Document NeaEp674neg3LBbyQYOvNa3y

FILE NAME Talc TALC DATE 1973 Oct 8 DOC TALC460 DOCUMENT DESCRIPTION Topics for Meeting with FDA Oct. 8 1973 _ _ DR TOPICS FOR MEETING WITH ALEXANDER M. SCHMIDT ON OCT 18 1973 1 The proposed regulations on talc published on August 12 1972 and as republished on September 28 1973 are founded and not consistent with the facts 2 The assumptions made and conclusions reached by FDA in August 1972 proposal not valid and are wholly | unsupportable such as a Since asbestes 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 packa, ging materials will migrate into food 3 No evidence offered by FDA to support these assumptions and Dr. Dr. by conclusions for reference to article in R. R. Merliss Science Sept. 17 1971 in which Merliss attempts to show a causal relationship rice between the use of polished and the high incidence of gastric cancer in Japan The data used for this purpose is spurious to say the least ; 4 a W; g, No scientific evidence offered by FDA in either proposals to prove that the ingestion of asbestos and | particularly tremolite is injurious 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 in 5 No one the scientific community 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 incidence of gastrointestin cancer this suspicion arises only in cases involving individuaml osst highly exposed to asbestos in occupational : settings ; 1972 6 FDA has chosen to ignore all of the comments filed by M and others in response to FDA's August proposal We are distressed with this fact Why did FDA choose only to respontdo the CSPI joint petition 000077 ^' There are many valid points raised and studies cited by 7 in its comments to which FDA has not responded a All forms of asbestos do not react in the same biological way from is no b There health hazard resultii ngen stig on of tremolite Supporting evidence for this is in Dr. Morris Kleinfeld's going epidemiological study New York State talc workers There is an absence of of evidence even ofa weaker association in those exposed to anthophyllite mining and milling persons in the occupation of mining and milling or to tremolice commercial talc There is further supporting evidence in the animal experiments of Dr. William Smith c The more strongly associated forms of asbestos namely crocidolite and amosite do not exist in commercial talc Both tremolite and anthophyllite have been shown be free of association with an excess of mesothelioma or gastrointestinal cancer d Tremolite contained in talc used in food packaging - material does not migrate into food e Ther isea risk relationship between exposure to asbestos and the possibilityreolfatead cato rcitnhoegetnyipce of effect and this risk is also fiber exposure f Talc cannot be processed to remove asbestos identifying by The test method proposed by FDA for the valid presence of asbestos in talc is not a scientifically limits established this method assure test method and the than 59.9 for amphiboles a degree of purity far greater and 99.99 for chrysotile What is the scientific foundation finor tatlhec ulnidmeirts on the number of asbestos fibers persmuichssiebvliedence has been FDA's proposed test method No offered by FDA No scientific evidence i.e. medical studies FDA in its September 28 1973 Notice in support offered by the studies cited relate to of its talc proposal All of no reference made to the asbestos filter issue Why was and studies on talc i.e. Dr. Morris Kleinfeld Dr. William Smith 000078 es ILE ETRE SLE EO 11 1 offered No evidence that asbestos material will by FDA to oven attempt to prove contained in talc used in fo.od pai cktae gd ing migrate to food to thus far we have no choice but Based on FDA's actionsFDA's actions are not well founded from to conclude that the reaction to pressum but may solely be a the in fact is founded say EDF and CSPI whose petition oo least occupational a Studies workers in petition relate to insulatiinon asbestos cited most heavily exposed to of settings for prolonged periods time relating to effect of _ b Niongesstutdiioens ofcitterdemion lpietteitiTohnese studies conspicuously missing c Critique of CSPI peticion by Dr. Wright 28th proposal which presents of FDA's September disorganized and 13 The portion conclusions is quite the Commissioner's to many relevant studies conspicuously omits reference 14 a Critique by Dr. Wrighotn FDA proposal | this proposal as a permanent intent on promulgatingmethod is validated it may If FDA as soon as a test regulation M's talc does not well destroy the U.S. talc test industry method and the tale of other food packaging pass the FDA proposed Without a talc producers does not pass M can economically material market there is no way remain in the talc business 000079