Testimony
Statement by
Lester M. Crawford
Acting Commissioner
Food and Drug Admininstration
Department of Health and Human Services
on
Hearing: Implementation of the Food Security Provisions of the Public Health Security and Bioterrorism Preparedness and Response Act
before the
Committee on Energy and Commerce
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JUNE 25, 2004
Good morning, Chairman Bilirakis and Members of the
Subcommittee. I am Dr. Lester M. Crawford, Acting
Commissioner of 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 colleague, Ms. Cathy Sauceda from Customs and
Border Protection (CBP) in the Department of Homeland Security
(DHS). Thank you for this opportunity to
discuss FDA’s actions to implement the food safety provisions
in Title III, Subtitle A - Protection of Food Supply - in the
Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 (Bioterrorism Act). I wish to thank the
Members of this Subcommittee for your leadership in enacting this
landmark legislation. This legislation represents the
most fundamental enhancement to our food safety authorities in many
years. As you know, it provided us with significant new
tools to protect the nation’s food supply against the threat
of intentional contamination and other food-related
emergencies. Implementing these new authorities has
been a top priority for FDA.
In my testimony today, I will first provide some background on
HHS’ food safety responsibilities. Then, I will
describe the many actions FDA has taken to implement the food
safety provisions in the Bioterrorism Act.
HHS’ Food Safety Responsibilities
FDA is the Federal agency that regulates 80 percent of the
nation’s food supply-everything we eat except for meat,
poultry, and certain egg products, which are regulated by our
partners at the United States Department of Agriculture
(USDA). FDA’s responsibility extends to live food
animals and animal feed. FDA is also 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. In
addition, FDA is responsible for assuring that the health
consequences of foods and medicines are accurately and honestly
represented to the public, so that they can be used as effectively
as possible to protect and improve the public health.
While FDA has the lead responsibility within HHS for ensuring the
safety of food products, the Centers for Disease Control and
Prevention (CDC) within HHS has an important complementary and
non-regulatory 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, in which FDA participates, provide an essential
early-information network to detect dangers in the food supply and
to reduce foodborne illness. In addition, these systems
can be used to indicate new or changing patterns of foodborne
illness. Because CDC detects and investigates outbreaks
of foodborne illness through its networks, CDC is able to alert FDA
and USDA about implicated food products associated with an outbreak
and works closely with the agencies to take protective public
health action. In keeping with its agency mission, CDC
also identifies, evaluates, and offers expert scientific opinion on
the effectiveness of foodborne disease prevention strategies.
FDA contributes to the Foodborne Diseases Active Surveillance
Network (FoodNet), the principal foodborne disease component of
CDC’s Emerging Infections Program (EIP). FoodNet
is a collaborative activity of CDC, FDA, the Food Safety and
Inspection Service of USDA, and ten EIP sites, (California,
Colorado, Connecticut, Georgia, New York, Maryland, Minnesota,
Oregon, Tennessee, and New Mexico). Through this active
surveillance system, these sites actively seek out information on
foodborne illnesses identified by clinical laboratories, collect
information from patients about their illnesses, and conduct
investigations to determine which foods are linked to specific
pathogens. This surveillance system provides important
information about changes over time in the burden of foodborne
diseases. These data help public health and food safety
agencies evaluate the effectiveness of current food safety
initiatives and develop future food safety activities.
FDA provides both monetary support and technical expertise to the
program.
In addition, just as FDA works with Federal, state, and local food
safety counterparts, CDC works extensively with Federal, state, and
local health departments to build their epidemiology, laboratory,
and environmental health expertise in foodborne disease
surveillance and outbreak response. All of these
collaborations draw on and apply the unique expertise within HHS to
address significant and emerging challenges to our food supply.
Implementation of Subtitle A of Title III of the Bioterrorism
Act
Subtitle A of Title III of the Bioterrorism Act provides the
Secretary of Health and Human Services with new authorities to
protect the nation’s food supply against the threat of
intentional contamination and other food-related
emergencies. FDA is responsible for implementing these
provisions. These new authorities improve our ability
to act quickly in responding to a threatened or actual terrorist
attack, as well as other food-related emergencies. Since this
legislation was signed into law just over two years ago, FDA has
been working hard to implement this law effectively and
efficiently. Throughout this process, FDA has enjoyed
close cooperation from our colleagues at CBP.
Registration of Food Facilities
Section 305 of the Bioterrorism Act requires registration of
foreign and domestic food facilities that manufacture, process,
pack, or hold food for consumption by humans or animals in the
U.S.. Thanks to this provision, FDA will have, for the
first time, a roster of foreign and domestic food facilities that
provide food for American consumers. In the event of a
potential or actual terrorist incident or an outbreak of foodborne
illness, the registration information will help FDA to quickly
identify, locate, and notify the facilities that may be affected.
On October 10, 2003, FDA and CBP jointly published an interim final
regulation to implement the registration requirement.
This regulation became effective on December 12, 2003.
We have provided two public comment periods that allowed a total of
105 days for interested parties to comment on certain provisions in
the interim final rule. We currently intend to publish
the final rule in the spring of 2005 after considering all the
timely comments we have received.
FDA’s electronic registration system became operational on
October 16, 2003, which allowed facilities almost two months to
register with FDA before the regulation became
effective. We worked hard to develop an electronic
system that is easy to use. The system is available 24
hours a day, seven days a week, to anyone with access to the
Internet. We are also providing technical assistance to
persons who need help with the registration process.
The electronic system will provide the facility with its
registration number nearly instantaneously upon successful
completion of the registration process. While
facilities are not required to register electronically, FDA
strongly encourages facilities to use the electronic system to
register. Although it will take longer for facilities
that register by mail to receive their registration numbers,
registration by paper also is relatively easy to
accomplish. As of June 24, 2004, 208,277 facilities
have registered. This includes 98,896 domestic and
109,381 foreign facilities.
Our goal has been to phase-in enforcement of the registration rule
in a manner that ensures a smooth transition with minimal effect on
commerce. Last December, FDA published two Compliance
Policy Guides that stated our intention to focus initially on
educating industry about how to comply with the new registration
requirement. For domestic facilities, FDA expects it
typically would discover a registration violation during a routine
inspection and would enforce the registration provision as
appropriate in each situation. Circumstances that could
merit regulatory action include a continuing failure to register or
a threat to the food supply associated with food from an
unregistered facility. In addition, FDA may consider
the failure to register as an additional charge in an enforcement
action that is based on other statutory violations.
Regarding foreign facilities, Section 305 states that food from a
foreign facility that is required to register, but has not done so,
must be held at the port of entry until the facility is
registered. Accordingly, FDA is enforcing the
registration requirement for manufacturers and shippers through the
prior notice interim final rule, which I will discuss in a
moment. In most cases, the failure of a facility,
domestic or foreign, to be registered is a violation that can be
readily corrected. As mentioned above, electronic
registration may be accomplished with minimal effort.
Thus, the ability to remedy a failure to register is relatively
straightforward for both domestic and foreign facilities.
Prior Notice of Imported Food Shipments
Section 307 of the Bioterrorism Act requires the submission to FDA
of prior notice of food, including animal feed, that is imported or
offered for import into the U.S. This advance
information enables FDA, working closely with CBP, to more
effectively target inspections at the border to ensure the safety
of imported foods before they move into the U.S. On
October 10, 2003, FDA and CBP jointly published an interim final
rule to implement this provision. This regulation
became effective on December 12, 2003. We recently
reopened and extended the public comment period on the Prior Notice
Interim Final Rule for an additional 60 days. Comments
will be accepted through July 13, 2004. Interested
parties will have had a total of 165 days to comment on the
provisions. We currently intend to publish the final
rule in March 2005. Since December 2003, we have been
receiving approximately 150,000 notifications each week about
articles of food being imported or offered for import into the U.S.
FDA and CBP worked collaboratively to ensure the new regulations
promote a coordinated strategy for border protection.
Thanks to this collaboration, prior notice may be submitted
electronically either by licensed brokers using CBP’s
Automated Commercial System (ACS) or by anyone using FDA’s
Prior Notice System Interface. FDA’s and
CBP’s systems are linked together. Regardless of
which system a submitter uses to transmit the prior notice to FDA,
the notices submitted are reviewed in the same timeframes and in
accordance with the same procedures.
Based on FDA’s current assessment, the timeframes in the
interim final rule for submitting prior notice are the least amount
of time that FDA needs to meet our statutory responsibility to
receive, review, and respond to the prior notice
submission. They take into account different modes of
transportation. The regulations require prior notice at
least two hours in advance of arrival by land via road, at least
four hours in advance of arrival by air or land via rail, and at
least eight hours in advance of arrival by water. The
staggered prior notice submission timeframes allow FDA reviewers to
expedite their review of shipments with shorter transport times
without negatively affecting the review times of shipments with
longer transport times.
FDA and CBP are committed to further increasing integration of our
agencies’ respective advance notice requirements with a goal
of: (1) achieving a uniform, integrated system; (2) building
on current operational procedures; and (3) implementing the law
with minimal disruption to current entry practices.
Toward this goal, on April 4, 2004, FDA and CBP issued a plan,
“Joint FDA-CBP Plan for Increasing Integration and Assessing
the Coordination of Prior Notice Timeframes.” The
plan describes the process by which FDA and CBP intend to increase
integration and examine whether we could amend the timeframe
requirements in FDA’s prior notice interim final rule to be
the same as those in CBP’s advance electronic information
rule. The plan was issued with an initial 30-day
comment period, which FDA has extended for an additional 60-day
period that ends July 13, 2004.
Although the interim final rules became effective December 12,
2003, FDA and CBP issued a Compliance Policy Guide that explains
our intention to focus initially on educating affected firms and
individuals about the new prior notice requirement while gradually
phasing in enforcement of the prior notice interim final
rule. This phase-in period will end August 12, 2004, at
which time full enforcement will begin.
While we cannot physically inspect every shipment, it is important
to note that every shipment that contains FDA-regulated products
that is entered for consumption or warehouse storage through
CBP’s ACS is electronically reviewed by FDA’s
Operational and Administrative System for Import Support 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
concentrate its limited inspection resources on high-risk shipments
while allowing low-risk shipments to proceed into commerce.
With the new prior notice requirement, specific information
mandated by the Bioterrorism Act must be submitted to FDA before
the imported food arrives in the U.S. This not only
allows the electronic system to review and screen the shipments for
potential serious threats to health (intentional or otherwise)
before food arrives in the U.S., but it also allows FDA staff to
review prior notices of those products flagged by the systems as
presenting the most significant risk and determine whether the
shipment should be held for further investigation. FDA
worked very closely with CBP in developing this screening system.
In addition, FDA has been actively working with the analysts at
CBP’s National Targeting Center to utilize their Automated
Targeting System as an additional tool to enhance the
Agency’s ability to focus attention on those imported foods
that may pose a serious threat to public health. We
anticipate that the use of FDA’s and CBP’s screening
systems will enable both agencies to effectively target shipments
posing the greatest risk in order to further focus our border
inspection efforts.
In developing the interim final rules to implement the registration
and prior notice requirements, FDA carefully considered all the
comments received during the public comment periods and strived to
develop provisions that were consistent with the Bioterrorism Act
and that achieve its objectives while minimizing the impact on
trade to the extent feasible. FDA and CBP have
conducted extensive domestic and foreign outreach to explain the
rules to consumers and the food industry. FDA has been
commended by numerous parties throughout the world for what many
describe as an unprecedented level of outreach.
Administrative Detention
Section 303 of the Bioterrorism Act gives FDA new authority to
administratively detain any article of food for which the Agency
has credible evidence or information that the food presents a
threat of serious adverse health consequences or death to humans or
animals. This authority is self-executing and provides
an added measure to ensure the safety of the nation’s food
supply. Section 303 also requires FDA to provide by
regulation procedures for instituting on an expedited basis certain
enforcement actions against perishable foods subject to a detention
order. On June 4, 2004, FDA published a final rule to
implement this section. The rule includes procedures
for detaining an article of food, expedited procedures for
detaining perishable foods, and the process for appealing a
detention order.
Maintenance and Inspection of Records for Foods
Section 306 of the Bioterrorism Act authorizes FDA to have access
to certain records when the Agency has a reasonable belief that an
article of food is adulterated and presents a threat of serious
adverse health consequences or death to humans or
animals. It authorizes the Secretary to publish
regulations to establish requirements regarding the establishment
and maintenance, for not longer than two years, of records by
persons (excluding farms and restaurants) who manufacture, process,
pack, transport, distribute, receive, hold, or import
food. On May 9, 2003, FDA published a proposed rule to
implement this section. We have received approximately
200 comment letters that we have carefully considered.
We intend to issue a final rule in the near future.
When finalized, the recordkeeping regulation will enhance
FDA’s ability to track and contain foods that pose a threat
of serious adverse health consequences or death to American
consumers from accidental or deliberate contamination of
food.
Authority to Commission Other Federal Officials to Conduct
Inspections
Section 314 of the Bioterrorism Act authorizes the Secretary to
commission other Federal officers and employees to conduct
examinations and investigations. Pursuant to this new
authority, FDA and CBP have signed a Memorandum of Understanding to
commission CBP officers to conduct examinations on FDA’s
behalf at ports where FDA may not currently have staff or to
augment FDA staff in the enforcement of FDA’s prior notice
requirements. This unprecedented FDA-CBP collaboration
significantly strengthens our ability to secure the border while
ensuring the movement of legitimate trade. In
accordance with this new authority, FDA has already commissioned
over 8,150 CBP officers. The Agency will continue to
explore use of this authority with other agencies as a tool to
further improve efficiencies.
Authority to Mark Articles Refused Admission into U.S.
Section 308 authorizes the Secretary to require the marking of
refused food (other than food required to be
destroyed). This provision is intended to prevent
unsafe foods that have been refused entry into the U.S. from
entering U.S. markets via the practice of “port
shopping.” This is a practice by which importers
send goods that have been refused entry at one port to a different
port in the hope of obtaining admission for the refused
goods. Obviously, this practice puts American consumers
at risk. Before passage of the Bioterrorism Act, FDA
had published a proposed rule to require the marking of refused
food. This proposal was withdrawn in light of the new
and additional statutory requirements. We are
considering a new rulemaking to implement Section 308.
Protection Against Adulteration of Food
Section 302 of the Bioterrorism Act contains numerous provisions
intended to increase protection against adulteration of
food. One of the requirements in this section is for
the Secretary to give high priority to increasing the number of
inspections of food offered for import. Thanks to a
fiscal year 2002 supplemental appropriation, FDA received
counterterrorism funds that enabled us to hire additional staff,
most of whom were hired to address food safety issues, primarily at
the border. With these additional employees, we have
more than doubled the number of ports that have an FDA presence
from 40 to 90 ports. We have increased by more than
six-fold the number of food examinations at the border.
In compliance with another requirement in this section, on October
16, 2003, we submitted a report to Congress, “Testing for
Rapid Detection of Adulteration of Food,” about the research
that is underway to develop tests and sampling methodologies to
rapidly detect adulterated food. FDA has commenced more
than 90 different research projects to develop tests and sampling
methodologies to increase the detection of adulterated
food. A number of the research projects are designed
specifically to develop tests suitable for inspections of foods at
ports of entry. For example, commercially available
test kits are currently being analyzed for a variety of food
matrices to evaluate their suitability for use in the field at
ports of entry. We are in the process of preparing the
second annual report on our research activities.
Also pursuant to a requirement in Section 302, HHS provided a
report to Congress on assessments of the threat of the intentional
adulteration of food.
Conclusion
In conclusion, thanks to the new authorities provided by the
Bioterrorism Act along with HHS’ other food safety
activities, the nation’s food safety system is stronger than
ever before. As you might imagine, it has been a
tremendous undertaking for FDA to implement the provisions in the
Bioterrorism Act in such a short period of time. We are
proud of our accomplishments and will continue our efforts to
implement the Bioterrorism Act in an efficient and effective
manner. We are thankful to Congress for these new
authorities that will serve to bolster the safety of our food
supply.
In addition to the new authorities provided to us in the
Bioterrorism Act, I would like to briefly mention some other
activities in which FDA has been involved to ensure the safety and
security of our nation’s food supply. We have
enhanced coordination with our partners in Federal, state, and
local governments, academia, and industry. To minimize
the risk that food will be subject to tampering or other malicious
actions, we have issued guidance for the food industry on the
security measures it may take. We are also working with
DHS to carry out our Sector-Specific Agency responsibilities under
Homeland Security Presidential Directive 7/Critical Infrastructure
Identification, Prioritization, and Protection for food other than
meat, poultry, and egg products. FDA has embarked on an
ambitious research agenda throughout the Agency to address
potential terrorist threats. To increase laboratory
surge capacity, FDA has worked closely with CDC and USDA to expand
the Laboratory Response Network by establishing the Food Emergency
Response Network. Through this aggressive and
collaborative program, FDA has made significant progress in
strengthening the safety and security of the nation’s food
supply.
Thank you for this opportunity to discuss our efforts to implement
the food safety provisions of the Bioterrorism Act. I
look forward to continuing to work with you and would be pleased to
respond to any questions.
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