Document e7qL0jjoywbjyjdyLGv6d39eE

FILE NAME Talc TALC DATE 1973 DOC TALC083 DOCUMENT DESCRIPTION Comments on the FDA's Proposed Regulations on Asbestos Filters and Talc ony December 1973 COMMENTS OF CENTER FOR ON THE FDA'S ENVIRONMENTAL DEFENSE FUND AND SCIENCE IN THE PUBLIC INTEREST PROPOSED REGULATIONS ON ASBESTOS FILTERS AND TALC 1. Introduction The Environmental Defense Fund EDF and the Center Interest CSPI welcome the opportunity for Science in the Public regulations restricting the to comment on the FDA's proposed talc in the use of asbestos filters and contaminated manufacture of food Sept. 28 1973 in response to the and drugs 38 Fed The FDA's proposed petition submitted Reg 27076 regulations by EDF and et seq were published CSPI on June 27 1973 end to the use of asbestos calling for an immediate talc in food and drug filters and contaminated manufacturing stated in their original petition For all the reasons and the reasons Commissioner of stated below Petitioners again request the the proposed reguFood and Drugs to promulgate their June 27th petition and published / lations submitted in - 27076 Sept. 28 1973 38 Fed Reg in the Federal Register the Federal Register the proposed / The FDA published in EDF and CSPI in their petition ~ regulations submittedPebtyitioners statement in support but did not publish of their proposals 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 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 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 / and 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 CSPI petition and after a lengthy review of the scientific literature on the health hazards of asbestos exposure the Commissioner has concluded that appropriate 2 EDF and CSPI did not recommend tests for detecting the presence of fibers in talc in their ori- ginal petition Petitioners discuss this problem however in these Comments infra pp to It is tions therefore reasonable to require precau- 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 filtration 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 talc contained less than fibers or 100 chrysotile a milligram of such 1000 amphibole asbestos 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 procedure 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 / The Commissioner has proposed no regulations governing ~ the use of asbestos filters in food and beverage manu- facturing or in the manufacture of parenteral drugs -~ FDA would prohibit and substantially reduce their use only in the manufacture of parenteral drugs and parenteral drug ingredients but continue to permit their use in the filtration of all foods beverages and parenteral 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 proposed a tolerance in foods and drugs FDA in effect has for asbestos fibers 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 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 prohibi thte use of asbestos filters in the manufacture of foods beverages and parenteral drugs HE ane e i 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 FDA unless there is treating them differently a clear scientific basis for If the Commissioner has deemed parenteral drugs to be adulterated within the meaning of section 501 from asbestos filters of the Act 21 U.S.C. 10.1 and foods to be adulterated from asbestos in talc within the meaning of section 402 of the Act then what are his grounds for maintaining that foods that are equally contaminated when and parenteral drugs 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 from inhalation injection or concerning the possible hazard of asbestos fibers 38 Fed Reg at 27076-27079 ingestion that to fibers thus are ubiquitous in air Asbestos of the earth's water and a large percentage this material which crust The amount of is added the environment additionally the use of asbestos and to food and drugs by is not known Therefore it is filters of asbestos in these obvious that the presence products is only one small source of expos- ure Id at 27077 be the rationale for his decision This non sequitur seems to of asbestos filters in the manufactured not to prohibit the use foods beverages and parenteral drugs But this rationale is deficient for at least three reasons First he has show that the amounts contributed by not presented data to filters are in fact small Second the Commissioner lacks of asbestos are harmless data to show that even small amounts to health And third even assuming arguendo that as- small source of exposure bestos filters are only one not be harmful in itself and that such a small amount may that the responsibility of it does not follow logically is somehow lessened If the Food and Drug Administration anything asbestos the fact that there to which modern man are so many other sources of can be exposed argues strongly those few essential uses that can in favor of prohibiting with such as the use of asbestos filters easily be dispensed in food and drug manufacturing Other federal agencies are controlling many of required to do their part in of asbestos See Petition pp 12-13 If every the other federal uses agency shrugged attitude of the off its responsibility with FDA this ubiquitous hazard the nonchalant would never be controlled Petitioners recognize that the Commissioner lacks authority to control and water pollution many sources of asbestos such as which may accidentally contribute air asbestos fibers to food and drug products to have the Commissioner exercise Petitioners seek only that authority which he undeniably does have such as asbestos from i.e. to keep potentially hazardous agents being intentionally added to food and drugs by food in accordance and drug manufacturers with the Commissioner's This is strictly delegable dis- the adulteration of foods and cretionary duty to prohibit drugs moving in with the policy interstate commerce It is also that he himself announced in the in accord 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 Supra 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 Favors the Conclusion the Available Evidence 4. The Weight Increase in nse Fibers Leads to an that Ingestion of Asbestos Gastrointestinal Cancers the Commissioner to the CSPI petition In response of the scientific literature an extensive review prepared and ingesting concerning the hazards of inhaling injecting Reg at pp 27076-27081 From asbestos fibers 38 Fed concluded that the evidence this review the Commissioner from ingestion of asbestos concerning the possible hazard at 27077 and inconclusive Id is contradictory particles of the with this characterization Petitioners disagree Contrary to the Commissioner's conclusion available evidence establishes at least a strong the available evidence certainly carcinogenic when ingested For that asbestos is presumption workers studies of asbestos example long epidemiological increased incidence of gastro- have consistently shown an over that of the general population intestinal tract cancers and by Elms and Simp- the studies by Selikoff etal See e.g. 10. See also P. son cited in our June 27th petition p Mortality in Rela- P. DeCoufle and V. Henderson Enterline ingestion tion to Occupational of Occup Med Vol articles cited on p Exposure 14 Dec. in the Asbestos Industry J. 1972 pp 897-903 And see other 9 infra This evidence is sufficient of asbestos to conclude that for a regulatory agency to the incidence of fibers may contribute gastrointestinal tract cancers Dr. Selikoff has testified that this is his firm belief Director of the Division Most recently Dr. Joseph Wagoner of Field Studies and Clinical Investigation the National Institute 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 U.S. District Court District of Minnesota Fifth Division Vol six studies which he 31 pp 4371-4537 Dr. Wagoner 4 believes support his opinion cited These studies all indicate that the incidence of G.I. cancer asbestos workers is significantly higher than that for among the population as a whole 4 These studies include Elms and M.J.C. Simpson Insulation Workers in of Indust Med 1. P.C. Belfast III 1940-1966 Brit J. Vol 28 pp 226-236 1971 2 E.E. Keal Asbestosis and Abdominal Neoplasms Lancet Vol 2 1960 p 1210 Enterline and M.A. Kendrick Asbestos Exposures 3 P.E. Mortality Arch Envir Health at Various Levels and Vol 15 pp 181-186 1967 in the Asbestos 4 M.L. Newhouse Cancer Among Workers Textile Industry presented at the Lyons Conference Oct. 2-5 1972 Carcino- 5 I.J. Selikoff E.C. HAasmbmeosntdosandArJc.h CEhnuvrigr Health genicity of Amosite 183-186 and Vol 25 Sept. 1972 pp A Report of the U.S. Public Health Ser- Cancer Among 6 J. Wagoner vice on the Incidence of Site Specific Asbestos Textile Workers Based on Observations Over the Period from 1940 to 1967 ~10- of these references appeared It It is striking that none references references appeared listed listed the these among the references among in the Commissioner his view view of medical evidence published . referred to by Register were At At least two these papers Commissioner their their June Petition See Petition P- 10. should cite earlier that the It It indeed puzzling as well as several some these same authors reports reports some while animal feeding studies that were negative unpublished of cancer while recent published evidence disregarding the more The Commis humans exposed to asbestos the the tract among of the to have based his assessment therefore appears sioner, record of the medical and distorted evidence on an incomplete he consulted these other studies Perhaps had he evidence. concerning po- po- different conclusion have come to a tential We strongly urge ingestion of asbestos him harm from him to consider them now. I that excess excess G some researchers may speculate rather rather from is not from ingestion migration workers the where they of fibers inhaled into the lungs pass into G tract tract Selikoff Selikoff and into Wagoner and bloodstream Dr. maintain workers workers are are dust others, however, exposed exposed fibers also ingest fibers are removed from the atmosphere which clearance and the lungs mucociliary mucociliary swallowed swallowed The latter several several animal The latter position is supported swallowed. -11- studies cited by FDA See in particular References 42 and 44 38 Fed Reg studies cited by at pp 27078-27079 There are no comparable FDA which would support the contrary theory numbers of fibers or that workers do not ingest significant are caused by fibers which migrate that gastrointestinal cancers 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 at a recent conference on Biological even further support Effects of Ingested Asbestos sponsored by the National Institute for Environ- mental Health Sciences November 18-20 1973. Dr. Volkeimer and Dr. Zaidi pointed out at that conference that submicro- scopic particles are able to rapidly penetrate the lining of tract and are persorbed into the the gastrointestinal blood and lymph systems factors such as nicotine and facilitate persorbtion presumably by caffeine apparently attacking the mucous barrier These multiple conditions which more nearly reflect human experience were contrasted rat feeding experiments using asbeswith Swinburn's unpublished tos in butter cited by the FDA Ref 40 Butter it was coat the intestinal walls and believed helps to naturally hinder at the persorbtion of conference the particles Pontefract also reported preliminary results of his unpublished fed % asbestos in their diet in study in which rats were -12- Three me corn oil of the 9 rats developed tumors which is experimental the first evidence that ingested asbestos is harmful See J.E. Brody Conferees Study Asbestos Hazard 32 Attachment A New York Times Nov. 11 1973 p Therefore while the evidence now available may not be which is the valid ex- sufficient to establish unequivocally planation for the asbestos workers increase of gastrointestinal cancers the weight of the evidence certainly among favors the conclusion that this increase may well be due to ingestion At the very least there is enough evidence to establish a pre-pre- fibers represents a potensumption that ingestion of asbestos tially grave health hazard The Commissioner apparently conclusion or he would not have proposed agrees with this talc as a food restrictions on the use of contamined additive declared an FDA policy of And he would not have to asbestos to the minimum feasible level reducing exposure See page 3 supra plain his failure foods beverages therefore to ex- It is almost impossible to the filtration of to apply his conclusions through asbestos filters and parenteral drugs for Detecting Fibers in Talc is 5. The FDA's Proposed Test Illegal and Inaccurate a Illegality The FDA has recommended the use microscopy as the method for detecting of polarized the presence optical of asbestos -13- fibers in talc Under this test procedure only fibers chrysotile and less than 5 microns in than 5 microns in length greater A talc sample that contains not more width will be counted fibers and not more than 100 such than 1000 such amphibole the FDA's test and be fibers per milligram pass permitted this test for use in food and drugs According to the FDA of talc at least will assure a purity procedure of asbestos and at least free of amphibole types 99.9 percent chrysotile asbestos fibers 38 Fed 99.99 percent free of Reg at 27080 Not only will this test not assure the degree of purity claimed by the probably still bestos fibers FDA but even assuming permit the addition of less than 5 microns in that it did it would perhaps millions of aslength per milligram of / - the body through the diet or through drugs talc to enter is to set The net effect of this test procedure for asbestos fibers in food level or tolerance permissible and one for which there is is a carcinogen Asbestos however level still no known safe exposure The FDA's proposed and A.M. Langer As- See I.J. Selikoff W.J. Nicholson Health Vol 25 1972 / Air Pollution Arch Envir of chrysotile bestos rule of thumb that one nanogram ^ in dia- p 10 for a about 1,000,000 tiny fibrils 300-400 may contain meter and 2,000 ^ in length -14- tolerance therefore Section 4039 A U.S.C. 34 38 A would of the which not be legally permissible under and Cosmetic Act 21 Food Drug prohibits the promulgation of a establishing such a tolerance regulation c3 before - the if a fair evaluation -~ Secretary ~ of the data fails to establish that the proposed A additive under the condi- use of the food in the regu- tions of use to be specified be safe Provided That lation will shall be deemed to be safe if no additive to induce cancer when ingested it is found it is found after by man or animal or for the tests which are appropriate food additives evaulation of the safety of to induce cancer in man or animal submit that there has been no evidence Petitioners presented to or a fraction of a that establishes that even by the Commissioner milligram of asbestos can be safely ingested a fair evaluation of the data appears to To the contrary establish at least a strong presumption when ingested as they are carcinogenic that asbestos fibers are when inhaled until such time as tests which are appropriate Therefore for the evaluation of the safety of food additives are con- ducted and show that asbestos is not carcinogenic it seems that the law does not permit the Commissioner quite clear for asbestos fibers in grade to set the kind of tolerance 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 fibers present in talc The recommended number of procedure asbestos 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 400X This would be acceptable if one of two condi- tions prevailed either 1 the vast majority of fibers in 5 talc were greater than microns or 2 the fiber size with distribution were uniform enough to predict reasonable the total number of fibers given only the number accuracy greater than 5 microns in length Unfortunately neither condition prevails The likelihood is that the vast majority talc that is crushed prior to of fibers in talc particularly commercial sale are less than 5 microns go unnoticed under the FDA's recommended in length and will procedure There is also no way to predict the total number of fibers present with than size talc any degree of certainty if only the number greater 5 microns is known since both fiber content and fiber distribution are subject to substantial variations in given deposits These conclusions were confirmed at the recent -16- Effects of Ingested Asbestos conference on Biological Dr. Rohl of Mount Sinai School of Medicine in New York is incapable of quantifying the that optical microscopy stated amount the majority of fibers present of asbestos in talc because less than 5 microns in length are The optical microscope therefore should not be used as a tool for quantifying 6 asbestos in talc is not capable of Thus the FDA's test procedure achiev- ing the claimed required to meet the agency's pro- degree of accuracy -- 99.9 free of amphibole asbestos goals of talc purity fibers and 99.99 free of chrysotile asbestos fibers Just as there is no data tiate the safety of supplied by these goals the or Commissioner tolerances to substanthere is also substantiate the degree of accuracy no data presented to Thus the entire talc proclaimed for the test procedure seems to be standard including the monitoring requirements which runs counter to the based on no more than guesswork knowledge we now have about the effects rapidly accumulating health and the great difficulty of quantifying of asbestos on of fibers present in talc the number and size distribution to the FDA Publication in the / See Comments Pertaining 188 September 28 1973 section Federal Register Vol 33 EMventions office 121.2006 Paragraph C prepared by of the hearing clerk November 1973 i 125 From 13 Countrics Find That Lethal Mineral Is Present Everywhere 4 By JANE E. BRODY | DURHAM More than 125 scientists from 13 coun- tries gathered here in the midst of the tobacco country last week to grapple with an urgent pub lic healta question What risk does the general public face from the ingestion of asbestos a mineral of a thousand uses whose potentially lethal fets fets ment pervade the human environ- | In three days of intense discussion and debate no final conclusions were reached a few worrisome preliminary find- ngs were presented and hundreds of yet unanswered questions were raised Only two facts went un hal- lenged that abestos is everywhere the air in water- ways in drinking water in foods foods and beverages drugs and talcum powder and that when when inhaled in large quantities as- bestos is dangerous causing incapacitating lung disease and highly lethal cancers The conference called by the National Institute of Environmental Health Sciences was prompted largely by the discov- ery earlier this year that the cities drinking water of Duluth Minn and other on Lake Su- perior was heavily contaminated with asbestos the presumed re- sult of pollution by a mining company that has been dump- ing 67,000 tons of rocky waste into the lake each day for 17 years The Government is seeking to end the dumping of these asbestos containing wastes into Lake Superior in an action cur rently being heard in United States District Court in Minneapolis But what can and what should it do about the countless other sources of asbestos con- tamination Asbestos represents a elas- sic problem that our modern industrial society will face over and over agam temirled Dr. David R. director of the Na- tional Institute It's a vital substance so we can't ban it bat there's a growing concerni about its possible health ef f.cts And since the health effects of asbestos often do not show until 20 to 30 years after jup even if we initial exposure stop all asbestos exposure to- day we will continue to see evidence of disease well into the next century said Dr. Rob- crt Burrell a microbiologist at West Virginia University in- Virtually all the reliable formation about the har~-n as- bestos can wreak on the huderived from the man body is experience of asbestos workers who have inhaled large quan tities of the fibers In addition to succumbing to the chronic lung disease asbestosis these workers are far more likely than the general population to die from lung can cer and mesothelioma an incurable cancer that altects the asbestos lining of the chest or abdomen Recently Dr. Irving J. Seli- : koff who directs a Federally sponsored asbgestos research center at Mount Sinai Medical Center reported that workers also had an increased risk of developing cancer of the gastrointestinal tract An estimated 100,000 new cases of gastrointestinal cancer will be diagnosed in the United States next year and although it is the nation's most common type of internal cancer its cause remains unknown i A big question explored ati last week's mecting was how inhaled asbestos might damage the digestive tract Dr. Sidney Laskin of New York University University noted that 25 to 50 per cent of inhaled particles were likely be coughed and then swallowed Intensive studies of the ef- fects of asbestos consumption on a variety of experimental animals are just getting under way But presented cate that can pass the small preliminary findings to the meeting indi- the fibrous mineral through the wall of intestine get into the bloodstream and lymph system and become widely distributed throughout the body organs in- cluding the brain Dr. Selikotf said that an un- expectedly large number of as- bestos workers he has been studying had died of brain tumors although the significance of this observation was not yet clear A pilot study conducted in Canada resulted in kidney and chest will tumors in three of nine rats fed asbestos mixedi with corn oil although none of the animals given corn oil alone developed cancer - Dr. Gerhard Volkheimer or Berlin reported that pardeles similar to asbestos libers were pesobed between cterla'cstotmuch the gastrointestinal more rapidly after the constump- tion of caffeine or nicotine H said that persorbed puticies could be found in breast milk and could cross the placenta to soUECTS the fetus - Dr. John Goldsmith of the Na- tional Cancer Institute urged that all unnecessary soUECTS of asbestos be empat.d empat.d To- ward this end the Center for Public Interest Science in the and the Environment d Detense Fund have requested a ban on asbestos filters used to pROCESS pROCESS many beverages and drugs and elimination of asbestos fr tale used in foods as sollas in cosmetic powder i N.V. Times Nov. 25 1973