Economic Development Administration Reauthorization Act of 2004

Mr. President, America has a major flaw in its defenses against bioterrorism. Hearings I chaired in the Government Affairs Committee on bioterrorism demonstrated that America has not made a national commitment to research and development of treatments and cures for those who might be exposed to or infected by a biological agent, chemical toxin, or radiological material. Correcting this critical gap is the purpose of legislation we are introducing today.

This legislation is a refined and upgraded version of legislation I introduced last year, S. 1764, December 4, 2001, and S. 3148, October 17, 2002, and I am delighted that Senator Hatch has joined me as the lead cosponsor of the new bill.

Obviously, our first priority must be to attempt to prevent the use of these agents and toxins by terrorists, quickly assess when an attack has occurred, take appropriate public health steps to contain the exposure, stop the spread of contagion, and then detoxify the site. These are all critical functions, but in the end we must recognize that some individuals may be exposed or infected. Then the critical issue is whether we can treat and cure them and prevent death and disability.

In short, we need a diversified portfolio of medicines. In cases where we have ample advance warning of an attack and specific information about the agent, toxin, or material, we may be able to vaccinate the vulnerable population in advance. In other cases, even if we have a vaccine, we might well prefer to use medicines that would quickly stop the progression of the disease or the toxic effects. We also need a powerful capacity quickly to develop new countermeasures where we face a new agent, toxin, or material.

Unfortunately, we are woefully short of vaccines and medicines to treat individuals who are exposed or infected. We have antibiotics that seem to work for most of those infected in the current anthrax attack, but these have not prevented five deaths. We have no effective vaccines or medicines for most other biological agents and chemical toxins we might confront. We have very limited capacity to respond medically to a radiological attack. In some cases we have vaccines to prevent, but no medicines to treat, an agent. We have limited capacity to speed the development of vaccines and medicines to prevent or treat novel agents and toxins not currently known to us.

We have provided, and should continue to provide, direct Federal funding for research and development of new

medicines, however, this funding is unlikely to be sufficient. Even with ample Federal funding, many private companies will be reluctant to enter into agreements with government agencies to conduct this research. Other companies would be willing to conduct the research with their own capital and at their own risk but are not able to secure the funding from investors.

The legislation we introduce today would provide incentives for private biotechnology companies to form capital to develop countermeasures--medicines--to prevent, treat and cure victims of bioterror, chemical and radiological attacks. This will enable this industry to become a vital part of the national defense infrastructure and do so for business reasons that make sense for their investors on the bottom line.

Enactment of these incentives is necessary because most biotech companies have no approved products or revenue from product sales to fund research. They rely on investors and equity capital markets to fund the research. They must necessarily focus on research that will lead to product sales and revenue and, thus, to an end to their dependence on investor capital. There is no established or predictable market for countermeasures. These concerns are shared by pharmaceutical firms. Investors are justifiably reluctant to fund this research, which will present challenges similar in complexity to AIDS. Investors need assurances that research on countermeasures has the potential to provide a rate of return commensurate with the risk, complexity and cost of the research, a rate of return comparable to that which may arise from a treatment for cancer, MS, Cystic Fibrosis and other major diseases.

It is in our national interest to enlist these companies in the development of countermeasures as biotech companies tend to be innovative and nimble and intently focused on the intractable diseases for which no effective medical treatments are available.

The incentives we have proposed are innovative and some may be controversial. We invite everyone who has an interest and a stake in this research to enter into a dialogue about the issue and about the nature and terms of the appropriate incentives. We have attempted to anticipate the many complicated technical and policy issues that this legislation raises. The key focus of our debate should be how, not whether, we address this critical gap in our public health infrastructure and the role that the private sector should play. Millions of Americans will be at risk if we fail to enact legislation to meet this need.

On November 26 of 2001, the Centers for Disease Control issued its interim working draft plan for responding to an outbreak of smallpox. The plan does not call for mass vaccination in advance of a smallpox outbreak because the risk of side effects from the vaccine outweighs the risks of someone actually being exposed to the smallpox virus. At the heart of the plan is a strategy sometimes called ``search and containment.''

This strategy involves identifying infected individual or individuals with confirmed smallpox, identifying and locating those people who come in contact with that person, and vaccinating those people in outward rings of contact. The goal is to produce a buffer of immune individuals and was shown to prevent smallpox and to ultimately eradicate the outbreak. Priorities would be set on who is vaccinated, perhaps focusing on the outward rings before those at the center of the outbreak. The plan assumes that the smallpox vaccination is effective for persons who have been exposed to the disease as long as the disease has not taken hold.

In practice it may be necessary to set a wide perimeter for these areas because smallpox is highly contagious before it might be diagnosed. There may be many areas subject to search and containment because people in our society travel frequently and widely. Terrorists might trigger attacks in a wide range of locations to multiply the confusion and panic. The most common form of smallpox has a 30 percent mortality rate, but terrorists might be able to obtain supplies of ``flat-type'' smallpox with a mortality rate of 96 percent and hemorrhagic-type smallpox, which is almost always fatal. For these reasons, the CDC plan accepts the possibility that whole cities or other geographic areas could be cordoned off, letting no one in or out--a quarantine enforced by police or troops.

The plan focuses on enforcement authority through police or National Guard, isolation and quarantine, mandatory medical examinations, and rationing of medicines. It includes a discussion of ``population-wide quarantine measures which restrict activities or limit movement of individuals [including] suspension of large public gatherings, closing of public places, restriction on travel [air, rail, water, motor vehicle, and pedestrian], and/or `cordon sanitaire' [literally a `sanitary cord' or line around a quarantined area guarded to prevent spread of disease by restricting passage into or out of the area].'' The CDC recommends that states update their laws to provide authority for ``enforcing quarantine measures'' and it recommends that States in ``pre-event planning'' identify ``personnel who can enforce these isolation and quarantine measures, if necessary.'' Guide C--Isolation and Quarantine, page 17.

On October 23, 2001, the CDC published a ``Model State Emergency Health Powers Act.'' It was prepared by the Center for Law and the Public's Health at Georgetown and Johns Hopkins Universities, in conjunction with the National Governors Association, National Conference of State Legislatures, Association of State and Territorial Health Officials, National Association of City and County Health Officers, and National Association of Attorneys General. A copy of the model law is printed at www.publichealthlaw.net. The law would provide powers to enforce the ``compulsory physical separation (including the restriction of movement or confinement) of individuals and/or groups believed to have been exposed to or known to have been infected with a contagious disease from individuals who are believed not to have been exposed or infected, in order to prevent or limit the transmission of the disease to others.'' Federal law on this subject is very strong and the Administration can always rely on the President's Constitution authority as Commander in Chief.

Let us try to imagine, however, what it would be like if a quarantine is imposed. Let us assume that there is not enough smallpox vaccine available for use in a large outbreak, that the priority is to vaccinate those in the outward rings of the containment area first, that the available vaccines cannot be quickly deployed inside the quarantined area, that it is not possible to quickly trace and identify all of the individuals who might have been exposed, and/or that public health workers themselves might be infected. We know that there is no medicine to treat those who do become infected. We know the mortality rates. It is not hard to imagine how much force might be necessary to enforce the quarantine. It would be quite unacceptable to permit individuals to leave the quarantined area no matter how much panic had taken hold.

Think about how different this scenario would be if we had medicines that could effectively treat and cure those who become infected by smallpox. We still might implement the CDC plan but a major element of the strategy would be to persuade people to visit their local clinic or hospital to be dispenses their supply of medicine. We could trust that there would be a very high degree of voluntary compliance. This would give us more time, give us options if the containment is not successful, give us options to treat those in the containment area who are infected, and enable us to quell the public panic.

Because we have no medicine to treat those infected by smallpox, we have to be prepared to implement a plan like the one CDC has proposed. Theirs is the only option because our options are so limited. We need to expand our range of options.

We should not be lulled by the apparent successes with Cipro and the strains of anthrax we have seen in the recent attacks. We have not been able to prevent death in some of the patients with late-stage inhalation anthrax and Robert Stevens, Thomas Morris Jr., Joseph Curseen, Kathy Nguyen, and Ottilie Lundgren died. This legislation is named in honor of

them. What we needed for them, and did not have, is a drug or vaccine that would treat late stage inhalation anthrax.

As I have said, we need an effective treatment for those who become infected with smallpox. We have a vaccine that effectively prevents smallpox infection, and administering this vaccine within four days of first exposure has been shown to offer some protections against acquiring infection and significant protection against a fatal outcome. The problem is that administering the vaccine in this time frame to all those who might have been exposed may be exceedingly difficult. And once infection has occurred, we have no effective treatment options.

In the last century 500 million people have died of smallpox--more than have from any other infectious diseases--as compared to 320 million deaths in all the wars of the twentieth century. Smallpox was one of the diseases that nearly wiped out the entire Native American population in this hemisphere. The last naturally acquired case of smallpox occurred in Somalia in 1977 and the last case from laboratory exposure was in 1978.

Smallpox is a nasty pathogen, carried in microscopic airborne droplets inhaled by its victims. The first signs are headache, fever, nausea and backache, sometimes convulsions and delirium. Soon, the skin turns scarlet. When the fever lets up, the telltale rash appears--flat red spots that turn into pimples, then big yellow pustules, then scabs. Smallpox also affects the throat and eyes, and inflames the heart, lungs, liver, intestines and other internal organs. Death often came from internal bleeding, or from the organs simply being overwhelmed by the virus. Survivors were left covered with pockmarks--if they were lucky. The unlucky ones were left blind, their eyes permanently clouded over. Nearly one in four victims died. The infection rate is estimated to be 25-40 percent for those who are unvaccinated and a single case can cause 20 or more additional infections.

During the 16th Century, 3.5 million Aztecs--more than half the population died of smallpox during a two-year span after the Spanish army brought the disease to Mexico. Two centuries later, the virus ravaged George Washington's troops at Valley Forge. And it cut a deadly path through the Crow, Dakota, Sioux, Blackfoot, Apache, Comanche and other American Indian tribes, helping to clear the way for white settlers to lay claim to the western plains. The epidemics began to subside with one of medicine's most famous discoveries: the finding by British physician Edward Jenner in 1796 that English milkmaids who were exposed to cowpox, a mild second cousin to smallpox that afflicts cattle, seemed to be protected against the more deadly disease. Jenner's work led to the development of the first vaccine in Western medicine. While later vaccines used either a killed or inactivated form of the virus they were intended to combat, the smallpox vaccine worked in a different way. It relied on a separate, albeit related virus: first cowpox and the vaccinia, a virus of mysterious origins that is believed to be a cowpox derivative. The last American was vaccinated back in the 1970s and half of the US population has never been vaccinated. It is not known how long these vaccines provide protection, but it is estimated that the term is 3 to 5 years.

In an elaborate smallpox biowarfare scenario enacted in February 1999 by the Johns Hopkins Center for Civilian Biodefense Studies, it was projected that within two months 15,000 people had died, epidemics were out of control in fourteen countries, all supplies of smallpox vaccine were depleted, the global economy was on the verge of collapse, and military control and quarantines were in place. Within twelve months it was projected that eighty million people worldwide had died.

A single case of smallpox today would become a global public health threat and it has been estimated that a single smallpox bioterror attack on a single American city would necessitate the vaccination of 30 to 40 million people.

The US government is now in the process of purchasing substantial stocks of the smallpox vaccine. We then face a very difficult decision on deploying the vaccine. We know that some individuals will have an adverse reaction to this vaccine. No one in the United States has been vaccinated against smallpox in twenty-five years. Those that were vaccinated back then may not be protected against the disease today. If we had an effective treatment for those who might become infected by smallpox, we would face much less pressure regarding deploying the vaccine. If we face a smallpox epidemic from a bioterrorism attack, we will have no Cipro to reassure the public and we will be facing a highly contagious disease and epidemic. To be blunt, it will make the current anthrax attack look benign by comparison.

Smallpox is not the only threat. We have seen other epidemics in this century. The 1918 influenza epidemic provides a sobering admonition about the need for research to develop medicines. In two years, a fifth of the world's population was infected. In the United States the 1918 epidemic killed more than 650,000 people in a short period of time and left 20 million seriously ill, one fourth of the entire population. The average lifespan in the US was depressed by ten years. In just one year, the epidemic killed 21 million human beings worldwide--well over twice the number of combat deaths in the whole of World War I. The flu was exceptionally virulent to begin with and it then underwent several sudden and dramatic mutations in its structure. Such mutations can turn flu into a killer because its victims' immune systems have no antibodies to fight off the altered virus. Fatal pneumonia can rapidly develop.

Another deadly toxin, ricin toxin, was of interest to the al-Qaeda terrorist network. At an al-Qaeda safehouse in Saraq Panza, Kabul reporters found instructions for making ricin. The instructions make chilling reading. ``A certain amount, equal to a strong dose, will be able to kill an adult, and a dose equal to seven seeds will kill a child,'' one page reads. Another page says: ``Gloves and face mask are essential for the preparation of ricin. Period of death varies from 3 to 5 days minimum, 4 to 14 days maximum.'' The instructions listed the symptoms of ricin as vomiting, stomach cramps, extreme thirst, bloody diarrhea, throat irritation, respiratory collapse and death.

No specific treatment or vaccine for ricin toxin exists. Ricin is produced easily and inexpensively, highly toxic, and stable in aerosolized form. A large amount of ricin is necessary to infect whole populations--the amount of ricin necessary to cover a 100-km\2\ area and cause 50 percent lethality, assuming aerosol toxicity of 3 mcg/kg and optimum dispersal conditions, is approximately 4 metric tons, whereas only 1 kg of Bacillus anthracis is required. But it can be used to terrorize a large population with great effect because it is so lethal.

Use of ricin as a terror weapon is not theoretical. In 1991 in Minnesota, 4 members of the Patriots Council, an extremist group that held antigovernment and antitax ideals and advocated the overthrow of the US government, were arrested for plotting to kill a US marshal with ricin. The ricin was produced in a home laboratory. They planned to mix the ricin with the solvent dimethyl sulfoxide, DMSO, and then smear it on the door handles of the marshal's vehicle. The plan was discovered, and the 4 men were convicted. In 1995, a man entered Canada from Alaska on his way to North Carolina. Canadian custom officials stopped the man and found him in possession of several guns, $98,000, and a container of white powder, which was identified as ricin. In 1997, a man shot his stepson in the face. Investigators discovered a makeshift laboratory in his basement and found agents such as ricin and nicotine sulfate. And, ricin was used by the Bulgarian secret police when they killed Georgi Markov by stabbing him with a poison umbrella as he crossed Waterloo Bridge in 1978.

Going beyond smallpox, influenza, and ricin, we do not have an effective vaccine or treatment for dozens of other deadly and disabling agents and toxins. Here is a partial list of some of the other biological agents and chemical toxins for which we have no effective treatments: clostridium botulinum toxin, botulism, francisella tularensis, tularaemia, Ebola hemorrhagic fever, Marbug hemorrhagic fever, Lassa fever, Julin, Argentine

hemorrhagic fever, Coxiella burnetti, Q fever, brucella species, brucellosis, burkholderia mallei, glanders, Venezuelan encephalomyelitis, eastern and western equine encephalomyelitis, epsilon toxin of clostridium perfringens, staphylococcus entretoxin B, salmonella species, shigella dysenteriae, escherichia coli O157:H7, vibrio cholerae, cryptosporidium parvum, nipah virus, hantaviruses, tickborne hemorrhagic fever viruses, tickborne encephalitis virus, yellow fever, nerve agents, tabun, sarin, soman, GF, and VX, blood agents, hydrogen cyanide and cyanogens chloride, blister agents, lewisite, nitrogenadn sulfur mustards, and phosgene oxime, heavy metals, arsenic, lead, and mercury, and volatile toxins, benzene, chloroform, trihalomethanes, pulmonary agents, Phosgene, chlorine, vinly chloride, and incapacitating agents, BZ.

The naturally occurring forms of these agents and toxins are enough to cause concern, but we also know that during the 1980s and 1990s the Soviet Union conducted bioweapons research at forty-seven laboratories and testing sites, employed nearly fifty thousand scientists in the work, and that they developed genetically modified versions of some of these agents and toxins. The goal was to develop an agent or toxin that was particularly virulent or not vulnerable to available antibiotics.

The United States has publicly stated that five countries are developing biological weapons in violation of the Biological Weapons convention, North Korea, Iraq, Iran, Syria, and Libya, and stated that additional countries not yet named, possibly including Russia, China, Israel, Sudan and Egypt, are also doing so as well.

What is so insidious about biological weapons is that in many cases the symptoms resulting from a biological weapons attack would likely take time to develop, so an act of bioterrorism may go undetected for days or weeks. Affected individuals would seek medical attention not from special emergency response teams but in a variety of civilian settings at scattered locations. This means we will need medicines that can treat a late stage of the disease, long after the infection has taken hold.

We must recognize that the distinctive characteristic of biological weapons is that they are living micro-organisms and are thus the only weapons that can continue to proliferate without further assistance once released in a suitable environment.

The lethality of these agents and toxins, and the panic they can cause, is quite frightening. The capacity for terror is nearly beyond comprehension. We do not believe it is necessary to describe the facts here. Our point is simple: we need more than military intelligence, surveillance, and public health capacity. We also need effective medicines. We also need more powerful research tools that will enable us to quickly develop treatments for agents and toxins not on this or any other list.

We need to do whatever it takes to be able to reassure the American people that hospitals and doctors have powerful medicines to treat them if they are exposed to biological agents or toxins, that we can contain an outbreak of an infectious agent, and that there is little to fear. To achieve this objective, we need to rely on the entrepreneurship of the biotechnology industry.

In the summer of 200_, the Defense Science Board completed a study of the countermeasures we have available. It focused on countermeasures-- diagnostics, vaccines, and drugs--for the top nineteen bioterror threats, and estimated what we have available today, what we might have available in five years and what we might have available in ten years.

If one assumes that we need diagnostics, vaccines, and drugs for all nineteen of these bioterror threats, we need fifty-seven countermeasures (19 times 3). It found that today we have only one of these fifty-seven countermeasures, a drug for Chlamydia psittaci. It found that in five years we might have twenty of the fifty-seven countermeasures and in ten years we might have thirty-four of the fifty-seven. These are optimistic assessments.

It set reasonable criteria for what constitutes an effective countermeasure. For diagnostics, it said that we are unprepared if our diagnostic takes more than 24 hours, requires confirmatory testing and the patient must be symptomatic. If said we are somewhat prepared if the diagnostic takes 12 to 24 hours, requires confirmatory testing, and works in some cases where the patient is asymptomatic. It said we are only truly prepared if the test takes less than 12 hours, requires no confirmatory testing, and detects the disease when the patient is asymptomatic. It found that we have no diagnostics today that meet the top standard and might have diagnostics for seventeen of the nineteen terror threats in five years and eighteen of the nineteen in ten years.

For vaccines it found that we are unprepared if we have no vaccine. We are partially prepared if we have a vaccine but have production or use limitations. And we are fully prepared if we have a vaccine generally available. It found that we have no vaccines today that meet the top standard and might have vaccines for two of the terror threats in five years and nine in ten years.

For therapeutics it found that we are unprepared if we have no approved treatment. We are partially prepared if we have a treatment available but have production or use limitations. And we are fully prepared if we have a treatment available. It found that we have one treatment that meets the top standard and might have treatments for the same agent in five years and seven treatments in ten years.

Obviously, we are woefully unprepared. The Defense Science Board only focused on the top nineteen threats, and there are many others for which we are also unprepared.

My proposal would supplement direct Federal Government funding of research with incentives that make it possible for private companies to form the capital to conduct this research on their own initiative, utilizing their own capital, and at their own risk--all for good business reasons going to their bottom line.

The U.S. biotechnology industry, approximately 1,300 companies, spent $13.8 billion on research last year. Only 350 of these companies have managed to go public. The industry employs 124,000, Ernest & Young data, people. The top five companies spent an average of $89,000 per employee on research, making it the most research-intensive industry in the world. The industry has 350 products in human clinical trials targeting more than 200 diseases. Losses for the industry were $5.8 billion in 2001, $5.6 billion in 2000, $4.4 billion in 1999, $4.1 billion in 1998, $4.5 billion in 1997, $4.6 billion in 1996, and similar amounts before that. In 2000 fully 38 percent of the public biotech companies had less than 2 years of funding for their research. Only one quarter of the biotech companies in the United States are publicly traded and they tend to be the best funded.

There is a broad range of research that could be undertaken under this legislation. Vaccines could be developed to prevent infection or treat an infection from a bioterror attack. Broad-spectrum antibiotics are needed. Also, promising research has been undertaken on antitoxins that could neutralize the toxins that are released, for example, by anthrax. With anthrax it is the toxins, not the bacteria itself, that cause death. An antitoxin could act like a decoy, attaching itself to sites on cells where active anthrax toxin binds and then combining with normal active forms of the toxin and inactivating them. An antitoxin could block the production of the toxin.

We can rely on the innovativeness of the biotech industry, working in collaboration with academic medical centers, to explore a broad range of innovative approaches. This mobilizes the entire biotechnology industry as a vital component of our national defense against bioterror weapons.

The legislation takes a comprehensive approach to the challenges the biotechnology industry faces in forming capital to conduct research on countermeasures. It includes capital formation tax incentives, guaranteed purchase funds, patent protections, and liability protections. We believe we will have to include each of these types of incentives to ensure that we mobilize the biotechnology industry for this urgent national defense research.

Some of the tax incentives in this legislation, and both of the two patent incentives I have proposed, may be controversial. In our view, we can debate tax or patent policy as long as you

want, but let's not lose track of the issue here--development of countermeasures to treat people infected or exposed to lethal and disabling bioterror weapons.

We know that incentives can spur research. In 1983 we enacted the Orphan Drug Act to provide incentives for companies to develop treatments for rare diseases with small potential markets deemed to be unprofitable by the industry. In the decade before this legislation was enacted, fewer than 10 drugs for orphan diseases were developed and these were mostly chance discoveries. Since the Act became law, 218 orphan drugs have been approved and 800 more are in the pipeline. The Act provides 7 years of market exclusivity and a tax credit covering some research costs. The effectiveness of the incentives we have enacted for orphan disease research show us how much we can accomplish when we set a national priority for certain types of research.

The incentives we have proposed differ from those set by the Orphan Drug Act. We need to maintain the effectiveness of the Orphan Drug Act and not undermine it by adding many other disease research targets. In addition, the tax credits for research for orphan drug research have no value for most biotechnology companies because few of them have tax liability with respect to which to claim the credit. This explains why we have not proposed to utilize tax credits to spur countermeasures research. It is also clear that the market for countermeasures is even more speculative than the market for orphan drugs and we need to enact a broader and deeper package of incentives.

The government determines which research is covered by the legislation and which companies qualify for the incentives for this research. No company is entitled to utilize the incentives until the government certifies its eligibility.

These decisions are vested in the Secretary, Department of Homeland Security. In S. 1764, the decisions were vested in the White House Office of Homeland Security, but it is now likely that a Department will be created. I have strongly endorsed that concept and led the effort to enact the legislation forming the new Department.

The legislation confers on the Secretary, in consultation with the Secretary of Defense and Secretary of Health and Human Services, authority to set the list of agents and toxins with respect to which the legislation and incentives applies.

The Secretary determines which agents and toxins present a threat and whether the countermeasures are ``more likely'' to be developed with the application of the incentives in the legislation. The Secretary may determine that an agent or toxin does not present a threat or that countermeasures are not more likely to be developed with the incentives. It may determine that the government itself should fund the research and development effort and not rely on private companies. The Department is required to consider the status of existing research, the availability of non-countermeasure markets for the research, and the most effective strategy for ensuring that the research goes forward. The legislation includes an illustrative, non-binding list of fifty- four agents and toxins that might be included on the Secretary's list. The decisions of the Secretary are final and are not subject to judicial review.

The Department then must provide information to potential manufacturers of these countermeasures in sufficient detail to permit them to conduct the research and determine when they have developed the needed countermeasure. It may exempt from publication such information as it deems to be sensitive.

The Department also must specify the government market that will be available when a countermeasure is successfully developed, including the minimum number of dosages that will be purchased, the minimum price per dose, and the timing and number of years projected for such purchases. Authority is provided for the Department to make advance, partial, progress, milestone, or other payments to the manufacturers.

The Department is responsible for determining when a manufacturer has, in fact, successfully developed the needed countermeasure. It must provide information in sufficient detail so that manufacturers and the government may determine when the manufacturer has successfully developed the countermeasure the government needs. If and when the manufacturer has successfully developed the countermeasure, it becomes entitled to the procurement, patent, and liability incentives in the legislation.

Once the list of agents and toxins is set, companies may register with the Department their intent to undertake research and development of a countermeasure to prevent or treat the agent or toxin. This registration is required only for companies that seek to be eligible for the tax, purchase, patent, and liability provisions of the legislation. The registration requirement gives the Department vital information about the research effort and the personnel involved with the research, authorizes inspections and other review of the research effort, and the filing of reports by the company.

The Secretary then may certify that the company is eligible for the tax, purchase, patent, and liability incentives in the legislation. It bases this certification on the qualifications of the company to conduct the countermeasure research. Eligibility for the purchase fund, patent and liability incentives is contingent on successful development of a countermeasure according to the standards set in the legislation, as determined by the Secretary.

The legislation contemplates that a company might well register and seek certification with respect to more than one research project and become eligible for the tax, purchase, patent, and liability incentives for each. There is no policy rationale for limiting a company to one registration and one certification.

This process is similar to the current registration process for research on orphan, rare, diseases. In that case, companies that are certified by the FDA become eligible for both tax and market exclusivity incentives. This process gives the government complete control on the number of registrations and certifications. This gives the government control over the cost and impact of the legislation on private sector research.

The registration and certification process applies to research to develop diagnostics and research tools, not just drugs and vaccines.

Diagnostics are vital because healthcare professionals need to know which agent or toxin has been used in an attack. This enables them to determine which treatment strategy is likely to be most effective. We need quickly to determine which individuals have been exposed or infected, and to separate them from the ``worried well.'' It is likely in an attack that large numbers of individuals who have not been exposed or infected will flood into healthcare facilities seeking treatment. We need to be able to focus on those individuals who are at risk and reassure those who are not at risk.

In terms of research tools, it is possible that we will face biological agents and chemical agents we have never seen before. As I've mentioned, the Soviet Union bioterror research focused in part on use of genetic modification technology to develop agents and toxins that currently-available antibiotics can not treat. Australian researchers accidentally created a modified mousepox virus, which does not affect humans, but it was 100 percent lethal to the mice. Their research focused on trying to make a mouse contraceptive vaccine for pest control. The surprise was that it totally suppressed the ``cell- mediated response''--the arm of the immune system that combats viral infection. To make matters worse, the engineered virus also appears unnaturally resistant to attempts to vaccinate the mice. A vaccine that would normally protect mouse strains that are susceptible to the virus only worked in half the mice exposed to the killer version. If bioterrorists created a human version of the virus, vaccination programs would be of limited use. This highlights the drawback of working on vaccines against bioweapons rather than treatments.

With the advances in gene sequencing--genomics--we will know the exact genetic structure of a biological agent. This information in the wrong hands could easily be manipulated to design and possibly grow a lethal new bacterial and viral strains not found in nature. A scientist might be able to mix

and match traits from different microorganisms--called recombinant technology--to take a gene that makes a deadly toxin from one strain of bacteria and introduce it into other bacterial strains. Dangerous pathogens or infectious agents could be made more deadly, and relatively benign agents could be designed as major public health problems. Bacteria that cause diseases such as anthrax could be altered in such a way that would make current vaccines or antibiotics against them ineffective. It is even possible that a scientist could develop an organism that develops resistance to antibiotics at an accelerated rate.

This means we need to develop technology--research tools--that will enable us to quickly develop a tailor-made, specific countermeasure to a previously unknown organism or agent. These research tools will enable us to develop a tailor-made vaccine or drug to deploy as a countermeasure against a new threat. The legislation authorizes companies to register and receive a certification making them eligible for the incentives in the bill for this vital research.

The legislation includes four tax incentives to enable biotechnology and pharmaceutical companies to form capital to fund research and development of countermeasures. Companies must irrevocably elect only one of the incentives with regard to the countermeasure research.

Four different tax incentives are available so that companies have flexibility in forming capital to fund the research. Each of the options comes with advantages and limitations that may make it appropriate or inappropriate for a given company or research project. We do not now know fully how investors and capital markets will respond to the different options, but we assume that companies will consult with the investor community about which option will work best for a given research project. Capital markets are diverse and investors have different needs and expectations. Over time these markets and investor expectations evolve. If companies register for more than one research project, they may well utilize different tax incentives for the different projects.

Companies are permitted to undertake a series of discrete and separate research projects and make this election with respect to each project. They may only utilize one of the options with respect to each of these research projects.

The first option is for the company to establish an R&D Limited Partnership to conduct the research. The partnership passes through all business deductions and credits to the partners. For example, under this arrangement, the research and development tax credits and depreciation deductions for the company may be passed by the corporation through to its partners to be used to offset their individual tax liability. These deductions and credits are then lost to the corporation. This alternative is available only to companies with less than $750,000,000 in paid-in capital.

The second option is for the company to issue a special class of stock for the entity to conduct the research. The investors would be entitled to a zero capital gains tax rate on any gains realized on the stock held for at least three years. This is a modification of the current Section 1202 where only 50 percent of the gains are not taxed. This provision is adapted from legislation I have introduced, S. 1134, and introduced in the House by Representatives Dunn and Matsui, H.R. 2383. A similar bill has been introduced by Senator Collins, S. 455. This option also is available to small companies.

The third and fourth options grant special tax credits to the company for the research. The first credit is for research conducted by the company and the other for research conducted at a teaching hospital or similar institution. Tax credits are available to any company, but they only are useful to a company with tax liability against which to claim the credit. Very few biotechnology companies receive revenue from product sales and therefore have no tax liability. Companies with revenue may be able to fund the research from retained earnings rather than secure funding from investors.

A company that elects to utilize one of these incentives is not eligible to receive benefits of the Orphan Drug Tax Credit. Companies that can utilize tax credits--companies with taxable income and tax liability--might find the Orphan Credit more valuable. The legislation includes an amendment to the Orphan Credit to correct a defect in the current credit. The amendment has been introduced in the Senate as S. 1341 by Senators Hatch, Kennedy and Jeffords. The amendment simply states that the Credit is available starting the day an application for orphan drug status is filed, not the date the FDA finally acts on it. The amendment was one of many initiatives championed by Lisa J. Raines, who died on September 11 in the plane that hit the Pentagon, and the amendment is named in her honor. As we go forward in the legislative process, I hope we will have an opportunity to speak in more detail about the service of Ms. Raines on behalf of medical research, particularly on rare diseases.

The guaranteed purchase fund, and the patent protections, and liability provisions described below provide an additional incentive for investors and companies to fund the research.

The market for countermeasures is speculative and small. This means that if a company successfully develops a countermeasure, it may not receive sufficient revenue on sales to justify the risk and expense of the research. This is why the legislation establishes a countermeasures purchase fund that will define the market for the products with some specificity before the research begins.

The Secretary will set standards for which countermeasures it will purchase and define the financial terms of the purchase commitment. This will enable companies to evaluate the market potential of its research before it launches into the project. The specifications will need to be set with sufficient specificity so that the company--and its investors--can evaluate the market and with enough flexibility so that it does not inhibit the innovativeness of the researchers. This approach is akin to setting a performance standard for a new military aircraft.

The legislation provides that the Secretary will determine whether the government will purchase more than one product per class. It might make sense--as an incentive--for the government to commit to purchasing more than one product so that many more than one company conducts the research. A winner-take-all system may well intimidate some companies and we may end up without a countermeasure to be purchased. It is also possible that we will find that we need more than one countermeasure because different products are useful for different patients. We may also find that the first product developed is not the most effective.

The purchase commitment for countermeasures is available to any company irrespective of its paid-in capital.

Intellectual property protection of research is essential to biotechnology and pharmaceutical companies for one simple reason: they need to know that if they successfully develop a medical product another company cannot expropriate it. It's a simple matter of incentives.

The patent system has its basis in the U.S. Constitution where the federal government is given the mandate to ``promote the Progress of Science and the Useful Arts by securing for a limited time to Authors and Inventors the exclusive right to their respective Writings and Discoveries.'' In exchange for full disclosure of the terms of their inventions, inventors are granted the right to exclude others from making, using, or selling their inventions for a limited period of time. This quid pro quo provides investors with the incentive to invent. In the absence of the patent law, discoverable inventions would be freely available to anyone who wanted to use them and inventors would not be able to capture the value of their inventions or secure a return on their investments.

The patent system strikes a balance. Companies receive limited protection of their inventions if they are willing to publish the terms of their invention for all to see. At the end of the term of the patent, anyone can practice the invention without any threat of an infringement action. During the term of the patent, competitors can learn from the published description of the invention and may well find a new and distinct patentable invention.

The legislation provides two types of intellectual property protection. The

first simply provides that the term of the patent on the countermeasure will be the term of the patent granted by the Patent and Trademark Office without any erosion due to delays in approval of the product by the Food and Drug Administration. The second provides that a company that successfully develops a countermeasure will receive a bonus of two years on the term of any patent held by that company. Companies must elect one of these two protections, but only small biotechnology companies may elect the second protection. Large, profitable pharmaceutical companies may elect only the first of the two options.

The first protection against erosion of the term of the patent is an issue that is partially addressed in current law, the Hatch-Waxman Patent Term Restoration Act. That act provides partial protection against erosion of the term, length, of a patent when there are delays at the FDA in approving a product. The erosion occurs when the PTO issues a patent before the product is approved by the FDA. In these cases, the term of the patent is running but the company cannot market the product. The Hatch-Waxman Act provides some protections against erosion of the term of the patent, but the protections are incomplete. As a result, many companies end up with a patent with a reduced term, sometimes substantially reduced.

The issue of patent term erosion has become more serious due to changes at the PTO in the patent system. The term of a patent used to be fixed at 17 years from the date the patent was granted by the PTO. It made no difference how long it took for the PTO to process the patent application and sometimes the processing took years, even decades. Under this system, there were cases where the patent would issue before final action at the FDA, but there were other cases where the FDA acted to approve a product before the patent was issued. Erosion was an issue, but it did not occur in many cases.

Since 1995 the term of a patent has been set at 20 years from the date of application for the patent. This means that the processing time by the PTO of the application all came while the term of the patent is running. This gives companies a profound incentive to rush the patent through the PTO. Under the old system, companies had the opposite incentive. With patents being issued earlier by the PTO, the issue of erosion of patent term due to delays at the FDA is becoming more serious and more common.

The provision in the legislation simply states that in the case of bioterrorism countermeasures, no erosion in the term of the patent will occur. The term of the patent at the date of FDA approval will be the same as the term of the patent when it was issued by the PTO. There is no extension of the patent, simply protections against erosion. Under the new 20 year term, patents might be more or less than 17 years depending on the processing time at the PTO, and all this legislation says is that whatever term is set by the PTO will govern irrespective of the delays at the FDA. This option is available to any company that successfully develops a countermeasure eligible to be purchased by the fund.

The second option, the bonus patent term, is only available to small companies with less than $750,000,000 in paid-in capital. It provides that a company that successfully develops a countermeasure is entitled to a two-year extension of any patent in its portfolio. This does not apply to any patent of another company bought or transferred in to the countermeasure research company.

I am well aware that this bonus patent term provision will be controversial with some. A company would tend to utilize this option if it owned the patent on a product that still had, or might have, market value at the end of the term of the patent. Because this option is only available to small biotechnology companies, most of whom have no product on the market, in most cases they would be speculating about the value of a product at the end of its patent. The company might apply this provision to a patent that otherwise would be eroded due to FDA delays or it might apply it to a patent that was not eroded. The result might be a patent term that is no longer than the patent term issued by the PTO. It all depends on which companies elect this option and which patent they select. In some cases, the effect of this provision might be to delay the entry onto the market of lower priced generics. This would tend to shift some of the cost of the incentive to develop a countermeasure to insurance companies and patients with an unrelated disease.

My rationale for including the patent bonus in the legislation is simple: I want this legislation to say emphatically that we mean business, we are serious, and we want biotechnology companies to reconfigure their research portfolios to focus in part on development of countermeasures. The other provisions in the legislation are powerful, but they may not be sufficient.

This proposal protects companies willing to take the risks of producing anti-terrorism products for the American public from potential losses incurred from lawsuits alleging adverse reactions to these products. It also preserves the right for plaintiffs to seek recourse for alleged adverse reactions in Federal District Court, with procedural and monetary limitations.

Under the plan, the Secretary of HHS is required to indemnify and defend entities engaged in qualified countermeasure research through execution of ``indemnification and defense agreements.'' This protection is only available for countermeasures purchased under the legislation or to use of such countermeasures as recommended by the Surgeon General in the event of a public health emergency.

The legislation contains a series of provisions designed to enhance countermeasure research.

The legislation provides for accelerated approval by the FDA of countermeasures developed under the legislation. In most cases, the products would clearly qualify for accelerated approval, but the legislation ensures that they will be reviewed under this process.

It provides a statutory basis for the FDA approving countermeasures where human clinical trials are not appropriate or ethical. Rules regarding such products have been promulgated by the FDA.

It grants a limited antitrust exemption for certain cooperative research and development of countermeasures.

It provides incentives for the construction of biologics manufacturing facilities and research to increase the efficiency of current biologics manufacturing facilities.

It enhances the synergy between our for-profit and not for profit biomedical research entities. The Bayh-Dole Act and Stevenson-Wydler Act form the legal framework for mutually beneficially partnerships between academia and industry. My legislation strengthens this synergy and these relationships with two provisions, one to upgrade the basic research infrastructure available to conduct research on countermeasures and the other to increase cooperation between the National Institutes of Health and private companies.

Research on countermeasures necessitates the use of special facilities where biological agents can be handled safely without exposing researchers and the public to danger. Very few academic institutions or private companies can justify or capitalize the construction of these special facilities. The Federal government can facilitate research and development of countermeasures by financing the construction of these facilities for use on a fee-for-service basis. The legislation authorizes appropriations for grants to non-profit and for-profit institutions to construct, maintain, and manage up to ten Biosafety Level 3-4 facilities, or their equivalent, in different regions of the country for use in research to develop countermeasures. BSL 3-4 facilities are ones used for research on indigenous, exotic or dangerous agents with potential for aerosol transmission of disease that may have serious or lethal consequences or where the agents pose high risk of life-threatening disease, aerosol-transmitted lab infections, or related agents with unknown risk of transmission. The Director of the Office and NIH shall issue regulations regarding the qualifications of the researchers who may utilize the facilities. Companies that have registered with and been certified by the Director--to develop countermeasures under Section 5 (d) of the legislation--shall

be given priority in the use of the facilities.

The legislation also reauthorizes a very successful NIH-industry partnership program launched in FY 2000 in Public Law 106-113. The funding is for partnership challenge grants to promote joint ventures between NIH and its grantees and for-profit biotechnology, pharmaceutical and medical device industries with regard to the development of countermeasures, as defined in Section 3 of the bill, and research tools, as defined in Section 4(d)(3) of the bill. Such grants shall be awarded on a one-for-one matching basis. So far the matching grants have focused on development of medicines to treat malaria, tuberculosis, emerging and resistant infections, and therapeutics for emerging threats. My proposal should be matched by reauthorization of the challenge grant program for these deadly diseases.

The legislation also sets incentives for the development of adjuvents to enhance the potency, and efficacy of antigens in responding to a biological agent.

It requires the new Department to issue annual reports on the effectiveness of this legislation and these incentives, and directs it to host an international conference each year on countermeasure research.

This legislation is carefully calibrated to provide incentives only where they are needed. This accounts for the choices in the legislation about which provisions are available to small biotechnology companies and large pharmaceutical companies.

The legislation makes choices. It sets the priorities. It provides a dose of incentives and seeks a response in the private sector. We are attempting here to do something that has not been done before. This is uncharted territory. And it also an urgent mission.

There may be cases where a countermeasure developed to treat a biological toxin or chemical agent will have applications beyond this use. A broad-spectrum antibiotic capable of treating many different biological agents may well have the capacity to treat naturally occurring diseases.

This same issue arises with the Orphan Drug Act, which provides both tax and FDA approval incentives for companies that develop medicines to treat rare diseases. In some cases these treatments can also be used for larger disease populations. There are few who object to this situation. We have come to the judgment that the urgency of this research is worth the possible additional benefits that might accrue to a company.

In the context of research to develop countermeasures, I do not consider it a problem that a company might find a broader commercial market for a countermeasure. Indeed, it may well be the combination of the incentives in this legislation and these broader markets that drives the successful development of a countermeasure. If our intense focus on developing countermeasures, and research tools, provides benefits for mankind going well beyond terror weapons, we should rejoice. If this research helps us to develop an effective vaccine or treatment for AIDS, we should give the company the Nobel Prize for Medicine. If we do not develop a vaccine or treatment for AIDS, we may see 100 million people die of AIDS. We also have 400 million people infected with malaria and more than a million annual deaths. Millions of children die of diarrhea, cholera and other deadly and disabling diseases. Countermeasures research may deepen our understanding of the immune system and speed development of treatments for cancer and autoimmune diseases. That is not the central purpose of this legislation, but it is an additional rationale for it.

The issue raised by my legislation is very simple: do we want the Federal government to fund and supervise much of the research to develop countermeasures or should we also provide incentives that make it possible for the private sector, at its own expense, and at its own risk, to undertake this research for good business reasons. The Frist- Kennedy law focuses effectively on direct Federal funding and coordination issues, but it does not include sufficient incentives for the private sector to undertake this research on its own initiative. That law and my legislation are perfectly complimentary. We need to enact both to ensure that we are prepared for bioterror attacks.

Mr. President, I ask unanimous consent that a summary of the bill be printed in the Record.

Mr. President, I rise today to introduce a bill to prevent unnecessary hardship for ranching families in the Sierra Nevada Mountains.

This summer, restrictions imposed for the Yosemite Toad and willow flycatcher will force about fifteen to thirty ranchers off the land that they have long used for grazing.

This bill requires the Forest Service to explore all the options available to avoid this outcome. For example, the bill makes it easier for the Forest Service to offer ranchers suitable alternative grazing land.

Besides alternative grazing arrangements, the Forest Service should look at fencing, active management of the cattle, and other options. If none of these alternatives are feasible, the bill provides relief for the most seriously affected ranchers.

The bill would allow ranchers to keep using 15 parcels of land during this calendar year where Yosemite Toad and willow flycatcher restrictions would otherwise make grazing unworkable. For many other ranches, where grazing and the species could coexist with some adjustments, environmental protections would fully remain in place.

I urge the Forest Service to quickly devise a long-term strategy to promote the coexistence of ranchers and the species. The Forest Service should work proactively with the Fish and Wildlife Service to establish a conservation plan for the species--with the goal of avoiding the need for any listing of it.

I believe that if the regulatory agencies collect better information on the Yosemite Toad and the willow flycatcher, we can find ways to protect the species without completely shutting down long-term ranching operations. I am committed to expediting these long-term solutions.

Mr. President, I rise to introduce the ``Unaccompanied Alien Child Protection Act of 2003,'' bipartisan legislation to reform the way the Federal Government treats unaccompanied alien children who are in Federal immigration custody. I am pleased to be joined by my colleagues, Senators Brownback, Voinovich, Kennedy, Cantwell, DeWine, Feingold, and Lautenberg in introducing this important measure.

Approximately 5,000 foreign-born children under the age of 18 enter the United States each year unaccompanied by parents or other legal guardians. These children are among the most vulnerable of the immigrant population.

Many have often entered the country under traumatic circumstances. They are young and alone, subject to abuse and exploitation. They are often unable to articulate their fears, their views, or testify to their needs as accurately as adults can.

Despite these facts, U.S. Immigration laws and policies have been developed and implemented without regard for their effect on children, particularly on unaccompanied alien children.

Under current immigration law, these children are forced to struggle through a system designed primarily for adults, even though they lack the capacity to understand nuances legal principles and procedures. Children who may very well be eligible for relief are often vulnerable to being deported back to the very life-threatening situations from which they fled--before they are even able to make their cases before the Department of Homeland Security or an immigration judge.

Prior to March 1, 2003, the Immigration Naturalization Service, INS, had responsibility for the care, custody, and treatment of unaccompanied alien children. Too often, the INS, fell short in fulfilling the protection side of these responsibilities.

The legislation that I am introducing today builds on Section 462 of Public Law 107-296, the ``Homeland Security Act of 2002'', which provided for the transfer of responsibility for the care

and placement of unaccompanied alien children from the now-abolished INS to the Office of Refugee Resettlement, ORR, within the Department of Health and Human Services. This provision was based on S. 121, comprehensive legislation relating to unaccompanied alien children that I introduced at the beginning of the 107th Congress.

With the enactment of the Homeland Security Act, we set into motion the centralization of responsibility for the care and custody of unaccompanied alien children in the Office of Refugee Resettlement. The first phase of this transfer of responsibility occurred on March 1, 2003. Once the transition is completed, we have finally resolved the conflict of interest inherent in the former system.

I am pleased that the provision transferring responsibility for the care and custody of unaccompanied alien children was contained in the Homeland Security Act. Its inclusion in the new law was an important first step in reforming the way unaccompanied alien children are treated. It was a key provision for two reasons: First, it will help ensure that the Secretary of Homeland Security is not burdened with policy issues unrelated to the threat of terrorism. The new Department has a huge and important mission and its attention should be focused on that mission. Second, it recognizes that the Federal Government has a special responsibility to protect these children who are in federal custody. The INS did not always live up that responsibility.

But, the transfer of authority to the ORR--by itself--is not enough to ensure that these children are properly treated. Congress now has a responsibilty to go beyond the simple transfer and set the priorities for ORR and its new jurisdiction over unaccompanied foreign-born minors.

A number of other important reforms that were contained in last year's S. 121 were left out of the Homeland Security Act. Enactment of these reforms will be crucial if we truly are to reform the manner in which these children are treated. As I mentioned, the Unaccompanied Alien Child Protection Act of 2003 builds on the Homeland Security Act in two ways: First, it would make a number of technical and conforming changes in law to bring about the smooth transfer of the INS's unaccompanied alien child-related functions to ORR. Second, it would make a number of more substantive reforms in law with respect the respect to the treatment of these children--reforms that are designed to ensure that such children are treated with fairness and compassion.

Other provisions include those that would keep children who are criminals or who pose a threat to national security under the custody of the Department of Homeland Security rather than transfer responsibility of them to the ORR.

I first became involved in this issue when I heard about a young 15- year old Chinese girl who stood before a U.S. immigration court facing deportation proceedings. She had found her way to the United States as a stowaway in a container ship captured off of Guam, hoping to escape the repression she had experienced in her home country.

She had been placed on a boat bound for the United States by her very own parents, fleeing China's rigid family planning laws, Under these laws, she was denied citizenship, education, and medical care. She came to this country alone and desperate.

And what did our immigration authorities do when they found her? The INS detained her in a juvenile jail in Portland, OR, for 8 months before her asylum hearing, and 4 months after she was granted asylum.

At her asylum hearing, the young girl stood before a judge, unrepresented by counsel, confused, and unable to understand the proceedings against her. She could not wipe away the tears from her face because her hands were chained to her waist. According to a lawyer who later came to represent her, ``her only crime was that her parents had put her on a boat so she could get a better life over here.''

While the young girl eventually received asylum in our country, she unnecessarily faced an ordeal no child should bear under our immigration system. This young Chinese girl represents only one of 5,000 foreign-born children who, without parents or legal guardians to protect them, are discovered in the United States each year in need of protection. This, is unacceptable treatment. We have a responsibility to do better than this.

Central throughout the Unaccompanied Alien Child Protection Act of 2003 are two concepts: 1. The United States Government has a fundamental responsibility to protect unaccompanied children in its custody; and 2. in all proceedings and actions, the government should have as a high priority protecting the interests of these children, most of whom are unable to understand the nature of the proceedings in which they are involved.

This bill would ensure that children who are apprehended by immigration authorities are treated humanely and appropriately by: ensuring that eligible unaccompanied alien children are promptly placed in the custody of Office of Refugee Resettlement after they are encountered by immigration officials; ensuring that the children have counsel to represent them in immigration proceedings and matters; authorizing the Director of ORR to provide guardians ad litem for the children to look after their interests; establishing clear guidelines and uniformity for detention alternatives such as shelter care, foster care, and other child custody arrangements; establishing minimum standards for detention and alternative settings that take into account the special needs of children; improving such children's access to existing options for permanent protection when U.S. immigration and child welfare authorities believe such protection is warranted; setting forth procedures that immigration officers should follow when apprehending unaccompanied alien children at the United states border or at United States ports of entry; establishing procedures to ensure that the true age of an alien who claims to be under the age of 18 is determined; ensuring that the Department of Homeland Security, rather than the Office of Refugee Resettlement, maintain custody over children who are either criminals or threats to national security; and establishing procedures to ensure that certain unaccompanied alien children from Mexico or Canada, encountered along the United States border, are returned to their homes, subject to formal agreements between the United States and those countries providing for their safe return without undue delay.

Without enactment of my legislation, none of these important parameters would be placed on the Office of Refugee Resettlement or the Department of Homeland Security.

This bill also includes provisions that provide for the safety of the significant number of unaccompanied alien children who are victims of smuggling or trafficking rings. For example, 2 years ago, Phanupong Khaisri, a 2-year old Thai child, was brought to the United States by two individuals falsely claiming to be his parents, but who were actually part of a major alien trafficking ring.

The INS was prepared to deport the child back to Thailand. It was not until Members of Congress and the local Thai community had intervened, however, that the INS decided to allow the child to remain in the United States until the agency could provide proper medical attention and determine what course of action would be in his best interest.

The Unaccompanied Alien Child Protection Act aims to prevent situations like this from recurring. Moreover, the legislation would ensure that children are released into safe and humane environments while awaiting a determination of their status when that is appropriate, and it would ensure that the children are protected from smugglers, traffickers, or others who might exploit them.

Further, it would require the ORR to take steps to ensure that unaccompanied alien children are protected from smugglers or others who may wish to do them harm, and authorizes reimbursement for State and local expenses associated with caring for unaccompanied alien children.

Children, even more than adults, have incredible difficulty understanding the complexities of the immigration system without the assistance of counsel. Despite this reality, most children in immigration custody are overlooked and unrepresented. Without legal representation, children are at risk of being returned to their home

countries where they may face further human rights abuses.

The Unaccompanied Alien Child Protection Act of 20032 would require that all unaccompanied alien children in Federal custody by reason of their immigration status have counsel to represent them in any immigration proceedings involving them. It would vest in the Director of ORR responsibility for ensuring that the children have counsel, and it would provide the Director power to establish an infrastructure for developing a system to recruit and support pro bono counsel who can represent these children without cost to them or to the government.

It provides, as a last resort, that counsel could be provided for the children at government expense, capping the fees that such counsel could charge in the event that the government pays for such counsel.

This bill would authorize, but not mandate, the Director of ORR to put into place a system of guardians ad litem who would help the court in determining the best interests of children in U.S. custody.

The vast majority of unaccompanied alien children have been forced to maneuver the immigration system without any representation or without any assistance. This is unacceptable. It results in many children participating in a system without any understanding of the process they are undergoing or the ramifications of their situation.

Under this section, the guardian ad litem would not be working ``for the child.'' Nor would he or she be working for the Department of Homeland Security. Instead, he or she would be an impartial observer reporting to the court and to the Office of Refugee Resettlement on what he or she thinks is in the best interest of the child.

The guardians ad litem system could be modeled after any of a number of systems already existing in juvenile courts throughout the American juvenile justice system. This system is not a novel legal concept, but one that is trusted and already in place in every state in proceedings involving juveniles.

Imagine the fear of a foreign-born child, in the United States alone without a parent or guardian. Imagine that child being thrust into a system she did not understand, given no legal aid, placed in jail that housed juveniles with serious criminal convictions. Mr. President, I find it hard to believe that our country would have allowed innocent children to be treated in such a manner.

That is why my colleagues and I are introducing this legislation today. The Unaccompanied Alien Child Protection Act of 2003 will help our country fulfill the special obligation to these children.

I am proud to have the support of the United States Conference of Catholic Bishops, the Women's Commission on Refugee Women and Children, the Lutheran Immigration and Refugee Service, the American Bar Association, the United National High Commissioner for Refugees, and many other organizations with whom I have worked closely to develop this legislation.

I urge my colleagues to join me by cosponsoring this important measure and ensuring that these reforms are finally enacted.

I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I rise today to offer legislation to provide lawful permanent residence status to Esidronio Arreola-Saucedo, Maria Elena Cobian Arreola, Nayely Bibiana Arreola, and Cindy Jael Arreola, Mexican nationals who live in the Fresno area of California.

Mr. and Mrs. Arreola have lived in he United States for nearly 20 years. They are the parents of Nayely and Cindy, who also stand to benefit from this legislation. The Arreolas also have three United States citizens children: Roberto, who is 11 year old; Daniel, who is 8; and Saray, their youngest daughter, who is six-years old. Today, Mr. and Mrs. Arreola, and her children face deportation.

The story of the Arreola family is quite compelling and I believe they merit Congress' special consideration for humanitarian relief. The Arreolas are in uncertain situation in part because of grievous errors committed by their previous counsel, who has since been disbarred. In fact, the attorney's conduct was so egregious that it compelled an immigration judge to write the Executive Office of Immigration Review seeking his disbarment for the legal detriment he caused his immigrant clients.

Mr. Arreola has lived in the United States since 1986. He was an agricultural migrant worker in the fields of California for several years, and as such would have been eligible for permanent residence through the Seasonal Agricultural Workers, SAW, program had he known that he could apply for it. Mrs. Arreola was living in the United States at the time she became pregnant with her daughter Cindy, but returned to Mexico to give birth to Cindy to avoid any problems with the Immigration and Naturalization Service. It is quite likely that the family would have qualified for cancellation of removal but for the conduct of their previous attorney.

Perhaps one of the most compelling reasons for permitting the family to remain in the United States is the devastating impact their deportation would have on their children: three of whom are U.S. citizens; the other two have lived in the United States virtually all of their lives. This country is the only the country they really know.

Nayely, the oldest child, is a junior in high school. She is an outstanding student with a 3.91 Grade Point Average who ranks fourth in her class of approximately 300 students. At her relatively young age, Nayely has demonstrated a strong commitment to the ideals of citizenship in her adopted country. She has worked hard to achieve her full potential both in her academic endeavors and through the service she provides her community.

Nayely is a member of Advancement Via Individual Determination, AVID, a college preparatory program in which students commit to determining their own futures through achieving a college degree. Nayely is also President of the key Club, a community service organization. She helps mentor freshmen and participates in several other student organizations in her school. Perhaps the greatest hardship to this family if she is forced to return to Mexico will be her lost opportunity to realize here dreams and further contribute to her community and to this country.

As the principal of her high school wrote, ``[s]he epitomizes what we seek to instill in all of our students. She has accepted the challenges and has made a commitment to better her future, to better her life, and to better herself through education.''

It is clear to me that Nayely feels a strong sense of responsibility for her community and country. By all indication, this is the case as well for all of the members of her fine family.

I understand that the Arreolas also have other family who are lawful permanent residents here in the United States. Mrs. Arreola also has three brothers who are U.S. citizens and Mr. Arreola has a sister who is a U.S. citizen. It is my understanding that they do not have any family to whom they might return in Mexico.

According to immigration authorities, this family has never had any problems with law enforcement. I am told that they have filed their taxes for every year from 1990 to the present. They have always worked hard to support themselves. As I previously mentioned, Mr. Arreola was previously employed as a farmworker, but now has his own business repairing electronics. His business has been successful enough to enable him to purchase a home for his family.

It seems so clear to me that this family has embraced the American dream and their continued presence in our country would do so much to enhance the values we hold dear. Enactment of the legislation I have introduced today will enable the Arreolas to continue to make significant contributions to their community and to the United States as well.

I ask unanimous consent that the letter of Xavier De La Torre, Principal of Granite Hills High School, as well as the numerous letters of support our office has received from members of the Porterville community be entered into the Record. I also ask unanimous consent that Nayely's essay entitled ``If I Could Change the World,'' which she wrote at age 15, be printed in the Record.

Mr. President, today I rise to introduce legislation to do what should have been done decades ago: fully ban asbestos in the United States. I am introducing the Ban Asbestos in America Act of 2003 to prohibit this known carcinogen from being used to manufacture products in this country. The bill also bans imports of asbestos products from other countries where asbestos is still legal. I am pleased that Senators Baucus, Boxer, Cantwell, Dayton, Jeffords and Leahy are original cosponsors of this important legislation.

The primary purpose of the Ban Asbestos in America Act of 2003 is to require the Environmental Protection Agency, EPA, to ban the substance within two years. Most people think that asbestos has already been banned. In fact, in 1989 EPA finalized regulations to phase out and ban the substance by 1997. But in 1991, the 5th Circuit Court of Appeals overturned EPA's ban, arguing that EPA did not ``first evaluate and then reject the less burdensome alternatives'' under the Toxic Substances Control Act. Unfortunately, the first Bush Administration did not appeal the decision to the Supreme Court. While new uses of asbestos were banned, existing ones were not.

As a result, it is still legal in 2003 to construct buildings in the United States with asbestos cement shingles and to treat them with asbestos roof coatings. It is still legal to construct new water systems using asbestos cement pipes imported from other countries. It is still legal for cars and trucks to be made and serviced with asbestos brake pads and clutch facings.

Asbestos is still not banned, and as a result, we're still using it. According to the U.S. Geological Survey, in 2001, businesses in this country consumed 26 million pounds of chrysotile asbestos to make roofing products, gaskets, friction materials and other products. Last month, my staff walked into a local home improvement store and bought off the shelf roofing sealants made with asbestos. In addition, we are still importing asbestos products from other countries, many of which have less stringent environmental and public health standards.

Everyone knows that asbestos is harmful. The term asbestos, like arsenic, lead, mercury or DDT, is synonymous with poison. Asbestos may well be the most regulated toxic substance that federal and state agencies have ever dealt with. At least eleven different Federal statutes address asbestos. The EPA, Occupational Safety and Health Administration, OSHA, Mine Safety and Health Administration and Consumer Product Safety Commission are only some of the Federal agencies tasked with implementing rules to protect workers and consumers from the dangers of this substance.

But the sheer volume of rules and regulations in place does not guarantee that public health and the environment are being adequately protected. We have significant evidence suggesting that because asbestos is still not banned, we're still not safe from its dangers. I'd like to highlight some of this evidence for my colleagues.

First, workers in this country are still being exposed to dangerous levels of asbestos. According to OSHA, ``An estimated 1.3 million employees in construction and general industry face significant asbestos exposure on the job. Heaviest exposures occur in the construction industry, particularly during the removal of asbestos during renovation or demolition. Employees are also likely to be exposed during the manufacture of asbestos products, such as textiles, friction products, insulation, and other building materials, and during automotive brake and clutch repair work.''

It is important to remember that there is no known safe threshold level of asbestos exposure. OSHA's permissible exposure limit of 0.1 fibers per cubic centimeter is based on technical measurement limitations. OSHA's limit assumes that workers exposed to this concentration have a lifetime exposure risk of 3 to 5 in 1,000 for cancer and 2 in 1,000 for asbestosis. This is a very high risk compared to the cancer risk levels that are considered acceptable for some environmental cleanups.

The extent to which workers are exposed to dangerous levels of asbestos is especially troublesome when one considers the frequency with which OSHA's standards are violated. On July 31, 2001, I chaired a Senate Health, Education, Labor and Pensions hearing on asbestos and workplace safety. At the hearing I learned from OSHA that since 1995, the agency had cited employers for violations of its asbestos standards 15,691 times. This is astounding given the known dangers of asbestos and the high risks of disease even when OSHA's exposure limit is being met.

As follow-up to the hearing, I asked OSHA to provide more information about asbestos-related violations. In an October 17, 2001 letter to me, Mr. John Henshaw, Assistant Secretary for Occupational Safety and Health, wrote that between fiscal year 1996 and fiscal year 2001, OSHA conducted a total of 190,971 inspections generating a total of 427,786 violations. Of these, 3,000 inspections and 15,691 violations involved asbestos. According to Mr. Henshaw, about 2 percent of inspections and 4 percent of violations were asbestos-related. In his letter to me, Mr. Henshaw wrote, ``OSHA does not consider any level to be an acceptable noncompliance level. We strive for 100 percent compliance.'' Despite OSHA's best intentions, workers are still being exposed to dangerous levels of asbestos.

It is also important to consider that the vast majority of workplaces where asbestos exposure occurs, such as construction jobs and auto repair shops, are not regularly inspected by OSHA. The Administration conducts inspections only in response to complaints or as a result of referrals from law enforcement or the media. Many more violations of the standard occur in the real world than are actually recorded by regulators. Many employees likely do not contact OSHA about potential asbestos exposure on the job because they think asbestos has been banned long ago and is no longer a problem.

But asbestos in the workplace is clearly still a problem. Recent news investigations provide more evidence that workers are being exposed to dangerous levels of this mineral. According to an article in the Seattle Post-Intelligencer on November 16, 2000, ``During the past three months, the P-I collected samples of dust from floors, work areas and tool bins in 31 brake-repair garages in Baltimore, Boston, Chicago, Denver, Richmond, Seattle, and Washington, D.C. Asbestos, almost exclusively chrysotile, which has been used for decades in brakes, was detected in 21 of the locations. The amount of asbestos in the dust ranged from 2.26 percent to 63.8 percent.''

When dust with these concentrations of asbestos in them is disturbed, airborne concentrations of asbestos occur that are well above OSHA's permissible exposure limit of 0.1 fiber per cubic centimeter. Under current OSHA regulations, if airborne asbestos concentrations exceed this level, employers must conduct air monitoring, take measures to reduce asbestos emissions, post warning signs and record concentrations of airborne asbestos. Workers are supposed to wear respirators and protective clothing and are required to undergo long term medical monitoring.

Now I recognize that much of the exposure to asbestos in the workplace comes from asbestos products installed years, and in many cases, decades ago. By one estimate, about 30 million tons of asbestos was used in this country between 1900 and 1980. Asbestos in place, in our buildings, schools and homes, will be with us for decades to come.

But given the known dangers of this mineral, why are we still using it? Why are we still adding it to products on purpose when there are perfectly acceptable substitutes? In retrospect, it is tragic that asbestos was so widely used during the 20th century, for the

economic and public health impacts have been disastrous. One very important step in overcoming the problems caused by asbestos is to stop adding to the problem--however incrementally--by continuing to use this dangerous mineral in products on purpose.

I'd like to point out some additional evidence supporting the need to ban asbestos in the United States and to raise awareness about this issue. Most of my colleagues are familiar with the tragedy in Libby, MT, where hundreds of workers and their families suffer from asbestos- related diseases caused by exposure to asbestos-tainted vermiculite.

For decades, the W.R. Grace mine in Libby supplied about 80 percent of the vermiculite used in this country. W.R. Grace very successfully marketed its product, without any warning labels, even though the company was well aware its product was contaminated with this known carcinogen. Asbestos-contaminated ore was shipped to more than 300 sites around the country for processing and use in industrial and consumer products. According to the EPA, 14 of these sites are so contaminated with asbestos that they still need to be cleaned up, even though the Libby mine closed in 1990. While this is a problem that came from a small mining town in Montana, the ramifications and consequences are clearly national in scope.

In addition, vermiculite from Libby is still around and is still a threat to public health. It is estimated that tens of millions of homes, schools and businesses contain insulation made with Libby vermiculite, known as Zonolite. A recent study conducted for EPA, entitled Asbestos Exposure Assessment for Vermiculite Attic Insulation, found that Zonolite in homes today contains up to 2 percent asbestos. This study included tests on Zonolite insulation from Seattle Public Utilities and from a home in Washington State. It found that when this insulation was disturbed, airborne concentrations of 3.3 asbestos fibers per cubic centimeters were measured. In other words, handling Zonolite asbestos can cause levels of asbestos in the air that significantly exceed OSHA's exposure limit for workers. Even more troubling, perhaps, the study found ``vermiculite that tests non-detect for asbestos by bulk analysis can still generate airborne asbestos concentrations when disturbed.'' When vermiculite without significant amounts of asbestos in bulk was disturbed, concentrations of asbestos in the air up to 0.5 fibers per cubic centimeters were detected. This means that even vermiculite with only trace amounts of asbestos in bulk can generate unhealthy concentrations of asbestos in the air.

Yesterday EPA launched a national consumer education campaign warning people not to disturb Zonolite attic insulation if they have it in their homes. The agency also warned people not to let their children play in attics with vermiculite for fear of asbestos exposure. EPA has developed a consumer education brochure and has created an asbestos hotline for people to call for more information. The Agency for Toxic Substances and Disease Registry and National Institute for Occupational Safety and Health have joined EPA in this education effort by creating materials to educate consumers and workers about the dangers of asbestos-contaminated vermiculite.

While we need to ensure that we are no longer adding asbestos to our products on purpose, we also need to ensure that asbestos in harmful concentrations isn't ending up in our consumer products by accident. I am glad EPA, ATSDR and NIOSH are now proactively reaching out to consumers and workers to warn them to stay away from vermiculite attic insulation. This is an important first step in dealing with just one aspect of the legacy created by W.R. Grace in Libby.

There is another important reason to ban asbestos that I would like to share with my colleagues. As I mentioned previously, the United States is still importing products that contain asbestos. Unfortunately, we do not have precise statistics on which products coming into this country contain the deadly mineral. The Department of Commerce's import database does not distinguish between asbestos- containing products and products containing asbestos substitutes. According to the U.S. International Trade Commission, in 2002 this country imported more than 44,000 tons of asbestos-cement products, some of which may have contained cellulose instead of asbestos.

With increased globalization and international trade, U.S. imports of asbestos containing consumer and industrial products will continue to rise--unless we prohibit these products from crossing our borders in the first place.

Although we do not have accurate numbers for the extent to which asbestos products are flowing across our borders, we do know that asbestos is being heavily marketed to developing countries. According to an August 2, 1999 USA Today article, ``As asbestos demand has plummeted in the industrialized world the past 25 years, it has soared in many developing nations and formerly communist countries. Its use in these countries is largely unregulated, haphazard and deadly.''

A more recent editorial in the Canadian Medical Association Journal compares the asbestos industry to the tobacco industry. The February 20, 2001 article by Doctors Joseph LaDou, Philip Landrigan, John C. Bailar III, Vito Foa and Arthur Frank reads:

``The commercial tactics of the asbestos industry are very similar to those of the tobacco industry. In the absence of international sanctions, losses resulting from reduced cigarette consumption in the developed countries are offset by heavy selling to developing nations. In a similar fashion, the developed world has responded to the asbestos health catastrophe with a progressive ban on the use of asbestos. In response, the asbestos industry is progressively transferring its commercial activities and the health hazards to the developing countries.''

Banning asbestos in the United States sends an important message to the rest of the world. The asbestos industry will no longer be able to justify its marketing to developing countries by pointing out that asbestos is still legal in the U.S., and therefore, it must be safe. More than 30 countries have already banned asbestos, and it is time for this country to follow suit. It is our moral responsibility as the world's strongest economy, the most powerful Nation and a leader in environmental protection and public health to ban this harmful substance.

That is why today I am introducing the Ban Asbestos in America Act. The legislation has five main parts. First, this bill protects public health by doing what the EPA tried to do 14 years ago: ban asbestos in the United States. The legislation requires EPA to ban it within two years of passage of the Act. As under the regulations EPA finalized in 1989, companies may file for an exemption to the ban if there is no substitute material available.

Second, the bill requires EPA to convene a Blue Ribbon Panel on asbestos policy and to have the National Academy of Sciences conduct an asbestos study. In response to the 2001 EPA Inspector General's report on Libby, Montana, the EPA promised to convene a Blue Ribbon Panel on asbestos and non-regulated fibers. But instead of convening a high level panel, EPA hired a non-profit organization, the Global Environment and Technology Foundation, to develop an asbestos policies focus group. Just yesterday EPA released GETF's Asbestos Strategies Report. I am very pleased that the Report recommends several aspects of the Ban Asbestos in America Act, including that Congress pass legislation to ban asbestos.

While the recommendations are certainly helpful in providing guidance to EPA, Congress and other federal agencies on the next steps to address asbestos, the GETF report does not replace a full fledged Blue Ribbon Panel. The Ban Asbestos in America Act codifies creation of a Blue Ribbon Panel as EPA first committed to in 2001. The panel will include participation from the Department of Labor and the Consumer Product Safety Commission. It will review the current laws and rules in place to protect workers and consumers, and make recommendations for improving protections within 2 years of passage of the Act.

In addition, the bill calls for EPA to have the NAS conduct a study on the current state of the science relating to the human health effects of exposure to asbestos and other durable fibers. The NAS study shall also include recommendations for a uniform system of asbestos exposure standards and for a uniform system to create protocols to

detect and measure asbestos. As I mentioned previously, asbestos is regulated under multiple statutes. There are different standards within EPA and across Federal agencies, and agencies rely on different protocols to identify the substance. The NAS shall be required to submit the study to EPA, other federal agencies and Congress within 18 months of passage of the Act.

Third, the legislation requires a survey to determine which products contain asbestos, either on purpose or as a contaminant. EPA will be required to conduct this review with input from the Department of Labor, the Consumer Product Safety Commission and the International Trade Commission.

The bill directs the EPA to conduct a survey on the status of asbestos-containing products, such as roofing materials, brake pads and gaskets, which contain asbestos on purpose. EPA must also study contaminant-asbestos products, such as some insulation and horticultural products, which contain asbestos as a contaminant of another substance. The study will examine how people use these products and the extent to which people are exposed to harmful levels of asbestos. The study must be finalized within 18 months to inform the Blue Ribbon Panel and the education campaign.

Fourth, based on the results of the study, EPA shall conduct a public education campaign to increase awareness of the dangers posed by asbestos-containing products and contaminant-asbestos products, including those in homes and workplaces. The agency shall give priority to those products posing the greatest risk, as determined by the study required by the bill. The education campaign must be conducted within 2 years of passage of the bill.

EPA and the Consumer Product Safety Commission shall still be required to conduct a national education campaign about vermiculite insulation within 6 months of passage of the Act. As many as 35 million homes and businesses may contain asbestos-contaminated insulation made with vermiculite from Libby. This requirement is still in the bill despite EPA's recent announcement of an education campaign about vermiculite attic insulation. This will ensure EPA's long-term commitment to educating the public.

Finally, the Ban Asbestos in America Act increases the federal commitment to finding new treatments for the terrible diseases caused by asbestos. At least 2,000 people per year die from mesothelioma, a deadly cancer of the lining of the lungs and internal organs caused by exposure to asbestos. The legislation would direct the head of NIH to ``expand, intensify and coordinate programs for the conduct and support of research on diseases caused by exposure to asbestos.'' The Centers for Disease Control would be required to create a National Mesothelioma Registry to improve tracking of the disease, which in many cases goes undiagnosed and thus unrecorded. In addition, the bill creates 10 mesothelioma treatment centers around the country to improve treatments for and awareness of this fatal cancer.

Our hope is that by continuing to work together, we will build support for the Ban Asbestos in America Act. If we can get this legislation passed, fewer people will be exposed to asbestos, fewer people will contract asbestos diseases in the first place, and those who already have asbestos diseases will receive treatments to prolong and improve quality of life. I urge my colleagues to support this important legislation.

In the meantime, we should do all we can to ensure that the rules in place to protect workers, consumers and schoolchildren from asbestos are followed and are strengthened if necessary. We also need to make sure that Federal agencies are given adequate resources to fully implement Congress' many mandates.

I ask unanimous consent that the text of the Ban Asbestos in America Act of 2003 be printed in the Record.

Mr. President, I rise today with my colleague, Ms. Snowe, to introduce the Fishing Quota Act of 2003, legislation to establish national criteria governing the use of individual fishing quota IFQ systems. Work began in earnest on this bipartisan bill in the Commerce Committee last spring, as the expiration of the national moratorium on the use of IFQs approached, and small boat fishermen voiced concerns that existing legislative criteria governing the use of IFQs would not offer sufficient protection to communities. I would like to thank Subcommittee Chair Snowe for her efforts to work with me and with other members of the Commerce Committee on this legislation, which draws from separate IFQ legislation that both Senator Snowe and I introduced beginning in the 106th Congress.

The IFQ moratorium established under the 1996 Sustainable Fisheries Act was set to expire September 30, 2000. Senator Snowe and I supported a 2-year extension of that moratorium to allow for hearings and full consultation with affected groups on the issues surrounding IFQs. Our discussions focused on the need to provide regional flexibility to use IFQs as a management tool, while providing national ``rules of the road.'' Such rules of the road would ensure IFQ systems developed after expiration of the moratorium are adopted with the support of the fishery, allocate quota fairly and equitably, address region-specific needs, further the conservation and management goals of the Magnuson- Stevens Act, prevent consolidation of quota, address the needs of small fishing communities, and recognize both the public nature of the resource and that issuance of an IFQ does not give rise to a compensable property right.

To develop such rules, we worked with fellow Commerce Committee members, including Senators Breaux, Lott, Boxer, Stevens, and Cantwell, consulted with interested groups, and obtained technical advice from the National Marine Fisheries Service. While New England has historically been opposed to IFQs, other regions are interested in utilizing IFQ programs in certain fisheries. I believe the resulting bill provides a balance between the need to provide national policy guidance that considers the concerns of communities and harvesters, but allows for development of IFQ systems, where appropriate, on a fishery- by-fishery basis. This preserves the balanced regional approach to fishery management that Congress intended in the Magnuson-Stevens Act. I also want to clarify that this bill does not authorize the establishment of ``processor quota,'' and relates only to issuance of harvester quota.

The bill Senator Snowe and I are introducing today sets forth a set of national criteria that councils wishing to adopt IFQs would follow. Importantly, this bill contains a provision that directs councils to consider the use of community or area-based approaches and strategies that would preserve the vitality of small fishing communities, including the allocation of quota to a fishing community. It also directs councils to consider use of other management measures, including those that would facilitate formation of fishery cooperative arrangements, taking account of the dependence of coastal communities on these fisheries.

This bill addresses many of the concerns raised by fishermen, and I understand the many concerns of small fisherman in New England regarding the use of IFQs. I believe this bill gives fishermen the power to decide whether to implement an IFQ program and ensures that those who do will operate under a fair system. First, no region could implement an IFQ system without approval of a two-thirds majority of eligible permit holders through a referendum process run by the Secretary of Commerce. In addition, any IFQ system developed under the legislation would have to meet a set of national criteria. These national criteria would include: (1) ensuring a fair and equitable initial allocation of quota, including the establishment of an appeals process for qualification and allocation decisions, taking into account present and historic participation in the fishery; (2) establishing limits necessary to prevent inequitable concentration of quota share; (3) preventing any person from acquiring an ``excessive share''; (4) considering allocation of a portion of the annual harvest specifically to small fishermen, skippers, crew members, fishing communities, or categories of vessels or gear types; and (5) providing for revocation of quota if the owner is no longer an active fisherman.

I also believe this bill responds to concerns that IFQ systems would undermine the national interest in conserving fishery resources held in the public trust. In order to respond to those concerns, the bill would: (1) specify that an IFQ is a permit under the Magnuson-Stevens Act and does not confer any right of compensation or any right, title or interest to any fish before it is harvested; (2) established that the quota expires after 10 years, unless extended by a fishery management plan; (3) require that the systems promote management measures to improve the conservation and management of the fishery, including reduction of bycatch; (4) provide for regular review and evaluation of the system, including specifying actions to be taken for any failure to meet the criteria; (5) require that the systems provide for effective enforcement, monitoring, and management, including use of observers; and (6) require that quota be revoked from individuals found to be subject to civil penalties under section 308 of the Magnuson- Stevens Act.

The bill also would require a 5-year recurring independent review of IFQ systems by the National Research Council, to: (1) evaluate the effectiveness of such systems and determine who the systems contribute to improved management, conservation and safety; (2) evaluate the social, economic and biological consequences of the systems, including economic impacts on fishing communities; (3) evaluate the costs of implementation; and (4) provide recommendations to ensure the systems meet Magnuson-Stevens Act requirements and the goals of the plans.

I believe this legislation provides guidelines for the use of IFQs that will help ensure the health of our marine fisheries. During the last reauthorization of the Magnuson-Stevens Act, our

Nation's fisheries were at a crossroads, and action was required to remedy our marine resource management problems, to preserve the way of life in our coastal communities, and to promote the sustainable use and conservation of our marine resources for future generations and for the economic good of the Nation. We must stay the course, and this bill will help us do just that. I remain committed to the goal of establishing biologically and economically sustainable fisheries so that fishing will continue to be an important part of the culture and economy of coastal communities throughout Massachusetts, as well as the economy of the Nation.

Mr. President, there are now nearly 200,000 American veterans today who are forced to wait at least 6 months for their first visit with a Department of Veterans Affairs physician. Despite having served their country and been promised health benefits, these veterans are receiving deferred and rationed health care because of chronic underfunding and bureaucratic red tape. It amounts to a broken promise with men and women who have served in our armed forces. To help ensure that our veterans receive the care they need and have been guaranteed, today I am pleased to introduce the Veterans' Prescription Drug Reform Act of 2003.

Veterans enrolled in the VA health care program are entitled to a prescription drug benefit. This is an essential benefit given the importance of pharmaceuticals in health care today. However, there's a bureaucratic catch: the benefit only applies to prescriptions written by a VA physician, and there are nearly 200,000 veterans who now wait 6 months or longer for their first visit with a VA physician. For those veterans in need of medicine and waiting months on end to see a VA physician, the benefit has little value.

The VA has reported to Congress that, while it has no exact figure, it estimates that tens of thousands of the veterans now on the waiting list are there primarily to access their prescription drug benefit. In many of these cases, veterans have already seen a private physician and have a prescription. But in order to use the VA pharmacy and receive their prescription benefit, these individuals must duplicate their health care visits and see a VA physician. This delays health care benefits for far too many veterans.

The Veterans' Prescription Drug Reform Act of 2003 would permit veterans already on the waiting list to fill a prescription written by a private physician at the VA pharmacy.

Specifically, the Veterans' Prescription Drug Reform Act of 2003 would give the Secretary of Veterans Affairs the authority to permit veterans on the waiting list for their first appointment with a VA physician at the date of enactment to use the VA pharmacy to fill prescriptions written by a private physician. It would also preserve the core healthcare mission of the VA by limiting this initiative only to those currently waiting for their first appointment. The proposal calls for a report to Congress in 1 year so that its potential expansion can be evaluated.

The Secretary of Veterans Affairs has told Congress that he would support such a proposal, and I look forward to working with Senator Harkin, who joins me in sponsoring this legislation, and my other colleagues in the Senate on this common-sense approach to reducing the lengthy wait-lines for veterans' healthcare.

I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I am pleased today to join with my colleagues, Senators Johnson and Smith, as well as the cosponsors of our legislation, Senators Akaka, Baucus, Bingaman, Cantwell, Daschle, Murray, and Stabenow in introducing the Native American Small Business Development Act.

As many of my colleagues are aware, last Congress the Committee on Small Business and Entrepreneurship unanimously passed nearly identical legislation, S. 2335, yet the bill was not taken up by the full Senate. Today, Senator Johnson, Senator Smith and I are reintroducing this bill because we recognize that there is an even a greater need for this legislation on tribal lands across the Nation. The economy continues to slump, access to capital is even more limited, and state funding for small business initiatives is being pulled back.

According to a report released by the U.S. Census Bureau, the ``three year average poverty rate for American Indians and Alaska Natives [from 1998-2000] was 25.9 percent. Higher than for any other race groups.'' With an unemployment rate well above the national average and household income at just three-quarters of the national average, Native American communities need a commitment from the Federal government that we will help them, particularly during these difficult economic times. To reaffirm this commitment, the Johnson-Kerry-Smith bill provides Native Americans the resources they need to take advantage of the opportunities of entrepreneurship.

Mr. President, this legislation bears the same name as legislation that recently passed the House, H.R. 1166, which was reintroduced by Congressman Tom Udall, a recognized leader in promoting the interests of American Indians. I would like to thank Congressman Udall for his work in stewarding the Native American Small Business Development Act through the House, this Congress and last, and for his assistance in working with Senators Johnson and Smith and me in drafting the Senate version of our legislation. And I would specifically like to thank Senator Smith for his continued support on this issue.

I would again like to thank the National Indian Business Association, the National Center for American Indian Enterprise Development, the Association of Small Business Development Centers, the Oregon Native American Business Entrepreneurial Network (ONABEN), Native American Management Services, Inc., and all of the tribes that met with us or provided information to help in the drafting of this legislation.

The Senate version of the Native American Small Business Development Act, while incorporating the heart of the Udall legislation, is more comprehensive and provides greater assistance to Native American communities. Senator Johnson, who serves on the Indian Affairs Committee, and I, as the lead Democrat on the Senate Committee on Small Business and Entrepreneurship, were able to combine the resources and experiences of our committees in developing this legislation.

Mr. President, our need to fashion a more comprehensive business assistance package for Native American small businesses stems in part from a growing lack of commitment from the Small Business Administration (SBA) to our Native American communities under this Administration.

While I applaud the Bush Administration for responding to congressional requests by including $1 million in the Administration's FY 2003 budget request for Native American outreach, I was disappointed that it did not seek the full level of $2.5 million requested in a letter I sent with my colleagues Senators Daschle, Wellstone, Johnson, Bingaman and Baucus. Our request specifically sought funding for the SBA's Tribal Business Information Center (TBIC) program, an initiative started and successfully operated under the Clinton Administration. The TBIC program was designed to address the unique conditions faced by American Indians when they seek to start or expand small businesses.

Mr. President, I am disappointed that the Administration has eliminated all funding for Native American outreach in FY2004. With an average unemployment rate on reservations as high as 43 percent, it is inconceivable that two years of outreach is sufficient to have met our shared goal of building sustainable economic opportunities in those communities.

Mr. President, I do not believe that anyone in this Congress would dispute that economic development in Indian Country has often been difficult to achieve and that one important way to help American Indians who live on reservations is to provide them with assistance to open and run their own small businesses. Helping Native Americans open and run small businesses not only instills a sense of pride in the owner and his or her community, it also provides much-needed job opportunities, as well as other economic benefits.

Although underfunded, the TBIC program has provided assistance to a number of small businesses on Indian reservations. TBICs have the support of the American Indian communities they serve because they provide desperately

needed, culturally tailored business development assistance in those communities. The Administration should be seeking to strengthen its commitment to programs that assist Native American communities. Unfortunately, the SBA cut off TBIC funding on March 31, 2002, and now 14 months later, has not met a request by a bipartisan group of Senators to begin the reprogramming process in order to keep the TBICs open.

The Native American Small Business Development Act will ensure that the SBA's programs to assist Native American communities cannot be dissolved by making the SBA's Office of Native American Affairs (ONAA) and its Assistant Administrator permanent. Our legislation would also create a statutory grant program, known as the Native American Development grant program, to assist Native Americans. It would also establish two pilot programs to try new means of assisting Native American communities and require Native American communities to be consulted regarding the future of SBA programs designed to assist them. In short, this legislation will ensure that our Native American communities receive the adequate assistance they need to help start and grow small businesses.

The ONAA will be responsible for helping Native Americans and Native American communities start, operate, and grow small businesses; develop management and technical skills; seek out Federal procurement opportunities; increase employment opportunities through the start and expansion of small business concerns; and increase their access to capital markets.

To be selected to serve as the Assistant Administrator for ONAA, a candidate must have knowledge of Native American cultures and experience providing culturally tailored small business development assistance to Native Americans. Under our legislation, the Assistant Administrator would be statutorily required to consult with Tribal Colleges and Tribal Governments, Alaska Native Corporations (ANC) and Native Hawaiian Organizations (NHO) when carrying out responsibilities under this legislation, which would give Native American communities a true voice within the SBA. The Assistant Administrator for ONAA would be responsible for administering the Native American Development program and the pilot programs created by the Native American Small Business Development Act.

The Native American Development program is designed to be the SBA's primary program for providing business development assistance to Native American communities. To offer this support, to the SBA will provide financial assistance in establish and keep Native American Business Centers (NABC) in operation. Financial assistance under the Native American Development program would be available to Tribal Governments and Tribal Colleges. Unlike the SBA's TBIC program, however, ANCs and NHOs would also be eligible for the grants.

NABCs would address the unique conditions faced by reservation-based American Indians, as well as Native Hawaiians and Native Alaskans, in their efforts to create, develop and expand small business concerns. Grant funding would be used by the NABCs to provide culturally tailored financial education assistance, management education assistance, and marketing education assistance.

The first pilot program under the legislation establishes a Native American development grant. This grant is modeled after the Udall legislation and is designed to bring the expertise of SBA's Small Business Development Centers (SBDC) to Native American Communities. Additionally, any private nonprofit organization, which has members of an Indian tribe comprising a majority of its board of governors or is an NHO or an ANC, may also apply for the grant. Nonprofits were included in the Senate version thanks to the thoughtful input of Senator Cantwell. Many American Indian communities in Washington state are served by an organization called ONABEN, which provides SBDC-like services to Native American communities in Washington, Oregon, Idaho, and California. Organizations like ONABEN, which also has the strong support of Senator Smith, should be encouraged to continue their good work assisting Native American communities, and including them in the grant program available to SBDCs was an important addition to the legislation.

Finally, our legislation establishes a second pilot program to try a unique experiment in Indian Country. Grant funding would be made available to establish American Indian Tribal Assistance Centers. These centers will consist of joint entitles, such as a partnership between an NABC, a Native American development center (which receive grants from the Department of Commerce) and possibly an SBDC. The purpose of this grant is to coordinate experts from various entities to provide culturally tailored business development assistance to prospective and current owners of small business concerns on or near Tribal Lands.

Mr. President, I would again like to thank Senators Johnson and Smith and all of the cosponsors of this important legislation to assist our Native American communities. I would also, again like to thank Congressman Udall for taking the lead in the House on providing critical assistance for small businesses in Native American communities. I would urge all of my colleagues to cosponsor this legislation to help us fulfill our commitment to Native American communities.

Mr. President, I have sought recognition to comment on legislation I am introducing today to provide a cost-of-living, COLA, adjustment for certain veterans' benefits programs. This COLA adjustment would affect payments made to nearly 3 million Department of Veterans Affairs, VA, beneficiaries, and would be reflected in beneficiary checks that are received in January 2004, and thereafter.

An annual cost-of-living adjustment in veterans benefits is an important tool which protects veterans' cash-transfer benefits against the corrosive effects of inflation. The principal programs affected by the adjustment would be compensation paid to disabled veterans, and dependency and indemnity compensation, DIC, payments made to the surviving spouses, minor children and other dependents of persons who died in service, or who died after service as a result of service- connected injuries or diseases.

The President's budget anticipates inflation to be at a two percent level at the close of this year as measured by the consumer price index, CPI, published by the Department of Labor's Bureau of Labor Statistics. If inflation is held to the 2 percent level, that will be the level of COLA adjustment under this legislation since it ties the increase directly to the CPI increase as measured by the Department of Labor. Whatever the CPI increase eventually turns out to be, however, veterans' and survivors' benefits payments must be protected by being increased by a like amount. The Congress already concurred with that judgment with the recent passage of the budget resolution; that resolution sets aside the funds necessary to finance the COLA increase envisioned by this legislation.

I ask my colleagues to support this vital legislation.

I yield the floor, and I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I have sought recognition to comment on legislation I have introduced today to further honor the sacrifices made by the family members of those who were killed or injured in service to our country. As we celebrate the victory won on the battlefield in Iraq, we must remember that the loss of American lives-- even a relative few--was a sobering price to pay.

The loss of life in service is most acutely felt by the spouses and children left behind. For them, we must make every effort--however inadequate that effort might be in comparison to the enormity of their loss--to recognize their needs. This bill attempts to do so by increasing educational assistance benefits for survivors, by providing additional dependency and indemnity compensation payments for

bereaved families, by authorizing a remarried spouse to be buried in a national cemetery with his or her deceased veteran-spouse, and by providing health, training and compensation benefits to children of certain veterans who served in or near the Korean demilitarized zone, DMZ, in the late 1960s, and who were born with Agent Orange-induced spina bifida.

The legislation I introduce today would increase the rate of monthly Survivors' and Dependents' Education Assistance, DEA, benefits from $680 to $985. DEA benefits are provided to the spouses and children of veterans who were killed, or profoundly wounded, in service. The increase I propose today would create parity between DEA benefits and veterans' educational assistance, Montgomery GI Bill, benefits. Such parity was recommended by a recent Department of Veterans Affairs, VA, program evaluation and is dictated by the common sense observation that college tuition is no less expensive for widows and orphans than it is for veterans.

Under this legislation, DEA-eligible survivors, like Montgomery GI Bill beneficiaries, would receive an aggregate of $35,460 worth of education benefits--$985 monthly for a total of 36 months. Thus, both veterans and survivors would have the resources necessary to meet the average cost of tuition, fees, and room and board at four-year, public institutions of higher learning. As was stated by VA's Deputy Secretary, Dr. Leo Mackay, at a Committee on Veterans Affairs hearing on June 28, 2001, VA ``believe[s] it is only fair that these benefits should be at the same level as those provided to veterans.'' VA estimates that a monthly benefit at that level will entice 90% of eligible persons to use the benefit.

This legislation would also put into effect a key policy recommendation made by a VA-contracted study examining the adequacy of survivors' Dependency and Indemnification Compensation, DIC, benefit. The 2001 study called for the DIC benefit--the basic rate of which is now set at $948 per month--to be increased by $250 per month during the 5-year period following the death of a veteran to further ease the transition of surviving spouses with dependent children. The contractor study based its recommendations on the reported income needs and expenses of DIC recipients; it found that spouses with children reported higher levels of unmet need than spouses without children-- even though spouses with dependent children already receive an additional $237 in monthly DIC benefits per child. In short, the contractor found that while widows with children are already afforded additional DIC benefits, they need more.

In July 2001, VA estimated that there were approximately 14,500 surviving spouses with dependent children. Reading the profiles of some of the young men and women who lost their lives in Iraq, I know that several spouses will, sadly, be added to that number. This provision of my bill is a small way to further recognize the needs of families based on an objective assessment of what those needs are.

Section four of this bill would codify a practice that VA routinely allows through a waiver process. Under current practice, when the remarried widow of a deceased veteran dies, her second husband must grant VA permission before VA will allow, under a waiver process, the widow to be buried in a national cemetery with her deceased veteran- husband. A woman, for example, who was married for 50 years to a World War II veteran and who remarries late in life after her first husband dies should not have to depend on a waiver process to ensure burial with her first husband. Remarried spouses whose second marriages end due to death or divorce have a statutory right to burial with their deceased veteran-spouse. The same statutory right should be afforded to remarried spouses who, though married at death, never lost their desire to be united with a prior spouse already at rest in a national cemetery.

Finally, my legislation would provide benefits to spina bifida children of veterans who served in or near the Korean DMZ between 1967 and 1969. Benefits would be provided on the same basis, and under the same rationale, as they are to children of Vietnam veterans who are born with spina bifida. In 1996, Congress authorized benefits for Vietnam children born with spina bifida based on evidence reported by the Institute of Medicine of an association between exposure to Agent Orange and the appearance of the birth defect spina bifida in a veteran's offspring. The same contaminant found in Agent Orange-- dioxin--was also used to clear brush in and near the Korean DMZ during the late 1960s. Indeed, veterans who served near the Korean DMZ during that time are already presumed by VA to have been exposed to herbicides, unless military records demonstrate otherwise, and they are, accordingly, already awarded compensation on a presumptive basis if they fall ill from conditions presumed by law to be presumptively service-connected for Vietnam veterans. VA, however, exercises no such latitude in addressing the needs of the children of Korean DMZ veterans born with spina bifida. It should--and this bill would direct VA to do so.

I first learned of this inequity from Mr. John Ruzalski, a resident of Hawley, PA. Mr. Ruzalski is a Korean DMZ veteran whose 27-year-old son suffers from spina bifida. I am grateful to Mr. Ruzalski for his service in Korea, and for bringing this matter to light, and am hopeful that the Congress can reward his vigilance on behalf of his son. Clearly, it makes no sense for VA to presume that Korean DMZ veterans should be treated like Vietnam veterans for purposes of compensating the veteran's service-related illnesses and yet treat their spina bifida children differently.

In summary, the provisions of this legislation will make a difference in the lives of those who fallen servicemembers loved even more than country--their families. I ask my colleagues for their support.

I ask unanimous consent that the text of this bill be printed in the Record.

Mr. President, as Chairman of the Committee on Veterans' Affairs, I have today introduced, at the request of the Secretary of Veterans Affairs, S.1133, the proposed ``Veterans Programs Improvement Act of 2003.'' The Secretary of Veterans Affairs has submitted this proposed legislation to the President of the Senate by letter dated April 25, 2003.

My introduction of this measure is in keeping with the policy which I have adopted of generally introducing--so that there will be specific bills to which my colleagues and others may direct their attention and comments--all Administration-proposed draft legislation referred to the Committee on Veterans' Affairs. Thus, I reserve the right to support or oppose the provisions of, as well as any amendment to, this legislation.

I ask unanimous consent that the text of the bill be printed in the Record, together with the transmittal letter and a section-by-section analysis which accompanied it.

Mr. President, as Chairman of the Committee on Veterans' Affairs, I have sought recognition today to introduce legislation that would restate, revise and update the Soldiers' and Sailors' Civil Relief Act of 1940, SSCRA.

The SSCRA, in summary, suspends some of the legal obligations incurred by military personnel prior to entry into the service so that they might give their full attention to military duty. As was stated by the Supreme Court in LeMaistre v. Leffers, 333 U.S. 1, 6, 1948, SSCRA is to be read ``with an eye friendly to those who dropped their

affairs to answer their country's call.'' With operations in Iraq now wrapping up, it is an appropriate time for a review of this World War II-vintage legislation to see how it might be modified to better address the needs of 21st Century servicemen and women.

I should mention at this point that I am aware that a bill to revise the SSCRA, H.R. 100, is currently pending in the House, and that my colleague from Georgia, Senator Zell Miller, has introduced companion legislation in the Senate as S. 792. My legislation is similar to H.R. 100 and S. 792, but it contains modifications and additions to those bills as suggested by reservists and their families, the Department of Defense, and by other groups. It is my intention to work with Senator Miller to craft legislation that incorporates the best features of the two bills.

This legislation would rename SSCRA the ``Servicemembers' Civil Relief Act'' to reflect that the Armed Forces are made up now of more than just soldiers and sailors, and keep in place the core protections that have been features of SSCRA for decades: stays of civil proceedings during a person's period of military service; an interest rate cap of 6 percent on debts incurred before active duty; protection from eviction and termination of pre-service residential leases; and legal residency protection. But it would also add several new provisions to this core.

Currently, the Higher Education Act of 1965 prohibits the SSCRA's 6 percent interest cap from applying to Federally-insured student loans. This bill would remove that prohibition. It would also require institutions of higher education to permit students who are called to active duty to return and complete classes at no additional cost.

In addition, SSCRA now precludes evictions from premises occupied by servicemembers having a monthly rent $1200 or less. This $1200 ceiling was set in 1991; it has not been adjusted since. This legislation would raise the rent ceiling to $1950 or the amount of a servicemember's basic allowance for housing, whichever is higher. It would thereby take post-1991 inflation into account, and avoid the need for frequent amendments to the law since housing allowances are adjusted annually based on housing costs in the area where the servicemember is assigned.

When the SSCRA was originally enacted in 1940, automobiles were not commonly leased. That, of course, has changed; many people now choose leasing as a way to finance their personal transportation needs. This legislation would protect servicemembers who have leased cars--just as it does those who had chosen the more traditional form of auto financing--in two ways. First, it would prohibit lessors, like purchase financers, from repossessing personal property for nonpayment or breach without court action. Second, it would allow servicemembers called to active duty to terminate automobile leases just as they can real property leases.

This bill also takes steps to offer some protection to professionals and small business owners who are called to active duty. It would include the practice of law among the ``professional services'' for which professional liability insurance obligations could be suspended subject to mandatory reinstatement. It would also authorize the Secretary of Defense to designate other professional callings that would be subject to these protections. And it would protect the assets of small business owners during military service if the servicemember is personally liable for trade or business debts.

Since 1940, the Soldiers' and Sailors' Civil Relief Act has provided important protections to the men and women who wear the uniform. But 60-plus years later, it is time for Congress to take a critical look at this law and revise it to reflect changes in our society since it was originally enacted. With the assistance of the Department of Defense, the National Guard Bureau, the Enlisted Association of the National Guard, and the Small Business Administration, the staff of the Committee on Veterans' Affairs, most notably Mr. David Goetz, the Committee's Associate Counsel, has undertaken the painstaking review that has yielded this rather extensive bill. It is my intention to seek further comment and then guide this important reform legislation to enactment.

I ask unanimous consent that the text of the bill be printed in the Record.