the Administration both in the 
legislative process and after this bill becomes law.
    As we continue the drafting process, we need and expect the 
Administration's cooperation in giving us full and open access 
to FDA's expertise and knowledge.
    We also must have the best estimates from the 
Administration for the resources that are necessary to permit 
FDA to do the job we are asking it to do in this bill-and to do 
it well.
    The time to act is now. I feel confident we have the 
political will here in Congress to get this done-and soon. The 
American people are counting on us. 
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