Document vVaZOYqGzQ2YXMEM1pvZrad5E

CH'OLE S L E IN A D '' > .\\.L, tteutye.s ESTABLISHED 1890 C*. A. H ' uK \ fi\. vST&PH S ^ <201 5 6 1 -6 1 0 0 1000 C OOLIDGE STREET SOUTH P L A IN F IELD. N .J. 0 7 0 8 0 A prii 18, 1973 M r. J. Callaghan Pfizer, Inc. 230 Brighton Road Clifton, New Jersey 07012 Dear Jack: RECEIVED - CLIFTOH APR 23 1973 M PM DIV. We are enclosing two copies of the notes taken by our M r. Rex Smith during the recent meeting of the Talc Group. This information is for your disposal and should be trated as confi dential . We will continue to keep you apprised of the substance of these meet ings in the future. CJD/aam Enclosure CONFIDENTIAL uri M r o m f - acturers exporters MINERALS, COLORS. PIGM ENTS PFI KA 00000011 L 4* Meeting of Talc Croup March 21, 1973 Attending: C. S, Thompson, Allan Harvey, Robert Bacon ( R. T . Vanderbilt Company); D r. W. H. Ashton (Johnson 6 Johnson); D r. William Smith (Pathologist, Fairlclgh Dickinson University); Fred Kuehl, Peter McCarthy (International Talc Company), W. Reltze (Johns Manvllle); Fred F. Roesch, Rex S. Smith (WHITTAKER, CLARK 6 DANIELS, IN C .); Duncan Ogden (Vermont T a lc ); A rt Nellson (self); Alan Dankworth (Engelhard M inerals). 1. D r. Smith opened the meeting with a discussion and slides of his experiments, using hcmpsters as a human model to test the effect of various mineral dusts, including tremolltlc talc, supplied by WC&D, on these animals. They were treated through the life cycle with various dosages and analyzed for emphysema (large air sacs on lungs), fibrosis (scars-solld fibrous tissues) and tumors. Hampsters wore chosen because of their short life cycle and they showed a proper balance of sensltlvlty/lnsensltlvlty to lung irritants so as to provide good screening. Fifty animals were used in each ex periment. The attached tables show details of numbers of tumors (Mesotheliomas) from various causes. It was found that a combination of irritants (total environment) !s more active, causing cancer at lower levels than required by either alone. Thus, small doses of cigarette smoko and soft chrysctile together might be carc'mogenous due to the Irritating effect of chrysotile causing a delayed clearance of smoke from the lungs. Short fibers caused less tumor growth than long, even though fibers were lying directly on the surface of the lung. Croclciollte, used In Table 2, was the most active. Table 3 Indicates that thicker spun glass fibers are less active than thin Silica fibers even though, theoretically, they have the same chemical composition. CONFIDENTIAL PFI KA 00000012 Based on his screening tests. D r. Smith said he could make a statement that tremollte or chrysotile has very little, If any, carclnogenous effect on animals. D r. Sellkoff's publications were discussed; consensus was that they lacked background and were extremely dangerous. 2. D r. W. H. Ashton (J 6 J) began discussion of Methodology for determining "asbestos" or "fibers" by reviewing J J experience with different Instruments. Least sensitive is optical microscope; next in order of increasing sensitivity ( and cost and difficulty to run) are X -ra y scan, X -ra y step scan, Electron scan, Electron differential scan, and DTA (Differential Thermal A nalyser). The latter is sensitive to 1% chrysotile. In the FDA, the cosmetic group wants to study methods and limits In depth so as to be on firm ground when a statement Is issued They have hired D r. Levine as consultant. The food group seems to be rushing towards a statement with little background and has little communication with cosmetic group. Optical microscopy can be very misleading because many "fibers" are actually rolled plates or plates viewed edgewise. This makes non-fibrous materials appear "fibrous". D r. Levine, in a survey on cosmetic talcs, found a large number containing "asbestos" by using an optical microscope. J & J took exception, and D r. Levine Is redoing the survey using X -ra y Diffraction. J & J recomends X -ra y Diffraction Scanning first; If negative, the product Is O. K. If there are peaks which Indicate asbestos form materials, go to step scanning; if this shows peaks then it is necessary to go to electron instruments for a quantitative analysis. D r. Selikoff prefers the electron microscope. FDA cosmetic group favors DTA, (Differential Thermal Analysis); food group may require optical microscope arb itra rily because thalr A pril 15 deadline (extended to May 1) doesn't give them much time for study. Contacts are Alan Spire, Director, (preferred) or D r. Corbin Miles, his assistant, (GRAS Review). A lot of talc goes Into food packaging so there Is a large stake there; not too much goes directly into food. A new paper by D r. Hoenzell In the October 1972 Journal of National Cancer Institute contradicts D r. Merllss' paper, saying that gastric cancer in Japan and Hawaii was not caused by talc In rice. D r. Klalnfleld's paper, "Mortality among Talc Miners and Millers In New York State", has been updated In a letter to D r. M arrlner of Johns - Manville; the new Information w ill be published In the Journal of Occupational Medicine. CONFIDENTIAL i PFI KA 00000013 3. W. Reltze (Johns - Manvllle) discussed their migration studies of talc-loaded papers, citing "prior precedent" that if an additive is non-mlgratory. It Is O .K . for food packaging. Those studies w ill be presented to the FDA. Many tests were made, Involving many low and high loadings (up to 40% T a lc ), and showed no migration. Tests wore made on paper Itself and on meat wrapped in the paper. Several tests have been made by DuPont on plastics; they also say there Is no migration, but won't be quoted. FDA, OSHA, NIOSH and USBM have encouraged presentation and discussion of'data on which they can base mandatory standards. It was decided that overall Interest would best be served by individual corporate presentations, each attacking from their own viewpoint rather than by an industry presentation. 4. M r. Baccn reported that his contacts In the U. S. Congress say that attitude towards FDA, OSHA, etc. is changing. O riginally, whereas anything that was said by these organizations had been considered almost sacred, opinion is now swinging opposite to the point where almost anything Is questioned. This should ease the burden somewhat, on industry. 1 USBM has announced a public symposium to study health and safety effects of talc dust; 9:00 A . M . , May 8, 1973 in the auditorium. Department of Interior, 18 S C Streets Northwest, Washington, D. C. Presentations should include information relating to characterizing of airborne dust from mining and milling of minerals and medical data on disease and exposure, as detailed as possible. A rt Nielson mentioned that FDA cosmetic group and NIOSH have started a crash .study of some kind at a pharmaceutical plant in Arizona. No details were available at the moment. RSS/ep Attachment Rex S. Smith CONFIDENTIAL PFI KA 00000014 DOSE 2150 mg 1 TABLE t TUMORS FOUND WITH VARIOUS DUSTS CHRYSOTILE AMOSITE ANTHOPHYLUTE CROCIDOLITE 9 9 3 3 10 0 00 2 TABLE 2 EFFECT OF FIBER LENGTH AVERAGE LENGTH OF FIBERS KIND OF CROCIDOLITE 6.9 Microns 5.3 Microns 0.9 Microns 0.4 Microns Soft Harsh Soft Harsh NUMBER . OF TUMORS 8 9 0 CONFIDENTIAL PFI KA 00000015 TABLE 3 EFFECT OF FIBER COMPOSITION MATERIAL DOSE Tremolltlc Talc Serpentine Rock Dust (chemically like chrysotlle, but not fibrous) 25 mg 25 mg Nemallte (Fibrous Magnesium Oxide) 25 mg Silica fibers Class Fibers Glass Fibers with phenolic binders 10 10 10 TUMORS 0 1 0 ft 0 0 CONFIDENTIAL PFI KA 00000016