Document kDRm0VX7E820YvzD3mjp5b7Dq
FILE NAME Talc TALC DATE 1973 Aug 11
DOC TALC112
DOCUMENT DESCRIPTION Memo - Report of Meeting with FDA
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Research Center Research
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August 11 197
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TALCS
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Jf, FDA MEETINGASBESTOSIN COSMETICTALCSeet
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AUGUST
1971 3 AUGUST
-
WASHINGTON
, DC
.
iH
i
an
a
i
y
purpose H The
and listofparticipants and discussants are given
:
res
*
' in theattached two handouts from the meeting meetingdiscusants
Resources basis mG Summary
: :
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rn os
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ep
vt
Dr. Romer NYCDepartmentofAir
. rn foo set set the
4
for
for
.
the meeting meetingandreiterated hisdemands that the FDA
a
cosmetic tales a, lt 2. evaluate .
tales was
ty
OE
ba
unacceptable acceptable 3 decide on the
limits limitsofasbestos and
theunacceptable
of
those
ie 1c
comotic taleswhich they deemed
used be
to
towardsbanning
concerning the
He will
of analytical techniques vice from various Government
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August 11 1971
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: CADANGST
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CADNGST FDA MEETING 2
,
ASBESTOS IN COSMETIC
TALCS
'
7
LE
Vermont
talcssource of J
generally -
relatively
free of tr"-og
molite or other asbestosminerals
:
.
:
bog
Cralley J Dr. Lewis : Reviewd
National Institute Institute of Occupational - .
4
-
Safety
andHealth
Cincinnati
Ohio
Sakae carcinogenesisexposure time time of carcinogenesis
es
published fibers heavy in talc
fesetan! talc by X rays
3
Reviewed his
study of ,
AAO toa fiber these
4
a
Medicine .
Mt. School .of
cy
ny
wee
study to
community environment workers
5
extrapolatable com unity
in the
Gouverneur emphasized the
workers studyof talc
Arch
stated it was not necessarily necessarily
-
He noted excess lung cancer in talc .
tremolite New York smoking district of
importanceof smoking in :
talc worker's
worker's worker's
8
, not in mesothelioma
AS
Be
a
sed
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1971 August 11
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FDA MEETING . |:
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i, ASABSBESTEOS STOSIN COSMETIC TALCS _ ~
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gusteftoce . rcienst rs omit.
Health = acre * tava 5
DescrPiabueldGrosanismal Industrial Foundpraevitouisloy pnreviously Dr. with talc previously phy cher
animal experiments animal animal
experiments
animal
expriments
*%
aA
used |on
tee
NTO sicians
These
gloves
injected
intentionallyinto bellies
of
animals
produced granulomas described intertracheal in
sters with three
of
jections of ham nickel and
types talc high nickel low
shelf cosmetic talc talc Nofibrosis afterlow
two years despite excessive amounts used He notedIan
s
Webster conclusions that fibers must be at leastmicrons long to be
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eos
Lo
harmful a z
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ioe
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&
nwtenga
oy
&
iterated
b
f
introduced introduciendtroduced interest evaluation and
that
in the consumer the interest
Pen
tee
the use of particulates
indicated Hisreviewof useof
fae
indicated indicated 1 the extreme reference
fare
impurity noted always beremoved removed frotmhe
phibole impurity hadbeen
Pennsylvania fiber content asbestos tohrirgionautgedh Belt filtered content
contentwater which originated
{
asbestos asbestos in wells wells
pris
oy
BO
renet
PDAs opticalmicroscopy microscopy
FE
one percent was detectable detectable
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RJLEE0003267
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TALCS COSMETIC | 2.
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MASEBEESTTOSING |IN
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subject of asbestos in injectable drugsand stated that more
than half of injectable drugs in a survey at the Mt. Sinai
Hospital Pharmacy contained asbestos inamounts amounts up to 1 micro-
gram |in a vial
2 OE
ney
4
|
Manville -
S. Speil
2
i
recognized importance technolgy
. Reviewed asbestos technology and the
-of respirable
^'
fraction vs total sample Suggested separation separation into airborne
4
sample counting or use of simulated simulated tests with samplers and
t
counting | by ACGIHmethods using
TLV with an expo- i
.
[oa
; an .
-
;
sure time factor pon? A
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Indicated 05 per cent
total not specific
a
\
centdetectable tald sample probably cosmeticistalcs clean by HS. eg pe
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;. FDA MEETING . COSMETIC
' TALCS :
a oh
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: ASBESTOS IN COSMETIC TALCS o 7
approximately 7 microscopy Indicated
one week week work forcom-
. plete evaluationofa talc sample Showed many slides 9,
;
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cent 3 cating presenceof fibersby EM chrysofile chrysofile not verified
;|
2. by electron diffraction diffraction Still feels identification identification of chry-
i
a 4 o sotile
by
shape shape
90 to $ per
certainl fo :
.F
gS
: fo
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8
2
;*
pf
/ Dr.Norwood -ChasPfizer &Company
f
i
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Do
_~ Pfizertalc
ray indicated slight slight chlorite chlorite Me oe : i
serpentine detectors ray impurity but but no amphiboles Suggested X-
, petrographic andchemical chemical analysis by
ray followed followed by Agreed
ar
emission Agreed
sf ..
Angstroms that 8.4 Angstroms amphibole amphibole sensia tve nd 7.3
|
approxi- plus
were sensitive ray
e
chrysotile chrysotile
:
for
Caneer W. T. ae
wa8
.
:
pographic andelectronprobe pographic ao
oP
EY
probe
a
Reviewed pographic *
pographic
pographic
clean fiber Reviewed
pographic pographic 2
.
i microprobe microprobe +analysis
exceptwhere there
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RJLEE0003269
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August 11 1971
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63
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Page 63
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METING
FDA MEETING
:
ASBESTOS
IN
COSMETIC
-
TALCS
oe
*
Sem in of q Hydromagnesite form is fibrous Diameter 200 Angstroms Angstroms 4
2.
with a hole down the center Hydromagnesite is known to
occur in some talc deposits
Geiger questions some
of
This
Art
Langer's identification of chrysotile fibrils ThiThsis
offensive Langer's was a smoke smoke screenbut a good counter
'to Langer Langer
finding chrysotile
everywhere 3
University South spent Dr. F. Di Pooley of z
by heavy techniques including Examined separation talc
sity separation in a
tn
EM
centrifuge
a
Wales L
ae
All fibrous
liquid den-
constituents constituentsconstituents were
diffraction electron identified as talc by >
,
made using goldplatelets Johnson beautiful EREDr. R./F R./F Rolle -
& Johnson
d
8
tes Showed beautiful
yet
electron
microyo grTheaphmsaic:romgierceraogprahp:hss
ofrolledup
of
Ne
talc Samples were
by replicationreplication using
palladium palladium : %
plating .. o
ly -
% ye
o ; .
,
apt ;af
ffs
ja
ae 3
&
1
-
F. Nicphroolpsoosned- Mtl.owSinai School OfMedicine program wets level andhighlevel study Dr. W.
high study
program
a
program
:
:
a
pitch Sfaolressurveying cosmetic talcs | The lowlowlow rleaveyl technique wouladnd + zi
examination include polarized
light microscopy microscopy and
identification
identification if neces-
cent
polarized liper
chrysotile
chrysot Spexafnidbril- liperchryslonogertile material sary Langer questions whether liper
chrysotile
lar form
could be
detected
detected and
showed studies his
with no X raypattern : visible after intensive
I countered
countered that
this
pertinent
was no longer
therefore
therefore thceoreufnotreered Nicholsn's
not pertinent
Nicholson'ssurvey : : ;
intial
and analysis 1. air sampling tests tests
preliminary screening gamut of samples after samples
statistical samples 2 } New
study study of
to
correlate York usage people and lungs $ with with talc
from a selected .
as above ge
Mt. Sinailungsurvey
of
fiber and talc content in the
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RJLEE0003270
August 10 1971 . oF
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FDA MEETING - COSMETIC ge ASBESTOS IN COSMETIC TALCS
wha
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En
be
sewn
epidemiological the ey
3232a complete complete
|
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epidemiological study of
workers the the
workers workers workers workers workers
workers
mining
and
producing.cosmetic -
producing.cosmetic producing.cosprmoducing.cosmeetic tic talts :
Lobe
^fi FP
4
&
# yin eams .
z 4 Mt. Sinai : Medicine 2 rn
C. Maggiore- Mt. i Sinai School of Medicine Medicine MedicineMedicine
i
Reported on Mt. Sinai eexplorxatoryploratory work towards thethe development
of instrumentation for completely completely characterizing many and all fibers and particles in a sample shape size chemical analysis etc.particles He indicated the need for approximately 300,000
years and2 to3 yyeearsars T
for design and
construction
construction of
prototype
unit
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