Document Qg1oJ1dD4ageX4vmgr13NwVRL

FILE NAME: Johnson & Johnson (JAJ) DATE: 0000 DOC#: JAJ047 DOCUMENT DESCRIPTION: Notes on Meeting with Dr. Langer, Mt. Sinai School of Environmental Science t I % % Meeting with Dr. Danger on July 9 'Concerning Analytical Analysis of Talc ' v. Protected Document-Subject to Protective Order JNJAZBSJM0MC743 I l I I 1 i On .Friday, J u l y 9, I visited Dr 1. Arthur Langer, Mt'. Sinai School of- Environmental Science. The expressed purpose p this visit was to observe the preparation of-tissue sections (from Tenovus Institute) for electron microscope examination. However, the subject of "asbestos" in JOHNSON'S* Baby Powder from.Dr. Danger's-point of view * ** . * was. also explored. ' Analy-s-i-s--o-f--t-h--e--TeTMnovus- Tisssmuei -S-a-mpKl-ejsj . -Only the tissue labeled submitted by Uterus 1 Surface ' us was.of sufficient size to be prepared for electron microscopy. The tissue was- sectioned end prepared by ' the method of Dr. F..Pooley. This method involved removal of the wax embedding medium, ashing away the majority of the organic matter in a 450*C muffle furnace, casting a -polyvinyl alcohol (PVA) film on the ashed section, carbon coating the section'held in the hardened PVA film, and transferring the section to .an electron micro- `scope.-grid by floatation on hot water. This technique if properly executed.leaves sufficient-relic of the tissue so *that the trained eye can tell where in the 'tissue' an observed particle is located'. As no replication step is involved, ambiguities in .the final preparation related to this step are removed. Pretectal D ocum nt-aub|cello Protective Order JNJAZSS_NOOOS744 I- J I i! 1 I! V < \ 7ir.;i:.g the grids prepared on Friday at about 11,000X. 'in the electron microscope, we were unable to find any particles which could obviously be identified as talc, however > fibrous-- structures were" dbserved under, higher magnification (30,OOOX and up) these fibers were identified by Dr. banger as chrysotile. His method of identification is based on. his experiences in observing the fibers of ^ pure " chrysotile under similar experimental conditions. 'The characteristic density profile across the diameter of the fibers is observed at high magnification, and indicates the presence of tubular chrysotile. Evidence such as this was observed in at least one other field in the one sample which .was examined. Light and Electron Microscopy of JOHNSON'S* Baby Powder Dr. Langer demonstrated his technique for observing "fibrous minerals" in JOHNSON'S* Baby powder. He shook a small amount of the talc from the container onto a glass slide, applied a drop of immersion liquid (index of refraction in the neighborhood of 1.52) and a cover slip. After examining,the sample in the light microscope for a short time he stated that he could pick up some non plate particles that could be amphiboles other asbestos forms, or fibrous t ' ' ' -------------- - - r Protected Document-Subject to Protective Order JNJAZ66_000006T46 talc (or, in my opinion, talc plate fragments). He said' he estimates the amount in this sample to be on the order of one or two percent. He indicated that he has observed the amount of "fibrous" content to vary from sample to sample. He had examined a JOHNSON'S* Baby Powder sample and that of a competitor (which resulted in Kretchmers press release) by the method stated above. In`Johnson's `^^sauct-iie^esfeimated^Sft-r in' the other 25% of the particles ..to be fibroic of which some could be "asbestos". I stress Iv that he makes no attempt to actually count the particles or to identify the fibers at this level of magnification. Using electron microscopy Dr. Langer has demonstrated to me .the presence of' some very fine'fibers at. moderately % high magnification which he identifies as chrysotilJg, asbestos by the typical tubular appearance of the fiber. w o b ""fliiich'-l wg.fr. niPTf"m t ar0 The JOHNSON'S* Baby Powder sample was prepared for electron.microscopy by sonifying a small portion of the powder in an excess-of water (maybe 25 to 1) for ten minutes.. The sonification served to break up aglomerated particles and to disperse the talc. A drop of the sus pension was placed on. an electron microscope grid and allowed'to dry. Protected Document-Subject to Protective Order JNJA5_OOOOOS746 In addition to the observation of the tubular structures as ail indication of ohrysQtiie Dr; Langer also pointed out', the typical thermal behavior of the fiber which is initiated by the heat generated at the sample, by the electron beam. The mineral dehydroxylates and' the surface of the ' fibers become amorphous. This process is observed as a lowly altering pattern of density in the microscope ^iimage._E.ventually_Uie~crystal is so deformed by the heat that- the fiber may appear, to be segmented , Although we did not perform selected area electron dif- fraction, on Friday, Dr. Langer has observed these patterns -from`chrysotile fibers found in JOHNSON'S Baby Powder. Selected area diffraction patterns, though not necessarily specific for a mineral, do allow one to distinguish mineral fibers from non-crystalline artifact. It must again be . f r . stressed that Dr. Langer has, to my knowledge, made no - i particle counts with this technique either. Summary ' * i 1. In the. uterus sample from Tenovus, chrysotile rather \\. than:talc was found. 2. Chrysotile is identified in the electron microscope by its characteristic tubular appearance (at high magnification). j Protected Document-Subject to Protective Order JNJAZ55_000005747 , U- \ In addition to the observation of the tubular structures as ah indication of ehrysQfciie Sr-i Langer also pointed out.the typical thermal behavior of the fiber which is initiated by the heat generated at the sample, by the electron beam. The mineral dehydroxylates and' the surface of the fibers become amorphous. This process is observed as a slowly altering pattern of density in the microscope fjmaga,-_L_.ventually_.the._crystal is so deformed by the heat that- the fiber may appear, to be segmented ( . Although we did not perform selected area -electron dif fraction. on Friday, Dr. Langer has observed these patterns from-chrysotile fibers found in JOHNSON'S Baby Powder. Selected area diffraction patterns, though not necessarily *, tv' * specific for a mineral, do allow one to distinguish mineral fibers from nn-crystalline artifact. It must again be stressed that Dr. Langer has, to my knowledge, made no particle counts with this tchnique either. 9 Summary 1. Iri the. uterus sample from Tenovus, chrysotile rather than:talc was found. %. Chrysotile is identified in the electron microscope by its characteristic tubular appearance (at high magnification). % Protected Document-Subject to Protective Order JNJAZS5_D0000S747 % A ' \. 3.. Light microscopy of JOHNSON'S* Baby Powder indicates the presence of fibrous minerals of which, according to Dr. Danger, some.could be "asbestos". Neither true quantitative or qualitative analysis Vas performed. 4Y Electron microscopy at high magnification shows a" few fibers to be present in JOHNSON'S* Baby- Powder which can be identified with chrysotile asbestosaccording - "tcTTir. Danger. No-quantitation was performed. .ti % Protected Document-Subject to Protectlvi Order JNJA265_000005748