Document e5mYKeeD812mxLxZzMjQm8mYe

PLAINTIFFS EXHIBIT WCD-224 departm ent of h ealth , education , and w elfare PIJDLIC HEALTH S ER V IC E POOD AND DRUG ADM INISTRATION W A S H I N G T O N . D .C . 2020-1 September 5, 1973 Norman F. Estrin, Ph.B. Vice President, Science Cosmetic, Toiletry & Fragrance Assoc. 1625 Eye Street, N.W. Washington., D.C. 20006 Dear Norman: This will confirm the discussion Dr. Sch.affner, Mr. Wenninger and I had with you last Friday, August 31, 1973, concerning methods of determination of asbestos in cosmetic talc products. There is considerable controversy among investigators with regard to the accurate determination of asbestos at concentrations of less than 2 percent. Apparently, conventional methods employing x-ray diffraction or differential thermal analysis are not sufficiently reliable to produce quantitative results of the desired precision. The Food and Drug Administration,.therefore, has boon exploring ...... refractory optical microscopy as a means of measuring asbestos in taTc"I A' copy of this method was handed to you on Friday. You w ere u r g e d t o c o n t a c t the scientific e x p e r t s in the c o s m e t i c industry and have them analyze samples of cosmetic talcs by this method. The results of their findings and their comments on this analytical procedure should greatly assist FDA in the assessment of the asbestos problem. . The second request submitted to you concerned a statistical measure ment of the amount of airborne talc that might be inhaled by an infant per day under average conditions of use of a baby talc product. This information should be helpful in estimating the potential exposure of a child to asbestos. ' Hie data provided by industry will supplement the efforts initiated by FDA in this matter and hopefully resolve the asbestos question in a scientifically sound manner. Heinz j, Kiesmami, Acting Director S~0ri Cosmetics Technology Office of Technology B The Cosmetic, Toiletry and Fragrance Association, Inc. 1625 EY E STREET, N.W , WASHINGTON, D. C. 20006 202/393-2070 Mr. C.U. Driscoll President Whittaker, Clark & Daniels, Inc. 1000 Collidge Street South P l a i n f i e l d , New Jersey 07080 P re sid e n t Norman F, Estrin, Ph.D. Vine P re sid e n t-- S cie n c e J- > ) The FDA, Mr. Driscoll -- -- has informed us that they are about to publish limits for as bestos in foods and will utilize an optical microscopy method for the determination. Their problem is that the Bureau of Foods has been considering an x-ray diffraction method for cosmetic analysis of asbestos that has a sensitivity of one to two percent, as opposed to the claimed sensitivity microscopic method of 0.001 to 0.1 percent. FDA does not feel it can publish two different methods of dif fering sensitivities and has asked our cooperation in testing their optical method. FDA proposes that cosmetic manufacturers test and submit coded data.for various cosmetic grade talcs, so that they can cheek.. on the validity of the method and get a feel for the type of results which can be expected. I ' -vo attached a copy of the method for your rev.iew and a. copy of a letter from Heinz J. Eiermann (FDA) requesting assistance from the Cosmetic Industry. If you would like to participate by testing talcs, please drop a note to me or to Mr. George Sandland (Bristol-Myers) who is chairing a subcommittee which will test this and other methods. Thank you for your cooperation. Cordially, Norman F. Estrin, Ph.D. Vice President - Science NFE:jj September 13th, 1973 Attachments - 2 il !H i*>! MEMBERSHIP LIST - CTFA TALC SUBCOMMITTEE G. W. Sandland, Chairman Bristol-Myers Products (SAC) Dr. DeWitfe Petterson ' Johnson & Johnson Research Center Dr. Murray Berdick (SAC) Chesebrough-Ponds, Inc. Dr. Robert Rolle Johnson & Johnson Research Center D r . George Cohen Bristol-Myers Products Mr. Fred Roesch Whittaker, Clark and Daniels Dr, Christopher Costello (SAC) Colgate-Palmolive Company Dr. Charles Rowland Avon Products, Inc. (SAC) Mr, Salvatore DiBianca The Mennen Company Dr. Harold Schwarts The Mennen Company (SAC) Mr, John Facq . Colgate-Palmolive Company Dr. Joseph Simko Colgate-Palmolive Company Mr. David Hamer Johnson &.Johnson Research Center Mr. Harold D. Stanley, Jr. Pfizer ' Mr, Alan M. Harvey R. T. Vanderbilt, Inc. Mr.- Wallace Steinberg Johnson & Johnson (SAC) M r . Ray.R, K ranimes. .. .......... ...Dr"..John Travers...........-.... . Whittaker, Clark and Daniels Avon Products, Inc, Mr,' Adolph Maruszawski (SAC) Kolmar -Laboratories, Inc. Dr, C. S, Thompson Mr. Louis D. Murino United Sierra Mr. Ronald Yakupcin Kolmar Laboratories D r . Tryggve Baak United Sierra . December 11 1973 December 10, 1973 TO; MEMBERS OR THE CTFA TALC SUBCOMMITTEE 5, SCIENTIFIC ADVISORY COMMITTEE: Attached herewith and submitted for your reading and comments is a finalized submission of the report of the CTFA Talc Subcommittee which we wish to submit to the Food & Drug Admini s tration. Please read-at once and, likewise, call me at once if you disagree with any of the content matter, .. .In view o f .the very short.time left to process.this......... submission, your immediate attention is of paramount importance. Thank you. w Georg_y W. Sandlsmd Chairman Cl FA Talc Subcommittee REPORT OF CTFA TALC SUBCOMMITTEE ON METHOD TO DETECT CHRYSOTILE AND TREMOLITE IN TALC. ' December 10, 1973 The Scientific Advisory Committee of the Cosmetic, Toiletry & Fragrance Association, 1625 Eye Street, N.W., Washington, D.G. 20006 at a meeting held on September 2, 1973, designated that a subcommittee be set up to study the optical microscopic method proposed by the Food and Drug Administration. This method was published in the Federal Register of September 28, 1973. The present membership of the CTFA Talc Subcommittee is shown on an attached sheet. . . At the first meeting of the Subcommittee, it was agreed to submit several samples of talc to members who volunteered to apply the FDA proposed optical microscopic methodl The following talc samples were distributed without identification - except for randomly applied and non-duplicated code numbers: Italian Talc Grade 1615 Montana Talc Source P Montana Talc Source F Vermont Talc Grade #66 Alabama Talc No. Carolina Talc Grade 643 In addition, a sample of Italian Talc spiked w/w with 1% chrysotile and 0,15% tremolite was sent to each participant. The participants were aware that the sample was spiked, but did not knew the pc*i .,,.-ctaga of spiking. The attached table summarizes all reports submitted: -2- - Sample 'No. of Fibers With R.I. Greater Than 1590 - No. of Fibers With R.I. Less Than 1574 Status With Regard to Pro posed FDA Method Mrs. Lucy McCrone, McCrone Associates for Chesebrough Spiked Italian Montana-Pfizer Alab ama Vermont No.Carolina' Montana-Ferry 320 120 0 0 0 0 0 16 ' Passes 0 Passes 0 Passes 0 Passes 0 Passes 0 Passes 0 Passes Mr. Harold Stanley of Pfizer V O Italian /''Hi*100 Montana-Pfizer 1Q Montana-Ferry 100 Alabama r w 100 Vermont ^ 100 No. Carolina /V. 100 >100 >100 >300 >100 >100 Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite Fails Chrysotile Passes tremolite Mr. David Hamer of Johnson & Johnson Italian Montana-Pfizer Montana-Ferry Alabama Vermont No. Carolina 0 1 25 0 0 0 0 0 0 0 0 0 Passes Passes Passes Passes Passes Passes Spiked Italian Dr.- John A. Refiner (U. of Conn.) for Avon 632 12,930 220 1,114 Fails Chrysotile Passes Tremolite Fails Chrysotile Passes Tremolite -3- 'Sample , Montana-1 Montana-H Alabama Vermont No. Carolina No. of Fibers No. of Fibers With R. I.- Greater With E.I. Less Than 1590 Than 1574 Status With Regard to Pro posed FDA Method Dr. John A. Reffner (U. of Conn.) for Avon Cont'd 0 5,844 Fails chrysotile Passes tremolite 13 9,281 Fails chrysotile Passes tx'emolite 26 15,125 Fails chrysotile Passes tremolite 41 165 Falls chrysotile ' Passes tremolite 14 11,852 Fails chrysotile Passes tremolite Dr. Tryggve Baak of United Sierra Spiked Italian MontanaTMI Montana-^ Alabama Vermont No. Carolina ' 3,000 1,000 0 0 .0 0 500 ; 2,000 0 0 0 0 0 0 Fails Passes Passes Passes Passes Passes Passes Richard E. Stevens of Ernest F. Filllam, Inc. fo:r Whittaker-C&D Italian Montana-f Montana-II Alabama Vermont No, Carolina 8,250 18,000 29,250 21,825 3,225 20,850 1,350 450 5,200 6,075' 675 6,000 Fails chrysotile & tremolite Fails chrysotile & tremolite Fails chrysotile & tremolite Fails chrysotile & tremolite Fails chrysotile & tremolite Fails chrysotile & tremolite Spiked sample was not run. AAAKBPXLF CF-BALL-8 -4- Sample No. of Fibers No. of Fibers With R.l. Greater With R.l. Less Than'1590 Than 1574 - S.tatus With Regard to Pro posed FDA'Method M r s , Lucy McCrone of McCrone 'Associates for Kolmar Italian Montana-I Montana-H Alabama Vermont *No, Carolina Spiked Sample 53 0 0 0 0 0 488 0 Passes 0 Passes 0 . Passes 0 Passes 0 Passes 0 Passes 16 Passes *Sample noted to contain some fiber bundles which are rolled up talc plus some non-fibrous tremolite .. The following participants examined their samples but were unable conscientiously to count particles with confidence, therefore, did not report numbers : Miss Marie Jones for Dr. G. Cohen - Bristol-Myers Products Research Lab Mr, Salvatore DiBianca - The Mennen Company .....Liberty Mutual: Insurance.Co.,.Research Center---for.Kolmar.Laboratories Mr. John Facq - The Colgate Palmolive Company, Research Center The table reveals strong inconsistency between results obtained by the different scientists applying the method to the same group of coded talc samples. This inconsistency is the result cf problems encountered in the methodology. 1. The alpha refractive index of talc - one of the two indices exhibited by talc, plates standing on edge - varies in. value between .1.539 and 1.5501. This in combination with item 2, below, m ly easily result in the mis-classification of such plates a 3 "fibrous, less than 1.574" and therefore chrysotile. Dr. Reffner of the University of Connecticut, in his report to Avon, admits that this factor is paramount -- "counts for chrysotile are high since (talc) edges will often be mistaken for fibrous particles". 2. The immersion method for the determination o f `relative refractive index becomes unreliable when applied to extremely small (ca. 1 pm.)particles. This is due in part to the fact that particles around lyP in width approach the limit of resolution of. the human eye when both size and contrast are considered, especially when applying the Becke line technique prescribed. This will t -5- 2. cause eye fatigue-and resulting errors. Thus, a fine talc shard or plate on edge may be easily mistaken for an asbestos fiber. This applies to both the chrysotile and atnphibole - portions of the test. 3. It is quite likely that chlorite - a mineral of varied compo sition commonly found in pharmaceutical grade talc - would , be incorrectly identified as tremolite. Refractive indices for chlorite vary in the range 1.57-1.66^. 4. The examination of a sample of one milligram dispersed on a single microscope slide presents the investigator with a preparation which is too dense for a petrographic study. 5. The method is laborious and time consuming. Dr. Reffner quotes .an analysis time of about five hours per sample and at JOHNSON & JOHNSON the investigator (D. H. Hamer) estimated at least two or three hours. ' 6. Dr. Walter C. McCrone in an earlier letter to the FDA suggested that there were relatively few scientists in the country who could use the method effectively. Scientists at Bristol-Myers, The Mennen Company,Liberty Mutual and Colgate-Palmolive bad great difficulty in following the method to conclusion. 7. ..The proposed 1-DA method implies that all fibrous particles in talc having optical properties similar to those of asbestos... minerals are in fact asbestos. This is probably an unwarraiited assumption. REFERENCES: 1. Deer, W.A., Howie, R.A., and Zussman, J . , Rock-Forming Minerals, Vol. 3, p. 121 (1962). 2. Ibid, p. 131. . ***&*****&&*&** We have concluded that the method published in the Federal Register does not provide a truly reliable means for the detection of asbestos in talc. It results in both false-positive and false-negative findings. It is also tedious and may consume as much as one half day per sample. The subcommittee urges that the Food and Drug Administration defer finalizing the proposed optical microscopic method and proceed into a Phase II program which would combine FDA and Industry in a strong effort to develop a truly reliable method for measuring chrysotile content in talc. We are confident that the detection and estimation of fibrous tremolite can also be done, if necessary, as a fringe benefit, at the same time. -6- We estimate that a satisfactory method will take at least six months to a year, to develop. We suggest a close liaison between FDA and industry in this all-out effort with updating reviews to take place as frequently as necessary. Review of Alternate Methods The CTFA Talc Subcommittee has reviewed several methods to detect chrysotile and tremolite in talc, including modifications of the optical microscopic method. These are listed with comments.' 1* . Optical Microscopic Method - may be used.with some modification. ' Possibly better selection of R.l. liquids and reduction of sample size per slide. 2. X -ray Step Scanning - A good method for detecting tremolite if we could accept about 0,2% as the threshold of detection. It does not distinguish fibrous from non-fibrous tremolite. The simultaneous detection of chlorite makes method impractical for chrysotile. 3. .... X-Ray Step Scanning -f Optical Microscopy - Acceptable as in //2 above but the optical method continues to present the dilemma in reliable identification of chrysotile. However, this does not rule out a major revision of the optical method to do the chrysotile identificatio ri and countin g ...... ....... .. ' 4. X-Ray Scanning - The problem of chlorite interference in the detection of chrysotile is present in all x-ray procedures thus far available. It is .ciiaRi.- the detection of 1% tremolite (both fibrous arid non-tiurous), 5. Differential Thermal Analysis - This procedure is capable of detecting chrysotile at the 1% level, however, it will not detect tremolite. 6. Scanning Election Microscopy - This procedure is not capable of identi fying asbestos. Even with energy dispersive analysis, completely satisfactory identification is not possible. 7. Transmission Electron Microscopy + Blectrcn Diffraction - This appears to offer the best, most reliable method and is probably capable of detecting chrysotile and tremolite (fibrous), both at a level of 0.1%, It is estimated that an installation would cost about $130M +, and is obviously prohibitive for the small manufacturer who uses talc. The amount of talc sample examined by this procedureis miniscule. -7- Sum m arV . .. The CTFA Talc Subcommittee has completed Its review of the Optical Microscopic Method for the Estimation of Chrysotile and Fibrous Tremolile in Talc, which appeared in the Federal Register, voi. 38 (No. 188),(p. 27076, September 28, 1973). It recommends postponement of the finalization of the proposed regulation on talc. In addition, a collaborative effort between FDA & industry to resolve a satisfactory method of estimating chrysotile and tremolite in talc, is recommended, with periodic liaison reviews to monitor the project status. A task force of industry experts has been designated to pursue alternate methods. We invite FDA to participate in collaboration with the task force. George 1). Sandland 'Chairman CTFA Talc Subcommittee GWSidd Jack Travers reported that HJOSH has proposed a revised (lower) TLV of 50 meg/cubic meter for crystalline silica. Bob Rolle described the latest results of Round Robin #3 using the CTFA Proposed Optical Microscope Procedure For Detection of Chrysotile in Talc. This is the method intended to be used as a back-up to the.DTA method, since DTA can give a false positive for chrysotile when non fibrous antigorite is present. Unfortunately, there was disagreement among 3 very capable investigators, McCrone Associates, Harold Stanley of Pfizer and Dave Hamer of Johnson & Johnson, It was agreed, however, that chrysotile is never found in cosmetic talcs, based on numerous analyses by several investigators. The only discoverer of chrysotile in cosmetic talcs has been Professor Lewin, and his results have been refuted in a repeat testing of the same samples by John Stuart at FDA, The committee concurred, therefore, that our only courses of action are either to rely only on DTA by itself (without a back-up procedure), or else, based on the wealth of data available, .. eliminate the need....for.a chrysotile.specification.in cosmetic.talc... Either way, we are confident at this point, that chrysotile won't be found and simply is not present in cosmetic talc. We are stiIT awaiting additional DTA results on tale samples (some spiked) which were sent to Colgate-Palmolive, Mennen, Pfizer, and Whittaker Clark & Daniels. In addition, Jack Travers has submitted a set of samples to John Reffner (V. of Comm) for DTA analysis. Jack Schelz described an inexpensive DTA unit sold by Columbia Scientific Industries costing $3350 without a recorder and about $4600 with a recorder. This instrument was evaluated by Dr. Schelz and was found to be capable of detecting serpentine minerals above the 0.5% w/w level in talc, when used according to the proposed CTFA test method. . It was agreed that we include in the procedure for chrysotile, the latest definition of a fiber as published by OSHA in Field Information Memorandum #74-92, which was sent to OSHA Assistant Regional Directors and Area Directors. This memorandum states thati "In order to be considered asbestiform or fibrous the following criteria will he used by the Salt Lake City Laboratory of OSHA, AAAKBPXLD CF-BALL-6 -2- A. Particles must appear to be fibrous, rather than as crystals or silvers. 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 "bundle of sticks" effect, unless they are at a non-divisible stage. A fibril cannot be subdivided and would be counted, if it meets the other criteria. The electron microscope may be used to prove the fibrous nature of the particles. The length to width ratios of 5 or more to 1 is not meant to imply that other particles are not hazardous." ... ...... The directive states at the.end.that the above guidance is... temporary and may change as a result of findings from an on-going NIOSH study on this subject. A CTFA Talc Task Farce <rare:...,:;ad of Be, Burdick, Dr, Estrln (CTFA), Mr. Lee, Dr. Rolle and 'Mr. Sandland will meet with Dr. Robert Schaffner, Mri Eiermann and their designated personnel at EDA on Friday, February 7, 1975. It is planned to propose the 0.5 to 1.0% limit for each fibrous tremolite and chrysotile in cosmetic talc. Our CTFA Task Force developed methodology will be submitted in latest form as part of the proposal. A preliminary meeting at CTFA Headquarters will be held in the morning and the meeting with FDA is scheduled at 1:00 P.M. A report of this meeting will be submitted to the members of the CTFA Talc Subcommittee, Allan Harvey reported that he will attend a meeting on Tuesday, February 11, 1975 which has been called by Dr, Raymond E. Shapiro of FDA who is heading up a Subcommittee on Asbestos Protocols. This subcommittee was assigned the job of reviewing all existing data with respect to the biological effects of orally administered asbestos, with particular reference to carcinogenesis, and if necessary of - 3- developing appropriate protocols for studies to elaborate on any data deficiencies in this area. At the meeting of February 11th, the subcommittee members will discuss a working draft which has been furnished to them to provide a basis for comment and discussion. A paper entitled "Is Shorfc-Fibered Asbestos Dust a Biological Hazard?" by Paul Gross, M . D . , Charleston, S. C. was discussed. Here Gross states there is evidence that asbestos particles which are submieroscopie in size (<5 microns)elicit only a macrophage reaction in the lungs of monkeys. Similar results resulted in several other animals including rats and hamsters when submicroscopic asbestos was injected intratracheally and intra-abdominally. There being no further business, the meeting was adjourned. Chairman, CTFA Talc Subcommittee .....O :>/ r , I; tJ / G \ ~ A /v^X^\^j ' TALC 'zfz&fec CTFA Specification TALC (Formerly TGA Spec No. 10) f t - ______ tjj/y^~~~ Revved; 3-23-cr; OCO-7) D EFIN ITIO N : Talc is a white, odorless or very slightly earthy, finely powdered, native, hydrous, mag nesium silicate, sometimes containing a small portion of aluminum silicate. TEST SPECIFICATION METHOD C o l o r ............................... O d o rless.................................... Identification S l i p ............................................. L u s tr e ...................... Carbonates ................................ Water-Solu ble rcr Screen Test . . , Alkalis and A cid s, .Water Soluble Substances Acid-Soluble Substances Loss on Ignition . . . Arsenic (as As } . . . . Lead (as Pb). . , , , As specified by the buyer and showing no change after heating As specified by the buyer Positive: Close match to CTFA Spectrum--IR with no indication of foreign materials As specified by the buyer Do. No effervescence Passes test 100% through 100 mesh 98% minimum through 200 mesh Finer grades: as specified by the buyer Neutral to litmus paper 0,1% maximum 2.0% maximum 5,0% maximum 3 ppm maximum 20 ppm maximum Heat 1 to 2 g at 200 C For 5 minutes CTFA G 3-1 USP X V III, pags 703 Observe reaction for cffsrvDiF canoe during digestion in Tost for Acid-Soluble Substances CTFA C 6-1 USP X V III, page 708 See Test for Reaction and Sol uble Substances. Do. USP X V III, page 708 Do. CTFA F 1-1, Parts -A and il CTFA F 2-1, Parts l-A and II t t f / ? -- --- COSMETIC, TOILETRY AND FRAGRANCE ASSOCIATION, INC. 1625 Eye Street. WAV., Washington, D.C. 20006 The Cosmetic, loiietry and Fragrance Association, Inc. 1133 15th STREET, N.W., WASHINGTON. D.C. 20005 * 202/33M770 * TELEX 89-2673 .' , j ames H. Merritt President Norman F, Estrin, Ph.D. Vice Pie'sident--Science TALC TASK FORCE MINUTES A meeting of the Talc Task Force was held on February 7th, 1975. After a pre-meeting at the CTFA Offices, the Task Force reconvened at the office of Dr. Robert Schaffner at the Food and Drug Administration, 200 C Street, SW, Washington, DC. Those in attendance were: Mr. George Sandland, Bristol-Myers (Chairman) Dr. Murray Berdick, Chesebrough-Pond's Mr. George Lee, Johnson & Johnson Dr. Robert Rolle, Johnson & Johnson . . Dr. Norman Estrin, CTFA . ` .Those in.attendance.from.the .Food.and ..Drug Administration.., wer . Dr. Robert Schaffner Mr. Henry Davis H r . Hp k v - TDr. William uutwxtz Mr. Ronald Yates . .` '' _ Mr. Sandland opened the meeting stating that the objective of the Task Force meeting was to give a status report on its activities and at the same time ascertain the status of work at FDA in this area,' Dr. Scnaffner responded FDA was still interested in development of satisfactory methodology and D.r. Horwitz noted briefly his work in this area. Mr. Sandland called'upon Dr. Rolle' to give a report on CTFA progress. Dr. Rolle reported on the development of a Differential Thermal Analysis procedure for serpentine followed by an optical microscopy procedure, with detection limits between 6.5 and 1%. For amphiboles like tremolite, an x-ray.diffraction method, fol lowed by dispersion staining optical microscopy has been . developed; this procedure allows determination of whether the >. ' * k* t ' .. ` EEB 2 4 1975 .' 6 -W. SANDLAND .4 A The Cosmetic, Toiletry and Fragrance Association, Inc 1133 15th STREET, N.W., WASHINGTON. D.C. 20005 202/331-1770 TELEX 89-2673 James H. Merritt Norman F. Eslrin, Ph.D. Vier Prreidenl--Selene TALC TASK FORCE MINUTES A meeting of the Talc Task Force was held on February 7th, 1975.' After a pre-meeting at the CTFA Offices, the Task Force reconvened at the office of Dr. Robert Schaffner at the Food and Drug Administration, 200 C Street-, SW, Washington, DC. Those in attendance were: ' Mr. George Sandland, Bristol-Myers (Chairman) Dr. Murray Berdick, Chesebrough-Pond's Mr. George Lee, Johnson & Johnson < Dr. Robert Rolle, Johnson & Johnson . . Dr. Norman Estrin, CTFA . "Thoe in attendance.from.the Food, and- .Drug -Administration.were; .. . Dr. Robert Schaffner Mr Henry Davis Mr. Heinz Eiremann Dr. William Horwitz Mr. Ronald Yates . ` Mr. Sandland opened the meeting stating that the objective of the Task Force meeting was to give a status report on its activities and at the same time ascertain the status of work at FDA in this area. ' Dr. Sc'naffner responded FDA was still interested in development of satisfactory methodology and Dr. Horwitz noted briefly his work in this area. Mr. Sandland called'upon Dr. Rolle' to give a report on CTFA progress. Dr. Rolle reported on the development of a Differential Thermal Analysis procedure for serpentine followed by an optical microscopy procedure, with detection limits between 0.5 and 1%. For amphiboles like tremolite, an x-ray diffraction method, fol lowed by dispersion staining optical microscopy has been . developed; this procedure allows determination of whether the F CS 2 4 1975 G-R SANDLAND material is fibrous or not. Dr. Rolls noted successful com-- pletion of round robin tests with detection levels between 0.5 and 1%. Dr. Rolle observed that he has been unable to obtain a single naturally occurring sample containing chrysotile Dr. Berdick questioned the need for a regulation on chrysotile since no sample has yet to be confirmed as containing this material. Mr. Eiremann responded that he sees no problem with a regulation covering both amphiboles and chrysotile, since "if chrysotile is not there, you should have no problems." Dr. Estrin and Dr. Berdick objected, stating that Mr. Eiremann was proposing regulations for the sake of regulation, and has not considered the wasteful tax on resources that would arise from inclusion of a standard for chrysotile. Dr. Berdick and Dr. Estrin concluded that if a regulation is not necessary, it should not be proposed. , Dr. Schaffner responded with a suggestion that CTFA send in a letter with documentation, showing the extent of tests andresults which would support a recommendation about the inappropriateness of a regulation for chrysotile. It was noted that Professor Lewin was the only scientist to .ever.have mentioned chrysotile in his report and the lack of confirmation of his results by other scientists. ............. . Dr. Schaffner asked for a progress .report on Professor Lewin*s cities, and stated et eu will , . i, ', concerning his progress. Mr. Sandland noted that CTFA specifications for Talc published as part of- the CTFA Standards, are up for revision. He reported that the new specifications will add a tremolite specification and the methodology for continuous scanning x-ray diffraction, b u t `added that CTFA would not expect to include a specification for chrysotile. He added that chrysotile has never been found in Cosmetic talcs from either European or dosmetic sources. FDA was asked for its present timetable, and responded, it is awaiting results from the Franklin Institute and have arrived at no definite time schedule for either a food or a cosmetic regulation. Mr..Sandland proposed limits of 1% for tremolite, stating that based on the OSHA limit of 2 fibers per cc in an 8-hour day.pro posed for 197 6, one would arrive at a safety factor of 48,-000 if such a limit were adopted. ~ , Mr. Eiermann questioned this calculation on the basis of his understanding of the OSHA limits for short and lonq-term exposures. AAAKBPXLE 3 Dr. Schaffner added the political inadvisability of citing' mine- worker standards for cosmetic talcs, and advised that xt would be more meaningful to have animal studies with talc than statistical estimates. ' Mr. Lee responded by noting animal work in progress. Mr. Eiremann then proposed "non-detectable" terminology rather than numerical limits. Mr. Yates noted briefly that there was ho progress yet on enrichment for chrysotile and that he was pessimistic about the possibilities in this area. . Mr. Lee offered participation of the CTFA Talc Subcommittee in evaluating any methods developed by FDA. There being no further business, the meeting adjourned. Norman F. Estrin, Ph.D. Vice President - Science NFEsmp 2/ 17/75 *