Document q3eV6DMOObmn74NwvRBzQZQL5

The Cosmetic, loiietry and Fragrance Association, Inc. 1 1 3 3 1 5 th S T R E E T , N .W ., W A S H IN G T O N , D .C . 2 0 0 0 5 - 2 0 2 / 3 3 1 - 1 7 7 0 T E L E X 8 9 - 2 6 7 3 Jam es H. M erritt P re titttrtf N o rm s n F ,.E strin , Ph.D. V/ee P ie 'sitfe n tS sle n c TALC TASK FORCE MINUTES /! Ll tY I i ffj 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 V7ere: Dr. Robert Schaffner Mr. Henry Davis 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. 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 0.5 and 1%. For amphiboles like tremolite, an x-raydiffraction method, fol lowed by dispersion staining optical microscopy has been developed; this procedure allows determination of whether the FEB 24 1975 G-W. SANDLAND Cosmetic, Toiletry and Fragrance^Association, inc. 1133 15th STREET, N.W., WASHINGTON. D.C. 20005 202/331-1770 TELEX 89-2673 James H. Merritt Pt*siel*nt Norman F. Eslrin, Ph.D. V iet P itiid e n t--S cltaet 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 Titohe 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. Scnaffner 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 FEB 24 1975 G.R SANDLAND e 2 * material is fibrous or not. Dr.. Rolle 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 everhave mentioned chrysotile in his report a n d t h e l a c k o f confirmation of his results by other scientists. Dr. Schaffner asked for a progress .report on Professor Dewin *s activitiesand stated ce u will speak to Dr= Lewin short , 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 dosiuetic sources. FDA was asked for its present timetable, and responded, it is e&e- 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 1976, 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 CF-BALL-7 3 Dr. Schaffner added the political inadvisability of citing'mineworker 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. NFEsmp 2/ 17/75 *