Toxicity of Amphibole Asbestos

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1 Toxicity of Amphibole Asbestos Disclaimer: The material presented in these slides has been reviewed by the U.S. EPA and approved for presentation. Approval does not signify that the contents necessarily reflect the views and polices of the EPA, nor does the mention of trade names of commercial products constitute endorsement or recommendation for use. 1

2 Asbestos-Related Diseases Cancer Effects: Mesothelioma Lung cancer Non-cancer Effects: Localized pleural thickening (LPT) Diffuse pleural thickening (DPT) Small interstitial opacities (SIO) Asbestosis Systemic autoimmune diseases 2

3 Lung Anatomy Airway Structure Diameter (cm) Number of Airways Trachea Main bronchi Lobar bronchi Bronchioles 0.15 ~500 Terminal bronchioles 0.05 ~33,000 Alveolar sacs ~8,400,000 3

4 Respirable Particles Size of Particle Area of Respiratory System Method of Deposition greater than 10 µm upper airway nose and throat to 5 µm trachea, bronchi, terminal bronchioles impaction sedimentation 0.5 µm or less alveoli diffusion 4

5 Relative Particle Size 5

6 Asbestos-Related Diseases Once inhaled, asbestos fibers remain in the lung for a very long time. Amphibole half-life >20 years (biodurable) Disease may develop 10 to 40 or more years after a person has been exposed to asbestos (latency) Asbestos-related diseases: - Pleural thickening - Autoimmune disorders - Asbestosis - Mesothelioma and lung cancer 6

7 Basis for our recent understanding Detailed analysis of the human epidemiological data for the Libby miner cohort and the Libby/Troy communities Detailed analysis of the human epidemiological data from the OM Scott, Marysville, OH cohort Evaluation of human epidemiological data from Western Minerals, Minneapolis, MN site and Wittenoom, Australia Evaluation of current literature as reviewed and presented in the Libby Amphibole Asbestos Toxicity Assessment by U.S. EPA,

8 Libby, Montana 8

9 Libby Miner Cohort 1959 to 2007, ~880 participants Mesothelioma 7 deaths (full cohort 18/1,871) Lung cancer 32 deaths (full cohort 111/1,871) Pleural abnormalities >51% of exposed population at CFE >1 f/cc-yr (range: <1 to 1,722 f/cc-yr) Relates to CFE and time from first exposure Parenchymal/interstitial abnormalities Asbestosis 22+ deaths Cardiovascular and autoimmune effects 9

10 Libby Community Based on ATSDR screening and follow-on of >7,000 participants > 400 deaths due to Asbestos Related Disease (ARD) or Non-Malignant Respiratory Disease (NMRD) Pulmonary fibrosis/asbestosis Subset of patients with rapid onset and progression with loss of pulmonary function > 18% have pleural abnormalities Latency correlates to CFE LPT maybe as short as 8 years LPT with calcification as short as 17 years 10

11 Libby Community Based on ATSDR screening and follow-on of >7,000 participants (cont d) Loss of pulmonary function Occupational exposures 22% of the participants Residential exposures 16% of the participants Cardiovascular disease Systemic autoimmune diseases (SAID) Rheumatoid arthritis Systemic lupus erythematosus Presence of autoimmune nuclear antibodies 11

12 Marysville, Ohio 12

13 OM Scott Facility, Marysville, OH Used Libby ore, expanded and used as a carrier for agricultural chemicals First report of pleural disease for LAA in 1980 bloody pleural effusion in 10 patients Pleural plaques in ~2% of the workers Rohs et al., 2008, 25 year follow-on of the OM Scott worker cohort ~28% of the workers with pleural effect LPT in 68/434 workers exposed to low-level LAA Fiber levels <1 f/cc-yr Low level parenchymal changes 13

14 OM Scott Facility, Marysville, OH (cont d) Dunning et al., 2012 results of a 30 year follow-on of the O M Scott worker cohort 3 mesotheliomas in the worker population Fiber levels at ~ 5.7, 43, & 47 fibers/cc-yr Lockey, JE, Dunning, K, Hilbert, TJ, et al HRCT/CT and associated spirometric effects of low Libby amphibole asbestos exposure. J Occup Environ Med 57(1): /168 individuals with LPT; 10/168 with DPT; and 21/168 with SIO (LPT total 119/434) 14

15 Western Minerals Facility, Minneapolis, MN 15

16 Western Minerals Facility, Minneapolis, MN Worker/residential cohort of 6,724 individuals Expansion facility using Libby ore to produce primarily Zonolite attic insulation (ZAI) Used dispersion modeling to estimate exposures Modeled worker, waste handler, installer, and residential exposures Ambient air fiber levels ranged from 0.26 f/cc to f/cc. Plant workers >5.3 f/cc Worker exposures: Moving waste rock 0.07 to 0.14 f/cc Using waste rock 0.02 to f/cc Installing ZAI to f/cc Pile player 0.14 to 1.72 f/cc 16

17 Western Minerals Facility, Minneapolis, MN Worker/residential cohort of 6,724 individuals 461 of the 6,724 potential individuals participated in actual screening 49 cases of pleural abnormalities (11%) 5 cases of diffuse pleural thickening (1.1%) 18 cases of parenchymal abnormalities (3.9%) Concluded: non-occupational exposures to LAA results in pleural abnormalities 17

18 Wittenoom, Western Australia 18

19 Wittenoom, Western Australia Crocidolite mine operated from 1943 to 1966 Mine and town were heavily contaminated Miner cohort 6,909 in 2000 (6,693 males, 416 females) Residential cohort 4,769 men and women in 2000 Estimated air concentration from 1943 to 1957 was ~1 f/cc New mill installed in 1957, air concentration was ~0.5 f/cc 19

20 Wittenoom, Western Australia Residential cohort, women 2,552 participants 437 deaths due to cancer 47 mesothelioma, 55 lung cancer Time of onset ranged from 24 to 52 years Death rate is 35 to 256 per 100,000 person years for combined lung cancer and mesothelioma 20

21 Wittenoom, Western Australia Miner cohort, 6,493 males, 416 females 830 deaths due to cancer 212 mesothelioma, 281 lung cancer Time of onset ranged from 10 to 52 years Death rate ranges from 115 to 364 per 100,000 person years for combined lung cancer and mesothelioma Asbestosis 91 deaths Circulatory 699 deaths 21

22 Wittenoom, Western Australia Miner cohort (cont d) Diffuse pleural thickening and asbestosis correlate with the incidence of peritoneal mesothelioma; not pleural mesothelioma Patients show a broad spectrum of pleural abnormalities Childhood exposure results in increased brain, prostate, and ovarian cancer 22

23 Toxicity values for LAA 1988 General Asbestos 2014 LAA (final) IUR (cancer) 0.23 (f/cc) (f/cc) -1 RfC (noncancer) no value f/cc = 90 f/m 3 f/cc = fibers per cubic centimeter f/m3 = fiber per cubic meter cc m 3 23

24 What is localized pleural thickening? Gross appearance at autopsy of asbestos-associated pleural plaques overlying the lateral thoracic wall. Gross appearance of large asbestos-related pleural plaque over the dome of the diaphragm. 24

25 EPA Concludes LPT is endpoint for RfC Localized pleural thickening (LPT) is the critical effect for deriving an RfC. LPT (pleural plaques) are well-recognized as a marker of exposure to asbestos, meaning they rarely occur except following exposure to asbestos (i.e., they are specific to asbestos). According to the American Thoracic Society (2004): Pleural plaques are indicators of exposure to asbestos. They are clearly the most common manifestation of the inhalation, retention, and biologic effect of asbestos. 25

26 Strength of Marysville, OH Cohort Used Libby #3 ore from 1959 to Libby ore contains Libby amphiboles; winchite, richterite, tremolite, magnesio-riebeckite, magnesioarfedsonite, and edenite (84:11:6:1:1:1) Low-dose, occupational exposures with IH data collected from 1972 Facility employed a medical monitoring program Have been able to follow the workers longitudinally from 1980 to current Able to develop strong job exposure matrix Clinical data (including spirometry) and radiographic data (CXR, HRCT) 26

27 Exposure response modeling Developed individual job exposure matrix Shape of dose-response curve directed model form(s) Benchmark-dose modeling used to estimate bench mark at 10% extra risk level Modeled full cohort and sub-cohort; data sets yielding BMCL70 that were nearly identical in magnitude (1.5E-03 to 2.6 E-03 PCM f/cc) Based on exposure-response modeling an reference concentration (RfC) was developed for Libby amphibole asbestos 27

28 Summary EPA has conducted an extensive review and analysis of the cancer and non-cancer literature and data Based on human epidemiological data from the Libby miner cohort and the Marysville, Ohio worker cohort, EPA has developed toxicity factors for both cancer and non-cancer endpoints. The cancer toxicity factor (IUR) is 0.17 (f/cc)-1 The non-cancer toxicity factor (RfC) is f/cc First non-cancer toxicity factor for a mineral fiber These values were used in the risk assessment for the Libby Asbestos Superfund site 28

29 Amphibole Solid-Solution Series Amphibole Asbestiform PCMe* Solution Series Wihchite Yes Yes Na, Fe Richterite Yes Yes Na Tremolite Yes Yes Ca, Mg Magnesio-riebeckite Occasionally Yes Na Magnesio-arfedsonite Yes Yes Na Edenite Yes Yes Na Actinolite Yes Yes Ca, Mg Amosite Yes Yes Mg, Fe Anthophyllite Yes Yes Mg, Fe Crocidolite Yes Yes Na Tremolite Yes Yes Ca, Mg *PCME = phase contrast equivalent (length 5 µm, width 0.25 µm, aspect ratio 3:1) 29

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