Good afternoon. 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. In addition, the Committee asked CDC to address the adequacy and effectiveness of other safeguards to prevent using biologic agents to harm the public 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, in view of concern that certain select agents could have serious adverse consequences for human health and safety.
In general, the safety and security record has been good in the sale and transfer of these agents and substances for research. Each year in the U.S., 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.
To ensure that adequate safeguards are in place, the Antiterrorism and Effective Death Penalty Act of 1996 established new provisions to regulate transfer of hazardous agents, and required the Secretary of Health and Human Services to promulgate regulations to implement these provisions. In response to this mandate, CDC published a final regulation in October 1996 which became effective on April 15, 1997.
The regulation amended existing CDC requirements for the packaging, labeling and transport of select agents shipped in interstate commerce, and 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 CDC 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.
CDC developed its regulation in consultation with an interdepartmental workgroup, composed of representatives from within HHS and from other Departments and Agencies, including the Departments of Justice and Defense. The goal in developing the regulation was to strike a balance between assuring the availability of materials to the scientific and medical community for legitimate research purposes and preventing access to these agents for other uses. This regulation is designed to ensure 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; and to implement a system whereby scientists and researchers involved in legitimate research may continue transferring and receiving these agents without undue burdens. Thus, the CDC regulation is based on the key principles of ensuring protection of public health, without encumbering legitimate scientific and medical research. I want to emphasize that we have worked extensively with our partners in the scientific community to develop and implement the regulation and have had excellent cooperation from various associations and from the facilities registered under this regulation.
Specifically, CDC’s 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.
Select Agent List
The CDC 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 or reasonably suspected of containing a select agent, unless exempted as a human or veterinary clinical specimen, are subject to the regulation. CDC intends to supplement or modify the list as appropriate.
The select agent list in CDC’s regulation is based on an existing list of selected infectious agents whose export from the U.S. is controlled due to their capacity for causing substantial harm to human health. In addition, CDC consulted with US military and civilian experts and members of the American Society for Microbiology, and solicited public comment on the proposed select agent list by publishing it in the Federal Register as part of the Notice of Proposed Rulemaking. The current select agent regulation, which is subject to change as new information becomes available, is a result of those consultations.
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). 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.
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.
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 necessary, 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 of registered facilities are expected to begin in the near future.
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.
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.
To date we have received approximately 1,000 inquiries from research, educational and commercial facilities for information on the regulation, presumably to determine whether they are required to register. We have mailed out approximately 600 application packages. Approximately 60 facilities have completed the application process and are now registered. Application packages are reviewed by CDC staff and the registration number is usually issued within two weeks of receipt. At the time of registration, each facility is given instructions for completing the required “Transfer of Select Agent” document and a supply of the required form. CDC has received transfer documents for approximately 130 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.
ADDITIONAL SAFEGUARDS TO PROTECT PUBLIC HEALTH
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. In addition to the regulatory controls designed to safeguard select agents from inappropriate use, prompt detection of disease threats requires careful monitoring by effective disease surveillance systems, backed up by the capacity to investigate and control outbreaks of a variety of health problems in a timely manner.
In 1994, CDC launched a national effort to revitalize the U.S. capacity to protect the public from infectious diseases. CDC's plan, "Addressing Emerging Infectious Disease Threats: A Prevention Strategy for the United States," is the foundation for a sound surveillance and response strategy for responding to disease threats. A recent report of the National Science and Technology Council, Committee on International Science, Engineering, and Technology (CISET) Working Group on Emerging and Re-emerging Infectious Diseases, emphasized that a global infectious disease surveillance and response network would enable us to respond effectively in the event of an attack involving biological or chemical agents.
Dealing with the diversity of circumstances that may be involved in bioterrorism requires a well-functioning public health surveillance and response system. Since the publication of CDC’s 1994 plan, we are working to reinforce the Nation’s public health infrastructure to deal with urgent threats to public health, whether intentional or unintentional, particularly at the state and local level. At present, CDC is providing resources to 32 state and large local health departments for infrastructure improvements.
This concludes my testimony. We appreciate the opportunity to participate in this important hearing. I will be happy to answer any questions you may have.