Bio-Terror Legislation (2001)

BIOTERRORBIBLE.COM: The following news and events are in respect to bio-terror and pandemic related legislation which occurred within the calendar year of 2001. The American government, more than any other nation, has been systematically preparing its population for an upcoming bio-terror related pandemic by passing draconian bio-terror legislation in the wake of the 9/11 attacks.

Bio-Terror Legislation (2001), Bio-Terror Legislation (2002), Bio-Terror Legislation (2003), Bio-Terror Legislation (2004), Bio-Terror Legislation (2005), Bio-Terror Legislation (2010), Bio-Terror Legislation (2011),  and Bio-Terror Legislation (2012).

Title:  The Center For Disease Control's Public Health Response To The Threat Of Bioterrorism
Date: July 23, 2001
Source: University of Virginia

Abstract: James M. Hughes, M.D. Director, National Center for Infectious Diseases Centers for Disease Control and Prevention Department of Health and Human Services Testimony before the Subcommittee on National Security, Veterans' Affairs, and International Relations Committee on Government Reform, U.S. House of Representatives.
Good afternoon, Mr. Chairman and Members of the Subcommittee. I am Dr. James M. Hughes, Director, National Center for Infectious Diseases (NCID), Centers for Disease Control and Prevention (CDC). I am accompanied by Dr. James W. LeDuc, Acting Director of NCID's Division of Viral and Rickettsial Diseases. Thank you for the invitation to update you on CDC's public health response to the threat of bioterrorism. I will discuss the overall goals of our bioterrorism preparedness program, and I will briefly address specific activities aimed at preparedness for a deliberate release of variola virus, the pathogen responsible for smallpox.

Vulnerability of the Civilian Population

In the past, an attack with a biological agent was considered very unlikely; however, now it seems entirely possible. Many experts believe that it is no longer a matter of "if" but "when" such an attack will occur. Unlike an explosion or a tornado, in a biological event, it is unlikely that a single localized place or cluster of people will be identified for traditional first responder activity. The initial responders to such a biological attack will include emergency department and hospital staff, members of the outpatient medical community, and a wide range of response personnel in the public health system, in conjunction with county and city health officers. Increased vigilance and preparedness for unexplained illnesses and injuries are an essential part of the public health effort to protect the American people against bioterrorism.

Public Health Leadership

The Department of Health and Human Services (DHHS) anti-bioterrorism efforts are focused on improving the nation's public health surveillance network to quickly detect and identify the biological agent that has been released; strengthening the capacities for medical response, especially at the local level; expanding the stockpile of pharmaceuticals for use if needed; expanding research on disease agents that might be released, rapid methods for identifying biological agents, and improved treatments and vaccines; and preventing bioterrorism by regulation of the shipment of hazardous biological agents or toxins. On July 10, 2001, Secretary Thompson named CDC's Dr. Scott Lillibridge as his special advisor to lead the Department's coordinated bioterrorism initiative. As the Nation's disease prevention and control agency, it is CDC's responsibility on behalf of DHHS to provide national leadership in the public health and medical communities in a concerted effort to detect, diagnose, respond to, and prevent illnesses, including those that occur as a result of a deliberate release of biological agents. This task is an integral part of CDC's overall mission to monitor and protect the health of the U.S. population. In 1998, CDC issued Preventing Emerging Infectious Diseases: A Strategy for the 21st
Century, which describes CDC's plan for combating today's emerging diseases and preventing those of tomorrow. It focuses on four goals, each of which has direct relevance to preparedness for bioterrorism: disease surveillance and outbreak response; applied research to develop diagnostic tests, drugs, vaccines, and surveillance tools; infrastructure and training; and disease prevention and control. This plan emphasizes the need to be prepared for the unexpected — whether it is a naturally occurring influenza pandemic or the deliberate release of smallpox by a terrorist. It is within the context of these overall goals that CDC has begun to address preparing our Nation's public health infrastructure to respond to acts of biological terrorism. Copies of this CDC plan have been provided previously to the Subcommittee. In addition, CDC presented in March a report to the Senate entitled "Public Health's Infrastructure: A Status Report." Recommendations in this report complement the strategies outlined for emerging infectious diseases and preparedness and response to bioterrorism. These recommendations include training of the public health workforce, strengthening of data and communications systems, and improving the public health systems at the state and local level.

CDC's Strategic Plan for Bioterrorism

On April 21, 2000, CDC issued a Morbidity and Mortality Weekly Report (MMWR), Biological and Chemical Terrorism: Strategic Plan for Preparedness and Response — Recommendations of the CDC Strategic Planning Workgroup, which outlines steps for strengthening public health and healthcare capacity to protect the nation against these threats. This report reinforces the work CDC has been contributing to this effort since 1998 and lays a framework from which to enhance public health infrastructure. In keeping with the message of this report, five key focus areas have been identified which provide the foundation for local, state, and federal planning efforts: Preparedness and Prevention, Detection and Surveillance, Diagnosis and Characterization of Biological and Chemical Agents, Response, and Communication. These areas capture the goals of CDC's Bioterrorism Preparedness and Response Program for general bioterrorism preparedness, as well as the more specific goals targeted towards preparing for the potential intentional reintroduction of smallpox. As was highlighted in the recent Dark Winter exercise, smallpox virus is of particular concern.

Preparedness and Prevention

CDC is working to ensure that all levels of the public health community – federal, state, and local – are prepared to work in coordination with the medical and emergency response communities to address the public health consequences of biological and chemical terrorism. CDC is creating diagnostic and epidemiological performance standards for state and local health departments and will help states conduct drills and exercises to assess local readiness for bioterrorism. In addition, CDC, the National Institutes of Health (NIH), the Department of Defense (DOD), and other agencies are supporting and encouraging research to address scientific issues related to bioterrorism. In some cases, new vaccines, antitoxins, or innovative drug treatments need to be developed or stocked. Moreover, we need to learn more about the pathogenesis and epidemiology of the infectious diseases which do not affect the U.S. population currently. We have only limited knowledge about how artificial methods of dispersion may affect the infection rate, virulence, or impact of these biological agents.

In 1999, the Institute of Medicine released its Assessment of Future Scientific Needs for Live Variola Virus, which formed the basis for a phased research agenda to address several scientific issues related to smallpox. This research agenda is a collaboration between CDC, NIH, and DOD and is being undertaken in the high-containment laboratory at CDC with the concurrence of WHO. The research addresses: 1) the use of modern serologic and molecular diagnostic techniques to improve diagnostic capabilities for smallpox, 2) the evaluation of antiviral compounds for activity against the smallpox virus, and 3) further study of the pathogenesis of smallpox by the development of an animal model that mimics human smallpox infection.

To date, genetic material from 45 different strains of smallpox virus has been extracted and is being evaluated to determine the genetic diversity of different strains of the virus. The NIH, with CDC and DOD collaborators, has funded a Poxvirus Bioinformatics Resource Center ( www.poxvirus.org) to facilitate the analysis of sequence data to aid the development of rapid and specific diagnostic assays, antiviral medicines and vaccines. A dedicated sequencing and bio-informatics laboratory also is being developed at CDC to help further these efforts. This laboratory will also be used to help characterize other potential bioterrorism pathogens. In addition, a team of collaborating scientists has screened over 270 antiviral compounds for activity against smallpox virus and other related poxviruses and have found several compounds which merit further evaluation in animal models.

These compounds were evaluated initially in cell cultures, and 27 promising candidates are being further evaluated for efficacy. The identification of one currently licensed compound with in vitro and in vivo efficacy against the smallpox virus has led to the development of an Investigational New Drug (IND) application by NIH and CDC to the FDA for use of this drug, cidofovir, in an emergency situation for treating persons who are diagnosed with smallpox. Researchers also have been funded by NIH to design new anti-smallpox medicines and to create human monoclonal antibodies to replace the limited supply of vaccinia immune globulin that is needed to treat vaccine complications that arise during immunization campaigns.

The Advisory Committee for Immunization Practices (ACIP) worked with CDC to develop updated guidelines for the use of smallpox vaccine. These guidelines were published in the MMWR in June 2001 and serve to educate the medical and public health community regarding the recommended routine and emergency uses and medical aspects of the vaccine as well as, the medical aspects of smallpox itself. Several infection control and worker safety issues were also addressed by the ACIP within the updated guidelines. While we are pursuing the development of additional smallpox vaccine to improve our readiness to respond to a smallpox outbreak, we are also working to ensure that the stores of vaccine that we have in the United States currently are ready for use, including protocols for emergency release and transportation of the vaccine.

Detection and Surveillance

Because the initial detection of a biological terrorist attack will most likely occur at the local level, it is essential to educate and train members of the medical community, both public and private, who may be the first to examine and treat the victims. It is also necessary to upgrade the surveillance systems of state and local health departments, as well as within healthcare facilities such as hospitals, which will be relied upon to spot unusual patterns of disease occurrence and to identify any additional cases of illness. CDC will provide terrorism-related training to epidemiologists and laboratorians, emergency responders, emergency department personnel and other front-line health-care providers, and health and safety personnel. CDC is working to provide educational materials regarding potential bioterrorism agents to the medical and public health communities on its bioterrorism website at www.bt.cdc.gov. For example, we are preparing a video on smallpox vaccination techniques for public health personnel and healthcare providers who may administer vaccine in an emergency situation. CDC is planning to work with partners such as the Johns Hopkins Center for Civilian Biodefense Studies and the Infectious Diseases Society of America to develop training and educational materials for incorporation into medical and public health graduate and post-graduate curricula. With public health partners, CDC is spearheading the development of the National Electronic Disease Surveillance System, which will facilitate automated, timely electronic capture of data from the healthcare system. CDC has also worked with organizations such as the Council of State and Territorial Epidemiologists to ensure that suspected cases of smallpox are immediately reportable in their jurisdictions and that clear lines of communication are in place.

Diagnosis and Characterization of Biological and Chemical Agents

To ensure that prevention and treatment measures can be implemented quickly in the event of a biological or chemical terrorist attack, rapid diagnosis will be critical. CDC is developing guidelines and quality assurance standards for the safe and secure collection, storage, transport, and processing of biologic and environmental samples. In collaboration with other federal and non-federal partners, CDC is co-sponsoring a series of training exercises for state public health laboratory personnel on requirements for the safe use, containment, and transport of dangerous biological agents and toxins. CDC is also enhancing its efforts to foster the safe design and operation of Biosafety Level 3 laboratories, which are required for handling many highly dangerous pathogens. In addition, CDC is helping to limit access to potential terrorist agents by continuing to administer the Select Agent Rule, Additional Requirements for Facilities Transferring or Receiving Select Agents (42 CFR Section 72.6), which regulates shipments of certain hazardous biological organisms and toxins. Furthermore, CDC is developing a Rapid Toxic Screen to detect people's exposure to 150 chemical agents using blood or urine samples.


A decisive and timely response to a biological terrorist event involves a fully documented and well rehearsed plan of detection, epidemiologic investigation, and medical treatment for affected persons, and the initiation of disease prevention measures to minimize illness, injury and death. CDC is addressing this by (1) assisting state and local health agencies in developing their plans for investigating and responding to unusual events and unexplained illnesses and (2) bolstering CDC's capacities within the overall federal bioterrorism response effort. CDC is working to formalize current draft plans for the notification and mobilization of personnel and laboratory resources in response to a bioterrorism emergency, as well as overall strategies for vaccination, and development and implementation of other potential outbreak control measures such as quarantine measures. In addition, CDC is working to develop national standards to ensure that respirators used by first responders to terrorist acts provide adequate protection against weapons of terrorism.

Communication Systems

In the event of an intentional release of a biological agent, rapid and secure communications will be especially crucial to ensure a prompt and coordinated response. Thus, strengthening communication among clinicians, emergency rooms, infection control practitioners, hospitals, pharmaceutical companies, and public health personnel is of paramount importance. To this end, CDC is making a significant investment in building the nation's public health communications infrastructure through the Health Alert Network, a nationwide program designed to ensure communications capacity at all local and state health departments (full Internet connectivity and training), ensure capacity to receive distance learning offerings from CDC and others, and ensure capacity to broadcast and receive health alerts at every level. CDC has also established the Epidemic Information Exchange (EPI-X), a secure, Web-based communications system to enhance bioterrorism preparedness efforts by facilitating the sharing of preliminary information about disease outbreaks and other health events among public health officials across jurisdictions and provide experience in the use of secure communications. An act of terrorism is likely to cause widespread panic, and on-going communication of accurate and up-to-date information will help calm public fears and limit collateral effects of the attack. To assure the most effective response to an attack, CDC is working closely with other federal agencies, including the Food and Drug Administration, NIH, DOD, Department of Justice (DOJ), and the Federal Emergency Management Agency (FEMA).

The National Pharmaceutical Stockpile As CDC recently reported to this Subcommittee, another integral component of public health preparedness at CDC has been the development of a National Pharmaceutical Stockpile (NPS), which can be mobilized in response to an episode caused by a biological or chemical agent. The role of the CDC's NPS program is to maintain a national repository of life-saving pharmaceuticals and medical material that can be delivered to the site or sites of a biological or chemical terrorism event in order to reduce morbidity and mortality in a civilian population. The NPS is a backup and means of support to state and local first responders, healthcare providers, and public health officials. The NPS program consists of a two-tier response: (1) 12-hour push packages, which are pre-assembled arrays of pharmaceuticals and medical supplies that can be delivered to the scene of a terrorism event within 12 hours of the federal decision to deploy the assets and that will make possible the treatment or prophylaxis of disease caused by a variety of threat agents; and (2) a Vendor-Managed Inventory (VMI) that can be tailored to a specific threat agent. Components of the VMI will arrive at the scene 24 to 36 hours after activation. CDC has developed this program in collaboration with federal and private sector partners and with input from the states.

Challenges Highlighted in Dark Winter Exercise

CDC has been addressing issues of detection, epidemiologic investigation, diagnostics, and enhanced infrastructure and communications as part of its overall bioterrorism preparedness strategies. The issues that emerged from the recent Dark Winter exercise reflected similar themes that need to be addressed.

1. The importance of rapid diagnosis — Rapid and accurate diagnosis of biological agents will require strong linkages between clinical and public health laboratories. In addition, diagnostic specimens will need to be delivered promptly to CDC, where laboratorians will provide diagnostic confirmatory and reference support.

2. The importance of working through the governors' offices as part of our planning and response efforts — During the exercise this was demonstrated by Governor Keating. During state-wide emergencies the federal government will need to work with a partner in the state who can galvanize the multiple response communities and government sectors that will be needed, such as the National Guard, the state health department, and the state law enforcement communities. These in turn will need to coordinate with their local counterparts. CDC is refining its planning efforts through grants, policy forums such as the National Governors Association and the National Emergency Management Association, and training activities. CDC also participates with partners such as DOJ and FEMA in planning and implementing national drills such as the recent TOPOFF exercise.

3. Better targeting of limited smallpox vaccine stocks to ensure strategic use of vaccine in persons at highest risk of infection — It was clear that pre-existing guidance regarding strategic use would have been beneficial and would have accelerated the response at Dark Winter. As I mentioned earlier, CDC is working on this issue and is developing guidance for vaccination programs and planning activities.

4. Federal control of the smallpox vaccine at the inception of a national crisis — Currently, the smallpox vaccine is held by the manufacturer. CDC has worked with the U.S. Marshals Service to conduct an initial security assessment related to a future emergency deployment of vaccine to states. CDC is currently addressing the results of this assessment, along with other issues related to security, movement, and initial distribution of smallpox vaccine.

5. The importance of early technical information on the progress of such an epidemic for consideration by decision makers — In Dark Winter, this required the implementation of various steps at the local, state, and federal levels to control the spread of disease. This is a complex endeavor and may involve measures ranging from directly observed therapy to quarantine, along with consideration as to who would enforce such measures. Because wide-scale federal quarantine measures have not been implemented in the United States in over 50 years, operational protocols to implement a quarantine of significant scope are needed. CDC hosted a forum on state emergency public health legal authorities to encourage state and local public health officers and their attorneys to examine what legal authorities would be needed in a bioterrorism event. In addition, CDC is reviewing foreign and interstate quarantine regulations to update them in light of modern infectious disease and bioterrorism concerns. CDC will continue this preparation to ensure that such measures will be implemented early in the response to an event.

6. Maintaining effective communications with the media and press during such an emergency. The need for accurate and timely information during a crisis is paramount to maintaining the trust of the community. Those responsible for leadership in such emergencies will need to enhance their capabilities to deal with the media and get their message to the public. It was clear from Dark Winter that large-scale epidemics will generate intense media interest and information needs. CDC has refined its media plan and expanded its communications staff. These personnel will continue to be intimately involved in our planning and response efforts to epidemics.

7. Expanded local clinical services for victims — DHHS's Office of Emergency Preparedness is working with the other members of the National Disaster Medical System to expand and refine the delivery of medical services for epidemic stricken populations.

CDC will continue to work with partners to address challenges in public health preparedness, such as those raised at Dark Winter. For example, work done by CDC staff to model the effects of control measures such as quarantine and vaccination in a smallpox outbreak have highlighted the importance of both public health measures in controlling such an outbreak. The importance of both quarantine and vaccination as outbreak control measures is also supported by historical experience with smallpox epidemics during the eradication era. These issues, as well as overall preparedness planning at the federal level, are currently being addressed and require additional action to ensure that the nation is fully prepared to respond to all acts of biological terrorism, including those involving smallpox.

Conclusion In conclusion, CDC has made substantial progress to date in enhancing the nation's capability to prepare for and, if need be, respond to a bioterrorist event. The best public health strategy to protect the health of civilians against biological terrorism is the development, organization, and enhancement of public health prevention systems and tools. Priorities include strengthened public health laboratory capacity, increased surveillance and outbreak investigation capacity, and health communications, education, and training at the federal, state, and local levels. Not only will this approach ensure that we are prepared for deliberate bioterrorist threats, but it will also ensure that we will be able to recognize and control naturally occurring new or re-emerging infectious diseases. A strong and flexible public health infrastructure is the best defense against any disease outbreak. Thank you very much for your attention. I will be happy to answer any questions you may have (University of Virginia, 2001).

Title: Biological And Chemical Attack Preparedness Act
Date: October 4, 2001
Source: Library of Congress

Abstract: Requires States, in consultation with local governments, to develop public health disaster plans for responding to biological or chemical attacks. Directs the Secretary of Health and Human Services to establish standards, approve, and oversee implementation of the plans.

Requires each plan to designate hospitals which will have procedures in place to treat residents in the event of an attack. Requires the Secretary, through the Director of the Office of Emergency Preparedness, to award grants to hospitals, health care providers, and State or local government entities to fund the implementation of preparedness plans (Library of Congress, 2001).

Bioterrorism Awareness Act
Date: October 15, 2001
Source: Library of Congress

Requires the Director of the Centers for Disease Control and Prevention to award an initial three-year grant to create and maintain an official Federal bioterrorism information website (Library of Congress, 2001).

Title: Biological Agent-Environmental Detection Act Of 2001
Date: October 17, 2001
Source: Library of Congress

Abstract: Directs the Secretary of Health and Human Services to form an interagency task force (to include representatives from industry) to encourage public-private research relating to environmental monitoring and detection tools with respect to biological (infectious) agents (Library of Congress, 2001).

State Bioterrorism Preparedness Act
Date: October 17, 2001
Source: Library of Congress

Abstract: State Bioterrorism Preparedness Act - Requires the Secretary of Health and Human Services to award grants to States to enable them to prepare for and respond to bioterrorism.

Sets forth requirements regarding: (1) State plans which shall include a description of the State process to detect and respond to bioterrorism and of State efforts to stockpile medications, vaccines, antibiotics, and medical supplies; (2) annual submissions to the Secretary of an updated State plan; (3) permissible uses of grant funds; and (4) fund allocations.

Requires specified Federal agencies to provide to States information, including: (1) a description of the probable agents of a biological or chemical attack; and (2) model or proposed bioterrorism plans with respect to such an attack.

Establishes within the Office of Homeland Security an Assistant Director for State Coordination.

Directs the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) carry out activities to implement a national communications system; (2) develop a national emergency communication plan; and (3) establish an Internet web-site that contains training, and bioterrorism-related emergency, information.

Requires: (1) the Secretary to award grants to each State to carry out table-top and computer-based biological or chemical attack simulations; (2) the CDC Director to provide each State with simulation exercises; (3) each State that receives a grant to complete at least one of the required simulations; and (4) the Secretary to provide for the conduct of a biological or chemical attack simulation in three geographically diverse States that receive a grant  (Library of Congress, 2001)

Title: Bioterrorism Prevention Act Of 2001
Date: October 23, 2001
Source: Library of Congress

Abstract: Amends the Federal criminal code to set penalties for: (1) possessing, using, or exercising control over a "select agent" (i.e., a biological agent or toxin that is listed and not exempt under the Antiterrorism and Effective Death Penalty Act of 1996 (AEDPA)) in a manner constituting reckless disregard for the public health and safety, knowing the agent to be a biological agent or toxin; (2) causing bodily injury to another in the course of a violation; (3) possessing such agents without registration; and (4) transferring such agents to an unregistered person.

Prohibits "restricted persons" (i.e., specified persons prohibited by the code from owning a handgun) from possessing, or taking specified actions with respect to, select agents. Allows the Secretary of Health and Human Services to designate categories or individuals who may be admitted to the United States on non-immigrant visas to permit them to work with such agents.

Amends the AEDPA to direct the Secretary to: (1) provide by regulation for the establishment and enforcement of standards and procedures governing the possession and use of biological agents and toxins in order to protect the public health and safety, including safeguards to prevent access to such agents and toxins for use in domestic or international terrorism or for other criminal purposes; and (2) promulgate an interim final rule.

Prohibits the disclosure under the Freedom of Information Act of agency information that identifies a person, or the geographic location of a person, who is registered pursuant to such regulations, and any site-specific information relating to the type, quantity, or identity of a listed biological agent or toxin or the site-specific security mechanisms in place to protect such agents and toxins, except for disclosures for purposes of protecting public health and safety, or to congressional committees or subcommittees with appropriate jurisdiction upon request.

Establishes civil penalties of up to $250,000 in the case of an individual and $500,000 in the case of entities for violation of AEDPA regulations regarding transfers of listed biological agents.

Directs the Secretary to report to Congress on compliance with the existing and expanded regulatory regime for control of select agents, and to provide recommendations for administrative or legislative initiatives (Library of Congress, 2001)

Title: Biological And Chemical Weapons Preparedness Act Of 2001
Date: November 7, 2001
Source: Library of Congress

Abstract: Amends the Public Health Service Act to direct the Secretary of Health and Human Services to develop a coordinated plan to achieve the following biological or chemical preparedness goals by 2010: (1) first responders (law enforcement, fire, and medical services) will have adequate response capacity, training, and technology; (2) sophisticated electronic disease surveillance and information exchange; and (3) development of the health care and public health workforce in key biopreparedness priority areas.

Requires such plan to include specific benchmarks and outcome measures. Funds activities through block grants to States. Includes Indian tribes in this program at their request.

Requires each participating States' public health agency to develop (with the recommendations of a State Bioterrorism Preparedness Advisory Committee) a certifiable plan. Sets forth uniform data collection and reporting requirements. Requires fiscal controls on the use of such funds, including audits, repayments, and withholding (after investigation).

Requires compliance with specified nondiscrimination acts. Establishes criminal penalties for fraudulently collecting payments.

Directs the Secretary to award competitive grants with an emphasis on building emergency surge capacity, biocontainment, and decontamination capabilities.

Authorizes additional appropriations for programs concerning; (1) vaccine, antibiotic, and therapeutic research and development; (2) protecting the food supply (including interdiction); and (3) research by specified federal agencies and departments.

Requires the Secretary to review Federal counterterrorism efforts in light of unique rural community requirements (Library of Congress, 2001).

Title: Bioterrorism Protection Act (BioPAct) Of 2001
Date: November 8, 2001
Library of Congress

Abstract: Amends the Public Health Service Act to provide for grants, scholarships, and loans in order to strengthen the nursing profession. Establishes the National Nursing Service Corps Scholarship Program.

Authorizes appropriations to: (1) increase hospital and provider capacity, training, and resources for treating bioterrorism victims; (2) increase and improve vaccine and antibiotic supplies for attack victims; and (3) provide for the coordination, training, and equipping of bioterrorism emergency responders.

Authorizes appropriations for Department of Agriculture activities to: (1) reduce agricultural pathogen and insect pest threats; and (2) increase Department information systems security.

Directs the Secretary of Health and Human Services to expand the Food and Drug Administration's capacity to ensure the safety of the food supply system, including imported food, and protect against the threat of bioterrorism.

Amends the Federal Food, Drug, and Cosmetic Act to: (1) permit debarment for repeated or serious food import violations; (2) deem as misbranded imported food without country-of-origin labeling; (3) deem as adulterated a food item imported by a debarred person; and (4) require registration of food manufacturing, processing, and handling facilities.

Directs the Administrator of the Environmental Protection Agency to: (1) undertake public water systems vulnerability assessments and review related emergency response plans; and (2) provide such systems with assistance for basic security enhancements and information systems protection.

Amends the Federal criminal code to set penalties for possessing a select agent known to be a biological agent, with reckless disregard for the public health and safety.

Authorizes appropriations for neutron scanner technology and technology to detect biological or chemical agents and for increased numbers of border patrol and immigration officers.

Directs the Attorney General to develop or carry out various programs, including programs to improve identification of those appearing on law enforcement "watch lists" and to mandate better tracking of visas.

Requires the Assistant to the President for Homeland Security to: (1) assess terrorist threats within the United States and its territories and possible responses to such threats; (2) implement a public education campaign concerning appropriate response to a terrorist attack; and (3) coordinate the deployment of chemical and biological detection capabilities.

Requires the President to: (1) establish a database of information concerning terrorist activity; and (2) reduce barriers to the sharing of such information among Federal law enforcement agencies and the intelligence community.

Requires the Secretary of Defense to: (1) increase military capability to respond to domestic crises involving chemical or biological weapons; (2) implement interagency crisis response and consequence management; and (3) accelerate response research and development.

Requires the Secretary of Energy to increase efforts relating to nonproliferation verification of chemical and biological materials in countries other than the United States.

Urges the President to seek to establish a United States-Russian Federation Biological-Chemical Working Group (Library of Congress, 2001)

Title: Agricultural Bioterrorism Countermeasures Act Of 2001
November 14, 2001
Source: Library of Congress

Abstract: Directs the Secretary of Agriculture, with respect to bioterrorism countermeasures, to: (1) expand Agricultural Research Service programs to protect the domestic food supply; (2) establish a Consortium for Countermeasures Against Agricultural Bioterrorism comprised of institutions of higher education in partnership with Federal agencies to develop long-term biosecurity programs; (3) enhance the National Research Initiative of the Competitive Grants Program of the Award Grants Program of the Cooperative State Research, Education, and Extension Service by awarding grants for bioterrorism protective measures; and (4) expand the capacities of the Animal and Plant Health Inspection Service and the Food Safety Inspection Service. Authorizes appropriations (Library of Congress, 2001)

Title: Bioweapons Control And Tracking Act Of 2001
Date: November 15, 2001
Source: Library of Congress

Amends the Public Health Service Act to direct the Secretary of Health and Human Services to: (1) establish and maintain a list of each biological agent and each toxin with potential to severely threaten public health and safety; (2) promulgate regulations establishing safety and security standards, procedures, restricted access, and registration requirements for listed agents and toxins, including traceability mechanisms; and (3) establish exemptions consistent with public safety. Imposes civil penalties for violations of these requirements (Library of Congress, 2001).

Title: Dems Ready Bioterrorism Bill
Date: November 26, 2001

Abstract: In an attempt to differentiate themselves from their GOP counterparts, House Democrats are preparing legislation they say will shield America from biological terrorism.

As anxieties about anthrax mushroomed on Capitol Hill -- with the deadly bacteria discovered in five congressional office buildings so far -- House Minority Leader Richard Gephardt (D-Missouri) said Thursday that new spending and police powers are necessary to protect the public.

At a press conference held in the open air away from any of the polluted buildings, Gephardt said his "Bioterrorism Protection Act" would earmark $7 billion for homeland security -- including $1.4 billion on vaccines and antibiotics -- and provide police with instant access to private databases such as the airline's SABRE system and Amtrak reservations.

"I talked to (Office of Homeland Security Director) Tom Ridge last night in a meeting," Gephardt said. "We did not talk about dollar amounts but I think this package is very sensible."

Other portions of the measure would allocate $1 billion on hospitals and emergency medical workers and $500 million on biological weapons detection.

One ambiguous part of the summary says that $13.5 million would go toward the development of biometric scanning techniques to be deployed at border checkpoints. The goal is to use "biometric techniques to identify suicide-biological bombs" -- an unusual phrase that raises the specter of infected terrorists knowingly trying to spread contagion inside America.

Gephardt's aides said the bill was still being drafted and the text would not be available until next week.

Acknowledging that Republican support is key to enacting the measure, Gephardt said, "I would be happy to make it a bipartisan bill."

House Speaker Dennis Hastert (R-Illinois) has not yet reviewed the proposal, an aide said. Hastert spokesman John Feehery said the speaker has "not yet made any decisions on which proposals to support."

This bill joins a medley of others that popped up soon after the anthrax-laden letters began to appear:

1. On Tuesday, the House approved the Bioterrorism Enforcement Act, which would establish criminal and civil penalties for possession and use of biological toxins. The bill is awaiting a vote in the Senate.

2. Sen. Pat Roberts (R-Kansas) has introduced a $1.1 billion bill that aimed to underwrite protection against biowarfare, making grants to research. (Pork alert: The "Arthropod-Borne Animal Disease Laboratory" in Laramie, Wyoming gets $30 million.)

3. The State "Bioterrorism Preparedness Act" has been introduced in both the House and Senate. It hands state governments $550 million in grants based on the size of their population.

Despite all the money Congress appears eager to spend on any proposal purporting to thwart terrorists, it faces serious technological challenges. The U.S. stockpile of smallpox vaccines is limited, and the government hopes to buy far more Cipro, the antibiotic most effective against anthrax.

Charles Pena, a senior defense policy analyst with the Cato Institute, doesn't believe more government spending will necessarily solve the problem.

"You can spend a lot of money trying to provide a certain level of security, but the bioterrorist threat is fairly wide ranging.... The terrorists could just be exhausting us getting us to respond to everything like it's a biological attack," Pena said.

He added: "You're talking about having a big security apparatus in place to protect against the vast threat. I know people don't like to think of it but there is a certain cost-effectiveness trade-off that has to take place where sending more money might not do much, and you might not gain much in the process."

Yet the backlog on smallpox vaccinations might contribute to some short-term government frugality.

Sue Reingold, an analyst with the Center for Strategic and International Studies who specializes in bioterrorism, said, "There are also clinical trials underway to see if they can dilute the vaccine by five-fold to get more doses out of it."

Reingold estimates there is currently enough for 12 million doses of the smallpox vaccine in the stock held by the Centers for Disease Control. Some good news: Reingold said it's possible for those who do receive smallpox vaccinations to inoculate people they may come in casual contact with -- such as shaking hands -- in what would essentially be spreading the cure to the disease.

The downside to widespread vaccination is that about one in every 5,000 people experience an adverse reaction to smallpox vaccination, especially for people who have a weakened immune systems or are undergoing chemotherapy (Wired, 2001)

Title: Bioterrorism Preparedness Act Of 2001
Date: December 4, 2001
Source: Library of Congress

Abstract: Amends the Public Health Service Act to add provisions granting additional authorities to the Secretary of Health and Human Services concerning bioterrorism preparedness and responding to public health emergencies. Requires the Secretary to develop and implement a plan which includes the development of specific criteria enabling measurements to be made of the progress made at the national, State, and local levels toward achieving the national goal of bioterrorism preparedness.

Requires the maintenance of an adequate national pharmaceutical stockpile of vaccines (including a smallpox vaccine), therapies, and medical supplies for use at the Secretary's discretion in the event of a biological threat or attack or other public health emergency.

Expands the role of the Centers for Disease Control and Prevention. Directs the Secretary to provide for the establishment of a coordinated network of public health laboratories to assist with the detection of and response to a biological threat or attack.

Provides for the appointment of an Assistant Secretary for Emergency Preparedness who shall head the Office for Emergency Preparedness.

Provides for a National Disaster Medical System to provide appropriate health and social services to respond to a public health emergency, if the Secretary activates the System.

Provides for enhanced regulatory control of biological agents and toxins.

Establishes a State Bioterrorism Preparedness and Response Block Grant Program to improve State and local preparedness and response capabilities.

Amends the Clayton Act to provide for a limited antitrust exemption with respect to the development of new countermeasures against bioterrorism.

Requires, under the Public Health Service Act, the development of a crisis communications and education strategy with respect to bioterrorist threats to the food supply. Expands animal and plant health inspection service activities and authorities.

Amends the Federal Food, Drug and Cosmetic Act to expand the authority of the Food and Drug Administration with respect to food presenting a serious threat to humans or animals.

Requires the registration of food manufacturing, processing, and handling facilities.

Directs the Secretary of Agriculture to utilize existing authorities to expand Agricultural Research Service and Cooperative State Research Education and Extension Service programs to protect the food supply of the United States (Library of Congress, 2001)