June 12, 2002 - Establishing the Department of Homeland Security

The American Society for Microbiology (ASM) is writing concerning issues related to the proposed Department of Homeland Security (DHS) and the policy implications for the civilian biodefense and infectious disease research programs. The ASM has reviewed the Administration's Bill to establish a Department of Homeland Security and S.2452 to establish a Department of Homeland Security and a National Office for Combating Terrorism, introduced by Senator Lieberman.

The ASM is the largest life science society with over 40,000 members and its principal goal is the promotion of scientific knowledge of microbiology for the benefit of human welfare. The ASM has worked with the Administration, the Congress and federal agencies on measures to protect against biological weapons and bioterrorism. Most recently, ASM provided expert advice on provisions to expand the Biological Weapons Statute in the USA Patriot Act and on Title II of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which expands controls on certain dangerous biological agents and toxins. ASM members are involved in research and public health initiatives aimed at eradicating the scourge of infectious diseases, which daily end the lives of thousands of Americans and tens of thousands around the world. Infectious diseases remain the major cause of death in the world for those under the age of 45 and particularly for children. They are the third leading cause of death in the United States.

The terrorist events of September 11 and the anthrax biocrime reveal the need and complexity of homeland defense. The ASM, therefore, supports efforts to establish a Department of Homeland Security that can provide oversight, coordination and leadership for biodefense activities. Given that science and technology will play a vital role in the biodefense of the nation, the ASM supports the establishment of an Office of Science and Technology as proposed in S 2452. This office will provide the necessary linkage between the Secretary of Homeland Security and all the numerous mission agencies charged with science and technology development.

It is critical that the proposed DHS build upon existing science and technology programs that hold promise in the defense against bioterrorism and in the effort against deadly infectious diseases. The ASM would like to submit the following comments to assist Congress as it deliberates how best to achieve this goal.

Biodefense research is part of the continuum of biomedical research aimed at protecting the nation and the world against infectious diseases. The capability to develop countermeasures and interventions is directly related to information generated by biomedical research on pathogenic microbes and the host response to these microbes. Therefore, it is critical that federal research efforts related to civilian human health-related biological, biomedical, and infectious diseases should be prioritized and conducted by, and at the direction of, the Department of Health and Human Services (HHS). It is important to distinguish between oversight functions such as policy and planning guidance and coordination, which would well be served by an Office of Science and Technology within a Department of Homeland Security, and the responsibility and authority for the direction, control and conduct of scientific research. ASM recommends that HHS, a public health and biomedical research agency of unparalleled success, should continue to be responsible for the conduct and direction of scientific research.

The Administration's Bill recognizes the necessity that HHS conduct the research and development programs related to infectious diseases. Section 303(a)(1) of the Bill provides that the Secretary shall carry out responsibilities related to civilian human health-related biological, biomedical, and infectious diseases through HHS and the Public Health Service "under agreements with the Secretary of Health and Human Services, and may transfer funds to him in connection with such agreements." Section 301(2) of the Administration's Bill, however, gives DHS primary authority and responsibility for the conduct of national scientific research including "directing, funding, and conducting research and development" related to biological threats. Additionally, at Section 303(a)(2), the Bill provides that DHS, in consultation with HHS, "shall have authority to establish the research and development program, including the setting of priorities."

The ASM understands the role envisioned for DHS is to integrate threat analysis and vulnerability assessments and identify priorities for preventive and protective steps to be taken by other federal agencies to protect the American public. The HHS, however, is best qualified to establish biomedical research and development programs and identify scientific opportunities and the research approaches for ensuring that biodefense needs are met in the best way possible. The NIAID is best able to bring together all aspects of biomedical research and the full capability of science to ensure breakthroughs and advances of high quality for biodefense. The proposed restructuring of program authorities in the Administration's bill will create unpredictability for research programs, will divert monies from research and will not be the best approach to achieving the goal of civilian biodefense, which requires the involvement of the best scientific minds and the support of excellent science based on merit review.

We have already seen the ability of HHS to respond to bioterrorism. In the months since September 11, 2001, the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH) has rapidly accelerated work to protect the nation against the threat of bioterrorism. This acceleration has occurred across the spectrum of scientific activities from basic research in microbial biology to the development of vaccines and therapeutics to research related to diagnostic systems. It is critical that this work continue to develop rapidly and efficiently without delay, disruption or loss of momentum.

ASM agrees that DHS should have an important role in developing the nation's defenses against, and responses to biological threats. The DHS can and should coordinate, review, and evaluate scientific and technical programs related to human, animal, and plant life. However, a scientific health agency, HHS, rather than the nonscientific, nonpublic health DHS should have the principal authority for developing and prioritizing scientific and health related programs. Essentially, therefore, the ASM suggests reversing the responsibilities identified in Section 303(a)(2) of the Administration's Bill. HHS, in consultation and coordination with DHS, should retain responsibility for accelerated research and development programs, including prioritizing such projects.

The ASM is also concerned that we not create a separate public health system for biodefense.

Therefore, the ASM would leave primary responsibility for planning for public health emergencies arising from biological causes with the Centers for Disease Control and Prevention. At the earliest possible moment after the outbreak of a contagion, it is critical to determine the nature of the organism and to distinguish between a bioterrorism attack and a natural event. Then, public authorities must respond rapidly and appropriately to the health threat that either one would present.

The ASM believes CDC should be charged with these tasks. Section 505(a)(2) of the Administration's Bill requires DHS to carry out these functions under agreement with HHS. Again, the ASM believes the important and appropriate role for DHS is to coordinate planning and development of programs and to lend technical assistance to the responsible agency. It is entirely appropriate for HHS to coordinate and consult with DHS. As with the direction and control of research, however, the primary duty and authority should remain with the scientific agency with the existing knowledge, experience, and expertise to fulfill the critical mission.

Because agriculture, the food supply, and the environment along with humans are potential targets of bioterrorism, it is important to integrate and coordinate programs related to human, animal, and plant agents. Section 302(a) of the Administration Bill transfers to DHS the select agent registration and enforcement programs of HHS. However, it does not transfer the select agent registration and enforcement programs of the Department of Agriculture to the DHS. Subtitle C of the Public Health Security and Bioterrorism Preparedness Act of 2002 mandated coordination of activities of HHS and the Secretary of Agriculture regarding "overlap agents" - that is, agents that appear on the separate lists prepared by HHS and Agriculture. Without doubt, such coordination must occur. Bioterrorism research extends and applies infectious disease and select agent research. The ASM believes that integration of the select agent registration program inevitably will assist in the creation of an efficient registration process thereby expediting registration.

The proper administration of the select agent program is key to the development of the nation's biodefense capability and response and must balance the concerns for public safety with the need to not unduly encumber legitimate scientific research and laboratory diagnostic testing. The ASM continues to believe that HHS has the scientific and institutional knowledge and expertise related to dangerous biological agents, biosafety, and biosecurity in microbiological and biomedical laboratories and that it is best qualified to achieve the goal of protecting the public health and safety without interfering with research, and clinical and diagnostic laboratory medicine. Transferring this program to DHS, a nonregulatory, nonscientific department, raises many questions with regard to the administration of this program which must be carefully considered by Congress, which recently enacted new legislation and additional requirements for select agents. The ASM, therefore, requests that a review be done by an interagency group with the involvement of scientific societies to assess the advisability of removing the select agent program from HHS authority.

Some additional specific measures in the Administration Bill require further consideration and comment by the ASM.
The ASM continues to study the Administration Bill to evaluate the best approach to achieving expedited research that advances the defense against bioterrorism but does not dilute the continuing, critical battle against naturally occurring infectious diseases. The ASM suggests expeditious review of the appropriateness of each transfer of a facility or responsibility related to biological organisms from an existing agency.

For example, as noted above, the defense against bioterrorism must be fully integrated into the nation's public health system that is led by the Centers for Disease Control and Prevention. Currently, CDC would use the national pharmaceutical stockpile in response to infectious disease outbreaks-both natural and intentional. Sections 501(3)(B) and 502(6) would transfer the Strategic National Stockpile to DHS. Such transfer should be reviewed carefully during further consideration of the Bill. HHS should be responsible for developing the materials in the stockpile. Therefore, it seems appropriate for HHS to continue management of the stockpile. The ASM, however, understands the coordination and oversight function envisioned for DHS, and the final resolution of the management of the stockpile ultimately must depend upon the resolution of the scope and role of DHS responsibilities and activities.

Similarly, transfer provisions relating to programs and activities of the Department of Energy's microbial genome research appear to be proposed although ASM cannot readily discern from the Bill the portions of the genome program that would be transferred under Section 302(2)(A) of the Bill.

In closing, we reaffirm ASM's commitment to work with the Administration and Congress to achieve the most efficient and effective system in the world for research, control, and response to the threat posed by biological agents.