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[Senate Hearing 111-1069]
[From the U.S. Government Publishing Office]

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2011

                                                       S. Hrg. 111-1069

   KEEPING AMERICA'S FAMILIES SAFE: REFORMING THE FOOD SAFETY SYSTEM

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                                   ON

 EXAMINING KEEPING AMERICA'S FAMILIES SAFE, FOCUSING ON REFORMING THE 
                           FOOD SAFETY SYSTEM

                               __________

                            OCTOBER 22, 2009

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions

  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                                 senate
?

          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                       TOM HARKIN, Iowa, Chairman
CHRISTOPHER J. DODD, Connecticut
BARBARA A. MIKULSKI, Maryland
JEFF BINGAMAN, New Mexico
PATTY MURRAY, Washington
JACK REED, Rhode Island
BERNARD SANDERS (I), Vermont
SHERROD BROWN, Ohio
ROBERT P. CASEY, JR., Pennsylvania
KAY R. HAGAN, North Carolina
JEFF MERKLEY, Oregon
AL FRANKEN, Minnesota
MICHAEL F. BENNET, Colorado

                                     MICHAEL B. ENZI, Wyoming
                                     JUDD GREGG, New Hampshire
                                     LAMAR ALEXANDER, Tennessee
                                     RICHARD BURR, North Carolina
                                     JOHNNY ISAKSON, Georgia
                                     JOHN McCAIN, Arizona
                                     ORRIN G. HATCH, Utah
                                     LISA MURKOWSKI, Alaska
                                     TOM COBURN, M.D., Oklahoma
                                     PAT ROBERTS, Kansas
                                       
                                       
           J. Michael Myers, Staff Director and Chief Counsel
     Frank Macchiarola, Republican Staff Director and Chief Counsel

                                  (ii)

  
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                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                       THURSDAY, OCTOBER 22, 2009

                                                                   Page
Harkin, Hon. Tom, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming, 
  opening statement..............................................     2
    Prepared statement...........................................     2
Gregg, Hon. Judd, a U.S. Senator from the State of New Hampshire.     3
Isakson, Hon. Johnny, a U.S. Senator from the State of Georgia...     4
Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio.......     4
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of 
  Pennsylvania...................................................     5
    Prepared statement...........................................     6
Franken, Hon. Al, a U.S. Senator from the State of Minnesota.....     7
    Prepared statement...........................................     8
Durbin, Hon. Richard J., a U.S. Senator from the State of 
  Illinois.......................................................    10
    Prepared statement...........................................    12
Dodd, Hon. Christopher J., a U.S. Senator from the State of 
  Connecticut....................................................    13
Hamburg, Margaret, Commissioner, U.S. Food and Drug 
  Administration, White Oak, MD..................................    15
    Prepared statement...........................................    17
Merkley, Hon. Jeff, a U.S. Senator from the State of Oregon......    23
DeWaal, Caroline Smith, Director of Food Policy, Center for 
  Science in the Public Interest, Washington, DC.................    30
    Prepared statement...........................................    32
Roberson, Michael, Food Marketing Institute, Arlington, VA.......    36
    Prepared statement...........................................    38
Ragan, Daniel L., Director, North Carolina Department of 
  Agriculture and Consumer Services, Food and Drug Protection 
  Division, Raleigh, NC..........................................    43
    Prepared statement...........................................    45
Stenzel, Thomas, President and CFO, United Fresh Produce 
  Association, Washington, DC....................................    50
    Prepared statement...........................................    52

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Senator Burr.................................................    65
    Bob Bauer, President, The Association of Food Industries.....    66
    Kraig R. Naasz, President & CEO, American Frozen Food 
      Institute..................................................    68
    Cheese Importers Association of America......................    70
    Fresh Produce Association of the Americas....................    73

                                 (iii)

    Letters:
        Daniel L. Ragan, Director, North Carolina Department of 
          Agriculture and Consumer Services......................    75
        Jeanne Ireland, Assistant Commissioner for Legislation, 
          Food and Drug Administration...........................    76
    Response by the Food and Drug Administration to questions of:
        Senator Enzi.............................................    76
        Senator Brown............................................    80
        Senator Reed.............................................    82
        Senator Bingaman.........................................    82
    Response by Caroline Smith DeWaal to questions of Senator 
      Enzi.......................................................    83

  

 
   KEEPING AMERICA'S FAMILIES SAFE: REFORMING THE FOOD SAFETY SYSTEM

                              ----------                              

                       THURSDAY, OCTOBER 22, 2009

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:06 a.m. in 
Room SD-430, Dirksen Senate Office Building, Hon. Tom Harkin, 
Chairman of the committee, presiding.
    Present: Senators Harkin, Dodd, Brown, Casey, Hagan, 
Merkley, Franken, Enzi, Gregg, and Isakson.
    Also Present: Senator Durbin.

                  Opening Statement of Senator Harkin

    The Chairman. The Committee on Health, Education, Labor, 
and Pensions will come to order.
    Good morning, everyone. We meet today to discuss an issue 
of basic importance to all Americans: the safety of our 
Nation's food supply. There is perhaps no issue that affects 
Americans as universally as food safety. Part of our daily 
lives, and, for many in my State and elsewhere, the production, 
preparation, and sale of food is a source of livelihood.
    Now, on the whole, Americans enjoy safe and wholesome food. 
But, to be honest about it, our food can be safer and it must 
be safer. Recent food outbreaks linked to spinach, peppers, 
peanut products, cookie dough dramatizes two important truths. 
First, our current regulatory system does not adequately 
protect Americans from serious, widespread food-borne 
illnesses. And second, the dangers associated with food-borne 
outbreaks are profound.
    The Centers for Disease Control and Prevention estimates 
that food-borne diseases cause approximately 76 million 
illnesses each year, including approximately 325,000 
hospitalizations and 5,000 deaths in the United States, each 
year. These are staggering numbers and totally intolerable. 
That's why, as we focus on a national healthcare reform, we 
can't afford to ignore food safety. Unsafe food is yet another 
strain on our healthcare system and it's a problem that we can 
and must address now.
    I am heartened by the fact that the Obama administration 
has made food safety reform a major domestic policy initiative. 
In March, the President created the Food Safety Working Group 
to develop recommendations for bringing our food safety system 
into the 21st century.
    Over the last 100 years, our meals have gotten more complex 
in this world. They include more varied ingredients, so they're 
subject to more diverse methods of processing and preparation. 
Today, raw agricultural products travel thousands of miles, 
from farms to processors to factories to the table. They're 
routinely processed and mixed along the way. In addition, we 
rely more and more on foods imported from abroad, often from 
countries with less rigorous regulation and different standards 
than our own. So, what do we need to do? Most of all, we need 
improved processes to prevent the contaminations of food in the 
first place.
    Even though our Nation has 150,000 food processors, the FDA 
visits just 7,000 plants each year, and it visits even fewer of 
the foreign facilities that process food for shipment into the 
United States. That's why we need to allocate sufficient 
resources. If we really want to do this job, we'd better come 
up with the resources to cope with this different food 
distribution system that we've had to develop over the last 20 
to 30 years to cope with the growing food industry and the 
inherent risks that threaten the safety of our food.
    So, again, it's past time to modernize our laws. We need to 
act now. I am pleased that the President's Food Safety Working 
Group has begun a national dialogue on this issue. I'm also 
grateful to many Senators who have worked together in a 
bipartisan fashion. I know we're going to hear from the lead 
sponsor, Senator Durbin, and also Senator Gregg and others who 
have been working diligently on this. I thank them for that and 
for their strong bipartisan efforts to get this bill put 
together.
    With that, I would yield to Senator Enzi.

                   Opening Statement of Senator Enzi

    Senator Enzi. Well, Mr. Chairman I'll just ask that my 
statement be included in the record so that Senator Isakson, 
who's a cosponsor on the bill, might have an opportunity to 
make a few comments.
    The Chairman. Absolutely.
    Senator Enzi. So, I would yield to Senator Gregg.
    [The prepared statement of Senator Enzi follows:]

                   Prepared Statement of Senator Enzi

    Good morning. Food safety is not a partisan issue--we all 
want the safest food supply possible. The United States has one 
of the best food safety systems in the world. But even in the 
best of systems, there is always room for improvement.
    The volume of food imports and the number of foreign 
producers and manufacturers are growing. At the same time, the 
supply chain is becoming more complex, due to innovations such 
as repackaging of fresh produce that mixes output from dozens 
of farms, or the potentially hundreds of ingredients in a 
ready-to-eat processed food.
    FDA is the gold standard worldwide among public health 
agencies. After many years of inadequate resources, Congress 
has provided significant funding increases to FDA for food 
safety and related activities such as information technology. 
While it is important to sustain these increases, FDA also 
needs a modernization of its authorities.
    The powers the agency was given 100 years ago were 
appropriate for a world in which most of our food was grown and 
processed domestically. That is no longer the case, and FDA's 
tools need to keep pace with the challenges.
    These outdated authorities coupled with a lack of resources 
have been made clear by recent outbreaks. For example, in the 
Peanut Corporation of America case last year, FDA did not know 
the facility was even making peanut butter, since the facility 
was initially registered as just roasting peanuts. There is 
currently no statutory requirement to update registration 
status when information changes. Last summer, during the 
Salmonella in tomato/peppers outbreak, FDA was not able to put 
enough ``boots on the ground'' to trace shipments back to the 
source of the contamination quickly.
    Clearly, the complex nature of our food safety system 
requires all of the global partners--regulators, importers, 
manufacturers, academia--and other stakeholders to come 
together to propose meaningful, collaborative solutions.
    I believe some of those solutions are contained in S. 510, 
the FDA Food Safety Modernization Act, which a number of 
members of this committee have cosponsored. I have a few 
concerns about the bill, particularly the provisions regarding 
FDA's relationship with farms as well as with State officials. 
While this bill is a good start, it is important that we go 
through regular order and do the hard work of making the bill 
even better. There is a lot of expertise on the HELP Committee 
about these issues, and we should bring that to bear on the 
legislation.
    I look forward to the testimony today.

    The Chairman. I recognize Senator Gregg.

                       Statement of Senator Gregg

    Senator Gregg. Thank you, Mr. Chairman.
    It's a pleasure, and I very much appreciate being at this 
hearing, and I very much appreciate your holding it.
    It's a pleasure to be here, of course, with Senator Durbin, 
who is, with myself, the original sponsor of this bill, which 
we started working on in 2008. In an act of great clairvoyance, 
we both decided that eating was important. We probably did that 
over lunch somewhere.
    [Laughter.]
    It's very clear that the FDA needed more authorities and 
that we had to have a better regime for the purposes of 
protecting our food supply. This bill attempts to do that. It 
obviously isn't perfect, but it's a major step down the road in 
making sure that our food supplies are better protected and 
that the FDA has the authorities necessary to step in when it 
becomes clear that there is a problem. It does have mandatory 
recall, which is absolutely critical, in my opinion. It also 
sets up a regime where the food processors will be required to 
set up their own inspection systems and therefore, hopefully, 
be a step forward in the area of making sure that inspections 
are more comprehensive.
    In addition, it addresses the international issue, which is 
a very serious issue, of foods coming into this country, 
because obviously a large percentage of our foods are imported.
    So, I want to thank Senator Durbin for his extraordinary 
work on this. I want to thank everybody who has participated by 
cosponsoring it. I especially want to thank the Chairman and 
the Ranking Member for making time available on the calendar of 
this committee so that we can move it forward. And we hope 
it'll move promptly.
    Thank you very much, Mr. Chairman.
    The Chairman. Thank you very much, Senator Gregg.
    Senator Isakson.

                      Statement of Senator Isakson

    Senator Isakson. Thank you, Mr. Chairman. I'll be very 
brief.
    I just want to commend Senator Durbin on this legislation. 
As many of you know, the salmonella outbreak in peanut butter 
turned out to be borne in two plants, one of them in South 
Georgia. As it turns out, the evidence of salmonella 
contamination by a positive test for salmonella were lying in 
the files in the filing cabinet of the Peanut Corporation of 
America when Georgia ag agents, at the request of FDA, did an 
inspection based on a complaint, but, because of the existing 
law, those records were not available to the Georgia 
inspectors, and therefore, salmonella, which possibly could 
have been stopped, ended up spreading around the country.
    So, I think Senator Durbin has done a great job in this 
legislation. I'm very proud to be a cosponsor, appreciate very 
much his being here. And it was a pleasure, yesterday, to meet 
Dr. Hamburg and get to know her better.
    So, welcome to both of you.
    The Chairman. Senator Brown.

                       Statement of Senator Brown

    Senator Brown. Thank you, Mr. Chairman.
    I particularly welcome to the committee Dr. Hamburg and 
Caroline Smith DeWaal, who's done such terrific work, and, of 
course, Senator Durbin for his leadership over the years.
    I'll also be brief.
    Each year, some 76 million people contract a food-borne 
illness in this country. The CDC estimates that 5,000 people 
die as a result. We've all heard these awful stories. In the 
last 2 years alone, our country has been faced with melamine in 
infant formula, harmful seafood from China, tainted peppers 
from Mexico, E. coli in spinach, salmonella in peanuts. And we 
wonder why our food safety system can't do a better job of 
preventing and detecting and minimizing the impact of food 
safety-related outbreaks.
    We know that we import more fruits and vegetables--a good 
thing in this country, for sure--that people are eating fruits 
and vegetables all year round. Think of visiting a supermarket 
25 years ago in February, versus today, and see what we have 
available. All wonderful things the Chairman's been so involved 
in, in dietary issues, preventive healthcare, encouraging 
people to eat better. But, we need to instill in people 
confidence that the fruits and vegetables imported, and the 
food processed in this country or abroad--we need to, 
obviously, build trust much more in our food safety system.
    Earlier this year, I introduced S. 425, the Food Safety and 
Tracing Improvement Act, to improve the ability of Federal 
agencies to trace the origins of contaminated food and provide 
the FDA and USDA with the authority to mandate recalls for 
adulterated and misbranded food products. So, we obviously need 
recalls. We also need these companies to do better 
traceability, if you will, so they know where these ingredients 
in foods came from.
    We have a better process to recall malfunctioning toasters 
than we do contaminated meat. And that, clearly, is a place 
we've fallen short.
    I'll just close with this, Mr. Chairman, that Nelly Napier, 
in Mentor, OH--it's a suburb just east of Cleveland--was an 80-
year-old grandmother with a zest for life. She was an avid 
reader, a skilled puzzle solver, and an unwavering fan--a 
difficult task--of the Cleveland Indians. She was the mother of 
six children. She had 13 grandchildren, 11 great grandchildren. 
She became ill in January, after eating a peanut butter 
sandwich that was tainted with salmonella. When the doctors 
were called, they told the family they couldn't do anything, 
and she died shortly thereafter. That's deplorable. We can 
clearly do better that.
    Senator Durbin's bill and the efforts of many on this 
committee, will be the major step we need to take.
    Thank you.
    The Chairman. Thank you very much.
    Senator Casey.

                       Statement of Senator Casey

    Senator Casey. Thank you Mr. Chairman.
    I want to thank Senator Durbin for being here and for his 
work, for many years, on this issue, in introducing S. 510, the 
Food Safety Modernization Act legislation. We're grateful for 
Senator Durbin's presence here, in working with Senator Gregg.
    Dr. Hamburg, we're very grateful to have you back in this 
room. We remember when you came here prior to your 
confirmation. We're grateful for your work.
    Just fairly simply, I, like I think everyone here, believe 
that the American people have a reasonable--or should have a 
reasonable expectation of a safe food supply. There are a lot 
of ways to get there, but we know that we have countless 
examples of why that is not the case, why that reasonable 
expectation of safety is not there. And we're grateful that 
there's legislation in front of us to do that.
    I just want to mention briefly the legislation Senator 
Grassley and I have, S. 429, the so-called Eat Safe Act. We 
introduced it in the last Congress. We have reintroduced it. 
It's really basic, in the sense that it's designed to address a 
critical aspect of this problem: food being smuggled into the 
United States of America. The greatest threat of smuggled food 
in agricultural products come from companies, importers, and 
individuals who circumvent U.S. inspection requirements or 
restrictions on imports of certain products from a particular 
country. Some examples of this are unpasteurized raw cheeses 
from Mexico, strawberries from Mexico that are contaminated 
with hepatitis A. Other examples, as well. I'll include those 
in my statement for the record.
    But, these smuggled food and agricultural products present 
a safety risk to our food, our plants, and animals, and pose a 
threat to our Nation's health, economy, and security.
    So, the Eat Safe Act is one of the ways to positively 
impact this urgent challenge we have in the country, and Mr. 
Chairman, I'm grateful that you called this hearing so we can 
highlight these issues, and look forward to the hearing.
    Thank you.
    [The prepared statement of Senator Casey follows:]

                  Prepared Statement of Senator Casey

    I want to thank the Chairman for calling today's hearing. 
It is an important step toward creating solutions to give 
Americans peace of mind that the foods they eat and give to 
their families is safe to consume. Americans have every right 
to expect a safe food supply. I am focused on food safety not 
only as a lawmaker but also as a consumer and a father. We all 
want food for our families that is nutritious and free from 
foodborne pathogens and contaminants.
    Our government currently has no laws or regulations 
requiring a national system for traceability of U.S. foods. 
While many in the food industry do employ voluntary 
recordkeeping systems, there is no consistency from one system 
to the next. But implementation of a national traceability 
system is only half of the battle. There are still 76 million 
cases of foodborne illness in this country every year.
    The United States Senate must look at ways to modernize the 
U.S. system of food inspection. We must provide the agencies 
that regulate food safety with additional authorities and 
resources to ensure the safety of our Nation's food supply. We 
must mandate science-based regulations to ensure the safety of 
food products that carry the most risk. Further, we must 
improve coordination between USDA, FDA, and the various other 
Federal and State agencies charged with regulating food safety.
    We must ensure the safety of both domestic and foreign food 
products. That is why I introduced the EAT SAFE Act with 
Senator Grassley. The EAT SAFE Act is designed to address a 
critical aspect of the food and agricultural import system--
food being smuggled into the United States. The greatest threat 
of smuggled food and agricultural products comes from the 
companies, importers, and individuals who circumvent U.S. 
inspection requirements or restrictions on imports of certain 
products from a particular country. Some examples of prohibited 
products discovered in U.S. commerce in recent years include 
unpasteurized raw cheeses from Mexico containing a bacterium 
that causes tuberculosis and strawberries from Mexico 
contaminated with Hepatitis A. These smuggled food and 
agriculture products present safety risks to our food, plants, 
and animals, and pose a threat to our Nation's health, economy, 
and security. The EAT SAFE Act addresses these serious risks by 
applying common-sense measures to protect our food and 
agricultural supply.
    I understand that many Americans are concerned about food 
safety issues. So am I. Ensuring that our food supply, both 
domestic and foreign food products, is safe is a high priority 
for me. As the Senate continues to address the issues we are 
discussing at this hearing, I will remain steadfast in my 
commitment.
    The Chairman. Senator Franken.

                      Statement of Senator Franken

    Senator Franken. Thank you, Mr. Chairman. And thank you for 
holding this very important hearing.
    I'd like to thank Senators Durbin and Gregg for putting 
forth this very important bill, S. 510.
    We have heard, repeatedly and correctly, that our current 
food safety system is broken. The system relies heavily on 
reacting to outbreaks after they have occurred, instead of 
preventing their occurrence in the first place. Once an 
outbreak has been identified, it then takes far too long to 
track, contain, and remove the offending substances, or 
substance, within the food chain. We need Federal legislation 
now, so that we can bring our country's food safety system into 
the 21st century.
    Right now, the FDA is unable to properly oversee our food 
safety system, because the agency lacks resources and authority 
in four key areas: No. 1, oversight of imported food products 
and ingredients; No. 2, access to food production records; No. 
3, mandatory recall of contaminated food; and No. 4, the 
ability to trace the origin of food products.
    I'm very pleased that S. 510 will move us forward in each 
of these areas and bring peace of mind to American families.
    We simply have to be able to track where imported food is 
coming from and its safety. Fifteen percent of our food comes 
from overseas.
    We must also ensure that FDA is equipped to address 
circumstances within the United States. For example, in late 
2008, the Minnesota Department of Health noticed an elevated 
number of salmonella cases. After comprehensive investigations, 
the Department of Health identified the King Nut brand of 
peanut butter as the culprit, produced by the Peanut 
Corporation of America, as referenced by Senator Isakson. This 
contamination and the subsequent investigation led to the 
multiple recalls of more than 2,000 products from our shelves. 
But, if we were able to more immediately trace foods back to 
their producers, we would have withdrawn the contaminated foods 
far more quickly, and we would have saved lives and prevented 
illness.
    Now, the recall is estimated to have cost the industry 
nearly a billion dollars, but the greatest cost was, of course, 
to American families. Over 700 became ill, and nine people died 
as a result of the PCA outbreak, including Shirley Almer, a 
Minnesota mother of three who had survived brain cancer and was 
in good health at the time of the outbreak.
    To me, the most egregious part of the story is that PCA 
knew that the peanut products sent to our market were tainted. 
Third-party inspections in 2007 and 2008 had already found 
salmonella contamination in 12 different tests. PCA's 
inspection reports were glowing and showed no evidence of the 
problems present within the facility.
    This is a clear indication that, while we need to increase 
the number of food inspections, it's equally important to 
strengthen the integrity of these inspections, like having a 
certification process for the inspectors.
    We all agree that food safety is a top priority for our 
families and our country, and I support giving the FDA the 
resources it needs and the capability it needs to ensure that 
the food on our table is safe and reliable.
    Mr. Chairman, I appreciate the opportunity to participate 
in this hearing today. I look forward to hearing from our 
witnesses to learn how we can work together to strengthen our 
Nation's food safety system and prevent senseless preventable 
deaths, like that of Shirley Almer.
    [The prepared statement of Senator Franken follows:]

                 Prepared Statement of Senator Franken

    Thank you Mr. Chairman. It is an honor to be here today, 
and I thank you for holding this hearing on such a critical and 
timely topic to the health of Minnesotans, and our Nation.
    With the recent outbreaks like E. coli in spinach and 
Salmonella in peanut butter, we all understand how serious the 
threat of contamination is to our food supply. We have heard 
repeatedly and correctly that our current food safety system is 
broken. The system relies heavily on reacting to outbreaks 
after they have occurred, instead of preventing their 
occurrence in the first place.
    Once an outbreak has been identified, it then takes far too 
long to track, contain, and remove the offending substance 
within the food chain. We need Federal legislation now so we 
can bring our country's food safety system into the 21st 
century.
    I am proud to come from a State with a strong public health 
tradition. Minnesota is regarded as the leader in early 
detection of foodborne diseases, and we have a long record of 
working effectively with the FDA on food safety. Minnesota has 
been home to the Homeland Security National Center for Food 
Protection and Defense since its inception in 2004. The 
Minnesota Department of Health was recently awarded a 3-year 
cooperative agreement with the FDA to establish a Food 
Protection Rapid Response Team.
    This award will help Minnesota adopt FDA's 10 
``Manufactured Food Regulatory Program Standards,'' enabling 
better communication between agencies responsible for food 
safety, and quicker action in the event of a problem.
    Right now, the FDA is unable to properly oversee our food 
safety system because the agency lacks resources and authority 
in four key areas: (1) oversight of imported food products and 
ingredients; (2) access to food production records; (3) 
mandatory recall of contaminated foods; and (4) the ability to 
trace the origin of food products. I'm very pleased that S. 510 
will move us forward in each of these areas, and bring peace of 
mind to American families.
    With regard to imported foods--we can do everything right 
with our food products here in the United States, but the 
reality is that about 15 percent of our food is imported from 
other countries. The FDA must be given the authority to verify 
that foods coming into this country are safe, so we can avoid 
situations like the 2007 melamine contamination in infant 
formula and pet food.
    We must also ensure that FDA is equipped to address 
circumstances within the United States. For example, in late 
2008, the Minnesota Department of Health noticed an elevated 
number of Salmonella cases. After comprehensive investigations, 
the Department of Health identified the King Nut brand of 
peanut butter as the culprit, produced by the Peanut 
Corporation of America (PCA). This contamination and the 
subsequent investigation led to the recall of more than 2,000 
products from our shelves, and is estimated to have cost the 
industry nearly $1 billion. But if we were able to trace foods 
back to their producers, we would have withdrawn the 
contaminated foods much more quickly and saved lives and 
prevent illness.
    But the greatest cost was to American families. Over 700 
became ill and 9 died as a result of the PCA outbreak, 
including Shirley Almer, a Minnesota mother of three sons, who 
had survived brain cancer, and was in good health at the time 
of the outbreak.
    To me, the most egregious part of this story is that PCA 
knew that the peanut products sent to our markets were tainted. 
Third-party inspections in 2007 and 2008 had already found 
Salmonella contamination in 12 different tests. PCA's 
inspection reports were glowing, and showed no evidence of the 
problems present within the facility. This is a clear 
indication we need to increase the number of food inspections, 
it's equally important to strengthen the integrity of these 
inspections--like having a certification process for 
inspectors.
    We all agree food safety is a top priority for our families 
and our country. And I support giving FDA the resources and 
capabilities it needs to ensure the food on our tables is safe 
and reliable. Mr. Chairman, I appreciate the opportunity to 
participate in this hearing today. I look forward to hearing 
from our witnesses to learn how we can work together to 
strengthen our Nation's food safety system, and prevent 
senseless, preventable deaths like Shirley Almer's.

    The Chairman. Thank you very much, Senator.
    Well, we're privileged to have with us the lead sponsor of 
S. 510, Senator Durbin. I first want to congratulate you and 
Senator Gregg, Senator Isakson, all of you that have worked on 
this bill. When I look at the supporters, the American Feed 
Industry Association, Frozen Food Institute, Center for Science 
in the Public Interest, Consumer Federation of America, 
Consumers Union, Food Marketing Institute, Grocery 
Manufacturers of America, National Fisheries Institute, 
National Restaurant Association, Trust for America's Health--
that's pretty impressive. So, I thank you for all the great 
work you've done to lay the groundwork for this. And I might 
just say that we really do want to mark up this bill and get it 
through, Senator Durbin, because I'd like you to start calling 
me by my first name again, ``Tom.'' What I mean by that is, 
every time I see Senator Durbin, all he says is, ``Food 
safety.''
    [Laughter.]
    I began to check my driver's license to see if my name had 
changed. So, that's just my obtuse way of saying that I know of 
no one who has been more persistent on this issue than Senator 
Durbin.
    Welcome to the committee, Senator Durbin.

                      Statement of Senator Durbin

    Senator Durbin. Thank you, Mr. Chairman and Senator Enzi. 
Thank you both for allowing me to come before you, today.
    I understand that this great committee has had two 
challenges, over the course of this Congress, with the illness 
of the great Ted Kennedy, our former chairman, and, of course, 
the focus rightly paid to healthcare reform. This committee did 
an extraordinary job in moving that issue forward. So, I was 
prepared to wait my turn, and I'm glad it's come today.
    I thank Senator Gregg for being my cosponsor, Senator 
Isakson, Senator Burr, and so many others who have made this a 
strong bipartisan bill.
    It's an honor to be here with Dr. Hamburg, from the FDA and 
Caroline Smith DeWaal. People who aren't here, and should be, 
include Nancy Donnelly, of Safe Tables Our Priority, who really 
raised my attention to this issue many, many years ago, when 
Nancy, living in Chicago, gave hamburger, bought at a local 
store, to her 6-year-old son Alex, who died within a matter of 
days from E. coli contamination. She's dedicated her life to 
food safety. I am here today because she hand-wrote a letter to 
me and told me this story. Though she didn't live in my 
congressional district, it touched my heart, and I decided I 
had to do something about it.
    It's been a long time coming, to put together this 
coalition that you just enumerated. And I hope it's an 
indication of a lot of hard work that's gone into this. There's 
more to be done. We can make this a better bill. But, I think 
we should seize this opportunity, this once-in-a-political-
lifetime opportunity, to do something significant on food 
safety.
    The numbers are overwhelming. The fact is that every 5 
minutes, three people in America are rushed to the hospital 
because of food illnesses. And sadly, at the end of the day, 13 
of those people will die, every single day, because of food 
illness in America.
    I have here a photograph of a lovely lady. Her name is 
Marianne Westerman, of Mendota, IL, a small town outside of 
Chicago. She's 80 years old. She's here with her grandson. She 
couldn't wait for the Labor Day weekend, to get together with 
her family. Marianne, a great cook, decided she'd make a salad 
before she drove up to Chicago to meet with the grandkids and 
all the members of the family. So, she reached in and took out 
a bag of spinach from her refrigerator. She thought this was a 
good, healthy food to give to her family. Hours after eating 
that spinach, Marianne Westerman was sprawled across her 
bathroom floor, vomiting violently and experiencing 
uncontrollable diarrhea. Then her kidneys failed. Marianne 
never made it to Chicago to see her family. Instead, she went 
straight to the hospital for 6 weeks. She was diagnosed with E. 
coli, and it was literally a life-and-death struggle as to 
whether she would survive. Thankfully, she did. But, the 
quality of her life will never be the same because of the bag 
of spinach that she used for that salad.
    Americans ought to be able to trust the products they buy 
in the stores, spinach and so many others.
    Our country has a good system, but we can make it better. 
There are far too many lives--and we've heard two other 
examples, here, of people who innocently use food products and 
lives are changed forever.
    FDA is a great agency. I really am a big fan. And they are 
working within the constraints of outdated laws, limited staff, 
and limited funding. They have been set up to react to 
outbreaks of contamination, and they do it well.
    This bill, that we're considering today, would empower the 
FDA to prevent the outbreaks. Until we can prevent widespread 
contamination, businesses will take the hit every time 
consumers lose confidence.
    Johnny Isakson, my colleague from Georgia, knows this story 
better than most. When it comes to the product, of course, of 
peanut butter. Americans love their peanut butter. But, the 
salmonella outbreak at Peanut Corporation of America led to one 
of the largest product recalls in history. This is the printout 
from the FDA, warning people not to buy the following products 
containing peanuts in America. There's a list of more than 
3,900 products included in this FDA warning. Not surprisingly, 
Americans didn't stop at those 3,900; they stopped buying 
peanut butter. What impact did that have on this major food 
industry in America? It ended up costing them over $1 billion 
because of the contamination in one plant in Georgia.
    Now, last summer--this is a show-and-tell--last summer, it 
was tomatoes. We remember that story, don't we? We were told, 
initially, tomatoes were responsible for a salmonella outbreak. 
So, retailers took tomatoes off shelves across America. 
Wholesalers destroyed their tomato supplies and tomato farmers 
were stuck with a product nobody wanted. We should have 
applauded this rapid response, but it turned out it was just 
plain wrong. The source of the contamination was not tomatoes. 
In the end, we found out, 6 weeks later, that the real source 
of the salmonella were jalapeno peppers imported from Mexico. 
Because of this mistake, tomato growers across America lost 
$150 million in product. Meanwhile, until the source was 
identified, more people got sick.
    The FDA Food Safety Modernization Act will give the Food 
and Drug Administration the resources and authority to quickly 
trace food-borne illness back to the source, prevent millions 
of cases, like Marianne's, each year, save industries, save 
businesses, like spinach, peanuts, tomato, so many others. And 
I think it's something we need to seize right now and do.
    This is our chance. I've been waiting for a long time for 
this moment, to have this kind of bipartisan support. And, 
Senator Harkin, I'm going to call you ``Tom'' again as soon as 
you report this bill.
    [Laughter.]
    But, until then, I'm going to work with you to make sure we 
get this to the floor. And I'm going to leave this, because I 
know, as a new chairman, you'd like to treat your committee to 
lunch----
    [Laughter.]
    Senator Durbin [continuing]. And I trust that all of these 
products have been safely inspected.
    I thank you for this opportunity to testify.
    [The prepared statement of Senator Durbin follows:]

                  Prepared Statement of Senator Durbin

    Thank you, Chairman Harkin and Senator Enzi. I also want to 
thank Senator Gregg and Burr, who worked closely with my staff 
and staff to the late Senator Kennedy to develop a strong, 
bipartisan bill.
    I think what you will hear from today's witnesses is that 
there is growing consensus among consumer advocates, public 
health officials and the food industry that we need to update 
our food safety laws.
    Every year, 76 million Americans suffer from a preventable 
food-borne illness, 325,000 are hospitalized, and 5,000 die. 
That means that every 5 minutes--3 people are rushed to the 
hospital because the food they ate made them sick. And at the 
end of each day--13 will die.

                            MARY ANN'S STORY

    This is Mary Ann Westerman of Mendota, IL. Mary Ann is 80 
years old. She's pictured here with her grandson.
    On Labor Day weekend, Mary Ann made a salad before driving 
to Chicago to meet her family. She took some spinach out of the 
refrigerator--a food she knew was healthy and assumed was safe. 
Hours after eating the spinach, Mary Ann Westerman was sprawled 
across her bathroom floor--vomiting violently and experiencing 
uncontrollable diarrhea. Then her kidneys failed.
    Mary Ann never made it to Chicago to see her family. 
Instead, she went to the hospital for 6 weeks, was diagnosed 
with E. coli, and received medical treatment through a hole in 
her neck.
    Thankfully, Mary Ann is still alive, but the quality of her 
life will never be the same. Americans ought to be able to 
trust the spinach that is in their refrigerator.
    This country has a good system, and most of our food is 
safe. But there are far too many lives--like Mary Ann's--that 
have been compromised by food-borne illness.

                      REFORM IS GOOD FOR BUSINESS

    FDA is working within the constraints of outdated laws, 
inadequate staff, and not enough funding. FDA has been set up 
to react to outbreaks of contamination.
    The bill this committee is considering today would empower 
FDA to prevent outbreaks. Until we can prevent widespread 
contamination, businesses will take the hit every time 
consumers lose confidence.
Peanut Butter
    Take peanut butter for example. Americans love peanut 
butter. But the salmonella outbreak at Peanut Corporation of 
America, led to one of the largest product recalls in history.
    Look at this list of the more than 3,900 peanut-related 
products that were recalled. Not surprisingly, Americans 
stopped buying food with peanuts in it. Because of the 
irresponsible conduct of one corporation, the entire peanut 
industry suffered. By some estimates, the industry lost almost 
$1 billion.
Tomatoes
    Last summer we thought tomatoes were responsible for a 
salmonella outbreak. So retailers took tomatoes off shelves. 
Wholesalers destroyed tomato supplies. Tomato farmers couldn't 
sell. We would have applauded this rapid response if tomatoes 
were actually the source of the contamination. Turns out they 
were not!
    It took almost 6 weeks before the real source of the 
salmonella contamination--Jalapeno peppers from Mexico--was 
discovered. Because of this mistake, tomato growers across the 
country lost almost $150 million. Meanwhile, until the source 
of the problem was identified, more people grew ill.

                               CONCLUSION

    The FDA Food Safety Modernization Act will give FDA the 
resources and authority to quickly trace food borne illnesses 
back to their source. We can prevent millions of cases like 
Mary Ann's each year.
    We can save industries--like spinach, peanuts and 
tomatoes--millions of dollars each year. I commend this 
committee for considering this bill to modernize our food 
safety system and urge your support for S. 510.

    The Chairman. Senator Durbin, thank you again for your 
great leadership and your persistence in this effort. No pun 
intended, but it's coming to fruition. We intend to move ahead 
with a markup as soon as possible and get this to the floor. 
But, thank you for a very provocative statement--provocative in 
a good sense--provoking our thinking that we really have to do 
something on this, and we really have to do it very soon.
    I recognize your leadership. And I know how busy you are. 
We thank you for appearing before the committee, and we'll do 
our darndest to get it done.
    Thank you very much, Senator Durbin.
    Before we turn to Dr. Hamburg, I would recognize Senator 
Dodd, who has been so wrapped up in healthcare reform. We're 
glad to see you here, at the committee----
    Senator Dodd. Nice to be with you.
    The Chairman [continuing]. From the healthcare reform 
endeavors you've been involved in. We thank you, very much, on 
behalf of all the committee, for everything you've done in your 
leadership on healthcare reform. You're recognized.

                       Statement of Senator Dodd

    Senator Dodd. Well, very, very briefly, Mr. Chairman, 
because we've got the commissioner here.
    Let me commend Senator Durbin, on his way out, for his 
tireless efforts on this behalf, and all of those who are 
gathered in the room here today who have such a strong interest 
in the subject matter, and Mike Enzi, who I've enjoyed working 
with, as well, on this matter, and the fact you've been able to 
pull this together. Hopefully, we can move forward with it.
    Obviously the information you've heard--I was stunned to--
you read these numbers, and it's hard to believe that they're 
as dramatic as they are, but here we lose--there are 76 million 
illnesses every year--325,000 hospitalizations, 5,000 deaths 
each year--at a cost of almost $7 billion, but all related to 
this subject matter.
    All of us know of stories in our own States. Haley 
Bernstein, of Wilton, CT, 3 years old, became ill, eating 
lettuce contaminated with E. coli. It has been quite an ordeal. 
She spent 14 weeks in the hospital, suffered kidney failure, 
had a seizure that led to bleeding in the brain, and temporary 
blindness. As a result of her illness she developed diabetes. 
Her food-borne illness occurred more than a decade ago, and she 
lives with the effects every single day of her life since then. 
She also has a vision deficit, weakness in her right side, and 
suffers from reduced kidney function. She's been on insulin 
pump for 7 years. She's one of the lucky ones. She survived.
    These stories get repeated day after day in every 
jurisdiction across the country. And so, this legislation has a 
sense of urgency to it that I hope all of us can appreciate.
    I just want to express my gratitude to the committee, and 
to others as well, to include the legislation we've offered 
dealing with food allergies. Again, this is--watching the 
peanut butter being held up, here--obviously it's a great 
source--I look at my friend from Georgia, here, knowing the 
importance of peanut butter in Georgia.
    For my little girl, Grace, it's a lethal product for her, 
until we come up with a non-allergic alternative. She's been in 
anaphylactic shock four times. She's 8 years old. And she's 
been near death on four occasions with airborne allergies; she 
doesn't have to ingest them, she just has to be in the presence 
of them, with things like cashews and others, things like 
citrus and shellfish and other items. So, the fact that we've 
got some provisions in here--by the way, my interest in it 
predates the birth of my child--going back to food labeling 
issues, as well as dealing with EpiPens and the safety of them, 
where there were recalls involved, and then becomes very 
personal when you have a child affected by it. Twelve million 
people in our country are affected by food allergies. Thank 
God, most of them are not as seriously affected as my daughter 
is, but many are. And, the fact that we're including something 
here dealing with that--the guidelines in grants to States, so 
they can develop some guidelines in developing the safety 
standards for people across the country--has great value, as 
well.
    I thank you, Mr. Chairman, for the bill and the efforts and 
the fact that everyone's so deeply involved in these questions. 
It means a great deal. And I thank you for that.
    I apologize to you, Madam Commissioner, if I can't stay for 
all of the hearing, but to hear your comments, as well. We're 
so pleased you are where you are. You bring a wonderful set of 
credentials to this. I had a wonderful chance to meet earlier 
and talk, and so forth, so I thank you.
    And thank you, Mr. Chairman, for your leadership on this, 
as well.
    The Chairman. Thank you, Senator Dodd.
    Dr. Margaret Hamburg was confirmed on May 18, 2009, by 
unanimous Senate vote, to become the 21st Food and Drug 
Commissioner. The second woman to be nominated for that 
demanding position, Dr. Hamburg is exceptionally qualified for 
her new job by her training and her experience as medical 
doctor, scientist, and public health executive. In 1990, Dr. 
Hamburg joined the New York City Department of Health and 
Mental Hygiene as Deputy Health Commissioner and, within a 
year, was promoted to commissioner, a position she held until 
1997. In 1994, Dr. Hamburg was elected to the membership of the 
Institute of Medicine, and one of the youngest persons to be so 
honored. Three years later, President Clinton appointed her to 
the position of Assistant Secretary for Policy and Evaluation 
in U.S. Department of Health and Human Services. And, of 
course, President Barack Obama nominated her for the FDA 
Commissioner on March 25, 2009.
    So, Dr. Hamburg, again, congratulations on your assuming 
this position. We welcome you to the committee. Without any 
objection, your statement will be made a part of the record in 
its entirety. And we ask you to please proceed as you so 
desire.

 STATEMENT OF MARGARET HAMBURG, M.D., COMMISSIONER, U.S. FOOD 
             AND DRUG ADMINISTRATION, WHITE OAK, MD

    Dr. Hamburg. Thank you very much, and good morning, 
Chairman Harkin, Ranking Member Enzi, and members of the 
committee.
    I am Dr. Margaret Hamburg, Commissioner of the Food and 
Drug Administration. Thank you, for this opportunity to discuss 
issues in food safety, especially the pending food safety 
legislation.
    Let me first commend you, Mr. Chairman, for your leadership 
and longstanding commitment to improving food safety. I also 
would like to thank the members of this committee and their 
staffs who worked hard on this important legislation, as well 
as Senator Durbin, the lead sponsor.
    Food safety is a core public health issue. Every year, 
millions of people in our country suffer from food-borne 
illness, hundreds of thousands are hospitalized, and thousands 
die. This does not need to happen. And we have a historic 
opportunity to see that it doesn't.
    We are joined by a coalition of consumer groups fighting 
for improvements in our food safety system and by major sectors 
of the food industry, who are advocating as well, for 
fundamental change.
    FDA is the Federal agency responsible for overseeing the 
safety of the food supply, except for meat, poultry, and 
processed egg products, which are overseen by our partners at 
the U.S. Department of Agriculture. Ensuring that foods are 
safe and secure is a vital part of the FDA's mission. And FDA 
is committed to ensuring that the U.S. food supply continues to 
be among the safest in the world.
    President Obama has made a strong commitment, as well, 
calling food safety one of the most fundamental 
responsibilities of government. On July 7th, a Food Safety 
Working Group established by the President issued its key 
findings on how to strengthen and modernize the food safety 
system for the 21st century, based on three core principles: 
prioritizing prevention, strengthening surveillance and 
enforcement, and improving response and recovery.
    The comprehensive food safety bill that you're considering, 
the FDA Food Safety Modernization Act, sponsored by a number of 
members of this committee, includes many of the authorities 
identified as vital by the Working Group.
    From FDA's perspective, there are three key questions that 
must be asked about food safety legislation: Does the 
legislation refocus the system to place a greater emphasis on 
prevention? Does the legislation provide FDA the legal tools 
necessary to carry out its existing and new food safety 
responsibilities? And does the legislation provide or 
anticipate resources for the agency to match its 
responsibilities? I'd like to address each of these questions 
in turn.
    First, Does the legislation refocus the system toward 
prevention? The legislation would, indeed, shift FDA's approach 
to food safety from one that reacts to outbreaks to one that 
seeks to prevent them in the first place. Key provisions in the 
legislation relevant to the goal of prevention include section 
103, which requires facilities to conduct hazard analyses and 
implement preventive control plans. Section 105 requires 
adherence to science-based safety standards for fresh produce 
to minimize the risks of serious adverse health consequences. 
These and other provisions are critical to modernizing our food 
safety system and improving health outcomes.
    Second, Does the legislation provide FDA the legal tools 
necessary to carry out its existing and new responsibilities? 
S. 510 represents a comprehensive and significant modernization 
of the food safety system and provides FDA with some essential 
legal tools. For example, section 301, the Foreign Supplier 
Verification Program, will provide FDA with important 
information about importers and require that importers verify 
the safety of the food they are bringing in. These requirements 
are enforced by a prohibitive act and the ability to refuse 
entry of the food into U.S. commerce. Section 207 provides 
important revisions to the existing standard for the 
administrative detention of foods that could help us prevent 
unsafe food from reaching consumers.
    Other provisions of the bill could be strengthened by 
including effective enforcement mechanisms and other legal 
tools. For example, S. 510 does not provide FDA with explicit 
authority to access food records during routine inspections. 
Such access is critical to our ability to assure the ongoing 
implementation of appropriate preventive measures and safety 
standards. This is one of the most significant gaps in FDA's 
existing authority.
    Section 103 outlines requirements for hazard analysis and 
risk-based preventive controls. However, the effectiveness of 
this provision would be greatly strengthened if it deemed food 
that violates this section as ``adulterated,'' rather than 
simply creating a prohibited act. That would allow FDA to seize 
foods in domestic commerce or refuse imports of products if not 
in compliance.
    Third, Does the legislation provide or anticipate resources 
for the agency to match its new responsibilities? Section 201 
provides a mandate for FDA to achieve specified frequencies of 
inspection based on risk. Inspections are a critical element to 
ensuring high rates of compliance with the preventive control 
standards. And that is essential to improvements in food 
safety. We embrace the intent of section 201, but our concern 
is that the bill does not provide a guaranteed, consistent 
funding source to help FDA fulfill its new responsibilities. 
The Administration supports inclusion of a registration fee, as 
provided in the President's budget, which could be used, in 
part, to fund this inspection mandate.
    We also suggest the inclusion of language that provides FDA 
flexibility to adjust the inspection frequencies, as 
appropriate, and language authorizing FDA to use accredited 
third parties to meet the inspection frequency for foreign 
facilities.
    Mr. Chairman, this is a historic moment for food safety in 
the United States, a moment for FDA, with our important 
partners at the State and local level, as well as 
internationally, to rise to the challenges of the 21st century. 
The legislation is a major step in the right direction. I look 
forward to working with you on this legislation.
    Thank you, again, for the opportunity to discuss this 
important legislation with you this morning. I'd be happy to 
answer any questions you may have.
    [The prepared statement of Dr. Hamburg follows:]
            Prepared Statement of Margaret A. Hamburg, M.D.
                              introduction
    Good morning, Chairman Harkin and members of the committee. I am 
Dr. Margaret Hamburg, Commissioner of Food and Drugs at the Food and 
Drug Administration (FDA or the Agency), which is part of the 
Department of Health and Human Services (HHS). Thank you for the 
opportunity to appear before you today to review current issues in food 
safety, especially pending food safety legislation that is of great 
interest to this Administration. I would first like to commend you, Mr. 
Chairman, for your leadership and your long-standing commitment to 
improving food safety. I also would like to commend many members of 
this committee and their staffs for their work on this important 
legislation, as well as Senator Durbin, the initial sponsor.
    By way of background, FDA is the Federal agency that is responsible 
for overseeing the safety of the food supply except for meat, poultry, 
and processed egg products, which are overseen by our partners at the 
U.S. Department of Agriculture (USDA). Ensuring that foods are safe and 
secure is a vital part of FDA's mission, and FDA is committed to 
ensuring that the U.S. food supply continues to be among the safest in 
the world.
    Food safety is a core public health issue. Every year, millions of 
people in the United States suffer from foodborne illness, hundreds of 
thousands are hospitalized, and thousands die. Public health has been 
defined by the Institute of Medicine as ``fulfilling society's interest 
in assuring the conditions in which people can be healthy.'' A 
precondition for health is having access to safe food.
    Food can become contaminated at many different steps--on the farm, 
in processing or distribution facilities, during transit, at retail and 
food service establishments, and in the home. Over the years, we have 
made progress to prevent both intentional and unintentional 
contamination of food at each of these steps. However, changes in 
consumer dietary patterns, changes in industry practices, changes in 
the U.S. population demographics, evolving pathogens, and an 
increasingly globalized food supply chain pose challenges that are 
requiring us to adapt our current food protection strategies.
    President Obama has made a personal commitment to improving food 
safety. In March 2009, President Obama stated that protecting the 
safety of our food and drugs is one of the most fundamental 
responsibilities our government has, and established the President's 
Food Safety Working Group. On July 7, the Working Group issued its key 
findings on how to upgrade the food safety system for the 21st century. 
The Working Group recommends a new public-health focused approach to 
food safety based on three core principles: prioritizing prevention, 
strengthening surveillance and enforcement, and improving response and 
recovery.
    The Working Group noted the need to modernize the food safety 
statutes to provide key tools for FDA, the Food Safety and Inspection 
Service at USDA, and other components of the Federal Government to keep 
food safe. Some of the necessary legislative authorities highlighted in 
the findings include:

     enhanced ability to require sanitation and preventive 
controls at food facilities, based on a scientific hazard analysis;
     the ability to access basic food safety records at 
facilities;
     enhanced ability to use resources flexibly to target food 
at the highest risk and achieve the maximum gain for public health;
     enhanced ability to establish performance standards to 
measure the implementation of proper food safety procedures; and
     the ability to require mandatory recalls.

    A food safety bill recently passed by the House of Representatives, 
H.R. 2749, the ``Food Safety Enhancement Act of 2009,'' addresses all 
of the above authorities and includes many of the other key 
recommendations of the Working Group.
    The comprehensive food safety bill under consideration in the 
Senate is S. 510, the ``FDA Food Safety Modernization Act.'' Its 
sponsors include many members of this committee. It also includes many 
of the authorities identified as important by the Working Group, such 
as preventive controls and mandatory recall authority.
    These bills illustrate that there is broad agreement on the general 
direction of food safety reform toward an improvement of risk-based 
preventive controls to reduce foodborne illness, a public health goal 
we all share. These legislative initiatives share the core principles 
identified by the Working Group: prioritizing prevention, strengthening 
surveillance and enforcement, and improving response and recovery.
    A coalition of consumer groups is fighting for improvements in the 
food safety system so that more families do not have to suffer tragic 
consequences from foodborne disease. Major sectors in the food industry 
also support and are advocating for fundamental change.
    But even with the President's support--even with the full efforts 
of HHS and USDA and other Federal, State, local, tribal, and 
territorial food safety partners--and even with the backing of consumer 
groups and industry, our efforts will fall short unless Congress 
modernizes food safety laws to deal with the challenges of the 21st 
century.
                        food safety legislation
    From FDA's perspective, there are three key questions to ask about 
food safety legislation:

      First, does the legislation refocus the system to place 
greater emphasis on prevention?
      Second, does the legislation provide FDA the legal tools 
necessary to match its existing and new food safety responsibilities?
      Third, does the legislation provide or anticipate 
resources for the Agency to match its responsibilities?

    I will focus on S. 510 for a discussion of these questions. I will 
address each of these three questions in turn and highlight a few of 
the many important authorities in this bill.
    Does the legislation support a new food safety system focused on 
prevention?
    The legislation would indeed transform FDA's approach to food 
safety from a system that far too often responds to outbreaks rather 
than prevents them. It would do so by requiring and then holding 
companies accountable for understanding the risks to the food supply 
under their control and then implementing effective measures to prevent 
contamination.
    FDA is eager to further the development of this modern system. 
Working with the Centers for Disease Control and Prevention and our 
partners at USDA, as well as with industry, consumers, States, 
localities, and other key stakeholders, we are working to establish 
basic standards for preventive controls. This system will make our 
overall approach and philosophy to food safety more consistent across 
government.
    Key provisions in the legislation relevant to this goal include 
section 103, which requires facilities to conduct hazard analyses and 
write and implement a preventive controls plan. Section 105 requires 
adherence to science-based safety standards for fresh produce to 
minimize the risk of serious adverse health consequences or death. 
These, and other provisions, are critical to modernizing our Nation's 
food safety system.
    Does the legislation provide FDA the legal tools necessary to match 
its existing and new responsibilities?
    In the modernized food safety system envisioned by the legislation, 
FDA has the fundamental responsibility of overseeing and verifying the 
implementation of preventive measures by hundreds of thousands of 
companies. The Agency also retains the existing critical role of 
protecting the public during an outbreak. FDA needs new legal 
authorities to be able to succeed in these roles and protect the public 
health.
    The Senate bill, S. 510, represents a comprehensive and significant 
modernization of the food safety system and provides FDA with some 
essential legal tools. For example, section 301 (Foreign Supplier 
Verification Program) will provide FDA with important information about 
importers and require that they verify for each supplier that food is 
not adulterated and is in compliance with allergen labeling 
requirements, preventive control requirements, and safety standards for 
produce. These requirements are enforced by a prohibited act and 
refusal of entry. These new requirements will help reduce risks to 
consumers from potentially harmful products by requiring importers to 
take appropriate steps to protect product safety.
    Section 207 provides important revisions to the existing standard 
for the administrative detention of foods. The current standard of 
``credible evidence or information'' of ``a threat of serious adverse 
health consequences or death to humans or animals'' is too high given 
that a key purpose of the provision is to provide time to gather 
information regarding the product's potential to cause significant 
harm. As a result, the existing authority is often not useful in 
situations where it otherwise could help us prevent or minimize the 
harmful effects of an adulterated or misbranded food.
    Other provisions of the bill, however, need to be strengthened by 
including effective enforcement mechanisms and other legal tools. For 
example, S. 510 does not provide FDA with explicit authority to access 
food records during routine inspections, one of the key authorities 
identified by the Working Group. Routine records access is a critical 
component of a food safety regulatory framework and is one of the most 
significant gaps in FDA's existing authority. Although FDA has routine 
records access for certain other FDA-regulated products, and USDA has 
routine records access for USDA-regulated products, FDA does not have 
explicit authority for routine access to records for the vast majority 
of foods under its jurisdiction. This authority is essential to enable 
FDA to identify problems and require corrections before people become 
ill. Under current limited authority, FDA generally only has access to 
required records during an emergency situation involving serious 
threats to health or life. Routine records access also enables the 
Agency to verify during routine inspections that firms are maintaining 
the required records. An investigation this year by the HHS Office of 
Inspector General found significant lapses in compliance with 
recordkeeping requirements.
    Another key legal tool that is not included in S. 510 involves 
information sharing. Enhancing FDA's information sharing authority is a 
critical element of an integrated Federal/State system and is also 
essential for effective public health communications with FDA's 
international regulatory partners. The Working Group highlighted the 
need to improve information sharing during a foodborne illness outbreak 
to speed the epidemiological investigation and traceback of the source 
of the illnesses to protect consumers and help industry recover faster. 
FDA recommends that language be included similar to that in section 
112(b) of H.R. 2749. Under that provision, FDA may provide Federal 
agencies, State and local government agencies, foreign government 
agencies, and certain international organizations both confidential 
commercial and trade secret information relating to food with 
provisions to ensure its confidentiality, consistent with international 
obligations. FDA may also receive such information from such agencies 
and organizations and maintain its confidentiality. When necessary to 
protect public health, FDA may also disclose to other persons 
confidential commercial information relating to food, provided those 
persons maintain the information's confidentiality. Such information 
sharing is critical for building an integrated food safety system 
partnership.
    Section 103 of S. 510 outlines requirements for conducting a hazard 
analysis and implementing risk-based controls. This authority is an 
essential component of a modern food safety system. However, the 
effectiveness of this provision would be greatly strengthened if it 
deemed food that is in violation of this section as ``adulterated,'' as 
in the House bill. As currently drafted, S. 510 addresses enforcement 
via the creation of a prohibited act. Creation of a prohibited act 
would support an injunction but would not provide a legal basis, for 
example, for a seizure, administrative detention (as amended by the 
legislation), or refusal of admission of imported food from a facility 
that is not in compliance with the requirements. We encourage this 
committee to include an effective enforcement mechanism, as provided in 
the comparable section of H.R. 2749. That would make this section 
consistent with most other enforcement mechanisms in the Federal Food, 
Drug, and Cosmetic Act.
    Similarly, section 105, which authorizes mandatory safety standards 
for fresh produce, addresses enforcement via the creation of a 
prohibited act. As explained above, this means that FDA may not seize 
or refuse admission of fresh produce because it is not in compliance 
with the requirements. Section 105 provides important authorities that 
will help prevent foodborne illnesses only if the standards are 
effectively implemented and enforced; therefore, it is essential to 
have effective tools for enforcing these requirements.
    Section 204 (Enhanced Traceback and Recordkeeping) does not include 
any type of enforcement mechanism. To encourage compliance and to have 
consequences for lack of compliance with these important requirements, 
it is necessary to include an effective enforcement mechanism.
    Does the legislation provide or anticipate resources for the Agency 
to match its new responsibilities?
    An important element of S. 510 is that it provides FDA a mandate to 
achieve specified frequencies of inspection based on risk. Inspections 
are a critical element to ensuring high rates of compliance with the 
preventive control standards and other food safety performance 
standards that will help drive improvement in food safety and reduced 
rates of foodborne illness.
    FDA supports the intent of section 201 to require a minimum 
inspection frequency based on risk. However, we are concerned that the 
bill does not provide a guaranteed consistent funding source to help 
FDA fulfill its new responsibilities. The Administration supports 
inclusion of a registration fee, as provided in the President's Budget 
for fiscal year 2010, which could be used, in part, to fund this 
inspection mandate. We also suggest the inclusion of language that 
provides FDA flexibility to adjust the inspection frequencies. Further, 
we suggest adding language to authorize FDA to use accredited third 
parties, such as foreign regulatory agencies, to meet the inspection 
frequency for foreign facilities.
    FDA supports the bill's inspection goals for domestic food 
facilities. However, food imports present a significant resource 
challenge. It is important that food imports meet the same requirements 
as domestic products, and we are pleased that the bill provides FDA 
with new tools to help ensure they do, including the requirement that 
importers verify that their foreign suppliers are in compliance and the 
authorization to require certification of compliance for imported food 
under certain circumstances.
    FDA plans to increase inspection of foreign food facilities, but we 
are concerned that the bill's foreign inspection mandate may not result 
in the best use of FDA's resources, in light of the approximately 
230,000 registered foreign facilities (as of the beginning of this 
month) and the high cost of overseas inspections. We think we can 
achieve cost-effective oversight of imports by working with foreign 
governments, using the bill's new tools for import oversight, 
supporting a strong accredited third-party inspection program, and 
increasing targeted, risk-based foreign inspections, consistent with 
the United States' international trade obligations.
    We are committed to working with Congress to ensure that FDA has 
sufficient resources, including fees, to carry out its inspection 
mandate. This will be essential to our success. We note that the 
current inspection mandate in the bill will far outstrip our current 
resources.
    It is also of critical importance to provide resources to help 
build the capacity of our State and local food safety partners. FDA 
supports section 205(d) of S. 510, which reauthorizes appropriations 
for food safety capacity-building grants. Grants that could be extended 
over multiple years, if the State meets FDA performance standards, 
would be especially helpful by providing greater certainty and 
continuity for the grant recipients, thus encouraging their 
participation in the food safety program.
                               conclusion
    This is a historic moment for food safety in the United States--a 
moment for FDA and its sister agencies in the Federal Government to 
rise to the challenges of the 21st century. Success means fewer 
hospitalizations and deaths, fewer economically devastating recalls, 
and greater health for the American people.
    The legislation is a major step in the right direction toward 
achieving the recommendations of the President's Food Safety Working 
Group. I look forward to working with you to address both the issues 
raised here today and any other matters of concern.
    Thank you again for the opportunity to discuss FDA's perspective on 
pending food safety legislation and the Administration's interest in 
improving food safety. We understand that the Administration may have 
additional views on this legislation. I would be happy to answer any 
questions.

    The Chairman. Dr. Hamburg, thank you very much for your 
statement. As I said, your total statement will be a part of 
the record in its entirety.
    You mentioned section 103 and HACCP. Let me just start 
there, if I might.
    Dr. Hamburg. OK.
    The Chairman. The FDA already makes use of preventative 
control programs for food safety. You have the Hazard Analysis 
and Critical Control Points in juice and seafood, but not in 
other foods. In 1996, FDA conducted a pilot program to consider 
expanding HACCP requirements to other foods, yet this expansion 
has not occurred. Can you tell us, either now or provide for 
us, what was learned from the 1996 pilot study and these HACCP 
programs to indicate the effectiveness of preventative control 
programs in food safety?
    I might just add to that issue, from my years of service on 
the Agriculture Committee, we fought long and hard, over many 
years, to get the HACCP program in agriculture, and for meat 
and meat products and it's worked quite well, quite frankly. 
So, I'm just wondering, What's happened with FDA? Has it worked 
all right with juice and seafood? Has it not been expanded? And 
you said 103 does do that, I guess----
    Dr. Hamburg. Yes.
    The Chairman [continuing]. In 510.
    Dr. Hamburg. I think we have seen, in a number of domains, 
that the HACCP approach and the implementation of a risk-based 
hazard-control approach is extremely beneficial to 
strengthening food safety and reducing risks. I do believe that 
this legislation is an opportunity for FDA to move forward in 
important ways to really refocus on the importance of 
prevention on the opportunity to put in this kind of a risk-
based approach, not just in the areas of seafood and juice, 
where we are currently employing that approach, but in the 
broader array of areas, so that, no matter what the food 
product, we can, in a systematic way, working with the 
producer, identify: Where are the points of vulnerability? How 
can those points of vulnerability be shored up? And how can 
FDA, working in partnership with producers, make sure that 
those points of potential risk are eliminated to the greatest 
degree possible?
    The Chairman. Do you know if you or your staff have looked 
at the pilot programs that they did in the late 1990s to see 
what----
    Dr. Hamburg. You know, I can't speak to the details of that 
pilot program, but I'd be happy to provide you with additional 
information.
    But, we do have ongoing real-world experience with this 
risk-based approach, and I think that certainly we in the FDA--
and I think you'll hear from the coalition of others supporting 
this bill--we all feel that the risk-based preventive approach 
reflected in the legislation is the direction that we must go.
    The Chairman. In reading over the testimonies last night, I 
noted that Ms. DeWaal's written testimony advocated requiring 
testing as a part of preventative controls. Now, I just wanted 
to know, do you agree that testing is a necessary component of 
a meaningful preventative control system?
    Dr. Hamburg. Testing is a very important part of a 
preventive control approach. I think that, again, we have real 
opportunities to put in place a more systematic and science-
based approach to testing through this legislation. Also, 
looking forward, we have opportunities to leverage remarkable 
advances in science to improve testing capacity so that we can 
do more onsite, in a real-time way, in order to provide the 
best possible protections to consumers.
    The Chairman. The last point that you brought up was on 
whether the bill provide resources, or anticipate that there 
would be resources, adequate to do the job we're now going to 
require the FDA to do? This has been a continuing battle for 
years. We keep asking the FDA to do more and more, and without 
the resources to do it. So, as we proceed on this, I just want 
you to know that I'm going to be asking for some pretty hard 
figures on what it would require, in terms of appropriations, 
to adequately carry out this food safety system that we are 
now, hopefully, anticipating getting. What will it require? As 
an appropriator, I need to know some pretty hard figures on 
that. Again, I don't want to be in the position of having 
passed a bill that purports to do all these wonderful things, 
and we don't provide the money for it, and we give false hope 
to people that now their food is going to be safer, when we 
don't give you the resources with which to carry it out. So, 
I'm not asking that question now, but I'm just telling you to 
anticipate that I'm going to be coming to you to ask you for 
some pretty hard figures on this, on what it's going to 
require.
    Dr. Hamburg. Mr. Chairman, I appreciate that enormously, 
because it is the case that our mandates and responsibilities 
have far outstripped our resources. We need to be able to have 
in place a comprehensive and effective program with sustained 
funding support, and we will work closely with you, as you move 
forward with this legislation, so that you understand, as 
explicitly as possible, what we think are the needs associated 
with the elements of this legislation.
    The Chairman. Thank you very much.
    My time has expired.
    Senator Enzi.
    Senator Enzi. Thank you, Mr. Chairman.
    I, too, am interested in those cost factors, and I know 
that the FDA has made significant advances in expanding its 
workforce, but I think it's still understaffed in a number of 
areas. The new authorities and requirements in this food safety 
bill would necessitate adding even more staff. What's being 
done to ensure sufficient recruitment, training, and retention 
of food safety employees?
    Dr. Hamburg. This is a very important priority for me, as 
the new commissioner, of course. And we are working hard to, 
No. 1, strengthen and restructure our food safety activities 
within the agency. I've created a new deputy commissioner for 
food safety, and we're aligning the different components of 
food safety, that have been spread throughout the agency, into 
a more integrated organizational structure with more 
accountability, as well as, hopefully, important synergies.
    We have been expanding, in terms of our workforce, over the 
last couple of years, although, to be honest, it's been a bit 
of a roller-coaster ride, in that we had had declining 
resources following the tragedies of 9/11 and the anthrax 
letters, there was a burst of renewed interest in food safety 
and new resources, and then those resources started to decline 
again, so in terms of inspectors and key staff, our numbers 
have been declining. Over the last couple years, we've had a 
new investment in this important area. So, we're rebuilding 
again, training, getting more inspectors out into the field. 
We're also, as this bill suggests, trying to put in place a new 
paradigm, which is this focus on prevention, rather than 
responding to outbreaks. That has also been a major focus of 
effort, to think about how to best approach that.
    And we're spending, also, a lot of time in the field, 
trying to learn more about the concerns of farmers, big and 
small, manufacturers, producers, distributors, so that we can 
shape a program that's truly responsive, and also working with 
partners at the State and local level and internationally.
    Senator Enzi. I'm the accountant, though, so I'm always 
looking for a little more specificity. I'm curious as to how 
many people you're short, at the present time, and how many 
additional people you think will be necessary to do something 
like this bill.
    Dr. Hamburg. As I said, we will work closely with you, in 
terms of providing you with the numbers. We are, over the next 
year or so, expecting to be adding some 350 new people into the 
food safety program, and about 125-plus of those will be in the 
field. We expect, with that, to be able to expand the numbers 
of domestic inspections by about 2,000. Internationally, it 
will be less, because those are more time-consuming and costly 
inspections. Also, ramping up our activities at the border will 
be part of our expanded activities, as well.
    Senator Enzi. And that's what you anticipate even before 
this bill is passed.
    Dr. Hamburg. Yes.
    Senator Enzi. OK. Thank you.
    You mentioned something about a registration fee. How many 
total dollars are you trying to raise? And how would you see 
that broken down among the people that are registering now?
    Dr. Hamburg. All of this does depend on the shape of the 
legislation that emerges, but we do know that, already, the 
demands, in terms of the food safety program, far outstrip the 
resources that we have. And moving forward to take on new 
responsibilities, it will be essential to have that supported 
with adequate resources and sustained, predictable funding. So, 
as I told Chairman Harkin, we will work closely with you and 
provide, our best numbers and statistics with respect to key 
personnel, support systems that are needed. We, along with 
other people, have important investments in IT and other areas, 
in order to put in place the comprehensive program that's 
needed. But, we are really eager to work with you. I understand 
that, actually, our staffs have already been providing 
considerable technical assistance, and we want to continue 
that.
    Senator Enzi. I'm sure that CBO will need some help along 
those lines.
    Dr. Hamburg. CBO has the ultimate expertise in costing out 
a bill. That's not our expertise, that's for sure.
    Senator Enzi. I see that my time is expired.
    I have a whole lot of other questions. I'll submit those in 
writing.
    Dr. Hamburg. I apologize for my lengthy answers.
    Senator Enzi. Lengthy is not a problem, but I'll have to 
get lengthy answers on the other questions from you in writing.
    Dr. Hamburg. All right.
    The Chairman. Senator Merkley.

                      Statement of Senator Merkley

    Senator Merkley. Thank you very much, Mr. Chair.
    And thank you for your testimony. I wanted to ask you a 
little bit about how we can make sure that small farms and 
organic farms do not find that they're getting directions from 
numerous organizations, if you will, as they work to comply 
with food safety and also comply with organic standards.
    Dr. Hamburg. This is a very important concern, and one that 
I certainly have heard, and we are trying to be as responsive 
as possible. You know, farms differ in size. Areas of farming 
differ in conditions. Strategies of farming differ, as well. We 
want to be able to produce a system that's responsive to the 
unique needs and circumstances that are reflected in the 
diverse array of agricultural types and conditions that exist 
in our country. We believe that that can be achieved within the 
approach that's outlined in this legislation.
    I have to tell you that I would have been, actually, 
visiting a farm today, out in California, and my colleague Mike 
Taylor, who's my senior foods advisor, would have been down in 
Florida on a farm, as well, but for this hearing. We thought it 
was important to be here, and we'll reschedule those visits. 
But, we are trying to work with those communities, understand 
their issues and concerns, and work flexibility into any 
guidance and rulemaking that we would pursue, so that we can 
have a system that works for everyone and ultimately works for 
the consumers. Because whether you are big or small, organic or 
not, food safety still has to be the top priority. That's what 
we're focused on. And we're focused on preventing contamination 
in the first place, to the greatest degree possible.
    Senator Merkley. Yes. Thank you.
    I'll tell you, as I was doing town halls, through the 
summer--while healthcare was the dominant issue, in almost 
every town hall--someone came to me, really concerned about the 
impact on small farms or on organic farms. There were also a 
lot of comments--and I've been assured that these are based on 
misunderstandings of the bill--but, a lot of concerns that 
roadside stands would be put out of business, farmers' markets 
would be put out of business, backyard gardens would be put out 
of business. I just want to give you a chance to put on the 
record that if, indeed, these are exempted, as I'm sure they 
are, to hear it from you, and to have it clearly stated.
    Dr. Hamburg. Well, I think that we would be striving, as I 
said, in our guidance and rulemaking, in all of our activities, 
to build in flexibility to address those very legitimate 
questions and concerns. There's a growing interest, as I'm sure 
you know, in this country, in having access to local foods and 
the produce from local farms. We want to support people's 
desire to do so, not hinder it. But, we want to make sure that 
wherever the food is grown, however it's produced, it meets 
important standards for safety.
    Senator Merkley. But, isn't there a specific exemption for 
direct farm-to-market, where it doesn't go through a food 
processor, that would take away the concerns of most of the 
folks who have roadside stands and farmers' markets?
    Dr. Hamburg. I'm getting expert consults, here. I think 
it's just that this legislation--correct me, if I'm wrong--
applies just when food is entered into interstate commerce. So, 
yes.
    Senator Merkley. Yes. OK. Folks back home will be glad to 
hear that.
    Thank you very much.
    Dr. Hamburg. Thank you.
    The Chairman. That's an area I've also been interested in. 
And it is true that the farm-operated roadside stand that sells 
food directly to consumers as its primary function would be 
exempt from registration as a retail food establishment, for 
whatever that's worth.
    Senator Gregg.
    Senator Gregg. Thank you, Mr. Chairman.
    Doctor, just so it's clarified in my mind, you support this 
bill, as presented by myself and Senator Durbin, is that 
correct?
    Dr. Hamburg. Yes. You know, as I indicated in my remarks, 
there are some areas that I would like to see some 
strengthening. But, I think it's a terrific and comprehensive 
approach to a problem that is very pressing and where FDA 
currently lacks critical authority.
    Senator Gregg. Thank you. ``Terrific and comprehensive,'' I 
like that.
    One of the issues that you mentioned and you raise and you 
red-flag for us is this question of the distribution of the 
trade secrets and commercial processes that are involved. And 
this is one of those issues where there's just not a good, 
clear answer, because you've got to balance the importance of 
getting the information, and using it effectively, with the 
importance of protecting the information to the entity that has 
that sort of information, and their view that it may actually 
affect their capacity to survive in the enterprise. You 
appreciate that subtlety, I'm sure----
    Dr. Hamburg. Absolutely.
    Senator Gregg [continuing]. Or that debate.
    I guess my concern is that the House bill, in this area, 
probably will drive a lot of people to simply not maintain the 
information, because they'll say, ``Oh, we don't want to have 
that information broadly distributed by the FDA, if they have 
access to it.'' So, I do think we have to be careful in that 
area. Do you understand our concern there?
    Dr. Hamburg. Yes. Of course, the protection of commercial 
confidential information is very vital to FDA, across a whole 
range of activities in the drug and medical product area, as 
well as in the food area. But, we do want to make sure that we 
can share information with key partners at the State and local 
level, or at the international level, when we need to respond 
to an ongoing outbreak in order to rapidly identify a problem--
--
    Senator Gregg. That is critical.
    Dr. Hamburg [continuing]. And contain and control it.
    Senator Gregg. I think if we had that sort conditionality 
on it, that it was an outbreak-related event that was some sort 
of--so, I would like to suggest that we work on that, because I 
see that as a tension between the House bill and our bill----
    Dr. Hamburg. Terrific.
    Senator Gregg [continuing]. And that we should be able, 
hopefully--it will be difficult, but I should hope we can get 
some resolution on it.
    Another area where you folks have some concerns, and which 
raises the issue, is when you can seize. It seems to me, you 
shouldn't be able to seize if it's a paper event. You know, in 
other words, if they fail to have their plan, or they fail to 
have it appropriately structured, I don't think that should be 
a seizure event. I think seizure has to be related to--there's 
a product that's failed, there's a product that's a risk.
    Dr. Hamburg. I think, clearly, we want to target the high 
public-health impact events. I think the greatest concern with 
respect to this somewhat arcane distinction between prohibited 
act and an adulterated product is that we oftentimes do have a 
real public health obligation to move as swiftly as possible, 
because a product is in commerce and may be harmful to health. 
And, in that case, we do not want to have to pursue, through 
the legal system, permission to act. We feel that we need to 
swiftly act.
    Senator Gregg. I hate to interfere, but my time's limited--
I mean, I don't think there's any disagreement there. I mean, 
if you folks have come to the conclusion there's a risk, 
obviously there's an event. The question is, if it's just a 
paper event--you know, if you find they don't have the right 
paper, we shouldn't have that.
    Dr. Hamburg. I don't think we would be seizing products 
based on that.
    Senator Gregg. If that's your view, then I think we're 
probably on the same wavelength.
    Dr. Hamburg. Yes.
    Senator Gregg. Well, I appreciate your support of the 
effort here, and I appreciate the great job you folks are 
doing. Hopefully, we can get this bill passed.
    Dr. Hamburg. Thank you. We certainly appreciate your 
leadership.
    Senator Gregg. Thank you.
    The Chairman. Thank you, Senator Gregg.
    Senator Franken.
    Senator Franken. Dr. Hamburg, thank you for your work.
    What is the cost, in dollars, of unsafe food in this 
country if you put together all the recalls of food and--which 
are necessary--the $100 million that was lost by the tomato 
industry, when it wasn't tomatoes, after all; it was jalapeno 
peppers; I guess, the billion dollars for the peanut industry; 
and then, on top of that, all the illness, all the 
hospitalizations, all the permanent injury that people sustain 
in illness, and the deaths? Is there a dollar figure for all of 
that?
    Dr. Hamburg. You know, someone may well have added that all 
up. I can't give you that number now, but the cost is very 
high. In some ways, it maybe is almost incalculable, in terms 
of the preventable deaths and illnesses that have occurred.
    But, your point is so important to underscore, in that this 
is more than just about people getting sick. While that is a 
huge and overriding concern, it also is about the health of our 
healthcare system, in terms of preventable costs, and the 
health of our economy, in terms of important industries that 
are badly damaged by these unnecessary food outbreaks. And so, 
there's a compelling reason to act, and act now, in terms of 
putting in place a program that is sensible and doable, that 
will, I think, dramatically modernize and transform our food 
safety system and bring down all of those human and economic 
costs.
    Senator Franken. Because the Chairman brought up the cost 
of this, in terms of enforcement and all the kinds of things we 
need to do, and I just hope that people are aware of the cost-
benefit analysis of doing the kind of measures that we need to 
do, in order to ensure food safety, that there is really an 
economic benefit to it.
    Dr. Hamburg. Absolutely.
    Senator Franken. Let me ask you about prosecution of the 
folks at the Peanut Corporation of America. What happened to 
them? They just went bankrupt? Is that what they did?
    Dr. Hamburg. Well, I think they did declare bankruptcy, and 
there is a criminal case that's ongoing.
    Senator Franken. Is it a Federal one or a State one?
    Dr. Hamburg. I believe it's both. Thankfully, they are the 
exception to the rule. Most companies are not at the extreme 
end that PCA was. We have had a lot of terrific cooperation 
working with industry when problems emerge. But, PCA was an 
extraordinarily----
    Senator Franken. I just want to make sure that people in 
this industry know that there is a criminal price to be paid if 
they withhold information and--the result is, people die--and 
that they should know--I just want to incentivize good 
behavior.
    Dr. Hamburg. Right.
    Senator Franken. You know what I mean?
    Dr. Hamburg. Indeed.
    Senator Franken. And it's important to me that we improve 
communications between the State and the Federal Government on 
this and--as well as between, say, the FDA and the CDC. Could 
you comment on how we can best get all these players to work 
together to make the most of our investment that we're going to 
make in this?
    Dr. Hamburg. It is absolutely essential that we have a 
coordinated, integrated strategy that uses all of the assets 
and strengths of local and State authorities, along with the 
FDA and FDA's critical partners at the Federal level, USDA and 
CDC. I would say that we are experiencing extraordinary 
cooperation at the present time. I think the President's Food 
Safety Working Group has been very helpful in bringing together 
the agencies at the Federal level that have responsibilities 
for food safety, and coming up with a sort of a coordinated 
vision and strategy. We are working extremely closely with CDC. 
Perhaps it helps that the director of the CDC used to work for 
me. So, we have a good line of communication. But, at every 
level, we are really embracing this new approach and working 
very well together.
    You'll hear, in the next panel, from a State health 
authority. But, that partnership is absolutely key, and in 
terms of our ability to actually fulfill our mandates across 
the Nation to engage State and local health authorities in 
doing inspections and providing oversight, in working to assure 
appropriate safety standards and preventive controls, is vital. 
So, we----
    Senator Franken. Thank you.
    Dr. Hamburg [continuing]. Are working hard. Then, it's a 
whole other discussion about the needs, in terms of the global 
world we live in and working with international partners, as 
well.
    Senator Franken. We'll have to have that whole other 
discussion with some other Senator.
    Thank you, Mr. Chairman. My time has run out.
    The Chairman. Thank you, Senator Franken.
    Senator Isakson.
    Senator Isakson. Thank you, Mr. Chairman.
    I want to reiterate both Senator Gregg's point, in terms of 
seizure, as well as Senator Merkley's point on direct farm to 
consumer sales. As I understand it, the exemption is if it's 
within the State. But, if it were interstate transferred from 
farm to consumer, it would be regulated. Is that correct?
    Dr. Hamburg. Yes.
    Senator Isakson. OK. Thank you. That's very important in 
Iowa, when you buy roadside corn when the crop comes in. The 
same thing in Georgia, when the farmer sells his peanuts or his 
tomatoes.
    On Senator Franken's question--and correct me if I'm wrong, 
because I may be--but, in the enforcement of FDA violations, 
the primary enforcement is criminal action, isn't it, like in 
the PCA's case?
    Dr. Hamburg. There is a continuum. And I would say PCA, was 
at the extreme end and hardly typical. Criminal actions are not 
required. In the majority of cases, we work with the companies, 
after identifying the problem, to get them fixed. There are 
areas where we need to work with other partners, in terms of 
enforcement actions. In fact, sometimes State and local 
authorities actually have stronger enforcement tools than the 
FDA does. And that's another important part of the partnership, 
although this legislation would enable us to take on some of 
those key additional authorities, such as mandatory recall.
    Senator Isakson. It's also my understanding that, currently 
and in the past, inspections have generally been made--you'll 
subcontract with the Department of Agriculture, for example, in 
Georgia, if you get a complaint on a potential violation at a 
facility. Is that correct?
    Dr. Hamburg. That's correct.
    Senator Isakson. I think most of the enforcement is 
complaint-based, not proactive. One thing this bill will do is 
expand your ability to be proactive. Is that correct?
    Dr. Hamburg. It will expand our ability to be proactive. It 
will expand our ability to work with farmers, producers, and 
manufacturers to prevent problems from occurring in the first 
place by identifying where are the hazards and how they can 
best be addressed. And that is very, very important, when you 
think about the system overall.
    Senator Isakson. And then, the lesson learned from PCA, 
there were 12 tests in their files proving positive for 
salmonella during times in which inspections by the Georgia 
Department of Agriculture were made, at your request, but 
because they didn't have access to those files, they couldn't 
see them. This legislation broadens the ability for that 
information to be made available, upon request, as long as it 
doesn't violate the proprietary interest. Is that correct?
    Dr. Hamburg. Yes. And your description of the situation 
with PCA underscores just why that is so vital.
    Senator Isakson. Well, thank you very much. I appreciate 
and look forward to working with you on this legislation.
    Dr. Hamburg. Thank you.
    The Chairman. Senator Hagan.
    Senator Hagan. I will pass on questions, at this time.
    The Chairman. Thank you very much, Senator Hagan.
    Dr. Hamburg, thank you very much for being here. We may 
follow up with some other written questions.
    Dr. Hamburg. Thank you.
    The Chairman. Thank you, Dr. Hamburg.
    Dr. Hamburg. Thank you. I look forward to working with you.
    The Chairman. Same here. Thanks, Dr. Hamburg.
    I've just been notified that a vote is likely to begin at 
11:50, so we'd like to proceed on to our next panel.
    So, we'll call our next panel: Caroline Smith DeWaal, 
director of the Food Safety Program at the Center for Science 
and the Public Interest, the leading consumer analyst on food 
safety reform. In 2002, she coauthored ``Is Our Food Safe? A 
Consumer's Guide to Protecting Your Health and Environment.'' 
Also, Tom Stenzel, president and CEO of the United Fresh 
Produce Association, a leading trade association for the 
produce industry. Mr. Stenzel has served in several government 
and industry leadership positions, including as a member of the 
U.S. Department of Agriculture Fruit and Vegetable Advisory 
Committee.
    Now, I will turn to Senator Isakson for purposes of an 
introduction.
    Senator Isakson. Thank you very much, Mr. Chairman.
    I'm pleased to be able to introduce Michael Roberson of 
Publix Grocery Stores. I had the privilege, when I served in 
the Georgia legislature many years ago, of welcoming Publix 
when they came to Georgia. They're a Southeastern supermarket 
of outstanding reputation, 12 successive years chosen one of 
the 100 best companies in America to work for. They employ 
20,000 Georgians, have 180 grocery stores, and one them is in 
my neighborhood, and I shop there every Sunday, when I'm home, 
with my wife. Dr. Roberson is a graduate of Mississippi State, 
with a bachelor's degree in microbiology, but a master's degree 
from the College of Veterinary Medicine in Michigan State 
University in food safety and food products. He's on every 
possible national and international board on food safety that 
you could want. He'll be an outstanding person to testify. And 
if anything, we always need an Eagle Scout, and he's an Eagle 
Scout. So, when it comes to food safety, we need all the Eagle 
Scouts we can get.
    I want to welcome Mr. Roberson and praise the Publix 
company for the great work they do in the Southeast, and 
particularly in my State of Georgia.
    The Chairman. Thank you very much, Senator Isakson.
    Now I'll turn to Senator Hagan also for the purposes of an 
introduction.
    Senator Hagan. Thank you, Mr. Chairman.
    Before I introduce Mr. Ragan, I want to also welcome Mr. 
Roberson. My family lives in Lakeland, FL. Publix is a 
wonderful corporate entity in that community. So, thank you.
    But, I do want to introduce Dan Ragan--Mr. Ragan. It's my 
pleasure to introduce him, today. Dan is the director of the 
North Carolina Department of Agriculture and Consumer Services 
Food and Drug Protection Division. Dan is a registered 
pharmacist who has worked for the Department for almost 10 
years. Since January, he has served as an assistant director of 
the Food and Drug Protection Division, and prior to that, he 
was an administrator of North Carolina's Drug Protection 
Program. He grew up in Raleigh, NC, and received his 
undergraduate degree in animal science from one of our fabulous 
universities, NC State, in 1978. He graduated from pharmacy 
school in 1982, from another great university, the University 
of North Carolina at Chapel Hill, before opening his own 
practice in 1987. He has run multiple retail pharmacy 
operations, as well as worked as a consultant in long-term care 
pharmacy operations.
    Dan, welcome, and we certainly do look forward to hearing 
from you and having you here, today. Thank you for coming.
    The Chairman. Well, thank you very much, Senator Hagan.
    We'll just proceed now. Again, your statements will all be 
made a part of the record in their entirety.
    What we'd like to do is, I'll just go from left to right, 
start with Ms. DeWaal and we'll go through. And if you could 
summarize in 5 minutes or so, I would be deeply appreciative.
    Ms. DeWaal, welcome. I was going to say welcome back to 
this committee, but I guess the last time you testified before 
me was on the Agriculture Committee, on the same subject, 
earlier this year. Welcome to this committee, Ms. DeWaal, and 
please proceed.

 STATEMENT OF CAROLINE SMITH DeWAAL, DIRECTOR OF FOOD POLICY, 
   CENTER FOR SCIENCE IN THE PUBLIC INTEREST, WASHINGTON, DC

    Ms. DeWaal. Thank you very much, Senator Harkin. And thank 
you and Senator Enzi for holding this hearing. I think it's a 
very important morning for food safety in the beginning of a 
modern system.
    I also want to thank Senators Durbin and Gregg, and many 
others, for cosponsoring the legislation, and also Commissioner 
Hamburg, for her leadership in this area.
    CSPI represents over 900,000 consumers, but I'm here today 
on behalf of a larger coalition of consumer organizations. And 
we want to explain to you that, in fact, the people who really 
pay for an unsafe food supply are the consumers who must rely 
on it every day.
    Let me tell you about one consumer. Michael Thomas was 50 
years old when he became a victim of tainted peanut butter. 
Michael loved peanut butter and had a spotless health history. 
Unfortunately, he ate some of the salmonella-contaminated 
peanut butter, and the consequences for him and his whole life 
and his family were very severe. Michael spent weeks in and out 
of emergency rooms. He suffered from dehydration, stomach 
pains, and high blood pressure. His right eye hemorrhaged. And 
harm extended to his heart, his nervous system, and intestines. 
This previously healthy man spent over 5 months bedridden. He 
lost his job. He lacked insurance at the time, so he paid out-
of-pocket for the medical bills. He ended up losing his house. 
He now lives with his family, his grown children. But, Michael 
was lucky enough to survive.
    I noticed many of the Senators today mentioned the Almer 
family and the Donnelly family and other families who haven't 
been so lucky. But, Michael was truly shocked when the peanut 
butter outbreak happened all over again to a new group of 
consumers. He was a victim of the 2007 peanut butter outbreak, 
an outbreak which, if it had been listened to--and acted on--
could have prevented the 2009 outbreak which, as you know, 
Senator, killed nine people.
    Consumers will continue to be the unwilling victims of our 
Nation's food safety system until Congress acts to fix it. 
Successive outbreaks caused by numerous healthy foods, things 
like spinach, lettuce, tomatoes, peppers, alfalfa sprouts, 
things we all should be eating every day, and even such treats 
as ice creams and cookie dough, have caused a steep decline in 
consumer confidence in the food supply.
    Reform of the food system is long overdue. We've already 
talked about the estimates of illnesses--76 million cases of 
illness, 325,000 hospitalizations--but, these are all 
preventable. Economists--Senator Franken asked already about 
what is the true cost--well, economists estimate that with the 
emergency room visits, the hospitalizations, and the lost work, 
the costs can be $40 billion to over $100 billion. Even if 
these numbers were cut in half, Senator, they're still too 
large. These can be prevented.
    While each story is tragic, there is good news, too. This 
is an area where the public really understands that the 
government plays a vital role in protecting them and their 
families. In a recent poll, 9 out of 10 American voters said 
that they support the Federal Government adopting new safety 
measures, including individual measures that are included in 
Senate 510. Things like requiring foreign countries to certify 
that their food safety systems are as strong as ours, requiring 
tracing systems to trace food back to the source, mandating 
government inspections of high-risk food plants, requiring food 
companies to test for contamination and to report those tests 
to the government, requiring produce standard--growers to meet 
standards, and also mandatory food recalls.
    Overall, we believe S. 510 is a strong food safety bill. 
But, we do recommend a few minor changes to the bill in the 
areas of the risk-based inspections system, mandating testing, 
making that a more clear part of the bill, and also 
strengthening the import provisions.
    I'd like to thank you for inviting me here today to discuss 
S. 510 and for the movement in your committee of addressing 
this important issue. We believe that food safety, as 
demonstrated here today, is truly a bipartisan measure and one 
that is supported by the interests here today before you, as 
well as voters all over the country. Though the year is fast 
drawing to a close, we believe that you do have time and you 
can make the time to address this.
    And truly, as Mike Thomas' story reminds us, failing to 
pass meaningful food safety legislation now is like setting the 
table for the next outbreak.
    Thank you, Senator Harkin.
    [The prepared statement of Ms. DeWaal follows:]
             Prepared Statement of Caroline Smith DeWaal\1\
    Good morning Mr. Chairman, Ranking Member Enzi and members of the 
committee. My name is Caroline Smith DeWaal. I am the director of food 
safety for the Center for Science in the Public Interest (CSPI). CSPI 
is a nonprofit health advocacy and education organization focused on 
food safety, nutrition, and alcohol issues. CSPI is supported 
principally by the 950,000 subscribers to its Nutrition Action 
HealthLetter and by foundation grants. We accept no government or 
industry funding.
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    \1\ The following members of the Safe Food Coalition and the 
MakeOurFoodSafe.org Campaign join in supporting this testimony: Center 
for Foodborne Illness Research and Prevention, Consumer Federation of 
America, Consumers Union, Food and Water Watch, National Consumers 
League, S.T.O.P.--Safe Tables Our Priority, and Trust for America's 
Health.
---------------------------------------------------------------------------
    CSPI works closely with the Make Our Food Safe Coalition that 
supports passage of food safety reform legislation in Congress. The 
coalition includes groups formed by and representing the victims of 
food borne illness, like Safe Tables Our Priority and the Center for 
Foodborne Illness Research and Prevention; broad-based consumer 
organizations, like Consumers Union and the National Consumers League; 
public health groups like the American Public Health Association and 
the Trust for America's Health; and it is coordinated by The Pew 
Charitable Trusts and the Consumer Federation of America.
            now is the time to repair our food safety system
    Thank you for asking me here today to discuss S. 510, the FDA Food 
Safety Modernization Act. The American public cannot wait any longer 
for solutions to address a seriously broken food safety system. 
Successive outbreaks caused by numerous healthy foods like spinach, 
lettuce, tomatoes, peppers, alfalfa sprouts, and even such treats as 
ice cream and cookie dough \2\ have demonstrated that our 100-year-old 
legal foundation and outdated strategies are inadequate to protect our 
citizens.
---------------------------------------------------------------------------
    \2\ Details of these outbreaks are listed on the Center for Science 
in the Public Interest Outbreaks & Recalls Web site at http://
www.cspinet.org/foodsafety/outbreak_report.html.
---------------------------------------------------------------------------
    Reform of the food safety system is overdue. CDC estimates that 
foodborne diseases cause 76 million illnesses, 325,000 hospitalizations 
and 5,000 deaths annually. Economists believe that these illnesses pose 
a huge burden to society, with estimates for emergency room visits, 
hospitalizations, and lost work ranging from $40 billion to well over 
$100 billion annually.\3\ \4\ Even if these numbers were cut in half, 
they are still too high. These are illnesses and deaths that are 
largely preventable.
---------------------------------------------------------------------------
    \3\ Trust for America's Health, Fixing Food Safety: Supply from 
Farm-to-Fork, Apr 30, 2008, at http://healthyamericans.org/reports/
foodsafety08/FoodSafety08.pdf.
    \4\ Roberts, Tanya (2007) ``The Economic Costs of Long-term 
Sequellae of Selected Foodborne Pathogens,'' Invited Speech, 
International Association of Food Protection, Orlando, FL.
---------------------------------------------------------------------------
    Foodborne illnesses are most severe for the elderly, the very 
young, pregnant women, and immunocompromised people, and some illnesses 
lead to chronic medical conditions. Unfortunately, some outbreaks cause 
consumers to stop buying healthy foods, a fact demonstrated by 
depressed spinach sales after the 2006 outbreak.\5\ Consumer confidence 
in the safety of food has declined in recent years due to the steady 
parade of outbreaks.\6\
---------------------------------------------------------------------------
    \5\ Elizabeth Weise & Julie Schmit, Spinach Recall: 5 Faces. 5 
Agonizing Deaths. 1 Year Later, USA Today, Sept. 20, 2007, available at 
http://www.usatoday.com/money/industries/food/2007-09-20-spinach-
main_N.htmm.
    \6\ Thompson West Research, Consumers Worried About Product Safety, 
Dec. 18, 2007, at http://west.thomson.com/news/releases/
productsafety.aspx.
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    Outbreaks are the result of an antiquated legal system that ties 
the hands of FDA when seeking food safety information from plants and 
limits the effectiveness of the agency to enforce the laws. The FDA 
operates under a number of laws that are 50 to 100 years old: the 
Federal Food and Drug Act of 1906,\7\ which focused on dangerous 
chemical preservatives; the Federal Food, Drug, and Cosmetic Act of 
1938,\8\ which addressed economic adulteration of food and provided 
authority to set food standards and inspect factories; and the Public 
Health Service Act of 1944, which gave the agency authority to prevent 
communicable diseases transmitted in food.\9\ Food additive and 
pesticides laws gave FDA additional authorities in the 1950s.\10\ None 
of these was designed to address microbial hazards or emerging 
technologies.
---------------------------------------------------------------------------
    \7\ Federal Food and Drugs Act of 1906, Pub. L. 59-384  34 Stat. 
768 (1906).
    \8\ Federal Food, Drug and Cosmetic Act of 1938, 21 U.S.C.  301.
    \9\ Public Health Service Act 42 U.S.C.  264.
    \10\ E.g. Federal Food, Drug and Cosmetic Act of 1938, 21 U.S.C.  
409, ``The Delaney Clause''.
---------------------------------------------------------------------------
    Within this legal structure, the agency has developed regulations 
to cope with the need for new oversight for modern hazards. In the 
1990s, the agency adopted regulations that put seafood and juice 
industries under mandatory Hazard Analysis and Critical Control Point 
(HACCP) programs. After a long hiatus, the agency recently adopted a 
new regulation covering egg safety at the production level.\11\ But the 
agency's approach of developing regulations food-by-food is proving 
brutally inefficient to protect the public. By the time one food is 
covered, the next problem has already emerged.
---------------------------------------------------------------------------
    \11\ Prevention of Salmonella Enteritidis in Shell Eggs During 
Production, Storage, and Transportation; Final Rule. 74 Fed. Reg. 
33,030 (July 9, 2009).
---------------------------------------------------------------------------
     consequences of broken food safety system fall on the consumer
    Those who pay the price for the antiquated legal and regulatory 
system are the consumers who must rely on it daily. Let me tell you 
about one consumer, a member of Safe Tables Our Priority. Michael 
Thomas was 50 years old when he became a victim of tainted peanut 
butter. Michael loved peanut butter and had a spotless health history. 
A father of four and grandfather of 20, Michael was known for his love 
of peanut butter. It was so well known that his own father called to 
warn him when he heard media reports about a peanut butter recall. 
Unfortunately, Michael had already eaten some of the Salmonella-
contaminated product--and the consequences were severe, leading to 
reactive arthritis.
    Michael spent weeks in and out of emergency rooms, suffering from 
dehydration, stomach pains, and high blood pressure. His right eye 
hemorrhaged. He was treated for nervous system damage, and damage to 
his heart, eyes, intestines, shoulders, and arms. This previously 
healthy man spent over 5 months bedridden. And because he lacked 
insurance at the time, he spent thousands on medical bills and lost his 
house due to the financial toll of his illness.
    But Michael was lucky enough to survive, only to be shocked and 
outraged when it happened all over again this year. Michael was a 
victim of the 2007-tainted peanut butter outbreak, but when he heard of 
the 2009 outbreak--which sickened hundreds and killed at least nine 
people--he couldn't believe it. In a 2009 letter describing his 
experience with foodborne illness, Michael says,

          ``I did take some comfort in the belief after it happened to 
        me that the system was fixed and would not happen to any more 
        families . . . but here we are once again, literally right down 
        the road from that very same plant I was poisoned from, with 
        exactly the same situation, but even more widespread than it 
        was before.''

    Just as Michael's 2007 experience was revisited in 2009, there is 
no question it will happen again--this year or next, from this product 
or another. Consumers will continue to be unwilling victims, until the 
system is fixed.
        the public is ready for congress to address food safety
    The stories of outbreaks and recalls over the last few years are 
tragic, and they have had a huge impact on consumer confidence in the 
safety of the food supply. But there is good news too. This is an area 
where the public understands that government plays a vital role in 
protecting them and their families.
    In a poll on Americans' Attitudes on Food Safety,\12\ commissioned 
by The Pew Charitable Trusts and conducted by Hart Research/Public 
Opinion Strategies, 9 out of 10 American voters support the Federal 
Government adopting new safety measures,\13\ including the following 
individual measures:
---------------------------------------------------------------------------
    \12\ These findings are derived from a nationwide survey of 1,005 
registered voters, conducted June 29 through July 3, 2009, by Hart 
Research Associates (D) and Public Opinion Strategies (R) on behalf of 
the Pew Charitable Trusts and the Produce Safety Project. Respondents 
were reached by telephone through a random-digit dial method of 
sampling. The results of the poll are statistically representative of 
the opinions of voters across the country, and carry a margin of error 
of 3.1 percentage points for the full sample, and higher 
margins of error for subgroups of the sample.
    \13\ According to the polling firms, support crossed gender, age, 
economic, and even partisan lines--96 percent of Democrats, 88 percent 
of independents, and 83 percent of Republicans said they supported the 
need for food safety legislation.

     92 percent support requiring foreign countries that export 
to the United States to certify that their food safety systems are as 
strong as ours;
     94 percent support requiring tracing systems that enable 
the FDA to trace food back to its source;
     91 percent support annual or semi-annual government 
inspections of facilities that process food that is at a high risk of 
contamination, including 75 percent who strongly favor this;
     92 percent support requiring food companies to test for 
contamination and report results to the government;
     90 percent support requiring produce growers to meet 
standards for water quality, manure use, and worker sanitation; and
     89 percent support giving the FDA authority to issue 
mandatory food recalls.

    Since 2007, Congress has conducted 28 oversight and legislative 
hearings on food safety. These hearings often discussed the painstaking 
investigations by Members of Congress and their staff of diverse 
outbreaks such as spinach tainted with E. coli O157:H7, peanut butter 
contaminated with Salmonella, and pet food adulterated with melamine. 
In every case, the hearings revealed flaws both in the food 
manufacturers' processes and in the Food and Drug Administration's 
oversight. With evidence of both unintentional and intentional 
contamination leading to large-scale outbreaks, it is little wonder the 
Government Accountability Office has highlighted the inadequate state 
of our food regulatory system and placed food safety in its high risk 
category 3 years in a row.\14\
---------------------------------------------------------------------------
    \14\ Gov. Acct. Off., High Risk Update: Revamping Federal Oversight 
of Food Safety, Rep. No. GAO-09-271, Jan. 2009.
---------------------------------------------------------------------------
    The evidence that FDA reform is needed has been made crystal clear 
in congressional hearings, victims' stories, and voter polling. In 
addition, I think you will hear today that there is widespread 
consensus among a broad range of stakeholders that the time for passing 
this reform is now.
            safety must be built into the food supply system
    The heart of any effective reform effort lies in prevention, not 
reaction. Congress should require every food processor regulated by FDA 
to have a food safety plan detailing that it has analyzed its 
operations, identified potential hazards, and is taking steps to 
minimize or prevent contamination. These hazard analysis and preventive 
control plans are already required for all meat and poultry plants,\15\ 
and such plans should be a prerequisite for all food processors that 
want to sell food in the United States.
---------------------------------------------------------------------------
    \15\ Hazard Analysis and Critical Control Point (HACCP) Systems, 9 
CFR  417 (2009).
---------------------------------------------------------------------------
    Prevention is our first line of defense when it comes to food 
safety. The Senate legislation establishes the industry's fundamental 
responsibility for ensuring food safety and provides a foundation for 
government inspections. However, the history of these programs where 
they have been implemented by FDA, such as in the seafood area, 
demonstrates that Congress must also give FDA the authority and funding 
to enforce compliance through regular inspections and access to company 
records.
    Additionally, FDA needs the authority to set performance standards 
for the most hazardous pathogens and to require food processors to meet 
those standards. The standards are used to ensure that food is produced 
in a manner that limits the likelihood of contamination by pathogens, 
chemicals, or physical hazards. Most importantly, performance standards 
set a level-playing field for the industry. Companies know in advance 
what standards will be enforced for their industry and products.
    With mandatory food-safety planning combined with performance 
standards, the government can focus on more effective government 
oversight through frequent inspections, with analysis of records and 
laboratory test results.
    S. 510, the FDA Food Safety Modernization Act, contains these 
essential elements. But a few elements should be strengthened to ensure 
that FDA can prevent many future outbreaks and address the other 
hazards that can impact so many consumers.
       effective federal oversight is needed to ensure compliance
    S. 510 is built on the framework of existing HACCP regulations 
adopted by the Food and Drug Administration. While this foundation 
mandates the actions that the industry itself is responsible for, it 
lacks similar specifics in describing the government's oversight and 
responsibilities. On behalf of the Make Our Food Safe Coalition, we 
would like to propose three changes that would strengthen S. 510:

Recommendation 1: Risk-Based Inspection and Inspection Frequency
    We believe it is critical to establish categories of risk to ensure 
that FDA will establish meaningful schedules of inspection. To be 
adequate, the statutory provisions on Federal inspection should do 
three things:

     Establish a minimum of three risk categories;
     Set inspection frequencies based on these categories, with 
the minimum frequency of once every 6 to 12 months for high-risk 
facilities; and
     Prohibit FDA from using certification by a private entity 
as a factor in setting the frequency of Federal inspection for a 
domestic facility.
Recommendation 2: Testing and Reporting Requirements, Affirmative 
        Reporting of Positive Test Results
    In order for a system based on preventive controls to be truly 
effective, food companies must be required to test for the types of 
contamination most common in their (or similar) products to determine 
whether their systems are actually working. We recommend that you 
strengthen the testing and reporting requirements of S. 510 by adopting 
requirements that:

     A facility conduct testing as a verification step in its 
preventive control plan; and
     Facilities report promptly to FDA any positive results 
from its testing program.
Recommendation 3: Imports and Imported Produce
    Imports of FDA-regulated foods present many difficulties for the 
agency, simply because of the current number of suppliers and the 
volume of imports. We generally support the language in S. 510 on 
imports, which provides for certification of food facilities that 
import food products. The language should be strengthened by:

     Requiring government-to-government certification for high-
risk foods;
     Clarifying that FDA has the principle responsibility for 
accrediting the import programs of foreign governments;
     Clarifying that private accrediting bodies must be under 
strict FDA oversight, and FDA should be notified of all actions they 
take regarding the agents they accredit; and
     Adding language requiring FDA to set up a system for 
determining whether standards for imported produce are at least equal 
to standards applicable to such commodities produced in the United 
States.

    Finally, I would like to highlight that FDA and State inspectors 
are also hampered in conducting inspections by restricted access to 
plant records that could help identify problems before they erupt into 
an outbreak. As the committee may recall, FDA had to invoke the 
Bioterrorism Act to obtain records from Peanut Corporation of America 
of 12 tests that were positive for Salmonella in the year and a half 
leading up to the outbreak.\16\ Food companies can refuse to disclose 
records to inspectors unless the FDA has a reasonable belief the food 
is adulterated, presents a risk of serious adverse health consequences 
or death, and the inspector presents a written demand.\17\ We saw this 
same situation play out in the 2007 Peter Pan peanut butter outbreak 
where, had inspectors been given access to test records, they would 
have been alerted to the plant's test results for Salmonella.\18\ To 
fix this, the law needs to be changed so that inspectors can access 
records that may allow them to prevent outbreaks. Meanwhile, the 
ability to access all food safety documentation during inspections is 
an essential tool to verify that control systems are present, 
maintained and operating properly.
---------------------------------------------------------------------------
    \16\ See, The Salmonella Outbreak: The Continued Failure to Protect 
the Food Supply: Hearing before the House Subcommittee on Oversight and 
Investigations, 111th Cong. (2009) (October 6, 2008 e-mail from Stewart 
Parnell to Sammy Lightsey).
    \17\ 21 U.S.C.  374(a)(1)(B); FDA, Regulatory Procedures Manual 
2008,  10-4-3.
    \18\ Two years before the outbreak, the plant manager refused an 
oral request from FDA inspectors to see company records of a positive 
Salmonella test telling them they would need a written request. Marion 
Burros, Who's Watching What We Eat, N.Y. Times, May 16, 2007, at http:/
/www.nytimes.com/2007/05/16/dining/16fda.html.
---------------------------------------------------------------------------
             s. 510, the fda food safety modernization act
    Both the House-passed bill and the one under consideration in this 
committee share many similarities: processors must re-register 
periodically, implement food safety plans, meet performance standards, 
and administer programs to verify the food they import complies with 
U.S. law. In addition, FDA must conduct risk-based inspections and can 
require high-risk imported food to be certified as complying with U.S. 
law. Lastly, FDA can order a recall of food likely to cause serious 
illness or death.
    There are numerous points of agreement when it comes to food safety 
reform packages being considered in Congress. We were very pleased to 
see the bipartisan consensus that emerged for H.R. 2749, which passed 
the House on July 30, 2009, with a vote of 283-142. We believe that 
food safety is truly a bipartisan measure that can be passed this year. 
It is strongly supported by voters all over the country. And truly, as 
Mike Thomas' story reminds us, if we don't act now, the next outbreak 
may be even more serious.
                               conclusion
    Now is the time for Congress to fundamentally reform our food 
safety system. The year is fast drawing to a close, but enactment by 
the end of this year should be the goal. Two years ago, Congress 
expressed its commitment to adopt a modern regulatory oversight program 
at FDA and fund it adequately to fulfill its mission.\19\ Congress has 
increased the FDA food budget by 50 percent in that period, which lays 
the ground work for this legislation. Bipartisan legislation has 
already passed the House of Representatives.\20\ That spirit of 
compromise has also infected the groups you see before you who have 
formed make-shift alliances to help deliver the message that reform is 
urgently needed. It is rare to see the level of consensus reflected 
among such diverse consumer and industry organizations on the need to 
fix our national food safety system. The public debate has defined the 
issues and we have a consensus for action. Congress can, with simple 
changes, take action this year to make food safer for American 
consumers. I urge you to act. There is no reason to delay.
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    \19\ Food and Drug Administration Amendments Act of 2007, Pub. L. 
110-85  1005, 121 Stat. 823, (2007).
    \20\ H.R. 2749, the Food Safety Enhancement Act, passed July 30, 
2009, by a vote of 283-142.

    The Chairman. Thank you, again, Ms. DeWaal, for your 
statement.
    Mr. Roberson, welcome. Again, if you could summarize in 5 
minutes we'd sure appreciate it.
    Thank you.

   STATEMENT OF MICHAEL ROBERSON, FOOD MARKETING INSTITUTE, 
                         ARLINGTON, VA

    Mr. Roberson. Thank you. Chairman Harkin, Ranking Member 
Enzi, and Members of the HELP Committee, I'm honored to 
represent the Food Marketing Institute to present testimony on 
S. 510, the FDA Food Safety Modernization Act.
    I ask that my written testimony be submitted for the 
record.
    My name is Michael Roberson, director of corporate quality 
assurance with Publix supermarkets of Lakeland, FL. I hold a 
bachelor's of science degree in microbiology from Mississippi 
State University and a master's in food safety from the College 
of Veterinary Medicine at Michigan State University. This 
provides me with the understanding of the microbial hazards 
associated with food.
    Publix is owned and operated by 140,000 associates, with 
2008 sales of $23.9 billion. Currently, Publix has 1,014 stores 
in Florida, Georgia, South Carolina, Alabama, and Tennessee, 
with multiple food manufacturing facilities. FMI is a national 
trade association that has 1,500 member companies made up of 
food retailers, wholesalers in the United States, accounting 
for three-quarters of all retail food store sales.
    The most important goal of all food retailers and 
wholesalers is to ensure that the food we sell is as safe as 
possible. To achieve this goal, supermarkets have many 
prevention programs in place to protect our customers. These 
include employee food safety training, extensive sanitation 
programs, food safety management systems, consumer education, 
and supplier control programs.
    Regrettably, recent food safety system failures have 
revealed weaknesses that highlight the need to update our food 
safety laws.
    As the purchasing agent for the consumer, and the final 
link in the supply chain, our industry understands, it is vital 
that the FDA has the necessary authority, credibility, and 
resources to meet the challenges of today's global marketplace.
    Mr. Chairman, I applaud you, Mr. Enzi, and all the members 
of the committee, for your commitment to improve food safety.
    I'd like to turn to S. 510, a bipartisan bill, introduced 
by Senator Durbin and cosponsored by your HELP Committee 
colleagues, Senators Dodd, Gregg, Alexander, and Burr, and 
Isakson.
    Food safety is a shared responsibility. We must improve the 
collaboration among all stakeholders, including government and 
industry. Many of the proposals in S. 510 are consistent with 
our approach by enhancing prevention and the tools available 
for intervention and response.
    We support the requirement that every registered facility 
have a hazard analysis and risk-based preventive control plan. 
The appropriate development and the use of a food safety plan 
goes a long way toward developing a culture within a company 
that is critical to ensuring food safety.
    We support the development of standards for produce safety. 
We believe that standards can be designed to accommodate any 
size farm. Publix expects all suppliers of fresh produce to 
maintain a food safety compliance program to address the 
management of good agricultural practices and minimize the 
microbial hazards associated with produce.
    We support the targeting of inspection records based on 
risk. We would encourage FDA to partner with State and local 
officials. We would also encourage that the FDA develop a 
separate classification for warehouse facilities that only 
holds foods that are not exposed to the environment, as is 
allowed in section 103.
    We support enhancing trace-back requirements--specifically, 
the legislation's establishment of pilot projects. Our industry 
recognizes that current traceability systems are not uniformly 
meeting the needs of the industry, the consumer, and the 
government. We understand that there will be technical 
challenges and significant costs associated with the 
implementation of traceability throughout the supply chain's 
infrastructure. That is why we see the pilot project approach 
as being critical.
    We support the mandatory recall provisions and the 
procedural limits in the bill. In 2007, the FMI board of 
directors adopted a policy urging Congress to grant FDA 
mandatory recall authority. We support the requirement for FDA 
to notify the public about a recall, but recommend that 
Congress direct FDA to use the most specific information 
available.
    We support the legislation's recognition of voluntary 
certification by accredited third-party auditors. Properly 
constructed third-party certification program can offer 
rigorous, objective evaluations of a manufacturer's food safety 
programs.
    Certification audits often exceed the legal requirements 
for food safety standards. These programs should not replace 
government oversight or attempt to deputize the private sector 
auditors as an enforcement arm of FDA. Certification audits are 
different than both a governmental inspection and 
noncertification audit. During a third-party certification 
audit, the auditor is measuring how the company manages food 
safety as part of its regular operations.
    We would also encourage that the committee further amend 
this section to ensure that all terminology is consistent with 
internationally recognized language and terms, such as those 
used by the Global Food Safety Initiative.
    Together, we believe that these provisions, along with 
those highlighted in my written statement, will help restore 
confidence in our Nation's food supply.
    Mr. Chairman, we appreciate the opportunity to testify, and 
the efforts of this committee.
    I look forward to your questions and will remain available 
for further discussion and information, should you need it.
    [The prepared statement of Mr. Roberson follows:]
                 Prepared Statement of Michael Roberson
    Chairman Harkin, Ranking Member Enzi and Members of the HELP 
Committee, I am honored to appear before you today on behalf of the 
Food Marketing Institute (FMI) to present our views and suggestions on 
helping protect our food supply and on S. 510, the FDA Food Safety 
Modernization Act. FMI and its member companies share the common goal 
of enacting legislation this year that will have a genuine and positive 
impact on our food safety system.
    I am Michael Roberson, the Director of Corporate Quality Assurance 
with Publix Super Markets, Inc. of Lakeland, FL. I lead a team of 
dedicated professionals responsible for food safety and quality 
assurance systems throughout Publix and our integrated chain of 
manufacturing, distribution, and retail food stores. With a B.S. degree 
in Microbiology from Mississippi State University, and a M.S. in Food 
Safety from the College of Veterinary Medicine at Michigan State 
University, I possess a technical background and a thorough 
understanding of the microbial hazards associated with food and factors 
most frequently implicated in food-borne disease.
    Publix is privately owned and operated by its 140,000 employees, 
with 2008 sales of $23.9 billion. Currently, Publix has 1,013 stores in 
Florida, Georgia, South Carolina, Alabama and Tennessee and five 
separate food manufacturing facilities. The company has been named one 
of FORTUNE's ``100 Best Companies to Work for in America'' for 12 
consecutive years. In addition, Publix's dedication to superior quality 
and customer service is recognized as tops in the grocery business, 
most recently by an American Customer Satisfaction Index survey.
    Today I am representing FMI, a national trade association that has 
1,500 member companies made up of food retailers and wholesalers in the 
United States and around the world. FMI members operate approximately 
26,000 retail food stores with combined annual sales of roughly $400 
billion, representing three-quarters of all retail food store sales in 
the United States. FMI's retail membership is composed of national and 
regional chains as well as independent grocery stores.
    The American consumer has access to a selection of products in the 
grocery store that is unmatched. Our customers have products available 
to them everyday that are grown and made not only in the United States, 
but throughout the world. As a result, fresh fruits and vegetables are 
available for purchase year round and fresh seafood can be found in the 
middle of our country far from any ocean. The average grocery store has 
about 47,000 individual items on its shelves, with large supermarkets 
having over 100,000 items for sale. Regardless of the number of items 
in a store though, the most important goal of food retailers and 
wholesalers is to ensure that the food we sell is as safe as possible 
and of the highest quality possible.
    Regrettably, high profile food safety outbreaks and recalls 
involving tomatoes, jalapenos, peanuts and pistachios have not only 
made headlines, but have caused illness and in some cases even death. 
While the causes of these problems were the result of poor food safety 
practices--and in some cases possibly criminal actions--they did reveal 
weaknesses in the existing food safety system and highlighted the need 
to update the laws and culture necessary to adequately protect our food 
supply. As the purchasing agent for the consumer and the final link in 
the supply chain, our industry understands that it is vital to ensure 
that the FDA has the necessary authority, credibility and resources to 
meet the challenges of today's global marketplace.
    As this process moves forward, consumer confidence is an essential 
factor in this debate. Food safety issues can be extremely complex and 
consumers vary greatly in their knowledge of the science and other 
issues affecting the safety of our food supply. However, as food safety 
issues draw national headlines, consumer awareness as well as concern 
about the safety of commercially prepared foods and products purchased 
at the supermarket heightens. As a result, shoppers may quickly alter 
purchasing decisions and will even go as far as avoiding an entire 
product category if they are not confident of its safety.
    In FMI's annual survey of consumers, U.S. Grocery Shopper Trends 
report (Trends), 83 percent of shoppers say that they are either 
somewhat or very confident in the safety of food in the supermarket. 
However, the vulnerability of consumer confidence is illustrated by the 
high percentage of shoppers who are only ``somewhat'' confident at 72 
percent compared to those that are ``very'' confident at 11 percent. We 
believe that strengthening consumer confidence is the responsibility of 
both private industry and the government working together.
    At the retail level, supermarkets have many prevention programs 
currently in place to protect our customers, including consumer 
education campaigns, employee food safety training, extensive 
sanitation programs, food safety management systems, and programs that 
involve working closely with our suppliers, especially those beyond our 
borders. I would like to share with the committee some programs 
utilized by Publix and by many other companies in the food industry at 
both the retail and manufacturing levels to help ensure the safety of 
the products on our shelves.
    Publix is committed to working with the supplier community, 
including our own manufacturing plants, to constantly improve the 
safety of the food they manufacture and process, and to this end 
participates in the Safe Quality Food (SQF) Program. SQF provides 
independent certification that Publix's suppliers' food safety and 
quality management systems comply with domestic and international food 
safety regulations. Recognized by the Global Food Safety Initiative 
(GFSI), accredited third party certification programs, such as SQF, are 
objective, independent bodies that are highly qualified to help enable 
suppliers to assure their customers that food has been produced, 
processed, prepared and handled according to the highest possible 
standards, which meet or exceed the standards set by the U.S. 
Government. Publix has chosen to use GFSI recognized accredited third 
party certification programs like SQF because they represent the 
cultural change that is needed in our food safety system. It provides 
an additional layer of review above anything that is required by local, 
State or Federal Government and helps ensure our brand of integrity and 
the protection of our consumer.
    Within the domestic retail setting, training store managers and 
workers in food safety is an important tool for protecting public 
health. Currently, Publix makes extensive use of the SuperSafeMark 
program to train and certify our retail management associates on the 
importance of food safety. SuperSafeMark is the most comprehensive food 
safety and sanitation instruction and certification program ever 
offered to food retail employees. This program includes methods for 
combating food-borne illness with time and temperature controls, 
measures to prevent cross contamination, and programs for personal 
hygiene, and cleaning and sanitizing best practices.
    When a problem is identified, we take immediate action and remove 
the recalled product from the distribution chain and retail shelves as 
quickly as possible. To help assist in the process, the food retail and 
manufacturing community collaborated and developed the Rapid Recall 
Exchange, an online resource that includes a secure and automated alert 
system allowing suppliers to send information to retailers and 
wholesalers about products that must be recalled and to do so rapidly 
and accurately in a standardized form 24 hours a day, 7 days a week. 
The Exchange has recently been introduced and we are encouraged that it 
will prove to be a useful tool to our industry.
    The final link in the supply chain is the consumer. Publix has long 
provided our customers with practical, science-based guidance on safe 
food handling at home through the Partnership for Food Safety 
Education. The Partnership brings together consumer advocacy groups, 
the FDA, U.S. Department of Agriculture, Centers for Disease Control 
and Prevention, national industry associations and health and 
scientific groups. FMI President and CEO Leslie Sarasin is the current 
chairman of the Partnership's Board.
    The Partnership created the award-winning ``Fight BAC!'' education 
program to teach children about food safety as part of their school 
curriculum. The Partnership's ``BAC Down!'' program urges consumers to 
use thermometers to ensure their refrigerators remain at safe 
temperature levels--no higher than 40 degrees F. Most recently, the 
Partnership launched the ``Be Food Safe'' campaign in cooperation with 
USDA to provide retailers with a wide range of resources to educate 
their customers about safe food practices. The campaign encourages the 
use of colorful, modular icons and photography to illustrate the basic 
and most important safe food-handling practices:

     Clean--Wash hands and surfaces often.
     Separate--Do not cross-contaminate foods.
     Cook--Heat foods to proper temperatures.
     Chill--Refrigerate foods promptly.

    All of these prevention programs at the retail level cannot ensure 
that we deliver safe food to our customers if the food coming into our 
stores isn't already produced and processed to the highest standards. 
While the entire food industry continues to work together in developing 
stronger and innovative food safety programs, FMI and its members 
recognize the crucial and evolving role for government to play in 
assuring the safety of our food supply.
    Mr. Chairman, I applaud you, Mr. Enzi and all the members of the 
committee for your commitment to improving our food safety system by 
holding this hearing and exploring the ways to achieve this common 
goal. I would like to specifically comment on S. 510, the FDA Food 
Safety Modernization Act introduced by Senator Durbin and cosponsored 
by a diverse bipartisan group, including your HELP Committee 
colleagues, Senators Dodd, Gregg, Alexander, Burr, and Isakson. Upon 
its introduction FMI sent a letter to Senator Durbin expressing support 
\1\ for his bipartisan effort and the legislation's recognition that 
all points in the supply chain play an important role in food safety 
which we would like to include in the record.
---------------------------------------------------------------------------
    \1\ FMI Letter to Senator Durbin March 2, 2009.
---------------------------------------------------------------------------
    Many of the proposals in S. 510 are consistent with our approach to 
improving the food safety system by emphasizing the need to have 
preventive measures as the foundation on which any food safety system 
should be built. The bill also recognizes that we need to focus the 
majority of our resources on facilities and products that pose the 
greatest risk of contamination that could result in food-borne illness 
or injury. We must continue to be sure that any changes meet certain 
criteria:

     Be supported by science;
     Have measurable benefits;
     Be affordable;
     Be realistic; and
     Be implemented without unintended consequences.

    It is also imperative that mitigating risk is the guiding principle 
for changes and that our focus is on actions that will have the 
greatest impact in reducing food-borne illness. There are many policy 
initiatives in the legislation that we support because of their clear 
focus on preventive measures.
      title i--improving capacity to prevent food safety problems
Sec. 103. Hazard Analysis and Risk-Based Preventive Controls
    We support the requirement that every registered food facility 
design, conduct and maintain an evaluation of food safety risks in 
their business that identifies potential sources of contamination, 
identifies appropriate food safety controls, and documents those 
controls in a food safety plan. The correct development and use of a 
food safety plan goes a long way toward developing a culture within the 
company that is critical to ensuring food safety. We commend the 
legislation for recognizing the low-risk nature of warehouse facilities 
that store packaged food that is not exposed to the environment by 
allowing the Secretary to modify the requirements for these facilities.
    At Publix, the food safety systems designed in our manufacturing 
operations have redundant food safety control processes. This begins 
with ingredient suppliers. Prior to producing new product, the food 
safety requirements and ingredient controls are verified. Pre-requisite 
food safety programs along with cleaning and sanitation elements lead 
into the Hazard Analysis and Critical Control Points (HACCP) food 
safety system. We recognize the importance of a quality-first food 
safety system and understand that food safety is everyone's mutual 
responsibility.
Sec. 105. Standards for Produce Safety
    We support directing FDA, in consultation with USDA and State 
departments of agriculture, to establish science-based standards for 
the safe production and harvesting of fruits and vegetables. Publix 
expects all suppliers of fresh produce to maintain strong food safety 
compliance programs to address the management of Good Agricultural 
Practices (GAPs) and minimize the microbial hazards associated with 
fruits and vegetables. Recent industry best practices guidance has been 
developed for fresh leafy greens, melons, and tomatoes. We support 
these collaborative efforts to improve food safety associated with 
fresh produce and believe standards can be designed that can be 
implemented on any size farm.
   title ii--improving capacity to detect and respond to food safety 
                                problems
Sec. 201. Targeting Inspection Resources
    We support directing FDA to allocate limited inspection resources 
depending on the ``risk profile of the facility.'' The risk of food-
borne illness and contamination varies greatly depending on the type of 
product that the facility produces. For example, at Publix one 
manufacturing facility may produce bottled water while a different 
facility produces spinach and artichoke dip. Understandably, the 
spinach and artichoke dip is comprised of many additional ingredients, 
requires refrigeration control, and would be considered a food with 
greater risks than bottled water. We would also encourage that FDA be 
allowed to develop a separate classification for warehouse facilities 
that only hold foods that are not exposed to the environment as is 
allowed in Section 103.
    In addition, we would encourage FDA be directed to consider the 
inspections performed by State and local officials. Our retail stores 
are inspected by State departments of agriculture and local health 
departments. Our manufacturing facilities and distribution centers are 
inspected by the USDA, FDA, and State departments of agriculture. With 
proper training and coordination, we believe that State and local 
inspections should assist FDA with its responsibilities in a cost-
effective and efficient manner.
Sec. 204. Enhancing Traceback and Recordkeeping
    We support the legislation's establishment of pilot projects to 
test and evaluate new methods for rapidly and effectively tracking 
fruits and vegetables. Our industry recognizes that current 
traceability systems are not uniformly meeting the needs of industry, 
the consumer, and government. Enhancing systems that will help minimize 
the time required to identify, isolate and remove product that may 
cause injury, illness or adverse health consequences is the most 
important goal of a traceability system.
    Moving forward, this is not a static process as technology 
improvements that may revise procedures both on the information side 
and the food processing side are constantly being updated. Improving 
traceability is a long term commitment among all commodity groups. The 
food industry has proactively undertaken a number of strong pilot 
projects addressing the unique needs of a particular product or 
industry that are already resulting in improvements in best practices. 
We understand there will be technical challenges and significant costs 
associated with the implementation of traceability throughout the 
supply chain's infrastructure and that is why we see the pilot approach 
as being critical to developing best practices. Collaboration with FDA 
is necessary to ensure that industry initiatives will better assist in 
the event of a food safety outbreak.
Sec. 205. Surveillance
    We support the enhancement of food-borne illness surveillance 
systems to improve the collection, analysis and reporting of data. 
Federal, State, and local food safety and health officials must be able 
to work together in an effective manner in order to quickly recognize a 
pattern of food-borne illness and identify the cause.
    The tomato scare in the spring and summer of 2008 exemplifies the 
importance of surveillance. When tomatoes were targeted as the cause of 
the salmonella outbreak, the food retail industry reacted to ensure our 
customer was protected. At Publix, this resulted in over 350,000 
tomatoes being removed from sale within a 3-hour timeframe. After 
millions of dollars of losses across the food industry, tomatoes were 
still in question until a team of experts at the University of 
Minnesota identified jalapenos as the culprit.
    Based on previous success, FMI has endorsed legislation introduced 
by Senator Klobuchar and Senator Chambliss that would establish 
regional food safety centers of excellence modeled on the system at the 
University of Minnesota. We believe S. 1269, the Food Safety Rapid 
Response Act, will enable the Centers for Disease Control and 
Prevention to:

     Better coordinate food-borne illness surveillance systems, 
and
     Better support State laboratories in outbreak 
investigations with needed expertise. We would encourage its inclusion 
in S. 510.
Sec. 206. Mandatory Recall
    In 2007, FMI's Board of Directors adopted a policy urging Congress 
to grant the Food and Drug Administration the authority to require a 
recall of seriously adulterated food when the entity responsible for 
its adulteration refuses to or delays in recalling the food. The 
provision in S. 510 requires FDA to give a responsible party the 
opportunity to cease distribution of an adulterated or misbranded food 
product while authorizing the Agency to issue a cease distribution 
order and a mandatory recall order if necessary.
    We support the mandatory recall provision and the procedural limits 
in the bill, including the direction to FDA to work with State and 
local public health officials, who are often valuable resources, and 
the limitation that the authority may only be exercised by the 
Commissioner. Mandatory recall is a significant action and should only 
be directed by the highest knowledgeable authority within the Agency 
and the Agency should be accountable for executing that authority.
    We support the requirement for FDA to notify the public about a 
recall, but would recommend that Congress direct FDA to notify the 
public with the most specific information available. General alerts can 
sometimes be misleading to consumers and do not provide sufficient 
direction for retailers to execute a recall. In order to recall foods 
effectively retailers need the greatest amount of specific information 
as possible.
            title iii--improving the safety of imported food
Sec. 301. Foreign Supplier Verification Program
    Food retailers are extremely reliant on imports as our customers 
demand a wide range of products--such as fresh produce--regardless of 
the season. However, importers play a mutually important role to import 
product into our country with the assurance that it is safe. At Publix, 
we only source food from suppliers that are able to meet our strict 
requirements for food safety and product quality. For Publix-branded 
products, this includes an in-depth review of total quality systems 
through audits and evaluations. We believe that food safety supplier 
verification activities will further assist to mitigate food safety 
risks associated with imported foods.
Sec. 302. Voluntary Qualified Importer Program
    We believe it is appropriate to establish systems to encourage the 
use of additional measures of assurance by importers and foreign 
producers. We support the use of incentives to encourage food producers 
to take steps beyond those that are required by law to ensure the 
safety of the food supply and the use of a variety of factors to 
determine the risk posed by different foods.
Sec. 306. Building Capacity of Foreign Governments With Respect to Food
    All food in the United States must meet the same high standards for 
safety, regardless of where the food was produced. Nonetheless, not all 
countries have the same standards for food production as exist in the 
United States. Accordingly, we commend S. 510 for including a provision 
that requires FDA to develop a plan within 2 years of the bill's 
enactment to assist foreign governments in building their technical, 
scientific and regulatory capacity.
Sec. 308. Accreditation of Third-Auditors and Audit Agents
    Properly constructed accredited third party certification programs 
provide rigorous, objective evaluations of a food producer's safety 
programs. Although these programs cannot replace government oversight, 
certification from an accredited third party can provide some assurance 
that the certified company has received extensive and objective 
scrutiny for compliance with food safety standards that often exceed 
the legal requirements.
    We support the legislation's recognition of certification by 
accredited third party auditors, but we would encourage that the 
committee further amend this section to ensure that all terminology is 
consistent with internationally, recognized language and terms. We also 
support the use of certification programs in the assessment of risk 
that FDA must perform in allocating its enforcement resources. 
Specifically, accredited third party certification programs are 
appropriate tools for use in both the Voluntary Qualified Importer 
Program (Section 306) and in the Import Certification Program (Section 
303).
    However, these programs should not replace government oversight or 
attempt to deputize private-sector auditors as an enforcement arm of 
the Federal Government. As an example, we are concerned with the 
provision that audits be ``unannounced''--the same manner that a 
government inspection is conducted. Audits performed under an 
accredited third party certification program are different than a 
``snapshot-in-time'' governmental inspection. During a third party 
certification audit, the auditor is watching and observing how the 
company manages safety as a part of its regular operations. It is a 
thorough rigorous assessment of the systems that are in place. Even 
announced, a company cannot just ``cover up'' fundamental procedural 
flaws.
    Most audits involve two parts: (1) a ``desk'' audit which is a 
review of all of the plant's documentation, written food safety plans, 
risk and hazard assessments, etc. and (2) an on-site evaluation. These 
two audits, together help, to verify compliance with Federal food 
safety standards and internationally recognized best practices. 
Announcing the audit ensures that the necessary people and documents 
will be available to the auditing company's auditors at the appropriate 
time and place.
    Mr Chairman, thank you for the opportunity to testify. We 
appreciate the efforts of this committee to help restore confidence in 
the food safety system and reduce food-borne illness. I look forward to 
your questions and remain available for further discussion and 
information should you need it.

    The Chairman. Mr. Roberson, thank you very much for a very 
succinct and forward statement.
    Mr. Ragan, please proceed.

    STATEMENT OF DANIEL L. RAGAN, DIRECTOR, NORTH CAROLINA 
DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES, FOOD AND DRUG 
                PROTECTION DIVISION, RALEIGH, NC

    Mr. Ragan. Thank you. Thank you, for the opportunity to be 
here today.
    I've been invited today to offer input as the director of 
the North Carolina's principal food protection agency, the 
North Carolina Department of Agriculture and Consumer Services. 
We are the State inspection program within North Carolina. And 
I'm proud to represent the Department of North Carolina and our 
commissioner, Steve Troxler.
    Statistically, as a State employee, you have to realize 
that we perform approximately 90 percent of all food safety 
inspections conducted annually in U.S. food manufacturing and 
distribution establishments. This past year, North Carolina had 
31 inspectors complete over 5,000 inspections.
    But, I want to draw your attention to three provisions that 
I think would make our food system more effective, stronger, 
and would be proactive.
    The first is the development of a national standard. We 
need to establish one set of nationally accepted food safety 
inspection program standards to create a system that assures 
that regulatory programs across the country are uniform in how 
they work and how they prevent and respond to food-borne 
illnesses. The model for this presently is the current 
Manufactured Food Regulatory Program Standards, the MFRPS, 
drafted by FDA with the input from the States. The program 
promotes equivalency between State programs and requires 
continuous evaluation and improvement, as well as auditing by 
FDA. It requires that inspections are conducted on a risk basis 
considering the nature of the product, the process, the firm 
history, and product distribution.
    Another aspect of the MFRPS involves the universal 
laboratory standards. Presently our laboratory is undergoing 
ISO 17025. It's an accreditation program that would allow our 
laboratory to produce defensible, accurate, reproducible, 
precise, and credible information. And it would be accepted by 
all State and Federal agencies.
    The second area that we need is coordinated training. 
Training is another key aspect of the MFRPS. The establishment 
of a nationally recognized standard is a futile endeavor if 
there is no coordinated effort to train the regulators in 
industry to meet and exceed those standards. The Association of 
Food and Drug Officials and the International Food Protection 
Training Institute are currently collaborating in the 
development of a certified training program for food regulatory 
specialists. This kind of work should be commended and 
encouraged.
    Training of our industry partners is also critical. If we 
work together, industry can proactively conduct hazard analysis 
so that effective preventive controls can be identified and 
implemented. In turn, regulatory agencies can verify through 
testing that quality control plans are effective and preventive 
controls are in place. We can never just test our way into food 
safety.
    The final area that we'd like to discuss is a rapid 
response to food-borne illness outbreaks. When food-borne 
outbreaks do occur, the response is tedious, it's time-
consuming, and it's expensive. It is however, a proactive 
desire to contain an outbreak. We have activated our rapid-
response team several times and engaged the assistance of our 
partners at the North Carolina Department of Environmental and 
Natural Resources and Public Health under the ICS structure. 
We've put a lot of feet on the ground in a hurry and we've 
utilized our partners' assistance in getting information out to 
the public.
    Recently, we utilized North Carolina's 86 local health 
directors to release information of a sandwich recall that was 
initiated for listeria.
    We also have developed technology to provide situational 
awareness under our rapid-response program. We use a Web-based 
information system to--during these recalls--collect and report 
information on a real-time basis. This is unique to North 
Carolina, but it's also something the Federal Government needs 
to encompass.
    We tried something new in one of our recalls recently, and 
that was the use of a reverse-911 capability. In a manner of 
minutes, by collecting information, we were able to transmit to 
2,200 firms, the information of a recall.
    Again, traceability has been mentioned here earlier. During 
a time of recall or rapid response, traceability is a huge 
issue to us. It becomes important for us to determine where is 
the contamination. Is it at the manufacturing? Is it as the 
storage? Is it shipping? Or, potentially, is it an act of 
terrorism?
    Restoration is also an issue for us in North Carolina. Our 
goal is to restore facilities to production so that businesses 
prosper and so North Carolinians can keep their jobs. But, it's 
been an unexpected encounter of additional expenses. During the 
peanut industry, as we've all discussed today, we spent 4 
months with one of our firms that was contaminated, working 
with them on a daily basis. The cost to us was in excess of 
$250,000 to get them back up and running. They made the 
commitment, we made the commitment. And I'm proud to say today, 
they're back up and running.
    Also, last year the tomato industry was damaged when a 
consumer advisory was issued that tomatoes were likely the 
source of the salmonella, when, in fact, it was the peppers 
from Mexico. While food safety standards must be uniform, they 
must also be scalable, particularly those that are imposed at 
the farm level. One-size simply does-not-fit-all.
    In summary, my message to you is clear. No. 1, impose a 
system that allows for national standards. No. 2, support 
intensive and appropriate training to those standards. And, No. 
3, prepare the regulators in the industry to quickly respond to 
potential food-borne illness and outbreak.
    Keep in mind, however, that while all these things are 
being discussed and need to be put in place, the issue is still 
money and still finances. For States to improve the food safety 
system and meet the expectations of these programs, as well as 
of the American public, they must be funded appropriately. More 
feet on the ground, more staff in the lab will require 
recurring multiyear funding.
    Thank you.
    [The prepared statement of Mr. Ragan follows:]
                 Prepared Statement of Daniel L. Ragan
              i. introduction--integrated proactive system
    I would like to thank Chairman Tom Harkin, Ranking Member Michael 
Enzi, and distinguished members of the committee for the opportunity to 
offer this testimony. We are faced with the challenging task of 
protecting the safety and economic viability of our Nation's food 
supply system. Americans are fortunate to enjoy one of the safest food 
supplies in the world. However, we are still faced with multi-state 
foodborne illness outbreaks that result in deaths and life-changing 
illnesses. Americans are beginning to question the safety of our food 
supply and are calling upon all of us to implement stronger food safety 
measures.
    We can achieve our shared vision for a safer food supply only if we 
concentrate on true integration and collaboration. Over 3,000 Federal, 
State, and local regulatory and public health agencies have a role in 
protecting the food supply. FDA provides guidance, model codes and 
other technical assistance to State, territorial, tribal and local 
regulatory partners to assist them in carrying-out their regulatory 
responsibilities. Since 1972, FDA has also contracted or entered into 
partnership agreements with many State regulatory agencies to perform 
inspections and investigations. In fact, more than half of all FDA 
inspections are performed under contract by States. As a result States 
perform approximately 90 percent of all food safety inspections 
conducted at food manufacturing and distribution establishments.
    Within the last 2 weeks the NC Department of Agriculture & Consumer 
Services initiated a recall of sandwiches due to the potential for the 
contamination of Listeria monocytogenes. Listeriosis is a bacterial 
infection that can result in stillbirths or miscarriages in pregnant 
women or cause serious illness in elderly or immunocom-
promised populations. This year FDA began funding environmental 
sampling as part of the contract with State regulatory programs. Our 
in-depth inspection of the subject food manufacturer was a firm under 
contract inspection with the FDA. Our laboratory testing initially 
identified Listeria monocytogenes only in the processing environment, 
which led us to conduct additional finished product testing. Testing 
determined sandwiches distributed by the firm may also be contaminated 
and a voluntary recall by the firm was initiated.
    An effective response to any food incident requires the 
collaboration of Federal, State, and local agencies. Our partnership 
with FDA allowed us to initiate a voluntary recall of a potentially 
hazardous food and prevent future illnesses in multiple States. We 
collaborated with the NC Department of Environment and Natural 
Resources and our 86 local health departments to notify the public and 
firms not under our regulatory jurisdiction, such as schools and other 
institutions, of the recall. In addition, we used technology referred 
to as reverse 911 to call thousands of firms in less than 1 hour that 
had received the recalled product.
    North Carolina hosted a listening session for FDA and USDA to allow 
the concerns of small and medium farmers to be expressed concerning 
upcoming food safety legislation. The farmers were committed to 
ensuring the safety of their produce. However, two themes that were 
clearly heard were scalability and there needs to be indemnification 
for farmers damaged by fresh produce-linked outbreaks. For example, the 
Salmonella St. Paul outbreak was initially linked to tomatoes. Further 
investigation linked the outbreak to a farm in Mexico. Unfortunately, 
for tomato farmers in the United States the economic damage was 
irreversible.
    We must continue to implement sensible measures which lead to the 
early identification of food safety issues and prevent foodborne 
illnesses from occurring. Food safety must be built into the entire 
lifecycle of a food, from production to consumption. We must not rely 
only upon epidemiological data alone, after illnesses and deaths have 
occurred, to alert us to food safety issues. Similarly, we will never 
be able to realistically maintain a system which relies solely upon 
testing to verify the safety of the American food supply.
    The food supply system is extremely complex. It includes more than 
150,000 registered domestic food manufacturers, over 1 million 
supermarkets, restaurants, and other food service establishments, and 
more than 2 million farms.
    Regulators must promote corporate responsibility for food safety. 
Firms should identify and evaluate hazards, implement preventive 
measures, and monitor the effectiveness of risk-based preventive 
controls. As new risks are identified or controls are found to be 
ineffective, industry must establish corrective actions. Regulatory 
agencies can then conduct risk-based inspections and testing to verify 
preventive controls were effective.
    Establishing the metrics for measuring our success will allow us to 
direct our resources most effectively. Of equal importance, regulatory 
agencies must have the authority and resources to protect the consumers 
when preventive measures fail.
    Trust must also be built between the regulatory agencies and the 
food industry. Last week, the NC Department of Agriculture & Consumer 
Services was notified by one of our firms of a positive Salmonella 
testing result. The firm had not shipped the product and had no 
mandatory requirement to report the positive finding to a regulatory 
agency. However, our relationship with the firm prompted them to 
immediately notify us of the issue. The Department, in collaboration 
with the FDA, is now verifying the firm's restoration plan through 
systematic inspections including environmental and finished product 
sampling. Like other States, North Carolina is committed to helping our 
firms quickly identify and respond to a food safety issue so they can 
safely resume production.
                             ii. standards
    Legislation under review by Congress will undoubtedly give the FDA 
new authority and tools and resources to comprehensively reform the 
Nation's food safety systems. Some proposals specifically address 
issues surrounding the recall of unsafe product by increasing the 
frequency of inspections at all food facilities, giving the FDA 
expanded access to records and testing results, and allowing the FDA to 
recall dangerous food products in the event a company fails to recall a 
product at the FDA's request. Increased inspection frequencies and 
mandatory recalls can only be achieved by leveraging the resources of 
State regulatory programs. Also, many State and local agencies 
currently have broader regulatory authorities than the FDA. The 
collaboration of all agencies allows us to rapidly and effectively 
minimize the public health impact of a food incident.
    Furthermore, rapid containment is necessary to minimize the 
economic impact of a food incident and to maintain consumer confidence.
Leveraging Existing Resources
    Current leveraging efforts have not been sufficient to ensure 
adequate oversight of the entire food supply chain. Throughout the 
years, numerous reports point out that the FDA does not take full 
advantage of the inspectional and surveillance capabilities of our 
State, territorial, tribal and local regulatory and public health 
partners. This situation is due in large part to the varied standards 
and laws in each State as compared with the Federal system, as well as 
to the lack of interoperable data systems and legal impediments to 
sharing data among partners.
Equivalency
    A fundamental concept to be found in a nationally integrated plan 
is the development of uniform standards and programs with demonstrated 
equivalency. The concept of equivalency allows States to use different 
approaches yet achieve the same level of public health protection. The 
demonstration of equivalency will allow the FDA and States to make 
greater use of each other's laboratory analytical and inspection data 
in pursing advisory, administrative, or judicial actions. North 
Carolina was one of the first pilot States for the Manufactured Food 
Regulatory Program Standards (MFRPS). MFRPS is a continuous improvement 
program developed by FDA for State and local food regulatory agencies 
to ensure equivalency in regulatory programs including inspections, 
sample analysis, compliance, training, and emergency response. While 
originally designed for food programs, North Carolina is now piloting 
MFRPS in our animal feed regulatory program. The interconnectivity of 
the food supply makes it necessary for us to demonstrate equivalency in 
both food and animal feed programs. In addition, the Retail Food 
Standards are another important tool in the standardization and 
continuous improvement of retail food regulatory programs.
Oversight and Accountability
    System integrity and credibility should be maintained through 
regular program oversight and accountability at all levels. The FDA 
conducts audits of State inspectors who perform inspections under 
contract. Also, many States have trained auditors to ensure inspections 
conducted under the authority of the FDA and State meet the same high 
standards. Maintaining the credibility of the regulatory program is a 
key feature of the MFRPS program through auditing all aspects of the 
inspection.
National Risk-based Planning
    Federal and State inspections should be conducted in accordance 
with a public health risk-driven national work plan. Multiple risk 
factors should drive the inspection frequency including the type of 
food being produced, population being served, and the compliance 
history of the firm. An integrated system will result in more 
coordinated response efforts to prevent food incidents from occurring 
and enhance our response to multi-state outbreaks when they do occur.
Laboratory Accreditation
    Regulatory programs must be supported by accurate and defensible 
laboratory results. Many States such as North Carolina are either ISO 
17025 accredited or in the process of receiving accreditation. ISO 
17025 accreditation allows for laboratory data to be accepted by 
Federal, State, and even international partners. Currently, the lack of 
laboratory accreditation hinders the capability of FDA to accept data 
from State regulatory partners. By providing the FDA the confidence to 
initiate regulatory actions based on State results can exponentially 
increase the Nation's capacity to detect and respond to food safety 
problems.
                             iii. training
    Uniform standards are worthless if regulatory officials and 
industry partners do not know how to implement, meet, and exceed them. 
An integrated food safety system can only be accomplished through an 
integrated and standardized training program for both regulatory 
officials and industry.
International Training Food Protection Training Institute
    The International Food Protection Training Institute in Battle 
Creek, MI provides the foundation for the certification of food 
regulatory specialists. In partnership with the Association of Food and 
Drug Officials (AFDO) and FDA, the Institute is committed to providing 
food regulatory specialists with continuous training through a network 
of university-affiliated centers and the use of multiple innovative 
instructional methods. The training of food regulatory specialists 
should be career-spanning as new food safety challenges emerge, 
inspection and investigation strategies evolve, and regulatory 
authorities change. The training provided by the Institute will 
complement the courses offered by FDA.
    North Carolina has demonstrated our commitment to training our 
staff by being the first State to modify and teach the ADFO-developed 
``Applications of Basics of Inspection and Investigation'' to our food 
regulatory specialists. Just last week we provided our modified course 
and sent our training coordinator to Battle Creek to teach inspectors 
from other agencies from around the country.
Industry Training
    The U.S. food industry will have greater responsibility for 
complying with increasing food safety regulations. State and Federal 
regulatory agencies have traditionally relied upon land-grant colleges 
and universities to deliver education and training programs that 
address the food industry's needs. Food safety experts agree the time 
has come to establish a measurable matrix to evaluate our industry 
partners. Without a concerted effort to educate, train and re-tool 
industry partners, legislation which is intended to improve the safety 
of our Nation's food supply will not meet that objective. An urgent 
need exists to increase both the regulatory community and industry's 
capacity to prevent food safety problems, detect and respond to food-
borne illness outbreaks, and protect our food supply from natural and 
deliberate contamination.
                       iv. response and recovery
Traceability
    An integrated, proactive system should decrease the number of major 
foodborne illness events. However, when an event occurs, States need 
the tools to provide timely traceability, rapid recall and to 
facilitate market recovery. Recent multi-state outbreaks linked to 
fresh produce and ingredients, such as the peanut recall earlier this 
year, have magnified our inability to rapidly trace and remove 
potentially contaminated foods from the market. Delays in market 
removal result in additional illnesses, deaths, and economic loss. 
``Rolling'' recalls only serve to undermine consumer confidence in the 
food supply and government. While the Bioterrorism Act of 2002 requires 
one step trace back and trace forward, current recordkeeping systems 
often do not provide investigators the information necessary to rapidly 
identify the source of a foodborne illness outbreak. FDA should provide 
guidance for uniform traceability requirements and systems for food 
manufacturers and distributors. Such guidance should be scalable and 
meet the needs of the entire industry.
Market Recovery
    National food safety scares, food illness outbreaks, and recalls 
have a direct economic impact on the specific entity at the center of 
the action, but they also have an economic impact that ripples 
throughout industries, into processing facilities, farms, and 
communities across the country. Put differently, when a foodborne 
illness outbreak occurs, that outbreak and any accompanying recall 
efforts, media notifications, and regulatory actions can devastate 
entire commodity markets and the farmers and processors involved with 
that particular market. For example, many North Carolina farmers who 
grow peanuts were just coming off their best crop year ever when the 
Peanut Corporation of America-based salmonella outbreak occurred. Many 
of those farmers were not able to secure contracts for the peanuts they 
harvested and many have lowered their planting projections as a result 
of weak demand in the market.
    Securing the safety of America's food supply simply cannot occur if 
some system is not put into place to ``re-establish'' markets damaged 
by a food-illness or outbreak and offer indemnification for the 
farmers, lest we limit the number of individuals involved in food 
production and become even more dependent on foreign sources for our 
food. Comprehensive food safety legislation must include market 
recovery assistance for industries battered by food safety scares, 
consumer advisories, recalls, and peripheral events. Such assistance 
may include provisions for State Departments of Agriculture, commodity 
associations, or others to access funds for market recovery efforts 
which can be narrowly tailored to the scale of the market disruption 
and which are targeted to audiences who can take actions to minimize 
that disruption.
Unified Rapid Response
    The use of the Incident Command System (ICS) has allowed North 
Carolina to engage all of our partners for a unified and rapid response 
to a food incident. During the Castleberry recall, the use of ICS 
allowed us to coordinate the efforts of over 700 regulatory officials 
to conduct more than 16,000 recall effectiveness checks. We continue to 
implement ICS and utilize rapid response teams to respond to any 
significant food safety event. As noted earlier, the PCA-based 
salmonella outbreak affected the entire food industry, including one 
major snack manufacturer in North Carolina. The use of ICS allowed us 
to efficiently coordinate recall effectiveness checks with our Federal, 
State, and local partners in addition to overseeing the restoration of 
a major snack manufacturer and conducting in-depth inspections of our 
peanut processors to restore consumer confidence.
                         v. information sharing
    As the Nation moves towards integration of the food safety system, 
real-time sharing of information must occur. Multiple surveillance 
activities for early detection of food safety issues and illnesses are 
in place yet the information is not systematically mined. Surveillance 
activities include conducting risk-based inspections, risk-based retail 
survey programs, recall effectiveness checks, and responding to 
consumer complaints.
Real-time Information Sharing
    Accurate and standardized data should be collected from all levels 
of government and systematically mined for early detection of food 
incidents. Real-time data sharing systems must be in place and 
accessible to all Federal, State, and local food protection agencies to 
provide for seamless sharing of all data. By combining the multiple 
layers of data we are collecting, we can begin to detect food safety 
issues before multi-state outbreaks occur and thousands of consumers 
become ill.
    North Carolina and other States are now piloting a project to share 
all manufactured foods inspection data with the FDA by interfacing with 
eSAF. We have also developed a real-time system for collecting recall 
effectiveness data that we have shared with all of our State and local 
regulatory partners. During the cookie dough recall initiated for E. 
coli O157:H7, we piloted the system with other States. The result was 
the ability to determine nationally the effectiveness of the recall and 
provide a platform for targeting resources during a response. Also, 
many States participate in eLEXNET, an electronic system of the Food 
Emergency Response Network (FERN) to store sample data results and 
allow users to identify trends.
Removal of Legal Barriers
    Currently, only a fraction of the data being collected is 
accessible to all food protection agencies. The legal barriers to 
sharing information must also be eliminated. The FDA currently requires 
all firms subject to their regulation to be registered underneath the 
Bioterrorism Act of 2002. However, States do not have access to this 
database. Conversely, many States are aware of firms that are not 
registered with FDA. The result is not one agency contains a complete 
and accurate inventory of food manufacturers, distributors, and 
retailers. The same is also true of the newest initiative of FDA, the 
Reportable Food Registry. While the FDA has committed to share 
information with the States as appropriate, having real-time access to 
all of the information collected can help all regulatory partners 
develop appropriate risk-based responses and implement preventive 
measures.
                              vi. funding
    A commitment from both the FDA and the States is necessary for the 
successful integration of a proactive and prevention-based food safety 
system. The States have demonstrated their commitment through the 
participation of multiple initiatives to build equivalent regulatory, 
laboratory, and emergency response programs. We have also demonstrated 
our commitment to share our data in real-time. An equal commitment from 
the Federal Government is necessary for full integration of the 
Nation's food safety system. Funding to State agencies must hinge upon 
measurable objectives and deliverables.
    The FDA contracts with State regulatory programs to conduct 
inspections and sample analysis, which contracts are generally 
renegotiated annually. The annual renewal of Federal funding prevents 
States from building the foundation for long-term success. However, to 
be fully successful, the national food safety system must be built with 
continuous input from FDA's regulatory and public health partners. It 
must be sustained through multi-year funding that will be provided to 
State and local regulatory and public health partners to build the 
necessary State and local infrastructures, contain adequate legislative 
authorities to facilitate information sharing and communication among 
all partners, and include infrastructure for a national electronic 
information-sharing mechanism. These actions will result in a national 
food safety system that reduces foodborne illness, identifies sources 
of risk throughout the system, and reduces time to detect and respond 
to outbreaks. A public health driven, collaborative, and leveraged 
approach to food safety activities and responsibilities will be 
reflected in improved public sector resource utilization at a national 
level, which provides additional capacity for ensuring a safe and 
secure food supply.
    Congress should provide dedicated, line-item funding from the 
Federal level to State and local programs. A current model for 
assessment and funding may be the USDA Talmadge-Aiken meat inspection 
program. Pursuant to the Talmadge-Aiken Act, States may enter a 
cooperative agreement with USDA, pursuant to which State plants receive 
``Federal inspection'' performed by federally licensed State employees. 
The T/A program provides funding to State programs that are uniform and 
consistent with USDA-FSIS standards based on the regulatory 
responsibilities (e.g., number and size of firms) of the State agency.
    Direction should be given for the Secretary of HHS to develop 
timelines for all States to be compliant with MFRPS and to demonstrate, 
at minimum, equivalency to FDA. Full implementation of MFRPS in all 
States will require greater funding to acquire the staff, training, and 
data management systems necessary. Funding should be based on 
regulatory responsibilities and meeting benchmarks for full compliance 
with MFRPS. While $5,000 was provided for pilot States to conduct a 
self-assessment and to create an operational plan for self improvement, 
this amount of limited financial support does not provide the States 
the capability to fully meet the requirements of MFRPS. Furthermore, 
funding for the International Training Institute for Food Protection 
and its affiliated universities is another key component for States to 
be in compliance with MFRPS.
    Congress should also increase funding for the food protection 
training institutes affiliated with land-grant colleges and 
universities for the development and delivery of a measurable 
comprehensive food safety education and training program that addresses 
the needs of industry in meeting the new food safety modernization act 
reforms. Similar to the training program for food regulators, the 
training program for industry should include a certification component.
    Funding is not only necessary to identify food safety issues, but 
to facilitate the recovery of the food industry following a major food 
incident. The restoration of a major food manufacturer is costly to 
both the government and industry. State regulatory agencies are 
committed to assisting our industry in recovering from a major food 
incident, however, the financial resources must be provided. Also, 
through no fault of their own, the entire farm to fork food continuum 
suffers when a significant food incident occurs. We must build a food 
safety system which promotes prevention, early identification, rapid 
response, and swift recovery to any type of food incident.
                            vii. conclusion
    I would like to thank the committee for this opportunity for North 
Carolina to present our perspective on the resources and commitment 
required for an integrated food safety system to be successful. Nothing 
is more important to the quality of our lives than the food we eat. We 
can no longer take the safety of our food supply for granted. State and 
local regulatory agencies are currently conducting 80 percent of the 
food safety and defense work in the United States including 
inspections, emergency response, consumer complaints, and laboratory 
testing. By investing in State and local regulatory program we can 
build the capacity necessary to protect the food supply and fulfill our 
obligation to the American public. I will be happy to answer any 
questions the committee may have.

    The Chairman. Thank you very much, Mr. Ragan.
    Mr. Stenzel, welcome, again, to the committee. Please 
proceed.

STATEMENT OF THOMAS E. STENZEL, PRESIDENT AND CFO, UNITED FRESH 
              PRODUCE ASSOCIATION, WASHINGTON, DC

    Mr. Stenzel. Thank you, Chairman Harkin, Ranking Member 
Enzi, and members of the committee.
    United Fresh Produce Association represents the growers, 
shippers, fresh-cut processors, and marketers of fresh fruits 
and vegetables who account for the vast majority of produce 
sold in the United States today. These include family 
businesses--small and large producers in both conventional and 
organic production.
    Mr. Chairman, we've worked together for many years now to 
promote increased consumption of fresh fruits and vegetables 
for America's children. And you know of our industry's 
commitment to safety. We're committed to doing everything we 
possibly can to ensure the safety of the products we grow, 
package, and deliver to consumers. Our association published 
the first food safety guidelines for the fresh-cut produce 
industry 17 years ago, and we developed the first industry 
guidelines, in the mid-1990's, to minimize on-farm 
microbiological food safety risks.
    Following the E. coli outbreak associated with one brand of 
spinach in September 2006, the industry undertook a 
comprehensive reevaluation of leafy-greens production, 
handling, and processing to ensure compliance with best 
practices in assuring safety. Other commodity groups have done 
likewise, with the tomato industry implementing rigorous 
standards and metrics that are now incorporated in State law in 
Florida.
    The industry is well along in a multiyear produce 
traceability initiative committed to driving a standardized 
system of case coding for total supply-chain traceability. And 
the industry is now working hard to drive harmonization of 
global good agricultural practices for all fruit and vegetable 
growers. With this unprecedented commitment to food safety from 
field to table, the public can be confident in the safety of 
the over 1 billion servings of fresh fruits and vegetables 
consumed in America every day.
    Yet, we, too, know that there must be changes in our 
Federal system of food safety oversight. We've seen the 
failures in our system up close; first, in failing to focus on 
the risk, where they're most likely to occur, and second, in 
misguided management of outbreak investigations that confuse 
the public and cast entire industry sectors into doubt.
    Our board of directors took the bold step, 3 years ago, to 
adopt a series of public policy principles calling for 
mandatory science-based regulation by the Federal Government. 
Let me explain the importance of these three principles.
    We believe, first, that produce safety standards must allow 
for commodity-specific food safety practices based on the best 
available science. In a highly diverse industry that is more 
aptly described as hundreds of different commodities, one-size 
clearly does-not-fit-all. The large majority of produce 
commodities have never been linked to a food-borne disease. FDA 
states that only five produce commodities have been associated 
with 80 percent of food-borne disease outbreaks in the past 10 
years.
    We believe produce safety standards must be consistent for 
any individual commodity grown anywhere in the United States or 
imported into this country. Consumers must have confidence that 
safety standards are met, no matter where the commodity is 
grown, nor whether it was grown by a small or large farmer, nor 
conventionally or organically.
    Last, we believe that this will require strong Federal 
Government oversight and compliance in order to be credible. We 
believe that FDA must determine appropriate nationwide safety 
standards with full input from the States, industry, academia, 
and consumers. In turn, it is then important for FDA to work 
with its partners at the USDA and State departments of 
agriculture to ensure compliance with produce safety standards.
    We're pleased that the consensus in Congress has grown in 
support of these principles, as embodied in S. 510 introduced 
by Senators Durbin, Burr, and many colleagues here.
    While most of my testimony today is about prevention of 
illness, and properly so, I also want to call your attention to 
the failures evident in outbreak management. Already discussed 
today, the tomato industry's impact, where for 6 weeks the 
industry was basically shut down in pursuit of the wrong 
product.
    The current system offers diffuse responsibility, which 
creates a lack of accountability. The current system doesn't 
use valuable industry expertise. And the risk communication and 
outbreak management is unacceptably broad and can actually be 
harmful to public health.
    Just consider this one fact. The 2006 E. coli outbreak 
linked to spinach is now known to have been limited to one 
farm, one packing plant, on only 1 day's production. The only 
contaminated spinach ever marketed was packaged on August 15, 
2006, 3 years ago; yet consumption of this nutritionally dense 
vegetable is still down from where it was 3 years ago. Public 
health is not well served by such misplaced fears.
    I also urge the committee to reject calls to water down the 
food safety requirements in this bill as a way to satisfy some 
who say that small farms or organic farms should not have to 
comply. Mr. Chairman, we have a number of small farms and 
organic farms in our membership, and they are committed to 
complying with whatever safety rules that FDA sets. Our 
industry has learned the painful lesson that we are only as 
strong as our weakest link.
    We believe a better plan is to offer technical assistance, 
training, and financial support, perhaps including reduced fees 
for small businesses, to assist small resource farmers to 
comply with the important food safety and traceability 
standards.
    Thank you very much.
    [The prepared statement of Mr. Stenzel follows:]
                Prepared Statement of Thomas E. Stenzel
                              introduction
    Good morning Chairman Harkin, Ranking Member Enzi, and members of 
the committee. My name is Tom Stenzel and I am President and CEO of the 
United Fresh Produce Association. Our organization represents more than 
1,500 growers, packers, shippers, fresh-cut processors, distributors 
and marketers of fresh fruits and vegetables accounting for the vast 
majority of produce sold in the United States. We bring together 
companies across the produce supply chain from farm to retail, 
including all produce commodities, both raw agricultural products and 
fresh ready-to-eat fruits and vegetables, and from all regions of 
production.
    I mention these characteristics because our organization's views on 
food safety are shaped by this broad and diverse membership across the 
entire produce industry, not any one sector or region. In the area of 
science and food safety, our association works to develop industrywide 
consensus on the best overall policies and practices to serve the 
American consumer.
    Let me begin by repeating something you've heard many times before, 
and will hear many times in the future. Food safety is our industry's 
top priority. The men and women who grow, pack, prepare and deliver 
fresh produce are committed to providing consumers with safe and 
wholesome foods.
    That is what drives food safety to be a process of continuous 
improvement, not a static achievement. We are on a continuum constantly 
striving to improve, while understanding scientifically that 
perfection--or zero risk--is not possible. Because our products are 
enjoyed by consumers in their fresh and natural state without cooking, 
we have to be right every single time--not one in a million, or even 
one in a billion.
    Now, I personally am confident in my produce choices today. I know 
the personal care and commitment of people I meet who are growing and 
processing fresh produce, and I trust them to be doing their very best 
to market safe products. And I know that their results are 
overwhelmingly successful, with the actual incidence of illness 
extremely low. Just look at the numbers.

     Over a billion servings of fresh produce are eaten every 
day.
     More than 5 million bags of fresh salads are sold every 
day.
     And, out of the hundreds of fruits and vegetables offered 
in a typical supermarket, only a very few have been implicated in 
illness outbreaks, and then rarely as compared with their volume of 
consumption.

    But, we also know that consumers today are walking into grocery 
stores and restaurants with concerns, doubts, and sometimes fears about 
produce. They don't understand those statistics; they don't know what 
farmers and processors are doing to protect the safety of their 
produce; and equally important, they do not have complete confidence 
that government is doing all it should to protect their health.
    Most importantly, we cannot lose sight that health experts are 
unanimous that Americans must increase our consumption of fruits and 
vegetables for better health. That's the juxtaposition we face today on 
food safety--it is simply unacceptable for Americans to fear consuming 
fresh fruits and vegetables that are essential to their good health.
                     principles for produce safety
    Mr. Chairman, we have worked together to promote increased 
consumption of fresh fruits and vegetables for the health for America's 
children for many years, and you know that our industry's commitment to 
safety is the bedrock of that effort. Our commitment to produce safety 
is twofold.
    First, we will do everything we possibly can as an industry to 
ensure the safety of the products we grow, package and deliver to 
consumers. Our association published the first Food Safety Guidelines 
for the Fresh-Cut Produce Industry 17 years ago, and we are now on our 
4th edition. We developed the first industry guidelines in the mid-
1990s to minimize on-farm microbiological food safety risks for fruits 
and vegetables, and worked closely with the FDA to publish Federal 
guidelines soon thereafter. Food safety has been at the forefront of 
our mission to serve the American public for many years.
    Following the E. coli outbreak associated with one brand of spinach 
in September 2006, we undertook a comprehensive reevaluation of leafy 
greens production, handling and processing to enhance every possible 
step we could take in assuring safety. Even though that problem was 
isolated to one small farm, the entire leafy greens industry has 
adopted the most rigorous scientific principles to minimize risk, and 
developed compliance protocols and audits that are now conducted by 
State government officials.
    Other commodity groups have done likewise, with the tomato industry 
implementing rigorous standards and metrics that have been incorporated 
in State law in Florida.
    Earlier this year, our association brought together worldwide 
leaders in produce safety standards and auditing, launching an ongoing 
initiative to drive harmonization around the most rigorous set of good 
agricultural practices known as GAPs, applicable to all produce 
operations.
    The committee should be familiar with our Produce Traceability 
Initiative (PTI), an industrywide commitment launched by three major 
trade associations in 2008 to drive a standardized, total supply chain 
traceability system with case coding to allow rapid traceback and 
isolation of any potential problems.
    I can tell you with certainty today, that produce is safer today 
than ever before, with an unprecedented commitment from food safety 
from field to table.
    Yet, we too know that there must be changes in our Federal system 
of food safety oversight to restore public confidence in what too often 
appears to be a broken system. We have seen the failures of food safety 
oversight up close, first in failing to provide the resources and focus 
on prevention of contamination where most likely to occur, and second 
in misguided management of outbreak investigations that confuse the 
public about true risk and cast entire industry sectors into doubt.
    In order to address these issues, our Board of Directors took the 
bold step 3 years ago to adopt a series of policy principles calling 
for mandatory, science-based regulation by the Federal Government. Let 
me repeat those principles once more:

     To protect public health and ensure consumer confidence, 
produce safety standards:

          Must allow for a commodity-specific approach, based 
        on the best available science.
          Must be consistent and applicable to the identified 
        commodity or commodity sector, no matter where grown or 
        packaged in the United States, or imported into the country.
          Must be federally mandated with sufficient Federal 
        oversight of compliance in order to be most credible to 
        consumers.

    Since that time, our industry has been a leading proponent of 
strong Federal Government oversight of food safety, testifying before 
the House or Senate more than 10 times, working extensively with FDA 
and USDA, and sharing perspectives with other stakeholders and the 
consumer community.
    We are pleased that the consensus in Congress has grown in support 
of these principles, which have largely been incorporated into H.R. 
2749 the Food Safety Enhancement Act passed by the House, and S. 510 
the Food Safety Modernization Act of 2009 introduced by Senators Durbin 
and Burr and colleagues.
    As this committee and the Senate consider changes to our food 
safety laws, let me explain the importance of each of these principles.

     Must allow for a commodity-specific approach, based on the 
best available science. We believe produce safety standards must allow 
for commodity-specific food safety practices based on the best 
available science. In a highly diverse industry that is more aptly 
described as hundreds of different commodity industries, one-size 
clearly does-not-fit-all. For example, the food safety requirements of 
products grown close to the ground in contact with soil are far 
different from those grown on vines or trees. The large majority of 
produce commodities have never been linked to a foodborne disease. In 
fact, a recent FDA Federal register notice confirms that five produce 
commodities have been associated with 80 percent of all foodborne 
disease outbreaks in the past 10 years, and that is where we must 
direct our resources.
    In addition, government and industry alike must be careful that 
broad strokes do not result in requirements that should not apply to 
specific commodities, and do nothing to enhance safety. Taking a 
general approach would be far too easy to add regulatory costs and 
burdens to sectors where those requirements are unneeded, without doing 
anything to enhance safety where most critical. Finally, as part of 
this commodity specific approach, FDA must develop a rulemaking 
procedure that establishes risk and science-based regulations for the 
production, handling and distribution of those types of fruits and 
vegetables for which the Secretary determines such standards are 
necessary to minimize the risk of microbial illness.
     Must be consistent and applicable to the identified 
commodity or commodity sector, no matter where grown or packaged in the 
United States, or imported into the country. We believe produce safety 
standards must be consistent for an individual produce commodity grown 
anywhere in the United States, or imported into this country. Consumers 
must have the confidence that safety standards are met no matter where 
the commodity is grown or processed. Because of the variation in our 
industry's growing and harvesting practices in different climates and 
regions, flexibility is very appropriate and necessary. For example, 
some production areas use deep wells for irrigation while others use 
river water supplied from dams. Some farms use sprinkler irrigation, 
others use a drip system laid along the ground, and still others use 
water in the furrows between rows of produce. But the common factor 
must be that all uses of water for irrigation must meet safety 
standards that protect the product. That must be true whether the 
produce is grown in California, Florida, Wisconsin or Mexico.
     Must be federally mandated with sufficient Federal 
oversight of compliance in order to be most credible to consumers. We 
believe achieving consistent produce safety standards across the 
industry requires strong Federal Government oversight and 
responsibility in order to be most credible to consumers and equitable 
to producers. We believe that the U.S. Food and Drug Administration, 
which is the public health agency charged by law with ensuring the 
safety of the Nation's produce supply, must determine appropriate 
nationwide safety standards in an open and transparent process, with 
full input from the States, industry, academia, consumers and all 
stakeholders. We are strong advocates for food safety standards based 
on sound science and a clear consensus of expert stakeholders.
    In turn, it is important for FDA to work with its partners at the 
USDA and State departments of agriculture to ensure compliance with 
produce safety standards. We do not see a need for thousands of new FDA 
inspectors moved from processing plants to farms and fields, but rather 
a close working relationship with the USDA that understand agricultural 
production and can better monitor and assure compliance with FDA rules.

    Together, these three policy principles provide a direction for a 
food safety regulatory policy that we believe would most help our 
industry enhance produce safety, concurrent with establishing the 
highest level of public trust in our industry and in our fresh produce 
offerings. It is our goal to support a U.S. regulatory framework for 
the fresh produce industry that incorporates these principles.
                        outbreak investigations
    While most of my testimony today is rightly focused on what we can 
do to prevent illness associated with our products, I must also include 
comments about the current management of outbreak investigations by 
Federal, State and local Government.
    In testimony I presented last summer to the House Energy and 
Commerce Committee, I discussed the multitude of failures evident in 
the Salmonella Saintpaul outbreak in 2008 that was eventually linked to 
jalapeno peppers, but only after shutting down the tomato industry. In 
that testimony, I highlighted several fundamental flaws in outbreak 
management that I believe should also be addressed in reform of food 
safety laws.
1. Diffuse Responsibility Creates Lack of Accountability
    The diffuse responsibility for public health in outbreak 
investigations results in no one agency or individual in charge, 
leaving local, State, and Federal officials vying for leadership; 
various agencies pursuing different priorities; and well-meaning 
individuals reacting independently to events rather than as part of a 
coordinated investigation moving forward in a logical and expeditious 
direction. Another indicator of this problem is the lack of a 
coordinated national training program for investigators at the Federal, 
State and local level. The resulting inconsistency of field work in 
these investigations is a major impediment to accurate and timely 
results.
    We suggest Congress direct the Administration to put in place an 
outbreak investigation structure with a clear chain of command. Take 
guesswork out of who's in charge, and drive real authority and 
accountability into the process. We suggest examining the system for 
National Transportation and Safety Board investigations, which from 
afar, seems designed for a 24-7 immediate response, with clear 
authority and command leadership, supported by a team of well-prepared 
experts. Simultaneously, HHS should mandate and provide the resources 
for nationally consistent training for all local, State and Federal 
employees involved in food safety investigations and inspections.
2. The Current System Doesn't Use Industry Expertise
    The government's failure to use industry's expertise in outbreak 
investigations is one of our most important lessons. Let me first say 
that this needs to be a transparent process in order to have public 
credibility. But there is an abundance of knowledge in the industry 
about specific commodities, growing regions and handling practices, and 
specific distribution systems that can be used to protect public health 
in an outbreak. Based on geographic distribution patterns of illnesses 
alone, industry representative advised FDA quickly that tomatoes were 
extremely unlikely to be the source of contamination, yet such input 
was ignored until proved correct 6 weeks later when jalapenos chopped 
up in salsa were linked to the outbreak.
    Congress and the agencies should find a proper and transparent way 
to bring industry expertise into its investigations. We specifically 
recommend that a group of experts in major produce commodities be 
selected and vetted by government well ahead of time, perhaps through a 
process similar to gaining a security clearance. Then, at a moment's 
notice, these pre-cleared experts could be assembled with government 
investigators to provide counsel in their areas of expertise.
3. Today's Risk Communication Is Unacceptably Broad
    These are complex issues indeed, and tough to explain. The 
principle of timely and candid communication with the press and public 
cannot be compromised. Yet, the public is not well-served by stoking 
fear of all spinach, or all tomatoes, or any other commodity when the 
actual risk is very limited. Consider this fact--the 2006 E. coli 
outbreak linked to spinach is now known to have been limited to one 
farm, one processing plant, on only one day's production run. There 
have been no further illnesses since that time reportedly linked to 
spinach. Yet, consumption of this nutritionally packed vegetable is 
still down from where it was 3 years ago. Public health is not well-
served by such misplaced fears.
                 congressional food safety legislation
    Let me now discuss our thoughts on S. 510 the Food Safety 
Modernization Act now before the Senate. We support this bill as an 
aggressive and comprehensive approach to reforming food safety law. 
While we would like to see further direction to HHS for improving 
outbreak investigations, we believe many of the tough issues have been 
addressed in this legislation, leading to the bipartisan nature of its 
co-sponsors.
    Specifically, we applaud the bill's commodity-specific approach to 
produce, which necessarily focuses resources where most needed. We 
applaud the bill's requirement that FDA work with USDA and the States 
in implementation and compliance measures. And, we applaud the bill's 
mandate for an expedited entry program for imports that can demonstrate 
compliance with U.S. food safety standards.
    I also want to urge the committee to reject calls to ``water down'' 
the food safety requirements in the bill as a way to satisfy some who 
say that small farms, organic farms, or others should not have to 
comply. Mr. Chairman, I have a number of small farms and organic farms 
in our membership, and all are committed to following whatever food 
safety rules that FDA deems to be important to protect public health. 
Size does not determine whether food safety is important--every 
consumer's health is just as important whether purchasing vegetables at 
a farmers market or a grocery store. Our industry has learned the 
painful lesson that we are only as strong as our weakest link. If 
Congress truly wants to build public confidence in our food safety 
system, all fruits and vegetables must comply with basic safety rules 
no matter where or how grown.
    Rather than seek exemptions from basic food safety requirements, we 
believe technical assistance, training and financial support--including 
reduced fees for all small businesses--are more appropriate ways to 
assist small resource farmers and produce distributors to comply with 
important food safety and traceability standards. We are confident that 
every produce grower--in this country or abroad--should be able to 
comply with the commodity-specific standards and guidance anticipated 
from FDA for the safe production and handling of fruits and vegetables.
    We urge the committee to move swiftly in deliberations on S. 510 in 
order to allow Senate consideration this year. With H.R. 2749 pending, 
passage of S. 510 would provide strong Senate leadership in conference 
to formulate final bipartisan legislation that can be broadly supported 
by both chambers, industry and consumers.
                               conclusion
    In conclusion, let me return to the important role fresh fruits and 
vegetables play in public health. Of course any reasonable person in 
the food industry would want to produce only the safest possible 
product. But for us, somehow it seems even more important because of 
the healthfulness of fresh produce. The very Department of Health and 
Human Services that regulates our safety has the dual responsibility to 
promote the importance of eating more fruits and vegetables to prevent 
chronic diseases such as cancer, heart disease, stroke, and more. Now, 
our Nation is faced with an obesity crisis that threatens the long-term 
health of our children and out-of-control escalation in health care 
costs unless we radically change eating habits to consume more fruits 
and vegetables.
    With that public health imperative, fears of food safety have no 
place in the fresh produce department. We, as an industry, must do all 
we can to prevent illnesses from ever occurring, and we will.
    But because science tells us there is no such thing as zero risk, 
government must also be able to assure the public that even if 
something does go horribly wrong in an isolated case, consumers can 
continue to have confidence in fresh produce. We must all be able to 
trust the overall system of government oversight and industry 
responsibility, working together to produce the safest possible supply 
of fresh, healthy and nutritious fruits and vegetables.

    The Chairman. Thank you again, Mr. Stenzel.
    And you're right, we've worked together, going back to the 
early 1990s, if I'm not mistaken. So, it's been a long and very 
enjoyable working relationship to get more fresh produce and 
vegetables, in our diets.
    Ms. DeWaal, there are a lot of things I'd like to cover 
with you, but just one, on the issue of food imports. Your 
testimony advocates requiring government-to-government 
certification for high-risk foods. Well, what if the FDA 
concludes that it cannot certify a particular foreign 
government's oversight program? Does that mean that no facility 
in that country should be allowed to sell high-risk foods into 
the United States? Or could the FDA certify facilities in such 
countries on a facility-by-facility basis?
    Ms. DeWaal. Thank you, Senator Harkin. The bill provides 
for that situation. First of all, S. 510 contains something, 
which isn't in the House bill, which complicates the imports 
section, a little bit. It's got what's called an ``accrediting 
body.'' And that body actually--I think you may want to look at 
that provision in the bill closely, because that body actually 
would get between two governments, the U.S. Government and a 
foreign government, in assuring that that foreign government 
can certify. I don't think that was the intent of the drafters. 
So, I think that this accreditation body is something you're 
going to want to take a close look at.
    Now, the bill does provide for the situation where you 
don't have the government-to-government certification, which, 
as you know, is critical to the meat safety area; it's what is 
actually used in the meat safety area to ensure the safety of 
imported products.
    In the FDA bill, it's a lot more complicated, because of 
the number of products and the number of countries involved. 
So, in that case, there are independent certifying agents. 
These may be third parties that just serve the role of 
certifying an entity in a foreign country to ship FDA-regulated 
food. This is a new concept. It's an important concept. It's 
one, I know, that FMI uses a lot and actually plays a role in. 
But, it's an important new concept in food safety that would be 
brought to bear. It's like the FDA would be adopting something 
that's already working in the private sector to help them in 
this area of imports.
    The Chairman. Anybody else have any views on this at all, 
or thoughts on the question I just asked on that, about foreign 
imports?
    Mr. Stenzel. Mr. Chairman, I think they're clearly going to 
be cases where FDA is not able to certify a foreign government 
having the exact same standards. So, there does need to be that 
system to allow for a high-risk product, independent 
certification that FDA accredits. They have to make sure that 
it's a reliable inspection, but there needs to be a way. That's 
only on the high-risk products. One of the important provisions 
of the bill is that it requires the importers to certify that 
the product, in our case, has been grown in accordance with 
U.S. safety standards. And we think that essentially is the 
right approach.
    The Chairman. Very good. Thank you, Tom.
    Mr. Roberson, did you have something on this?
    Mr. Roberson. Senator Harkin, my colleague Ms. DeWaal 
referred to the program that FMI has, and that is the Safe 
Quality Food Program. That program has been benchmarked through 
the Global Food Safety Initiative, and as part of that 
accreditation process, the SQF program has to go through an 
ANSI certification, so it does provide a very high level of 
accreditation to that third-party accredited certification 
audit.
    The Chairman. Right. Exactly.
    One thing I just wanted to ask all of you, and that is in 
S. 510, we're trying to set up regimes in which consumers would 
be very confident that their food would be risk-free. But, 
isn't there also an element that we need more education of the 
general populace on what their responsibilities are once they 
get this food?
    Mr. Roberson, in terms of grocery stores, in terms of 
information that grocery stores could put out, if you buy fresh 
produce and stuff that's not triple-washed and bagged, this 
needs to be washed, this needs to be cleaned. Your fruit that 
you buy, your apples, your pears and things, please wash them 
thoroughly before you give them to your children or eat them. I 
don't know if Publix does that. I don't know that, or if other 
stores do that. But, it seems to me that there's got to be an 
element in this also of informing consumers of what they should 
do.
    Mr. Roberson. Senator Harkin, thank you for the opportunity 
to respond. You're absolutely right, consumers do play a role 
in the link of the food supply continuum, that farm-to-fork 
discussion that we've all spoken about for years. Publix and 
other member companies of FMI have, for many years, partnered 
with the Partnership for Food Safety Education, the development 
of the Fight Back Campaign, over 10 years ago, and most 
recently, in partnership with the USDA and FDA, the development 
of the new Be Food Safe Campaign. There are excellent consumer 
education programs that are out there, and we do partner with 
the Partnership for Food Safety Education to make that 
available to consumers.
    The Chairman. Ms. DeWaal, you obviously are a big consumer 
representative.
    Ms. DeWaal. Yes, Senator. We strongly support consumer 
education. In fact, we send it out in our magazine, which goes 
out about 10 times a year.
    The key issue, I think, though, is the--I think consumers 
are very willing to do their part, but they should be the last 
line of defense and not the first line of defense for unsafe 
food. And I think we would all agree on that.
    The Chairman. We all agree with that.
    Ms. DeWaal. Thank you.
    The Chairman. The other thing is that it's got to be part 
of a school curriculum, maybe even in elementary education, 
kids ought to be taught about this. I'll think about that with 
my fresh fruit and vegetable program.
    Mr. Ragan, my time is out, but if you had a view on this--
    Mr. Ragan. The only addition that I'd like to make from 
North Carolina is that we've actually got a bilingual 
specialist who's putting out these programs in both English and 
Spanish.
    The Chairman. Very good. You're ahead of the curve.
    Thank you very much.
    Senator Enzi.
    Senator Enzi. Thank you, Mr. Chairman.
    Ms. DeWaal, I need a little clarification about your 
recommendation to require that every positive test be sent to 
the FDA. Some of the products can be remediated after they do 
the test and others may be destroyed on a positive test and 
never endanger anybody. So, I don't want to discourage 
companies from doing testing, but I also don't want to 
overwhelm the FDA with information that might no longer be 
useful. Are you worried that this reporting might result in the 
FDA looking for a smaller needle in a bigger haystack?
    Ms. DeWaal. Senator Enzi, I think that's an excellent 
question. The key to mandatory reporting is that, first of all, 
there be efficient IT systems at the Food and Drug 
Administration. These are computer-based systems that would 
allow the information to be transmitted to the agency, but the 
agency would necessarily be looking at every positive test 
result. Similar systems are actually being used at the 
Environmental Protection Agency, where they actually get a 
volume of data from water--the water processors, people who are 
responsible for ensuring the safety of water. That's the model 
we've been looking at. But, again, it does rely not on an 
individual at FDA who's responsible for looking at every one of 
these positive test results, but to have efficient systems that 
kick out the things that are abnormal or where the agency can 
identify, for example, that a company is not taking a critical 
step to control it.
    This is very important, though, because of the issue with 
the peanut butter outbreak earlier this year, where that 
company had almost a dozen positive test results that they'd 
never shared. In fact, they were hiding them and sending the 
products out anyway.
    Senator Enzi. I'm still trying to figure out what to do 
with the dilemma of people who know they're doing something 
wrong, but they don't do anything about it, regardless of how 
many tests we impose on everybody else. So, I appreciate that 
answer.
    Mr. Roberson, Publix seems to be able to respond very 
quickly to recalls. In your testimony, you mentioned the Rapid 
Recall Exchange, which is an alert system regarding recalls. 
Can you tell me how this voluntary program works with the 
Mandatory Reportable Food Registry that just got underway 
earlier this year?
    Mr. Roberson. Absolutely, Senator Enzi. Thank you, for the 
question.
    The Rapid Recall Exchange is a system that was built 
collaboratively through different levels of the industry. Both 
the retail industry, the restaurant industry, working in 
collaboration with the manufacturing industries, realized that 
it was important to put together a one-stop shop, you might 
say, of a system that would communicate recalls immediately and 
instantaneously with everybody throughout the purchasing side 
of the food industry. In doing such, when we receive that 
information, we can quickly communicate recalls. In Publix's 
case, we have 1,014 stores over five States. We can communicate 
that quickly from our corporate office to all of our stores. 
And within just a matter of minutes, we can remove suspect 
recalled product from the marketplace.
    There is a link that this Rapid Recall Exchange is--in a 
future addition, I believe--it's going to have the capabilities 
of linking into the new FDA Reportable Food Registry. I don't 
have enough details on that to answer it in full but, I 
understand there will be a future linkage between the two.
    Senator Enzi. If you can get me some more information on 
that, I'd appreciate it.
    Mr. Ragan, I was particularly interested in the FDA's 
relationship with the State and the local regulatory 
authorities. And you mentioned the partnerships and training 
arrangements. I've heard a bit from my State that there's some 
problems with that training. In your opinion, do these 
activities need updating?
    Mr. Ragan. The training itself?
    Senator Enzi. Yes.
    Mr. Ragan. Yes, sir. Our primary goal in working with FDA, 
I guess, has been through a consulting program. We consult with 
them on the issues that we find. We consult with them on their 
scientific issue. But, we certainly can use more training from 
them, on a formal basis. Presently, our inspectors are--before 
they're released to the field--undergoing approximately 62 
courses online. I believe most of those online courses are 
provided by FDA. But, training in-house is always better than 
something online.
    Senator Enzi. OK. Thank you.
    You mentioned that you had 31 inspectors and they did 5,000 
inspections. On average, how frequently does your department 
inspect a North Carolina food facility?
    Mr. Ragan. Our goal is to do them annually. Again, we're 
trying to do it based on a risk basis. I can't say that we're 
meeting that goal at this point in time, but we're trying to do 
it on an annual basis. Our program is annually.
    Senator Enzi. How many establishments are there in North 
Carolina?
    Mr. Ragan. Fifteen hundred manufacturers and 6,000 
retailers.
    Senator Enzi. OK. Thank you.
    I see that my time is expired. I'll submit a bunch of 
questions to Mr. Stenzel.
    Thank you.
    The Chairman. Thank you very much, Senator Enzi.
    Senator Hagan.
    Senator Hagan. This is a question to Mr. Ragan. One of the 
things that I'm really concerned about, in particular, is the 
farmers in North Carolina. I know, during the tomato recall, 
that so many of them had to throw their tomatoes out. They lost 
that whole season, and obviously they are very concerned about 
anything that would impact their livelihood. So, I mean, 
obviously we want food safety, but I think we have got to be 
very secure in what it is that we're putting out, as far as the 
recall. Any comments?
    Mr. Ragan. I think you're correct. The tomato industry in 
North Carolina was damaged with the incorrect information, last 
year.
    We had a listening session with FDA with some of our 
smaller and medium-sized farmers, and they all came across with 
two issues. One is that they would like to see this be a 
scalability issue, based on the size of the farm. They'd also 
like to see that there will be some sort of restoration--
financial restoration to them, when they are damaged from these 
type of issues.
    Senator Hagan. What do you mean by ``scalability''?
    Mr. Ragan. We're talking about smaller farms not meeting 
quite the same strict requirements as the huge, large farmers.
    Senator Hagan. OK. Alright.
    Also, this question has three parts, having to do with 
North Carolina--how often does North Carolina have to initiate 
a recall? How does the voluntary recall actually work? And 
then, the last part, What additional authority does the State 
need to better facilitate recalls?
    Mr. Ragan. Actually, our recalls are not part of our law. 
All of our recalls are voluntary. We can't go in there and 
demand that someone recall something. We had an issue recently 
where a firm was very slow in recalling their product, and we 
had to--that's when we used the reverse 911.
    Other things that we could do is increase our laws to 
require that they do do their recalls, requiring that they have 
an obligation to the public, as the manufacturer or as the 
distributor, to pull a product back in.
    Senator Hagan. One final question.
    Can you discuss the ways in which the Federal, State, and 
local entities actually collaborate when a recall takes place?
    Mr. Ragan. Certainly.
    Typically, our recalls are generated from information from 
our department, from our laboratory. We contact FDA. We contact 
them for their scientific basis, also for their regulatory 
basis. If it's a widespread issue, we contact DINR. We've 
gotten help from DINR, we've gotten help from Public Health. 
We've released press releases. They've released press releases. 
Anything to get information to the public so that a product 
that is out there that is potentially contaminated is not being 
consumed.
    Senator Hagan. Thank you. Thank you very much.
    I really do appreciate all of you coming and testifying, 
today.
    Mr. Ragan. Thank you.
    The Chairman. Thank you, Senator Hagan.
    Senator Merkley.
    Senator Merkley. Thank you, Mr. Chair.
    Earlier this year, a father and son came to my office--Jake 
Hurley the son, and Peter Hurley, his father--and their story, 
I think, raises a couple of concerns about our food safety. 
Jake loved peanut butter and crackers, in the little packages 
that came out. When he became sick earlier this year, they knew 
about the King Nut peanut butter issue, but they were assured 
that the brand that they were eating was fine. And so, they 
continued--even while he was sick, he continued to eat his 
favorite food, peanut butter. And it turned out it was, in the 
end, a brand also coming from the same source.
    Another piece of this was--and I think Ms. DeWaal made 
reference to this--there is a third-party inspector who had 
found a series of positive tests at this particular site, but, 
those tests had not been passed on to the FDA. So, a couple of 
questions:
    The first is--several of you talked about traceability. 
What can we do to greatly improve the traceability so that, 
when there are several brands coming out of a factory, the 
public finds out about that quickly? Do we need to go further 
than the bill currently goes? Do you have any specific 
recommendations?
    And second, in regard to third-party inspections, the bills 
do call for using third-party inspectors, both the bill on the 
House side and the bill on the Senate side; but, when you have 
a situation where an inspector hasn't reported the results, 
what kind of penalties--I'd like to know what happened in this 
case and certainly what should happen in future cases.
    Ms. DeWaal, do you want to start off?
    Ms. DeWaal. Thank you very much, Senator Merkley.
    First of all, on the issue of traceability, it's critical, 
and traceability needs to be on food products from the consumer 
all the way back through the production cycle.
    Now, the bill that's in front of you has a pilot study for 
traceability, and the House legislation has a slightly stronger 
provision. It's really a mandate they move to traceability, but 
also it gives the FDA the opportunity to spend some time 
exploring what is the right approach.
    With respect to the second question you asked, the issue of 
third-party certifiers, I want to be very clear that that only 
applies to imports. That's true for both the Senate bill and 
the House bill. This is not a system that should replace 
inspection by FDA of our domestic plants.
    And the last issue you raised is, What are the penalties? 
FDA is operating with very inadequate penalties. I mean, their 
penalties were designed around the turn of the last century. 
They need civil penalties. They need the ability to give 
meaningful penalties to people who violate the law. Right now, 
they can--they have criminal penalties, but they need the 
ability to move forward with civil monetary penalties. That is 
missing from this legislation, except for in the recall area. 
So, I would hope you would look at that issue.
    Senator Merkley. Well, help me understand this. Am I 
correctly informed about it being third-party inspectors, or 
was it in-house inspectors, who failed to pass on the 
information to the FDA?
    Ms. DeWaal. My understanding is that the owner of the plant 
had the information. I'm not sure whether he passed it on to 
the third-party auditor. But, it is clear that the third-party 
auditor involved didn't do a very good job. And because the 
system of third-party auditing--both in the international area 
and domestically--has come out from the industry itself, there 
is different levels of quality. I mean, certainly American 
consumers shouldn't be relying on subpar or poor quality third-
party certifiers. That's why it's important that FDA be the 
agency charged with domestic inspections, in all cases.
    Senator Merkley. So, let me push this a little further. Is 
there an inherent conflict of interest? If I'm a third-party 
inspector and I'm tough, and I pass on positive results to the 
FDA, am I going to get hired again anywhere? I mean, is that an 
inherent challenge we have right now in the system?
    Ms. DeWaal. Well, one of the ways that the legislation 
actually addresses this is, it does put that responsibility on 
the labs, as well. So, the laboratories involved will be 
certified, hopefully, under the legislation, and they will also 
have some obligations to pass on results. So, the third-party 
certifier is a private contractual relationship for domestic 
products. They may pass on the results or may not. But, you're 
right, they probably won't get hired if they do. But, it's 
critically important that the company themselves have the 
responsibility to share that information with FDA, and also, 
the requirement to actually conduct the tests. One of the 
things that's critical in this bill is that we not just pass 
the requirement to report tests, but not a requirement to 
actually do the verification testing. We need both.
    Senator Merkley. I'm over time, but after my colleague asks 
questions, if we have a chance to come back to this 
traceability issue, I'd appreciate it.
    The Chairman. Senator Merkley, the vote has been called.
    Senator Franken.
    Senator Franken. I'll try to keep it short. The other 
Senators' questions have been so good.
    But, Ms. DeWaal, I just want you to explain in more detail 
the improvements that you think should be made in the bill.
    Ms. DeWaal. Thank you very much, Senator Franken.
    There are probably three areas that--where we're most 
concerned. One is the area of the frequency of inspection. The 
bill requires high-risk plants to be inspected once a year. In 
the House bill, there's a range provided, but there could be 
some greater specificity as to what exactly are high-risk 
facilities. So, we're asking for at least three categories of 
risk built into the bill, with appropriate inspection 
facilities.
    The second is in the area of testing. As I mentioned 
earlier, we want a mandatory verification testing built into 
the bill, together with this issue of reporting positive tests 
results.
    The final area is the area of imports. We've got this 
accreditation body in the bill that's playing a role that we 
think is--it's a role that could be played on--if FDA chose to 
do it, but it certainly shouldn't be a requirement that an 
accredited body approve a foreign government. Yet, that appears 
to be what's in the bill today. So, we would like the committee 
to look very closely at the language around the accreditation 
body. And we can certainly provide the committee with specific 
recommendations on that.
    Senator Franken. Thank you.
    Just briefly, Mr. Roberson, you mentioned the Food Safety 
Rapid Response Act, in your testimony, which is an effort to 
model regional centers of excellence after the system at the 
University of Minnesota. Others have mentioned the need to 
improve the workforce for outbreak investigations. Are you 
familiar with Senator Klobuchar's bill, S. 1269, at all?
    Mr. Roberson. I am not very familiar with it, Senator 
Franken.
    Senator Franken. OK. Anybody else on the panel?
    [Laughter.]
    All right. Well, I think it would be a good start in 
improving our Nation's capacity to conduct outbreak 
investigations, so I'm just shilling, here, for my senior 
Senator, I guess.
    [Laughter.]
    But, thank you.
    And thank you, Mr. Chairman.
    We should vote, huh? I guess?
    Thank you all. Really. Great.
    The Chairman. We've gone into the second half.
    Senator Merkley, did you just have a quick followup on that 
before we leave here?
    Senator Merkley. If anyone would like to comment on the 
traceability and ways that we really need to push to make it 
work. It's been mentioned that we have a pilot project in the 
bill. Is that enough? Is there a promising technology we need 
to pursue? Just any comments on this traceability.
    I just want to note that it's so important, for example, 
not just to find the problem to alert consumers, but also to 
protect every other agricultural segment that may be--there may 
be suspicion, but tracing down the fact that they're not 
involved, that the tomato growers were not involved, is very 
important, as well.
    Mr. Stenzel. That's exactly right, Senator Merkley. The 
produce industry is totally committed to a total supply-chain 
traceability of our products. Following the hearing, I'd like 
to submit some background on that, for you, so you can see we 
do have the technology today to supply a total traceability 
system.
    Senator Merkley. Please.
    That's it.
    The Chairman. Very good.
    Senator Merkley. Thank you.
    The Chairman. Well, thank you.
    Any other last things for the record?
    [No response.]
    The record will remain open for 10 days, to allow 
submission of statements and questions for the record from 
other Senators.
    I thank you all for being here. And again, not only that, 
thank you for your total involvement in this effort to get a 
good food safety bill through.
    As I said at the opening, we have one that has broad 
support, which we always like. Hopefully we can go to a markup, 
here, pretty soon in this committee. I'll be talking with 
Senator Enzi about that, and others on the committee, to see if 
we can get a markup scheduled pretty soon, and hopefully we can 
get this bill passed and on down to the White House before 
year's end.
    Thank you all very much.
    The committee will stand adjourned.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                   Prepared Statement of Senator Burr

    Good morning. I would like to thank Chairman Harkin for 
holding today's hearing on the important subject of how we can 
better ensure the safety of our Nation's food. I would also 
like to thank all of our witnesses for traveling to be with us 
today, and I would like to extend a particularly warm welcome 
to Dan Ragan, the Director of the North Carolina Department of 
Agriculture and Consumer Services Food and Drug Protection 
Division. I am pleased Dan will be able to share the 
experiences and perspectives of North Carolina as we consider 
legislation to better protect our Nation's food supply.
    We are all too familiar with the high-profile nationwide 
outbreaks and recalls in recent years in which pathogens in 
peanut butter, pistachios, peppers, and spinach resulted in 
illnesses in people across our country. In addition to the 
health concerns, many of these incidents also had a significant 
economic impact on American growers and producers across our 
Nation. These outbreaks have led me to believe that the Federal 
Food and Drug Administration needs improved regulatory tools to 
protect our Nation's food supply. The Centers for Disease 
Control and Prevention estimate that 76 million food-related 
illnesses occur annually in the United States, with 325,000 
people hospitalized and 5,000 dying as a result. Our committee 
has held several hearings on the topic of food safety over the 
years, and I have enjoyed working on bipartisan food safety 
legislation with my colleagues on both sides of the aisle. 
While the devil is always in the details when it comes to the 
legislative process, I sincerely hope we can advance bipartisan 
food safety legislation this Congress. It is time for Congress 
to take action to modernize and strengthen our Nation's food 
safety system.
    I am proud to be a cosponsor of The FDA Food Safety 
Modernization Act of 2009. This bill improves FDA capacity to 
prevent food safety problems by requiring additional hazard 
analysis and preventive controls and increased scrutiny of 
imported foods. In addition, our bill also improves our 
capacity to detect and respond to food-borne illness outbreaks 
by increasing FDA resources to conduct more periodic inspection 
of facilities. This legislation would also improve planning for 
intentional human contamination or adulteration of food, 
providing food manufacturers with the tools to defend against 
intentional contamination.
    Within the last 2 weeks, the North Carolina Department of 
Agriculture and Consumer Services initiated a recall of 
sandwiches due to the potential for the contamination of 
Listeria monocytonegenes, a bacterial infection that can result 
in still births or miscarriages in pregnant women or cause very 
serious illness in elderly or immunocompromised individuals. 
This recent episode illustrates that an effective response to 
any food incident requires the appropriate collaboration 
between Federal, State, and local agencies.
    I'd also like to point out that increased regulation and 
testing alone will not fix our food safety system. We need to 
pay special attention to training the next generation of food 
safety inspectors and using our Nation's land grant 
universities to educate food suppliers and processors. Having 
qualified, competent individuals working with our food 
suppliers will ensure the proper relationship between industry 
and government. Utilizing the existing infrastructure our land 
grant college and universities have to educate suppliers and 
processors on good manufacturing practices will foster a 
proactive response rather than a reactive response. Only when 
we have a collaborative process among all involved will we be 
able to fully implement a comprehensive food safety system.
    I hope this morning's hearing will provide a frank 
discussion of what is working well and what is not working well 
to protect our Nation's food supply and keep our constituents 
safe and healthy as we continue to work on bipartisan food 
safety legislation. I thank the Chair.

    Prepared Statement of Bob Bauer, President, The Association of 
                            Food Industries
    The Association of Food Industries (AFI) appreciates the 
opportunity to present testimony regarding legislation intended to 
improve the safety of America's food supply.
    AFI is a trade association serving the food import trade. AFI is 
committed to developing programs that facilitate the businesses of its 
member companies, encourage free and fair trade, and foster compliance 
with U.S. laws and regulations for the food industry. AFI members are 
responsible for importation into the United States of a significant 
percentage of products such as olives, olive oil, pasta, nuts, dried 
fruit, canned seafood, canned vegetables, canned fruit and many other 
processed food products from around the globe.
    AFI is pleased to support enactment of S. 510, ``FDA Food Safety 
Modernization Act,'' though we feel modest changes would strengthen the 
legislation. Specifically, we endorse recommendations that would assure 
the integrity of sampling and analysis of imported products subject to 
Import Alert. Further, we note that implementation of sound legislation 
may give rise to trade violations. In the current climate of 
significant tensions in trade relations, we recommend addition to the 
bill of a provision specifying that no provision of S. 510 may be 
construed to authorize a violation of international trade obligations 
of the United States.
    We believe that the provisions of S. 510 could be implemented in a 
manner that avoids violation of international trade agreements. Express 
direction for implementation to avoid such violations would assure due 
consideration to international obligations during the rulemaking 
process. Provisions of the legislation that could give rise to trade 
issues include, for example, the provisions requiring all registered 
food facilities to implement preventive controls plans and authorizing 
performance standards to minimize food hazards, if these provisions 
were implemented in ways that go beyond what is necessary to protect 
human health. Other provisions in S. 510 could be implemented in a 
manner that discriminates against imported products. These include, for 
example, provisions requiring third-party certification for designated 
imported foods and provisions imposing supply chain verification 
requirements on importers, but not on domestic producers.
    To address these concerns, AFI recommends that S. 510 be amended to 
provide that no provision of S. 510 may be construed to authorize a 
violation of international trade obligations of the United States.
    AFI has grave concerns about the ``Food Safety Enhancement Act of 
2009'' (H.R. 2749), passed by the House on July 30, 2009. The House 
legislation includes provisions that appear to be in clear conflict 
with U.S. obligations under international trade agreements.
                country of origin labeling--section 202
    Section 202 provides that a processed food is misbranded unless its 
labeling identifies the country in which final processing of the food 
occurred. It provides that a non-processed food is misbranded unless 
its labeling identifies the country of origin of the food. A food would 
not be deemed to be misbranded if: (a) in the case of a processed food, 
the label informs the consumer where final processing occurred in 
accordance with existing Customs and Border Protection requirements; 
and (b) in the case of a non-processed food, the label informs the 
consumer of the country of origin in accordance with existing U.S. 
Department of Agriculture requirements.
    Although country of origin labeling is not normally considered to 
be a food safety measure, its presence in a bill exclusively devoted to 
food safety (and called the ``Food Safety Enhancement Act'') suggests 
that it is intended as a sanitary or phytosanitary measure in this 
case. It therefore would likely be analyzed under the Agreement on the 
Application of Sanitary and Phytosanitary Measures (the ``SPS 
Agreement'').
    According to Article 2.2 of the SPS Agreement, ``Members shall 
ensure that any sanitary or phytosanitary measure is applied only to 
the extent necessary to protect human, animal or plant life or health, 
is based on scientific principles and is not maintained without 
sufficient scientific evidence. . . . '' Section 202 of H.R. 2749 does 
not appear to be based on any scientific or public health 
justification. In fact, since the vast majority of imported foods are 
already required to have country of origin labeling, the principal 
effect of section 202, although probably not intended by its authors, 
would be to require country of origin labeling for all domestically 
produced U.S. foods. It is not clear how this change would protect 
human health.
    Section 202 also appears to violate Article 5.1 of the SPS 
Agreement. Article 5.1 states that:

          ``Members shall ensure that their sanitary or phytosanitary 
        measures are based on an assessment, as appropriate to the 
        circumstances, of the risks to human, animal or plant life or 
        health, taking into account risk assessment techniques 
        developed by the relevant international organizations.''

    Section 202 of H.R. 2749 does not appear to be based on any 
assessment of risk.
              recordkeeping and traceability--section 107
    Section 107 would require FDA to issue regulations creating ``a 
tracing system for food that is located in the United States or is for 
import into the United States.'' This tracing system would require food 
companies to maintain records sufficient to enable FDA ``to identify 
each person who grows, produces, manufactures, processes, packs, 
transports, holds, or sells such food in as short a timeframe as 
practicable but no longer than 2 business days.'' Section 107 also 
would generally remove the current exemption for farms, thereby 
requiring them to maintain traceability records. Violations of the 
traceability requirements would be a prohibited act subject to criminal 
prosecution.
    When read in conjunction with section 213 of the bill, which gives 
FDA extraterritorial jurisdiction over violations that relate to food 
intended for import into the United States, it appears that section 107 
would create detailed recordkeeping requirements for foreign food 
companies at every stage of production and distribution all the way 
back to the farm. In addition, H.R. 2749 would apparently authorize 
civil and criminal penalties against foreign companies that fail to 
comply with traceability recordkeeping requirements.
    Section 107 may violate several provisions of the SPS Agreement, 
including the following:

     It may violate Article 2.2, because it imposes 
traceability requirements beyond what is necessary to protect human 
health.
     It may violate Article 5.1, because it is not supported by 
an assessment of risk. We are not aware of any attempt by FDA to show 
that this traceability requirement would reduce the risk of foodborne 
illness as compared to existing recordkeeping requirements.
     It may violate Article 5.6, which requires that sanitary 
and phytosanitary measures may not be more trade-restrictive than 
necessary to achieve the appropriate level of protection, ``taking into 
account technical and economic feasibility.'' In many foreign 
countries, producing records capable of tracing food back to the farm 
within 2 business days is not currently technically or economically 
feasible.
     It may violate Article 10.1, which requires members to 
``take account of the special needs of developing country Members, and 
in particular of the least-developed country Members.'' Section 107 
would disproportionately impact countries that export raw agricultural 
commodities, which tend to be less developed countries.
            importer documentation requirements--section 136
    Section 136 provides that the Secretary of Health and Human 
Services (Secretary) may, by regulation or guidance, require the 
submission of unspecified ``documentation or other information for 
articles of food that are imported or offered for import into the 
United States'' and may specify the format in which such documentation 
or other information must be submitted. Section 136 further provides 
that failure to submit such unspecified documentation or information, 
or submission of inaccurate or incomplete documentation or information, 
is a prohibited act that would subject the party in violation to 
criminal prosecution or civil penalties of up to $7.5 million.
    Section 136 appears to violate Article 2.3 of the SPS Agreement, 
because it discriminates against imported foods by authorizing open-
ended documentation requirements applicable only to imports. Article 
2.3 states that:

          ``Members shall ensure that their sanitary and phytosanitary 
        measures do not arbitrarily or unjustifiably discriminate 
        between Members where identical or similar conditions prevail, 
        including between their own territory and that of other 
        Members. Sanitary and phytosanitary measures shall not be 
        applied in a manner which would constitute a disguised 
        restriction on international trade.''

    Section 136 could be implemented in a way that would impose 
arbitrary and unjustifiable documentation requirements on imports.
    Section 136 also may violate Article 8 and Annex C, Sections 1(c) 
and (e) of the SPS Agreement, which requires that import control 
requirements must be limited to ``what is reasonable and necessary.'' 
Specifically, members are required to ``ensure, with respect to any 
procedure to check and ensure the fulfillment of sanitary or 
phytosanitary measures, that: . . . (c) information requirements are 
limited to what is necessary for appropriate control, inspection and 
approval procedures . . . ; (e) any requirements for control, 
inspection and approval of individual specimens of a product are 
limited to what is reasonable and necessary . . . ''
    Section 136 also appears to violate Article VIII of the General 
Agreement on Tariffs and Trade of 1947 (GATT 1947), because it has the 
potential to impose excessive documentation requirements on food 
imports and because it would impose substantial penalties for minor 
breaches of such documentation requirements. According to Article VIII 
of GATT 1947,

          ``Contracting parties also recognize the need for minimizing 
        the incidence and complexity of import and export formalities 
        and for decreasing and simplifying import and export 
        documentation requirements. . . . No contracting party shall 
        impose substantial penalties for minor breaches of customs 
        regulations or procedural requirements. In particular, no 
        penalty in respect of any omission or mistake in customs 
        documentation which is easily rectifiable and obviously made 
        without fraudulent intent or gross negligence shall be greater 
        than necessary to serve merely as a warning.''
                       importer fees--section 204
    Section 204 would require food importers to register with FDA and 
pay an annual registration fee of $500.
    Section 204 may violate Article VIII of GATT 1947. Article VIII 
provides that:

          ``[a]ll fees and charges of whatever character (other than 
        import and export duties and other than taxes within the 
        purview of Article III) imposed by contracting parties on or in 
        connection with importation or exportation shall be limited in 
        amount to the approximate cost of services rendered and shall 
        not represent an indirect protection to domestic products or a 
        taxation of imports or exports for fiscal purposes.''

    The registration fee that H.R. 2749 would impose on food importers 
is not related in amount to any services rendered to importers. The fee 
amount appears to be arbitrarily set to equal the registration fee that 
H.R. 2749 would assess on registered food facilities.
    Therefore, AFI respectfully opposes enactment of legislation that 
includes these problematic provisions of H.R. 2749 because they would 
apparently violate international trade obligations without meaningful 
benefit to the safety of the U.S. food supply.
    Once again, we want to thank the committee for this opportunity to 
submit our views. We are grateful to the Chairman and Ranking Member 
for seeking public input, and to Senator Durbin for his bipartisan 
leadership on this issue. AFI and its members are ready to work with 
the committee and the Senate in developing legislation that advances 
the safety of the U.S. food supply, which need not raise concerns about 
compliance with international trade obligations.
Prepared Statement of Kraig R. Naasz, President & CEO, American Frozen 
                             Food Institute
    Chairman Harkin, Ranking Member Enzi and members of the committee, 
I am pleased to submit this statement on behalf of the American Frozen 
Food Institute (AFFI). We appreciate your commitment to food safety and 
commend the committee for holding this important hearing.
    The American Frozen Food Institute (AFFI) serves the frozen food 
industry by advocating its interests in Washington, DC, and 
communicating the value of frozen food products to the public. The 
Institute is comprised of 500 members including manufacturers, growers, 
shippers and warehouses, and represents every segment of the $70 
billion frozen food industry. As a member-driven association, AFFI 
exists to advance the frozen food industry's agenda in the 21st 
century.
    AFFI's members are committed to food safety, which is their highest 
priority. Consumers have a reasonable expectation that the food 
products they buy are safe. While much is being done to ensure the 
safety of food, safeguards must be continually updated. To that end, 
since 2004, AFFI has led a coalition of trade associations and food 
companies advocating for modernization of the Current Good 
Manufacturing Practices (CGMPs) administered by the Food and Drug 
Administration. These regulations, which form the foundation of food 
safety assurance programs in manufacturing facilities, were last 
updated in 1986. AFFI continues to encourage FDA to review and 
modernize the CGMPs.
    Consistent with modernization of FDA's regulations, AFFI also 
supports efforts to modernize our Nation's food safety laws. In 
particular, AFFI believes that S. 510, the ``FDA Food Safety 
Modernization Act of 2009,'' is a reasonable, common sense approach to 
enhancing food safety and consumer confidence in our food supply. 
Importantly, the food industry accepts primary responsibility for 
ensuring the safety and quality of the food supply. As such, AFFI 
agrees with the bill's cornerstone provision that food companies must 
identify hazards that may occur in the production of their products and 
implement the most effective controls for mitigating those hazards. 
These measures must be documented in a written plan and should be 
available for FDA review during inspections.
    AFFI concurs with the bill's adoption of a risk-based inspection 
regime. And we concur with the increased focus on raw agricultural 
commodities. AFFI also believes that FDA should have the authority to 
order a mandatory recall of products presenting serious adverse health 
consequences when a company has refused to conduct a voluntary recall. 
Moreover, AFFI supports stronger enforcement authorities for FDA, 
provided such authorities are not overly broad and incorporate basic 
elements of due process.
    AFFI supports increased appropriated funding for FDA as outlined in 
S. 510 to enable FDA to do the job that Congress prescribes and 
consumers and the food industry expect. Food safety can best be 
enhanced when both government and industry apply proven, science-based 
approaches and work cooperatively with one another.
    Although AFFI is in conceptual agreement with the direction and 
content of S. 510, we look forward to working with the committee to 
refine the bill and to address certain specific concerns. For example, 
in our view, requirements for implementation of safeguards related to 
food security and defense should not be treated the same as preventive 
controls for food safety. Guarding against deliberate contamination, 
which presents risks that cannot readily be anticipated, requires a 
different approach than controls implemented to prevent unintentional 
food safety hazards that may be deemed reasonably likely to occur. Food 
defense requires a different analytical framework and process control 
terminology. Food defense vulnerability assessments should not be 
confused with food safety preventive controls. S. 510 should be revised 
to reflect these differences and the requirement to implement a food 
defense plan should be separate from that for food safety plans.
    AFFI believes the scope of the administrative detention provision 
in the bill is overly broad and subjective. In particular, the bill 
would allow FDA to prevent the distribution of food because the agency 
has ``reason to believe'' that a food is ``adulterated or misbranded.'' 
Instead, FDA's ability to detain food should be limited to situations 
where there is ``credible evidence'' that the food presents a serious 
threat of adverse health consequences. This is the standard that was 
adopted when the Bioterrorism Act was passed after the events of 2001.
    S. 510 would subject a company to criminal penalties for the 
failure to comply with a mandatory recall order. Current law already 
provides for criminal penalties for distribution of adulterated or 
misbranded food. Moreover, the potential damage to a food company's 
reputation and the potential for civil liability from the distribution 
of food believed to be unsafe is by far the most significant incentive 
to remove a violative product from the marketplace. For these reasons, 
AFFI questions the need to authorize regulators to impose additional 
civil money penalties.
    Additionally, AFFI understands the rationale that has been offered 
in support of imposing re-inspection and recall fees. However, we 
believe that these are government functions; fully funding FDA through 
the appropriations process is the preferable approach and the 
appropriate pathway for assuring FDA has adequate resources to do its 
job.
    Finally, AFFI wishes to comment on a few provisions that are not 
part of S. 510, but are found in the bill passed by the House of 
Representatives, H.R. 2749. First, AFFI favors improvements in 
traceability, but it is critical that any new legal requirements be 
commensurate with existing technology and the capabilities of all food 
companies, especially small businesses. Therefore, food safety 
legislation should make information gathering and analysis the 
centerpiece of any traceability provision and a clear prerequisite to 
government rulemaking. Such analysis is essential to determining what 
traceability actions are feasible, practicable, cost-effective and 
useful. In addition, we believe FDA should have the flexibility to 
establish traceability performance goals based on the information 
gathering process. In effect, dictating specific traceability 
requirements in advance of adequate study prejudges this process.
    Second, although AFFI supports making finished product testing 
results available to FDA during inspections, we do not support sending 
those test results directly to FDA. Nor would we support relying on 
selected test results for regulatory action. Finished product testing 
is just one tool used to ensure the effectiveness of a food safety 
system, essentially a snapshot; mandated testing and reporting regimes 
perpetuate the mistaken belief that finished product testing is a 
substitute for proper manufacturing and process controls. A robust food 
safety system, including environmental sampling and zone control which 
uncovers and controls potential sources of contamination, is the key to 
pathogen eradication.
    As a final point, AFFI is supportive of providing FDA expanded 
access to food safety records during routine inspections and during 
investigation of the actual distribution of an adulterated product. We 
oppose, however, the records access proposal in H.R. 2749 granting FDA 
routine and remote access to food safety plans. In our experience, 
records reviewed remotely and out of the context of an on-site 
inspection are of little benefit and can be misleading.
    In summary, AFFI and its members are strongly committed to ensuring 
that consumers receive safe and wholesome foods. Accordingly, AFFI 
supports modernization of the Nation's food safety laws and 
regulations. Thank you for this opportunity to testify. AFFI looks 
forward to working with the committee to shape the future of food 
safety and to ensure the well-being of American consumers.
   Prepared Statement of the Cheese Importers Association of America
    The Cheese Importers Association of America (CIAA) appreciates the 
opportunity to submit testimony for the record of this important 
hearing regarding a topic of the highest priority for our members. The 
CIAA is an association consisting of cheese importers who support 
efforts to enhance America's food safety regulatory systems. We are 
concerned that public confidence in food safety has eroded, and we 
support legislative actions to provide meaningful improvements to 
better assure food safety. While the FDA Food Safety Modernization Act 
of 2009, as introduced by Senator Durbin takes great strides to remedy 
the issues plaguing our food supply, we have significant concerns about 
some provisions.
    The CIAA represents the vast majority of firms engaged in the 
business of importing, selling, promoting, and distributing cheese and 
cheese products in the United States. Its members are long-tenured food 
importers, many of whom operate a business that has been in their 
family for many years. They have a track record of success and 
compliance with requirements relating to food safety, product security, 
and trade facilitation.
    The CIAA has a long record of mutual cooperation with the FDA. Due 
to the proximity of the East Coast ports in New York and New Jersey, 
through which many of our members' products enter the country, we have 
developed good rapport with the FDA New York District Office. We 
continually work with the District management to ensure efficient 
importation and clearance of goods. In the past, we have held seminars 
for both New York and Buffalo FDA personnel to educate them on our 
industry and products. These seminars help FDA better understand the 
specific nature of our imported products, while continuing to foster a 
good working relationship between cheese importers and the FDA. 
Additionally, we recognize the importance of a safe food supply, which 
is why we have worked in conjunction with FDA to stop importation of 
products that do not conform to FDA standards, specifically raw milk 
cheeses that are less than 60 days old.
    We appreciate the bipartisan approach the Senate has taken to this 
issue. It is often difficult to achieve consensus on food safety, and 
we view this bill as a tremendous opportunity for the Senate to provide 
meaningful improvement in food safety on a bipartisan basis. As the 
American consumer has developed a palate for imported and specialty 
cheeses, our members continually strive to supply a safe supply of 
imported cheeses. Importers support supply chain improvements, and 
other such advances designed to ensure a safe food supply.
    We have serious reservations regarding the Food Safety Enhancement 
Act as passed by the House of Representatives. As the committee 
considers the FDA Food Safety Modernization Act, we respectfully ask 
that you take into consideration our concerns regarding specific 
provisions in the House bill. We appreciate your consideration of our 
comments.
                             trade concerns
    While we appreciate that the provisions of the Food Safety 
Enhancement Act are not intended to breach U.S. duties under 
international trade agreements, we are concerned that implementation of 
its provisions could cause that result. We respectfully request 
addition of a provision to any final legislation specifying that no 
provision of the bill shall be construed to authorize a violation of 
international trade obligations. Such a provision would ensure that FDA 
consults with the U.S. Trade Representative in development of 
implementing regulations. Thereby, trade violations that Congress did 
not intend may be avoided.
                         civil money penalties
    We respectfully oppose the excessive civil money penalty authority 
provided in the House bill. Traditionally, civil money penalties have 
been justified as a means of imposing a penalty for relatively minor 
regulatory violations that do not justify prosecution. If an agency 
determines that a civil money penalty should be imposed, agency 
personnel serve as both prosecutor and judge. Judicial review is not on 
a de novo basis, meaning that a reviewing court must sustain the 
penalty if the agency acted within its authority and there was evidence 
to support its finding. Under this standard, the reviewing court is 
charged to accept every factual assertion of the agency and no factual 
assertions of the appellant.
    While this procedure is highly efficient for a regulatory agency, 
it also grants the agency vast power to impose fines without meaningful 
accountability. When an agency has authority to impose civil money 
penalties that can threaten the viability of a business, it is 
imprudent to contest the civil money penalties even if the accused is 
innocent. Instead, the accused company ``settles'' with the agency by 
paying a relatively modest fine and signing a ``consent agreement'' in 
which the company is required to perform various acts, including 
actions the agency has no authority to require.
    The House bill authorizes extreme civil money penalty authority, 
especially for unintentional violations. With respect to unintentional 
violations, the bill provides for civil money penalties of up to 
$20,000 for individuals and up to $250,000 for other persons for each 
day a violation occurs, with a cap of $1 million in any single 
proceeding. The bill authorizes such fines for almost any error in the 
intensively regulated arena of food production and marketing, including 
minor errors in record keeping or food labeling. In food law, it is 
common for a single mistake to result in scores of violations. Further, 
it is common for a minor error to remain undiscovered for weeks or 
longer. So, if a minor labeling error caused violations on 30 lots that 
were shipped on a single day and the error went undiscovered for one 
month, the House bill would authorize civil money penalties of 
$225,000,000.
    In reviewing these facts, we mean to imply no disrespect for the 
officials of the Food and Drug Administration. However, we have grave 
concerns regarding the effect of such sweeping authority without 
meaningful accountability.
    The current Senate bill amends the Food, Drug, & Cosmetic Act by 
providing that any person who does not comply with a recall order will 
be assessed the civil penalties spelled out in the current law. We 
understand the necessity for such a provision for noncompliance when 
there is a serious public health threat which demands a recall. We 
encourage the Senate not to add extraneous penalties which may have the 
effect of harming small businesses that mistakenly and unintentionally 
commit a violation.
                      information technology (it)
    The single step that could most dramatically improve FDA's 
effectiveness in scrutinizing the safety of food imports would be to 
provide the agency modern information technology capabilities. While 
inter-operability with the IT systems of other Federal agencies would 
be desirable, we suspect that delays to achieve inter-operability 
mandates are likely to cause delay and expense that far exceed the 
potential benefit of comprehensive inter-operability. We respectfully 
recommend that the bill include a requirement that the committee be 
provided an annual GAO report regarding FDA's IT capabilities regarding 
imports.
                       country of origin labeling
    We respectfully oppose the House bill's Country of Origin Labeling 
(COOL) provision. This provision mandates that all processed food 
labels list the country in which final processing occurred. Without 
this information, products would be ``misbranded.''
    Imported processed foods already are required to declare their 
country of origin on the label under the Tariff Act of 1930 and U.S. 
Customs regulations. There is absolutely no need to create a redundant 
set of FDA regulations on country of origin labeling.
                              traceability
    Cheese importers proudly comply with the ``one-up, one-back'' 
recordkeeping requirements of the Bioterrorism Act. Under the current 
regime, companies must maintain records of where their raw materials 
come from, both suppliers and transporters, and where their finished 
products go, both customers and transporters. However, we are gravely 
concerned that sweeping traceability system recordkeeping requirements 
for all foods and food ingredients in the House passed legislation 
would impose exorbitant costs without meaningful food safety benefit.
    The Food Safety Enhancement Act would mandate a tracing system 
under which industry would be required to identify each person who 
grows, produces, manufactures, processes, packs, transports, holds or 
sells food . . . within 2 business days. This farm to retail tracing 
system would require companies to maintain ``pedigrees'' for each food 
and food ingredient at an expense beyond estimation. It would also 
require records capable of tracing foods back to coffee bean growers in 
the Andes, cocoa bean growers in West Africa, harvesters of wild Brazil 
nuts in South America, wheat farmers in Kansas or dairy farmers in 
Switzerland. No need has been demonstrated for this sweeping 
requirement.
    It is inappropriate to require such a system in the absence of a 
determination by FDA that the system is necessary to protect public 
health and an estimate of the cost of compliance. Processed foods, such 
as cheese imports, which are already heavily monitored under current 
law, do not require such a ``farm to fork'' traceability system.
                                  fees
    Both the House-passed and Senate bills include new fees that would 
affect cheese importers. Under the FDA Food Safety Modernization Act, 
importers will be charged an annual fee to participate in the Voluntary 
Qualified Importer Program, as well as fees charged if FDA needs to re-
inspect the importer's facility.
    Understanding that food safety legislation is likely to include 
some form of revenue generation, food importers request that the 
language be written in such a manner that importers are not charged 
several times for the same fee. While importers are not required to 
participate in the Voluntary Qualified Importer Program, it behooves 
them to do so, as the program allows for expedited processing of their 
imports. Yet, because many importers are small businesses, we would ask 
that fees for both the Voluntary Qualified Importer Program and the 
reinspection costs be set in a manner that accounts for the size of the 
business (or the frequency of imports) so that the assessment is 
proportionate to the size of the firm.
                  inspections and inspection frequency
    The new risk-based inspection schedule set forth in the Food Safety 
Enhancement Act is inappropriately prescriptive. The legislation before 
the committee today does not set forth such a detailed risk schedule 
for foods; rather, it directs the FDA to allocate resources for 
inspection of registered facilities according to their risk profile 
based on numerous factors set forth in the legislation. While these are 
reasonable factors upon which to create a risk profile, we respectfully 
submit that food science, rather than legislated directives should 
determine level of risk. A true science-based approach to categorizing 
risk would lead to the most appropriate and effective allocation of FDA 
resources.
    Cheese importers appreciate that, under the FDA Food Safety 
Modernization Act, the FDA may enter into agreements with foreign 
governments to facilitate inspection of foreign facilities registered 
with FDA. Source inspections provide the surest proof that products 
imported for sale in the United States are safe.
                        third-party inspections
    Cheese importers support regulatory oversight of third-party 
inspections. Given the long-standing resource concerns at FDA, 
certified third-party inspectors could play a critical role in closing 
some of the gaps in our food safety system, especially with respect to 
overseas facilities. Commissioner Hamburg requested authority to 
examine the use of third-party inspectors as a way to expand the 
capacity of the FDA. The FDA Food Safety Modernization Act requires 
that the FDA implement a system to recognize accreditation bodies no 
later than 2 years after enactment, and cheese importers support the 
implementation of such a system for accrediting third-party auditors to 
certify ``eligible entities''. We believe these accreditation bodies 
and ``third-party auditors'' can be an important asset, but how the FDA 
would certify these entities, what their role would be, how their work 
integrates with the agency, and other important questions remain to be 
answered.
    Cheese importers urge that Congress give FDA flexibility in its 
implementation of such a system to assure maximal use of FDA resources.
    Once again, we want to reiterate our appreciation of the 
opportunity to submit these comments. We are grateful to the Chairman 
and Ranking Member for seeking public input, to Senator Durbin for his 
bipartisan leadership on the issue, and the committee for their work.
    The CIAA, and its members, stand ready to work with the committee 
and the Senate to craft legislation that addresses the challenges 
facing our system in the most responsible manner.
  Prepared Statement of the Fresh Produce Association of the Americas
    The Fresh Produce Association of the Americas (FPAA) would like to 
thank the HELP Committee for holding a hearing on food safety, and we 
would like to take this opportunity to present information for the 
record concerning food safety and imported produce. The FPAA is a trade 
association headquartered in Nogales, AZ, the largest port of entry for 
fresh fruits and vegetables imported into the United States from 
Mexico. Last year alone companies in Nogales imported over 4 billion 
pounds of fresh produce for distribution across North America.
                            imported produce
    As an association of U.S. importers, the members of the FPAA 
experience first-hand the scrutiny that each shipment of fresh produce 
is subject to before entering the United States. One hundred percent of 
all shipments of fresh produce must submit detailed information to the 
U.S. Food and Drug Administration and Customs and Border Protection. 
Our Federal agencies use this information to target inspections on any 
and all trucks that they would like to receive further examination and 
any product that they would like to sample, inspect or test. Again, 
this applies to every single truck, every single day, 365 days a year.
    While every box is not individually inspected by the FDA or the 
USDA, information on every shipment is reviewed and a statistically 
valid sample is inspected to insure the quality and safety of imported 
fresh produce. Actually, imported produce is inspected nine times more 
often than domestically grown produce which is grossly out of 
proportion to risks from imported fruits and vegetables versus domestic 
fruit and vegetables. Our Federal agencies, including FDA, CBP, USDA, 
the U.S. Department of Transportation, as well as other Federal, State, 
and local agencies have the ability to deny entry to any shipment 
arriving at our ports of entry and exercise that authority when 
necessary.
    Fresh produce from Mexico has been imported for over a century. 
From the very beginning, growers have continuously looked for better 
ways of growing and harvesting fresh produce. By constantly looking for 
ways to improve the quality and safety of fresh fruit and vegetables, 
they are able to continue to sustain their businesses and to provide 
jobs to the hundreds of thousands of employees that rely on them for 
work. Food safety is good for business, and they know it.
    As the development of food safety legislation moves forward, the 
FPAA would be very open to testifying before the HELP Committee if 
there are future hearings. Legislation that has passed the House of 
Representatives and current bills in the U.S. Senate have importer-
specific sections. It is in the interest of the industry and the U.S. 
Congress to make these regulations as effective as possible in 
increasing the safety of our food supply. For that reason, the FPAA 
would like be considered for any future hearings.
           equal level of standards using risk-based analysis
    The FPAA supports the efforts of Congress to pass legislation that 
would work to maximize the efforts of the FDA and the food industry and 
to create a system where domestic and imported produce must be held to 
the same level of standard. The FPAA strongly believes that FDA should 
be regulating domestic produce with the same level of vigor as that of 
imported produce. In addition, FDA needs the flexibility, through 
rulemaking and changes to operational procedures, to best implement 
systems for a domestic and an import supply chain and to develop risk-
based systems that provide the maximum benefit.
    Microorganisms are present in all countries. No geographic 
location, be it domestic or foreign, makes a commodity more or less 
susceptible to contamination. Preventative controls, proper monitoring, 
and research are the keys to decreasing the chance of unintentional 
contamination. By working together to ensure that food safety and 
security procedures cover all facets of the produce industry, imported 
and domestic, we are better able to bring consumers a greater variety 
of fresh, wholesome, and safe fruits and vegetables that contribute to 
a healthy diet. Again, the FDA and the industry must be given the 
flexibility to focus the maximum amount of resources on the processes, 
items, and areas representing greatest risk.
    As with all facets of life, nobody has all the answers to make the 
world 100 percent safe but we continue to implement the best science-
based food safety programs available and undergo stringent third party 
food safety audits by American auditing bodies to showcase these 
efforts.
                      ongoing food safety efforts
    FPAA members work closely with FDA, CBP, and other agencies to 
continue to improve processes and procedures that will strengthen 
oversight of imported food while expediting trade with our trading 
partners. We feel this is important in dealing with broader, long-term 
issues, and also on streamlining and strengthening the day-to-day 
technical issues. As an industry, we are committed to continuing that 
dialogue, no matter the outcome of legislation moving through Congress.
    In fact, the FPAA and its members pushed for years to bring the 
FDA's mobile laboratory to Nogales, AZ, the Nation's largest port of 
entry for fresh produce from Mexico.
    After years of working with the FDA, the mobile lab was stationed 
in Nogales, AZ in April 2009. Of the hundreds of samples and thousands 
of tests taken, I am proud to report that not one shipment tested 
positive for microbial contamination. We continue to work with FDA to 
bring the mobile lab back to Nogales for future season. The mobile lab 
allows the FDA to gather information on a broader number of shipments 
and commodities, gives faster test results, and helps the industry and 
FDA add another layer to the monitoring of food safety processes.
                        adequate funding for fda
    Food safety legislation is just one facet of successfully 
implementing procedures to increase the safety of the food supply. The 
FPAA also strongly supports proper funding for FDA to allow the agency 
to hire the necessary number of personnel and to develop the necessary 
infrastructure, including regional labs and mobile labs. Congress must 
continue to increase FDA funding to levels that allow the FDA to 
perform the mission outlined by Congress. This is especially critical 
given that new food safety legislation will increase the amount of 
resources that FDA will need to complete its mission.
    The current bill being discussed in the U.S. Senate, S. 510, ``The 
FDA Food Safety Modernization Act,'' gives the FDA authority to create 
a fee structure for certain activities that would be paid by the 
industry. The FPAA believes that legislation should clearly state that 
fees for importers and for domestic growers should be equal. If fees 
are higher for imports, it is likely that legislation would violate WTO 
and other trade agreement obligations.
      foreign government and third-party certification recognition
    The FPAA strongly supports collaboration with foreign governments 
in reviewing and recognizing the food safety systems of foreign 
governments. This is especially important concerning the oversight of 
what will become required food safety plans. The FPAA believes it is 
important for FDA to engage with foreign government to understand 
current food safety systems in place with U.S. trading partners, and to 
acknowledge those systems that equally contribute to the overall 
requirements of the FDA.
    The FPAA also supports a careful consideration of third-party 
certification in the context of S. 510, ``The FDA Food Safety 
Modernization Act,'' given that limited FDA resources could hamper the 
FDA's capacity to inspect and verify all domestic and foreign entities 
for what will become required food safety plans.
                               conclusion
    Again, the FPAA would like to thank the HELP Committee for their 
dedication in discussing food safety and in trying to develop common-
sense, effective legislation that will develop equal oversight of 
imported and domestic produce and will work to strengthen the safety of 
the U.S. food supply. We hope we can be of assistance as this process 
moves forward. The combined efforts of the FDA, Congress, and the 
industry are integral to our future success.
                                 ______
                                 
   Department of Agriculture and Consumer Services,
                        Raleigh, North Carolina 27699-1070,
                                                  November 6, 2009.
    Senator Enzi, I would be honored to respond to your questions 
regarding my testimony provided at the Senate HELP Committee Hearing, 
``Keeping America's Families Safe: Reforming the Food Safety System'' 
on October 22, 2009.
    As you recognize, the relationships between FDA and State 
regulatory programs are critical for ensuring the safety of the food 
supply. In North Carolina, we have formed the NC Fresh Produce Task 
Force, which consists of Cooperative Extension, Farm Bureau, NCDA&CS, 
and industry. The Fresh Produce Task Force has been a leader in 
developing a training curriculum for Good Agricultural Practices 
(GAPs), conducting research, and other initiatives to ensure the safety 
and economic viability of fresh produce in North Carolina. In September 
2009, the Fresh Produce Task Force hosted FDA and USDA for a listening 
session with small and medium-size farmers in North Carolina. Both 
agencies quickly realized the strong interagency and public-private 
partnerships that exist in North Carolina. The trust between the 
regulatory community and industry allowed the farmers to openly express 
their concerns regarding new food legislation, especially in the areas 
of indemnification, traceability, and scalability of regulations. I 
firmly believe FDA does recognize the importance and value the 
relationships State officials have with industry along the entire farm-
to-fork continuum of food production.
    Multiple challenges face a State regulatory agency when a food 
product is recalled. Ingredient-driven recall, such as the peanut 
butter recalls earlier this year, can be extremely difficult to contain 
since the list of recalled product changes by the minute as thousands 
of products are affected. Also, the distribution of the recalled 
products is often unknown. Today, retailers receive foods from multiple 
non-traditional sources, such as the Internet. Small, independent 
grocery stores and convenience stores often do not receive the recall 
notices and fail to properly respond to the recall. When a distribution 
list is available, it is often in a paper-based format and it is time-
consuming to extract the data to conduct recall effectiveness checks. 
The act of conducting a recall effectiveness check costs us 
approximately $65 per inspection and resources are diverted from 
conducting inspections, responding to consumer complaints, and other 
preventative measures.
    The recent recall of contaminated sandwiches distributed across 
several Southeastern States marked the first time the Food and Drug 
Protection Division utilized the Reverse 911 capabilities of our 
Department. The State of North Carolina, through the leadership of 
Commissioner Troxler and the Emergency Programs Division, has invested 
in a number of technologies to facilitate emergency communications and 
public notification. Operating from a list of firms which received 
recalled product and past customers which may still have product, we 
contacted 1,473 firms who received a notification of the potential 
hazard posed by these products. The Division received dozens of follow-
up calls from retailers across the State and in subsequent recall 
effectiveness site visits, found that many firms removed the tainted 
product from shelves as a result of our Reverse 911 campaign, as well 
as our traditional media outreach. The Emergency Programs Division also 
has capacity for blast fax and e-mail release, and we are currently 
developing emergency contact databases for rapid notification of 
regulated firms. We have developed several web-based software platforms 
which allow for real-time personnel management, resource expenditure 
tracking, and food emergency data collection. Each of these systems has 
been used in actual food emergencies and has been presented to and 
shared with other State and Federal agencies. In addition, our division 
is equipped with modern radio communications equipment, allowing for 
communication during large scale disasters and facilitating instant 
communication with emergency response personnel across the State.
    North Carolina is in a very unique position in regards to audits of 
our FDA contract inspection program. With the guidance and assistance 
of FDA, we are able to conduct our own audits of our inspectors 
conducting FDA contract inspections. Instead of the FDA conducting 
audits of our inspections, the FDA is auditing our auditors to ensure 
equivalency in our auditing programs is achieved. Seven percent of 
inspections performed under contract with FDA are audited. Last year, 
NCDA&CS conducted 17 contract inspection audits and FDA completed 1. 
The audit ensures the physical inspection of the firm is being 
conducted in a manner equivalent to the FDA. In addition, as part of 
the Manufactured Foods Regulatory Program Standards (MFRPS), NCDA&CS 
conducts audits of the physical inspection, inspection report, and 
sample transcript. The MFRPS has been one of FDA's greatest 
achievements in promoting equivalency and continuous improvement in 
State regulatory programs.
    Please let know if I can provide any additional information.
            Sincerely,
                                              Daniel Ragan.
                                 ______
                                 
                      Food and Drug Administration,
                                       Rockville, MD 20857,
                                                  November 9, 2009.
Hon. Tom Harkin, Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
    Dear Mr. Chairman: Thank you for providing an opportunity for the 
Food and Drug Administration (FDA or the Agency) to testify at the 
October 22, 2009, hearing entitled ``Keeping America's Families Safe: 
Reforming the Food Safety System.'' This letter provides responses to 
questions for the record, which we received on November 2, 2009.
    Please find FDA's responses in the enclosed document. We have 
restated each question in bold type, followed by our responses.
    Thank you again for your continued leadership on food safety. We 
look forward to continuing to work with you on this important 
legislation. Please let us know if you have further questions or 
concerns.
            Sincerely,
                                            Jeanne Ireland,
                            Assistant Commissioner for Legislation.
                                 ______
                                 
 Response to Questions of Senators Enzi, Brown, Reed, and Bingaman by 
                    the Food and Drug Administration
                       questions of senator enzi
    Question 1. FDA has indicated it will spend $2.5 billion on 
information technology contracts at FDA in the coming years to help 
improve food safety. In June of this year, the Government 
Accountability Office (GAO) released a report highlighting deficiencies 
with FDA's plans for modernizing its information technology systems. 
What has FDA done to address the weaknesses highlighted by GAO, and 
what still needs to be done?
    Answer 1. FDA's success in protecting the public health depends on 
its effective use of information technology. Accordingly, we are 
committed to continuing improvements in the strategic management of our 
information technology resources. GAO's main finding was that FDA lacks 
a strategic plan for IT. FDA is now in the process of putting together 
such a plan, with the assistance of the MITRE Corporation, which is a 
federally funded research and development center with extensive 
experience supporting complex information technology (IT) planning for 
Federal agencies. It is anticipated that this plan will be adopted in 
the spring of 2010.
    GAO recommended further progress in enterprise architecture (EA). 
The chart below lists FDA's current EA initiatives and the progress 
regarding each initiative:

 
------------------------------------------------------------------------
          EA Initiative               Value Added           Status
------------------------------------------------------------------------
IT Information Management.......  Ensures project     Operational.
                                   requests are
                                   justified and
                                   support FDA
                                   business and IT
                                   objectives.
                                  Ensures software
                                   and hardware
                                   requests are
                                   justified and
                                   comply with FDA
                                   standards.
IT Applications Assessment......  Provides            Operational.
                                   information to be
                                   used in
                                   determining
                                   applications that
                                   can be retired,
                                   reused or
                                   combined in order
                                   to improve
                                   business support
                                   and reduce
                                   application
                                   development and
                                   maintenance costs.
Enterprise Performance Lifecycle  Promotes project    Under development.
 (EPLC).                           management best
                                   practices through
                                   proactive
                                   integration with
                                   IT investment
                                   owners/project
                                   management teams
                                   by providing
                                   advice, counsel,
                                   guidance and
                                   recommendations
                                   on the approach
                                   to conduct
                                   regular review
                                   cycles of
                                   planning,
                                   requirements,
                                   design,
                                   development,
                                   testing,
                                   implementation,
                                   and maintenance
                                   of IT investments.
EA Repository Enhancement.......  Provides high       Under development.
                                   level summary
                                   reports based on
                                   stakeholder
                                   inquiries
                                   providing
                                   immediate value
                                   to assist in
                                   proactive
                                   planning to
                                   support business
                                   and IT
                                   decisionmaking.
Enterprise Information            Provides key data   Under development.
 Management (EIM).                 to business and
                                   investment
                                   decisionmakers
                                   regarding the
                                   status and
                                   maturity of
                                   agency IT
                                   investments.
------------------------------------------------------------------------

    GAO also recommended several changes to strategically manage IT 
human capital including the development of a skills inventory, needs 
assessment, and gap analysis, and develop initiatives to address skills 
gaps as part of the strategic approach. As part of our response to 
these recommendations, senior management in each division within OIM 
have assessed strategic workforce needs for their respective divisions 
to analyze and identify gaps. The Chief Information Officer is 
developing a release management plan incorporating the EPLC and 
capacity planning to ensure high quality and on time delivery of IT 
requests. In addition, the Chief Information Officer is continuing to 
look at these assessments and is developing hiring plans and 
priorities. The resultant information is being used to recruit skilled 
personnel to FDA. A survey was developed by a communications team made 
up of members from each division within OIM and facilitated by an 
external consultant to determine baseline areas where the 
organizational working ``climate'' could be improved. The survey 
results are being used to generate constructive dialogue with staff 
during meetings and to further identify pertinent organizational 
challenges and opportunities that OIM staff feels should be top 
priorities.

    Question 2. What progress is FDA making to achieve its goal to 
improve its use of information technology?
    Answer 2. FDA is making progress in a variety of fronts. In 
September 2008, FDA announced the selection of 10 contractors to 
receive a total of up to $2.5 billion for IT and data center management 
services during the next 10 years. The contract is the cornerstone of 
FDA's Information Technology for the 21st Century (ICT21) 
bioinformatics initiative, an extensive IT modernization program 
encompassing data management, data warehousing, IT infrastructure, and 
IT security. The 10 contractors will compete for data information 
technology task orders through this contract. To date, FDA has 
competitively awarded seven task orders through the ICT21 contract 
vehicle: three in fiscal year 2008 and four in fiscal year 2009.
    FDA has made excellent progress on the data center modernization 
activities under the ICT21 investment. The three task orders awarded on 
September 29, 2008, are for the transition of all FDA software 
applications and hosting operations to FDA's new data centers over a 2-
year period. These task orders are currently on schedule. The 
architectural design of the two new data centers has been completed and 
will greatly improve the security and reliability of FDA's IT platform 
that serves the regulatory programs. The data center on the White Oak 
campus supports the test and development environment and the 
contractor-hosted data center in Ashburn, VA supports all production IT 
systems.
    As noted, FDA issued four task orders in fiscal year 2009. The 
Agency issued a task order for the Parklawn IT lab on March 13, 2009, 
and it is on schedule to achieve all of its milestones. FDA issued the 
remaining three task orders for the White Oak Data Center IT Lab, White 
Oak Data Center equipment, and the FDA mail on September 10, 2009, 
September 23, 2009, and September 30, 2009, respectively. We are also 
on track with these three remaining task orders.

    Question 3. Do you think FDA takes the necessary steps to assure 
these IT contracts are being awarded to qualified entities with a 
history of good business practices?
    Answer 3. Yes, FDA is awarding its IT contracts to qualified 
entities with a history of good business practices. Since the passage 
of the Federal Acquisition Streamlining Act of 1994, FDA has 
implemented procedures to document contractor past performance on in-
process/current contracts and use past performance information in the 
source selection process. The collection and use of past performance 
information motivates contractors to improve their performance because 
of the potential use of that information in future source selection 
decisions. As a result of the increased attention on past performance, 
FDA is achieving better performance on its in-process/current contracts 
because of the active communication and feedback between the contractor 
and the Government, and FDA is better able to select highly qualified 
contractors for new contracts as confidence in a prospective 
contractor's ability to perform satisfactorily is an important factor 
in making a best-value source selection decision.

    Question 4. How do you envision the requirement for food safety 
plans be enforced for foreign facilities? Do you foresee a different 
approach to securing the foreign supply chain based on whether the 
product is sourced from developed or developing countries?
    Answer 4. S. 510 requires foreign facilities that export foods to 
the United States to have food safety plans in place, a requirement 
which also applies to domestic facilities. This requirement is 
important, because foodborne illness outbreaks occur with both 
domestically and foreign-sourced food. Prevention of problems in the 
first place is critical for all foods and is a much more effective 
approach for imports than relying primarily on detection of unsafe food 
at the border. Enforcement of this requirement for food safety plans 
will depend partially upon inspections. To accommodate the need for 
increased foreign inspections, FDA has established a cadre of 
experienced investigators who will exclusively conduct foreign food 
inspections.
    Given the volume of foreign facilities, however, FDA inspections 
alone will not provide adequate coverage of the firms exporting 
products into the U.S. market. We think we can achieve cost-effective 
oversight of imports by working with foreign governments, using the 
bill's new tools for import oversight, supporting a strong accredited 
third-party inspection program, and increasing targeted, risk-based 
foreign inspections.
    FDA would not base its approach to foreign supply chain safety on 
whether the food came from a developed or developing country. There are 
clearly a number of countries that have safety systems that ensure a 
level of safety comparable to that of the United States, and we would 
be more apt to utilize those regulators to perform audits and 
potentially certify food as meeting FDA safety criteria. On the other 
hand, in countries where the food safety systems are not as robust, FDA 
would more heavily utilize the other mechanisms noted above, such as 
increased import oversight, third-party audits, and inspections by FDA 
personnel.

    Question 5. A GAO report issued just last week places great 
emphasis on the fact that the computer systems at FDA and Customs and 
Border Protection cannot communicate. GAO indicated staff from both 
agencies were developing and using work-arounds, but this doesn't 
strike me as being the best solution. Could you comment on the 
potential gaps in enforcement caused by this lack of interoperability, 
and what is FDA doing to improve the systems?
    Answer 5. To clarify, FDA collects and maintains import data in a 
system known as the Operational and Administrative System for Import 
Support (OASIS). This system has been in operation since 1998 and was 
built as a tool to manage workflow for entry reviewers and compliance 
officers. The data in OASIS is received via the automated interface 
between CBP's Automated Commercial System (ACS) database and OASIS. 
OASIS is the only system in the Federal Government that exchanges 
import admissibility data with the CBP's ACS in real time. Accordingly, 
OASIS and ACS do communicate with each other.
    Although FDA and CBP benefit from the data flow between these two 
systems, improvements can be made. FDA strongly supports and works 
closely with CBP in its efforts to complete the Cargo Control portion 
of their Automated Commercial Environment (ACE) system. This new system 
will provide additional data elements to FDA and enhanced capability in 
the exchange of data between the two agencies.
    Regarding GAO's finding about insufficient information-sharing 
between FDA's and CBP's computer systems, FDA and CBP developed an 
interagency agreement that calls for CBP to modify its existing 
software to provide FDA with time-of-arrival information for land and 
air shipments. FDA and CBP are working to test the system.
    Regarding GAO's recommendation that FDA streamline its refusal 
process with CBP's redelivery process to address the lack of 
communication, FDA believes that continuing to engage with CBP to 
develop a joint refusal/redelivery process is important. CBP and FDA 
have begun discussions of the joint form as a prerequisite to 
considering this joint notice as a national procedure. Additional 
discussions are needed to complete this evaluation, after which we hope 
that national procedures can be drafted, cleared, and implemented. If 
approved, this joint notice should:

     Improve importer compliance with FDA refusal procedures;
     Help ensure that violative products are exported or 
destroyed; and
     Expedite the response time for the entry refusal process.

    Question 6. I think that a lot of the things we need to do depend 
ultimately on FDA having good information about who is producing and 
processing what food products. There seems to be general agreement that 
the current database of food facilities is not up to the task. One 
proposal that makes a lot of sense to me is making sure each facility 
has a unique numerical identifier. Do you agree? If so, please update 
me on the progress FDA has made toward implementing this identifier.
    Answer 6. Yes, the Administration believes that a requirement for 
unique facility identifiers (UFI) would be very useful. FDA needs a 
provision that will distinguish between numbers that FDA currently 
assigns to registered food facilities and a true UFI, such as a Dunn & 
Bradstreet Data Universal Numbering System (DUNS) number, particularly 
one for which the accuracy of the supporting information is 
independently verified.
    Specifically, such a provision would require each person in the 
distribution chain who manufactures, processes, packs, transports, or 
holds food to use a unique identifier for each facility owned by such 
person, as established or designated by FDA. The UFI would be 
interoperable with other parties in the distribution chain that 
manufacture, process, pack, transport, or hold food. UFIs would help 
FDA correct and eliminate inaccuracies in its inventory of registered 
food facilities, and assist in establishing enforcement priorities, 
targeting risky imported products, and tracing products linked to 
specific establishments in the event of a safety issue. The current 
lack of a UFI complicates proper identification and targeting, which 
can lead to cases of mistaken identity, and prevents automated 
interagency data exchanges and queries on foreign firms of interest, 
both for purposes of security and for admissibility.
    Mandating use of a UFI from a single system would permit FDA to 
link to information systems in other agencies, allowing FDA to share 
information with other agencies based on the common identifier. This 
would permit, for example, FDA and USDA to instantly deteimine whether 
they are dealing with the same firm.
    In order to provide express authority for a UFI requirement, we 
would recommend that the Senate bill, like H.R. 2749, include 
provisions to require that registrations for food facilities, 
importers, and brokers include the submission of appropriate UFIs; that 
traceback systems include the ability to reference to UFIs; and that 
appropriate UFIs are required when food products are offered for 
import.

    Question 7. FDA conducts ``filer evaluations'' to assess the 
accuracy of information provided by importers and customs brokers. 
Approximately what percentage of registered importers and brokers are 
evaluated in this way?
    Answer 7. In fiscal year 2009, the Agency evaluated 32 percent of 
FDA filers. FDA selects filers for evaluation based on the volume of 
import entries the filer submits, the date the filer was previously 
evaluated, and the results of that evaluation, and other criteria. An 
FDA filer may be an importer or a broker. There is no general 
requirement for importers or brokers to register with FDA. An importer 
or broker would only be required to register if they also are an owner, 
operator, or agent in charge of a facility that is required to register 
under section 415 of the Federal Food, Drug, and Cosmetic Act. Note 
that sections 136 and 204 of H.R. 2749 include a requirement for 
importers to register and provisions to help ensure they provide 
complete and accurate information regarding imported food.

    Question 8. Could you tell me more about FDA's audits of State 
inspectors who perform inspections under contract? For example, how 
often are they audited? What does that entail?
    Answer 8. The table below provides the total number of audits 
performed for the years 2000 through 2008.

        FDA Food Contract Inspection Audit Summary for 2000-2008
------------------------------------------------------------------------
 
------------------------------------------------------------------------
CY 07-08...................................................        358
CY 06-07...................................................        442
FY 05......................................................        355
FY 04......................................................        386
FY 03......................................................        421
FY 02......................................................        326
FY 01......................................................         47
FY 00......................................................         52
                                                            ------------
  Total....................................................      2,387
------------------------------------------------------------------------
 FY = Fiscal Year, CY = Contract Year.

    FDA's Manufactured Food Regulatory Program Standards (MFRPS) are 
being used to improve FDA's oversight of the food contract inspection 
program with State agencies. The standards are based on performance 
(i.e., how inspections are conducted) rather than inspection outcomes. 
Consequently, the standards provide a comprehensive examination of a 
State's inspection program as well as a program for continuous 
improvement.
    MFRPS Standard No. 4, Inspection Audit Program (the Audit Program) 
is a standardized quality assurance program available to FDA and States 
for evaluating the food contract inspections. The Audit Program was 
developed jointly by FDA and the States to audit the food contract 
inspections and it has been in use since fiscal year 2008. The audit 
program established (1) procedures for conducting audits of contract 
inspections, (2) a percent-based performance standard, (3) a required 
frequency of audits, (4) auditor training requirements, and (5) 
standardized records (an audit form, and quarterly and annual summary 
report forms of audit findings) to document the audits.
    State inspectors must be audited every 3 years; however, most State 
inspectors are audited each year. The audit is used to evaluate State 
inspectors' knowledge, skills, and ability to conduct a food 
inspection. Performance criteria are grouped into three components of 
the inspection process: (1) preinspection assessment, (2) inspection 
observations and performance, and (3) oral and written communication. 
The preinspection assessment evaluates State inspectors' review of any 
previous inspections. State inspectors' ability to recognize violative 
conditions or practices, distinguish between significant and 
insignificant observations, and recognize isolated incidents versus 
trends is included in the auditor's evaluation of State inspectors' 
inspection observations and performance. State inspectors are also 
evaluated on their ability to explain findings clearly and adequately.
    Although FDA audits the State inspection programs with which we 
contract, we recognize that there are limitations in our current 
approach, and the Agency is engaging in internal discussions on 
potential enhancements to the audit program.
                       questions of senator brown
    Question 1. Last month, the Government Accountability Office (GAO) 
released a report which found that the agencies responsible for 
ensuring the safety of our Nation's imported food are hampered in their 
efforts by gaps in enforcement and collaboration. For example, the 
Customs and Border Protection's (CBP) computer system does not 
currently notify FDA or the Food Safety and Inspection Service (FSIS) 
when imported food shipments arrive at U.S. ports. FDA points out that 
this lack of communication may potentially increase the risk that 
unsafe food could enter U.S. commerce without FDA review. Second, the 
GAO report notes that FDA has limited authority to ensure importers' 
compliance with its regulations. And third, the report says that CBP 
and FDA do not identify importers with a unique number, resulting in 
FDA not being able to target food shipments originating from high risk 
importers. Do you believe that current legislative proposals before the 
Congress (H.R. 2749 and S. 510) go far enough in addressing the 
problems identified in the GAO report? Is FDA supportive of GAO's 
recommendations which include civil penalties on firms and persons who 
violate FDA laws and identifying foreign firms with a unique 
identifier?
    Answer 1. Both H.R. 2749 and S. 510 contain important provisions, 
which will enhance FDA's ability to address the safety of imported 
food. However, it is the House bill, H.R. 2749, which contains the 
authorities recommended by GAO relating to civil penalties and unique 
identifiers.
    With regard to civil penalties, FDA is supportive of the GAO 
recommendation that FDA seek authority from Congress to assess civil 
penalties on firms and persons who violate FDA's food safety laws. The 
Administration supports section 135 of H.R. 2749, which would establish 
such civil monetary penalties for violations relating to food.
    With regard to unique identifiers, FDA agrees with the GAO 
recommendation that FDA explore ways to improve the Agency's ability to 
identify foreign firms with a unique identifier. The use of a unique 
identifier would improve the Agency's ability to accurately identify 
foreign, as well as domestic, firms. This ability would be especially 
helpful in enabling FDA to target high risk shipments. Requiring a 
unique facility identifier as part of registration for both domestic 
and foreign facilities also will be helpful in traceback activities 
during a foodborne illness outbreak or other emergency.
    The Administration supports the provisions relating to unique 
identifiers in H.R. 2749, which appear throughout the bill. For 
example, facility registration must include a unique facility 
identifier (see sections 101 and 206). Importer and broker registration 
must include appropriate unique facility identifiers (see sections 204, 
205, and 206). FDA must identify technologies for a traceback system to 
use unique facility identifiers (see section 107). Appropriate unique 
facility identifiers are required when food is offered for import (see 
section 206).

    Question 2. H.R. 2749 requires country of original labeling 
requirements for both processed and non-processed foods. In the case of 
processed foods, the labeling must identify the country in which the 
final processing of the food occurs. In the case of non-processed 
foods, the labeling of the food must identify the country of origin of 
the food. S. 510 does not specifically provide for country of origin 
labeling. What is the FDA's position on country of origin labeling with 
respect to processed and non-processed foods? Does the FDA believe that 
food safety legislation should include a requirement that imported 
foods have country of origin labels?
    Answer 2. FDA does not consider country-of-origin labeling to be a 
food safety measure because it does not provide any information 
regarding the safety of the food.
    Congress has already assigned responsibility for enforcing 
mandatory country-of-origin labeling to two other agencies: Customs and 
Border Protection (CBP) and USDA's Agricultural Marketing Service 
(AMS). The Tariff Act, enforced by CBP, generally requires imported 
articles to be marked to indicate country of origin to the ultimate 
purchaser. Foods in their natural state, such as fresh produce, are not 
required to be marked individually at the point of importation. 
However, at the point of retail, produce must be marked to indicate 
country of origin in accordance with AMS requirements. The AMS 
requirements apply to seafood, produce, peanuts, macadamia nuts, 
pecans, ginseng, and certain meats.

    Question 3. H.R. 2749 contains new user fees (an annual $500 
registration fee for each facility; fees to cover either the government 
cost of reinspection due to a violation or the cost of a food recall; 
fees to cover the cost of issuing exportation certifications for foods 
when needed to meet foreign specifications; and an annual $500 fee for 
the registration of food importers). S. 510 only includes fees to cover 
the government cost of a reinspection or recall action and fees paid by 
some importers to cover certain administrative costs. Instead of 
registration fees, the Senate bill pays for food safety through 
increasing authorization levels for FDA. Dr. Hamburg, in your testimony 
you advocate for the inclusion of registration fees, in part, to fund 
the inspection mandates. Can you explain why the FDA would prefer user 
fees versus simply increasing authorization levels?
    Answer 3. The President's fiscal year 2010 budget called for a 
registration fee to help FDA increase its inspection coverage and to 
enhance its other food safety activities. A registration fee will help 
provide a guaranteed and consistent funding source to help FDA fulfill 
its responsibilities. Registration fees should not supplant 
appropriated funds. An effective food safety system provides benefits 
to consumers and industry by protecting the public health and 
protecting the economic health of industry. Therefore, it is 
appropriate that the cost of implementing and maintaining this system 
be shared by taxpayers through appropriations and industry through user 
fees.

    Question 4. H.R. 2749 requires domestic and foreign food facilities 
to register every year. The Senate bill requires domestic and foreign 
food facilities to register every 2 years. There is a strong argument 
to be made that facilities should have to register annually so that the 
FDA can have the most current information about foreign importer 
facilities. Does the FDA have a position on whether domestic and 
foreign food facilities should register every year (as the House bill 
requires) or every 2 years (as the Senate bill currently requires)?
    Answer 4. The requirement in the Senate bill, S. 510, for 
facilities to register every 2 years represents a significant 
improvement over the existing statutory provision, which only requires 
registrants to notify the Secretary in a timely manner of changes to 
their registration information. However, the Federal Food, Drug, and 
Cosmetic Act requires FDA to maintain an up-to-date list of registered 
facilities. Requiring updated information on an annual basis would 
significantly increase the likelihood that registration information is 
current. Having accurate, current information is obviously of great 
importance during an emergency.
                       questions of senator reed
    Question 1. Dr. Hamburg, as you know, the shellfish industry has a 
long history of collaborating closely with the FDA and State regulators 
to reduce food-borne illness associated with shellfish. Their efforts 
in this area, which have led to a significant level of investment by 
industry members, include the implementation of quicker and more 
effective refrigeration practices and the dissemination of educational 
messages to encourage those at increased risk of illness to refrain 
from eating uncooked shellfish.
    It is my understanding that at a recent meeting of the Interstate 
Shellfish Sanitation Conference (ISSC), the FDA announced its intention 
to mandate additional postharvest processing measures such as 
individual quick freezing, high hydrostatic pressure, mild heat, and 
low-dose gamma irradiation for oysters harvested in the Gulf of Mexico 
during certain parts of the year. These new requirements will be 
implemented beginning in 2011 with the aim of reducing the risk of 
infection from the bacteria Vibrio vulnificus.
    Industry members along the East Coast have expressed concern that 
these Gulf of Mexico mandated post-harvest processing rules could be 
extended to other regions without a full assessment of the risks and 
benefits, the cost of compliance, or the impacts on sales. Would you 
clarify the FDA's plans for implementing its new requirements for post-
harvest processing, including the potential economic impacts on the 
industry as well as any plans to cover additional regions or strains of 
bacteria?
    Answer 1. FDA's announcement planning to propose new requirements 
relates only to processing of oysters harvested during warm months in 
the Gulf of Mexico and that are intended to be eaten raw, with the goal 
of reducing the risk of infection from Vibrio vulnificus. Vibrio 
vulnificus is not found outside warm coastal waters. FDA believes that 
Vibrio vulnificus raises unique issues for public health and that 
further discussion with industry and review are necessary before any 
additional action, with respect to other pathogens.
                     questions of senator bingaman
                    risk-based screening of imports
    Question 1. The September 2009 GAO report on food safety has a good 
discussion of the importance of the PREDICT screening system to 
quantify the risk of imported food shipments. I am pleased that FDA 
continues to value the participation of New Mexico State University in 
the continued development and deployment of PREDICT.
    What is the current status of PREDICT and what are FDA's plans in 
terms of schedule and budget to continue the development and deployment 
of PREDICT for all FDA-regulated products?
    The GAO report discusses the need to identify foreign manufacturers 
with a unique identifier, and I understand FDA supports new statutory 
authority to require the use of a unique identifier by food facilities, 
such as sec. 206 of H.R. 2749. Does FDA need additional statutory 
authority to implement and to take full advantage of the capabilities 
that PREDICT provides for all FDA-regulated products? If not, can you 
please provide a list of any additional statutory authority that FDA 
believes is needed.
    Answer 1. During the summer of 2007, FDA conducted a pilot test of 
a limited version of the PREDICT prototype, using seafood entries in 
Los Angeles. Beginning in January 2008, FDA further developed and 
enhanced the PREDICT prototype. Beta testing of the full production 
version began in late September 2009 in Los Angeles, using a limited 
set of targeting criteria, covering all products subject to FDA 
jurisdiction. National deployment is expected to begin during December 
2009 and will require several months to complete.
    FDA does not need additional statutory authority to implement the 
PREDICT system per se; however, we do believe that enactment of new 
authority for a unique facility identifier, as is contained in H.R. 
2749, would provide an important component of a more robust and better 
targeted import-review program. The additional information about food 
facilities provided under the changes to the facility registration 
requirement (section 101 of H.R. 2749) also would be helpful in this 
regard.
                small producers and scale of enterprise
    Question 2. In implementing the recommendations of the President's 
Food Safety Working Group for fresh produce, what specific 
accommodations, if any, does FDA believe are appropriate for small 
producers, including organic farmers and local direct-to-consumer 
operations?
    Answer 2. FDA has begun work on a regulation to establish 
enforceable standards for produce safety under our current authorities. 
The regulation will be based on the prevention-oriented public health 
principles embraced by the Working Group.
    FDA recognizes that the produce sector consists not only of large 
national and international operators but also many small producers, 
including many who market directly to consumers through roadside 
stands, farmers markets, and other arrangements. FDA will carefully 
consider the public health and economic impacts of applying the 
requirements of the new rules to small producers and will consider 
appropriate adjustments in the regulation.
    FDA will work with the industry to facilitate compliance with the 
new regulation through the following ways:

     issuance of a science-based ``hazards guide'' to assist 
producers and processors in designing their preventive controls;
     provision of other technical assistance and guidance on 
how to comply with the new rules;
     establishment of reasonable time periods for 
implementation of the rules, taking into account firm size; and
     cooperation with USDA extension programs and industry-
sponsored education efforts to foster understanding and implementation 
of the requirements.

    To learn more about the concerns of small growers/processors, FDA 
has held three listening sessions--a small one in Delaware; one in 
North Carolina, which included approximately 60 growers; and one in 
Florida, with approximately 60 growers. In these three States, FDA also 
toured a total of eight farms of varying size, commodity types, and 
farming methods. We are planning a session in December for the States 
of Washington and Oregon.
    In developing these regulations, FDA also is working closely with 
USDA to tap into USDA's expertise with the different scales and 
approaches to agriculture. For example, USDA has detailed a fresh 
produce expert to FDA to help integrate these perspectives on 
scalability and production methods into our produce safety standards. 
In addition, FDA has recently hired noted experts on food safety and 
agriculture from the States of California and North Carolina to work on 
food issues. This team is focused on developing produce safety 
standards that accommodate the needs of the varying scales and 
approaches to agriculture and adhere to the prevention-based public 
health principles endorsed by the President's Food Safety Working 
Group.
     Response to Questions of Senator Enzi by Caroline Smith DeWaal
    Question 1. You suggest that developing regulations food-by-food is 
inefficient. I see your point, but I also give weight to Mr. Stenzel's 
arguments that a commodity-specific approach is the right way to 
proceed. Could you address the disparity?
    Answer 1. First and foremost, let me thank you for the opportunity 
to testify before the Senate HELP Committee on reform of our Nation's 
food safety system. This was a very important hearing and a milestone 
in the effort to get a modern food safety system in place for FDA 
regulated foods.
    While they may sound inconsistent, the statements made by Mr. 
Stenzel and I are not, so I welcome the opportunity to clarify this 
point. The consistency lies in the fact that my specific statement 
related to the food processing area, whereas his comments were in the 
area of on-farm food production and standard setting.
    A preventive approach in the food processing area requires the use 
of process control systems, like HACCP, throughout the food chain. For 
the last 15 years, FDA has been implementing process control systems in 
a few sectors, like the seafood and juice industries. But the agency 
stopped and the absence of these programs has resulted in significant 
problems over the last 10 years.
    S. 510 will put every food processor under the requirement to 
conduct a hazard analysis that identifies the hazards most commonly 
linked to the type of foods being produced and to develop a plan to 
prevent those hazards from arising in the food facility. These 
specifics of the plans are developed by the food facility itself but 
they will be a requirement across the board for all facilities, just as 
they are today required for all meat and poultry plants regulated by 
the U.S. Department of Agriculture.
    Thus the same systematic review and plan is required for all food 
facilities, but the approach may vary by facility. Thus the plan would 
look very different for a peanut processor and for a company producing 
canned vegetables. The food control plans would be reviewed by FDA 
inspectors during their visits who would determine the overall 
effectiveness and make suggestions for improving the plans.
    Mr. Stenzel's statements addressed the on-farm aspects of fruit and 
vegetable production. Under S. 510, FDA is largely involved with 
setting standards for this sector. While there may be a number of 
commonalities in the standards for different commodities, there are 
also important differences. So I agree with Mr. Stenzel that FDA's 
written standards for on-farm production should provide for necessary 
commodity-specific differences. This is comparable to previous example 
highlighting the difference between process control plans for a peanut 
processer and a canning facility.

    Question 2. FDA has estimated a cost of $16,700 per inspection for 
foreign food facilities. You have recommended an inspection frequency 
of 6-12 months. Resources for the agency, both in dollars and 
personnel, are increasing, but are not infinite and are certainly not 
enough to achieve your recommended inspection frequency. Given these 
pressures, what do you think is a more realistic goal for inspection 
frequency?
    Answer 2. Inspection is a cornerstone of credible food safety 
legislation. Frequent inspections are essential to ensuring business 
compliance and justifying public trust. As the spate of recent 
foodborne-illness outbreaks and contamination incidents prove, our 
current food safety system does not ensure compliance with safety 
standards. Without a mandate to perform inspections, FDA has not 
devoted sufficient resources to this task, resulting in an average 
inspection frequency of approximately once every 5 to 10 years. It is 
essential that the Senate food safety bill include a mandate for a 
rigorous risk-based inspection schedule.

     Under S. 510, inspections are conducted to review food 
safety plans and ensure an adequate hazard analysis.
     Inspections also assure compliance with performance 
standards, and sanitation and microbial testing requirements.

    With respect to imports, the legislation adopts a ``lifecycle 
approach,'' giving FDA the authority to examine practices before the 
food reaches the U.S. ports of entry, in an effort to ensure that 
imports meet the same high standards applied to our domestic food 
industry.
    The schedule we are proposing would require FDA to inspect high-
risk facilities at least once every 6 to 12 months, low-risk facilities 
at least once every 18 months to 3 years, and warehouses at least once 
every 5 years. While the public, when polled by Consumers Union in 
2008, expressed a preference for monthly inspections, we recognize the 
constraints placed on agency funding. The schedule we propose takes a 
responsible position between the need for an effective, mandated rate 
of inspection and responsible budgetary restraint. We believe it is 
manageable within the proposed structure of S. 510 due to the following 
factors.
    We are not proposing that foreign food facilities be inspected by 
FDA on the same schedule as domestic facilities. Provisions within S. 
510 allow for less frequent direct inspection by FDA of foreign 
facilities without sacrificing safety. Let me outline those provisions.
    First, the bill requires every importer to have a Foreign Supplier 
Verification Program (Sec. 301). This program mandates importers to 
have in place a program that assures food products are produced in 
compliance with U.S. law and are not adulterated or misbranded. 
Additionally, importers can take advantage of the Voluntary Qualified 
Importer Program for many products, and that program could further 
increase FDA's level of confidence that a product is produced in 
compliance with our laws and to our standards.
    Second, the bill gives FDA the option to review a foreign country's 
food safety system to determine whether it is capable of providing 
assurances that the food produced in that country is subject to 
statutes, regulations, standards, and controls that are sufficient to 
ensure exports meet our standards for safety (Sec. 305). These are 
nation-to-nation agreements that indicate that though the practices may 
vary slightly, the government asserts equivalent controls and achieves 
the same level of consumer protection as is required in the United 
States. This review includes an audit of how the country inspects its 
own food supply that can establish whether FDA can rely on the foreign 
country inspections. This provision will permit FDA to focus its 
resources on those countries where the government cannot assure a 
proper level of safety for its exports.
    In these circumstances, the legislation provides an additional tool 
for FDA: Certification of imported foods by national governments or 
approved third-party agents. When it comes to national governments, the 
use of ``export certification'' is well understood. It is also used by 
the Department of Agriculture when it comes to meat and poultry 
products and that the Department relies on the foreign governments to 
provide the inspections required under the law. USDA's job is to audit 
the foreign national program, including plants that that government has 
approved to ship products to the United States, on a regular basis to 
ensure that the program continues to meet our national requirements. 
FDA should follow the same approach.
    Third-party certification agents are a more innovative approach, 
one adopted from the private sector, and can be used for countries or 
industry segments where the national government is not capable of 
providing an export certification role. Clearly the preference of 
consumer organizations would be to have a national government playing 
this role, but we agree third-party certification agents--with 
appropriate oversight and restrictions on conflict of interest--are an 
improvement over FDA's current approach. Again, the third-party agent 
would be regularly audited by the FDA to assure that it is conducting 
appropriate oversight, including inspections, to assure that food 
products meet the U.S. requirements.
    The bill permits FDA to require that certain high-risk foods be 
imported only once they are certified as being produced in compliance 
with U.S. law (Sec. 303). Certification audits, while not a substitute 
for inspections, if properly structured and administered provide a 
heightened degree of assurance that an item offered for import is safe. 
(As I testified at the hearing, there is one aspect of how the 
certification program is structured in S. 510 that should be revised. 
The bill should be amended to avoid placing private accrediting bodies 
in the position of accrediting foreign governments, and to improve the 
accountability of private accrediting and certifying entities. Consumer 
groups have forwarded to the committee a description of our concerns 
and proposed changes to the import certification provisions within the 
bill.)
    FDA may still want to rely on some direct inspections for some 
foreign food products and the bill provides for this by permitting FDA 
to enter into agreements with foreign governments for the direct 
inspection of high-risk facilities and mandates the agency to direct 
resources toward inspection of those facilities, but permits FDA to 
determine the appropriate schedule (Sec. 307).
    These tools are all useful, because as you rightly point out, it is 
not feasible for the agency to conduct inspections in every plant that 
ships foods to the United States. A robust inspection framework is 
essential to restore consumer confidence in FDA-regulated foods and the 
cost of a vigorous inspection schedule becomes manageable once the 
inspection schedule for domestic facilities is delinked from the one 
for foreign.

    [Whereupon, at 12:03 p.m., the hearing was adjourned.]

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