[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
FEDERAL EFFORTS TO MITIGATE VULNERABILITIES IN THE FOOD SUPPLY CHAIN
=======================================================================
HEARING
before the
SUBCOMMITTEE ON EMERGING
THREATS, CYBERSECURITY, AND
SCIENCE AND TECHNOLOGY
of the
COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
JULY 24, 2007
__________
Serial No. 110-59
__________
Printed for the use of the Committee on Homeland Security
[GRAPHIC NOT IN TIFF FORMAT]
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
__________
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______________________________________________________________________
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COMMITTEE ON HOMELAND SECURITY
BENNIE G. THOMPSON, Mississippi, Chairman
LORETTA SANCHEZ, California, PETER T. KING, New York
EDWARD J. MARKEY, Massachusetts LAMAR SMITH, Texas
NORMAN D. DICKS, Washington CHRISTOPHER SHAYS, Connecticut
JANE HARMAN, California MARK E. SOUDER, Indiana
PETER A. DeFAZIO, Oregon TOM DAVIS, Virginia
NITA M. LOWEY, New York DANIEL E. LUNGREN, California
ELEANOR HOLMES NORTON, District of MIKE ROGERS, Alabama
Columbia BOBBY JINDAL, Louisiana
ZOE LOFGREN, California DAVID G. REICHERT, Washington
SHEILA JACKSON LEE, Texas MICHAEL T. McCAUL, Texas
DONNA M. CHRISTENSEN, U.S. Virgin CHARLES W. DENT, Pennsylvania
Islands GINNY BROWN-WAITE, Florida
BOB ETHERIDGE, North Carolina MARSHA BLACKBURN, Tennessee
JAMES R. LANGEVIN, Rhode Island GUS M. BILIRAKIS, Florida
HENRY CUELLAR, Texas DAVID DAVIS, Tennessee
CHRISTOPHER P. CARNEY, Pennsylvania
YVETTE D. CLARKE, New York
AL GREEN, Texas
ED PERLMUTTER, Colorado
VACANCY
Jessica Herrara-Flanigan, Staff Director & General Counsel
Rosaline Cohen, Chief Counsel
Michael Twinchek, Chief Clerk
Robert O'Connor, Minority Staff Director
______
SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY, AND SCIENCE AND
TECHNOLOGY
JAMES R. LANGEVIN, Rhode Island, Chairman
ZOE LOFGREN, California MICHAEL T. McCAUL, Texas
DONNA M. CHRISTENSEN, U.S. Virgin DANIEL E. LUNGREN, California
Islands GINNY BROWN-WAITE, Florida
BOB ETHERIDGE, North Carolina MARSHA BLACKBURN, Tennessee
AL GREEN, Texas PETER T. KING, New York (Ex
VACANCY Officio)
BENNIE G. THOMPSON, Mississippi (Ex
Officio)
Jacob Olcott, Director & Counsel
Dr. Chris Beck, Senior Advisor for Science & Technology
Carla Zamudio-Dolan, Clerk
Dr. Diane Berry, Minority Senior Professional Staff Member
(II)
C O N T E N T S
----------
Page
STATEMENTS
The Honorable James R. Langevin, a Representative in Congress
From the State of Rhode Island, Chairman, Subcommittee on
Emerging Threats, Cybersecurity, and Science:
Oral Statement................................................. 1
Prepared Statement............................................. 2
The Honorable Michael T. McCaul, a Representative in Congress
From the State of Texas, Ranking Member, Subcommittee on
Emerging Threats, Cybersecurity, and Science and Technology:
Oral Statement................................................. 4
Prepared Statement............................................. 5
The Honorable Bennie G. Thompson, a Representative in Congress
From the State of Mississippi, Chairman, Committee on Homeland
Security
Oral Statement................................................. 6
Prepared Statement............................................. 7
The Honorable Donna M. Christensen, a Delegate in Congress From
the U.S. Virgin Islands........................................ 36
The Honorable Bob Etheridge, a Representative in Congress From
the State of North Carolina.................................... 40
The Honorable Marcy Kaptur, a Representative in Congress From the
State of Ohio.................................................. 38
Witnesses
Panel II
Dr, David Acheson, Assistant Commissioner, Food Protection, U.S.
Food and Drug Administration:
Oral Statement................................................. 8
Prepared Statement............................................. 11
Mr. Dan Baldwin, Assistant Commissioners, Office of International
Trade, U.S. Customs and Border Protection:
Oral Statement................................................. 28
Prepared Statement............................................. 30
Dr. Carol Maczka, Assistant Administrator, Office of Food Defense
and Emergency Response, Food Safety Inspection service:
Oral Statement................................................. 16
Preapred Statement............................................. 17
Dr. Tom McGinn, Chief veterinarian and Director, Food and
Agriculture Security, Office of Health Affairs, U.S. Department
of Homeland Security:
Oral Statement................................................. 22
Prepared Statement............................................. 24
Panel II
Dr. Craig Henry, Senior Vice President, Chief Operating Officer,
Scientific and Regulatory Affairs, Grocery Manufacturers
Association and Food Products Association...................... 61
Mr. Shaun Kennedy, Deputy Director, National Center for Food
Protection and Defense, University of Minnesota--Twin Cities
Campus:
Oral Statement................................................. 47
Prepared Statement............................................. 49
Dr. Allen Mathys, Vice President for State and Federal
Regulations, Grocery Manufacturers Association and Food
Products Association:
Prepared Statement............................................. 63
Dr. Lee M. Myers, State Veterinarian, Assistant Commissioner of
Animal Industry, Georgia Department of Agriculture:
Oral Statement................................................. 54
Prepared Statement............................................. 56
Appendix
Additional Questions and Responses:
Responses from Dr. David Acheson............................... 71
Responses from Dr. Craig Henry................................. 90
Responses from Dr.Tom McGinn................................... 91
Responses from Dr. Lee M. Myers................................ 96
FEDERAL EFFORTS TO MITIGATE
VULNERABILITIES IN THE FOOD
SUPPLY CHAIN
----------
Tuesday, July 24, 2007
U.S. House of Representatives,
Committee on Homeland Security,
Subcommittee on Emerging Threats, Cybersecurity,
and Science and Technology,
Washington, DC.
The subcommittee met, pursuant to call, at 10:21 a.m., in
Room 311, Cannon House Office Building, Hon. James R. Langevin
[chairman of the subcommittee], presiding.
Present: Representatives Langevin, Christensen, Etheridge,
Green, Kaptur, Thompson (ex officio) and McCaul
Mr. Langevin. The subcommittee will come to order. The
subcommittee is meeting today to take testimony on Federal
Efforts to Mitigate Vulnerabilities in the Food Supply Chain.
Good morning. I would like to thank our witnesses for being
here today. This hearing was originally scheduled, as you know,
for last Thursday, but we had to postpone the hearing due to
the House-Senate Conference Committee on the 9/11 bill. So I
appreciate the witnesses' flexibility and patience, and I
sincerely thank you all for coming back here today on what I
know is a very important subject.
Recent months have brought increased attention to
vulnerabilities in the United States' food supply chain.
Today's hearing will present us with both the public and
private sector perspectives on how best to secure our food
distribution networks. In the last year, we have witnessed
food-borne illness outbreaks associated with spinach lettuce,
and peanut butter, among others. This spring, incidents
including the melamine contamination of vegetable proteins used
in pet foods, the diethylene glycol contamination of toothpaste
and drug residues in fish demonstrate how intentional food
adulteration can pose a far greater challenge than
unintentional contamination.
Now, many of these incidents were traced back to problems
associated with the Chinese food supply. And it is evident that
China's food and drug safety standards are often weak, poorly
enforced or both, though I am encouraged by recent indications
that China's food and drug administration will be making their
processes more transparent in order to ensure more stringent
safety measures.
Unfortunately, China isn't the only problem country.
Developing nations in Africa and parts of Latin America also
have significant food safety issues, and it would be
shortsighted to place the blame on one country or one region.
This is a global problem and has the potential to cripple the
food supply throughout the United States. We are here today to
figure out how, in working with both the private sector and
public sector partners, we can mitigate vulnerabilities and
secure our food supply chain here at home.
Just as the Nation's food sector is comprised of a variety
of distinct businesses and operations, so, too, is the Federal
Government's effort in defending the food supply from
intentional attacks and natural hazards. Now it is not an easy
task, and there is a lot of work that we must complete, but we
all understand what is at stake.
Now I am reminded that, 100 years ago, Upton Sinclair's
investigation into the Chicago meatpacking plants led to the
formation of the Food and Drug Administration in the United
States. That investigation is still relevant today and
demonstrates the need for transparency in ensuring the safety
of these systems.
In fact, in 2004, the President issued Homeland Security
Presidential Directive 9 to help achieve this goal. HSPD-9
establishes a national policy to defend the agriculture and
food system against terrorist attacks, major disasters and
other emergencies. In March 2005, the GAO identified confusion
over the Department of Homeland Security's role in
agroterrorism. The GAO voiced concern that the agency hadn't
yet evolved into its leading role under Homeland Security
Presidential Directive 9. Though 2 years have passed,
significant problems still remain. Now, as the DHS Office of
the Inspector General reported in a February 2007 review of
Homeland Security food defense activities, the enormity of the
food sector and the complexity of government oversight pose
substantial challenges to the food defense and critical
infrastructure protection. The complexity of both systems has
resulted in the recent publication of several reports critical
of the bureaucracies associated with these efforts.
In February 2007, GAO designated the Federal oversight of
food safety as a high risk area for the first time. GAO found
that a fragmented system, whereby 15 agencies collectively
administer at least 30 laws related to food safety, causes
inconsistent oversight, ineffective coordination and
inefficient use of resources. This report found several
management problems that reduced the effectiveness of the
agencies' routine efforts to protect against agroterrorism. For
example, GAO noted that weaknesses in the flow of critical
information existed among key stakeholders.
Also, in February, the Department of Homeland Security's
Inspector General issued a record that found that DHS, USDA and
HHS were failing to meet their obligations under HSPD-9 to
prepare an integrated food defense plan. The Inspector General
recommended that DHS pursue recruitment, hiring and retention
of staff with expertise in matters of post-harvest food
defense; work collaboratively with USDA and HHS on grants and
other funding mechanisms to carry out food defense missions;
and identify a single senior DHS official to be accountable for
coordinated implementation of all DHS food sector
responsibilities; and provide this official with clear
authorities and adequate staffing to perform this function.
Now, I hope that the officials before us today can discuss
their efforts to improve some of the issues that have been
raised. The integrity of our Nation's food supply is critical
to our national, economic and health security. There is much
work to be done to fully secure our food supply chain, and we
must act swiftly to shore up the remaining vulnerabilities.
That concludes my opening statement.
The chair now recognizes the ranking member of the
subcommittee, the gentleman from Texas, Mr. McCaul, for the
purpose of an opening statement.
[The statement of Mr. Langevin follows:]
Prepared Statement of the Honorable James R. Langevin, Chairman,
Subcommitteee on Emerging Threats, Cybersecurity, and Science and
Technology
Good morning. I'd like to thank our witnesses for being here today.
This hearing was originally scheduled for last Thursday, but we had to
postpone the hearing due to the 9/11 conference, so I appreciate the
witnesses' flexibility and patience and I thank you all for coming back
to be here today.
Recent months have brought increased attention to vulnerabilities
in the United States' food supply chain. Today's hearing will present
us with both the public and private sector perspectives on how to best
secure our food distribution networks. In the last year, we have
witnessed food-borne illness outbreaks associated with spinach, lettuce
and peanut butter, among others. This spring, incidents including the
melamine contamination of vegetable proteins used in pet foods, the
diethylene glycol contamination of toothpaste, and drug residues in
fish demonstrated how intentional food adulteration can pose a far
greater challenge than unintentional contamination.
Many of these incidents were traced back to problems associated
with the Chinese food supply. It is evident that China's food and drug
safety standards are often weak, poorly enforced or both, though I am
encouraged by recent indications that China's Food and Drug
Administration will be making their processes more transparent in order
to ensure more stringent safety measures. Unfortunately, China isn't
the only problem country. Developing nations in Africa and parts of
Latin America also have significant food safety issues, and it would be
short-sighted to place the blame on one country or in one region. This
is a global problem, and has the potential to cripple the food supply
throughout the United States.
We are here today to figure out how--in working with both private
sector and public sector partners--we can mitigate vulnerabilities and
secure our food supply chain here at home. Just as the nation's food
sector is comprised of a variety of distinct businesses and operations,
so too is the Federal government's effort in defending the food supply
from intentional attacks and natural hazards.
It's not an easy task, and there is a lot of work that we must
complete, but we all understand what is at stake. I am reminded that,
100 years ago, Upton sinclair's investigation into the Chicago
meatpacking plants led to the formation of the Food and Drug
Administration in the United States. That investigation is still
relevant today and demonstrates the need for transparency in ensuring
the safety of these systems.
In fact, in 2004 the President issued Homeland Security
Presidential Directive 9 (HSPD-9) to help achieve this goal. HSPD-9
establishes a national policy to defend the agriculture and food system
against terrorist attacks, major disasters, and other emergencies. In
March 2005, GAO identified confusion over the Department of Homeland
Security's role in agroterrorism. The GAO voiced concern that the
agency hadn't yet evolved into its leading role under Homeland Security
Presidential Directive 9 (HSPD-9). though two years have passed,
significant problems remain.
As the DHS Office of the Inspector General reported in a February
2007 review of homeland security food defense activities, ``the
enormity of the food sector and the complexity of government oversight
pose substantial challenges to food defense and critical infrastructure
protection.'' The complexity of both systems has resulted in the recent
publication of several reports critical of the bureaucracies associated
with these efforts.
In February of 2007, GAO designated the federal oversight of food
safety as a high-risk area for the first time. GAO found that a
fragmented system--whereby 15 agencies collectively administer at least
30 laws related to food safety--causes inconsistent oversight,
ineffective coordination, and inefficient use of resources. This report
found several management problems that reduce the effectiveness of the
agencies' routine efforts to protect against agroterrorism. For
example, GAO noted that weaknesses in the flow of critical information
existed among key stakeholders. Also in February, the Department of
Homeland Security's Inspector General issued a report that found that
DHS, USDA, and HSS were failing to meet their obligations under HSPD-9
to prepare an integrated food defense plan.
The Inspector General recommended that DHS pursue recruitment
hiring, and retention of staff with expertise in matters of post
harvest food defense; work collaboratively with USDA and HHS on grants
and other funding mechanisms to carry out food defense missions; and
identify a single senior DHS food sector responsibilities, and provide
this official with clear authorities and adequate staffing to perform
this function.
I hope that the officials before us today can discuss their efforts
to improve some of the issues that have been raised. The integrity of
our nation's food supply is critical to our national, economic and
health security. There is much work to be done to fully secure our food
supply chair, and we must act swiftly to shore up the remaining
vulnerabilities.
Mr. McCaul. Thank, Mr. Chairman.
Thank you for holding this hearing. I would like to start
out by pointing out that the United States' food supply is
among the safest in the world. Still, public health officials
estimate that over 5,000 people die and many more get sick from
food-borne illnesses each year. Recent incidents of
nonterrorist-related food contamination, such as the E-coli
outbreaks in produce and antibiotics in fish from China, show
just how easy it would be for a terrorist to manipulate our
food supply against us and to utilize it as a weapon of mass
destruction. I don't want to overstate the threat posed by
terrorist attacks against food supply. In fact, there are very
few recorded acts of intentional food contamination, I believe
only two in the United States. But there is no question that
the food supply chain is vulnerable, and I am not very
confident that we are protecting this critical asset.
The U.S. food and agricultural sector is comprised of more
than 2 million farms, approximately 900,000 firms and 1.1
million facilities, almost entirely under private ownership.
This sector accounts for about 20 percent of the Nation's
economic activity, and we cannot afford to have consumer
confidence undermined. Federal efforts to ensure the safety of
our food supply have historically been fragmented. There are at
least 30 different food safety laws and a patchwork of
regulations administered by 15 different agencies. Subtle
differences between food products can dictate which agency
regulates it. For example, if a packaged ham sandwich is open-
faced, it is regulated by the USDA. If it has two slices of
bread, it is regulated by the FDA. That is almost comical when
you think about it.
What is needed here is a cross-agency perspective, one plan
that provides a single framework to ensure that all agencies'
goals are complementary and reinforcing, not redundant. We can
and must do better. There are some encouraging signs, including
the recent establishment of DHS's Office of Health Affairs and
the consolidation of agriculture inspectors within Customs and
Border Patrol's overall antiterrorism mission.
The focus of today's hearing is on the food safety and food
defense efforts. It is a sensitive topic, and I hope that we
hear more about what we are doing to enhance the protection of
our food supply rather than on the vulnerabilities themselves.
We certainly don't want to advertise our specific
vulnerabilities, so please consider this in your testimony.
And with that, I yield back the balance of my time.
Prepared Opening Statement of the Honorable Michael McCaul, Ranking
Member, Subcommittee on Emerging Threats, Cybersecurity, and Science
and Technology
The United States' food supply is among the safest in the
world. Still, public health officials estimate that over 5,000 people
die (and many more get sick) from food borne illnesses each year.
Recent incidents of non-terrorist related food contamination, such as
the E. coli outbreaks in produce and the antibiotics in fish from China
showed just how easy it would be for a terrorist to manipulate our food
supply against us and to utilize it as a weapon of mass destruction.
Yesterday I traveled back to Washington from my home
district in Texas via airplane. Like many other Members of Congress I
travel by plane frequently, either back and forth from my district or
on House business. And every time I board an aircraft I think of 9/11
and of the potential danger of air travel posed by terrorists to myself
and my family. Now imagine that feeling of apprehension every single
time you pick up your fork to eat dinner or drink a glass of milk. It
would change the way we live.
I don't want to overstate the threat posed terrorist
attacks against the food supply. In fact there are very few recorded
acts of intentional food contamination (and only 2 in the US). And an
attack on the food supply does not have the explosive effect of an
incident like 9/11 or a nuclear bomb that is typically associated with
groups like al-Qa'ida.
But there is no question that the food supply chain is
vulnerable--and I am not so confident that we are protecting this
critical asset. The U.S. Food and Agriculture Sector comprises of more
than 2 million farms, approximately 900,000 firms, and 1.1 million
facilities, and is almost entirely under private ownership. This sector
accounts for about 20% of the Nation's economic activity when measured
from inputs to tables of consumers at home and away from home. We
cannot afford to have consumer confidence undermined.
I am concerned when I hear the terms ``inconsistent
oversight'', ``ineffective coordination'', and ``inefficient use of
resources,'' associated with the Federal Government's handling of food
and agriculture defense activities. We MUST and we CAN do better.
The Homeland Security Act of 2002 assigned DHS the lead
coordination responsibility for protecting the Nation against terrorist
attacks, including agroterrorism. Subsequent homeland security
presidential directives provide more detailed guidance. DHS was
assigned this coordinating role because Federal efforts in this area
have historically been fragmented. There are at least 30 different food
safety laws and a patchwork of regulations administered by 15 agencies.
With such a fragmented approach, I question whether the government can
really provide useful guidance to the private sector in protecting the
food supply chain? Subtle differences in a food products presentation
result dictate which agency regulated the product. For example, if a
packaged ham sandwich is open-faced, it is regulated by the USDA; if it
is a closed sandwich (2 sliced of bread as opposed to one, FDA is the
regulating agency.
DHS is admittedly somewhat late to the game in its efforts
to protect the Nation's food supply as the other leading agencies with
missions in this area, FDA and USDA, have long histories of protecting
the Nation's food products. But there was, and still is, a lack of
coordination between those two agencies. For example, USDA and FDA each
provided to DHS separate Food and Agriculture Sector Specific Plan(s)
to fulfill the National Infrastructure Protection Plan--that is two
separate plans for the same sector. What is needed here is a cross
agency perspective, one plan that provides a single framework to ensure
all agencies' [USDA, FDA, DHS] goals are complementary and reinforcing,
not redundant.
We are encouraged with the recent establishment of DHS'
Office of Health Affairs. The Secretary's designation of this Office as
the single focal point for internal and external coordination on the
Department's food and agriculture responsibilities demonstrates that
this sector is starting to get recognition as critical infrastructure
that needs protecting.
The challenges posed by food defense are not easy. I don't
want to give the impression that I think protecting this critical
infrastructure will take simple physical security measures such as that
we use to secure chemical facilities and nuclear power plants. Food is
not a fixed asset. It moves into and across the country rapidly so it
can be eaten before it perishes without enough time to detect whether
there has been contamination. There are several opportunities whether
in manufacturing, processing, packaging, or transit for would-be
terrorists to gain access to products and introduce harmful agents.
A positive example that shows how DHS can contribute to
reducing fragmentation and compartmentalization is their effort to
consolidate the agriculture inspector function within Customs and
Border Patrol's overall antiterrorism mission. There are 131 million
conveyances entering this country every year and with the volume of
trade continuing to increase dramatically, CBP is best positioned to
meet the agriculture inspection demands. CBP has developed a
sophisticated, streamlined and efficient process to identify and target
high risk shipments which is being applied to identify high risk
agriculture shipments. Although when the agriculture inspection
function transferred from USDA to DHS, there certainly were cultural
and managerial differences to overcome, they have been overcome with
the support of both agencies. Now they are focused on strengthening
CBP's capability to apply their automated targeting and risk analysis
techniques to agriculture. Transferring the inspector function back to
USDA would be a step in the wrong direction back toward an inefficient
and fragmented approach to safeguarding the Nation's imported goods.
USDA would have to rebuild capacity and create a new capability to
automatically target high risk agriculture goods, rather than leverage
mechanisms employed by CBP.
DHS and our Committee need to engage stakeholders in the
agriculture community, and establish direct relationships with those
stakeholders and regularly solicit input. As I learned in drafting H.R
1717, which authorizes the National Bio--and Agro-Defense Facility, it
is critical to engage the private sector and state and local officials
in the policy discussions. Doing so will build trust between the
homeland security and agriculture communities and facilitate
information sharing that is in the best interest of the Nation.
Which brings me to my last point. The focus of today's
hearing is on food safety and food defense efforts. It is a sensitive
topic. I hope today what we hear is more about what the Federal and
State governments and the private sector are doing to enhance the
protection and defense of our food supply, than on the vulnerabilities
themselves--which have been mentioned in certain press pieces recently.
We certainly don't want to advertise our specific vulnerabilities so
please consider this in giving your testimony. . .
Mr. Langevin. Thank the gentleman. The chair now recognizes
the chairman of the full committee, the gentleman from
Mississippi, Mr. Thompson, for the purposes of an opening
statement.
Mr. Thompson. Thank you very much. I would like to begin by
thanking the distinguished chairman for reconvening the
previously postponed hearing today. The theme of this hearing
is extremely fitting, given the circumstances this past year,
where our Nation has had to deal with issues of pet food,
spinach, peanut butter and, more recently, bans on toothpaste
and even the FDA ban on seafood products. The major threat to
the food agriculture sector is a crisis of confidence, where a
poorly prevented or recognized event causes people to question
the safety of food regionally or nationally. The time to
address whether our food infrastructure is designed to mitigate
our abilities is before an occurrence and not after the fact.
We have been extremely fortunate that our agriculture has
been safe, but we have got work to do if we want to be more
secure. Currently, 15 agencies collectively administer at least
30 laws related to food safety, causing ineffective oversight,
inefficient coordination and inconsistent agency leadership.
One concern I look forward to hearing our witnesses address
today is the current agency leadership structure in place in
the event of a food-borne emergency. HSPD-9 sets out to address
this by establishing the Department of Homeland Security as
having the lead role in policy coordination in an event of
national significance. However, a recent GAO report says that
USDA is not planning for DHS to assume the lead coordinating
role if an outbreak among poultry occurs that is sufficient in
scope to warrant a Presidential declaration of an emergency or
major disaster, or a DHS declaration of an Incident of National
Significance. Such an inconsistency in planning perpetuates the
confusion of who is in charge. I look forward to the second
panel, comprised of industry, academic and State agricultural
officials, giving us a more local perspective of what
uncoordinated efforts mean for our communities. Further, I look
forward to discussing State and industry involvement throughout
all of the coordinating and planning. Reports indicate that
they do not have the ability and information to fulfill their
assigned roles in protecting agriculture.
Though I am pleased to hear that strides have been made in
CARVER + Shock technology in hardening our infrastructure
against an international attack, technology is only as good as
its application. Unless the relevant agencies begin to take
HSPD-9 a step further, the United States will lack a
coordinated national approach to protect against agroterrorism,
possibly resulting in gaps and needless duplication of effort.
By overcoming these challenges, the United States will be in
better position to protect against and respond to a food-borne
disease outbreak, whether natural or intentional.
Thank you, Mr. Chairman, and I yield back.
[The statement of Mr. Thompson follows:]
Prepared Statement of the Honorable Bennie G. Thompson, Chairman,
Committee on Homeland Security
The theme of this hearing is extremely fitting given the
circumstances this past year, where our nation has had to deal with
issues of pet food, spinach, peanut butter, and more recently bans on
toothpaste, and even the FDA ban of seafood products.
The major threat to the food agriculture sector is a crisis of
confidence, where a poorly prevented or recognized event causes people
to question the safety of food regionally or nationally. The time to
address whether our federal infrastructure is designed to mitigate
vulnerabilities is before an occurrence and not after the fact. We have
been extremely fortunate that our agriculture has been safe, but we've
got work to do if we want to be more secure.
Currently, 15 agencies collectively administer at least 30 laws
related to food safety, causing ineffective oversight, inefficient
coordination, and inconsistent agency leadership. One concern I look
forward to hearing our witnesses address today, is the current agency
leadership structure in place in the event of a food-borne emergency.
HSPD-9 sets out to address this by establishing the Department of
Homeland Security as having the lead role in policy coordination in an
event of national significance. However, a recent GAO report says that
USDA is not planning for DHS to assume the lead coordinating role if an
outbreak among poultry occurs that is sufficient in scope to warrant a
presidential declaration of an emergency or major disaster, or a DHS
declaration of an Incident of National significance.
Such an inconsistency in planning perpetuates the confusion of
who's in charge. I look forward to the second panel--comprised of
industry, academic and state agriculture officials--giving us a more
local perspective of what uncoordinated efforts mean for our
communities. Furthermore, I look forward to discussing State and
industry involvement throughout all of the coordination and planning.
Reports indicate that they do not have the ability and information to
fulfill their assigned roles in protecting agriculture. Though I am
pleased to hear that strides in CARVER+sHOCK technology have been made
in hardening our infrastructure against an intentional attack,
technology is on as good as its application.
Unless the relevant agencies begin to take HSPD-9 a step further,
the United States will lack a coordinated national approach to protect
against agroterrorism, possibly resulting in gaps or needless
duplication of effort. By overcoming these challenges, the United
States will be in a better position to protect against and respond to a
food-borne disease outbreak, whether natural or intentional.
Mr. Langevin. I thank the Chairman.
Other members of the subcommittee are reminded, under the
rules, opening statements may be submitted for the record.
Before I turn to the panel. I ask unanimous consent that the
gentlelady from Ohio, Ms. Kaptur, be allowed to participate in
today's hearing. I thank her for her attendance. Under the
committee rules, Ms. Kaptur will be recognized for questions
after the committee members.
I think it is appropriate to recognize here that Ms. Kaptur
serves on the Appropriations Subcommittee of Agriculture, Rural
Development, and Food and Drug Agencies, and actually
introduced H.R. 2997, the Assured Food Safety Act of 2007, that
would require a seal approval of imported foods coming into the
country by seal of approval by USDA or FDA. And I was proud to
cosponsor the legislation with the gentlelady. So I ask
unanimous consent she be allowed to participate in the hearing.
STATEMENT OF DAVID ACHESON, M.D., F.R.C.P., ASSISTANT
COMMISSIONER FOR FOOD PROTECTION, FOOD AND DRUG ADMINISTRATION
Mr. Langevin. Without objection, I welcome the first panel
of witnesses.
Our first witness is Dr. David Acheson, Assistant
Commissioner of Food Protection, Food and Drug Administration,
at the U.S. Department of Health and Human Services. Dr.
Acheson provides advice and counsel to the Commissioner on
strategic and substantive food safety and food defense matters.
Dr. Acheson has published extensively, and is internationally
recognized both for his public health expertise in food safety
and his research in effective diseases.
Welcome, Dr. Acheson.
Our second witness, Dr. Carol Maczka, is the Assistant
Administrator, Office of Food Defense and Emergency Response,
Food Safety Inspection Service, at the U.S. Department of
Agriculture. Dr. Maczka has more than 20 years of experience in
the field of risk assessment.
Our third witness, Dr. Tom McGinn, Office of Health
Affairs, Department of Homeland Security. Dr. McGinn is the
Director of Veterinary and Agriculture Security for the Office
of the Chief Medical Officer. In his position, he is
responsible for internal and external coordination of DHS
veterinary and agricultural programs.
Welcome to you as well.
Our fourth witness is Dan Baldwin, Assistant Commissioner,
Office of International Trade, Customs and Border Protection,
Department of Homeland Security. Mr. Baldwin's office directs
the national trade policy and national trade program functions
at CBP and provides uniformity and clarity for the Department
of CBP's national strategy to facilitate legitimate trade.
Without objection, the witnesses' full statements will be
inserted into the record.
I want to welcome the panel here. Thank you for your
testimony and your presence. And I now recognize each witness
to summarize his or her statement for 5 minutes, beginning with
Dr. Acheson.
Dr. Acheson. Good morning, Chairman Langevin, and members
of the subcommittee. I am Dr. David Acheson, Assistant
Commissioner for Food Protection of the FDA.
FDA appreciates the opportunity to discuss our food defense
activities, and I am pleased to be here today with my
colleagues from the Department of Homeland Security and the
Department of Agriculture.
The Commissioner of Food and Drugs, Dr. Andrew von
Eschenbach, recently appointed me to the new position of
Assistant Commissioner For Food Protection. My first priority
in this position is to develop a new strategy for the
integration of food safety and food defense that will address
changes in the global food safety and food defense system,
identify our most critical needs and serve as a framework to
help us address the challenges we face.
Food safety and food defense continue to be top priorities
for this administration. A terrorist attack on the food supply
could have both severe public health and economic consequences,
while damaging the public's confidence in the food we eat. To
promote the safety of imported products, last week the
President established an interagency working group to review
the procedures, regulations and practices that are in place to
make sure that imported food and other products are safe.
Secretary of Health and Human Services Michael Leavitt will
chair this working group. FDA will play a key role in the
group's activities. The group expects to report back to the
President within 60 days with its recommendations.
At FDA, ensuring the products we regulate are safe and
secure is a vital part of our public health mission. The agency
regulates everything Americans eat, except meat, poultry and
processed egg products, which are regulated by USDA. A great
deal has been done in the past few years to enhance the safety
and defense of the food supply in the United States. FDA has
worked with other Federal, State, local, and tribal food safety
agencies, as well as law enforcement and intelligence-gathering
agencies, and with industry to significantly strengthen the
Nation's food safety and defense systems across the entire
distribution chain, from farm to table, to better protect our
food supply against deliberate and accidental threats. This
cooperation has resulted in greater awareness of potential
vulnerabilities, the creation of more effective prevention
programs, new surveillance systems, and the ability to respond
more quickly to outbreak of food-borne illness.
FDA is working closely with DHS and other Federal agencies
to implement the President's Homeland Security Presidential
Directives. The HHS and USDA Secretaries, or their designees,
exercise key responsibilities as food-sector-specific agencies.
DHS serves as the coordinator of the food agriculture sector
with the Government Coordination Council. HHS and USDA serve as
co-leads for the food sector, and USDA serves as the lead for
the agriculture sector. With the close working relationship of
FDA and USDA and the other government and industry
collaborators, the Food and Agriculture Sector activities to
protect critical infrastructure have set the organizational and
operational standard for other critical infrastructure sectors.
DHS recently released our sector-specific plants. To implement
HSPD-9, FDA has been involved in numerous activities.
For example, to increase lab surge capacity, FDA, in
coordination with USDA, established the Food Emergency Response
Network, or FERN, to include a substantial number of Federal,
State and local labs that are capable of analyzing large
numbers of food samples for agents of concern. At present, the
FERN network includes 134 laboratories, representing all 50
States and Puerto Rico. FDA has also developed an online food
defense awareness training course in partnership with USDA. We
have completed 13 vulnerability assessments as part of the
strategic partnership program on agroterrorism. FDA has also
conducted or provided funding for food defense research
activities and participated in numerous emergency response
exercises. In our food defense activities, FDA works closely
with our State partners. For example, earlier this year, FDA
conducted a Food Defense Surveillance Assignment for FDA and
USDA personnel and participating State and local authorities to
conduct food-defense-related inspections and reconciliation
exams, and to collect and analyze samples of food products.
This year, FDA, in cooperation with CDC, USDA and State and
local organizations representing food, public health and
agricultural interests, initiated the ALERT awareness program.
It provides a uniform and consistent approach to food defense
awareness at any point in the supply chain, from farm to
retail. ALERT identifies five key points that industry and
businesses can use to decrease the risk of intentional food
contamination at their facility. In 2003, FDA issued guidance
on the security measures the food industry may take to minimize
the risk that food will be subject to tampering or other
malicious or terrorist actions. FDA issued a general guidance
entitled, Food Producers, Processors and Transporters: Food
Security Preventive Measures, and a number of others.
Also in 2003, FDA began using the CARVER+Shock analytical
tool to perform vulnerability assessments. FDA's approach has
been to seek voluntary, mutually beneficial partnerships with
various segments of the food industry. We have completed such
cooperative assessments with segments of the regulated
industry. The CARVER+Shock method to determine the
vulnerability of individual food facilities to biological,
chemical or radiological attack has resulted in the development
of a software tool now available free of charge on the FDA's
Web site. In conclusion, due to the enhancements being made by
FDA and other agencies, and due to the close coordination
between the Federal and State food safety, public health, law
enforcement and intelligence-gathering agencies, the United
States food defense system is stronger than ever before.
Although we have made progress, we are continuously working
to improve our ability to prevent, detect and respond to
terrorist threats. Thank you for the opportunity to discuss
FDA's food defense activities. I would be happy to answer any
questions you may have.
[The statement of Dr. Acheson follows:]
Prepared Statement of David Acheson, M.D., F.R.C.P.
INTRODUCTION
Good afternoon, Chairman Langevin and Members of the Subcommittee.
I am Dr. David Acheson, Assistant Commissioner for Food Protection at
the Food and Drug Administration (FDA or the Agency) which is part of
the Department of Health and Human Services (HHS or the Department). I
am pleased to be here today with my colleagues from the Department of
Homeland Security (DHS) and the Department of Agriculture (USDA). FDA
appreciates the opportunity to discuss our food defense activities.
A great deal has been done in the past few years to enhance the
safety and defense of the food supply in the United States. FDA has
worked with other Federal, state, local, and tribal food safety
agencies, as well as with law enforcement and intelligence-gathering
agencies, and with industry to significantly strengthen the nation's
food safety and defense system across the entire distribution chain,
from farm to table, to better protect our food supply against
deliberate and accidental threats. This cooperation has resulted in
greater awareness of potential vulnerabilities, the creation of more
effective prevention programs, new surveillance systems, and the
ability to respond more quickly to outbreaks of foodborne illness. The
Office of Management and Budget and the relevant food safety agencies
are collaborating on ways to most effectively address issues raised in
the Government Accountability Office's designation of Federal oversight
of food safety as a high-risk item in February 2007.
Food safety and food defense continue to be top priorities for this
Administration. A terrorist attack on the food supply could have both
severe public health and economic consequences, while damaging the
public's confidence in the food we eat. The changes in food defense
that we have been implementing in the last few years are fundamental
enhancements.
The Commissioner of Food and Drugs, Dr. Andrew von Eschenbach,
recently appointed me to the new position of Assistant Commissioner for
Food Protection. My first priority in this position is to develop a new
strategy for the integration of food safety and food defense that will
address changes in the global food safety and food defense system,
identify our most critical needs, and serve as a framework to help us
address the challenges we face. The goal is to ensure a comprehensive
and robust food safety and food defense program that is tailored to
meet the risks posed by the types of foods we regulate and that focuses
on prevention, ensures compliance with preventive controls, and rapidly
responds when contaminated food or feed is detected, or when there is
possible risk to humans or animals.
In my testimony today, I will first briefly describe HHS' role in
counterterrorism activities. Then, I will discuss our collaborative
activities with our food safety and defense partners. I will also
describe some of FDA's food defense activities to enhance protection of
the food supply.
HHS' ROLE IN FOOD-RELATED COUNTERTERRORISM ACTIVITIES
Under the President's National Response Plan, HHS leads Federal
public health activities to ensure an integrated and focused national
effort to anticipate and respond to biological weapons, emerging
diseases, and other threats. HHS is also the principal Federal agency
responsible for coordinating all Federal-level assets activated to
support and augment the State and local medical and public health
response to mass casualty events.
FDA is the Federal agency that regulates all of the food we eat
except for meat, poultry, and processed egg products, which are
regulated by our partners at USDA. FDA also is responsible for ensuring
that human drugs, human biological products, medical devices, and
radiological products as well as veterinary drugs are safe and
effective and that cosmetics are safe.
FDA's primary mission is to protect the public health. Ensuring
that FDA-regulated products are safe and secure is a vital part of that
mission. While performing our mission, we play a central and a
leadership role in the nation's defense against terrorism. First,
terrorists could use an FDA-regulated product, such as food, as a
vehicle to introduce biological, chemical, or radiological agents into
the U.S. stream of commerce. Second, FDA-regulated products, such as
human drugs, vaccines, tissues, blood, blood products, and medical
devices, as well as veterinary drugs, will play a central role in
preventing or responding to human and/or animal health concerns created
by an act of terrorism. It is HHS's goal, with FDA working closely with
other HHS agencies and other Federal agencies, and with State, local,
and tribal governments, industry, and the public, to reduce the
likelihood that an FDA-regulated product could be used to poison or
otherwise harm Americans. We also help ensure that the nation's public
health system is prepared to deter a potential threat and is ready to
respond to an act of terrorism.
By way of background, although FDA has the lead responsibility
within HHS for ensuring the safety of food products, the Centers for
Disease Control and Prevention (CDC) has an important complementary
public health role. As the lead Federal agency for conducting disease
surveillance, CDC monitors the occurrence of illness in the U.S.
attributable to the entire food supply. The disease surveillance
systems coordinated by CDC provide an essential early-information
network to detect dangers in the food supply and to reduce foodborne
illness.
COLLABORATION WITH FOOD SAFETY AND FOOD DEFENSE PARTNERS
In its food safety and defense efforts, FDA has many partners--
Federal, State, local, and tribal agencies, academia, and industry. FDA
is working closely with our Federal partners such as USDA, DHS, the
Homeland Security Council at the White House, the Department of State,
the Central Intelligence Agency (CIA), and the Federal Bureau of
Investigation (FBI) to have the best information possible and to be
prepared to act as needed. I also want to emphasize FDA's close working
relationships with its sister public health agency, CDC, with Customs
and Border Protection (CBP) in DHS, and with USDA's Food Safety and
Inspection Service (FSIS). Some of our many Federal partners include
USDA's Animal and Plant Health Inspection Service (APHIS), USDA's
Foreign Agriculture Service, USDA's Agricultural Research Service,
USDA's Food and Nutrition Service, Department of the Army Veterinary
Services Activity, the Environmental Protection Agency (EPA), and the
Department of Treasury's Alcohol and Tobacco Tax and Trade Bureau.
FDA's activities in a public health emergency are coordinated
through the HHS Secretary's Operations Center. This relationship
facilitates communication among all HHS Operating Divisions, the
Department, and other Federal agencies and departments, including DHS.
FDA also has worked closely with the Interagency Food Working Group of
the White House Homeland Security Council on three initiatives--
development of a national network of food laboratories, identification
of vulnerabilities and subsequent mitigations for commodities of
concern, and the development of a national incident management system.
Further, FDA worked in partnership with EPA, USDA, DHS, and the
Department of Defense (DoD) to describe general Federal roles and
responsibilities for decontamination and disposal in response to
animals, crop, and food incidents.
In addition, FDA's Office of Criminal Investigations (OCI)
maintains professional relationships with domestic and foreign law
enforcement agencies as well as the intelligence community so that it
can receive and act on any information regarding the intentional
contamination of FDA-regulated products. OCI has a specialized
counterterrorism staff with the clearances, capabilities, and
backgrounds to analyze information from law enforcement and
intelligence community agencies and to assist those agencies in
conducting terrorism-related threat assessments involving FDA-regulated
products. OCI has agents assigned to selected FBI Terrorism Task Forces
throughout the United States.
FDA is working closely with DHS and other Federal agencies to
implement the President's Homeland Security Presidential Directives
(HSPDs). The Secretary of DHS is responsible for coordinating the
overall national effort to enhance the protection of the critical
infrastructure and key resources of the nation, including food and
agriculture defense. The President has issued HSPD-7,-8, and)--9, which
identify critical infrastructures, improve response planning, and
establish a national policy to defend the agriculture and food systems
against terrorist attacks, major disasters, and other emergencies.
Among other things, HSPD-9 calls for the development of a National
Veterinary Stockpile (NVS). FDA and CDC participate in NVS Steering
Committee activities.
The HHS and USDA Secretaries or their designees exercise key
responsibilities as food sector-specific agencies. DHS serves as the
coordinator of the Food and Agriculture Sector within the Government
Coordination Council (GCC). The GCC is charged with coordinating
agriculture and food defense strategies, activities, and communication
across government and between the government and the private sector
partners.
Within the GCC, HHS and USDA serve as co-leads for the food sector,
and USDA serves as the lead for the agriculture sector. The Food and
Agriculture Sector is a public-private partnership that combines
expertise from several Federal agencies (FDA, USDA, EPA, DoD,
Department of Commerce, Department of the Interior, and the Department
of Justice) as well as that of state, local, and tribal officials
(representing agriculture, public health, and veterinary services), and
the private sector (more than 100 trade associations and individual
firms participate). As part of the HSPD-7 National Infrastructure
Protection Plan (NIPP) development, FDA and USDA developed sector-
specific plans with input from states and the private sector. DHS
recently released the sector specific plans. With the close working
relationship of FDA and USDA and the other government and industry
collaborators, the Food and Agriculture Sector activities to protect
critical infrastructure have set the organizational and operational
standard for other critical infrastructure sectors. DHS has applauded
the Food and Agriculture Sector's organizational structure, consensus
building, and the steps it has taken to improve food defense.
FDA also is working closely with our state partners to enhance food
defense. For example, earlier this year, FDA conducted a Food Defense
Surveillance Assignment for FDA and USDA personnel and participating
state and local authorities to conduct food defense-related inspections
and reconciliation examinations (to verify the accuracy of declarations
in the shipping documents by comparing them with the actual products)
and to collect and analyze samples of food products that may have an
elevated risk for intentional contamination. The activities in this
exercise were planned in cooperation and collaboration with USDA and a
number of organizations representing state and local interests
including the Association of American Feed Control Officials,
Association of Food and Drug Officials, Association of Public Health
Laboratories, Association of State and Territorial Health Officials,
National Association of County and City Health Officials, National
Association of Local Boards of Health, National Association of State
Departments of Agriculture, National Environmental Health Association,
and United States Animal Health Association. The purpose of this
assignment was to deter intentional contamination of food through
heightened and targeted preventive activities at various points in the
food supply and to test the system for responding to an increased risk
from food so that gaps in the system can be identified and addressed.
This assignment enhanced multiple Federal, state, and local government
agencies' preparedness for a future threat involving an FDA-regulated
product. Since that time, FDA has issued a Protein Surveillance
Assignment (PSA) to increase food defense awareness and assess the
safety of the human food and animal feed supply following the finding
of contaminated vegetable protein concentrate coming into the country
from China. FDA continues to further integrate our food defense
activities into our food safety work.
In addition, FDA and CDC have collaborated with the Council of
Association Presidents to develop a nationwide food defense awareness
training program. This Council, which consists of ten of the major
state and local public health and regulatory professional associations,
has an outreach capability to reach virtually all state and local
public health officials. The training program, which began in March
2006 with a satellite downlink nationwide broadcast, has helped to
raise food defense awareness at the local, state, and Federal levels.
This program is now available for streaming download on the website of
FDA's Center for Food Safety and Applied Nutrition.
Now, I would like to describe some of FDA's other food defense
activities.
INDUSTRY GUIDANCE AND PREVENTIVE MEASURES
This year, FDA, in cooperation with CDC, USDA, and state and local
organizations representing food, public health, and agriculture
interests, initiated the ALERT awareness program. It provides a uniform
and consistent approach to food defense awareness at any point in the
supply chain, from farm to retail establishment.
ALERT identifies five key points that industry and businesses can
use to decrease the risk of intentional food contamination at their
facility: They are:
A. How do you ASSURE that the supplies and ingredients
you use are from safe and secure sources?
L. How do you LOOK after the security of the products
and ingredients in your facility?
E. What do you know about your EMPLOYEES and people
coming in and out of your facility?
R. Could you provide REPORTS about the security of
your products while under your control?
T. What do you do and who do you notify if you have a
THREAT or issue at your facility, including suspicious
behavior?
We have prepared ALERT materials in several languages and offer
training on the ALERT system on our website that is suitable for state,
local, and industry stakeholders.
In 2003, FDA issued guidance on the security measures the food
industry may take to minimize the risk that food will be subject to
tampering or other malicious, criminal, or terrorist actions. FDA
issued a general guidance entitled ``Food Producers, Processors, and
Transporters: Food Security Preventive Measures.'' The guidance is
designed as an aid to firms that produce, process, store, re-pack, re-
label, distribute or transport food or food ingredients. In addition,
we have issued specific security guidance for the milk industry, for
importers and filers, for retail food stores and food service
establishments, and for cosmetic processors and transporters. During
domestic inspections and import examinations, FDA's field personnel, as
well as our state counterparts, continue to hand out and discuss these
guidance documents.
To help reduce the risk of an attack on the food supply, FDA and
our partners at USDA developed a web-based food security awareness
training program entitled, ``Protecting the Food Supply from
Intentional Adulteration: An Introductory Training Session to Raise
Awareness.'' The training is directed at individuals who play an
important role in defending our nation's food from attack: Federal,
state, local, and tribal food-industry regulators; school food
authorities; and nutrition assistance program operators and
administrators. Representatives from the food industry and individuals
essential in responding to a food emergency due to an intentional
attack--such as law enforcement, public health, and homeland security
officials--also are encouraged to participate in the training program.
The program is available to any interested individuals free of charge.
VULNERABILITY AND THREAT ASSESSMENTS
FDA's risk-based approach to food defense helps the Agency
determine where to focus its resources. As part of its efforts to
anticipate threats to the food supply, FDA has conducted extensive
scientific vulnerability assessments of different categories of food,
determining the most serious risks of intentional contamination with
different biological or chemical agents during various stages of food
production and distribution. FDA's initial assessment utilized an
analytical framework called Operational Risk Management (ORM) that
considers both the severity of the public health impact and the
likelihood of such an event taking place. As part of this process, FDA
has incorporated threat information received from the intelligence
community.
To validate our findings, FDA contracted with the Institute of Food
Technologists to conduct an in-depth review of ORM and provide a
critique of its application to food security. This review validated
FDA's vulnerability assessment and provided additional information on
the public health consequences of a range of scenarios involving
various products, agents, and processes.
The ORM approach provided a high-level view of foods and agents
that were of greatest concern. Since the completion of the ORM, FDA has
undertaken more in-depth vulnerability assessments of specific food
commodities using a method called CARVER+Shock. This method uses
processes adapted from techniques developed by DoD for use in assessing
the vulnerabilities of military targets to asymmetric threats. Results
of these updated assessments are being used to develop technology
interventions and countermeasures, identify research needs, and provide
guidance to the private sector.
In 2003, FDA began using the CARVER+Shock analytical tool to
perform vulnerability assessments to identify what an individual or
group, intent on doing damage to the food and agriculture sector, could
potentially do based on the person's or group's capability, intent, and
past history. The CARVER+Shock methodology was modified under Homeland
Security Council leadership for use in the food and agriculture sector
by FDA, USDA, and DoD with coordination by DHS, CIA, and FBI. FDA's
approach has been to seek voluntary, mutually beneficial partnerships
with various segments of the food industry. We have completed such
cooperative assessments with segments of the regulated industry that
involve bottled water, fluid dairy products, juice products, and infant
formula. FDA also has collaborated with USDA to provide assistance to
the USDA Food and Nutrition Service on the use of this analytical tool
on specific commodities in the school lunch program.
Since 2005, FDA has been part of a joint Federal initiative along
with USDA, DHS, and the FBI called the Strategic Partnership Program on
Agroterrorism (SPPA). The SPPA initiative is again using the
CARVER+Shock tool and, through industry and state volunteers, is taking
the tool to local venues. Local industry, FBI, DHS, FDA, USDA, State
Departments of Health, and State Departments of Agriculture participate
in these assessments. These assessments not only identify
vulnerabilities in other food commodities but also build local
infrastructure around food defense issues. The SPPA program will run
for approximately two years and has a goal of completing 40-50
assessments during this period. The results from these assessments will
be used to identify mitigation strategies and to focus food defense
research questions. These assessments included yogurt, export grain,
baby food--applesauce, frozen entrees/pizza, bottled water, fresh cut
produce, apple juice, fluid milk processing, milk at retail, infant
formula, flour, stadium retail food service, and animal feed.
Just last month, FDA released a new CARVER + Shock software tool to
help processors, manufacturers, warehousers, and transporters in the
food industry utilize the CARVER+Shock method to determine the
vulnerability of individual food facilities to biological, chemical, or
radiological attack. The software tool is available free of charge on
FDA's website.
LABORATORY ENHANCEMENTS
An additional step in enhancing our response capability is to
improve our laboratory capacity. An important component of controlling
threats from deliberate foodborne contamination is the ability to
rapidly test large numbers of food samples that could potentially be
contaminated for a broad array of biological, chemical, and
radiological agents. To increase surge capacity, FDA has worked in
close collaboration with USDA's FSIS to establish the Food Emergency
Response Network (FERN) to include a substantial number of laboratories
capable of analyzing foods for agents of concern. We are seeking to
expand our capacity through agreements with other Federal and state
laboratories. At present, the network includes 134 laboratories
representing all 50 states and Puerto Rico. Participation continues to
grow. Once it is operating at full capacity, FERN will encompass a
nationwide network of Federal, state, and local laboratories working
together to build the capacity to test the safety of thousands of food
samples, thereby enhancing the nation's ability to swiftly respond to a
terrorist attack.
Last fall, the FERN network proved to be a critical asset in the E.
coli O157:H7 outbreak associated with fresh spinach. FERN expanded our
laboratory capacity to handle the large number of food samples being
tested. In addition, FERN analysts worked closely with CDC's Laboratory
Response Network personnel to harmonize and approve a modified FERN
method for detecting E. coli O157:H7 in spinach. This method allowed
for substantially improved testing of spinach samples as it allowed for
the detection of E. coli O157:H7 at lower levels. The FERN program also
supplied the necessary reagents to the laboratories performing the
testing.
More recently, on April 30, 2007, FDA issued a domestic vegetable
PSA, in conjunction with our state and local regulatory partners, to
test a variety of protein concentrates commonly found in the U.S. food
and animal feed supply for the presence of melamine. Eight State FERN
laboratories are involved in the analysis of the samples being
collected.
IMPORTS
To manage the ever-increasing volume of imported food shipments,
FDA utilizes risk-management strategies in the review of foods that are
being imported or offered for import into the United States. Currently,
working with information submitted either through CBP's electronic
systems used for import entries or through FDA's Internet-based Prior
Notice System Interface, FDA screens shipments electronically before
they arrive in the U.S. to determine if the shipment meets identified
criteria for physical examination or sampling and analysis or warrants
other review by FDA personnel. This electronic screening allows FDA to
better determine how to deploy its limited physical inspection
resources at the border on what appear to be higher-risk food shipments
while allowing lower-risk shipments to be processed in accordance with
traditional import procedures after the electronic screening. FDA is
working to enhance its targeting ability by utilizing data from a much
wider range of sources to inform our entry decisions.
These are just a few of the many activities we have underway to
enhance protection of the food supply.
CONCLUSION
In conclusion, due to the enhancements being made by FDA and other
agencies and due to the close coordination between the Federal and
state food safety, public health, law enforcement, and intelligence-
gathering agencies, the United States' food defense system is stronger
than ever before. Although we have made progress, we are continuously
working to improve our ability to prevent, detect, and respond to
terrorist threats.
Thank you for this opportunity to discuss our food defense
activities. I would be pleased to respond to any questions.
Mr. Langevin. Thank you, Dr. Acheson. I appreciate your
testimony.
The chair now recognizes Dr. Maczka to summarize your
statement for 5 minutes.
STATEMENT OF CAROL MACZKA, PH.D., ASSISTANT ADMINISTRATOR,
OFFICE OF FOOD DEFENSE AND EMERGENCY RESPONSE, FOOD SAFETY
INSPECTION SERVICE, USDA
Ms. Maczka. Hello, Mr. Chairman and members of the
subcommittee. I am pleased to appear before you today to
discuss the issues of defending our food supply. I am Dr. Carol
Maczka, Assistant Administrator for the Office of Food Defense
and Emergency Response at USDA's Food Safety and Inspection
Service, FSIS.
My office manages all food defense activities within FSIS
and coordinates its activities through DHS, FDA, other Federal
and State agencies as well as industry. FSIS is the public
health agency in USDA responsible for ensuring that meat,
poultry and egg products are safe, secure, wholesome and
correctly labeled and packaged. Inspection personnel form the
backbone of FSIS's food safety system. FSIS has more than 7,000
inspectors at Federal meat, poultry and egg products plants and
import establishments. FSIS also has program investigators
nationwide who conduct food safety and food defense
investigations and enforcement. Consistent with Homeland
Security Presidential Directive 9, the agency works with
government and industry on improving awareness and warning
systems, vulnerability assessments, mitigation strategies,
response planning and recovery, and research and development.
FSIS uses a comprehensive system to ensure that imported meat,
poultry and egg products are safe and secure. It includes an
initial determination of the equivalence of a country's
inspection systems, on-site audits, and reinspection of all
meat and poultry products coming into the United States. FSIS
import inspectors ensure shipments are properly labeled and
examined. Import surveillance offices conduct surveillance
activities at ports and in commerce, and coordinate with other
agencies, such as Customs and Border Protection. The agency
also works with Customs' National Targeting Center to develop
rule sets for targeting high-risk shipments entering the
country, and is moving forward on a system that will allow the
sharing of import tracking data by FSIS, Customs, and DHS.
FSIS and FDA co-chair the Food Emergency Response Network,
FERN. It is a coordinated effort between Federal, State and
local laboratories to provide ongoing surveillance, as well as
detection and surge capacity for large-scale food-related
events. The agency has developed specific procedures for
sampling food, depending upon the threat level designated by
DHS. The agency also engages in active surveillance through a
series of food defense verification procedures that are
performed daily in all FSIS-regulated facilities. The agency's
Consumer Complaint Monitoring System and national surveillance
system monitors food-related consumer complaints, which assist
the agency in identifying potential attacks on the food supply.
FSIS has conducted food defense awareness training nationwide
with State and local inspectors, and in cooperation with FDA
with Federal agencies. FSIS has created and distributed model
Food Defense Plans for use by meat, poultry and egg products
facilities, and import establishments. These plans identify the
types of preventive steps that establishments might take to
minimize food defense risks. The agency has also held numerous
workshops and Web casts on Food Defense Plans to reach out to
small plants. In the area of responding to food emergencies,
FSIS has developed State response plans and conducted six
exercises with industry and State and Federal agencies to test
emergency response procedures. A total of 15 exercises are
planned, which will take into account 50 States. FSIS also
continues to enhance its readiness for a possible outbreak of
avian influenza. The agency has conducted an exercise and
developed a testing protocol for detecting high path avian
influenza in poultry meat.
In addition, FSIS has actively engaged its partners in
developing pandemic plans. This spring, FSIS worked closely
with FDA to respond to the discovery that some swine and
poultry had been fed pet food scraps containing melamine. FSIS
quickly ensured that swine and poultry were held under State
quarantine or voluntarily by owners. A joint risk assessment
concluded that the potential exposure to the public, even in
the worst case scenario, was well below any level of public
health concern. Subsequently, FSIS cleared animals on farms in
question for inspection and processing.
In conclusion, Mr. Chairman and members of the
subcommittee, I want to thank you for this opportunity to
discuss FSIS's leadership role in protecting the food supply.
We take pride in knowing that our Nation's food supply is among
the safest in the world, but we also realize that it is vital
to continue to improve our system. I am happy to answer any
questions you may have.
[The statement of Ms. Maczka follows:]
Prepared Statement of Carol Maczka, Ph.D.
Mr. Chairman and Members of the Subcommittee, I am pleased to
appear before you today to discuss the issue of defending our food
supply system from farm to table. I am Dr. Carol Maczka, Assistant
Administrator for the Office of Food Defense and Emergency Response at
the United States Department of Agriculture's (USDA) Food Safety and
Inspection Service (FSIS).
The program area within FSIS that I lead is the Office of Food
Defense and Emergency Response (OFDER), which manages all homeland
security activities within FSIS. OFDER makes sure that policy makers,
scientists, field staff and management are prepared to prevent and
respond to any food security threat. OFDER develops and coordinates all
FSIS activities to prevent, prepare for, respond to, and recover from
non-routine emergencies resulting from intentional and non-intentional
contamination affecting meat, poultry, and processed egg products.
OFDER also serves as the agency's central office for homeland security
issues and ensures coordination of its activities with the USDA
Homeland Security Office, the Department of Homeland Security (DHS),
the FDA, other Federal and State government agencies with food-related
responsibilities, and industry.
FSIS is the public health agency in the USDA responsible for
ensuring that the nation's commercial supply of meat, poultry, and
processed egg products is safe, secure, wholesome, and correctly
labeled and packaged. FSIS is charged with administering and enforcing
the Federal Meat Inspection Act, the Poultry Products Inspection Act,
the Egg Products Inspection Act, portions of the Agricultural Marketing
Act, and the regulations that implement these laws. FSIS also ensures
compliance with the Humane Methods of Slaughter Act, which requires
that all livestock be handled and slaughtered in a humane manner. The
Agency is responsible for determining equivalence to Federal standards
at the State level and among our foreign trading partners.
FSIS plays a key role in the nation's food safety system, which
also includes agencies such as the Department of Health and Human
Services' Food and Drug Administration as well as state, tribal and
local food safety partners. FSIS works closely with these agencies and
other partners to share information and protect public health.
Our inspection program personnel form the backbone of FSIS' public
health infrastructure in laboratories, plants, and import houses
throughout the country. FSIS has more than 7,600 inspectors and
veterinarians in approximately 6,000 Federal meat, poultry, and
processed egg product plants, and at approximately 130 import
establishments every day to prevent, detect, and respond to food-
related emergencies. In fiscal year 2006, inspection program personnel
performed antemortem and postmortem inspection procedures to ensure
public health requirements were met in the processing of more than 46
billion pounds of livestock carcasses, almost 57 billion pounds of
poultry carcasses, and about 4.4 billion pounds of liquid egg products.
In fiscal year 2006, FSIS inspection program personnel conducted
more than eight million procedures to verify that establishments met
food safety and wholesomeness requirements. In addition, during fiscal
year 2006, approximately 3.9 billion pounds of meat and poultry and
about 5.9 million pounds of egg products were presented for import
inspection at U.S. ports and borders. FSIS also has Program
Investigators nationwide who conduct food safety, food defense, and
outbreak investigations and enforcements.
The Agency also engages in active surveillance through a series of
food defense verification procedures performed daily in all FSIS-
regulated facilities. With a strong food safety verification system in
place, FSIS has been focusing on fortifying existing programs with a
greater emphasis on food defense and improving internal and external
lines of communication, including the integration of the food defense
system databases with the larger public health data infrastructure.
Homeland Security Presidential Directives most relevant to our work
are:
HSPD-5: Management of Domestic Incidents;
HSPD-7: Critical Infrastructure Identification,
Prioritization, and Protection;
HSPD-8: National Preparedness; and especially
HSPD-9: Defense of U.S. Agriculture and Food.
HSPD-9 was signed on January 30, 2004, and establishes a national
policy to defend the agriculture and food system against terrorist
attacks, major disasters, and other emergencies. It directs the
Secretary of Agriculture to work with other Federal department and
Agency leaders on improving awareness and warning systems,
vulnerability assessments, mitigation strategies, response planning and
recovery, outreach and professional development, and research and
development.
FSIS uses a comprehensive system to ensure that imported meat,
poultry, and processed egg products are safe and secure. It includes a
thorough analysis of each country's food laws and inspection systems to
determine initial equivalence; on-site audits of each country's food
safety system to ensure equivalence is maintained; and port-of-entry
inspection on all meat, poultry, and processed egg products coming into
the United States. It is enhanced by FSIS' Import Surveillance Liaison
Officers, who conduct a broader range of surveillance activities at
import facilities and in commerce, and serve as liaisons to improve
coordination with other agencies like U.S. Customs and Border
Protection (CBP).
Every day, FSIS personnel are at U.S. ports, inspecting shipments
as they come in and pulling out samples. The Agency focuses on stopping
illegal shipments at their point of entry. When meat and poultry
imports enter the United States, FSIS import inspectors ensure that
each shipment is properly certified, examine each lot for general
condition and labeling, and conduct reinspection as directed by a
centralized computer system, the Automated Import Information System.
Using protocols developed by FSIS with USDA's Office of Inspector
General and the Animal and Plant Health Inspection Service (APHIS),
111,000 pounds of ineligible product were detected and 1,766,050 pounds
of product detained in fiscal year 2006 out of 9 billion pounds of meat
and poultry and about 5.9 million pounds of egg products presented for
import inspection at U.S. ports and borders.
The Agency also worked with CBP's National Targeting Center to
develop rules for targeting high-risk, FSIS-regulated shipments
entering the country. This effort included a two month pilot program in
2006 in which a total of 3,229 shipments were screened at two ports
using the rule sets. The Agency is also moving forward on a system
which will allow the sharing of import tracking data by FSIS, CPB, and
DHS to further strengthen our ability to ensure the safety and security
of imported meat, poultry and processed egg products through better and
more rapid access to data on imports.
FSIS is currently working with other Federal government agencies to
integrate its International Trade Data Systems (ITDS) design
requirements with the ePermits system developed by Animal and Plant
Health Inspection Service (APHIS) and the larger Automated Commercial
Environment under development by US Customs and Border Protection.
Ultimately, these efforts would result in a Federal-government wide
linkage of all inspection and border control data systems, meeting
FSIS' regulatory needs along with those of sister agencies.
FSIS and FDA are leading the development of the Food Emergency
Response Network, a joint effort of national, State, and local
laboratories to provide ongoing surveillance and monitoring of food and
to promptly respond to a foodborne illness outbreak or intentional
contamination that targets the Nation's food supply. In addition, FERN
is a critical source of data for the FSIS public health data
infrastructure.
FERN enables FSIS to utilize State and local laboratories in
handling the numerous samples required to be tested in the event of an
attack on the food supply, a natural outbreak, or even a hoax,
involving a meat, poultry, or egg product. It is vital for the Agency
to respond rapidly to such emergencies to not only protect the public's
health, but also to ensure public confidence in the safety of the food
supply. The first line of this rapid response is the laboratories,
which must be provided with training, methodology, and state-of-the-art
laboratory equipment.
FERN provides ongoing surveillance, as well as detection and surge
capacity for large-scale food-related events. It enables not only the
sharing of standardized methodologies and proficiency testing but also
a secure electronic reporting system for lab results. Four Federal Labs
and 18 existing State labs are currently under FSIS cooperative
agreements. Additionally, FSIS has cooperative agreements targeting
total of 25 State labs geographically located across the country. The
FERN laboratories will eventually be proficient to screen for the same
threat agents as Federal labs, some with capability to do confirmation
testing. FSIS primarily focuses on microbiological agents with our
partners at FDA focusing on chemical and radiological agents.
Another example of interagency coordination and collaboration by
FSIS is participation in the integrated consortium of lab networks
developed by DHS. This consortium ensures coordination among Federal
and State partners focused on both food and agriculture. The consortium
ensures consistency of methods development, reporting of lab results
and the sharing of lab results among all Federal and State partners.
The Agency has developed specific procedures on monitoring and
sampling to be taken depending on the threat level as determined by the
DHS. The appropriate testing is based on vulnerability or risk-based
assessments for selected domestic and imported food products, which
allows the Agency to rank food products and potential contaminating
agents in order of highest concern. The Agency's enhanced Consumer
Complaint Monitoring System (CCMS), a national surveillance system that
monitors food-related consumer complaints which will eventually be
integrated with other data systems, also assists in the Agency's
efforts to track potential attacks on the food supply.
FSIS' comprehensive and ongoing training and education efforts
ensure that every FSIS employee fully understands their role in
preventing, or responding to, an attack on the food supply. Food
defense awareness training is also conducted at locations nationwide
with State and local inspectors and in cooperation with other Federal
agencies. Training courses were also developed in conjunction with the
FDA; USDA's Food and Nutrition Services; and the Department of
Transportation (in development) to focus specifically on food defense
for each agency's respective workforce.
FSIS has created and distributed model food security plans that
meat, poultry and processed egg products facilities and import
establishments can use to develop and implement a Food Defense Plan.
These plans identify the types of preventive steps that establishments
might take to minimize food security risks for products under their
control. A simplified version of guidance on food defense plans was
developed in consultation with industry trade groups. This guidance
provides an easy three-step process which will result in a completed
food defense plan. The Agency has also held numerous workshops and
Webcasts on Food Defense Plans to reach out to as many small and very
small plant owners and operators as possible; Webcasts specifically
targeted to State officials; efforts to reach various targeted
audiences, such as Spanish speakers and various industry and trade
associations.
As it is widely understood that the response to most large-scale
food emergencies will be initiated at the State level, FSIS and FDA
have worked with the National Association of State Departments of
Agriculture (NASDA) to develop, test, and implement an emergency
response template.
FSIS continues to enhance readiness for a possible outbreak of
avian influenza. The agency's goal is to ensure that all appropriate
preparations are being made for the potential spread of the H5N1 strain
of the virus to the United States, whether in birds or in humans. FSIS
has also carried out a tabletop exercise on avian influenza with other
Federal and State agencies, as well as industry and consumer groups.
USDA is playing many important roles in this effort. The
Department's four-part approach to combating avian influenza includes
limiting the spread of the virus overseas through international
outreach. Second is educating the American public through a proactive
campaign to inform without causing alarm. Third is USDA's and the
Department of Interior's aggressive surveillance program in partnership
with States, which includes wild birds, live bird markets, backyard
flocks and thanks to the cooperation of industry--testing of commercial
flocks. The fourth aspect is to practice executing our response plan.
As you may know, USDA has a long and successful history of dealing with
highly pathogenic avian influenza.
It should be noted, of course, that detection in birds does not
signal the start of a human pandemic. This virus is not easily
transmitted from person to person. Most human illnesses that we've seen
overseas have resulted from direct contact with sick or dead birds. No
human illnesses have been attributed to properly handled and cooked
poultry. This is another area where FSIS and USDA have been actively
engaged with our partners in government, industry and the consumer
community to make sure concerns related to any possible pandemic are
addressed before that ever happens.
As part of its coordinated response plan with the Animal and Plant
Health Inspection Service (APHIS), the Agency has developed a product
testing protocol for detecting Highly Pathogenic Avian Influenza in
poultry meat. In should be stressed, however, that cooking poultry to
an internal temperature of 165 degrees kills all viruses and all other
foodborne pathogens, including avian influenza.
In fiscal year 2006, FSIS' activities better prepared the Agency
and its stakeholders to detect, respond, and recover from food-related
emergencies. In the area of food defense, FSIS conducted about
1,200,000 daily food defense verification procedures in FSIS-regulated
and State-inspected facilities. The Agency also conducted six tabletop
exercises with stakeholders and other local, State, and Federal
agencies to test and validate standard operating procedures and
directives for responding to non-routine (emergency) incidents. A total
of 15 tabletop exercises are planned, which will take into account all
50 states.
In April and May of this year, FSIS worked together closely with
FDA to respond to the discovery that some swine and poultry in the
human food supply chain had been fed animal feed supplemented with pet
food scraps that contained melamine and related compounds. FSIS and FDA
alerted the public and investigated the source and extent of the
situation. As soon as the situation arose, we also ensured that swine
and poultry on farms known to have received or suspected of receiving
contaminated feed that had tested positive for melamine and melamine-
related compounds were held under State quarantine or voluntarily by
the owners. After a risk assessment conducted by scientists from FSIS
and FDA, in consultation with scientists from CDC, the Environmental
Protection Agency and DHS, concluded the potential exposure to the
public, even in a highly unlikely worst-case scenario, was 250 times
lower than the dose considered safe and therefore well below any level
of public health concern, FSIS cleared the animals in question for
inspection and processing.
FSIS has also developed and implemented a series of FSIS directives
(two of which have been updated thus far in fiscal year 2007) for each
of the agency's eight program areas that prescribe how protective
measures defined by Homeland Security Presidential Directive 3,
Homeland Security Advisory System are to be implemented. Directive 3
established a threat advisory system to effectively communicate the
level of risk of a terrorist attack to the American people. It
prescribes that agencies develop appropriate ``Protective Measures'' in
response to each of the five threat levels established. The measures
developed by FSIS include active surveillance through a series of food
defense verification procedures performed daily in all FSIS-regulated
facilities, including import inspection facilities and in-distribution
facilities. Results of the verification procedures are reported to and
are analyzed by the agency. The results of the analysis direct outreach
and guidance initiatives and countermeasures development.
The Office of Management and Budget and the relevant food safety
agencies are collaborating on ways to most effectively address issues
raised in GAO's designation of Federal Oversight of Food Safety as a
high-risk item in February 2007.
USDA, the Department of Health and Human Services, and DHS are
working together to create a comprehensive food and agriculture policy
that will improve the government's ability to respond to dangers to the
food supply. For fiscal year 2008, the Agency has proposed a budget
which includes $31 million to further improve FSIS' ability to detect
and respond to intentional or accidental contamination of the food
supply.
While food defense is critical to our work, another threat to the
food supply is naturally-occurring pathogens. Our work identifying and
limiting pathogens in the food supply will also help mitigate
vulnerabilities in food defense.
In conclusion, Mr. Chairman and all Members of the Subcommittee, I
want to thank you again for this opportunity to explain the vital role
played by USDA and FSIS in protecting the nation's food supply. We take
pride in knowing that our nation's food safety and food defense system
for meat, poultry, and processed egg products is the best and safest in
the world. But we also realize that it is vital not to stand still but
instead to continue improving our nation's food safety and food defense
systems. We take this stand not only as public health professionals but
also as everyday Americans who ourselves rely on the results of what we
do. I am happy to answer any questions you may have.
FSIS FOOD Defense Mission and Initiatives
To prevent, prepared for, respond to, and recover from an
intentional attack on the food supply and large scale food-related
emergencies.
Consistent with HSPDs 5,7, and 9.
------------------------------------------------------------------------
Outreach and training to prepared -Security guidance materials
stakeholders to protect the food supply. for food processors,
transporters, &
distributors.
-Self assessment and food
defense plan tools for
industry, including
training.
-Food defense awareness
training for employees,
industry, and other Federal
and State government
agencies.
------------------------------------------------------------------------
Assessing Food System vulnerabilities for -Ten FSIS vulnerability
developing countermeasures. assessments conducted-
identified products, agents,
and nodes of highest
concern, as well as
countermeasures.
-Participate in Strategic
Partnership Program on
Agroterrorism (DHS, FBI,
FDA) to conduct
vulnerability assessments
(includes States & industry)
-Workshops for industry, G8
task force, & APEC economies
on methodologies to conduct
vulnerability assessments to
protect imports and exports.
Collaborated with FDA and
State Department on the
workshops for G8 countries
and APEC economies
------------------------------------------------------------------------
FSIS Food Defense Initiatives
------------------------------------------------------------------------
Developing countermeasures to mitigate -Coordinating with ARS,
vulnerabilities. CSREES, DHS on filing
research needs relating to
critical food defense data
gaps (e.g., detection
methods, feasibility, and
agent characterization
studies).
-Working directly with
industry and through DHS's
Sector Coordinating Council
to develop countermeasures.
------------------------------------------------------------------------
Conducting surveillance to identify -Daily testing of samples for
attack on the food supply. specified threat agents.
-Homeland security
directives--direct personnel
on what food defense
verification procedures to
perform on a daily basis in
federally-inspected
establishments and in
distribution. working with
industry to harden
infrastructure.
-Targeting illegal & high-
risk shipments with Customs
and Border Protection.
------------------------------------------------------------------------
Managing food defense & food safety -Created the Emergency
emergencies. Management Committee & a Non
Routine Incident Management
System for managing &
tracking non-routine
incidents.
-Conduct food defense
exercises with States,
industry, consumer groups, &
other federal agencies (eg;
FBI, DHS, FDA). 6 conducted
to date, 4 planned in FY07,
and 5 in FY08. Conducted and
A1 outbreak exercise in FY
06 and planning a Pandemic
exercise in FY 07.
-Guidance for industry on the
disposal of food products &
facility decontamination.
-Template for developing
State response plans for
food emergencies.
-Provide training on Incident
Command System and ESF 11
for key personnel.
------------------------------------------------------------------------
Ensuring Agency Continuity of Operations. -Conduct agency-wide COOP
exercises.
-SOPs to ensure critical
essential functions are
maintained.
-Established alternative
relocation sites, designated
essential personnel, and
identified vital records.
Developed All-Hazards, Avian
Influenza, & Human Pandemic
plans.
------------------------------------------------------------------------
Mr. Langevin. Thank you for your testimony, Dr. Maczka.
The chair now recognizes Dr. McGinn for 5 minutes to
summarize your statement.
STATEMENT OF TOM MCGINN, D.V.M, DIRECTOR, AGRICULTURE AND
VETERINARY DEFENSE, OFFICE OF HEALTH AFFAIRS, DHS
Dr. McGinn. Thank you, Mr. Chairman, and members of the
subcommittee. I appreciate the opportunity to talk to you today
about the safety of our national food system. My name is Dr.
Tom McGinn, and I serve as the Director of Food, Agriculture
and Veterinary Defense within the Department of Homeland
Security's Office of Health Affairs, which is led by the Acting
Assistant Secretary and Chief Medical Officer, Dr. Jeff Runge.
My job is to be the primary point of contact within DHS to
synchronize our food, agriculture and veterinary assets. One of
our responsibilities within the Office of Health Affairs is to
coordinate 30 programs within DHS that address some aspect of
food, agriculture and veterinary defense. I am pleased to
testify today with Dr. Acheson, with Carol and with Dan Baldwin
from Customs and Borders as well. These are valued friends and
colleagues.
FDA and USDA represent the sector-specific agencies with
the subject matter expertise and the legal authority for the
protection of the food in our country. Together with the
private sector and our State and local and academic partners,
who you will hear from later today, we all provide food defense
for the United States. Together we cultivate a complex,
effective set of resources that are becoming better known to
each of us and better able to be integrated into a National
Incident Management System.
I will highlight the following three areas: one, the
contribution of DHS to food defense; two, the Office of Health
Affairs' strategic plan to further implement HSPD-9; and three,
the way forward for food defense.
DHS's contribution to food defense: Food defense includes
activities beyond our borders and across our domestic food
supply chain, as well as in our homes. It involves everyone,
from the local ice cream shop to the most capable sector-
specific agencies of the Department of Health and Human
Services and the U.S. Department of Agriculture. The large
majority of incidences involving food issues are handled at the
private, State and local level, with the leadership of HHS and
USDA. DHS makes its resources available to instances involving
food when requested by Federal agencies or the President or
when multi-agency involvement requires the integration of
Federal, State and local resources to preserve the security of
our Nation. DHS also makes its resources available to its
Federal partners and to its Centers of Excellence to do
research in the area of threat. It makes its resources
available to States to build surge capacity to reduce the risk
to the food supply, and to train and exercise food defense
systems.
Secretary Chertoff created the Office of Health Affairs as
part of a reorganization on January 11th, 2007. Its mission is
to protect the health and security of the American people, and
the coordination and collaboration of the DHS components with
Federal, State and local partners and the private sector. With
specific reference to agroterrorism, the Secretary appointed
the chief medical officer to be the official accountable for
the implementation of the Department's responsibilities for
veterinary, food and ag security, and it includes the
coordination of the Department's responsibilities for the
implementation of HSPD-9, the defense of U.S. agriculture and
food.
Number two, in the area of post-harvest preparedness and
HSPD-9, the enormity and complexity of the food sector poses
substantial challenges to food defense and critical
infrastructure. These challenges include overlapping roles and
responsibilities among Federal departments and agencies, and
the Office of Management and Budget, but the relevant food
agencies are collaborating to address these issues. DHS brings
unique and complementary tools and expertise to bear, and such
tools as the National Security Risk Assessments and the
integration of surveillance. The Department of Agriculture and
FDA provides tools and expertise in the area of food and
agricultural critical infrastructures. The Food and Drug
Administration and USDA work closely with Customs and Border
Patrol on a day-to-day basis in imported food inspections and
laboratory analysis.
As a highlight, I would like to mention that these agencies
worked well together during the recent melamine incident, which
is consistent with the intention of HSPD-9. HSPD-9 was issued
to establish a national policy to defend the Nation's food and
agricultural systems against terrorist attacks, major disasters
and emergencies. DHS has 17 of the 21 tasks designated to us,
and we lead or co-lead in 12 of these tasks. The landscape of
food safety and defense is changing. Evolving risks include a
tremendous growth of imported food markets.
Federal and State regulatory programs, as well as
laboratories, are currently the backbone of our Nation's food
safety network. Threats to the food supply typically cross
State borders and have national implications. We need to be
diligent in coordinating planning involving the key
stakeholders, importantly including State and local authorities
and the private sector. Realistic exercises help to develop the
relationships, plans and preemptive tools we need to prevent,
mitigate and respond to food system events. An alignment of
resources at the interagency level with local, State and
national governments, with strong collaboration with the
private sector is, or needs to be, continually strengthened.
Number three, the way forward: We are focusing our efforts
more completely on resilience within the food chain. DHS is
currently studying key components of the Nation's food chain in
partnership with the FBI, USDA and FDA in programs with the
industries and the States to better understand the
vulnerabilities of 50 major food and agricultural commodities.
The challenge is sharing this information in an appropriate
manner with all relevant stakeholders. FDA has a great example
of a Web-based tool as a first step. Another tremendous first
step----
Mr. Langevin. Dr. McGinn, if you could summarize your
statement. We are way over the 5 minutes.
Dr. McGinn. Okay. Thank you. In summary, a more resilient
food infrastructure is a most important way to build resilient
communities. The recent Mayor of Gulfport said that a simple
way of building resiliency is the restoration of a favorite
restaurant. It gives a place for his people to rest in a
tragedy, such as in recent hurricanes, and spend a few minutes
outside of a familiar place with familiar food, and finding
confidence that the rest of his community will be restored. He
clearly understood that food system resilience is part of
community resilience.
Mr. Chairman, I will stop with those comments, and I will
be happy to entertain any questions as we go forward. Thank
you.
[The statement of Dr. McGinn follows:]
Prepared Statement for Dr. Tom McGinn, DVM
INTRODUCTION
Mr. Chairman and Members of the Subcommittee, thank you for this
opportunity to talk with you about the safety, and in particular the
post-harvest defense, of our food supply. The United States has not
only the most bountiful food production capacity in the world, but it
is among the safest as well. Safety is not an inherent quality of U.S.
food production--it takes continual dedication to ensure the safety and
security of the food supply. I appreciate the chance to highlight the
contributions of the Department of Homeland Security (DHS) to Food,
Agriculture and Veterinary (FAV) Defense. I will also discuss the role
that DHS played in the recent pet food contamination incident as
demonstration of the diversity of DHS programs. Finally, I will discuss
the Office of Health Affairs' (OHA) strategic plan to further implement
Homeland Security Presidential Directive 9 (HSPD-9) along with state
and local governments and the private sector. Importantly, managing any
event will not be a federal issue alone. Success in the realm of food
safety and defense will depend upon coordination among states, local
and private entities, and national programs that utilize our Nation's
resources effectively.
DHS OFFICE OF HEALTH AFFAIRS (OHA)
Secretary Chertoff created the Office of Health Affairs as part of
the departmental reorganization on January 18, 2007 in response to P.L.
109-295 '516. OHA was created to protect the health and security of the
American people in coordination and collaboration with other DHS
components, federal, state and local partners, and the private sector.
Responsibilities and activities of OHA do not duplicate or supplant
activities currently being provided by other components of DHS or the
departments and agencies of the Executive Branch. The Chief Medical
Officer (CMO) has the following responsibilities:
To serve as the Secretary's principal medical and
veterinary authority for DHS;
To coordinate DHS biodefense activities, to include
policy, planning, strategy, requirements, operational programs
and metrics;
To ensure internal/external coordination of DHS'
medical [including veterinary] preparedness and response
activities;
To serve as the primary DHS point of contact for
federal/state/local/tribal governments and the private sector
on medical [including veterinary] and public health issues; and
To discharge DHS' responsibilities under Project
BioShield, in coordination with the Science and Technology
(S&T) Directorate.
The Department serves as the integrator of federal, state and local
resources that are needed to preserve the security of the Nation. With
specific reference to agroterrorism preparedness, in a memo dated March
28, 2007, Secretary Chertoff designated OHA's Assistant Secretary and
Chief Medical Officer as the DHS official accountable ``for the
implementation of the Department's responsibilities of veterinary, food
and agriculture security. . .[who] will also coordinate the
Department's responsibilities for implementation of Homeland Security
Presidential Directive 9, Defense of the United States Agriculture and
Food.''
Within OHA, I serve as the Director of Food, Agriculture and
Veterinary (FAV) Defense. FAV goals are to ensure that the food and
agriculture sectors are actualized as Critical Infrastructure;
understand and strengthen public confidence in food protection through
assessment and enhancement; ensure critical stakeholders are
functionally aligned; and assist all DHS Food, Agriculture and
Veterinary programs in attaining operational capability. OHA/FAV
Defense activities are working to foster efficiency and effectiveness
across DHS regarding food, agricultural and veterinary defense.
HSPD-9, Defense of United States Agriculture and Food, was issued
to establish a national policy to defend the nation's agriculture and
food systems against terrorist attacks, major disasters, and other
emergencies. HSPD-7, Critical Infrastructure Identification,
Prioritization and Protection, identifies DHS as ``responsible for
coordinating the overall national effort to enhance the protection of
the critical infrastructure and key resources of the United States,''
and recognizes the DHS Secretary as ``the principal federal official to
lead, integrate and coordinate implementation of efforts.'' HSPD-9
assigns to the DHS Secretary tasks in this area that are specific to
the defense of food and agriculture. These tasks include mitigation of
vulnerabilities in food, agriculture and water systems, as well as
developing robust biological threat awareness capacity. Of the 21 tasks
for which DHS has been designated some degree of responsibility, we
have the lead for 12. Those 12 activities fall under the following five
pillars:
(1) Awareness and Warning--Includes intelligence operations and
biological threat assessment and analysis activities
(2) Vulnerability Assessments--DHS, in coordination with USDA
and HHS, is to conduct comprehensive studies to determine the
nation's vulnerability to a wide variety of foodborne pathogens
and adulterants
(3) Mitigation Strategies--DHS will aid in prioritizing,
developing and implementing, as appropriate, mitigation
strategies and shall build upon existing efforts to expand
development of screening and inspection procedures at the
borders
(4) Response Planning & Recovery--Includes activities involving
local response capabilities and coordinated response planning
(5) Outreach and Development--Includes information sharing and
analysis mechanisms, specialized training in agriculture and
food protection, continued development and research for
countermeasures against introduction of animal/plant diseases,
plans to provide biocontainment labs for researching
capabilities and establishing university-based Centers of
Excellence.
All five pillars, in fact, are being undertaken across all sectors,
in collaboration with all Federal agencies.
THE PET FOOD CONTAMINATION INCIDENT
Approximately sixty percent of American households contain pets.
Early this year, the U.S. government became aware that high levels of
low-grade melamine, which contained not just pure melamine, but
additional melamine analogues, were intentionally added to products
labeled as ``wheat gluten'' and ``rice protein concentrate.'' These
products were imported from China into the U.S. and subsequently
incorporated into many pet food products. In addition, certain salvaged
pet food products that were melamine contaminated were unknowingly fed
to some food producing animals. This combination of contaminants was
not detected until it was learned that certain pet foods were sickening
and killing cats and dogs. In addition to the illness and death burden,
many lessons observed were highlighted by this incident are also being
addressed.
Contaminated ``wheat gluten'' and ``rice protein concentrate'' were
imported into the United States in the fall of 2006. Menu Foods, the
producer and distributor of many brands of pet foods nationally and
internationally, became aware of reports of illness and death in pets
and began recalling certain brands of pet food in March 2007. Chinese
sources admitted to intentionally adding melamine to increase nitrogen
content in rice products and wheat gluten, which falsely elevated
protein measurements. In addition to pet food products, melamine-laced
feedstuffs were also fed to production animals in the U.S. These
animals could have entered the human food chain. Compounds fed to food-
producing animals may, through tissue adulterant residues, make it into
the human food chain. An interagency risk assessment considered the
risk to humans from melamine-contaminated products fed to food
producing animals and concluded that this was very unlikely to cause
harm to humans.
While more research is needed on the exact cause of the illnesses
in cats and dogs, this melamine event demonstrated a potentially
significant vulnerability to the human food supply due to the global
nature of our food and agricultural systems.
COLLABORATION AMONG DHS ENTITIES
OHA worked to organize the Department's various components soon
after the pet food contamination incident began. Initial meetings
generated a comprehensive list of capabilities that each component
could leverage to respond to this incident. It also identified methods
of sharing timely information. As the situation evolved and the true
scope emerged, an Interagency Working Group (IAG) met at the DHS
National Operations Center. The IAG established the process for a
national-level Situational Report (SITREP), as well as the
corresponding flow of information. OHA took the lead in forming the IAG
and worked with the Operations Directorate to produce and disseminate
the SITREP.
Heretofore, DHS had not established a formalized process for
reporting on issues such as a food contamination event. The National
Biosurveillance Group (NBSG), composed of the National Biosurveillance
Integration System (NBIS) member Federal agencies, developed and
implemented a formalized process. This was accomplished by coordinating
information flow among DHS, the components and headquarters of
Department of Health and Human Services (DHHS), and USDA, as well as
other affected DHS entities. The efforts of other DHS offices assisted
in the coordinated response. These efforts are summarized below:
Customs and Border Protection (CBP)--CBP used its FDA-coordinated,
automated systems and laboratory analytic capabilities to identify,
target, sample and test additional incoming shipments of wheat, corn,
and rice glutens for the presence of melamine. During the enforcement
operation, CBP tested samples of products from 23 countries shipped by
suppliers and producers that account for over 59 percent of the
imported volume of the merchandise in the previous 12-month period.
That contributed to a greater degree of assurance that products coming
into the U.S. were free of the contamination and that the melamine
issue was isolated to a few Chinese producers.
National Protection & Programs Directorate (NPPD)--The Homeland
Infrastructure Threat & Risk Analysis Center (HITRAC) is a shared
program between NPPD and the Office of Intelligence and Analysis.
HITRAC monitored intelligence and related infrastructure information
from open sources and classified reporting. HITRAC shared this
information with the members of the IAG for use in their analysis.
Science and Technology (S&T)--The S&T National Science, Technology
and Threat Awareness Reachback (NSTTAR) service provided real time,
technical information and analysis reachback capability. This was
provided to the homeland security community for anticipating,
evaluating and responding to foodborne threats. NSTTAR, the Biodefense
Knowledge Center, the Chemical Security Analysis Center located at the
US Army facility in Edgewood, MD and the Department Of Energy Field
Intelligence Establishment (intelligence division) were all called upon
for technical and threat support relating to melamine toxicity,
contamination paths, effects in food chains, production sites and the
potential for intentional misuse. The National Center for Food
Protection & Defense, one of the DHS Centers of Excellence, prepared
and provided a continuous assessment of the situation. The assessment
included potential impact on the domestic food chain, international
trade, and public confidence. It also addressed the incident relative
to the overall trade situation with China and an on-going timeline of
events.
COLLABORATION AMONG FEDERAL ENTITIES
As a result of the pet food contamination incident, DHS/OHA
fostered senior level engagement to enhance partnerships in homeland
security. DHS brought unique and complementary tools and expertise to
bear, such as tools for national security risk assessment and
investment. Other agencies, such as the Department of Agriculture and
the Food and Drug Administration, provided tools and expertise
regarding the Food and Agriculture Critical Infrastructure. The Food
and Drug Administration also worked closely with CBP on a day-to-day
basis in food inspections and laboratory analysis. In addition, OMB and
the relevant food safety agencies are collaborating on ways to most
effectively address issues raised in GAO's designation of Federal
Oversight of Food Safety as a high-risk item in February 2007.
Another point of synergy was the overall public communication
effort. The huge volume of information requests generated by
governmental and private sources was handled through interagency press
conferences. During one such call, nearly 200 members of the press
participated. The government presented a common access point for
information--questions, concerns, and suggestions.
AREAS OF FUTURE ENGAGEMENT
In a recent report by the DHS Office of the Inspector General
(OIG), four main limitations in the Department's food defense and
security efforts were identified. First, DHS must improve internal
coordination. Second, DHS needs to engage its public and private food
sector partners more effectively. Third, DHS could do more to
prioritize resources and activities based on risk. Finally, DHS must
fully discharge its food sector responsibilities.
In response to the OIG report, our Chief Medical Officer has the
responsibility for food and agriculture efforts including:
Working to ensure collaboration with the Food
Information Sharing and Analysis Center (ISAC)
Seeking improvement in DHS' relationship with food
sector partners
Expanding national infrastructure coordinating center
outreach efforts
Evaluating the feasibility of providing financial
support and/or facilitating the detailing of state or local
government and private sector representatives to OHA and NPPD
Developing and maintaining a DHS report on sector
research and development initiatives
Expediting the review of existing food sector
assessments
Expanding food sector modeling
Evaluating the integration of additional federal
foodborne illness reporting, surveillance and detection systems
Continuing to develop and disseminate information
about food subsystem specific operational protective measures
and best practices with FDA and USDA
Areas the OIG identified that are still in need of attention
include:
Developing a grant process to support non-urban,
multi-jurisdictional preparedness
Working with DHHS and USDA to prepare integrated food
defense budget for fiscal year 2009
Considering collaboration of food-specific criteria
and guidelines for Customs--Trade Partnership Against Terrorism
with food industry with USDA/FDA
Studying the integration of food defense awareness
into transportation security and considering additional
research to improve the security of food in transit
Expanding efforts to sponsor food contamination event
exercises with an emphasis on exercises spanning multiple state
and local jurisdictions
COLLABORATION WITH THE PUBLIC AND PRIVATE SECTORS
The landscape of food safety and defense is changing. Evolving
risks include the tremendous growth of imported food markets from
countries that have limited regulatory oversight. Federal and state
regulatory programs and laboratories are currently the backbone of the
nation's food safety network. However, threats to the food supply
typically cross state borders and have national implications.
A concerted communication strategy for these types of operations is
essential, and falls within the purview of DHS. Additionally,
information flow is typically much faster than anticipated, frequently
outpaces the ability to analyze and interpret, and comes in from
various sources. Frequently, information is made available to the
private sector before the government is informed. DHS is building the
mechanism through its National Operations Center (NOC), the National
Biosurveillance Integration Center (NBIC) and the National
Infrastructure Coordination Center (NICC) to gather and analyze such
information in real time. DHS is forming partnerships with members of
the food sector and its academic centers of excellence to improve
information sharing and mutual awareness.
CONCLUSION
The food chain infrastructure is rapidly globalizing, which demands
a commensurate improvement in our preparedness posture. This
globalization, manifested by both the vertical integration of certain
commodity groups such as poultry and grain, and the seemingly opposite
phenomenon of `subcontracting' various pieces of common production
processes (as in the pet food contamination incident), outlines why it
is so important that our planning efforts be comprehensive and all-
inclusive of intelligence, disciplined information sharing with states
and local governments and the private sector, coordinated incident
management, and maintenance of public confidence.
Mr. Chairman, thank you for the opportunity to address the
Subcommittee. I look forward to continuing my working relationship with
you, and I am happy to address any questions or concerns that may arise
regarding this topic.
Mr. Langevin. Thank you, Dr. McGinn.
The chair now recognizes Mr. Baldwin, to summarize your
statement for 5 minutes.
STATEMENT OF DAN BALDWIN, ASSISTANT COMMISSIONER, OFFICE OF
INTERNATIONAL TRADE, U.S. CUSTOMS AND BORDER PATROL
Mr. Baldwin. Thank you, Mr. Chairman, members of the
subcommittee. I am pleased to appear before you today to
discuss the actions we are taking at Customs and Border
Protection to ensure the safety of imported food.
My name is Daniel Baldwin, and I am the Assistant
Commissioner in the Office of International Trade at U.S.
Customs and Border Protection. My office holds the
responsibility of formulating CBP's trade policy, developing
programs and enforcing the U.S. import laws. The food and
agriculture industry contributes significantly to the United
States' economy. And as the value and complexity of our food
imports continues to grow, CBP recognizes the challenges we
face to maintain a safe and secure food supply.
CBP has taken great strides towards securing America's
borders, including the protection of our food supply, and the
economic health of American agriculture. Since September 11th,
2001, CBP's primary mission has to be to secure the Nation's
borders from terrorists and terrorist weapons, while
facilitating the flow of legitimate travel and trade. In
support of this mission, CBP has designed strategies to manage
the risk of an agricultural product contamination that may
cause harm to the American public or damage the Nation's
economy. CBP has worked extensively to coordinate activities
and enforcement actions with USDA and HHS. As the guardian of
our Nation's borders, CBP has broad authority to interdict
imports of food and agriculture products at the ports of entry.
We frequently interact with FSIS and FDA on questions regarding
enforcement actions, as those agencies house the subject matter
expertise on food and agriculture admissibility.
CBP is able to rely on the statutory authority of other
Federal agencies, with the specific mandate of enforcing food
safety regulations to finalize enforcement actions on those
food safety issues. As with our approach to antiterrorism, CBP
has taken a multi-layered approach to protect the safety of
America's food imports.
In my testimony today, I would like to highlight the three
key aspects that CBP has utilized in its effort to date: CBP's
National Trade Strategy, CBP targeting methodologies, and CBP
personnel. After briefly discussing these three topics, I can
highlight some of our experiences with these food safety
operations.
Pursuant to our twin goals of fostering legitimate trade
and travel while securing America's borders, CBP has developed
a National Trade Strategy to help our agencies successfully
fulfill our trade facilitation and trade enforcement mandate.
Our National Trade Strategy is based upon six Priority Trade
Initiatives. These PTIs are antidumping and countervailing duty
protection; intellectual property rights enforcement; textile
and wearing apparel enforcement; revenue protection; punitive
actions; and of course, agriculture and food safety. Under the
terms of our Trade Priority Strategy, we focus CBP resources in
our efforts to address these key areas of trade. I would like
the committee to know that agriculture is one of our key six
priority issues.
The goals of our National Agriculture Strategy are, first,
to detect and interdict any instances of agro and bioterrorism;
second, to detect and prevent unintentional introduction of
pests or diseases into the United States; third, to detect and
prevent unintentional introduction of adulterated, contaminated
or unsafe agriculture and food products; and fourth, to promote
our Nation's economic security through the enforcement of these
trade laws. To support this national strategy, CBP employs
several robust targeting methodologies, ensuring the compliance
and safety of our food and agriculture products imported into
the United States.
CBP, in coordination with FSIS and FDA, utilizes the
following mechanisms to ensure safety of the American food
supply. First, our Automated Targeting System, which is based
on various algorithms and rules, and is a flexible, constantly
evolving targeting system that integrates enforcement and
commercial databases. ATS is essential to CBP's ability to
target high-risk cargo entering the United States based upon
advance manifest information. Another system CBP uses is our
Automated Manifest System, which provides us with the advance
cargo information, to be used for targeting and screening of
all imported merchandise. We utilize AMS to ensure appropriate
coordination with other regulating agencies. And finally, the
Automated Commercial System, ACS, CBP's automated system of
record for entry processing and cargo clearance allows us to
screen for additional food and agriculture risks.
I would also like the committee to know, the majority of
the targeting criteria present in the system today are intended
to prevent the introduction of contamination, pests or disease.
Approximately 87 percent of the criteria used in our ACS
systems are agriculture related.
In addition to these CBP systems, CBP also maintains the
National Targeting Center. The NTC is the facility at which
personnel from several separate government agencies are co-
located to review advance cargo information on all inbound
shipments. Personnel from CBP, FDA, FSIS, APHIS, are all
stationed at the NTC.
In addition to the sophisticated targeting systems and
coordination between the agencies, CBP maintains a diverse
workforce that is specially trained to detect and prevent
imports that may be harmful to the health of the American
public. CBP officers and CBP agriculture specialists receive
specific training on ag/bioterror incidents. We currently have
the ability to rapidly deploy more than 18,000 CBP officers,
2,000 agriculture specialists and 1,000 import specialists in
response to emerging threats to our agriculture and food
supply. Furthermore, CBP's Laboratory and Scientific Services
maintains eight separate laboratories around the country, with
a 24/7 technical reachback center.
While we have found various examples recently where we have
coordinated with FDA and HHS and DHS along the lines of
melamine, toothpaste, seafood imports, we are finding that that
level of cooperation has been very important in ensuring the
safety of our Nation's food supply. Food defense and food
safety concerns will only increase as world trade in food and
agriculture continues to grow and diversify. CBP will continue
to approach this as a challenge worthy of a combined government
effort. We will continue to partner with other Federal agencies
in order to refine our targeting skills and ensure the
prevention of contaminated products entering the United States.
Thank you, Mr. Chairman, ranking member, other members of
committee for this opportunity to testify today, and I would be
happy to answer any of your questions.
[The statement of Mr. Baldwin follows:]
Prepared Statement of Daniel Baldwin
INTRODUCTION
Mr. Chairman and members of the Subcommittee, I am pleased to
appear before you today to discuss the actions we are taking at Customs
and Border Protection (CBP) to ensure the safety of imported food. My
name is Dan Baldwin and I am the Assistant Commissioner in the Office
of International Trade at U.S. Customs and Border Protection. My office
holds the responsibility of formulating CBP's trade policy, developing
programs, and enforcing U.S. import laws. The food and agriculture
industry contributes significantly to the United States economy. As the
value and complexity of our food imports continues to grow, CBP
recognizes the challenges we face to maintain a safe and secure food
supply. To meet this challenge, OMB and the relevant food safety
agencies are collaborating on ways to most effectively address issues
raised in GAO's designation of Federal Oversight of Food Safety as a
high-risk item in February 2007.
CBP has taken great strides toward securing America's borders,
including the protection of our food supply and the economic health of
American agriculture. Since September 11, 2001, CBP's priority mission
has been to secure the nation's borders from terrorists and terrorist
weapons while facilitating the flow of legitimate travel and trade. In
support of this mission, CBP has designed strategies to manage the risk
of an agricultural product contamination that may cause harm to the
American public or damage to the nation's economy.
CBP has worked extensively to coordinate activities and enforcement
actions with USDA and HHS, and in particular the FDA. As the guardian
of our nation's borders, CBP has broad authority to interdict imports
of food and agricultural products at the Port of Entry. We frequently
interact with USDA and FDA on questions regarding enforcement action,
as those departments house the subject matter expertise on food and
agriculture admissibility standards. CBP is able to rely on the
statutory authority of other federal agencies with the specific mandate
of enforcing food safety regulations to finalize enforcement actions on
food safety issues.
CBP'S CURRENT ENFORCEMENT STRATEGY
As with our approach to anti-terrorism, CBP has taken a multi-
layered approach to protect the safety of America's food imports. In my
testimony today, I would like to highlight the three key aspects that
CBP has utilized in its efforts to date: CBP's National Trade Strategy,
CBP Targeting, and CBP Personnel. After briefly discussing these three
topics, I will discuss our experience with food safety operations.
NATIONAL TRADE STRATEGY: AGRICULTURE ESTABLISHED AS PRIORITY TRADE
INITIATIVE
Pursuant to our twin goals of fostering legitimate trade and travel
while securing America's borders, CBP has developed a National Trade
Strategy to help our agency successfully fulfill our trade facilitation
and trade enforcement mandate. Our National Trade Strategy is based
upon six Priority Trade Initiatives (PTI), these PTI's are: Antidumping
and Countervailing Duty, Intellectual Property Rights, Textiles and
Wearing Apparel, Revenue, Agriculture, and Penalties. Under the terms
of our trade prioritization strategy we focus CBP resources in our
efforts to address areas of key trade importance. I would like the
committee to note that Agriculture is one of our six PTIs.
The goals of the agriculture trade strategy include:
(1) The detection and prevention of agro-terrorism and bio-
terrorism, i.e., the intentional contamination of an
agricultural product or food, or the intentional introduction
of diseases or pests intended to cause harm to the American
public, American agriculture, or the nation's economy.
(2) The detection and prevention of the unintentional
introduction into the United States of pests or diseases that
would cause harm to the American public, American agriculture,
or the nation's economy.
(3) The detection and prevention of the unintentional
introduction of adulterated, contaminated, or unsafe
agricultural and food products into the United States that
would cause harm to the American public, American agriculture,
or the nation's economy.
(4) The promotion of our nation's economic security through the
facilitation of lawful international trade and enforcement of
regulatory trade laws.
TARGETING
CBP uses various targeting mechanisms to ensure the compliance and
safety of food and agricultural products imported into the U.S. These
mechanisms are specifically designed to incorporate the food safety
concerns of USDA and HHS.
One of the systems used is our Automated Targeting System (ATS).
ATS, which is based on algorithms and rules, is a flexible, constantly
evolving system that integrates enforcement and commercial databases.
ATS is essential to CBP's ability to target high-risk cargo entering
the United States. ATS is the system through which we process advance
manifest information to detect anomalies and ``red flags,'' and
determine which cargo is ``high risk'' and should be scrutinized at the
port of arrival.
Another system CBP uses is the Automated Manifest System, which
provides us with advanced cargo information to be used for targeting
and screening of all imported merchandise. This advance information
allows CBP to identify shipments of interest in advance of arrival. By
identifying shipments in advance, CBP is better able to focus resources
on those shipments which may be of concern, prevent their introduction
into the commerce, and ensure appropriate coordination with other
regulatory agencies.
The Automated Commercial System (ACS), CBP's automated system of
record for entry processing and cargo clearance, allows us to screen
for additional food and agricultural risks. The majority of the
targeting criteria present in this system are used to prevent the
introduction of contamination, pests, or diseases. Approximately 87% of
the cargo criteria in ACS are agriculture related.
In addition to these CBP automated systems, CBP maintains the
National Targeting Center (NTC). The NTC is the facility at which
personnel from several separate government agencies are co-located to
review advanced cargo information on all inbound shipments. At the NTC,
CBP personnel are able to quickly coordinate with personnel from other
federal agencies such as the FDA, Food Safety and Inspection Service
(FSIS), and Animal Plant Health Inspection Service (APHIS) to target
high risk food shipments
Furthermore, the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (BTA) authorized FDA to receive
prior information to target shipments of food for human or animal
consumption prior to arrival. The BTA gave CBP the opportunity to
assist FDA with the prior notice requirements. CBP worked in concert
with FDA to augment an existing automated interface to institute a
prior-notice reporting requirement with minimal disruption to the
trade. In addition, under the BTA, we worked with FDA to commission
over 8,000 CBP officers to take action on behalf of the FDA. This
commissioning allows FDA to assert a 24/7 presence to enforce the Act
at all ports.
PERSONNEL
In addition to sophisticated targeting systems and coordination
between agencies, CBP maintains a diverse workforce that is specially
trained to detect and prevent imports that may be harmful to the health
of the American public. CBP Officers and CBP Agriculture Specialists
receive specific training on ag/bio-terror incidents. We currently have
the ability to deploy more than 18,000 CBP Officers, 2,000 Agricultural
Specialists, and 1,000 Import Specialists in response to emerging
threats to our agriculture and food supply. Furthermore, CBP's
Laboratory and Scientific Services (LSS) maintains seven separate
laboratories around the country, with a 24/7 technical reach back
center. LSS employs approximately 220 chemists, biologists, engineers,
and forensic scientists.
Our diverse workforce enables CBP to mount rapid and effective
responses to protect U.S. agricultural resources by utilizing the
specialized training of CBP Officers, Agriculture Specialists, Import
Specialists, International Trade Specialists, and Laboratory
Technicians. Each of these CBP occupations works together to gather
intelligence, establish target criteria, gather and test samples, and
analyze and report results. Because of their specialized training in
the use of personal protective equipment for handling potentially
hazardous or infectious materials, CBP Agriculture Specialists play a
vital role during food safety operations.
FOOD SAFETY OPERATIONS
Trade analysis and targeting methodologies designed to ensure the
safety of the food supply allow CBP to proactively identify shipments
containing possible food contamination prior to its arrival. This
targeting allows us to fulfill our mission while allowing us to
facilitate legitimate trade.
While food safety has recently grown in importance in the public
eye, CBP has been involved in food safety related initiatives for the
past several years.
In 2006, CBP was involved in the detection of numerous incidents of
food contamination or smuggling of prohibited food products from China.
A significant number of shipments of Chinese poultry products were
seized including 45 containers smuggling prohibited product. CBP
developed a food safety operation to combat the smuggling by targeting
known smugglers of prohibited poultry products.
In April 2007, it was discovered that food from China was
contaminated with melamine potentially harmful to animals as well as
humans. CBP initiated a special operation to determine the scope of the
potential problem. The nature of the operation was to augment FDA's
focus with the intention to assess the risk of contamination from
countries worldwide and to identify possible transshipment of Chinese
product. CBP sampled and conducted laboratory analysis, the results of
which were coordinated with FDA.
In this most recent action, CBP targeted and detained 928 entries
(shipments) over a four-week period. Samples were pulled on 202
entries, comprising over 400 separate production lot samples, and sent
to CBP's laboratories for analysis. All samples tested negative for the
presence of melamine. As a result of the operation, CBP tested samples
of product from 23 countries and shipped by suppliers/producers that
account for over 59% of the imported volume of the merchandise in the
previous 12-month period. This scientific data gives the government and
the public assurance that the melamine issue relating to imports was in
fact isolated to a few Chinese suppliers, and not a widespread, global
problem. In coordination with FDA, CBP developed a follow-up monitoring
program that uses a computer-generated statistical sample to measure
ongoing compliance.
This high profile enforcement effort has helped CBP refine its
methodology to conduct future food safety operations and enhance our
working relationship with other federal agencies. In response, CBP has
developed a Concept of Operations Document for food safety to
institutionalize our communication and cooperation as well as the
methods, processes, and procedures. Additionally, this food safety
incident has brought to the forefront the need to maximize the power of
the government to respond to future food safety issues.
As you are well aware, there have been further contamination
issues, for example, with imported toothpaste and selected seafood.
Based on lessons learned from the melamine incident, we are
coordinating with FDA to develop an appropriate action plan
commensurate with the threat.
CONCLUSION
Food defense and food safety concerns will only increase as world
trade in food and agriculture continues to grow and diversify. One of
the methods CBP will use to ensure the safety of the food supply is to
use statistical sampling to monitor for compliance. CBP will continue
to approach this as a challenge worthy of a combined government effort.
We will continue to partner with other federal agencies in order to
refine our targeting skills and ensure the prevention of contaminated
products from entering the U.S.
Mr. Langevin. Thank you, Mr. Baldwin. I want to thank the
witnesses for their testimony. I will remind each member, he or
she will have 5 minutes to question the panel.
And I now recognize myself for questions. I think the one
thing that is on everyone's mind today is, how secure are we in
terms of preventing what happened in terms of contaminated food
and products coming out of China entering the food supply
again? Are we there yet to ensure that it can't happen again?
So my question is, what efforts are underway to ensure that the
Chinese don't continue to intentionally add melamine or other
dangerous products to their exports? What is the U.S. doing to
sanction China? And what does HHS expect yet out of its meeting
with China at the end of the month? Pose that to the panel.
Dr. Acheson. This is David Acheson of FDA. Maybe I could
take the first shot at that, since you specifically addressed
HHS. Since the melamine issue, and in fact before that in
relation to a number of technical issues, we have worked very
closely with Chinese authorities to try to address specific
food safety concerns. Clearly, the melamine situation was
something that we did not predict. Since that has happened,
there has been an ongoing, and continues to be, close dialogue
with Chinese authorities to address this problem, to deal with
it.
I think we have to accept that their food safety system,
the Chinese food safety system, is not the same as that in the
United States. It is a rapidly expanding economy. They are
exporting a lot of food to the United States. And we have to
work with the government and build systems to essentially
address that challenge. To that end, there are ongoing meetings
with Chinese government officials. There will be one occurring
at the end of this month. There will be another one in August.
There is a further one planned for September. All towards
trying to develop a memorandum of understanding that will focus
on how to address these problems.
Mr. Langevin. Do you see them moving aggressively to
mitigate these problems to ensure that it is not going to
happen again?
Dr. Acheson. I think, within the capacity of the Chinese
government to attain those goals, yes. I think they are very
committed to try to prevent it. But as I said, they are dealing
with a very fragmented system. So one of the things they are
trying to put in place, I think very deliberately, is a system
of certification or authorization that will ensure that
products that are exported do meet a certain level of safety
and security to ensure that they won't harm American consumers.
Mr. Langevin. And since we can't rely necessarily on the
Chinese to fully solve this problem because the system is so
fragmented, then what are we doing to step up our efforts? Are
we there yet to ensure that the food coming in or product
coming into the United States is secure?
Dr. Acheson. Well, again, we are obviously focusing on the
areas that are of the greatest concern. Using a risk-based
strategy, we focused on testing products that we had concerns
about, either historically or because of human illness. That
was what led to the recent announcement of the import alert in
relation to aquacultured fish of five different species related
to the use of specific drugs. And as you know, there is now in
place a hold so that we have to test that material.
Clearly, the melamine and wheat gluten was something that
we weren't anticipating. We learn from these things constantly
and are, as we move forward, trying to focus our strategies
based on risk. Ultimately, where we need to take this, though,
however, is to focus it on prevention. We need to prevent these
problems from happening in the first place, as opposed to
reacting when they do.
Mr. Langevin. I agree.
Dr. Maczka?
Ms. Maczka. Well, I think FSIS does have a very robust
import system where we are able to ensure the safety of food
coming into the United States. It involves an initial
determination of a country's equivalence to our systems. It
also involves on-site audits and then reinspection of all
products coming into the United States. If something were to go
wrong with a particular product, we can increase audits in a
country. We can step up reinspection of products coming into
our country. We also, one of the things that we are working on
collectively together here with Customs and Border Protection,
DHS and FDA and the Centers of Excellence is a study on
melamine and other pathways that can be used for economic
adulteration, and so that we can put protective measures in
place.
Mr. Langevin. Thank you.
Dr. McGinn?
Dr. McGinn. We are stronger and more secure than we have
ever been in our food supply, yet incidences like melamine give
us an opportunity to get even stronger. Since this incident,
our Center of Excellence you will hear from this afternoon has
been looking extensively at food imports from China, and doing
that in collaboration with USDA and FDA and Customs and
Borders, as well as the intelligence community. So we are
actually doing a review of the imported foods to see what
additional concerns there are. We are certainly going to be
able to make those available to you.
Mr. Langevin. Thank you.
And Mr. Baldwin?
Mr. Baldwin. Very quickly, just to echo the comments made
earlier, I think we do have the safest food supply security
system in the world. And targeting and intelligence gathering,
I think, is one of the key components, so that even when you do
detect an incident like this, that we are able to have a
concept of operations in place how to deploy, how to proceed so
we can mitigate any of these circumstances and anticipate any
future developments.
Mr. Langevin. I thank the panel.
The chair now recognizes the ranking member, Mr. McCaul,
the gentleman from Texas, for 5 minutes.
Mr. McCaul. I thank the chair. Just as a follow-up on the
food imports from China, particularly the seafood, and maybe
Dr. Acheson, you are the expert to address this. How confident
are you that these imports coming into the country now from
China, as I understand they have not been banned, what is your
comfort level that there is no contamination, particularly
given the fact that one of the certifying labs that qualifies
to certify that it is not contaminated is actually from China?
Dr. Acheson. FDA is very comfortable that those five fish
that we have the import alert are essentially being held. You
are correct in saying that it is not a ban. It is not intended
to be a ban. What it is intended to be is a hold at the port of
entry in some way, or in some holding situation, preventing it
from going into commerce until FDA has seen clear evidence that
the fish does not contain any of the antimicrobial agents that
we have concern about.
Now you point out, what can we do if we don't believe the
lab results? Well, we can check the lab results. We can test it
ourselves. We can ensure that the samples were taken correctly,
that the assays were done correctly, that the controls were
done correctly by reviewing the paperwork. And if we are not
comfortable, it doesn't proceed.
Mr. McCaul. You said, you can test it yourselves. I mean,
do you?
Dr. Acheson. We have certainly done that. We challenge
things on a regular basis in terms of--I mean, import alerts
are not new. We have been doing them for years. And we have
many out there.
Mr. McCaul. Let me just say, let's say it is certified in
China that it is not contaminated. It comes to our country. Do
you have any systems to perhaps do any sampling to ensure that
this food is safe coming into the United States?
Dr. Acheson. Yes, indeed, we do. We undertake sample
assignments on top of import alerts. To give you a case in
point, several years ago, we had problems with cantaloupe from
Mexico. There was a countrywide import alert, much like China.
We worked with the government of Mexico to fix it. Once the
country was coming off the import alert, we continued to test
cantaloupe. It was fine for a couple years. We then found a
problem, and we worked with the government again to fix it. So,
yes, simply the import alert is not it. We will continue to
follow-up, and we will continue to test, and we will continue
to look more widely.
Mr. McCaul. How was this discovered in the first place? How
did you discover that, gee, we have food coming in from China
that is contaminated?
Dr. Acheson. With the melamine or with----
Mr. McCaul. The anti--or the microbe agents that were found
in the fish.
Dr. Acheson. Through testing programs. Those testing
programs go back to 2001, where we first started to see
problems and we were putting individual companies on import
alert. And we have been doing that for some time. And we have
essentially been ramping up, adding more and more companies, to
the point at which we said, this isn't working. The technical
discussions with China aren't solving the problems. We need to
make this countrywide to protect the American consumer.
Mr. McCaul. Mr. Baldwin, another topic. We have a farm bill
coming up this week in Congress, and there is some discussion,
in fact some Members of Congress would like to move inspection
authority away from Customs and Border Patrol and give it back
the USDA at the inspections being done at ports of entry on the
border. Can you comment, even though the USDA does not want
that mission, by the way--not something that I support--but can
you comment on that and then also comment on the transition
that did take place between USDA to CBP at the border? And how
well is that transition going, and how well are your
inspections at the border?
Mr. Baldwin. Sure. First off, I would offer that I believe
a transfer of our CBP agriculture specialists back to USDA
would in fact be a detriment to our food supply security
efforts. We have a significant number of diverse workforce that
we have at the border that we can leverage and use for a
diverse array of food supply chain issues. I think we have had
tremendous success in the few short years since CBP agriculture
specialists have been at the border with our CBP officers, who
look for immigration issues, cargo issues, and agriculture and
pest contamination issues. I think we are underestimating the
tremendous improvements we have made with USDA in forming our
task force and working with our bioterrorism act personnel with
FDA and soon FSIS and our NTC. I think we are making tremendous
headway in solidifying our efforts and creating the best food
supply chain security efforts at the border. I think a move
back, this reaction would be a detriment to our efforts.
Mr. McCaul. Thank you. I see my time has expired.
Mr. Langevin. Thank the gentleman.
The chair now recognizes the gentlelady from the Virgin
Islands, Mrs. Christensen, for 5 minutes.
Mrs. Christensen. Thank you, Mr. Chairman.
Thank you for holding this hearing and making sure it
happened, despite the fact that we had to put it off. And thank
the panelists again for your flexibility in being here this
morning. I have a lot of concerns about our food safety, given
all of what has already been referenced here by my colleagues,
and what seems to be a tremendous increase in food
contamination, and sometimes the length of time it takes to
find out what the source is and so forth. So I am hearing that
coordination is improving and so forth. I hope so.
I have a quick question for Dr. McGinn. The Office of
Health Affairs, how does that relate to the Chief Medical
Officer? Is that the same office? Is there some coordination
there? What is their role in the food safety issue?
Dr. McGinn. The Chief Medical Officer is the head of the
Office of Health Affairs. The Chief Medical Officer is a
position that is about a year old within DHS, and then most
recently, that has become the Office of Health Affairs.
Mrs. Christensen. Okay. I just wanted to know.
Dr. McGinn. And the veterinary component is a component of
the medical component within DHS.
Mrs. Christensen. Okay.
And Dr. Acheson, you talk about the laboratories that are
in the FERN, in the network. And they include the 50 States and
Puerto Rico. How does that network address issues with the
territories, either the Virgin Islands or the ones in the
Pacific?
Dr. Acheson. The network is constantly expanding. And at
this stage, I don't have specific information as to what is on
tap in those, but I can certainly find that information and get
that back to you specifically on that question. But that
network has worked well. We used it in spinach, and we used it
in melamine.
Mrs. Christensen. Okay. And, apparently, a week ago or so,
there was another hearing in one of the Energy and Commerce
subcommittees, and what was reported there is a cause for a lot
of concern, one that--and I read about this in the paper either
Sunday or Monday as well--that FDA inspects about 1 percent of
the food over which it has jurisdiction. This is what was
reported at the subcommittee. And of that 1 percent, just a
fraction is actually sampled, that the agency sometimes allows
importers to take possession of suspect foods and arrange for
the testing by private laboratories that may or may not be
approved by FDA. This is from testimony given in a hearing at a
House subcommittee last week.
And the other issue is the fact that you have 13
laboratories that test for these kinds of problems, and seven
of them FDA intends to close. Can you just help me figure out,
can you just respond to those concerns that were raised in
another subcommittee hearing?
Dr. Acheson. Sure. You raised a lot of points there. Let me
try to cover them briefly.
Mrs. Christensen. The 1 percent.
Dr. Acheson. Yeah.
Mrs. Christensen. The private labs testing for suspect
goods, private labs that are not FDA approved, and also the
closing of 7 out of 13 laboratories that are used. And it goes
on; inspectors, the number of inspectors are less, but the food
imports have doubled, you know.
Dr. Acheson. First of all, the 1 percent is correct. In
order for a product to be imported, a food product to be
imported into the United States, there are a number of things
that has to happen. The paperwork for that, usually submitted
electronically, is 100 percent through our prior notice center,
in collaboration with Customs and Border Protection. What that
does is, it will target certain foods that are of concern from
a food defense and bioterrorist perspective. And if we see
anything anomalous there, it gets put to one side in terms of
potentially a hold or an inspection. On the food safety side,
again, all that food is screened electronically. Some of it,
where we have never seen a problem historically----
Ms. Christensen. So 100 percent is screened, but 1 percent
is inspected. Is that what you are saying?
Dr. Acheson. Yes, 100 percent is screened electronically.
About 80 percent of that electronic screening is then diverted
for an FDA individual to look at it and make a determination,
should this be inspected or should it not be inspected, based
upon experience? Now a lot of that is stuff that goes through
really quickly because, again, it is high volume. It is things
we have never seen problems with. And that is how the 1 percent
then gets picked out. It is based upon risk. It is based upon
areas where we have seen problems, and it is based upon
concerns that we have either had in the past or currently have.
So it is vetted 100 percent, but you are correct in saying that
only 1 percent is actually physically inspected.
In terms of the private labs, yes, private labs do get
used, as they are allowed to be used for import alerts. But,
again, FDA is able to look at the data from the private labs.
They have to ensure that the samples are collected properly,
under the appropriate conditions, that the testing is done
correctly, that the assays are validated, that the controls are
appropriate. And if there are any problems with that, FDA will
refuse to take that data and do. I could not tell you what
percentage that we refuse, but I can find that out for you. But
we do do that.
Finally, on the lab closures that you mentioned, yes, you
are correct, there is a current consideration of consolidating
labs. Those labs were developed and situated in the days when
shipping samples around was much more complex than it is now.
We can obviously, as you all know, ship materials across the
U.S. very easily. The goal here is to improve efficiency, to
improve through put and to do more faster, cheaper, so that, at
the end of the day, even though physically some labs will
close, we envisage that what we will be able to do here is to
get more samples tested faster for less money, thus increasing
overall efficiency, simply because of the way things move in
modern technology.
Mrs. Christensen. Thank you for your answer.
Mr. Chairman, I think that this bears some looking into,
just so that we can be sure that we are giving the proper
oversight for some of these changes, closing of the labs and
the low percentage of inspections and some of the other issues
raised.
Mr. Langevin. I couldn't agree more, and I promise you that
we will continue to exercise aggressive oversight in this area.
And this hearing will be the first of what I intend to be
several hearings on the subject.
The chair now recognizes the gentlelady from Ohio, Ms.
Kaptur.
Ms. Kaptur. Mr. Chairman, I want to thank you very much for
permitting me to come here today and participate in this very
important hearing. Thank you for your leadership on this issue.
And it is a pleasure to join the panel, if only briefly.
Thank you for your focus on food safety, an issue that I
have followed for quite a number of years. I would like to ask
any of the panelists to respond to very specific questions
here.
Do any of you know what percent of the U.S. food supply is
currently imported and what percent of the U.S. drug supply is
currently imported or even, generally speaking, what that might
be?
Dr. Acheson. This is David Acheson, FDA.
Let me start on the food supply because I can speak to
that. For drugs, I do not have that information, but we could
certainly get that for you.
Overall, about 13 to 15 percent of the U.S. food supply is
imported, but it varies greatly with commodities. Seafood is
about 80 percent. Others are much less. Produce varies with the
time of year, but it can be 30 to 40 percent.
Mr. Baldwin. I would just like to add that I think it is
somewhere between 4 to 5 percent of all imports in the United
States that are actually, you know, our food supply, our food
products. Four to 5 percent of all imports of all products are
food products.
Ms. Kaptur. What about drugs?
Mr. Baldwin. That information I do not have specifically,
but I would be happy to get that for you.
Ms. Kaptur. Does anybody want to take a guess? I am talking
about the components of those products, not just the final
product.
Mr. Acheson, you do not want to comment on that?
Dr. Acheson. I did not come armed with information to
specifically discuss the importation of drugs, but as I have
said, I would be very happy to get that information to you.
Ms. Kaptur. Is it your sense that the majority comes from
offshore on the drug side?
Dr. Acheson. I know that drug ingredients are imported, but
yes, in terms of finished drugs, I think it is not a huge
number.
Mrs. Kaptur. I think the American people were very
surprised to find that large amounts of our medications and,
perhaps, vitamins are comprised of ingredients that come from
offshore. I think it is quite a significant number, and it is
surprising to me that you do not really have that at the top of
your fingertips here today.
Dr. Acheson. Well, I apologize. I am focused on food and
feed as opposed to drugs, but I promise we will get that
information to you.
Mrs. Kaptur. Is it your impression that food imports and
drugs imports into the United States are growing?
Do any of the panelists want to answer that?
Ms. Maczka. On the meat, poultry and egg side, no. As far
as your first question----
Mrs. Kaptur. Meat and--excuse me?
Ms. Maczka. Meat, poultry. Meat and poultry, which is what
FSIS regulates, 6 to 8 percent is imported. That is in response
to your first question.
Dr. Acheson. In response to your question about is it
increasing, certainly, on the food side, yes, it is.
Mrs. Kaptur. Yes. With 1 percent or less inspected, as a
country we have been pretty lucky, actually.
I wanted to ask you: Who are the worst offenders by nation
in terms of food safety and then drug safety? If you were to
kick off those who have been cited the most times, which three
countries would be at the top of your list or which five
countries would be at the top of your list as the worst
offenders on the food side and then the worst offenders on the
drug side?
Dr. Acheson. In the context of the foods that the FDA
regulates--and we inspect and refuse foods on a regular basis.
For example, in June, the FDA refused foods from 80 different
countries. China and India were at the top of the list and,
certainly, in recent months have been at the top of the list.
Part of that is related to the volume of products that are
imported. We do import a lot of foods from China and from
India, so there is a denominator component to this.
I suspect where you are going is the proportion or the
percentage of foods from individual countries that are unsafe,
and I do not have all of the denominator information at hand,
but again, you know, we could provide that.
Mrs. Kaptur. To provide the inspection, do you focus on key
importers?
Dr. Acheson. In terms of the inspections, there are a lot
of parameters that are weighed into this. From a food defense
perspective, yes. The intelligence, the country of origin, the
foods, those kinds of things on the food safety side, again,
yes, in relation to proprietary records, the history of
problems with the importers or the foods.
Mrs. Kaptur. There is very little time remaining in my 5
minutes, but I did want to place on the record the distinction
between what the U.S. Department of Agriculture calls a
``recall'' if we find something that is out there that we are
troubled with. There are all of these stories that come out in
the paper that we are going to recall certain products.
The problem is that we recover almost none of it. Five
percent or less is ever recovered, so we might read that
something is recalled, and people say, ``Oh, I feel so safe.
The toothpaste is recalled or the steak is recalled or the
hamburger is recalled or the fish is recalled.'' Yet, the truth
is that the Department of Agriculture, speaking for the
Department of Agriculture, is able to recover almost none of
it. So it is still out there. It is still out there.
So I just wanted to place on the record in this very
important subcommittee the fact that some of the language that
is used is very misleading to the public.
I believe my time has expired, Mr. Chairman.
Mr. Langevin. Well, the gentlelady raises a very important
point, and the American people need to be aware of this, and we
need to see what we can do to step up efforts to enhance the
recall effort to make sure it actually has meaning and that the
product is actually recovered. I could not agree more. I thank
the gentlelady.
The Chair now recognizes the gentleman from North Carolina,
Mr. Etheridge, for 5 minutes.
Mr. Etheridge. Thank you, Mr. Chairman, and thank you for
holding this hearing. I think it is vitally important.
Let me ask the panelists. You know this is a critical issue
to the American people, and I want to go back so I can come
forward.
In November of 2003, the GAO had a report titled
Bioterrorism: A Threat to Agriculture and the Food Supply, and
they found that most of USDA's and the FDA's field staff had
not received training on security matters, and although the
field staff were instructed to be vigilant and on heightened
alert, they were also told not to document or to report their
observations regarding security at the plants because the
information could be obtained under a Freedom of Information
Act request. My question is this:
Has this policy changed? Number two, can you confirm that
staff were instructed not to document or to report
observations? Number three, do field staff currently receive
security-specific training?
Who wants to tackle that first? Okay.
Ms. Maczka. Thank you, Congressman.
Well, we perform food defense verification procedures in
our plants every day, and I do not have the numbers with me,
but hundreds of verification procedures are performed, and we
document the results of those in what we call a Memorandum of
Interview. The inspection personnel are supposed to take the
results of that and discuss it with plant management so that
countermeasures can be put in place. So I think our system
there is quite strong.
Mr. Etheridge. Well, let me ask you a question. You did not
answer my question.
Number one, has the policy changed? Was that correct what
GAO put out in 2003 or was that incorrect?
Ms. Maczka. The policy has not changed. We have been doing
these food defense verification procedures since the events of
9/11, and we continue to do them, and our staff does get
ongoing training, by the way. We have food defense awareness
training of all of our field staff as well as headquarters
staff.
Mr. Etheridge. So we do document?
Ms. Maczka. Yes, we do document.
Mr. Etheridge. We do report the observations?
Ms. Maczka. Yes, we do.
Mr. Etheridge. To whom?
Ms. Maczka. To the trade associations and to industry so
that countermeasures can be put in place, and we also analyze
the information at headquarters to look at trends.
Mr. Etheridge. So it does come to the Department?
Ms. Maczka. Absolutely.
Mr. Etheridge. Okay. Does anyone else want to comment on
that?
The FDA.
Dr. Acheson. Yes. This is David Acheson. I will speak on
the FDA side.
In terms of the training, we have been aggressively
adopting a training program with our inspectors, mainly focused
on raising awareness and having them understand the importance
of giving out guidances to the industry in terms of what they
can do to ensure the security of the food supply.
As I mentioned in my oral, we have developed a program
called ALERT, which is heavily focused on raising awareness. It
basically operates from farm all the way through to retail.
Virtually every inspector has been trained on ALERT. We have
developed a Web-based training system for that, suitable for
both industry and for our inspectors. Certainly, about 2 months
ago, we were up to--about 95 percent, 96 percent of the
inspectors had received that training and were implementing it,
and we have used this in some of our assignments as well.
Mr. Etheridge. Okay. So it is currently an operation that
is ongoing?
Dr. Acheson. Yes, that is correct.
Mr. Etheridge. Thank you.
Dr. McGinn, can you describe what steps the Department has
taken to lead an interagency in response to an act of
agroterrorism or other disasters in the agricultural sector?
Because, obviously, your department would have that charge.
Specifically, what plans have you developed, what training
exercises have you done, and what are the staffing changes in
the Department to accomplish the mission in your department?
Dr. McGinn. Okay. As it relates to the staffing issues, our
office is new, the Office of Health Affairs, and currently we
are an issuer and are actually adding people in the area of
food as well as in animal agriculture, in public health, and
agro threat. This year, we are hoping to, as the IG report
said, add the persons who are needed to actually staff up this
coordinating role up to about 11 people the first year, and
then by the end of 2009 we are looking to add up to about 40
people to actually do this coordinating role and several
million dollars to do this effort. That is not a lot
considering it is one-sixth of the economy and that this is a
critical infrastructure for our country.
In terms of the exercising and the planning and in terms of
attacks on our country, one of the main ways that we within the
Department of Agriculture are preparing for that is in actually
assisting the States to be prepared because any incident that
is going to be of national significance is going to be in a lot
of States at the same time. So one of our key responsibilities
is to provide grants to the States to be able to then utilize
and to actually do the training and exercising and build the
kinds of capacities that we need to have in order to be able to
respond in multiple States at any given time.
Mr. Etheridge. Can you tell us where we are along that
track in terms of getting that done?
Dr. McGinn. In terms of the grand analysis, that is one of
the key things, that I add personnel to our office, which I
intend to do. We have already begun the analysis of this, and
we are looking at what States are actually spending on those
grants in terms of building this kind of preparedness, and the
research capacity within the labs as well as the field
personnel are critical, as you know.
In order to effectively do this kind of analysis with the
grants, I am going to need some additional--the personnel that
we are bringing on staff right now to actually do that, and I
will be able to follow through on it. My intention is to do an
annual review of those grants and then to be able to share that
information back with the States so that they will be able to
do a better job of competing for those resources to build
capacity in the States.
Mr. Etheridge. Thank you, Mr. Chairman. My time has
expired.
Mr. Langevin. I thank the gentleman.
Given the import of this issue and the fact that I know
Chairman Thompson wanted to question--he is on his way back--
with the panel's indulgence, we are going to go to a second
round of questions. So, with that, I will begin recognizing
myself.
I wanted to inquire of Dr. McGinn: The Inspector General
released a report in February on the role of DHS in post-
harvest food security. The IG noted that there are four main
limitations in DHS' efforts. First, DHS must improve internal
coordination. Second, DHS needs to engage its public and
private food sector partners more effectively. Third, DHS could
do more to prioritize resources and activities based on risk.
Finally, DHS must fully discharge its food sector
responsibilities.
So my question is how many staffers has DHS dedicated to
this mission, and how have you worked to improve these areas?
Dr. McGinn. Within the 30 programs across DHS, there are
several people who are actually involved, but in our office
currently, I am an office of one, but I have the ability to
actually add up to five people as FTEs and then some detailees
as well to get to eleven by the end of this first year that we
are in place so that the IG Office or the IG report recommended
that we have a very limited number of staff and that we need to
actually add to our resources to actually be able to discharge
our responsibilities, not just for HSPD-9 but for the other
HSPDs, as well as other issues as were mentioned by the
Executive order and the Office of Budget and Management. There
are lots of different issues that we are actually working to
synchronize our resources in.
Mr. Langevin. Do you feel that level of resources in
staffing is going to be adequate to complete your mission?
Dr. McGinn. It is very adequate to start the job in this
first year of our existence. We are a new office, and we are
rapidly developing capabilities, not just in the veterinary
area but also in the medical area as well. Coordinating those
responsibilities across all of DHS is a huge task as well. So,
yes, we have got the resources to start the job, and then our
ramp-up over the next couple of years will in fact give us the
full capability to discharge those responsibilities.
Mr. Langevin. To the panel, Mr. Kennedy's testimony that we
will hear later suggests that food and ingredient movement is
not well characterized across firms--or food and ingredient
products. He states that a clearinghouse for such information
that would be accessible for research and threat purposes would
be a significant step forward.
What efforts are underway to create such a tool?
Dr. Acheson. This is Dr. Acheson at FDA.
I am not sure I quite understand the scope of the question.
Is it suggesting that the traceability is inadequate?
Mr. Langevin. That is what he is suggesting, yes.
Dr. Acheson. Okay. Under the Bioterrorism Act, there is a
requirement for certain facilities to maintain records of one
up and one back; in other words, where they receive the
material from and where they send it. That has served us well
in relation to recent outbreaks. Obviously, we have not had to
test it in a terrorist situation, but that structure has
allowed us to, essentially, trace forward and trace back when
an outbreak occurs, to determine origins and where food has
gone.
Mr. Langevin. Would anybody else on the panel care to
comment?
Ms. Maczka. We also have procedures in place to trace
forward and to trace back.
Mr. Langevin. Thank you.
Let me ask this last question within the time that I have
left.
China has claimed that the U.S. is raising unnecessary
alarm about the safety of their food products. According to one
of their ministers, ``one company's problem does not make it a
country's problem. If some food products are below standard,
you cannot say all of the country's food is unsafe,'' end
quote. Do you agree?
Dr. Acheson. Let me take the first shot at that.
I would agree that one company's problem does not mean that
there is a problem nationwide. However, if we return to the
example of the imported fish, we have been putting one company
at a time on import alert as we have been demonstrating that
their products are problematic and of concern to the public
health in the United States. Beginning last October, we
expanded our surveillance of these categories of fish and did a
lot of testing, and overall, about 25 percent of the species
that we had concerns about from a variety of different
companies contained these unapproved anti-microbial agents. So
that was clearly not just one company, and it was at the point
where we had to say this had to be countrywide. It is correct
to say it is not 100 percent, but I do not believe for 1 minute
that we are overreacting. I think it is very important that we
do this.
Mr. Langevin. Anybody else on the panel?
Ms. Maczka. Our process is such that we not only determine
if a country's system is equivalent to us and is eligible to
export to us, but we also look into whether establishments
should be certified. So we take it on an establishment-by-
establishment basis as well as a country basis.
Mr. Langevin. I thank the panel.
The Chair now recognizes the gentleman from Texas, Mr.
McCaul, for 5 minutes.
Mr. McCaul. Thank you, Mr. Chairman.
Dr. McGinn, I look forward to seeing your office go from a
one-man shop to many hirees in your office and in ramping up
your efforts. I know you are under a lot of--I will not say
``stress''--but a lot of responsibilities for one person to
bear, so I look forward to seeing that progress.
My second round of questioning has to do with something
that impacts probably more of my home State of Texas, and that
is foot and mouth disease. When I go down to some of the border
towns, you actually see cattle going back and forth between
Mexico and Texas. It has been going on for a long time, and
obviously the threat of contamination is real. In Minnesota, we
had a recent scare of foot and mouth disease which, actually,
turned out not to be foot and mouth disease, but it did
provide, I think, an opportunity for the USDA and the DHS to
sort of test their efforts in working together on this. My
question is to the panel.
Could you comment on the coordination between the USDA and
the DHS on that issue in this particular case? Then if you
could comment also on the overall threat, if you will, of foot
and mouth disease, which would have a real damaging impact not
only on border States but on the whole ranching industry?
Dr. McGinn. I will lead off.
As it relates to that recent incident that you were
describing, it was an excellent opportunity, as most incidences
are, to develop additional strengthening capability. Some of
the encouraging things that we did in a collaborative sort of
way was we were immediately on the cell phones with each other.
We have each other's cell phone numbers. We call each other any
time, day or night. Certainly, when the incident was brought to
our attention it was in the evening, and the questions or the
requests that came to us were of an intel nature, and so what
we were asked to do was to look at the intentional aspects of
this to rule out or to rule in these sorts of things early on
because the sooner you can determine if there is an intentional
component, particularly in a biological or in a chemical
situation, you are much farther ahead of the ability to contain
that situation. So we were asked, and we worked through the
night, actually, on behalf of the USDA to actually determine
the issues of risk around intentional disruption.
Another thing that was, really, very encouraging that was
done was Customs and Borders Protection and the USDA worked
together to look at if in fact we were to have an incident that
would progress, that we would need to be able to know in the
last few weeks what animals had actually come across the border
so that we would know the size of the tracing-out that needed
to be done, and it was incredibly encouraging how quickly that
information was able to be brought together from their joint
efforts, and they got not just all of the cattle and swine, but
they got down to the camels and the goats and everything else
that had come into the country over that period of time.
So those two are two great examples of some increased
collaborative work that was done.
One more that I would add to that is the Center of
Excellence--and you will hear from Shaun Kennedy this
afternoon--which worked closely with the plant owners in
Minnesota to actually deal with that situation, so that there
is a feedback loop from the private sector that these Centers
of Excellence are so helpful in creating for all of us. That
was a part of that incident as well. So those are three
examples of increased and excellent coordination.
Mr. McCaul. That is good to hear.
Mr. Baldwin, do you have any comments?
Mr. Baldwin. I would just echo what Dr. McGinn has said. I
think that we have found that our cooperation with the USDA,
especially on the foot and mouth issue, has been tremendous. I
mentioned earlier in my testimony that I think that 87 percent
of our criteria in our automated commercial systems are
dedicated to agriculture and food systems, and I will tell you
that those are predominantly on the foot and mouth issue that
we have been addressing for quite a few years. So I think that
the work we have done in the past few years on foot and mouth
with the USDA has been a tremendous example of how cross-
cutting work with the agencies is really the way to go and how
it has proven to be successful, and we are always working to
improve that.
Mr. McCaul. Dr. Maczka, you mentioned in your opening
statement the avian flu in poultry. Obviously, that is of great
concern as the risks can be very high. We have talked a lot
about the fish coming from China as being contaminated.
How much of our poultry is actually imported from Asian
countries?
Ms. Maczka. Right now, we receive--none of our products
are--no products are coming in from China. No meat, poultry or
egg products, FSIS-inspected products, are imported from China,
and no establishments, processing establishments, are certified
to export to us.
Mr. McCaul. That is good to hear.
In terms of poultry that is imported, I would assume most
of the poultry is homegrown in the United States, that most of
the poultry consumed in the U.S. is actually raised in the
United States.
Ms. Maczka. The numbers that I gave before, 6 to 8 percent,
of our poultry and meat are exported, and I do not have the
breakdown of what is meat and what is poultry, but I can get
that to you.
Mr. McCaul. In terms of what Americans consume, most of
that is homegrown in the United States and is raised and not
imported?
Ms. Maczka. That is correct.
Mr. McCaul. I see my time has expired.
Mr. Langevin. I thank the gentleman.
The Chair is now pleased to recognize the chairman of the
full committee, the gentleman from Mississippi, Mr. Thompson,
for 5 minutes.
Mr. Thompson. Thank you very much, Mr. Chairman.
One of the issues I think the committee is grappling with
is who would be in charge if something happened, and I guess I
will go with Dr. McGinn first by saying:
If an incident of national significance were declared along
the lines we have talked about, who would be in charge?
Dr. McGinn. Well, if an incident of national significance
is declared, then the Department of Homeland Security is the
coordinator of the overall response. Therefore, we would be in
a leadership role as it relates to that. The technical leads
come from whatever emergency support function is involved with
the incident. In this particular situation, if it were both the
FDA and the USDA as technical leads, then we would be
coordinating with them in terms of the subject matter expertise
and the legal responsibilities within our responsibilities for
an incident of national significance to coordinate under the
National Response Plan.
Mr. Thompson. So is your definition of ``coordination'' the
equivalent of being in charge or just serving as the traffic
cop for the particular incident?
Dr. McGinn. Well, ``being in charge'' is exactly what it
means, but it also recognizes that the subject matter
expertise, whether we are talking transportation or whether we
are talking food or health as sectors--recognizing that those
expertises are needed in that emergency support function
actually leads to support in that particular area. We
definitely hope when an incident occurs, whether it is food--or
agriculture-related, that we would be first, and most of them
are incidents at the local level. The progression of most
incidents is, if it progresses to the place where it is at the
State level, then the State would be in charge. If it
progresses further, then either the FDA or the USDA is actually
in charge. So as the incident progresses--and they can progress
very fast or they can progress slowly--who is in charge changes
as it does within any incident command system-type
responsibility, as you know from your work in firefighting.
Mr. Thompson. Dr. Acheson, you have heard Dr. McGinn's
comments about the coordinating role of DHS.
Is that your understanding?
Dr. Acheson. Absolutely, yes, yes.
Mr. Thompson. And there is no conflict between who is in
charge and who is the lead in this scenario?
Dr. Acheson. No. I mean, as Dr. McGinn pointed out, things
tend to build up at some speed or another. For example,
spinach. The FDA was in charge of that. It was not declared a
national emergency. We stayed in charge and we took care of it.
We worked with other Federal agencies during the course of
that.
Melamine was slightly different. Again, there were very
close coordination efforts between the FDA, the USDA, the DHS,
and a whole variety of other Federal agencies in that context.
So, absolutely. Depending on the level of the emergency, it
will vary who is in charge, but we are totally in sync with
that.
Mr. Thompson. Dr. Maczka, would you like to respond to
that?
Ms. Maczka. I am in agreement with my colleagues here that
that is pretty much the way it works, and actually we have
tested it out in some of our State district exercises where we
have invited our colleagues to these exercises, and it has
played out that way.
Mr. Thompson. So you all have basically said that there is
no gray area as we proceed along this line in terms of who is
in charge, whether the protocols are already established and
all of that?
Dr. Acheson. Yes.
Ms. Maczka. Yes.
Dr. McGinn. Yes.
Mr. Thompson. Thank you.
I think, as we go forward, you will see, Mr. Chairman, some
other comments relating to this, but I wanted to make sure we
were on the record with that issue.
I yield back.
Mr. Langevin. I thank the chairman.
I want to thank the witnesses for their valuable testimony
and the members for their questions. The members of the
subcommittee may have additional questions for the witnesses,
and we will ask you to respond expeditiously in writing to
those questions.
At this time, the first panel of witnesses is dismissed,
and the Chair now calls up our next panel. Thank you.
I would like to welcome our second panel of witnesses.
Thank you for being here today.
Our first witness is Shaun Kennedy, the Deputy Director of
the National Center for Food Protection and Defense at the
University of Minnesota. The University of Minnesota is a DHS
Center of Excellence. We are so happy to have you here today,
Mr. Kennedy.
Our second witness is Dr. Lee Myers, State Veterinarian and
Assistant Commissioner of the Animal Industry Division in the
Georgia Department of Agriculture. Dr. Myers has spearheaded
numerous initiatives to improve the States' and the Nation's
capacity to prevent and to respond to agricultural emergencies,
including acts of agroterrorism. I welcome you here today as
well.
Our third witness is Dr. Craig Henry, Senior Vice President
and Chief Operating Officer of Scientific and Regulatory
Affairs of the Grocery Manufacturers Association and Food
Products Association. Dr. Henry, we thank you for being here,
and please send our regards to Dr. Matthys, who was going to
testify before we switched the schedule on him, so we
appreciate your filling in.
Without objection, the witnesses' full statements will be
inserted into the record, and I will now ask each witness to
summarize his or her statement for 5 minutes beginning with Mr.
Kennedy.
STATEMENT OF SHAUN KENNEDY, DEPUTY DIRECTOR, NATIONAL CENTER
FOR FOOD PROTECTION AND DEFENSE, UNIVERSITY OF MINNESOTA--TWIN
CITIES CAMPUS
Mr. Kennedy. Mr. Chairman and members of the subcommittee,
I would like to thank you for giving me the opportunity to
discuss recent events involving the food system in the United
States and our future needs for reducing the possibility of
intentional disruption or contamination of this system.
As you have noted, I am here today as a representative of
the university community that is committed to finding new
solutions to protecting the food system and also as the co-
director of the National Center for Food Protection and
Defense.
At the Center, we are focused on fundamental and applied
research to develop new strategies, tools and approaches to
address the threat of intentional food contamination. The
university research community is one important partner with the
public and private sectors in developing innovative solutions
to the threat presented by intentional food contamination.
Food terrorism is not a new threat. In fact, the use of
food as a weapon is actually one of the oldest weapons that is
still of concern for catastrophic harm. However, a more global
food system now means that intentional contamination of one
location can literally reach around the country or across the
globe to cause economic harm, illness and even death in
multiple locations simultaneously.
I have been personally struck by the degree to which the
public intuitively understands the threat of intentional
contamination of the food system. One group of NCFPD
researchers found that consumers would allocate more funding to
protect the food system than a range of other critical
infrastructures even though they perceive the relative
probability of an attack on the food system to be lower than
those other infrastructures. Upon reflection, this is not
surprising. The food system is the one critical infrastructure
where we cannot take ourselves out of the target population.
The implications of this are not trivial. I think it is
important to consider that a long history of Federal, State and
local food safety regulations and enforcement has allowed us to
be confident, not only in the safety of our food but in the
quality of our government. A loss of public confidence in our
ability to deliver a safe food supply could challenge both
public trust in government and public confidence in the
integrity of our food system.
There is, unfortunately, however, no silver bullet for
fortifying the food system. The strengths of our system--
affordable and fresh fruits, vegetables, meat, poultry, eggs,
and dairy all year long--also represent the challenges of this
complex system. The Federal and State agencies and the private
sector which own and manage the food system have all made
dramatic strides in protecting the food system from potential
terrorism since it became a front and center concern. There is,
however, much more to be done, and we should not be surprised
by this.
Protecting our food supply from intentional contamination
represents a far more difficult challenge than the Mother
Nature problems we are used to dealing with since it involves
things that should not happen. While zero risk is, by
definition, unachievable, through intensive and targeted
research we can reduce the risk. Research themes that I believe
to be central to this effort, that NCFPD are actively engaged
in, include the following:
The first is event modeling. That is how we can stay ahead
of terrorists and others who want to cause us harm. One of the
criticisms from the 9/11 Commission was that various Federal
agencies suffered from a lack of imagination. In short,
terrorists had explored more innovative threat scenarios than
those for which the government had prepared. Having learned
this lesson once, we cannot afford to do so again. Realistic,
flexible and dynamic models of potential food system events are
thus an invaluable tool for vulnerability and consequence
assessment, intervention prioritization, resource allocation,
and decision support during an event.
The second area of focus is in agent and food matrix
interactions. We know a great deal about how conventional
foodborne pathogens interact with food and the environment, and
yet it is still not entirely clear how the E. coli 0157:H7
contaminated the spinach in last year's outbreak. Intentional
contamination of food for public health or economic harm or
economic opportunism elevates the challenge of understanding
how agents interact with the food system to an entirely new
level. Efforts are, unfortunately, complicated by the fact that
traditional ``select agents'' comprise only a small subset of
the agents of concern. With the food itself serving as a very
effective and efficient delivery vehicle, the agents of concern
go well beyond those of traditional chemical and biological
weapons considerations.
All of you are undoubtedly familiar with the ``sniffer'' at
Ronald Reagan National Airport, which represents a great stride
forward in detecting potential explosives to prevent them from
being taken onto airplanes. Detecting potential explosives in
air samples, however, is very different than rapidly detecting
agents of concern in frozen cream of broccoli soup or hot dogs,
let alone a truck of produce. Novel sample acquisition and pre-
analytical processing strategies are therefore a crucial link
in any effective detection strategy.
Third, the food system is very much that, a system. As
such, it presents inherent challenges with respect to risk and
vulnerability assessments as well as the prioritization of
investments to enhance food system protection. Unlike many of
the 17 critical infrastructures and key resources, it is
primarily composed of complex systems, and it is specific
elements within these systems and the interdependencies of
these systems that are of most concern.
In conclusion, Mr. Chairman and members of the
subcommittee, thank you again for the opportunity to talk with
you about recent food system events and the challenges they
represent for protecting and defending our food supply. We need
better food system intelligence, more flexible and responsive
prevention, preparedness, response, and recovery strategies,
and an expanded armamentarium of technologies and trained
professionals to meet these new challenges. The university
research community is an important partner in this national
imperative. As Co-Director of the National Center for Food
Protection and Defense, I am honored to have had this
opportunity to provide you with my perspective.
Thank you.
[The statement of Mr. Kennedy follows:]
Prepared Statement of Shaun P. Kennedy
Mr. Chairmen and Members of the Subcommittee, thank you for giving
the National Center for Food Protection and Defense, a Department of
Homeland Security funded Center of Excellence, based at the University
of Minnesota (NCFPD) the opportunity to discuss recent events involving
the food system in the United States and our future needs for reducing
the possibility of intentional disruption or contamination of the U.S.
food system. The rapid globalization of our food supply chain has added
demands upon our existing food safety systems. The threat of
intentional contamination of the U.S. food system represents a further
significant increase in the challenges that must be addressed to reduce
the probability of public harm. Building upon prior experiences with
challenges in the United States, one of the important pillars of an
effective defense is fundamental and applied research to develop new
strategies, tools and approaches to address the threat. This program
would include preparation, prevention, response, and recovery. The
university research community is one important partner with the public
and private sectors in developing innovative solutions to the problems
presented by intentional food contamination. The National Center for
Food Protection and Defense is honored to have the opportunity to
provide one perspective on both the continuing research needs and also
how university researchers such as those participating in NCFPD can
help address the considerations of intentional attacks on the food
system.
Before moving into specific concerns and future needs, some
historical perspective is provided on food system contamination to
position the challenges ahead of us. While the horrific events of
September 11, 2001 have changed our national view on nearly everything,
food terrorism is not a new threat.
The use of food as a weapon is actually one of the oldest weapons
that is still of concern for catastrophic harm. The Athenians'
contaminated the drinking water for the city of Kirrha of the
Amphictyonic League in 590-600 B.C., taking advantage of the resulting
severe gastrointestinal illness of all inhabitants to overtake the
city. A similar strategy was employed by the Carthaginian General
Maharbal, utilizing contamination of wine left for his enemy which then
rendered them defenseless to his ensuing attack. In more modern times,
the Japanese Army experimented with the use of food for the delivery of
pathogens such as Bacillus anthracis, Shigella spp, Vibrio cholerae,
Salmonella Paratyphi and Yersinia pestis.
Frequently cited examples of intentional contamination of food for
political gain or intentional harm in the U.S. include the 1984
Rashnishee cult contamination of salad bars in Oregon and the
disgruntled grocery worker who contaminated ground beef in Michigan in
2002. Importantly, these historical examples all represent local
contamination. Our ever more global food system means that intentional
contamination at one location does not limit the impact of such an act
to its immediate environment or a single geographic location. As
illustrated by recent foodborne illness outbreaks as well as the recent
contamination of wheat gluten with melamine from China, food
adulteration from around the world can now have direct consequences
across the nation. The challenges of our global, just-in-time food
system represent a unique area of concern which was recognized by the
Administration in implementing Homeland Security Presidential Directive
9 (HSPD-9).
The public, independent of sophisticated risk and vulnerability
assessments, intuitively understands the concerns associated with
intentional contamination of the food system. In a survey conducted by
NCFPD supported researchers at the University of Minnesota in 2005,
consumers ranked the probability of an intentional attack on the food
system behind attacks on air transportation, all other public
transportation, the energy grid, national monuments and the release of
a threat agent in an urban area. In contrast, however, consumers ranked
the food system as the infrastructure of this list in which they are
most concerned about an attack based on their recommendation that more
funds be invested in food protection than in the other sectors. This
apparent paradox is actually not surprising. The food system is the one
critical infrastructure that reaches into every home, every day, with
the potential for those of ill will to cause direct, widespread harm.
It is the one critical infrastructure where you can not take yourself
out of the target population.
The intuitive insight of the public into the importance of
attending to the defense of the food system does not, unfortunately,
translate into easy, readily available solutions to close potential
vulnerabilities. The federal and state agencies involved in the food
system have made dramatic strides in protecting the food system from
potential terrorism since it became a front and center concern.
Similarly, the private sector, which owns and manages the food system,
has also worked incredibly hard to identify and address potential food
system vulnerabilities. There is, however, much more to be done, and we
should not be surprised by this.
For many of us, Upton Sinclair's expose and novel ``The Jungle''
was our introduction to food safety and the need for private and public
sector efforts to ensure a safe food supply. After more than one
hundred years experience with the food safety regulations that this
groundbreaking book helped push forward, food safety continues to pose
a significant public health challenge. In the last year, foodborne
illness outbreaks associated with spinach, lettuce and peanut butter,
among others, have reminded us of these concerns. This spring the
melamine contamination of vegetable proteins, diethylene glycol
contamination of toothpaste and drug residues in fish serve as
surrogate models of how intentional food adulteration can pose a far
more significant challenge than unintentional food contamination. There
is thus much more work to be done to protect the food system. Some of
these research needs that are central to effective and full
implementation of HSPD-9 are addressed by NCFPD.
Event Modeling
One of the primary criticisms from the 9/11 Commission was that the
various federal agencies suffered from a ``lack of imagination''. In
short, terrorists had explored more innovative threat scenarios than
those for which the government had prepared. Having learned this lesson
once, we can not afford to do so again. The recent melamine
contamination provides a stark reminder, even though it was a simple
case of economic subterfuge. Although not its apparent intent, the
event outlined a pathway of contaminating a pet food raw material as a
means of getting a contaminant into animal feed so that it could make
its way into the human food supply. While no public harm resulted from
this non-obvious scenario, it did demonstrate the ability to
contaminate the U.S. food system from afar. It is therefore worth
further investigation if only for the economic and psychological
consequences of such an event.
Realistic, flexible and dynamic models of potential food system
events are thus a very important tool for consequence and vulnerability
assessment, development of shields and mitigation strategies, resource
allocation and decision support during an event. One such modeling
system has been developed through collaboration of NCFPD investigators,
the Food and Drug Administration--Center for Food Safety and Applied
Nutrition (FDA-CFSAN), the U.S. Department of Agriculture--Food Safety
Inspection Service (USDA-FSIS), the Centers for Disease Control (CDC)
and a broad range of state agency experts and the private sector.
Although highly successful, including its use for the 2008 Bioterrorism
Report from the National Bioterrorism Analysis and Countermeasures
Center, efforts on this and other models have highlighted some
significant challenges. While there are specific research projects
already underway in each of these areas, there is still far more to do:
Food and ingredient movement is generally very well
understood within firms, but it is not well characterized
across firms or food and ingredient products. This importantly
includes the degree to which the federal, state and local
agencies can access specific details on movement either in real
time or for planning purposes. Given that supply chain
management is the core competency of many food system
companies, it is unrealistic to expect them to provide details
on how the system works in real time without clear assurances
of the protection of such information. A clearinghouse for such
information that would be accessible for research and threat
assessment purposes, but with no potential for private sector
competitive disadvantage, would be a significant step forward;
Imported products, especially ingredients, represent a
special challenge with which the current data and information
systems were not designed to deal. The Department of Commerce
data on imported food products is based on a categorization
system designed to ensure compliance with various tariffs,
duties and import/export restrictions. Efforts by USDA such as
the Offshore Pest Inspection System (OPIS) and the FDA's
Operational and Administrative System for Import Support
(OASIS) are significant strides forward, but more robust
systems to both enable analysis of product and country specific
imports over time as well as real time targeting for inspection
based on such analyses would be beneficial;
Like all catastrophic event models, food system event
models are based on a broad range of assumptions of how the
various stakeholders in an event would respond--from the
impacted food company to potential patients and everyone in-
between. Event models would be much more useful for all
involved if there were a more robust, exercise driven database
on probable responses and their potential effectiveness.
Agent Behavior
One of the outstanding questions from the E-coli 0157:H7 outbreak
associated with spinach last year is how was the spinach actually
contaminated--did the bacteria come from the soil, animal feces,
process/harvest cross--contamination, irrigation/surface water
contamination or some other source? This challenge stems at least
partially from limited understanding of the bacteria's interaction with
such diverse environments, something which the industry has stepped
forward to address through a competitive research program. Intentional
contamination of food for public health or economic harm elevates the
challenge of understanding how agents interact with the food system to
an entirely new level. This importantly encompasses agent/matrix based
vulnerability assessments, new detection and diagnostic strategies and
potential event response.
DHS, EPA, FDA and USDA, among others, have probed various aspects
of this select agent/matrix challenge. Fundamental projects at both FDA
and USDA on some select agents and other contaminants of concern, and
how they might impact product characteristics or survive in food
products, have increased our knowledge base. NCFPD investigators'
efforts on detection (e.g., botulinum neurotoxin detection
technologies, micro-fluidic pre-analytical sample processing),
inactivation (e.g., Bacillus anthracis process inactivation) and
decontamination (multiple agents in complex systems) are important
steps forward but also illustrative of the challenges ahead, including;
Traditional ``Select Agents'' comprise only a small
subset of the agents of concern. With the food itself serving
as a very effective and efficient delivery vehicle, the agents
of concern go well beyond those of traditional chemical and
biological weapons considerations. If the food can be used to
deliver nutritionally important, targeted levels of vitamins
and minerals, agents that can cause harm could also be thus
delivered. The range of agents that need to be well understood
consequently is far longer than the Select Agents of general
concern;
The range of potential agents highlights a detection
challenge. Melamine is a good example of a potential agent that
would only have been found in the wheat gluten if you knew to
look for it. Conventional quality assurance test methods would
not have highlighted its presence. This would also be true for
a broad range of food/agent combinations so there is a need for
both specific detection technologies for specific agents of
concern and broadly useful techniques to rapidly identify that
something is amiss and thus requires further testing;
Understanding how such agents behave in complex food
matrices and processes is a nascent area of research, and one
that is not traditionally rewarded. Knowing that a particular
chemical will turn a certain fluid food product a strange
color, thus eliminating that combination as a potential threat,
is an incredibly valuable finding for removing a food/agent
combination from the list of those of concern. It is not,
however, the subject of traditional federally-funded research.
Results in this area, nevertheless, will make a significant
difference in enabling focus on a smaller set of agent/food
combinations;
Private companies, academia, national laboratories and
a range of agencies have devoted a great deal of effort to
novel detection technologies, pushing the scientific frontier
forward in innumerable ways. All of you undoubtedly are very
familiar with the ``sniffer'' at Ronald Reagan National
Airport, which represents a great stride forward in detecting
potential explosives to prevent them being taken onto
airplanes. Food systems, however, provide a unique challenge
due to the complexity of the food matrix itself. Food systems
from frozen cream of broccoli soup to hot dogs make the
challenge ever more so difficult than air or bodily fluids.
Novel sample acquisition and pre-analytical processing
strategies are therefore a crucial link in any effective
detection strategy.
Systems Strategies
The systems-based nature of the food system presents inherent
challenges with respect to risk and vulnerability assessments as well
as prioritization of investments to enhance food system protection.
Unlike many of the seventeen critical infrastructures and key
resources, it is primarily composed of complex systems and it is the
interdependencies of these systems that are of most concern in the food
system, not specific assets at a location with an address. This is the
very reason that DHS is funding several projects to look at new
approaches for determining criticality and assessing risk and
vulnerability for systems-based infrastructures. While working toward
new additions to the tool kit for risk and vulnerability assessments
for the food system, there are a number of other systems focused
efforts that can both deliver near term improvements as well as form
the foundation for long term fundamental improvements. Current projects
at NCFPD in food supply chain security and transportation system
resiliency are being coupled with economic assessment tools to help
focus potential investments. In addition, new approaches to both public
health systems surveillance/response and social sciences such as risk
communication are important ongoing NCFPD research efforts and aim at
closing other research gaps. Examples include:
For many foodborne illness outbreaks today, the
detection system that identifies that a food has been
contaminated is the public health system. For the melamine
contamination it was veterinarians identifying unusual patterns
of illness and for the E-coli 0157:H7 associated with spinach
outbreak last year it was the public health authorities at
state and local level. In both cases, however, much of the food
had already been consumed before anyone identified the problem.
Any approach that could therefore decrease the time from first
presentation of illness to recognition of the outbreak could
dramatically reduce the potential consequences.
An ongoing example of such efforts that includes investigators
from NCFPD, other academic institutions and collaborators
across federal agencies and associations is an examination of
how various local, state and federal agencies respond to and
manage foodborne illness disease outbreak investigations. The
goal is to develop a set of performance standards that result
in an even more rapid response to any food related disease
outbreak than is already provided today;
Reducing the potential vulnerability within any
specific food supply chain, including its distribution system,
first requires characterizing how that system functions in the
interdependent infrastructures we have today. Once
characterized, more effective vulnerability and risk
assessments are possible, thus highlighting points for the most
effective introduction of interventions by either the private
or public sector. Projects are underway that look at best
practices in the food industry as a starting point. These
studies will be complemented by recently initiated efforts on
more detailed analyses of the transportation system and
imported product pathways. Perhaps more so here than in any
other area, public-private partnerships are crucial to moving
things forward as each group has detailed information in
different areas that have to be brought together for an
effective outcome;
A challenge for all investments in terrorism
prevention, response and recovery is determining how much
should be spent to reduce the probability or the consequences
of an attack. In either the private or the public sector, there
is a limited amount of potential funding available and it has
to be focused on the points of greatest impact. This is perhaps
even more important in the food system than in some of the
other critical infrastructures because of its complicated,
globally dispersed and highly dynamic, privately held, nature.
Secondary benefits for food defense-motivated investments,
alternative investment returns through vehicles such as
insurance/re-insurance and better means of capturing the
potential impact of events at the firm and system level are all
areas of ongoing research that should help guide future
investments;
In the focus on ``hard'' tools for event prevention
and response, the importance of ``soft'' tools such as risk
communication is often overlooked. Effective risk communication
before, during and after an event will significantly reduce the
consequences of the event itself. Food, because of its very
personal nature, requires that any such risk communication
strategies take into account the very different information and
communication needs of the range of groups and cultures in the
U.S. Research on how to communicate most effectively with
various underserved and non-traditional audiences is
highlighting the range of strategies required. This research
importantly includes the current collaboration of NCFPD
investigators and other experts with the various federal,
state, local and private sector groups who are front and center
in any food system event. Products such as the NCFPD developed
Risk Communication Best Practices are only a start in the
significant effort to use risk communication as an effective
intervention strategy.
Summary
Outstanding progress has been made by both the private and public
sectors in reducing the probability and potential impact of intentional
food contamination. Much more, however, is needed for full and
effective implementation of HSPD-9. This includes the need for ongoing
basic through applied research to address each of the primary policy
areas identified in HSPD-9 for effective protection of the food system:
Prioritization of the critical food protection and
defense needs is a continual process due to the dynamic nature
of our food system. As the system changes, our research
strategies, prevention efforts and preparedness must change.
Supply and demand changes, new products, new markets, and new
consumer demands drive the ever changing nature of our food
system. The shift of corn from animal feed to ethanol
production illustrates this well;
Forewarned is forearmed. Understanding changes
underway and anticipating their impacts underpins effective
early warning systems and robust prevention and preparedness.
Public-private partnerships can support robust food system
intelligence to recognize potential threats. While imports of
wheat gluten from China nearly doubled between 2005 and 2006,
and economic adulteration was rampant, we were unaware;
Mitigating vulnerabilities at critical production,
processing, distribution and other nodes builds off of the
identification and prioritization of critical elements and
resources within the food system, but includes the need to
develop new mitigation strategies as the vulnerabilities
continue to evolve. Collaboration across DHS, EPA, FDA, USDA,
state/local agencies, the private sector owners of the food
system and academia will be an important ongoing partnership
for vulnerability mitigation strategy/technology development
and cost effective deployment;
Melamine contamination, antibiotic residues in
imported fish and other imported product adulterations
illustrate the need for enhanced screening procedures for
imported products. Foodborne illness outbreaks associated with
domestically sourced products reinforce that the same need
exists for domestic production. Unfortunately it is just as
unlikely to successfully ``test in'' food system defense as it
is to ``test in'' food safety. Enhanced procedures for
targeting inspection and detection will continue to be
important from the farm (wherever in the world it is) through
distribution to the final containment point, prior to consumer
access;
Given the degree to which the global food system is
necessarily open and therefore potentially vulnerable, efforts
must include enhancing response and recovery procedures to deal
with the realistic probability that there will be an actual
food system event. Both public/private partnerships and very
innovative strategies for preparedness will be required for
effective response and recovery efforts;
Determining the right way to communicate to
underserved communities is best not done in the face of a
crisis just as designing practical facility decontamination and
contaminated product disposal protocols is best not done when
you have contaminated facilities and products. It will take
continual effort to develop flexible strategies to make
response and recovery efforts most effective;
Across all of these policy goals for HSPD-9, the need
to develop the future leaders in food protection and defense is
central to creating the enduring capability that is needed in
the future. The students, from high school through post-
doctoral, that are engaged in NCFPD and other academic programs
in food protection and defense are how the policy goals
outlined by HSPD-9 and addressed above are made sustainable
over the long haul.
In conclusion, Mr. Chairmen and Members of the Subcommittee, thank
you again for the opportunity to talk with you about recent food system
events and the challenges they represent for protecting and defending
our food supply. The threat of intentional contamination of our food is
real. While we all have come to enjoy an abundant, affordable, diverse
and safe food supply as our birthright, our overall successes have made
us complacent. Our food system is global and will always be global: we
all demand coffee and chocolate; bananas and bonita. . .and our year-
round cornucopia of food results from an ever-changing global supply
chain. Ironically, the very advances that afford us these luxuries also
create new dilemmas: a small intentional contamination can become a
national foodborne disease outbreak due to the scale of production and
wonder of the supply chain. We need better food system intelligence,
more flexible and responsive prevention, preparedness, response and
recovery strategies, and an expanded armamentarium of technology,
training professionals and tested interventions to meet these new
challenges. The university research community is an important partner
in this national imperative. As Co-Director, on behalf of the National
Center for Food Protection and Defense (NCFPD), we are honored to have
provided you with our perspective on continuing research needs and how
university researchers can help address this global threat to food
system and American way of life, and defend the safety of the food
system through research and education.
Mr. Langevin. Thank you, Mr. Kennedy.
The Chair now recognizes Dr. Myers for 5 minutes.
STATEMENT OF DR. LEE M. MYERS, STATE VETERINARIAN AND ASSISTANT
COMMISSIONER OF ANIMAL HUSBANDRY, GEORGIA DEPARTMENT OF
AGRICULTURE
Dr. Myers. Mr. Chairman and members of the committee, thank
you for the opportunity to testify as to the State involvement
in protecting our Nation's food and agricultural systems. My
name is Lee Myers. I am the State Veterinarian and Assistant
Commissioner with the Georgia Department of Agriculture, and I
am appearing here today on behalf of the National Association
of the State Departments of Agriculture and as President of the
United States Animal Health Association. NASDA represents the
commissioners, secretaries and directors of agriculture in the
50 States and 4 territories, and the USAHA has served as the
Nation's animal health forum for well over a century. I would
like to outline the critical role that State agriculture
departments play in defending agriculture and food in our
country and describe our efforts and challenges to build
capacity to combat food and agricultural emergencies.
State agriculture departments license, permit, inspect, and
oversee activities along the entire farm to fork continuum in
cooperation with our Federal partners, with the USDA and the
FDA. You may be surprised to hear that 80 percent of all food
inspections nationwide are conducted by representatives of
State and local authorities. State employees by the thousands
are on the ground each day, inspecting agricultural facilities
at the operational level. We own farms; we own buying stations,
slaughterhouses, food processors, cold and dry storage units,
warehousers, wholesalers, retail and food service
establishments. We also oversee the transportation of
agricultural commodities and products between all of these
entities. Our employees collect samples, analyze those samples
in State laboratories, and issue seals of approval that
commodities or products meet the government standards to be
transported, planted, processed or otherwise consumed by the
general public.
When problems arise, such as these recent recalls that have
been discussed earlier today of spinach, peanut butter, canned
meat products, and pet foods, it is the employees of the State
Departments of Agriculture who respond within hours to track
down these contaminated products, assure that these recalled
items are removed from the grocery shelves, and directly
oversee their destruction. Also, State Departments of
Agriculture are the primary agencies responsible for the
protection, response and recovery to animal and plant pests and
diseases, natural disasters and other hazards that can harm the
agricultural industry.
We must recognize that 99 percent of emergencies are not
incidents of national significance and are managed by State and
local authorities, not the Federal Government. This includes an
outbreak of a foreign animal disease, which would be managed
through a unified command structure with our colleagues in the
USDA, utilizing State-issued quarantines and State requirements
for carcass disposal and State requirements for debris removal.
The DHS recognizes that State regulatory programs and
laboratories are the backbone of the Nation's public network
for ag and food safety.
What I have described, gentlemen, is the boots on the
ground, front-line defense for our Nation's food and ag. This
is ``a day in the life'' of the State Department of
Agriculture. Although the vast majority of resources and these
tactical operations and interfaces with the private sector are
realized at the community level, States are the most
underfunded component of the national food and ag security
strategy. Available funding is irregular; it is modest and on a
catch-as-catch-can basis. So how can Congress help us get it
right and overcome the challenges of building the necessary
capability to combat food and ag emergencies?
Firstly, there is an urgent need for Congress to provide
consistent and sustained funding to State agricultural
authorities, to develop agricultural security programs and
abilities within each State. The USAHA at its last annual
meeting passed a resolution urging Congress to appropriate
funding to States for the development of animal emergency
management plans and the implementation of sustainable
capabilities. It is difficult to rationalize that the U.S.
Government doles out billions to protect our ability to surf
the World Wide Web, and yet, the March 2007 Congressional
Research Service Report indicates that agriculture has received
on average 2 percent of the nondefense Homeland Security budget
over the last 5 years to assure that we have a safe and secure
food supply, one of the primal essentials to sustain life. Ag
and food defense must become a national priority and require
that it be named as a State priority on State strategic plans.
We believe that resources should be directed to each State
agency and that Congress and Federal departments should develop
a detailed, integrated budget with sustainable dollars.
Secondly, we recommend that Congress request Federal
departments to work with States to expedite the development and
the implementation of tools to identify critical infrastructure
and key resources and conduct vulnerability assessments. NASDA,
in cooperation with the USDA, the FDA and the DHS, announced
the availability of a model food emergency response template
over a year ago, and this template provides a guidance for
managing food emergencies of varying magnitudes. However, State
government agencies need assistance to develop and to implement
their food emergency plans, and we believe it is cost-effective
to invest in State and local governments with these valuable
tools. NASDA has also partnered with other stakeholders to
develop similar tools for the animal and plant sectors, but
again, resources are short to complete the development and the
implementation for tactical work in the States.
Thirdly, there is no operational, comprehensive and secure
communication network for agriculture to share these alerts of
threats and linking local, State, Federal, and private partners
with the appropriate security clearances. The DHS has
identified strengthening information-sharing and collaboration
as a specific priority, but quite frankly, progress is moving
at a snail's pace, and as a consequence we have these
duplicative communication systems that rarely communicate with
each other. A single integrated Homeland Security communication
network for all sectors, including ag and food, should be
imperative and a time certain established. The fulfillment of
these three requests would be a good start in mitigating the
current crisis of confidence that was referenced earlier.
In conclusion, the State Departments of Agriculture and the
USAHA appreciate the efforts of Congress and the administration
to enhance the safety and security of our food supply, but yet
there is a lot of work that needs to be done, and we want to be
in full partnerships with our Federal colleagues to help ready
America to prepare for, to plan for and to stay informed during
significant agricultural or food emergencies.
Thank you, Mr. Chairman, for the opportunity to share a
State perspective with the committee.
[The statement of Dr. Myers follows:]
Prepared Statement of Dr. Lee M. Myers
Mr. Chairman and members of the Committee, thank you for the
opportunity to testify on the safety and protection of our Nation's
food and agriculture system against terrorist attacks, major pests and
diseases and other emergencies. My name is Lee Myers. I am the State
Veterinarian and Assistant Commissioner of Animal Industry for the
Georgia Department of Agriculture, and I appear here today on behalf of
the National Association of State Departments of Agriculture (NASDA).
NASDA represents the commissioners, secretaries and directors of
agriculture in the fifty states and four territories. States clearly
form the first line of defense against the threat of a terrorist attack
against our food supply. Today, I would like to broadly outline the
critical role the state agriculture departments play in food safety and
defense, and describe our efforts and challenges to prepare for food
and agriculture emergencies.
Complexity of Regulation for Food and Defense of the Agriculture Sector
The ``farm to table'' food supply chain is a complex system that
includes millions of acres of cropland, billions of livestock and
poultry, thousands of feedlots, processing plants, warehouses, and
packaging and distribution networks that bring food from around the
nation and the world to neighborhood markets and restaurants across the
nation.
The threat of a terrorist attack on the food and agriculture
industries is likely to involve the contamination of commodities rather
than the destruction of infrastructure. However, the diverse and
widespread nature of the industry makes it extremely difficult to
identify and secure every facility that might be a potential target. In
the case of food, for example, introduction of minute levels of certain
hazardous agents could cause widespread harm, including serious
economic and social disruption. Local, state and federal partners as
well as the industry itself have already taken important steps to help
protect the food and agriculture industry from terrorist attack. NASDA
believes there needs to be a greater linkage at all levels of
government and the private sector of resources, expertise, and
initiatives to achieve our shared security and emergency preparedness
goals.
Roles of State Agriculture Departments in Food Safety and Defense
Protecting the nation's food and agriculture industry demands the
coordinated effort of public, private and university partners in the
same way that all of these stakeholders have cooperated for decades on
issues of food safety, animal health and plant protection. In the area
of food safety, for example, the statistics are surprising: while this
is the shared responsibility of all partners, approximately 80% of all
food safety inspections are conducted by state and local agencies.
State agriculture departments need sufficient field inspection
forces to promote biosecurity of food and agriculture businesses;
enhance prevention by enforcing uniform food and agriculture safety and
security laws with industry; provide routine surveillance of food,
plant and animal products; respond quickly in the event of an attack;
and provide the means to restore confidence in the food and agriculture
sector. States agriculture departments are the lead agencies in the
prevention, detection and eradication of plant and animal pests and
diseases in accordance with the national and state response plans.
Vulnerability
Recent food safety events have made regulatory agencies and
industry realize the landscape of food safety and defense is changing.
Risks include the tremendous growth of the imported foods market with
limited regulatory oversight and centralized food production,
processing and storage. According to USDA's Foregin Agriculture Service
(FAS) statistics, 48 percent of America's agricultural consumption was
imported in 2007. This includes ``bulk'' products such as wheat and
cotton, ``intermediate'' products such as oils and livestock,
``consumer oriented'' products such as butchered meat and vegetables,
and ``other'' products such as timber and seafood.
State regulatory programs and laboratories are currently the
backbone of the Nation's food safety network. However, threats to the
food supply typically cross state borders and have national
implications. There are limited resources to develop preparedness and
response plans for animals and plants (i.e. crops, hay, pasture, and
rangeland). ``Point source'' facilities exist in agriculture (plans to
protect them are similar to other fixed facilities). The ``nonpoint
sources'' are more difficult to plan for, but need to be carefully
considered in any agriculture preparedness and response plans.
Vulnerability Assessments in the Food and Agriculture Sector
The assessment of terrorist threats to food and agriculture and
evaluation of the agriculture industry's vulnerabilities will form the
basis for developing a preparedness and response strategy for the
Nation's food and agriculture industry. The challenge is to determine
the likelihood of various forms of attack and identify on a priority
basis the gaps in the existing systems.
The states have been conducting this activity for several years. In
July 2004, NASDA and it's affiliate organization, the Association of
Food and Drug Officials (AFDO) conducted a survey of states to collect
information about homeland security activities in state departments of
agriculture. The purpose of the survey was to obtain a baseline
assessment of state initiatives, including emergency response and
planning, vulnerabiilty assessments, specific funding for agriculture
and food defense, and training. All fifty states responded to this
baseline survey. The survey data found that many states had completed a
substantial number of vulnerability assessments utilizing a variety of
methods from formal surveys and expert panels to informal assessments
during regular inspections. The survey found that many states had
developed plans across all sectors of the plant, animal, and food areas
to mitigate perceived vulnerabilities.The survey also found that states
have participated in dozens of exercises or drills to test emergency
response capability and most included other state or federal agencies.
Specific highlights of the survey results are:
52% of respondents indicated that their food program
had received some level of funding for food security
initiatives.
56% or 28 states have developed a written food
emergency response plan.
44% or 22 states have conducted some type of food and
agriculture vulnerability assessment.
18% or 9 states have developed some type of
vulnerability reduction plan to address food and agriculture
vulnerabilities.
The baseline survey results indicate that states are engaged in
many areas of food and agriculture defense, but more needs to be done.
In addition, states are working with our federal partners in
several activities. We are participating in the Administration's Food
and Agriculture Coordinating Council (FACC) and Government Coordinating
Council (GCC) to help meet the goals of Homeland Security Presidential
Directive 9 (HSPD-9). Many state agriculture departments have
participated in vulnerability assessments through the Strategic
Partnership Program on Agroterrorism (SPPA), and we commend USDA for
this collaboration. SPPA is a Federal Bureau of Investigation (FBI)-led
partnership with FSIS, the Food and Drug Administration (FDA) and the
Department of Homeland Security (DHS) that brings a variety of
stakeholders together to conduct vulnerabilty assessments on a variety
of food commodity systems. One goal of the SPPA initiative is to
identify countermeasures that need to be developed.
However, state departments of agriculture need access to the
findings of SPPA to help develop cost-effective measures to enhance our
ability to prevent an attack, detect an attack at the earliest possible
time, respond to protect both the public health and industry and
recover from an attack by restoring public confidence and the economic
viability of affected sectors. NASDA urges USDA, FDA, DHS, and other
federal partners to complete risk and vulnerability assessments in all
areas of the food and agriculture industry and share information
relevant to the development of specific state preparedness strategies.
Such information sharing is imperative as states develop and refine
individual State Homeland Security Strategies (SHSS) and will be
important for the seamless integration of state plans into the National
Homeland Security Strategy.
These initial efforts have strengthened our ability to prevent,
rapidly detect, and respond to bioterrorism incidents, but need to be
expanded. One key issue at the state level is the amount of effort
required to accomplish this huge task. DHS, FDA, and UDSA have funding
to accomplish vulnerability assessments, but the availability of
funding is a ``catch as catch can'' basis from state to state. Funds
need to be targeted directly to the state departments of agriculture to
accomplish this work.
Without better targeted and consistent funding, we will have to
compete with other non-agriculture in-state homeland security entities.
For example, the state homeland security grants have an 80/20 split,
with the local governments receiving 80% of the funding. We realize
that all emergencies are local, and for the most part this is a model
that works well. However, there is no local authority for agriculture
agencies as exists for public health, fire services, or law
enforcement. The agricultural authority in most states rests with the
state agriculture department; but since these departments are
considered a ``state'' entity, they do not qualify for the local
funding. This discrepancy needs to be remedied to benefit state food
defense capability.
Challenges for State Departments of Agriculture
Emphasis Needed on Food Defense
The President's National Homeland Security Strategy recognizes the
importance of securing the Nation's food supply and designated
agriculture as a ``critical infrastructure.'' However, ``food defense''
is difficult to achieve and needs to be considered one of the highest
priorities for DHS. NASDA has been concerned that the emphasis on
homeland security in border protection overshadows the need to remain
vigilant in protecting the food and agriculture industry from the
introduction of pests and disease at the border. We strongly believe
that prevention of animal and plant terrorism and protection for the
Nation's food supply must be considered a critical priority of DHS.
Federal Funding and Support
Managing the short and long term consequences of an attack on the
food supply is among the responsibilities of state and local government
supplemented by the resouces of the federal government. Issues related
to activities such as initial response, animal and plant quarantines,
withhold orders, tracing of contaminated product, secure communications
following an event, and short and long term recovery are some of the
many responsibilities faced by state governments.
To date, federal support for state departments of agriculture for
agriculture and food defense has been very limited and inconsistent.
Modest USDA support was provided to enhance animal and plant
laboratories and to begin work on projects including rapid notification
and other systems. While almost a billion dollars in FY03 was provided
through the Centers for Disease Control (CDC) to state health agencies
for uses including food security, agriculture departments have been
excluded from receiving funds. In June 2003, NASDA released a state
resource survey conducted by AFDO. The survey data indicated that of
$960 million federal counter-terrorism funding given to states, a mere
$43 million (4.5%) went to Plant and Animal Disease Response,
Surveillance and Testing; and $3.6 million (0.4%) was devoted to
protecting all other elements of the food supply, such as
manufacturing, processing, distribution, storage and retail levels for
food.
Federal funds should be better targeted and consistent to help
states accomplish many of the tasks described above. The Congressional
Research Service (CRS) issued a Report to Congress on March 12, 2007
titled ``Agroterrorism: Threats and Preparedness.'' The report notes
that ``as a percentage of non-defense budget authority for homeland
security, agriculture receives about 2.1% of the total.'' The report
further notes that ``regular appropriations for agriculture in DHS are
irregular and tied to particular initiatives, such as university
research grants or facility construction.''
DHS Grant Program
NASDA has been very concerned that the overall decreased funding
available to states under the DHS Homeland Security Grant Program will
have a significant impact on states' abilities to prepare for
emergencies affecting food and agriculture. The problem is further
complicated by the fact that the grant program is currently one of the
only sources of funding to states to support homeland security
preparedness in all sectors. DHS could address this problem by assuring
that the risk calculation--which is one of two components that is used
to determine each state's allocation under the grant program--fully
considers the risks, vulnerabilities, and impacts associated with
threats to our food and agriculture sector.
With appropriate funding, states could:
develop programs dedicated to food defense, animal
defense, and plant defense;
improve inspection, testing and surveillance activities;
conduct additional threat, vulnerability and risk
assessments;
work with industry to identify critical infrastructure,
key resources, and develop mitigation strategies and defense
capabilities.
Food and Agriculture Defense Planning
The states are particularly interested in one activity where DHS
could assist in food defense planning and preparedness training for
state agriculture, health and emergency management agencies. In
Feburary 2006, NASDA, in cooperation with USDA's Food Safety Inspection
Service (FSIS), the Food and Drug Administration (FDA), and the
Department of Homeland Security (DHS), announced the availability of a
model Food Emergency Response Plan Template. The template is a tool
that will enhance the protection of the Nation's agricultural industry
and food security through increased prevention, detection, response,
and recovery planning.
The template provides states with a guide for developing a food
emergency response plan. It is designed to assist states with
development of either a stand-alone plan for responding to a food-
related emergency or an addendum to an existing all-hazard state
emergency response plan. Because a food emergency could occur at any
point in the food chain from farm to fork, including pre-harvest
production and transportation, the application of this template assists
in managing emergencies with varying magnitude and scope.
The template is also a ``building block'' in the national effort to
develop a seamless system of food defense from local, state and federal
perspectives. It identifies how these efforts will be effectively
integrated with the National Response Plan (NRP) and state response
plans, including descriptions for responding to, mitigating and
recovering from a domestic incident. In addition, the template provides
a baseline structure for preparing state-level plans to protect
critical infrastructure and key resources identified through the
National Infrastructure Protection Plan (NIPP).
The state agriculture departments and other state government
agencies need assistance to develop and implement their food emergency
plans, along with preparedness training and education. NASDA has asked
DHS to provide initial funding for this activity. We believe it is
cost-effective to provide state and local governments with a valuable
readiness tool to facilitate seamless regional and national responses
to food emergencies.
In addition to the food defense template, NASDA has partnered with
others at the state and regional level to develop animal and plant
defense planning and response templates. These templates are in a final
stage of development, but additional funding is needed for full
implementation and associated training. These templates should be
incorporated into the context of an all-hazards approach.
Communications and Coordination of State and Federal Resources
Providing the means for the food and agriculture sector to
communicate during all phases of emergency management, particularly
during a response, is the foundation for overall preparedness. There is
a vital need to establish a well coordinated and efficient
communication strategy that links agriculture stakeholders and allows
for the rapid dissemination of information. Since local and state
agriculture or health departments will often be the first to respond to
a food emergency, communication channels between local, state and
federal partners must be clearly defined and practiced. The same is
true for any animal or plant emergency as well. Some of the information
that needs to be efficiently shared includes: specific threat alerts
from intelligence partners; incident notifications from field staff,
industry or others; routine surveillance information from inspections,
laboratory analyses and other local and state sources; and other
information deemed critical to preventing human illness, death or
serious economic harm to the industry from a terrorist attack at any
juncture from farm to fork.
State and federal governments must effectively communicate and
coordinate resources in an emergency using the Incident Command
Structure (ICS). Despite the federal emphasis on ICS, the response to
the recent melamine contaminated proteins was not managed using ICS.
States had no situational awareness and could not effectively respond
to their constituents. The Nation's slow response eroded consumer
confidence in the pet food industry and threatened the confidence of
the human food supply. While not a replacement for ICS in this event,
NASDA set up and operated an information network to keep directly
affected states informed.
The use of ICS would have allowed the federal government to
leverage state resources during the response to the melamine incident
and other national recalls. Resources include animal diagnostic
laboratories, food testing laboratories, and regulatory and
administrative personnel to repond to and support the concerted effort.
As we strengthen our laboratory resources and other response
capabilities, management of resources on a national scale using ICS
will become increasingly important.
At present, there are serious impediments to establishing such a
system which need to be addressed. These include:
The loss of information through unnecessary
``classification'' of documents, and the inefficient processing
of security clearances for state agriculture officials;
Federal resistance to accepting investigation results,
recalls and other actions from nationally accredited state and
local laboratories;
The lack of an operational, comprehensive and secure
communications network to share threat alerts and other
information linking local, state, federal and private partners,
with appropriate security clearance;
The lack of a comprehensive incident notification
process for the food and agriculture industry;
The lack of adequate risk communications preparedness
and response planning and training; as a result, states are
hampered in their ability to disseminate adequate safety and
technical information to the media and public during an
incident.
Many state agriculture officials have experienced substantial
delays in the processing of their security clearances. In order for
NASDA to function as an important organization, assisting in the
liaison between state and federal governments, and participate fully in
the homeland security initiatives of the food and agriculture sector
government coordinating council, key staff have a need to know certain
sensitive information. There is an immediate need for DHS to expedite
security clearance applications for key state agriculture personnel.
NASDA also believes more effort is needed to address the
communications gap bewteen state and federal partners in the sharing of
critical information and intelligence. Federal agencies should review
currently classified information and make determinations about whether
it needs to remain classified for security purposes. The results of
state and local inspections and laboratory analyses found to be
consistent with federal requirements should be recognized as equivalent
to federal inspections and analyses. Development of rapid
communications and incident notification systems should have top
priority and include both public and private sector decision-makers.
NASDA supports ongoing work being done by DHS to implement the
Homeland Security Information Network (HSIN). HSIN could be a
significant communications tool for local, state and federal partners,
but the system is not yet operational, despite years in the making.
Another important area is the need to protect the confidentiality
of information. Because the majority of agricultural assets are in the
private sector, necessary information may be proprietary or pertain to
trade secrets or business operations. Congress should require that such
information obtained from the states be maintained as confidential.
Recommendations to Enhance Food and Agriculture Defense Capabilities
As we have emphasized throughout our testimony, states clearly form
the first line of defense against the threat of a terrorist attack
against our food supply. The federal government should capitalize on
the proven strengths of the state programs by providing funding,
guidance, and coordination of resources to effectively protect the
agriculture and food sector. NASDA offers the following recommendation
to enhance our food and agriculture defense capabilities:
Congress and federal departments should develop a
detailed integrated budget for food and agriculture defense, as
requested by HSPD-9.
DHS should survey state departments of agriculture to
determine homeland security requirements; further DHS should
fund these requirements as a priority through state grants or
other federal legislation that directs resources for food and
agriculture defense.
DHS should develop an action action review process for
agriculture and food incidents of national importance; such review
should identify the gaps, lessons learned, and solutions to improve
reponse and coordination.
DHS Office of Health Affairs should review the Homeland
Security State Grant Program for food and agriculture defense and
publish annual guidance for this sector to better target resources.
Conclusion
The state agriculture departments appreciate the efforts by
Congress and the Administration to enhance the safety and security of
the Nation's food supply and the agricultural production system which
supports it. As partners in the federal system, we stand ready to work
with the Committee and Congress to accomplish these goals.
Mr. Langevin. Thank you, Dr. Myers.
The Chair now recognizes Dr. Henry to summarize his
statement for 5 minutes.
STATEMENT OF DR. CRAIG HENRY, SENIOR VICE PRESIDENT AND CHIEF
OPERATING OFFICER, SCIENTIFIC AND REGULATORY AFFAIRS
Mr. Henry. Thank you, Mr. Chairman and members of the
subcommittee, for inviting GMA to participate in this hearing
to discuss Federal efforts to mitigate vulnerabilities to the
food supply chain.
The food industry is committed to assuring the safety and
security of the U.S. food supply. Food defense addresses the
intentional adulteration of food products and/or ingredients
using chemical, biological, radiological agents. This requires
a vigilant effort from the food manufacturer to know how to
identify the vulnerabilities and to adopt effective mitigation
strategies.
The food industry has worked collaboratively with various
Federal agencies for several years now to ensure the best
practices are identified and disseminated and to develop
mechanisms for Federal agencies to share intelligence with the
food industry that can enable companies to target their
vigilance.
In preparing for a deliberate attempt to contaminate the
food supply, food companies have participated in vulnerability
assessments with government officials, with industry trade
associations or independently, and participated as well in
Table Top Exercises designed to simulate an actual attack on
the food supply.
Food safety and food defense are the ultimate goal of all
food companies, and achieving that goal requires the
cooperative efforts of the regulatory agencies; that is
Federal, State and local, as well as the food industry.
Deliberate contamination of the food supply is still viewed
as a relatively low potential risk but a serious concern versus
food safety concerns from conventional contamination or product
mishandling or mislabeling, which also includes economic
adulteration, which has the potential to be a food safety
event.
I would like to mention the Strategic Partnership Program
on Agroterrorism. The ``SPPA,'' as it is referred to, is a
cooperative initiative among Federal and State government
agencies and private sector volunteers to provide government
and industry with more a complete, sector-wide perspective of
food and agricultural defense. Under the initiative,
vulnerability assessments are conducted in the food and
agriculture sector using CARVER+Shock evaluation to help
distinguish between real and perceived food defense
vulnerabilities and risks.
The Public Health Security and Bioterrorism Preparedness
and Response Act of 2002, otherwise known as the ``Bioterrorism
Act,'' provided the FDA with the authority to promulgate
regulations concerning the registration of food facilities, the
establishment and maintenance of records, prior notice of
imported food shipments, and the administrative detention of
food. The FDA rules are in place and are being enforced.
Unfortunately, funding for the 600-plus additional inspectors
initially provided to the Center for Food Safety and Applied
Nutrition to better enforce the regulations has evaporated, and
the Agency has had to reduce staffing to cover the budget. This
has largely negated any gain in efficiency the Agency perceived
by having prior notice of all food imports so they could
coordinate sampling and inspection efforts. Agency funding is
critical to enforcement operations.
The GMA is an active member of the Food and Agriculture
Sector--Government Coordinating Council. This is a self-
organized, a self-run and a self-governed committee composed of
members in the food and agricultural sectors, and it serves as
the government's point of entry into each sector for developing
and coordinating a wide range of infrastructure protection
activities and issues.
There is also the Food and Agriculture Sector Joint
Committee on Research. This committee has identified a number
of private sector needs such as better vulnerability assessment
tools. As mentioned previously today, the FDA recently released
a CARVER+Shock software tool that provides a means for all
companies to conduct a vulnerability assessment of their
operations. CARVER+Shock vulnerability assessment tool is used
to assess the vulnerabilities within a system or infrastructure
to an attack. As you may know, ``CARVER'' is an acronym for
Criticality, Accessibility, Recuperability, Vulnerability,
Effect, and Recognizability.
A seventh attribute, ``Shock,'' has been added to the
original six to assess and combine health, economic,
psychological impacts of an attack within the food industry.
Lastly, I would like to mention another valuable tool,
which is the Table Top Exercise. Joint industry, regulatory
agency, health department, and law enforcement officials
participate in training exercises simulating an intentional
product contamination event.
Thank you for the opportunity to be here with you today,
and I am pleased to answer any questions you may have.
[The statement of Mr. Matthys follows:]
Prepared Statement of Dr. Allen W. Mathys
Mr. Chairman and Members of the Subcommittee
I am Allen Matthys, Vice President, Federal and State Regulations,
Grocery Manufacturers Association (GMA). Thank you for inviting GMA to
participate in this Hearing to discuss Federal efforts to mitigate
vulnerabilities in the food supply chain. The food industry is
committed to assuring the safety and security of the U.S. food supply.
This includes company or third part audits as well as a review of any
government inspection reports.
Food safety concerns deal with identifiable risks and incorporate
mitigation steps (including Hazard Analysis Critical Control Point
(HACCP) evaluations, time/temperature processes, etc.) to control or
reduce the likelihood of a problem occurring. Food defense addresses
the intentional adulteration of food products and/or ingredients using
chemical, bacteriological and/or radiological agents. This requires a
vigilant effort from the food manufacturer to know how to identify the
vulnerabilities and to adopt effective mitigation strategies.
The food industry has worked collaboratively with various federal
agencies for several years to ensure that best practices are identified
and disseminated and to develop mechanisms for federal agencies to
share intelligence with the food industry that can enable companies to
target their vigilance.
In preparing for a deliberate attempt to contaminate the food
supply, food companies have participated in vulnerability assessments
with government officials (the Strategic Partnership Program
Agroterrorism (SPPA)), with industry trade associations, or
independently and participated in Table Top Exercises designed to
simulate an actual attack on the food supply. The SPPA program
introduced industry to the CARVER + Shock vulnerability assessment but
the information was available only to those companies that participated
in the SPPA event. FDA recently released a CARVER + Shock software tool
that provides a means for all companies to conduct a vulnerability
assessment of their operations.
Food safety and food defense are the ultimate goal of all food
companies. Achieving that goal requires the cooperative efforts of the
regulatory agencies (federal, state, and local) and the food industry.
Food Industry Action
When information surfaced indicating that the food and agriculture
sector was considered as a potential target for terrorist
organizations, regulatory officials communicated this information to
the industry. FDA officials indicated that they had conducted an
internal analysis of several food product categories using the CARVER +
Shock analyses and identified a number of considerations that affect
the risk that a food, at a particular point in its production, could
become the target of intentional contamination. The following four
characteristics were common to each of the food products identified as
being at a higher risk:
Large batch size, resulting in large number of servings
Short shelf life or rapid turnaround at retail and rapid
consumption
Uniform mixing of contaminant into food
High accessibility to the critical node of production,
processing or distribution
The ``higher risk'' foods received priority attention by FDA for
the identification and implementation of preventive measures. Likewise,
USDA began a similar analysis of meat and poultry products. [The
initial reports were then provided to Department of Homeland Security
(DHS) officials and duly classified as ``Top Secret'' and thus became
inaccessible to food industry representatives.]
Points to Cover:
Deliberate Contamination still viewed as a low potential risk
versus food safety concerns from conventional contamination or product
mishandling or mislabeling (also economic adulteration has potential to
be a food safety event).
Strategic Partnership Program Agroterrorism (SPPA)
Individual food companies have volunteered to participate in the
SPPA program for several commodity groups identified by FDA/USDA as
fitting the potential target profile. The SPPA is a cooperative
initiative among federal and state government agencies and private
sector volunteers to provide government and industry with a more
complete sector-wide perspective of food and agriculture defense. Under
the initiative, vulnerability assessments are conducted in the food and
agriculture sector using CARVER + Shock* evaluation to help distinguish
between real and perceived food defense vulnerabilities and risks
within the food and agriculture sector. It also assists in identifying
potential mitigation measures and strategies that may be appropriate
for the food and agriculture sector. In addition, the SPPA has assisted
in the identification of research needs and the allocation of research
investments to address priority needs.
These vulnerability assessments with industry on a variety of foods
regulated by the Food and Drug Administration a number of research
questions were generated. The commodities evaluated were dairy
products, fruit juices, bottled water, water used for food processing,
and infant formula. The research questions fell into the following
general categories:
partitioning of chemical compounds into the water or lipid
fractions of a food;
thermal stability of chemical and microbiological agents;
stability of chemical and microbiological agents to acidic
and alkaline pH;
changes in food conductivity upon exposure to chemical
agents;
UV inactivation of biological agents;
effectiveness of disinfection agents against chemical and
biological agents;
oral toxicity of chemical agents; and
filtration to eliminate or reduce chemical and biological
agents
A summary of the main research results released to date is provided
at
http://www.cfsan.fda.gov/dms/defres05.html
Regulatory Requirements under Bioterrorism Act
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Bioterrorism Act) provided FDA with the authority
to promulgate regulations concerning registration of food facilities,
establishment and maintenance of records, prior notice of imported food
shipments and administrative detention of food. FDA rules are in place
and being enforced. Unfortunately, funding for the 600+ additional
inspectors initially provided to CFSAN to better enforce the
regulations has evaporated and the agency has had to reduce staffing to
cover the budget. This has largely negated any gain in efficiency the
agency received by having prior notice of all food imports so they
could coordinate sampling and inspection efforts. Agency funding is
critical to enforcement operations.
GMA is an active member of the Food and Agriculture Sector--
Government Coordinating Council (FASCC).FASCC
A self-organized, self-run and self-governed committee, composed of
members in the food and agriculture sector that serves as the
government's point of entry into each sector (i.e., plant and animal
producers, processors/manufacturers, restaurants/food service, retail,
warehouses and agriculture production) for developing and coordinating
a wide range of infrastructure protection activities and issues (e.g.,
research and development, outreach, information sharing, vulnerability
assessments/prioritization, shielding and recovery).
GCC FASCC: The government counterpart to the SCC that is
established to enable interagency coordination of agriculture and food
defense strategies and activities, policy, and communication across
government and between the government and each sector to collaborate
and develop consensus approaches to the CI/KR protection. Membership is
comprised of various levels of government (Federal, State and
Territorial, local and tribal). .
Food and Agriculture Sector Joint Committee on Research
Guidelines available to industry
Materials available from FDA, USDA, and industry
http://www.cfsan.fda.gov/dms/defguids.html
Private Sector Needs
Better vulnerability assessment tools (FDA software tool
attempts to address this need)
Efficient area surveillance technologies
Chemical/biological agent detection sensors--must be
rapid, inexpensive, low false positive, low false negative, multi-
agent, multi-food, easy to use, low acquisition and operation costs
Definitive cleaning/sanitizing and decontamination methods
Traceability tools
Robust communication tools between the food industry and
federal, state and local authorities
A clear understanding of how a bioterrorist event will be
communicated to consumers and coordinated with other stakeholders
Basic understanding of CBR agents
Coordinated activities between the various federal
agencies are still confusing and needs to be clarified including how
state authorities are integrated into the food defense strategies and
tactics
CARVER + Shock Vulnerability Assessments--Tools for individual company
evaluations
*CARVER + Shock is an offensive targeting prioritization tool
adapted from the military version (CARVER) for use in the food
industry. The tool can be used to assess the vulnerabilities within a
system or infrastructure to an attack. It allows the user to think like
an attacker to identify the most attractive targets for an attack. By
conducting a CARVER + Shock assessment of a food production facility or
process, the user can determine the most vulnerable points in their
infrastructure, and focus resources on protecting the most susceptible
points in their system. Conduct vulnerability assessment; identify
critical nodes, under take mitigation steps to reduce vulnerability.
CARVER is an acronym for the following six attributes used to
evaluate the attractiveness of a target for attack:
Criticality--measure of public health and economic impacts
of an attack
Accessibility--ability to physically access and egress
from target
Recuperability
ability of system to recover from an attack
Vulnerability--ease of accomplishing attack
Effect--amount of direct loss from an attack as measured
by loss in production
Recognizability--ease of identifying target
A seventh attribute, Shock, has been added to the original six to
assess the combined health, economic and psychological impacts of an
attack within the food industry.
The attractiveness of a target can then be ranked on a scale from
one to ten on the basis of scales that have been developed for each of
the seven attributes. Conditions that are associated with lower
attractiveness (or lower vulnerability) are assigned lower values
(e.g., 1 or 2), whereas, conditions associated with higher
attractiveness as a target (or higher vulnerability) are assigned
higher values (e.g., 9 or 10). Evaluating or scoring the various
elements of the food sector infrastructure of interest for each of the
CARVER-Shock attributes can help identify where an attack is most
likely to occur in that infrastructure. Federal agencies, such as FDA
and the Food Safety and Inspection Service (FSIS) of the United States
Department of Agriculture (USDA), have used this method to evaluate the
potential vulnerabilities of farm-to-table supply chains of various
food commodities. The method can also be used to assess the potential
vulnerabilities of individual facilities or processes.
Table Top Exercise
Joint industry/regulatory agency/health department/law enforcement
officials participate in training exercises simulating an intentional
product contamination event.
Mr. Langevin. Thank you, Dr. Henry. I am glad that you
brought up the CARVER+Shock program. I was reading in my
briefing material about this program, and it is an important
tool, obviously.
Again, I want to thank all of the witnesses for their
testimony. I will now recognize myself for 5 minutes.
To the panel, based on your work with the Federal
Government over the years, how would you grade the Federal
effort on food security?
We will start with you, Mr. Kennedy.
Mr. Kennedy. I have been greatly encouraged by the
collaboration we have received since we started with the
National Center for Food Protection and Defense and how all
three of the primary agencies are very much working with us on
advancing the research to try and further protect the food
system. We work very closely with FSIS, with CFSAN and with the
Office of Health Affairs and DHS, and as I believe Carol Maczka
mentioned in the first panel, we are now working together on an
imported foods research project specifically related to China
and to other foreign countries.
Mr. Langevin. Thank you.
Dr. Henry.
Mr. Henry. From the industry perspective, I would say the
process that has been put forth by the Federal Government has
certainly matured and improved since the onset of 9/11
initially, and I think during the early years the industry saw
a real challenge amongst the various agencies to have, if you
will, nice, coordinated communications so that each agency knew
what was going on, how the funding was being applied, what the
net results were going to be, and I think that that has really
portrayed itself very well in recent years. Currently, through
the SPPA initiative and other integrated stakeholder programs,
we are much better set now to execute a program, should it
occur, with an event that develops within the United States.
Mr. Langevin. Dr. Myers.
Dr. Myers. I believe there have been tremendous efforts put
forward by the Federal Government. However, there still remains
a large disconnect between the Beltway here in the Washington
area and Federal departments and what is happening in the real
world--boots on the ground level--with State governments. State
governments need to be brought in as full working partners,
many times at the developmental stage rather than at the end of
the process where we are asked for casual comments very often
on short timelines. We want to be full working partners
throughout the continuum, developing from the initial policy
development stage to full implementation.
So there has been tremendous effort, I think, particularly
a working collaboration between Federal Governments, but there
needs to be great enhancement of reaching out and working with
local and State partners.
Mr. Langevin. So to quantify this a little more, I want to
ask each of you to assign a letter grade to the Federal
Government's efforts on food security.
Mr. Kennedy.
Mr. Kennedy. I would say a ``B'' at this point.
Mr. Langevin. Dr. Henry.
Mr. Henry. I would concur. A ``B'' would be appropriate.
Dr. Myers. I concur, a ``B.''
Mr. Langevin. Thank you.
Mr. Kennedy, the University of Minnesota has a great food
security simulation that has been funded by DHS.
How has this simulation been put to work, and can you tell
us about some problems that your scientists are most concerned
about today?
Mr. Kennedy. The simulation that, I believe, you are
referring to is something called the Consequence Management
System, and it is built by obtaining data from the private
sector in how food actually moves within the system, both
internationally and in the United States, combined with public
health system response data on how we would expect an actual
outbreak to progress. So it allows us to provide more realistic
evaluations of how potential intentional food contaminations
would unfold, what would the consequences be, and therefore,
how would certain interventions change that outcome to reduce
the possible consequences.
One of the challenges in developing a system like this is
that it is very dependent upon the private sector data, and
quite understandably, the private sector needs to check that
information, so we do not have an easy vehicle to ensure that
we have all of the appropriate data into the models on private
sector food movement.
The second challenge that we encounter is we do not have a
good idea of exactly how the public health system will respond
if there is an event. As a simple example, in a research study
2 years ago, the researcher found that emergency room
physicians when presented with a case history got Bacillus
anthracis right 75 percent of the time on the first try and
botulinum neurotoxin right 50 percent on the first try. How
fast will we know when it actually happens? That is an unknown
in our models.
Mr. Langevin. Thank you.
Briefly, Dr. Henry, you spoke about the CARVER+Shock
program. I know one of your biggest issues of the private
sector is a better vulnerability assessment tool.
So can you expand upon how the CARVER+Shock software tool
is helping you and what more the private sector is looking for
in this area?
Mr. Henry. Certainly.
The CARVER+Shock tool now being brought to bear online by
the FDA is a very positive step forward. As you know, a number
of our members are large as well as small and very small
production facilities. They do not have the luxury of coming to
various places, especially like Washington, D.C., to obtain
training in the area of CARVER+Shock. This online tool will
provide an excellent vehicle for them to capture that
information and match it against their own in-house food
defense program. We see the CARVER+Shock program, of course,
being enhanced through additional efforts such as the one that
we will be carrying forth with GMA later on this year where we
will be doing an online Web and are basically open to certainly
our members and others, where they can gain hands-on input, ask
questions and try to expedite the utilization of that tool.
Mr. Langevin. Very good. Thank you, Dr. Henry.
I thank the panel.
The Chair now recognizes the ranking member, Mr. McCaul of
Texas, for 5 minutes.
Mr. McCaul. Thank you.
When we look at this threat, I see two scenarios. One is
manmade. One could be intentional, deliberate, an act of
terrorism. The other, probably more likely, scenario is
accidental. It could be natural. It certainly could be manmade
but not an intentional act.
I agree with you, Dr. Henry, that the threat level of a
deliberate attack is low, and let us hope it stays that way,
but the risk could be very high. Dr. McGinn and I discussed,
you know, one nightmare scenario of botulism being put in an
ice cream factory which distributes all throughout the country,
and of course children would be the primary consumers, and I
know there are all sorts of nightmare scenarios. My first
question is:
We just heard from the panel of Federal experts--the FDA,
the DHS, the USDA--about their efforts. One of the biggest,
more recent concerns is the importation of contaminated fish
from China. That could be just as damaging as a deliberate
attack. So whether we are importing from a country that
actually intentionally wants to harm us through that vehicle or
whether it is just accidental, how confident are you--and this
is to the panel as a whole--that our ability to screen and
sample as our imports come into this country--how confident are
you in terms of our ability to secure and make safe the food
coming into this country?
Ms. Myers. I may take an initial stab at that. That is one
of the things we are struggling with at the State level, is the
increase in ethnic and diversity of foods, many times that have
foreign labels that are difficult for us to translate, with
symbols we don't understand. And these type of foods are
increasing at an alarming rate through imports.
So I think we are very concerned about the type of foods,
the volume, and the different mechanisms by which they land on
the shelves. Our ability can only be as good as we are informed
and trained. And so, again, I point to the disconnect that we
really need better information sharing; we need better training
tools. A lot of these are actually tested in State
laboratories. And I may use the melamine as a recent example.
You may remember, actually, it was the veterinary community
that discovered the problem initially in companion animals. And
so there is a disconnect again between companion animal
surveillance, what we might see there. The majority of these
diseases through animals are zoonotic; they are contagious from
animals. So we have a lot of shoring up to do. There are a lot
of lessons learned and gaps that we need to overcome. And a lot
of this was discovered in State veterinary labs first. So as
was pointed out, I think our main gap is the ability to quickly
detect that something is there before we diagnose it or
recognize it as an outbreak.
Mr. McCaul. Thank you, Dr. Myers.
Dr. Henry?
Mr. Henry. Yes. I think the foremost issue here on dealing
with imports or any other products coming into the United
States, but particularly focusing today on food, is funding. As
you may be aware, GMA is a member of the Coalition for a
Stronger FDA. Many efforts have been put forth here on the Hill
to try to have Congress focus on the lack of funding that is
necessary, as was brought up in my testimony. Funding, tied
with proper resource allocation, is paramount to getting the
job done. I think that, as Dr. Acheson testified earlier, that
when you have known agents, it makes it a lot easier to go out
there and try to make sure your screening and your inspection
process is adequate and efficacious. Certainly the situation
with melamine, the food industry, along with the Federal
Government and the State agencies, we are all kind of
scratching our head, and we are working very diligently right
now to try to identify what the unknown agents are. And in this
case, of course, it was pretty well defined as not an intent of
harm, but more as an intent of economic adulteration to create
a low-grade product into a high-grade product and then command
a higher price.
I think, as we go through this process, we also need to
look at the funding, which Dr. Myers brought to bear. In the
case of CARVER+Shock or the SPPA meetings or anything else, the
State agencies certainly are not getting the funding they need
and many times do not have the resources to attend a lot of
these events. And I think that that is paramount, especially if
we are going to maintain a close communication and operating
system to address these things.
I certainly want to touch upon two other areas, and that is
the importance of risk-based inspection and allocating risk
among both USDA and the Food Safety Inspection System directly
and FDA. As you may know, GMA leads the Coalition for Risk-
Based Inspection, and certainly would look forward to Congress
moving that along, because that is an excellent platform for
the United States to embrace today. We also are driving now
forth with our industry on a Food Safety Task Force, and later
this fall, we will be holding a special symposium here on
suppliers' best practices. And that workshop is really to get
down and try to define what we are doing right and what we
could do better to make sure the imports coming into the United
States are safe and meet the quality that the consumer expects
today. Thank you.
Mr. McCaul. Thank you.
Mr. Kennedy, do you have any comments?
Mr. Kennedy. In addition to concurring with the other
panelists, I would just like to point out one item of
additional concern, which is that, as you look at the box of
food that you are eating tonight or the can that you pick up,
look at that list of ingredients and recognize how many of
those ingredients we don't know necessarily from what country
they came from when they are in that finished product. So as
Mr. Langevin pointed out earlier, and in my written testimony,
there is a comment on a repository for information on where
food comes from, how it moves, that we can trace. Right now, if
there were intelligence indicating that a specific country's
source of ingredients were of concern, a food company may not
actually know that their ingredient comes from that particular
company or country. We don't have that supply chain
verification mandated all the way back to the primary supplier.
Mr. McCaul. I see my time has expired. Mr. Chairman, I
thank you for holding this hearing. I look forward to working
with you on legislation to address this important issue.
Mr. Langevin. Likewise, and I thank the ranking member. I
want to thank the witnesses for their valuable testimony and,
again, the members for their questions.
The members of the subcommittee may have additional
questions for the witnesses, and I would ask that you respond
expeditiously in writing to those questions. Your presence here
was important, and I thank you for that. Hearing no further
business, the subcommittee now stands adjourned.
[Whereupon, at 12:24 p.m., the subcommittee was adjourned.]
A P P E N D I X
----------
Additional Questions and Responses
Responses from Dr. David Acheson
Submitted by Stepen R. Mason, Acting Assistant Commissioner for
Legislation
__________
Questions from the Honorable James Langevin, Chairman, Subcommittee on
Emerging Threats, Cybersecurity, and Science and Technology
Responses from Dr. Craig Henry
Question 1.: Under the National Response Plan, DHS is supposed to
be a ``coordinating agency'' during a terrorist attack, major disaster,
or other emergency involving the nation's agriculture or food systems.
Please detail your agency's experience in DHS carrying out its role as
coordinating agency? Has this been an effective process? If not what
have been the challenges?
Question 2.: With more than 15 agencies administering at least 30
laws related to food safety, how has your Department prepared against
vulnerabilities? What type of coordination or information sharing do
you routinely practice?
Question 3.: What type of staffing challenges (vacancies,
retention, recruitment, expertise, etc.) exists within your Department
in carrying out your food mission?
1. GMNFPA experience with DHS as a coordinating agency.
DHS serves as the coordinating agency for the Critical
Infrastructure Sector Coordinating Councils. Food and Agriculture is
one of seventeen identified Critical Infrastructures as identified in
Homeland Security Presidential Directive 7. DHS works in concert with
FDA, USDA, State and local officials and food industry representatives
(through the Food and Agriculture Sector Coordinating Council (FASCC)
and its Sub-Councils) in addressing food defense issues. As the
assigned regulatory agencies, USDA and FDA play a major role in food
defense efforts. FDA is responsible for implementing regulations under
the Bioterrorism Act of 2002 (Registration of Food Facilities,
Establishment and Maintenance of Records, Prior Notice of Imported Food
Shipments, and Administrative Detention). Likewise, Food Safety and
Inspection Service (FSIS) and Agricultural Marketing Service (AMS) have
implemented directives and guidelines for meat and poultry
establishments and government purchase contracts respectively that
incorporate food defense initiatives into the plant environment. FDA
has prepared a single source web link to assist the food industry in
meeting its food defense obligations http:www.cfsan.fda.gov/ dms/
defterr.html.
2. GMNFPA experience in addressing food industry vulnerabilities.
GMNFPA, in partnership with the Juice Products Association and
representatives of juice processing companies conducted a vulnerability
assessment of the juice industry using the method. In 2006--07 the
association participated in the Strategic Partnership Program
Agroterrorism (SPPA) vulnerability assessments for juice, baby food,
and breakfast cereal with representatives from DHS, FDA, USDA, FBI,
State and local food regulators. The results of these vulnerability
assessments are classified and not directly available to the industry.
FDA and USDA contracted to have appropriate software developed to
permit private industry vulnerability assessments without access to the
actual agents of concern. The software was beta tested by interested
GMNFPA members who provided suggestions which led to appropriate
modification and a more user friendly product. The software is now
available on the FDA web page for downloading to a company computer for
use to further safeguard individual company vulnerability assessments.
Additional information on possible corrective actions.
3. GMA/FPA staffing challenges to accomplishing food defense
mission.
GMA/FPA has one FTE assigned to represent the association on the
FASCC and Sub-council and to deal with food defense related regulations
and legislation. A significant portion of staff deal with various food
safety issues including participation in industry training initiatives.
__________
Questions from the Honorable R. Langevin, Subcommittee on Emerging
Threats, Cybersecurity, and Science and Technology
Responses from Dr. Tom McGinn
Question 1.: Under the National Response Plan, DHS is supposed to
be a ``coordinating agency'' during a terrorist attack, major disaster,
or other emergency involving the nation's agriculture or food systems.
Please detail your agency's experience in DHS carrying out its role as
coordinating agency? Has this been an effective process? If not what
have been the challenges?
Respone: Secretary Chertoff created the position of Chief Medical
Officer (CMO) within the Preparedness Directorate of the Department as
part of the Second Stage review in July 2005. The office of the CMO
officially commenced operations in September 2005 with a staff of three
people. Since becoming operational, the office exceeded many of its
original goals and milestones in 2006. On January 18, 2007, in response
to the changing domestic security needs of the Nation, and recognizing
the cross-cutting potential for responsibilities within the Department,
Secretary Chertoff further expanded the role of the CMO and proposed
that the Office be renamed the Office of Health Affairs (OHA) reporting
directly to the Secretary through the Deputy Secretary.
OHA's role as the coordinator of DHS's efforts related to
protecting the Nation's food supply focuses on Homeland Security
Presidential Directive--9 (HSPD-9) (Food and Agro-Defense). Under this
Presidential Directive, OHA leads the coordination for HSPD-9
implementation efforts. To assist OHA with broader access to expertise
in its coordinating role, Deputy Secretary Michael Jackson requested
``In the interest of coordination. . .that each Directorate and Office
with primary expertise related to HSPD-9 (S&T, NPPD, I&A, CBP, and
FEMA) assign a subject matter expert for each HSPD-9 provision.''
OHA also has coordinated the support of subject matter experts from
the DHS/S&T managed Centers of Excellence at the University of
Minnesota and Texas A&M University to provide advice, incident
monitoring, event assessments and the capturing of lessons learned
during several recent food and agriculture sector incidents, such as
the recent foot and mouth disease (FMD) outbreak in the United Kingdom.
Also of note is the fact the OHA was tasked to chair and coordinate
the inter-departmental working group to prepare the DHS response to the
Presidential Executive Order on Import Safety.
Question 2.: With more than 15 agencies administering at least 30
laws related to food safety, how has your Department prepared against
vulnerabilities? What type of coordination or information sharing do
you routinely practice?
Response: DHS is working with USDA and FDA to conduct comprehensive
risk assessments for agricultural and food commodities, which can then
be used to identify protective measures and research and development
gaps. Additionally, we are working with those agencies and sector
partners to exercise communications, response and recovery efforts. OHA
also coordinates 30 programs within 6 Directorates, including S&T and
IP. A major threat in the food and agriculture sectors is a crisis of
confidence, where a poorly prevented or recognized event causes people
to question the safety of food regionally or nationally. Therefore, a
swift confidence-building response is a critical objective of our
planning and exercising efforts.
The Department of Homeland Security (DHS), U.S. Department of
Agriculture (USDA), Food and Drug Administration (FDA), and the Federal
Bureau of Investigation (FBI) are collaborating with the private
industry and the states in a joint initiative referred to as the
Strategic Partnership Program for Agroterrorism (SPPA) Initiative. The
SPPA Initiative is a true interagency coordinated partnership program,
where an industry member or trade association and a state volunteer to
participate. Each assessment involves a site visit followed by
facilitated discussions between industry and government
representatives. During the course of this program, every Food and
Agriculture Sector sub-sector will be studied (i.e. production,
processing, retail, warehousing, and transportation) in order to assess
vulnerabilities across the entire farm-to-table continuum. The primary
purpose of the program is, in full partnership with the private sector
and the states, to validate or identify vulnerabilities at specific
points within the agriculture and food supply chain and the sector as a
whole. These visits are built upon the work done by the Sector Specific
Agencies (SSAs) in order to assist in implementing the National
Infrastructure Protection Plan (NIPP) and the food and agriculture
Sector Specific Plans (SSP). All of the visits are being conducted on a
voluntary basis.
A sector focused information sharing strategy that addresses
incident information reporting, sector defense guidance and event
lessons learned, such as those from the SPPA program, is essential.
Such information sharing programs fall within the purview of DHS.
It is also important to note that information sharing must be based
upon accurate and timely data. Often, open source information from
developing events typically flow much faster than anticipated,
frequently outpaces the ability to validate, analyze and interpret such
information. As a result, information is sometimes made available to
the private sector before the government is informed. Therefore,
several important information sharing channels have been developed that
will aid the sector. For example, while not yet mature and fully
functional, a sector specific portal on the Homeland Security
Information Network (HSIN) is being developed.
Significantly, DHS is leading an interagency effort to establish a
National Biosurveillance Integration Center (NBIC). NBIC's mission is
to provide situational awareness and facilitate early recognition of
biological events, to include natural disease outbreaks, accidental or
intentional use of biological agents, and emergent biohazards through
the acquisition, integration, analysis and dissemination of information
from existing human disease, food, agriculture, water, meteorological,
and environmental surveillance systems and relevant threat and
intelligence information. NBIS will coordinate and gather
biosurveillance information across the federal government and
disseminate biosurveillance information to contributing partners for
use by senior decision-makers.
In response to the mandates specified in HSPD-9 and HSPD-10,
reflected in the above mission statement, DHS established the NBIS
Program and by December 2005 achieved a nascent operational capability
with a 24/7 Watchdesk in the National Operations Center (NOC).
Concurrently, development of the NBIS Operational Display System (NODS)
IT system began. In September 2006, a contract was awarded for
development and fielding of the NBIS 2.0 IT system as a follow-on to
the initial NBIS NODS System. Throughout this period to the present,
the program has continued to add subject matter expertise while
negotiating increased involvement and participation from prospective
future member departments and agencies. In January 2007, Memorandums of
Understanding (MOUs) were established with the Departments of State,
Agriculture, Defense, Interior, and Health and Human Services.
Subsequently Department of Transportation was added through an existing
umbrella MOU. As the program evolves, an estimated five additional
Federal NBIS Member Agencies (NMAs) will be added (11 total), in
addition to select private sector and international organizations.
With the passage of Public Law 110-53 on August 3, 2007, the NBIS
mission and the role of the partner agencies have been reinforced and
codified.
Question 3: What type of staffing challenges (vacancies, retention,
recruitment, expertise, etc.) exists within your Department in carrying
out your food safety/defense mission?
Response: In the near term, OHA is actively recruiting five
additional staff and leveraging the support of NPPD and SMEs from the
sector specific Centers of Excellence The FY08 budget funds enough
personnel to continue a focus on the veterinary and agro-defense
policies, modestly expand partnership efforts and enhance operational
and strategic planning efforts, as well as ad-hoc incident
coordination. In FY 2009, the OHA Food, Agriculture and Veterinary
(FAV) Defense Office will continue to be involved with policy, planning
and preparedness efforts, as well as sector specific strategic planning
at the Federal, state and local levels. The OHA FAV Defense Office will
continue to lead coordination efforts between DHS entities, as well as
between other Federal, state, local and private level entities.
One challenge to current coordination efforts is that preparations
for a FAV-related emergency are, as is often the case, simultaneous
with real-time events. This requires that DHS have enough staff
capability to plan, coordinate, communicate, and respond to events and
responsibilities now, as well as plan, coordinate, and communicate for
future emergencies. Further, events such as infected swine importation
from Canada into Minnesota, and the U.K. FMD outbreak have shown that
an incident does not have to be intentional to cause great harm at a
national level. These recent events all required a direct or indirect
role for the OHA FAV Defense Office. These incident management
activities have included interagency coordination, information/event
reporting and providing advice directly to the Secretary and White
House Homeland Security Council. These incidents have also required OHA
to lead the coordination and integration of effort within DHS, and with
state, local and private sector entities.
The OHA FAV Defense office must continue its efforts to work with
FDA, USDA, and our other partners to protect our homeland against food,
agricultural and veterinary threats. This includes the implementation
and coordination of over 30 DHS-specific biodefense/agrodefense
activities under HSPD-9.
Question 4.: Dr. McGinn, do you believe your Department needs
additional authorities to fulfill your HSPD-9 responsibilities?
Response: None at this time. However, as OHA expands its engagement
with the private sector and the states, other authorities may be
required to protect sensitive private sector information that is
critical to understanding and sharing sector specific risk, threat,
criticality, vulnerability, sector component shielding and mitigation
strategies.
Question 5.: Dr. McGinn, can you describe what steps the Department
has taken to lead an interagency response to an act of agro-terror or
other major disasters in the agriculture sector? Specifically, what
plans have you developed and what training exercises have you
completed?
Response: DHS, in accordance with HSPD-5, has drafted a revised
National Response Framework (NRF) that provides the policy and
operational framework for response to all major incidents and
disasters, including those that might occur with the food and
agriculture infrastructure. Under DHS guidance and coordination, each
sector specific agency has developed annexes to provide sector specific
guidance for the response to such events. The National Response
Framework is in the comment period. OHA is working with NPPD to gather
state and industry response to the documents.
The Framework is designed to simplify the National Response Plan
for senior officials. OHA co-led a working group on animal issues as
part the revisions to the NRP in February of 2007. While the proposed
Framework document does add some information about service and
companion animals, it does not include recommendations from the animal
issue working group for a mission area[0] that would address the
disaster management needs of the broader livestock and pet populations.
This is a short coming for the private sector and does not provide the
needed guidance for federal, state and local governments when dealing
with the needs of these populations in times of disaster.
DHS, in accordance with HSPD-7, has developed and published the
National Infrastructure Protection Plan (NIPP) that provides guidance
for developing protection and event mitigation plans for our critical
infrastructures. In addition, USDA and FDA, developed the Sector-
Specific Plans (SSP) for agriculture and food. These SSPs provide an
overarching planning framework for a cooperative effort between
Federal, state, local and tribal governments and the private industry
to protect agricultural and food systems from the effects of major
disasters or a terrorism event that targets or impacts the food and
agriculture sector.
DHS is also advancing scientific research and analysis through
several national facilities. The Plum Island Animal Disease Center
(PIADC) is one such facility that provides diagnostic, research, and
teaching services to prevent the introduction and spread of foreign
animal diseases. As PIADC is aging and becoming increasingly costly to
operate, DHS is working with USDA to build the next-generation
laboratory that will allow advanced research to understand and develop
better preventions against the threats to humans, crops, and animals.
DHS sponsors two university Centers of Excellence to study emerging
issues related to food and agro defense. One center at the University
of Minnesota, conducts research on food defense and actually has
developed a tool that allows rapid analysis of the probable
distribution footprint for a contaminated food product and of the
potential human morbidity and mortality from such events. The other is
a Center of Excellence at Texas A&M University where research into the
potential threats to animal agriculture is conducted.
DHS also wants to integrate the various border defenses and enhance
them with human and technological capabilities to defend this country
against the deliberate or accidental introduction of foreign pathogens
or pests that could affect the viability of our crops and animals. One
key part of our border defense is the agricultural specialists within
DHS' Customs and Border Protection (CBP). These inspectors are
specifically trained and capable of focusing on reducing the risk from
imported foods, plants, or animals. Agricultural inspectors intercept
more than 4,000 prohibited meat, plant, and animal products every day
at US ports of entry. DHS recently formed a task force with the USDA to
address the concerns of agricultural stakeholders and to identify and
close gaps in the inspection process.
In March of 2004, after a series of facilitated conferences, firms
and organizations representing a broad range of constituents across the
food and agriculture sector created the Food and Agriculture Sector
Coordinating Council (FASCC). Shortly after the formation of the FASCC,
DHS, USDA and FDA agreed to form a government counterpart to the FASCC
called the Government Coordinating Council (GCC). The two councils work
collaboratively on sector defense initiatives and information sharing.
The industry sector coordinating council (SCC) is comprised of private
companies and associations representing key components of the food
system. The SCC has seven sub-councils spanning the farm-to-table
continuum--agricultural input, animal producers, plant or crop
producers, food processors, retail operations, warehouses and import/
export establishments. The government coordinating council (GCC) is
comprised of Federal, state, tribal and local governmental agencies
responsible for a variety of activities including agricultural, food,
veterinary, public health, laboratory, and law enforcement programs. In
simple terms, the SCC and GCC are the liaison bodies that will plan,
coordinate, and implement homeland security policies and programs for
the food and agriculture sector. These bodies pre-date the NIPP and
were created to build upon the Information Sharing Analysis Center
(ISAC) approach to information sharing.
DHS has also engaged the Centers of Excellence at the University of
Minnesota and Texas A&M to assist in developing food and agriculture
disease and product adulteration event modeling tools, as well as
training tools and programs. Additionally, the DHS Office of Grants and
Training has funded several university and community college training
and training tool development efforts that are focused on the food and
agriculture sector. Finally, there have been numerous regional and
state sector specific response exercises funded by DHS, such as High
Plains Guardian, an exercise conducted by the State of Kansas.
Question 6.: According to a February 2007 DHS Inspector General
report, DHS does not have a clearly defined system of authorities or
adequate staffing to carry out food sector responsibilities. What has
been done to address this issue?
Response: With the assignment of departmental responsibility for
coordinating DHS roles and missions under HSPD-9, OHA FAV Defense
Office is currently expanding its staff base and mission capability.
The present office staff expansion is focused on the recruitment and
hiring of 5 additional sector specialists in the near term and to
continue the growth of the sector focused staff in FY08. OHA has a
Senior Sector Specialist that has joined the FAV team under an American
Association for the Advancement of Science (AAAS) Fellowship and is
also negotiating with the DHS/S&T Office of University Programs for an
additional Fellow within this specialty to be assigned to work out of
the FAV Defense Office to work the intersection of the Research,
Development (S&T) and the OHA Operational missions.
Question 7.: According to the 2007 DHS Inspector General report,
``until DHS develops a method to adequately track federally funded
research efforts, the United States will lack a coordinated national
approach to protect against agroterrorism, possibly resulting in gaps
or needless duplication of effort.'' Are there currently any
coordinated efforts to track federally funded research?
Response: Initial steps have been taken to track federally funded
food and agricultural defense research. DHS has provided FDA and USDA
with a summary of each of its projects in this area for use by the Food
and Agricultural Sector Joint Committee on Research and for inclusion
in the 2007 Food and Agricultural Sector Critical Infrastructure/Key
Resources Protection Annual Report. ``In addition, an effort has been
initiated at the DHS sponsored National Center for Food Protection and
Defense to develop a combined database listing all DHS, USDA, and FDA,
academic and industry programs in this area.
Question 8.: GAO issued two reports in 2002--on foot-and-mouth
disease and on mad cow disease--examining U.S. measures for preventing
those diseases from entering the United States. Because of the sheer
magnitude of international passengers and cargo that enter this country
on a daily basis and the inspection resources that are available,
completely preventing the entry of those diseases may not be feasible.
GAO found that USDA did not provide timely guidance to border
inspectors for screening cargo and international passengers after foot-
and-mouth disease struck Europe in 2001.
What federal efforts have been taken to address this vulnerability?
How has communication improved between USDA and border inspectors?
Our nation's ports could be unnecessarily vulnerable to the
intentional introduction of a disease or pest, unless the Department is
able to analyze the reasons for declining agricultural inspections and
streamline the flow of information between USDA and DHS inspectors at
ports of entry.
What federal efforts have been taken to address this vulnerability?
Response: The United States Department of Agriculture (USDA) and
U.S. Customs and Border Protection (CBP) developed a joint procedure
that specifically identified the roles and responsibilities of CBP
Agriculture Specialists (CBPAS) at the ports of entry regarding
products received from restricted countries. Both agencies agreed to
amend their existing Memorandum of Understanding (MOU), which addresses
the agencies' respective functional responsibilities and requirements
for coordination at Headquarters and in the field. The MOU was signed
on February 9, 2003 which gave CBP the authority to enforce USDA
restrictions.
As a result, CBP and USDA performed an assessment of the controls
in place to prevent shipments listed as being on hold in CBP's database
from exiting ports of entry without proper authorization. Animal and
Plant Inspection Services (APHIS) and CBP have established that if CBP
has any questions about a shipment, they will contact the APHIS subject
matter expert to request guidance on clearance. Currently, CBP
personnel thoroughly review the documentation associated with shipments
received from Foot-and-Mouth Disease (FMD) affected countries to ensure
that prohibited product is refused entry, when appropriate. As
necessary, CBP requests guidance or technical expertise from USDA on
imported products. Agriculture Programs and Liaison (APL) has issued
alerts, musters, and memoranda updating the field with the latest
information and instructing CBP personnel to thoroughly review the
documentation associated with shipments received from FMD-affected
countries.
How has communication improved between USDA and border inspectors?
Response: CBP recognizes the importance of communicating and
working collaboratively with USDA to identify, address and develop
measures to exclude harmful plant pests and foreign animal diseases in
protecting American agriculture. The revised MOU stipulates that the
headquarters Agriculture Programs and Liaison (APL) office will
continue to assist CBP Directors of Field Operation (DFOs) with any
significant changes in operational procedures that require consultation
with USDA in accordance with the MOA prior to implementation.
CBP and USDA communicate relevant and vital information between
both agencies. The USDA, APHIS is in a unique position of being both a
partner and ally to CBP in fulfilling its agricultural mission.
Conversely, CBP collects and maintains valuable information that
contributes to the USDA's scientific knowledge base, upon which the
USDA determines national policies and procedures to protect this
country from agro-terrorism and other forms of agricultural economic
harm. CBP has arranged training for USDA employees at the National
Targeting Center (NTC) to hone their skills in targeting. There is
presently one USDA liaison at the NTC to assist with the development of
the agro-terrorism rule concepts and certain agricultural health and
safety concerns. Data sharing allows USDA to develop specific alerts
and targeting information for CBP, which are used at the ports of entry
(POEs). Targeting plans call for CBP to enhance advance targeting
systems support to collect information that will better identify,
monitor, and report on current and emerging threats.
Daily communications between CBP and APHIS Headquarters, monthly
meetings between executive Directors from APL and APHIS, quarterly
meetings between the Assistant Commissioner Office of Field Operations
and APHIS Deputy Administrator, as well as quarterly meetings between
the Commissioner and APHIS Administrator, all provide timely
opportunities to discuss and share information at various levels USDA
and CBP are responsible for communicating relevant and important
agricultural information up and down their respective chain of command,
as needed. This protocol enables every level of management to remain
fully appraised of USDA information and to assess its potential impact
at the local level.
__________
Questions from the Honorable James Langevin, Chairman, Subcommittee on
Emerging Threats, Cybersecurity, and Science and Technology
Responses from Lee M. Myers, DMV, MPH, Dipl. ACVPM
Please Note: The responses below are submitted on behalf of the
National Association of State Departments of Agriculture. The
statements are intended to represent state agriculture departments as a
whole and not any individual state agency.
Question 1: Under the National Response Plan, DHS is supposed to be
a ``coordinating agency'' during a terrorist attack, major disaster, or
other emergency involving the nation's agriculture or food systems.
Please detail your agency's experience in DHS carrying out its role as
coordinating agency. Has this been an effective process? If not what
have been the challenges.
Response: The National Association of State Departments of
Agriculture (NASDA) believes that it is too early to project the
effectiveness of DHS as a coordinating agency during an agriculture or
food emergency. Hurricane Katrina has been the only major emergency
since the formation of DHS and there are many reports detailing the
lessons learned to this disaster. State agriculture representatives
from Louisiana and Mississippi expressed frustration about the lack of
federal government coordination and slow assistance to the agriculture
sector during Hurricane Katrina. Many individuals, businesses, and
agencies have not yet received financial compensation from the federal
government as a result of hurricane damage.
One of the primary issues that Congress has not yet resolved is the
application of agriculture to the Stafford Act. The provisions of
agriculture and food should be clearly outlined in the Stafford Act and
should not be subject to individual interpretation. In the event of
natural disaster, the agriculture and food sector should receive
emergency assistance and compensation to help minimize disruption of
the food supply. The responsibilities of federal agencies for
agriculture and food during an emergency should be codified to minimize
competing interests and agency conflicts.
Question 2: With more than 15 agencies administering at least 30
laws related to food safety, how has your Department prepared against
vulnerabilities? What type of coordination or information sharing do
you routinely practice?
Response: State agriculture agencies have completed a substantial
number of vulnerability assessments utilizing a variety of methods,
although states are relying upon the federal government to provide
consistent tools for data collection and assessment. The joint efforts
of the FBI, DHS, USDA, and FDA to develop a Strategic Partnership
Program Agroterrorism (SPPA) initiative are encouraging. NASDA
appreciates the FDA providing the assessment tool on-line for use by
private industry in the food sector, and encourages the USDA to
complete a similar on-line version for production agriculture. Only
through consistent data collection and analysis in each state can a
national threat matrix be formulated. State government agencies need
additional resources to conduct these assessments, and develop and
implement their food emergency plans. States need assistance in
implementing cost-effective measures that enhance our ability to
prevent an attack, detect an attack at the earliest possible time,
respond to protect both the public health and industry and recover from
an attack by restoring public confidence and the economic viability of
affected sectors.
As indicated in my written and oral testimony, there is no
operational, comprehensive and secure communications network for
agriculture to share threat alerts and other information linking local,
state, federal, and private partners, with appropriate security
clearances. Current methods of routine communication are primarily
through a hodge-podge system of emails and conference calls, neither of
which provide a secure environment.
Question 3: What type of staffing challenges (vacancies, retention,
recruitment, expertise, etc.) exists within your Department in carrying
out your food safety/defense mission?
Response: States are in dire need of additional human resources to
fully implement their food safety/defense duties. State appropriations
specifically for agriculture defense have been limited and the homeland
security duties in most states are being assumed by personnel with full
schedules in traditional regulatory programs.
Recruitment and succession planning is vital for the success of
state food defense programs. It is critical that states successfully
attract highly qualified career employees. With the majority of state
employee salaries well below the market midpoint, recruiting and
retaining a workforce to develop new programs and ensure business
continuity is challenging to say the least.
The development and implementation of a national food defense
strategy must be identified as a national priority and the compensatory
resources allocated to state agriculture authorities from Congress.