Good morning. I am Claude A. Allen, Deputy Secretary, Department of Health and Human Services (HHS). I am pleased to be here to describe HHS's role in regulating the possession, use, and transfer of select agents that are capable of causing substantial harm to human health.
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. Recent use of anthrax as a bioterrorist agent has heightened this concern. In general, the safety and security record in the sale and transfer of these agents and substances for research has been good. 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. Each year in the United States, thousands of samples of infectious agents are shipped without incident.
Historically, HHS's Centers for Disease Control and Prevention (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 partners in the scientific community to develop and implement the regulation on behalf of HHS.
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 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 biological 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.
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, are subject to the regulation. The list is not meant to be static and agents can be added or deleted as appropriate.
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 4th 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 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 registered 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 approximately 60 registered facilities.
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.
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.
As of October 24, 250 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 2500 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 with FBI personnel and other authorized law enforcement agencies to provide access to the information when necessary.
This month, Secretary Thompson developed a draft bill for the consideration of Congress to improve the Department's ability to prevent or respond to public health emergencies created by terrorist attacks. The bill, the "HHS Bioterrorism Prevention and Emergency Response Act of 2001," makes amendments to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and related statutes to address several issues related to bioterrorism, including select agents. Among other issues addressed, new authority would be provided to regulate the possession, use, and transfer of those select agents that the Secretary found to be a national security threat. The Secretary would develop and implement an appropriate regulatory framework to accomplish these safeguards.
Title II of the bill includes these provisions. Section 203(b) would add to title III-F of the Public Health Service Act a new section 351B, directing the Secretary, by regulation, (1) to establish and maintain a list of those biological agents and toxins listed under section 351A of that Act that the Secretary determines to be a national security threat; and (2) to provide for the establishment and enforcement of standards and procedures governing the possession, use, and transfer of such agents and toxins designed to protect public safety and national security, including safeguards to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose. Violations would be subject to civil penalties of up to $250,000.
In determining whether to include an agent or toxin on the lists for regulation of transfer or of possession or use, the Secretary will consider the effect on human health of exposure to the agent or toxin, the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans, the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin, and other appropriate criteria. In making these determinations, the Secretary will consult with public health, scientific, intelligence, and military partners.
Through the regulatory regime established, the Secretary will provide for the establishment and enforcement of safety procedures for the transfer of these biological agents and toxins. The regulations will also provide safeguards to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose. Due to the extremely sensitive nature of the information collected, the bill also provides an exemption from the Freedom of Information Act for any information provided to the Secretary under these regulations, or under CDC's current Select Agent regulations.
The Secretary will develop and implement these expanded regulations within its overall framework for public health preparedness for and response to acts of bioterrorism. HHS is responsible for the public health response to any biological or chemical attack, as well as for disease surveillance and medical preparedness. Our anti-bioterrorism efforts are focused on improving the nation's public health surveillance network to quickly detect and identify the biological agent that has been released; strengthening the capacities for medical response, especially at the local level; expanding the stockpile of pharmaceuticals for use if needed; and expanding research on disease agents that might be released, rapid methods for identifying biological agents, and improved treatments and vaccines.
HHS 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.
The Department of Health and Human Services is committed to working with other federal agencies as well as state and local public health partners to ensure the health and medical care of our citizens. We have made substantial progress to date in enhancing the nation's capability to respond to a bioterrorist event. But there is more we can do to strengthen the response. 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, HHS 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.
Mr. Chairman, that concludes my prepared remarks. I would be pleased to answer any questions you or members of the Subcommittee may have.
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