Document 1QYxZZvpg6Om8Ep9RvL1NxomZ

FILE NAME: Talc (TALC) DATE: 1973 DOC#: TALC083 DOCUMENT DESCRIPTION: Comments on the FDA's Proposed Regulations on Asbestos Filters and Talc IV -M. COMMENTS OF ENVIRONMENTAL DEFENSE 0ON"THb D^ FILTERS MID T A L C __ __"_ .----- - 1. Introduction . The Environmental Defense Fund (EDF) and the Center for Science in the Public Interest (CSPI, welcome the opportunxty to comment on the FDA's proposed reflations restrrctrng the use of asbestos filters and asbestos-contaminated talc rn e manufacture of food and drugs, 38 Fed. Reg. 27076 (Sept. 28, 1973). The FDA's proposed regulations were pu rs ln response to the petition submitted by EDF and CSPI on dune 27, 1973, calling for an immediate end to the use of as es os filters and asbestos-contaminated talc in food and drug manufacturing. # , j_-- -in -*-heir origins! petition For all the reasons stated 1 - . _nns stated below, Petitioners again request the and the reasons staceu i Commissioner of Food and Drugs to promulgate the proposed r e lation. submitted in their dune 27th petition and publrs e 1/ b u u * ----------- . .... 4. Fed Reg. 27076 (Sept. 28, 1973). m the Federal Register, 38 Fed. Reg 1/ The FDA published in the federal f f ^ L h S i / p f i t i o n , publis^Petitioners' statement in support of their proposaxs. . -2- Although the Commissioner's own proposed regulations represent an important step in the right direction, in Petitioners opinion they fall far short of what is required of him by law to protect the public health and safety. 2. The Commissioner's Response to the EDF/CSPI Petition In their original petition, EDF and CSPI requested the Commissioner to publish and promulgate four regulations. These would, respectively, require the FDA to: 1. Prohibit the use of asbestos filters in all food and beverage manufacturing; 2. Prohibit the use of asbestos filters in all drug manufacturing; 3. Prohibit the use of talc as a direct or indirect additive in food and food packaging materials, unless the manufacturer first demonstrates by appropriate tests that the talc is free of asbestos particles; 2/ and 4. Prohibit the use of talc as a component of any drug or drug packaging material, unless the manufacturer first demonstrates by appropriate tests that the talc is free of asbestos particles. 3/ In response to the EDF/CSPI petition, and after a lengthy review of the scientific literature on the health hazards of asbestos exposure, the Commissioner has concluded that: 2/ EDF and CSPI did not recommend "appropriate tests" for -- detecting the presence of fibers in talc in their ori ginal petition. Petitioners discuss this problem, however, in these "Comments," infra, pp. 15 tol6. -3- It is therefore reasonable to require precau tions to be taken in the manufacture of food and drugs, as part of good manufacturing practices, to assure that the amount of asbestos fibers in any food or drug is re duced to the minimum feasible level. In accordance with this declaration of FDA policy, and as part of "good manufacturing practices," the Commissioner has proposed a more limited version of three of the four 3/ regulations requested by Petitioner. These would: 1. Prohibit the use of asbestos filters, or require membrane filtration following asbestos filtra tion, in the manufacture of parenteral drugs and parenteral drug ingredients; 2. Prohibit the use of talc as an additive to food or food packaging material, unless the manufac turer determined, after viewing under the light microscope at 400X, that a milligram of such talc contained less than 1000 amphibole asbestos fibers or 100 chrysotile asbestos fibers greater than 5 microns in length; and 3. Prohibit the use in drugs of talc containing asbestos, as determined by the same test proce dure proposed for detecting asbestos fibers in talc used in food. The differences between Petitioners' proposed regulations and those proposed by the Commissioner can be briefly summar ized as follows: 1. Asbestos filters -- EDF and CSPI would prohibit all use of asbestos filters in food and drug manufacturing. 3/ The Commissioner has proposed no regulations governing " the use of asbestos filters in food and beverage manu facturing or in the manufacture of non-parenteral drugs. -4 -- FDA would prohibit and/or substantially reduce their use only in the manufacture of parenter al drugs and parenteral drug ingredients, but continue to permit their use in the filtra tion of all foods, beverages, and non-parent eral drugs. 2. Talc -- EDF and CSPI would prohibit the use of talc -- FDA would permit the use of talcs containing small amounts of asbestos fibers as determined by optical microscopy. FDA, in effect, has proposed a "tolerance" for asbestos fibers in foods civ\d drugs. These differences are obviously significant and are discussed in more detail below. 3. The Commissioner's Proposed Regulations on Asbestos Filters are Internally Inconsistent The Commissioner's unexplained decision to impose restrictions on some but not all uses of asbestos filters in food and drug manufacturing is perplexing and apparently quite arbitrary. The Commissioner has failed to explain why, in his judgment, there is sufficient medical evidence to pro hibit the addition of asbestos-contaminated talc to any food or drug and to prohibit the use of asbestos filters in the manu facture of parenteral drugs, but not to prohibit the use of .asbestos filters in the manufacture of foods, beverages and non-parenteral drugs. -5- This is an inconsistency which obviously requires explanation if the Commissioner's proposed regulations are to withstand judicial scrutiny. It seems axiomatic that all avenues by which asbestos may enter the body through foods or drugs should be subject to the same or equal restrictions by the PDA, unless there is a clear scientific basis for treating them differently. If the Commissioner has deemed parenteral drugs to be "adulterated" from asbestos filters within the meaning of section 501(a) of the Act, 21 U.S.C. 10.1, and foods to be "adulterated" from asbestos in talc within the meaning of section 402 (a) of. the Act, then what are his grounds for maintaining that foods and non-parenteral drugs that are equally contaminated when they are filtered through asbestos filters are safe under those same statutory provisions. At the very least the Commissioner is required to explain these apparent inconsistencies. In our opinion, however, they cannot be rationally explained. Petitioners have urged and the Commissioner has agreed at least in principle, that "the amount of asbestos fibers in any food or drug [should be] reduced to the minimum feasible level." 38 Fed. Reg. at 27079 (emphasis added). The Commissioner, however, points out in a lengthy review of the evidence -6- concerning the possible hazard from inhalation, injectron or ingestion of asbestos fibers, 3B Fed. Keg. at 27076-270,9. that: _ Asbestos fibers thus are."^uitous in^air, ciult.an?he amo5ntPofCthis material which s s s s Se SsroHpstos products is only one small source P ure. Id.r at 27077. This non seguitur seems to be the rationale for his decision not to prohibit the use of asbestos filters in the manufactured foods, beverages and non-parenteral drugs. But this rationale is deficient for at least three reasons. First, he has not presented data to show that the amounts contributed by filters are in fact "small." Second, the commissioner lacks data to show that even small amounts of asbestos are harmless to health. And third, even assuming. a r S ^ ' that as bestos filters are "only one small source of exposure," and that such a small amount may not be harmful in xtself. it does not follow logically that the responsibility of the Food and Drug Administration is somehow lessened. If anything, the fact that there are so many other sources of , asbestos to which modern man can be exposed argues strong y -7- in favor of prohibiting those few non-essential uses that can easily be dispensed with such as the use of asbestos filters in food and drug .manufacturing. Other federal agencies are required to do their part in controlling many of the other uses of asbestos. See Petition, pp.' 12-13. If every federal agency shrugged off its responsibility with the nonchalant attitude of the FDA, this ubiquitous hazard would never be controlled. Petitioners recognize that the Commissioner lacks authority to control many sources of asbestos, such as air and water pollution, which may accidentally contribute asbestos fibers to food and drug products. Petitioners seek only to have the Commissioner exercise that authority which he undeniably does have, i ^ . to keep potentially hazardous agents such as asbestos from being intentionally added, to food and drugs by food and drug manufacturers. This is strictly in accordance with the Commissioner's non-delegable, non-dis cretionary duty to prohibit the adulteration of foods and drugs moving in interstate commerce. It is also in accord with the policy that he himself announced in the Federal Register Notice: that it is "reasonable" to require that "the amount of asbestos fibers in any food or drug [be] reduced to the minimum feasible level." Sui-ra, p. 3 . We can see no rational basis for not applying this policy with an even hand to all uses of asbestos filters for foods and drugs. "8- 4. ingestion ofJ ^ s b e s ^ s _ J i ^ S J ^ r.agtrointestinajjCancers. - - ln response to the EDF/CSPI petition, the Commissioner prepared an extensive review o f t h e scientific literature concerning the hasards of inhaling, injecting and mgestrng hestos fibers. 38 Fed. Keg. at ,, . 2707.-270.1. From aS , that "the evidence this review, the Commissioner concluded that t . .M ,, hazard from ingestion of asbestos concerning the possi ia at 27077. ^ r a d i c t o r y and inconclusive. !_' particles is contradictory _ . h TT-it-h this characterization Petitioners disagree with this c ^ contrary to the Commissioner's conclusion, available evidence. Contrary the available evidence certainly establishes a ror that asbestos is carcinogenic when ingested. Fo presumption studies of asbestos workers example, long-term epidemiological studies of onsistently shown an increased incidence of gastr have consistently population. intestinal tract cancers over that of the g ni and by E Ins and Simp see, e^.., the studies by Selikoff et_al, and by a nnr June 27th petition, p. 10- See also P. son cited in our June z/rn y _ Enterline, P. DeCoufle, and V. Henderson, Mort Y ^ . . ExDosure in the Asbestos Industry, __l tion to Occupational Exposur Mea vol 14, Dec. 1972, pp. 897-903. And see other rvf Occup. Med., voi. i** __ on p . 9 , ^ - -- ls/ u " for a regulatory agency to conclude .that ingestion o as 4- jHn-hP to the incidence of gastrointestinal fibers may contribute to tract cancers . . -9- Dr. Selikoff has testified that this is his firm belief. Most recently, Dr. Joseph Wagoner. Director of the Division of Field Studies and Clinical Investigation, the National Insti tute for Occupational Safety and Health, Department of Health, Education and Welfare, has testified that he is also of the considered opinion that ingestion of asbestos fibers is a carcinogenic hazard. Transcript of Proceedings, United states, et al v. Reserve Mining Company, et al, No. 5-72 Civil 19, D.S. District Court, District of Minnesota, Fifth Division, Vol. 31, pp. 4371-4537. Dr. Wagoner^cited six studies which he believes support his opinion. These studies all indicate that the incidence of G.I. cancer among asbestos workers is significantly higher than that for the population as a whole. 4/ These studies include: i p n Flms and M.J.C. Simpson, "Insulation Workers in L l A s t T i f f 1940-1966". Brit. J. of mdust. .Mad., 2. e ?e ". Keal^P,''Asbestosis and Abdominal Neoplasms,' ' i ^ i ^ i t e i u n e ' ^i'M.^'Ken toick, "Asbestos-Dust Exposures 3 ' at^Various Levels and Mortality," Arch. Envir. Health. 5 ICJ* Selikoff E.C. Hammond, and J. Churg, qenicity of Amosite Asbestos," Arch. Envir. Health, Vol. 25, sept. 197 2, pp. 183-186; a n d ^ Health ger_ 6. J. Wagoner, "A Report ~ p^cific Cancer Among S,s." .sa" s . s j : ^ ' the Period from 1940 to 1967.. -10- +-hese references appeared It is quite striking that none of these r among the 52 ret listed by the Commissioner m his re Federal Register, view of the medical evidence publrshe referred to by Petitioners in Rt least two of these papers were referred . ,, ,, n t h Petition, see Petition, p. 10. their June 27th , ite earlier Tina that the Commissioner should ci rt- is indeed puzzling Of these same authors as well as severa reports hy some of these ^ ^ n#gati,, > while ..unpublished" animal feeding ^ of cancer of disregarding the more recent pub is e ^ comls- the G-I tract among humans exposed to as ,,ears to have based his assessment of the sioner, therefore, appears to the ,,edical evidence on an incomplete and distorte .. ce perhaps had he consulted these other stud to a different conclusion concerning the po- might have come bestos Me strongly urge tential harm from ingestion of asbesto . him to consider them now. that the excess of G I Some researchers may speculate th rkers is not from ingestion but rather from cancers among workers i +.on of fibers inhaled into the lungs, where t y the migration o tract. Dr. Selikoff, the bloodstream and into the G-I tract. pass into the that workers who are Dr. Wagoner and others, however, ma fibers d to dust in the atmosphere also ingest many fibers eXP ,,ho lungs by mucociliary clearance and h-,,h re removed from the lungs by a which are re _ supported by several animal swallowed. The latter position is PP -11- studies cited by FDA. See, in particular, References 42 and 44, 38 Fed. Reg. at pp. 27078-27079. There are no comparable studies cited by FDA which would support the contrary theory that workers do not ingest significant numbers of fibers or that gastrointestinal cancers are caused by fibers which migrate directly from the lung through the tissues to the gastro intestinal tract. The position of Selikoff, Wagoner and others, that ingested asbestos is harmful received even further support at a recent conference on Biological Effects of Ingested Asbestos" sponsored by the National Institute for Environ mental Health Sciences, November 18-20, 1973. Cr. Volkeimer and Dr. Zaidi pointed out at that conference that submicro scopic particles are able to rapidly penetrate the lining of the gastrointestinal tract and are "persorbed" into the blood and lymph systems. Co-factors such as nicotine and caffeine apparently facilitate "persorbtion," presumably by attacking the mucous barrier. These multiple factor cond , which more nearly reflect human experience, were contrasted with swinburn's unpublished rat feeding experiments using asbes tos in butter, cited by the FDA, Ref. 40. Butter, it was believed, helps to naturally coat the intestinal walls and hinder persorbtion of micro-particles. Pontefract also reported at the conference the preliminary results of his unpublished study in which rats were fed 1% asbestos in their diet in -12- corn oil. Three of the 9 rats A s l o p e * tumors, which is the first experimental evidence that ingested asbestos is harmful. See J.E. Brody, "Conferees Study Asbestos Hazard," New York Times, Nov. 11, 1973, P- 32 (Attachment "A"). Therefore, while the evidence now available may not be sufficient to establish unequivocally which is the valid ex planation for the increase of gastrointestinal cancers among asbestos workers, the weight of the evidence certainly favors the conclusion that this increase may well be due to ingestion. At the very least, there is enough evidence to establish a pre sumption that ingestion of asbestos fibers represents a poten tially grave health hazard. The Commissioner apparently a,tees with this conclusion, or he would not have proposed testrictions on the use of asbestos-contamined talc as a food additive. And he would not have declared an FDA policy of reducing exposure to asbestos to the "minimum feasible level. a supra It is almost impossible, therefore, to ex See page 3, supra. j-iPlain his failure to apblv his conclusions to the foods, beverages, and non-parenteral drugs through asbes 5. rna's Proposed n tJ C s _ B S ^ S 3 J ^ S S i J l L ^ S - i S . Illegal and Inaccurate a. Illegality The FDA has recommended the use of polarized optical as the method for detecting the presence of asbestos microscopy -13- fibers in talc. Under this test procedure, only fibers greater than 5 microns in length, and less than 5 microns an width will be counted. * talc sample that contains not ore than 1000 such amphibole fibers and/or not more than 100 sue chrysotile fibers per milligram-will pass the PDA's test and be permitted for use in food and drugs, according to the PDA. this test procedure will "assure a purity of talc at leas 99.9 percent free of amphibole types of asbestos and at lea. . f chrvsotile asbestos fibers." 38 Fed. 99.99 percent free of chrysocn Reg. at 27080. . ,,Ot only will this test not assure the degree of purr y claimed by the PDA, but even assuming that it did, rt would probably still permit the addition of perhaps millions of as bestos fibers less than 5 microns in length per milligram, of bale to enter the body through the diet or through drugs. The net effect of this test procedure is to set a permissible level or "tolerance" for asbestos fibers in food y nnp for which there is Asbestos, however, is a carcinogen, and one still ,,o known safe exposure level. The PDA's proposed T/ See I.J. " U k r f ^ J ^ ; S ho^ ; . aStaltt; v" ! * , 1972, - bestos Air pollution > of chrysotile may^contai^about 300-<00 l m dia meter and 2,000 & m length. -14- tolerance, therefore, would not he legally p o s s i b l e under section 409(c)(3)(A) of the Food, Drug and Cosmetic Act, 21 u.s.c. 348(c)(3)(A), Which prohibits the promulgation of a regulation establishing such a tolerance (C) (3) . . . if a fair evaluation of the data before the Secretary (A) fails to establish that the proposed f o o d additive under the condi- i t u o n f w f l ? be sIfirProvid|di That^ s as;- tL^TwWch appropriate for ^ iveS( evaulation of the safety or ^ to induce cancer in man or animal. Petitioners submit that there has been no evidence presented to or by the Commissioner that e s t a b l i s h that even a fraction of a milligram of asbestos can be safely ingested. To the contrary, "a fair evaluation of the data" appears to establish at least a strong presumption that asbestos fibers ate carcinogenic when ingested, as they are when inhaled. Therefore, until such time as "tests which are appropriate for the evaluation of the safety of food additives" are con ducted and show that asbestos is not carcinogenic, it seems quite clear that the law does not permit the Commissioner f asbestos fibers in food-grade to set the kind of tolerance for asbesto talc which he has in fact proposed. -15- b. Inaccuracy Even assuming, arguendo, that the FDA's tolerance for asbestos fibers in talc were legally permissible, it would still be insufficient because the recommended test procedure is incapable of accurately measuring the number of asbestos fibers present in talc. The recommended procedure utilizes only an optical microscope and is designed to count only fibers greater than 5 microns in length. This is about the limit of fiber size that can be detected with an optical micro scope at 40OX. This would be acceptable if one of two condi tions prevailed: either (1) the vast majority of fibers in talc were greater than 5 microns; or (2) the fiber size distribution were uniform enough to predict with reasonable accuracy the total number of fibers given only the number greater than 5 microns in length. Unfortunately, neither condition prevails. The likelihood is that the vast majority of fibers in talc, particularly talc that is crushed prior to commercial sale, are less than 5 microns in length and will go unnoticed under the FDA's recommended procedure. There is also no way to predict the total number of fibers present with any degree of certainty, if only the number greater than 5 microns is known, since both fiber content and fiber size distribution are subject to substantial variations in given These conclusions were confirmed at the recent talc deposits. -16- conference on "Biological Effects of Ingested asbestos . Dr. Rohl, of Mount Sinai School of Medicine in New York, state that optical microscopy is incapable of quantifying the amount of asbestos in talc because the majority of frbers present are less than 5 microns in length. The optical microscope, therefore, should not be used as a tool for quantifying / asbestos in talc. _ Thus, the FDA's test procedure is not capable of achiev ing the degree of accuracy required to meet the agency's pro .. T go 9% free of amphibole asbestos claimed goals of talc purity - 99.9, free V fibers and 99.99% free of chrysotile asbestos fiber as there is no data supplied by the Commissioner to substan tiate the safety of these goals <or tolerances,, there is also no data presented to substantiate the degree of accuracy proclaimed for the test procedure. Thus, the entire talc standard, including the monitoring requirements, seem, to b based on no more than guesswork, which runs counter to the rapidly accumulating knowledge we now have about the effects o asbestos on health and the great difficulty of quantifying the number and sire distribution of fibers present in talc. " -- " . . +->-! f d a Publication in the 6/ See "Comments Pertaining t o j ^ Septelter 28 , 1973, section Federal Register Vo . ' Spared by EMventions, office 121.2006, Paragraph C, preparea y of the hearing clerk, November, - liMhi'&Od /lnOyMiialh U '7c0)0 n11/*,i7iihini'JnJ 125 From 13 Countries Find ' That Lethal Mineral Is Present Everywhere lly JANE E. BRODY DURJJ \M, N .C.--More than 120 scientists from 13 coun tries g.-uhered here in tire mtdst of tl'.e tobacco country last week to gn'pok1 with an urgent pub lie health question: What nsk does the general public face from the ingestion of asbestos, a mir.etal of a thousand u^cs whose potentially lethal id cos pervade the human environ- mnnt? : In three days of intense dis cussion and debate, no niial conclusions were reached, a few worrisome prelinunaty u:n- ip :s were presented and hun dreds of as-yct unanswered questions were raised. " Only two tacts went un T,alIciuted: that abestos is every where-- in the air, in water- wavs, in drinking water, in p, ,'ds and beverages, drugs and talcum powder; and tint uen inhaled in large quantities, as bestos is dangerous, causing in capacitating lung disease and highly lethal cancers. The conference, called by the National Institute of Environ mental tic dth Sciences, was prompted largely by the discov ers' earlier this year tit t irw drinking water of Duluth, Minn., and other cities on Lake Su perior was heavily contaminated with asbestos, the presumed re sult of pollution by a mining companv that has been dumpirw 67,000 tons of rocky waste irdo the lake each day for 17' years. . 1 The Government is seeking to| end the dummng of these as bestos containing wastes mtoj Lake Superior in an action cur rently being heard in United States District Court in Minnea polis. But v.h.il can amt wnat should it do about the countless other sources of asbestos con- minatmn' . -Asbestos topi events a clas- c problem that our modern ilusrn.il society will tace over u! over a;,am," i> n: ir> cd Dr. tv id U. : : director of the \'a- onal In-titute. " It's a vital ibstar.ee. so we can't ban d. at mere's a growing concern Wait its possible health et- And since the health effects! of asbestos often do not. show inn until 20 to 30 years after initial exposure^ "even if y.e stop all asbestos exposure to- day we will continue to see evidence of disease well into the next century," said Dr. Kooert Burrell, a microbiologist at 'West Viiginia University. . ! Virtually, all the reliable in formation about the harm as bestos can wreak on the hu man body is derived trotn the experience of asbestos won-.eis who have inhaled large quan tities of the fibers. . In addition to succumbing to the chronic lung disease as- 'bestosis, these workers aie tar more likely than the genera population to' die irom lung can cer and mesothelioma, an in curable cancer thaL aliccts tne lining of the chest or abdomen, v Recently Dr. Irving J. behkoff, who directs a Fcdeially sponsored asbgcstos . r^ cy 'cll center at Mount Sinai Medical Center, repotted that asnestos workers also had an increased risk of developing cancer ot the gastrointestinal tract. An estimated 100,000 new cases of gastrointestinal cancer will be diagnosed in the Initect States next year, and almougn it is the nation's most common type of internal cancel, us ` cause remains unknown.: - A big question explored ati last week's meeting was now' inhaled asbestos might carnage; the digestive tract. Dr. oiuney, Laskin of New York University noted that 25 to 50 per cent of inhaled pat tides were hlwly to be coughed up and then swallowed. . Intensive studies of tne el e c ts of asbestos consumption on a varictv of experimental animals are just getting under way. But piehmtnary tm duy. presented to the meeting indi cate that the tiorous uncial can pass through the wall of the small intestine, get into the bloodstream and lymph system and become widely dis.ubutcd throughout the body organs, in cluding the brain. Dr Sclikotf said that an un expectedly large > " r i. as bestos woikcts he has tiecn studying had died of brain tu mors, although the significance of this observation was not yet CleAr"p'dot study conducted in! Canada insulted in kmiiey and; chest-w >.U tumors in three ot; nine rats fed asbestos mixed; with com oil. although none li the an.msK given corn on alone developed cancer. _ . p r, Gerhard Vnlkhctmcr or Berlin reported that pPa.'-rriuvlcS similar to asbestos libers were '''pesobed'' between eel ot ithc gastrointestinal tract main more rapidly niter the consump tion of caffeine or men ,n... said that pcismbcu . P im j m could be found m b:cam l.um and could cross the placenta to the fetus. . . , . v, - Dr. John Goklsmr - " lional Cancer Im--t ll-ltC urged that ''all unnecc- -ai y SO'Ji cT-S nf asbestos be ein (1 '* To- ward this end, th ( c 'ter tor Science in the P:ubiu' InU if T and the Enwromr .-M il D c U " " i Fund have requesaati a ban or. asbestos filtci s, u--.cel l 1> n: many beverages ar::l cl: v." S. and, limination of r X i I . "t cU a1- v, a1! a? f\), V, V r ^ S Mod. 2 S-, 1973