107th Congress

Bioterrorism

H.R. 3016, H.R. 3256, H.R. 3310, H.R. 3555, H.R. 3832, S. 1486, S. 1520, S. 1685, S. 1706, S. 1715/S. 1765, S. 1747, S. 1764, and S. 2115

Background

Significant congressional attention to bioterrorism issues continued in the 107th Congress following the exposure of congressional staff and postal workers to anthrax spores in fall 2001. These issues included restrictions on possession, shipment, and transport of selected biological agents and toxins; vaccine research and development; Federal interdepartmental collaborations; public health infrastructure readiness and improvements; and protection of the food supply. As a result, 17 bioterrorism bills were introduced that were of interest to the National Institutes of Health (NIH); 12 of these bills would have involved activities specific to the U.S. Department of Health and Human Services (DHHS) and its components. Five bills were introduced that contained provisions restricting the possession of certain biologics and toxins. A number of bills aimed at providing counterterrorism measures against agricultural bioterrorism were also introduced. Three bills would have authorized funding for bioterrorism research at NIH.

Two of the 17 bills were enacted (see the Public Laws articles entitled "Provide Appropriate Tools Required to Intercept and Obstruct Terrorism [PATRIOT] Act of 2001, P.L. 107-56" and "Public Health Security and Bioterrorism Response Act of 2002, P.L. 107-88"). In addition, the fiscal year (FY) 2002 U.S. Department of Defense (DoD) Appropriations Act (P.L. 107-117) provided $85 million for the National Institute of Allergy and Infectious Diseases (NIAID) for biodefense-related research and development and other related needs, $70 million for NIAID for the construction of a biosafety laboratory and related infrastructure costs, and $71 million for improving laboratory security at NIH and the Centers for Disease Control and Prevention (CDC). (For additional information on bioterrorism-related funding for NIH biodefense research, see the article entitled "Appropriations for the National Institutes of Health, Fiscal Year 2003.")

Provisions of the Legislation/Impact on NIH

H.R. 3016-Antiterrorism and Effective Death Penalty Act of 1996, Amendments

H.R. 3016, introduced by Representative W.J. "Billy" Tauzin (R-LA), contained provisions similar to P.L. 107-56 with respect to the possession, shipment, and transport of select agents by certain restricted individuals. The bill would have authorized the Secretary of Health and Human Services (HHS), in consultation with the Attorney General, to designate categories of individuals who may possess, ship, or transport select biological agents and toxins. The Secretary of HHS would also have been required, by regulation, to establish and enforce standards and procedures governing the possession and use of biological agents and toxins. Provisions would have prevented disclosure by Federal agencies of information on registered persons and sites authorized to use select agents and toxins, except for public health and safety purposes or to respond to congressional committees of jurisdiction.

H.R. 3256-Servicemembers Health Protection Act of 2001

H.R. 3256, introduced by Representative Tammy Baldwin (D-WI), would have required the establishment of a National Center for Military Deployment Health Research within DHHS. This center would have been required to create policies for conducting and supporting research; conduct research on deployment-related health issues of members of the Armed Forces, veterans, and their families; and serve as the national center for the coordination of private and public research on these issues. The bill would also have authorized the center to make grants for relevant research, with a requirement that the applications be assessed, to the extent possible, through the NIH peer-review process. The center would also have been required to establish and operate 25 centers for research, education, and clinical activities related to postdeployment illnesses.

H.R. 3310-Bioterrorism Preparedness Act of 2001

H.R. 3310, introduced by Representative Greg Ganske (R-IA), would have amended Section 317F of the Public Health Service Act to require the Secretary of HHS, in coordination with appropriate Federal department and agency officials, to establish a joint interdepartmental working group on bioterrorism. Among its activities, this group would have coordinated research on pathogens likely to be used in a biological threat to or attack on the civilian population. The bill would have:

• Amended a General Accounting Office (GAO) reporting requirement to include information on genome sequencing of priority pathogens as determined by the Director of NIH and the working group
• Required the Secretary of HHS to establish and maintain a list of every biological agent and toxin that has the potential to pose a severe threat to public health and safety
• Provided for exemptions for the use of attenuated or inactive biological agents and toxins in biomedical research or for legitimate medical uses
• Required the Secretary of HHS to conduct and award grants, contracts, or cooperative agreements for research, investigations, experiments, demonstrations, and studies in the health sciences relating to the epidemiology and pathogenesis of biological agents and toxins and for the development of new vaccines and therapeutics, diagnostic tests, and other relevant areas of research The measure also contained other provisions targeted to food safety. H.R. 3310 was the companion to S. 1715/S.1765 discussed below.

H.R. 3555-U.S. Security Act of 2001

Although H.R. 3555, introduced by Representative Robert Menendez (D-NJ), contained broad provisions aimed at physical, information, and transport systems security, the bill would have also specifically targeted public health activities, including those of CDC and NIH. Relevant provisions were intended to ensure that CDC is equipped with modern facilities, communication systems, and staff protections, and to provide NIH with the necessary resources and tools to develop better research and treatments for anthrax, smallpox, and other leading biological threats. Specific provisions would have:

• Authorized the Director of CDC to design, construct, and equip new facilities and renovate existing facilities for defending against and combating bioterrorism and other public health threats; provided multiyear contracting authority to carry out these activities; and authorized $300 million for FY 2002 to remain available until expended
• Authorized $85 million for CDC for FY 2002 for the establishment of a scientific communications center, and authorized $96 million for FY 2002 to improve security at CDC facilities
• Required the Secretary of HHS to establish and implement national standards for the imposition of quarantines in the United States
• Authorized $10 million for FY 2002, to remain available until expended, for NIH research on sequencing the genomes of smallpox, anthrax, and other leading biological pathogens
• Required the Secretary of HHS, through the Director of CDC, to maintain a database on possession and physical attributes of select biological agents, and make it available to authorized personnel of DHHS, the Federal Bureau of Investigation, agencies and departments of the intelligence community, Federal, State, and local law enforcement, and U.S. national security departments and agencies
• Require the Secretary of HHS to maintain an appropriate information technology infrastructure and protect confidentiality.

Additional provisions of interest would:

• Expand the National Marrow Donor Program to include development of a contingency plan to provide bone marrow to persons needing this treatment because of nuclear accidents, disaster, or war, including terrorist attacks involving chemical and biological weapons.
• Require the Administrator of the General Services Administration, within 1 year, to submit a report to Congress describing the results of a risk management assessment of Federal buildings.

H.R. 3832-Services Acquisition Reform Act of 2002

Although not specific to bioterrorism, H.R. 3832, introduced by Representative Thomas M. Davis III (R-VA), contained provisions relevant to research and development. These provisions would have authorized the head of an executive branch agency to engage in basic research, applied research, advanced research, and development projects that 1) are necessary to the responsibilities of the agency in the field of research and development, and 2) have the potential to facilitate defense against or recovery from terrorism or nuclear, biological, chemical, radiologic, or technological attack. To engage in such projects, the head of the agency would have been authorized to exercise the same authorities that the Secretary of Defense uses in Title 10, U.S. Code, except for those subsections specific to military departments. Title 10 authorities could have been used only if authorized by the Director of the Office of Management and Budget.

S. 1486-Biological and Chemical Attack Preparedness Act of 2001

S. 1486, introduced by Representative Chet Edwards (D-TX), would provide for an upgrade of CDC capacities for improving Federal vaccine, antibiotic, and therapeutic research and development. A total of $844 million would be authorized for FY 2002 and such sums as necessary for FYs 2003 through 2006.

S. 1520-State Bioterrorism Preparedness Act

S. 1520, introduced by Senator Evan Bayh (D-IN), would have required Federal agencies to disseminate to States emergency health information and any information collected or prepared on probable agents that could be used in a biological or chemical attack.

S. 1685-Kids and Terrorism Preparedness Act

S. 1685, introduced by Senator Christopher J. Dodd (D-CT), would have required the Secretary of HHS, in consultation with the Commissioner of the Food and Drug Administration, Director of NIH, and heads of other appropriate Federal agencies, to convene meetings with drug manufacturers and biotechnology and medical device manufacturers to create a plan for the development of new, and enhancement of existing, diagnostics, drugs, vaccines, biologics, and medical devices that may be appropriate to protect and treat children who are exposed to biological, chemical, and radiologic agents or nuclear toxins.

S. 1706-Bioweapons Control and Tracking Act of 2001

S. 1706, introduced by Senator Tom Harkin (D-IA), would have required the Secretary of HHS to carry out the following activities:

• Establish and maintain a list of every biological agent and toxin that has the potential to pose a severe threat to public health and safety.
• Establish and enforce safety standards and procedures for possession, use, and transfer of such agents.
• Require registration of the possession, use, and transfer of biological agents and toxins.
• Maintain a national database of the location of such agents and toxins.

The Secretary of HHS would also have been required to restrict access to these agents to those individuals who need to handle or use them, and to provide for prompt screening of such individuals using criminal, immigration, and national security databases to identify restricted persons. Individuals who knowingly possess or transfer a select agent without obtaining a registration would have been subject to a fine, imprisonment for not more than 5 years, or both.

S. 1715/S. 1765-Bioterrorism Preparedness Act of 2001

S. 1715/S. 1765, introduced by Senator Bill Frist (R-TN), would have amended Section 317F of the Public Health Service Act to require the Secretary of HHS, in coordination with appropriate Federal department and agency officials, to establish a joint interdepartmental working group on bioterrorism. Among its activities, this group would have coordinated research on pathogens likely to be used in a biological threat to or attack on the civilian population. These bills would have:

• Amended a GAO reporting requirement to include information on genome sequencing of priority pathogens as determined by the Director of NIH and the working group.
• Required the Secretary of HHS to establish and maintain a list of every biological agent and toxin that has the potential to pose a severe threat to public health and safety.
• Provided for exemptions for the use of attenuated or inactive biological agents and toxins in biomedical research or for legitimate medical uses.
• Required the Secretary of HHS to conduct and award grants, contracts, or cooperative agreements for research, investigations, experiments, demonstrations, and studies in the health sciences relating to the epidemiology and pathogenesis of biological agents and toxins and for the development of new vaccines and therapeutics, diagnostic tests, and other relevant areas of research.

The measures also contained other provisions targeted to food safety. These measures were the companion to H.R. 3310 discussed above

S. 1747-Provide Funding to Improve the Security of the American People by Protecting Against the Threat of Bioterrorism

S. 1747, introduced by Senator Harkin for himself and Senator Arlen Specter (R-PA), would have provided funding to the DHHS Public Health and Social Services Emergency Fund for activities related to bioterrorism. Included would have been $125 million for the expanded bioterrorism-related research and development activities of NIAID, $96 million for the construction of laboratories and related infrastructure needs at NIAID, and $73 million for improving laboratory security at CDC and NIH. These sums would have been made available for FY 2002 from amounts appropriated under the 2001 Emergency Supplemental Appropriations Act (P.L. 107-38).

S. 1764-Robert Stevens, Thomas Morris, Jr., Joseph Curseen, Kathy Nguyen, Ottilie Lundgren, and Lisa J. Raines Biological and Chemical Weapons Research Act

S. 1764, introduced by Senator Joseph I. Lieberman (D-CT), would have authorized the Director of NIH to award grants and contracts (including funding for staff and staff training) to construct, maintain, and manage biosafety level 3 and 4 facilities, which are facilities for research on indigenous, exotic, or dangerous agents that have a potential for lethal consequences or pose a high risk of life-threatening disease. Any awardee of such grants or contracts would have been required to allow NIH to inspect its facility at any time. Such sums as may be necessary would have been authorized for this activity.

The bill would also have authorized the Director of NIH to award partnership challenge grants to promote joint ventures between the Agency, its grantees, and for-profit biotechnology, pharmaceutical, and medical device industries for the development of countermeasures and research tools. The Director of NIH would have been required to issue regulations within 90 days of the date of enactment of the bill to implement the awarding of these grants. Authorized would have been $200 million for each of the FYs 2002 through 2006.

S. 1764 also contained provisions aimed at providing patent, liability, and indemnification incentives and protections to increase research by commercial, for-profit companies to develop vaccines, microbicides, diagnostic technologies, and other drugs relevant to biological and chemical weapons.

S. 2115-Public Health Service Act, Amendment of 2002

S. 2115, introduced by Senator Max Cleland (D-GA), would have established within CDC a center to be known as the National Center for Bioterrorism Preparedness and Response. The director of the center, who was to be appointed by the Director of CDC, would have been required to carry out the following activities:

• AAdminister grants to State and local public health entities, such as health departments, academic institutions, and other public health partners, to upgrade public health core capacities.
• Maintain, manage, and, in a public health emergency, deploy the National Pharmaceutical Stockpile administered by CDC.
• Establish, in consultation with DoD, the U.S. Department of Justice, and the U.S. Department of Energy, a list of biological, chemical, and radiologic agents and toxins that could pose a public health and safety threat; regulate and track the agents and toxins listed; establish procedures for access to listed agents, including a screening protocol to ensure that individual access to such agents is limited; and establish safety standards and procedures for, and require registration for the possession, use, and transfer of, such agents.
• Train, prepare, and equip bioterrorism emergency response teams; expand and improve the Laboratory Response Network; develop and implement disease surveillance measures; and develop response plans for all conceivable contingencies.

Status and Outlook

H.R. 3016 was introduced on October 3, 2001. The bill was reported out of the House Energy and Commerce Committee on October 9, and a supplemental report was filed on November 6. H.R. 3016 was discharged from the House Judiciary Committee on October 16, and was placed on the Union Calendar.

H.R. 3256 was introduced on November 8, 2001, and was referred to the House Committees on Energy and Commerce, on Veterans' Affairs, on the Budget, and on Armed Services. On January 28, 2002, the measure was referred to the House Armed Services Subcommittee on Military Personnel.

H.R. 3310 was introduced on November 16, 2001, and was referred to the House Committees on Energy and Commerce, on Agriculture, and on the Judiciary.

H.R. 3555 was introduced on December 20, 2001, and was referred to the House Committees on Energy and Commerce, on Transportation and Infrastructure, on Education and the Workforce, on Government Reform, on Ways and Means, on Armed Services, on International Relations, on Financial Services, and on the Judiciary. On March 18, 2002, H.R. 3555 was referred to the House Judiciary Subcommittee on Crime.

H.R. 3832 was introduced on March 4, 2002, and was referred to the House Committees on Government Reform and on Armed Services. On April 4, an Executive comment was requested from DoD.

S. 1486 was introduced on October 2, 2001, and was referred to the Senate Health, Education, Labor and Pensions Committee.

S. 1520 was introduced on October 9, 2001, and was referred to the Senate Health, Education, Labor and Pensions Committee.

S. 1685 was introduced on November 14, 2001, and was referred to the Senate Health, Education, Labor and Pensions Committee.

S. 1706 was introduced on November 15, 2001, and was referred to the Senate Health, Education, Labor and Pensions Committee.

S. 1715 was introduced on November 15, 2001, and was referred to the Senate Health, Education, Labor and Pensions Committee. In a procedural measure aimed at clearing the measure for floor action, S. 1715 was reintroduced as S. 1765 on December 4 and placed on the Senate Calendar on December 5. See S. 1765 below.

S. 1765, formerly S. 1715, was introduced on December 4, 2001, and was referred to the Senate Health, Education, Labor and Pensions Committee. The measure was placed on the Senate Calendar on December 5. On December 20, provisions of S. 1765 were incorporated into H.R. 3448 and passed. (See the article entitled "Public Health Security and Bioterrorism Response Act of 2002, P.L. 107-88".)

S. 1747 was introduced on November 29, 2001, and was referred to the Senate Health, Education, Labor and Pensions Committee.

S. 1764 was introduced on December 4, 2001, and was referred to the Senate Finance Committee.

S. 2115 was introduced on April 11, 2002, and was referred to the Senate Health, Education, Labor and Pensions Committee.

There was no further action on this legislation during the 107th Congress.