Document yk8omoQBv6X6YwqRyYYMEE1XV

. The Cosmetic,Toiletry and Fragrance Association, Inc. W/ _______ ___ ___ __ _____ _ . 1U' ' 1625 EYE STREET, N.W., WASHINGTON, D, C. 200Q3 202/3A3-2070 James H. Merritt f't-esfd&nt Norman F. Estrin, Ph.D. y ce President-Science December 26, 1973 Hearing Clerk _ Food & Drug Administration Department of Health, Education and Welfare Room 6"86 5600 Fishers Lane Rockville, MD 20852 Re: Proposed. Order Method for Asbestos in Talc Published in the Federal Register (38 F.R., No. 188, pgs. 27076-27081) September 28, 1973 Dear Sir: This letter and attachment is being submitted in response to tne 'proposal`published on September 28, 1973 (Federal Register, Vol. 33, No. 188., pages 2707 6-27 031) in which a method is proposed for the determination of asbestos particles iii food and drugs. The comments are being submitted on behalf of The Cosmetic, Toiletry ^ and Fragrance Association, Inc., a national association representing manufacturers and packers of cosmetic products as well as the manufacturers and vendors of cosmetic product ingredients and _ supplies. Members of the Association manufacture approximately 8c^ of the cosmetic products distributed in the United States. While the Association is not directly affected oy the Federal Regis>-er Pj^opQsa.1 cited above, one or its scientific subcommittees, tne ^ CTFA Talc Subcommittee, has completed a critical review of tie opti cal microscopic ma'chod published in this proposal, m the belie^ that -this review is reveiant for your consideration of this proposal, the report of the CTFA Talc Subcommittee, dated December 10, 1973. is attached as part of this submission. As a result o f round robin testing of five different types of talc, b y members of the CTFA Talc Subcommittee, the subcommittee concluded that the proposed method does not provide a reliable means for t h e detection of asbestos in talc and that it results in both PLAINTIFFS EXHIBIT WCD-380 r Goodhue WCD 000086 -2 - false-positive and false-nqgative findings. The procedure-; is also tedious and may consume as much time as one-half day per sample. The subcommittee has also reviewed several alternative methods to detect chrysotile aiid tremolite in talc including modifications of the optical microscopic method. As a result of its review the subcommittee feels confident that a feasible method can be developed, and recommends a collaborative effort between FD7v and industry to develop such a method, i , i The questions concerning asbestos detection and the relationship of asbestos to human health are indeed 'complex ones. At a confer ence last month, sponsored by the National Institute of Environ mental Health Sciences and the Environmental Protection Agency, three serious difficulties in determining the effects of asbestos on human health were presented: 1. "The term asbestos itself is misleading, for it encom passes a whole group of minerals that are distinct from each other in chemical composition, particle size, and probably biological effect. 2. Many of these particles are so small that, detection is extremely difficult and time consuming, placing restraints on the scope of research that can be reasonably undertaken. 3. Perhaps the most serious difficulty in asbestos research, however, is the very long period between initial exposure and evidence of biological effects."^) Other points made at this Government sponsored meeting that merit consideration were: 1. Chrysotile fibers re too small to be detected by conven tional optical microscopy. ' 2. Amphibole asbestos fibers are larger. But they also require sublight microscopes for careful examination and cannot be positively identified without additional microchemical or selective area diffraction analysis. 3. A question yet to be answered is the effect of low-level exposure to asbestos on the general population. 4. Dr. Ian Webster of the National Institute for Occupational Diseases in Johannesburg, Republic of South Africa, reported at the conference that very little ingested " asbestos penetrates the walls of the stomach and colon and that almost all that does is of the smaller chrysotile type. Chemical & Engineering News, December 10, 1973, pages 18-19 Goodhue WCD 000087 -3 - S.imilarly studies with .inhaled asbestos also show that the fibex is absorbed is predominately the chrysodile type. 5 Dr.'William Eisenberg of the Food and Drug Administration was quoted as stating that "at present, analysis by .polarized light microscopy is used to determine purity of food and drugs,, even though this method probably ' misses many] of the smaller :and more easily absorbed ^ asbestos fibers that may be! present in these materials. In liaht of the1perplexing questions raised at this conference, , the Association considers it premature for FDA to impose its proposed optical method and place a limit on asbestos in talc for food use. The CTFA urges deferment of promulgation of the proposal until. 1. Determination of the standard deviation of the proposed compliance test method. 2. Evaluation of the validity of the assumption that a single milligram sample can be taken as statistically representa tive of any lot as well as the limit size of any lot so sampled. , 3. A re-evaluation of the economic cost and practicality of the proposed Compliance Test Methods. 4 An intensive search is undertaken for an alternate procedure * that is more reliable and more practical than the proposed test methods. " The Cosmetic, Toiletry and Fragrance Association, Inc., stands ready to assist the Food and Drug Administration in method development: ^ research as well as to provide assistance in other areas discussed above where as its scientific expertise may be or value. Cordially, Norman F. Estrin, Ph.D. Vice President - Science NF:mp Attachment cc: CTFA Talc Subcommittee _ CTFA Scientific Advisory Committee Original and seven copies filed with Hearing Clerk. Copies sent to: Commissioner A. Schmidt Dr. R. Schaffner Mr. S. Fine Dr. V. Wodicka M r . 'P. Hutt -w- Goodhue WCD 000088