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Testimony on Interstate Transportation of Human Pathogens by James M. Hughes, M.D.
Director, National Center for Infectious Diseases
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services

Before the Senate Committee on the Judiciary
March 6, 1996


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.


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