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FILE NAME Talc TALC DATE 2019 July DOC TALC187 DOCUMENT DESCRIPTION Public Health Then and Now Article - Nondetected- The Politics of Measurement of Asbestos in Talc 1971-1976 PUBLIC HEALTH THEN AND NOW Nondetected The Politics of Measurement of Asbestos in Talc 1971-1976 David Rosner PhD MPH Gerald Markowitz PhD and Merlin Chowkwanyun PhD MPH The recent lawsuits against Johnson & Johnson have raised the issue of what and when talcum powder manufacturers knew about the presence of asbestos in their products and what they did or did not do to protect the public level exposure to asbestos in talc is said to result in either mesothelioma or ovarian cancer Johnson & Johnson has claimed that there was no detectable asbestos in their products and that any possible incidental presence was too small to act as a carcinogen But what exactly does nondetected mean Here we examine the historical development of the argument that asbestos in talcum powder was nondetected We use a unique set of historical documents from the early 1970s when level pollution of talc with asbestos consumed the cosmetics industry We trace the debate over the Food and Drug Administration's efforts to guarantee that talc was up to 99.99 free of chrysotile and 99.9 free of amphibole asbestos Cosmetic talc powder manufacturers through their trade association pressed for a less stringent methodology and adopted the term nondetected rather than asbestos as a term of art Am J Public Health Published online ahead of print May 16 2019 e6 doi AJPH.2019.305085 "herecent lawsuits against Johnson & Johnson and particularly the 4.8 billion verdict against the company have raised the issue of what and when talcum powder manufac- turers knew about the presence of asbestos in their products and what they did or did not do to protect the public.,, Since the 1960s asbestos even at low levels has been recognized as a cause of lung cancer and mesothelioma Since the early 1970s the cosmetics industry as represented by the Cosmetic Toiletry and Fragrance Association CTFA has claimed that there was either no asbestos or that any residual asbestos in their products was nondetected But what exactly does nondetected mean Here we examine the historical devel- opment of the argument that asbestos in talcum powder was nondetectable We use a unique set of historical documents from the early 1970s when the Food and Drug Administration FDA raised concerns over findings of low level pollution of talc with asbestoWse trace the debate over the FDA's efforts to guarantee that talc was up to 99.99 free of chrysotile and 99.9 free of amphibole asbestos Talc pow- der companies counterproposals were less stringent they proposed methodologies that were capable of detecting asbestos up to 99.5 The difference in these methodologies meant that potentially billions of asbestos fibers could be released into the air when babies were powdered or adults powdered themselves Cosmetic talc powder manufacturers pressed for the less stringent methodology and adopted the term nondetected asbestos rather than asbestos- free as a term of art The CTFA the industry trade association which represented companies such as Johnson & Johnson Col- gate Pfizer Mennen Avon and other manufacturers of cosmetic talc products spearheaded the efforts to define how to measure asbestos in talc These contests over method- ology were enormously important They should be seen as part of parallel battles over operationalization of regulatory terms Since 1958 the FDA had been embroiled in controversy over proper interpretation of the so- called Delaney clause which banned approval of food additives that were carcinogenic But how exactly to define zero as historian Sarah Vogel puts it was far from evident and resulted in decades of debates over the clause's interpretation. When the controversy over talc began the National Institute for Occupational Safety and Health NIOSH was arguing that only an asbestos exposure approaching zero could ensure workers protection against cancers If as- bestos could cause cancer among workers even at minimal levels of exposure then consumer advocates and federal officials worried that everyday users of products with asbestos were at risk too In earlier articles we have traced how two other trade associations representing manufacturers of asbestos products reacted to the changing political scientific and regulatory efforts to control asbestos exposure.5 Here we look at a third the CTFA representing an industry whose market was the broad public men and women mothers and fathers and even babies ORIGINS OF THE CONCERN OVER TALC The suspicion that asbestos was a dangerous pollutant in Public Health Then and Now Peer Reviewed Rosner et al AJPH July 2019 Vol 109 No.7 PUBLIC HEALTH THEN AND NOW talc can be traced back to the 1930s when a number of clinical reports appeared indicating that talc workers were suffering from a pneumoconiosis whose symptoms resembled asbestosis the insidious lung disease that was of major concern at the time For example Waldemar Dreessen published a study of workers in two mills in 1933 and concluded that he silicate dusts of tremolite talc i.e. talc mixed with tremolite one of the six major forms of asbestos and slate induce a fine diffuse bilateral fibrosis of the lungs which is definitely demonstrable in the ray In 1942 F.W. Porro and his associates presented 15 cases of talc miners and millers with pneumoconiosis They wrote It would appear from a consid- eration of Dreessen's analysis that the dust responsible for the disabling pneumoconiosis must be the talc itself in the form of tremolite or soapstone or both They also commented that common to all cases is moder- ately frequent presence of asbes- tos bodies in the lesions .... The presence of asbestos bodies in fibrotic areas implies a degree of similarity between asbestosis and pneumoconiosis due to talc In 1956 A.C. Hunt publishing in Thorax wrote that commer- cial talc is a mixture of the pure mineral talc hydrated magnesium silicate with related minerals such as dolomite serpentine anthophyllite and tremolitThee amount of pure talc in commer- cial specimens is very variable In 1963 the National Safety Council an historically managefriendly group founded in 1912 by industry to inform companies about help them adongoing health and safety problems in their plants issued a pamphlet that stated Talcosis is usually associated with tremolite talc The council noted that the diseases produce changes in the lungs and symptoms similar to those of asbestosis By the 1960s miners of talc had been identified by occupational health researchers as at increased risk for lung cancer Morris Kleinfeld and his colleagues conducted a study to ascertain the health hazards associated with exposure to dust in talc mining and milling They concluded that the data on carcinoma of the lung and pleura shows an overall mortality from carcinoma of the lung and pleura to be approximately four times that expected The asbestos manufacturers identi- fied tremolite in some body talcum powders In addition researchers identified tremo- lite in samples of cosmetic talc products Louis Cralley and his colleagues analyzed 22 talcum products and found that all of them had an appreciable fiber content ranging from 8 to 30 The fibrous material was predominantly talc but probably contained minor amounts of tremolite anthophyllite and chrysotile as these are often present in fibrous talc mineral deposits Some went even farther arguing that cosmetic prod- ucts were a threat to consumers It is difficult to conceive of a better way of having fibers inhaled than the use of cosmetic talcum powders In light of growing suspicion that asbestos even at minimal levels was carcinogenic the FDA called representatives of a wide range of cosmetics manufacturers and scientists to Washington in August 1971 to discuss in detail analytical methods for the determination of minor amounts of asbestos like materials in talc with particular reference to cosmetic grade talcs or as one member of the CTFA called it the asbestos in talc problem meeting brought together a number of parties talc manufacturers including Johnson & Johnson and Pfizer government officials from the FDA the Bureau of Mines NIOSH and the US Geological Survey physicians and scientists such as Irving Selikoff William Nicholson and Arthur Langer of Mt. Sinai School of Medicine and Seymour Lewin of New York University and representatives ofJohns Manville and the Consumers Union At the meeting as reported by Pfizer researchers attendees discussed a number of different methods for identifying asbestos in talc including light microscopy ray diffraction electron microscopy and electron diffraction The meeting laid out the evolving concerns of industry consumers researchers and the FDA regarding how to evaluate the dangers from asbestos contamination in their products in light of the growing evidence that even the smallest exposures to asbestos could prove carcinogenic By August 1972 some results had begun to come in from both inside and outside NIOSH indicating that there was a problem NIOSH had independently been testing nine commercially available baby powders by using electron microscopy Its study indicated possible asbestos fiber contamination of commercial baby powders A month later Seymour Lewin under contract with the FDA began reporting his findings of the contamination of talcum powders Of the 102 samples of standard commercial products containing talc that he tested ray diffraction showed that 59 of the products had no detectable amounts of any asbestiform minerals had small but definite percentages of both tremolite and chrysotile and 7 had substantial percentages AJPH July 2019 Vol 109 No.7 Rosner et Reviewed Public Health Then and Now e2 PUBLIC HEALTH THEN AND NOW of one or both of these asbes- tiform minerals In a memo CTFA representatives noted Lewin's conclusion that over 40 percent of the samples may con- tain asbestiform minerals such as chrysotile or tremolite There was a lot at stake for both the industry and consum- ers The Wall Street Journal in February 1973 gave a detailed summary of Lewin's findings telling its readers that 10 of the 200 talcum powders tested contain % to % asbestos impurities with a handful running as high as 10 to 20 The impact was expected to fall primarily on manufacturers of dusting powders baby powders after shave products and the containing cosmeticThse Journal reported that the FDA would impose stringent limits on these products but optimistically predicted that manufacturers would likely support these changes Most cosmetic concerns agree that asbestos must be eliminated from their products and some have already moved to do so partly under FDA pressure Apart from economic considerations the political milieu of the time also gave both the manufacturers and the FDA reason to worry Skepticism of large institutions was burgeoning with activist ire aimed at everything from major research universities to the military to large corporations Advocacy for the interests of the everyday consumer particularly around health and safety concerns was exemplified by the attorney Ralph Nader who became the public face of a revived con- sumer movement that thrived from the early 1960s into the 1980s Nader had made his mark with a scorching investigation of automobiles entitled Unsafe at Any Speed which had shaken the entire industry and led to sweep- ing legislative reforms.2,,He subsequently led young investigative dubbed Nader's Raiders wrote critical and detailed reports on other targets including government agencies like the Federal Trade Commission and Department of Veterans Affairs The FDA was no exception to this muckraking One Naderspawned entity Public Citizen created a Health Research Group headed by the physician Sidney Wolfe It focused on pharmaceutical safety and transparency in the approval process taking advantage of new laws like the Freedom of Information Act to request previously classified material.23 Other groups most notably activists in the women's health movement set their sights on the safety of synthetic hormones and contraceptives.Corpora- tions and the FDA both faced a new culture of accountability for corporations over the safety of their products for the FDA over the ability to ensure that safety if corporations themselves could not provide it It is in this context that the exchanges on methodology between the CTFA and the FDA occurred THE INDUSTRY GOES ON THE OFFENSIVE In the fall of 1973 the FDA announced its proposed rule in the Federal Register drug drug ingredient or drug packaging material containing talc that fails to meet the specifications ... as determined by the method set out ... shall be deemed to be adulterated in violation of ... the Act and thus not a substance generally recognized as safe The standard was exacting The FDA proposed using a polarizing microscope that they believed could accurately ensure a purity of talc at least 99.9 percent free of amphibole types of asbestos fibers and at least 99.99 percent free of chrysotile asbestos fibers The industry reacted immediately and negatively to the proposed rule Two weeks after the announcement in the Federal Register the CTFA Subcommittee of Scientific Advisory Com- mittee on Asbestos in Talc met and attacked the FDA's method- ology as not completely reliable and discriminatory arguing it was not clear that the methods used really measured true asbes- tos fibers The CTFA suggested that the methods could actu- ally be finding nonfibrous or nontoxic materials hrysotile might fall within the critical range of refractive indices used the CTFA contended Further committee members claimed that the counting even if ac- curate would take an inordinate amount of perhaps six hours a technician to reach a tentative identification of the asbestos content The tedium effect on the person count- ing is obvious the committee maintained.26 The CTFA organized a round robin test to determine the reliability of the methodologies proposed by the FDA After distributing samples of talc from a variety of mines from a number of states it asked various companies to have their experts determine whether the samples contained chrysotile or amphi- bole asbestoTs he CTFA had provided samples that they had spiked with known amounts of different asbestos fibers to see how accurately or inaccurately the methodologies performed The round robin test revealed strong inconsistency among the different scientists applying the method to the same group of coded talc sampleTsheCTFA e3 Public Health Then and Now Peer Reviewed Rosner et al AJPH July 2019 Vol 109 No.7 PUBLIC HEALTH THEN AND NOW concluded that the method published in the Federal Register does not provide a truly reliable means for the detection of asbes- tos in talc Given that the meth- odology was tedious and may consume as much as one half day per sample the subcommittee urge that the Food and Drug Administration defer finalizing the proposed optical microscopic method and proceed to a program which would combine FDA and Industry in a strong effort to develop a truly reliable method The CTFA subcom- mittee estimated that a satisfac- tory method will take at least six months to a year to develop if industry and the FDA worked together.27 The industry was willing to challenge the FDA since some privately believed that the FDA is reluctant to take any legal action in any problems with industry The CTFA had been told that the FDA had neither the money nor the manpower to pursue matters so that they will have airtight cases in scientific matters The CTFA also challenged the government even though one representative ofJohns Manville reported that some talc suppliers were distributing products with high amounts of three of the major forms of aschrysotile tremolite and anthophyllite might be lying to the government about it R.S. Lamar ofJohns Manville was specifically referring to R.T. Vanderbilt Company talc products which always have and continue to contain chrysotile as a significant mineral component in addition to tremolite and anthophyllite He concluded his private correspon- dence with another Manville executive It is apparent that the R.T. Vanderbilt presentation to OSHA Occupational Safety and Health Administration NIOSH FDA MESA Mine Enforcement Safety Administration etc. are based on something less than the truth This struggle between the government and industry over the FDA recommendation was highly consequential In March 1975 the objections of industry to the earlier FDA notice of rule- making in the Federal Register had undermined the FDA's efforts to adopt stricter standards The Food and Drug Administration has ... examined numerous talc samples of undefined grade in the past two years using the proposed methodology the Federal Register had announced and finds that approximately twothirds of such samples are within these limitations of 99.9 amphibole free and 99.99 chrysotile free The implication of this was that possibly one third were not free of asbestos The Commissioner therefore concludes that the proposed limitations would not impose an unreasonable burden on manufacturers of talc if these limita- tions were adopted But industry was objecting and hence The Commissioner ... ... decided to delay any final regulation for talc until an acceptable method for determining the presence of asbestos particles can be developed for this substance The industry had won a major battle and it proceeded to promulgate its own methodology referred to as J4-1 and its own definition of talc Cos- metic talc is a white essentially odorless fine powder ground from naturally occurring rock ore consisting mainly of mag- nesium silicate ... with lesser amounts of naturally associated minerals . and containing no detectable fibrous asbestos miner- als emphasis added J4-1 was less stringent than the FDA standard it was only reliable to 0.5 as compared with the FDA's methodology which claimed ac- curacy to 0.01 This meant that future cosmetic talc products might in fact contain asbestos below the 0.5 detectable limit Furthermore the CFTA promulgated its own definition of talc's purity by avoiding precise statements in favor of vaguer language in its description of the asbestos content of the manufac- turers products After extensive discussions of advantages and disadvantages of listing a 0.5 maximum limit as opposed to nondetected terminology the Standards Committee voted for the use of ... nondetected One industry representative however acknowledged the dishonesty in using nonde- tected as the definition for safety of cosmetic talc products You will notice that a talc standard definition for cosmetic talc was adopted unanimously H.D. Stanley of Pfizer wrote to R.E. Norwood following a July 8 1976 meeting of theCTFA Had I been there I would have objected to their definition I particularly object to the section ... that reads containing no detectable asbestos minerals Stanley pointed out the irony that a nondetected level de- pended on the adequacy inadequacy the methods used to detect it Using an insensitive method would allow manufacturers to claim that asbestos had not been detected but would simultaneously lead to serious breaks in communication be- tween the buyer and the seller who would believe that the product was truly asbestos This observation was not trivial and got to the heart of the problem the cosmetics industry faced As Arthur Rohl a researcher in Irving Selikoff's department at Mt. Sinai School of Medicine pointed out if the wrong AJPH July 2019 Vol 109 No.7 Rosner et Reviewed Public Health Then and Now e4 PUBLIC HEALTH THEN AND NOW methodology was used billions of particles of asbestos could escape detection He wrote that Even at the lowest level of detection by ray diffraction i.e. 0.25 there would be about 10 fibers Cosmetic talcum powder for example which had been scanned and chrysotile not found might contain billions of fibers released during dusting with a gram dose How dangerous talc products were then depended on what one used to measure risk Industry objections to research that found asbestos in talc was noted by researchers themselves In 1976 follow- ing publications by Mt. Sinai researchers of the presence of asbestos in commercial talcum powders bought off the shelf in local stores representatives of the CTFA visited Mt. Sinai in an apparent effort to get the institution and the researchers to qualify if not retract their findings In one such meeting the primary authors of the Mt. Sinai studies informed the industry group that they had found asbestos in 10 samples by using ray diffraction and transmission electron microscopy In a memo the Mt. Sinai authors wrote Dr. Langer was somewhat disgusted by the talc industry's attitude He said the results of his work ha been known to the industry for several years but nothing was done until the ... results became public A few days after that meeting the industry was partially mollified when the dean of Mt. Sinai Thomas Chalmers was quoted in the media as qualifying news reports claiming that most of the talcum powder currently on the market contain asbestoIst is the opinion of Mount Sinai's Department of Pediatrics that baby talc is a useful and safe product he stated to WCBS.35 CONCLUSION LEGACY OF THE CTFA CAMPAIGN By 1977 the FDA essentially gave up its efforts to regulate asbestos in talc as the J4-1 method created by the CTFA had been adopted by the industry despite the CTFA's own acknowledgment that its methodology was inadequate to the task John Schelz ofJohnson & Johnson who was chair of the CTFA Taskforce on Round Robin Testing of Consumer Talcum Products reported on a round robin test of samples of talc and found that J4-1 had failed its test for identifying asbestiform amphibole contaminants with accuracy reliability and practicality These objectives have not yet been achieved emphasis in original he wrote and suggested a partial retest.36 Despite this the J4-1 method one that the industry itself acknowledged is incapable of determining level pollution is still the standard within industry The industry methodology was no more capable of determining level exposures than was the methodology the FDA first proposed and may have been less accurate than were the consuming methods they critiqued For the following half century the debate over the presence or absence of asbestos in talc has continuTehde implica- tions of this for science regulation and consumer safety have resulted in conferences symposia and many scientific papers ever since But it is no mere scholastic issue In 1995 for example Edward Kavanaugh president of the CTFA responded to a petition by a citizen advocacy group the Cancer Prevention Coali- tion that asked the FDA to label cosmetic talc products as potential carcinogens He reiterated the industry's standing position that such warnings were not necessary to protect the health of consumers and would un- necessarily alarm consumers regarding the use of safe cosmetic products The FDA did not act on the petitioners appeal The recent lawsuits against various talc manufacturers have once again brought the issue of asbestos in talc to public attentioThne consequences of industry's actions and inactions of its knowledge or lack thereof were identi- fied a half century ago are still with us AJPH ABOUT THE AUTHORS David Rosner Gerald Markowitz and Merlin Chowkwanyun are with the Department ofSociomedical Sciences Mailman School of Public Health Columbia University New York NY Gerald Markowitz is also with the John Jay College and Graduate Center City University of New York New York NY Correspondence should be sent to David Rosner PhD Mailman School of Public Health Columbia University 722 West 168th St Room 935 New York NY 10032. Reprints can be ordered at htt/p/ www.ajph.org by clicking the Reprints link This article was accepted March 10 2019 doi AJPH.2019AJ.PH.20319.3005085A5JPH.020198.3055085 CONTRIBUTORS D. Rosner and G. Markowitz wrote the first drafts of the article M. Chowkwanyun edited and added substantive historical context and additional documentation ACKNOWLEDGMENTS We thank Colleen Lanier Christiansen Sadie Bergen and Valentina Parisi for their assistance CONFLICTS OF INTEREST David Rosner and Gerald Markowitz wrote a 2017 Report to the Court in a legal case that formed the original basis of this article They received funding from plaintiffs law firms for research and writing Merlin Chowkwanyun has no potential conflict of interest ENDNOTES 1. See for example Tina Bellon J & Loses Bid to Have 4.7 Billion Talc Verdict Set Aside Vows to Appeal Reuters December 19 2018 www reuters.com/article/us-johnson-johnsonbillionappealidUSKCN1O127P accessed January 17 2019 Lisa Girion Johnson & Johnson e5 Public Health Then and Now Peer Reviewed Rosner et al AJPH July 2019 Vol 109 No.7 PUBLIC HEALTH THEN AND NOW Knew for Decades That Asbestos Lurked in Its Baby PowderA Reuters Investiga- tion December 14 2018 www reuters.com/investigates/special-report/ johnsonandjohnson accessed January 13 2019 2. These documents have been released through the discovery process ofa num- ber of lawsuits against talc manufacturers and producers of baby and body powders The primary documents used here are available on toxicdocs.org as identi- fied in the references 3. Sarah Vogel Is It Safe BPA and the Struggle to Define the Safety of Chemicals Berkeley CA University of California Press 2013 47 4. National Institute for Occupational Safety and Health NIOSH Criteria for a Recommended Standard ... Oc- cupational Exposure to Asbestos 1972 https://cdn.toxicdocs.org/2R/2RxDB b5zErM1pYGanagm843Gr b5zErM1pYGanagm843Gr zErM1pYGanagm843Gr.pdf zErM1pYGanagm843Gr.pdf accessed March 15 2019 5. See David Rosner and Gerald Mar- kowitz Ain't Necessarily So The Brake Industry's Impact on Asbestos Regulation in the 1970s American Journal of Public Health 107 2017 1395-1399 David Rosner and Gerald Markowitz Educate the Individual to a Sane Appreciation of the A Risk His- tory of Industry's Responsibility to Warn ofJob Dangers Before the Occupational Safety and Health Administration American Journal of Public Health 106 2016 28-35 Gerald Markowitz and David Rosner Unleashed on an Unsuspecting World The Asbestos Information As- sociation and Its Role in Perpetuating a National Epidemic American Journal of Public Health 106 2016 834-840 6. Waldemar C. Dreessen Effects of Certain Silicate Dusts on the Lungs Journal of Industrial Hygiene 15 1933 66-78 quote on p 78 7. FW Porro J.R. Patton and A.A. Hobbs Jr Pneumoconiosis in the Talc Industry American Journal of Roentgenology and Radium Therapy 47 1942 518 8.A.C. 8.A.C. Hunt Massive Pulmonary Fibro- sis From the Inhalation of Talc Thorax 11 1956 287 294 9. National Safety Council Dusts Fumes and Mists in Industry Data Sheet 531 1963 p 7 https://cdn.toxicdocs.org/wq/ wqy2qoZBDG0a2bYMGM9GX48KJ wqy2qoZBDG0a2bYMGM9GX48KJ wqy2qoZBDG0a2bYMGM9GX48KJ.pdf wqy2qoZBDG0a2bYMGM9GX48KJ.pdf accessed March 15 2019 10. M. KleinfeldJ.Messite O. Kooyman and M.H. Zaki Mortality Among Talc Miners and Millers in New York State Archives of Environmental Health 14 1967 663-667 quote on p 665 11. Johns Manville Research and Engineering Center Body Talcum Powders October 31 1968 pp 1-2 https://cdn.toxicdocs.org/gb/ gbq4wMVNy39gQpYQoRr0EpBE3 gbq4wMVNy39gQpYQoRr0EpBE3 gbq4wMVNy39gQpYQoRr0EpBE3 gbq4wMVNy39gQpYQoRr0EpBE3.pdf gbq4wMVNy39gQpYQoRr0EpBE3.pdf gbq4wMVNy39gQpYQoRr0EpBE3.pdf accessed February 25 2019 12. L.J. Cralley M.M. Key D.H. Groth W.S. Lainhart and R.M. Ligo Fibrous and Mineral Content of Cosmetic Talcum Products American Industrial Hygiene Association Journal 29 1968 350-354 quote on p 353 13. G.W. Wright Asbestos and Health in 1969 American Review of Respiratory Disease 100 1969 467 47q9uote on p 476 14. Asbestos in Talc Methodology Conference at FDA Washington DC Pfizer Memo on August 3 Meeting August 10 1971 https://cdn.toxicdocs.org/ RjqZD73bLJ2LRDzpaZeKexZb7 RjqZD73bLJ2LRDzpaZeKexZb7 RjqZD73bLJ2LRDzpaZeKexZb7.pdf RjqZD73bLJ2LRDzpaZeKexZb7.pdf RjqZD73bLJ2LRDzpaZeKexZb7.pdf accessed March 15 2019 Johns Manville Research and Engineering Center Memo for File FDA Food and Drug Administration Meeting - Asbestos in Cosmetic Talcs August 3 Washington DC August 11 1971 https://cdn.toxicdocs.org/GJ/ GJ48dMXmZpZ3qj8Mpg3v7xY7 GJ48dMXmZpZ3qj8Mpg3v7xY7.pdf accessed April 3 2019 15. See also FDA Memorandum of a Symposium Asbestos and Talc August 3 1971 https://cdn.toxicdocs.org/DM/ DMV5eMX50wdQMQv0LVNEw7myO DMV5eMX50wdQMQv0LVNEw7myO pdf accessed March 15 2019 16. NIOSH Fiber Exposure During Use of Baby Powders Preliminary Report July 1972 pp ii 6 https toxicdocs.org/4v/4vw152B9nBVK34J5v 4vw152B9nBVK34J5vBNa 3ZZme.pdf accessed March 15 2019 The term asbestiform fibers includes fibers that possess great strength and flexibility durability a surface structure relatively free of defects .... Commercial quality asbestos is an example of an asbestiform fiber See Historical Back- ground Terminology and Physiochemical Properties in National Research Council Committee on Nonoccupational Health Risks of Asbestiform Fibers Asbestiform Fibers Nonoccupational Health Risks Washington DC National Academies Press 1984 25 18. Seymour Lewin New York University to Alfred Weissler FDA August 3 1972 https://cdn.toxicdocs.org/85/85Jy ymOw7EB568x1mExoqRQVe 85Jyym Ow7EB568x1mExoqRQVOw7eEB56.8x1mpExoqdRQVef.pdf accessed February 25 2019 19. Memorandum ofmeeting with FDA companies and CTFA Cos- metic Toiletry and Fragrance Associa- tion https://cdn.toxicdocs.org/rr/ rr5nNZexD4dQE8wEvyXZj28a rr5nNZexD4dQE8wEvyXZj28a.pdf accessed February 24 2019 20. Jonathan Spivak FDA Plans to Impose Limits on Asbestos in Certain Cosmetics Wall Street Journal February 26 1973 16 21. Ralph Nader Unsafe at Any Speed The Designed Dangers of the American Automobile New York NY Grossman Publishers 1965 Justin Martin Nader Crusader Spoiler Icon New York NY Merloyd Lawrence 2002 22. Edward F. Cox Robert C. Fellmeth and John E. Schultz The Nader Report on the Federal Trade Commission New York NY R.W. Baron 1969 Paul Starr with assistance from James F. Henry and Raymond P. Bonner The Discarded Army Veterans After Vietnam The Nader Report on Vietnam Veterans and the Veterans Administration New York NY Charterhouse 1973 23. On Health Research Group see Ava Alkon Late Century Consumer Advocacy Pharmaceuticals and Public Health Public Citizen's Health Research Group in Historical Perspective PhD dissertation New York NY Columbia University 2012 Nancy Tomes Remaking the American Patient How Madison Avenue and Modern Medicine Turned Pa- tients Into Consumers Chapel Hill NC University of North Carolina Press 2016 314-317 Wendy Kline Bodies of Knowledge Sexuality Reproduction and Women's Health Chicago IL University of Chicago Press 2010 106 107 24. Kline Bodies of Knowledge 97 Vogel Is It Safe 50-63 126 25. Department of Health Education and Welfare FDA Asbestos Particles in Food and Drugs Notice of Proposed Rulemaking Federal Register 38 September 28 1973 2707980 https://cdn.toxicdocs.org/R2/ R26RZ08ZMOL6YjvN5rNgneVZB R26RZ08ZMOL6YjvN5rNgneVZB.pdf R26RZ08ZMOL6YjvN5rNgneVZB.pdf accessed February 24 2019 26. Minutes CFTA Subcommittee of cientific dvisory ommittee on Asbestos in Talc October 11 1973 htps:/cdn.toxicdocs.org/2q/2qJmaLo https://cdn.toxicdocs.org/2q/2qJmmaLo r4005gyRvVLaLv207 5gyRvVLaLv207.pdf accessed February 24 2019 27. George Sandland Report of CFTA Talc Subcommittee on Method to Detect Chrysotile and Tremolite in Talc December 10 1973 https://cdn.toxicdocs.org/ By580NKq569YeJOEo3yvEx8km By580NKq569YBy5e80NKq569YeJOJE03yvEx8km.pOdf BEy50803NKyq5v69EYexJO8E0k3ymvE.x8pkmd.pfdf accessed February 24 2019 28. H. Schwartz to G. Mennen D. Horne L. Wallace January 18 1973 https://cdn.toxicdocs.org/zo/ zoQjL87oyxvjNQ5D6LY3znQE0 zoQjL87oyxvjNQ5D6LY3znQE0 zoQjL87oyxvjNQ5D6LY3zozQjL87noyxvQjNQ5DE6LY3z0nQE0..pdfpzoQjL87odyxvjNQ5D6LfY3znQE0.pdf accessed March 15 2019 29. See R.S. Lamar Johns Manville to V.E. Wolkodoff October 11 1974 p 2 https://cdn.toxicdocs.org/gb/ gbq4wMVNy39gQpYQoRr0EpBE3 gbq4wMVNy39gQpYQoRr0EpBE3 gbq4wMVNy39gQpYQoRr0EpBE3 gbq4wMVNy39gQpYQoRr0EpBE3.pdf gbq4wMVNy39gQpYQoRr0EpBE3.pdf accessed March 15 2019 30. Asbestos Particles in Drugs for Parenteral Injection Federal Register 40 no 51 March 14 1975 11865-66 https://cdn.toxicdocs.org/By/ By4GYmaDEJ4wNRExn4Z1DpBp8 By4GYmaDEJ4wNRExn4Z1DpBp8.pdf accessed February 25 2019 31. CTFA Standards Committee Minutes August 21 1975 https://cdn.toxicdocs.org/ V3 V3pEx8RX2wqVY3BQXJMGqrVq083pEx8RX2wqVY3BQXJMGqrq08 V3pEx8RX2wqVY3BQXJMGqrq08.pdf V3pEx8RX2wqVY3BQXJMGqrq08.pdf accessed February 25 2019 32. H.D. Stanley to R.E. Norwood July 27 1976 Bates no PFI_KA_00000784 https://cdn.toxicdocs.org/zb/ zb02zbxnMgamYzb0Q2zbxznMgajmYQzojoGgGY1DMgb6 Yzb012zbxDnMgamMYQzjboGgY61DMb6 zb02zbxnMgamYQzb02zzbxnjMgamYoQzjoGGgY1gDMb6.Ypdf 1zbD02zMbxnMbgam6YQzj.oGgpY1DMdb6.fpdf accessed February 25 2019 33. A.N. Rohl Asbestos in Talc Environmental Health Perspectives 9 1974 129-132 quote on p 130 Memorandum of Meeting at Mt. Sinai between Arthur Langer and Arthur Rohl and Clifton Wilson and Ronald Yates March 22 1976 https://cdn.toxicdocs.org/ba/ baxK5KjeY8EaoDzVQv6dkZ333 baxK5KjeY8EaoDzVQv6dkZ333.pdf baxK5KjeY8EaoDzVQv6dkZ333.pdf accessed February 25 2019 35. Tony Biesada to Bill Stephenson Re Media Coverage March 25 1976 https://cdn.toxicdocs.org/ jgJJ25DJR6QEj1L092M486rx2 jgJJ25DJR6QEj1L092M486rx2 jgJJ25DJR6QEj1L092M486rx2.pjgJ25DJdR6QEj1L09f2M486rx2.pdf accessed March 15 2019 36. CFTA Task Force on Round Robin Testing of Consumer Talcum Products for Asbestiform Amphibole Minerals Minutes May 17 1977 https://cdn.toxicdocs.org/Mx/ MxRLgx1X6b9z7D59NGKKenwV MxRLgx1X6b9z7D59NGKKenwV.pdf accessed February 25 2019 37. E. 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