26 December 2001 Source: http://www.access.gpo.gov/su_docs/aces/aaces002.html ----------------------------------------------------------------------- [Congressional Record: December 20, 2001 (Senate)] [Page S13902-S13911] From the Congressional Record Online via GPO Access [wais.access.gpo.gov] [DOCID:cr20de01-115] PUBLIC HEALTH SECURITY AND BIOTERRORISM RESPONSE ACT OF 2001 Mr. REID. Mr. President, with the attention of the Senator from Mississippi, Mr. Lott, I ask unanimous consent that the Senate now proceed to H.R. 3448, which is at the desk. The PRESIDING OFFICER. The clerk will report the bill by title. The legislative clerk read as follows: A bill (H. R. 3448) to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. There being no objection, the Senate proceeded to consider the bill. Ms. LANDRIEU. I am very concerned about help for for-profit hospitals if they must deal with bioterrorist attack. Their services are critical, and they face the same challenges as other hospitals. They should be eligible for Stafford Act assistance under certain circumstances. Mr. KENNEDY. I understand the concerns of my colleague. In many places for-profit hospitals are the only providers. I will work with her to address these legitimate needs in conference. food safety Mr. DURBIN. Mr. President, I am pleased that the sponsors of the bill recognize the importance of strengthening our Nation's protections for food safety and of addressing potential bioterrorist threats against our food supply. Among the bill's provisions are new authorities for the Food and Drug Administration to require the maintenance of food records, to inspect such records, and to detain unsafe foods. I would appreciate clarification regarding the standard of serious adverse health consequences or death, which applies to the authorities for inspection of records and administrative detention, among others. It is my understanding that some have suggested that foodborne pathogens such as salmonella, listeria monocytogenes, shigella dysenteriae, and cryptosporidium parvum, which in 1993 sickenened over 400,000 people in Wisconsin who drank contaminated water, may not pose a threat of serious adverse health consequences to healthy adults. Most of these pathogens have been identified by the CDC as possible biological agents that could be used in an attack against our citizens, and they could clearly pose a threat of serious adverse health consequences or death to vulnerable populations, such as children, pregnant women, the elderly, transplant recipients, persons with HIV/ AIDS and other immunocompro- mised persons. Do the sponsors intend for the standard in this bill, cited in the sections on inspection of records, administrative detention, debarment, and marking of refused articles, to enable the Food and Drug Administration to act when a foodborne pathogen presents a threat of serious adverse health consequences or death to such vulnerable populations mentioned above, even if healthy adults may not face the same risk? And do the sponsors agree that the pathogens I mentioned previously may present such a risk of serious adverse health consequences or death? I believe we must ensure that the law is fully protective of all American consumers. I hope that the sponsors share my concerns. Mr. KENNEDY. Will the Senator from Illinois yield? Mr. DURBIN. I am happy to yield to the Senator from Massachusetts. Mr. KENNEDY. First, I commend my colleague for his longstanding advocacy for food safety. He has been a [[Page S13903]] leader, both in the House of Representatives and here in the Senate, in seeking the resources, the authority and the public awareness which will reduce the yearly epidemic of foodborne illness. The CDC has estimated that foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year. I also point out that he has played an instrumental role, with our colleagues, Senator Mikulski, Senator Collins, and Senator Clinton, in assuring that food safety is addressed in this legislation. In response to my colleague's inquiry, I fully concur with his interpretation of the food safety provisions in our legislation. It is precisely our intent, with respect to the food safety sections of this bill, that the standard of serious adverse health consequences or death with respect to these provisions in this bill should be understood to enable the FDA to protect all Americans, including vulnerable populations such as children and the elderly. I agree that there are instances where foodborne pathogens, such as those mentioned by my colleague, whether accidentally or deliberately introduced into food, may threaten some more vulnerable individuals but not the healthy adult population. For that reason, my colleague is correct that the agency would be able to exercise these food safety authorities to protect such vulnerable populations. Mr. FRIST. Will my colleague yield? Mr. KENNEDY. With pleasure. Mr. FRIST. I concur with Senator Kennedy's remarks regarding this standard as it applies to the food safety provisions in this bill. As 21 C.F.R. 7.41 regarding health hazard evaluation makes clear, the FDA evaluation will take into account a list of factors, one of which is ``an assessment of hazard to various segments of the population, including children, livestock, etc. who are expected to be exposed to the product being considered with particular attention paid to the hazard to those individuals who may be at greatest risk.'' I believe these provisions will help protect the safety and security of our food supply. Mr. DURBIN. I appreciate my colleagues' willingness to clarify these important points, and join them in supporting this important legislation. antitrust exemption Mr. WELLSTONE. Mr. President, I am a cosponsor of this legislation because it is extremely important, but as I noted when the bill was originally introduced, I am concerned about the scope of the antitrust exemption. I have three concerns in particular: There is no opportunity for public comment prior to the granting of an exemption; the period of exemption is too long; and the criteria for granting the exemption are too broad with respect to competitive impact on areas not directly related to the agreement. Mr. KENNEDY. I understand my colleague's concerns and commend him for his commitment to protecting consumers. His concerns are legitimate and I will work to improve these provisions in response to his concerns in the conference. COMBATING BIOTERRORISM Mr. JEFFORDS. Mr. President, and my distinguished colleagues, I am pleased that we are moving so quickly on legislation to combat bioterrorism--this is certainly a timely issue. I would like to engage my colleagues in a colloquy to clarify our commitment to another important issue--the security of our Nation's water supply. At the end of October of this year, I was joined by the ranking member of the Environment and Public Works Committee in introducing S. 1593 and S. 1608. S. 1593 authorizes the Administrator of the Environmental Protection Agency to establish a grant program to support research projects on critical infrastructure protection for water supply systems. S. 1608 establishes a program to provide grants to drinking water and wastewater facilities to meet immediate security needs. I understand that the gentleman from Tennessee, the gentleman from Massachusetts and the gentleman from New Hampshire support the modified provisions of these bills. Is that correct? Mr. FRIST. That is correct. Mr. KENNEDY. Yes, that is correct. Mr. GREGG. Yes, that is correct because in the interest of time, we are unable to change the bill prior to conference. Mr. SMITH. I too would like to thank Senator Frist, Senator Kennedy, and Senator Gregg for agreeing to work with us to ensure these two proposals are included in the bioterrorism proposal. I regret that with the end of session quickly approaching, there is no time to incorporate these provisions into the underlying bill. As we all recognized in our support for these proposals, since the September 11 attacks, Americans throughout the country have become concerned about the security of our Nation's water supply. While it is widely believed that our water supply is safe, there are a few vulnerabilities that must be addressed. Our bills would provide resources for research into security at facilities and assessment tools while also providing seed money to encourage additional spending on security measures. Mr. JEFFORDS. Our colleagues on the House side also recognized this need by including water security provisions in the bioterrorism bill, H.R. 3448, that was passed by the House on December 12. I would like my colleagues' assurance that during conference they will press for adoption of the modified versions of S. 1593 and S. 1608. Mr. KENNEDY. I intend to press for adoption of these provisions. The security of our Nation's water supply is crucial to the health and well-being of our citizens. Mr. GREGG. I concur, and I intend to press for adoption of these provisions. Mr. FRIST. I agree and you have my commitment to do the same. Mr. SMITH. I again would like to thank my colleagues for agreeing to fight for these provisions during conference. It was with great reluctance that Senator Jeffords and I agreed to allow S. 1765 to be brought to the floor without our legislation included so that we can move forward on this important bill and conference it with the House. However, it is important that these immediate needs be addressed and that our proposals be included in the final legislation. I look forward to working with my colleagues to ensure that the provisions we agreed to that comprise the modified versions of S. 1593 and S. 1608 are included in the bioterrorism bill. Mr. JEFFORDS. Finally, I want to commend Senators Kennedy, Frist, and Gregg and say that I am looking forward to working with them during the conference on these measures. Mr. KENNEDY. Mr. President, I urge the Senate to approve this important bipartisan legislation to respond to one of the most severe dangers our country faces, the grave threat of bioterrorist attacks. I commend my colleagues Senator Frist and Senator Gregg for their impressive continuing leadership on this vital issue. We are all well aware of the emergency we face. In recent weeks, a handful of anthrax cases stretched our health care system to the breaking point. A larger attack could be a disaster, and the attack of the past weeks has clearly sounded the alarm. The clock is ticking on America's preparedness for a future attack. We've had the clearest possible warning, and we can't afford to ignore it. We know that lives are at stake, and we're not ready yet. The Department of Health and Human Services has made anthrax vaccine available to workers at risk for exposure to the deadly spores, but there has been few plans to distribute the vaccine and inform workers about the risks and benefits of vaccination. In a major outbreak, our public health agencies and hospitals would be strained to the breaking point by the task of providing vaccinations against anthrax, smallpox, or other deadly plagues to thousands or even millions of Americans. Some cities have already developed plans and procedures for providing care to patients affected by bioterrorism, but too few communities are adequately prepared. The needs are great. A summit meeting of experts on bioterrorism and public health concluded that $835 million was needed just to address the most pressing needs for public health at the State and local levels. The National Governors Association has said that States need $2 billion to improve readiness for bioterrorism. John Hopkins Hospital is spending $7.5 million to improve its ability to serve as a regional bioterrorism resource for [[Page S13904]] Baltimore. Equipping just one hospital to this level in each of 100 cities across America would cost $750 million. The Appropriations Committee has recognized the importance of significant investments in bioterrorism preparedness. The Department of Defense conference bill provides as important down payment for the Nation's needs for bioterrorism preparedness. I commend Senator Byrd, Senator Stevens, Senator Inouye, Senator Harkin, and Senator Specter for their impressive leadership in this area. In particular, they have begun to address the basic issue of State and local preparedness and the readiness of hospitals to deal with bioterrorism by providing $1 billion for these purposes. The need for help at the State and local level is especially urgent. In the first 3 weeks of October alone, state health departments spent a quarter billion dollars responding to the anthrax attack. Many departments were forced to put aside other major public health responsibilities. Massachusetts has suspended many public health activities other than bioterrorism, and has fielded over 2,000 calls from worried residents, each one taking half an hour of time for personnel. South Dakota has had to suspend an investigation of serious food poisoning outbreak to investigate rumors of anthrax attacks, even though no actual attack appears to have occurred. The Georgia Health Department has spent 3,000 person-hours just in 1 week on anthrax. Hospitals across the country have immediate needs. According to the American Public Health Association, hospitals are hard-pressed even during a heavy flu season, and could not cope with a lethal contagious disease like smallpox. The Bioterrorism Preparedness Act we are proposing will address these deficiencies. It provides new resources for bioterrorism preparedness to the States under a formula that guarantees help to each State. These resources will be available to improve hospital readiness, equip emergency personnel, enhance State planning, and strengthen the ability of public health agencies to detect and contain dangerous disease outbreaks. The need is great at the State and local level, but gaps need to be addressed at the Federal level too. So far, we have had only a handful of patients diagnosed with anthrax, but our resources have been stretched to the breaking point. We can't afford further delays in meeting these critical needs. Ft. Detrick, one of our two national reference laboratories, processed over 19,000 samples after the attacks began, and they are already stretched to the limit. The story was the same at CDC. Usually, a few dozen CDC experts respond to a disease outbreak. But CDC assigned nearly 500 specialists to the anthrax attacks. One out of eight employees at CDC headquarters in Atlanta is working on the current outbreak. Staffers worked round the clock and slept in hallways and only 18 cases of actual illness was known. In a recent article, CDC Director Koplan summed up the situation this way: Right now, we are working flat out. I keep thinking, if you know you;re in a marathon, you pace yourself for a marathon; if you know you're in a sprint, ou pace yourself for a sprint. But our guys are sprinting, and the sprint distance is long over. We're sprinting a marathon. The diversion of resources to anthrax has also led to the neglect of other important health priorities. According to a recent article in the Chicago Tribune, CDC has had to postpone programs to prevent meningitis among college students. They've delayed the development of vaccines urgently needed to combat diseases in the developing world. They've deferred activities to contain the spread of deadly infections resistant to antibiotics. Hawaii is facing a serious outbreak of dengue fever. When local health authorities asked CDC to analyze lab samples, they were told that no facilities were available due to the anthrax outbreak. Instead, the Hawaii doctors had to send their important samples to a lab in Puerto Rico for analysis. Dr. David Satcher, the Surgeon General, recently said that the country ``should be ashamed of the condition of the laboratories of the CDC.'' These vital national resources, he said, were without power for 15 hours during the early days of the anthrax outbreak. Computers are covered in plastic to protect them from leaky roofs, and termites have chewed holes through laboratory floors. Dr. Satcher is right to call this problem a national disgrace. We cannot continue to expect the CDC to do a first class job, if we provide only third-rate facilities. Clearly, our legislation is an important downpayment on preparedness. But we must make sure that our commitment to achieving full readiness is sustained in the weeks and months to come. Since September 11, the American people have supported our commitment of billions of dollars and thousands of troops to battle terrorism abroad. But Americans also want to be safe at home. We have an obligation to every American that we will do no less to protect them against terrorism at home than we do to fight terrorism abroad. Federal stockpiles of antibiotics, vaccines, and other medical supplies are an essential part of the national response. We have a strategic petroleum reserve to safeguard our energy supply in times of crisis. We need a strategic pharmaceutical reserve as well, to ensure that we have the medicines and vaccines stockpiled to respond to bioterrorist attacks. Our legislation establishes this reserve, and authorizes the development of sufficient smallpox and other vaccines to meet the needs of the entire U.S. population. The legislation will also help protect the safety of the food supply, through increased research and surveillance of dangerous agricultural pathogens. Our legislation draws on the work and suggestions of numerous colleagues on both sides of the aisle. One of the important areas addressed in the legislation is the threat of agricultural bioterrorism. Deliberate introduction of animal diseases could pose rave dangers to the safety of the food supply. Such acts of agricultural bioterrorism would also be economically devastating. The outbreaks of ``mad cow'' disease in Europe cost over $10 billion, and the foot and mouth outbreak cost billions more. We must guard against this danger. Protecting the safety of the food supply is a central concern in addressing the problem of bioterrorism. Senator Clinton, Senator Mikulski, Senator Harkin, Senator Collins, and Senator Durbin have all contributed thoughtful proposals about food safety. Our bill will enable FDA and USDA to protect the Nation's food supply more effectively. We are grateful for the leadership of other Senators who have made significant contributions to this legislation. Senator Bayh and Senator Edwards contributed important proposals on providing block grants to States, so that each State will be able to increase its preparedness. Their proposals ensure that each state will receive at least a minimum level of funding. We are also grateful for the contributions that many of our distinguished colleagues have made to meet the special needs of children. Senator Dodd, Senator Collins, Senator Clinton, Senator DeWine and Senator Murray have emphasized the crucial needs of children in any plan to deal with bioterrorism. The legislation includes significant initiatives to provide for the special needs of children and other vulnerable populations. The events of recent weeks have also shown the importance of effective communication with the public. Our legislation incorporates proposals offered by several of our colleagues on improving communication. Senator Carnahan has recognized the importance of the internet in providing information to the public. The legislation includes the provisions of her legislation to establish the official Federal internet site on bioterrorism, to help inform the public. Senator Mikulski also contributed provisions on improving communication with the public. A high-level, blue-ribbon task force can provide vitally needed insights on how best to provide information to the public. Senator Mikulski also recommended ways to ensure that states have coordinated plans for communicating information about bioterrorism and other emergencies to the public. [[Page S13905]] The Centers for Disease Control and Prevention have a leading role in responding to bioterrorism. Senator Cleland has been an effective and skillful advocate for the needs of the CDC. Our legislation today incorporates many of the proposals in his legislation on public health authorities. Hospitals are also one of the keys to an effective response to bioterrorism. We must do more to strengthen the ability of the Nation's hospitals to cope with such attacks. Senator Corzine has proposed to strengthen designated hospitals to serve as regional resources for bioterrorism preparedness. I commend him for his thoughtful proposals, which we have incorporated in the legislation. We must also ensure that we monitor dangerous biological agents that can be used for bioterrorism. There is a serious loophole in current regulations, and we are grateful for the proposals offered by Senator Durbin and Senator Feinstein to achieve more effective control of these pathogens. In a biological threat or attack, mental health care will be extremely important. We are indebted to Senator Wellstone for his skillful and compassionate advocacy for the needs of those with mental illnesses. In the event of a terrorist attack, thousands of persons would have mental health needs, and our legislation includes key proposals by Senator Wellstone to meet these needs. Mobilizing the Nation's pharmaceutical and biotech companies so that they can fully contribute to this effort is also critical. Senator Leahy, Senator Hatch, Senator DeWine, and Senator Kohl made thoughtful contributions to the antitrust provisions of the bill, which will help encourage a helpful public-private partnership to combat bioterrorism. This legislation is urgent because the need to prepare for a bioterrorist attack is urgent. I urge my colleagues to approve this legislation, so that the American people can have the protection they need. Mr. FRIST. Mr. President, I am thankful to be able to come to the floor today, along with many of my colleagues, to announce the Senate passage of the Frist-Kennedy Bioterrorism Preparedness Act of 2001. Over the past several weeks, we have been working in a bipartisan manner to address this critical issue, and I am grateful for the work of Senators Gregg, Kennedy, and others. Everyone has worked very hard to get us to this point, and I will continue to work with them in conference to ensure final passage of this crucial legislation. I am also thankful for the work of my colleagues to ensure that there is an appropriate level of funding for bioterrorism preparedness and response activities that will be available immediately. I commend Senators Stevens, Byrd, Specter, Inouye, and Roberts and others for their strong support in securing the necessary funding. With the passage of the latest appropriations bills, we have secured well over $2.5 billion for bioterrorism activities in addition to those provided for agroterrorism. I am also pleased with the level of funding for State and local preparedness and response activities--at least $1 billion--which is one of my top priorities. However, our efforts cannot end when the funding is secured. We must provide greater guidance and authorities through an authorization bill, which is why final passage of a bioterrorism authorization bill is equally important. Both the House and the Senate have signaled the need for increased authorization with the passage of the Tauzin-Dingell Public Health Security and Bioterrorism Response Act of 2001 and the Frist-Kennedy Bioterrorism Preparedness Act of 2001. We must work together in conference to ensure final passage. A variety of increased authorizations are necessary to protect our food supply, prevent agroterrorism, develop appropriate countermeasures, and ensure appropriate State and local preparedness and response. For example, in the Frist-Kennedy Bioterrorism Preparedness Act of 2001, we have greatly expanded the ability to protect our Nation's food supply by increasing authorities for the Department of Agriculture and the Food and Drug Administration. We need to ensure that our food supply is safe. With 57,000 establishments under its jurisdiction and only 700-800 food inspectors, including 175 import inspectors for more than 300 ports of entry, the Food and Drug Administration (FDA) needs increased resources for inspections of imported food. Our legislation 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 U.S. 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. This bill also 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 their ability to trace the source and chain of distribution of food and to 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. This important legislation 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 form 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. No one has worked harder on these agricultural provisions than my colleague Senator Roberts. I know he understands deeply the threat that we face in these areas and has helped provide real leadership in pointing the way to solutions. Additionally, the Frist-Kennedy ``Bioterrorism Preparedness Act of 2001'' 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, this crucial legislation ensures that the 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, our legislation 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. This legislation 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 the Department of Justice approval of such agreements is required to ensure such agreements are not anti-competitive. I appreciate the work of Senator Hatch and his advice in crafting the antitrust language. These FDA authorities and market incentives--which can only be provided [[Page S13906]] by additional authorizing legislation--are critical to the rapid development of vaccines and other countermeasures. I want to thank Senators Hutchinson and Collins for their important work with this portion of the bill. Both the House and Senate bills also include protections, similar to those currently provided to those who join the National Guard, to help protect the employment rights of medication volunteers within the National Disaster Medical Response System (NDMS). The bills also extend necessary liability protections to those volunteers. Senator Enzi provided beneficial advice about how to craft this portion of the legislation. Moreover, both bills contain additional measures to assist with the tracking and control of biological agents and toxins. With respect to the control of biological agents and toxins, the Secretary of Health and Human Services is required to review and update a list of biological agents and toxins that pose a severe threat to public health and safety and to enhance regulations regarding the possession, use and transfer to such agents or toxins. Again, these needed protections will not go into effect until we pass authorizing language. Although the ``Public Health Threats and Emergencies Act of 2000'' established basic grant programs to assist with strengthening the public health infrastructure, the language was based on the assumption that each year five more states would receive enough money to be prepared for a bioterrorist attack. Given the recent set of events, we cannot wait 10 more years for our public health infrastructure to be strengthened. We must put in place a mechanism to ensure that every state has sufficient funding to improve their public health infrastructure so that they are able to respond to a potential biological attack. I agree that we must provide resources necessary to develop smallpox and other needed vaccines, drugs, and biologics to counter potential biological agents. But it is even more important that we provide needed resources to those who will be on the front-lines in responding to a potential attack. Hospitals and other medical facilities must become better prepared to respond and to deal with the public health emergency after such an attack. And doctors, nurses, firefighters, police, and emergency medical response personnel need better training and equipment to combat biological threats and provide needed treatment. Therefore, the two new grant programs included in the ``Bioterrorism Preparedness Act''--the State Bioterrorism grant program and the Designated Bioterrorism Response Medical Center program--are essential. Finally, our legislation would also ensure that we enhance coordination among local, state and federal agencies responsible for responding to a biological attack, and that this response appropriately deals with the special needs of children and other vulnerable populations. Almost half of all public health departments serve jurisdictions whose emergency response plans do not address incidents of bioterrorism. Agencies have not determined a single list of biological agents likely to be used in a biological attack, several agencies have not been consulted in crafting the list or determining an overall emergency response plan, and agencies have developed programs to provide assistance to state and local governments that are similar and potentially duplicative. The Bioterrorism Preparedness Act of 2001 establishes an Assistant Secretary for Emergency Preparedness at HHS to coordinate all functions with the Department relating to emergency preparedness, including preparing for and responding to biological threats or attacks. It also creates a federal interdepartmental Working Group on Bioterrorism that consolidates and streamlines the functions of two existing working groups first established under the ``Public Health Threats and Emergencies Act of 2000.'' Recent reports regarding the treatment of children during the anthrax scare, including the cutaneous anthrax case in a 7 month old boy, have highlighted the need to more fully address the special needs of children when responding to bioterrorism attacks. Within the Frist- Kennedy ``Bioterrorism Preparedness Act of 2001,'' numerous provisions were added to specifically address this critical issue, with the emphasis on streamlining the language so that the children's health and welfare issues were considered in concert with the general provision of services. These provisions include a specific reference that the vaccines, therapies and medical supplies within the stockpile appropriately address the health needs of children and other vulnerable populations; requiring the Working Group to take into consideration the special needs of children and other vulnerable populations; establishing the National Task Force on Children and Terrorism--an advisory committee of child health experts on infectious disease, environmental health, toxicology, and other relevant professional disciplines--to offer advice to the Secretary; along with other crucial additions. I want to thank Senators Dodd, DeWine, Collins, and Clinton for their assistance in crafting appropriate language to address the special needs of children and other vulnerable populations. Along with my colleagues, I am appreciative of the steps we have taken thus far to ensure that we are prepared to respond to biological threats or attacks, and I look forward to continuing to work with them to ensure final passage of bioterrorism authorization legislation. I want to thank Senator Jeffords and Senator Bob Smith for their input and advice regarding water safety and how we should more adequately protect our nation, Senators Sessions and Shelby for their important input on the various training activities, and Senator Lieberman for his crucial input regarding our disease surveillance and coordination infrastructure. I look forward to continuing to work with all of the Senators and their staff. I must also commend Senator Kennedy again for his efforts. He has been a true partner on this bill and the Frist-Kennedy ``Public Health Threats and Emergencies Act of 2000,'' which we signed into law last year. Finally, I want to thank my staff--Allen Moore, Dean Rosen, Helen Rhee, Craig Burton, Allison Winnike, and Shana Christrup--as well as the staff of other Senate offices for all of their efforts, including Vince Ventimiglin, Katy French and Steve Irizarry of Senator Gregg's staff; David Nixon, David Bowen, David Dorsey, and Paul Kim of Senator Kennedy's staff; John Mashburn of Senator Lott's staff; Stacey Hughes of Senator Nichles' staff; Abby Kral of Senator DeWine's staff; Claire Bernard and Priscilla Hanley of Senator Collins' office; Kate Hull of Senator Hutchinson's staff; Raissa Geary of Senator Enzi's staff; Laura O'Neill of Senator Session's office; Debra Barrett and Jim Fenton of Senator Dodd's staff; and Bruce Artim and Patty DeLoatche of Senator Hatch's staff. Their tireless work has been essential in assisting us in getting this far. Mr. LIEBERMAN. Mr. President, I rise to discuss the Senate's action this evening on bioterrorism. Today, the Senate has taken an important step toward improving the Nation's ability to prepare for, and respond to, the threat of bioterrorism by adopting legislation, authored by Senator Kennedy and Senator Frist, and of which I am a cosponsor. The Senate bill, S. 1765, recognizes that any meaningful improvement in this area must begin with improvements in the Nation's public health system, a fact underscored by a series of hearings conducted by the Committee on Governmental Affairs on bioterrorism earlier this year. As a result of those hearings, I believe that there are several areas in which the Senate bill could be further strengthened especially in terms of the way the Federal Government's efforts to combat bioterrorism are organized. In anticipation of Senate consideration, I prepared an amendment to the original Kennedy/Frist bioterrorism bill, S. 1715, to address these concerns. However, given Senate's interest in acting on this important measure before adjournment, I agreed to defer offering this amendment at this time. I do, however, believe that the underlying issues need to be addressed Specifically, I would like to see additional attention given to bioterrorism within the Centers for Disease Control and Prevention, CDC. The underlying bill recognizes the need to strengthen [[Page S13907]] CDC bioterrorism role. Currently, CDC's bioterrorism activities are currently coordinated by the Bioterrorism Preparedness and Response Program within the National Center for Infectious Diseases. While many of the agents of concern are infectious diseases, many are not, including toxins and chemical agents. Even more to the point, many of the elements of the CDC bioterrorism program actually reside in other Programs and Centers. The pharmaceutical stockpile program resides within the National Center of Environmental Health. The Health Alert Network is in the Public Health Practices Program. Surveillance and detection activities are in the Epidemiology Program Office. Coordination of these activities, competition for resources, and line authority is a major problem. The importance and unique nature of the bioterrorism mission also requires creation of a separate ``intellectual'' center. The underlying bill also recognizes both the importance of expanding the role of HHS within the Government to provide leadership on bioterrorism preparedness and response. In addition, it recognizes the need to coordinate such activities within the many parts of HHS, including FDA, CDC, OEP, NIH, etc. The amendment would codify basic government management responsibilities and tools for the new Assistant Secretary position including agency performance measures, performance evaluation capability, technology verification. Detection is key to responding to bioterrorism attacks. Although health agencies have surveillance systems, they do not rely upon standard methodologies or real-time data collection. Though some States and localities have also begun to incorporate ``syndromic'' indicators, this practice is not widespread or standardized and they are not integrated into other health data systems. CDC is working on development of a new internet-based system, the National Electronic Disease Surveillance System, NEDSS, but its deployment is many years in the future. The amendment establishes an accelerated deployment schedule, including the development of data collection and reporting protocols, in consultation with state and local health agencies. CDC has initiated an internet-based Health Alert Network to provide real-time information to state and local health officials. Unfortunately, a number of States are not yet included in the network and very few county and municipal health departments are included. The amendment would establish an accelerated schedule for deployment. Lack of interoperability of communication systems, and more recently in IT systems, is a long-standing problem in emergency response among federal agencies, much less between federal and state agencies. The underlying bill recognizes the need for better interagency coordination through the creation of an interagency working group. The amendment would specifically charge the group with addressing interoperability of IT and communication systems and give the Secretary of HHS authority to provide technical and financial support to resolve such problems. The amendment would require the Secretary of HHS to contract with the Institute of Medicine to analyze the response of the public health system of the recent anthrax attacks and provide a ``lessons-learned'' report to help guide improvements at the federal, state, and local level. Finally, I would note that the House bill also recognizes the need to improve our public health surveillance and communications systems. The House bill also seeks to incorporate performance measures as part of expanded bioterrorism program in a manner similar to what I propose. Now that Senate has acted, I look forward to working with the conferees to ensure that our Nation is prepared for meeting this new threat. I ask unanimous consent that the amendment that I was prepared to submit, be printed in the Record. There being no objection, the amendment was ordered to be printed in the Record, as follows: Amendment No.-- On page 11, between lines 19 and 20, insert the following: ``(d) National Center for Bioterrorism.--There is established within the Centers for Disease Control and Prevention a National Center for Bioterrorism, to develop, manage, and provide scientific and medical capabilities to prepare for, and respond to, bioterrorism attacks, including-- ``(1) analyzing and applying intelligence and threat assessment information to the preparation, development and stockpile of vaccines, antibiotics and other pharmaceuticals, medical training, and other preparation and response capabilities; ``(2) detecting biological and chemical agents, detecting and conducting surveillance, and making a diagnosis of related diseases; ``(3) disease investigation and mitigation; and ``(4) the provision of guidance to Federal, State, tribal, and local officials, concerning preparation for and response to bioterrorism attacks.''. On page 13, strike line 3. On page 13, line 7, strike the period and insert a semicolon. On page 13, between lines 7 and 8, insert the following: ``(3) coordinate the standards and interoperability of information technology and communications systems within the Department of Health and Human Services and among Federal, State, tribal, and local health officials and health service providers relevant to emergency preparedness and biological threats or attacks; ``(4) develop and maintain advanced health surveillance systems to provide early warning of natural disease outbreaks or bioterrorist attacks to Federal, State, tribal, and local health officials and to aid response management; and ``(5) develop and maintain a program to continuously evaluate the capabilities and vulnerabilities of the national health and emergency preparedness plans and systems to identify and respond to natural disease outbreaks or bioterrorist attacks, including the establishment of performance measures. ``(c) Evaluation Group and Exercises.-- ``(1) In general.--The Assistant Secretary for Emergency Preparedness shall establish an evaluation group, to be composed of at least 10 individuals who are experts on public health preparedness and bioterrorism from both within and without the federal government, to test and evaluate the capabilities and vulnerabilities of the national health and emergency preparedness plans and systems to identify and respond to natural disease outbreaks or bioterrorist attacks on a continuous basis, including the conduct of local, regional, and national-scale exercises. ``(2) Annual report.--At least annually, the evaluation group established under paragraph (1) shall prepare and submit to the Secretary and to the Committee on Health, Education, Labor and Pensions, the Committee on Governmental Affairs, and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce, Committee on Government Reform, and the Committee on Appropriations of the House of Representatives a report concerning the results of the tests and evaluations conducted under paragraph (1). ``(d) Performance Measures.-- ``(1) In general.--Not later than 1 year after the date of enactment of this title, the Assistant Secretary for Emergency Preparedness, in cooperation with the evaluation group established under subsection (c)(1), shall establish a system of performance measures to evaluate responses to bioterrorism threats and vulnerabilities. Such system shall establish benchmarks and evaluate the corresponding roles and performances of agencies with responsibilities for bioterrorism responses in Federal, State, tribal, and local governments. ``(2) Report.--Not later than 30 days after the date on which the system is established under paragraph (1), the Assistant Secretary for Emergency Preparedness shall prepare and submit to the Secretary, and to the appropriate committees of Congress, a report concerning the performance measures and evaluations developed as a part of the system. ``(3) Revisions.--The Assistant Secretary for Emergency Preparedness, in cooperation with the Evaluation Group, shall periodically review and revise the performance measures developed under paragraph (1) and promptly report any revisions to the Committee on Health, Education, Labor and Pensions, the Committee on Governmental Affairs, and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce, the Committee on Government Reform, and the Committee on Appropriations of the House of Representatives. ``(e) Technology Verification.--The Assistant Secretary for Emergency Preparedness shall establish a technology verification group from among relevant agencies of the Federal Government, including the Department of Defense, the Centers for Disease Control and Prevention, the Federal laboratories, and the National Institute for Standards and Technology. Such group, in consultation with appropriate representatives of the private sector, shall-- ``(1) evaluate, test, and verify the performance of promising technologies for reducing and responding to bioterrorism threats; ``(2) make recommendations to relevant Federal, State, and local agencies for the acquisition of successful technologies that can significantly reduce bioterrorism threats; and ``(3) prepare and submit to the Committee on Health, Education, Labor and Pensions, [[Page S13908]] the Committee on Governmental Affairs, and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce, the Committee on Government Reform, and the Committee on Appropriations of the House of Representatives, a report concerning the recommendations made under paragraph (2). On page 17, between lines 8 and 9, insert the following: ``SEC. 2815. NATIONAL HEALTH SURVEILLANCE SYSTEM. ``(a) Establishment.-- ``(1) In general.--The Secretary, acting through the Assistant Secretary for Emergency Preparedness, shall establish a National Health Surveillance System that utilizes computerized information systems and the Internet to provide early warning of natural disease outbreaks or bioterrorist attacks to Federal, State, tribal, and local health officials and assist such officials in response management. ``(2) Use of existing systems.--Such system, to the maximum extent feasible, shall utilize existing health care data systems of primary care providers, health insurance and reimbursement programs, and other sources of health information including those maintained by Federal, State, tribal and local health agencies. ``(b) Data and Information Standards.--Not later than 12 months after the date of enactment of this title, the Assistant Secretary for Emergency Preparedness, in cooperation with medical providers and State and local public health officials, shall identify the nature and manner of health surveillance data to be compiled for purposes of subsection (a) and shall establish standards and procedures to ensure the standardization and interoperability of such data. ``(c) Collection and Analysis Capability.--As soon as practicable, but not later than 36 months after the date of enactment of this title, the Assistant Secretary for Emergency Preparedness shall establish the mechanisms and information systems necessary for the collection and rapid real time evaluation of data transmitted for purposes of subsection (a) concerning public health and bioterrorist emergencies, and provide such evaluations on at least a daily basis to Federal, State, tribal, and local public health and emergency authorities. ``(d) Assistance to State and Local Health Agencies and Health Care Providers.--The Assistant Secretary for Emergency Preparedness may provide technical, material, and financial assistance to State, tribal, and local public health agencies, health providers, and other entities that the Assistant Secretary recommends participate in the surveillance system developed under this section. ``(e) Authorization of Appropriations.--There is authorized to be appropriated $120,000,000 for fiscal year 2002 to carry out this section. ``SEC. 2816. NATIONAL HEALTH ALERT NETWORK. ``(a) In General.--The Secretary, acting through the Assistant Secretary for Emergency Preparedness, shall establish and maintain a National Health Alert Network, that utilizes, to the maximum extent practical, advanced information and Internet technology. ``(b) Requirements.--The network established under subsection (a) shall-- ``(1) be capable of the timely transmission of emergency medical information and information identifying potential and ongoing public health and bioterrorism emergencies to all appropriate Federal health authorities, to all State and local public health authorities, and to hospitals and other medical practitioners in affected areas; and ``(2) include data on the medical nature of the emergency, recognition of disease symptoms, the possible scope of infections, recommended treatments, the sources and availability of appropriate medicines, and such other data as may be recommended by the Secretary. ``(c) Implementation Objectives.--Not later than 180 days after the date of enactment of this title, the Secretary shall ensure that all State public health departments are connected to the network established under subsection (a). Not later than 1 year after such date of enactment, the Secretary shall ensure that all municipal public health agencies in municipalities with populations larger than 250,000 persons, as well as all county and tribal public health agencies, are included in the network. ``(d) Assistance to State and Local Health Agencies.--The Secretary may provide technical, material, and financial assistance to State and local public health agencies, health providers, and other entities that the Assistant Secretary for Emergency Preparedness recommends for participation in the network. ``(e) Reporting Requirement.--The Secretary shall prepare and submit to the appropriate committees of Congress reports describing the progress made by the Secretary in implementing the network described in subsection (a). Such reports shall be submitted-- ``(1) not later than 1 year after the date of enactment of this title; ``(2) at such times as the Secretary determines to be appropriate after the completion of each phase of the implementation objectives described in subsection (c); and ``(3) annually thereafter as determined appropriate by Congress. ``(f) Authorization of Appropriations.--There is authorized to be appropriated $100,000,000 for fiscal year 2002 to carry out this section.''. On page 19, line 3, strike ``Section'' and insert ``(a) In General.--Section''. On page 21, line 8, strike ``and''. On page 21, line 11, strike the period and insert ``; and''. On page 21, between lines 11 and 12, insert the following: ``(11) coordinate and standardize data and communication systems and requirements to ensure the interoperability and seamless data transmission necessary to prepare for, identify, assess, and respond to health emergencies and bioterrorist attacks, including the National Health Surveillance System and the National Health Alert Network. On page 23, between lines 16 and 17, insert the following: ``(c) Technical Assistance and Grants to Ensure Interoperability.-- ``(1) In general.--The Secretary, in consultation with the working group, may provide technical and financial assistance to a public or private entity to ensure the interoperability and seamless transmission of data and communications deemed necessary to prepare for, identify, assess, or respond to a health emergency or bioterrorism attack. ``(2) Authorization of appropriations.--There is authorized to be appropriated $25,000,000 for fiscal year 2002 to carry out this subsection.''. (b) Formal Inquiry into Anthrax Attacks and Bioterrorism Preparedness.-- (1) In general.--Not later than 45 days after the date of enactment of this Act, the Secretary of Health and Human Services shall enter into a contract with the Institute of Medicine of the National Academy of Sciences for the conduct of a formal independent inquiry into the response of the United States to anthrax attacks throughout the United States Postal System and the state of preparedness for other biological and chemical threats, including the recommendations described in paragraph (2). (2) Completion and report.--The inquiry conducted under paragraph (1) shall be completed not later than 270 days after the date on which the contract under such paragraph is awarded. Not later than 30 days after the date on which such inquiry is completed, the Secretary of Health and Human Services shall submit to the appropriate committees of Congress a report concerning the results of such inquiry, including the recommendations of the Institute of Medicine concerning the preparedness of the United States for future bioterrorism attacks (including recommendations for both occupational and public safety). Mr. BIDEN. Mr. President, the final day of a legislative session often brings a flurry of activity as bills get un-jammed, compromises emerge, and the Senate produces progress on important issues. Depending upon one's perspective, these last-minute actions include both good things and bad things. Nevertheless, I think we all can agree that today's passage of the Bioterrorism Preparedness Act is a real accomplishment in improving America's homeland defense. This bill authorizes $3.25 billion for comprehensive measures to take the first step in improving our nation's capability, in the event of a biological weapons attack, to respond quickly, contain the attack, and treat the victims. I want to applaud Senators Kennedy and Frist for coming together in a bipartisan spirit and displaying real leadership in drafting this bill. When Sam Nunn testified in early September before the Foreign Relations Committee on the threat posed by biological weapons, he was very clear--bioterrorism is a direct threat to the national security of the United States and we need to invest the necessary resources to counter this threat accordingly. As troubling as the recent spate of anthrax by mail attacks was, we were very fortunate that this was a comparatively small-scale attack. Eighteen Americans contracted inhalation or cutaneous anthrax; unfortunately, five individuals died. The next time a biological weapons attack occurs, we may not be so fortunate in dealing with a small number of victims who emerge over a period of weeks and months. Instead, we may face thousands of victims flooding local emergency rooms and overwhelming our hospitals in a matter of hours. Let's be real here--the anthrax attacks, as small-scale as they may have been, have greatly stressed our national public health infrastructure. One out of eight Centers for Disease Control employees at their headquarters in Atlanta is working on the current anthrax outbreak, forcing the CDC to sideline other essential core activities for the time being. Folks, what we have just been through is small potatoes compared to what we potentially will face. Plain and simple, we can't afford to be so under-prepared in the future. [[Page S13909]] Among Sam Nunn's recommendations for countering biological terrorism, he declared, ``We need to recognize the central role of public health and medicine in this effort and engage these professionals fully as partners on the national security team.'' There are many good things in this bill, ranging from the expansion of the National Pharmaceutical Stockpile to efforts to enhance food safety, but I am especially pleased that the Bioterrorism Preparedness Act provides direct grants to improve the public health infrastructure at the state and local level. Our doctors, nurses, emergency medical technicians, and other public health personnel are our eyes and ears on the ground for detecting a biological weapons attack. We can't afford not to do everything we can to make sure they have the necessary tools and resources in containing any BW attack. This bill goes a long way toward fulfilling that core commitment. So I am very pleased the Senate today has passed the Bioterrorism Preparedness Act and I look forward to a quick reconciliation of this bill with counterpart House legislation early next year. When this bill was introduced, I had expressed my serious concern that it was ignoring the international aspects to any effective response to potential bioterrorism. As Chairman of the Foreign Relations Committee, I know that we cannot address the threat of bioterrorism within the borders of the United States alone. A biological weapon attack need not originate in the United States to pose a threat to our nation. A dangerous pathogen deliberately released anywhere in the world can quickly spread to the United States in a matter of days, if not hours. The scope and frequency of international trade, travel, and migration patterns offer unlimited opportunities for pathogens to spread across national borders and even to move from one continent to another. Therefore, I continue to believe we need to view all infectious disease epidemics, wherever they occur, as a potential threat to all nations. It is for this reason that, when the Bioterrorism Preparedness Act was being drafted, Senator Helms, the distinguished Ranking Member on the Foreign Relations Committee, and I had worked together in seeking to insert provisions in this bill to enhance global disease monitoring and surveillance. With Senator Kennedy's strong backing, we had sought to ensure the full availability of information (i.e., disease characteristics, pathogen strains, transmission patterns) on infectious epidemics overseas that may provide clues indicating possible illegal biological weapons use or research. Even if an infectious disease outbreak occurs naturally, improved monitoring and surveillance can help contain the epidemic and tip off scientists and public health professionals to new disease that may be used as biological weapons in the future. The World Health Organization (WHO) established a formal worldwide network last year, called the Global Alert and Response Network, to monitor and track infectious disease outbreaks in every region of the world. The WHO has done an impressive job so far working on a shoestring budget. But this global network is only as good as its components--individual nations. Many developing nations simply do not possess the personnel, laboratory equipment or public health infrastructure to track disease patterns and detect traditional and emerging pathogens. In fact, these nations often just seek to keep up in treating those who have already fallen ill. Doctors and nurses in many developing countries only treat a small fraction of the patients who may be ill with a specific infectious disease--in effect, they are only witnessing the tip of a potentially much larger iceberg. According to the National Intelligence Council, governments in developing countries in Africa and Asia have established rudimentary or no systems at all for disease surveillance, response or prevention. For example, in 1994, an outbreak of plague occurred in India, resulting in 56 deaths and billions of dollars of economic damage as trade and travel with India ground to a halt. The plague outbreak was so severe because Indian authorities did not catch the epidemic in its early stages. Authorities had ignored or failed to respond to routine complaints a flea infestation, a sure warning signal for plague. Owing to the lack of resources, developing nations are the weak spots in global disease monitoring and surveillance. Without shoring up these nations' capabilities to detect and contain disease outbreaks, we are leaving the entire world vulnerable to either a deliberate biological weapons attack or an especially virulent naturally occurring epidemic. For all of these reasons, Senator Helms and I had worked together in proposing language to authorize $150 million in FY 1001 and FY 2003 to strengthen the capabilities of individual nations in the developing world to detect, diagnose, and contain infectious disease epidemics. The proposed title would have helped train entry-level public health professionals from developing countries and provide grants for the acquisition of modern laboratory and communications equipment essential to any effective disease surveillance network. Upon first glance, $150 million is chump change in a bill that authorizes more than $3 billion. But I have been assured by public health experts that $150 million alone can go a long ways in making sure that developing countries the basic disease surveillance and monitoring capabilities to effectively contribute to the WHO's global network. The bottom line is that these provisions would have offered an inexpensive, common-sense solution to a problem of global proportions. I was greatly disappointed, therefore, when the White House expressed resistance to the language Senator Helms and I had worked out and sought to drop it from the final bill. While voicing support for our ideas, the White House believed that the Bioterrorism Preparedness Act should only focus on domestic defenses against bioterrorism and was not the appropriate vehicle for the international programs we proposed. I strongly disagreed. It doesn't make sense to draw artificial boundaries between ``domestic'' and ``international'' responses to bioterrorism. I have already pointed out that pathogens deliberately released in an attack anywhere in the world can quickly spread to the United States if we are unable to contain the epidemic at its source. The National Intelligence Council has concluded that infectious diseases are a real threat to U.S. national security. To ignore the international arena in favor of domestic solutions alone just doesn't make any sense. Therefore, when the Bioterrorism Preparedness Act was introduced in November without any provisions to enhance global disease surveillance, I announced my intention to introduce an amendment to ensure this bill would enhance the capabilities of developing nations to track, diagnose, and contain disease outbreaks resulting from both BW attacks and naturally occurring epidemics. This week, the Senate leadership chose to move this bill under an unanimous consent procedure. I initially objected because I strongly believed the Senate should have an opportunity, at the very least, to vote on an amendment to incorporate global disease surveillance activities in the Bioterrorism Preparedness Act. But I understand the urgency of the moment. There is no greater vulnerability in our nation's defenses than against the threat of bioterrorism and it is the responsibility of Congress to act quickly to correct this deficiency. Therefore, I have chosen, for now, to cease my effort to include this amendment in this bill. Office of Management and Budget Director Mitch Daniels today sent me a letter where he expresses appreciation for the proposals contained in this amendment and recognizes that ``International public health has a critical role to play in protecting the United States and our global partners''. Furthermore, Daniels highlights the Administration's intention to engage in discussions with myself and other interested colleagues on these proposals when the Congress reconvenes in January. I ask for unanimous consent that the full text of this letter be included at the end of this statement in the Congressional Record. I expect the Administration to follow up on this letter by planning and budgeting for improved global pathogen surveillance in Fiscal Year 2003. The need is urgent and our ability to lessen the threat posed by bioterrorism is real. [[Page S13910]] The steps we take to combat bioterrorism overseas can keep diseases from reaching our shores and will give us vital early warning of new diseases and strains for which we must prepare. Let me again salute today's passage by the Senate of the Bioterrorism Preparedness Act. While it does not include every essential proposal in enhancing our nation's bioterrorism defenses, it still accomplishes a great deal. If this bill becomes law, which I have no reason to doubt, it is my hope that the Congress will follow up next year with the necessary appropriations to carry out the programs authorized in this bill. Let me close with an excerpt of testimony from the Foreign Relations Committee hearing on bioterrorism in September from Dr. D.A. Henderson, the man who spearheaded the international campaign to eradicate smallpox in the 1970's. Today, he is the director of the newly-formed Office of Emergency Preparedness in the Department of Health and Human Services, which has the mandate to help organize the federal government's response to future bioterrorist attacks. Dr. Henderson was very clear on the value of global disease surveillance: ``In cooperation with the WHO and other countries, we need to strengthen greatly our intelligence gathering capability. A focus on international surveillance and on scientist-to-scientist communication will be necessary . . .'' There being no objection, the letter was ordered to be printed in the Record, as follows: Executive Office of the President, Office of Management and Budget, Washington, DC., December 20, 2001. Hon. Joseph R. Biden, Jr., U.S. Senate, Washington, DC. Dear Senator Biden: I very much appreciate the important proposals contained within Title VI of the Kennedy-Frist bioterrorism bill. International public health has a critical role to play in protecting the United States and our global partners from the threat of infectious disease. As you are aware, the Administration supports the version of the Kennedy bill that does not include Title VI. These issues are critical, however, and I would very much like to resolve them outside the context of the current bioterrorism bill. Your willingness to discuss these matters in the future is critical to the movement of this important piece of legislation and I would welcome the opportunity to engage in these discussions at the beginning of the next session. Thank you very much for your consideration of this request. Sincerely, Mitchell E. Daniels, Jr., Director. additional bioterrorism preparedness issues Mr. HATCH. I would like to commend my colleagues, Senators First, Kennedy, and Gregg for their work in crafting the bipartisan Bioterrorism Preparedness Act. The Act takes a significant step forward in providing the necessary tools to combat future acts of bioterrorism. Mr. FRIST. I thank the gentleman from Utah for his comments. On behalf of myself, Senator Kennedy, and Senator Gregg, I also want to thank him for his significant contributions to the legislation, and for his support for this measure. Mr. HATCH. I understand that there are efforts currently underway to pass this legislation by unanimous consent before the Senate adjourns for the year, and I strongly support those efforts. Because we are trying to clear this measure under a tight time frame, I also understand that there will not be an opportunity to make modifications to the text of the legislation prior to final Senate passage. Mr. KENNEDY. That is correct. Mr. FRIST. My friend from Utah is correct. Mr. HATCH. Before Congress passes a final anti-bioterrorism law, I believe there are several important issues that must be addressed. Because there will not be an opportunity to address these matters before the Senate passes anti-bioterrorism legislation, I strongly believe that the House-Senate conference committee should: (1) permit the approval of priority countermeasures solely based on data from animal studies; (2) clarify the Health and Human Service Secretary's role and authority in distribution, and use of, priority countermeasures and other medical responses to bioterrorist attacks; and (3) provide additional enforcement provisions with respect to prohibiting the unlawful shipment, transportation, and possession of biological agents and toxins. These issues have not been sufficiently addressed in the legislation before us. We must all recognize that this language the Senate is about to adopt has not been the subject of any congressional committee mark- up. While the extraordinary situation confronting our nation regarding biological attacks requires expeditious action, we also must ensure that there is flexibility in the conference committee to guarantee that novel and, frankly, evolving issues, concerning bioterrorism are adequately addressed. This is what happened during the House-Senate conference of the U.S.A. Patriot Act and, with diligence, we can duplicate that success again. Mr. GREGG. I agree that the conference committee should address each of the issues that you have raised. I will actively work to ensure that these provisions are included. Mr. KENNEDY. I concur with my colleague from New Hampshire. Mr. FRIST. I also agree that these important issues should be addressed during a conference with the House of Representatives and we will call on the Senator from Utah to participate in discussions concerning these issues. Mr. GREGG. I agree with my colleague from Utah that additional specificity with respect to the language on animal trials would be desirable, particularly with respect to clarifying that the FDA has the authority to promptly promulgate a final rule in this area. I also believe that the Secretary of Health and Human Services should have clear authority to prioritize the distribution of scarce countermeasures under certain circumstances. Finally, I believe there is great value in considering the inclusion in a final bill of intermediate enforcement authority with respect to the unlawful shipment, transport, possession, or other use of biological agents or toxins. Mr. FRIST. I agree with Senator Gregg. The Senator from Utah can be assured that these issues will receive my active support during conference consideration of this measure. Mr. KENNEDY. I also agree with Senator Gregg. I thank the Senator from Utah for bringing these important issues to the attention of the Senate. I will look forward to working with him in resolving these issues during the conference. Mr. HATCH. I also request that my colleagues support the inclusion of provisions to establish an animal terrorism incident clearinghouse. Mr. GREGG. I will actively support this provision. Mr. FRIST. I concur with my colleague from New Hampshire. Mr. KENNEDY. I also believe that this issue should be given serious consideration. Mr. HATCH. I thank my colleagues for their comments. I look forward to working with them during the conference to ensure that this important legislation is passed by Congress so that our nation can be better prepared to meet the threat of bioterrorism and public health emergencies. WATER SUPPLY SECURITY Mr. JEFFORDS. Mr. President, and my distinguished colleagues, I am pleased that we are moving so quickly on legislation to combat bioterrorism--this is certainly a timely issue. I would like to engage my colleagues in a colloquy to clarify our commitment to another important issue--the security of our Nation's water supply. At the end of October of this year, I was joined by the Ranking Member of the Environment and Public Works Committee in introducing S. 1593 and S. 1608. S. 1593 authorizes the Administrator of the Environmental Protection Agency to establish a grant program to support research projects on critical infrastructure protection for water supply systems. S. 1608 establishes a program to provide grants to drinking water and wastewater facilities to meet immediate security needs. I understand that the Senator from Tennessee, the Senator from Massachusetts and the Senator from New Hampshire support the modified provisions of these bills. Is that correct? Mr. FRIST. That is correct. Mr. KENNEDY. Yes, that is correct. Mr. GREGG. Yes, that is correct because in the interest of time, we re unable to change the bill prior to conference. [[Page S13911]] Mr. SMITH of New Hampshire. I too would like to thank Senator Frist, Senator Kennedy and Senator Gregg for agreeing to work with us to ensure these two proposals are included in the bioterrorism proposal. I regret that with the end of session quickly approaching, there is not time to incorporate these provisions into the underlying bill. As we all recognized in our support for these proposals, since the September 11th attacks, Americans throughout the country have become concerned about the security of our nation's water supply. While it is widely believed that our water supply is safe, there are a few vulnerabilities that must be addressed. Our bills would provide resources for research into security at facilities and assessment tools while also providing seed money to encourage additional spending on security measures. Mr. JEFFORDS. Our colleagues on the House side also recognized this need by including water security provisions in the bioterrorism bill, H.R. 3448, that was passed by the House on December 12th. I would like my colleagues' assurance that during conference they will press for adoption of the modified versions of S. 1593 and S. 1608. Mr. KENNEDY. I intend to press for adoption of these provisions. the security of our nation's water supply is crucial to the health and well-being of our citizens. Mr. GREGG. I concur, and I intend to press for adoption of these provisions. Mr. FRIST. I agree and you have my commitment to do the same. Mr. SMITH of New Hampshire. I again would like to thank my colleagues for agreeing to fight for these provisions during conference. It was with great reluctance that Senator Jeffords and I agreed to allow S. 1765 to be brought to the floor without our legislation included so that we can move forward on this important bill and conference it with the House. However, it is important that these immediate needs be addresed and that our proposals be included in the the final legislation. I look forward to working with my colleagues to ensure that the provisions we agreed to that comprise the modified versions of S. 1593 and S. 1608 are included in the bioterrorism bill. Mr. JEFFORDS. Finally, I want to commend Senators Kennedy, Frist, and Gregg and say that I am looking forward to working with them during the conference on these measures. Amendment No. 2692 Mr. REID. Mr. President, I understand Senators Frist, Kennedy, and Gregg have a substitute amendment at the desk which is the text of S. 1765. I ask unanimous consent that the amendment be considered and agreed to and the motion to reconsider be laid upon the table; that the bill, as amended, be read a third time and passed, the motion to reconsider be laid upon the table; that the Senate insist on its amendment, request a conference with the House on the disagreeing votes of the two Houses, and that the Chair be authorized to appoint conferees on the part of the Senate, without intervening action or debate. The PRESIDING OFFICER. Without objection, it is so ordered. The amendment (No. 2692) was agreed to. (The text of the amendment is printed in today's Record under ``Amendments Submitted and Proposed.'') Mr. LOTT. Mr. President, I thank Senator Reid for moving this very important Bioterrorism Preparedness Act forward. I commend Senators Frist, Kennedy, and Gregg for their work. We intend to work with the House and get this passed quickly when we return. I thank Senator Reid. Mr. REID. I appreciate everyone's cooperation. The Presiding Officer (Mr. Corzine) appointed Mr. Kennedy, Mr. Dodd, Mr. Harkin, Ms. Mikulski, Mr. Jeffords, Mr. Gregg, Mr. Frist, Mr. Enzi, and Mr. Hutchinson conferees on the part of the Senate. ____________________