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 ASM considers it 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.  We would like to focus our comments on issues that Congress should consider on how best to achieve this goal.

THE ROLE OF THE DEPARTMENT

OF HOMELAND SECURITY  

1.         Role of science and technology in Homeland Security is Critical 

The terrorist events of September 11 and the anthrax biocrimes reveal the need and complexity of homeland defense.  The ASM, therefore, supports oversight, coordination and leadership for biodefense activities in a Department of Homeland Security (DHS).  Given that science and technology will play a vital role in the biodefense of the nation, the ASM believes it is essential to establish a strong science and technology function in the DHS.  This science component will provide the necessary linkage between the Secretary of Homeland Security and the numerous mission agencies charged with science and technology development. 

2.         The Department of Homeland Security has an important role to play in defending the nation against biological threats. 

The DHS will have an important role in developing the nation's defenses against, and responses to, biological threats.  The role of DHS should be to integrate threat analysis and vulnerability assessments and to identify priorities for preventive and protective steps to be taken by other federal agencies to protect the American public.  The DHS can coordinate, review, and evaluate scientific and technical programs related to human, animal, and plant life.  The DHS will be a proper governmental vehicle to coordinate and to integrate the expanded roles of mission agencies in bioterrorism related research.  The important role of the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) should be recognized and strengthened and it should interface with the proposed DHS. 

It will be important to define the boundaries between DHS and the mission agency with major responsibility for protecting the nation's health, HHS.  An appropriate coordination office or position should be established within DHS.  One approach, for example, would be for DHS to establish a position or appoint a person with the appropriate scientific background who would report to both the DHS Secretary and the HHS Secretary.  That person would also work with the National Institutes of Health (NIH) and National Institute of Allergies and Infectious Diseases to ensure integration of threat and vulnerability analysis about bioterrorism.  The goal, of course, would be mutually agreed upon research priorities that address threatening biological agents.  

Other mechanisms and/or functions may be needed for HHS and DHS to serve the vital role of coordinating the pursuit of an integrated research and development agenda for counter-terrorism, including highly directed, high risk, fast-paced, classified projects, and to manage between research results and applications to develop and evaluate specific technologies and for procurement.  For example, NIH/NIAID has already accelerated basic and clinical research related to bioterrorism to focus on "Category A" agents considered by CDC to pose the highest threat.  Last fall, the NIAID conducted a study to show that existing stocks of smallpox vaccine could be diluted at least 5-fold to provide immediate protection in case of a smallpox attack.  NIAID also accelerated screening of antiviral compounds for activity against smallpox and related viruses and accelerated development of a "new generation" bioengineered anthrax vaccine and a promising Ebola virus vaccine.  It has launched seven new fiscal year 2002 initiatives to expedite biodefense research. 

3.         ASM recommends that HHS continue to be responsible for the prioritization, direction, and conduct of federal research efforts related to civilian, human, health-related biological, biomedical, and infectious diseases. 

Pathogenic microbes pose a threat to national security whether they occur naturally or are released in a bioterrorism attack.  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 be served by the DHS 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 of DHS 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 believes that 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. 

The HHS, the federal agency with the major mission for protecting the public health, is best qualified to establish biomedical research and development programs, identify scientific opportunities and the research approaches for ensuring that biodefense needs are met in the best way possible.  The National Institute of Allergy and Infectious Diseases (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 ability to build on the body of scientific knowledge underpins the capability of the United States to combat bioterrorism.  For example, the national response mounted by NIH/NIAID to AIDS demonstrates the capability of science to respond to a threat.  The response was based on years of accumulated scientific knowledge and biomedical research that had been well supported by Congress.  The response to bioterrorism will require the same long-term dedication of financial resources and scientific talent.  

The NIAID, working with the DHS, has the knowledge about scientific capabilities to respond to threats and vulnerabilities related to the biological sciences.  It can identify the science and infrastructure relevant to the most pressing issues and take advantage of the most highly leveraged opportunities for research that can contribute to counter-terrorism solutions.  Because it is difficult to distinguish an introduced infectious disease from a naturally occurring one, the strategies to protect against either event in terms of new scientific and technical approaches, including surveillance, prevention and response, are the same.  There will be dual benefits for public health in that investment in research to develop new therapeutics, vaccines, antivirals, genomics, diagnostics, sensitive detection devices and innovative surveillance approaches for biological agents will carry over to public health breakthroughs for all infectious diseases. 

The nation has already seen the ability of HHS to respond to bioterrorism.  In the months since September 11, 2001, the NIAID 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.  

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 PUBLIC HEALTH SYSTEM FOR BIODEFENSE 

The ASM is also concerned that the nation 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 HHS and Center for Disease Control.  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.  A scientific person within the DHS with the appropriate public health background and reporting to both the DHS Secretary and HHS Secretary could work closely with the CDC Director to achieve mutually agreed upon public health priorities for bioterrorism preparedness and response.

ADMINISTRATION AND ENFORCEMENT

OF THE PROGRAM FOR REGISTRATION FOR

POSSESSION AND USE OF SELECT AGENTS 

Agriculture, the food supply, and the environment are potential targets of bioterrorism along with humans.  It is important, therefore, 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 and surveillance extends and applies to 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 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. 

EACH TRANSFER OF A SCIENIFIC FUNDTION

SHOULD BE SPECIFICALLY REVIEWED  

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.  Similarly, the proposed transfers within the USDA should be carefully reviewed, in particular the justification should be considered for transferring Plum Island which addresses animal diseases but not incorporating the equivalent functional unit that addresses plant diseases. 

 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.  At this time, we also recommend that there be an external review of the CDC to ensure optimal preparedness for public health emergences and bioterrorism and to ensure appropriate integration with existing programs.

CONCLUSION

We appreciate the opportunity to present this testimony.  The ASM is committed to working with Congress and the Administration to achieve the most efficient and effective system in the world for research, control, and response to the threat posed by biological agents.