Document dnDj1JN7rmGMz374qerpzBo5Q
MEMORANDUM
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION
TO Dr. Robert M. Schaffner, Director Office of Technology (BF-400)
July 31, 1973
FROM : Dr. Alfred Weissler, Acting Director Division of Color Technology (BF-430)
SUBJECT: Summary and Comments on Prof. Lewin's Analytical Results for Asbestos in Talc
1. The purposes of this memorandum are to present a summary of the analytical results for asbestos in Cosmetic talcum-type powders obtained by Prof. Seymour Z. Lewin of New York University in his role of consult ant to FDA; to compare his results with those obtained by other labora tories on some of the same samples; and to make some comments on the gen eral question of suitable techniques for the analysis of asbestos in talc.
2. I asked Dr. Lewin in December 1971 to undertake asbestos analyses in ________ 100 samples of cosmetic powders; the scope was expanded on two subsequent
occasions, to include a total of 195 samples. i chose Dr: Lewin fur Lliis work because he is an internationally-recognized expert on mineralogical chemistry and because he is a member of the academic community and there fore likely to be impartial in a confrontation between industry and government. Furthermore, his competence had previously been recognized by industry (by virtue of their own use of him as a consultant) which appeared to confer a desirable immunity against possible industry attacks on the validity of the results.
3. Dr. Lewin's findings are shown in Table I; the key to the identities of the numbered samples is given in Table IV. Please note also the ex planatory comments in Dr. Lewin's memo of July 10, 1973, which is an Attachment to Table I. No varieties of asbestos other than chrysotile (a serpentine) or tremolite (an amphibole) were found by Dr. Lewin in the 195 samples which he examined. As shown in Table I, Dr. Lewin found definite indications of chrysotile in 17 of the samples (many of these also had tremolite) and definite indications of tremolite but not chryso tile in an additional 18 of the samples. These results were obtained primarily by means of X-Ray diffraction, supplemented in some cases by optical microscopy and other techniques. However, Dr. Lewin points out on page 2, paragraph 1 of the Table I Attachment that the chrysotile he has identified in commercial products shows several significant dif ferences from "classical" chrysotile: in the location of its X-Ray dif fraction peaks, in its appearance under the microscope, in its reactivity toward dilute acid, and in its behavior with respect to differential thermal analysis.
Page 2 - Dr. Robert M. Schaffner
4. In Table II, I have compared Dr. Dewin's results for tremolite with those obtained for some of the same samples at FDA. (by means of optical microscopy) and at the Pfizer Minerals, Pigments, and Metals Division (by means of X-Ray diffraction). This comparison, which was undertaken in order to obtain additional information on the samples, shows good semi-quantitative agreement among the three laboratories. Whatever quantitative differences exist in the amounts of tremolite found can be understood readily on the basis of such factors as (a) preferred orien tation of plates and fibers in the packing of the X-Ray diffraction sample, and (b) inhomogeneities in sample composition, caused for example by air elutriation within the container when it is shaken.
5. In Table III, I have compared Dr. Dewin's results for chrysotile with those obtained for some of the same samples by four other labora tories ; the additional two laboratories included in this part of the study are Columbia Scientific Industries of Austin, Texas (who sell the Stone apparatus for differential thermal analysis) and the Health Protection Branch of the Department of National Health and Welfare of the Canadian government in Ottawa. The agreement of results from dif ferent laboratories is much less satisfactory for chrysotile than that discussed above for tremolite. For example, samples 89 and 163 were "found by Dr; Trewin to contain 37 and 107, of chrysotile, respectively, but chrysotile was not found in these samples by the otheT' laboiaLuiies-s-- Also, a preliminary finding of chrysotile in a sample of Johnson and Johnson Shower to Shower Body Powder has been disputed by the company, which claimed that their own analyses by several different techniques fail to show the presence of chrysotile. The explanation for these differences is attributable largely to Dr. Dewin's inclusion in the term "chrysotile" of mineral species which show significant differences from classical chrysotile, as discussed in paragraph 3 above.
6. The difficulties involved in analyzing talc and other samples for small amounts of asbestos have been pointed out by many investigators. It is not surprising that the results of different laboratories disagree sometimes, especially in the presence of transitional or altered mineralogical species. Moreover, with regard to the two varieties of asbestos of concern here, it is unfortunate that the one which is a clear inhala tion hazard to man, namely chrysotile, poses an intrinsically more dif ficult analytical problem than the othei) tremolite, which has not yet been shown to present a biological hazard. This is due in part to the less prominent X-ray diffraction peaks of chrysotile and to the fact that the fibers are often too small to be seen in the optical microscope.
7. In connection with a proposed new regulation on the safety of cos metic talcum powders, we face the problem of specifying an analytical test for asbestos which must be satisfied by the powders if they are not to be considerated adulterated. On the basis of information available at present, I recommend consideration of the following procedure. The powders shall be examined first by X-ray diffraction, which has a sensi tivity of the order of 1% for chrysotile and somewhat greater sensitivity
Page 3 - Dr. Robert M. Schaffner
for tremolite. If either species is found, confirmation that the species is present in fiber form is to be obtained by optical microscopy and elec tron microscopy. This is necessary because tremolite is known to occur in a non-fibrous form, and the X-ray diffraction pattern of chrysotile is the same as that of antigorite, a non-fibrous form of the same min eral. The sample is considered adulterated if the presence of fibrous tremolite or chrysotile is shown by the above procedure. An alternative procedure, based solely on optical microscopy (which is a less expensive and more widely available technique) might be proposed. However, the difficulty with optical microscopy alone is that it may completely miss the presence of chrysotile if the fibers are submicroscopic, which may well be the case in finely-milled talc; X-ray diffraction is not subject to this source of error.
Enclosures
TABLE I
FINAL REPORT X-RAY POWDER DIFFRACTION ANALYSES OF COMMERCIAL COSMETIC POWDERS
Fhlogo- o=> Dolo Sample Talc Chlorite Pite' Quartz mite
1 70# 3# 7# Rodo Rodo
2 100# nodo
Rod0 Rodo Rodo
3
99#
R D do
i#
Rode, Rede
4 100# Rodo
Rodo nod Rodo
5 95# 2# 3# nodo Rodo 6 80# 2# 5# Rodo n 0do
7 86$ 7#
2#
2#
8 95# 2$ 3# Rodo Rod
9 89# 7$
2#
2# nodo
IO 93# 3$
2#
2# Rodo
li .___ 90$____2$___ __ 2$____ ___4#____ 2%
12 100# Rodo
nodo Rodo Rodo
13 60# Rodo Rodo Rod Rodo
14 31# 50# 2# 10# 7#
15 100# Rodo 16 =*<=. 093
Rodo CO<53
nodo Rodo <3*C=? QO
17 60# 18 90#
19 97# 20 3 5 # 1 21 67# 22 59# 23 42# 24 94#
23 95# 26 95# 27 78# 28 ea20$
30# 4#
6o# 25# 35# 50#
1# 2# 1# Rodo i#
0 -V*
4# 2# 2# 1# 2# 1$
2# 3# 4# 2# Rodo
Rodo 2# Re do
4#
3# Rodo
3# 3# Rodo Rodo Ro do Redo
6$ 2# Redo Rodo
3# 5# 3$ Rodo Rod* R odo 20# Ro do
<M
29 cao9^$ ` Rodo 30 97# 1# 31 47# 50# 32 Go$ 7#
2# 2$ 2# 3$
Rodo R d o
3#. 2$
Rode 8# 8#
TramCalcite elite
Rodo Redo Rodo Red. Redo Rodo Rodo Rodo Rodo Rodo
Rde Re Glo Rde Rodo Redo Rodo Rd* n.do Rodo Ro do
Rodo Redo Ro d o Ro d 09
Rodo Rode
n*d0 Redo <SG
Ro Ro Rodo Rodo Redo Rodo Rodo Rodo Redo Ro do Rod; Ro do IO#
R do n*do Rodo Redo Rodo Redo Redo Rde Rodo Rodo Redo Rodo
o^ o Rdo Rodo Rodo
Rdo Rodo Redo ned*
Chiyso- Other
felle
Speciesgaytt=* saesswtw*r
Rode Rodo Rodo Rodo Rodo Rodo
?
Callide
Rodo Rodo Rodo n,, cL
'
Rodo Rodo Rodo Rodo 1 <EPC=>
ZnUnde-
Kaolin Star
Rodo Redo Rodo Rode
Rodo Rodo
?
Rodo 9
?
Rodo Rodo
Rodo Rodo rioo Rodo
Kaolin, Mica
Kaolin
Fage 2
SanIt
Fh!ego= o= D o l o Chlorite pite . Quarts1 mite Caleit#
33 552 34 782 35 782 36 a08$
4o2 72 5$ 4
22 Rodo 4^ 32 22 io2 n.odo rudo
32 82 52 hodo
hodo hodo ho do hodo
37 382 50^
52 ho do
72 ho do
38 872 5$
42 22
22 hodo
39 9^2 32 40 672 252
hodo hods
32 32
hodo 5$
hod hodo
4i 332 8$
22 22
52 hodo
42 892 62
ho do hodo 3$ 22
43 972 riscU n sd0 32 n.odo hodo 44 C3>5> S>c=>
45 662 302
hodo
hodo
4$ h o d o
46 482 4o2
hod
52
72 h o d o
...47 ____982 ______ h o d o _____________ h o d o _n.pdft _____ h o d o
22
-3 882 42
22 42 h o d o
49 1002 rudo
hod
hodo
hodo
hodo
30 952 52
hod
hodo
nodo h o d o
51 1002 n& d o
hod
riodo
hod
hodo
52 872 82
22
32
hodo
riodo
53 902 42
22 22
22 h o d o
54 cao87$
3$
42 h o d o
42 h o d o
55 8o2 152
52Z l o d o
ho do
hodo
56 9o2 7$
rudo 32
n 0do nodo
57 802 152
h o d'or
hodo
5$ h o d o
58
962 ri<jdo
42h e d o
hodo
h o do
59 cao90$ 6 0 cao60$
Ho do
302
hodo Hodo
32
hodo
h o do
72
hodo
22
61 382 402
rio d o
42 182
ho do
62 852 22
H o d o * 3$
hodo
102
S3 872 22
2#
4^
ho do
hodo
64 cao80/c>
52
3# 22
32 h o d o
65 caQ78^ 152
ru d o
hodo
42 h o d o
66 842 52
32 . 32
32 h o d o
67 782 152 68 802 152 69 972 12
hodo ho do hodo
hodo ndo ho do
52 5$
hodo
hodo hodo
22
Treia= olifce
ho dc 1 rudo rud0 hodo node nod, hodo hod ho do hodo hodo c=>
Chryso til# hod ho do hodo hdo hdo hodo node hodo hodo hodo hodo Of3>
hodo hodo h o dohodo
dcl0 nodo
h do
rudo
hado
ruda hodb
hdo hodo ho da hade ho do
ru.d,,-
hodci
52
hodo
n 0d 0 oda
22
hodo CLo
hodo hodo hodo
hodo
hodo hodo hodo hod
rude ?
hodo hodo hodo h o do hodo hodo h d o hodo he do hodo
rudo
22
hodo
,rudo
hodo
Dth^r Specie-
Mica
ZhO, Kaolin
Stereh ZhStearc ZnStear0 ZnSfcearo
pagfe
Phlogo 0 Sam oli Tale C h lo rite Bit
TO 28#
71 85$ 72 86# 73 ca 80$ 74 90#
75 75# 76 75#
77 91# 78 85/# 79 81# 80 e a o5 0 i 81 e a 08o$
82 ea.7S# 83 Q a,,S4 j 84 a92$ 85 o ac36 86 85
87 Qae30 88 61# 89 68#
90 55# 91 ca* 50 92 64#
93 55# 94 e a 045$ .S 5 86 96 28#
97 31# 98 e a c4 o i
60# 10#
5# 10# ned*
5# o do nodo
2# 5$ 40# 7# 12# 6# 4#
5# 4# 50# rudo
no do li
rudo i# 4$
Dodo n 0do
ii nodo
n 0da
5#
nodo
2#
3# nodo
4# 3#
nodo n 0do
nodo nodo
5# 5# 4# 2#
1# 4# 4 i nodo
nodo
8#
1# 6$
2# 4#
___ 5#_____ nodo
nodo nodo
HoCi He do
2# 4$
n 0do
4#
no dp
5i
3 i 8#
3# n cdo
7# n cdo
no do
6i
4fa 6#
3 i 6#
n.do
5#
3# 6#
1# 5
3# n<sd0
99 c a 4 0 i riodo 3 i rie do
iOO @aP8o 101 63# 102 63# 103 93# 104 91#
10# 8# 2# 3#
3/
4#
3# ndo ntdo
1#
rio do
7# 3# rio d0 2#
m ite
7# rie do n 0do
5# 5# 15# 10# nodo 3# 2# nodo 4# 3# 4# 3# Gi 4^ 12# 25# 10# 25# 3# 20# 25# 35# 4# 45# 35# 6^
6
2# 4# 15# 4
3#
OaXeite lite
nodo fie Q0
2 He do
5# 5# n.do ned. nodo 8# nodo nodo no d 0 n-.do nodo no do n .d 0
3 n*do Hodo
2#
5# n cdo n cdo nodo n.do nodo
no do 2#
rio do
3# ricdp riedo rio do nodo
5 3# 5# nodo n cdo n tdo nodo rio do T i9do nodo nodo n.do 4#
5# 3#
n cdo
5# 5# 4# 2# S 12# n.do
2 n 0d*
n 0do Dodo n cdo rio Q-o n 0dc
n . d
15# 10# rud& riod
Chrjrs= Other t i l a S^aeies
n.da Rode nodo rud* n 0dc ndo Ho do nodo n 0dc n 0d0
9
? 9
? 9c ? ? ?
5# 5# 5# 5# 5# 4$ 9
ZnStear Mi@a
3i 10# 15# n 0do
n 0do
n do riodo
7# rudo n 0do
K a@ lin, Miea
K a o lin ,, Mies
2xStear9
S arm!* TaXo C h l o r i t
105 106
107 108
109 110 111 112
92$ 91$ 87$ 81$ 74$
99$ 42$ ea 60#
3$ 3$ 5$ 10$
15$ n dd 0
40$ rie do
113 75 $
il4 53$
115 5 3 $ 116 53$ 117 42$
118 119" 120
53$ 49^--
46$
121 8 7 $
122 56#
123 5 i $
124 54 $
125 5 5 $
126 75$
127 85$ 128 60$
129 9 7 $
130 ca 882
131 ea92
132 95^ 133 94^
134 93$
135 93$
136 89$
137 9 1$
C(TOt
85$
39 ca852
15$ 40$ 40$ 40$
35$ 40$ 4O7& 40$
8$
35$ 40$ 40$ 40$ 10$ node nde tie d D
7#
3$ 3$
2#
3$ 2$ 4$ 4$ . 7 $
nodo
140 c a c852
rio do
p it*
page 4
&=> DXs=> Q u a rta mit!
C a lc it
1$
12
2$ 2$
3$ 1$ 2$
rude
2$ 32 nod 2 32 Hdo He do 4#
2$ 2$
62 3$ 3$ Hod
15$ Hodo
Ho Clo nod He do Hodo Ho do Hodo Hodo
10$
Tran* Chrys . lit& tils?
Hodo Hodo Ho do
2$ 2$ Hod
12 Hd
Hod Hodo Ho d Hodo
? Hodo Hodo Ho do
rio do
3#
n .d 0
3$
node
3$
nd
3$
He de
15$
nde
3$
tl0U9_o__ _____O(L/eOt-_____
He do
B$
2 $ Hodo
Ho do nd<>
5$
32
ndo He d
3$ 2$
32 Ho do
4$ 4$
Ho do
Hod
He do He do
Hodo
2$
3 $ Hodo 2$ Hodo
4 $ Ho do
2 $ node
3 $ Hodo
3$ n de
3$ Ho do
22
3$ 2$ 2$
7 $ Hodo
4 $ Hodo
4 $ Hodo
4 $ Ho C1q
4$ 2$
4 $ Ho d -
cesi
dp
___ H_o_d,4-o-------
4$ Hodo
3$ n c do 4$ Hod
4$ Hodo
3$ Hodo
3$ Hodo
8 Hodo
Hodo Hodo
Hodo Had
3# Ho do
3$ Hodo
22 Hodo
Ho do Hodo
Hodo He do
2 $ He do
2 $ He d
2 $ Hodo
2 $ Ho do
3 $ Ho Oio
Hod Hodo
Hodo Hodo Hodo Ho do Hed Hodo Hd Hodo Ha do He do Ho do He do n .d o Hod. Hod ado Hodo trac trac Hod rudeH do Hdo Ado Hodo Ho do Hodo
nodo Hodo Hodo Hodo
? n 0d o Ho do
? H 0do
? ? *>
? Hodo He do Hod Hodo trace Hod, Hodo Hdo nodo Hod Hodo Ho.do n Ddo nodo
n 0d 0
2$
12 n 0do
n& d
Hodo
Other Sr? slus
Ka-elin
Salicylic A e,,B@ric
Boric Aci( CatihdcyX,
ZaStear
MgOO^
ZnStar<
Sfim o 1
- page 5
PhXego o
T a la C h lo r ite
P ita Q uartz
141 80# n do n d o 20
142 143 144
19% 55% c a o70#
1% 20 100
50 n do nd
40 30 60
145 c a 070 #
30
n<> do
nodo
146 147 148 149 150 151 152
c a 8 5 $ e a 0C5 # s a , 45$ oac.5 0 0
80#
<%% o a o 70#
153 c a * 8c #
154 155 156
157 15B
o a .70^ ca*>84#
19% 63% 18%
159 160
60%
161 162
59% 58%
163 55% 164 92%
165 166 167 168 169
92% c a .50 %
16 % -- eaga
170 171
520 10%
172 173 174
430
<sao9 9 # c a 06o#
A s do n#do 400 100
2$ 250
20
2#
100 100 100
20 70 100 250 250 250 2# 30 50 400 100 c^cc* (Saco 9 odD 100 500 n 0do 1#
ndQ n edo n od 0 n 0do Aodo n ,d 0 Hodo
Hodo
40 n edo n 0d<, n<>do nodo
2# n 0do Ao do ndQ node
20 Ho do Ho do nodo
cam n .d o Ao do n 0do Ho d 0
20
40 node nodo 100
50 20 ndo
nod0
40 40 6$ 30 30 ffcodo nodo 20 20 3$ node no do 20 xudo PO c=ca
50 50 Ho do riodo 150
Dle=> m lt
10
G a le ite nodo
!2trem=> life
\
nod
Chryso=> tile
Ho do
50 250 n .d o
n 0do n cd 0 n 6do
riodo 5# 5#
no dc 10#
?
3 0 n 0d *
n .d o
20
n 0do Hedo
8# 120 nodo 100 n c do
50
50 node node
5# nodo n 0d Q
riodo node
20 8# nod n do nodo
Hod, nodo node
? node riodo nodo
Aodo n o d 0
n Qdo
node
20 n do
20 n .d o
3 0 A . dp
180
riodo
20 100
40 100
40 100
40 100
5$ 200
100 Ho do
20 n .d .
20 n o d .
80 n .d o
120
node
pco (2X33
c=><s 1c a 8 c #
250 15#
50 nodo n od 0
node n od 0 node n 0d 0 n 0do
2# nod
20 ,60 n 0do nod nod. n 6do riodo 100 n bd 0 n .d o n *d 0 _ 20 QMD
n 0d 9 node
20 node n 0d 0
n 0do ?
n 0d 0 80
riodo ?
tra c e node n 0dg 100
10 ? ? n c do
00
80 nod0 n 0do
? n 0d 0 '
O th er S n ee ies E n Stear, MgCO^
Z n Stear0 K a o lin 2n S t a r 0 K a o lin , ZnO E n Stear0 K a o lin E n S te a ro K a o lin K a o lin F y rp p h y ll
ite E n O ,B o ric
A cid ZnO
Gypsum
K a o lin ,
Mica
S a m le 'EaXe C h X o r lt c
0*04
175 ea860 176 ao7 9 $ ITT 84$
173 c a e500
179 97$ 180 88$
c a o7O0 182 eao4O0
183 ca>7 6 $
184 93$
185 ca#5O0 186 c a o5O0
187 ca *S 5 0
188 70$ 189 72$ 190 c a o 8 2 $ 191 96^ 1 9 a 100$
193 cao 930 194 ca*9 ^ 0
195 97$
3$
30 10$ 20$ n 0d 0 no do no do
25$ 10$
2$
8$
5$ 5$ 15$ 12$ 12$ 20 ndo 20 20 no do
pag o
Ph.lge>=> -B it Q uartz
ru&*
2$ 4$ 2$
nd n .d e n do
15$
n 0d nodo nodo nodo no do
2$
nodo 20
n do ndo nodo ndo no do
10$
15$ 2$
5$ 3$ n c do n,,do n 0do n 0d 6
2$
nd0 ndo
2$ 3$ 3$
nd0 nodo n ftdo
2$
n 0d 0 nodo
I>oX= m ita C a X cite
0hrys=> O tlie r
lite
S p e cjU is
ru le n edo Rodo
4$
n ed 0 12$ nodo ndo
2$
Rodo nodo nodo Rodo
4$ 2$
~ 3$~ 2$
Redo 2$
3$ 3$
Rodo Rodo Rodo
Ro d 0
ndo
n 0do 10$
Red
10$
nodo
25$ 25$
5$ 5$ 5$
nodo nodo
no de nodo
30 nodo
Rodo Rodo Rodo nodo Rodo Rodo Rodo Rodo
1$ 3$ Rodo Rodo 2$ 10 1$ " RCU Rodo Rodo Rodo Rod Rodo
? ?
nodo ?
Rodo Ro do Rodo
? ? ' nodo Rodo ? Red ? n 0d 0 ~ ?-------Rodo Rodo ? ? Ro do
K ao ln K ao lin ZnO Zn' ZnO
Z n S te a r0