Document MJZZrGXxrRKeXBXkmMYrz8j7L

FILE NAME: Talc (TALC) DATE: 1973 Oct 8 DOC#: TALC460 DOCUMENT DESCRIPTION: Topics for Meeting with FDA Oct, 8, 1973 TOPICS FOR MEETING WITH DR, ALEXANDER M. SCHMIDT ON OCT. 18, 1973 1 The proposed regulations on talc published on August 12, 1972 "aid as republished an September 28, 1973 are ill-founded and not consistent with the facts. 2. The assumptions made and conclusions reached by FDA in August 1972 proposal*were not valid and are wholly unsupportable; such as ' (a) Since asbest's is carcinogenic when inhaled, it may be injurious to health when ingested. . (b) Talc can be processed to remove asbestos. (c) Asbestos contained in talc used in food packaging _ materials will migrate into food. 3. No evidence offered by FDA to support these assumptions and conclusions,except for reference to a r t i c l e b y ( Dr. R. R. Merliss in Science (Sept. 17, 1971), in which Dr. Merliss attempts to show a causal relationship between the use of talc-polished rice and the h i g h _incidence of gastric cancer in Japan, The data used for this purpose is spurious, to say the least, 4. Nofmedical-scientific evidence offered by FDA in either proposals to prove that the ingestion of asbestos, and particularly tremolite, is injurious t o health. As a matter of fact, the studies cited by FDA in ^the.. 'September 28 proposal indicate that ingestion is not injurious, based on the animal studies reported. 5. No one in the medical-scientific coin-unity has concluded that asbestos, when ingested is carcinogenic. Even in _ those studies where there is some suspicion that 'ingestion of asbestos may result in a higher i n c i d e n c e ^ gastrointestrn cancer, this suspicion arises only in cases involving _ individuals most highly exposed to asbestos in occupational settings. X. . , ` * 6. FDA has chosen to ignore all of the comments filed by J-M . and others in response to FDA's August 1972 proposal, we are distressed with this fact. Why did FDA choose only to respond to the.EDF-GSPI joint petition? CRMC-HT-TALC-000077 7 There are many valid points raised and studies cited by 7 '- j!5 i,, H a - c o m m e n t s , to which FDA has not responded: (a) All forms of asbestos do not react in the same . biological way. (b) There.is no health hazard resulting_trom_ ingestion of tremolitc- Supporting evidence for this x? in Dr. Morris Kleinfeld's on-going epidemio-ogreal study of New York State talc workers. There is an absence of evidence, even of a weaker association, in those persons exposed to anthophyllite mining and or to tremo11.0 in the occupation of mining and milling commercial tall There is further supporting evidence in the animal experiments of Dr. William Smith. (c) The more strongly cancer-associated forms of asbestos, namely crocidolite and amosite, do no. exist in commercial talc. Both tremolite and excess have been shown to-be free of association with an excess of either mesothelioma or gastrointestinal cancer. (d) Tremolite contained in talc used in food packaging material does not migrate into food. There is a dose-risk relationship between exposure S a-beltos and the possibility of a carcinogenic . e?fect! and this risk is also related to the type of fiber exposure. (f) Talc cannot be processed to remove asbestos. The test method proposed by FDA for identifying the 8. a degree of purity far greater than U . M and 99.99% for chrysotile. f o r arnphxbole. What is the medical-scientific foundation for the limits on 9. the number of asbestos fibers permissible m talc und^r FDA's^roposed test method? No such evidence has been offered by FDA. . 10. W H B 8 & S m a srs- " - Dr. William Smith. CRMC-HT-TALC-000078 - ce**aA h\t FDA to oven attempt to prove S r a s S S o f S S a i K talc used in food packaging material will migrate to food. B a se d OT1 ^ f ; = a? C S r ? D V r a c a ; n r a 5 a V nont 0 w e U i fo u n d e d EDF and C S P I , whose petition is m ^ least. (a) Studies 9iid1i;vP ; ^ ^ . a 1U ,a S . i S i ' `ii0n, f. oupftiSnai sitings, for prolonged periods of tine. (b) No studies cited in P ^ ^ e ^ s t S d i ^ c o n s p i c u o u B l y ingestion of tremaUte. mese stu missing. (c) critique of EDF-CSPI petition by Dr. Wright. The portion of KDA's Septe? er .* 13. S h a " s i ? n^ i t 3 refeience to nany relevant studies (a) Critique by Dr. Wright on PDA proposal. L4. If FDA intent on promulgating " */-P" ndated,P it"may regulation as .soon as a tss1r j -m 's talc does not fell destroy the U.S. talc ^ u s t r y ^ J M ^ o pass the FDA proposed test TMetn . hout a food packaging S^rSf - economically remain in the talc business. CRMC-HT-TALC-000079