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Testimony on Threat of Bioterrorism in America: Assessing the Adequacy of Federal Law Relating to Dangerous Biological Agents by Stephen M. Ostroff, M.D.
Associate Director for Epidemiologic Science
National Center for Infectious Diseases
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services

Before the House Committee on Commerce, Subcommittee on Oversight and Investigations
May 20, 1999

Good morning. I am Dr. Stephen Ostroff, Associate Director for Epidemiologic Science, National Center for Infectious Diseases at the Centers for Disease Control and Prevention. I am pleased to be here to describe CDC's role in regulating the shipment of select agents that are capable of causing substantial harm to human health.

Overview of CDC's Regulation

In recent years, the threat of illegitimate use of infectious agents has attracted increasing interest from the perspective of public health because certain select agents could seriously compromise human health and safety. In general, the safety and security record in the sale and transfer of these agents and substances for research has been good. Each year in the United States , thousands of samples of infectious agents are shipped without incident. Moreover, continuing the shipment of infectious agents between medical and research facilities is necessary to further medical research and the diagnosis and treatment of infectious diseases.

Historically, CDC has had the responsibility for providing guidance to the research community for safely packaging and shipping biohazardous materials. The Antiterrorism and Effective Death Penalty Act of 1996 required the Secretary of Health and Human Services to promulgate new regulations which resulted in a significantly expanded CDC role by placing additional controls on the shipment of selected etiologic agents that could be used for bioterrorist purposes. In response to the mandate, a final regulation was published in October 1996 which became effective on April 15, 1997. CDC has worked extensively with our partners in the scientific community to develop and implement the regulation, even though we believe the regulatory framework has adversely impacted the longstanding working relationships with some of these partners.

The regulation placed additional shipping and handling requirements on facilities that transfer or receive select agents that are capable of causing substantial harm to human health. For purposes of the regulation, a select agent is defined as a microorganism (virus, bacterium, fungus, rickettsia) or toxin, including genetically modified or genetic material from those select agents, listed in the regulation.

The regulation was developed in consultation with an interdepartmental workgroup, composed of representatives from within the Department of Health and Human Services (HHS) and from other Departments and Agencies, including the Departments of Justice (DOJ) and Defense (DOD). The goal in developing the regulation was to balance the need to assure the availability of materials to the scientific and medical community for legitimate research purposes with the imperative of preventing access to these agents for other uses. This regulation is designed to ensure that these infectious agents are shipped only to institutions or individuals equipped to handle them appropriately and only to those who have legitimate reasons to use them without posing undue burdens on the legitimate user community. The regulation is based on key principles of ensuring protection of public health without encumbering and discouraging essential and legitimate scientific and medical research.

The regulation was designed to establish a system of safeguards to be followed when specific agents are transported; collect and provide information concerning the location where certain potentially hazardous agents are transferred; track the acquisition and transfer of these specific agents; and establish a process for alerting appropriate authorities if an unauthorized attempt is made to acquire these agents. The rule includes six fundamental components: (1) a comprehensive list of select agents; (2) registration of facilities transferring these agents; (3) transfer requirements; (4) verification procedures including audit, quality control, and accountability mechanisms; (5) agent disposal requirements; and (6) research and clinical exemptions.

(1) Select Agent List

The regulation includes a list of select agents subject to the rule. This list includes approximately 40 viruses, bacteria, rickettsiae, fungi, and toxins with the potential to cause substantial harm to human health. All materials that are known to contain or are reasonably suspected of containing a select agent, unless exempted as a human or veterinary clinical specimen, are subject to the regulation. The list is not meant to be static and agents can be added or deleted as appropriate.

(2) Registration of Facilities Handling Select Agents

Commercial suppliers of select agents, as well as government agencies, universities, research institutes and private companies that seek to transfer or receive these agents, are required to register with CDC and obtain a unique site registration number. The registration process requires that a responsible facility official certify that the facility and its laboratories meet the Biosafety Level 2, 3, and/or 4 standards for working with dangerous pathogens as described in the 3rd edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL). An updated version of the BMBL will be published soon. Additional requirements for handling toxins are found at 29 CFR 1910.1450 - "Occupational Exposure to Hazardous Chemicals in Laboratories." The facility's unique registration number indicates that the facility is registered to work with select agents at a prescribed biosafety level. The number also is used to help validate all requests for transfer of dangerous human pathogens.

(3) Transfer Requirements

Prior to transferring a select agent, both the shipping and receiving parties must complete required sections of an official transfer form. This form lists the agents and requires information about the requestor as well as the transferor, including their registration numbers, the type and amount of agent requested, and the proposed use of the agent. This form must accompany the purchase order and requests for obtaining these agents. Both the requesting and transferring facilities must retain a copy of this form. In addition, a copy is sent to CDC for documentation, and to be available to federal and authorized state and local law enforcement authorities if needed. The form also can be used for tracking purposes.

(4) Verification Procedures

To ensure management oversight of the transfer process, each facility shipping or receiving a covered select agent must designate a responsible facility official. The responsible facility official for the requesting facility must sign each request. The responsible facility official sending the agent must verify that the recipient holds a currently valid registration number, indicating that the recipient has the required biosafety level capability. If the responsible facility official is unable to validate the necessary information, the official contacts the CDC for assistance. If appropriate, law enforcement authorities would be notified. Copies of the completed form are required to be kept by both the requestor's and transferor's facility. Receipt of an agent must be acknowledged by the recipient within three working days.

CDC may inspect a facility, with or without cause, to verify registration information and to ensure that the facility meets the appropriate biosafety level requirements and complies with the regulation. Routine inspections have been completed at 10 registered facilities.

(5) Agent Disposal Requirements

Select agents must be stored securely in accordance with prudent laboratory practices, and facilities must have in place procedures for the appropriate disposal of the agents. Disposal of select agents must be at the facility, by known effective methods. CDC must be notified of the disposal or complete consumption of a select agent.

(6) Research and Clinical Exemptions

Licensed vaccines containing less pathogenic strains of some of the select viral and bacterial agents are exempted from the list of agents. Transport of clinical specimens for diagnostic and verification purposes are also exempt, as are certain toxins used for legitimate medical purposes or biomedical research. However, isolates of agents from clinical specimens must be destroyed or sent to an approved repository after diagnostic procedures have been completed. Otherwise, such isolates cannot be transferred to another site unless the receiving site is registered.

Implementation Status

As of May 17, 123 facilities have completed the application process and are now registered, including facilities at universities, government agencies, private research institutions, and commercial businesses. CDC has received transfer documents for more than 500 shipments of select agents.

CDC has developed a computerized database to track applications, registrations, and select agent transfers. A paper file is also kept on each registered facility. All files are stored in accordance with HHS data security policies. CDC has worked closely with FBI personnel to ensure that the FBI and other authorized law enforcement agencies have access to the information if necessary.

CDC's Role in Addressing Bioterrorist Threats

In the past year CDC has gained a greater responsibility to enhance our nation's public health capacity to respond to the threat of biological terrorism. A primary role of CDC is prompt detection of disease threats which are naturally occurring or intentional. This requires careful monitoring by effective disease surveillance systems, backed by the capacity to investigate and control outbreaks of a variety of health problems in a timely manner.

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 plan have been provided to the Subcommittee.

Law Enforcement and CDC's Public Health Mission

In this larger context of responding to bioterrorist threats, there are certain areas where further work is needed to develop appropriate safeguards against the threats to public health and safety presented by biological agents, toxins, and delivery systems.

CDC appreciates the need to craft appropriate restrictions and sanctions for improper possession and handling of these substances. We believe it is critical for safeguards to be carefully balanced against other important societal concerns, notably the need to support and encourage legitimate and important research involving these substances. Federal Government agencies are actively collaborating with the private sector on a wide range of research efforts addressing the bioterrorism threat and these efforts need to be expanded. We must bring the best and brightest minds to bear on the development of vaccines, antivirals, antibiotics, and other therapies for exposure or illness due to biologic agents; to develop and test protective equipment; and to develop reliable, rapid assays capable of detecting minute concentrations of biologic agents.


In conclusion, a strong and flexible public health infrastructure is the best defense against any disease outbreak -- naturally or intentionally caused. To meet the challenges posed by infectious diseases, including outbreaks that may result from bioterrorism, we must strengthen our capacity to detect and respond to infectious diseases. CDC's on-going initiatives to strengthen disease surveillance and response at the local, State, and Federal levels can complement efforts to detect and contain diseases caused by the biological agents that might be used as weapons. Addressing the threat of bioterrorism requires an unprecedented level of cooperation and partnership, bringing together agencies with diverse missions. These include public health and law enforcement agencies, civilian and military agencies, and public and private organizations. Finally, CDC fully supports criminal sanctions designed to capture and punish those who possess these agents for nefarious purposes. These sanctions need to be carefully developed so that they do not unduly curb the research vitally needed to prepare our nation to respond effectively to a bioterrorist attack in order to minimize its consequences.

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

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