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.
Conclusions
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.
