Counterterrorism is one of
five initiatives established for FDA to address five critical
challenges facing the agency.
The counterterrorism initiative focuses on the Agency's responsibilities
to quickly respond to terrorism and to enhance food security.
FDA will assist in countering the terrorism threat by: 1) preparing
for the possibility of attacks on the U.S. population through
a strengthened product monitoring infrastructure and emergency
preparedness plans; and 2) responding rapidly and appropriately
in the event of an actual attack with effective medical countermeasures
and product disposal actions.
The following is an excerpt describing this initiative from
FDA's Strategic Plan:
Strengthen the FDA's capability to identify, prepare
for, and respond to terrorist threats and incidents. |
Even if a small number of contaminants were intentionally
introduced to some part of the food chain, such an incident
could seriously damage public confidence in the safety
of the nation’s food supply. |
Most of the food safety-related legislative and regulatory
changes over the past decade have been aimed at protecting the
nation's food supply from hazards that occur both naturally
and accidentally in the lengthy farm-to-table food supply chain.
But now there is widespread concern that naturally occurring
pathogens that could spread easily through the food chain could
be used as a bioterrorist weapon. Such an attack would be particularly
dangerous for children, the elderly, and those who are immunocompromised.
Government officials and food industry observers speculate that
the foods most likely to be targets are those that are minimally
processed at a central location, and/or are ready-to-eat, such
as milk and fresh produce.
In addition to the impact on health and safety, bioterrorism
against the food supply would also directly harm the U.S. economy.
U.S. agriculture contributes $1 trillion to our gross domestic
product (GDP) annually and provides 22 percent of all jobs in
this country. The food production industry exceeds $200 billion,
with over $55 billion worth of products exported each year.22
The production of food is so extensive (most of it comes from
500,000 farms and is handled by 57,000 food processors and 6,000
meat, poultry, and egg product processors) that if even a small
number of contaminants were intentionally introduced to some
part of the food chain, such an incident could seriously damage
public confidence in the safety of the nation's food supply
and could result in staggering economic losses for the agriculture
industry.
The FDA has also been engaged in an accelerated, major new
focus on helping to develop and make available better countermeasures
for biological, chemical, and radiological attacks. The FDA
is going to be critically important in bringing these products
to fruition. While the countermeasures that the agency has made
available already have given the FDA a deeper and more effective
stockpile of treatments than ever, in many cases they are based
on old technology. There's strong reason to believe new technology
can produce antidotes and vaccines that are even safer and more
effective--and so more valuable--than what's available to us
now.
The FDA plays a central role in the nation's defense against
terrorism.
The FDA's regulatory authority and responsibility cuts across
critical elements in any counterterrorism plan. First, terrorists
could use FDA-regulated products, such as imported food, to
introduce deadly diseases into the country. Second, FDA-regulated
products, such as human and animal drugs, vaccines, blood, and
other blood products, would play a central role in countering
the effects of terrorism if another attack takes place. It is
the FDA's responsibility, working closely with other agencies,
the food industry, and the American public, to reduce the chance
that an FDA-regulated product is used in an attack. We must
ensure that the nation's public health system is able to deter
a potential threat and be prepared to respond.
On June 12, 2002, the president signed the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (P.L.
107-188, H.R. 3448/S. 1765). The bill authorizes $545 million
for food protection (out of a total of $2.369 billion for bioterrorism
response). The bill contains $130.25 million in appropriations
for HHS and requires the FDA to: 1) register food processors
and inspect their records, 2) detain adulterated food, and 3)
take a number of steps to ensure the safety of imported foods
(among other provisions).
The agency is now in the process of refocusing its efforts
to incorporate enhanced security and safety measures.
Far from changing the FDA's 100-year-old mission of consumer
protection and public health promotion, the events of Sept.
11, 2001, and the subsequent anthrax attacks and discovery of
terrorist activities potentially related to food contamination,
have underscored the importance of the FDA's mission. The agency
is now in the process of refocusing its efforts to carry out
that mission in a changed world.
The FDA must have the capability to assess and effectively
respond to risks associated with terrorist-related health and
safety threats to the U.S. public. The agency's two greatest
challenges are to facilitate development of medical countermeasures
and to safeguard regulated products.
The agency's approach for countering the terrorist threat will
involve working with industry to develop medical countermeasures
using state-of-the-art science, collaborating with other responding
agencies and organizations, strengthening the FDA's own preparedness
and response capabilities, and remaining vigilant against potential
threats to our nation's health and security.
For example, to continue to meet the challenges of protecting
the food supply in the face of these new threats, over the coming
years the FDA believes the best solution will be the adoption
of a risk-based import surveillance system to replace its current
import program, and to improve its ability to focus efforts
on the highest-risk points in the food supply--points of high
risk from both a security and a safety standpoint.
For imports, the FDA needs a system that is fully linked with
Customs entry processes, and the agency is working closely with
the Department of Homeland Security to achieve this. Customs
processes have historically been designed to address revenue
and trade issues, not public health issues. That's changing.
The FDA is moving in the direction of a modern, risk-based system
for food imports.
The FDA is developing a science-based, "life cycle"
approach to assuring the safety of food products. This approach,
based on the principles of efficient risk management, will enable
the agency to achieve the greatest food protection with its
limited resources. For example, when it comes to bulk imports,
instead of a taking a snapshot at the border by examining and
sampling a particular shipment, the FDA is trying to get a broader
picture that covers the product's history from raw materials,
through production, transportation to the U.S. manufacturer
or producer if there is one, storage, and to the ultimate consumer.
The FDA is also considering risk information in deciding how
to manage food imports, whether by: 1) working with foreign
countries and manufacturers to improve compliance with safe
manufacturing abroad as an alternative to detailed inspections
at the border, 2) using better information about imports to
focus border checks on final products that present significant
potential risks, or 3) collaborating with domestic producers
to improve checks on the safety of the ingredients they use.
We need these creative new strategies to protect America's
food supply from deliberate attack. And in many cases, these
enhancements to the agency's existing systems for food safety
can help us prevent and contain conventional foodborne illness
outbreaks. But the FDA must continue to take other efforts aimed
specifically at safeguarding our foods against the conventional
threats, such as accidental contamination with bacteria and
food spoilage. To achieve this goal, the FDA has developed five
objectives and strategies.
Protecting America From Terrorism: FDA's Objectives
Objective 1. Facilitate the development and availability
of medical countermeasures to limit the effects of a terrorist
attack on the civilian or military populations.
Medical products (human and animal drugs, vaccines and other
biological products, blood and blood products, medical devices)
must be readily available to prevent, diagnose, and treat illnesses
resulting from a terrorist attack. In addition, specialized
products could be needed for certain groups, such as military
personnel, first responders to emergencies, residents near nuclear
facilities, pregnant women, immunocompromised persons, and children.
Highlights for
Objective 1
-
Foster development of novel products
for use as medical countermeasures.
-
Foster development of existing
products for use as medical countermeasures.
-
Work with partners to facilitate the
availability of an adequate inventory of medical
countermeasures and supplies to be used in emergency
situations.
-
Ensure that public health needs
and legal mandates are satisfied when medical countermeasures
are needed in an emergency.
|
Objective 2. Enhance the agency's emergency preparedness
and response capabilities to be better able to respond in the
event of a terrorist attack.
To respond effectively to terrorism-related emergencies and
crises, the FDA must be prepared for a wide range of circumstances
and contingencies. Many types of emergencies could require the
FDA's assistance. Reaching a new level of readiness for terrorist
attacks will involve several key action items.
Highlights for
Objective 2
-
Conduct emergency response drills
with other organizations
-
Develop crisis management plans
-
Expand the FDA's capacity to test
for agents that may be used deliberately to contaminate
FDA-regulated products.
-
Collaborate with science, law
enforcement, intelligence and international communities;
and coordinate with federal, state, and local jurisdictions.
|
Objective 3. Ensure the safety and security of FDA personnel,
physical assets, and sensitive information.
- Ensure the proper level of personnel
background security investigations are conducted.
- Enhance the physical security
of FDA facilities.
- Develop a Continuity of Operations
Plan (COOP) to continue mission-critical functions.
- Educate and train appropriate
personnel on the handling and dissemination of sensitive information.
Objective 4. The FDA must uphold its responsibility for
ensuring the safety of approximately 80 percent of the nation's
food supply. The possibility of food products being used
as a vehicle for attack is particularly worrisome because such
an event potentially affects everyone in the United States.
The FDA must have the capability to assess and then reduce risks
associated with unexpected and potentially widespread health
and safety threats.
Highlights for
Objective 4
- Assess the vulnerability of the U.S. food
supply to an attack by terrorists.
- Establish methods to protect food that has been
identified as at-risk
- Implement the foods provisions of the Public
Health Security and Bioterrorism Preparedness and Response
Act of 2002.
- Increase research to develop rapid and confirmatory
laboratory methods to analyze suspect foods for
select agents or toxins.
- Strengthen and expand eLEXNET (electronic
Laboratory Exchange Network) to facilitate electronic
transfer of laboratory data.
|
Objective 5. Protect the safety and security of human drugs,
biologics (vaccines, blood and blood products, gene therapy,
human tissues, and cellular therapies), medical devices (including
radiation-emitting and screening devices), veterinary drugs,
and other FDA-regulated products.
- Implement the applicable provisions
of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002.
- Participate in the completion
of a thorough review of areas of alleged vulnerability to
identify those areas of highest safety and security concerns.
- Develop and implement preventive
strategies to address the highest-priority vulnerabilities.
___________________
Footnote
22Food Safety and Protection
Issues in the 107th Congress, August 2002, Congressional Research
Service.
Complete FDA Strategic
Plan
|