Welcome to the 2018 AEG NOA Symposium January 17, 2018

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1 Welcome to the 2018 AEG NOA Symposium January 17, 2018 December 2018 NOA Calendar Photo Kink banded chrysocle veins in serpencnite from the Sanbagawa Metamorphic Belt, Kanto Mountains, Honshu Island, Japan 1

2 TODAY S AGENDA NOA Regulatory Issues w/ Two Extended Discussion Sec@ons NOA at Dam Sites NOA at various other construc@on sites NOA Lab Issues And more. 2

3 NOA-Related Issues are Becoming of Ever Increasing Concern 3

4 Review of OrganizaCons Which Scheduled NOA Related Symposiums in the US in 2017 Mark Bailey, PG President, Asbestos TEM Labs AEG NOA Symposium January 17, 2018

5 Other Scheduled NOA/EMP CDC NIOSH + NASEM Elongate Mineral ParCcle Workshop (proposed and cancelled three Part I - Nomenclature and Characteriza@on Why? USGS Lowers & Meeker (2002) 68 pages of references to asbestos related defini@ons in the scien@fic and regulatory literature covering just 9 asbestos morphological terms Acicular, Asbes@form, Asbestos, Cleavage, Cleavage Fragment, Fiber, Fibril, Fibrous, Par@ng Part II - Health Effects Workshop 5

6 Other Scheduled NOA/EMP ASTM Johnson Conference for the Discussion of Asbestos Issues July 31-Aug 4 th, 2017 Day 1 CDC NIOSH/NAS Elongate Mineral ParCcle: Part II - Health Effects Workshop: Novel Findings on Environmental Asbestos Exposure Days 2 thru 4 Regular Mee@ng The Mon@cello Conference on Elongate Mineral Par@cles Oct 16-19, 2017 Sponsored by the Stone, Sand And Gravel Associa@on 6

7 The Term Elongate Mineral (EMPs) is Being Increasingly Used in Place of NOA 2016 AEG NOA Symposium John Balmes, MD UCSF and UCB A Review of the NIOSH Roadmap for Research on Asbestos Fibers and Other Elongate Mineral ParCcles To many people, asbestos is a very narrow term. EMP is a broader term inclusive of not just asbestos, but also: Cleavage fragments Other non-serpen@ne/nonamphibole elongate minerals which may cause disease such as: Erionite Fibrous talc Refractory ceramic fibers Carbon nano-tubes 7

8 CDC NIOSH EMP Workshop Nomenclature & Ongoing debate in the asbestos community involves a variety of issues, many of which center around nomenclature. A novice to the asbestos literature would have difficulty grasping the significance and subtle@es of the many terms used to describe various asbestos-related mineralogical structures. To confound the issue, many of these terms carry different defini@ons, depending upon the source that is consulted. The purpose of this report is to give the user a consolidated source of the various defini@ons that have been put forth and are being used. This report is not intended to endorse any par@cular defini@on, but rather point out the varia@ons, differences and inconsistencies that exist in the literature. 8

9 CDC NIOSH + NAS EMP Workshop on Nomenclature & Characteriza@on CDC NIOSH EMP Workshop Proposed for Sept 7-8, 2016 CANCELLED 9/1/2016 Reason for CancellaCon: Based on CDC s concerns with government administered mee@ngs which might have the poten-al to result in recommenda-ons Na@onal Academy of Sciences EMP Workshop Proposed for May 15-16, 2017 CANCELLED 5/3/17 Reason for CancellaCon: I regret to inform you that because of budgetary uncertainty Na@onal Academy of Sciences EMP Workshop Proposed for Jan 25-26, 2018 CANCELLED 12/14/17 Reason for Cancella@on: I regret to inform you that NIOSH, the workshop sponsor, has asked the Na@onal Academies to cancel the Elongate Mineral Par@cles workshop 9

10 ASTM Johnson Conference July 31 Aug 4, 2017 University of Vermont, Burlington 10

11 ASTM Johnson Conference Since 1986, Johnson Conferences have served as forums for wide-ranging discussion of asbestos issues. The Johnson Conference has a tradi@on of no recording/ no publica@on that has encouraged forthright presenta@ons and discussions of novel ideas and controversial issues. These conferences have generated lively exchanges of ideas that have shaped many of the asbestos monitoring methods and strategies used today. Scope Detec@on, repor@ng, risk assessment, and regula@on of asbestos and other fibrous minerals. 11

12 ASTM Johnson Conference CDC NIOSH Health Effects Workshop Non-Cancer Outcomes Experience with Libby Amphibole (LA) shows that exposure predominantly causes a non-malignant pleural disease, and can increase the risk of systemic autoimmune diseases. Mouse models show other non-regulated amphboles (AZ) also give immune system response similar to regulated amphiboles Biomarkers Mul@ple talks on new ways for tracking changes in the body due to asbestos exposure through TEM and biochemical markers Cancer Outcomes Tumor immunology and immunotherapy for pleural mesothelioma Unraveling mechanisms of alveolar epithelial cell mitochondrial DNA damage: 12

13 ASTM Johnson Conference Geology NOA Training, CDRP Update, NOA in Arid Landscapes, Erionite + XRD, Modes of Fibrous Growth in Amphiboles, Talc Forma@on Regulatory Perspec@ves Differences Between Commercial Asbestos & NOA, Finalizing the Libby Ac@on Plan research Program, Developing Analy@cal Methods Challenges of Reconciling Two Asbestos Labs NOA Test Results, New Methods for Asbestos in Pharmaceu@cal Grade Talc, Op@cal Analysis of the Fibrous/Acicular Zeolites 13

14 ASTM Johnson Conference Methods Around the World & Miscellaneous Measuring Asbestos in Heavy Dust (Germany), Asbestos-In-Soil (Australia), ISO Standard Methods for of Asbestos (Canada), Italian Asbestos Superfund Legal Aspects Asbestos-Containing Cigarepes, of Amphiboles, Factor for Indirect and Directly Prepared TEM Samples w/ Amphiboles, When is Zero Actually Zero Risk Methods for Different Purposes, Elongate Mineral What Should Be Measured?, Comparison of PC and TEM-PCME Air Sample Analysis at Libby, Respirable Asbestos in Soil, Use of FBAS Soil Samples to Make Cleanup Decisions Asbestos TEM Laboratories, Inc. 14

15 Conference on Elongate Mineral October 15-20,

16 Conference on Elongate Mineral Defining EMPs In Nature of EMPs in Rocks, Air, Soil & Water In Lungs of EMPs found in lungs Effects & Mechanisms Toxicity, bio-persistence, modelling of EMP-lung cell toxicity Human Exposure, Effects & Risks Epdimiologic evidence for EMP-related health effects dimensions and mesothelioma Risk from exposures Mesothelioma and Talc Risk for EMPs Future Research 16

17 Summary Much related to NOA and EMP issues is happening on a na@onal & interna@onal basis. A variety of organiza@ons have subgroups focused on NOA/EMP issues CDC NIOSH ASTM D22.07 Asbestos in Air The Na@onal Stone, Sand & Gravel Associa@on CARB AQMDs & APCDs AEG 17

18 THE END February 2018 NOA Calendar Photo Fibrous AsbesCform Mg-Riebeckite Asbestos TEM Laboratories, Inc. Wilson Creek Range, Arizona, CA 18

19 ASTM Johnson Conference Day 1 Health Effects Workshop Non-Cancer Outcomes Differen@al Non-Cancer Outcomes of Fibrous Amphiboles in Mice Jean Pfau The experience with Libby Amphibole (LA) has taught us that exposure predominantly causes a non-malignant pleural disease that has a progressive and atypical clinical presenta@on, and can increase the risk of systemic autoimmune diseases. The public health impacts of these findings are highlighted in the growing awareness of "naturally occurring asbestos" in places where it was not previously predicted to occur, leading to environmental exposures in wide areas of the U.S. A mouse model has been used to compare the non-cancer effects in mice of exposure to LA with those of a newly discovered mixture of amphibole fibers from Arizona. The results demonstrated that LA is not unique in producing autoimmune outcomes in mice, and yet supported our hypothesis that the Arizona amphibole would have a somewhat unique immune profile despite chemical and morphological similari@es with LA. Importantly, we are demonstra@ng immune changes and autoan@bodies at very low exposure levels in mice. Asbestos TEM Laboratories, Inc. 19

20 ASTM Johnson Conference Day 1 Health Effects Workshop Non-Cancer Outcomes Non Cancer Exposure-Response Modeling for Libby Amphibole Asbestos Robert Benson, David Berry, James Lockey, William Bratn, Timothy Hilbert, Grace LeMasters» The United States Environmental Protec@on Agency (EPA) developed a quan@ta@ve exposure-response model for the non-cancer effects of Libby Amphibole Asbestos (LAA). The model is based on the prevalence of localized pleural thickening (LPT) in workers exposed to LAA at a workplace in Maryville, Ohio, that used vermiculite ore from Libby, Montana, to produce commercial products. In addi@on, modeling results for an alterna@ve cohort were also summarized in the Toxicological Review of Libby Amphibole Asbestos. Fibrous Amphibole in Libby, MT: Unique Biologic Response? Brad Black, MD, Center for Asbestos Related Disease, Libby MT.» The asbestos paradigm has held to the belief that asbestosis is on the decline, and pleural plaques are simply a marker of exposure and not associated with significant disease. Observa@ons in the Libby Amphibole cohort (over 7,000 pa@ents) followed by the Center for Asbestos Related Disease in Libby, MT for over 16 years suggest atypical mechanisms of disease. Asbestos TEM Laboratories, Inc. 20

21 ASTM Johnson Conference Day 1 Health Effects Workshop Non-Cancer Outcomes SEM, TEM and IHC Reveal the Deposi@on Papern and Transloca@on Pathways of Inhaled Asbestos Fibers That Cause Lung Injury, Fibroprolifera@ve Disease and Cancer Arnold Brody, Ph.D.» All asbestos varie@es cause asbestosis, lung cancer and mesothelioma. The fundamental mechanisms through which inhaled fibers mediate these diseases are being uncovered. Before we could embark on studies at the molecular level, it was necessary to determine the deposi@on and distribu@on paperns of the inhaled fibers auer exposure and through the consequent levels of injury that result in disease. We used SEM and TEM to establish - the various routes that fibers take through the body. Amazing new ability to track fibers, injuries biochemical markers indica@ng injury and which trigger previously unrealized responses from the body. Biomarkers Session Mul@ple talks on new ways for tracking changes in the body due to asbestos exposure biochemically. Discovery and Valida@on of Mesothelioma Biomarkers Serum protein biomarkers of mesothelioma and asbestos exposure Novel Diagnos@cs and Therapeu@c Modali@es for Mesothelioma Asbestos TEM Laboratories, Inc. 21

22 ASTM Johnson Conference Day 1 Health Effects Workshop Cancer Outcomes Tumor immunology and immunotherapy for pleural mesothelioma The Asbestos Paradigm in Unraveling the Mechanisms of Alveolar Epithelial Cell Mitochondrial DNA Damage: Implica@ons for Lung Cancer Erionite Carcinogenic Potency: Epidemiological Assessment and Toxicological Considera@ons Mysteries at the Bio@c Interface Asbestos TEM Laboratories, Inc. 22

23 Johnson Conference Day 1 Geology Towards a Training Program for Geologists and Other Asbestos Professionals Working on NOA Projects - R. Mark Bailey, Bradley Erskine NOA at the Calaveras Dam Replacement Project: A status report - Bradley Erskine Conceptual Model for Surficial Redistribu@on of Naturally Occurring Asbestos in Arid and Semi-Arid Landscapes: Case Study in Southern Nevada, USA Brenda J Buck, Rodney V. Metcalf, Brep T. McLaurin Update on Erionite - Mar@n Harper Erionite Analysis by TEM - Robyn Ray Two Modes of Fibrous Growth Habit in Amphiboles - Rodney V. Metcalf, Brenda J. Buck Addi@onal XRD and Pre-Concentra@on Developmental Work on the Determina@on and Characteriza@on of Erionite and Other Zeolites, Gary Tomaino Using Stable O and H Isotope Ra@os to Constrain Condi@ons of Talc Forma@on in Southwest Montana and Other Economically Significant Loca@ons - Marian E. Buzon, Mickey E. Gunter Mineralogical Resources for Those Dealing with Respirable Mineral Dust - Mickey E. Gunter Asbestos TEM Laboratories, Inc. 23

24 Johnson Conference Day 1 Regulatory Perspec@ves ASTM E "Standard Prac@ce for Comprehensive Building Asbestos Surveys" - The Applica@on to Industry - Tom Laubenthal Asbestos at the Source: Understanding the Differences Between Regulated Commercial Asbestos, Asbes@form Minerals in Rocks, and False Posi@ves - Don Halterman Avoiding 1%: Analy@cal Mindfulness and Sta@s@cal Monitoring - Frank Ehrenfeld Finalizing the Libby Ac@on Plan Research Program - Maureen R. Gwinn, David L. Berry, Andrea Kirk, Annie Jarabek, David Bussard, Ronald Hines, Deborah McKean, Michael Scozzafava State Asbestos Regula@ons Between the Lines: What is the Nature of Enforcement? - Thomas B. (Brad) Mayhew Any of These Minerals That Have Been Chemically Treated and/or Altered - Daniel T. Crane Part 1 Background of the Issue Part 2 How OSHA Uses Standard Tools to Address This Requirement Death by Point Coun@ng - F. Stephen Masek Asbestos TEM Laboratories, Inc. 24

25 Johnson Conference Day 3 DEVELOPING ANALYTICAL METHODS Challenges of Reconciling Two Asbestos TesCng Laboratories AnalyCcal Results on an NOA Job Site with Complicated Amphibole Mineralogy - R. Mark Bailey, John Harris ASTM Dust Methods: The Effects of the Ultrasonic Prepara@on Technique on Asbestos Concentra@on, How to Interpret the Results - Andreas Saldivar, Leonard Burrelli Asbestos in Talc Pharmaceu@cal And Cosme@c Talc: XRD Methodology and Sta@s@cs for Iden@fica@on, Detec@on Limits and Limits Of Serpen@ne in Support Of ASTM WK Test Methods - Gary P. Tomaino Fluidized Bed Asbestos Segregator Inter-Lab Round Robin J. Januch, D. Berry, L. Woodbury Update on New Methods for Asbestos in Pharmaceu@cal Grade Talc - Mar@n Rutstein, et al Concentra@on Methods Improve Detec@on Limits for the Analysis of Talc for Asbestos - Julie Pier Effec@veness of PLM for the Analysis of Chryso@le Asbestos Spiked Into Talc - Julie W. Pier Micro-Raman and Wavelength Dispersive Spectroscopy (WDS) Analysis Comparison of Samples from Former Talc Mines in the Gouverneur Mining District, New York. B. D. McNamee, A. Celes@an Libby Libby and Other Amphiboles, the Ends Are In Sight - Jeanne Spencer Update on ASTM WK52495: Standard Test Method For Qualita@ve Determina@on of Fibers Consistent with Libby Amphibole Asbestos Fibers in Loose Fill Vermiculite by Transmission Electron Microscopy - Jeanne Spencer Comparison Between PCM and TEM Analysis of Filters Loaded with LA-Spiked Soil Standards Using the FBAS Prepara@on Method - David Berry, Lynn Woodbury Op@cal Analysis of the Fibrous/Acicular Zeolites: A Spindle Stage Approach K. Pourtabib, M. Gunter Electron Backscaper Diffrac@on for Phase Iden@fica@on in Asbestos Analysis: Real World Case Studies - Bryan Bandli Insight into the Analysis on Dispersion Staining Curves - Derek Ho Examples of Determining the Detec@on Limit for Asbestos Analysis Using ASTM James R. Millepe 25

26 CDC NIOSH EMP Workshop Take 1 Proposed Sept 7-8, 2016 Part I - Nomenclature & Characteriza@on I. Characteriza@on of EMPs in Bulk and Soil Samples Illustra@ve Case Studies on Terminology and Characteriza@on: Talc Taconite Panel: Presenters on EMPs in Bulk and Soil samples in Discussion with the Audience II. Characteriza@on of EMPs in Air and Water Samples Illustra@ve Case Studies on Terminology and Characteriza@on: Libby Calavaris Dam Project Panel: Presenters in Discussion of EMPs in Air and Water Samples with the Audience III. Characteriza@on of EMPs in Biological Samples Panel: Presenters EMPs in Biological Samples in Discussion with the Audience Research Priori@es for Characteriza@on Background Level Issues Characteriza@on Issues: a. How much of the sample is representa@ve of the whole sample? b. Resolving varia@on between different laboratories c. What is the minimal number of EMPs (EM and EDS) for accurate characteriza@on d. Analy@cal calibra@on and reference materials Mar@n Harper Dan Crane Eric Chaxield Emerging technologies for EMP characteriza@on (auto coun@ng, personal monitoring, etc.) Panel: Presenters on research, priori@es, background level, emerging technologies and other issues in Discussion with the Audience Asbestos TEM Laboratories, Inc. 26

27 2016 AEG NOA Symposium A Review of the NIOSH Roadmap for Research on Asbestos Fibers and Other Elongate Mineral John Balmes, MD University of California, San Francisco and Berkeley January 2009 drau NIOSH Roadmap document which provided an overview of the state of the science and a plan for future research in areas including toxicology, mineralogy, epidemiology, and exposure assessment. The focus of the proposed research is on clarifying the rela@onship between human health effects and the physical and chemical characteris@cs (e.g., mineralogy, morphology, dimension, surface proper@es) of a wide range of elongate mineral parccles. Transi@onal par@cle from upstate New York iden@fied by the United States Geological Survey (USGS) as anthophyllite asbestos altering to talc. Photograph courtesy of USGS. 27

28 ASTM Johnson Conference topics include, but are not limited to, the following: Medical Research, Dose/Response, Toxicology, and Fate in the Body Sampling, Exposure Assessment, and Risk Regulatory Environmental Monitoring and and Methods Soils, Talc, Natural Occurrences of Asbestos, and Vermiculite Products Legal Aspects Quality Assurance Mineralogy and Nomenclature Other Hazardous Elongate Asbestos TEM Laboratories, Inc. 28

29 CDC NIOSH EMP Workshop Take 1 Proposed Sept 7-8, 2016 Part I - Nomenclature & Characteriza@on I. Characteriza@on of EMPs in Bulk and Soil Samples II. Characteriza@on of EMPs in Air and Water Samples III. Characteriza@on of EMPs in Biological Samples Background Level Issues Characteriza@on Issues How much of a sample is representa@ve of the whole sample? Resolving varia@on between different laboratories What is the minimal number of EMPs (EM and EDS) for accurate characteriza@on Analy@cal calibra@on and reference materials Emerging technologies for EMP characteriza@on (auto coun@ng, personal monitoring, etc.) Asbestos TEM Laboratories, Inc. 29

30 CDC NIOSH + NAS EMP Workshop Take 2 Proposed to occur Sept 7-8, 2016 Part I - Nomenclature & Characteriza@on - CANCELLED 9/1/2016 Reason Given for CancellaCon: Based on CDC s concerns with government administered mee@ngs which might have the poten-al to result in recommenda-ons, NIOSH is cancelling the por@on of the EMP Workshop on nomenclature and characteriza@on scheduled for Sep 7-8, We deeply regret the substan@al inconvenience this cancella@on with such late no@ce may cause you. Part 2 - Health Effects - WITHDRAWN 9/1/2016 Reason Given for CancellaCon: Because Part I was cancelled. Asbestos TEM Laboratories, Inc. 30

31 CDC NIOSH + NAS EMP Workshop Take 3 Na@onal Academy of Sciences EMP Workshop Proposed to occur May 15-16, 2017 Nomenclature and Characteriza@on - CANCELLED 5/3/17 Reason Given for CancellaCon: I regret to inform you that because of budgetary uncertainty, NIOSH, the workshop sponsor, has asked the Na@onal Academies to postpone the Elongate Mineral Par@cles workshop originally planned for May 15 and 16 in Washington, DC, to the fall of Asbestos TEM Laboratories, Inc. 31

32 NIOSH/NAS EMP Academy of Sciences EMP Workshop Proposed to occur Jan 25-26, 2018 Nomenclature & CANCELLED 12/14/17 Reason Given: I regret to inform you that NIOSH, the workshop sponsor, has asked the Na@onal Academies to cancel the Elongate Mineral Par@cles workshop planned for January 25 and 26 in Washington, DC. We appreciate the great effort you have made to prepare and aside for this mee@ng and apologize sincerely for inconvenience this may cause you. Asbestos TEM Laboratories, Inc. 32

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