Summary of the Frist-Kennedy “Bioterrorism Preparedness Act of 2001”
December 4, 2001
The Frist-Kennedy “Bioterrorism Preparedness Act of 2001” is designed to address gaps in our nation’s biodefense and surveillance system and our public health infrastructure. This new legislation builds on the foundation laid by the “Public Health Threats and Emergencies Act of 2000” by authorizing additional measures to improve our health system’s capacity to respond to bioterrorism, protect the nation’s food supply, speed the development and production of vaccines and other countermeasures, enhance coordination of federal activities on bioterrorism, and increase our investment in fighting bioterrorism at the local, state, and national levels. The legislation would authorize approximately $3.2 billion in additional funding for Fiscal Year 2002 (and such sums in years thereafter) toward these activities.
Title I—National Goals for Bioterrorism Preparedness
Title I of the “Bioterrorism Preparedness Act” states that “the United States should further develop and implement a coordinated strategy to prevent and, if necessary, to respond to biological threats or attacks.” It further states that it is the goal of Congress that this strategy should: (1) provide federal assistance to state and local governments in the event of a biological attack; (2) improve public health, hospital, laboratory, communications, and emergency response preparedness and responsiveness at the state and local levels; (3) rapidly develop and manufacture needed therapies, vaccines, and medical supplies; and (4) enhance the safety of the nation’s food supply and protect its agriculture from biological threats and attacks.
Title II—Improving the Federal Response to Bioterrorism
Title II requires the Secretary of Health and Human Services (HHS) to report to Congress within one year of enactment, and biennially thereafter, on progress made toward meeting the objectives of the Act. It provides statutory authorization for the strategic national pharmaceutical stockpile, provides additional resources to the Centers for Disease Control and Prevention (CDC) to carry out education and training initiatives and to improve the nation’s federal laboratory capacity, and establishes a National Disaster Medical Response System of volunteers to respond, at the Secretary’s direction, to national public health emergencies (with full liability protection, re-employment rights, and other worker protections for such volunteers similar to those currently provided to those who join the National Guard).
The bill further amends and clarifies the procedures for declaring a national public health emergency and expands the authority of the Secretary during the emergency period. In declaring such an emergency, the Secretary must notify Congress within 48 hours. Such emergency period may not be longer than 180 days, unless the Secretary determines otherwise and notifies Congress of such determination. During that emergency period, the Secretary may waive certain data submittal and reporting deadlines.
A recent report by the General Accounting Office raised concerns about the lack of coordination of federal anti-bioterrorism efforts. Therefore, the bill contains a number of measures to enhance coordination and cooperation among various federal agencies. Title II establishes an Assistant Secretary for Emergency Preparedness at HHS to coordinate all functions within the Department relating to emergency preparedness, including preparing for and responding to biological threats and attacks.
Title II also creates an interdepartmental Working Group on Bioterrorism that includes the secretaries of HHS, Defense, Veteran’s Affairs, Labor, and Agriculture, the Director of the Federal Emergency Management Agency, the Attorney General of the United States, and other appropriate federal officials. The Working Group consolidates and streamlines the functions of two existing working groups first established under the “Public Health Threats and Emergencies Act of 2000.” It is responsible for coordinating the development of bioterrorism countermeasures, research on pathogens likely to be used in a biological attack, shared standards for equipment to detect and protect against infection from biological pathogens, national preparedness and response for biological threats or attacks, and other matters.
Title II also establishes two advisory committees to the Secretary. The National Task Force on Children and Terrorism will report on measures necessary to ensure that the health needs of children are met in preparing for and responding to any potential biological attack or event. The Emergency Public Information and Communications Task Force will report on appropriate ways to com-
municate to the public information regarding bioterrorism. Both of these committees sunset after one year.
The title also contains a congressional recommendation that there be established an official federal Internet website on bioterrorism to provide information to the public, health professionals, and others on matters relevant to bioterrorism. The title further requires that states have a coordinated plan for providing information relevant to bioterrorism to the public.
Additionally, Title II helps the federal government better track and control biological agents and toxins. The Secretary of HHS is required to review and update a list of biological agents and toxins that could pose a severe threat to public health and safety and to enhance regulations regarding the possession, use, and transfer of such agents or toxins. Violations of these regulations could trigger civil penalties of up to $500,000, and criminal sanctions may be imposed. Existing law already regulates the transfer of these pathogens.
Title III—Improving State and Local Preparedness Capabilities
Numerous reports in recent years have found the nation’s public health infrastructure lacking in its ability to respond to biological threats or other emergencies. For example, nearly 20 percent of local public health departments have no e-mail capability, and fewer than half have high-speed Internet or broadcast facsimile transmission capabilities. Before September 11, only one in five U.S. hospitals had bioterrorism preparedness plans in place.
Title III addresses this situation by including several enhanced grant programs to improve state and local public health preparedness. In addition to converting the current public health core capacity grants established under the “Public Health Threats and Emergencies Act of 2000” to non-competitive grants, the bill replaces the current 319F competitive bioterrorism grant with a new state bioterrorism emergency program that provides resources to states based on population and that would guarantee each state a minimum level of funding for preparedness activities. States must develop bioterrorism preparedness plans to be eligible for such funding. Activities funded under this grant include conducting an assessment of core public health capacities, achieving the core public health capacities, and fulfilling the bioterrorism preparedness plan. This program would only be authorized for two years.
The bill also establishes a new grant program for hospitals that are part of consortia with public health agencies, and counties or cities. To be eligible for the grant, the hospital’s grant proposal must be consistent with its state’s bioterrorism preparedness plan. Using these grants, hospitals will acquire the capacity to serve as regional resources during a bioterrorist attack. This program is authorized for five years.
Title IV—Developing New Countermeasures Against Bioterrorism
To better respond to bioterrorism, Title IV expands our nation’s stockpile of smallpox vaccine and critical pharmaceuticals and devices. The bill also expands research on biological agents and toxins, as well as new treatments and vaccines for such agents and toxins.
Since the effectiveness of vaccines, drugs, and therapeutics for many biological agents and toxins often may not ethically be tested in humans, Title IV ensures that the Food and Drug Administration (FDA) will finalize by a date certain its rule regarding the approval of new priority countermeasures on the basis of animal data. Priority countermeasures will also be given expedited review by the FDA.
Because of the limitations on a market for vaccines for these agents and toxins, Title IV gives the Secretary of HHS authority to enter into long-term contracts with sponsors to “guarantee” that the government will purchase a certain quantity of a vaccine at a certain price. The government has the authority, through an existing Executive Order, to ensure that sponsors through these contracts will be indemnified by the government for the development, manufacture, and use of the product as prescribed in the contract.
Title IV also provides a limited antitrust exemption to allow potential sponsors to discuss and agree upon how to develop, manufacture, and produce new priority countermeasures, including vaccines and drugs. Federal Trade Commission and Department of Justice approval of such agreements is required to ensure they are not anti-competitive.
Title V—Protecting Our Nation’s Food Supply
With 57,000 establishments under its jurisdiction and only 700–800 food inspectors, including 175 import inspectors for more than 300 ports of entry, FDA needs increased resources for inspections of imported food. The President’s emergency relief budget included a request for $61 million to enable FDA to hire 410 new inspectors, lab specialists, and other experts, as well as invest in new technology and equipment to monitor food imports.
Title V grants FDA needed authorities to ensure the safety of domestic and imported food. It allows FDA to use qualified employees from other agencies and departments to help conduct food inspections. Any domestic or foreign facility that manufactures or processes food for use in the United States must register with FDA. Importers must provide at least four hours notice of the food, the country of origin, and the amount of food to be imported. FDA’s authority is made more explicit to prevent “port-shopping” by marking food shipments denied entry at one U.S. port to ensure such shipments do not reappear at another U.S. port.
The bill gives additional tools to FDA to ensure proper records are maintained by those who manufacture, process, pack, transport, distribute, receive, hold or import food. The FDA’s ability to inspect such records will strengthen its ability to trace the source and chain of distribution of food and determine the scope and cause of the adulteration or misbranding that presents a threat of serious adverse health consequences or death to humans or animals. Importantly, the bill also enables FDA to detain food for a limited period of time while FDA seeks a seizure order if such food is believed to present a threat of serious adverse health consequences or death to humans or animals. The FDA may also debar a person who engages in a pattern of seeking to import such food.
Title V also includes several measures to help safeguard the nation’s agriculture industry from the threats of bioterrorism. Toward this end, it contains a series of grants and incentives to help encourage the development of vaccines and antidotes to protect the nation’s food supply, livestock, or crops, as well as preventing crop and livestock diseases from finding their way to our fields and feedlots.
It also authorizes emergency funding to update and modernize USDA research facilities at the Plum Island Animal Disease Laboratory in New York, the National Animal Disease Center in Iowa, the Southwest Poultry Research Laboratory in Georgia, and the Animal Disease Research Laboratory in Wyoming. Also, it funds training and implements a rapid response strategy through a consortium of universities, the USDA, and agricultural industry groups.