Good morning, I am Dr. James M. Hughes, Director of the
National Center for Infectious Diseases (NCID), Centers for
Disease Control and Prevention (CDC). I am accompanied by Dr.
Stephen A. Morse, Acting Associate Director for Laboratory
Science, NCID. We are pleased to be here to discuss interstate
transportation of human pathogens and their control and
acquisition. CDC serves as co-chair of an interdepartmental
committee working to develop a framework for controlling the
acquisition and transfer of infectious agents. My statement will
describe the composition of that committee, its charge, and the
proposed framework.
In recent years, the threat of biological terrorism has
become an area of increasing concern from the perspective of both
public health and domestic security. As part of the
comprehensive preparations underway to address emerging terrorist
threats, the President designated the U.S. Department of Health
and Human Services (HHS) to be the leader for developing plans
for the medical consequences of terrorism with weapons of mass
destruction. The timeliness of this mission was made all the
more imperative by the recent disclosure that an individual in
Ohio was able to order and receive at his private residence three
vials of lyophilized pathogen, Yersinia pestis (plague bacillus).
In the summer of 1995, the Office of Emergency Preparedness
(OEP) within HHS convened an informal, interdepartmental
workgroup of federal scientists and health professionals to
review the existing system under which organisms are safeguarded
from inappropriate use, yet made available for necessary
scientific work. Specifically, the workgroup 1) reviewed the
current safeguards for the sale of Biosafety Level 3 and
Biosafety Level 4 organisms; 2) reviewed the safety procedures
for registry and sale of recombinant DNA products- 3) reviewed
the adequacy of shipment controls for Biosafety Level 3 and
Biosafety Level 4 organisms; and, 4)collated and reviewed the
adequacy of the current laws and regulations governing the
interstate and international acquisition and shipment of
Biosafety Level 3 and Biosafety Level 4 organisms.
Based on this informal review, Dr. Philip Lee, the HHS
Assistant Secretary for Health, directed CDC and OEP to cochair a
committee composed of representatives from CDC, the Food and Drug
Administration, the National Institutes of Health, OEP, and to
invite participation from the U.S. Departments of Commerce,
Defense, Justice, and Transportation, the Environmental
Protection Agency, and the U.S. Postal Service.
The charge to this committee is to: 1) prepare an overview
integrating the regulations governing the shipment of infectious
agents in interstate commerce; 2) prepare a single list of
infectious agents that would be used by the Federal government to
monitor the shipment of these agents in interstate commerce; 3)
develop a legal framework for enforcement of Federal regulations
related to the acquisition and shipment of these restricted
agents; and 4) consider whether a registry for tracking the
purchase of restricted recombinant DNA materials is needed. As
part of its charge, this committee is looking at strengthening
criminal penalties for the illicit use of these agents.
THE CURRENT SYSTEM
In the 1960's and 70's, the CDC published editions of the
Classification of Etiologic Agents on the Basis of Hazard,
which were lists of infectious microorganisms categorized by
potential severity of laboratory-acquired infection. This
publication became the basis for establishing the CDC/NIH
guidelines (Biosafety in Microbiological and Biomedical
Laboratories) published first in the 1980's and updated
periodically, as well as the NIH Guidelines for Research
Involving Recombinant DNA Molecules. These documents have
become the "gold standard" for the safe conduct of
biohazardous research throughout the US (and in several
foreign countries).
The current safeguards governing the acquisition and
distribution, in the United States, of infectious and/or toxic
agents are not comprehensive. There is no single set of
consistent regulations but rather a number of different
departmental regulations that address the shipping and handling
of infectious agents. Taken together, these are effective at
controlling the packaging, labeling, and transport of infectious
materials, but they are not completely effective at controlling
the possession and transfer of human infectious agents within the
United States.
Within existing research facilities the handling of
human infectious agents are safeguarded by institutional
biosafety officers or biosafety committees guided by the
principles and criteria described in the CDC and NIH manual,
Biosafety in Microbiological and Biomedical Laboratories and the
NIH Guidelines for Research Involving Recombinant DNA Molecules.
However, there is no central registry of existing laboratories
that handle these agents, no means of knowing the number or
location of Biosafety Level 3 and Biosafety Level 4 facilities,
and no means for ensuring that the laboratories are adhering
voluntarily to the principles found in CDC and NIH guidelines.
These safeguards may appear inadequate in the context of
today's focus on biological terrorist, but they must be
evaluated taking into consideration the historical
perspective of how successful they have been. Estimates of
the interstate transfer of dangerous human infectious agents
for legitimate scientific research among academic and
commercial institutions range from several hundred to a few
thousand per year. And, despite those numbers, only the
single episode of the inappropriate transfer in Ohio last
year has been reported. Moreover, it is important to note
that even in the Ohio instance, the existing voluntary
system of safeguards resulted in the alerting of federal
officials and the safe retrieval of the unopened, intact
vials by local authorities.
We believe breaches of existing safeguards for these agents
have rarely occurred and the current goal is to strike a balance
between assuring the availability of infectious and recombinant
DNA materials to the scientific and medical community for
important public health and biotechnological research and
preventing access to these agents for other than legitimate
scientific and medical purposes.
PRINCIPLES AND COMPONENTS OF THE HHS DRAFT PROPOSED FRAMEWORK
While recognizing that it is possible for a determined
terrorist to circumvent almost any system regulating the
acquisition and transfer of dangerous pathogens, existing
criminal laws concerning the use of biological weapons can be
strengthened, and these enhancements will be described for you by
my colleague from the Department of Justice.
I would like to describe one possible framework that has been
proposed and is under discussion by the interdepartmental
committee under which a policy for controlling the safe
acquisition and transfer of infectious human agents will be
developed, reviewed, and implemented. We already have informally
discussed this framework with a number of interested parties in
the research community, and the reaction has generally been
supportive. However, it's important to note that this proposal
is still under discussion and that many of the specifics remain
to be decided. To ensure that we continue our progress in
protecting the public health, we are committed to reaching
closure on the detailed aspects of the following framework and
publishing, within 180 days, a Notice of Proposed Rule Making.
In accordance with the Administrative Procedures Act, we will
fine tune the proposal in response to the public comments.
In developing our proposed framework, we were guided by a
number of key principles beyond that of ensuring that the public
safety is protected without encumbering legitimate scientific and
medical research. To be successful, the proposed framework
should:
- focus on strengthening public-private sector
accountability through involvement with professional associations
and coordination with the research community;
- minimize the burdens of an additional, expansive federal
regulatory structure; and
- dovetail with expanded federal criminal sanctions.
As part of this framework, we are proposing to develop: 1) a
comprehensive list of "restricted" infectious agents; 2) a unique
registration of laboratories handling these restricted agents; 3)
transfer requirements; 4) verification procedures; 5) agent
disposal requirements; and (6) research and clinical exemptions.
Specifically, the proposed framework would:
- collect and provide information concerning the location
where specific potentially hazardous microorganisms are used;
- track the acquisition and transfer of these specific
microorganisms; and
- establish a process for alerting appropriate authorities if
an unauthorized attempt is made to acquire these agents.
These proposals can be implemented under existing HHS
statutory authority (42 USC 264) by making appropriate
modifications to the current CDC regulations governing the
"Interstate Shipment of Etiologic Agents" (42 CFR Part 72).
Restricted Agent List
A "restricted" agent list would be composed of those agents that
have the potential to pose a severe threat to the public health.
The proposed list would be compiled after consultation with
experts representing appropriate professional groups
and updated as needed.
Unique Registration of Laboratories Handling Restricted Agents
Commercial suppliers of these restricted agents, as well as
universities, research institutes and companies that are working
with these agents, or that want to work with these agents, would
be required to register with an organization approved by the
Secretary, and obtain a unique site registration number.
Registration would require the applicant institution to certify
that its laboratory or laboratories meet the Biosafety Level 3
and/or Biosafety Level 4 standards for working with dangerous
pathogens as described in the 3rd edition of the CDC/NIH
Biosafety in Microbiological and Biomedical Laboratories manual
and the NIH Guidelines for Research Involving Recombinant DNA
Molecules.
Under this proposed framework, we believe that the function of
registering institutions and assigning unique registration
numbers could be accomplished by a nongovernmental, professional
organization authorized by the Secretary, HHS. Moreover, the
framework envisions the registration process to be self-
supporting through collection by the organization of a site
registration fee. Each institution's unique registration' number
would be used to help validate all requests for transfer of
dangerous human pathogens.
Transfer Requirements
A simple, approved government form should be developed to aid
in tracking requests for restricted agents. All transfers of
restricted agents would require this form to be completed in
advance of any shipment. This form would include the list of
restricted agents and would require information about the
requester as well as the transferor, including their registration
numbers, the restricted agent requested, and the proposed use of
the agent. It would be required that this form accompany the
purchase order and requests for obtaining restricted agents, and
that a copy be maintained in a designated central repository
which would be available to the FBI and other appropriate
authorities. Falsification of this form would be a federal
criminal offense.
Verification Procedures
The requestor's responsible institutional official would have
to sign each request, certifying that the researcher is
officially affiliated with the institution and that the
laboratory meets current CDC/NIH Guidelines for working with the
requested agent. The responsible institutional official sending
the restricted agent would be required to verify that the
recipient holds a current registration number, indicating that
the recipient has Biosafety Level 3 or Biosafety Level 4
capacity. Inability to validate the necessary information would
result in notification of the appropriate authorities. Copies of
the completed form would be kept by both the requesters and
transferees institution. Receipt of a restricted agent would
have to be acknowledged by the recipient. Institutions would be
given specific instructions on how to report suspicious requests
to appropriate authorities.
Agent Disposal Requirements
There would be a statement on the form that the infectious
agents must be stored under secure conditions and destroyed after
completion of the work or transferred to an approved repository.
Institutions should have in place procedures for the appropriate
disposal of the agents.
Research and Clinical Exemptions
In order to provide strains for reference diagnostic and research
studies at Biosafety Level 2 facilities, less pathogenic strains
such as vaccine strains of restricted viral agents as described
in the CDC/NIH Biosafety in Microbiological and Biomedical
Laboratories manual should be exempted from the list of
restricted agents. Transportation of Clinical specimens for
diagnostic and verification purposes also must be exempt.
However, isolates of restricted agents from clinical specimens
should be destroyed after confirmation or sent to an approved
repository after diagnostic procedures have been completed.
Other than for the purposes I've indicated, such isolates could
not be transferred to another site without using the transfer
form and approval by the responsible institutional officials.
OTHER SURVEILLANCE AND RESPONSE SYSTEMS FOR INFECTIOUS THREATS
In addition to assuring proper controls for these pathogens,
prompt detection of infectious threats requires careful
monitoring by effective surveillance and response systems. Like
radar or "early warning" systems that detect threats to national
security, surveillance with appropriate laboratory support is
critical to an effective defense against infectious diseases.
Since 1994, CDC has focused on implementing its plan, Addressing
Emerging Infectious Disease Threats: A Prevention Strategy for
the United States. The plan contains specific goals based on
recommendations from the National Academy of Science's Institute
of Medicine, which documented that the capacity of the U.S.
public health system is in jeopardy. This plan is the foundation
for CDC's domestic and international surveillance and response
strategy for infectious disease threats.
During 1995, a U.S. government interagency working group,
including representatives from almost 20 different agencies,
reviewed the U.S. role in detecting and responding to outbreaks
of infectious diseases. Dr. David Satcher, Director of CDC,
chaired this working group, established under the aegis of the
Committee on International Science, Engineering, and Technology
(CISET) of the National Science and Technology Council. The
CISET working group report, Infectious Disease--A Global Health
Threat, released in July 1995, made nineteen recommendations for
action by the U.S. government. The report emphasized that a
global disease surveillance and response network could enable the
United States to respond quickly and effectively in the event of
an attack involving biological or chemical warfare, and noted
that the experience gained in controlling naturally occurring
microbes will enhance our ability to cope with a biological
warfare agent, should the need arise. The release of nerve gas
in the Tokyo subway system in March 1995 has underscored our need
to be well prepared to counteract deliberate attempts to
undermine human health.
Implementation of a framework for controlling the acquisition
and transfer of infectious agents, together with the CDC plan
Addressing Emerging Infectious Diseases and the CISET working
group recommendations on infectious disease, will help the public
health system identify, control, and prevent infectious diseases
before they cause widespread epidemics.
CONCLUSIONS
Infectious diseases will remain important, evolving, complex
public health problems. To meet the challenges posed by
infectious diseases and threats of biological terrorism, we must
strengthen our capacity to detect and respond to emerging
infectious diseases. The proposed framework will provide
effective controls for the acquisition and transfer of dangerous
human pathogens. This framework will help ensure that these
agents will be available for legitimate scientific purposes and
will protect against attempts to obtain these agents for illicit
purposes.
Thank you for the opportunity to testify before the committee.
I will be happy to answer any questions you may have.
