Document qoNMxj5pGDLgRbVVpGG6nr3R

DRAFT TO: Mr. Anthony Romero Criteria Manager Division of Criteria Docunentation Standards Development NIOSH - 8A-37 5600 Fishers lane Rockville, Maryland 20852 Dear Mr. Romero : The Cosmetic, Toiletry and Fragrance Association, Inc. (CIFA) is a national trade association representing the cosmetic industry. CIFA is ccBgrioed of more than two hundred Active member companies which manufacture or distribute finished cosmetic products in the United States. In addition, CIFA includes mere than two hundred Associate member companies from related industries^ such as manufacturers of coemetic raw materials and packaging materials. We estimate that CIFA menhers are responsible far mare than 90% of the cosmetic products manufactured and distributed in the united States. The CIFA Talc Subcarmittee read with concern the first draft of the Stanford Research InstitufoI>',T&lc -- O ' -c- ~ Mcmbero-of fee Talc Subcaimitbee, which is composed of industry scientists|~including mineralogists, w ish -to offersthe following oaiments which we hope will be >\ helpful-toryestin the preparation of subsequent drafts: I. - The Stanford Research Institute is apparently unaware that CIFA has developed voluntary purity standards for cosmetic grade talcs (Attachment 1).. These standards distinguish between cosmetic grade talcs{pn^findustrial grade f l r a . The infhm m aHnr^ yw^j Hr l c^, -r f mi 1 d he to youjjin distinc|rishing coanetic grade talcs from the industrial grade talcs for whjisht ycou axe considering development of occupational hygiene standards PLAINTIFFS EXHIBIT WCD-171 WCD 001593 -2 - Zh reviewing the CTFA Cosmetic Oble Standards, you will note the omission.! of a specification for chrysotile. The ornissin of such a Edification , ,the absence.of was dictated by - in a of 3,397 nranplen of wwiratigi?jjrac|e t a lc a . from[sudbjsourcs^as Montana, Vermont, Alabama, North Carolina, (turtjirf Italy. Results of this round robin Study were submitted to the FOod and Drug Administration in September, 1975 ^ (Attachment 2). These findings are especially interesting in the light ____ ' > of several reported findings of chrysotile in talc sanples^ The CTFA Tfclc / Subcommittee has determined that the x-ray diffraction method used for v\ C * * detection of chrysotile in these studies will give a false positive indication when chlorite is present. Unfortunately, the researchers failed to perform the confirmatory analyses, which we believe would indicate that the material detected was chlorite]7a harmless material) rather than chrysotile. II. The CTFA Talc Subocrmittee suggests that any occupational hygiene standards which may be developed for industrial grade talcs exclude cosmetic 4 grade talcs. The basis far this suggestion is the extensive review by the U.S. Food and Drug Ackninistration of the safety of cosmetic talcs. CXrer^the-Gounter The CTFA has made presentations to the FDA/ /\ Antiperspirant Drug Review Panel in July, 1975, the FDA/OTC Miscellaneous External Drug Review Panel in August, 1977, and the FEA/OTC Antimicrobial U Drug Review Panel in - < January, 1977 (Attachment 3). The T&lc Suboannitbee's conculsion is also supported by other reviewers (Attachments 4, 5, , 7 and 8), who have concluded that cosmetic grade talcs are not hazardous to its users. III. The Stanford Research Institute Draft contains numerous ambiguities and ~~ 'misuses of minaraboglcal terms. Correct terminology haa tearradequately described in submissions made to NIOSH by CTFA's member oenpanies, WCD 001594 -3 - Jahnsan & Johnson, Inc. and R. T. Vanderbilt, Inc. (Attachnants 9 and 10). ' The CTFA Talc Subccmiiittee suggests the use of the mineralogical definitions* A established by the U.S. Bureau of Mines (Attachments U and 12). IV. The research data & W in the SRI report does not provide well-fburxJed support for the environmental limit of 0.1 mg/hr for talcs which do not contain asbestos and/or quartz. Several recent epidemiology studies by investigators ------------ w qs ~~V such as Fine, Selevan and tfegman. suffer fran the deficiency of irccmplete (exposureffieasurefcents over] the entire caqaoouro period ef the workers &)t.jLeruxhS< These studies do not contain adequate analysis of the dust to discern its composition and contaminants over the study period. The CIFA Tain Sub- uX M. ccrrrdttee does not feel-- ifeJpossible far a reliable dose/response relationship to be established cn the basis of these and other limited studies in the literature. The Talc Subccmnittee does, however, generally agree with line 3058 in the SRI report which states "Toxicological information in the available literature on hixnans and animals exposed to talc does not adequately characterize talc according to its particle size, mineral composition and purity." V. The Subccmnittee, in addition, has prepared the following specific oarments: a. I-Cinma jfcwtsgencraMy- find no precedent far t h e ___ of an occupational standard to protect against its^curialative e f f e c t b. The designation of talcs "not found to contain asbestos or free silica" (line 786) without specifying seme level of content, presents difficulties, "zero" The concept implied by this designation could lead to impractical regulation and^umerewsaiy e c q n a ^ iTrbblgns. The detection and quantification of asbestos and silica at 3zero levels" is arbitrary.and WCD 001595 ijL t& tsfT r] c. tte a * * * * of 0.1 l i M t / u M h. = = e for great * concern ben one considers the gravimetric methods currently available.; Application of the gravimetric method would lead to results in which the normal levels of background particulates 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 caiponent from tte background particulates, and then quantitating it. Hiis require^ the application of difficult and sophisticated techniques not ecnramly available, d. The CTFA Talc Subcommittee does not believe that the labeling and posting recommendations are applicable to cosmetic grade talcs. Voluntary specifications developed by the oosnetic industry, and the submissions to FDA b y tbs cosmetic industry, anply demonstr ate the safety of cosmetic grade talcs. labeling and posting requirocents, . - ' if ' ' such a s those" recommended in the SRi draft, would threaten the image of a product considered -tafe by FDA under normal consumer usage. The CTFA T&lc Subocrrdttee hopes that the above catments 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 say provide additional catments and information. Sincerely, Norman F. Estrin, Ph.D. Vice President - Science WCD 001596 1. Cosmetic 'tele, CTFA Specification - The Oosnetic Toiletry and Fragrance Association Inc. (10/7/76 Revision). 1 2. v Estrin, Dr. Neman, Letter to Dr. Robert Schaffner (FDA) September 23, 1975. 3. C1FA Presentation to FEA/CVesr-the-Counter Antiperspirant Drug Review Panel, July 9, 1975. 4. HiIdick-Staith. G.Y., The Biology of Talc. British Journal of industrial Medicine 33:217-229, 1976. 5. Hildick-anith, G.Y., tele - Recent Epidsniological Studies. In Proceedings of the 4th International Symposium on Inhaled Particles and Vapours. Inhaled Particles IV, Part 2: 655-665, Edinbur^i, 1975. 6. Cosmetic tele Powder: The lancet, No. 8026, June 25, 1977. 7. Kennedy, Donald, Letter to S. M. Wolfe, B. Gordon. Public Citizen Health Research Group, January, 1979. 8. GSA "Draft Commercial Item Description A-A-42 telcun Powder", January 16, 1979. 9. Johnson & Johnson to Mr. Anthony Romero, December 13, 1978. 10. R. T. Vanderbilt to Dr. J. M. lane, November 3, 1978. 11. Ampian, S.G., Asbestos Minerals and Their iton-rAsbestos Analogs. Review of Mineral Fibers, Electron Microscopy of Microfibers, Pennsylvania State University. August 23-25, 1976. 12. Campbell, W. J. et al. Selected Silicate Minerals and Their Asbestifonm varieties: Mineralogies! Definitions and Identificatlon-Charaeterization. U. S. Department of the Interior. Bureau of Mines, IC 8751, 1977. WCD 001597