.­-~~--._----~-----_.,._---_..~---~---_.-.--.~~_.-----.--~...- --- .. , .._-..-------, ---_._-------~.-~--

DEPA[{Tl'v{ENT OF f-IEf\'{--,T(--{ & [-{UrvtAN SER\/{CES

Eli GranekMcGivney & Kluger80 Broad Street23rd FloorNew York, NY 10004

Dear Mr .. Granek:

DEC -;2 2009

F09-8987

Public Health Service

Food and Drug AdministrationBockviUe MD 20857

-'

In cespoose to youc cequesc of October 30, 2009 for information pertaining tothe presence of asbestos in talc.

~EnCtosed ace Lhe records you requested~

We llave searched oue fiLes and find no responsive irlfOnIl.:lti.on _

__YOUE [equesc i.s aLso being c-e(ccced to one of ()UC COOI!=K)(lCnC {)ffiL~es_

_ ~Certatn filateflal has been deleted froln the records furnished to you beCatlse apreliminary revie\v of the records tn(Jl.catcd that the deleted InfOCfuation is not re(lulred tobe publicly disclosed and tltat disclosure is nor appropriate_ FDA has taken ttlis approachto facilitate the process 0 f responding to you. (f you dispute Fl)i-\' s prelitninar}:determination and \vould ltke fDA to reconsider .any particular clcletion ~ please Ic[ usknO\V In \Vilting at ttle (ollov""'lng address: Food and Drug Adruinistratioo) Division ofFreedoOl of f'llfoffilatH)fl 1 {iFf·3 5 ~ 560() Fishers [_ane~ ltockvltlc~ Cvil) 20857 \vithin 30days from the date of this lelter_ If·\ve do not receive a response to that (flue period 1 wewill consider the cnatter closed_ [f you do request further consideration and if ttlC agencythen fonnally denies your request {or any or all of the prcviou${y-vvithheld infornlation~

you \villilave the right to appeal that decl sion _i\n y Iette_r 0 f den ia I \viI I explain ho\.v to

make this appeal.

The follo\ving cha(-ges for thi.s request to date 1l1ay be included in a (nonillty invoice:

Reproduction$~ .. 50 Scarch590400 o ~rotal:$ 203 .. SO

THE ABO\fE TO~I~AL {V(_~y~ NO'r REfl~E(~T~rH£ FlNAL CflARGES FOIl. Tl-{(S R~:QUl~S~~.

rLEASE 00 NOT SEND Pi\' \~lV{£N'[ UNLESS YOll REC£l\-f£ AN (t'\[\fO{CE.

For OFF[C£REKecuLLve Opeca~ioos ScaffCentec foe food Safetyand Applied NULclLion

Enclosure-

HHS00000001

.. _ .-_... I _.. _ ..... - ..... _., .. ~ • _ ....... .- .\

DEPARTMENT OF HEALTH., EDUCATION. AND WaFAREPUBLIC HEALTH SERvICE

FOOD AND DRUG ADMINISTRATIONWASHINGTON. D.C- 20204

~_ .. ! -.. August 29 .. 1975 ..

Dr.. John MooreChief,. An_imal Sci.ence and Technology BranchNIEHSP.O. Box 12233Research Tria~gle Park t NC 27709

Dear Jack;

AI. Harvey and Dr .. Thompson called me yesterday morning abouttheir efforts to supply us with a sample of their "tremolitett

for the asbestos feeding studies.

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They have located an area, from.vhich they have a small sample,which is pretty close t.o pure n.tremoliteu.. They estimated that·upon grinding they would have a mat,erial that is 90%+ Ittreinolitell

•

The question they posed, was. to what mesh pass through should they. grind this material. The~r initial survey of so-called food-grade'talc showed in ~2~~~fi~a--.t:_~9-l1..~,fQ.:(..~~sh.-size-·.pass-th~-ough-.--....--Ihey~---· .:r:ecommended that our tltremolite" be 50_ ground that 9-5% or morewould pass through a 325 mesh screen. As. a ballpark estimate•Thompson guessed that 4 to 5% would be greater than 45 microns inlength; ~iLh an average length of about 20 microns. The material wouldbe ground using a compressed air mill impingement process rather thanball-milling. The former process, they felt. would enha~ce brea~ge

along the normal fracture plane, thus leading to the possibility ofhaving more of the shorte~ particles•

... -=... - ..-

. ~

They noted 'that some foo~-grade talc and tales .for the drug industryare mostly less than 325-mesh in size. ·In addition, we felt that today-

. as well as in the past,' there was a greater 'possibility of greateringestion of talc through pharmaceutical exposures than through foodexposures. In addition, possibly more people could be exposed through.the former usage-than the latter usage.

For these combination of reasons, they felt that grinding to pass Lhrougha 325. mesh screen Qas preferable. Of course, the final choice would beours ..

I promised to see if I could develop anything more specific on the meshsize pass thr~ugh characteristics of talc for food and drug usage. However,based on the information pres·ented to me yesterday,. I feel that for· ourparticular purpose, a minus 325-IDesh material would be preferable.

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P.age 2

I had a misconception corrected about trenio.llte found in talc from Califor­nia and several other commercial ·sources. This material, as mined, isnot fibrous but is of a crystalline habit. Apparently tremolite of afibrous habit is not of a conmon occurrence. We were shown a sample -of"fibrous" tremolite when we were in Ampian'l s office 1ast month •

. We also discussed the term - fiber. Apparently, among some groups,.the term "fiber" takes on the immediate connotational aspect of"asbestos fiber"... ~ Harvey and Dr. Thompson fe1t a term not havingany ~ediate connotational meaning to the hearer should be used in thefuture. It seems we ~ll now have to be semanticists as wel1 asscientists; but for a good cause.

Best r.egards.

Sincerely yours,

%~~Raymond E. Shapiro, Ph .. D.Epidemiology Unit~ HFF-I08Bureau of Foods

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Between:

Memorandum for the Recordof a Telephone Conversation

Friday Morning, August 29·'1 1975

Mr. Ray KrammesWhittaker" Clark and Daniels1000 Cooledge StreetSouth Plainfield, NJ 07080

Phone: 201/561-6100

and

Dr. Raymond E.· ShapiroEpidemiol.ogy Unit" BIT-lOB

.-.....

I called Dr. SChaffner,. earlier in the moin~g, to ascertain if he hadany specifications for food_ grade talc. He suggested cal1ing Mr •. FredF... Roesch, a v?-ce-president in the above company. Whittaker, C1ark andDaniels are big jobbers- of·minerals, colors -and chemicals. Mr~ Roeschwas in conference ~en ·1 called and L was referred to Mr. Krammes.

Mr. Krammes told me that, the talc ~hey sell for the polishing ofrice is 98% through a 100. mesh screen. They call this talc·"White Snow~t and he thought -it· ,came -ei-ther from South- Korea or China;probably South Korea. I· told Mr. Krammes that Dr. Fred-Poo~ey,'Cardif£~

Wales, had examined two ta1cs from Asia. used commercially in the U.K••-one from South. Korea and ooe from India.. Since thi.s company had notimported any talc from India.J Mr. Krammes was quite- sure now that"White· Snow" came from South-, Korea.

As for the U.P.S. talc USed in the dust~g of capsules and in thetableting of pills:t Mr. Krammes told me that the product they sell forthis use was called Alpine talc from Alpine. A1abama. This materialis ground so that lOO~ goes through a 325 mesh screen.

I remarked to· Mr•. Krammes that with all the talc mines in this country,I was s.urprised they were importing talc for the polish~ng of rice. Mr:Kranunes then remarked that· with the controversy_of "asbestos" in talc~

and possib1e. health· implications,.many ta~c mines in this. country hadclosed-: and -they -were· using --an overseas·:source . for this food purpose.

I then thanked ttr .. Krammes for this. imformation & and .his assistance inthis matter.

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The Ontario Resear"ch Foundat ion (ORP) supplied chemical and size character­istics data throughout the milling program, and the assistance" of R. ·U. Glass,D. R. Hollingbery, B. J. Ferguson, and E. Brown, ·a11 of ORF, is gratefullyacknowledged. Numerous analytical personnel assigned to Avondale ResearchCenter and stud"ent. assistants from the Department of Geology, University ofMaryland. provided mos~of the data summarized ~n this report~ Their assist­ance 1s acknowledged in the sections of the report to which they contributed.

SAMPLES

Tremolite

Twelve hundred pounds of nonfibro~s t.remolit:e. containing approximately25 percent serpent-ine plus minor amounts of talc and other minerals t wascollected from veins at two levels in the Vanderbilt mine, Balmat. N.Y. Thissample was milled by Vanderbilt to minus 325 mesh in a Wheeler mill. 5 Becauseof sl"ight variations in t.he mineralogy of the samples at the two levels in themines, the sample was blended, using the NBS sample preparation facilities.Blending was performed in a la-eu-it v blender (fig. l)~· but because of" thelimited capacity "of the blender, approximately 960 pounds yas "blended~ usinga four-stage blending proce.dur"e. The blended "tremolite was repacka.ged in 38virg in card board drums, "conta ining a bout 25 pounds each.. Homogeneity of t.hesamples was verified by fluorescent X-ray spectrography f~r samples collectedfrom six randomly selected drums, which were being filled for shipment toNIEHS. No significant differences were detected by the various characteriza­tion procedures.

Chrysotile

Two chrysotile test mater"ials were purchased in quantit:ies of approxi­mately 1,000 pound.s each". The short"":'fiber chrysotile,. identified as COF-25.was purr:hased from the fin"ion Carbide Corporation. Niagara Falls, N4!Y" Thissample was ob'tained from the New Idria serpentinite mas~ "locat.ed in thesouthern part of the Diablo Range in southwestern San Benito and westernFresno Counties of Californ.ia. The ore boOdy is unusual because of the virtualabsence of long fibers and the high chrysotile content of the ore. To_checkfor homogeneity, samples of COF-25 were randomly selected from nine drums ofthe material shipped to NIEHS. No significant differences were detected inthe nine lots by the various characterization procedures.

A broader range fiber-length test material, identified as Plastibest-20 twas obtained from the Johns-~~nville Jeffrey mine, AsbesLos~ Quebec, Canada.Plastibest-20 is a particularly clean grade of chrysotile used by the plastics"industry~ To check for homogeneity, samples of Plastibest-20 were collec.tedfrom "10 drums of the test material supplied to NIEHS4 No measurable differ­ences in composition vere observed, using the various characterization pro­cedures ..

SReference to specific trade name$ or equipment does not imply endorsement bythe" Bureau ot Minesot"

.

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late~a.fu~. 1 tiuca U76.. .. ..... --...... ... r ., ...... ...:r

..Dr. L &.. $&aptTO

XplQad:olei7 t1e.tt., R7f-lOS...Dr. A.. Laa.prHoIalt S1na1 School of Ko4iche... York. }lev York

- ttr 4 lAnser. had Juat f1~b.~ ape.ak.1ni with HariG:' Au.rro. cou.c:a~

ub••toa 1D Ul.c t and v.&ntad to 1.a.foDl .. of ~,iaforaatioa.·1IeAadZlvC.n Ka ... Burros.

Dr. LaAJer b.ad eUJX1u.ed tveuty lI~eacbl of talC\l1l. pW'dcr "C!dda_...-r.purch&sad off-~e-ahalf. The_a were. ~tt.d11, c1a.clc aru ......1..for e-acil of tbu.o brands.. I-ray d.1ttractiDn_8t-op-.CaQl11A&. ~J'd.ait.... uaed a:ui taa Iluaben below r~t ~l.iht ~rce1lt. reD.".t t1a.t:vtlQt.T aazspla.a c:ouu.iDa4 asb•• to., ru.&1q. trot! two to t'Wetltl' PUC4J1t..Five coatainod anthophylUte .and trcmoUta (.1 + T), 3 eouta:1A".~Ute (T) alo:te.. and two C:Otltaiued ao..thoph,"111te (j.) alem.. 1M u\ut.a.containiug t:alc.um powd~r.. are.:

plus

Ca.ebmctre Rouq~t

JS.&ner " &l..acl. ..naby ta-lcCotj" llrB..oa~

liT 5..abyFabre;g.1 BrutYardley Inv1a1ble.Yardley Slack.E:aP.uh LeatherItenn~o

~Q1--i~T)

'lSI'11:1.U (A+t)30% qu.artz

8%5Z5%

3.5%2.X fA)21

Dr. L4n58r pro=i••d 'to .ClAd • latter CO:lf1.ndg i. tile 1nfo~tlon g:1V"8tlov.r tb. t.alephoue.;I with come additional d"t.a.11a.

DUcu••1l1£ th e r"iulta ~ D~~ La.neer r~d that if tUS4 "~ab~-r

-.ample. r.pr &n.t IIQre. chaI:. a OQa tiDe. occurrtnCJ!~ atuple x~r.y

diffraction aaaly.t.s should pick up aa'btstOJI. .t lft.et at th. five'P.arCmlt l*vtll and a.PO"V...

I nave: vrittan Or .. Lanser to obtain aAl9Pl'i:.8 of these t..&lc..a fer ourc.iu:d.-a t.o ..

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Dr. Arthur It. LaaaarM.oclaU· Prof..aor of lUaara.1.o:&T'Reali'. Phyw1.et1~ Soct:ioanspcrtmaat: ot ~ty ~1el,,*

!1oun.t: S1Jt.ai Sehool of tiedJ.cae .of :cbe. C1t:,. UatTler.tty of ~ York

Fifth AYe1Mae and looth Str..t1Mv" York.. n l0Q29

Dear Art:

your in.fo~t:10Q oa. talcC&\ povdo.r. ii. vould grN..t:l)' appEeC1at.e

your otutd1.ng t:S ~ it .ac all pcssiblt. a:=pla.ai of the talcua ptlVura

\I.8&d. in you ,*cudy'to If tho lot !nIIi1bQrs are avallabltl. p.laaaa send

Sblcerely your.)

.R.ay.ond E. Shapiro .. Ph·.D.2pli5eu1.o1ogy Utd.t. a.rF-IOS

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I ... woacIertwa ....thu ,.. I.a4. .., 1aforN~ _ t.,wru'J.M fa

It.a1.1ae talc fa IH11eral. a.ad tM .... Dr. Vcpew ..... Ul flIUttedU•

k. Ift4 . halq1tIIIpt. .,. Jlhaal ..,Wt.tt.~c.u.aa .···f·~""CA't!fJJT en~Val.

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The 4a~tl .f lAa.e.er.. vb.lclt I Yttrltau,. PTe you. yutClr~,. afu.naoon.aakelJ ooc: WOftder whatill-r ~ ·yalae. far_~ in ulc ~-tbe

~1Il t of tifA -•.@.n.h.~ -...pliQ~•.at the.c:1IIe taken:l or an 1..tlcctiwor n ftO~.de Qreas:! occurreace-.. -I "Hll...-re ,.ou. ...d.emaed that8t.pl~ x-ny dlffr..aet.lon .anal,.... 2a&:t au aL&.1yclca.1. Hfld.tlfity(!-f oa:e or two perc:eaL. TMnfero.. Lt Up~ of t.!l1ls Il8V' cIA"t4. IVf>\l.l.! rec~G for yaur .e«s.e14ct'"..~ton a JPilrN1 of all ule::ut!~r.. t cm.-th~lf 0: ..1D-~ thia tecl1D.l4UC- ..

X~d L.. Sha..-ira s: 'Ph .. ~ e

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University College, CardiffPomJ Addraa: Unlverdty College. P..o. 80. ". Cardiff CFI IXl~

. Telephone Cardiff #2 J 1- . TeJegranu.: Coleg CardiA"

From.-=-._. ~:~__~ • D • Poo1ey

Department of _.!!!_~::~~_~_~~~loi.tatio~

9th March 1976

Dr. R.E. Shapiro, Ph.D. 1

Epidemiology Unit, HFF-I08,Dept. of Health', Education & Welfare,Public Health Service,Food and Drug Administration,WASHINGTON D.C. ~

Dear Dr. Shapiro,

Thank you for your recent letters -it w'as nice to hear from you again. RegardingItalian talc as used in Dr. Wagner's experi­ments, we have the folloWing mineralogicaldata :- .

TalcChlori.·te·Carbonate ­Quartz

90 - 92%6%1.0 - 2.0%1 - 1.5'%

The samples we have examined from thismine have not been found to contai~ anyasbestos minerals.

I am sorry I have nO information on glassfibre or the preparation of short chrysotilefibres - qui te a problem I should imagine'.

I would like again to ask you about thepossibility of research support for a tech­nique to identify and quantify asbestos in.air, water and tissue samples. We have workedup what we think is a suitable technique andrequire some support to get it going.

If it is of interest, I can send somedata to you on the· procedure to identify,quantify and estimate mass of minerals andfibre.

• - _ - - 'r ~ ::- -- • - _ : _ - ' -. - I ,"- I I - ~ _ _ _ I. ~, : _ _ - : - _ _.. _ ,." _ _ - I I ~ ... ~ - .. I _ - I _ r ~

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Hr. Ii. ti.enaalm. HFP-440Pr. v. Horvit:, lIFF-IOl

Dr. B.. E. ShapiroEpidem101ogy Ilni.t, lIFF-108

Talc and Asbestos Analyau Techniques

Karch 18, 1976

i'

The. attached 1etter frOlil Dr.. Fred Poole.y 1nd1.eatea the pur1.ty of thelta114Il bile used by Dr". J. C. llagoer 1.0. h1.a inha1at.1on studies.The. re"aulu were reported at a meeting 1n Ed:1:nburgh. Scotland~ l.a.atSeptember •

Analytical methodology for asbestos 1.8 • pressing queat:1on for t.hisBureau. Dr. Pooley 1. an internatlon.aI.ly recognUed expert in thiaarea... I.s there any vay ve ,could support hi..s researc.h? If 80. rillwrite for further details.

Raymond E. Shapiro:- Ph.D.Epidera1.o1oty Unit, HFl-I08

At:tachment: Letter dated 9th March' 1976 to Dr .. R. E. Shapiro fromDr. F~ D. Poo1ey~ Cardiff. ~ales.

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H&rdl 1e. 1976

Dr.l'r.II.. PoolAy:bept.. .t J"t1JMeral bpl.olt&t ioutmi..r.1ty ea.llc.e~~

CJ.blTE CitSOuth 'deaUttited U:cpioar

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Ra}1llD:1Cl L Shapiro f' Jib.I) ..Et'~101oU Uait.. aT..... 19likre.a.u of FOGda) FlU.

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-ENVIRONMENTAL SCIENCES LABORAT"ORYMOUNT SINAI SCHOOL OF MEOICI~E~- 10 EAST 102ND STREET~ NEW YORK. N. Y. 10029

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Animal experiments with talc.

Wagner JC, Berry G, Cooke TJ, Hill RJ, Pooley FD, Skidmore JW.

Italian talc has been tested on rats usin·g three routes, intra-pleuralinoculation, in'halation and ingestion~ Groups exposed to superfinechrysotile asbestos and untreated controls were included for comparison~ Inall the experiments animals were' allowed to live out their IivesA The ·intra­pleural inoculation of talc produced no mesotheliomas in contrast toeighteen produced by, the chrysotile asbestos. After ingestion, one.leiomyosarcoma occurred with Italian· talc and one with chIYsotile asbestos.Whether these tumours are a c9nsequence of the feeding is uncertain. Theinhalation studies demonstrated that with equal dosage, talc can produce asimilar amount offibrosis as asbestos·"·However, the chrysotile exposed ratsdeveloped lung adenomas) adenomatosis and an adenocarcinoma, whereasthe only lung tumour seen in animals exposed to talc ·was a small adenoma,which may have been an incidental. finding.

PMID: 1236243 [PubMed - indexed for MEDLINE]

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Ia ft,fl1' ·to Y.1# ltltter of ktokr 9, 1915l · -wa .,. $efi41t&t ,... tIil4e·r·$e-,at.~ ~..r. ta. r~_B~t.t 'I. 14". larda .~1ea of ~tt¢ taleus~~ fo~ aaalys:.te .fo~ t:r~lit.. ~1e.,ou vtl1 rc-eei1iie arethe f.Uow1s~··s -

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I·' y.. ~n· ~y uti·~ ...,l-es for e.alua1:tmt of ~thotls.. ,ka1l4~taet 1t4. r~ f'OU ftrr~ iDten.t.

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o I V IS 10 N a F B R 1 S T 0 L - M Y E R sea M P A N.Y

:;"\.. ~\).v \4~" ..,·- :'~.i/:' / .., -. ~I .( .rK ~tl(\.;../ ,-.J') t ..1"

225 LONG AVENbif'HILLS10E. NEW JERSEY 07207

TELE PHD N E 20~l-923-500_b

October 9, 1975

Mr. Heinz Eiermann_Division of Cosmetic Technology

Food and Drug Administration200 C Street, s.w~

Washington, D. C~ 20204

Dear Heinz:

. We will have in publication soon, a revised CTFA Standardfor Cosmetic Talc, which \\li11 include 'a specification for'FibrousAmphibole at uNone Detected ll using.a new method 'involving X-raydiffraction and microscopy with. dispersion staining. .

Some time ago, Professor Seymour Lewin evaluated 195cosmetic talcum powders obtained from the marketplace, and detectedtre·mo1i te in· se-vera1" us i ng .X- ray di ffracti on .

We would like to'evaluate some of the same samples,applying our latest CTFA methodology, and it would be of particularinterest to do some of the ones which showed high .levels oftremolite, Or which were questionable. About 5 grams of each wouldbe sufficient, and 10 s-amples would be a good number to do.

If you ar~ able to comply with this request, it will begre.atly appreci ated if you waul d send them to .·my attenti on. ,

With best regards..

Sincerely,

.it-y~/42.'lt--,,+tt:t.r~--...;:,LGeorge W'. Sandland·Chairman crFA Talc Subcommittee

GWS/dp

cc: Dr. Norman F. EstrinMr. Eugene LambertDr. John Menkart

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DEPARTMENT OF HEALTH., EDUCATION. AND WELFAREPUBLIC HEALTH SERVICE

FOOD AN.D DRUG ADMINISTRATION

WASHINGTON. C.CA 2.0204

March 19, 1976

Dr. Arthur M. LangerEnvironmen~al Sciences LaboratoryMt. Sinai School of MedicineCity University of New YorkNew York, NY 10029

Dear Dr. Langer:

As a follow-up to the telephone conversation on March 18,.1976 betweenyou and Mr. Heinz J. Eiermann,. we are transmitting to you the followingsubsamples of commercial cosmetic talc products:

DeST - 76-l358DeST - 76-1359DeST - 76-,1360DeST - 76-1362DeST - 76-1363neST - 76-1364

We would appreciate an analysis'of these products 'for asbestiformminerals by x-ray diffraction and any other applicable technique(s) .that

. are~ in your opinion, appropriate fo.r the analysis of fibrous asbestiformminerals.

We would also appreciate receiving portions of those talc products whichwere implicated in your 'recent talc studies. These samples will be usedfor the. purpose of analytical research and for the comparison ofmethodol·ogies. .You will be informed of the results of' our examinationof these samples4

Thank you for your cooperation.

Sincerely yours.,

Ronald L. YatesProduct Composition BranchDivision of Cosmetics TechnologyBureau of Foods

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BETy.,JEE~T:

SUBJECT:

MEPfORANDUM OF MEETINGMarch. 22, 1976

at

EnvirOIlmental Sciences LaboratoryMount Sinai School of Medicine

City University of New York

}[embers of the Staff of Environme11tal Sciences I.raboratories

Arthur }f, LangerArthur N. Rohl

Division of Cosmetics Technology, FDA

Clifton H.. t~ilson

Ronald L. Yates

Analytical Methodology for the Detection and Determination ofAsbestos Minerals in Talc

_Upon arrlvlng at the laboratory, Dr. Wilson and Mr. Yates weregreeted by Dra Roh14 He stated that Dr. Langer would be presentas soon as possible. Mr~ Yates gave" Dr. Rohl the cosmetic talcsamples that Dr. Langer had agreea to analyzee In turn werequested and received subsamples of the 10 cosn~tic tales inwhich Dr~ Langer reported the pr~s~lce of tremolite and/or.anthophyllite. Tnese are:

l~ Body powder) Cashmere-Bouquet2. Rosemary talc.3. Brut for Men, Faberge4. Air Spun Face Powder., Coty5. Baby talcJ Bauer and Black6. Black Label, Yardley7•. After Shave talc, English Leather8.- ZBT Ba.by Powder94 Invisible talc, Yardley

10. Sha~e talc, Mennen

Dr. Langer arrive.d approximately 30 minutes after our arrival.Mr,. Yates presented him with the coverin.g letter concernin·g thecosmet{c talc samples ·neST had provided for his analysis ...

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·Dr. Langer, Dr. Rohl, Dr. Wilson and Mr~ Yates then discussed thefo.llowing topics: .

Sample Preparation and Instrumental Conditions for Analysis ofTalc by x-raY Diffractioil4 - Dr. Langer stated that he did notbelieve it possible to prepare a sample for x-ray analysis thathad a completely random orientation of the chrystal lattice. Hedid not think that· random distribution was important if samplepreparation techniques were consistent. ~lr. Yates informed Dr.Langer that in the proposed CTFA method, preferred· orientationwas inevitable because the sample was pressed hydraulically.Dr. Langer thought the technique acceptable if consistentresults were· obtained. Dr. Langer demonstrated the samplepreparation technique used by his group. After prep·aration was·completed, sample was step-scanned in increments of 0.02°through the arealof interest until a count of 2000 was obtainedat each step. Divergence slits of 40 are frequently, although.not always! used. ~TIen Dr. Wilson asked Dr. Langer about the·possibility of scatter and high background from the use of a 4°slit, Dr. Langer stated that the use of a smaller slit wouldprobably increase resolution and sensitivity.· He was somewhatnoncoIDDlittal about the effect of a 4° slit oU· quantitativeresul ts. Dr. Langer summe.d up by stating that if good standardsare used and sample preparation is reproducible and consistent,reliable analytical results should be obtained. He said thatall of ·the 10 samples._ found to con·tain tremolite and anthophyllite

·by x-ray diffractometry were examined by transmission electronmicroscopy using selected area.diffraction to verify x-ray results4Dr. Langer was somewhat disgus ted by the talc indus try's at t.itude .He said.~he· results of his work has been known to the industry forseveral years but nothing 't\Tas done lJntil the analytical ·resultsbecame public.

Tremolite. - Dr. Langer stated that tremolite and talc fibers can beeasily differentiated using light microscopy.· The cleavage oftremolite and anthophyllite is 90° to the crystal axis while talchas an angular cleavage. There is also a difference in refractiveindex. Tremolite and anthophyllite can be differentiated by thedifference in aspect ratio. Dr. Langer demonstrated by preparing ·aslide of Cashmere Bouquet t.al·c. Under the microscope tremolite wasobserved as short particles with 90° cleavage. Anthophyllite hadthe same cleavage but was definitely fibrous, having aspect ratiostypically 30 or 40 to 1. Talc fibers·appeared to have a cleavage

·of approximately 60°. Dr. Wilson asked Dr. Langer to examine a.sample of tremolite he had brought along. Dr~ Wilson said thathe had been using the sample as a standard but that x-ray analysisindicated impurities. Dr. Langer examined the sample using

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opt~eal microscopy.· He stated it contained anthophyllite, trerno­lite, qua~tz anq talc. X-ray analysis of the sample indicatedtalc, anthophyllite and tremolite. He had .a microscopist on hisstaff examine the sample using optical microscopy. His analysisconfirmed Dr. Langer's results. Dr.' Langer stated that ourt~emolite standard was very impure and probably originated fromNew York. He gave Dr. Wilson the address of the Cape Asbestos Co.in London, a firm that could prGvide samples of Korean tremolite,considered to b~ the'purest available.

Dr. Langer said detectability levels for tremolite was approxi­mately O~l% by x-ray diffractometry. If tremolite particles hadaspect ratios of 3 to 1 or greater they were consider~d fibrous.

Chrysotile. - According to Dr. Rohl, detectability by x-rayfluorescence was 0.25% depending on size and crystallinity. Dr.Rohl had some photographs taken of chrysotile fibers (fibrils)using transmission electron microscopy (T~). Photograph showedfibers containing several fibrils and iridividual fibrils. Aspectratios \Vere extremely high.' wllen examining tales by TElvl a countof 3-S/grid square is considered background. In two of the 19c.ommercial cosmetic tales eX'amined, fiber counts of approximately24 fibrils/grid square were obtained. Dr. Langer considered thisto be quite low and probably not hazardous. In general he did

. not thinlc that chrysotile was a real prob·lem as f.ar as cosmetictales 'were concerned.. lie refut·ed claims made by some that

'asbestos fibers were'not present in the env~ronment due to useof asbestos brake shoes in auto~obiles. He stated that theyhave analyzed dust obtained from auto brake drums and haveidentified asbestos fibers .

.Nickel. - In reference to the high amounts of nickel present in sometales, Dr. L&~ger said that nickel replaces rr~gnesium in the talclattice and becomes a nickel hydroxy silica·te complex. He is notconvinced that nickel is harmless in this form because of-itssimilarity to nickel hydrox~de, which has been found to causerhabdomyosarcomas in rats when injected.

Transmission Electron Microscopy (TEM). - Dr. Rohl demonstrated tl1euse of TEM for the analysis of tales using previously preparedsamples. Using a. prepared sanlple of unknown identity, he pointedout structures typical of talc and tremolite. He also demonstrated·that use of selected area diffraction. The crystal to be· examinedis centered on the screen and the beam is then passed through the~rea of the crystal desired. The diffrac~ion pattern is displayedon the screen as a series of dots quite similar to a Lauephotograph. The patte:n can then be conlpared with those ofstandards for characterization.

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In general, th~ Environmental Sciences Laboratory is well equippedfor mineralogical analysis having two transmission"ele~tron"

microscope"s, t~oJO scanning electron "microscopes, an x-ray _diffractometer, an "optical microscope-and a differential thermalanalyzer ..

.~//£?~t:11 ;:~--./

Ronald L'!l Yates

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New Brunswick, N.J ..November. 8 I 1972

. · Subject: ANALYSIS OF' JOHNSON I S* BABY POVIDERFOR TREMOLITE ASBESTOSPROJECT NO. 503

.The two lots of JOHNSON'S Baby Powder examined by Dr~

Lewin had been previously analyzed qualitatively byX-Ray diffractometry (report of October 31, 1972).It was desired to further analyze these samples forthe· presence of trace quantities of amphibole asbestos'minerals;' such as,·tremolite. An X-Ray step-scanningprocequre had been developed for the detection oftremolite in Vermont talc. The limit of detection ofthis method is 0.1% by weight 'of tremolite. Figure 1.sho~s the peak obtained for an intense tremolite reflection

o(8.38A or 10.5° 28) for a standard sample of 0.5%tr€:ffiolite in Vermont talc. Plots of" the step-scansthrough the same, region for JOHNSON1S Baby Powder, LotslOST and. l09T, are shovm in'Figures 2 and 3, respectively.The results do not indicate the presence of amphibole'mine·rals.. Therefore, the samples' of JOHNSON I S BabyPowder do not contain tremolite within the limit of.detection o~ the X-Ray d~ffraction step-scanning technique.

Since tremolite does not exhibit intense thermal transi­tions distinguishable from t~lc, differential thermalanalysis is not applicable for the detection bf thismineral in talc at low levels.

ab

*A Trademark of JOHNSON & JOHNSON.

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·Subject:

New Brunswick, NtJJ •.October 31, 1972

ANALYSIS OF JOHNSON'S* BABY POWDERFOR CHRYSOTILE ASBESTOSPROJECT NO. 503

X-Ray Diffraction

Samples from the two lots of JOHNSONtS Baby Powderwhich had been examined by Dr. Lewin were subjected'.to qualitative analysis by means of continuous X-Ray

. diffractometer scans. The following .mineral contentwas determined:

Lot lO.8T

Lot l09T

Major:Trace:

'Major:Trace:

TalcChlorite, Magnesite

Talc ,Chlorite, Magnesite,

Dolomite

The step-scanning technique was then employed forincreased sensitivity' in ~he detection of chrysotileasbestos. It had been previously demonstrated thatwith this procedure it was possible to detect chrysotilein talc at a level of 2-3% by weight .. The results,shown in Figures 1 and 2, indicate no diffraction peakin the region corresponding to an intense chrysotile

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reflection (7.31A or 12.1 2e). Therefore, the samplesof JOHNSON'S Baby Powder do not contain chrysotile atthe minimum detectable level which is att~ined.by

X-Ray diffraction.

Differential Thermal Analysis

A semi-quantitative method based on· the analysis ofstandard samples of chrysotile in talc had been developedusing the techn~que of differential thermal analysis(DTA). The limit of detecti9n of this method is 1%

,by weight of chrysotile. Therrnog~ams of JOHNSON'SBaby Powder, Lots lOST and l09T, showed no thermal

*A Trademark of JOHNSON & JOHNSON.

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peaks in the temperature ranges characteristic ofchry~otile. One percent chrysotile added to each ofthese samples was easily detected in the ~herrnograms.

On the basis of these results·, no chrysotile is present~n the samples of JOHNSONtS Baby Powder at the minimumlevel detectable by DTA~

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X-ray Stu·dy. 0 f .Johnson & Johnson t S .Baby Powd.erRetain l08T (4-17-72)

Gordon E. BrownPrinceton University

Retain lOST (4-17-72) of Johnson & Johnsonls Baby'Powder was.examined by slow, con~inuous scanning x-ray techniques. .A Norelco.vertical diffractometer with a LiF crystal monochrometer and samplespinne.r was used in this work. Other pertinent experimental condi~

tions were as follows: CuK~ radiation (40KV, 20~)i scan speed =1/4°28/min.i scale factor = 4; time constant = 4; 1° slits; scanrange = 5-BOo 29j PHA (12V baseline, 1.2V window); amount of powder= o. 1 gr. (< 325 mesh).

The-diffraction tracing is attached to this report and a list ofd. spacing's is given in Table 1. Twenty-four of the recorded peaks

have been assigned to talc using cards 19-770A and 13-558 from theASTM.powder diffraction file•. Seven additional peaks were also re­corded and all but. one have been attributed·to chlorite, magnesite,chal~opyrite and rutile. The unknoVJIl peak repres'e'nts a d-value of1.48A•.

No evidence of chrysotile or tremolite was found in the· x-raydataooutlined above. The two strongest chrysotile peaks ·{7.31 and.3.65A} as well as the three strongest tremolite peaks (8.38, 3.12and 2~70A) were ·unobserved. The peak at 3.12A is. attributed to talc. (006,115) and cannot be a tremolite peak. Peaks due-to cUKp werealso searched for but were not found.

It is conc·luded that' retain -108T (4-17-72) from Johnson & John­son's Vermount talc mine is a very pure talc with less than 5% im­purity due 'mainly to chlorite and magnesi~e. A careful search forchrysotile and tremolite impurities proved negative.

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Table 1: X-ray Data fo·r Johnson and Johnson l s Baby PowderRetain lO8T (4-17-72)

0

2Q·(deg. )Mineral hkl deAl

Talc 002 9.45 9.·36

Chlorite 002 7.14 12.40

Talc 004 4.69 18.93

Talc 020,111 4.57 19.42

Talc 022 4~13 21.50

Chlorite· 004 3.56 25.0

Rutile(?) 3.26 27.33

Talc 006,115 3.12 28.58

Magnesite 1~ 104 2.75 32.58

Talc 130 2.64 34.00

Talc 200,132,131 2.60 34.50

Talc 133,132,117 2 .• 49 36.08

Tal·c 204 2.45 36.73

Talc 008 2.34 38.46

Talc many including 134 2.·28 40.50

Talc 136 2.10 43.18

Talc 136 1.94 46.80

Talc 0.0.10 1.87 48.62

T·alc 242 1.7.3 52.93

Talc 244,l38 1.69 54.34

Talc 1.65 5.5.90

Chalcopyrite(?) 1.58 58.37

Talc 0.0.12,317 1.56 59.21

Talc 060,332 1.53 60.52

Talc 330 1.51 61.30

Unknown 1.48 62.85·

Chlorite ·.139·,208 1.42 65·.65

Talc· 2.0.10 1.39 67.18

Talc 1.3.12 1.39 67._ 53 (Kilt1 )

Talc· 0.0.14 1.34 70.38

Talc 264. 1.30 72.90

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Postal Address: Untversity College t Ne'vport Road, Cardiff CF2 ITA ..Telephone Cardiff 44-2 I I Telegranls: Coleg Cardiff

University .College, Cardiff

From_ u.~ ••n~~.~••~.~r•••~••!_.Q.~!~..u.~.QQ~~.l§:y __ u ••••_ ••n.~__ •••nn••••••••• _ ••

Department O[.._.n_n_..M.!p:g.~~J:. ~.~P.!.Q~~.~.9:.t.;h.QA.~ .

AIR MAIL

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FDP/MM .

Dr. A. J. Goudi·e,5, Finley,.Edis·on,New Jersey 08817,U.S.A.

·Dear Dr. Goudie,

8th November, 1972.

/

We have extensively examined the sample 108/Tpowder for chrysotile asbestos but can find no evidenceof any of the mineral at all. Both.ele~tron microscopeand X-ray techniques .have been employed and we havealso applied a chrysotile concentrating technique whichwe have developed to·the sample which enables'us to

. definitely demonstrate chrysotile at the 0.10% leveland nothing was found.. I will be corninunicating a

. number of simple .tests to you in the near future fordemon$trating chrysotile at low levels.

·Yours sincerely,

1fV;.F.D. Pooley

HHS00000055

./

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1f

II

Dr. A. J. GoudieJohnson and Johnson. Research Center501 George Street

New Brunswick, New Jersey 08901

EXAMINATION

OF

JOHNSC>N AND JOHNSC>N'8 BAJ3Y POWDER

,/

Date: 27 October 1972

MA Number: 2546

Copy "2 of 4

walter c. mCcrone associatesl inc. " .2820 SOUTH MICHIGAN A VENUE ~. CHICAGO,.1LLINOIS 60616

HHS00000056

Johnson and Jolmson therefore requested Walter Ce McCrone Associates to ex-

amine samples from" the same batches" to determme whether they contained any

EXAMINATION OF- JOHNSON AND JOI-INSON'S BAllY POWDER

Summary

Two samples of Johnson and Johnson's Baby Powder, batch number

.~~8:e:: ~:9:~WW;::::::::~=: ::::1:::1:::~:~::eb:e:::::~:~e~;our .1

" x-ray diffraction, ligJ1t microscopy, u"ansmission electron microscopy and elec- Itron diffraction to ~etermine whether they contain any asbestiform m-inerals.

Both samples"_contained an insignificant amount of tremolite ­

a few isolated crystals ~ Neither sample contained chrysotile.

Introduction

On behalf of the FDA, Professor Seymour Z. Lewin of New York, I

University is" examinillg a number of commercial talcum po,vders for the presence ~" ~

i!

of asbestiform minerals. Two of the samples which he has examined are samples Iof Jomlson and Johnson's Baby Powder,- batch number lOST and batch number 109Tj~

-' ~

~

Iasbestiform minerals.

Matel-'ials and Method of Conducting Tests"f t

Two samples were submitted, identified as Johnson and" Johnson's

Baby Powder, batch numbers lOST and l09T.

For x-ray diffraction examination, the samples were examined on

a Phillips-Norelco verticle "diffractometer using CuKa radiation and a scanning

, speed of 10 per minute". The dispersion staining tecbnique was used for the light

microscopical examination alld the electron microscopy-electron diffraction ex­

amination was carried out using procedures previously" described (MA report

2330-~; dated 10 August.1971).

walter c~ mecrone associates, inc~

HHS00000057

Results

.X-ray D-iffi"action

The diffractograms we:re carefully examine~ in the ViClllity of the

major pea](s of chrysot ile and tl~enl0Ii tc . Ne ither ill il1eral was presen til The

presence of peaks ill the vicinity of 12. 0-12-5° 28, the region in Which on·e of_the

principal lilIes of chrysotile may be found, was correlated with peaks in the vi­

cinity of 6° 2B and are thus attributable to chlorites. No. significant peaks were

observed in the 24 0 region which would be required were cbrysotile present.- .

,Light Microscopy

Using the dispersion stailling teclmique and a liquid of refractive

index 1.550, the samples ,vere examined for chrysotile particles and fibers,· but

none could be found. Using a similar technique with a liquid of refractive index

1.605, the samples were similarly examined for the presence of tremolite and a

few illdividual crystals were fOlllld, . some rod shaped. .

Electron Microscopy and Eleciroll Diffraction

Several electron microscope grids from both ~ampleswere ex~

a.mined in their entirety and although some fibers were observed these were ~hown

by electron diffraction to be shards of talc or rolled talc. No chrysotile fibers

were found.

Conclusion

A detailed examination of two samples of Johnson and Johnson'~

Baby Powder, batch numbers lOST and l09T has sho,vn this material to be Bub-. .

stantially free of asbestiform minerals. A few tremolite rods were observed in

both samples. No chrysotile has been detected.

·Respectfully submitted,

I rJ (/L ,I-It .·~r~./ a't}t... - .~--...-,

Ian M. StewartManager, Electr<?D Optics Group

walter c. mecrone associates, incl

HHS00000058

COLORADO SCHOOL ·OF MIN ES RESEARCH' INSTITUTE

P.. O. Box 112

GOLDEN .. 'COLORADO 80401

October 27 1 1972

Project CI0704

Dr. Al Goudie'5 Finley Ro~d

Edison NJ 08817

Dear Dr. Goudie:

In compliance with your request I hav;e made X-ray diffraction step scanson Baby Powder Talc Samples lOST and I09T for the purpose of deter­mining if serpentine (possibly chrysotile) is presentlr It is my understand­ing that a contention has been·made that these samples contain approxi­mately 30/0 chrysotile~

The results of these studies do not substantiate this.. They do show thatth'e sample containS chlorite which give similar, but distinguishable X-r·aydiff~action Ifeaks.. If the chlorite .peaks were mistakenly assumed to resultfrom the presence of chrysotile, then one would mistakenly assume thatthe samples contain about 30/0 c.hrysotile based on the diffraction peak inten­sity resulting from the addition of .30/0 chrysotile to the samples ot

Asbestosform chrysotile is but one species of the mineral serpentine.Other species are not asbestosform.. However 1 ~.11 species· give similarX-ray diffraction patterns so that X-ray diffraction can only indicate thepr.esence or absence of serpentine ... If X-ray diffraction indicates thepresence of serpentine 1 other methods must be used to determine if it ischrysotile. HoweverJ according to the FDA guidelines 1 if a talc sample·yields no diffraction data which could be ascribed to serpentine (includingchrysotile) then the talc is regarded as acceptable relative to chrysotilecontent .

.The most effective way to ascertain if a serpentine mineral may be pre­sent in a sample by diffraction is to first determine if the material yieldsa diffraction pe~k in the vicinity of 7 A. This is the most intens'e diffrac­tion peak for serpentine. However, this diffraction peak cannot be usedindiscriminately.· since other non-asbestos minerals have their most intensediffraction peaks in the same region. An awareness of the geological and

. mineralogical associations of talc immediately suggests the chlorite min­erals. They are commonly associated. with talc and yield their most.intense diffraction peak at essentially the s arne place as. that of se rpentine· .

Alineral Industry Research

HHS00000059

COLORADO SCHOOL OF MINES RESEARCH INSTITUTE

Dr .. Al Goudie Page 2 October 27 1 1972

(including chrysotile).. Fortunately there is a way to distinguish betweenthe serpentine minerals and chlorite minerals by X-ray diffraction.

o

Chlorite gives a diffraction peak at about 14 Aand serpentine ·does not ..Thus if a suspect 7 Apeak is observed then the sample must be checkedfor a 14 Apeak.. If a 14 it.. peak occurs, the 7 'A peak represents chlorit-e

l

not serpentine.. The X-ray diffraction mu·st be determined by accumu­lating counts for a few minutes at each of small increments across thepeaks. Continuous .counting or counting rates give neither adequatecounting statistics nor sufficient peak discrimination .

.S.tep scanning of several splits of Samples lOaT and l09T rev.eale·d thepres·ence of a peak in the 7 it region as shown aD. the accompanying charts ..However, they also ·show the presence of peaks in the 14 Aregion whichare in the proper position to show that the 7 it peaks. result from the presenceof chlorite and not serpentine.

Since the contention was made that Samples l08T and l09T contain about30/0 chrysotile, they were spiked with 2. '70/0 and 2·. 80/0 J respectivelYI of

. .

finely milled chrysoti.le which was obtained from J~hns-Manville. As maybe seen from Charts 2 a·nd 8 the chlorite and· chrysotile peaks are dis­tinguishable and distinctive. The chlorite peak occurs at about 7. 06 A..The chrysotile peak is quite broad and shows at least 2 maxima at approxi- .mately 7. 32 A and 7" 38 A.. It was firs t thought that this broadening mayhav·e resulted from Qvergrinding, however, relatively coarse ungr·oundmaterial gave the same pa~tern. It is possible that the peak broadnessnesults from. different varieties of serpentine in addition to chrysotile ..

.Step scans of Samples lOaT and l09T spiked wit.h 2. 70/0 and 2 .. 8% ·chroso­tile, respectivelYI show that the area under the chrysotile peak is com­parable to the area under the chlorite peaks. If one were to mistakenlyassume that the 7.06 Apeak resulted from chrysotile instead of chlorite,he would calculate ·that the samples ·contain about 30/0 based on increaseddiffraction intensities after the addition qf, chry·sotile. This would beespecially true if step scanning were' not used since the chlorite andserpentine peaks would not be resolved.. It is probable that the contentionthat the two talc sa·mples contain about 30/0 chrysotile is mistakenly based

.on the magnitude of the 7 .A chIo·rite peak.. If,this is SO, it could ·have beenavoided by step scanning the proper regions4

. Sincerely J

:?:1/~Q/V/W .. T. CaneerAssistant ManagerMining Division

\¥TC/psk

HHS00000060

~-~~ ."

DOM£ S T te OPE RA Tl NG COMPANY

Mr. George SandlandChairman, CTFA Committeeon Asbestos in TalcBristol Myers Products

·225 LOl1g Avenueliillsi·de.J r-le~;,T ~ersey 07207

NEW BRUNSWICK. N. J. 06903

. December 29, 1975

Dea·.r George J

The sa~ples of S. Z. Lewin Gosmetic talcum powde~s you received fromMr. Henry Davis, Division of Cosmetic Technology, ~ureau of Foods,Food and Drug Adminis·tration have been analyzed for asbestiforma-r:nphibole by the CTFA procedure entitled IIDetection~of AsbestiforraAnlphibole Minerals in Cosmetic Talc ll

• As· you know the GTFA methodrequires a slow x-ray diffraction scan in the region of 8.85-8.04A(11.O-IO.Oo2G) for a peak indicating the possible presence of an~mphibole mineral~ If a peak is seen in this region then the talc·

o is acid trea~ed to remove interfering carbonate min~rals and thenexamining by an optical microscopy/dispersion-staining procedureto confirm, the presence of amphibole and to see if it is the asbes-~tifor~ variety. The criteria for asbestiform amphibole is the on~

adopted by the U.S. Department of Labor, Occupational Safety andHeal th Adminis tra tion, Field Informat·ion Memorandum .1174- 92 ,. November21, 1974 which requires:

a. Particles must appear to be fibrous rather than as ~rystctls

or slivers ..

b. The maximum diameter· of a fiber to be counted is 3 microns~

c. The maximum length of a fiber to be counted is 30 microns.

d. The length to width ratio must be 5 or more to 1, that is,5 times or more longer than wide ..

e. The separate or individual fibers must contain fibrils or· the'lbundle of sticks ll effect·, unless they are at a~ non-divisiblestage. A fibril cannot be subdivided and would be counted)if it meets ~he other criteria. The length to width ratio of5 ·or more to 1 is hot meant to imply that otlrer. particles arenot hazardous.. .

JA~J 14 1976

G. W.. SAND1.AND

HHS00000061

/'

.'... :

• I .......

Analysis of FDA Samples for Asbestiform Amphibole

FDA CodeflDCST

13381339·1340

1341

1342

1343

1344 ­

1345

.13461347

1348

13491350

13511352

Amphibole.X-ray

Diffra~ction

TraceTraceMinor

~1inor

Trace

Minor

Minor

Minor

None DetectedTrace

Minor

None DetectedMin"or

None DetectedNone Detected

Asbestiform AmphiboleD~spersion StaininglOptical Microscopy

*Amphibole confirmed/not asbestiformAmphibole· confirmed/·not asbestiformArnpllibo Ie confi1.-1ned/not asbestiformAmphibole confirmed/noL· asbes,tiformAmphibole confirmedno~ asbestiform

. Amphibole confirmed/not asbestiform

Amphibole confirmed/asbestiformAmphibole confirmed/not asbestiform

Amphibole confirmed/.·not asbestiform.

Pass/Fail

PassPassPass

Pass

Pass

Pass

Pass

.Pass

PassCondi tio.nal·

FailaPass

PassPass

PassPass

Quantitative Estimation

Trace = 0 - 2% ·Cw/w)Mi~or = 2 - 10% (w/w)

*Talc was very fine; its size approached the resolution of thedispersion staining/optical microscopy method (S um) so adefinitive answer by this m~thod·was not possible. A scanningelectron microscope was employed for the d~tection of I1fibers 1t

using the OSHA definition and none were seen:

aA first examination reveated one bundle of amphibole fibers.This sample when examined twice more by the same operator didnot reveal any asbes.tiform amphibole ..

HHS00000062

Mr. Davis also requested that serpentine analysis be performed onse·veral sanlples. Sample DCST 1339 was found to conta·in a.pproxi­mately 1% serpentine by differential thermal analysis. (DTA) ..Samples neST 1341 1 1347 and 1351 .had· many interfering DTA peaksin the thermogram caused by large quantities of impurities suchas chlorite and as a result the pres~nce or absence of serpentinecould not be determined.. Samp·le DCST 1352 has no detectable levels

.. of serpentine. We know of no completely successful routine backupmethod to DTA, however an optical microscopy examination of allfive samples revealed no fibrous serpentine minerals.

F~ Robert Rolle, Ph~D~

Chairman, CTFA Task Forceon Methodology for theDetection of Asbestos Talc

kd

HHS00000063

MEMORANDUM OF MEETING·March 11, 1976

BETWEEN: Industry Representatives of CTFA Committee onAsbestos in Talc

Norman Estrin, C~FA

, George"Sandland, Bristol-MyersRobert Rolle, Johnson and· JohnsonGeorge Lee, Jognson and JohnsonJohn Schelz, Johnson and Johnson

arid ~

Representatives of the Division of Cosmetics Technology

Ronald L. Yates, Product Composition BranchHenry.M. Davis, Product Composition Eranch

SUBJECT: Meeting with CTFA Talc Committee for the Purpose of Discussing'the Results of the Testing of Talcum Powder Products Using "aCTFA Proposed Met99d for the Detection ·of Asbestifcrm AmphiboleMinerals in Cosmetic Grade· Talc.

Dr. Estrin requested this meeting for the purpose of discuss~ng the resultsobtained fr~m the analysis of 15 coded- samples of cosmetic tales that had.been sent to CTFA by the Division ·of Cosmetics Technology on No·vember 4,1975. The samples were previously analyzed by Dr. S. Z. Lewin using x-raydiffractometry. neST also analyzed the same samples using optical microscopytechniques. These samples were requested by the CTFA to evaluate methodo­logy that they are propos~ng for the detection and determination of amphiboleminerals in cosme~ic tales .

. At commencement of meeting, Dr .. · Estrin provided all present with cop1es of. the result-s obtained from the analysis· of the samples provided by neST. Mr.Davis gave each participant a table identifying the coded tales. Mr. Davisand Mr. Yates were also pro·vided cop"ies of the proposed analytical methodfor the detection and determination of amphibole minerals. The methodconsists, briefly, of a combination of two techniques; x-ray diffractometryand optical microscopy. A compressed pellet of talc is slow-scanned in thex-ray diffractometer under pr~viously determined_conditions. ·If.amphib41eis present, quantity is estimated by cnmp~ring net count to count obtainedfrom talc standards containing known amounts. of amphibole. (tremolite). The·sareple is then examined.by optical microscopy using dispersion stainingtechniques~ This ·step is used to confirm amphibole and to. determinewhether the· mineral .is present in the fibrous form by OSHA definition.

HHS00000065

Meeting 2

The results of the CTFA·analyses by x-ray dif£ractometry were, with theexception of one sample, in general agreement with those obtained byDr~ s. Z. Lewin. However, the results of the optical microscopicexaminations of these samples by CTFA and neST could not be compared dueto the usage of differing definitions as to what constitutes a fiber;i.e. length to diameter ratios of 5 to 1 and 3 to 1. respectively.

Dr. Estrin stated that these products which were analyzed by Dr. Lewin·and the CTFA c6nm.ittee weref·~obtained by Dr. Lewin prior to 1973 and areno longer represe.ntativer; of commercially available cosmetic. talcproducts.

Attachments: CTFA Talc Committee1. Analysis of FDA Samples for Asbestiform'Amphibole

2.. Detection of Asbes·tiform .Amphibole Minerals inCosmetic Grade Talc .

Division of Cosmetics·Technology1. Identification of· Cosmet.ic Tal·cs res ted for Amphibo±e

Minerals by CTFA Talc Committee

HHS00000066

r- ~ 1·5

-;I,jD- <fv.(}DEPARTt~ENT OF HEALTH. EDUCATION. AND WELFARE

PUBLIC HEAL TH SERVICE

FOOD AND DRUG ADM IN,STRATlON

ROCKVILLE. MARYLAND 20857

Sidney M.·Wolfe, M.D.Mr. Benj ami n Gordon _Pub 1; c. Cit i zen·Health Research Group2000 P Street, N.W.Washington, D.C. 20036

Dear Dr. Wolfe and Mr. Gordon:

Your letter of August 4, 1978, raised the question of talc carcino­genesis based on two le·tters submitted to the Ne~1 Eng' and Journal ofMedicine earlier this year. In particular~ Dr. Marshall Deutsch statedthat talc is closely related to the carcinogen asbestos and is likelyto contain microscopic asbestos particles. Both talc and asbestos havebeen of concern to the Food and Drug Administration for several years,and we welcome this opportunity to discuss our continuous work in thisarea with you. We will preface our remarks, however, with some back­gro~nd material (Sections 1-2).

1. References Cited

The references cited in your letter are useful only because theyraise ·an issue that deserves consideration on its own merits. Thereferences themselves, however, are merely personal letters to theeditor; their claims are neither scieritifically ~ontrolled studies.by the authors nor revi·ewed by peers. Indeed the letter ofMoorehead and Dei merely refers to the one by Deutsch, who in turnquotes from a paragraph in Clinical Chemistry 22(7):1141, 1976,about an oral presentation to be given by K. ·GriffithS. Thisparagraph speaks only about lIelectron microscopic microanalysis U

for identification in tissue of lI contaminating particles such asasbestos or ta lc.. .- .. .11

Dr. Deutsch IS .assertion that asbestos partic~les found on surgi­cally removed ovaries could have migrated from talc· used to dustco~doms is unsupported speculation. He futther asserts thatJapanese men have more stomach cancer than men. in other countriesbecause ~hey ingest ric·e dusted Uwith a mixture of talc and glu­cose. 1I He gives· no r:eference, but presumably has in mind .nTalc­Treated Rice and Japanese Stomach Cancer,1I by R.R. Mer.liss,Science 173:1141-42~ 1971. The facts, however, are that mostJapanese eat unpolished rice; only. the affluent can afford

JJlN I 8 1979.

HHS00000067

Page 2 Sidney M; Wolfe,. M.D.

polished rice coated with glucose and talc. Furthermore, persons.of Japanese ancestry in Hawaii and California, who do eatpolished, coated rice~ have a lower incidence of stomach cancerthan the 'native Japanese! ,A~parently, the native Japanese areaffected by many.other environmental factors that could causestomach cancer (see Haenszel~ W., M. Kurihara, M. Segi andR. K. C. Lee.~ l1Stomach Cancer among Japanese in Hawaii, II Journal ofthe National Cancer Institute 49(4):969-988, Octo~er 1972). . --

Finally, Moorehead and Dei allege that FDA regulations discouragethe replacement of.talc in older drugs. The extent of testing toassure the adequacy of the reformulated products depends upon thedrug itself. Currently, the replacement of talc with an accept­ab 1e.. e.XG i pi ent wou 1d not change ; ..ts drug status ; that is, new drugapplications would not be required for uold l1 drugs. Although ne\";drugs waul d re·qui re7supp 1ementa1 app 1i cat ion, the fi r'm may sti 11market' its currently. approved formulation while' its application' ispending. The FDA-sanctioned hardships alleged by Moorehead andDei appear to be without foundation.

2. Asbestos versus Talc

Talc is a naturally occurrin'g hydrous magnesi urn si 1'; cate simi 1ar"in chemical composition to various asbestos minerals. However,unlike the fibrous forms~ of asbestos, talc normally exists as 't'abul ar or pl aty forms (attachment A). Indeed mo·:st. asbest iformm;n,erals also exist i,n non-fibrous f'orms. (See Dr., Ampiantsarticle in attachment B.) Thus talc and asbestos are not simil~r

in morphology. 'As you know~ such experts as Mearl F. Stanton(NIH/National Cancer Institute) contend, on the basis of severalstudies, that it is not the chemical nature of· asbestos as much asits phys;··cal configuration--long thin fibers--which make it carcin­ogenic' (attachment C). There is to date no conclusive evidencethat. pure talc is carcinogenic in man or an.ima.ls (attachment D).The FDA Asbestos .Work Group and the aTe Panel on AntiperspirantDrug .Products have reviewed the voluminous literature on talc andhave independently determined that the evidence-,implicates asbes­tos contamination of talc as the offending e>;po.sure in·Utalc U

carcinogenesis.

Industry awareness' of our concern has led to improvement· in' themining and processing of talc to minimize asbestos contamination.In 1973~ the FDA published a proposed ~u.le to prohibit the use oftalc contaminated at the 0.1 percent level with asbestos in foodsand drugs (38 FR 27076~ September 28, 1973, attachment E). Imple­mentati on of· th is rule has been necessari ly de', ayed unt i 1 an

. appropr~at~ly.sensitive method for regulatory purposes could be

HHS00000068

·Page 3 - Sidney M. Wolfe, M.D.

developed (40 FR 11865, March 14, 1975~ attachment F). In coop­eration with scientists from industry, our scientists have beenmaking progress in the development of-such regulatory methods.(attachment B).

Meanwhile~ the FDA Bureau of Foods has· carried Qut several x-raypowder diffraction surveys of the asbestos contamination of cos­metic talc (talcum powders). They found that cosmetic grades oftalc are usually free of asbestiform particles. For example, in a1977 investigation of 46 talc samples, the FDA found only three tocontain asbestos (tremolite or anthophyllite; see. attachment E)and even then the level was only 0.1 percent or less. One firm,

-Johnson &Johnson, has also done extensive testing for asbestiformparticles in cosmetic-grade talc;- all results to date have beennegative.

3c Status of Current Studies on the Health Effects of Asbestos andTalc

Even in the case of asbestos-contamination, one must distinguishbetween the likely routes of e~posure: inhalation, injection, andingestion. In man, inhalation exposure to asbestos, especiallywhen'combined with cigarette smoking,' has produced lung cancers •.This has been well documented by Selikoff, by Hammond, and others

. in epidemiological studies of industrial workers -(see referencesin attachment E). We are also aware of animal studies of.asbestosinhalation which report lung tumors (attachment G).

Government agencies are sponsoring toxicological studies in ani­mals on the effects of ingested "and inje~ted· asbestos. Two ofthese~ supported by th~ Environmental Protection Agency and theNati~nal Institute of Environmental Health Sciences~ involve theihgestion of various kinds of asbestos particles -by; both hamstersand rats (attachment H). These studies were started only recentlyand FDA will follow their outcome closely.

Two FDA injection studles using six" dose levels of small chryso­tile fibers administered intravenously in both rats anq. mice(essentially lifetime studies) have gone to necropsy. An excessof lung tumors in the high dose mice, but not in rats~ as comparedto controls is suggested from preliminary, unanalyzeq reports ofgross necropsy findings. Histopathology and statistical analyseswill require about seven months to complete .. Already, however,the use of asbestos in filters used· in the manufacture of paren­teral drugs is restricted by FDA regulation (attachments E and F).

HHS00000069

Page~4 - Sidney M. Wolfe s M.D.

Finally, there are two animal inhalation studies on talc itself.The completed study was negative for carcinogenesis (attachmentI). The ongoing study, contracted by FDA with Lovelace Founda­tion, Albuquerque, New Mexico, and initiated in 1975, has shown nopositive result thus far. There are~ to our knowledge~ no cur-

"rent, direct studies of talc ingestion"or intrave~ous injection,since the former has not yet been- shown to be a hazard--even forasbestos itself--and asbestos contamination "of the latter ;salready unacceptable.

In summary, we share your interest in the safety of talc in foods, drugsand cosmetics. The FDA is continuing its study of talc through thesponsorship of contracts for" methods development and for animal studies;we also attempt to communicate with external scientific groups perform­ing similar animal or epidemiologic studies. At pr~sent, we believethat if talc poses any risks in the products under our control, it is· .related to contamination by asbestos fibers. However, the" FDA is pre­pared to take whatever prudent additional action is indicated to protectthe public health, if and when results of definitive tests show that thekinds of talc in foods, drugs, or cosmetics may represent a carcinogenichazard. FDA and other governmental "agencies are well aware of thedangers of asbestos and are actively seeking the necessary informationto establish enforceable limits on, thes~ mineral particles in productsunder our control.

We hope that these comments fully respond to your inquiry about ourcur~ent efforts "in this area. If ybu need further information, pleasecontact Dr~ Armand Casola, chairman of the FDA Asbestos Work Group. You"may reach him by telephoning 301-443-6714~ or bY,writing him at theBureau of Drugs~ Division of "Anti-Infective Drug Products (HFD-140).

Sincerely yours,

nonald KennedyCommissioner of Food and Drugs

Enclosures (9)"

HHS00000070

+ ,

Attachrrent A

REFERENCES

(1) Cosmetic Talc - X2250"(2) Anthophyllite Asbestos, U. I .A.C. Std. X.2200

Attachment B

I. !wI.' Asher and P. P. McGrath, Etls .; Electron Microscopy ofMicrofibers: Proceedings of the First Frn. Office of Science SunmerSymposium: 'held at the Pennsylvania State University; August 23-25,1976.

Attachment C

Mearl "F. Stanton and Contarice Wrench; l-iechanismS of MesotheliomaInduction Witll Asbestos and Fibrous Glass; J. Nat. Cancer Inst.48:797-821, 1972.

Mearl Fe Stanton, ~i.D.i Fiber carcinogenesis: Is Asl:estos the cnlyHaza~d?

Mearl F. Stanton, et al., carci11CJg'enicity of Fibrous Glass: PleuralResp:>nse in the Rat in Relation to Fiber Dimension, J. Nat. cancer"Inst. 58 :587-5.97, 1977.

Attachment D

Gavin Y. Hildick-Srnith; '!he Biole>gy of '!ale; British Journal ofIndustrial Medicine 33:217-229, 1976. -

Attachment" E

Federal Register, Vol. 38, N:>o 188, september 28, 1973, P=lge 27076.

Attachrrent F

Federal Register, Vol. 40, N:>. 51, Mclrch 14, 1975, p:lge 11865.

Attachment G

B. K. J. Ieong, R. J. Kcx::iba, H. C. Pernell, R. W. _Lisowe,' L. W.l{aJnpyi Inducti01 of Pulmonary carcinana in Rats 1:¥ Chronic Inhalationof Dust From Pulverized Asbestos Pipe Covering; Journal of '1bxicologyand Envirorunetnal Health 4: 645-659 I 1978.

Attachment H

John A. M::ore i NIEHS Oral Astestos Studies; Workshop en Asl::estos iJuly 18-20, 1977, National Bureau of Starrlards, Gaithersburg, :MD.

HHS00000071

Attachrrtent I

A. P. wehner, G. M. Zwicker and W. C. Cannon, C. R. Watson and W. w.Carlton; Inhalaticn of Talc Baby Powder by' Hamsters; Pdc Cosmet.Tbxicol. 15:121-129, 1977.

A. P. W=hner, C. L. Wilkerson, w. C. Cannon, R. L. Busch1:om and T. M•.Tanner; Pulmonary Dep:>sition, Translocation and Clearanc:e of InhaledNeutron-Activated Talc in Hamsters; Ftl. Cbsmet. 'Ibxicol. 15 :213-224,1977.

HHS00000072

r·t

4, 19·78

Dr. Dona.l d Ke nne dyCommissionerFood and Drug Administration200·C Street, S.W.Room 6815Wash~ngton, DC 20204

Dear Dr. Kennedy:

The strong likelihoo.d that talc is carcinogenic wasthe sUbject of a letter from Dr. Marshall E. Deutsch to theNew England Journal of Medicine on F'ebruary 16, 1978 (page 405).

A more re cent letter to the Sfu'1le journal by Drs. W. R. .iMoorehead and T.O. Dei (June 15, 1978, pp. 13·6·5-66) states that:

(a) talc is still used by U~S. drug companies both ·inthe manufacturing process and as a riller incertain tablets;

"Cb) a maj or drug firm rthas not used talc in any ofthe new drugs that it has develop,ed in the lastfive years because it pecognizes the .possibledanger of' talC;"

(c) FDA regulation's .discourage i·ts replacement -in~older' drugs because the new formulation withouttalc would have to be resubmitted and approved.by the FDA--and this proce.dure would take a long time.

If there is good reason to believe--even if the evidenceis not conclusive--that talc is carcinogenic, prudence woulddic~·~te· that its use be eliminated promptly in FDA~regulated

products such as drugs and cusmetics.

It would be greatly appreciated if you would let us .know what steps FDA is taking to achieve this objective.

sincer~l

S~dne~.M. ~~r~ .

. Benj min Gordon ~SMW ~ BG:pm

HE.l\LTH Rf-:SEARCH GROUP • 2000 P STREET, N.W.. ~ WASHINGTON, D..C. 20036 • (202) 872-0320

HHS00000073

DEPARTMENT OF HEALTH. EO·U-CATION.: AND WELFARE

I .E·······

-5anf~ A. Miner, Ph.D.Director, Bureau of Foods, HPP-l

..

Taylor ,M.. QubmAssociate Director for Compl1anee, HFHOO - -

Status Report On Tale

DE(.? 1978

==::::::

:::.:.::::.:;

~~~~~?~, i::::::::==.............

................

Attae~. is a' report -'that' ~mmarizes.. the ·Current state ~or .our knowledie'coneeming tale .ccmtamlDated with -esbe:stoL .--- ~Tbis ··-update- was ..equested,~ by ..

.~~ . :~~~~,~~._;~ Talc,·'''' 81-..&·-eom~ _~-.-bab.Y·powder-_.~tber- ~etiCs; b2S·not.been sbown-·"- -

, to ealJS(f. the bealtb·-"~effeet8·~-assoe1ated·'with -tbe·-inttalatiOlf :or· asbeStos.·· AddI-·' .tlonany, 'aside from·.-tbe -DOted inerease In i:Utroint~ttnel,~eer·83SOelated 'with - -~.Jpa~-~ to·· 8sbestclt there is-.~:..iiridenee that -the ingest1cn of smellamounts d asbestos .found .In·_food and water~~ health risk-to man. .

"~.," - '.-:'.'--.- -'. - . ~- . -. --, - - , <:~~~.:.. ~~~ ..~', ""'·:-.--u':· 'nle lastapfte,f·adJen eoae_ tale aDd ftStrlated the utWmtion of

asbestoP.".: mters in, the -,~uf~--or~ drugs .8ftc1. parenteral -drugingredleDtS. AddltloDaDyJ tt l del8.yed--the'tlDallZ8t1on -of the establishment of good

_.. '.:~mmiata.ctIIriDg .·praeuee~~~~-_lf!r _tak~ased:-~in .f~- ~&~~ pending the

,: ~~-~~:-~ -_.~&_,-:-"~-~~, .- - ~~~1W-«i;__~~~1:bere. '~.~.~ ottgoIng-ltsbesto:il:teedlDg-.sttidtBs-od 'an inhale,tion-Study _~ ~.-._ .~~ ~ .. ~: ... _.. :on ~e~~t:_b!l..··been-..~lgned_.to·tiddr_.tbese'1Usttcms.: ·AdditionaIJY,prqj~- --.:.... -·:·.E~~~~::

, .:.::.,~.- :-,-.~ -·-is -tieiDg·.m8de.-iD··1he development or analytIei1,.:iitetbodolCgy -fOr .the .separation and· -. &.~_., l~~~~~~~:~

. determ~--·of·8sbeitos in foods~ drugs and tale. -'Farther aet1OD·awai~ the- ...-. ·t~;~;;;.. cutaom-e or these studies.. ~.- ~~.':. ~";"

. ".~ ~._: _' -.'The .~em ,- areas' that need .resolution, priM to_~~y further agency aetion with.-::-.-:_- :<~:~,;_;: ~te;>'-~e~ude: - ._.: .'

..\~::.,'_.' ·::-(l)<:·:··:1-t,~···:~~~onoi·-1beeo~n~ti~n,·llberg~metry~8nd ·ehemiealCompositi~ 'of'LJ-ae fibers to the ~t1on -o! __ .dise8se in relation t~ both,the,L-maJ.ation·'~~lngestion·.ofasbestOs~must-~.,de1lned. : ,-

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HHS00000074

(2) The potential for ttte produetion of eaneer and other diseaes by theingestion of asbestos must be determined.

2•.

DEPARTMENT OF HEALTH'4 EO"UCATIO.N t AND WELFARE

Director, Bureau of- Foods,

(4) The leYels of oeetJr'renee of· asbestos in foods above beckgrotmd leveismust be determined. "

(5) Problems of separation of asbestos from the tood matrix must beresolved..

Attachment

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~;;;;;;; ::::.:::::::::-....::.•::-_:-.~:::...-~••~:..'";.~::::::::...::::::::::::::::.-:'-:.:::::::::::;::::::6=::::::::::;::.:.~._-::.:.:.:::::::::::: :::::::::'6+.::+:::"::::::::::::::::::::;:;:::::..._+:...~+::..:-:.. :;::::::::::::::::::::::::::::-.;;;:=::.:::::~~:::::::.:+~-:_-:.-+::::::_::+::..::::: ::::::::::

HHS00000075

INTRODUCTION

Talc is GRAS for use in food-packaging materials, in dietary supplements and

in chewing' gum, is, a prior-sanctioned food ingredient for use in coating polished

rice, is allowed for use as an antisticking agent in forms used in molding various

-food shapes, and is regulated for use as a pigment and colorant under several

indirect food additive regulations.

contaminated with asbestos. _

Talc, however,- has been shown to be

Documented evidence reveals that airborne asbestos fibers are related to human

disease, spec~ically pulmonary fibrosis, carcin~oma, and pleural mesothelioma.

Quantification of health risks associated with -specific airborn~ concentrations,

fiber dimensions and .chemical composition of the fibers, however, is inexact. The'

problem of estimating the ·magnitude of this risk to human health is further ~­

complicated by the 2\D-to-40-year' latency period between exposure and the

appearance of disease.

Additionally, the inhalation effects of asbestos raise questions ab~ut the ingestion

of talc contaminated with asbestos. Because of the ubiquitous natur~ of asbestos, .. -

the known health hazard from inhalation exposur-e, and the possible hazard from

ingestion, it is necessary to reduce exposure to this contaminant wherever possible.

The followin~ is an update of the steps taken ·by the Bureau of Foods towards the

developm.ent _of a regulatory p_olicy regarding talc contaminated with asbe~tosll

HHS00000076

BACKGROUND

Regulatory Status

FOOD - On .September 23, 1973,. the FDA proposed to restrict the

utilization of asbestos f~lters in the. manufacture of parenteral drugs and

parenteral drug ingredients and to establish good manufactm;ing practice

limitations for asbestos-contaminated talc· used directly. as a food or drug

ingredient, or in food and drug packaging materials, within certain analytical

restrictions. ~he finalization of this proposal in regard to talc had to be

delayed (40FRn86~) pending the development of a suitable method for

determining the presence of asbestos in talc.· However, the restriction on the

use of asbestos filters in drug preparation ·was finalized.

At the present time, talc is generally recognized as safe under §182.70

as a substanee migrating to food from cotton and cotton fabrIcs used in dry

food packaging, and under §182.90 "as a substance migrating to· food- from.

paper and paperboard products. Tal~ is a prior-sanctioned f,cod ingredient for

use in coating polished rice. FDA opinion letters. to trade associations have

stated general recognition of safety of talc for use in dietary supplements and

in.· chewin.g gum when the talc meets the speeificatio.ns of" the u.s.

Pharmac.opoeia. Talc is also cleared for use as a pigment and colorant under

§§175.300, 175.380, 175.390, 176.170, 177.1210, 177.1350, and 177.1460. :., Another

opinion letter allowed· for· the use of talc as an antisticking agent in forms

use~. in molding various food shapes.

HHS00000077

COSMETICS - There are no regulations concerning the use of talc: as an

ingreqient in cosmetic products.

Under current law the burden of proof that a cosmetic may be harmful in that

it contains a harmful substance rests with FDA. "FDA must have data or

other information demonstrating that a produc:t contains a poisonous or

deleterious substance that is harmful under customary conditions of use

before any action can be taken either to restrict or prohibit the, use of an

ingredient or product.

Summary of Health Effects

INHALATION - Asbestos fibers are Imown to cause cancer when inhaled -

in large amounts. Occupational' exposm-es to asbestos M've been found to

induce asbestosis and mesothelioma of the pleura and peritoneum as well as

cancer of the lung, esophagus, and stomach, after latent periods of 20 ~to 40

yearso From FDA's standpoint, the major inhalation problem of exposure is

that d~e to fibrous asbestos-contaminated cosmetic t~.c (baby. pO~wder).

INGESTION - Because of the recognition of disease probl~ms associated. ~

with occupational· exposures to asbestos, questions were '·raised about the ..

ingestion of this material as a contaminant of talc. ~o date, _t~ere ~e n~

satisfactory answers to these questions.

HHS00000078

UPDATE OF INFORMATION

Toxicological Studies

Completed studies - Inhalation

(1) - Inhalation of Talc Baby Powder by Hamsters. Wehner, A.R.,

Zwicker, G.M., Cannon, W~C., . Watson, C.R., and Carlton, w. W... Fd. 'Cosm eto

Toxicol. 15:121, 1977.

'The talc used was cosmetic-grade with no asbestos fibers found; exposure' to talcaerosol had no effect on' bOdy \veight, stEvival,/ or type, incidence or'degree ofhistopathological change in exposed compared to sham-exposed controls.

(~) - Pulmonary .Deposition,· Translocatio.n and Clearance of Inhaled

Neutron-Activated Talc in Hamsters. Wehner, A.P., Wilkerson, C.L.,·

Cannon, W.C., Buschbom, R.L., and Tanner, T.M. -Fd. Cosmet. ToXieol. 15:2~3,

1977.

Study was conducted' to determine pulmonary deposition, translocation andc1e'arance of jnhaled talc in lo-week-old hamsters receiving a single 2-hour nose­only· exposur~ "to neutron-activated talc. From 20 to 80 mg talc (6-8% of inhaled-quantity) was _deposited in the alveoli~ The biological half-life of the talc depositedin the alveoli was 7-10 days. Alveolar clearance was essentially complete 4 monthsafter exposure. No translocation of talc to liver, kidneys, ovaries or other parts ofthe body was fOllild. Several hundred micrograms. of talc were found in the faecalsamples.

(3) - Talc Dusting Studies. Pooley, F.

Talc dusting experiments have been perform~d to estimate the level of exposure toinfants during applications. (See Attachment A).

HHS00000079

Completed studies _. Ingestion

A number of animal studies have been perform·ed both to determine \vhetherasbestos fibers can penetrate the gut and to determine if any pathological effectsoccur upOn ing~tion of asbestos. There appears to be connicting evidence as towhether: upon ingestion in food and water, asbest.os fibers can penetrate the gut ofanimals. No experimental evidence ·has been developed to date in which gut tumors'in animals have been produced upon the ingestion of· even large amounts ofasbestos. .

(1) - rhe Short-Term Effects of Chronie Asbestos Ingestion in R~ts.

Bolton, R.E. and Davis, J.M.G. AIin. occup. Hyg. 19:121, 1976.

Rats fed a diet supplemented with an asbestos (Chrysotile A, Crocidolite, andAmosite~. ·margarine ,formulation lor periods of up to 1 year w.ere examined for ~

short-term clearance and evidence of penetration of, or damage to, the gutmucosa; no evidence of asbestos retention within gut lumen, and no ·sign of cellpen.etration or dam~ge to the intestinal mucosa. -

(2) - _A Preliminary Study 9f Biochemical Changes in the Rat Small·

Intestine Following Long-Term Ingestion of Chrysotile Asbestos. Jacobs, R.,

Dodgson, K.S., Richards, R.J., Br. J. exp. PathG 58:541, 19770

Rats fed chrysotile asbestos for 10 months (0.5-50 mg/day) iIi crushed pellet diet orinargarine; changes· are reported in DNA, RNA,· protein and brush border enzymesin small intestine mucosa lining -cells and gut lumen; intracellular levels of RNA,DNA and protein remained unchanged, but significant alterations, cons~stentwith a·.mineral-induced cytotoxicity, were found in the lumen level of DNA (fj' ) and RNA(J;) in the treated rats; most intracellular enzyme levels were consistently, but -notsignificantly, elevated in animals maintained on diets containing asbestos, while the·activities within the lumen were significantly higher than those found in normalanimals.

(3) -" Effects of Ingested Chrysotile on DNA Synthesis in the Gastro-

intestinal Tract and Liver of the Rat. ~ Amacher, D.E., Alarif, A, Epstein, S.S.

Environ. Hlth. Perspect. 9:319, 1974.

HHS00000080

11ale rats gavaged vlith chr·ysotile ·suspensions in normal saline (5, 100, 500 mg/kg)were sacrificed in 2 weeks; a dose-response study indicated that 2 weeks after a 5mg/kg dose, DNA synthesis was increased in ·small intestine and colon, and reducedin liver; sYnthesis was reduced in small intestine 2 weeks after 500 mg/kg dose;following 100 mg/kg, a transient increase in DNA synthesis was noted in stomachand small intestine· at 1 and 7 days, respectively, and increased in colon from 28-63days; data suggest that asbestos penetrates gastrointestinal muco.sa and influencesregulation of DNA synthesis in GI tract•

. (4) - Public IIealth· Aspects of Asbestos Fibers in Drinking ~Vater.

Cooper, R.C., Cooper, W.C. AM. Water iVorks Assoc. J. 70:338, 1978.

A review of several health-related aspects of· the presence of asbestos fibers indrinking water.. Concludes that, at present, there is no concrete evidence thatasbestos ingested via drinking water causes disease in man.

(5) - An.imal Experiments with Talc. Wagner, J.C., Berry, G., Cooke,

T.J., Hill, R.J., Pooley,- F.D., and Skidmore, J. W. In Inhaled Particles and Vapours,

IV. ed. Walter, lV.C., New York, Pergamon (in press).

Rats were fed 100 ·mg per day of UICC Canadian chrysotile prepared in milk powderon a five-day per week schedule for a total of 100 days of ingestion. The meansurvival.for the experimental rats was 619 days as compared to the controls (641days). One gastric leiomyosarcoma was observed in the chrysotile group. No·tumors of this type were found to o~cur in the controls.

(6) - Gibel, W., Lohs, K., Horn, K.H., Wildner, G.P., and Hoffman, F.

Tierexperimente1le untersuchungen uber eine Kanz·erogene wirkung von asbesti­

filter - material nach oraler aufnahmee Arch. Geschwuistforseh 46:437, 1976.

Rats were fed 50 mg/kg body weight per day of asbestos filter material added as awater suspension which contained approximately 52% chrysotile. The studyreported a statistically significant (p ~~. 0,.01) increase in the incidence of malignanttumors in exPerimental rats as compared to controls.. The average survival timefor e>q>erimental rats was 441 days as compared to 702 days in untreated· controls.

HHS00000081

Ongoing studies - Inhalation

An ongoing study (Lovelace Foundation) on the inhBlation of pure talc

by hamsters is ne~ing completion and the results are expected to be submitted to

FDA in' the near future. To date, all findings are negative.

Ongoing studies - Ingestion

The effects of ingested asbestos are currently being investigated by the

National ,.Institute of Environmental Health Sciences. Newborn rats and hamsters

are receiving 1% asbestos by gavage until weaning. when they 'will be put on diets

containing 1% "asbestos until death. Additionally, lifetim~ feeding studies in rats

and hamsters are being conducted to determine the toxicity of ingested asbestos.

\vith and witho~t dimethylhydrazine. Complete histopathological evaluations will

be performed ~t termination of exposure in all of :these studies. 'These studies are

scheduled for completion in 1979. (Attach·ment B)

Analytical Methodology

The FDA currently has :a contract with Structure Probe, Inc., of West. - .

Chester, PA to develop analytical methodology for the determination of asbestos in

foods, drugs, and talc. Successful preliminary methods have been. developed for

wine and beer, while good -progr~s has been made ·on methods for catsup and

. mayonnaise. The methods being developed use the scan.ning electron microscope

HHS00000082

Cosmetic Talc Surveillance Program

-The "Bureau of Foods has a modest surveillance program under which it

monitors the asbestos fiber ·content of retail units of cosmetiC! talcum powder

products. To date, it has not found any grossly contaminated products_.

GRAS Review of Talc

The FDA is conducting a compreheIl:Sive study. of direct human food ingre­

dients classified _as generally reeognized as safe (GRAS) or subject to a prior

sanction. Under this review, the safety of talc is being re-evaluated. This

compound was the subject of a search of the scientific literature from 1920 to the·

present, and is being evaluated by the FDA with the aid of the Select Committee

on GRAS Substances of the Life Sciences Research Offiee, Federation of American

Societies for Experimental Biology (F.ASEB). In 1974, the FAD/WHO Committee set

no limit, within good manufacturing practice, _for the acceptable- dally intake· of

talc pending the development of a satisfactory method for estimating asbes~os-like

particles in talc. The Select Co·mmittee tentatively concluded that there is no

evidence in the available information on asbestos-free talc that· demonstrates or~uggests reasonable grounds to suspect a hazard- to tl:te publie when used at levels .

that are now current or that might reasonably be expected in the .future (see

Attachment B.)

The Uses of talc. considered by the Select Committee include use in paper and

paperboard packaging materials, in cotton. and cotton fabrics use~ in dry. food

packaging, as a coating- for rice, in chewing gum base, and as a filler in cross-linked. .

polyester resins for use on food ·contact surfaces~

HHS00000083

PROBLEM AREAS

Toxicology

(1) The contribution of the fiber concentration, fiber geom etry and

chemical composition of the fibers to the production of disease in relation to

both the inhalation. and ingestion of asbestos must be defined.

(2) The potential for the production of cancer -and other diseases by the

ingestion of asbestos must be determined.

Methodology

(1) There must be a refinement in the existing methodology for the

determination of asbestos in foods and talc.

(2) The 'levels of occurrence of asbestos in" foods above background

levels must be determined.

(3) Problems of separation of asbestos from the food matrix must be

resolved. (It is anticipated that methods suitable for use by FDA for most

food types .will. be developed by the end of the current contract in July 1979)0 .

HHS00000084

11= .~.. •

CONCLUSION

Studies have been instituted tq determine the health effects qf the inhalation

of talc and the ingestion of asbestos, .and to develop adequate analytical

methodology for the determination of asbestos in foods and cosmetics. To date,

there is no evidence to suggest a health hazard from the ingestion of asbestos or

the inhalation of talc. In addition, the analytical methodology has not been

developed and refined to a point where very small amounts of asbestos

contamin·ating talc could be. detected. Therefore, until these issues have been

resolved, no f~ther action is contemplated.

HHS00000085

Microscopy of Talc Exhibit 1

~ - 715

July' 20, 1971

NEW BRUNSWICK. N. J.

..~ r ? +

-~ N~~W. Na5he~t; Ph. D._,Director of Science Information. .

Submitted in triplicate

Prel~inaryLiterature Reports on Talc ' Exhibit 4

JQhnson &:. ·Johnson Press Statement, Exhibit 3June 29, 1971.

Methods of Assay for ;Fiber Content of Talc Exhibit z

Prelinlinary Literature Reports on Asbestos Exhibit 5

Very truly yours,JOHNS'ON &= JOHNSON

Dear Dr. Schaffner:

Subjec~: JOHNSONI·S ~aby·Powder

....: •..:.

R .. 'Schaffner, Ph.. D.Director, Office of Product TechnologyBureau of F"oodsFood and Drug Ad.m.inistrationDepartm.ent of Health J .Education, and Welfare

.200 lie 11 Street.I . "

Was~ington, D. C.

.. During our m.eeting of July 8, 1971 on the sU,bject, you. requestedadditional inform.at~onwhich is being provided as follows:

.~.

HHS00000086

.~' '.. :.., ...

.,.....<~:. . ; .~- -.:.

MICROSCOPY OF TALC

FIGURE 2

., .. Subject: Beneficiated Verm.ont Talc used in ·JOHNSONIS Brand Ba~y

. Powder. .Magnification: 5500XC·omm.ent: This picture (the only one in this collection). was taken by

the Pulp and Paper Institute before we bought our ·SEM. and shows the characteristic platelet structure of our talc.

.. -.4 FIGURE 3

* JEOL Scanning El~ctronMicroscope, Model JSM-Z.

HHS00000087

~ 2 -

FIGURE 4f'

FIGURE 6

.. .

FIGURE 5

.~_»:~I:: ~.~. ~..... :... ".:.. ~

- :. _:~:t?~_j\~:$Ubject:'- Beneficiated Vermont talc spike-d by us with c~inmercial~ :'.··::·~·r·?':·.';.'~·~~·:··~':··· '. asbestos (mainly chrysotile) at the 250/0 W Iw level~

--':-:'{\~"::Magnificatio~: _ 500X -.' ~/-'.~::.~.,.:~ ...'~: .Comm.ent: SaIne as in Figu're 5.: .~~~:~';'- ......... ~~ . -

FIGURE 7

. Subject: B.eneficiated Vermont talc· spiked by us with conunercial. .asbestos (mainly chrysotile) at the 50/0 w /w level.'

Magnification: SOOX. Com.rnent: Same as i~ Figure 5.

l,

HHS00000088

I'

Beneficiated. Verm.ont talc spiked by us'with connnercial

FIGURE 8

asbestos,

R. Rolle, Ph. D.Assistant Director of Analyt~cal·Res.earch

presence.one"·~::,}~~·trrin~nt: . Even at the 1% level of spiked (by us) chrysotile

.~ .

:. ~ .,~ ,~:' .,,\.:. ~. :.... . ' .::

- . -. . . ~.". -.

" .' ..

. '"

IHHS00000089

1. Italian Talc Mine:

As you re'quested in au'·r ITIeeting of September 21, 1972, we are providingour data' as follows:

F-7f Ip

NEW BRUNSWICK. N. J.

,October 1 7 J 1972

i

~ f

Dear DrG Schaffner:

Reports by:

(a) Prof. F~ D .. Pooley (University College, ,Cardiff, U. K.)(b) Atomic Energy Research Establishment

(Aa Eo Ra E~, Harwell)(c) Mining Institute, Torino, Italy.(d) Prof. S. Lewin (New York University)

Subject: .. SHOWER-'rO-SHOWER Brand Body Powder

Ro. Schaffner, Ph. D.Director, Office of Product TechnologyBureau of FoodsFood and Drug AdministrationDepartment of Health, Education, and W'elfare200 lIell St'reetWashington,. D. Go 20204'

As a result of a finding by Professor So Lewin that a SHOWER-TO-SHOWERBrand Body Powder salllple contained 50/0 chrys9tile asbestos, w"e haveca r ried out extens i ve studie s on the sam.ple in, que stion 0 btained. froIn Prof.Lewin as well as representative samples from producti.on of SHOWER-TO-:­SH9WER Body Powder.

2. Investigation of SHOWER-TO-SHOWER Body Powder:

Reports by;

(a) Prof~ M .. J. Buerger, (MIiIaT.)(b) Prof. Go E. Brown (Pri~ce~onUniversity)(c) McCrone Associates

(Dr. I. Ste\yart)(Dr. W. McCrone)

(d) C'olorado School of· Mines Research Institute(e) Prof. F. D. Pooley (University College, Cardiff, U. K. )(f) Prof. S. S·. Pollack (Carnegie-Mellon University)(g) Mro J 0 Schelz (Johnson &: Johnson.).·(h) Dr. J .. M. Wehrung (Sper'ry-Rand)

HHS00000090

R. Schaffn;~r,~~.Ph.D., ~..).:'B"...",~..

- 2 - October 1 7, 1972

A review of the data shows that:

A review of the data 'by the various exper~s clearly shows that Prafl;! Lewin'sfinding is wrong and has no basis in fact~. We would like'to point out thata release of such untrue inform.ation will create a great deal of unwa.rrantedala:r:m. alTIong the public and will cause serious da:rnage to. our r~putation andbu·siness.

Italian Fontana TIline does not contain chrysotile ·asbestos deposits ..

The Italian talc powder fr·oIn the Fontana mine used in SHOWER-TO­SHOWER Body Powder ·has been shown to be free of chrysotileasbestos by both Prof. Pooley and Prof. Lewin.

Investigations by all available rn.ethods carried out by experts.'failed. to .establish any chrysotile asbestos in SHOWE'R-TO-SHOWERBody Powdero The investigations included transmission electr'on:m.icroscopy and electron diffraction, x-ray scan, step scan, Guiniercam.era, differential ther:mal analys is (DTA), petrographic techniquesincluding optical staining technique.s, and scanning' electron m.ic:rosc6py"

111

24

'-1-

:1 3.

/In view of the nature 6f the. enclosed material and the comments regardingProfessor Lewin1 s work, we request that this material be held in strict.confidence by the eInployees of the Food and .Drug Adm.inistration interestedin this subject, unles s we consent to other us e of ,it ..

On behalf· of m.yself and my colleagues, I wish to thank you for gIVIng ust,he opportunity to fully review our data. o~ this subject on Septem.ber 21 ..

Very truly yours,·JOHNSON & JOHNSON

W" Nashed, Ph. D.Director of Science InforIllation

WN/cw

Attach ..

HHS00000091

·F-7l4

NEW 8RU~SWICK, N. J~ 08903

March 7 ~ 1974'

R~ Schaffner, p~~D.Director~ Office of Product TechnologyBureau of E'oodsFood and~ Drug Adm.inistration200 tlGII StreetWas1?-ington# DC 20204

. Dear Dr. Schaffner:

Thank you for your help in arranging a briefing session betweenJohnsot & Johnson and the Commissioner •. As a result of thissessions we are continuing our coo.perative effo'rts to ·help resolvethe talc/a s-be s tas question. -

Weare J therefor e 2 s ubmi.tting her ew!th the following inforrn.ation.:

I} Es.t.iITlation. of Talc Dust' Exposure for Infants

This report cOnlprises rneasurelllents of··,Clust levelsachieved. when a v::ho1e can of 9 OZII .of JOHN"SON1S Baby'P'Qwder is q.us ted and r elating the exaggera ted high dus tcondition to TIlaxilTIuITI use on babies (frequency and'dusting tirn.e) elicited fr.om. two .studies by A •. Eden•. M. D ....

. The resulting exposure level is compared to ·talc TLVfor m.iners.

2) A· prooJ copy of a publication entitled~ liThe Detection ofChrysotile Asbestos at Low' Levels in Talc by DifferentialTherm.al Analysis lf by John p~ Schelz2 ·J.ohnson & .Johnson.

With respect to Item (1}2 we believe the infant ·exposure data is farin excess of real e·xposure da ta sinc.e it is based~ t?n dusting ,g£ awhole can of- babr powderG How~ver, it is being subtnitted for what­ever value it TIlay have in your investigation of infant exposure."

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Dr. Schaffner -2- March 7~ 1974

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We would like to consider this data (ItelU 1) ap confidential and theFood and Drug. Administration is not. authorized to make it publicwithout written perITlission ·from. the corn·pany4J

·Ver-y truly yours it

, JO~SON & JOHNSON

. VJ· NtrA.by: W. Nashed. Ph. D.

Director of Science Inforrn.a tia:n

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A tta chrn.ent

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•~$Ubject: An Estimated Upper Limit for Talc Dust

Exposure of Infants Compared with theOSHA Threshold Limit Value for· Talc Miners

Dr. W. Nashed: .

New Brunswick, N .. J ..

February 19, 1974

. . !~ Upper limits .for talc dust exposure for infants in a one week period"~~ere estimated on a particle-time basis from experimental data supplied by...~~~ F. D. Pooley and Alvin Na Eden, M.D. The experimental values used to es­··:.·t:tm,ate -an upper limit for talc exposure for infants were those whi'ch correspond

..t·c{<maximum expos ure condi ti o·ns. Whenever' estimates were~ employed, corJ-serva ti ve-··.nti"rtlbers were se lected, that is, val ues whi ch_ tended to increase the· es timated':~*:posure. ' .

,~. A second estimate was made which more closely approximates' median ex-~ .~~~~re levels of infants to talc dust, but even this was based on conservative.: .....as,$.umpti ons and probab1y re.present an expos u·re 1eve1 wh i ch i 5 generally greater;' ···.t~·~in normal. For example, ,all estimates were based on applying the talc directly

. ··t·ti".·,;:the di aper area from_ a contai ner, whi ch' is the mode of ap-pl i cati on whi ch.t:r.e·ates the greatest concentra.tion of talc dust. An alternate mode which pro-

. ,.~l~:qes subs tanti a11 y 1es 5 dus tis emp1~yed ·by -many mothe rs who t rans fe r tal c from·~.,:~h~ ··con tai ner to thei r ,hand and gently 5 troke th is povlder onto the infant.

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. . _;. To p-rovi de a bas is of compari$on a parti cl_e-time exposure was computed::··_:_:···:fo.~r a talc miner in contact with the OSHA TlIl-.V. for. talc of 20 mppcf for a 40

.. _': ·~·hQ_~ ..r week.

·Jhis particl~-time exposure ~alue for a miner is at least 370 times th~'

"c'orrespondi ng upper 1i mi,t exposure val ue for an infant and is about 7840 times..··'tij.e exp~s'ure of an infant under more nearly medi.an. conditions. .

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:"""" For ease of comparing results the exposure levels are pre'sented in the. :':attathed tab1ea. A compl ete summary of -the computations and assumptions are di 5­

: ... :·~#ssed in the attacned report.

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370·

7,840

Rati 0 of- Mi nerto Infant Exposure

800

2.16.

0.102

Exposure L~vels I·

mppcf-hrs per week

Infant - Upper Limit Exposure

Infant - Median Exposure

.Type of Es ti rna te

OSHA T.L.V~ for Miners

. :Summary Table Comparing the Talc Dust Exposure Levels

for Talc Miners and Infants

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l-d. N. Sivertson •ManagerStatistical andComputer Operations

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.eIc February 19, 1974

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Section

I.

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III.

.1 V•

. V.

TABLE OF CONTENTS

SubJect

Comparison' of Talc .Dust Expaiure forInfants and Talc Miners.

Report by F. 06 Pooley on DustingExperiments Performed with JOHNSON1s*

- Brand Baby Powder. .

Data Submitted by Alvin N. Eden, M~D.

Investigating Methods by Which Baby- Powder was ,App1i ed to Infants by.

Thei r Mothers.

"

Data Submitted by Alvin N. Eden, M~D ..Investigati'ng'Time (In, Seconds) Re­quired for the Application of-BabyPowder to Different Areas of Infants

- by Various r~ethods of Application-and Weights' of Powder Per Application .

. Summary of Parameters Associ ated withPowdering a Baby as They Affectthe, Ta l.c C1 cud Subrni tted by ·-Or. F. D.Pooley.

~.

.: .' .. ~::>'::.-~ .Jrademark of JOHNSON & JOHNSON.

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S·UBJECT:

DISCUSSION

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. OTC vclu·i£~ 160192 is irJe~tical- to (:TC vwlu&le 14·0062 tvliicn ~ppearn il'~ t~;c

aatiper8pira~t ad~i2istr2tive ree6rd~ Tkere nr~ n~ ot~cr 13b~li~t c12ic~

iu tkle s ubt4i.s 3 iOR t~a t are a Pf,ropi: 1.('.1 ':e for ~'.~,"jt~ter rul~:-{Eilti)"'"! g a ·TL,:~!· ~~ f0:"-~\ )

.9 fur tner oSC t io'lS, is acce g'sary wi th th is VGJ lu~e [i..4d i t c:~-~;. bed iSC/1T :.:L~: ..'; •

"'c;a ta Ie .".~3,d eo h y J 011'5 S c~:e anrl Jch:t S~ii '-.0;-

OTC- voluae 160191 conta ~-;.~--~-~;~;.L~-~~~i~~Y.~t--~~~'A~;i~;-;~:~;ira11ltra)H~1 i~}llI!eeth.~t of 7-9-75. Th.::! rri:;s~ .. tat.i';L' 16 c-·o~t,,':ip.;lil im tlft? t.;;mscript (>1

. -t~~at GJe!"et .lu~. No furt~eT dcti~m i5 j:~.ece5.5r.iry for thi;; 'l'oltJtH~ SRi it (::.F.m.

be '"'. iscarde:cl •

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_..... CONTENTS

TAL.C PRESENTATION B~ JOHNSON &t. JOHNSONTO THE O. T. C. ANTIPERSPIRANT.PANELJuly 9~ 1975, WASHINGTON, D. C.

INTRODUCTION

TALC MINE·RALOGY

BIOLOGY OF TALe;

ANIMAL STUDIES

G. Hildick-Smith, M. D. - DirectorMedical Affairs, Johnson &: Johnson

F • Pooley, Ph. D. - DepartIIlent·ofMineral Exploitation, UniversityCollege ·Cardiff, Wales, u. K.

F. R. Rolle, Ph. D. - AssistantManager of Analytical Research,Johnson & Johnson

G. Hildick-Srnith, M. D.

G. ·Lord, D. V. M. J Ph. D. - DirectorJohnson &: Johnson Research Foundation

A. ·Wehner .. D. M. D. - Biology DepartmentBattelle Pacific Northwest Laboratories

w. E. Smit~, M. D. - Director,. HealthResearch Institute, . FairleighDickinson University

HUMAN STUDIES.

SUMlv1ARY

G. ··Hildick~Sm..ithi M. D.

G. Hildick-Srnith, M. D.

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INTRODUCTION

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.GAVIN HILDICK-SMITH, M. D.Director, Medical AffairsJohnson &: Johnson

. MeInbers of the Panel, Ladies and GentleInen, we appreciatethe opportunity to present data on talc as the subject is very corn.plex,.w~ have elected to review SQtne very iITlportant aspects. When sub­sequent data are presented, there !nay be a better unde·rsta·nding oftheir significance. The data "that we review will be concerned withonly cosmetic grade talc used in costnetics and two or three productswhich incl.ude such products as dusting powders and aerosol talcproducts.

We will not discuss tales used in industrial p~ocesses, whichi~ altogether another subj.ect. O~r objective is to present data to thePanel to support our belief that cosInetic grade talc, as used in cos­metic products, is not a hazard to health.

W e have provided for the Panel. a background volume en~itIed,IICosInetic Talc, CTFA Presentation to OTC Antiperspirant Panel,July 9, 1975. 11 That's the black book you hav.e.

The volwne contains a section headed. 11 Backgroundll and -pro­vides selected correspondence between Johnson and Johns·on and the_Food and Drug Administration since 1971. It identifies the reportsand docum.e.nts submitted by our Com.pany to the FDA which iilformation,·

. of course. is ~vailable to the Panel. .

In .addition, we have provided the Panel with tables of pertinentdat~ that will be covered in the ·presentatio~s. An agenda for. the pre.­sentation is 5ubnlitted and consists of, initially, a review of talcmineralogy by Professor Pooley of the DepaItm.ent of Mineral Exploita-·tion~ University College, Cardiff, Wales. Dr_. Pooley is· a worldexpert on the Inineralogy and analysis and physical character~stics

of talc and consults on this subject and others relating to mineralogyfor the British Government and other govermnents.

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He Vlill discuss the mineralogy of talc, genesis, morphology, *

../ chemistry, and uses as well as describing the difference .between~/ -industrial and cosmetic tales.

Following Dr. Pool~YI Dr. Rolle of Johnson and Johnson willgive definitions of talc and discuss .m.ethods of analysis of mineralsin talc which will include methods for assaying asbe~tos.

I shall then talk briefly ab?ut biology ~f tales.

Dr. Lord of Johnson and Johnson will then introduce Dr. Wehnerand give inforOlation on dosage that Dr. Wehner used in his animalinhalation study that be will describe. Dr •. · Wehn.er Vlill present dataon a long-terIn animal inhalation study using cosmetic talc in whichno adverse changes were noted in any of the animals studied.

Dr. Wulf of C·arter Wallace Com.pany will describe an animalinhalation study of an aerosol antiperspirant product containingcosrn.etic talc which produced no abnorm.alities in the animals· hestudied.

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Dr. W. E. SInith, Director of the Health Resea·rch Instituteat Fairleigh Dickinson University will discuss studies in animalswhich show that talc and SOIne forms of asbestos do not producecancer in anitnals.

I shall then review an epideIniological study conducted in atalc mine p.opulation that shows that the incidence of cancer in thosenrlners ·wh·o have died was not any different from that of the normalpopulation and that those exposed to cosmetic _talc dU~t5 showed nodifference in type .of disease from which they died fraIn a controlpopulation.

Finally, I shall summ.arize th·e salient points of the presen-.~

tation which support our belief that norrn.al use of cosmetic gradetalc is not hartnful.

We will report today on data that has been recently developed,but not yet published. On those studies, where a final report iscomplete, we have included it in our background volume. On· those~studies where the work is cOInplete, but the final report is. still· inpreparation, we have asked the principal investigator to present hisdata.

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We are very pleased that experts in the field haye been ableto join us in this meeting to present their data as· indicated in theagenda. We hope that questions will be asked of them. after thei~

pres.entations or those of us who have be.en involved in the field.

We hope that the data provided wilt be of sam.e assistance tothe Panel.

* Talc was known to the ancient Egyptians,. Assyrians, and 'Chinese and has been 'in use ev.er since. The greatest use of talcat this tim.e is in a wide variety of industrial processes and products.·These include ceramics, paint, paper, and roofing tn~terials and·in· the making of rubber goods.

Talc used in such industries should be referred to as in­dustrial talc as it nearly always is composed of a variety ofmineral.dusts to prpvide the physical properties n~eded and ismined froIn. a variety of.. rock deposits.

SaIne industrial tales xnay contain silica, quartz and alliednrlnerals ,vhile others can. contain asbestos. Due to the possiblehealth hazard of working in mines, government regulations controlthe axnount and type of dusts to which :miners are exposed.

At this tirne~ the xnaxiInurn talc dust exposure is definedas a Threshold Limit Value, TLV J of 20 nrlilion particles perc·ubic foot and 2 fibers per ml in a working environrnent basedon a'n eight hour day for.. a five d'ay working week.

'Presently, the National Institute of Occupatlonal Safetyand Health is reviewing the TLV of dusts on health in such minesand allied industries.

As industrial talc is pri:marily a concern o·{ the NationalJns.t~tute.of Occ·upational Safety and Health, we are confining ourreview to the area of cosmetic· grade tales ~ and their consumer usesand are not concerned with discussing industrial tales to which nlostof ·the tnedical reports and the rn.edicalliterature refer.

Cosmetic grade talc that is used in toiletry and cosmeticproducts is a grade .of talc that is at least 90 p~r.cent mineral talcand is free of fibrous minerals, including asbestos •

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In order to assess the possible health hazard of cosmetictalc in cosll1etic and toiletry products, its composition must be knownas well as the aIllount and respirable fraction of the dust in the en­vironm.ent and the tim.e to which the individuals· ar e exposed to thet~lc- containing produ~ts.

~ Data that are to be presented will attempt to cover· salientfeatures {or. the evaluation of cosxnetic tales. It should be mentionedthat the data submitted prim.arily·relate to studies conducted oncosmet~c grade talc dusting powdet-s.· The inform.ation is relevantto cosITletic grade talc aerosol powders as both forms of cosmetict~~lcs have fracti~ns that fall within the respirable pa.rticle· range.

At this point. I would like to introduce Professor· F. Pooleyof the Department of Mineral Exploitation at the University Collegeof Wales_ Cardiff, who will talk on the nrineral~gy of talc.

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TALC MINERALOG-Y

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F. POOLEY, Ph. D.Department of Mineral ExploitationUniversity College

. Ca'rdiff, Wales, U.K.·

Thank YOUJI Doctor. Mr. ·Chairman, Ladies and Gentlemen.rn.ern1Jers of the Panel, before launching into a description of talcaDd its form.ation and chem.istry, '1 think first of all, I would justlike to show one slide to de£in~ the asbestos minerals becaus e m.ostconcerns with tales center around possible asbestos tnineral contentof talc and powders and I think it would 1?e very good just to illustrate.and talk about the various asbestos minerals first •

. On this slide, I have listed the v~rious narn..es of Illineralswhich are accepted as being asbestos minerals. There are twogroups of thes e, the Serpentine Group and the Am.phibole Group.Under the' Serpentine Group, ,\\"e have a mineral referred to ~lS

Chrysotile, I believe all of you are ve1:y fanriliar with the nam.e.Under the Arn.phibole Grop,p, we have several nlinerals': Cro·cidolite ..Arn.osite,' Anthophyllite, Trem.olite, and Actinol.ite. These -allhave non- fibrous counterparts.

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In the right band colwnn, we can also find these mineraltypes in non-fibrous forms. As far as talc is concerned, we are

. only really interes ted in three of the minerals in that par~icu1ar

left hand column, first of all, Chry·sotile,. the Serpentine, andAnthophyllite and Trem.olite 7 and perhaps, Actinolite, the Tr~lTIolite

and Actinolite being very similar in chemistry. Crocidolite 'andAmosite we are really not concerned ab.out as it doesnft occur withtal~.

The name. talc powder. refers cozn.m.ercially to materialwhich contains talc as one of its principal ingredients. In a brief)ook at the broad spec~rwn of talc -powders produced throughout theworld. one finds that the actual talc mineral content of talc powders,varies from a figure of about 95 percent by weight; talc content, tolc:ss than 40 percent by weight talc content. The narn-e, in certaincases, is not applicable in industrial situations •

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Talc, the Inineral itselijl is a sheet silicate and I have gota little sketch drawing on th'e pad over here. I sketched out, roughly,a unit of talc. Talc is co:mpos~d of two layers of Si04 tetrabydrawhich are bound together by a layer of brucite znagnesium. hydroxideInolecules. Thus, in a talc crystal, if you l~ke, we have layers of ,'~.~

these sandwiches. one on top of the other and there is no chemicalbinding between each layer. When any .force is applied to a talccrystal, these .sandVJiches tend to move very easily with respectto each other and this. in fact" imparts the particular texture andproperty of talc.

In the pure talc, we can expect to find that by weight, thereis-~ 31. 7 percent m.agnesiuIn oxide., 63. 5 percent SiOZ, and 4. 8 percent'water by weight.

Talc is formed in nature .from. two different types of rocks;.first of ~11; froIn Serpentine rocks, the rn.etarnor"phic change ofSerpentine rocks, and secondly, by metamorphic changes indue-edin carbonated rocks.

In this slide,_ I have two equat.ions which represent the twocom.znon pathways in n'ature in which talc is formed. In equationone. we have Se1"peIitine which, with the addition of carbon di.oxide·,and under heat and pres sure" can change, to form talc plus Inagnesiu!ncarbonate and water.

In the second equation# we have dolorn..ite which is a calcium.. magnesium carbonate to which we have added SiOZ plus water underthe influence of heat and pres.sure; this ·can also be altel~ed to talcplus carbonat.e mineral.

In both cases, we end up, after znetam.orphic action of theSerpentine and the dolomite, with a talc plus a carbonate situation.This repres ents an ideal situation and -in nature we very rarelyge~ ~this true geom.etic change.

We find in. com.m.ercial deposits of talc, which may be derivedfrom. alt.ered Serpentines or carbonated rocks, that there are nUInerousother a,ssociated minerals with the talc which were formed duri~g theform.ation of the talc and the level of these IIlineral itnpurities in'the talc depend upon the initial1evel of iIllpurities which existed inthe original S erp~ntine and dolomitic type rocks •

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The mineralogy of talc rocks is further kept cOIllplicated bythe fact that in all deposits' w'e tnay fin~ that there are intrusionsof surrounding rocks into the ore itself.' These m.ay often be mined'With the talc and crushed up and finally end up in a talc product.

The conunon minerals which are found in association withtalc or in a talc", .I don't know if you can read this. Th.e major

. minerals consist of the c.arbonates which are produced during theformation of talc and thes e carbonates are; magnesiuOl carbonate,calciwn znagnesiurn carbonate, and also one finds calcium carbonateagain, calcite~ We also find in lllOst talc deposits, chlorite mineralswhich are, again, magnesium. silicates, which contain aluIninunland they have a very similar structure. There are sheet silicateswith very similar structures.

Also, in Inajor forITl, we can find trernolite, the asbestosntineral which is a ITlagnesium. silicate and anthophyllite, an asbestosmine.rai, which is a magnesium iron silica~e; and quartz.

" Accotllpanying these major rn.in~rals, we often find in largenwnbers, sInall quantities of trace Inine·rals. arnong which we caninclude calcite, actinolite~ Inuscovite, serpentine, s'ulfide nlinerals,pyrite, enstatite, olivine;J magnetite. All of these minor minerals,'and also the major impurities fOWld ill talc ore bodies are really

'. form.ed due to impurities in the original rock which has rnetatnor­phosed. if you like. to talc.

As I xnentioned, in comlnercial talc', . the actua~ quantityof talc IDineral varies frorrl 95 percent to well below 40 percent

.and to illustrate the type of variation that one ca~ find in corruner­cial talc powders, I have some figures on a slide here on someanalyses we performed on conunercial tales.

In this first colunm we find the percentage talc in this 5 am.ple ,.. and we look downjO we can see. for example, that 80 percent talc ...-

content here which would. represent a typical cosInetic grad~ of 'talc her·e. 29 percent' .talc only. a very large alnount of treInoliteWhich. in fact, represents industrial ·grade powder, this particu-lar powde'r is used for paper xnanufacture. Going down the list, ,96 percent. 98 percent talc, very high grade powders, in fact thisparticular powder, number four, repre~ents the' Br~tish Pbarnlaceut­ical G·rade Talc in .Gre.at Britain.

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Again, coming down the list, 4~, 48 percent talc. -Here,we have .very high chlorite c.ontent" and again, these representtypical industrial tales in fillers a·nd paints and the rubber industry.

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Coming down the list_·again, we have t:narginal powders, 88and 90 percent talc, 91, 92, 56 percent talc with- a 31 percent carbonatecontent. tales containing large quantities of carbonate, again, usedas fillers in paint and plastics industries. Thes e repres ent a typical.spectr a of ·industrial and cos rnetic grad e powaer s becaus e nlanygrade powders are being represented by the powders with talccontent over 90 percent.

To move on, as I illustrated, the tnineralogy of talc powdersis quite extreme and this mineralogy reflects itself. In fact, inthe chemistry of talc powders on the little diag.rarn, I mentionedthat pure talc, theoretically, would- contain 31. 7 percent tnagnesiumoxide, and 63. 5 percent SiOZ- If you look at the chemistry of taleswhich contain large quantities of the minerals, we find large dis­crepancies in this ideal chemical formula.

In this particular table, I've pro"duced the cllem.istry oftypical high grade talc,' a chloride-rich talc,. a carbonate-rich

.talc, a treOlolite-rich talc, and a· carbonate-rich talc with highll1~gnetite content. This is, in fact, an iron oxide.

If we look at high grade talc, 30. 4 which is very clos·e to thetheoretical ITlagnesiwn content of pure talc, 62.1 percent SiOZI again.,very close with traces of calciutn, iron, titaniuIl1., a little aluminum.

- which 'Will probably represent-the chlorite mineral content of thepowder, a little COZ which is reflecting the carbonate content ofpowder.

When we look at the chlorite-rich talc, we look at the SiOZ· content. it drops very radically and we have a very large alunlinum.

content. This particular powder would probably have about 40percent chlorite mineral by weight.

In this carbonate-rich talc.• we find a drop in the magnesium.and the silicon and if we look aiong at the end of .the column here.18~ percent C02 by weight in the powder.

In the trern.olite-rich talc, we find that we have an increasei~ the calcium co.ntent which again reflects the trem.olite content ofthe powd~r with the corresponding drop in the 'm.agnesiun1 .con~ent

; of the powder.

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Finally, in this last column, we have a very high iron content,6. ~3 percent, again.. rene·cting the rrrlneral content, in this case.Jnagnetite at 18 percent, c-arbon dioxide reflecting· the carbonatecontent of the powder. We see that the mineral content of. thepowder does alter the cherrrlstry.

Similarly, if we were to exanrlne the·'trace elem.ent contentof t~lc powd·ers, the trace elem.ents ·are also influenced by the traceIDineral content of the powders. For exam.ple, titanium. in a talcnormally reflects a rutile mineral, TiOZ titaniu:m dioxide •

The mineral content of the talc powders also influence theznqrphology of the dust fraIn particles which are form.ed· from.the various. different types of ores.

~ this particular micrograph of a high grade talc, we cansee r efiected .the sbe.et-like structur e of the mineral. Thes every, very .thin sheets look like torn paper or pages of a book,and slightly angular, . very flatJ' translucent particle·s; One couldimagine these, in fa~t, slipping .apart ve~y easily -- a high gradetalc.

Her~. we have a slightly different picture. Here we havesheets of talc around a InQre electron dense rnaterial~ niore opaque.These particles represent chlorite zninerals, and carbonate tniner­als, altering th.e rnorpholog.y of the particles,. slightly blockedhere and less angular and not as flat .

.On the next slide we have a trem.olite rich talc; .rern.em.ber,. trem.olite ~an be a chenrical in fibrous fortn., again, very few sheetsof talc around•

.Just to illustrate how those particles,.· in terms of m.orphologycompare with conunercial asbestos nrlnerals, here we have a ..picture of aznosite asbestos to compare with those other particlesand here we have the typical appearance of Chrysotile asbes·tos inSerpentine minerals. It's very easily recognizable by extremelyfiJ:ie fiber~- and distinct morphological characteristics.

, .

Ju.st to swn up. there is a very wide variation in mineralogyof talc powders as the·re ar·e limited sources of talc. The mineral­osical camp.osition is dictated by ·50urce and geological forznation.

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Second. we find froIn location to location, the mineralogyof tales \vill change dep~nding upon the composition of the original

~~ rock from. which the talc is forIned.

The minerals in the ore reflect the chenristry of the powders.They reflect the trace chemistry of the powders, and also. to saIneextent. dictate the morphology of the particles which were form.edfrom that particular ore.

From. the talc we examined, cosrn"etic grade talc p.orIl1.al1ycontain over 90 percent talc. With the corrunon contanrinates inthe talc~ being carbonate minerals· and chlorite minerals.

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F. R. ROLLE, Ph. D•.Assistant Manag.er .of Analytical ResearchJohnson & Johnson' ,

I would like to further emphasize what Profes sor Pooleyhas said concerning the m.any uses of the word talc. May I have thefirst slide, please.

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This is a photograph of a talc platelet by a scanning electronrnicroscope which is part of th~ next slide, the first definition.Talc is a rnin!Zralogically defined species having the ideal cheITlicalformula Mg3Si4010(OH)Z.· The second use of the word talc is inrelationship to cosmetic talc. Cosmetic talc comprised of talctogether with associated mineral itnpurities as n:rlnor constituents.

The trace minerals conun.only associated with cosInetic.talc are phlogopite, muscovite., quartz JI and iron oxide.

On the next slide I have a photograph of ,a typical· c,os~etictalc•. It has chlorite.. talc and carbonates. 'Can we gOo-back to thedefinition .of talc again?

There is a third Ineaning which Pro·fessor Pooley has tnen­tioned, industrial talc. A very i:rnpure industrial product whi~hoften contains less than 50 percent talc and therefore representsa misuse of .the word talc. In saIne instances, industrial talchas been analyzed and found to contain no talc, but to ~consist entirelyof associated nrinerals such as chlorite, pyrophyllite or tnUsco,,~te.

The tertn, Iftalcose dustt1 nlay be suggested for these applicatio.ns.

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I have a photograph of ~ndustrial talc and this talc' was act­ually used by Dr.' William Smith in a medical study which he willbe discussing today.

This particular industrial talc contained 50 percent tremolite,35 percent talc, 10 _percent antigorite, and the reznaining fivepercent was carbonate and chlorite.

Let 'me. go on t.o the subject of asbestos and talc. Therehave been numerous' allegations about the asbestos cont~nt of cos­inetic talc. As a consequence, the CTFA form.ed a task force on.xnethodology for the detection of asbestos in talc.

I was Chairtnan of that task ~orce. and Cit our first meetingabout a year ago we had representa,~ives froIn. "governlllent; we hadrepresentatives from. the' talc suppliers like Pfizer and CyprusMineral Corporation, and of course, we bad the CTFA tnernberco:mpanies. At that first meeting, we set the objectives for thedetection of asbestos in talc.

The method m.ust be sp'ecific .for the detection of asbestos---iIi talc and it, or a follow-up m.ethod, IYlust discriminate betwe.en

fibrous and non-fib,rous forms of asbestos. I will.be definingwhat I mean by fibrous in a Itliriute.

It Inust have definable detection linllts, must be re-produc­ibl'e among different workers with different instruInents, must bewritten 50 there is a pa-55 or fail on talc.

. ..It bas always been a problem in defining a fiber. We used

to call a fiber anything that bad an aspect' ratio; a· ratio of three.to one. The U. S. Department of Labor, Occupational Safety andHealth Adm.infstration, in November, 1974, stated a definition 'offiber, particula:rly with regard to tremolite and talc. '

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. I think this is so iInportant, 11m going.to read the definition. for you. Talking about what is a fiber: particle IIlust appear

to be fibrous rather than as 'crystals or slivers, . the niaxiIl1umdiameter of a fiber to be -counted is· three m.:j.crons, the maximum

··length 0'£ a fiber to be .counte.~ is 30 m.icro~s, the length-to-width. ratio of 'five or more to one. that is. five times or :more longerthan wide. The next is the crucial aspect. of the definition of afiber.

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The separate or individual fibers must contain fibrils orthe I1bwidle of sticks" effect, unless they are at a non-divisiblestage. A fibril cannot be subdivided and y/ould be counted if itmeets the other criteria. The electron lUic~oscopemay be used

. to prove the fibrous nature of the particles.. The length-to-widthr'atio of five or Inore to one is not .Ineant to irn.ply that other particle sare not hazardous.

A Let m.e IrlQve on to the subject of analysis of amphiboleminerals. that is the trernolite, actinolite that we mentioned intalc.

My task force com.mittee looked at the five rnethods;J. infrared,. optical microscopy~ scanning electron D1.icroscopy, X-ray fluorescenceand X-ray diffraction. The method adopted was X-ray diffractionwhich has a detection leyel of about one-half percent amphibolein talc•.

What I m.ean by detection l~vel is that I have my inst10t urnents. squeaked up to :maximum sensitivity and abo,ut the best they cando is one-half percent amphibole in talc by X-ray diffraction.

This metho.d was put through a round robin analysis andCTFA has different instrurn.ents, different laboratories and is in

_cotnplete agreeInent.

On the next slide I have the official CTFA procedure forthe detection of asbestiforrn or fibrous a?1phibole nrlnerals incostnetic grade talc_. The procedure is r~ally to look for the Inost.

_intense x- ray diffraction peak for the amphibole minerals. Ifyou do not see that peak~ then you follow tIle bottom arrow thatsays stop, am.phibole absent and the talc would pass for am.phibolecontent.

If positive. one then proceeds to .optical microscopy anddisper$ion staining to see if it has the right xnorphology, that itis a fiber or not, and for final confirInation, that it is an am.phiboleby dispersion staining m.ethod.·

If it is fibrous amphibole at this level, the talc fails.

Let tne turn now to the detection of Serpentine, particu­larly Chrysotile. The task force considered the following tnethods;

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.~ , optical microscopy, scanning electron microscopy, the rose dye~..: procedure, transnrlssion e.lectr.on microscopy, and differential

therm.al analysis. The method adopted by the CTFA, was differ­ential therm.al analysis.

Before I discuss differential therm.al analysis which is called·DTA, 1 would like to say a few words about transmission electronmicroscopy known as TEM.

TEM is scientifically· a valid method, however. it is nota practical m.etbod. CTFA was irtterested in a practicaltnethodthfLt could be done in a QA laboratory or even in a plant environm.ent.One of the problems that one' always faces with TEM i~' that it isextremely sensitive and it approaches the level ,o·{ background.contamination so that you can get false p~sitives by TEM•

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. ~ For example.. last year at·Mt. Sinai Hos.pi~al in New YorkCity, Dr. Langer reported a background count of two Chrysbtilefibils per TEM at· m.agnification of 31, 000. There is a tr~nsrrrls sionelectromicroscope laboratory that used to pc locate.d near an as­bestos factory. One and a half miles, I think, was the distancefroIn. the asbe.stos. factory~

They used to find a backgr.ound contamination of sixChry'sotile fibrils per TEM field of view at a tnagnification of 3, 000and.. ~t certain tim.es of the year. or when the wind .was blowingin a ce.rtain. direction, the level went up to 30 Chrysotile fibrilsper TEM field of view. By TEM field of view, I ITI.ean· the ph.otographwhich you are looking at. .-

One other criticism. that has been leveled at TEM is. one,it is very hard to quantify and is the best semi-quantitative :method.Secondly, the weight of the mate'rial that you are actually lookingat is probably, most as suredly, les s than a microgram an~ youalways have to ask yourself, how representative is this of the bulk.m.aterial. This. is really a COInIIlon problem. that we h·ave with these~~ho&.' .

At least with X-ray diffraction.and the DTA procedure, youare 'approaching a level of a milligram. up to. a gram. of talc whichyou are actually looking at. This is a probleIn of representationof a microgram of talc. trying to say something about that sInallq'uantity of talc.

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One of the strange things about developing the m~thodology

for detection of C~rysotile in talc, was that we alw~Y5 had to ·m.a.kepositives. The way we did that is we. spiked Chrysotile in cosIl1etictalc.

The reason why we did that was because we couldn't findany naturally occurring Chrysotile in talc and it was sort of frus- .trating to try an4 develop a rn.ethod for Chrysotile in talc when youhave never seen Chrysotile in talc. Anyway,· we developed a method.went through a round robin test, and it. was approved. .

We started asking ourselves, if we can1t find Chrysotilenaturally occurring in talc, why are we developing a method? We

..asked the FDAjI have you ever found Chrysotile in talc'. The FDA-.. said, verbally~ no. \Ve asked the member c.ompanies of <;;TFA~o go ba.ck through their file~ to see if they' ever found' Chrysotilein talc, "and asked the s~ppliers to go back and loo~ at their talc,and the CTFA now has available analyses of around 1,400 talcsaxnples from allover the world.. using different in5truments~ andno one .has ever detected Chrysotile in talc.

On the ne~t slidell. I have a submission that John'son andJohnson submit,ted to the CTFA, Analysis of Chrysotile and Alter­nate Sources of Talc by Johnson and Johnson. We used TEM,·DTA. X-ray diffraction, and opt~cal microscopy on tales throughoutthe world, Italy, India, Korea, U. S. A.,· Brazil, so on and so forthand we 1ve never found Chrysotile in talc.

Let Ine sununarize now. I have three points I want to tnake •. One, if the terIn talc is us~d. it Inust be defined or mineralogical

analysis provided. Two, there are n'o detectible aIIlounts of Chryso­tile in cosnletic talc. Three, the CTFA' now has a specificationo£ a half percent fibrous amphibole in talc. Thank you.

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BIOLOGY OF TALC

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;. GAVIN HILDICK-SMITH t M. D.Director. Medical Aff(tirsJohnson & Johnson

. I would like to go on and. talk about the biology of the activityof talc. Cosrn.etic and toiletry products containing costnetic gradetalc are used world-wide and Johnson and Johnson has ":marketeddusting powder containing cosm.etic talc since 1894, with the currentconsumer complaint level being 0.4 complaints per million unitsfor the last 100 million units sold.

As·talc·has been used lor· industrial purposes and in healthcare products for IIlany years. it ts not surprising that the tnedicalliterature contains information on it. Unforturiately, almost allof the publications on talc do not contain precise information onthe quality and quantity of the talc used. Consequently, it is" verydifficult to as sess exactly I the biological activity of cosmetic

~ grade talc. The" published articles r~lating to respired talc dusts 'fall.into several general categories. .. .

One of thes e relates to industrial health;. Most publishedreports in this field refer to the ill health of Ininers arising from.prolonged exposure to high levels of nrlxed mineral dusts .often·cont~ining asbestos, the studies being done before governmentregulations i:mprove4 the dust environment in the mines. Theminers are reported to have developed varying degrees of iIn­paired pulmonary function" but no cases to O1y knowledge havebe'en reported in this group.

,The sec·ond category really falls into what I term acci­

dental suffocation. The accidental spilling of excessive amountsof talc onto· the face of a baby or a sm.all child by the Inother or thechild has been reported with aspiration of the powder causingvarying degrees of 11 suf~ocationtl and pultnonary insult.

The third category relates to what might be terIIled misuseor excessive exposu~e to talc. "Isolated reports refer to indivi­duals who have had excessive exposure or have overused talcwith resul~ing pulxnonary changes being reported in these s~bjects•

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A number of isolated reports are in the literature and someare referred to in the black book. Qne of the"m I think Dr. Millerreported on was a patient whose job was to' clean out flues contain­ing talc .powder used in' processing rubber. who developed pulmonarydisease. He worked for about nine 'years in this job as I understandit. Unfortunately, the ex~ct ~mount 'of dust to which this subje~t

was exposed is not reported. The data in the paper on the analysisof the X-ray curves would indicate that the dust c"ontained about 30percent of a non-talc nrlneral and· alsoJi I believe, contained antho.­phyllite asbe,stas. As such, this dust would' carn.e Wlder our descrip­tion as' an industrial talc dust.

No publications have been found to show that any adverseeffects arise from. the norm.al usage of cosmetic or toiletry productscontaining cosmetic grade talc. There are no data to indicate thatcosm.etic grade talc is a carcinogen, in spite of suggestions by'Bljer and others that talc containing chrysotile might cause cancer.

+Conventional usage of talc introduced into the plural cavity,for instance~ in the tre~trnent of collapsed lungs has apparently·failed to produce intrathoracic cancer. -

AniInal studies have been conducted with talc to researchits biological activity. but.,most studies are of limited value as theyalso failed to identify the amount and""· com.position of the talc dustut~zed. .

As the published literature contains data that fails to identify. the precise talc, dusts studied, in most instances further 'studies. had to be conducted to precisely determine the biological activityof cosmetic grade talc as opposed to the industrial ta.lc dusts.

In order to assess the biological activity of cosmetic talcdust, studies have been conducted to assess its sensitizing poten·tial, ·

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effect on cell Ilieznbranes, influence on cell cultures, and impacton macrophage function.

Hum.an skin test studies designed to determine whether talcitself is a' sensitizer have shown that it is not an allergen. Forinstance.. ten separate Draize studies conducted in the last few years",involving a total of 2, 181 test "subje"cts~ failed to produce a singlesignificant skin reaction in any of the subjects" teste"d.

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These data w_ere confirmed by ten s·eparate 11 rnaxirirlzation"allergic test studies. Incidentally,. it was mentioned that talc can

·C contain nickel and, because of that" we chal1enge~ individualswho were nickel-sensitive with~talc containing nickel and did notfind any allergic response.

. . In vitro study of the eff~ct of a variety of dusts on viablecells has been conducted to provide an indication of their biologicalactivity•. Schnitzer and Pundsack 'studied the. biological activity of·tal-c compared with that o~ asbestos and silica in a test system. utiliz­ing red blood cells. The results of the study showed that asbestosand silica readily lyzed red cells, while cosmetic talc itself wasshovrn to have no lytic action.

In a;nother study that is in the book, primary embryoniclung explants grown in vitro were used to assess their histologicalresponse_ to various mineral dusts includil~g chrysotile, silica, andboth industrial and cosmetic talc. The data showed that all butcosmetic talc produced a fibroblastic response. No changes wereseen"with the cosmetic talc.

Schepers and· Durkan evaluated the pulmonary histological~. response to a variety of II+ineral dusts and concluded that talc was.'--.' predominantly cytogenic while trem.olite and anthophyllite·had

fibrogenic properties.

The pulmonary macrophage is considered ·to play an importantrole in cleansing th·e lWlg, am.ong other t~ingsJ of inhaled dusts.Im.pairrnent-of nortnal functions of the macrophage by c.igarettesmoke and harmful dusts such as free silica is thought to be im.­portant in the development of pulmonary ~isease by these dusts.

A.s such. the effect of cosIn.etic talc dust on some asp~cts

of lTlacrophage .fWlction was studied by exposing com.m.ercially av~il­

able cosmetic talc dusting powder to pulm.onary macrophages xnain­tained in buff~.red plasma. The results of the unpublished study.showed that the macrophages readily ingested the talc pa·rticlesand-that this did not i.mpair their viability or their ability to furtherphagocytose colloid" particles introduced into the media.

The ~ data· obtained 'With talc particles is in strong contrastto that reported for free silica particles which rapidly kill pulmonaryJl1acrophages.

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In summary. the data obtained on in·vitro study of the biolog­ical activity of cosmetic talc dust indicate that it is biologically inertin contrast ~o such .dusts as free silica and asbestos which readilyproduce pulmonary disease. t

At this tim.e.. Dr. A. Wehner will review the r·esults of astudy conducted in hamsters .in which the anilTlals were exposed todifferent amounts of cosnletic talc dust and ·allowed to live out theirnorIna! life without showing any significant abnormality.

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Dr. Lord of Johnson and Johnson will introduce Dr. Wehn"erand cornm.ent on the talc doses used i~ the animal study to be reportedby Dr. Wehner ..

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G. LORD l D. V. M., Ph. D.Inrector, Johnson & JohnsonResearch Foundation

Before introducing Dr. Wehner, I would like to discussbriefly the rationale behind the experimental design of the studywhich he will be reporting on.

In'designing an exposure regimen for an inhalation studyof ~aby powder, three aspects were considered to be very important.The first.was the maximum. duration of dustil1g J in other words,the m.axi:rnum time that a mother takes in dusting th~ infant.

The second. was the character of the dust cloud.

The third. were niem.bers 'of the hUInan race m.ost lilcelyto be' exposed.

To establish th-e maxiznUIn duration of exposure, a groupof mothers were 'observed and timed during the period of dustingtheir. infants. As might be expected, ther ~ wa s great varia tionin both method and duration of dusting. How~verJ the maxim.uInduration appeared to be in the order of three tninutes a day, or nine20- second periods of dusting.

'As far as the dust cloud was concerned, the character ofthe dust cloud was established in Dr. Fred Pooleyt s laboratoriesby maximizing the du.s-ting procedure.. The entire contents o~_.a

can of baby powder was em.ptied by shaking over the pelvic r-egionof an infant mannequin. A dust sam.pler .was placed at the level of.the nares and the dust was collected throughout the procedure-.Characterization of the collected dust indicated the cOnlpositionto be 345 milligram.s cubic meter of air of which eight milligramscubic llleter fell into the respirable range. These, therefore,served as the bases for the· chronic animal exposure.

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The last consideration concerned the tnernbers of the humanrace most likely to be exposed to the powders. We felt that themale and female infant and the female who then went on to mature.and to have babies of her own represented the im.portant target individuals.As.. ·you will se.e, our experitnental animal groups reflect these considera­tions.

Three groups of hamsters were exposed to baby powder for30 days, which is equivalent to the infant life of a hamster. They werethen followed for the retnainder of their life span.

Two additional· groups were ~xposed for 300 days. a p~riod of tiIllein a ·hamster's life roughly equivalent to the age of a w.otnan through herchildbearing. age. The actual duration of exposu·re of the .various groupswill be reviewed when the results of this study. at:"e di.scussed by Dr.Wehner ..

Aft~r discussions with a toxicologist from. t"he EPA and a toxi­cologist from the FDA we weighted som.e of these exposure values by·certain fact.ors and this will COIne up also in Dr•. Wehnerls report.

. At this point, Dr;. Wehner will discuss with yo.u the results of theinhalation toxicity stud·y·which ~"as designed to satisfy the saf~ty of

I ~~t . talculTl powder under a talc attnosphere comparable to and severalfold that which lnight occur·under normal use.

Dr. Wehner was educated in medicine and dentistry at the Gutten­berg University in West Germany. Dr. Wehnerls work since joining.Battelle in 1967 has prirrlarily involved initiating, or ganizin.g J supervis­ing J and conducting research program..s in in1}alation· toxicology in relatedfields.

He is presently directing three long term projects investigatingthe inhalation effects ·0£ cigarette 5 In.Oke , talc. asbestos and cementdust in rodents. These studies are sponsored by the National CancerInstitute, u. S. and foreign industry respectively.

Previously, he was project director of a five year study for theNational Cancer Institute investigating· the .carcinogenicity of diethylnitrosamine,inhaled asbestos, cobalt oxide, nickel oxide. and cigarette smoke in ·hamsters.With that, I give you D.r. Wehner •

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A •.WEHNER, D. M. D.,Biology DepartmentBattelle Pacific Northwest Laboratories

Thank you, Dr. ·Lord. Mr. Chairm.an, Ladies and Gentle­men, I~zn Al Wehner and r'm. associated with Battelle PacificNorthwest Laboratories'. Battelle is an independent, non-profitresearch institute and we're conducting contract research forvarious govermnent agencies and for private industry.

Three years ..ago Johnson' and J"ohnson approached us witha request to conduct a long term inhalation study with baby powder.These studies were cOInpleted earlier this year and .the final reporton these studies is now in preparation.. You ~"ave a first rough andincomplete draft in the tnat~rial that was handed to you.

I will give you. a brief overview of the J &: J study, more". specifically, I will discuss the objective of tIle study, the experi-~JIlental design, why we used haznsters, the exposure conditions,the pos~ mortem procedures, the pathologic evaluation, the proofof deposition of talc parti~les-in the lung and. I "\viII read to you theswnrnary of the histopathologic findings because· they are rather complex.

As to the objectives of t'he study, it was sim.ple and straight­forward rn.ainly to find out 'V:J"hetber under controlled laboratoryconditions tbere were any biological effects of the inhaled- babypowder in a suitable anim.al Inodel.

The experimental design is shown in this table which you ,-also have in the handout. This study consisted, actually, of twosub-studies; one, consisting of the 30 day exposures... The ~O dayexpo.sure groups cOTIlprising gr.oup one, two and three, with groupsix as the control. The second.• -consi5ti~g of 300 day exposure groups

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