Document yjgBqgxvX5mw72kLzdea7dxr

FILE NAME: CTFA (CTFA) DATE: 1975 Feb 13 DOC#: CTFA039 DOCUMENT DESCRIPTION: Memo - CTFA Talc Meeting with FDA - Cross Reference with J&J #11 a V3A3Y PRODUCTS COMPANY February 13, 1975 SUBJECT: CTFA Talc Subeommittaa Keating with Food and Drug Administration Washington, B . C . February 7, 1975. U is - '.tottrcc: "This meeting was held in Dr. K.H. Schaffner 's office on. February 7, 1975 at 1:00 PM. Representing FDA were: Dr. S. Schaffner, Mr. B. Eiermann, Hr. H- Davis, Dr. if, Horowitz and Dr. rates. The CTFA was represented toy: Dr. H. Sstrin, Hr. G. Sacdland, Dr. M. Berdick, Dr. R. Rolle ana <5. Dee. Dr. Estrin introduced Xto. S&ndland 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 b y the Franklin Institute, who are investigating an SEM. isethodThey're attempting to develop methodology far detecting low levels of asbestos contamination and have experienced difficulty in presenting a uniform sample to the SEM. I t 's expected that this study may take one to two years. Any further steps to be taken with regards to Pood 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 Protected Document-Subject to Protective Order r J&J-0089S04 J JNJAZ55_GOOOM775  of sensitivity, Dr. Yates 'replied in a tone of frustration that all attempts hai'a met with failure; they had investi gated heavy density liquid separation. Dr. Yates did not state that efforts would be continued in this direction, but we volunteered help in evaluating' methodology should they develop something. Sr. Rolls outlined ths proposed CTrS. methods end the expected limits of uetectio".. It was emphasised to the YHA that these were methods e va iretad at-.d r Gcor.v.snad for oos-arin talc would he grarLiral to apply for indu3triai any r.atu;Ei-cccscri:*t orysoti. ? in ?.\c for his msth-ons J.- ; .. ".:1s r..: 2c;.ri..^ t ...- s_V 'sue Pc *.tg i.-r, sKSSElaec kcmercss talcs from s r c b n `crlc. for cos.-r.eciss application and nave not Sc-t.tr; ch rvHOtiie. The writer reiterate5 similar S&3 s x p - x ian-ce with domestic and overseas talcs. Dr. Schaffnet agreed that no one has purported to have seen chrysotile in cosmetic talc except Professor Iswin. At this point, Dr. Schaffner asked us whet Professor lew in was doing (if anything) in talc analysis. Dr. Rolle outlined a conversation, he had had with Professor Levin the day before and Dr. Scharfner directed Dr. Horowitz to interview Professor Lewin 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 PDA 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 if the CTFA would submit supporting data attesting to the absence of chrysotile in talc the FDA would take the natter under consideration. Mr. Sand land indicated that the CFA will be proposing self-regulatory action by amending its present c t f a Talc. Standard to include the asbestiform tremolite proposal. Mr. G. s and land stated that a regulation of 154 asbestos in tale was not only achievable by throughly tested methods, but also gave a safety factor of- 48,300 (Sivertson calcula tion) . Mr. 'Eiermann bluntly said that the calculation was wrong since the standard of 2 fibars/cc. is not a time weighted average. Before we had a chance for rebuttal Dr. Schaffner 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 we did not correct Mr. Eiermann1s misunderstanding of the calculation. Protected Document-Subject to Protective Order J&J-00898S5 JN JA 255Ji00O 13776 -3 - *- Dr. Sehaffner emphasized that there is an ultimate and snore important need for talc clinical safety data in order to satisfy the consumerisfc advocates. The writer assured hi m that this would .he forthcoming from j s j . Copies of the DTh and X-Ray Diffraction Detection Procedures together with the Sivertson Report "An Estimate of a Safe bevel of Asbestos in Baby Powder Tale" were distributed to the EDA representatives and the meeting was closed with Dr. Estrin thanking the PDA for -the opportunity of exchange and discussion. The general impression 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 consumerist 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 CF& attendees, it was agreed that the CTFA 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 FDft. paj Protected Docum ent-Subject to Protective o rder J8J-0089806 JfiJA Z 6 S_ ,0 0 0 0 1 3 7 7 7