Dr. Valberg's Qualifications I am Peter A. Valberg, a public health professional specializing in human health risk assessment, inhalation toxicology, epidemiology, and biological modeling of human exposure to environmental chemicals, gases, and airborne particles such as asbestos. I was for 23 years a faculty member in the Department of Environmental Health at the Harvard School of Public Health in Boston, Massachusetts. I am the author of 88 articles in peer-reviewed journals, plus many reports dealing with lung biology, airborne pollutants, and health effects. I received a BA degree (summa cum laude) from Taylor University in 1964, a Ph.D. degree in physics in 1970 from Harvard University (as a student of Nobel laureate Prof. Norman F. Ramsey), and an M.S. degree in human physiology in 1975 from Harvard University. My postdoctoral training included Biomedical Physics and Biomaterials Science (Massachusetts Institute of Technology, 1974), Alveolar Macrophage Function (National Heart, Lung, and Blood Institute, 1977), Pulmonary Pathology (University of Vermont Lung Center, 1979), Analytical and Quantitative Light Microscopy (Woods Hole Marine Biological Laboratory, 1984), and Advanced Quantitative Risk Assessment (University of Cincinnati, 1991). I held the following academic research and training awards: Atomic Energy Commission Fellow (1964-67), Cottrell Research Corporation Science Grant (1972-75), National Science Foundation Fellow (1974-75), National Institutes of Health (NIH) New Investigator Pulmonary Research Award (1976-78), and Andrew W. Mellon Foundation Faculty Award (1981-1983). I was a faculty member in the Physics Department of Amherst College from 1969-75. I was then invited to join"the Harvard University School of Public Health. After spending two years as a Research Associate at the Harvard School of Public Health (HSPH), I was appointed in 1977 to the faculty of the Department of Environmental Health. I was promoted to Associate Professor of Physiology in 1985, and remained on the faculty in the Department of Environmental Health for fifteen years. At HSPH, I directed and participated several in research programs funded by the NIH, dealing with inhaled particles, lung function, and pulmonary diseases. As a faculty member in HSPH's Department of Environmental Health, I taught in part orin whole a variety of graduate and undergraduate courses on human physiology, airborne particles, and inhalation toxicology. These courses were taught at HSPH, as well as at Harvard College, Harvard Medical School, Massachusetts Institute of Technology, and Tufts University. The course titles included: Risk Analysis in Environmental and Occupational Health; Principles of Environmental Health; Human Physiology; Respiratory Physiology; Normal and Abnormal Human Physiology; Principles of Toxicology; Toxicology of Ambient Air Particles; Methods in Cell Biology; Structure and Function of the Mammalian Respiratory System; Indoor Air Quality; Aerosol Technology. While a full-time faculty member at Harvard, I was invited to be a visiting scientist at other institutions on two occasions. In 1982, I was a Visiting Scientist at the Inhalation Toxicology Research Institute (ITRI) in Albuquerque, NM (the current name of this institute is the Lovelace Respiratory Research Institute, LRRI). At ITRI, I designed and coordinated animal research that tracked the fate of radioactive substances inhaled into the body. In 1989, I was a Visiting Researcher at the Institute of Occupational Medicine in Helsinki, Finland. There, I participated in research on human subjects that examined the condition of their lung cells, as recovered by a lung 1 " lavage procedure. Throughout my research, teaching, and consulting career, I have been engaged in the study of the human health effects of chemical and physical agents in our environment. I have served in an advisory capacity to a variety of governmental organizations concerned with health. These include the National Heart Lung and Blood Institute of NIH, the NIH Division of Research Grants, the Office of Health and Environmental Research (U.S. Department of Energy), the National Academy of Sciences, the U.S. Navy Office of Occupational Health and Preventive Medicine, the U.S. Department of Transportation, and the U.S. Environmental Protection Agency (USEPA). I also have been an advisor to the Health Effects Institute, the Center for Indoor Air Research, and the American Conference of Governmental Industrial Hygienists. I began working with Gradient Corporation in 1990, while I was on the faculty 'at Harvard. Gradient is an environmental consulting company that provides health risk analyses to a variety of parties including government and industry. My work.at Gradient has involved the application of results from scientific research towards understanding the extent of human exposure.,to chemicals in the environment, as well as estimating the potential health risks of such exposures. As a Principal at Gradient, I provide expertise in risk assessment, human toxicology, and biological modeling of human exposure to environmental chemicals, gases, and airborne particles and fibers. I have completed numerous projects evaluating exposure and health effects of air pollutants, environmental chemicals, soil contamination, air toxics, and combustion emissions. Case Materials on Ms. Pamela Collins that I Received and Reviewed The following materials were provided, and I examined them in preparing my opinions: Transcript of deposition of Ms. Pamela Collins dated May 7, 2008 Transcript of deposition of Ms. Pamela Collins dated February 3, 2009 Ms. Pamela Collins' "Plaintiffs' Responses to Defendants' Master Consolidated Discovery Requests," dated November 30, 2007 • Assorted medical records for Ms. Pamela Collins from Bellevue Hospital, Cleveland Clinic, Firelands Regional Medical Center, North Coast Cancer Care, Northern Ohio Medical Specialists, University of Toledo Medical Center, Summary Opinion Following my review of Ms. Pamela Collins' case materials, and after considering the relevant peer reviewed scientific and medical literature, and relying on my background, experience, education and training, I have reached two central opinions in this matter. First, to a reasonable degree of scientific certainty, Ms. Pamela Collins' described use of asbestos gloves most likely did not cause or contribute to her developing pleural mesothelioma. Second, to a reasonable degree of scientific certainty, Ms. Collins' carcinogen and radiation dose from her exposure to tobacco smoke most likely did increase her risk for developing pleural <). f - '3 .1(/~ mesothelioma. • ~~ .{2(....J.. The following considerations have led me to my opinions. The use of asbestos gloves has been shown to release relatively low levels of airborne chrysotile fibers (Cherrie et al., 2005; Samimi and Williams, 1981). There are no available studies that report an ' reased risk of cancer associated 2 ·. with asbestos-glove use, and hence the claim that this occupational activity led to mesothelioma has no available epidemiology to support it. Moreover, there is considerable debate as to whether chrysotile-fiber exposure contributes to risk of mesothelioma. The preponderance of evidence supports inhaled amphibole fibers as being the type of exposure that is responsible for increasing the risk of developing mesothelioma. Numerous authors have analyzed the mesothelioma risk of chrysotite versus amphibole fibers, and have concluded that, by far, the evidence supports a role for amphibole fibers, but not for chrysotile fibers (Bernstein et al. 2006; Hodgson and Darnton, 2000; Bennan and Crump, 2003,2008). In fact, analysis of pleural mesothelioma in predominantly-chrysotile exposed cohorts, where the cumulative dose falls below the range of 15-500 (f/ml)-year level, shows that there is no statistically significant increased risk of mesothelioma (Lacquet et al., 1980; McDonald et al., 1984; Albin et . al., 1990; Piolatto et al., 1990). Thus, even if we were to assume a mesothelioma risk from chrysotile fibers, an exposure threshold has to be reached that is unlikely to have been exceeded by the asbestos glove use that Ms. Pamela Collins describes. Another main consideration is that Ms. Pamela Collins was a long-term cigarette smoker. Her own smoking history amounts to about 32 pack-years. In addition, both of her parents were smokers, and her husband of 20 years was a smoker. Hence the quantity of cigarette smoke inhaled by Ms. Collins was considerable, and started at an early age. Over 50 compounds in tobacco smoke have been identified as carcinogens, and smoking causes cancer in multiple organ systems. For example, smoking has been shown to be a risk factor for cancers of the lung, larynx, oral cavity, nasal sinus cavity, esophagus, bladder, kidney, and cervix (NCI, Monograph #10, 1999). .. "1n addition to the long list of chemical carcinogens present in cigarette sm;;" it is also well known that cigarette smoke contains radionuclides, which cause smokers' lun s and pleura to be dosed with ionizing radiation (Desideri et at., 2007; Papastefanou, 2009; Pm ,tt et aI. 2009). Ionizing radiation is known to cause many types of human cancer, acting both as an initiator and a promoter for cancer cells. Radiation is consequently a risk factor for all cancers, including mesothelioma. Notably, patients receiving the mildly radioactive contrast agent "Thorotrast" demonstrate an increased mesothelioma risk (van Kaick et al., 1999; Andersson et ai., 1995; Ishikawa et al., 1995; Travis et al., 2003). In addition, workers in the nuclear industry have an elevated mesothelioma risk correlated to their radiation exposure (Cardis et al., 2007; Telle-Lamberton et al., 2004; Omar et al., 1999; Richardson et al., 2007; Atkinson et al. 2004; , Sponsler and Cameron, 2005). Finally, patients receiving therapeutic ionizing radiation are known to have excess mesothelioma incidence (Brown et al., 2006, 2007; Teta et ai., 2007; Travis et ai., 2005; DeBruin et al., 2009). In summary, the low and intermittent levels of exposure to chrysotile, due to activities such as those described by Ms. Pamela Collins from use of asbestos gloves, most likely cannot be expected to have caused pleural mesothelioma or created a risk above background or baseline. Ionizing radiation and tobacco smoke, however, are both known multi-organ carcinogens. To high degree of scientific certainty, it is most likely that radiation (and other tobacco-smoke carcinogens) from Ms. Collins' cigarette-smoke exposure substantially increased Ms. Collins' risk of developing various cancers, including Ms. Collins' pleural mesothelioma. Date: March 9, 2009 Peter A. Valberg, Ph.D. Cambridge, MA 3 Literature Citations v-Albin, M.; Jakobsson, K; Attewell, R.; Johansson, L.; Welinder, H. 1990. 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