Document dQm2DBp0RvjgeX27p8MRXj3K9

) The Cosmetic, Toiletry and Fragrance Association, Inc. / ----------- -- ------------------- -- -------------------------------------------- ----------- ------------------------------------------------------------------------------ 1625 EYE STREET, N.W., WASHINGTON, D. C. ?.OD0B 202/39J-2070 NOTED James R Merrltt prtsiattm Norman F. Estrin, Ph.D, Vice Pr*ilMon(~~$ctncc Mr. George Sandland JAN 101974 Bristol-Myers Company 225 Long Avenue G. W. SANDLAND Hillside, New Jersey At a meeting on January 4th with Heinz Eiermann, George -- -- he stressed again the need for Industry supplying data on concentrations of Talc in the breathing area. He stated that the figure was of critical importance to both Industry and FDA in arriving at a suitable figure for regulatory purposes. He presented the following calculations which I am reproducing here for your study: The FDA proposal states that 1,000 fibers are equivalent to 0.1%; 1Q0 fibers are equivalent to 0.01%, OSHA limits are 5 fibers per milli liter per 8 hour day and 10 fibers per milli liter, per 15 minutes, per 5 hour day. Five fibers per milliliter is equivalent to 5,000 fibers per liter which is equivalent to 0.5% , or 0.005 milligrams. If one gram of Talc is suspended in 1 liter of air, it is equivalent to 0-005 milligrams per thousand milligrams or 0.0005% Asbestos in Talc. What FDA urgently needs is a figure of how many grams or milli grams of Talc are suspended in one liter of aip in, for example, a baby's breathing area so that a calculation such as the one above can be made and an Asbestos in Talc limit published. I urge you tc discuss these calculations with your Subcommittee and to collect any necessary data. Best personal regards. Norman F. Estrin, Ph.D. Vice President - Science N F E :j j January 8th, 1974 PLA IN TIFFS E X H IB IT WCD-205 LoGiudice/WCD/0187 November 16 , 1973 TO: Mr. P, A. Miinger FROM: T . W olf Talc Dust Inhalation from Powdering of Eablea I recommend that estimate of renpiration of dusting talc by babies beat be carried out by an in vibro study with an Anderson Mini-sampler for air-borne dust, which classifies particles by their aerodynamic proper ties. The resulting "respirable" and "non respirable" fractions will be cpiantibated by atomic absorption measurement of magnesium. If this work were contracted to an outside laboratory, the findings vould be more impartial than results obtained at Colgate, The FDA needs information on the amount of talc a baby broathse while being powdered^-. The parameters involved are: 0 mcnrit breathed, that is, the amount of talc reaching the mouth and nose at a baby's respiration race. percent respirable, that is, the proportion retained by.the lungs. Amount of talc used and how applied. Geometry of surface powdered, and distance to the mouth. Absorption of powder by moist skin; assume .initially that this io not significant. To make the experimental determination, we need to consider: 1. HOW WS WILL DEFINE THE RESPIRABLE FRACTION. Brown et' at^?^ state the nose filters out almost all particles larger than 5 micrometers (;im), that filtering efficiency falls with de creasing size and reaches zero at 1 pm. Below 1 - \V .H21 Ihe lung no longer retains all particles breathed. The figures refer to spheres of unit density, (i) Sec letter, C. V, Sandland to Members of Subcommittee on Asbestos In Talc, (C. H. Costello). Asbestos In Talc, Sept. Ik. 1973< ' Rrowr,, J. H/, Cooke, K. M., Ney, F. 0 , and Fetch, T. F ., "Influence of Particle Sise upon the Retention of Particulate Matter in the Hunan Lung1, J. 'Am. Public Health Assoc., hO t50-^8 U950). LoGiudice/WCD/0188 - 2- Tele consists of platelets of density .8 gm/ml. The value found for ''size" depends on particle chape, density and method of measure ment. Only if the method of measurement depends on the same properties by which tip nose discriminates against particles and by which the lung retains them are the results valid f The method of measurement should depend 2. SHOULD WE SUBDIVIDE THE RESPIRABLE FRACTION? The 5 inn cut-off represents where some particles enter the lung, while not till 1 urn do all enter the lung. Also the 5 pi cut-off couid possi bly be changed by future research. 3. SHOULD WE COLLECT THE NON-RESPIRABLE FRACTION7 The baby may breathe through the mouth also. 1, SAMPLING FLOW A baby's breath intake ,1 b so low that a large number of experiments may be required to obtain a measurable amount of talc. Higher flow will result in distortion of the dust cloud. 5. TYPE OF S A I L E R We considerably reduce work by siring into fractions during sampling. Sizing should be.' on the basis of the particle1 aerodynamic properties. 6. HOW TO SIMULATE POURING .AND WHERE TJ PLACE SAMPLER Th procedure must be reproducible, yet must simulate powdering. A baby-sized doll would accurately position the sampler nert to the nostrils, and create an area for applying the powder. 4. 7. PRODUCTS USED CASHIERS B3U0UE1 is suggested. Comparison of particle size distribution should enable estimation of results for other talcs. C. MEASUREMENT OF AMOUNT COLLECTED Talc, Si (OH);:,, contains l&i magnesium, which la reasonably specific for talc. We*require 70 nanograns Mg/eample for detectability by Atomic Absorption.- 9. NUMBER OF EXPERIMENTS How many powderinga are needed to accumulate a measurable amount of talc has to be determined by experiment. We need to run enough ex periments to be statistically meaningful. 1 Anderson, A.A., "A Sampler for Respiratory Health Hazard Assessment'', American Industrial Hygine Association Journal. ?7 I0O-165 (1966), LoGiudice/WCD/0189 - 3- 10, SCHEDULING PLACE AND TIME A draft-and-dust-free room should be used. While it would be possible to run these tests at the Hesearch Centre, we ought to consider whether more believable results would be obtained by contracting this study to Battelle Institute or some other independent laboratory. It is impossible to estimate whether the work will require a few weckB or several months. It will depend on how the questions posed above axe answered and how many povderings are needed to give a detectable amount of talc. A large number of air samplers are available, based on many types of mea surement. Those based on aerodynamic size that appear best suited are the Hexhlet and Anderson collectors, HEXHLET (a,b) This collector consists of a soxhlet thimble, or a filter, through which air is drawn at 50 litres ./minute, preceded by an array of horizontal shelves. All material of 5 jura (unit density, spherical, falling in air),and larger, deposits on the shelves. Thus only respirable talc Is collected on the filter. While it Is possible to recover the larger diameter talc also, it is hard to do so accurately unless a substantial amount is deposited. No information is possible on particle sizes within the respirable fraction., The filter would be ashed before analysis by'atomic absorption. ANDERSON, MODEL Ml-000 (c,d,e) Air is drawn through a series of 8 plates, four inches in diameter, each having V)0 holes. Flow rate is 28 11ores/rain. The first three plates collect particles too large to pass through the nose ( > ?9 9-30 vua,^-li uni), four collect the portion retained end partially retained l3~& pxn, ? - 3 pm, 1-3 p, 0.3-ljim) and one collects that not retained . (0.1-0.3 urn). We would have to wash the talc from each plate, perhaps with a volatile washing liquid (since talc is not soluble). We could combine fractions. (a) C. F. Cassella & Co. Ltd,, Regent House, Britannia Walk, London, Wl, England. (b) Higgins, R, I, and Dewell, P . , "The Measurement of Airborne Dust Con centration in Iron Foundries using the Hexhlet Dust Sampler", BCIRA Journal 8 1*25-1+3 (i960). (c) 2000 Inc., 5399 South State Street, Salt Lake City, Utah 81*107 (d) M a m fac t u r e r 1s Literature (e) Anderson, A. A,, "A Sampler for Respiratory Health Hazard Assessment . American Industrial Hygiene Association Journal 27 I6C-I65 (l':>66). LoGiudice/WCD/0190 - h- ANDERSON, MINI-SAMPLER (c, d) This is a smaller version using the some principles as the Pl-OOO. There are five stages: 1 not reaching lung jim), 3 respired (5.5*3.5 pa 3-5-? pa, 2-0.3 jra) and 1 not retained ( < 0 . 3 pm). The flov rate is 1.1 litres/min., the plate size 1 inch and the overall dimensions 1 " x 1 1/8'1 diameter. The Anderson Mini-sampler offers important advantages. The flow rate is about double the rate breathed by a sleeping, nevborn baby (f), while the others sample at 20 times (Anderson 2.1-000) and 36 times (hexhlet) the Mini-sampler rate. It s\ibdivides the respirable fraction into three, which could be pooled, but could also yield added information without unreason able extra work. Also it separately collects the fractions filtered out by the nose anu that only partially retained by the lung. Its small size would enable exact placement corresponding to a baby's nostrils, and make washing the talc from collection plates convoi lent. Its small size and low price ($115 in 1971) make it feasible to monitor each powdering experiment with, say, 3 samplers, thereby speeding up the work. The question of whether a flov rate ns low as 1,4 litree/minuta ip high enough to accumulate sufficient talc to measure will have to be determined by experiment. However, it does seem reasonable, since the sampler will be only 1-1,V feet from the powder source, the talc typically contains ?5r? material under 5 ;wi (sedimentation raialy3is, after breaking up agglomerates which might be present), and the detection limit for atomic absorption should be about 0,4 rag of tolc, (c) 2000 Inc., 5899 South State Street, Salt Lake City, Utah 84107 (d) Manufacturer's Literature (f) Speetor W.S (Ed) ^Handbook of Biological Data" , Philadelphia, TWics cc: C. H. Costello W. J. King . J. P, Simko, Jr. D. McCrae Information Center LoGiudice/WCD/0191