Mesothelioma is a rare form of cancer in which malignant cells are found in the mesothelium, a protective sac that covers most of the body’s internal organs. Pleural mesothelioma refers to the thoracic-based form of the disease, the most common type of mesothelioma.

Although asbestos exposure is a major risk factor for mesothelioma, it can remain latent for more than 20 years and may require a predisposition to the disease. In addition, it can also occur in individuals that previously experienced radiation exposure (e.g. treatment for Hodgkin’s lymphoma).

Dr. Krug noted that, “Diagnosing mesothelioma is often difficult, because the symptoms are similar to those of a number of other conditions. In addition, a physician’s initial evaluation of a patient may reveal pleural effusion, but it can often be missed on pleural fluid cytology.”

Common symptoms of mesothelioma are shortness or breath or chest pain among others including tumor fevers, sweats, weight loss, and pneumonia.

A surgical biopsy is often required to effectively diagnose a patient with mesothelioma according to Dr. Krug. PET scans can aid in staging as well, detecting unexpected metastases in 10 percent of cases.

Prognostic factors include gender, lymph node status, and histology, but Dr. Krug also pointed to other potential markers that may be indicative of the disease.

“Serum markers may also have prognostic significance as studies show that patients with mesothelioma have higher levels of Soluble Mesothelin-Relation Protein (SMRP) and Osteopontin,” said Dr. Krug.

Like any cancer, treatment for mesothelioma depends on many factors including the stage of the cancer, where the cancer is, and how far the cancer has spread. Dr. Krug described treatments such as surgery, chemotherapy, and radiation that may benefit patients as described in the NCCN Guidelines for MPM.

Surgical procedures for MPM can range from a pleurectomy/decortication for those patients with early stage disease to more aggressive procedures, such as extrapleural pneumonectomy. Extrapleural pneumonectomy includes the removal of pleura, the lung, diaphragm, and pericardium, but can result in major complications and should only be performed by experienced surgeons.

“The role of aggressive surgery remains controversial,” said Dr. Krug. “As outlined in the Principles for Surgical Resection for Malignant Pleural Mesothelioma in the NCCN Guidelines, physicians need to be highly selective when choosing potential candidates for this procedure.”

Surgery alone can be inadequate due to residual disease and a high rate of relapse, so the NCCN Guidelines recommend a combined modality therapy approach for select patients noted Dr. Krug.

The NCCN Guidelines consist of a section detailing the Principles of Radiation Therapy for MPM that stress the need for a multimodality approach including evaluation of the patient by radiation oncologists, surgeons, medical oncologists, diagnostic imaging specialists, and pulmonologists.

“Radiation is recommended as an adjuvant therapy to improve local control after surgery, and it is also an effective palliative treatment for relief of chest pain that is often associated with mesothelioma,” said Dr. Krug.

Dr. Krug explained that MPM was historically felt to be chemoresistant, but that recent studies have shown that certain regimens can benefit patients and also can be added for systemic therapy either before or after surgery.

“The NCCN Guidelines recommends pemetrexed (Alimta®, Lilly USA, LLC) with cisplatin (Platinol®, Bristol-Myers Squibb) or carboplatin (Paraplatin®, Bristol-Myers Squibb) as the optimal first-line combination chemotherapy regimen for patients, though others can be considered based on comorbid conditions,” said Dr. Krug. “On the other hand, there are extremely limited data on the benefit of second line therapy. A few specific regimens are listed as second line options in the NCCN Guidelines.”

The NCCN Guidelines are developed and updated through an evidence-based process with explicit review of the scientific evidence integrated with expert judgment by multidisciplinary panels of physicians from NCCN Member Institutions. The most recent version of this and all the NCCN Guidelines are available free of charge at NCCN.org.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 21 of the world’s leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.

The NCCN Member Institutions are:

• City of Hope Comprehensive Cancer Center, Los Angeles, CA
• Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA
• Duke Comprehensive Cancer Center, Durham, NC
• Fox Chase Cancer Center, Philadelphia, PA
• Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT
• Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA
• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL
• Memorial Sloan-Kettering Cancer Center, New York, NY
• H. Lee Moffitt Cancer Center &amp
• Research Institute, Tampa, FL
• The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, Columbus, OH
• Roswell Park Cancer Institute, Buffalo, NY
• Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO
• St. Jude Children’s Research Hospital/University of Tennessee Cancer Institute, Memphis, TN
• Stanford Comprehensive Cancer Center, Stanford, CA
• University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL
• UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA
• University of Michigan Comprehensive Cancer Center, Ann Arbor, MI
• UNMC Eppley Cancer Center at The Nebraska Medical Center, Omaha, NE
• The University of Texas M. D. Anderson Cancer Center, Houston, TX
• and Vanderbilt-Ingram Cancer Center, Nashville, TN.

For more information, visit NCCN.org.

"The grants that were selected for funding this year, have the potential to accelerate development of novel therapies that will have a significant impact on how we treat patients with mesothelioma," says Raffit Hassan, MD, Senior Investigator at the National Cancer Institute and Meso Foundation Science Advisory Board Chairman.

This round, the Meso Foundation received 56 grant applications. Its scientific peer reviewers selected the top eight based on their innovation, research design, and promise. These include studies of a targeted vaccine anticipated to yield effective treatment without the side-effects currently associated with traditional mesothelioma treatment; a novel study of the role of hormones in malignant mesothelioma; several studies looking at improving the specificity and effectiveness in mesothelioma of drugs already available to cancer patients, while reducing their side effects; and a study focused specifically on peritoneal mesothelioma, aimed at targeting residual tumor cells after surgical debulking as well as enabling earlier detection. The full list of projects can be seen in the Mesothelioma Research Grant Awards section of CureMeso.org.

"We are thrilled that our mesothelioma research funding continues to foster such strong interest among brilliant medical scientists and we have high expectations for these projects. As the national nonprofit advocating for mesothelioma patients today, and for all those who will be diagnosed in the future, we will continue raising funds for life-saving research and we won’t stop until there is a cure," says Chris Hahn, Executive Director for the Mesothelioma Applied Research Foundation.

Mesothelioma is a malignant tumor of the lining of the lung, abdomen or heart caused by asbestos. Medical experts consider it one of the most aggressive of all cancers. For decades it was regarded as untreatable, deadly and hopeless; and so, in a sad, self-fulfilling prophecy, the need for research to develop effective treatments was mostly ignored. For the Mesothelioma Applied Research Foundation and today’s patients, their families, and the millions of Americans who in the last five decades have been exposed to asbestos and are at risk for the cancer, this is unacceptable. The Foundation believes in a cure for this tragic disease, and is committed to funding the research critically-needed to understand and improve treatment of the disease.

In addition, the Mesothelioma Applied Research Foundation provides patients and families with the most up-to-date information on mesothelioma treatments, clinical trials and medical referrals. The Foundation hosts the annual International Symposium on Malignant Mesothelioma, which unites doctors, researchers, patients and families, legal advocates, union representatives and other concerned individuals to share information and advance meso research. The Foundation also leads the effort in Washington, D.C. to gain federal investment in mesothelioma research funding and to ban the further use of asbestos. For more information visit the Mesothelioma Applied Research Foundation’s website at http://www.curemeso.org.

Rosetta Genomics, Ltd., a leading developer and provider of microRNA-based molecular diagnostics, announced today that the results of a joint study with the NYU Langone Medical Center were published online on February 16th, 2010, and are set to be published in the March 1st issue of the American Association for Cancer Research’s journal, Cancer Research. The study, "Hsa-Mir-29c* is Linked to the Prognosis of Malignant Pleural Mesothelioma," demonstrates the potential of a single microRNA to act as an independent prognostic factor for time to progression as well as survival after surgery. The abstract of the study may be viewed online at: http://cancerres.aacrjournals.org/cgi/content/abstract/0008-5472.CAN-09-3993v1

In the study, 142 MPM tumors were analyzed for microRNA expression levels using Rosetta Genomics’ proprietary microRNA-based array and qRT-PCR technologies. The results clearly demonstrate that higher levels of miR-29c* in MPM predict a more favorable prognosis. Not only was the microRNA able to separate MPM patients by time to progression after surgery, but it also stratified these patients by their survival.

When examining Time to Progression (TTP) of MPM, the expression level of miR-29c* enabled the identification of two groups with significantly different median TTP: 4 months versus 14 months in the study’s training set, and 5.5 months versus 12.8 months in the study’s test set.

When examining survival rates for MPM, the expression level of miR-29c* enabled the identification of two groups as well: median survival of 8 months versus 32 months in the study’s training set, and median survival of 9.1 months versus 21.6 months in the study’s test set. This new diagnostic capability may help physicians apply more aggressive therapeutic modalities to the poor prognosis group.

Furthermore, the study found that over-expression of miR-29c* in mesothelioma cell lines resulted in significantly decreased proliferation, migration, invasion and colony formation.

"This is an exciting discovery which may have significant clinical impact on the treatment of MPM," said Harvey Pass, M.D., Professor and Chief, Division of Thoracic Surgery and Thoracic Oncology at NYU Langone Medical Center, and the lead investigator of this study. "While MPM is an aggressive cancer, our study showed that we can use a single microRNA to identify subgroups of patients who differ significantly in their time to progression and survival. When applied to a clinical setting, these findings may enable clinicians to apply multimodality therapy to the most appropriate patients. Furthermore, I think it is remarkable that a single biomarker can provide such insights into disease prognosis."

"In addition to the significant clinical importance of being able to forecast outcomes of MPM, this study demonstrates the tremendous potential microRNAs hold as biomarkers," noted Kenneth A. Berlin, President and CEO of Rosetta Genomics. "NYU Langone Medical Center chose Rosetta Genomics’ platform technology for this study as it was the most technologically advanced, offering an extremely high sensitivity and specificity suitable for studying microRNAs in the clinical setting. The results of this study further validate the strength of our microRNA platform technologies and our ability to leverage that strength to help advance the standard of care."

About microRNAs

MicroRNAs (miRNAs) are recently discovered, small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. MicroRNAs’ unique advantage as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block. It has been suggested that their small size (19-21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to degrade rapidly in samples preserved by this method. In addition, early preclinical data has shown that by controlling the levels of specific microRNAs, cancer cell growth may be reduced. To learn more about microRNAs, please visit www.rosettagenomics.com.

About miRview™ Products

miRview™ are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview™ mets accurately identifies the primary tumor site in metastatic cancer and Cancer of Unknown Primary. miRview™ squamous accurately identifies the squamous subtype of NSCLC, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview™ meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview™ tests are designed to provide objective diagnostic data; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, over 100,000 patients a year may benefit from the miRview™ mets test, 60,000 from miRview™ squamous, and 60,000 from miRview™ meso, with similar numbers of patients outside the U.S. The company’s tests are now being offered through distributors around the globe. For more information, please visit www.mirviewdx.com.

About Rosetta Genomics

Rosetta Genomics is a leading developer of microRNA-based molecular diagnostics. Founded in 2000, the company’s integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development of a full range of microRNA-based diagnostic tools. The company’s first three microRNA-based tests, miRview™ squamous, miRview™ mets and miRview™ meso, are commercially available through its Philadelphia-based CLIA-certified lab. Rosetta Genomics is the 2008 winner of the Wall Street Journal’s Technology Innovation Awards in the medical/biotech category. To learn more, please visit www.rosettagenomics.com .

Linda Reinstein, executive director and co-founder of the Asbestos Disease Awareness Organization, knows first hand the pain that can result from asbestos exposure and the impact it has on families. Reinstein lost her husband Alan to asbestos exposure in 2006 and is passionate and committed to raise awareness of asbestos-related diseases and encourage action to prevent families from going through the anguish of losing a loved one due to asbestos exposure. Reinstein has taken ADAO’s message of unity in action to many other countries and has represented the organization at landmark asbestos conferences in Tokyo, Bangkok, London, Amsterdam, and Hong Kong. This year, Reinstein will bring ADAO’s conference to Chicago.

The weekend will provide information and inspiration for those impacted by asbestos-related disease as well as others who advocate for safe environments. There will be a private gathering for family, patients, and caregivers on the evening of April 9 followed by a welcome reception for all registered participants. Our special guest will be entertainer Jordan Zevon whose father, rock musician Warren Zevon, died of mesothelioma caused from asbestos exposure. There will also be a recognition segment to the April 10 conference to honor those who have demonstrated exceptional service to enhance asbestos awareness. In addition, the Unity and Hope Brunch on April 11 will honor and remember loved ones lost to asbestos disease, as well as show support for those still suffering.

What:

ADAO’s 6th Annual International Asbestos Awareness Conference

Global Mission: Call to Action to Prevent, Detect and Treat Asbestos-Related Diseases

Science and Technology Prove Asbestos is a Carcinogen

Scheduled Events:

Friday, April 9, 5 – 6 p.m.: Private Gathering for families, patients and caregivers

Friday, April 9, 7 – 9 p.m.: Evening Reception with entertainer Jordan Zevon

Saturday, April 10, 8 a.m. – 5:30 p.m.: Conference

Sunday, April 11, 9:30 – 11:30 a.m.: Unity and Hope Brunch

Where:

Marriott Renaissance Hotel
1 Wacker Drive
Chicago, Illinois

Why:

To share information and provide support to those affected by asbestos-related diseases, including survivors, families, and physicians. Prominent physicians, scientists, safety and health directors, and survivors will present current and up-to-date information regarding the status of asbestos in the United States and worldwide.

Who:

Brad Black, M.D., medical director, Center for Asbestos Related Disease; Barry Castleman, ScD, environmental consultant; Jeff Camplin, CSP, CPEA; Sean Fitzgerald, PG; Arthur Frank, M.D., Ph.D., chair, Department of Environmental and Occupational Medicine, Drexel University’s School of Public Health; Patrick Gerkin, Ph.D., assistant professor, Grand Valley State University; Fernanda Giannasi, ABREA; Michael Harbut, M.D., MPH, FCCP, co-director, National Center for Vermiculite and Asbestos-Related Cancers, Karmanos Cancer Institute; Tanis Hernandez, LCSW, Center of Asbestos Related Disease; Laurie Kazan-Allen, founder and coordinator, IBAS; Hedy Lee Kindler, M.D., University of Chicago, and president, International Mesothelioma Interest Group; Richard Lemen, Ph.D., MSPH, former Assistant Surgeon General; Terry Lynch, International Vice President, Insulators Union; The Honorable Patrick Martin, member,
Canadian Parliament; Linda Reinstein, executive director and co-founder, ADAO; Kimberly Rowse, RN, Center for Asbestos Related Disease; Jordan Summer, musician; James Webber, Ph.D., research scientist, Wadsworth Center; Jordan Zevon, ADAO national spokesman and musician.

In addition, six individuals will be recognized for their tireless work to raise awareness of asbestos exposure. They are:

• The Honorable Richard Durbin, United States Senator will receive the Tribute of Hope Award
• Dr. Hedy Kindler will be recognized with the Dr. Irving Selikoff Lifetime Achievement Award
• Center for Asbestos Related Disease (CARD), Libby, MT, will receive the Tribute of Unity Award
• Fernanda Giannasi will be honored with the Tribute of Inspiration Award
• Honoree to be announced, the Warren Zevon “Keep me in Your Heart” Memorial Tribute
• June Breit will be honored posthumously with The Alan Reinstein Memorial Award

How:

Registration for the April 10 conference includes lunch and the April 9 evening reception. Cost is $150 for survivors, caregivers, families, and students. Cost for physicians and healthcare professionals is $300 each.

Cost for the Remembrance Brunch on April 11 is an additional $25 for those attending the conference, and $50 for non-conference guests.

Registration is limited. To reserve your registration or for more information go to www.adao.us. Please note that parking fees are not included in registration fees

About Asbestos Disease Awareness Organization (ADAO)

The Asbestos Disease Awareness Organization (ADAO), founded by Linda Reinstein and Doug Larkin, and asbestos victims and their families in 2004, seeks to give asbestos victims and concerned citizens a united voice to raise public awareness about the dangers of asbestos exposure. ADAO is the largest independent non-profit organization dedicated to preventing asbestos-related diseases through education and legislation. ADAO’s mission includes supporting global advocacy and advancing asbestos awareness, prevention, early detection, treatment, and resources for asbestos-related disease.

www.AsbestosDiseaseAwareness.org

About Barbara Ann Karmanos Cancer Institute

Located in mid-town Detroit, Michigan, the Barbara Ann Karmanos Cancer Institute is one of 40 National Cancer Institute-designated comprehensive cancer centers in the United States. Caring for nearly 6,000 new patients annually on a budget of $216 million, conducting more than 700 cancer-specific scientific investigation programs and clinical trials, Karmanos is among the nation’s best cancer centers. Through the commitment of 1,000 staff, including nearly 300 physicians and researchers on faculty at the Wayne State University School of Medicine, and supported by thousands of volunteer and financial donors, Karmanos strives to prevent, detect and eradicate all forms of cancer. Its long-term partnership with the WSU School of Medicine enhances the collaboration of critical research and academics related to cancer care. Karmanos is southeastern Michigan’s most preferred hospital for cancer care according to annual surveys conducted by the National Research Corporation. For
more information call 1-800-KARMANOS or go to www.karmanos.org

About International Ban Asbestos Secretariat (IBAS)

The International Ban Asbestos Secretariat (IBAS), established in 2000, provides a conduit for the exchange of information between groups and individuals working to achieve a global asbestos ban and seeking to alleviate the damage caused by widespread asbestos use. Such use may be largely historical in the established economies of the West but is continuing in developing nations. Since its inception, IBAS has been involved in co-sponsoring and supporting national and international conferences furthering the above aims. In so doing, IBAS has sought to counter the asbestos industry’s control of the information stream and provide a platform for victims to speak out against the injustices they have suffered. Through its coordinator, Laurie Kazan-Allen, IBAS channels the views of a global network of victims’ groups, medical and legal professionals and concerned individuals. IBAS has a continuing role in raising public awareness of asbestos hazards and providing informed comment on current developments.

Nearly 30 tons of asbestos and asbestos containing debris, as well as over 2,700 pounds of hazardous materials and waste oils were removed from the site. The removal work, conducted by EPA’s contractor with EPA oversight, began in June 2009 and concluded in October 2009.

Although EPA found the former mill building structurally adequate, the lack of a fire suppression system coupled with the disrepair of the roof and many windows and the presence of asbestos and hazardous substances in drums and containers presented a health threat to anyone on the site and may have posed additional risks in the event of a fire. All visible friable asbestos and asbestos-containing material was removed and trucked in sealed containers to a licensed landfill. The abandoned drums and containers containing lead, volatile organic compounds, semi-volatile organic compounds and ignitable and corrosive wastes were removed and disposed of at a licensed facility.

EPA conducted air monitoring throughout the removal effort to ensure the safety of its workers and the surrounding community. No asbestos fibers were detected outside of the former mill building by the air monitors during the removal action.

The Blackburn & Union Privileges site was added to the Superfund “National Priority List” in 1994. Industrial and commercial processes on the site date back to the 1600s. Between 1891 and 1915, the site was used for manufacture of tires, rubber goods, and insulating materials. The crushing of raw asbestos in the manufacture of brake and clutch linings occurred at the site between 1915 and 1937. Various cotton and fabric production processes were conducted at the site from 1937 until 1985.

After considering public comments, in September 2008 EPA decided on an overall site cleanup plan. The cleanup plan includes these major components: removal of Neponset River and Lewis Pond contaminated sediment; cleanup of contaminated on-site soil; cleanup of on-site groundwater which could pollute local surface water; restriction on future uses of the South Street on-site properties. EPA is currently negotiating with the potentially responsible parties that owned facilities and or operated at the site for the performance of the cleanup work.

Since 1992, the DoD has been charged with promoting research on diseases related to military service. Since then it has funded over $5.4 billion for a range of diseases – some only tangentially related to military service, but it completely omitted mesothelioma research even though asbestos was used all over military installations and vehicles, especially Navy ships. In fact, one third of those who currently die from mesothelioma were exposed to asbestos on U.S Navy ships and shipyards. These are the veterans who served in the defense of our country and the hard working men and women who helped build our fleet.

Therefore, since 2004 the Mesothelioma Applied Research Foundation and its passionate arsenal of patients, caregivers, bereaved family members, researchers, doctors, union representatives and concerned mesothelioma attorneys have advocated that Congress direct the DoD to include mesothelioma research in its portfolio. They have met personally with their elected government officials at the Foundation’s annual Washington, D.C. Advocacy Day and in their home states, testified at hearings, prepared educational materials, and participated in the Foundation’s grassroots advocacy through countless emails, letters and phone calls.

In 2007 the Senate Defense Appropriations Subcommittee acted, directing DoD to fund mesothelioma research through its Peer Reviewed Medical Research Program (PRMRP). As a result, in early 2008 the DoD awarded its first mesothelioma research grant ever, a $1.4 million award to Courtney Broaddus, M.D. for exciting work to understand the role of macrophage induced inflammation in mesothelioma.

The meso community gratefully appreciated this important first step. But 38 meso researchers had applied. DoD’s funding only 3% of the applications did not comply with the Senate’s directive that DoD begin to seriously address this critical disease. So the Foundation continued its vigorous advocacy. This year, the DoD took its responsibility more seriously, and has just announced awards totaling several million dollars for three important mesothelioma projects: Harvey Pass, M.D. and Margaret E. Huflejt, PhD. will investigate new markers for early detection of mesothelioma and will identify new therapeutic targets. And Lee Krug, M.D. will lead a multi-site clinical trial of a promising new therapy based on the WT-1 vaccine, which will directly impact patients and offer them new hope.

Doctors Broaddus, Krug and Pass have all been supported by Meso Foundation grants in their earlier work, and they demonstrate the exponential impact of the Foundation’s seed funding. For example, in 2006, the Foundation awarded $100,000 to Dr. Krug to support the first phase of his WT-1 vaccine trial. The success of that trial led to his recent DoD award, yielding a 2000% rate of return on the Foundation’s initial funding investment.

Thanks to the Foundation’s advocacy, the DoD is beginning to seriously address mesothelioma. The Meso Foundation will continue to advocate that DoD rigorously pursue research to develop mesothelioma treatments, for the sake of our nation’s veterans and other heroes from so many walks of life who are impacted by this disease.

The Mesothelioma Applied Research Foundation is the national non-profit dedicated to finding a cure for mesothelioma by funding mesothelioma research, educating and supporting mesothelioma patients, and advocating for a national commitment to end the mesothelioma tragedy. More information is available on the Foundation’s website at www.curemeso.org.

Chairman Lautenberg, Chairman Boxer, Ranking Member Inhofe and other members of the committee, thank you for the opportunity to speak about how we can improve our framework for assessing and managing chemical risks.

Understandably, the public is turning to government for assurance that chemicals that are ubiquitous in our economy, our environment and our bodies have been assessed using the best available science, and that unacceptable risks have been eliminated.

But, under existing law, we cannot give that assurance. Restoring confidence in our chemical management system is a top priority for me, and a top environmental priority for the Obama Administration.

EPA is the agency tasked with ensuring that the chemicals used in the American economy are safe. But, Mr. Chairman, the current law that gives EPA that authority is outdated, and does not provide the tools to adequately protect human health and the environment as the American people expect, demand and deserve.

Chairman Lautenberg, I commend you for your long standing leadership on this issue and look forward to working with you, Chairman Boxer and other Members of this committee as you consider ways to improve the safety of chemicals.

The Toxic Substances Control Act (TSCA) was signed into law in 1976 and was intended to provide protection of health and the environment against risks posed by chemicals in commerce. However, when TSCA was enacted, it authorized manufacture and use, without any evaluation, of all chemicals that were produced for commercial purposes in 1976 or earlier years. Thus, manufacturers of these “grandfathered” chemicals weren’t required to develop and produce the data on toxicity and exposure that are needed to properly and fully assess potential risks. Further compounding this problem, the statute never provided adequate authority for EPA to reevaluate existing chemicals as new concerns arose or as new scientific information became available.

TSCA does provide some authority to EPA to mandate industry to conduct testing, but even in these cases it has taken years to obtain data and information. As a result, there are large, troubling gaps in the available data and state of knowledge on many widely used chemicals in commerce.

TSCA also doesn’t place any legal obligation on producers to conduct testing on new chemicals being introduced into commerce. They are required only to supply existing data to EPA and are not required to provide all the data necessary to fully assess a chemical’s risks.

In the rare cases where EPA has adequate data on a chemical, and wants to protect the public against well-known, unreasonable risks to human health and the environment, there are too many legal hurdles to take quick and effective regulatory action

For example, in 1989, after years of study, EPA issued a rule phasing out most uses of asbestos – a chemical whose health effects had been exhaustively studied and demonstrated to cause lung cancer, mesothelioma and asbestosis in humans. Yet, a federal court overturned the rule because EPA failed to clear the many hurdles imposed under TSCA before existing chemical risks can be controlled

Due to these legal and procedural hurdles in the law over the last 30 years, EPA has only been able to require testing on around 200 chemicals produced and used in the United States, and it has only issued regulations to control five existing chemicals determined to present an unreasonable risk under Section 6 of TSCA. Five from a total universe of more than 80,000 existing chemicals listed on the TSCA Inventory. Though many of these chemicals likely pose little or no risk, the story is clear—we’ve only been able to effectively regulate a handful of chemicals and we know very little about the rest.

TSCA must be updated and strengthened.

Earlier this fall, I announced the Obama Administration’s legislative principles for how this law should be revised and modernized. Let me highlight the Obama Administration’s principles:

First, chemicals should be reviewed against safety standards that are based on sound science and reflect risk-based criteria protective of human health and the environment. Safety standards should be driven solely by scientific evidence of risks. EPA should have the clear authority to establish safety standards that reflect the best available science while recognizing the need to assess and manage risk in the face of uncertainty.

Second, the responsibility for providing adequate health and safety information should rest on industry. Manufacturers must develop and submit the hazard, use, and exposure data demonstrating that new and existing chemicals under review are safe. If industry doesn’t provide the information, EPA should have the necessary tools to quickly and efficiently require testing, or obtain other information from manufacturers that are relevant to determining the safety of chemicals, without the delays and obstacles currently in place, or excessive claims of confidential business information.

Third, EPA should have clear authority to take risk management actions when chemicals do not meet the safety standard, with flexibility to take into account a range of considerations, including children’s health, economic costs, social benefits, and equity concerns. EPA and industry must include special consideration for exposures and effects on groups with higher vulnerabilities – particularly children. For example, children ingest chemicals at a higher ratio to their body weight than adults, and are more susceptible to long-term damage and developmental problems. Our new principles offer them much stronger protections.

Fourth, EPA should have clear authority to set priorities for conducting safety reviews. In all cases, EPA and chemical producers must act on priority chemicals in a timely manner, with firm deadlines to maintain accountability. This will not only assure prompt protection of health and the environment, but provide business with the certainly that it needs for planning and investment.

Fifth, we must encourage innovation in green chemistry, and support research, education, recognition, and other strategies that will lead us down the road to safer and more sustainable chemicals and processes. All of this must happen with transparency and concern for the public’s right to know.

Finally, implementation of the law should be adequately and consistently funded, in order to meet the goal of assuring the safety of chemicals, and to maintain public confidence that EPA is meeting that goal. To that end, manufacturers of chemicals should support the costs of Agency implementation, including the review of information provided by manufacturers.

I know that legislative reform may take time. Consequently, I have directed my Assistant Administrator of Pollution Prevention and Toxic Substances, Steve Owens, to utilize our current authority under TSCA to the fullest extent possible, including Section 6 authority to label, restrict, or ban a chemical, to ensure that we do everything we can to protect the American people and the global environment from dangerous chemicals. While fundamental reform is needed to fully protect against chemical risks, this is a step forward.

Specifically, EPA is currently evaluating an initial set of chemicals based on available hazard, exposure, and use information, for potential action. We will complete and make public “action plans” for the chemicals which will outline the risks that the use of these chemicals may present and what steps we may take to address those concerns. Following this, we aim to complete and make publicly available a group of chemical action plans every four months. EPA intends to engage stakeholders and dialogue with other federal partners, as well as the public, in the discussion about prioritizing chemicals for future risk management action over the coming months through public notices and public meetings.

But let me be clear – this is no substitute for meaningful reform of the underlying law. The need for fundamental TSCA reform has been recognized by industry groups, including the American Chemistry Council, environmental groups, public health groups, several States and cities, and many other groups who have all called on Congress to Act. I too call on Congress to act on this issue and give EPA the tools to adequately protect human health and the environment.

The time has come to bring TSCA into the 21st Century. EPA looks forward to working with this committee on this very important issue.

The data comes from the EPA’s Toxics Release Inventory, commonly referred to as TRI. It’s one of the EPA’s largest publicly available databases, arming communities with valuable information on more than 650 toxic chemicals released by various industries. The chemical information in the inventory is calculated by industrial facilities and reported to the EPA, as required by law.

“We encourage people to use data from the Toxics Release Inventory in order to gain a better understanding of what is being released into their neighborhoods,” said Laura Yoshii, acting EPA administrator for the Pacific Southwest region. “Industry and communities informed with accurate information can use the inventory as a starting point to find opportunities to reduce the amount of pollutants released into the air we breathe, the water we drink and the land we enjoy.”

In California, 1,336 facilities reported a total of 44 million pounds of toxic chemical releases.

Total releases include toxic chemicals discharged by facilities to air, water, land, and underground, and the amount transferred off-site for disposal. Regulatory controls apply to many of the reported releases. Reporting facilities must comply with environmental standards set by local, state and federal agencies.

Here’s a look at toxic releases in California from 2006 – 2008, reported in pounds:

Data from 2008 in California show:

• Total reported on-site and off -site releases decreased 21% due primarily to decreases across all media—air, water and land releases and off-site transfers with the exception of the increase in underground injection releases
• Air releases decreased by 18%, 2.9 million pounds
• Water releases decreased by 45%, 1.8 million pounds
• California reported an increase in underground injection releases of 50%, 34,885 pounds
• The top five released chemicals are lead, ammonia, asbestos, zinc compounds, and nitrate compounds
• Hazardous waste, petroleum refineries and gold ore mining account for 68% of total releases
• In California, 8 million pounds of total releases of PBT chemicals were reported, a 19% decrease or 1.9 million pounds. Lead and lead compounds top the list

Annual Toxics Release Inventory reporting began in 1987 after the enactment of the Emergency Planning and Community Right-to-Know Act (1996). The inventory provides information to the public on annual toxic chemical releases reported by certain industrial and federal facilities. The TRI does not include data on toxic emissions from cars and trucks, nor from the majority of non-industrial sources, such as agriculture. In 2000, TRI expanded to include persistent bioaccumulative and toxic chemicals, or PBTs, at ranges from 0.1 grams to 100 pounds. PBT pollutants are toxic chemicals that remain in the environment and food chain, posing risks to human health and ecosystems.

The top facilities in California for total on-site and off-site releases of all chemicals (reported in pounds) are:

	Facility Name	City	Total Releases
1	Chemical Waste Management Inc.	Kettleman City	15,966,454
2	Western Mesquite Mines Inc.	Brawley	4,092,180
3	Clean Harbors Buttonwillow LLC	Button-Willow	1,662,201
4	Valero Refining Co. (California Benicia Refinery)	Benicia	1,611,849
5	Shell Oil Products US (Martinez Refinery)	Martinez	883,422
6	Chevron Products Co. Div. of Chevron USA Inc.	El Segundo	862,304
7	Chevron Products Co. (Richmond Refinery)	Richmond	808,729
8	Tesoro Refining & Marketing Co.	Martinez	761,889
9	Exide Technologies	Los Angeles	730,496
10	ConocoPhillips San Francisco Refinery	Rodeo	711,139

TRI Explorer

TRI Explorer is a tool that you can use to see the Toxics Release Inventory (TRI) data. It allows you to look at data by state, county, or zip code; by chemical; or by industry. It provides maps that you can click on to find TRI facilities, chemicals and industries in a particular area.

National TRI Findings:

• There was a 6% decrease in total reported releases into the environment nationwide from 2007 to 2008
• The number of facilities reporting chemical releases decreased 5% nationally
• Total PBT chemical releases decreased by 2% nation-wide

For more on the TRI program including additional city, county and facility information, please visit the EPA’s Web sites: http://www.epa.gov/tri, http://www.epa.gov/triexplorer and http://www.epa.gov/enviro.

State fact sheets are available at: http://www.epa.gov/region09/toxic/tri/ and http://www.epa.gov/triexplorer/statefactsheet.htm.

For more information on the PBT Chemicals Program, please visit the EPA’s Web site at http://www.epa.gov/opptintr/pbt

"These significant penalties reflect the fact that this employer, an asbestos contractor with extensive knowledge of the OSHA standards that govern asbestos removal and handling, chose not to follow these standards and put its workers, including young, inexperienced college students, in harm’s way," said acting Assistant Secretary for OSHA Jordan Barab.

OSHA found that several Cambria Contracting workers, who were cleaning up debris at the former AM&A department store warehouse on Washington Avenue, had not been trained in asbestos hazards and how to protect themselves. The workers also lacked proper respirators and protective clothing, and had not been informed of the presence of asbestos at the site. In addition, the employer failed to determine the asbestos exposure level and to establish a regulated work area for asbestos removal and handling. It also did not use vacuums with HEPA filters to collect debris but used methods to move debris with asbestos-containing material that typically can cause asbestos to be released into the air.

OSHA defines a willful violation as one committed with plain indifference to or intentional disregard for worker safety and health.

"This employer knew that training and other safeguards, which are well-known in the industry, were required, yet chose not to provide them," said Robert Kulick, OSHA’s New York regional administrator. "That is unacceptable and needlessly placed the health of these workers at risk."

"Asbestos is well recognized as a health hazard since inhalation of asbestos fibers may lead to lung cancer and other diseases," said Arthur Dube, OSHA’s Buffalo area director. "As exposures frequently occur during renovation and demolition work, we strongly urge contractors to ensure that their workers are adequately trained and protected against asbestos hazards."

Detailed information on asbestos is available on OSHA’s Web site at: http://www.osha.gov/SLTC/asbestos/index.html and http://www.osha.gov/SLTC/asbestos/construction.html.

Cambria Contracting has 15 business days from receipt of its citations and proposed penalties to comply, meet with OSHA or contest the findings before the independent Occupational Safety and Health Review Commission. The inspection was conducted by OSHA’s Buffalo Area Office; telephone 716-551-3053.

Under the Occupational Safety and Health Act of 1970, OSHA’s role is to promote safe and healthful working conditions for America’s men and women by setting and enforcing standards, and providing training, outreach and education. For more information, visit http://www.osha.gov.

Numerous honorees will be recognized at the 2010 event for their outstanding work and dedication to asbestos awareness related activities including:

• The Honorable Richard Durbin, United States Senator, Tribute of Hope Award
• Dr. Hedy Kindler, Selikoff Lifetime Achievement Award
• Center for Asbestos Related Disease (CARD), Libby, MT, Tribute of Unity Award
• Fernanda Giannasi, Tribute of Inspiration Award
• Honoree To be Announced, Warren Zevon "Keep me in Your Heart" Memorial Tribute
• June Breit, honored posthumously, The Alan Reinstein Memorial Award

"As we get even closer to a full asbestos ban, we are encouraged yet simultaneously reminded that the reverberations of asbestos exposure can last decades," stated Linda Reinstein, Co-Founder & Executive Director of the Asbestos Disease Awareness Organization. "Our annual conferences drive home the importance of the need for increased awareness, education and research. We are again honored to have the opportunity to bring together some of the world’s most renowned experts while recognizing some of the most influential leaders in the battle against asbestos exposure. They are true asbestos awareness heroes and prove that together, change is possible."

"I’ve received countless requests for my father’s song, ‘Keep Me In Your Heart,’ to be used at memorials for asbestos victims," stated Jordan Zevon, ADAO Spokesperson. "You can imagine how proud it makes me to know that my father’s Grammy winning song has touched so many families, but it is bittersweet because of the nature of those requests and the origin of the song’s conception. The ADAO "Warren Zevon Keep Me In Your Heart Tribute", the success of his album, and my recent fatherhood would have made my Dad burst with pride. In his honor, I will continue to work with ADAO to ban asbestos to spare future generations from the same fate."

ADAO’s mission is to provide the most advanced medical, occupational and environmental information available about asbestos related diseases to individuals throughout the world. Presentations will include preventing exposure, advances in diagnosing and treating asbestos-related diseases, providing patient resources, and a global advocacy session.

The conference is made possible with the support and collaborative efforts of the Barbara Ann Karmanos Cancer Institute and the International Ban Asbestos Secretariat (IBAS).

Online registration is available at http://adao.eventbrite.com/ and additional conference details can be found at http://www.asbestosdiseaseawareness.org/events/conference.html.