Stem Cell Research Enhancement Act of 2009

Mr. President, I rise today in support of S. 485, the Select Agent Program and Biosafety Improvement Act of 2009. Today, I reintroduced this important legislation with my friend Senator Ted Kennedy. We first introduced this bill in June 2008. I thank my colleague from Massachusetts for his partnership. I enjoyed working closely with him in the 109th Congress on the Pandemic and All-Hazards Preparedness Act, which was signed into law in December 2006. He continues to be one of the great leaders in the United States Senate, and I look forward to continuing to work with him to ensure our laws protect the American people from health threats of all kinds.

This bill will enhance our nation's biosecurity and improve the biosafety of our most secure laboratories. We must do everything we can to make sure that biological agents and toxins that could present a serious threat to public health are kept safe and secure in containment laboratories and out of the hands of terrorists.

In December 2008; 6 months after we introduced this legislation for the first time, the bipartisan Commission on the Prevention of WMD Proliferation and Terrorism reported it is ``more likely than not'' that a weapon of mass destruction will be used in a terrorist attack by the end of 2013. The Commission's report, World at Risk, found that terrorists are more likely to obtain and use a biological weapon than a nuclear weapon and, therefore, the U.S. government should make bioterrorism a higher priority. According to the report, ``Only by elevating the priority of the biological weapons threat will it be possible to bring about substantial improvements in global biosecurity.'' Many of the specific recommendations contained in that report are reflected in this legislation.

S. 485 achieves two overarching goals. First, it reauthorizes and improves the Select Agent Program. This program was created in the 1990s to control the transfer of certain dangerous biological agents and toxins that could be used for bioterrorism. The program expanded after the anthrax attacks in 2001; however, the authorization expired at the end of September 2007.

Second, the bill evaluates and enhances the safety and oversight of high containment laboratories. These laboratories are used by scientists to study select agents and other infectious materials. Labs are categorized

by their safety level. There are four levels, termed Biosafety Level-- BSL--1 through 4, with 4 being the highest level. The number of these labs has grown, both domestically and internationally, in the last several years.

The Select Agent Program is jointly administered by the U.S. Department of Health and Human Services HHS Centers for Disease Control and Prevention--CDC--and the U.S. Department of Agriculture's--USDA-- Animal and Plant Health Inspection Service--APHIS. The program was intended to prevent terrorism, and protect public and animal health and safety, while not hampering important life-saving research. This is an obvious struggle that requires careful consideration, particularly when science is rapidly advancing around the globe.

Under the USA PATRIOT Act, it is illegal to possess ``select agents'' for reasons other than legitimate research. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 further required laboratories and laboratory personnel to undergo background checks by the FBI prior to approval for possession of select agents. As of February 2009, there are 82 select agents, meaning the agents pose a severe threat to public or animal health and safety. Thirteen of these agents are found naturally in the United States. There are 336 entities and 10,463 individuals registered with the CDC to work with select agents and toxins, and 64 entities and 4,149 individuals registered with APHIS.

We take four key actions in S. 485 to strengthen the Select Agent Program.

First, our legislation reauthorizes the program through 2014 and calls for a comprehensive evaluation of the program. The review, to be conducted by the National Academy of Sciences, will look at the effects of the program on international scientific collaboration and domestic scientific advances. This is timely because the WMD Commission recently suggested the need for an interagency review of the Select Agent Program and its impact on biological security and legitimate scientific research. Historically, the United States has been an international leader in biosecurity. In fact, last year Canada proposed legislation to tighten safety and access to pathogens and toxins of concern for bioterrorism. Canada's legislation, which was reintroduced earlier this month, would establish a mandatory licensing system to track human pathogens, similar to our Select Agent Program. It also ensures compliance with the country's Laboratory Biosafety Guidelines across the country.

Second, the bill ensures a comprehensive list of select agents. Currently, CDC and APHIS develop a list of agents and toxins to which the program regulations apply. However, we believe some additional factors should be considered in revising the list. For example, scientific developments now make it possible to create agents from scratch or to modify them and make them more deadly. Highly infectious viruses or bacteria that are otherwise difficult to obtain can now be created by scientists using ``synthetic genomics.'' In addition, we now have more information from the Department of Homeland Security--DHS-- about the threat posed by certain bioterrorism agents.

In 2002, U.S. researchers assembled the first synthetic virus using the genome sequence for polio. Later, in 2005 scientists reconstructed the 1918 Pandemic Influenza virus. Then in January 2008, ``safe'' form of Ebola was created synthetically. While this ``safe'' Ebola can be used for legitimate research to develop drugs and vaccines to protect against it, a scientist could also change it back to its lethal form. Also, earlier this year, advancements in technology yielded the first synthetic bacterial genome.

We must consider these scientific advances, including genetically modified organisms and agents created synthetically, if we are to address all agents of concern. In addition, DHS's recent bioterrorism risk assessments provide new information for our assessment of biological threats. This information should also be considered when determining which agents and toxins should be regulated.

Next, the bill encourages sharing information with state officials to enable more effective emergency state planning. State health officials are currently not made aware of which agents are being studied within their state. This leaves medical responders, public health personnel, and animal health officials unprepared for a potential release, whether accidental or intentional.

Lastly, S. 485 clarifies the statutory definition of smallpox. The Intelligence and Terrorism Prevention Act of 2004 criminalized the use of variola virus, the agent that causes smallpox. The statutory definition of the virus includes agents that are 85 percent identical to the causative strain. Researchers are worried this could be interpreted to also include the safer strain used to develop the smallpox vaccine, as well as less harmful naturally occurring viruses. This sort of ambiguity could be detrimental to necessary medical countermeasure research and development. Our bill requires the Attorney General to issue guidance clarifying the interpretation of this definition.

In addition, in this legislation we take three key actions to evaluate and enhance the safety and oversight of high containment laboratories.

First, our bill evaluates existing oversight of BSL 3 and 4, or high containment, labs. The bill requires an assessment of whether current guidance on infrastructure, commissioning, operation, and maintenance of these labs is adequate. As I mentioned, the number of these labs is increasing around the globe. As these new facilities age, we need to make sure they are appropriately maintained. It is essential that laboratory workers and the public can be assured that these facilities are as safe as possible. If the guidance we currently have in place is not adequate, then we need to know how to improve it. In addition, the recent report by the WMD Commission called for HHS and DHS to lead an interagency effort to tighten government oversight of high-containment labs.

Second, the bill improves training for laboratory workers. The WMD Commission report also called for standard biosafety and biosecurity training for all personnel who work in high-containment labs and funding the development of such educational materials. As the number of laboratories and personnel increases, we must ensure workers are appropriately trained. Accidents and injuries in the lab, such as chemical burns and flask explosions, may result from improper use of equipment. Our bill develops a set of minimum standards for training laboratory personnel in biosafety and biosecurity, and encourages HHS and USDA to disseminate these training standards for voluntary use in other countries.

Finally, the bill establishes a voluntary Biological Laboratory Incident Reporting System. This system will encourage personnel to report biosafety and biosecurity incidents of concern and thereby allow us to learn from one another. Similar to the Aviation Safety Reporting System, which gathers information on aviation accidents, this system will help identify trends in biosafety and biosecurity incidents of concern and develop new protocols for safety and security improvements. Lab exposures to pathogens not on the select agent list will also be captured through this type of voluntary reporting system. The WMD Commission recommended promoting a culture of security awareness in the life sciences community and establishing whistleblower mechanisms within the life sciences community so that scientists can report their concerns about safety and security without risk of retaliation. We believe such a reporting system would help fulfill this recommendation.

In closing, I encourage my Senate colleagues to join Senator Kennedy and me as we work to improve our nation's biosecurity and biosafety systems by passing S. 485, the Select Agent and Biosafety Improvement Act of 2009. I want to thank the many researchers, scientists, and state health officials from across the country who shared with me and my staff their ideas, experiences, and recommendations. In this time of exciting scientific advances, we must ensure our laws and prevention programs are updated to reflect current conditions. In addition, we must remain vigilant in our efforts to protect the American people from bioterrorism. The Select Agent Program is an important part of ensuring the nation's safety and security, and I

look forward to working with my colleagues to reauthorize and improve the program.

Mr. President, I rise today to once again introduce legislation that would give our veterans, surviving spouses, and certain dependent children the option to buy dental insurance coverage through the Department of Veterans' Affairs, VA. My bill is based on a very successful program that has been in place since 1998 for military retirees and their families.

Under the TRICARE Retiree Dental Program, TRDP, military retirees are given the option to purchase dental coverage through the Department of Defense. Since the program started, over 1 million eligible participants have chosen to buy dental coverage through this plan, including over 56,000 in my home State of North Carolina. Those individuals have access to a network of about 112,000 dental plan providers across the Nation. Premiums range from $14 to $48 per month per person, depending on the region and type of dental plan selected. With this kind of success, it seems only fitting that we offer the same kind of benefit to our veterans.

VA runs the largest integrated health care system in the Nation. Although VA provides dental benefits to the 7.9 million veterans enrolled in the healthcare system, these benefits are either limited to a select group of people or can only be provided under very limited circumstances. For example, VA provides comprehensive dental care to veterans for 180 days after they leave service; who have service- related dental conditions; who are in nursing homes and require dental care; or who fall under other very strict guidelines.

My bill would supplement this limited coverage by giving veterans and survivors the option to purchase a more comprehensive dental plan. Of course, many veterans may have dental coverage through their employers or through an individual policy. My bill extends this dental plan option to all enrolled veterans.

As I mentioned, the bill is modeled after the successful program that is now offered to TRICARE retirees. Federal employees also have access to a similar benefit option for dental coverage. Like these other programs, this VA program would be entirely voluntary and provide needed coverage from a network of dental professionals in local communities.

This bill would not replace VA's dental services; it is just another option for those who want to have access to group insurance rates that they could not otherwise get on their own. This idea is like the 44 year relationship VA has with Prudential, who provides active duty servicemembers and veterans with group life insurance policies. The most important part of the relationship is that servicemembers and veterans get to reap the benefits of group rates and competition.

Mr. President, I rise to introduce--the ``Stem Cell Research Enhancement Act similar to legislation that I have sponsored in the last two Congresses with Senators Harkin, Hatch, Kennedy, Feinstein, and Smith.

I believe medical research should be pursued with all possible haste to cure the diseases and maladies affecting Americans. In my capacity as ranking member and at times chairman of the Labor, Health and Human Services, and Education Appropriations Subcommittee, I have backed up this belief by supporting increases in funding for the National Institutes of Health. I have said many times that the NIH is the crown jewel of the Federal Government--perhaps the only jewel of the Federal Government. When I came to the Senate in 1981, NIH spending totaled $3.6 billion. In fiscal year 2009, NIH will receive approximately $29 billion to fund its pursuit of lifesaving research. The successes realized by this investment in NIH have spawned revolutionary advances in our knowledge and treatment for diseases such as cancer, Alzheimer's disease, Parkinson's disease, mental illnesses, diabetes, osteoporosis, heart disease, ALS, and many others. It is clear to me that Congress's commitment to the NIH is paying off. This is the time to seize the scientific opportunities that lie before us and to ensure that all avenues of research toward cures--including stem cell research--are open for investigation.

I first learned of the potential of human embryonic stem cells in November of 1998 upon the announcement of the work by Dr. Jamie Thomson at the University of Wisconsin and Dr. John Gearhart at Johns Hopkins University. I took an immediate interest and held the first congressional hearing on the subject of stem cells on December 2, 1998. These cells have the ability to become any type of cell in the human body. Another way of saying this is that the cells are pluripotent. The consequences of this unique his legislation is property of stem cells are far reaching and are key to their potential use in therapies. Scientists and doctors with whom I have spoken--and that have since testified before the Labor-HHS Appropriations Subcommittee at 20 stem cell-related hearings--were excited by this discovery. They believed that these cells could be used to replace damaged or malfunctioning cells in patients with a wide range of diseases. This could lead to cures and treatments for maladies such as juvenile diabetes, Parkinson's disease, Alzheimer's disease, cardiovascular diseases, and spinal cord injury. In all, well over 100 million Americans could benefit from stem cell research.

Embryonic stem cells are derived from embryos that would otherwise have been discarded. During the course of in vitro fertilization, IVF, therapies, sperm, and several eggs are combined in a laboratory to create 4 to 16 embryos for a couple having difficulty becoming pregnant. The embryos grow in an incubator for 5 to 7 days until they contain approximately 100 cells. To maximize the chances of success, several embryos are implanted into the woman. The remaining embryos are frozen for future use. If the woman becomes pregnant after the first implantation, and does not want to have more pregnancies, the remaining frozen embryos are in excess of clinical need and can be donated for research. Embryonic stem cells are derived from these embryos. The stem cells form what are called ``lines'' and continue to divide indefinitely in a laboratory dish. In this way, the 21 lines currently available for Federal researchers were obtained from 21 embryos. The stem cells contained in these lines can then be made into almost any type of cell in the body--with the potential to replace cells damaged by disease or accident. At no point in the derivation process are the embryos or the derived cells implanted in a woman, which would be required for them to develop further. The process of deriving stem cell lines results in the disruption of the embryo and I know that this raises some concerns.

During the course of our hearings in this subject, we have learned that over 400,000 embryos are stored in fertility clinics around the country. If these frozen embryos were going to be used for in vitro fertilization, I would be the first to support it. In fact, I have included $2,000,000 in the HHS budget each year since 2002 to create and continue an embryo adoption awareness campaign. But the truth is that most of these embryos will be discarded. I believe that instead of just throwing these embryos away, they hold the key to curing and treating diseases that cause suffering for millions of people.

President Bush opened the door to stem cell research on August 9, 2001. His policy statement allowed limited Federal funding of human embryonic stem cell research for the first time. There is a real question as to whether the door is open sufficiently.

A key statement by the President related to the existence of approximately 60 eligible stem cell lines--then expanded to 78. In the intervening 5 years, it has become apparent that many of the lines cited are not really viable, robust, or available to federally funded researchers. The fact is there are only 21 lines now available for research. Perhaps, most fundamental is the issue of therapy. It was not addressed in the President's statement, but it came to light in the first weeks after the President's announcement that all of the stem cell lines have had nutrients from mouse feeder cells and bovine serum. Under FDA regulations, these lines will face intense regulatory hurdles before being useful in human therapies. In the intervening years, new technology has been developed so that mouse feeder cells are no longer necessary for the growth of stem cells. It only makes sense that our Nation's scientists should have access to the latest technology.

Since August 9, 2001, new facts have come to light and the technology has moved forward to the extent that the policy is holding back our scientists and physicians in their search for cures. I have a friend and constituent in Pittsburgh named Jim Cordy who suffers from Parkinson's. Whenever I see Jim, he carries an hourglass, to remind me that the sands of time are passing and that the days of his life are slipping away. That is a pretty emphatic message from the hourglass. So it seems to me that this is the kind of sense of urgency which ought to motivate Congress and the biomedical research community.

On March 19, 2007, Dr. Elias Zerhouni, President Bush's appointee to lead the National Institutes of Health, testified before the Senate Labor-HHS-Education Appropriations Subcommittee regarding the NIH budget and stem cells. At that time he stated, ``It is clear today that American science would be better served and the nation would be better served if we let our scientists have access to more cell lines . . . To sideline NIH in such an issue of importance, in my view, is shortsighted. I think it wouldn't serve the nation well in the long run.'' His testimony clearly shows that the time has come to move forward.

The Stem Cell Research Enhancement Act lifts the August 9, 2001, date restriction, thus making stem cell lines eligible for federally funded research regardless of the date on which they were derived. Expanding the number of stem cell lines would accelerate scientific progress towards cures and treatments for a wide range of diseases and debilitating health conditions. The bill puts in place strong ethical requirements on stem cell lines that are funded with Federal dollars. In fact, several stem cell lines currently funded with Federal dollars would not be eligible under the policies put in place by this bill. The requirements include: embryos used to derive stem cells were originally created for fertility treatment purposes and are in excess of clinical need; the individuals seeking fertility treatments for whom the embryos were created have determined that the embryos will not be implanted in a woman and will otherwise be discarded; the individuals for whom the

embryos were created have provided written consent for embryo donation; and the donors can not receive any financial or other inducements to make the donation.

When President Bush's Council on Bioethics reported on several theoretical methods for deriving stem cells without destroying embryos, I immediately scheduled a hearing to investigate these ideas. On July 12, 2005, the Labor-HHS Subcommittee heard testimony from five witnesses describing several theoretical techniques for deriving stem cells without destroying embryos. The stem cells would theoretically have the key ability to become any type of cell. The techniques discussed included single cell derivation of stem cells; altered nuclear transfer; deriving stem cells from so-called ``dead'' embryos; and, perhaps the most promising, turning adult cells back into stem cells.

Legislation, which I first introduced with Senator Rick Santorum in the 109th Congress, was meant to encourage these alternative methods for deriving stem cells without harming human embryos. That legislation has been incorporated into the current bill, which amends the Public Health Service Act by inserting a section that:

1, Mandates that the Secretary of Health & Human Services shall support meritorious peer-reviewed research to develop techniques for the derivation of stem cells without creating or destroying human embryos.

2, Requires the Secretary to issue guidelines within 90 days to implement this research and to identify and prioritize the next research steps.

3, Requires the Secretary to consider techniques outlined by the President's Council on Bioethics--such as altered nuclear transfer and single cell derivation.

4, Requires the Secretary to report yearly on the activities carried out under this authorization.

5, Includes a ``Rule of Construction'' stating: Nothing in this section shall be construed to affect any policy, guideline, or regulation regarding embryonic stem cell research, human cloning by somatic cell nuclear transfer, or any other research not specifically authorized by this section.

6, Define ``human embryo'' by reference to the latest definition contained in the appropriations act for the Department of Health & Human Services.

7, Authorizes ``such sums as may be necessary'' for fiscal year 2010 through 2012.

Knowing that scientists are never certain exactly which research will lead to the next great cure; I have always supported opening as many avenues of research as possible. Based on that line of reasoning, I have always supported human embryonic, adult, and cord blood stem cell research. My goal is to see cures for the various afflictions that lower the quality of life--or end the lives--of Americans. I believe this bill implements this philosophy by opening of embryonic stem cell research and encouraging alternatives.

Importantly, the bill does not allow Federal funds to be used for the derivation of stem cell lines--the step in the process where the embryo is destroyed. Also, the bill does not address the subject of cloning, which continues to be banned in the appropriations bills for Health & Human Services.

President Barack Obama has indicated that he will overturn the current restrictions. I feel it is important to codify this important policy change so that the policy does not ping-pong back and forth with each successive President. This uncertainty slows the progress of science. Young scientists rightly avoid fields of science for which funding may come and go due to political whim rather than scientific and medical merit. A temporary end to the current restrictions is an incomplete and ultimately self-defeating solution.

I strongly believe that the funding provided by Congress should be invested in the best research to address diseases based on medical need and scientific opportunity. Politics has no place in the equation. Throughout history there are numerous examples of politics stifling science in the name of ideology. Galileo was imprisoned for his theory that the planets revolve around the Sun. The Institute of Genetics of the Soviet Academy of Sciences opposed the use of hybrid varieties of wheat because it was based on the science of the West. Instead, they supported a doctrine called ``acquired characteristics,'' which was made the official Soviet position. This resulted in lower yields for Soviet wheat throughout the former Soviet Union in the first half of the 20th century. These historical examples teach us that we must make these decisions based on sound science, not politics. I urge this body to support the Stem Cell Research Enhancement Act so that this Congress does not look as foolish in hindsight as these examples.

Mr. President, I rise to introduce--the ``Stem Cell Research Enhancement Act similar to legislation that I have sponsored in the last two Congresses with Senators Harkin, Hatch, Kennedy, Feinstein, and Smith.

I believe medical research should be pursued with all possible haste to cure the diseases and maladies affecting Americans. In my capacity as ranking member and at times chairman of the Labor, Health and Human Services, and Education Appropriations Subcommittee, I have backed up this belief by supporting increases in funding for the National Institutes of Health. I have said many times that the NIH is the crown jewel of the Federal Government--perhaps the only jewel of the Federal Government. When I came to the Senate in 1981, NIH spending totaled $3.6 billion. In fiscal year 2009, NIH will receive approximately $29 billion to fund its pursuit of lifesaving research. The successes realized by this investment in NIH have spawned revolutionary advances in our knowledge and treatment for diseases such as cancer, Alzheimer's disease, Parkinson's disease, mental illnesses, diabetes, osteoporosis, heart disease, ALS, and many others. It is clear to me that Congress's commitment to the NIH is paying off. This is the time to seize the scientific opportunities that lie before us and to ensure that all avenues of research toward cures--including stem cell research--are open for investigation.

I first learned of the potential of human embryonic stem cells in November of 1998 upon the announcement of the work by Dr. Jamie Thomson at the University of Wisconsin and Dr. John Gearhart at Johns Hopkins University. I took an immediate interest and held the first congressional hearing on the subject of stem cells on December 2, 1998. These cells have the ability to become any type of cell in the human body. Another way of saying this is that the cells are pluripotent. The consequences of this unique his legislation is property of stem cells are far reaching and are key to their potential use in therapies. Scientists and doctors with whom I have spoken--and that have since testified before the Labor-HHS Appropriations Subcommittee at 20 stem cell-related hearings--were excited by this discovery. They believed that these cells could be used to replace damaged or malfunctioning cells in patients with a wide range of diseases. This could lead to cures and treatments for maladies such as juvenile diabetes, Parkinson's disease, Alzheimer's disease, cardiovascular diseases, and spinal cord injury. In all, well over 100 million Americans could benefit from stem cell research.

Embryonic stem cells are derived from embryos that would otherwise have been discarded. During the course of in vitro fertilization, IVF, therapies, sperm, and several eggs are combined in a laboratory to create 4 to 16 embryos for a couple having difficulty becoming pregnant. The embryos grow in an incubator for 5 to 7 days until they contain approximately 100 cells. To maximize the chances of success, several embryos are implanted into the woman. The remaining embryos are frozen for future use. If the woman becomes pregnant after the first implantation, and does not want to have more pregnancies, the remaining frozen embryos are in excess of clinical need and can be donated for research. Embryonic stem cells are derived from these embryos. The stem cells form what are called ``lines'' and continue to divide indefinitely in a laboratory dish. In this way, the 21 lines currently available for Federal researchers were obtained from 21 embryos. The stem cells contained in these lines can then be made into almost any type of cell in the body--with the potential to replace cells damaged by disease or accident. At no point in the derivation process are the embryos or the derived cells implanted in a woman, which would be required for them to develop further. The process of deriving stem cell lines results in the disruption of the embryo and I know that this raises some concerns.

During the course of our hearings in this subject, we have learned that over 400,000 embryos are stored in fertility clinics around the country. If these frozen embryos were going to be used for in vitro fertilization, I would be the first to support it. In fact, I have included $2,000,000 in the HHS budget each year since 2002 to create and continue an embryo adoption awareness campaign. But the truth is that most of these embryos will be discarded. I believe that instead of just throwing these embryos away, they hold the key to curing and treating diseases that cause suffering for millions of people.

President Bush opened the door to stem cell research on August 9, 2001. His policy statement allowed limited Federal funding of human embryonic stem cell research for the first time. There is a real question as to whether the door is open sufficiently.

A key statement by the President related to the existence of approximately 60 eligible stem cell lines--then expanded to 78. In the intervening 5 years, it has become apparent that many of the lines cited are not really viable, robust, or available to federally funded researchers. The fact is there are only 21 lines now available for research. Perhaps, most fundamental is the issue of therapy. It was not addressed in the President's statement, but it came to light in the first weeks after the President's announcement that all of the stem cell lines have had nutrients from mouse feeder cells and bovine serum. Under FDA regulations, these lines will face intense regulatory hurdles before being useful in human therapies. In the intervening years, new technology has been developed so that mouse feeder cells are no longer necessary for the growth of stem cells. It only makes sense that our Nation's scientists should have access to the latest technology.

Since August 9, 2001, new facts have come to light and the technology has moved forward to the extent that the policy is holding back our scientists and physicians in their search for cures. I have a friend and constituent in Pittsburgh named Jim Cordy who suffers from Parkinson's. Whenever I see Jim, he carries an hourglass, to remind me that the sands of time are passing and that the days of his life are slipping away. That is a pretty emphatic message from the hourglass. So it seems to me that this is the kind of sense of urgency which ought to motivate Congress and the biomedical research community.

On March 19, 2007, Dr. Elias Zerhouni, President Bush's appointee to lead the National Institutes of Health, testified before the Senate Labor-HHS-Education Appropriations Subcommittee regarding the NIH budget and stem cells. At that time he stated, ``It is clear today that American science would be better served and the nation would be better served if we let our scientists have access to more cell lines . . . To sideline NIH in such an issue of importance, in my view, is shortsighted. I think it wouldn't serve the nation well in the long run.'' His testimony clearly shows that the time has come to move forward.

The Stem Cell Research Enhancement Act lifts the August 9, 2001, date restriction, thus making stem cell lines eligible for federally funded research regardless of the date on which they were derived. Expanding the number of stem cell lines would accelerate scientific progress towards cures and treatments for a wide range of diseases and debilitating health conditions. The bill puts in place strong ethical requirements on stem cell lines that are funded with Federal dollars. In fact, several stem cell lines currently funded with Federal dollars would not be eligible under the policies put in place by this bill. The requirements include: embryos used to derive stem cells were originally created for fertility treatment purposes and are in excess of clinical need; the individuals seeking fertility treatments for whom the embryos were created have determined that the embryos will not be implanted in a woman and will otherwise be discarded; the individuals for whom the

embryos were created have provided written consent for embryo donation; and the donors can not receive any financial or other inducements to make the donation.

When President Bush's Council on Bioethics reported on several theoretical methods for deriving stem cells without destroying embryos, I immediately scheduled a hearing to investigate these ideas. On July 12, 2005, the Labor-HHS Subcommittee heard testimony from five witnesses describing several theoretical techniques for deriving stem cells without destroying embryos. The stem cells would theoretically have the key ability to become any type of cell. The techniques discussed included single cell derivation of stem cells; altered nuclear transfer; deriving stem cells from so-called ``dead'' embryos; and, perhaps the most promising, turning adult cells back into stem cells.

Legislation, which I first introduced with Senator Rick Santorum in the 109th Congress, was meant to encourage these alternative methods for deriving stem cells without harming human embryos. That legislation has been incorporated into the current bill, which amends the Public Health Service Act by inserting a section that:

1, Mandates that the Secretary of Health & Human Services shall support meritorious peer-reviewed research to develop techniques for the derivation of stem cells without creating or destroying human embryos.

2, Requires the Secretary to issue guidelines within 90 days to implement this research and to identify and prioritize the next research steps.

3, Requires the Secretary to consider techniques outlined by the President's Council on Bioethics--such as altered nuclear transfer and single cell derivation.

4, Requires the Secretary to report yearly on the activities carried out under this authorization.

5, Includes a ``Rule of Construction'' stating: Nothing in this section shall be construed to affect any policy, guideline, or regulation regarding embryonic stem cell research, human cloning by somatic cell nuclear transfer, or any other research not specifically authorized by this section.

6, Define ``human embryo'' by reference to the latest definition contained in the appropriations act for the Department of Health & Human Services.

7, Authorizes ``such sums as may be necessary'' for fiscal year 2010 through 2012.

Knowing that scientists are never certain exactly which research will lead to the next great cure; I have always supported opening as many avenues of research as possible. Based on that line of reasoning, I have always supported human embryonic, adult, and cord blood stem cell research. My goal is to see cures for the various afflictions that lower the quality of life--or end the lives--of Americans. I believe this bill implements this philosophy by opening of embryonic stem cell research and encouraging alternatives.

Importantly, the bill does not allow Federal funds to be used for the derivation of stem cell lines--the step in the process where the embryo is destroyed. Also, the bill does not address the subject of cloning, which continues to be banned in the appropriations bills for Health & Human Services.

President Barack Obama has indicated that he will overturn the current restrictions. I feel it is important to codify this important policy change so that the policy does not ping-pong back and forth with each successive President. This uncertainty slows the progress of science. Young scientists rightly avoid fields of science for which funding may come and go due to political whim rather than scientific and medical merit. A temporary end to the current restrictions is an incomplete and ultimately self-defeating solution.

I strongly believe that the funding provided by Congress should be invested in the best research to address diseases based on medical need and scientific opportunity. Politics has no place in the equation. Throughout history there are numerous examples of politics stifling science in the name of ideology. Galileo was imprisoned for his theory that the planets revolve around the Sun. The Institute of Genetics of the Soviet Academy of Sciences opposed the use of hybrid varieties of wheat because it was based on the science of the West. Instead, they supported a doctrine called ``acquired characteristics,'' which was made the official Soviet position. This resulted in lower yields for Soviet wheat throughout the former Soviet Union in the first half of the 20th century. These historical examples teach us that we must make these decisions based on sound science, not politics. I urge this body to support the Stem Cell Research Enhancement Act so that this Congress does not look as foolish in hindsight as these examples.

As we prepare to tackle the many challenges of our health care system, let's take the time to make sure that nursing schools are in a position to teach and train a new generation of nurses and nurse educators. Today, I am introducing the Nurse Education, Expansion, and Development (NEED) Act to provide schools of nursing with grants for faculty, equipment, and clinical laboratories. The proposed grants give colleges of nursing the flexibility to use federal funds to address the very problems that keep nursing schools from hiring more teachers today.

The healthcare crisis is complicated and the challenges are immense, but the runaway costs and inefficiencies in our health care system are no longer sustainable. So as we begin to look at healthcare reform in this Congress, let's keep in mind one lesson we learned from Massachusetts' recent experience. After a landmark healthcare reform law to extend healthcare coverage to every person in the State, the sudden demand for primary care professionals outpaced the supply.

Nurses can help fill that primary care gap. Today, nurse practitioners are already taking over at the helm of primary care in many areas that don't have any primary care physicians. Nurses are staffing health care clinics, and many are opening their own practices. Increased standards of training have opened new doors for nurses who want to further their careers but do not want to attend medical school. The numbers tell the story. In 2000 there were roughly 90,000 nurse practitioners in the U.S. By 2015, it is estimated there will be as many as 135,000.

Unfortunately, the number of nurses is not keeping pace with the growing health care needs of our Nation. In 2000, the U.S. Department of Health and Human Services found that the U.S. is 110,000 short of the number of nurses we need. By 2005, the shortage had doubled to 219,000. By 2020, it is expected we will be more than 1 million nurses short of the need.

Contributing to this shortage is a lack of faculty to teach and train future nurses. In a survey of more than 400 schools of nursing last year, the American Association of Colleges of Nursing found that 63 percent of the schools reported vacancies on their faculty. An additional 17.8 percent said

they were fully staffed, but still needed more faculty to handle the number of students who want to be trained. Last year, nursing colleges across the Nation denied admission to 49,948 qualified applicants because there were not enough faculty members to teach the students.

Statistics paint a bleak picture for the availability of nursing faculty now and into the future. The median age of a doctorally prepared nursing faculty member is 56 years old. The average age of retirement for faculty at schools of nursing is 65 years. It is expected that 200 to 300 doctorally prepared faculty will be eligible for retirement each year from 2005 through 2012, reducing faculty even though more than 1 million replacement nurses will be needed.

The number of qualified students turned away from nursing schools in Illinois reflects the national trend and continues to grow. In 2002- 2003, 502 qualified students were rejected from Illinois nursing schools. In 2008, 2,523 students were turned away because of lack of faculty and resources--over 1600 more students than in 2007. To avoid the vast shortage HHS is projecting, we have to figure out how to make a significant increase that we can sustain in the number of nurses graduating and entering the workforce each year.

My hope is that the bill I am introducing today can be part of the answer. Nursing schools need the resources to teach and train a new generation of nurses and nurse educators. Let's not take on health care reform without considering the more than 2.9 million nurses in our country today who are critical to our health care system. And as we look at improving our health care system, let's start by investing in the nursing pipeline today for the health care needs of tomorrow.

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

As the Congress tries to help Americans overcome the most serious economic crisis since the Great Depression, we face two urgent yet conflicting priorities. We have to increase demand for American products to resuscitate our economy. And we have to reduce the financial burden that our children will assume. We need to let consumers keep more of their own money without reducing the revenues that the government needs to pay for essential services.

In addition, we need to stop the reckless lending that brought us this economic disaster.

Today, I introduce the Protecting Consumers from Unreasonable Credit Rates Act to try to get at each of these goals. My bill sets a ceiling of 36 percent annualized interest rates on consumer credit.

Consumers spend approximately $27 billion every year on predatory payday loans, high-cost overdraft loans, and hugely expensive refund anticipation loans. Imagine if a portion of that $270 billion 10-year cost of credit could be redirected towards buying American goods and services. The Center for Responsible Lending estimates that a strong federal usury cap would save low-income borrowers $5 billion each year.

And, in an era that has called for trillions of taxpayer dollars to bail out banks and jumpstart economic demand, this proposal costs the taxpayers nothing.

The Protecting Consumers from Unreasonable Credit Rates Act would establish a new Federal annualized fee and interest rate calculation-- the FAIR--and institute a 36-percent cap for all types of consumer credit.

In 2006, Congress enacted a Federal 36 percent annualized usury cap for certain credit products marketed to military servicemembers and their families, which curbed payday, car title, and tax refund lending around military bases. My bill would expand on that premise to include all types of credit for all borrowers.

If a lender can't make money on 36 percent interest, then maybe the loan shouldn't be made.

Although I hope to gain widespread support for this bill from responsible lenders, I understand that some of the financial service firms in this country will be uneasy with a broad bill establishing a high interest rate cap. I hope this bill can open an honest conversation about consumer credit rates.

My opening question in that conversation is this: what services do you provide for which you can justify charging your customers more than 36 percent in annual interest?

Fifteen States and the District of Columbia have already enacted broadly applicable usury laws that protect borrowers from high-cost payday loans and many other forms of credit, while 34 States and the District of Columbia have limited annual interest rates to 36 percent or less for one or more types of consumer credit.

But there is a problem with this State-by-State approach. Those limits can sometimes be evaded by out-of-State lenders that are based in States that have weaker usury laws.

Various Federal and State loopholes allow unscrupulous lenders to charge cash-strapped consumers pay 400 percent annual interest for payday loans on average, 300 percent annual interest for car title loans, up to 3500 percent annual interest for bank overdraft loans, between 50 and 500 percent annual interest for loans secured by expected tax refunds, and higher than 50 percent annual interest for credit cards that charge junk fees.

Consider 66-year-old Rosa Mobley, who lives on Social Security and a small pension.

The Chicago Tribune reports that Ms. Mobley took out a car title loan--a type of payday loan in which the borrowers put up their cars as collateral--for $1,000. Ms. Mobley was charged 300 percent interest.

She wound up paying more than $4,000 over 28 months and at the time of the report was struggling just to get by.

This bill would require that all fees and finance changes be included in the new usury rate calculation and would require all lending to conform to the limit, thereby eliminating the many loopholes that have allowed these predatory practices to flourish.

It would not preempt stronger State laws, it would allow State attorneys general to help enforce this new rate cap, and it would provide for strong

civil penalties to deter lender violations.

I included in this bill the flexibility for responsible lenders to replace payday loans that some borrowers once relied on with reasonably priced, small-dollar loan alternatives. The bill allows lenders to exceed the 36 percent usury cap for one-time application fees that cover the costs of setting up a new customer account and for processing costs such as late charges and insufficient funds fees.

The Protecting Consumers from Unreasonable Credit Rates Act would eliminate predatory lenders, but it also would help borrowers make smarter choices.

Congress established the Truth in Lending Act over 40 years ago to help consumers compare the costs of borrowing when buying a home, a car, or other items by establishing a standard Annual Percentage Rate that all lenders should advertise.

My first mentor in politics, the late Senator Paul Douglas from my home State of Illinois, said all the way back in 1963 that too often lenders:

compound the camouflaging of credit by loading on all sorts

of extraneous fees, such as exorbitant fees for credit life

insurance, excessive fees for credit investigation, and all

sorts of loan processing fees which rightfully should be

included in the percentage rate statement so that any

percentage rate quoted is meaningless and deceptive.

That was before anyone had ever heard of ``subprime lending.''

Unfortunately, as the use of credit has exploded and as the complexity of the credit products offered by lenders has become mind- boggling, Congress and the Federal Reserve have taken several actions since the passage of Truth in Lending to weaken the APR as a tool for comparison shopping. Today, many fees can be excluded from the rate that is given to borrowers. The APR no longer gives consumers the convenient and accurate information it once did. One payday lender in Pennsylvania used the various exclusions to disclose what was really a 400 percent APR as 6 percent.

This bill would give consumers a way to accurate compare credit options, by requiring that the new FAIR calculation be disclosed both for open-end credit plans such as credit cards and for closed-end credit such as mortgages and payday loans.

The bill is supported by 100 groups at the national and local levels, including the Consumer Federation of American, the National Consumer Law Center, the Center for Responsible Lending, USPIRG, and Consumers Union, and I include a copy of their letter of support for the Congressional Record.

As Congress considers some very complicated economic challenges, I urge my colleagues to also consider simple solutions. We can help give more money to American consumers today without borrowing money that must be repaid tomorrow. Let's start by eliminating some of the worst abuses in lending by establishing a reasonable fee and interest rate cap.

I urge my colleagues to support the Protecting Consumers from Unreasonable Credit Rates Act.

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

Madam President, I think everybody recognizes that our current health care system is in very serious crisis. We have 46 million Americans who lack any health insurance. We have even more than that who are underinsured. The cost of health care is soaring. And we end up spending twice as much per person on health care as do the people of any other nation, despite having so many people uninsured and underinsured.

While a lot of the discussion regarding the health care crisis focuses on insurance coverage, there is another crisis equally severe that we do not talk enough about; that is, the crisis in access to doctors and dentists--in fact, the crisis in terms of primary health care.

The truth is that in our country today, we have some 56 million Americans, including Americans who have health insurance, who simply cannot find a doctor and, even more, cannot find a nurse. The absurdity of that is that when somebody cannot find a doctor, that person will end up going to the emergency room at great cost to our Nation or, equally likely, that person may not go to the doctor at all, gets sick, and ends up in the hospital, and we are spending tens of thousands of dollars treating that person when we could have spent far less if that man, woman, or child had access to a doctor when the illness first developed.

I am very gratified, and I thank President Obama, I thank Senator Inouye and Senator Harkin, Congressman Obey, the Democratic leadership in the House for taking this Nation a giant step forward in terms of addressing the crisis in primary health care in the stimulus package.

What happened in the stimulus package is that $2 billion was allocated for community health centers, to help those community health centers expand, to help in the growth of new community health centers. On top of that, another $300 million was appropriated for the National Health Service Corps. The National Health Service Corps is one of the important health programs we have in this country because it provides debt forgiveness and scholarships for young physicians so they can go out and serve in underserved areas.

Many medical school graduates are leaving school $100,000, $150,000 in debt, and they have no choice but to end up becoming specialists, making a whole lot of money in order to pay back those debts. What we have done in the stimulus package is almost triple the amount of money going into the National Health Service Corps, which means that we are going to be able to enable thousands of young physicians and dentists to go out and work in underserved areas, which is a huge step forward for primary health care. That was a very important part of the stimulus package.

In fact, on top of all of that, this sum of money is going to create 44,000 sustainable jobs as we create a primary health care infrastructure and as we provide health care to an additional 4 million Americans.

As significant as what we did in the stimulus package is, it is only a downpayment for what we have to do to address the crisis in terms of primary health care. Therefore, I am very proud to announce that today I introduced, along with 21 of my Senate colleagues--and they are in alphabetical order--Senators Begich, Bingaman, Boxer, Brown, Burris, Cardin, Casey, Durbin, Harkin, Inouye, Kennedy, Kerry, Johnson, Leahy, Menendez, Merkley, Mikulski, Schumer, Stabenow, Tester, and Wyden--all of those Senators join with me in new legislation which, in fact, is going to revolutionize primary health care in America.

Also today, the majority whip in the House, Jim Clyburn of South Carolina, introduced a similar bill which I believe has 78 cosponsors. That legislation is called the Access for All America Act. Its goal is to significantly expand community health centers all over this country, as well as the National Health Service Corps.

The community health center concept was developed by Senator Ted Kennedy over 40 years ago. The truth is that the concept of community health centers has been long supported in a bipartisan manner. President Bush was supportive of the concept. Senator McCain certainly mentioned it in his campaign for President, and Senator Hatch--many Republicans have supported it, as well as many people on our side of the aisle.

The reason for that bipartisan support is that everybody here understands that community health centers provide quality health care in a cost-effective manner. What community health centers do is provide comprehensive health care in terms of access to doctors and dentists. I point out that there is a major dental crisis all over this country. Community health centers by law have to provide mental health counseling. On top of that, community health centers provide the lowest cost of prescription drugs in the United States of America.

Today, there are approximately 1,100 community health centers all over America. In my State of Vermont, we have gone from 2 to 7 in the last 5 years, and they are now providing health care to over 80,000 Vermonters.

We have 1,100 in this country today. What this legislation will do is go from 1,100 community health centers to 4,800 community health centers, quadrupling the number of health centers in America. By doing that, we will provide comprehensive, high-quality primary health care in every underserved area in this country--a giant step forward in terms of making primary health care accessible to every man, woman, and child in this Nation.

In my view, we need to move toward a national health care program which guarantees health care for all people, but we can take this important step forward in terms of primary health care quite soon.

Here is one of the very wonderful aspects of what this legislation does. Right now, we spend about $2.1 billion a year for community health centers. This legislation, over a 5-year period, will take that number up to $8 billion. It will go from $2 billion to $8 billion as we quadruple the number of community health centers.

What study after study suggests is that in fact this investment will end up saving us money. This investment in primary health care will save us money because those people who get sick will now be able to go to a community health center--perhaps the most cost-effective primary health care in America--rather than walking into an emergency room, which is one of the most expensive health care providers in the country. In addition, when people have access to health care and get treatment when they need it, they are not going to get very sick and end up in a hospital, where it will cost tens of thousands of dollars to deal with their illness.

So what this legislation does is quadruple the number of community health centers, and it very substantially increases the amount of money that goes to the National Health Service Corps so we can provide debt relief and scholarships to young physicians who will then go out and serve us in underserved areas.

In my view, this legislation, if passed--and I think we have a good chance to pass it because there is a whole lot of bipartisan support here in the Senate for this concept, a lot of support in the House as well--will revolutionize primary health care in America. It will bring us to the day when virtually every American will have access to a doctor, a dentist, mental health counseling, and low-cost prescription drugs. It will enable us to produce the doctors, the dentists, the nurses, and the other health care providers we desperately need to get out

into rural, urban America, and underserved areas. It will be a major step forward in providing the primary health care infrastructure we need as we in fact move to a national health care program.

This is important legislation, and I thank all of the 21 Members of the Senate who have already come on as original cosponsors. We hope that many more will come on in the coming weeks and months. My hope is we can get this bill out of committee and see it passed as a stand- alone piece of legislation.

Mr. President, I yield the floor, and I suggest the absence of a quorum.