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FILE NAME Brakes BRK DATE 2011 DOC BRK210 DOCUMENT DESCRIPTION Journal Article - Deconstructing a State Art Review of the Asbestos Brake Industry NEW SOLUTIONS Vol 21 4 545-571 2011 Features DECONSTRUCTING A STATE REVIEW OF THE ASBESTOS BRAKE INDUSTRY DAVID STEVEN EGILMAN EMILY LAURA ARDOLINO SAMANTHA HOWE TESS BIRD ABSTRACT State of the art is a legal concept that describes what was known as knowable by experts including manufacturer's state of knowledge about the potential hazards of their product at a point in time In 2004 Paustenbach et al published a state review that describes the development of knowledge about asbestos hazards to brake mechanics performing asbestos brake installation and maintenance Paustenbach et al.'s review however omits important pieces of corporate knowledge dismisses several historical scientific conclusions and ignores the way experts have applied the results of scientific research to protect workers and consumers handling asbestos brakes By taking their state review out of the legal liability context Paustenbach et al create a misleading version of events that fails to properly address the question of what asbestos brake manufacturers knew or should have known about the potential hazards of their brakes to mechanics over time Without proper presentation of this information judges and juries cannot adequately assess whether these companies had a duty to warn or take other action to prevent injury to those exposed to their asbestos brakes Keywords mesothelioma corruption bias corporation 545 '2011 Baywood Publishing Co. Inc. doi http://dx.doi.org/10.2190/NS.21.4.e http://baywood.com 546 / EGILMAN AL Over the past 20 to 30 years entire corporations and private consultancies with hundreds of millions of dollars in annual revenue have been established to produce scientific knowledge that corporations can use to avoid regulation and defend against worker and consumer lawsuits These lawsuits seek compensation for injuries and pollution resulting from corporate product manufacture and use Most of the sponsored reviews have been designed to cast doubt on the relationship between exposures and disease e.g. smoking or asbestos and lung cancer 1-5 However in most states the injured party must show that a company should have known about a risk before the company can be held responsible for having produced injuries Thus lawsuits hinge on a state analysis answering the question Who knew what when In response over the past decade companies have begun to fund these same consultants and historians to create revisionist histories of what companies should have known about a particular risk at a particular time 6 An accurate state analysis is not revisionist but should contextualize the information within the relevant standards of the times in which a product was produced 7 To highlight several of the typical methods experts have used to generate results that meet the litigation needs of their corporate clients we critically examined a corporate expert medico state review Environmental and occupational health hazards associated with the presence of asbestos in brake linings and pads 1900 to present published by Paustenbach Finley Lu Brorby and Sheehan in 2004 8 The authors guide readers through three time periods through 1959 1960 through 1974 and 1975 through discussing the published literature regarding asbestos dust and disease and characterizing the development of knowledge about pulmonary fibrosis lung cancer and mesothelioma in asbestos workers They conclude that the published literature regarding asbestos hazards and brake work failed to document asbestos exposures sufficient to cause asbestos diseases Paustenbach et al overlook several key components of a state review and thus inappropriately conclude that brake manufacturers did not have a duty to warn consumers of the asbestos hazards of brake work As we will illustrate historical standards stated that manufacturers had a duty to test products and warn workers as well as end product users of potential hazards and there was sufficient evidence to require that greater action be taken to protect workers from asbestos exposure Paustenbach et al limit their review to published studies omitting information privately held by the corporations that manufactured asbestos products as well as This stands in contrast to a medical state review which provides the most current information on a disease and its treatment and generally does not include a historical analysis of the medical literature as with a medico state review DECONSTRUCTING A STATE REVIEW / 547 international literature about the dangers of asbestos They contrary to historical and scientific evidence response curves fiber type data and quantitative epidemiologic evaluations are necessary to establish any basis for understanding the health effects of asbestos exposure in brake mechanics Their set of criteria does not account for the way industrial hygienists and occupational physicians used scientific information to protect workers during the periods in question including both friction product manufacturers and brake mechanics Further the authors mistake the premise of a state review by focusing on causation instead of cause for concern which is the appropriate consideration for triggering a warning For public safety all substances or products that trigger cause for concern generate a duty to warn 9 Current proponents of public health must be aware of corporate production of inaccurate science and be prepared to deconstruct and reject these arguments in order to facilitate the implementation of policies that protect the public workers and the environment rather than cor- porate economic interests In the first half of this article we introduce the studies that Paustenbach et al dismiss and present data they omit in order to evaluate the validity of their state review We compare the contemporaneous types of knowledge that physicians and others accepted to the available information illustrating what was known about the association between asbestos brake work and disease over the past 100 years 10 We subsequently examine state through the perspective of what corporations actually knew at certain points in the past and what duties corporations held according to community standards at the time Our review includes corporate documents uncovered through toxic tort litigation international knowledge available within the United States and a analysis of several of the articles cited by Paustenbach et al EXCLUSION OF UNPUBLISHED STUDIES CORPORATE DOCUMENTS AND THE INTERNATIONAL CONSENSUS ON THE DANGERS OF ASBESTOS Paustenbach et al restrict their state review to published literature while excluding unpublished research conducted by corporations as well as internal documents and communications among company executives In other words the who in Paustenbach et al.'s answer to who knew what when is limited to regulatory officials and the physicians in the public domain who generally had access only to the published medical literature Asbestos product manufacturers however a commissioned variety of confidential studies including epidemiologic studies animal studies and dose measurements had access to data from their own employees who incurred exposures including those related to brake maintenance The corporations took concerted action to keep study results linking asbestos exposure with pulmonary fibrosis and 548 / EGILMAN AL cancer out of the public domain and filled the literature with adulterated animal and human studies asserting that asbestos was not a carcinogen course of action that helped delay effective regulation on asbestos use and warnings 3 5 11-13 This privately held information has become available through document production and depositions related to litigation Dr. Paustenbach and his authors omit this information despite having access to these discovery materials Limiting an analysis to published information is particularly inappropriate in this case since the brake manufacturers concealed knowledge and published misinformation about the risks of asbestos exposure Corporate documents reveal that the brake companies knew more about the risks to brake mechanics than did the medical and regulatory sectors This information includes speeches and minutes from meetings of the Friction Manufacturing Standards Institute FMSI and personal correspondence among company executives industrial hygiene consultants and representatives from industrysponsored asbestos research institutes Appendix 1 lists some of the documents omitted from Paustenbach et al.'s review International Knowledge In addition to omitting unpublished information Paustenbach et al largely ignore the importance of international consensus and regulations on asbestos Efforts to research and identify the cause of pneumoconiosis in industrial workers originated in England in the first decade of the 20th century Regulation of asbestos exposures in the workplace and inclusion of related asbestos diseases in insurance programs occurred early in the 20th century in Germany and England By 1930 representatives in the English Parliament had proposed to include asbestosis in worker's compensation programs and in 1931 the country had adopted the British Asbestos Regulations Paustenbach et al make note of regulations that required monitoring and dust control in industries where workers were exposed to asbestos but assign little importance to them as indicators of what was known about asbestos hazards in 1931 2 p 45 It should be noted that Ford and General Motors two of the funders of Paustenbach et al.'s paper had major operations in Europe beginning in the 1930s Castleman details the development of knowledge about asbestos hazards in England Germany and other European countries citing various case reports and studies of which were translated into English and published in important medical journals well as regulations and workers compensation and insurance policies that recognized asbestosis and lung cancer as industrial diseases 12 Instead of discussing the implications of these regulations and medical consensus Paustenbach et al highlight the fact that there was no national guideline for asbestos regulation in the United States until 1946 and no official national regulation of asbestos until 1971 while diminishing the fact DECONSTRUCTING A STATE REVIEW / 549 that some states Illinois Oregon and California had issued asbestos recommendations prior to 1946 and all states including Michigan had adopted the ACGIH asbestos Threshold Limit Values TLVs by the 1960s They also discount the 1943 Federal Maritime Commission's Minimum Safety Standards for shipbuilding which required periodic medical evaluation and respirators for workers exposed to asbestos dust and the 1960 Walsh regulations which included TLV requirements for asbestos that applied to all federal contracts above 10,000 14 15 A PROBLEMATIC APPROACH TO A REVIEW OF ASBESTOS LITERATURE Experts have always relied on multiple sources of information in order to solve medical and scientific mysteries 16 However Paustenbach et al privilege a limited and fixed set of evidence that they claim may be used to establish a effect relationship between asbestos and disease They restrict their evidence to a subset of epidemiologic studies conducted on specific worker populations that include dose measurements and fiber type Unfortunately conveniently for them these data do not exist Though they concede that a large body of literature existed to support a link between asbestos and pulmonary fibrosis mesothelioma and lung cancer they diminish the importance of many of these studies and case series for one or more of the following reasons ) case studies are not sufficient to establish a causal link between asbestos and disease 2 the study lacks response data 3 the study lacks fiber type information 4 the study fails to explicitly state criteria used to diagnose asbestosis and 5 epidemiologic studies that follow cohorts in a particular occupation e.g. textile insulation brake manufacturing cannot be used to analogize risk to workers in another occupation i.e. brake maintenance The authors do not adequately explain these assertions nor do they cite any scientific historical or current supports their criteria Paustenbach et al acknowledge that no early studies documenting the existence of pulmonary fibrosis asbestosis in asbestos workers relied on response fiber type or quantitative exposure data Despite arguing that there was insufficient data in these studies to quantify the extent of exposures they assert that these same studies established risk to highly exposed asbestos manufacturing workers including friction product manufacturing workers 2 p 49 Case Studies Case reports of lung disease in asbestos workers appeared in the literature in the first decade of the 1900s 17 18 In 1924 W.E. Cooke published the groundbreaking autopsy findings of Nellie Kershaw a year textile manufacturing worker describing fibrosis of the lungs due to the inhalation of 550 / EGILMAN AL asbestos dust 19 In the following years in both the United States and England major medical journals published a flurry of similar case reports documenting pulmonary fibrosis and definitively attributing it to asbestos inhalation 12 20 Paustenbach et al would have readers believe that the early case studies describing asbestosis and later lung cancer and mesothelioma did not convince experts of asbestos dangers and that epidemiologic studies are and have always been a prerequisite to establishing a consensus that a certain exposure caused a disease However case studies have been reliably used by doctors throughout the 20th and into the 21st century in order to make causal determinations about occupational exposures In the first half of the 20th century it was accepted practice for doctors to attribute causation to occupational exposures when the diseases were unusual or unique 21 Case comparisons are epistemologically identical to formal epidemiologic studies a doctor publishes an unusual case as compared to the control group consisting of all other patients the clinician has seen or read about If a patient presented with the unique signs and symptoms of a disease that rarely occurred in the general population and the patient had a history of exposure to an agent associated with the disease a physician could find to a reasonable degree of medical certainty that exposure to that agent is what caused the disease Percival Pott did this as early as 1775 when he determined that a high incidence of scrotal cancer in chimney sweeps disease uncommon in the general population due to the soot they encountered at work 22 Similar causal inferences of associations between industrial agents and occupational diseases were made through cluster observations for a variety of occupational hazards including exposure to benzene radium vinyl chloride and chromium Fleming et al conclude that even in modern medicine where formal epidemiology has increased in importance case reports and cluster observations continue to generate important conclusions about effect relationships 21 In addition to case studies pathology and clinical findings provided evidence of causation particularly when a disease agent left a unique marker of exposure Asbestos leaves specific markers such as asbestos bodies coated asbestos fibers and pleural plaques in the lungs and pleura of patients with asbestosis asbestos lung cancer and mesothelioma Asbestosis manifests a characteristic ray appearance affecting the lower lobes of the lungs and pleura which distinguishes it from other lung diseases such as tuberculosis and also from other types of fibrosis such as silicosis 9 12 By 1930 lung rays had become a tool for identifying asbestos disease and medical practitioners who observed these markers in fibrotic tissue linked asbestos with fibrosis 12 13 Merewether Response Data and Fiber Type Information The number of case reports that confirmed both clinically and radiologically the existence of pulmonary fibrosis in asbestos workers spurred an depth DECONSTRUCTING A STATE REVIEW / 551 investigation by the British Factory Inspectorate In 1930 Merewether and Price published the results of their investigation sectional study of currently employed workers which had no control group an official government report In the same year Merewether published another lengthy report in the Journal of Industrial Hygiene United States that detailed the disease progression and included safety recommendations for workers in the asbestos industry 9 24 The Merewether and Price study did not include specific dose measurements for the various processes fiber analysis or a control group for comparison Nevertheless the authors were able to conclude that a response relationship existed Furthermore the 1930 paper described various producing processes found in the asbestos industry including manufacturing and finishing work done on asbestos brakes and clutches and clearly outlined guidelines for reducing hazardous dust exposures in the workplace Although Merewether studied only textile workers these recommendations were intended to apply to all workers involved in dusty processes including end users of asbestos products and those who worked in manufacturing facilities not yet studied The report noted for example that working with insulation materials which were often only % asbestos was a dangerous trade 9 Merewether listed among the hazardous producing processes awing grinding trimming polishing and other abrading machines used on dry asbestos products all common to many end uses of asbestos products including insulating pipe fitting and brake maintenance and recommended the application of Efficient Localized Exhaust Ventilation at producing points 9 Merewether also specifically addressed the need for ventilation during work on brakes and clutches and told employers manufacturers that protective measures include the education of the individual as in other dangerous trades to a sane appreciation of the risk and to his personal responsibility in the prevention and suppression of dust thus charging them with the responsibility to warn risk workers of the hazard 17 By 1930 Merewether had established the need to warn about asbestos hazards absent any dose measurement fiber type discussion or specific response information 17 Paustenbach et al acknowledge the importance of Merewether and Price's study in that it offered confirmation that there was a clear risk of developing asbestosis from inhalation of asbestos dust and that duration of exposure and amount of dust inhaled were key factors for predicting disease 2 p 45 However they criticize the study because it did not provide data on the doseresponse relationship between asbestos exposure and disease This is exactly our point contemporaneous experts did not require dose or fiber type information to establish effect relationships and implement public health interventions Merewether and Price included copious warnings in their report noted the general applicability of the study's findings across various occupations and recommended warnings and workplace controls Paustenbach et al fail to 552 / EGILMAN AL mention these aspects of the report and regard with a certain degree of surprise the fact that Merewether and Price's study appears to have resulted in the British Asbestos Regulations of 1931 His Majesty's Stationery Office 1931 which required monitoring and dust control in industries where workers were exposed to asbestos 2 p 45 Studies on Friction Product Manufacturers Workers and Their Application to Brake Mechanics Paustenbach et al.'s discussion of the surge in asbestos health effects studies following the publication of Merewether and Price's 1930 report mitigates the relevance of these studies to the plight of brake mechanics The authors identify eight other publications they claim include data specific to workers in brake manufacturing plants 24-31 The authors thoroughly discuss their findings and credit the studies with making clear links between asbestos exposure from friction products and disease however they fault the studies because most were carried out in manufacturing settings as opposed to garages did not identify asbestos fiber type and failed to quantify the concentration of asbestos fibers to which workers were exposed They argue that the data from the studies of friction product manufacturing workers cannot apply to brake mechanics using friction products because their exposures are not comparable Their assertion is uncited and unfounded and it conflicts with information that brake manufacturing companies had at their disposal Castrop GM's industrial hygienist for example describes the risk of working with friction products in manufacturing plants dust exposures to asbestos and other ingredients of the brake lining exist when the dry materials are handled and emptied into the mixers and in the subsequent operations ofslitting grinding or surfacing emphasis added 32 Brake mechanics slit ground and surfaced these same brakes in auto body shops and cleaned out asbestos dust by use of pressured air and sweeping These processes produced visible dust in the breathing zone of workers wherever they performed this work It is clear that early research such as Merewether and Price's study should have applied to all workers in the asbestos industry and also to end users of asbestos products as the paper included precautions for molding cutting sawing grinding finishing and lathing tasks several of which are involved in the installation of brakes and clutches The authors specifically mention brake and clutch linings as a source of containing materials and aptly note that part from manufacture certain work is carried on which involves use or manipulation of asbestos or products containing it 24 Paustenbach et al also diminish the value of these studies for end users by insisting that quantitative data is necessary for making the link in the absence of studies done on mechanics In 1934 Osborn reported the quantitative brake work exposure data the other studies lacked reporting some exposure levels that DECONSTRUCTING A STATE REVIEW / 553 were three times higher than the safe threshold that was proposed to protect against asbestosis just four years later 33 However the authors fault this study as well by pointing out that the report did not include an analysis of health effects However Osborn did express concern about the levels of exposure he uncovered calling for a very much more effective exhaust hood when a dust count was too high during grinding 33 clearly because higher exposures endangered workers health Osborn noted the marked difference between processes that included dust control measures and those that did not For example the exposures incurred by a worker operating an internal brake grinder with a good dust removal system were found to be 4 mppcf million particles per cubic foot whereas a worker operating an external brake grinder with a poor ventilation system was exposed to 17 mppcf Brake mechanics grinding or finishing brakes before installing them were not warned of asbestos hazards or the need to ventilate their workspaces until the 1970s and were therefore more likely exposed to these higher concentrations Moreover Osborn expressed concern about high exposures during intermittent operations a type of exposure typical of those incurred by brake mechanics during compressed air blowout of brake dust from drums 33 Paustenbach et al do not discuss these aspects of the study in their analysis Furthermore the principle of the maximum allowable concentration later the threshold limit value designed to reduce nonmalignant disease applied to all asbestos exposures regardless of occupation and therefore epidemiology studies that included response data for specific occupations were not necessary to determine if a job created a risk of contracting asbestos disease 34 Brake Mechanics and Mesothelioma Paustenbach et al regard the time period from 1960 through 1974 as one in which the focus of health effects studies expanded to include manufacturing environments and end users of containing products including brake linings and pads 2 p 54 They argue that the preponderance of medical literature suggesting that asbestos exposures could result in mesothelioma appeared during these years noting that this was when industrial hygienists began to measure the dust exposures of brake mechanics Indeed the 1960s and 1970s saw the publication of several studies that documented mesothelioma in the end users of asbestos products including brake mechanics 35-41 Paustenbach et al however dismiss these studies claiming that the health effects studies of primary interest during this and subsequent eras are those epidemiological studies that quantitatively evaluated the association of work as a garage mechanic and asbestos diseases This uncited assertion is another instance of Paustenbach et al.'s application of a temporally inappropriate selection of evidence The first studies that 554 / EGILMAN AL quantitatively compare asbestos disease rates for different occupations did not appear until the late 1980s and therefore could not have been of primary interest during the 1960s and 1970s In fact during this era no author of asbestos studies suggested that quantitative evaluation of workers performing any asbestos job was required to establish that these workers were at risk The medical literature of the time was made up of case series and reports from medical registries the same types of evidence that Paustenbach et al dismiss These papers did not merely include a reference to occupations such as garage mechanics or service station operators as Paustenbach et al state but concluded that their cancers were caused by asbestos exposure when the reported jobs involved exposure to asbestos products including friction products This conclusion fits within a larger scientific model that attributes a rare or unique disease to an occupational exposure to a substance such as asbestos and mesothelioma if the medical community has accepted a causeeffect relationship between that substance and the disease These analyses therefore were not intended to establish whether asbestos exposures from end product use were significant contributing causes of mesothelioma but rather to alert the wider medical community to the variety of jobs that presented a risk of causing asbestos diseases Paustenbach et al again misinterpret expert consensus on asbestos hazards for brake mechanics when considering publications that called for implementation of exposure controls during brake work or substitution of asbestos friction products For example the authors cite a 1970 paper by Hatch a consultant for automobile manufacturer Ferodo and another 1970 paper by Lee a consultant for the automobile manufacturer British Leland as studies that measure the amount of asbestos fibers released during brake servicing 42 43 While it is true that these studies do include these measurements it is misleading to suggest that their intention was to determine whether asbestos was a risk for brake mechanics The title of Hatch's paper was Possible Alternatives to Asbestos as a Friction Material and Lee's paper evaluated the efficacy of dust reduction of various brake cleaning methods Risk to brake mechanics was already assumed in these papers it was not an issue the authors sought to determine In 1970 Hickish and Knight consultants for Ford Motor Company published the first and only study of brake mechanics that measured dust exposures over the course of an entire hour day Paustenbach et al selectively report some of the data from this study that appears to support their argument exposure to asbestos during brake maintenance was not as severe as was anticipated however they omit important conclusions including the fact that the asbestos standard may be exceeded in the dust cloud during actual brake cleaning They also omit the conclusion that during truck servicing personal exposures in the vicinity do exceed the standard On a daily basis the personal exposure levels are below the standard although that of the brake cleaner approaches it DECONSTRUCTING A STATE REVIEW / 555 This standard however did not protect against the risk of cancer see below TLV and Cancer Moreover the authors omit Hickish and Knight's recommendation that care should be exercised during brake cleaning to avoid inhalation of the dust produced as well as their caveat that their studies have not included maintenance procedures which involve the filing or grinding of brake lining material and they would envisage that these would give rise to considerably increased air contamination by chrysotile asbestos with the attendant need for strict precautions to prevent the inhalation of fibres 44 Criteria to Diagnose Asbestosis Paustenbach et al discount the studies by Stone and Hawes 1937 and George and Leonard 1939 because they do not provide quantitative information indicate whether workers were handling raw asbestos or fabricating molded brake linings or provide the criteria used to diagnose asbestosis 2 p 49 Interestingly Paustenbach et al acknowledge that no studies between 1930 and 1950 provided diagnostic criteria for the diagnosis of clinical asbestosis Stone and Hawes examined 148 workers at a Dewey's Multibestos brake lining manufacturing facility and found that 82 percent of them had asbestosis 30 45 George and Leonard consultants for the company reexamined the workers and found that 13 percent of the workers had developed clear and advanced asbestosis through the manufacture and finishing of brake pads and linings 28 Despite the difference in the two results the 13 percent rate was enough to alert industry to a problem Hawes stated that asbestos was the most dangerous of all dusts and exposure was often fatal 45 Osborn had already shown that exposures during finishing operations exceeded the TLV In combination these two studies provided exposure and disease information HISTORICAL SIGNIFICANCE OF OMITTED INFORMATION AND DATA Experts Issued Warnings Even with Imperfect Data In their dismissal of many studies Paustenbach et al demonstrate a fundamental misunderstanding of how research in industrial hygiene was interpreted and used to implement worker protection during the first six decades of the 20th century They confuse cause for warning or action with causation asserting that the duty to test and warn is not triggered until there is consensus that asbestos caused an increased rate of disease in a particular group of exposed workers or bystanders Causal consensus is not the marker that determines when manufacturers had a duty to take action to prevent injury to those handling their products Companies have a duty to warn wherever a 556 / EGILMAN AL reasonable man would want to be informed of the risk in order to decide whether to expose himself to it 46 This is an especially important distinction when an industry's financial interests delay causal consensus as they did in the case of asbestos products Paustenbach et al are correct in noting that the field of industrial hygiene was just emerging during the first half of the 20th century Early industrial hygienists knowingly worked with imperfect measurement techniques and often focused on specific occupations However despite the imperfection of the techniques of industrial hygiene research or their divergence from today's industrial hygiene practices the research conducted led experts to reasonably conclude that asbestos exposure was dangerous and manufacturers in fact had a duty to warn workers end users and workers in other occupations It is vital to note that before the 1970s there was no standard technique for counting asbestos fibers and there was no way to accurately convert total dust counts to fiber counts 47 Industrial hygienists could measure only the total number of dust particles in the air and dust counts could not distinguish asbestos fibers from rock or other dust Research funded by the Quebec Asbestos Mining Association showed that there was no way to correlate particle and fiber counts making the acquisition of historical dose estimates essentially impossible 48 Dr. Anthony Lanza the associate medical director of Metropolitan Life Insurance and a consultant for General Motors proposed the earliest guidelines for maximum allowable concentrations of containing dust in 1935 based on analogy to preexisting guidelines for silica 27 In 1938 a study by Dresseen et al of the U.S. Public Health Service formed the basis of a 5 mppcf guideline 49 This study and others utilizing the best measurement techniques available at the time based the guidelines on measurements of total dust particles The authors of this recommendation based it on imperfect data derived from exposure to dust that contained low percentages of asbestos fibers 47 Despite this 50 percent of workers studied who had been exposed to dust at the proposed threshold developed asbestosis after 20 years of exposure The Duty to Warn Brake Mechanics 1970s Corporate documents that were available to Paustenbach et al directly contradict their assertion that brake installation and maintenance produce less asbestos exposures from work with brakes did not exceed the TVL These documents show that the brake manufacturing companies were indeed aware of the risk to mechanics in the 1970s In 1972 Ed Drislane the president of the Friction Materials Standards Institute wrote a letter to J. H. Kelly of Bendix Corporation noting that brake installation exposed mechanics to dangerous levels of asbestos hen customers of yours drill linings chamber linings cut linings or grind linings they may very well raise the asbestos concentration in the atmosphere to above the OSHA standard of 5 fibers per cubic centimeter cc He went on to directly compare factory and user exposures DECONSTRUCTING A STATE REVIEW / 557 Some members of FMSI have indicated that the drilling and grinding operations are problem areas in brake lining factories with existing exhaust systems Therefore if a customer of yours started drilling or grinding without having proper dust collectors he would probably be in violation of the OSHA standard It therefore becomes your responsibility as a supplier of the brake lining to warn the customer of this possibility 50 I. H. Weaver president of the major brake manufacturer Raybestos Manhattan confirmed Drislane's assessment of dangerous exposures in a 1973 speech to FMSI If this kind of thing grinding drilling and cutting operations occurs in fabrication operations of major OE customers it appears to me there can be no argument about the need for educational measures to reduce chances of unnecessary exposure during grinding drilling or cutting operations To those who argue that labeling or other types of warning need not apply to replacement materials because fabricators or appliers handling replacement quantities are exposed relatively intermittently I say emphatically this just ain't necessarily so Large volume replacement users present major potential hazards and even small job shops can needlessly expose people to high fibre concentrations if operations are performed without controls 51 Furthermore Paustenbach et al summarize a 1975 bulletin issued by the National Institute for Occupational Safety and Health NIOSH entitled Current Intelligence Bulletin 5 Asbestos Exposure During Servicing of Motor Vehicle Brake and Clutch Assemblies by stating that the NIOSH document stood for the proposition that the full extent of asbestos disease in brake servicing personnel is not known at present because this particular occupational group has not been studied systematically up to now 52 The authors mischaracterize by omitting the bulletin's determination that servicing motor vehicle brake and clutch assemblies resulted in dangerous exposures and the copious recommendations for controlling exposures to brake mechanics The bulletin also included recommendations for designated areas for brake maintenance work use of respirators and efficiency vacuums for cleaning work areas and ventilation systems for brake and clutch installation and servicing operations which included grinding arcing and compressed air blowout 52 In Appendix 2 we have reproduced some excerpts from the 1975 bulletin that Paustenbach et al omitted from their analysis Furthermore a 1980 Italian study of a friction materials manufacturing plant conducted by Scansetti et al and published in English revealed exposure measurements higher than the data cited by Paustenbach et al during the same period They found that the mean concentration of fibers without full control measures was approximately 1.5 cc for clutch facings 1 cc for brake linings and 1.5 cc for pads 53 This is much higher than the mean exposures that NIOSH reported 0.05 cc while using a variety of controls which were not generally implemented in commercial use Paustenbach et al cite the NIOSH data 558 / EGILMAN AL and several other international studies which they note all fall within the NIOSH data range 2 p 76 but fail to cite this study Historical Context of Fiber Type Defense Paustenbach et al argue that many of the studies used to make causal deter- minations about the danger to brake workers were inadequate because they did not consider fiber type as a factor in the potential for asbestos to cause disease 2 pp 39 46 This assertion is anachronistic as fiber type was not a consideration of early investigations into asbestos hazards Questions concerning the difference in potency of various fiber types did not arise until the 1960s and were primarily an industry tactic to create doubt about the capacity of chrysotile asbestos to cause mesothelioma in end users such as brake mechanics 54 55 Most 1960 literature never mentioned fiber type and all studies including Wagner's mesothelioma case series involved workers who probably had exposure to multiple fiber types 56 Prior to 1960 specific asbestos types such as Canadian South African or British asbestos were mentioned in some documents In 1937 A. J. Lanza explained the origin and purpose of the fiber type defense in response to a question posed to him by the owner of the Multibestos asbestos brake manufacturing facility Bradley Dewey Of course the asbestos people in Canada have advanced that idea for some time as an explanation of why asbestos seems to be more clinically severe in England than in this country but I have always had the feeling that their argument was motivated by interest rather than to make a scientific contribution 57 Corporations understood that the differentiation between the risks of different types of asbestos was a public relations strategy that lacked a scien- tific foundation Quantifying Exposure TLV Irrelevant After Introduction of Asbestos as a Carcinogen Before addressing the TLV it is first important to note that the development of knowledge about the carcinogenic effects of asbestos happened much earlier than 1955 when Paustenbach et al claim Recognition that asbestos caused cancer occurred nearly 20 years earlier with the first case reports of pleural carcinomas in autopsied asbestosis patients 58-63 In 1938 Nordmann was the first to definitively link asbestos and cancer in a published review of the case literature on the issue of carcinoma and asbestosis 64 He based this determination on distinguishing characteristics of carcinomas among asbestotics including ) an unusually large number of carcinomas among asbestotics compared to workers suffering from silicosis 2 the young age of a large proportion of lung cancer deaths among asbestotics compared to the general population 3 consistent lapse of time 15-21 years between first exposure to asbestos and DECONSTRUCTING A STATE REVIEW / 559 death from lung cancer and 4 characteristic tumors in the lower lobes of the lung Nordmann's determination of asbestos cancer causality reflected contemporaneous understanding of scientific knowledge production Notably the effect relationship between asbestos and cancer was based on pathological evidence and included none of Paustenbach et al.'s criteria for state formal epidemiology fiber type and dose measurements or response data Before 1950 pathologists compared the physical findings of microscopic cancers in asbestotics to the lack of such findings in the lung tissue of silicotics to conclude that asbestos was a carcinogen 12 Autopsy studies of silicotics served as the control group for these studies Castleman outlines a large number of studies that supported the asbestos relationship prior to 1955 12 Despite all this evidence Paustenbach et al do not consider the causal relationship between asbestos and cancer to be confirmed until Doll's 1955 epidemiology study which compared lung cancer rates found in asbestos worker autopsies with the lung cancer rates in the general population of England and Wales 65 Doll concluded that asbestos caused lung cancer despite the fact that he did not have any exposure information a specific control group or smoking histories With the development of cancer addressed we now turn to the concern over the TLV Paustenbach et al rely heavily on the fact that measurements of average dust exposures to brake mechanics taken after 1970 using workplace exposure controls were consistently below the 1970 asbestos TLV However TLVs were designed only to protect against the noncarginogenic effects of asbestos not lung cancer or mesothelioma The development of knowledge about another inhaled lung carcinogen nickel carbonyl illustrates this point showing the type quantity and quality of information that was relied on during the 1950s to establish effect relationships With the publication of several case reports linking nickel carbonyl with lung cancer health experts treated nickel carbonyl as though it were a carcinogen even though they only suspected but had no definitive proof of its carcinogenicity 66 Because nickel carbonyl was not a major product or profit center for any manufacturer the corporations that manufactured it did not try to influence the medical literature or standard process for its control Without the influence of industry public health authorities took action based on scientific medical and public health principles 67 In 1956 Smyth of the Mellon Institute and Union Carbide Corporation explained the public health response to carcinogenic substances in a publication of a lecture presented at the 17th Annual Meeting of the American Industrial Hygiene Association At this time it is prudent to set the standard for a cancergenic substance substantially at zero as has already been done for nickel carbonyl and no considerations can justify allowing the inhalation of any concentration which is avoidable 68 560 / EGILMAN AL Therefore even suspected carcinogens were treated with extreme caution by responsible industries government and scientists Public health actions were taken to protect and safeguard the public's health before it was compromised Stokinger the chair of the American Council of Governmental Industrial Hygienists ACGIH Threshold Limit Value Committee commented that levels should be adjusted by a safety factor from 100 to 500 for carcinogens 69 This would have meant that once the carcinogenicity of asbestos was established the TLV to protect from cancer due to asbestos ought to have been at least 100 times less than the mppcf TLV intended to lower the incidence of asbestosis Asbestos was suspected as a carcinogen as early as the 1930s and even according to Paustenbach et al.'s narrow standard its link to lung cancer was confirmed no later than the 1950s However regulatory action was slow to develop after this initial recognition because asbestos product manufacturers engaged in a successful campaign to forestall ACGIH classification of asbestos as a carcinogen 47 As Stokinger puts it The TLV's are industry's values But industry generally does not develop anywhere near enough of kinds and amounts of data that can be used for establishing a TLV of a new substance But industry has the sole responsibility to develop data on its own products government is not in a position to develop enough facilities to handle the problem in total nor should it when reliable toxicologic consultants are now available 69 Although Dr. Paustenbach has testified in litigation that he did not think anybody froma scientific body standpoint put forward an occupational exposure limit for asbestos that they thought would eliminate the increased risk of lung cancer or mesothelioma Paustenbach et al fail to disclose the fact that asbestos TLVs did not apply to carcinogens in their review 70 As John Wells the medical director of Uniroyal noted at the 1964 Selikoff conference But as far as a safe level of asbestos dust is concerned our own conclusion in Hogansville Ga is that there is no safe level The safe level is nil and anything above the safe level represents certain risk 71 Therefore Paustenbach et al.'s arguments that are based on a lack of exposure measurements response or fiber type are spurious after 1955 when they acknowledge that the relevant scientific community determined that asbestos was a carcinogen By 1965 the fact that there was no safe level of exposure to asbestos became painfully obvious as the medical literature was inundated with mesothelioma cases not only in miners and manufacturing workers but in end users such as brake mechanics and insulators and also in workers wives children siblings and others who lived in the vicinity of asbestos factories 12 DECONSTRUCTING A STATE REVIEW / 561 CONCLUSION Dennis Paustenbach is the President and Founder of ChemRisk a scientific consulting firm that specializes in using risk assessment methods to characterize and provide improved understanding of complex exposures 72 Paustenbach has outlined and described the business model for his company and consulting I've followed a model of trying to learn about the substance share what I've learned in the published literature and if they ask testify about it 73 Paustenbach marketed this model in a speech to the Asbestos Information Association These kinds of 250,000 500,000 investments in ChemRisk research go a long way If you've got 100 cases and it takes 4 million for the lawyers and consultants to get ready for the case and to take it to trial you can see this is a drop in the bucket 74 Thus corporate investments in research will generate scientific papers that companies can use to avoid regulation and compensation This is a perversion of the scientific method which if used correctly does not promise particular results He also explained the magnitude of the benefits There are over 60,000 cases in the United States . . involving brake dust It's a serious litigation matter . . . recently most of the time the cases are not lost but last December just three months ago there was a 30 million dollar verdict on a meso with a brake mechanic 30 million 30 million A single meso case Even though there was other exposures in his life So you can lose a brake dust case And I think the more data you have the better off you are and it's best to get the approval of your colleagues in the scientific community 74 Awareness of knowledge production that is designed to serve corporate interests has increased over the past decade leading courts and the public to place greater scrutiny on corporate science 5 75 As a result some consultants have modified their business plans to avoid this critique Paustenbach now partially or completely funds his own research he then markets this research through letters to companies engaged in lawsuits and solicits consulting arrangements to use the resultant knowledge production to defend law suits 76 During a 2008 examination Paustenbach stated I've always like so many Americans I felt sorry for the underdog so I felt there were times in the environmental movement when there was a redistribution of wealth that was inappropriate . . . So I thought scientists had a responsibility to talk about these matters and that's what I've chosen to do 73 It is important to note that Paustenbach conducted research on hundreds of toxins for over a hundred companies see Appendix 3 562 / EGILMAN AL The production of knowledge designed to serve corporate interests can stifle regulatory efforts and affect public health policy by creating doubt about the association between exposures to toxic substances and disease Corporate experts call for a false epistemology that requires a continually changing arbitrary set of criteria to establish a effect relationship which is always one set of information beyond the available information When animal studies are missing the consultants call them a key data gap that precludes public health intervention and of course compensation On the other hand when this type of information is available the corporate consultants demand epidemiologic studies reducto ad absurdum as in this case Paustenbach et al call for epidemiologic studies that use exact measurements of historical exposures that were never measured Proponents of public health must be aware of the revisionist techniques of corporations and companies hired to generate scientific findings that serve their economic interests These findings are presented to create the appearance of sound science to persuade the courts and regulators to deny claims of harm and the need for regulatory action Public health advocates need to be well prepared to invalidate such purported scientific findings This report has provided a framework for deconstructing revisionist scientific reports prepared on behalf of corporate interests Editor's Note Dr. Egilman serves as an expert witness to injured workers and to asbestos product manufacturing companies in asbestos tort cases Appendix 1 follows APPENDIX 1 Information Omitted by Paustenbach et al Source American Industrial Hygiene Association 77 Year Information 1958 Guidelines Cited brake linings as source of asbestos exposure Ford Motor Company Fibrous Asbestos Emissions 78 B. Newman Perilous Particles Wall Street Journal 79 1971 Report prepared for the State of Illinois Part of a deliberation on banning asbestos In the summary Ford stated that nhalation of fibrous asbestos has been considered the source of asbestosis and mesothelioma . . Ford also notes Semi linings are superior in performance to traditional linings about equivalent in terms of wear and noise but the cost penalty is severe 1.25 just for front brakes DECONSTRUIG 1972 The article beginswith a description of mechanics blowing dust outof brake parts and states What the mechanics don't seem to know thousands of other mechanics that the brown dust is dangerous A And if a mechanic breathes in enough dust from worn out linings it could eventually kill him Ed Drislane Executive Director Friction Manufacturers Standards Institute 50 STAE 1972 Internal document In a letter to J. H. Kelly of Bendix Corporation Ed Drislane stated hen customers of yours drill linings chamber linings cut linings or grind linings they may very well raise the asbestos concentration in the atmosphere to above the OSHA standard of 5 cc He went on to state that if a customer of yours REVIW started drilling or grinding without having proper dust collectors he would probably be in violation of the OSHA standard It therefore becomes your resonsibility as a supplier of the brake lining to warn / 563 the customer of this possibility Source I. H. Weaver Raybestos Chairman of FMSI Asbestos Study Commission 51 Daniel Stone Bendix Corporation 80 APPENDIX 1 Cont'd 564 / Year Information 1973 Address Delivered at the Annual Meeting of the Friction Materials EGILMAN Standards Institute Many other elements of the OSHA Regulations came out more favorably toward industry than the recommendations that were submitted by NIOSH and the Advisory Committee and stiff resistance by industry will be needed to prevent OSHA from strengthening the regulations in months to come . . . | was exceedingly surprised when the final OSHA Standard came out in favor of considerably milder wording The OSHA Advisory Committee had recommended using the word danger on asbestos labels which was then downgraded to caution Now I am perplexed that industry resists the OSHA labeling requirement as vigorously as it does 1976 Ballot for Publication in FMSI Catalogs of Recommended Procedures for Brake Service Shops Representative of the Bendix Corporation voted in favor of the Asbestos Study Committee recommending to the Board of Directors the printing of a page in FMSI Catalogs recommending procedures for reducing asbestos dust during brake servicing However the representative noted that the drawback of course is several pennies cost DECONSTRUCTING A STATE REVIEW / 565 APPENDIX 2 Excerpted from 1975 NIOSH Bulletin Current Intelligence Bulletin 5 Asbestos Exposure During Servicing of Motor Vehicle Brake and Clutch Assemblies 52 . . . Data was presented by investigators from the Mount Sinai School of Medicine in New York City indicating that workers engaged in the maintenance and repair of automobile and truck brake linings are exposed to potentially hazardous levels of airborne asbestos dust The present findings indicate that enough asbestos is preserved to produce significant exposures during certain brake servicing procedures The full extent of asbestos disease in brake servicing personnel is not known at present because this particular occupational group has not been studied systematically up to now However a review of the scientific literature on the association between asbestos exposure and mesothelial tumors of the pleura peritoneum has revealed at least four cases of these rare tumors in persons who were employed injobs involving automobile brake servicing Italics added The environmental studies of brake lining servicing operations outlined above together with observations of mesothelial tumors in persons so employed affirms the necessity for instituting and maintaining recommended control measures in this industry so that the health hazards of asbestos are minimized . . Recommended Interim Procedures for Asbestos Brake and Clutch Servicing 1. If possible an area shall be designated for all brake and clutch repairs Entrances into this area shall be posted with an asbestos exposure warning sign as follows Asbestos Dust Hazard Avoid Breathing Dust Wear Assigned Protective Equipment Do Not Remain in Area Unless Your Work Requires It Breathing Asbestos Dust May Cause Asbestosis and Cancer APPENDIX 3 Paustenbach's Underdogs and Toxic Substances Paustenbach's Underdogs 81 3M Abbott Laboratories Aerojet Air Products Alcoa Allergan Allied Signal Amchem American Petroleum Institute American Paper Institute Amoco Apple Computers ARCO Beazer Corporation Boeing Borg Warner Bucyrus 566 / EGILMAN AL Buffalo Pumps Caterpillar Chemtura Champion Paper Cheese Institute Chemical Manufacturers Association Chevron Chemical Company Chevron Land & Development Chrysler Coltec Industries Garlock Dow Chemical Eli Lilly chemicals and asbestos Exxon Fermenta First Federal Fischer Scientific FMC Food Trade Association Ford Land & Development Ford Motor Company Formaldehyde Institute GTX General Dynamics General Electric General Telephone Georgia Pacific Gould Ind GSF Industries GSX Inc. Halogenated Solvents Industry Alliance HSIA Hawker k Hawker Beachcraft Hercules Hewlett Packard Company Holly Sugar Honeywell Hughes Aircraft IBM ICI Americas Industrial Health Foundation James River Paper Johnson & Johnson John Crane Joslyn Koppers Kaiser Gypsum Leslie Controls Lockheed Missiles & Space Los Alamos Lucent Maxus Energy Corporation McKesson Mead Paper Mercedes Benz Merck Miles Mobay Mobil Oil Corporation Monsanto Montrose NACASSI Northrop Northwest Paper and Pulp Association Occidental Petroleum Pacific Treatment Pacific Gas & Electric Pfizer Plantronics PPG Incorporated Procter & Gamble Questar RCA Reichhold Rh^nePoulenc R.J. Reynolds Roche Rocketdyne Rockwell Rogers Seeds Sandoz Pharmaceutical Semiconductor Industry Asso- ciation Shell Sidney Regional Transit Authority Simpson Paper Company Southern Wood Piedmont Stauffer Chemicals Syntex Agribusiness Texas Instruments U.S. Steel Union Carbide Volkswagen Vulcan Chemicals Warren Pumps Westvaco Weyerhauser Yarway Zeneca Toxic Substances on Which Paustenbach has Conducted Research 81 Asbestos Asphalt Fumes BEHP Benzenes Beryllium 1,3 - Butadiene Carbon Tetrachloride Chlorinated Hydrocarbons Chlorine Chloroform Chromium CIN Copper Chromium Arsenate Creosote DDT Decabromodiphenyl Oxide DES Dicyclopentadinolyron ferrocene Diesel Exhaust Dioxins Ethylcyanoacrylate Ethylene Oxide Fly Ash Formaldehyde Furans Glycol Ethers Hydrogen Sulfide Selexol Lead Mercury Methyl Alcohol Methyl bromide Methyltertiary ether MTBE Methylene Chloride Nitroglycerine Nitros- amines PBDE Perfluorooctonoic Acid PFOA Pesticides Petroleum Products Phosphorus radionucleotides PFOS Polychlorinated biphenyls PCBs Polycyclic Aromatic Hydrocarbons PAHs Perfluorooctonoic Acid Silica Silver Styrene Tetrachloroethylene PCE Tobacco Toulene Trichloroethylene Trihalomethane Vinyl Chloride VPA Welding Rods NOTES 1. D. Egilman J. Kim and M. Biklen Proving Causation The Use and Abuse of Medical and Scientific Evidence Inside the Courtroom Epidemiologist's Critique of Judicial Interpretation of the Daubert Ruling Food and Drug Law Journal 58 2003 223-250 568 / EGILMAN AL 20. Pulmonary Asbestosis Journal of the American Medical Association 90 1928 119-120 21. L. E. Fleming A. M. Ducatman and S. L. Shalat Disease Clusters A Central and Ongoing Role in Occupational Health Journal of Occupational Medicine 33 1991 818-825 doi 00043764-199107000-00018 22. P. Pott Chirurgical Observations Relative to the Cataract the Plypus of the Nose the Cancer of the Scrotum the Different Kinds of Ruptures and the Mortification of the Toes and Feet London T. J. Carnegy for L. Hawes W. Clarke and R. Collins 1775 23. W. E. Cooke Pulmonary Asbestosis British Medical Journal 2 1927 1024-1025 doi bmj.2.3491.1024 24. E. R. A. Merewether and C. W. Price Report on the Effects of Asbestos Dust on the Lungs and Dust Suppression in the Asbestos Industry London His Majesty's Stationery Office 1930 25. S. H. Osborn Forty Report of the State Department of Health 1934 26. W. B. Fulton et al Commonwealth of Pennsylvania Department of Labor and Industry Industrial Hygiene Section Bureau of Industrial Standards Asbestosis Part II The nature and amount of dust encountered in asbestos fabricating plants Part III The effects of exposure to dust encountered in asbestos fabricating plants on the health of a group ofworkers 1935 27. A. J. Lanza W. J. McConnell and J. W. Fehnel Effects of the Inhalation of Asbestos Dust on the Lungs of Asbestos Workers U.S. Public Health Report 50 1935 1-12 doi 10.2307 4581423 28. A. W. George and R. D. Leonard An Ray Study of Workmen in the Asbestos Industry Covering a Period of Ten Years Radiology 33 1939 196-202 29. D. Brachmann Asbestose Bei Bremsbandschleifern Und Bohrern Asbestosis in Brake Grinders and Drillers Arbeitsschutz 3 1940 172-174 30. M. J. Stone Clinical Studies of Asbestosis American Review of Tuberculosis 41 1940 12-21 31. D. L. G. Thomas Pneumonokoniosis in Victorian Industry Medical Journal of Australia 1 1957 75-77 32. V. Castrop Recognition and Control of Fume and Dust Exposure National Safety News 57 1948 20-21 52 73-80 33. S. H. Osborn Forty Report ofthe State Department ofHealth Grinding Brake Linings 5 1934 34. W. A. Cook The Occupational Disease Hazard Industrial Medicine 11 1942 193-197 35. W. C. Hueper Occupational and Nonoccupational Exposures to Asbestos Annals of the New York Academy of Sciences 132 1965 184-195 doi 10.1111 j.1749-6632 1965.tb41101.x 36. M. L. Newhouse and H. Thompson Mesothelioma of Pleura and Peritoneum Following Exposure to Asbestos in the London Area British Journal of Industrial Medicine 22 1965 261-269 doi oem.22.4.261 37. M. L. Bentley Control of the Use of Containing Friction Materials Annals of Occupational Hygiene 13 1970 31-32 38. A. D. McDonald et al Epidemiology of Primary Malignant Mesothelial Tumors in Canada Cancer 26 1970 914-919 doi 1097-0142 CNCR2820260427