[Senate Hearing 111-1069]
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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
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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
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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.
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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.
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\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.
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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.
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\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.
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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\
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\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.
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\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''.
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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.
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\11\ Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation; Final Rule. 74 Fed. Reg.
33,030 (July 9, 2009).
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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:
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\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\
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\14\ Gov. Acct. Off., High Risk Update: Revamping Federal Oversight
of Food Safety, Rep. No. GAO-09-271, Jan. 2009.
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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.
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\15\ Hazard Analysis and Critical Control Point (HACCP) Systems, 9
CFR 417 (2009).
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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.
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\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.
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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.
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\1\ FMI Letter to Senator Durbin March 2, 2009.
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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.]