Nanotechnology Regulatory Science Act of 2011

Mr. President, today I am proud to introduce the Water Infrastructure Resiliency and Sustainability Act of 2011 along with my colleagues, Majority Leader Reid and Senator Boxer. This legislation will allow local communities to improve their water infrastructure in the face of changing hydrological conditions.

Improving our water infrastructure is a major challenge to my constituents living in Maryland and to all Americans. It is no secret that America's current water infrastructure systems are in poor condition. Our water and wastewater systems have been given a D-, the lowest possible grade. In the United States, close to 250,000 water mains wasting 1.7 trillion gallons of water break each year.

Unfortunately, Marylanders have experienced this crisis first hand. In July of this year, a water main break in Cumberland, Maryland, caused close to $300,000 in damage to a local, family-owned business. Last January, a Prince George's County water main break shut down a portion of the Capital Beltway, closed local businesses and schools, and required 400,000 residents to boil their drinking water to ensure its safety.

The EPA has estimated that traditional necessary repairs and replacement costs over the next twenty years will cost over $600 billion.

We, as a Congress, have stepped up in the past to assist communities in fixing aging water infrastructure systems. The Safe Water Drinking Act Amendments of 1996 established the Drinking Water State Revolving Fund. The fund helps public water systems finance infrastructure projects needed to comply with Federal safe drinking water regulations.

But we need to do more. EPA Administrator Lisa Jackson told Congress that adapting to changing hydrological conditions is a ``significant issue'' that water and waste water systems must address soon. These hydrological changes will likely result in ``too little water in some places, too much water in other places, and degraded water quality'' in other areas across the country.

According to a recent study by the National Association of Clean Water Agencies and the Association of Metropolitan Water Agencies, the costs in dealing with this new recognized problem could approach $1 trillion through 2050.

The Water Infrastructure Resiliency and Sustainability Act aims to help local communities meet the challenges of upgrading water infrastructure systems to meet these hydrological changes. The bill directs the EPA to establish a Water Infrastructure Resiliency and Sustainability, WIRS, program. Grants will be awarded to eligible water systems to make the necessary upgrades. Communities across the country will be able to compete for federal matching funds, funds which in turn will help finance projects to help communities overcome these threats.

Improving water conservation, adjustments to current infrastructure systems, and funding programs to stabilize communities' existing water supply are all projects WIRS grants will fund. WIRS will never grant more than 50 percent of any project's cost, ensuring cooperation between local communities and the federal government. The EPA will try to award funds that use new and innovative ideas as often as possible.

A healthy water infrastructure is as important to America's economy as paved roads and sturdy bridges. Water and wastewater investment has been shown to spur economic growth. The U.S. Conference of Mayors has found that for every dollar invested in water infrastructure, the Gross Domestic Product is increased to more than $6. The Department of Commerce has found that that same dollar yields close to $3 worth of economic output in other industries. Every job created in local water and sewer industries creates close to four jobs elsewhere in the national economy.

This legislation would create jobs throughout the economy today, while helping water and wastewater systems make improvements to keep water clean and safe for tomorrow. I believe that by investing in water infrastructure, we can make progress for the American people on both jobs and clean, safe water.

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

Mr. President, today I am introducing legislation in the Senate that would prohibit the use of racial profiling by Federal, State, or local law enforcement agencies. The End Racial Profiling Act, ERPA, had been introduced in previous Congresses by former Senator Russ Feingold of Wisconsin and I am proud to follow his example. I want to thank Senators Blumenthal, Durbin, Gillibrand, Kerry, Lautenberg, Levin, Menendez, Mikulski, and Stabenow for joining me as original co- sponsors of this legislation.

Racial profiling is ineffective. The more resources that are spent investigating individuals solely because of their race or religion, the fewer resources are being directed at suspects actually demonstrating illegal behavior. Former DHS Secretary Michael Chertoff stated in response to questions about the December 2001 bomb attempt by Richard Reid that ``the problem is that the profile many people think they have of what a terrorist is doesn't fit the reality . . . and in fact, one of the things the enemy does is to deliberately recruit people who are Western in background or in appearance, so that they can slip by people who might be stereotyping.''

Racial profiling diverts scarce resources from real law enforcement. In my own state of Maryland, in the 1990's, the ACLU brought a class- action lawsuit against the Maryland State Police for illegally targeting African-American motorists for stops and searches along Maryland's highways. The parties ultimately entered into a federal court consent decree in 2003 in which they made a joint statement that emphasized in part ``the need to treat motorists of all races with respect, dignity, and fairness under the

law is fundamental to good police work and a just society. The parties agree that racial profiling is unlawful and undermines public safety by alienating communities ``

Racial profiling demonizes entire communities and perpetuates negative stereotypes based on an individual's race, ethnicity, or religion. Earlier this year, I spoke out on the Senate floor and in the Senate Judiciary Committee to share my thoughts on the hearings held in the House of Representatives entitled ``The Extent of Radicalization in the American Muslim Community and that Community's Response'' chaired by Congressman Peter King. This hearing served only to fan flames of fear and division. This spectacle crossed the line and chipped away at the religious freedoms and civil liberties we hold so dearly. Radicalization may be the appropriate subject of a Congressional hearing but not when it is limited to one religion. When that is done, it sends the wrong message to the public and casts a religion with unfounded suspicions.

I agree with Attorney General Holder's remarks to the American-Arab Anti-Discrimination Committee, where he stated that ``in this nation, security and liberty are--at their best--partners, not enemies, in ensuring safety and opportunity for all . . . I've spoken to Arab- Americans who feel that they have not been afforded the full rights-- or, just as important, the full responsibilities--of their citizenship. They tell me that, too often, it feels like `us versus them.' That is intolerable . . . In this Nation, the document that sets forth the supreme law of the land--the Constitution--is meant to empower, not exclude . . . Racial profiling is wrong. It can leave a lasting scar on communities and individuals. And it is, quite simply, bad policing-- whatever city, whatever state.''

Using racial profiling makes it less likely that certain affected communities will voluntarily cooperate with law enforcement and community policing efforts. Minorities living and working in these communities may also feel discouraged from travelling freely, and it corrodes the public's trust in government.

The bill I am introducing today, the End Racial Profiling Act, would build on Department of Justice's current ``Guidance Regarding the Use of Race by Federal Law Enforcement Agencies'' issued in 2003. This official DOJ guidance certainly was a step forward, but it does not have adequate provisions for data collection and enforcement for state and local agencies. The DOJ guidance also does not have the force of law.

ERPA would prohibit the use of racial profiling by Federal, State, or local law enforcement agencies. The bill clearly defines racial profiling to include race, ethnicity, national origin, or religion as protected classes. It requires training of law enforcement officers to ensure that they understand the law and its prohibitions. It creates procedures for receiving, investigating, and resolving complaints about racial profiling. It would apply equally to Federal, State, and local law enforcement, which creates consistent standards at all levels of government.

The vast majority of our law enforcement officials that put their lives on the line every day handle their jobs with professionalism, diligence, and fidelity to the rule of law. However, Congress and the Justice Department can still take further steps to prohibit racial profiling and root out its use. I look forward to working with my colleagues to enact this legislation.

Mr. President, I rise today to introduce the Safeguarding American Agriculture Act of 2011, with Senator Feinstein.

With the recent ten-year anniversary of the September 11 terrorist attacks, it is appropriate to reflect on the significant changes our country has undertaken to strengthen our homeland defenses. We must examine how well we are protecting the American people and our way of life today, and, where vulnerabilities remain, take decisive action to bolster our defenses. The act we introduce today does just this, by seeking to strengthen our Nation's agricultural import and entry inspection functions to better safeguard American agriculture and natural resources against foreign pests and disease.

Invasive species arrive at U.S. ports of entry every day, often hidden in the wooden crates, pallets, and shipping containers used to transport agricultural cargo, or concealed in the imported goods themselves. Failure to detect and intercept these non-native pests and diseases imposes serious economic and social costs on all Americans.

The U.S. Department of Agriculture estimates that foreign pests and disease already cost the U.S. economy tens of billions of dollars annually in lower crop values, eradication programs, emergency payments to farmers, and increased costs for food and other natural resources. The invasive asian stink bug, for example, is ravaging mid-Atlantic crops, often destroying significant portions of apple, peach, blackberry, raspberry, strawberry, tomato, pepper, sweet corn, and soybean harvests. The bug continues to spread despite ongoing Federal, State, and local eradication efforts. Invasive species threaten our competitiveness in international trade when trading partners decide to stop importing U.S. agricultural products due to the presence of an invasive pest or disease. For example, Japan continues to ban the importation of fresh potatoes from Idaho due to a 2006 outbreak of Potato Cyst Nematode in the State. A research team comprised of biologists and economists from U.S. and Canadian universities and the U.S. Forest Service published a study last month finding that invasive wood-boring pests, such as the emerald ash borer and the asian longhorned beetle, cost homeowners an estimated $830 million a year in lost property values and cost local governments an estimated $1.7 billion a year as a result of damaged trees and woodlands. Worst of all, according to the U.S. Government Accountability Office, the accidental or deliberate introduction of a foreign disease, such as avian influenza or foot-and-mouth disease, would likely result in catastrophic economic losses for our Nation and take lives.

In light of the current and potential staggering economic costs of invasive species--which fall on businesses, taxpayers, and local governments that have no way to avoid the harm it is clear that focusing on prevention, specifically improving agricultural import and entry inspection operations at our ports of entry, is a very cost- effective strategy.

Of course, economic costs are just one aspect of the severe consequences that can result from foreign pests and disease slipping through our ports. In my home State of Hawai'i, which is home to more endangered species per square mile than any other area on the planet, invasive species and disease could permanently devastate our fragile ecosystem. In many regions of the country, invasive species threaten native fish prized by fisherman, and destroy wetlands that support waterfowl hunting. Even an important part of our American tradition and pastime, baseball, is at stake. For the past 127 years in Kentucky, Louisville Slugger, the world's largest and oldest maker of baseball bats, has manufactured high quality baseball bats from northern white ash trees harvested in Pennsylvania and New York. However, the company is very concerned that the destructive emerald ash borer beetle, which has already destroyed millions of ash trees in several States, including Michigan, Wisconsin, Ohio, Pennsylvania, and New York, could lead to the extinction of northern white ash trees, preventing Louisville Slugger from providing future generations with the company's famous ash bats.

Following the attacks of September 11, Congress passed the Homeland Security Act of 2002, which unified Federal customs, immigration, and agriculture inspection officers under the new U.S. Department of Homeland Security. The decision to transfer frontline agricultural import and entry inspection functions from the Department of Agriculture's Animal and Plant Health Inspection Service, or APHIS, into the Department of Homeland Security's Customs and Border

Protection, or CBP, was a controversial decision.

I have long been concerned that the transfer resulted in significant disruptions to the agriculture mission and undermined the effectiveness of agricultural inspections. Other Members of Congress have expressed similar concerns, and there have even been efforts to remove agricultural inspection responsibilities from the Department of Homeland Security and return them to the Department of Agriculture.

While I understand these sentiments, as Chairman of the Subcommittee on Oversight of Government Management, I understand that such drastic reorganizations are often costly and disruptive. In light of our Nation's fiscal challenges, I have concluded it is most efficient and effective to focus on strengthening the agricultural inspection mission within CBP, which in recent years, has made meaningful progress in stabilizing the agency's agricultural import and entry inspection operations.

The Safeguarding American Agriculture Act seeks to build upon these gains and fully achieve important measures of success identified in the June 2007 Report of the APHIS-CBP Joint Task Force on Improved Agriculture Inspection, which stated ``Success will be accomplished when the agriculture function within CBP is positioned prominently throughout the organization. The potential introduction of plant and animal pest and diseases will be regarded with the same fervor as all other mission areas within CBP.''

The Act would enhance the priority of, and accountability for, the agriculture mission by establishing within CBP an Office of Agriculture Inspection led by an Assistant Commissioner responsible for improving agricultural inspections across the Nation. This provision would improve efficiency and coordination by unifying agriculture policy development with agriculture operations. An agricultural chain of command that extends from the Assistant Commissioner for Agriculture Inspection to frontline agriculture specialists at the ports would also effectively address a key issue the task force identified in its 2007 report: ``Management and leadership infrastructure supporting the agriculture mission in CBP should be staffed and empowered at levels equivalent to other functional mission areas in CBP.''

Under the present organizational structure, the Deputy Executive Director for CBP's office of Agriculture Operational Oversight within the office of Agriculture Programs and Trade Liaison, which falls under the Office of Field Operations, is responsible for improving oversight of the agricultural mission across all CBP field offices by ensuring a more consistent application of agriculture inspection policy. However, the Deputy Executive Director lacks operational authority over the agriculture mission. Moreover, the dissemination and implementation of agricultural policy at the ports is ultimately at the discretion of CBP Officers who typically do not have agriculture expertise and are primarily focused on the critical mission of preventing terrorists and terrorist weapons from entering the country.

To maintain a highly skilled and motivated agriculture specialist workforce, the Act would require CBP to create a comprehensive agriculture specialist career track that identifies appropriate career paths and ensures that agriculture specialists receive the training, experience, and assignments necessary for successful career. The bill also would require CBP to develop plans to improve agriculture specialist recruitment and retention and to make sure agriculture specialists have the necessary equipment and resources to effectively carry out their mission.

To strengthen critical working relationships and promote interagency experience, the Act would authorize the Secretary of Homeland Security and the Secretary of Agriculture to establish an interagency rotation program for CBP and APHIS personnel.

Taken together, the enhancements contained in the Safeguarding American Agriculture Act of 2011 would elevate the stature of the agriculture mission in CBP to match the magnitude of the challenge posed by invasive pests and disease. I strongly urge my colleagues to support this important legislation.

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

Mr. President, I rise today with Senator Cardin to introduce the Nanotechnology Regulatory Science Act of 2011 which will authorize a program of regulatory science by the U.S. Food and Drug Administration on nanotechnology-based medical and health products.

Nanotechnology holds great promise to revolutionize the development of new medicines, drug delivery, and orthopedic implants while holding down the cost of health care. However, Congress and the FDA must assure the public that nanotechnology-based products are both safe and efficacious. The Nanotechnology Regulatory Science Act of 2011 will enable the FDA to properly study how nanomaterials are absorbed by the human body, how nanomaterials designed to carry cancer fighting drugs target and kill tumors, and how nanoscale texturing of bone implants can make a stronger joint and reduce the threat of infection.

Nanotechnology, or the manipulation of material at dimensions between 1 and 100 nanometers, is a challenging scientific area. To put this size scale in perspective, a human hair is 80,000 nanometers thick.

Nanomaterials have different chemical, physical, electrical and biological characteristics than when used as larger, bulk materials. For example, nanoscale silver has exhibited unique antibacterial properties for treating infections and wounds. Nanomaterials have a much larger ratio of surface area to mass than ordinary materials do. It is at the surface of materials that biological and chemical reactions take place and so we would expect nanomaterials to be more reactive than bulk materials.

The novel characteristics of nanomaterials mean that risk assessments developed for ordinary materials may be of limited use in determining the health and public safety of products based on nanotechnology.

The FDA needs the tools and resources to assure the public that nanotechnology-based medical and health products are safe and effective. The development of a regulatory framework for the use of nanomaterials in drugs, medical devices, cosmetics, sunscreens and food additives must be based on scientific knowledge and data about each specific technology and product. Without a robust regulatory science framework there is no way to know what data to collect. More than a dozen material characteristics have been suggested even for relatively simple nanomaterials. Without better scientific knowledge of nanomaterials and their behavior in the human body, we do not know what data to collect and examine.

In 2007, the FDA Nanotechnology Task Force published a report analyzing the FDA's scientific program and regulatory authority for addressing nanotechnology in drugs, medical devices, biologics, and food supplements. A general finding of the report is that nanoscale materials present regulatory challenges similar to those posed by products using other emerging technologies. However, these challenges may be magnified because nanotechnology can be used to make almost any FDA-regulated product. Also, at the nanoscale, the properties of a material relevant to the safety and effectiveness of the FDA-regulated products might change.

The Task Force recommended that the FDA focus on improving its scientific knowledge of nanotechnology to help ensure the agency's regulatory effectiveness, particularly with regard to products not subject to premarket authorization requirements.

The FDA has already reviewed and approved some nanotechnology-based products. In the coming years, they expect a significant increase in the use of nanomaterials in drugs, devices, biologics, cosmetics, food, and over-the-counter products. This will require the FDA to devote more of its regulatory attention to nanotechnology based products.

The FDA has already begun to devote some resources to the understanding of the human health effects and safety of nanotechnology. The FDA has established a Nanotechnology Core Facility at the National Center for Toxicological Research in Jefferson Arkansas. In August, Arkansas Governor Beebe and FDA Commissioner Hamburg signed a memorandum understanding creating a Virtual Center of Excellence in regulatory science pertaining to nanotechnology. Under the agreement, the state's five research universities--the University of Arkansas, Fayetteville; the University of Arkansas for Medical Sciences; the University of Arkansas at Little Rock; the University of Arkansas at Pine Bluff, and Arkansas State University--will work with the NCTR to establish a nanotechnology collaborative research program dealing specifically with toxicity. In addition, UAMS will offer a Master's degree and a certification program in regulatory science.

Let me talk for a few minutes about two areas where nanotechnology is already being applied to health care, the early detection of cancer and multifunctional therapeutics.

The early detection of cancer can result in significant improvement in human health care and reduction in cost. Nanotechnology offers important new tools for detection where existing and more conventional technologies may be reaching their limits. The present obstacle to early detection of cancer lies in the inability of existing tools to detect these molecular level changes directly during early phases in the genesis of a cancer. Nanotechnology can provide smart contrast agents and tools for real time imaging of a single cell and tissues at the nanoscale.

Nanotechnology promises a host of minimally-invasive diagnostic techniques and much research is aimed at ultra-sensitive labeling and detection technologies. In the in vitro area, nanotechnology can help define cancers by molecular signatures denoting processes that reflect fundamental changes in cells and tissues that lead to cancer. Already, investigators have developed novel nanoscale in vitro techniques that can analyze genomic variations across different tumor types and distinguish normal from malignant cells.

In the in vivo area, one of the most pressing needs in clinical oncology is for imaging agents that can identify tumors that are far smaller than is possible with today's technology. Achieving this level of sensitivity requires better targeting of imaging agents and generation of a larger imaging signal, both of which nanoscale devices are capable of accomplishing.

Perhaps the greatest near-term impact of multifunctional therapeutic compounds will come in the area of tumor targeting and cancer therapies. Nanotechnology can be used to develop new methods of drug delivery that better target selected tissues and cells, and to improve on the efficiency of drug activity in the cytoplasm or nucleus. Drug delivery applications will provide a solution to solubility problems, as well as offer intracellular delivery possibilities.

The introduction of nanotechnology to multifunctional therapeutics is at an early stage of development. The delivery of nanoscale multifunctional therapeutics could permit very precise site specific targeting of cancer cells. More sophisticated ``smart'' systems for drug delivery still have to be developed that sense and respond to specific chemical agents and are tailored to each patient. Multifunctional therapeutic devices need to be developed that simultaneously detect, diagnose, treat and monitor response to the therapy. For example, various nanomaterials can be made to link with a drug, a targeting molecule and an imaging agent to seek out cancers and release their payload when required.

In conclusion, the Nanotechnology Regulatory Science Act of 2011 will provide the FDA the authority necessary to scientifically study the safety and effectiveness of nanotechnology-based drugs, delivery systems, medical devices, orthopedic implants, cosmetics, and food additives regulated by the agency. This bill is a sound investment on the promise of nanotechnology to improve human health and reduce costs in the 21st century.

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

Mr. President, I rise today with Senator Cardin to introduce the Nanotechnology Regulatory Science Act of 2011 which will authorize a program of regulatory science by the U.S. Food and Drug Administration on nanotechnology-based medical and health products.

Nanotechnology holds great promise to revolutionize the development of new medicines, drug delivery, and orthopedic implants while holding down the cost of health care. However, Congress and the FDA must assure the public that nanotechnology-based products are both safe and efficacious. The Nanotechnology Regulatory Science Act of 2011 will enable the FDA to properly study how nanomaterials are absorbed by the human body, how nanomaterials designed to carry cancer fighting drugs target and kill tumors, and how nanoscale texturing of bone implants can make a stronger joint and reduce the threat of infection.

Nanotechnology, or the manipulation of material at dimensions between 1 and 100 nanometers, is a challenging scientific area. To put this size scale in perspective, a human hair is 80,000 nanometers thick.

Nanomaterials have different chemical, physical, electrical and biological characteristics than when used as larger, bulk materials. For example, nanoscale silver has exhibited unique antibacterial properties for treating infections and wounds. Nanomaterials have a much larger ratio of surface area to mass than ordinary materials do. It is at the surface of materials that biological and chemical reactions take place and so we would expect nanomaterials to be more reactive than bulk materials.

The novel characteristics of nanomaterials mean that risk assessments developed for ordinary materials may be of limited use in determining the health and public safety of products based on nanotechnology.

The FDA needs the tools and resources to assure the public that nanotechnology-based medical and health products are safe and effective. The development of a regulatory framework for the use of nanomaterials in drugs, medical devices, cosmetics, sunscreens and food additives must be based on scientific knowledge and data about each specific technology and product. Without a robust regulatory science framework there is no way to know what data to collect. More than a dozen material characteristics have been suggested even for relatively simple nanomaterials. Without better scientific knowledge of nanomaterials and their behavior in the human body, we do not know what data to collect and examine.

In 2007, the FDA Nanotechnology Task Force published a report analyzing the FDA's scientific program and regulatory authority for addressing nanotechnology in drugs, medical devices, biologics, and food supplements. A general finding of the report is that nanoscale materials present regulatory challenges similar to those posed by products using other emerging technologies. However, these challenges may be magnified because nanotechnology can be used to make almost any FDA-regulated product. Also, at the nanoscale, the properties of a material relevant to the safety and effectiveness of the FDA-regulated products might change.

The Task Force recommended that the FDA focus on improving its scientific knowledge of nanotechnology to help ensure the agency's regulatory effectiveness, particularly with regard to products not subject to premarket authorization requirements.

The FDA has already reviewed and approved some nanotechnology-based products. In the coming years, they expect a significant increase in the use of nanomaterials in drugs, devices, biologics, cosmetics, food, and over-the-counter products. This will require the FDA to devote more of its regulatory attention to nanotechnology based products.

The FDA has already begun to devote some resources to the understanding of the human health effects and safety of nanotechnology. The FDA has established a Nanotechnology Core Facility at the National Center for Toxicological Research in Jefferson Arkansas. In August, Arkansas Governor Beebe and FDA Commissioner Hamburg signed a memorandum understanding creating a Virtual Center of Excellence in regulatory science pertaining to nanotechnology. Under the agreement, the state's five research universities--the University of Arkansas, Fayetteville; the University of Arkansas for Medical Sciences; the University of Arkansas at Little Rock; the University of Arkansas at Pine Bluff, and Arkansas State University--will work with the NCTR to establish a nanotechnology collaborative research program dealing specifically with toxicity. In addition, UAMS will offer a Master's degree and a certification program in regulatory science.

Let me talk for a few minutes about two areas where nanotechnology is already being applied to health care, the early detection of cancer and multifunctional therapeutics.

The early detection of cancer can result in significant improvement in human health care and reduction in cost. Nanotechnology offers important new tools for detection where existing and more conventional technologies may be reaching their limits. The present obstacle to early detection of cancer lies in the inability of existing tools to detect these molecular level changes directly during early phases in the genesis of a cancer. Nanotechnology can provide smart contrast agents and tools for real time imaging of a single cell and tissues at the nanoscale.

Nanotechnology promises a host of minimally-invasive diagnostic techniques and much research is aimed at ultra-sensitive labeling and detection technologies. In the in vitro area, nanotechnology can help define cancers by molecular signatures denoting processes that reflect fundamental changes in cells and tissues that lead to cancer. Already, investigators have developed novel nanoscale in vitro techniques that can analyze genomic variations across different tumor types and distinguish normal from malignant cells.

In the in vivo area, one of the most pressing needs in clinical oncology is for imaging agents that can identify tumors that are far smaller than is possible with today's technology. Achieving this level of sensitivity requires better targeting of imaging agents and generation of a larger imaging signal, both of which nanoscale devices are capable of accomplishing.

Perhaps the greatest near-term impact of multifunctional therapeutic compounds will come in the area of tumor targeting and cancer therapies. Nanotechnology can be used to develop new methods of drug delivery that better target selected tissues and cells, and to improve on the efficiency of drug activity in the cytoplasm or nucleus. Drug delivery applications will provide a solution to solubility problems, as well as offer intracellular delivery possibilities.

The introduction of nanotechnology to multifunctional therapeutics is at an early stage of development. The delivery of nanoscale multifunctional therapeutics could permit very precise site specific targeting of cancer cells. More sophisticated ``smart'' systems for drug delivery still have to be developed that sense and respond to specific chemical agents and are tailored to each patient. Multifunctional therapeutic devices need to be developed that simultaneously detect, diagnose, treat and monitor response to the therapy. For example, various nanomaterials can be made to link with a drug, a targeting molecule and an imaging agent to seek out cancers and release their payload when required.

In conclusion, the Nanotechnology Regulatory Science Act of 2011 will provide the FDA the authority necessary to scientifically study the safety and effectiveness of nanotechnology-based drugs, delivery systems, medical devices, orthopedic implants, cosmetics, and food additives regulated by the agency. This bill is a sound investment on the promise of nanotechnology to improve human health and reduce costs in the 21st century.

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

Mr. President, today I introduce the Effective Teaching and Leading Act to foster the development of highly skilled and effective educators.

We are working towards reauthorizing the Elementary and Secondary Education Act--ESEA--this Congress for the first time since 2001. One of my highest priorities for reauthorization is to build the capacity of our Nation's schools to enhance the effectiveness of teachers, principals, school librarians, and other school leaders.

Decades of research have demonstrated that improving educator and principal quality as well as greater family involvement are the keys to raising student achievement and turning around struggling schools. To strengthen teaching and school leadership, the Effective Teaching and Leading Act would amend Title II of the Elementary and Secondary Education Act, ESEA, to provide targeted assistance to schools to develop and support effective teachers, school librarians, principals, and school leaders through implementation of comprehensive induction, professional development, and evaluation systems.

Every year across the country thousands of teachers leave the profession--many within their first years of teaching. A report by the National Commission on Teaching and America's Future has estimated that the nationwide cost of replacing public school teachers who have dropped out of the profession is $7.3 billion annually.

Fortunately, we have some proven strategies to support teachers that will keep them in our schools. Evidence has shown that providing new teachers with comprehensive mentoring and support during their two years reduces teacher attrition by as much as half and increases student learning gains. The Effective Teaching and Leading Act would help schools implement the key elements of effective multi-year mentoring and induction for beginning teachers.

The bill also significantly revises ESEA's current definition of ``professional development'' to foster an ongoing culture of teacher, principal, school librarian, and staff collaboration throughout schools. All too often current professional development still consists of isolated, check-the-box activities instead of helping educators engage in sustained professional learning that is regularly evaluated for its impact on classroom practice and student achievement. Effective professional development is collaborative, job-embedded, and data- driven.

It is also clear that evaluation systems have an important role to play in teacher and principal development. Through Race to the Top and other initiatives many states and school systems are focusing on reforming their evaluation systems. When evaluation is done right, it provides teachers and principals with individualized ongoing feedback on their strengths and weaknesses and offers a path to improvement. The Effective Teaching and Leading Act would require school districts to establish rigorous, fair, and transparent evaluation systems that use multiple measures, including growth in student achievement.

Principals and school leaders also have a critical role to play in leading school improvement efforts and managing a collaborative culture of ongoing professional learning and development. Research has shown that leadership is second only to classroom instruction among school- related factors that influence student outcomes. As such, this bill would provide ongoing high-quality professional development to principals and school leaders, including multi-year induction and mentoring for new administrators.

Recognizing the importance of creating career advancement and leadership opportunities for teachers, the Effective Teaching and Leading Act supports opportunities for teachers to serve as mentors, instructional coaches, or master teachers, or take on increased responsibility for professional development, curriculum, or school improvement activities and calls for significant and sustainable stipends for teachers that take on these new roles and responsibilities.

The bill also addresses working conditions that are so critical for effective teaching. Under the legislation, districts would conduct surveys of the working and learning conditions educators face so this data could be used to better target investments and support.

Improving teaching and school leadership is not simply a matter of sorting the good teachers and principals from the bad. What is needed is a comprehensive and integrated approach that supports new teachers and leaders as they enter the profession; provides on-going professional development that helps them improve and their students to achieve; and that fairly assesses performance and provides feedback for improvement. This is the approach taken by the Effective Teaching and Leading Act.

I worked with a range of education organizations in developing this bill, including the American Federation of Teachers; American Association of Colleges for Teacher Education; Association for Supervision and Curriculum Development; National Association of Elementary School Principals; National Association of Secondary School Principals; National Board for Professional Teaching Standards; Learning Forward; and the New Teacher Center. I thank them for their input and support for the bill.

I urge my colleagues to cosponsor the Effective Teaching and Leading Act and work for its inclusion in the upcoming reauthorization of the Elementary and Secondary Education Act.

Mr. President, I ask unanimous consent that this bill be printed in the Record.