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Foods
Medical Products
Blood Donations
Radiation Products
Veterinary Products
Cosmetics
Field Operations
Toxicological Research
- Working
with industry to reduce threats and contain outbreaks of foodborne
illness -- FDA has issued new industry guidance on
security measures, and has encouraged specific additional
industry security measures in response to the increased threat
level. The guidance will help food producers, warehouses,
importers, stores, restaurants, and other food establishments
minimize the risk that their food will be subject to terrorism.
[Counterterrorism
Home Page]
- Increasing
risk-based surveillance of domestic and imported food
-- FDA has increased inspections of domestic food facilities
and sampling and lab analysis of foods produced here and abroad.
[Counterterrorism
Home Page]
- Developing
PrepNet food safety network -- With the
U.S. Department of Agriculture and other federal agencies,
FDA is designing this safety net that will help prevent and
respond to chemical, biological or radiation contamination
of our nation’s food supply. [Counterterrorism
Home Page]
- Implementing
the 2002 Bioterrorism Act -- Under the Bioterrorism
Preparedness and Response Act of 2002, FDA is developing regulations
to require all of the more than 400,000 domestic and foreign
food facilities to register with FDA. This will allow FDA
to follow through quickly on high-risk situations. Also, the
new rules will require importers to tell FDA in advance about
food shipments, will improve FDA’s ability to detain suspected
food, and will require food companies to keep better records
so any contamination can be traced back to its source. The
law also strengthens FDA’s authority to detain suspect food
and allows for more grants to the states to help inspect food
facilities. [Counterterrorism
Home Page]
- Increasing
ability to quickly identify outbreaks of foodborne illness
-- FDA is working with the U.S. Centers for Disease Control
and Prevention to ensure that outbreaks or unusual patterns
of illness are investigated quickly. [Counterterrorism
Home Page]
- Increasing
participation in the first Internet-based food safety system
-- FDA’s goal is to have 79 laboratories around the country
participating in eLEXNET (Electronic Laboratory Exchange Network).
This shared electronic data system consolidates and shares
microbial food contamination findings among federal, state
and local laboratories. [Counterterrorism
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- Helping
to speed development of new emergency treatments and diagnostic
tests -- FDA is adapting its review processes and
working around the clock to speed the development of products
to diagnose, treat or prevent outbreaks from exposure to anthrax,
smallpox, plague, and other biological, chemical and radiological
agents that could be used by terrorists. FDA is even assuming
many of the responsibilities normally carried out by drug
sponsors. Specific efforts to date have focused on:
- an antidote for cyanide poisoning,
- products to reduce the effects of radioactive cesium
and thallium,
- a drug to lessen the effects of smallpox infection,
- new antitoxins to prevent or treat botulism and anthrax,
- novel vaccines to prevent smallpox,
- antimicrobials to treat anthrax and plague, and
- a drug to treat viral hemorrhagic fever.
[Counterterrorism
Home Page]
- Speeding
availability of critical medical products -- FDA
has made it possible for critically important treatments and
diagnostic tests still under investigation to be made rapidly
available for emergency use through rapid turn-around of applications.
Flexible, creative ways are being found to share information
about these new products (for example, videos for patients
who might receive smallpox vaccine). [Counterterrorism
Home Page]
- Providing
researchers with early guidance and assistance --
FDA is providing guidance early on to researchers so that
discoveries made in the laboratory can be more quickly turned
into counterterrorism products available to first responders,
health professionals and the military. [Counterterrorism
Home Page]
- Relying
on animal efficacy studies -- Under a new regulation,
FDA can now approve medical treatments against chemical, biological,
radiological, or nuclear agents based on evidence of effectiveness
from animal studies when human studies are not ethical or
feasible. Human data supporting the safety of such products
is still required. [Counterterrorism
Home Page]
- Ensuring
an adequate stockpile of emergency medical products
-- FDA is working with the Department of Homeland Security’s
Strategic National Stockpile, as well as with industry, the
National Institutes of Health, CDC, the Defense Department,
and foreign governments to ensure the safety and effectiveness
of stockpiled vaccines and other medical products so that
they are available to respond to terrorist attacks. [Counterterrorism
Home Page]
- Offering
research grants and other funding --
- requested grant applications for clinical trials of
treatments for plague,
- provided funding to study the impact of long-term use
of antibiotics that could be used for post-exposure prevention
in healthy adults and in special populations (such as
pregnant women) and,
- is investigating funding mechanisms to encourage development
of a test to rapidly diagnose plague at an early and treatable
stage.
[Counterterrorism
Home Page]
- Working
with the military -- FDA has worked with the Joint
Chiefs of Staff to help obtain critical medical products for
combat readiness. It has helped U.S. Special Forces obtain
medical countermeasures for airborne hospitals used in evacuating
battlefield casualties. It has provided intensive consultation
and review to help make available needed investigational and
licensed medical products such as antisera and vaccines. FDA
recently approved pyridostigmine bromide for combat use by
U.S. military personnel to protect them from the lethal effects
of the nerve gas Soman. The agency also recently cleared a
high-tech battlefield wound dressing that can stop massive
bleeding within minutes and a decontamination lotion for use
by the military to remove or neutralize chemical warfare agents
and other toxins from the skin, preventing serious burns and
death [Counterterrorism
Home Page]
- Protecting
children -- FDA has been providing guidance to parents
and health professionals when they use antibiotics and other
drugs to treat children and pregnant and nursing women stricken
by bioterrorist attacks. The advice covers such areas as:
- proper dosage,
- adverse effects, and
- how to mix tablets with foods or drinks to give to children
in an emergency.
[Counterterrorism
Home Page]
- Detecting
bioterrorism agents -- FDA is helping develop methods
to detect biological agents that terrorists might use in an
attack. [Counterterrorism
Home Page]
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- Keeping
the blood supply safe -- FDA has provided guidance
to blood donation centers and healthcare facilities on prudent
measures to reduce any possible risk of transmitting anthrax
through blood donated by people who may be infected with the
disease. [Counterterrorism
Home Page]
Top
- Helping
companies develop drugs to prevent and treat radiation exposure
-- FDA has called for manufacturers to submit marketing applications
for Prussian blue, a mineral compound that can help treat
people exposed to radioactive elements such as cesium-137.
FDA has provided guidance to first responders and health professionals
on how to use potassium iodide to reduce the risk of thyroid
cancer in radiation emergencies. [Counterterrorism
Home Page]
- Reviewing
radiation devices used against terrorism -- FDA is
monitoring the safety and effectiveness of radiation-emitting
devices used to detect potential security threats in airports
and other locations, devices used to destroy biological agents
released in a terrorist attack, and devices used to treat
victims of radiation exposure. [Counterterrorism
Home Page]
Top
- Increasing
security measures for animal feed -- FDA is working
with other government agencies and the animal feed industry
to minimize the risk of terrorist attacks on feed for animals
that are raised for human food. [Counterterrorism
Home Page]
- Facilitating
the supply of critical animal drugs -- FDA is ensuring
the availability of veterinary drug products to meet emergency
needs. [Counterterrorism
Home Page]
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- Working
with the cosmetic industry to reduce threats -- FDA
has issued draft guidance to industry on security steps they
can take to help ensure that their products are secure against
terrorism. [Counterterrorism
Home Page]
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- Increasing
inspections -- Thanks to increased bioterrorism funding
from Congress, FDA has hired over 800 new inspectors and other
field personnel to keep watch on imports and other avenues
our enemies might try to use to contaminate our food or tamper
with other FDA-regulated products. FDA now can conduct 24,000
import inspections a year – double the number from just last
year. FDA has also increased inspections of facilities that
manufacture medical products that could be used in response
to a terrorism threat. [Counterterrorism
Home Page]
- Upgrading
laboratories -- FDA has upgraded its laboratories
to handle the increased number of sample analyses. Lab scientists
are developing rapid methods for detecting bacterial and viral
food contaminants. [Counterterrorism
Home Page]
- Scrutinizing
imports -- FDA plans to cover an additional 45 ports
of entry where there are significant shipments of FDA-regulated
products. The agency is also strengthening its import information
systems to improve targeting of suspect products. The links
between import and domestic information are being tightened
so imported products can be better traced in this country.
[Counterterrorism
Home Page]
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- Enhancing
research facilities and technologies -- FDA is developing
a Level 3 lab at its National Center for Toxicological Research
to safely allow analysis and research on select agents. The
lab will be used to test food samples that may be contaminated
by biological, chemical or radiological means. The center
is continuing research to identify and characterize biological
warfare agents using technologies involving DNA and proteins.
[Counterterrorism
Home Page]
- Developing
methods to detect explosives -- The center is developing
sensor technologies to detect nitrogen-based explosives in
airline cargo by refining its patented methodology currently
used to detect and identify deteriorating food. [Counterterrorism
Home Page]
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