Document ba83NZpeGbLjpaZXRbz1rvYNZ

Mr. V. E. Rose Director o f Division of Criteria Documents and Standard Development 5600 Fisher Lane Rockville, Maryland 20850 Dear Mr. Rose: December 13,1978 S ^ S L fS tsa i damage to certain parts o f the talc industry. to * * TM -PM**TM n . point,for Inthe C/nitedStates.* considerationconcern ToM, -Coinpodtlon of Talc Mlnod 1 0 7 sag) North Carolina Talc -- The presence of tremolite ^ not Iei Htrtil+ftri in our source o f talc (The Hitchcock Corporation, Murphy, Norm Our X-Ray diffraction examination program started in August th^Norm CrniS talc has never shown the presence of any .e r e determined ty veto. M^nHont consulting laboratories. 2 ftisunfair and inaccurate to clafm that a talcis0* * < ^ W * r * ^ incorrect conchisions ^fcansa^^as , __ .aahg5tos form minerals and can be c J % a talcs contain asbestosform minerals talcrepresents one of thefinest quality cosmetic talcsavaflab.e. i The study as "sumamed" in Table m -2, completely ignores allforeign M c T n S ^ l " d 7 te me OOUPW o.fintmed pr** Ta!*,,, ore. continued.ll*nw*fMS***** Ctocaoo 1 ExacUlv* Driv* Wltowtxoo'it,nSnob 80521 (312)873-5775 4 5777 Branch OtBce*: Oetrott 19D0 Big Beaver Road Troy. UicHsn 48084 (313) B4O-6620 4 SCSI ONO 2598 Marrillytow Lina Crndnattl. Ohio <5231 (513)825-3424 IM P O R TE R S M ANUFACTURERS EXPORTERS M IN E R A L S , C O LO R S, p ig M E N T S Ctnadt P.O.Box 593 Staton G Toronto. Ontario, M4T2N4, Canada (416)921-35*8 PLAINTIFFS EXHIBIT WCD-314 WCD 001014 W H I T T A K E R , C L A R K & D A N I E L S , INC, Mr. V. E. Rose - 2- Deoember 13, 1978 A major part o f this report (149 out o f 203 pages) represents literature references going back to 1896. I suggested that all o f these references were "lifted" from the literature by a professional searcher. Some of these references appear to be based on sound m edical conclusion, but many are inclusive reports which are listed probably to make the large size o f the report more im pressive. Very truly yours, W HITTAKER, C L A R K & DANIELS, IN C . Frederick F . Roesah Executive V ice President FFR/cs ca: Mr. George W. ScuvSLand Chairm an C T F A Talc Subcommittee Mr. Charles Haynes C T F A Headquarters Washington, D C WCD 001015 RomroiLs-iMivBRg t o o s u h c t s A DIVISION OP BHI8T O L - M Y E B B C O M P A N Y CEB LONG AVENUS HILLSIDE.NEW JERSEY 07207 TELEPHONE C01-SE3-6A^a March 29, l979 Mr. Ray R. Krammes WHITTAKER, CLARK & DWilELS 1000 Coolidge S t. So. P la in fie ld , HJ 07080 Dear Mr. Kranmes: This w ill confirm that there w ill be a meeting of the CTFA in Washington, D.C. on Tuesday, April 3 , 1979 a t 10 A.M. The subject will be: Review SRI Draft of C riteria Document to Niosh on T alc. ' I ' l l be looking forward to seeing you. Sincerely yours CWS/nfi G. W. Sandland Chairman, CTFA Talc Subcommittee WCD 001016  h . oesMEira :TOILEIES FRAGRANCE ***0OlCKINC. ita u * m m , n,w,, vuumncton, d.c jkxs m w am m-w TO : Norman Estrln m tti C harles Hayncs SUBJECT t_ T a lc zil tte e response to th e JS rch 1979 SRI T a lc R eport DATEi Jfay 1st, 1979 P a t o u r d is c u s s io n , a tta ch e d is a d ra ft o f th e T a lc S ufcecninittee's -npp--|iaQ to th e la te s t SRI R e p a rt. The d ra ft was developed by key Subcommittee members and any in te re s te d ta lc n a n a fa cta re rs/u e ss a t a s p e c ia l A p ril 3rd , 1979 m eeting. B a r in fo rm a tio n purposes, new passages fro m th e o rig in a l d ra ft, response a re in d ic a te d . Through th is memo I an re q u e stin g a CUBA le g a l S ta ff re vie w , along w ith any a d d iti m a i T e le S iisocm nittee in p u t. A ll examanta/su g g e s tio n s should he a d d rd sse d 'to ity a tte n tio n , h r ifcndav May H th , 1979. --------------------- *------ CRHtpac 5/1/79 CC: Steve fctfectnra e u x T e le S u b a w n itte e E nclosures WCD 001019 Mr. Anthony Bomero Division ol*1Criteria Documentation ft Standards Development NIOSH - 8A-37 5600 Tishers Lane Bockville, Maryland 20852 * ' * Dear Mr. Romero: It. Cosmetic, Toiletry 4 Fr.gr.nc. Association. Inc. ( C B M !. . nstlonel trade association representing the ccmdtlc industry. It Include, mere then tec hundred entire me-ber eompenieB uhich manufacture or distribute finished eomeetle product, in the United States. In sddlticn, CTFA include. ,, r e then teo hundred Associate member compenle. Iron misted industries, such as manufacturer. ol cosmetic rs. msterlsl. pachaglng materiels. U. estlmst. the CTFA meters m e responsible lor m o m then 90% ol the eoimetic product, smnu- leetumd end distributed in the United States. The CTFA Talc Subcommittee read ith concern the lirst and second dralts ol the Stanlord Beseareh Institute report to ,,lOSE entitled, "Till:". This Subcommittee, h i d is composed ol industry scientists Ircm ration, discipline, includine mineralogy, oilers the I d l c i n g comments d i c h hope .ill be helpful in the preparation ol subsequent drafts: 1. CTFA STASDAEO FOE COSEETIC BEADS TALC ' The Stanlord Bernard: Institute, in d.reloping this T U c Boeument, baa o j m d n o t m j e r o ^ ^ .^ WCD 001020 voluntary purity standard (Attachment 1) established in October, 1976 by the CTFA for Cosmetic Talcs. Cosmetic Grade Talcs, which specify a composition^of 90% ' hydrated magnesium silicate and the absence of detectable asbestos, should not be. grouped with industrial talcs of lower and less defined purity in the development of occu pational hygiene standards. Unlike that of very impure talc mixtures, the pathogenicity of high purity talcs (conforming to the CTF Standard) has been extensively and carefully evaluated (References 1-10). It is stressed that these carefully defined studiesjnurt L j l be distinguished from .historic literature citations loose generic referenced the term `cosmetic talo'^Waich only denote physical and tactile properties deemed appropriate for cosmetic use, but earrXpS.bo universal meaning in terms of mineral composition or contaminants. An extensive CTFA presentation has been made to the FDA/OTC Antiperspirant Drug Review Panel in July, 1975 in support of P*A Cosmetic Grade Talc* as a safe and useful ingredient (Attachment 3). Similar positive reviews of data were conducted by the FDA/OTC Miscellaneous External Drug Review Panel in August, 1077 and the FDA/OTC Anti microbial IX Drug Review Panel in January, 1977. Other reviewers (Attachments 4,5,6,7,8) have also concluded that CTFA cosmetic talcs are not' hazardous to its users. WCD 001021 3- There have been old reports In the literature of unsub stantiated findings of chrysotile asbestos in talcs. However, these mistakened detections of chrysotilejeere actually chlorite mineral, mis-identified in X-ray Dif fraction through negligent confirmatory analyses. In your review of the CTFA Cosmetic Talc Standard,you will note the absence of a specification for chrysotile. This was supported and dictated by the absence of chrysotile. verified through a round robin study of 3,397 samples of, cosmetic talcs from sources such as Montana, Vermont, Alabama, North Carolina and Italy. The results of this round robin study were submitted to the Food and Drug Administration in September, 1975 (Attachment 2). BASIS rOB TLV AMENDMENT There is no firm basis for projecting and amending the permissible occupational exposure limit. The available research data cited in the S.B.I. report suffer from a common deficiency of Incomplete dust analysis and exposure measurements during the sntire period of workers' exposure. The S.B.I. March 1979 report itself stated that the data available are insufficient to draw valid conclusions. For example: . - lines 5099, 5099 and 5100 "More comprehensive epidemiologic studies^concerning _ exposure to talc without asbestos mineral with follow-up studies of populations and cohorts * already reported on.M . - -- lines 5141. 5142 and 5144 Ii WCD 001022 -4 "Animal inhalation studies that evaluate the degrees of pathogenic effects on .. tissue of pure talc, dolomite, chlorite, magnesite, non-fibrous tremolite, and the tale-related mineral pyrophyllite, alone and in combination, are needed." " - lines 4941, 4042 and 4943 % "...the evidence presented in any one of those papers (17, 65, 66) is not conclusive *or purposes of setting a permissible exposure limit... Various Intimately-informed reviewers in the NIOSH Experts, Government Agency and External Panel have also connected on the inadequacies of the epidemiologic studies, for example: _ Burgess, W.A. - External Reviewer A.I.H.A. many of the early studies involved exposures to >io*mg/m3 to a talc containing concentrations of free silica up to 18%." ii it U not possible to obtain historical data for It i. possible that a r a w ol talcs were in us* and the concentrations were higher than those noted during the environmental component of this study." "The Selevan study does not present exposure data..." Peters, J.B. - NIOSH Expert Reviewer n___ Rubino's study adds little useful information to standard setting." "Selevan-s study contains little ^ TM nr Dtal information to match up with the health effects. Thiessen, J.V. - Agency Reviewer, Dept, of the Army "From an epidemiological perspective. articles or studies cited establishes a direct ciusgl i S i & a a S p ha., 1 ,0 0 th* 14 auartz and a disease state. WCD 001023 5- "None of the evidence given demonstrates a reasonable model that shows the old standard as being too high." "More toxicological data Is needed concerning the health effects of relatively pure talc and talc with its associated minerals....as well as epidemiologic*studies on occupationally exposed persons. Establishment of a new standard should be contingent on such studies." Damstraj. T. - Agency Reviewer, NIEHS , "Many of the studies cited did not adequately characterize talc by mineral composition, particle size, or purity...." Uarkle, R.A. - Agency Reviewer, Bureau of Hines "Tiie exhaustive 87 page section on biological effects of exposure describes mainly studies done at concen trations much greater than the current TX.V of approximately 3.0 milligrams per cubic meter or where the talc contained silica or asbestos." CTFA agrees with S.B.l. that "the evidence presented by the literature references is not conclusive for the purpose of setting a permissible exposure." Te also agree with S.R.I. that further epidemiological studiea should be carried*out, but urge that theae should be designed toward projecting a recommended permissible exposure level which is based on determined exposures to talc that has been properly analyzed and shown to he in the category to be regulated. Until more valid data are generated, a lowering of the present TLV for CTPA Cosmetic Talc is wholly arbitrary and an unwarranted Inflationary action. I I I . LABELING AND POSTING J' In the prevailing absence of direct occupational suae WCD 001024 i -6- and effect data, the proposed label and posting warnings which specifically single out Talc are unjustified and prejudicial., This type of warning language wrongly implies to the worker and the public that a high purity talc such as nCE&k Cosmetic Grade Talc" is very toxic. f The CTFA would endorse the recommendation for training and counseling under Section 5, page 9 as an effective documentable and controllable awareness tool in the handling of any general dust substance. However, we find the labeling and posting requirement to be a redundant, passive means of employee communication. If HZOSH still considers warnings and posting* to be r necessary, then they should reflect the uncertainty of the data supporting this need. Therefore, it would be more appropriate to use language such as: DUST EXCESSIVE INHALATION HAY CAUSE adverse RESPIRATORY EFFECTS MEDICAL In view of the known adverse effects of x--ray radiation, it is recommended that the medical surveillance require ments specify that a frontal view be done, followed by a sidle Ties' 'only Then'taecessary. '' ,, . r. t* h "***- WCD 001025 WORK PRACTICES TSe recommend that NIOSH follow OSHA's recent standard setting precedence of stipulating performance type standards. It is preferable that examples of acceptable controls and work practices be provided as appendices and not as standards.. In this manner OSHA would not inhibit Innovative control techniques. ACTION LEVEL The "actios level" of the SRI document serves no purpose. Ve understand an "action level"kfi' that level above which medical, labeling and posting, personnel protective equip ment, training, monitoring and record keeping take effect. According to lines 52 to 58: : "The "action level" is defined as a concentration in the sir of the workplace at or above one-half the recommended environmental limit (see Section 1}. Exposure to talc at LOWER concentrations requires adherence to the following sections 2, 3 (a and b), 4, 5, 6, 7 and 8 (a and c)," The work LOVER implies that any measurable level down to, zero activates the standard requirement as an "action level.'" Ve find this contrary to all existing OSHA standards and directives and indeed store stringent than any other standard, including the asbestos standards. This amounts to promulgating a zero standard. WCD 001026 I ! The CTFA Tile Subcommittee hopes that the above comments will be helpful to you, and would be pleased to provide further assistance.. In particular, the CTFA would appreciate receiving copies of future' drafts so that we may provide additional comments and information. Sincerely, Norman F. Estrin, Ph.D. Vice President-Science i*f*- ? WCD 001027 i -9- ATTACHMENTS S I. y 2. S 3. S S 5. / 6. S i. /s. Cosmetic Talc, CTFA Specification-The Cosmetic Toiletry end Fragrance Association Inc. (10/7/76 Revision}... Estrin, Dr. Norman, Letter to Dr. Bobert Schaffner (FDA) September 23, 1975. CTFA Presentation to FDA/Over-the-Counter Antiperspirant Drug Review Panel, July 9, 1975. - fe Hildick-Smith. G.Y., The Biology of Talc. British Journal of Industrial Medicine 33:217-229, 1976. Hildick-Smith, G.Y., Talc - Recent Epidemiological Studies. In Proceedings of the 4th International Symposium on Inhaled Particles and Vapours. Inhaled Particles IV, Part 2: 655 665, Edinburgh, 1975. Cosmetic Talc Powder The Lancet, No. 8026, June 25, 1977. Xennedy, Donald, Letter to S. M. Wolfe, B. Gordon. Public Citizen Health Research Group, January, 1979. GSA "Draft Commercial Item Description A-A-42 Talcum Powder" , January 16, 1979. ' REFERENCES 1. Wehner, A.P., Zwicker, G.M., Cannon, W.C., Watson, C.R. and'Carlton, W.W.: Inhalation of Talc Baby Powder by Hamsters. Food and Cosmetics Toxicology 15:121-129, 1977. II. Wehner, A.P., Wilkerson, C.L., Cannon, W.C., Busshbom, R.L., and Tanner, T.M.: Pulmonary Deposition, Translocation and Clearance of Inhaled Neutron-Activated Talc in Hamsters. Food and Cosmetics Toxicoloey 15:213-214. 1977* III. Wehner, A.P., Tanner, T.U., Buschbom, R.L.: Absorption of Inserted Talc by Hamsters. ' Food and Cosmetics Toxicoloey 15:453-455, 1977. - IV. Wilkerson, C.L., Wehner, A.P. -, and Rancitelli: Leaching of Radionuclides from Neutron-Activated Talc In Serum and in Dilute Hydrochloric Acid. ' Food and Cosmetics Toxicoloey 15:589-593, '1977. r . * vf*. - 'r' Si*-. . i- . T |11 *' " ** WCD 001028 -10- V. VI. VII Vili. IX. X. Teratologic Evaluation of EDA 71-43 (Talc), PB-221 804, Food and Drug Research Lab., Inc., January 1073. _ Mutagenic Evaluation of Compound IDA 71-43, Talc. PB-245 458, Litton Bionetics, Inc. 9 December 1974. ' * Lord, G.H.: Biological Effect of Talc in the Experimental Animal. Food and Cosmetics Toxicology 16:51-57, 1978. jPrhi*l*l*i-p*s, J__._C.,, _Y_ou_ng_,__P_._J_._, H_a_r_d_y_, I. and Gangolli, S.D.: Studies^on*the*Absorption and Disposition of SH-Labelled Talc in the Hat,' Mouse,' Guinea-Pig and'Babbit. Food U Cosmetics Toxicology 16:161-163 1978. Luchtrath, H. and Schmidt, K.G., Beitr, Silikosforsch, 61,1, 1059. MacNab, G. and Harington, J.S.: Matura London, 214,522, 1967. WCD 001029 DRAFT % TO: Hr. Anthony Romero Criteria ttmagsr . Division of Criteria Documentation t Standards Development KOE6H - BA-37 5600 Fishers lane tc*ville, Maryland 20852 nwar Mr. Ronero: Use toanetic. Toiletry and Fragrance Association, Inc. (CTfA) is a national trade association representing the ooanetic industry. CJSK ``"gkfffetfsei of nore than tao hundred Active nfflher corpmtf.es vWoh manufacture or distribute finished acanetic products in the United States. Bi addition, COEA includes rare than two hundred Associate nwtber ccepenies fmn related industrie^ such as manufacturers of coeaetic raw materials and packaging materials. Ws estimate that CIEA enters are responsible fcr note than 90% of the coonetic products imnufactured and distributed in the United States. lhe C3FA tele Suboonndttee read with concern the firstdotftc the Stanford rd. aioerndti*., rfch i cmcatd of inSuetty il*** mineralogists, wiah-to offertthe following consents Otfrii we hope will be helpful-ae=^-in the preparation of ubeequent drafts: - I. . tee Stanford Research Institute is apparently mawre that OTA has developed voluntary purity standards far oometic grade talM tRttaehmet 1. tee* ^andards distinguish^^ tele, tee infaraation provided ty the etandards should be of ispoctance to SoilEi distinguishing coaartic grade talcs firm the illustrisi grade talcs fior w b ^ h p are ceraiderinTdevelcpmmt of oaa*etiocal lygi* standards. WCD 001030 -2- Xa reviewing tte CBEA Cwmetic Tsle standards, you will *e the aalsiicc... ' of a specification Cor dheyaotU*. B omtesksi of wdi 9 jgy.lfiuatitwi i s dictates ,397 samples of coeretfcgraje tele* fim(mrfj/iiofficeaJas Mcntana, Veoncnt, Caxo3ix^,(anrr such-utItaly. ''Result* of thte m m A ittbin *tu3y were submitted to the TccA and Drug AArinistration in Septa*er, 1975 . (Attachment 2). Itese findings are especially of several reverted findings of chrysotila la talc *anpl**^ B * COTA tele / gubccrwittee ha* determined that the x-ray diffraction method used for C- '1 detection of chrysotile in these studies will giwfe a false poaitiw inSicationwhen chlorite i* present. Unfortunately, the reawrdhers ' . , C4f .lc'1 ^nrt to perform the confirmatory analyses, %*itiiwe heliwe wwld indicate that the imterial detected was chlnritejTa harmless neterial) lather than chryaotile. n. Be CJFh Ohio Subocrrrdttoee suggests that any occupational hygiene standards vfrichmay be developed for industrial grade talc* exclude coenetic y.A.' talcs. She basis for this suggestion is the extensive review fcy the t.S. Pood and Drug jsdninistratim of teles. COTA has made potations to the f ^ A Antiperspirant Drug Serf Panel in July, 1975, the SEA/OCC Miscellanea External Drug Serf Bnnel in August, 1977, arri the HR/OIC Antimicrobial II Drug Serf Panel in . - C Jtoiary, 1977 (Attach*** 3). *Bale ahcamtdttee* ocnculsicn is also supported by other reviewers (Attachments 4, 5, 6, 7 and B), who hare pop-oh*^ ttet aoonetlc grade tale* are Jt hasardcus to its users. IH. B e Stanford Research Institote Drift cotteins amercus wisiguities and Blaises of adnaralogical terms. Correct teminolcgy has been adequately terr**-* in made to WQGH ty COTA's nether cxrpmies, ' WCD 001031 -3- jtixuai i Johnecn, Inc. and R. T. Vanderbilt, toe. (attachments S and IP). ' Qhe CTFA Subacnmittee suggests the use of the ndneralogfoal definitions- established by the 0.6. Bureau of Hines (Attadmeits 11 and 12). IV. She research data l i W in the SRI report does not provide well-founded support for the envinxmental limit of 0.1 ng/n? fa r tales tfiich do not contain sMsstos anVor quartz. Several recent epidemiology studies by investigators such as H miffw fron the deficiency of incomplete |o5 C3suEe|(fcesSrtients overjthfe entire pew'period eff-the wxbeEK e^yterea^C ip w studies do not contain adequate analysis of the dust to discern its oaiposition and contaminants over the study period. B * C3E& Hale Sub- jJ M J catmittee does not feeWtl possible for a reliable dose/respense relaticnship to be established tn the to* of .these and other limited studies in the literature. She BOc Subcatmittee does, however, generally agree with line 3058 in the SRI report which states "Tbslcologioal information in tie available literature on txsrens and animals exposed to tale does not adequately characterize talc according to its particle size, mineral cenpositien and purity,* V . he Subcamittae, in addition, has prepared the following specific cairaents; iI1 ii in m irmllj noTF** ehawajinUMiiXLeaLlv lrCTu^aBs-rewlr^tary 1-OsoeetaeBjm find no precedent for the est^lishnsit of an occupational ve effect^ - B designation of talcs 'tot fomd to contain asbestos or free silica" {line 786)^without pfYri,fy^TVj sene level of content, presorts difficulties. B n concept foplied by this designation could lead to impractical nd imecessary eoonanic prdbleBs. filedetection arid ^n4-4*w+-ir>% of asbestos and silica at "sero.levels* is.arbitrary-and fflanriy beyond the state of the art. u x _ jCudtfLA&t A 8 s 4 e J T* d p W T , f rht*. s*h a +4 WCD 001032 - 4- c. Ibe adaption of a 0.1 Aj/r? reccnrfcKtad limit^wwld be "= for great * e m %ten m e w i d e the gravimetric methods currently raileble., of the gravimetric method weuld leed to reeulti in *dh tie rr"TM1 Isvels of background particulate in an industrial virament frequently eyprcecb or weed the proposed limit, 1* *** limit were to be adopted, it would becane necessary to develop tfdllful analytical far separating the talc omgcncnt ironbediground particulates, snd then quantitating it. Bii* require/tt* application of difficult and sophisticated techniques not oomcnly available. d. Hie ciFh Talc fiuboaanittoe doe not believe that the labeling end porting reDonraoidationB ere applicable to oewnetic grade talca. Voluntary specifications developed by the oewnetic industry, and the euJmlBsions to FDR iff the coenetin industry, w p l y dmewtrat* the afety of eoametic grade talcs. labeliw 5 posting requirwents, srdi a th^reoaanemtad in^Se^Cdraft, w x d threaten the image of a ppeduet o f e d a e d -ft by FDR under noml c o n f e r usage. ^^ JX&*HMiT -tt> & A & * * **Urt*Kr ? B CJFA ttlc Subcatndttee hopes that the above oemnenta will be helpful to you, aI would be pleased to provide further assistance. In particular, the CEPA would appreciate receiving copies of future drafts eo that we may jeovide oauuentfl and information. Sincerely, Hannan F Estxin, Ph.D. Vice Frwidwit - sedanes WCD 001033 v n* *' * A' ' jmRQMEKTS t 1. coaictic Talc, CIFK Specification - She Coeretic Toiletry and Fragrance ' ' Association jnc. (10/7/76 Revision). 2. v Eatrin, Hr. Neman, letter to Dr. Robert Schaffner (FUR) September 23, 1975. 3. C3FA Presentation to BDA/Chrer-lhe'Ccunter Antlperspixant Drug FkjLess panel, July 9, 1975. 4 HUdick-Snith. G.Y., Biology of Tialc. British Journal of a*itrial Medicine 33:217-229, 1976. 5 Hildick-anith, G.Y., THlc - Recent Epidemiological Stadias. In Proceeding * of the 4th International Syapositxiton Inhaled Particles and Vapours. Inhaled Particles IV, Part 2: 655-665, Tflinhirgh, 1975. 6. 'Bale powders The lancet, So. 8926, Jane 25, 1977. ?. Kennedy, Donald, letter to S. H. Wolfe, B. Gordon. Public Citizen Health ' Research Group, January, 1979. GSR "Draft o^TTTiPrr<ai Iten Description ft-A-42 Tblcun Boaier", January 16, 1979. Johnson fiJotaaon to Hr. Anthony Rcmero, Pecm ber 13, 1978. 10, R. T. Vanderbilt to Dr, J. M. Lane, ItoWBtoer 3, 1978. 31. Aroian, S.G., Asbestos Minerals and Their Nm^shestoBtaalogs. Review of Mineral Fibers, Electron Microscopy of Microfibers, Pennsylvania State University. August 23-25, 1976. 12. cancbell, W. J. et al. Selected Silicate Miwx^s and ifteix A^estifom U. s.Varieties: Mineralcoical Definitions aid I^Uficatim-^ct^iratim. Department of the Interior. Birsau of Mines, 3C 8751, 1977. WCD 001034 The Cosmetic, Toiletry and Fragrance Association, Inc. 1133 16th STREET. N.W., WASHINGTON, D.C. 20005 - 202/331-1770 * TELEX 33-2673 M INP TE S c t f a m e suBccwfrnEE A meeting of the C H A Talc Suboannittee as held on Tuesday, J^pril 3rd, 1979 at the (UFA Offices in Washington, D.C. A list of the meeting attendees is attached. Jam H.AHHsUrrMitt E. EdwIanrdbKraHvwafraMuUQMh NormaMnatFa. EisfMiltn-,tPahr.tD*, SwtmarpmhxxnHto-floMwc*NaOmouahrwa OtcUfenr-nR*i fCa.MRuhnoadt Caffirm^fMcjvifsaaiurteotiiWii,wC^SMyWmyOttietdhwr trtCrfiRtijtaioRKiitrtay Chairman Sardland opened the meeting and discussed the NIOSE^ Stanford Research Institute (SET) talc doconentaticn to date. The majority of the meeting as sport in review of the tench, 1979 SRI (second) draft, in an effort to develop a list of problems as related to the cosmetic industry. Sicng the points listed as potential problems were: a. A definition of "pure talc" (lines 33-35). b. The work-place "action level" (lines 52-58). c. The time-weighted average (twa) oorcemtration of 1.5 itig/cm of air (lines 82-86). d. The Dfedical Surveillance1' section (lines 100+). e. The "labeling and Posting" section (lines 185+). f. The "Informing Employees of Hazard f m n Talc" section (lines 315+). Chairman Sandland stated that is as the Subcommittee's intent to review and incorporate the days' cements in the Sutcaimittee's original draft. Upon canpleticn, the ebeunent will be sutmitted to the O T A far review and distribution, prior to submission to NIOSH. There being no further business, the meeting was adjourned. Itespectfully submitted, a. Charles R. Baynes Director of Cosnetic Chemistry CRH ae 4/10/79 J A J***?, T ^ . /> y /h r WCD 001591 COSMETIC, TOILETRY ND FRAGRANO ASSOCIATION, INC. COMMITTEE MEETING ATTENDANCE COMMITTEE NAME : CrFA Subcormittee DATE OF MEETING Tuesday, Jferil 3rd, 1979 PLACE: C3FA Offices, Washington, D.C. MEMBERS1 NAME/CQMPANY_________________________ Mr. George Sandland / Bristol-Myers Products Dr. Tryggve Baak / Mr, Louis Murino / Cyprus Industrial Minerals Carany Er. Murray Berdick / Chesebrough-Pend's,. bio. Mr. Bay Krsunnes / Whittaker, Clark & Ttan-i,lp Mr. George Lee / Johnson Baby Products Mr. Fred Roesch / Whittaker, Clark & Daniels Dr. Joseph siiriko / Colgate-Palnolive Ccmpany Dr. Jack Schelz / Johnson Johnson Research Dr. John Travers / Avon Products, ins. Mr. Ed Xausreyer / Kolmar Laboratories Dr. C. S. Ihnrpson / R. T. Vanderbilt, Kw. Charles Haynes / CTFA Fred Ellearbusch / Bristol-Myers Jshn Hilovsky / The Mermen Ccnpany Donald Kirby / American Cycnamid Robert Mcllwain / Englebard Qy Haas / Qiglehard Allan Harvey / R. T. Vanderbilt ATTENDANCE YES fl/j t] t3 t3 l4 3 * 4 t3 t3 :3 1*4 I3 l4 l4 \4 14 14 i4 r4 l WCD 001592 y* s#1 draft -------------------- -----------------------------------------------------------------------------------------A TO: Mr. Anthcny Romero Criteria fanager Division of Criteria Docurentaticn fiStandards DevelMBent N30SH - 8A-37 5600 Fishers lane Itodcville, Maryland 20352 Dear Mr. Ranero : Hie Coanetic, TOiletry and Fragrance Association, Hie. (CIFAJ is a trade association representing the coanetic industry. C3FA ia caiti-iaai of sore than two hundred Active masher companies which manufacture or distribute finished cosmetic products in the United States. 3ii addition, C3FA includes more than two hundred Associate merber companies from related industries, such as manufacturers of coernetic raw materials and packaging naterials. We estimate that CSCFA raters are responsible for mere than 90% of the cosmetic products manufactured and distributed in the Onited States. Hie C C A Ohio Subcorraittee read with concern the first draft of the Stamford Research Distitut^"lialc-- S.c;c''>i.-.e.^'.' -i- f M&dbeif*~B he T W c * mineralogists, wish to offerithe following camits which we hope il] he > helpful-te=3Btrin the pnaxaticn of subsequent drafts: - -*C. I. - Hie Stanford Research Institute is apparently unaware that C OE A has developed voluntary purity standards for cosmetic grade ta lcs {Attachant 1) Hiese standards distinguish J y tween, ooaretio grade t a l c s ^ ^ S r t r i a l grade ta in s. Hie anfhranHrm nrrurffled Kr * * * y*.*- ^ fip|!r|r|.(1-- to Scujin distingpishing cornneidc grade talcs from the industrial grade talcs for fe&iyou are considering development of occupational hygiene standards. ^ WCD 001593 -2- m reviewing the CTFA Gametic Okie Standards, jdu will note the aaissitn... of a ^ecification for ctaysotllfi. Theorfosipn of sue* a pacification' the absence of chrysotile,__ _ . __ was dictated by - ' in a study of 3,397-aaBples of cam H ric igjrraafdlee talcs- OMM front fsou rcesj.a s Montai, Venmnt, Alabama, ifcrth C a m lina, nd) in ~ - -J-fr ----- - , Italy. Results of this round ifebin Study were submitted to the Food and Drug Acbdnistxation in September, 1975 ,, (Attachrent 2). These"findings are especially interesting in the light Jvvtftu 3v&e o f several repairted findings of chrysotile in talc amplest The CTFA Thlc ' 7s / Subcommittee has determined that the x-ray diffraction method used for vl f. ' \C. of chrysotile in these studies will givfe a false positive indication wten chlorite is present. Unfortunately, the researchers . q,ca`'.iC1-- felled to perform the 'confirmatory analyses, which we believe would indicate that the material detected was chlorite]Ta harmless material) rather than chrysotile. II. The CTFA Tfrln Subocrmittee suggests that any occupational hygiene standards vhich may be developed far industrial grade talcs exclude cosmetic 4 grade talcs. The basis tor this suggestion is the extensive review by the U.S. Food and Drug Mhdnistration of the safety of cosmetic talcs. CXrer-the-Counter The CTFA has made presentations to the EUR/ A Antiperspirant Drug Review Panel in July, 1975, the EDR/CTC Miscellaneous External Drug Review Panel in August, 1977, and the FDft/OIC AntiMcrbbial II Drug Review Panel in _ January, 1977 (AttacOinent 3 ). The Talc Subccrarittee' oonculsion is also supported by other reviewers (Attachments 4 , 5, 6, 7 and 8), who have onnniirirl that cosmetic grade talcs are not hazardous to its users. III. The Stanford Research Institute Draft contains mmezous faiguitiea and 7r^ T"'*rtniSu of mineralogical- terns. Oorrecfc teminology. habaatv^dtquaffiy described in submissions node to NI06H by CTFA's member ccnpenies, WCD 001594 Jthnsan * Johrtaars, Ine. and H. T. Vanderbilt, me. {Attadmaiits .9 ani lpj. * Ohe CIFA Tale Subcamittee suggests th use of tl mineraingir*,] definitirns- -a ' estabUsfaea by th b.S. Bureau of Mirtea 11 anri T?y~--------- -- 'M IV. Ihe research data < U in the SRI report does not provide well-founted *$port for the environmental limit of 0.1 mg/fo3 for talcs which do not contain asbestos and/or quartz. Several recent epidemiology studies by investigators ---- ---' '"^s v such as Fine, Selevan and Wigmun. ftnffw firm the deficiency of inoaiplete . Jr du^[eqDSare||toasurti6ents over) th entire eatpoouro period ef-feh& warkerss m ^ L ertu A c Bieee studies do not contain adequate analysis of the dust to its coiposition and contaminants over the study period. Tte CHEA fai.- Sub- jJ __ ocmdttee does not feel-itJpossible far a reliable dose/resparuse relationship to be established cn the basis of these and other iwi+wi stuiies in the literature, m e l&lc Suboonmittee does, however, generally agree with line 3056 in the SRI report which states "Tbedcological infanraticn in the available literature on hmens and animals exposed to fcie A - w not adequately characterize talc according to its partinia size, mineral corposition and purity,' 1% _ V. Ohe Subcomttee, in addition, has prepared the following specific consents: & -{jfrweiit Afl-generaa? 'iigTeasca leapd-catOEy *- " ttbasaatts^j^e find no precedent for the estahlisbrent of an occupational standard to protect against its ~*,**~f**U&iHj b. The designation of talcs "not found to contain asbestos or free silica" (line 786) without specifying sane level of content, presents difficulties, "zero" The ft concept isplied by this designation could laid to Ispeactical _ regtdatiqn ardjjmy&ssajy economic pmblgns. The detection a3 quantification of asbestos and ailloa at 3aero.levels" is arbitrary.and clearly beyond the state of the art. WCD 001595 fX\[dLJ7] c, Ite adoption of a 0.1 reconmended limit^wculd be cause for great ' concern ben one considers the gravimetric methods currently available..' fifplication of the gravimetric method would lead to results in which the normal levels of background partim l a t m in an industrial environment frequently approach or exceed the proposed limit. If such a limit were to be adopted, it would become necessary to develop skillful analytical techniques far separating the talc carpcnent from tte background particulates, and then quantitating it. Ibis requirejsthe application of difficult and sophisticated techniques not ccnrcnly available. d. The C3FA Tblc Saboonciittee does not believe that the labeling and posting reccnraendations are applicable to cosmetic grade talcs. Voluntary specifications developed by the cosnetic industry, and the submissions to H A by the cosmetic industry, anply demonstrate the safety of cosmetic grade talcs. labeling and posting requireoents, y ts such as those' reccmmended in the $SKl draft, would threaten the image / y s' y of a product considered-tefe by H A under normal ocnwaner usage. ^ & * fytfUrzttA* . The CJFA Talc Suboannittee hopes that the above occtrrents will be helpful to you, and would be pleased to provide further assistance. In particular, the CIFA would appreciate receiving copies of future drafts so that we may provide additional oannents and information. Sincerely, Neman F. Eatrin, Ph.D, Vice President - Science WCD 001596 Anacaggns \ Ooanetic T a lc , CffiA Specification - The OoanetLc Toiletry and Praoranee Association me. (KV7/76 Revision). s^ v Estate, Dr. Norman, Letter to Dr. Robert Schaffner (Era) septeiber 23, 1975. CQFA Presentation to roVCXrer-Uie-Counter Antiperspirant Drug Review PflnGlf Olily Bf 1975* RU dick-anith. G.Y., Ohe Biology of Talc. British Journal of industrial Medicine 33:217-229, 1976. G *Y:' " Recent E&ldaniological Studies, m Proceedings of the 4th International SOTposium on Inhaled Particles and Vapours V Inhaled Particles IV, Part 2 : 655-665, Edinburgh, 1975. Cosmetic Bale Powder: Die lancet, No. 8026, June 25, 1977. Kennedy, Donald, letter to S, M. Wblfe, B. Garden. Public Citizen Health Research Group, January, 1979. GSA "Draft Oamaercial Iten Description A-A-42 Thlcun Powder", January 16, 1979. Johnson & Johnson to Mr. Anthony Romero, December 13, 1978. R. Vanderbilt to Dr. J. M. lane, November 3, 1978. Anpian, S.G., Asbestos Minerals and Their tton-Asbestos Analogs. Review of Mineral Fibers, Electron Microacqoy of Microfibers, Pennsylvania State University. August 23-25, 1976. Csnpbell, W. J. et al, Selected Silicate Minerals and TteiV Aabestifiaan varieties: Mineralcgical Definitions and IdentificationK2suseterization. U. S. Department of the Interior. Bureau of Mines, 3C 8751, 1977. ''.v.Yr..v*y-'J WCD 001597