STATEMENT OF

JAMES M. HUGHES, M.D.

DIRECTOR

NATIONAL CENTER FOR INFECTIOUS DISEASES

CENTERS FOR DISEASE CONTROL AND PREVENTION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE

SUBCOMMITTEE ON TECHNOLOGY, TERRORISM,

AND GOVERNMENT INFORMATION

SUBCOMMITTEE ON YOUTH VIOLENCE

COMMITTEE ON THE JUDICIARY

U.S. SENATE

April 20, 1999

I am Dr. James M. Hughes, Director, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC). Thank you for the invitation to discuss the need to enhance the public health capacity in the United States to respond to the threat of bioterrorism. I will provide a brief discussion of the current situation and then I will describe the actions that CDC is taking to strengthen and modify our current public health laboratories and disease surveillance and control to ensure an effective response to acts of biological and chemical terrorism.

Vulnerability of the Civilian Population

In the past, an attack with a biological agent was considered very unlikely; however, now it seems entirely possible. Many experts believe that it is no longer a matter of "if" but "when" such an attack will occur. They point to the accessibility of information on how to prepare biologic weapons and to activities by groups such as Aum Shinrykyo, which, in addition to releasing nerve gas in Tokyo's subway, experimented with botulism and anthrax. In 1997, the FBI investigated a situation in Las Vegas in which an individual was in possession of the organism causing anthrax. Although he had an attenuated strain of anthrax used in an animal vaccine rather than a virulent strain, the incident provided another reminder of how easily a terrorist might cause serious illness and panic in a U.S. city.

An attack with a chemical agent is also increasingly likely. Such an attack might involve the release of a noxious gas, such as a nerve gas, phosgene, or lewisite, or an airborne chemical, such as hydrogen cyanide, chlorine, or pesticides, that can kill many people. Early in an investigation, it may not be obvious whether an outbreak is caused by an infectious agent or a chemical toxin; however, most chemical attacks will be localized, and their effects will be evident within a few minutes. An attack using a chemical agent will demand immediate reaction from emergency responders - fire departments, police, EMS, and emergency room staff - who will need adequate training and equipment. In contrast, when people are exposed to a pathogen like anthrax or smallpox, they will not know that they have been exposed, and they may not feel sick for some time. This delay between exposure and onset of illness, or incubation period, is characteristic of infectious diseases. The incubation period may range from several hours to a few weeks, depending on the exposure and pathogen.

The initial response to such a biological attack on civilians is likely to be made by the public health community rather than by the military or emergency responders. Thus, protection against terrorism requires investment in the public health system. This point is underscored in a report, commissioned by the Department of Health and Human Services Office of Emergency Preparedness and recently released by the Institute of Medicine and the National Research Council, Chemical and Biological Terrorism: Research and Development to Improve Civilian Medical Response, which stresses the need for long-term public health improvements in surveillance and epidemiology infrastructure. Copies of the report have been provided to the Subcommittees. The financial costs of these improvements will be relatively modest. For example, without these investments, it has been estimated that responding to an initially undetected and consequently uncontrolled anthrax attack that results in infecting 100,000 people could cost $26 billion.

Public Health Leadership

As the nation's disease prevention and control agency, it is CDC's responsibility to provide national leadership in the public health and medical communities in a concerted effort to detect, diagnose, respond to, and prevent illnesses, including those that occur as a result of a deliberate release of biological or chemical agents. This task is an integral part of CDC's overall mission to monitor the health of the U.S. population.

In 1998, CDC issued Preventing Emerging Infectious Diseases: A Strategy for the 21st Century, which describes CDC's plan for combating today's emerging diseases and preventing those of tomorrow. It focuses on four goals, each of which has direct relevance to preparedness for bioterrorism: disease surveillance and outbreak response; applied research to develop diagnostic tests, drugs, vaccines, and surveillance tools; infrastructure and training; and disease prevention and control. This plan emphasizes the need to be prepared for the unexpected—whether it be a naturally occurring influenza pandemic or the deliberate release of anthrax by a terrorist. Copies of this CDC plan have been provided to the Subcommittee.

Strengthening Public Health Readiness to Address Bioterrorism

Increased vigilance and preparedness for unexplained illnesses is an essential part of the public health effort to protect the American people against bioterrorism. Toward this end, CDC, working in collaboration with State and local health departments, many other public health partners, and other Federal agencies, has begun the effort to upgrade national public health capabilities to respond to biological and chemical terrorism.

Further, because terrorists may employ a wide range of biological and chemical agents, this country's infectious disease surveillance networks must have enhanced capacity to detect unusual events, unidentified agents, and unexplained illnesses. In addition, State and Federal epidemiologists must be trained to consider unusual or rare threat agents when a suspicious outbreak occurs and be prepared to address questions related to their transmission, treatment, and prevention.

Focus Areas For Public Health Action

In December 1998, CDC established the Bioterrorism Preparedness and Response Activity (BPRA), to lead an agency-wide effort to prepare for and respond to acts of terrorism that involve actual, threatened, or suspected uses of biological or chemical agents. BPRA is charged with the coordination of CDC's epidemiological and laboratory response following a suspected or actual attack and response to health threats from unknown biological or chemical agents.

In February, in an effort to provide support and assistance to State and large metropolitan health departments in enhancing their ability to be prepared for and respond to a terrorist attack that involves a biological or chemical agent, CDC announced the availability of nearly $41,000,000 in Public Health Preparedness and Response to Bioterrorism cooperative agreement funds. This announcement, along with other extramural and intramural strategies, focuses on strengthening four components of the public health infrastructure to improve the national capacity to address biological and chemical terrorism:

• Detection of unusual events. Because the initial detection of a biological or chemical terrorist attack will most likely occur at the local level, it is essential to educate and train members of the medical community—both public and private—who may be the first to examine and treat the victims. It is also necessary to upgrade the surveillance systems of State and local health departments, which will be relied upon to spot unusual patterns of disease occurrence and to identify any additional cases of illness as the disease spreads throughout the community and beyond.

To enable States and major cities to build core capacity to monitor and detect potential biologic and chemical threat agents, CDC will make up to 30 awards as a part of the Public Health Preparedness and Response to Bioterrorism cooperative agreement. CDC will also lead the development of new disease surveillance networks in hospitals and other health care facilities and will evaluate new surveillance mechanisms to improve the nation's ability to detect low incidences of unexplained illnesses.

• Investigation and containment of outbreaks. The initial response to an outbreak caused by an act of chemical and biological terrorism will take place at the local level. In the most likely scenario, CDC—as well as DOD and security agencies—will be alerted to a bioterrorist attack only after a State or local health department has recognized a cluster of cases that is highly unusual or of an unknown cause. For this reason, it is imperative that State and local health departments have sufficient resources to conduct epidemiologic investigations.

Through the cooperative agreement and other mechanisms, CDC will provide State and large metropolitan health departments with tools, training, and financial resources for local outbreak investigations, and help develop rapid public health response capacity at the local, State, and Federal levels. Additionally, in the event of a suspected or an actual attack, CDC will be prepared to assist State health departments in identifying threat agents and their modes of transmission, in instituting control measures, and in providing consultation on medical management.

CDC is also working to establish a National Pharmaceutical Stockpile which will ensure the availability of drugs, vaccines, prophylactic medicines, chemical antidotes, medical supplies, and equipment that might be needed in a medical response to a biological or chemical terrorist incident.

• Laboratory diagnosis. In the event of a biological or chemical terrorist attack, rapid diagnosis will be critical, so that prevention and treatment measures can be implemented quickly. CDC will fund approximately 34 State and major metropolitan health departments under the cooperative agreement to improve capacity to diagnose biologic threat agents. At the same time, CDC will make up to four additional awards to enable selected State health laboratories to function as reference facilities for the identification of chemical threats. In addition to evaluating existing technology for identifying priority biological agents, CDC will develop a Rapid Toxic Screen that can assess exposure to 150 different chemical agents. CDC will develop guidelines and quality assurance standards for the safe and secure collection, storage, transport, and processing of biologic and environmental samples. Working with other federal partners, CDC will develop a Rapid Assay and Technology Transfer laboratory to quickly identify pathogens and chemicals that might be used by terrorists and to serve as a triage laboratory.

Finally, CDC is working with public health partners to plan the development of a multi-level network of laboratories which will be used to provide the most immediate diagnosis of a biological agent in the event of a suspected terrorist attack. This network will ultimately include hospital laboratories, commercial reference laboratories, State and local health laboratories, and highly specialized Federal facilities. It will not only enhance public health capacity to address bioterrorism, but also contribute to the overall public health capacity to address naturally occurring infectious diseases.

• Coordination and Communication. In the event of an intentional release of a chemical or biological agent, rapid and secure communications will be especially crucial to ensure a prompt and coordinated response. Thus, strengthening communication among clinicians, emergency rooms, infection control practitioners, hospitals, pharmaceutical companies, and public health personnel is of paramount importance. In order to assure the most effective response to an attack, CDC will work closely with The FBI, which will take the lead in the criminal investigation of a terrorist attack, and with other government agencies, including the Food and Drug Administration (FDA), National Institutes of Health (NIH), DOD, and the Federal Emergency Management Agency.

In the event of a terrorist attack, we will need to ensure that the public is provided with accurate and timely information. An act of terrorism is likely to cause widespread panic, and on-going communication of accurate and up-to-date information will help calm public fears and limit collateral effects of the attack.

Internationally, global health security will be enhanced as CDC, in collaboration with the World Health Organization, responds throughout the world to reports of illnesses from unusual pathogens, suspected bioterrorism, and other outbreaks that might threaten the U.S. population.

Planning and Preparedness

CDC is working to ensure that all levels of the public health community—Federal, State, and local—are prepared to work in coordination with the medical and emergency response communities to address the public health consequences of biological and chemical terrorism. CDC will assist States and major cities in developing local public health bioterrorism preparedness plans that are well integrated into existing emergency response plans at the local, State, and Federal level. CDC is creating diagnostic and epidemiological performance standards for State and local health departments and will help States conduct drills and exercises to assess local readiness for bioterrorism.

In addition, CDC, NIH, DOD, and other agencies are supporting and encouraging research to address scientific issues related to bioterrorism. For example, for several of the agents likely to be used as bio-weapons, we need to create rapid, simple, low-cost diagnostic kits that can be used in the field to test large numbers of people exposed to a biological or chemical agent within a short time frame. In some cases, new vaccines, antitoxins, or innovative drug treatments are also required. Moreover, we need to learn more about the pathogenesis and epidemiology of these rare diseases. We also have only limited knowledge about how artificial methods of dispersion may affect the infection rate or virulence of these diseases.

Disease Prevention

Disease experts at CDC are considering various strategies for preventing the spread of disease during and after bioterrorist attacks. Strategies under evaluation include: creating protocols for immunizing at-risk populations, isolating large numbers of exposed individuals, and reducing occupational exposures; assessing methods of safeguarding food and water from deliberate contamination; and exploring ways to improve linkages between animal and human disease surveillance networks since threat agents that affect both humans and animals may first be detected in animals.

CDC is enhancing its ongoing efforts to foster the safe design and operation of Biosafety Level 3 and 4 laboratories, which are required for handling highly dangerous pathogens.

Conclusions

In conclusion, the best public health method to protect, respond, and defend the health of civilians against chemical and biological terrorism is the development, organization, and enhancement of life-saving public health prevention tools. Such tools include expanded State public health laboratory capacity, increased surveillance and outbreak investigation capacity, and health communications and training at the local, State, and Federal levels. The tools we develop in response to bioterrorism threats are "dual use" tools. Not only will they ensure that we are prepared for man-made threats, but they also ensure that we will be able to recognize and control the naturally occurring emerging infectious diseases and the hazardous materials incidents of the late 20th century. A strong and flexible public health infrastructure is the best defense against any disease outbreak.

Thank you very much for your attention. I will be happy to answer any questions you may have.