Document 4amyLy4VJZJoDR0rLzLN355mj

FILE NAME: CTFA (CTFA) DATE: 1975 Feb 13 DOC#: CTFA039 DOCUMENT DESCRIPTION: Memo-CTFA Meeting with FDA-Cross Reference with J&J#11 V3A3Y PRODUCTS COMRAMV February 13*. X975 SUBJECT: CTFA Talc Subcommittee Meeting with Food and Drag Administration Washington* D.C February 7, 1975, IIVii UiS l ?.b.Uti&S _ si v> .r" )' discuss io~3 . mmi** 5 -- * <4?* --suites*ar: or This meeting was held in Dr- R.H* Schaffner's office on February l>1375 at 1:00 PM. Representing FDA wares Dr. R. Schaffner, Mr. H. Biermann, Mr- B- Davis, Dr* W* Horowitz and Dr* Tates. The CTF& was represented by: Dr. H. Sstrin, Mr* G- Sandland, Dr* M. Berdick, Dr. R- Roll and G. Lee- Dr. Estrin introduced Mr* 5andland as chairman of the CTFA Talc Subcommittee and indicated that the purpose of our meeting was to present the analytical methodology which had been developed by the CTFA Task Force as applicable to cosmetic talcs FDA indicated that there had been no eminent plans to publish new proposed methodology in this regard and did not give us the impression that this matter was being assigned any urgency. They reported no further work with the optical microscopy method. Dr. Horowitz was asked by Dr. Schaffner to elaborate on the only apparent area of analytical activity which is being directed towards Food Regulatory* This is being carried out under contract by the Franklin Institute, who are investigating an SEM method. They're attempting to develop methodology far detecting low levels of asbestos contamination and have experienced difficulty in presenting a uniform sample to the SEM. it* s expected that this study may take one to two years. Arty further steps to be taken with regards to Food Regulation will therefore have to wait on developments from the. Franklin Institute. When questioned as to FDA efforts and progress in the approach of ''concentrating asbestos" to increase the level ~2 * ox sensitivity, Dr* Yates `replied in a tone of frustration that all attempts hat?s raet with failure; they had investi gated heavy density liquid separation- Dr- Yates did not state that efforts vioiid be continuad in this direction, but we volunteered help in evaluating methodology should they develop something. Sr. Holla outlined the proposed CT?& methods and the expected limits of detection. It t-ras s^phasiced to the VDA that these era methods avislooted and rooost.andsd for cos*"cic tal-c: r*r.:; wo*4-.f ha ar ar U r a l to apply for induatrl?! --f -- -O--. - ?.i- `2r. any r.atc ;ex -cccv rr ir c c.irysotA. a ;n r.n`.c for his I* ::t.** '"* . v*7***. t *. `.ts t.*n axg&lnef ACfc3 ?G&3 ta lc s from asrr-v ch * o x Id foy cosmetics ap p lica tio n and asvs not fct.iri c i i r i w t i l e - The writer rsi'cerared siicilar J&J experience with 02*25t i c and overseas ta lc s * Dr* Scbstffner agreed th a t no one has purported to have seen chrysotS-ie in cosm etic t a lc except Professor Dewin* At th is p o in t, Dr. Schaffner asked us what Professor Levin was doing (if anything) in talc analysis. Dr. Kolle outlined a conversation he had had with Professor Lewin the day before and Dr. Schaxfxier directed Dr. Koror/it to interview Professor Lewis* for his most current views regarding chrysotile in talc* Dr. Berdick made the point that if chrysotile is not expected to be found in talc, then the FDA should not propose regulations to cover chrysotile. After an exchange of philosophy, where Mr. Eiermann took a strong stand for chrysotile in talc regulation. Dr. Schaffner suggested that xf the CTFA would submit supporting data attesting to the absence of chrysotile in talc the FDA would take the matter under consideration* Mr. Sand land indicated that the CTFA will bs proposing self-regulatory action by amending its present CTFA Talc Standard to include the asbestiform tremolite proposal* Mr* G. Sandland stated that a regulation of 1% asbestos in talc was not only achievable by throughly tested methods, but also gave a safety factor of- 48,300 {Sivertson calcula tion) * Mr* Eiermaxm bluntly said that the calculation was wrong since the standard of 2 fibers/cc* is not a time weighted average* Before v/e had a chance for rebuttal Dr* Schafner said that the Sivertson calculation was foolish since no mother was going to powder her baby with 1% of a known carcinogen irregardless^ of the large safety factor* Because of Dr. Schaffner1s strong stand v/e did not correct Mr* Eiermarm*s misunderstanding of the calculation * Protec&ed D ocum ent-Subject to P ro tective O rder JNJAZ55 S0001377$ - 3** Dr* Schaffner emghasxzed that; there is an ultimate and sbre important need for talc clinical safety data in order to satisfy the consumerist advocates. The writer assured hist that this onXfi.be forthcoming from .x s j . Copies of the DT.S and X-Hay Diffraction Detection Procedures together with the Sivertson Report "An Estimate of a Safe bevel of Asbestos in Baby Powder Tale" were distributed to the FDA representatives and the meeting was closed with Dr. Esirin thanking the FDA for the opportunity of exchange and discussion. The general ingress ion received by the writer was that the FDA was not anxious to publish further proposals relative to *'asbestos-in-talc" pending outcome of the Franklin Institute Study, as long as the consumer1st advocates remain quiescent, it is also evident that the FDA would depend on clinical data to defend the safety of talc. In a post-meeting caucus of the CTFh attendees, it was agreed that the CTF& would proceed to compile information from, consultants and manufacturers which attest to the fact that chrysotile has never been found in cosmetic talcs and submit this to the FDA* paj Protected Document-Subjectto Protective o rd er % J&J-90S98Q6 JNJAZ65JSJQD13777