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NOV.22.2004 1=33PM c. CRMC RESEARCH ' U U ) 3 U.J 0 1 ' V NO. 305 P.3 John H. Marsh Asb. Cases/GA USDC/GA 10/27/80 Vol. I JHM 8003 Transcript of Remarks by * Raul Kotin, M.D. iBKMaaa S PLAINTIFF'S j CXHIOIT - S*8* : Senior Vice President, Health safety k Environment -. Johns-Manvi.He Corporation - ` , , before * Consumer Product Safety Commission ' f-it * . ' i. :, * tr ,i -. iv June 9, 1977 , " i. 'c'iair.-i-:: \ . . : 1 ` ' 1 ' '\ . . .. . \ , - Perhaps the best way to beginis by introducing myself. I'.m Paul Kotin, a physician', and.a.patholcgist. I entered the -" * . ' field of environmental medicine, environmental pathology, in * * 1952. From the tima that I left.World War,II until 1961, I was a .professor of pathology at the University Of Southern California, School of Medicine. In 1961 I left to Join the government, w* . ... * the national Institutes of Health, for a ten-year period. The first five years of which l was scientific director for etiology of the National Cancer Institute, And, for the nest five years, the founding director"of the National Institute of Environmental Health Sciences. After giving my government ten years of time, X felt that 1 owed, I went back again to academia tor four years as dean of the medical school of Temple University and was also provost for the health sciences at Temple. Three years ago X jolned.'Johns-Manville Corporation as medical director and senior vice president-for health, safety and environment. During, the entire period X practiced environmental and occupational medicine as. a consultant to^both.management and labor ,*;and regulatory agencies as. well.' . i. . , . JHM 14997 OO51999 NOV.22.2004 1:33PM *. CRMC RESEARCH 0 :.i U -a 3 I .5. 0 NO.305 P.4 Page 2 John H. Marsh Asb. CaS6S/GA USDC/GA 10/27/80 Vol- I JHM 8003 What I'd liKe to talk about today Is the question of asbestos and health, particularly as it relates to the regulatory ' - posture of the federal government, and more specifically to the Consumer Product Safety Commission. I think the first generalization, probably the only thing that X hope will be accused of being a cliche, is that all things are hazardous w* . ., . im MIM4... | * , and, basically, we live by virtue of our ability to use * * 1 ." ' . > .<< * * ' ` * ' _ '. , hazardous agents in a non-hazardous manner. Those hazardous agents that we cennot'hase in a non-hazardous manner, of course, represent agents which have to be approached With a great ' deal of caution and care. . , .. ., i ` ~-- ' ` I . iw'*. ' 1 would like to talk a little bit about the-unique ' properties of asbestos and why it is used in many products. ' *. X would like to review the potential problems associated with exposure to asbestos, including the morbidity and the mortality data relating to asbestos exposure, and perhaps oven refer to an analysis of the_trends in asbestos-related disease. ' X would'like to discuss very briefly the principles of asbestos- related disease production. Moving from the effect of asbestos to the material itself, 1 would like to discuss locked-in versus non-locked In products, and friable versus the non-frisble. X guess generally one might say the" responsible use of the material and the less responsible use. Certainly the risk to the consumers and the general public will be an important part of what X have to say in view of the Commission's responsibility. Such responsibility covers not only`the identifiable consumer but certainly extends into the area of the general population, V'J .. .............................. tUM. 0052000 NOV.22.2004 1:33PM CRMC RESEARCH 0 0 J 1 0-* 3 I 5 U NO.305 P.5 Page 3 John H. Marsh Ab. Cases/GA ; USDC/GA 10/27/30 ; Vol. I JHM 8003 Let me first refer immediately to your decision on April 26. . 1 find that the Commission's action is one that I can fully support, in the sense Of the consumer use of certain asbestos-' . containing products. . -i--- *" ia2.*~ * '.............. ': .' But in the generic sense, the responsible control and use '. of asbestos clearly represents an important and perhaps the only , option available to society if it la to take advantage of this , . mineral whOiia unique properties make it virtually indispensible for certain uses. At the outset it is important to emphasize ii ` that all judgments made and positions taken vis-a-vi's asbestos must be predicated on information, on data, and bn responsible judgment, The societal daciaions/that must be made will be wise only to the extent that they axe based on fact or informed judgment. Approaches to the problem must begin with, an analysis of the.potential problems associated.with exposure to asbestos. Since the major potential hazard is the impact on health, information from two sources is necessary. These are morbidity and mortality i.e., what is the impact on sickness and on causes to death related to asbestos exposure? ' Again, X would emphasize trends being analyzed in asbestos-related disease. And secondly, if the problem is going to be approached at its most elemental level, an analysis of tho fundamental principles of the biology at work in the induction of asbestos-related disease is required. Let me digress end say that the question of asbestos-related disease is not at issue. Asbestos-Xjp^it^l - f .1, ...r Kfi h A. . J 4 9 Q 052001 NOV.22.2004 1:34PM CRMC RESEARCH 0 nJ > .3 1 i l NO. 305 P.6 rage 4 and adequately documented in literature. John H. Marsh Ash. Cases/GA USDC/GA 10/27/80 Vol. I JHM 8003 As Z said, the morbidity`and the mortality impact from ' exposure to asbestos has been reported in literature. And from all of these reports it is unequivocal that the characteristics of all environmentally determined or caused diseases, apply to asbestos-related diseases as well. Stated differently, the . hazards associated with this one environmental agent really . * - * >- * -- '"'vJ*'* i . . - esc subsumed within the principles of. the hazards that are , available and exist in the general environment. X think this has some very important implications for the regulation of this material. ..... '. Mow what are these characteristics. The first is dose . ` response and I am sure`.that you are aware that the definition of a dose is the product of concentration of the agent multiplied by the duration of exposure. From this, some generalizations can be made. First, the greeter the exposure, the greater the risk. Secondly, there ie e level of exposure clearly demon * strated that exists without any evidence of adverse effect (and indeed taking into account all the caveats of adequate time having elapsed since initial exposure and a measurable exposure as well).Third,in the world of dose response, at least on the basis of available data, Jbhe greater percentage of those exposed do not develop asbestos-related disease. All of which in no way negates the capability of this product to produce and represent a hazard but, again, puts it in the ball park, I m of general hazards. Asbeseos-relatcd disease, at least in two instances, lung ' concur ar.d aVocstosis, is in the case of lung ear.cur uneevivocally 0052002 CRMC RESEARCH o n u M 8 i3 1 5 Q NO.305 P.7 . Vage S John H. Marsh Asb. Cases/GA USOC/GA 10/27/80 Vol. I JHM 8003 T p and X might s&y for all practical purposes related to the con comitant exposure to cigarette smoke. The relationship of I cigarette smoking to the development of asbestosis is less on- - phatie, , is less determinate, and indeed asbestosis can develop in persons exposed to excessive concentrations of asbestos who do not have histories- of smoking. And certainly, as with all diseases, antecedent or intereurrcnc diseases effeetthe response of a man to an environmental agent. Again, let me reemphasize in the area of general principles of toxicology and environmental hazards, no adverse effective level has been demonstrated and this,'X think, reemphasises the non-uniqueness of-asbestos as an environmental hazard . ^ r . V> Finally, there-are-stigmata.of'exposure to asbestos that'are useful in the sense of providing indications of.hyper-reactivity if you will to this material since a man is not a homogenious entity end it is these stigmata that X think as they become more end more universally .-recognized-iffcr` great hopes_for"continuing ` to maintain asbestos as an item of commerce and at the same time producing no adverse effect'. Let me give you an example, certainly sunburn is a stigma of exposure to sun end sunburn is indeed a risk factor in the development of skin cancer. The . ...analogy is really not to'far-fetched. - - *........................... .. * . Moving away from* # the general. practical aspects, in terms of the approach to'regulation, X think that it is important ' .&../ * . to remember that in all the fundamental studies on asbestos the mechanisms at work from the reaction and interaction of asbestos at the molecular level, with a cell, with the tissue, with atf H M " <*! crtian. nr ws*>, ,, ... . 0052003 NOV.22.2004 1:34PM CRMC RESEARCH (J J i 0 .> 3 I '5 Q NO.305 P.8 Page 6 John B. Marsh Asb. caees/GA USDC/GA 10/27/80 ! Vol. X JHM 8003 biologically accepted principles. I think this is important to emphasize, that again as a hazardous material it obeys the * law of pharmacology, toxicology,' pathology, biochemistry, and the other disciplines that make up the health sciences. An analysis of the data demonstrating the past or demonstrating the effect of the past, in terms of asbestos-related disease,' the conclusion at least insofar as one'man's Opinion is clear that this potential toxicity is capable o% being controlled and the material can be used safely. I'm going to*cop out"by _ using somebody else's definition of safety. Now I fully - recognize all the problems associated with the term safety^ but I don't think one can improve on either tho analysis of gaiety or its definition as developed by Dr, William Lawrence who is . Mu is & Harvard ` university fellow and a faculty member in the area of scientific and international affairs. Mis address to this year's meeting *f the American Chemical Society observed and let me quote: "first the meaning of the term safety is not well understood. And in part as a consequence, the distinction between matters of empirical fact and matters of value judgment is often not appreciated or preserved. For most purposes, 1 find it useful to define safety as A judgment of the acceptability of risk, and risk in turn as a measure off the probability and severity of harm to human health. A thing is safe if its attendent risks arc judged to be acceptable.a` Quoting Dr. Lawrence further, he says: "By its preciseness'and connotative power this w a*, * ' , . ; ...................................tHMienne 0052004 NOV.22.2004 1:34PM CRMC RESEARCH g {) j .) i] ^ 3 I 5> 0 NO.305 P.9 Page 7 John H. Marsh Asb, Cases/GA DSDC/GA 10/27/80 Vol. I JHM 8003 definition contrasts Sharply with simplistic dictionary definitions that have safe meaning something like 'free from risk*1 Nothing can be absolutely free,from risk." This Is the and of Dr. Lawrence's comments. . There can be no doubt that occupational exposure to asbestos has been associated with the development-of asbestosis and an. increase risk to mesothelioma and bronchogenic cancer in a percentage of workers exposed in the past. The data identifying asbestos exposure as a causative factor in gastro-intestinal cancer reveal a significantly lower, attack rate. These tumors ' ' are suggestive and. reflect a massive exposure and even perhaps to fiber modification in the respiratory tract prior to ingestion. Xn fact the demonstration of the increased risk An gastro intestinal cancer has been in the occupational siiutation, - where it is reasonable to assume that virtually all of the. fibers related to gastro-intestinal. tract activity first entered . the respiratory tract and then moved up to the throat where either it was expectorated .which is the unusual thing* with perhaps 90 percent being unconsciously swallowed, hs X mentioned before* bronchogenic cancer is virtually limited to workers who smoke cig.ircttes. But the development of asbestosis and * 1 .. i * * # mesothelioma appear to be little but demonstrably effected in the ' l--- . * ` first east: and mesothelioma shows no relationship to smoking as a cofactor at all.Xe is interesting in a recent report from Mt, Sinai School of Medicine the data show that persons who smoke and have asbestosis appear to have double the age adjusted ( - ' JHM 1500 0052005 NOV.22.2004 1:35PM CRMC RESEARCH 0 l) ! b 3 I b '.J NO.305 P.10 . rage B John H. Marsh Asb. Cases/GA USDC/6A 10/27/80 Vol. I JHM 8003 ' . death r-tes of nonsmokers with asbestosis. In other words, .i workers with esbestosis if segregated Into a smoking and nonsmoking group, those who ere smokers will have double the age adjusted death rates. Is the risk to asbestos-related disease exclusively limited to' the workplace? There are data that suggest that this is m w -- *mmm --'. -- -- . , .t 9* " . . 9a 4 !*jr '** not the case. There are neighborhood cases of asbestos- rolated disease demonstrated by research and studies in the `States, and research and studies in the United Xingdom. Again, these neighborhood cases reflect exposures to effluents in tha . days of virtual non-regulation and in the days of high (I wouldn't know how to define high precisely) -- excessive exposure perhaps is a better description. Another group that has been identified as being at risk to asbestos-related disease at a site other than the workplace are the instances of the asbestos-related disease in family members, of asbestos . * . k i -- . m-- ( k * -4IT I" * '* workers, eonjugal eases. Two important things need to be said about neighborhood cases and conjugal cases. There ere no data, despite the oft repeated statement. . .`that these represent minimal exposures." Actually, the exposures, and __ let us suy the conjugal eases, represent maximal exposures. They are exposures that are 24 hours a day, certainly day-long exposures. They are resuspended exposures to asbestos brought home by the worker. You have a spectrum of susceptibilities. . , ' .1 JHM 15004 052006 NOV.22.2004 1:35PM Page 9 John H. Marsh Asb. Caaes/GA USDC/GA 10/27/BO Vol. I JHM BOO3 . In the workplace , presumably, you have the optimum person, \ one who has passed the preemployment examination, is capable of coming to work everyday. In the average layman's terms is a heulthy person, with the spectrum of resistance and susceptibilities that go with him. In a household, you have the spectrum of the neonate, the infant, to the senescent, the person who is in his seventies or eighties, indeed, without' in anyway minimizing the importance of neighborhood and conjugal casus, one can't reenphosize too strongly that'the corrolery ' of' this is not necessarily that they have been exposed minimally. The third compartment of the-population is the general ' , - .population. ' - . Here there * "... isn't a.shread of evidence that ' .. t he, ` ... qeneral population, has had any -impact on its morbidity" or' mortality as a result of exposure*to.asbestos, speaking as.of 2:35 today. I obviously Can make no case for the future. I think that this can be said with all the certainty that was reflected in my last comment because uniquely one of the asbestosfjcu-lated .. diseases that I mentioned before is mesothelioma, a cancer of the ceils that line the chest and abdominal cavity and also cover the lungs and the chest and intestine and the abdomen. , Th^re is no disease that I am aware of that I think any ' responsible opinion would say that is caused exclusively by * a single agent. For mesothelioma, while the one identifying agent that wo have in tho environment as being causally related is asbestos, there are a given number of cases and hr. Selikoff may aay its is percent asbestos unrelated, t may say 20 percent, . . . ` ' 0052007 NOV.22.2004 i:35PM CRMC RESEARCH rage 10 John H. Marsh Asb. Cases/GA , CTSDC/GA 10/27/80 Vol. X JHM 8003 ' tho differences are really judgmental but there is no questioning the non-sfibestos related cases of mesothelioma. But these cases of mesothelioma are excellent markers. Because we know of no other factors that can cause themt we've got something that we ' can measure and measure very accurately. Again# because it is. an unusual cancer it isn't going to take, and hasn't in fact in the past required, a tremendous nurliar dt cases to give yc'u uume statistically valid data on which to base conclusions or make .judgments. A very perceptive surgeon saw three cases of ` . angiosarcoma of the liver in Louisville three years ago, and .that is all it took for him to realize that, gecularily, all" three worked in one place, x am trying to emphasize that, because of the importance of the issue of whether asbestos is a general population hazard or not, one has to make as critical and resoluted defense as possible of the use of mesothelioma as the marker. X would submit that there is no authority in the field that would question the use of mesothelioma as the marker. X would further submit that there are no data to suggest that mesothelioma is on the increase. X guess the next thing that one has to concern one's self with i5 the projections of disease. Vie have data on the occurrence and we know that the current prevalence of asbestos-related disease reflects past exposures. Xt is clear that the disease 1 that v?e now see is the consequence of deficiencies in the past. Projections for future occurrence of asbestos-related disease are essentially valid only to the extent that they clearly state the JHM tSOOfi. 0052008 NOV.22.2004 1:36PM CRMC RESEARCH Q 0 vl i S ! S (J*\305 P.13 '` page 12 John H. Marsh Asb. Casas/SA USOC/GA 10/27/80 Vol. 1 JHM 8003 past exposure they reflect or the current exposure out of vl.ich projections are made. Again, X would submit that there are no students in the field that would not accept this as a valid generalization. -* '' ' , The responsible uses of asbestos require an analysis of '- its environmental location as well as the potential hazards ' ; t. * . ... and the population targets in each of the several environmental compartments. In a submission X will provide for the Commission I will .1 ` * *" . have these outlined, but let me just read them* If one were to bogi-\ asbestos at the mine, follow it to. the mill,its use in manufacture, its distribution, concern`one's self with waste disposal, concern one's self with asbestos as a mineral, as distinguished from asbestos as a component of a product, one could define a scries of potential vectors for hazard and different populations at risk. Further, if one moves to the area of ongoing use one has to worry about the availability of the asbestos in the product as advantageous or as an undesirable component of llic environment. One, of course, has to worry about the exposure during maintenance wnd repair of equipment or maintenance and repair of asbestos-containing products. Again, one has the additional problem of worrying about demolition. Hu have a series of environmental compartments to which one can relate the exposure populations at risk. Everything from the mine and mill to the product is a potential hazard to the worker. Waste diiposai presents a hazard to the worker in the neighborhood in c,ithor solid waste form, liquid waste form, or aunospheric contmtn>i'.!'.o.*. ... _______-- ............_J ?*\ HP 15007 36PM rage 12 John H. Match Asb- Cases/GA USDC/GA 10/27/80 Vol. I JHM 8003 Xn the case of the transport it is the worker that is *t risk. ' In the case of product use it is the general public that is at risk, an the case of demolition it is ths worker and the neigh- . borhood. . '' If one uses this as a grid to which one then appliea asbestos both as a fiber and as a product, one can begin to identify responsibilities. Xn this cas, as an employee of * ' 4 4 ** - , management, there are responsibilities that X think management has. The obligation of the primary producers and manufacturers is jbo ensure responsible use of asbestos and this requires ' ` ongoing surveillance of the material. This really can be divided into perhaps three rather arbitrary periods of time. xThe prst. think that one can use the word "obligation" to describe the relationship to the past and that is the obllgatio -his information so that tha purchasers of Asbestos fiber . nd the asbestos produets themselves are capable of safe use nd, where necessary, education of the customer by the producer a facilitate for compliance with all regulations, let me iphasisu the words "safe use" having given you a definition safety. in addition to this responsibility for the product and your ligation to it through its environmental train you have >ther way of manifesting this and that, is the labeling actions for safe product;;. And really it is society that :mines how much you inform. Xn same areas one can be NOV.22.2004 1:36PM CRMC RESEARCH U...U..J i| j j ^ I tj fNO.305 P.15 Page 13 John h. Marsh Asb. Caeea/GA USDC/GA 10/27/80 Vol. X JHM 8003 disappointed at how little information might be given on a pact of cigarettes, or wish that there might be more on a bottle of elorox or even on a package of aspirin tablets. Nevertheless there is the ceution "use only as directed," etc. . This is what I refer to as generic labeling. At times there is a need for special labeling, as indicated in terms of long irritants, skin irritants, potential cancer hazards. ete. Industry has a responsibility for research in these areas, to make \ ie ^ product for all of its uses as minimally potentially hazardous as it can. In other words, producers must concern themselves with end uses of the products as well as the user.. Bach _ product must be examined. A decision must be inadu as to the benefit risk of each product. Certainly the Consumer Product Safety commission in its deliberations in the past that X have read address themselves to this in an important and intensive way. Xt is important to remember that as of now all evidence suggest that asbestos-related disease is the result of in halation of excessive amounts of asbestos fiber. Therefore, the major effort should be directed to reducing or eliminating the likelihood of fiber becoming airborne so that indeed it ean be used without the likelihood of respiration. For the present management has a responsibility to provide an acceptable work environment, recognising that there arc no hazard-free voids in life. Nevertheless, management must assume responsibility for generating no new cases of disease. Xn 'addition. ftvinecnm-->nt *mst aath**r.dnt.-* .Mint rr>n *:sd in JHM 15009 0052011 MOV.22.2004 1:36PM CRMC RESEARCH D O j l '.l S 3 1 5 \ f^-305 P.16 I'agci 14 ' John H. Marsh Asb. Cases/GA OSDC/GA 10/27/30 Vol. I JHM 8003 . developing criteria and setting standards and must ' .` ' . . ' comply with standards already promulgated through engineering controls, appropriate work practices, ongoing industrial hygiene and personnel monitoring,participation in research projects, identifying high risk groups, and the development of products with' locked-in fiber. -- I. would like to sum up what Z have been trying'to 'say. The availability of fiber as a hazard ccortainly is the guiding principle in the performance of my job. This responsibility is manifested in terms of what is the likelihood of the product being a hazard to tha user. No less than what is the likelihood of ten aspirins being.taken rather than two which could make you very sick or fifty aspirins , which might kill you. There is no way of guaranteeing that a person is not going to take the fifty aspirins. And ! suspect that there is no way of guaranteeing that a person deliberately intent on releasing locked-in and bound fiber will not be able to release this locked-in fiber. Management, in full compliance with all the regulations, going beyond when its technology and engineering allows it to, produces very, very useful products. And let me use as a classical example of a bound-in product, asbestos cement, there are a variety. To become more specific let's say asbestos-cement used for the delivery of potable water. You have a material that is economically feasible (I don't know much about that, X am just repeating what I'm told by our.management, by our sales people) that it La a highly competitive product. X do know that it frequently is the difference between potable water being .. JH1A 15010 0052012 NOV.22.2004 1:37PM CRMC RESEARCH a u u ') ) $ s i b l NO.305 P.17 Page*'15 . available in certain parts of the world and not being available in certain parts of the world. But even that would not be enough were it not for the fact that it is possible to deliver hazard-free water through asbestos-cement, great material. Again, one has to recognize that it is important that we atop for red lights, it's important that planes don't go off the runway at eithar National or Bulles, and that it is important not to run. into a tree on a slippery road. % think that these are specific examples of where you have materials that clearly meet social needs. My message is that the useful, the unique special properties'.of asbestos, can be preserved and can be .. .... . emphasized.' The instances where, asbestos products may`be potentially more hazardous are instances where this commission very legitimately addresses itself. ' . -f # * , John H. Marsh ! Asb- Caaes/GA \ nsnc/GA 10/2T/30 'jH^non 0052013