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FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023
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EXHIBIT E
FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023
RESEARCH ARTICLE
The Definition of Asbestos - A Manufactured Defense to
Avoid Regulation and Victim Compensation
Triet H Tran1*; David S Egilman, MD, MPH2; Tess Bird, MSc, DPhil3;
Kate Clancy4
1. NEVER AGAIN CONSULTING
2. Department of Family Medicine, Brown University, Providence,
United States
3. Wesleyan University, Connecticut, United States
4. Colorado School of Public Health, Colorado, United States
* tranhaotriet@gmail.com
ABSTRACT
OPEN ACCESS
Background: The Occupational Safety and Health Administration
Published: June 30, 2022 (OSHA) first identified asbestos as a regulated workplace hazard in
1971. In the half century since, OSHA has fully rescinded only one of
Citation Tran TH, Egilman DS, et its hundreds of regulations, one that happened to regulate a form of
al., 2022. The Definition of asbestos found as an accessory mineral in cosmetic talc. This
Asbestos – A Manufactured extremely rare action grew out of a 20-year campaign by Talc
Defense to Avoid Regulation Mining and Manufacturing Companies (TM&MCs) to redefine some
and Victim Compensation, of the asbestos routinely found in talc as “non-asbestos” to keep talc
Medical Research Archives, out of the regulation. Under this new definition, at least 50% of the
[online] 10(6). products sold as asbestos became “non-asbestos.”
https://doi.org/10.18103/mra. Methods: We used systematic search techniques and grounded
v10i6.2778 theory to review published studies, government records, corporate
documents and public statements.
Copyright: © 2022 European Results: Current asbestos regulations and testmethods rely heavily
Society of Medicine. This is an on asbestos geologic definition which determine the majority of
open- access article distributed asbestos fibers as “non-asbestos.” In essence, this geologic definition
under the terms of the Creative defined some asbestos out of existence. However, asbestos
Commons Attribution License, regulations should be driven by the health effects of asbestos.
which permits unrestricted use, Conclusions: TM&MCs funded experts and lobbied OSHA to
distribution, and reproduction in promote an overly restrictive definition of asbestos and to support
any medium, provided the inadequate test methods in place of more effective procedures.
original author and source are These companies subsequently relied on these same restrictive
credited. definitions and inadequate tests to falsely claim that their cosmetic
DOI talcs are free of asbestos. Replacing the restrictive geologic
https://doi.org/10.18103/mra. definition of asbestos with a health definition is needed to protect
v10i6.2778 the public from the well-known dangers of asbestos.
ISSN: 2375-1924 Keywords: regulation; asbestos; asbestiform; non-asbestiform; talc;
cancer
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The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation
Background there is no medical evidence that such “non-
In May 1990, the Occupational Safety and Health asbestiform” fibers are non-hazardous to exposed
Administration (OSHA) held five days of hearings workers and consumers.5
regarding a request by RT Vanderbilt (RTV), a talc For many companies, creating a lenient, easily-met
mining company, to reconsider regulation of “non- standard, whether it protects public health or not,
asbestiform” asbestos. William L. Kitchen, the only is far cheaper than developing safer products or
worker to testify at the hearings, posed the key providing adequate safety recommendations
regulatory question: “Should we …be listening to which may reduce sales.6 TM&MCs have
the mineralogists or be listening to the medical successfully blocked regulation of asbestos-
experts, particularly when a number of the containing talc by controlling the definitions for
mineralogists have very strong financial ties to the asbestos and lobbying agencies to rescind
companies that are going to be regulated under regulation of their products.7 The companies relied
these standards.” His question aptly reflected two primarily on consultant geologists rather than
sides of the debate around asbestos: one that medical experts to assert the claim that “non-
protected the health of workers by recognizing the asbestiform” fibers did not cause cancer.8
health hazards of all forms of asbestos, or one However, workers had been exposed to both
that served the financial interests of the Talc asbestiform and “non-asbestiform” asbestos, which
Mining and Manufacturing Companies (TM&MCs). were present in every bag of asbestos. In
For over 100 years, asbestos and talc companies addition, neither epidemiologic nor pathologic
have relied on manipulating the definition of studies could distinguish the health effects of either
asbestos in order to prevent regulation and avoid form of asbestos.5
compensation of people who have developed Asbestos is a commercial term used to describe
asbestos caused disease.1,2 certain amphiboles and one serpentine rock.3 Bags
In 1971, OSHA issued a regulation that defined of asbestos contain fibers that form as fibers
asbestos as chrysotile and amphibole fibers longer (asbestiform) or cleave into fibers (non-
than 5µm.3 Talc products contained hazardous asbestiform).9 (See Figure 1) 100% of the minerals
materials that this OSHA regulation would classify (including both forms) in these bags were and are
as asbestos. We describe the TM&MCs 20-year sold as asbestos.10,11 Single fibers fitting either
lobbying effort to limitthe definition of asbestos definition can and often do have the same length
so as to maintain the appearance of safety in their and length/width (aspect) ratio (See Figure 1).9 In
products. The companies convinced OSHA to limit fact, although RTV’s redefinition effort was driven
the definition of asbestos to chrysotile and by its desire to rescind regulation of its talc by
amphibole fibers that had “grown” as fibers claiming it only contained “non-asbestiform”
(asbestiform habit).4 As a result, in 1992, OSHA tremolite, itsmain witness Ann Wylie had found
rescinded the regulation of “non-asbestiform” asbestiform fibers in RTV talc years before the
fibers (cleaved from larger rocks with the same OSHA hearing. The whole re-definition effort was
size and shape of asbestiform fibers), the first and a cynical effort to protect talc companies from the
only OSHA regulation that has ever been scrutiny and liabilitythat attached to sales of a
withdrawn. This change made “non-asbestiform” product that contained fibers that caused cancer.12
fibers disappear from OSHA regulations, although
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The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation
Figure 1: Non-asbestiform Fig. 26 & B Asbestiform Asbestos Fig. 14 from Campbell et al. (1977)
Methods chronologically, with some exceptions to facilitate
The authors described and analyzed the various reader understanding of the issues uncovered.
changes of the definition of asbestos in the past In recent litigation,the CTFA, J&J, and LuzeNever
100 years. The study design employs a Again Consulting have claimed that many of the
“Grounded Theory” approach, or an “inductive documents we cite were “confidential trade
methodology,” which is a systematic generation of secrets.” Our review of documents is limited to the
knowledge from systematic research. This synthesis documents made available to us, as well as those
of historical and scientific evidence typically released to the public domain.
consists of comparing public vs. corporate
knowledge over time. Ethical Issues/Statement
We reviewed primary source material consisting Ethics approval and informed consent were not
of corporate documents uncovered in litigation and necessary as this is a review of historical
government documents released through FOIA documents. All cited documents were released
requests. Talc-related documents were deposited from confidentiality by various courts.
in a searchable database that was accessible to
researchers during Gail Ingham, et al. v. Johnson & Aim and Scope
Johnson, et al., a personal injury/product liability Our paper adds a critical health perspective to
lawsuit in District Court in St. Louis, Missouri (2018) the discussion of risks of the accessory mineral
regarding the use of commercial talcum powder. asbestos found in talc. The current asbestos/talc
This document database included records policy issue is mired in erroneous assumptions and
produced by the numerous TM&MCs. technical limitations related to the definition of
The authors also reviewed depositions of asbestos. By narrating the history of asbestos
individuals connected to talc litigation. These definition with regards to talc, we aimed to clarify
findings are combined with a review of the the assessment of risks associated with asbestos as
published literature. We provide a narrative found in talc. In addition, we discuss how the
review of meetings, events, newspaper reports, asbestos definitions have impacted on the
tests and research conducted, and FDA and regulation of asbestos content of construction
industry decisions. The review is organized materials and everyday consumer products. A
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The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation
correct definition should be based on health and standard. OSHA set length as the only criterion to
epidemiology data instead of arbitrary geologic define fiber: “‘Asbestos fibers’ means asbestos
terms is needed to protect the public from the fibers longer than 5 micrometers.”17 In 1973, the
well-known health risks of asbestos exposure. Our Food and Drug Administration (FDA) defined
study aims to 1) Provide policy-makers a more asbestos as “a generic term for a number of
balanced understanding of the toxicity of different hydrated silicates that, when crushed or processed,
types of asbestos fibers than the information separate into flexible fibers made up of fibrils.”7
provided by the asbestos industry (which The FDA has never changed this definition. In
government agencies have historically relied on) 1974, Judge Miles Lord, in the first legal case
and 2) Provided policy-makers a better concerning federal regulation of corporate
understanding of the difference between the pollution, defined asbestos as follows: “Asbestos is
geologic and the health definitions of asbestos. a generic term for a number of hydrated silicates
Geologic definitions of asbestos are arbitrary that, when crushed or processed, separate into
while health definitions are driven by flexible fibers made up of fibrils.”18
epidemiology. Policies should focus on the health In 1986, OSHA established counting rules which
definition of asbestos to best protect the well- limited fibers to those with a length width aspect
being of the public. ratio greater than 3:1 and longer than 5 microns.19
The United States Environmental Protection Agency
Results (EPA) established an aspect ratio of 5:1 for
The original definition – includes all asbestos fiber asbestos with length longer than 0.5 microns.20 At
forms the time, there was no specific geologic definition
Asbestos disease became a major public health for the term asbestos fiber.21
problem for industry in the 1930’s when workers
began to successfully sue for compensation.13,14 In An opportune void
1938, companies that manufactured asbestos It was easy to formulate a debate over definitions
brakes funded animal studies at SaraNever Again since geologists had never agreed to any specific
Consulting Laboratory in New York. The studies definition of asbestos (which historically had been
determined that asbestos fibers, rather than non- a commercial and not a geologic term). A 1987
fibrous round particles with the same chemistry, book on the subject of asbestos fibers noted that:
caused lung fibrosis.15 Unfortunately, the exposure “A search of more than 50 technical and scientific
measurement technology used until the mid-1960s texts, glossaries and dictionaries produced no
could only count the total number of particles, both authoritative definition of fiber or fibrous that is
fibers and non-fibrous in air samples.1 Thus, applicable to asbestos and appropriate for use
epidemiological studies of workers exposed prior by health professionals.”22 The 1974 Glossary of
to the 1970s relied on total particle counts (millions Geology quotes Lewis Carroll to describe the state
of particles per cubic foot MPPCF) to assess of geologic definitions of minerals, implying that
exposures.1 In 1974, Canadian researchers who the definitions used were subjective: (p. vii)23
conducted studies of asbestos mining workers “When I use a word,” Humpty
found that particle counts could not be converted Dumpty said, in rather a scornful
to fiber counts.16 Researchers, therefore, had little tone, “it means just what I choose it
basis for distinguishing the health effects of to mean—neither more nor less.”
different sizes and shapes of asbestos mineral “The question is,” said Alice,
particles. “whether you can make words
In 1971, OSHA adopted the American Conference mean so many different things.”
of Governmental Industrial Hygienists (ACGIH) TLV “The question is,” said Humpty
of 12f/cc for “all asbestos” as its first permissible Dumpty, “which is to be master—
exposure limit (PEL).3 In 1972, OSHA issued the that's all.”
first specific regulation designed to limit worker In the early 1970s, Pfizer and Johns Manville (JM)
exposure to all forms of asbestos.17 OSHA used began to warn customers of the presence of
four geologic terms— anthophyllite, tremolite, asbestos in their talc products. RTV complained in
chrysotile and actinolite— and the names of two a letter to JM and Pfizer that these warning were
commercial asbestos products— amosite hurting their talc sales and a bitter dispute ensued
(cummingtonite-grunerite) and crocidolite between the companies. RTV asked Pfizer to stop
(riebeckite) - to define the applicability of the
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The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation
warning its customers that talc contained asbestos: position has never been supported
(p. 1)24 by any scientistof renown or any
It'sa crazy world isn'tit? Here we other talccompany, Vanderbilt has
have been producing and selling remained adamant in that defense
tremolitic talc for 30 years and we of it. Their lobbying efforts were
see from a recent advertisement of successful in obtaining certain
your Minerals Division (enclosed) letters… [from OSHA]. Although
that tremolite is an undesirable these letters were ambiguous,
impurity intalc -- like asbestos. I'll Vanderbilt used them to certify the
bet your West Coast ceramic safety of their product until the
customers are surprised to learn labor department rescinded the
this. letters on January 19, 1977.
In the minds of many, talc and [Emphasis added]
asbestos are one and the same. The Pfizer warned about the presence of asbestos in
more your Minerals Division their talc products and acquiesced to OSHA
continues to muddy the water by regulation: (p. 3)6
discussing talc and asbestos and JM, another major talc producer,
asbestiform minerals in their with considerable expertise and
advertising copy, the more firmly asbestos took a radically different
this misconception will be implanted approach. On September 30,
in the minds of Government 1974, they issued a letter stating
regulators and others who have a that their Grantham talcs contained
vested interest in the hazards of amphiboles of asbestos and placed
asbestos. Already NIOSH talks of asbestos warning labels on their
a "talc alert" and the WALL STREET talc packages. In June 1976, they
JOURNAL runs a leading article officially shut down the Grantham
(enclosed) on the hazards of “pure talc operation in Death Valley and
talc.” went out of the talc business.
This is a criticaltime for the talc …MPM [Pfizer’s]scientistsbelieve
industry. Your Minerals Division can that after grinding, tremolite
help by giving more careful particles either meet the OSHA
consideration to the consequences definition of a fiber or failed to
of their talc advertising copy. meet it. If the fiber definition is
In response to thisletter, Pfizer summarized RTV’s met, tenderness best the form
strategy for defending their talc from regulation: particle exists.
(p. 2)6 Based on the above, Pfizer has
R. T. Vanderbilt has been the chosen not to attempt to challenge
largest producer in the United the OSHA regulations.
States of “industrial talc” with high JM feared that RTV’s refusal to acknowledge the
amphibole content…. Prior to the health risks of asbestos in their talc products would
publication of the original undermine the industry’s ethical and professional
standard, they launched a massive credibility. JM’s director of environmental services,
effort to block the standard and Edward Fenner, in a memo to coworkers stated his
later to overturn it. Initiallytheir objections to a published paper written by RTV’s
thrust was that the amphiboles were geologist CS Thompson: (p. 1)25
not asbestos and should not be …[I] disagree with almost
included in the asbestos standard. everything said by Thompson. I
Later they took the position that the object strongly to an earlier
amphiboles involved, especially statement …Re: “Misinformation”
tremolite, existed in both supplied by competitor.
“asbestiform” and “non– Furthermore, in all of Thompson’s
asbestiform” varieties and that gobbledygook regarding the
Vanderbilt talc contained of the minerology of Vanderbilt’s “talc”
non-harmful variety. Although their at no point does he admit to the
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The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation
fact that their “talcs” contain not Deleting non-asbestiform fibers from the definition of
only fibrous tremolite but chrysotile asbestos
and anthophyllite as well. This we Using Geologists to Influence Government
have proved by every available Regulatory Bodies. Beginning in the 1960s, the
technique. These findings are well National Institute for Occupational Safety &
documented in numerous R&D Health (NIOSH) and others had found asbestos
reports. I am afraid that Dr. fibers (with an aspect ratio of 3:1) in cosmetic talc
Thompson long ago gave up any products.30,31 Facing the threat of FDA proposed
professional ethics he might have regulation and OSHA regulation of asbestos found
had and is now persisting with a in cosmetic talcs, the TM&MCs began a campaign
program that is not only technically to redefine asbestos.
false but even more tragic morally In 1973, the Congressman who represented RTV’s
and ethically wrong. He totally mining district wrote to OSHA on their behalf
ignores the medical consequences supporting deregulation of RTV talc because it
of his immorality. [Emphasis in was his “…understanding that there was no
original] evidence that tremolite was carcinogenic.”32 In July
Unfortunately, RTV and other talc companies 1974, RTV met with the Secretary of Labor
continued to supply the same “misinformation” in Stender, to request that OSHA rescind regulation
the years to come. Neither asbestos mining and of its talc:33
manufacturing companies nor geologists had ever “RTV...requested relief from the
used any definition that distinguished Asbestos Standard for our non-
“asbestiform” from “non-asbestiform” until OSHA fibrous or non-asbestiform
began to regulate all forms of asbestos in 1972.26 tremolite, anthophyllite and
(In fact, in 2002, the United States Geological actinolite “pending thorough
Survey (USGS) created a 75-page “Tabulation of investigation by NIOSH which was
Asbestos-Related Terminology” and “asbestiform” then estimated to be concluded in
does not appear in any asbestos definition until one (1) year. Secretary Stender at
1977).21 this meeting stated that the R.
In 1973, the FDA proposed regulation of asbestos Vanderbilt Company, Inc. was
in talc.7 As a result,, RTV, which sold “tremolitic” being held "Hostage" without
talc (50-70% tremolite and anthophyllite), and documentation on tremolite,
J&J, whose iconic product was talcum baby anthophyllite and actinolite.” (p. 1)
powder that contained asbestos, faced a On August 6, 1974 Stender wrote to
considerable problem.27 In response, RTV and Vanderbilt that “…non-asbestiform
Johnson and Johnson (J&J) took advantage of the minerals such as non-asbestiform tremolite
vacuum of geological definitions of asbestos to are not within the scope of the existing
defend the safety of their talc products by Asbestos Standard.” This was not enough
beginning a campaign to restrictthe definition of for Vanderbilt who wrote back: (p.1-2)33
asbestos to only those fibers that could be shown “This was a step forward but the
to have originally formed in bundles like hairs on a lack of a definition for of fibre still
brush. The asbestos definition propounded by RTV holds us ‘Hostage.’ We are
and J&J excluded single fibers of the same size. therefore now losing a considerable
The two companies began a campaign to have amount of business and suffering
OSHA restrict the definition of anthophyllite, irreparable economic harm...We
tremolite, and actinolite (ATA) asbestos to only meet today not to decide what is or
fibers that originated in an asbestiform habit. what isnot carcinogenic, but only
However, both forms are found in all asbestos to ask that our industrial talcs
deposits and products and it is impossible to containing tremolite, anthophyllite
determine the origin of a single fiber after and actinolite be excluded from the
processing (e.g., talc used in cosmetics is processed Asbestos Standard immediately
by milling and sieving, which destroys many of the pending results of the NIOSH
asbestos bundles.)28,29 investigation now in progress. We
are suffering financially as a result
of not being excluded pending
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The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation
documentation, we ask most Asbestos is a commercial name and
sincerely for a quick exclusion. As ithas been applied to a group of
we mentioned on July 2, thisis the highly fibrous silicatesspecifically
course of action EPA and MESA chrysotile and several of the
have taken while awaiting results of amphibole minerals. These minerals
the same NIOSH study.”33 are characterized by very unique
[Emphasis added] physical properties that include
In the 1980’s, RTV’s consultant geologists began to high tensile strength, resistance to
lobby OSHA to adopt a geologic rather than a acid and heat, flexibility enough to
health-based definition of asbestos that would be woven into cloth and unique
rescind regulation of non-asbestiform asbestos. The optical properties.
geologists argued that non-asbestiform asbestos Two of these requirements (those asbestos fibers
was not asbestos because it was not developed or must have a mean aspect ratio of at least 20:1
formed in a fibrous habit. RTV consultant, Dr. Ann and appear in bundles) would eliminate OSHA
Wylie, Associate Professor in the Department of regulation of much of the asbestos found in talc
Geology at the University of Maryland, first used in cosmetics. The talc companies were aware
promoted this geologic definition asbestos in a that microscopy, when applied to cosmetic talcs,
1983 legal opinion provided to RTV.34 Later, generally only detected individual fibers whose
Wylie presented this geologic definition in a 1984 derivation could not be determined.28,29,38 Further,
presentation co-authored with John Kelse of RTV, tremolite, actinolite, anthophyllite, and harsh
Vanderbilt, Richard J. Lee (another RTV consultant) chrysotile have low tensile strength and poor
and Kelly F. Bailey, a geologist employee of flexibility39-41Non-asbestiform fibers have justas
Vulcan Materials Company.8 They claimed much flexibility as "true asbestos". There is nothing
“difference exists mineralogically and unique, diagnostic, or special about the flexibility
biologically” between “elongated non-asbestiform of asbestiform fibers.42
cleavage fragments” and asbestos fibers.8 In the same month, Wylie asserted that the term
Wylie’s participation was crucial to RTV’s efforts. asbestos should be limited to fibers that had
In 1985, Slim Thomson, RTV’s mineralogist, “grown” or formed in a fibrous habit (group of
reciprocated Wylie’s contribution to RTV in a letter fibers) with aspect ratios greater than 20:1.4 (See
endorsing her application for tenure.35 Her Figure 1) However, many minerals form in a
department chair thanked Thomson, noting that fibrous habit; fibrous tremolite and anthophyllite
RTV’s recommendation “…will constitute the most naturally chemically convert to talc and vice versa
important piece of document to be used in the while maintaining the same fibrous structure: (See
entire promotion and tenure process.”36 Figure 2)
In 1984, Wylie testified as a representative of
RTV at OSHA hearings and promoted the
adoption of her geologic definition of asbestos:37
5 Talc + 6 Calcite + 4 Quartz ↔ 3 Tremolite + 6 CO2 + 3H20
7 Talc ↔ 3 Anthophyllite + 4 Quartz + 4H2O
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The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation
Figure 2: Talc and amphibole ends in a single fiber (Compton and Millette 2004)
In 1987, RTV reviewed a draft of a Wylie paper characteristics when viewed by
on asbestos definition.12 John Kelse of Vanderbilt light microscopy:
was concerned about the paper and suggested 1. Mean aspect ratios ranging
“several embellishments.” [Emphasis added] from 20:1 or greater for fibers
Kelse asked Wylie to emphasize the fact that the longer than 5 μm,
aspect ratio should be used only as a “screening 2. Very thin fibrils, usually less
tool only – as one of many variables which helped than 0.5 μm in width,
distinguish non-asbestiform particles from 3. One or more of the following:
asbestiform particles. As for health effects, the a) Parallel fibers occurring in
possible role of many other variables to be bundles,
recognized, (e. g. hardness, surface charge, b) Fiber bundles displaying
durability, etc.) When you say on page 6, for splayed ends
example, the particles with aspect ratios greater c) Fibers in the form of thin needles
than 15:1 are the particles ‘known to be d) Matted masses of individual fibers
carcinogens’, we know what you mean but fear e) Fibers showing curvature
others willnot.”12 The “known to be carcinogens” Wylie’s definition hinged on the mean aspect
language does not appear in Wylie’s papers ratio, but she did not report any mean aspect ratio
published in this time period.43-47 for any asbestos variety in this paper.44 However,
In August 1990, Wylie presented a more in 1984 she reported that the 20:1 aspect ratio
extensive test method criterion to define asbestos was too high: “Aspect ratios between 8:1 and
at a NIOSH meeting which was published in a non- 19:1 are characteristic of fibers of amosite and
peer review summary of the meeting papers:(p. anthophyllite.”4 In 1985, Wylie reported that a
1)44 20:1 cut off would fail to account for 50% of
ASBESTOS FIBERS. Asbestiform commercial amosite fibers.48 Puffer and Germaine
mineral fiber populations (2019) found the mean aspect ratio of amosite to
generally have the following be 11.7.49 In addition, PLM cannot identify fibers
less than 0.3 µm wide and in many fibers are
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The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation
thinner than that. Campbell et al. (1977) also a thick mass;” parallel means “side by side and
showed that neither length nor aspect ratio could having the same distance continuously between
distinguish habit from cleavage formed asbestos them.”
fibers since they overlapped. (See Figure 3) Julie Pier, who was in charge of testing for
Shedd (1985) measured the dimensions of asbestos in talc for Rio Tinto Minerals and J&J,
crocidolite asbestos and found that the majority of summarized the problems related to the limiting
crocidolite asbestos fibers would be considered the identification of asbestiform fibers beginning
“non-asbestiform” by the Wylie criteria.50 Millette with the concern that “It is not known whether
(2015) commented on the Wylie’s criteria: “Trying cleavage fragments of similar dimensions to
to use two or more of those mineralogical asbestiform fibers pose the similar health risks”: (p.
characteristics would result in misclassifying up to 11)55
80% of the asbestos fibers.”51 • Amphiboles are naturally elongated; when
At OSHA, Wylie conceded that her 20:1 criterion ground consistently produce “cleavage
could not distinguish asbestiform from non- fragments” that meet 3:1 and 5:1 criteria
asbestiform asbestos: • On a microscopic scale, one cannot
“The use
Preview
FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023 EXHIBIT E FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023 RESEARCH ARTICLE The Definition of Asbestos - A Manufactured Defense to Avoid Regulation and Victim Compensation Triet H Tran1*; David S Egilman, MD, MPH2; Tess Bird, MSc, DPhil3; Kate Clancy4 1. NEVER AGAIN CONSULTING 2. Department of Family Medicine, Brown University, Providence, United States 3. Wesleyan University, Connecticut, United States 4. Colorado School of Public Health, Colorado, United States * tranhaotriet@gmail.com ABSTRACT OPEN ACCESS Background: The Occupational Safety and Health Administration Published: June 30, 2022 (OSHA) first identified asbestos as a regulated workplace hazard in 1971. In the half century since, OSHA has fully rescinded only one of Citation Tran TH, Egilman DS, et its hundreds of regulations, one that happened to regulate a form of al., 2022. The Definition of asbestos found as an accessory mineral in cosmetic talc. This Asbestos – A Manufactured extremely rare action grew out of a 20-year campaign by Talc Defense to Avoid Regulation Mining and Manufacturing Companies (TM&MCs) to redefine some and Victim Compensation, of the asbestos routinely found in talc as “non-asbestos” to keep talc Medical Research Archives, out of the regulation. Under this new definition, at least 50% of the [online] 10(6). products sold as asbestos became “non-asbestos.” https://doi.org/10.18103/mra. Methods: We used systematic search techniques and grounded v10i6.2778 theory to review published studies, government records, corporate documents and public statements. Copyright: © 2022 European Results: Current asbestos regulations and testmethods rely heavily Society of Medicine. This is an on asbestos geologic definition which determine the majority of open- access article distributed asbestos fibers as “non-asbestos.” In essence, this geologic definition under the terms of the Creative defined some asbestos out of existence. However, asbestos Commons Attribution License, regulations should be driven by the health effects of asbestos. which permits unrestricted use, Conclusions: TM&MCs funded experts and lobbied OSHA to distribution, and reproduction in promote an overly restrictive definition of asbestos and to support any medium, provided the inadequate test methods in place of more effective procedures. original author and source are These companies subsequently relied on these same restrictive credited. definitions and inadequate tests to falsely claim that their cosmetic DOI talcs are free of asbestos. Replacing the restrictive geologic https://doi.org/10.18103/mra. definition of asbestos with a health definition is needed to protect v10i6.2778 the public from the well-known dangers of asbestos. ISSN: 2375-1924 Keywords: regulation; asbestos; asbestiform; non-asbestiform; talc; cancer Medical Research Archives | https://esmed.org/MRA/mra/view/2778 1 FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023 The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation Background there is no medical evidence that such “non- In May 1990, the Occupational Safety and Health asbestiform” fibers are non-hazardous to exposed Administration (OSHA) held five days of hearings workers and consumers.5 regarding a request by RT Vanderbilt (RTV), a talc For many companies, creating a lenient, easily-met mining company, to reconsider regulation of “non- standard, whether it protects public health or not, asbestiform” asbestos. William L. Kitchen, the only is far cheaper than developing safer products or worker to testify at the hearings, posed the key providing adequate safety recommendations regulatory question: “Should we …be listening to which may reduce sales.6 TM&MCs have the mineralogists or be listening to the medical successfully blocked regulation of asbestos- experts, particularly when a number of the containing talc by controlling the definitions for mineralogists have very strong financial ties to the asbestos and lobbying agencies to rescind companies that are going to be regulated under regulation of their products.7 The companies relied these standards.” His question aptly reflected two primarily on consultant geologists rather than sides of the debate around asbestos: one that medical experts to assert the claim that “non- protected the health of workers by recognizing the asbestiform” fibers did not cause cancer.8 health hazards of all forms of asbestos, or one However, workers had been exposed to both that served the financial interests of the Talc asbestiform and “non-asbestiform” asbestos, which Mining and Manufacturing Companies (TM&MCs). were present in every bag of asbestos. In For over 100 years, asbestos and talc companies addition, neither epidemiologic nor pathologic have relied on manipulating the definition of studies could distinguish the health effects of either asbestos in order to prevent regulation and avoid form of asbestos.5 compensation of people who have developed Asbestos is a commercial term used to describe asbestos caused disease.1,2 certain amphiboles and one serpentine rock.3 Bags In 1971, OSHA issued a regulation that defined of asbestos contain fibers that form as fibers asbestos as chrysotile and amphibole fibers longer (asbestiform) or cleave into fibers (non- than 5µm.3 Talc products contained hazardous asbestiform).9 (See Figure 1) 100% of the minerals materials that this OSHA regulation would classify (including both forms) in these bags were and are as asbestos. We describe the TM&MCs 20-year sold as asbestos.10,11 Single fibers fitting either lobbying effort to limitthe definition of asbestos definition can and often do have the same length so as to maintain the appearance of safety in their and length/width (aspect) ratio (See Figure 1).9 In products. The companies convinced OSHA to limit fact, although RTV’s redefinition effort was driven the definition of asbestos to chrysotile and by its desire to rescind regulation of its talc by amphibole fibers that had “grown” as fibers claiming it only contained “non-asbestiform” (asbestiform habit).4 As a result, in 1992, OSHA tremolite, itsmain witness Ann Wylie had found rescinded the regulation of “non-asbestiform” asbestiform fibers in RTV talc years before the fibers (cleaved from larger rocks with the same OSHA hearing. The whole re-definition effort was size and shape of asbestiform fibers), the first and a cynical effort to protect talc companies from the only OSHA regulation that has ever been scrutiny and liabilitythat attached to sales of a withdrawn. This change made “non-asbestiform” product that contained fibers that caused cancer.12 fibers disappear from OSHA regulations, although Medical Research Archives | https://esmed.org/MRA/mra/view/2778 2 FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023 The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation Figure 1: Non-asbestiform Fig. 26 & B Asbestiform Asbestos Fig. 14 from Campbell et al. (1977) Methods chronologically, with some exceptions to facilitate The authors described and analyzed the various reader understanding of the issues uncovered. changes of the definition of asbestos in the past In recent litigation,the CTFA, J&J, and LuzeNever 100 years. The study design employs a Again Consulting have claimed that many of the “Grounded Theory” approach, or an “inductive documents we cite were “confidential trade methodology,” which is a systematic generation of secrets.” Our review of documents is limited to the knowledge from systematic research. This synthesis documents made available to us, as well as those of historical and scientific evidence typically released to the public domain. consists of comparing public vs. corporate knowledge over time. Ethical Issues/Statement We reviewed primary source material consisting Ethics approval and informed consent were not of corporate documents uncovered in litigation and necessary as this is a review of historical government documents released through FOIA documents. All cited documents were released requests. Talc-related documents were deposited from confidentiality by various courts. in a searchable database that was accessible to researchers during Gail Ingham, et al. v. Johnson & Aim and Scope Johnson, et al., a personal injury/product liability Our paper adds a critical health perspective to lawsuit in District Court in St. Louis, Missouri (2018) the discussion of risks of the accessory mineral regarding the use of commercial talcum powder. asbestos found in talc. The current asbestos/talc This document database included records policy issue is mired in erroneous assumptions and produced by the numerous TM&MCs. technical limitations related to the definition of The authors also reviewed depositions of asbestos. By narrating the history of asbestos individuals connected to talc litigation. These definition with regards to talc, we aimed to clarify findings are combined with a review of the the assessment of risks associated with asbestos as published literature. We provide a narrative found in talc. In addition, we discuss how the review of meetings, events, newspaper reports, asbestos definitions have impacted on the tests and research conducted, and FDA and regulation of asbestos content of construction industry decisions. The review is organized materials and everyday consumer products. A Medical Research Archives | https://esmed.org/MRA/mra/view/2778 3 FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023 The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation correct definition should be based on health and standard. OSHA set length as the only criterion to epidemiology data instead of arbitrary geologic define fiber: “‘Asbestos fibers’ means asbestos terms is needed to protect the public from the fibers longer than 5 micrometers.”17 In 1973, the well-known health risks of asbestos exposure. Our Food and Drug Administration (FDA) defined study aims to 1) Provide policy-makers a more asbestos as “a generic term for a number of balanced understanding of the toxicity of different hydrated silicates that, when crushed or processed, types of asbestos fibers than the information separate into flexible fibers made up of fibrils.”7 provided by the asbestos industry (which The FDA has never changed this definition. In government agencies have historically relied on) 1974, Judge Miles Lord, in the first legal case and 2) Provided policy-makers a better concerning federal regulation of corporate understanding of the difference between the pollution, defined asbestos as follows: “Asbestos is geologic and the health definitions of asbestos. a generic term for a number of hydrated silicates Geologic definitions of asbestos are arbitrary that, when crushed or processed, separate into while health definitions are driven by flexible fibers made up of fibrils.”18 epidemiology. Policies should focus on the health In 1986, OSHA established counting rules which definition of asbestos to best protect the well- limited fibers to those with a length width aspect being of the public. ratio greater than 3:1 and longer than 5 microns.19 The United States Environmental Protection Agency Results (EPA) established an aspect ratio of 5:1 for The original definition – includes all asbestos fiber asbestos with length longer than 0.5 microns.20 At forms the time, there was no specific geologic definition Asbestos disease became a major public health for the term asbestos fiber.21 problem for industry in the 1930’s when workers began to successfully sue for compensation.13,14 In An opportune void 1938, companies that manufactured asbestos It was easy to formulate a debate over definitions brakes funded animal studies at SaraNever Again since geologists had never agreed to any specific Consulting Laboratory in New York. The studies definition of asbestos (which historically had been determined that asbestos fibers, rather than non- a commercial and not a geologic term). A 1987 fibrous round particles with the same chemistry, book on the subject of asbestos fibers noted that: caused lung fibrosis.15 Unfortunately, the exposure “A search of more than 50 technical and scientific measurement technology used until the mid-1960s texts, glossaries and dictionaries produced no could only count the total number of particles, both authoritative definition of fiber or fibrous that is fibers and non-fibrous in air samples.1 Thus, applicable to asbestos and appropriate for use epidemiological studies of workers exposed prior by health professionals.”22 The 1974 Glossary of to the 1970s relied on total particle counts (millions Geology quotes Lewis Carroll to describe the state of particles per cubic foot MPPCF) to assess of geologic definitions of minerals, implying that exposures.1 In 1974, Canadian researchers who the definitions used were subjective: (p. vii)23 conducted studies of asbestos mining workers “When I use a word,” Humpty found that particle counts could not be converted Dumpty said, in rather a scornful to fiber counts.16 Researchers, therefore, had little tone, “it means just what I choose it basis for distinguishing the health effects of to mean—neither more nor less.” different sizes and shapes of asbestos mineral “The question is,” said Alice, particles. “whether you can make words In 1971, OSHA adopted the American Conference mean so many different things.” of Governmental Industrial Hygienists (ACGIH) TLV “The question is,” said Humpty of 12f/cc for “all asbestos” as its first permissible Dumpty, “which is to be master— exposure limit (PEL).3 In 1972, OSHA issued the that's all.” first specific regulation designed to limit worker In the early 1970s, Pfizer and Johns Manville (JM) exposure to all forms of asbestos.17 OSHA used began to warn customers of the presence of four geologic terms— anthophyllite, tremolite, asbestos in their talc products. RTV complained in chrysotile and actinolite— and the names of two a letter to JM and Pfizer that these warning were commercial asbestos products— amosite hurting their talc sales and a bitter dispute ensued (cummingtonite-grunerite) and crocidolite between the companies. RTV asked Pfizer to stop (riebeckite) - to define the applicability of the Medical Research Archives | https://esmed.org/MRA/mra/view/2778 4 FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023 The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation warning its customers that talc contained asbestos: position has never been supported (p. 1)24 by any scientistof renown or any It'sa crazy world isn'tit? Here we other talccompany, Vanderbilt has have been producing and selling remained adamant in that defense tremolitic talc for 30 years and we of it. Their lobbying efforts were see from a recent advertisement of successful in obtaining certain your Minerals Division (enclosed) letters… [from OSHA]. Although that tremolite is an undesirable these letters were ambiguous, impurity intalc -- like asbestos. I'll Vanderbilt used them to certify the bet your West Coast ceramic safety of their product until the customers are surprised to learn labor department rescinded the this. letters on January 19, 1977. In the minds of many, talc and [Emphasis added] asbestos are one and the same. The Pfizer warned about the presence of asbestos in more your Minerals Division their talc products and acquiesced to OSHA continues to muddy the water by regulation: (p. 3)6 discussing talc and asbestos and JM, another major talc producer, asbestiform minerals in their with considerable expertise and advertising copy, the more firmly asbestos took a radically different this misconception will be implanted approach. On September 30, in the minds of Government 1974, they issued a letter stating regulators and others who have a that their Grantham talcs contained vested interest in the hazards of amphiboles of asbestos and placed asbestos. Already NIOSH talks of asbestos warning labels on their a "talc alert" and the WALL STREET talc packages. In June 1976, they JOURNAL runs a leading article officially shut down the Grantham (enclosed) on the hazards of “pure talc operation in Death Valley and talc.” went out of the talc business. This is a criticaltime for the talc …MPM [Pfizer’s]scientistsbelieve industry. Your Minerals Division can that after grinding, tremolite help by giving more careful particles either meet the OSHA consideration to the consequences definition of a fiber or failed to of their talc advertising copy. meet it. If the fiber definition is In response to thisletter, Pfizer summarized RTV’s met, tenderness best the form strategy for defending their talc from regulation: particle exists. (p. 2)6 Based on the above, Pfizer has R. T. Vanderbilt has been the chosen not to attempt to challenge largest producer in the United the OSHA regulations. States of “industrial talc” with high JM feared that RTV’s refusal to acknowledge the amphibole content…. Prior to the health risks of asbestos in their talc products would publication of the original undermine the industry’s ethical and professional standard, they launched a massive credibility. JM’s director of environmental services, effort to block the standard and Edward Fenner, in a memo to coworkers stated his later to overturn it. Initiallytheir objections to a published paper written by RTV’s thrust was that the amphiboles were geologist CS Thompson: (p. 1)25 not asbestos and should not be …[I] disagree with almost included in the asbestos standard. everything said by Thompson. I Later they took the position that the object strongly to an earlier amphiboles involved, especially statement …Re: “Misinformation” tremolite, existed in both supplied by competitor. “asbestiform” and “non– Furthermore, in all of Thompson’s asbestiform” varieties and that gobbledygook regarding the Vanderbilt talc contained of the minerology of Vanderbilt’s “talc” non-harmful variety. Although their at no point does he admit to the Medical Research Archives | https://esmed.org/MRA/mra/view/2778 5 FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023 The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation fact that their “talcs” contain not Deleting non-asbestiform fibers from the definition of only fibrous tremolite but chrysotile asbestos and anthophyllite as well. This we Using Geologists to Influence Government have proved by every available Regulatory Bodies. Beginning in the 1960s, the technique. These findings are well National Institute for Occupational Safety & documented in numerous R&D Health (NIOSH) and others had found asbestos reports. I am afraid that Dr. fibers (with an aspect ratio of 3:1) in cosmetic talc Thompson long ago gave up any products.30,31 Facing the threat of FDA proposed professional ethics he might have regulation and OSHA regulation of asbestos found had and is now persisting with a in cosmetic talcs, the TM&MCs began a campaign program that is not only technically to redefine asbestos. false but even more tragic morally In 1973, the Congressman who represented RTV’s and ethically wrong. He totally mining district wrote to OSHA on their behalf ignores the medical consequences supporting deregulation of RTV talc because it of his immorality. [Emphasis in was his “…understanding that there was no original] evidence that tremolite was carcinogenic.”32 In July Unfortunately, RTV and other talc companies 1974, RTV met with the Secretary of Labor continued to supply the same “misinformation” in Stender, to request that OSHA rescind regulation the years to come. Neither asbestos mining and of its talc:33 manufacturing companies nor geologists had ever “RTV...requested relief from the used any definition that distinguished Asbestos Standard for our non- “asbestiform” from “non-asbestiform” until OSHA fibrous or non-asbestiform began to regulate all forms of asbestos in 1972.26 tremolite, anthophyllite and (In fact, in 2002, the United States Geological actinolite “pending thorough Survey (USGS) created a 75-page “Tabulation of investigation by NIOSH which was Asbestos-Related Terminology” and “asbestiform” then estimated to be concluded in does not appear in any asbestos definition until one (1) year. Secretary Stender at 1977).21 this meeting stated that the R. In 1973, the FDA proposed regulation of asbestos Vanderbilt Company, Inc. was in talc.7 As a result,, RTV, which sold “tremolitic” being held "Hostage" without talc (50-70% tremolite and anthophyllite), and documentation on tremolite, J&J, whose iconic product was talcum baby anthophyllite and actinolite.” (p. 1) powder that contained asbestos, faced a On August 6, 1974 Stender wrote to considerable problem.27 In response, RTV and Vanderbilt that “…non-asbestiform Johnson and Johnson (J&J) took advantage of the minerals such as non-asbestiform tremolite vacuum of geological definitions of asbestos to are not within the scope of the existing defend the safety of their talc products by Asbestos Standard.” This was not enough beginning a campaign to restrictthe definition of for Vanderbilt who wrote back: (p.1-2)33 asbestos to only those fibers that could be shown “This was a step forward but the to have originally formed in bundles like hairs on a lack of a definition for of fibre still brush. The asbestos definition propounded by RTV holds us ‘Hostage.’ We are and J&J excluded single fibers of the same size. therefore now losing a considerable The two companies began a campaign to have amount of business and suffering OSHA restrict the definition of anthophyllite, irreparable economic harm...We tremolite, and actinolite (ATA) asbestos to only meet today not to decide what is or fibers that originated in an asbestiform habit. what isnot carcinogenic, but only However, both forms are found in all asbestos to ask that our industrial talcs deposits and products and it is impossible to containing tremolite, anthophyllite determine the origin of a single fiber after and actinolite be excluded from the processing (e.g., talc used in cosmetics is processed Asbestos Standard immediately by milling and sieving, which destroys many of the pending results of the NIOSH asbestos bundles.)28,29 investigation now in progress. We are suffering financially as a result of not being excluded pending Medical Research Archives | https://esmed.org/MRA/mra/view/2778 6 FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023 The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation documentation, we ask most Asbestos is a commercial name and sincerely for a quick exclusion. As ithas been applied to a group of we mentioned on July 2, thisis the highly fibrous silicatesspecifically course of action EPA and MESA chrysotile and several of the have taken while awaiting results of amphibole minerals. These minerals the same NIOSH study.”33 are characterized by very unique [Emphasis added] physical properties that include In the 1980’s, RTV’s consultant geologists began to high tensile strength, resistance to lobby OSHA to adopt a geologic rather than a acid and heat, flexibility enough to health-based definition of asbestos that would be woven into cloth and unique rescind regulation of non-asbestiform asbestos. The optical properties. geologists argued that non-asbestiform asbestos Two of these requirements (those asbestos fibers was not asbestos because it was not developed or must have a mean aspect ratio of at least 20:1 formed in a fibrous habit. RTV consultant, Dr. Ann and appear in bundles) would eliminate OSHA Wylie, Associate Professor in the Department of regulation of much of the asbestos found in talc Geology at the University of Maryland, first used in cosmetics. The talc companies were aware promoted this geologic definition asbestos in a that microscopy, when applied to cosmetic talcs, 1983 legal opinion provided to RTV.34 Later, generally only detected individual fibers whose Wylie presented this geologic definition in a 1984 derivation could not be determined.28,29,38 Further, presentation co-authored with John Kelse of RTV, tremolite, actinolite, anthophyllite, and harsh Vanderbilt, Richard J. Lee (another RTV consultant) chrysotile have low tensile strength and poor and Kelly F. Bailey, a geologist employee of flexibility39-41Non-asbestiform fibers have justas Vulcan Materials Company.8 They claimed much flexibility as "true asbestos". There is nothing “difference exists mineralogically and unique, diagnostic, or special about the flexibility biologically” between “elongated non-asbestiform of asbestiform fibers.42 cleavage fragments” and asbestos fibers.8 In the same month, Wylie asserted that the term Wylie’s participation was crucial to RTV’s efforts. asbestos should be limited to fibers that had In 1985, Slim Thomson, RTV’s mineralogist, “grown” or formed in a fibrous habit (group of reciprocated Wylie’s contribution to RTV in a letter fibers) with aspect ratios greater than 20:1.4 (See endorsing her application for tenure.35 Her Figure 1) However, many minerals form in a department chair thanked Thomson, noting that fibrous habit; fibrous tremolite and anthophyllite RTV’s recommendation “…will constitute the most naturally chemically convert to talc and vice versa important piece of document to be used in the while maintaining the same fibrous structure: (See entire promotion and tenure process.”36 Figure 2) In 1984, Wylie testified as a representative of RTV at OSHA hearings and promoted the adoption of her geologic definition of asbestos:37 5 Talc + 6 Calcite + 4 Quartz ↔ 3 Tremolite + 6 CO2 + 3H20 7 Talc ↔ 3 Anthophyllite + 4 Quartz + 4H2O Medical Research Archives | https://esmed.org/MRA/mra/view/2778 7 FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023 The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation Figure 2: Talc and amphibole ends in a single fiber (Compton and Millette 2004) In 1987, RTV reviewed a draft of a Wylie paper characteristics when viewed by on asbestos definition.12 John Kelse of Vanderbilt light microscopy: was concerned about the paper and suggested 1. Mean aspect ratios ranging “several embellishments.” [Emphasis added] from 20:1 or greater for fibers Kelse asked Wylie to emphasize the fact that the longer than 5 μm, aspect ratio should be used only as a “screening 2. Very thin fibrils, usually less tool only – as one of many variables which helped than 0.5 μm in width, distinguish non-asbestiform particles from 3. One or more of the following: asbestiform particles. As for health effects, the a) Parallel fibers occurring in possible role of many other variables to be bundles, recognized, (e. g. hardness, surface charge, b) Fiber bundles displaying durability, etc.) When you say on page 6, for splayed ends example, the particles with aspect ratios greater c) Fibers in the form of thin needles than 15:1 are the particles ‘known to be d) Matted masses of individual fibers carcinogens’, we know what you mean but fear e) Fibers showing curvature others willnot.”12 The “known to be carcinogens” Wylie’s definition hinged on the mean aspect language does not appear in Wylie’s papers ratio, but she did not report any mean aspect ratio published in this time period.43-47 for any asbestos variety in this paper.44 However, In August 1990, Wylie presented a more in 1984 she reported that the 20:1 aspect ratio extensive test method criterion to define asbestos was too high: “Aspect ratios between 8:1 and at a NIOSH meeting which was published in a non- 19:1 are characteristic of fibers of amosite and peer review summary of the meeting papers:(p. anthophyllite.”4 In 1985, Wylie reported that a 1)44 20:1 cut off would fail to account for 50% of ASBESTOS FIBERS. Asbestiform commercial amosite fibers.48 Puffer and Germaine mineral fiber populations (2019) found the mean aspect ratio of amosite to generally have the following be 11.7.49 In addition, PLM cannot identify fibers less than 0.3 µm wide and in many fibers are Medical Research Archives | https://esmed.org/MRA/mra/view/2778 8 FILED: NEW YORK COUNTY CLERK 01/05/2023 04:16 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 7 RECEIVED NYSCEF: 01/05/2023 The Definition of Asbestos-A Manufactured Defense to Avoid Regulation and Victim Compensation thinner than that. Campbell et al. (1977) also a thick mass;” parallel means “side by side and showed that neither length nor aspect ratio could having the same distance continuously between distinguish habit from cleavage formed asbestos them.” fibers since they overlapped. (See Figure 3) Julie Pier, who was in charge of testing for Shedd (1985) measured the dimensions of asbestos in talc for Rio Tinto Minerals and J&J, crocidolite asbestos and found that the majority of summarized the problems related to the limiting crocidolite asbestos fibers would be considered the identification of asbestiform fibers beginning “non-asbestiform” by the Wylie criteria.50 Millette with the concern that “It is not known whether (2015) commented on the Wylie’s criteria: “Trying cleavage fragments of similar dimensions to to use two or more of those mineralogical asbestiform fibers pose the similar health risks”: (p. characteristics would result in misclassifying up to 11)55 80% of the asbestos fibers.”51 • Amphiboles are naturally elongated; when At OSHA, Wylie conceded that her 20:1 criterion ground consistently produce “cleavage could not distinguish asbestiform from non- fragments” that meet 3:1 and 5:1 criteria asbestiform asbestos: • On a microscopic scale, one cannot “The use