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Homeland Security

Thursday, June 5, 2003

Statement of Paul Redmond Assistant Secretary for Information Analysis Department of Homeland Security and Eric Tolbert Director Response Division Emergency Preparedness and Response Directorate Department of Homeland Security

Hearing Before The Select Committee on Homeland Security Subcommittee on Intelligence and Counterterrorism and Subcommittee on Emergency Preparedness and Response
United States House of Representatives


Good afternoon. We are honored to appear before you today to discuss our Department's role in bio-terrorism preparedness in general, and BioShield specifically. Preparing our citizens for a bio-terrorism event is one of the significant challenges the Department faces.

The Emergency Preparedness and Response Directorate:

First we want to provide you some background about the Emergency Preparedness and Response Directorate, its Response Division, and our role in the Department. We are proud to join the Department, and we want to assure the Members of this Subcommittee that EP&R will not lose sight of its main responsibility of helping people and communities affected by disasters. The mission statement of EP&R,

"To lead the Nation to prepare for, mitigate the effects of, respond to, and
recover from major domestic disasters, both natural and man-made, including acts of terrorism,"

contains the same core responsibilities that guided the Federal Emergency Management Agency (FEMA) as an independent Agency.

The Response Division coordinates and implements the federal response to Presidentially declared disasters. During FY 2002, FEMA expended nearly $3.9 billion in disaster funds to aid people and communities overwhelmed by disasters, which included earthquakes, floods, ice and winter storms, fires, hurricanes, tornadoes, and tropical storms. FEMA responded to 42 major disasters involving 37 States and 4 U.S. Territories.

The Response Division is charged with developing and maintaining an integrated, nationwide operational capability to respond to and recover from disasters and emergencies, regardless of their cause, in partnership with other Federal agencies, State and local governments, volunteer organizations, and the private sector.

The risks associated with acts of terrorism pose a significant challenge for EP&R. FEMA's rapid and decisive response to the events of September 11 demonstrated the Agency's role in consequence management. As a result, the Nation is looking to the emergency management community-and EP&R in particular-to face this challenge. Augmenting and maintaining the Strategic National Stockpile, and strengthening their future capacity, to ensure there are adequate supplies in the event of a national emergency are important steps in meeting the challenge.

Project BioShield

In his State of the Union Address, President Bush announced Project BioShield as an effort to develop and make available modern, effective medical countermeasures, especially vaccines and anti-toxins to protect against a biological, chemical, or radiological/nuclear threat agents. This new Project will be built on the many health advances in basic medical science and pharmaceutical manufacturing technology that our society has enjoyed in recent years.

Specifically, Project BioShield will ensure that resources are made available to pay for advanced development and large-scale acquisition of "next-generation" medical countermeasures as soon as scientists can assert that the envisioned countermeasure is reasonably likely to be licensable, and that large-scale manufacturing of a safe and effective product is reasonably feasible, within the near term. President Bush has proposed creating a mandatory funding authority to spur development of medical countermeasures. This authority will help ensure that the private sector contributes to this effort by ensuring them that if they can produce a needed countermeasure, the government can and will purchase it.

Second, Project BioShield will strengthen the capabilities of the National Institutes of Health (NIH) by expediting research and development on medical countermeasures based on promising, recent scientific discoveries. The new authorities provided to NIH would apply only to support research and development of biomedical countermeasures against bioterrorism threat agents. Funding of grants and contracts will remain subject to rigorous scientific and peer review, but expedited peer review procedures could be used when appropriate.

Finally, Project BioShield will enable the Food and Drug Administration (FDA) to make promising treatments available in emergency situations if alternative treatments are not available. This authority is not intended to alter the FDA's thorough review before licensing a product. Rather, BioShield authorities will supplement the traditional FDA licensing process to ensure that we could respond effectively in a crisis to use medical countermeasures that experts have judged safe and effective. These countermeasures will be subject to Government controls, and can only be used after certain certifications have been made. Furthermore, all civilian use would be voluntary and the benefits of the treatment in question to be used in an emergency situation must outweigh the expected risks.

We must continue to encourage scientific initiative and creativity to ensure rewards for innovators who bring needed countermeasures to the American public. And, the breakthroughs resulting from Project BioShield are likely to have important spillover benefits in preventing and treating other diseases, and in strengthening our overall biotechnology infrastructure.

The Department of Homeland Security is working closely with the Department of Health and Human Services and the Department of Veterans Affairs, as those entities are equipped to identify contracting and procurement issues with the pharmaceutical industry; to assess when new countermeasures can be made that will be safe and effective; and to make recommendations for programmatic progress and areas of improvement. EP&R will be responsible for the Department's role as proprietor of the budget authority under BioShield (we estimate the use of nearly $900 million in the President's FY 2004 Budget) to allow the federal government to purchase critically needed vaccines or medication for biological, chemical, and radiological/nuclear defense measures, and to ensure the adequacy of the nation's stockpiles of pharmaceutical, vaccine and other medical supplies, and to promote removal of barriers to the development and production processes.

Emergency Preparedness and Response Bio-preparedness Activities

The Department of Homeland Security's work in the bio-preparedness arena includes developing an environmental surveillance system and associated response plans; the Bio-Watch surveillance program; participating in Metropolitan Washington Council of Governments Bio-terrorism Task force; and participating in major bio-terrorism response exercises such as TOPOFF 2 and Exercise Silent Night.

As one of its responsibilities, EP&R has assumed responsibility for the National Disaster Medical System (NDMS). This system assists State and local governments by providing primary care to disaster victims in the field, patient evacuation from disaster areas, and definitive care, when needed. The three other federal partners for NDMS are the Departments of Health and Human Services, Defense and Veterans Affairs.

NDMS is a nationwide medical response system to supplement State and local medical resources during disasters and emergencies and to provide backup medical support during an overseas conflict. The System is activated in response to all-hazards, thus preparing the teams to respond to any event including a terrorist event that may be chemical, biological or nuclear in nature.

EP&R has also assumed the responsibility, together with the Centers for Disease Control and Prevention, of maintaining and deploying the Strategic National Stockpile. The President's budget for Fiscal Year 2004 includes a request for $400 million to maintain the Strategic National Stockpile. The Strategic National Stockpile is made up of pharmaceuticals, vaccines and medical supplies housed in various areas around the country in case of emergencies. By dispersing the assets, the necessary supplies can be delivered to any disaster site within 12 hours. Once development and production of needed pharmaceuticals and vaccines is completed through BioShield, these new items may be placed in the Strategic National Stockpile.

Bio-Watch, an inter-agency initiative involving the Department of Homeland Security, Department of Energy, the Department of Defense, and the Environmental Protection Agency, is developing sophisticated air monitoring and analysis systems to detect large-scale releases of biological agents. Our role is to develop response plans that are more pro-active and responsive in managing the consequences of a biological or chemical attack.

The Metropolitan Washington Council on Governments' Bioterrorism Task Force provides a national model for integrated bio-terrorism response planning. The effort focusing on the National Capital Region provides a structure for Federal, State, local, private sector and cross-jurisdictional coordination, communication, and effective detection and response.

Finally, EP&R is working closely with other federal agencies, State and local contacts on two significant bioterrorism Exercises: The Top Officials 2 (TOPOFF 2) exercise, which is occurring this week, is a major counter-terrorism exercise focusing on the nations response to bioterrorism. Participation in TOPOFF 2 and other bioterrorism exercises enables the response elements to be better prepared to deal with a terrorist attack involving biological, chemical or radiological weapons

Closing
While we have not limited our remarks to BioShield, we hope this information provides you sufficient background on our work to prepare this Nation in the event of a biological attack. We would be pleased to answer any questions the Subcommittee members may have.



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